Implementation research toolkit

Implementation Research Toolkit An aid to help you address critical health system barriers

What is implementation research and why is it valuable? Implementation research (IR) has been used to increase the use of bednets in Africa to reduce malaria, address the rise in multi-drug resistant tuberculosis in eastern Europe, prevent mother-to-child transmission of HIV in South Africa, and ensure that ivermectin is distributed to 60 million Africans to control onchocerciasis, otherwise called river blindness. It is a very powerful type of research that can identify implementation barriers and improve health care delivery. The need to address implementation barriers and improve delivery of health services is often greatest in settings where health systems are the weakest or non-existent. Implementation research addresses these bottlenecks by identifying optimal approaches for a particular setting. Unfortunately, the essential skills to conduct this type of research are limited in these settings and academic public health curricula rarely provide courses on this topic. This is a type of research that requires partnership and multidisciplinary teams. It goes beyond scientists to include policy-makers, the media and community members. So this toolkit was developed to help countries struggling with critical health systems issues to learn new approaches that can rapidly address specific challenges.

Who can use this toolkit? • • • • • • Health care service providers Programme staff Researchers Decision-makers Finance and administration officers Media

What does the toolkit provide? Participant manual, workshop session slides, and links to relevant further reading and references. The IR Toolkit workshop modules consist of an introduction and six core elements. Introduction and basic orientation Contextualizing implementation research issues Developing an implementation research proposal Planning to conduct implementation research Data analysis and presentation Communicating research findings and feeding them back into the health system Monitoring and evaluating the project

Learn how to: • Identify barriers to implementation and formulate the research question • Make your case for funding • Set up a study design and appropriate methodologies • Plan the project (budget, personnel, timelines, monitoring and evaluation) • Collect, analyze and present research information • Develop a dissemination plan • Monitor and evaluate your research project

What participants say about the toolkit I learned there are 3 questions I need to ask each time each time I start implementation research: what is happening, was it expected and why is it happening? This is crucial. I see implementation research as a people science, a science of people, it tries to define the dynamics of the behaviors of people and social forces that actually influence the outcome of an intervention. Aftab A. Ali Mukhi The Aga Khan University, Pakistan In order to get the policy changed, you have to produce all this evidence in one whole picture, not compartmentalized. When you want to get something done, you have to pull everyone together. Dr Nurhuda Binti Ismail Universiti Technologi MARA Selayang Capmus, Malaysia We’ve learned so many things about the ethical issues, this is a new, different and solid approach to ethical issues. Hammed Oladeji Mogaji Federal University of Agriculture, Abeokuta, Nigeria We have very successful concepts that have been proven, but when you take them out in the field, they are not as successful as they were in very carefully controlled conditions. So implementers are beginning to ask, why aren’t they so successful? That’s where implementation research comes in. Dr Isaac K. Nyamongo University of Nairobi, Kenya

Who developed this? The toolkit was developed by TDR, the Special Programme for Research and Training in Tropical Diseases. Over 200 researchers, academics, disease control programme managers, policy-makers, health administrators, communication scientists and journalists contributed to test and evaluate the toolkit. Major funding was provided by USAID, with additional support from the Implementation Research Platform at the World Health Organization.

Where can I get the toolkit? All materials are free and available online at: www.who.int/tdr/publications/topics/ir-toolkit

Need additional information? Contact us: TDR, the Special Programme for Research and Training in Tropical Diseases Research Capacity Strengthening Unit 20, avenue Appia 1211 Geneva 27, Switzerland World Health Organization www.who.int/tdr tdrnews@who.int

Comments and suggestions about the toolkit should be addressed to: Dr Olumide Ogundahunsi Ogundahunsio@who.int

Editing and Design by Inís Communication – www.iniscommunication.com

TDR/RCS/14/1

The Special Programme for Research and Training in Tropical Diseases (TDR) is a global programme of scientific collaboration established in 1975. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases. TDR is sponsored by the following organizations:

World Bank

TDR/World Health Organization 20, Avenue Appia 1211 Geneva 27 Switzerland Fax: (+41) 22 791-4854 tdr@who.int www.who.int/tdr



Implementation Research Toolkit Facilitators’ guide

Implementation Research Toolkit Facilitators’ guide WHO Library Cataloguing-in-Publication Data: Implementation research toolkit. Contents: Facilitator guide, Workbook, Brochure and Slides. 1.Research. 2.Delivery of Health Care – methods. 3.Program Development – methods. 4.Translational Medical Research 5.Teaching Materials I.World Health Organization. II.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. ISBN 978 92 4 150696 0 (NLM classification: W 20.5) Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2014 All rights reserved. The use of content from this health information product for all non-commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases. This information product is not for sale. The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-generating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner whatsoever. The designations employed and the presentation of material in this health information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and borders. Mention or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO, including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or depicted. The views expressed in this health information product are those of the authors and do not necessarily reflect those of WHO, including TDR. WHO, including TDR, and the authors of this health information product make no warranties or representations regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information product. Editing and design by Inís Communication – www.iniscommunication.com Acknowledgements This Toolkit was developed by the Special Programme for Research and Training in Tropical Diseases (TDR) to strengthen implementation research (IR) capacities of individuals and institutions in low-and middle-income countries where the greatest need exists. It is supported by core contributions to TDR from the following: Belgium, Brazil, China, Cuba, Germany, Ghana, India, the Islamic Republic of Iran, Japan, Luxembourg, Malaysia, Mexico, Netherlands, Nigeria, Norway, Panama, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom of Great Britain and Northern Ireland, the World Bank and Zambia. Specific support was also provided by USAID, and by the Implementation Research Platform, which is based at the World Health Organization and brings together the Alliance for Health Policy and Systems Research; the Special Programme of Research, Development and Research Training in Human Reproduction; the World Health Organization’s Department of Maternal, Newborn, Child and Adolescent Health; and the Partnership for Maternal, Newborn and Child Health and TDR. The toolkit was initiated by Jane Kengeya-Kayondo and Soumya Swaminathan. Henry Lucas, Sandy Campbell, Dirce Guilhem, Boatin Boakye, Yodi Mahendradhata, Colla Jean MacDonald and James Foreit prepared the initial materials for the modules in the toolkit. Guidance and advice on the development process was provided by a steering committee which included the following Miguel Angel Gonzalez Block, Kathleen Handley, Kazi Mizanur Rahman, Wynne E. Norton, Jason B. Smith, Uche V. Amazigo, Linda Kupfer, Shenglan Tang, Isaac K. Nyamongo, Nhan Tran. The Toolkit has benefited from the contributions and advice of many individuals and we wish to thank the following individuals for the input from the compilation and restructuring of the modules through the pilot workshops and final editing: Review and feedback on content: Taghreed Adam, Sam Adjei, Irene Agyepong, Bill Brieger, Effie Espino, Timothy France, Prea Gulati, Jamie Guth, John Gyapong, Adnan Hyder, Regina Kamoga, Barrot Lambdin, Jeff Lazarus, Temina Mandon, Yolanda Ogbolu, Joe Okeibunor, Dimeji Oladepo, Obinna Onwujekwe, Johannes Sommerfeld, Thomas Sukwa, Fabio Zicker. Facilitation of pilot workshops: Ayat Abu Agla, Riris Andono Ahmad, Oladele Akogun, Khaleda Islam, Andres Z. Jaramillo, Baralee Meesukh, Isaac K. Nyamongo, Tuoyo Okorosobo, Martin Ota, Ayo Palmer, Shagufta Perveen, Mike Sanchez, Honam Irene Tsey. Over 200 researchers, academics, disease control programme managers, policy-makers, health administrators, communication scientists and journalists contributed to test and evaluate the toolkit. The following implementers and researchers contributed to the pilots and provided feedback/ comments: Wondwossen Belehu, Paul Bukuluki, Meg C. Doherty, Mary Ellsberg, Katherine Fritz, Meseret Gossa, Nancy Glass, Paul C. Hewett, Elijah Oyaro June, Kuyosh Kadirov, Etienne Karita, Joseph Kariuki Muriithi, Kathleen Kostelny, Jeremias L. Messias, Aragaw Biru Muhammed, Abraham Mukolo, Ester M. Mungure, Tina C. Musuya, Ramadhani S. Mwiru, Edith Nakku-Joloba, Kenneth K. Ngure, Walter O. Obiero, Spallanzani Oduor Ohaga, Eunice A. Omanga, Patrick O. Owiti, Deidra Demeatra Parrish, Nancy A. Perrin, Paul Bitwahiki Ramazani, David Sando, Helen Semu, Anuraj Shankar, Nicholas Shiliya, Helen N. Siril, Amanda C. Tichacek, Rogers Twesigye, Michael Wessells, Olufemi A. Adegoke, Naeemah Abrahams, Nurelign Mohammed Ahmed, Laurence Natacha Ahoua- Leray, Meghan Bishop, Emily Bobrow, Kerry Bruce, Jeanine Condo, Koen Frederix, Khanyisa Gala, Piotr Andrzej Hippner, Andrea Howard, Locunda Erin Higgins Hummert, Mubiana Inambao, John Barton Jemmott, Deyessa Kabeta, Jolly Kamwanga, Amira Karam, Matthew Raymond Lamb, Lebohang Mary Ledikwe, Virginia Letsela, Tonderai Mabuto, Mokgadi Rebecca Malahlela, Abdelhamid Mjidila Charmaine Mlambo, Yael Moverman, Martha Mukaminega, Fhumulani Mavis Mulaudzi, Iris Bongiwe Ndondo, Mathew Ngunga, Bonisile Nhlabatsi, Thobo Matuhogonolo Phologolo, Asta Helen Rau, Letitia Lynn Reason, Mary Pat Selvaggio, Vandana Sharma, Anne Teitelman, Mark Tomlinson, Renay Weiner, Robert Carl Yohnka, Vincent Kudakwashie Zishiri, Abdul Aziz Abdulai, Ismail Adem Abdilahi, Ayat Abu-Agla, Elsheikh Elsiddig Ahmed, Alaaedieen Mokhtar Ali, Wagdy Abdel Moniem Amin, Frank Biney, Peter Chibatamoto, Amel Abdu Gesmalla, Musse Mohamed Hasan, Mirriam Kangwende, Freddy Eric Kitutu, Rugare Abigail Kwakye, Kedibonye Dundu Macha, Talent Maphosa, Matshelo Tina Matlhaga, Chawangwa Modongo, Mohamed Farah Mohamoud, Fadzai N.N. Mutseyekwa, Kwame Shanaube Mwange, Magdy Fawzy Nasrallah, Matsiri Tiroyaone Ogoposte, Sandra Simbeza Sinzala, Henry Wamani, Anisuddin Ahmed, Dhana Raj Aryal, K.C Ashish, Lu Gao, Shaikh A. Shahed Hossian, Khaleda Islam, Nurhuda Binti Ismail, Gamini Jayakody, G.A.J.S.K Jayasooriya, Frederick Dony Jiloris, Pahalagedera Kusumawathie, Huq, Trisasi Lestari, Li Lin, Nafisa Lira, Hammed Oladeji Mogaji, Aftab Ali Akbar Mukhi, Abdul Razak Abdul Muttalif, Shagufta Perveen, Likke Prawidya Putri, Khalid Hussain Shaikh, Raihan Sharif, Ravi Vitrakoti, Nandyan N. Wilastonegoro, Wenti Xu, Quudus Adegboyega Yusuff, Hakeem Abiola Yusuff, Martha Ali Abdullai, Sheila Addei, Enoch Oti Agyekum, Gifty Ofori Ansah, Rahma Eltigani Mohammed Ahmed, Naa Korkor Allotey, Efua Asante, Frank Baiden, Azza Tag Eldin Bashir Babiker, Boniface Denakpo, Eva Engman, Ferrer Blanca Escribano, Lawrence Gyabaa Febir, Boniphace Salustian Jullu, Esther Kyungu, Towela Maureen Maleta, Humphreys Kampila Nsona, Mariam Oke, Mona Babiker Omer, Senga Kali Pemba, Themba B. Phiri, Tatcheme Filemon Tokponnon, Finally, we would like to acknowledge the South African Medical Research Council Durban, College of Health Sciences University of Botswana Gaborone, the International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b) and the TRAction project in Dhaka and the Dodowa Health Research Center of the Ghana Health Services as well as Ayishatu Gibrin and Najoua Kachouri for their contributions in organising the pilot workshops. Responsibility for the views expressed and for any errors of fact or judgment rests with Margaret Gyapong, Edward Kamau, Robinah Najjemba, and Olumide Ogundahunsi, authors of this toolkit. AbbreviAtions ACT artemisinin-combination therapies ANC antenatal care ART antiretroviral therapy BCC behavior change communication BMI body mass index CAS complex adaptive system CHW community health worker CMS Cooperative Medical Scheme COS Community of Science DOT directly-observed therapy ERC ethics review committee FGD focus group discussion HDI Human Development Index HIV human immunodeficiency virus HRP Special Programme of Research, Development and Research Training in Human Reproduction IC informed consent ICF intensified case finding IDRC International Development Research Centre IEC information, education and communication iKT integrated knowledge translation IR implementation research IRB institutional review board IRP Implementation Research Platform KT knowledge translation KZN KwaZulu-Natal LLIN long-lasting insecticide-treated net LOI letter of intent LSHTM London School of Hygiene and Tropical Medicine LTFU loss to follow-up M&E monitoring and evaluation MDR-TB multidrug-resistant tuberculosis NGO nongovernmental organization NSF National Science Foundation NTBCP national TB control programme OER Office of Extramural Research PI principal investigator PLHIV person/people living with the human immunodeficiency virus PMTCT prevention of mother-to-child transmission QDA qualitative data analysis RFP request for proposals SAGE Strategic Advisory Group of Experts SARS severe acute respiratory syndrome SMART specific, measurable, achievable, realistic and timebound SOP standard operating procedure SWOT strengths, weaknesses, opportunities and threats TB tuberculosis TDR Special Programme for Research and Training in Tropical Diseases UNDP United Nations Development Programme UNICEF United Nations Children’s Fund USAID United States Agency for International Development WHO World Health Organization Contents bACkground And introduCtion to the implementAtion reseArCh toolkit 1 Part I. PlannIng and organIzIng the workshoP 4 Part II. detaIled InformatIon and materIals for conductIng IndIvIdual modules 8 FACilitAting the introduCtion And bAsiC orientAtion 12 FACilitAting module 1 ConteXtuAliZing implementAtion reseArCh issues 18 FACilitAting module 2 developing An implementAtion reseArCh proposAl 30 Contents FACilitAting module 3 plAnning And ConduCting An implementAtion reseArCh proJeCt 64 FACilitAting module 4 dAtA, AnAlYsis And presentAtion 74 module 4a: QuantItatIve data management analysIs and PresentatIon 76 module 4b: QualItatIve data collectIon, analysIs and PresentatIon 84 FACilitAting module 5 disseminAting the reseArCh Findings 90 FACilitAting module 6 monitoring And evAluAting An implementAtion reseArCh proJeCt 100 background and introduction to the implementation research toolkit Overall aim and rationale Effective implementation research “requires a broad, systemic (and therefore multidisciplinary) approach, it cuts across public and private sectors, and it needs researchers from biomedical, pharmaceutical, the social sciences, public health and health economics sectors to work together. These researchers must take into account the local context of the health system, advocate for political commitment and most importantly must be driven by the needs of health care providers, control programme implementers and policy-makers. It is critical to identify these contextual conditions and build them into the research process. In addition, implementation research (IR) has to address ever more complex innovation processes at national, regional and global levels” (WHO 2011). This toolkit is designed to strengthen IR capacities of individuals and institutions in low- and middle-income countries where the greatest need exists. It is focused on demand-driven research questions based on needs identified with relevant stakeholders/implementers in the health system. It covers the processes involved in implementation research highlighting the central paradigm of stakeholders engagement in identifying issues, formulating appropriate research questions, team work in project design, data collection and analysis, monitoring and evaluation of the project as well as feedback and uptake of the findings in the system. Intended participants and beneficiaries Implementation research is teamwork and requires people with different skills, experiences and backgrounds to come together in order to address an implementation problem and answer questions posed by health care providers, programme managers, implementers or other service providers in the execution of their duties. An IR project team can therefore include researchers and as well as, health care providers, programme managers, policy-makers, students, civil society organizations and NGOs depending on the context and the nature of the project. This toolkit can be used as a training tool for IR research teams. It can also be adapted as instructional material on implementation research in schools of public health. Planning and organizing the workshop Ideally the workshop is delivered in seven modules through the whole research project from defining and contextualizing implementation research issues, to developing the research proposal, planning to conduct the research, collecting and analysing the data, communicating and feeding back findings into the health system and finally monitoring and evaluating the project. Workshops should be organized as close to the relevant research activity as possible. For example, the project planning module should be delivered after funding for the project is secured and before 1 undertaking any field work, the data collection and analysis module should be delivered before initiating data collection etc. Workshop participants should be given access to the references, case studies and materials for the reflection exercises at least two weeks before the applicable workshop. The suggested duriation for each module is provided later in this guide (page 13). Expected outcomes The need to address implementation bottlenecks is often greatest in settings where health systems are weak or non-existent. Unfortunately, it is in such settings that knowledge of IR and the necessary skills to frame appropriate research questions, conduct, manage, interpret and utilize research results for programme planning and policy implementation are limited. In general the curricula of public health academic programmes do not focus on research in real life context central to IR. Such training invariably does not adequately prepare researchers, practitioners, providers and decision-makers in the health system for partnerships (team approach) and interdisciplinary approaches to addressing barriers to implementation. It is expected that utilization of the toolkit will promote the understanding of IR as teamwork involving a systematic approach to understanding and addressing barriers to effective and quality implementation of health interventions, strategies and policies. IR teams and health systems will be able to conduct and use the outcomes of research to improve/optimize health care and systems in the areas of greatest need. Toolkit materials The toolkit was developed and designed to be implemented mainly in a workshop setting. It is intended to be a dynamic and interactive programme in which facilitators actively engage the participant teams in the learning process. A range of materials and learning methods have been carefully developed to enable this to happen in an effective and engaging way. Participant workbooks A participant workbook has been developed for each of the seven modules. These are intended to provide all of the information participants need during the workshop, including all the information contained in each module’s slide set. It is worth highlighting to the participants at the outset of the workshop that they do not need to reproduce or note down the content of slides. These are referred to in the respective sections of the participant workbook. Each workbook also provides a reference list and links to suggested reading materials, as well as other resources that address specific topics in greater detail. Slide decks For each module a set of slides has been developed. The content of the slides has been kept intentionally brief to encourage discussion and critical thinking during the workshop sessions (and to avoid facilitators and participants ‘reading from slides’ rather than thinking). The slides can be adapted for a specific workshop setting or set of participants. Before each workshop, facilitators should review the relevant slides so any final modifications or customizations can be made. 2 Facilitators’ guide This guide provides essential information to the organizers and facilitators to plan and implement such a workshop. It includes: • information on planning and preparing for the workshop; • an overview of the teaching and learning methods used; • detailed instructions for delivering individual modules. Note: To avoid any possible confusion, all references to figures/tables and boxes in this guide have matching numbers to those used in the Participant workbooks. This does mean that in some places the order of references may seem incorrect in this guide. The guide comprises two parts, as follows: Part I. Planning and organizing the workshop a. Designing the structure, timeline and content of the workshop: Contains suggestions for establishing the structure and content of an IR training workshop. b. Inviting participants and other contributors: Provides suggestions on inviting the participants and other contributors to the workshop, with specific suggestions on: • Drawing on the expertise of specialists. • Planning a formal opening and closing ceremony. • Involving team members from different sectors in individual countries. c. Key teaching/learning methods: Discusses the facilitation of the workshop, and the teaching/ learning methods used. • Criteria for selecting facilitators. • Role of the facilitators. • Ground rules for participatory training. • Planning and running the modules. d. Planning for the IR workshop: Contains a checklist for workshop planning and preparations (e.g. facilities and equipment). e. Evaluation methods: Provides an overview of workshop evaluation methods: • Measuring the participants’ views and reactions. • Assessing changes in the participants’ knowledge. • Feedback on the workshop itself/facilitation. • Follow-up questionnaire to promote understanding of changes in participants’ practices. Part II. Detailed information and materials for conducting individual modules This part includes the workshop schedule and the ‘step-by-step’ instructions to conduct each sessions. It also presents all the support materials needed to run the module, such as slides with accompanying talking points, flipcharts and their contents, and case study materials with notes on issues that may arise. Finally, it includes tips to help you respond to questions that may be raised by participants, identifies matters that may be sensitive and about how to deal with them. 3 part i. planning and organizing the workshop a. Designing the workshop structure, timeline and content The IR workshop modules consist of seven core elements. The developmental stage of participants’ research projects and experience of the team determines the workshop sstructure and emphasis. Workshop participants should be selected/invited as a homogeneous group in relation to their IR concepts/problems. Mixed groups with proposals in different stages of development cannot be planned or facilitated effectively. b. Selecting/inviting participants and other contributors Participants at the workshop should be selected as research teams with a minimum of 3 and maximum of five persons in each team. The disciplines represented in the team will depend on the nature of the research problem to be addressed but in all cases each team must include at least one implementer. The team leader should list the members and their roles in the project to ensure they will be available for the whole duration of the workshop. The selection criteria should be clearly spelled out. As much as possible, select facilitators familiar with the general local, national or regional context of the participants. The facilitators should be experienced in the subject matter to be covered and preferably active implementers/researchers. This increases the likelihood of using illustrations the participants can relate with and enhance assimilation of the concepts. Facilitators should spend time prior to the actual workshop reviewing the material and compiling appropriate illustrations. c. Planning for the workshops Budget: the costs for accommodation, feeding, materials, travel and any other related allowances are important considerations for a cost-effective workshop. Full funding must be available before inviting participants to the workshop. It is essential to establish good communication with participants prior to the commencement of the workshop. The following are examples of issues participants need to be aware of ahead of time; workshop objectives, dates and venue for the workshop, the responsibilities of the participants including their availability during the workshop, completing the pre-workshop assignments. Travel arrangements should allow participants to arrive a day before the workshop. It is best for participants to all stay in the same location for the duration of the workshop. This will facilitate group learning and completion of assignments at the end of the day. Each workshop module should be delivered prior to the corresponding research activity (for example the project planning module should be delivered before inception of the project). Use the following checklist for the first workshop session: 1. Participants and facilitators introduce themselves individually. 2. All agree to general code of conduct (ground rules e.g. respect, politeness, mode of address, speaking clearly, taking turns to speak etc.) at the beginning of the workshop. 4 3. Assign one participant to act as time keeper for the workshop sessions. 4. Assign teams/participants to review and present the sessions (daily – preferably first thing the following morning). Reviews should focus on what was learnt, what went well and what could be improved. The facilitators should hold daily reviews of the progress of workshop activities and adjust accordingly. d. Key teaching/learning considerations You should read this section before you start conducting sessions. Preparing your sessions • It is important that you are thoroughly familiar with the toolkit material, and with the order of ideas in the modules. This is necessary even if you are an experienced facilitator and/or knowledgeable about IR. • Read through all the modules rather than just focusing on those you will present. Having an idea of how the different sessions fit together will help you focus on the information for each session without duplicating material that will be presented in later sessions. It also makes it easier to draw linkages with information from previous sessions or to defer a question if the topic will be covered later on in the workshop. • Read the session objectives from this guide to remind yourself of what the session aims to achieve. • In coordination with other facilitators, consider splitting some sessions between two or more facilitators, particularly long sessions that involve different activities. • Keep this guide with you at all times and refer to it throughout the course preparation, delivery and follow-up as needed. Key concepts The toolkit uses key concepts to emphasize specific areas of focus and principles of action. The key concepts covered in each module are clearly outlined (across all materials) and will be reinforced throughout the course (i.e. by facilitators and participants), by repeatedly writing and referring to them, using them to structure sessions and presentations, and reiterating them verbally. Key concepts from preceding days should be reviewed and reinforced at the start of each subsequent day. Facilitating sessions • Talk in a natural and lively way. It is preferable to present the information in a conversational manner instead of reading out the presentation notes exactly as they are written. Avoid reading from the screen if you can. • Speak clearly and slowly, projecting your voice so that all participants can hear and understand what you are saying. • Face the audience and maintain eye contact with participants when speaking. Move around the room to keep participants engaged. • Explain to participants exactly what each overhead or flipchart shows, and highlight clearly the main points from which they should learn. • Remember, slides and flipcharts are only visual aids to help your facilitation; do not expect participants to learn from them without your help. 5 Involving the participants • Constantly read the mood and atmosphere of the group. Is everyone participating? Do people look interested or not? • Use ice-breakers and warm-ups if the energy level seems low. Consider having a short break if participants appear tired or overwhelmed by the amount of information being presented. • Involve all participants. Read and use both verbal and non-verbal cues to encourage participation. Ask questions directly to quiet individuals, without embarrassing them. • Ensure that participants get a chance to speak one at a time; assign them an order in which to speak if necessary. People are less likely to interrupt others if they know that they will have a turn to talk. • Encourage respectful discussion and sharing of ideas and experience. Learning is more effective and faster when it builds on what learners already know or have experienced. • Encourage team work and a sense of belonging through active participation. • Ensure that the discussion is not dominated by one or two persons and that all participants have a chance to pose and answer questions. • Acknowledge all participants’ responses in order to encourage continued engagement. • Encourage succinct answers by commenting positively on the interventions of participants who give responses that are short and to the point. • Ask participants to keep their workbooks closed while answering discussion questions so that they think about possible answers rather than read the information from their manuals. • Re-cap and reflect on the points raised regularly throughout the sessions. • Identify issues/observations that require follow up. Basic requirements of facilitators and adult learning principles In line with the key principles of adult learning, facilitators should aim to: • Have a warm and welcoming attitude and an ability to show approval and acceptance of participants. • Be able to develop a good rapport with the group. • Be enthusiastic about the subject. • Be able to create an interactive environment, i.e. by asking questions, moving around the room, always addressing the whole group, and avoiding focusing on a small group or individuals. • Ensure to have a non-judgemental approach to participants (even if you do not share their views). • Be able to lead without stifling participation. • Be flexible when circumstances demand. You also need to: • Ensure that the appropriate visual materials, such as flipcharts or slides/projectors are available and ready. • Keep visual aids simple and legible. • Regularly check that participants understand the information being presented. • Use interactive techniques (e.g. such as asking open-ended questions that require participants to explain and give detailed answers that demonstrate their comprehension). • Give participants a genuine chance to arrive at the answers to the questions included in each session themselves. Questions are asked in such a way that participants should be able to find 6 the appropriate answer by looking at the relevant figures displayed or by drawing from their own experience, or from material that has been covered previously in the workshop. • Sometimes, participants may need additional help in finding the answer; in such cases, you may opt to give them a hint. In other instances, you may find that asking the question again in a different way can help. Quick checklist of facilitation skills Movements Take centre stage; avoid standing in a corner or behind a desk. Face the audience; do not face the board or screen when speaking. Avoid blocking the audience’s view. Make eye-contact with people in all sections of the audience. Use natural gestures and facial expressions, while remaining culturally sensitive. Move around the room; approach people to get their attention and encourage their participation. Speech Speak clearly, slowly and loudly enough for everyone to hear; be natural and lively; vary the tone of your voice as appropriate. Write difficult new words on the flipchart; pronounce and explain them. Be mindful that some members of your audience may not be familiar with expressions and illustration from a different cultural context Interaction Interact with and engage all participants; address them by name as appropriate. Ask the questions suggested in the text; ask different participants; encourage quiet participants to speak. Allow time for participants to answer; do not give the answers too quickly; drop hints if needed. Respond encouragingly and positively to all answers; correct errors with tact and sensitivity. Avoid discussions which are off the point or distracting; postpone them if necessary. Give satisfactory answers to questions from participants, or promise to address them later. Visual aids Have the required aids and equipment ready; check and arrange them before the session. Make sure that everyone can see clearly; arrange the room so they can have a good view of the presenter and the screen. Point to what you are talking about on the projector or on the screen as appropriate. If using a flipchart or a board, write in large, clear letters. Cover, turn off, or remove visual aids that are not in use any more. Use of materials Follow the session plan accurately and completely; use your guide. Prepare thoroughly; read and obtain any materials that you need beforehand. Prepare your helpers (e.g., for role-plays) before the session; practise if possible. Do not learn the session by heart; follow the guide but talk in your own way. 7 Time management Emphasize important points; try to avoid repetition unless really useful. Do give a few local examples; avoid introducing too much extra material. If it is necessary to read from the guide, look at the audience regularly. Keep to time: pace yourself; gauge the group regularly to ensure that you are not moving too fast or too slow; do not take too long with the early parts of the session. Be familiar with the content, the slides transition and the duration of the presentation. e. Evaluation methods Use anonymous self-administered questionnaires for the evaluation. The initial assessment should be conducted at the beginning of the workshop. The aim of this assessment is to establish baseline information about the participants’ knowledge, skills and competences in relation to the seven modules of the tool kit. The information obtained from this assessment will guide the facilitators on areas for greater emphasis during the sessions. An identical questionnaire is administered at the end of the training workshop to assess the changes in participants’ knowledge. To assess the participants’ views and reactions about the module (content, and delivery) and facilitation, a self-administered questionnaire is administered at the end of each module. The feedback can be used to improve the course and also to better plan for future courses. part ii. detailed information and materials for conducting individual modules Toolkit modules: Quick reference The IR Toolkit workshop modules consist of an introduction and six core elements: Module Title Suggested duration Notes Introduction and basic orientation 0.5 day Typically combined with introductions, an opening ceremony and module 1 1 Contextualizing IR issues 1.0 day 2 Developing an implementation research proposal 5.0 days Stand alone 3 Planning and conducting an IR project 0.5 day Can be combined with module 4 4 Data analysis and presentation 1.5 days Can be combined with module 3 5 Disseminating the findings 1.0 day Can be combined with module 6 6 Monitoring and evaluating an IR project 1.0 day Can be combined with module 5 8 Summary description of workshop modules The IR Toolkit workshop modules consist of and introductory module and six core elements. Introduction and basic orientation The introductory module serves as a baseline introduction and quick reference for participants (and is also useful as an introduction for new facilitators). It provides a summary of the 6 core modules, their rationale, basic terms and principles, as well describes the following: • What is IR? • Key characteristics of IR and the IR cycle. • IR-focused self-assessment for participants. The module is typically combined with an introduction/formal opening ceremony) and comprises a half-day workshop with a tutorial, presentation slides and materials for further reading. Module 1: Contextualizing implementation research issues Module 1 has been designed to help researchers, implementers and decision-makers appreciate the value of IR, and improve their understanding of the environmental and contextual issues around IR and interventions in general. In addition, the module serves as an introduction to ethical considerations related to IR projects. The module covers the following key concepts and their application with examples: • Understanding the environment and context. • Understanding the intervention. • Ethics and ethical issues in IR. Module 2: Developing an implementation research proposal This module builds on the premise of an understanding of the contextual nature of IR, engaging the right stakeholders, articulating the problem/barrier to be addressed and assembling an appropriate and multi-disciplinary team (i.e. covered in Module 1). It takes participants through a process of formulating appropriate research question(s), choosing the appropriate study design to answer the question(s) and preparing an outline of the project activity plan. It covers the following key concepts with examples. • Identifying barriers to implementation and formulating the research question. • Making your case for funding (introduction, rationale and objectives). • Study design and appropriate methodologies. • Planning the project (budget, personnel, timelines, monitoring and evaluation). The module helps participants think and work through all the essential steps to develop a research proposal. 9 Module 3: Planning to conduct the research Module 3 addresses the steps that take place once resources to support an IR proposal have been secured. It provides information needed to plan for the research project, including preparation of the study protocol for an ethical review process. Module 3 covers the following key concepts with examples. • Preparing for ethical review. • Project implementation process. • Good practices in IR. Module 4: Data analysis and presentation This module has been designed to help the research team, implementers and researchers understand appropriate data analysis procedures for qualitative and quantitative data; understand the appropriate use of statistics in quantitative research; and describe and document the data analysis processes in a qualitative study. It employs examples to illustrate the applications of the underlying concepts. Module 5: Dissemination of research findings This module has been designed to assist the research team to: • Appreciate the concept of knowledge transfer in the uptake and use of research findings. • Describe the barriers and facilitators of knowledge transfer in relation to a research project. • Understand the value of disseminating information throughout the project cycle. • Appreciate the value of developing a comprehensive dissemination strategy in a research project; • Appreciate the importance of tailored dissemination tools for the different target audiences. It illustrates the key concepts of knowledge translation with examples and provides structured guidance on preparation of research reports, peer reviewed papers, press releases, conference presentations and policy briefs. Module 6: Monitoring and evaluation The final module has been designed to help the research team track progress against set plans, check compliance to established standards, identify trends and patterns, adapt strategies and inform decisions for project management. It also helps builds skills to determine the relevance and fulfilment of objectives, developmental efficiency, effectiveness, impact and sustainability. On completion of this module, the research team will be able to appreciate the process involved in the development of a monitoring and evaluation plan and describe implementation process of an IR project. 10

FACILITATING THE INTRODUCTION AND BASIC ORIENTATION Implementation Research Toolkit FACILITATING THE INTRODUCTION AND BASIC ORIENTATION Learning objectives and expected outcomes [slides 3–4] This introductory module serves as a baseline introduction and quick reference guide. It provides an introduction to basic terms and principles, along with an orientation to subsequent toolkit modules and their rationale. By the end of the introduction, participants should gain a good overall understanding of the following key concepts and their application: 1. What is implementation research? 2. Key characteristics of IR and the IR cycle. The module is typically combined with an introduction/formal opening ceremony and comprises a half-day workshop/tutorial, slides and materials for further reading. It also includes a self-assessment opportunity regarding the participants’ current IR-related knowledge and understanding. What is implementation research? [slides 5–7] In this initial session, the primary facilitation goal is to ensure that all participants understand the fundamental distinction between IR and other forms of investigative research in the health and life sciences field. The importance of research to identify solutions and options for overcoming implementation obstacles in health systems, disease control programmes and health care delivery is widely recognized. IR addresses such implementation bottlenecks, identifies optimal approaches for a particular setting, and promotes the uptake of research findings: ultimately, it leads to improved health care and its delivery. The need to address implementation bottlenecks is often greatest in settings where health systems are the weakest or non-existent, including in low- and middle-income countries. Unfortunately, local institutions often have limited knowledge of IR and lack essential capacities to frame relevant research questions, and conduct, manage and interpret research results for programme planning and policy implementation. Academic public health curricula tend not to focus on such research. As 13 Facilitating Introduction and Basic Orientation a result, most training do not adequately prepare researchers, practitioners, providers or decision- makers to use essential partnership and interdisciplinary approaches. The current IR toolkit was developed to help fill that gap. IR has been defined in various ways by different institutions.1 Common interpretations focus on the systematic approach to understanding and addressing barriers to effective and quality implementation of health interventions, strategies and policies. IR is demand-driven and the research questions are framed based on needs identified with relevant stakeholder/implementers in the health system. Use these two slides to discuss and illustrate how IR is different from biomedical or other research. Allow sufficient time to explain clearly what IR is and for participants to fully consider these differences. Probe with questions/examples regarding how interventions are implemented at the community level and accessed by local populations. Depending on your assessment of understanding and grasp of these key issues, you may spend additional time highlighting specific characteristics of IR as summarized in Table 1 (below and in participant workbook for this module). All facilitators should review this table carefully before this introduction session. Invite/encourage participants to share their experiences with IR, and share/discuss points of views. Table 1: Key characteristics of implementation research Characteristic Summary/description Systematic The systematic study of how evidence-based public health interventions are integrated and provided in specific settings, and how resulting health outcomes vary across communities. Balances relevance with rigor, strictly adhering to norms of scientific inquiry. Multidisciplinary Analysis of biological, social, economic, political, system and environmental factors that impact implementation of specific health interventions. Interdisciplinary collaborations between behavioural and social scientists, clinicians, epidemiologists, statisticians, engineers, business analysts, policy makers, and key stakeholders. Contextual Demand driven. Framing of research questions is based on needs identified by implementers in the health system. Research is relevant to local specifics and needs, and aims to improve health care delivery of the health system in a given context. Generates generalizable knowledge and insights that can be applied across settings. Mindful of cultural and community-based influences. Complex Dynamic and adaptive. Multi-scale: occurs at multiple levels of health systems and communities. Analyses multi-component programmes and policies. Non-linear, iterative, evolving process. 1 IR is sometimes referred to as “operational research”, or “implementation science” 14 Interacting IR domains [slide 8] As part of the overall toolkit introduction, it is also instructive for participants to think in terms of five main interacting ‘domains’ that IR encompasses (Figure 2 in workbook). The six steps of the implementation research cycle [slides 9–10] Once participants have a solid grasp of what IR is, the next critical inflection point is that they understand that each part of the IR cycle requires a specific set of skills and knowledge. When you describe the six steps of the IR cycle you are implicitly outlining the skills/knowledge sets required to implement IR (and those imparted through the current toolkit). Use the IR cycle diagram without main labels/text (slide 4) to explore with participants what each of the six steps represent and include. Then switch to the IR cycle diagram with labels/text (slide 5) to explain each step in more details, and highlight how the individual steps link to one another. Where possible, use examples/case studies when explaining each step. Throughout the explanation of IR cycle steps, continuously refer to and highlight: • each of the elements in the inner circle; • how key stakeholders are involved in each step, including key informants. Once the six steps of the IR cycle have been presented and discussed thoroughly, remind participants that the skills/capabilities the IR toolkit aims to develop match the six steps of the cycle [slide 6]. Self-assessment framework [slides 11–12] The teams that come together to tackle a specific IR challenge should be multidisciplinary: with varied roles, working in diverse sectors, and largely with very different backgrounds. An IR-focused self-assessment usefully reveals some of these differences within each team. It also allows teams to identify their relative strengths and weaknesses (including relative to other teams taking part in the workshop) and setting of team’s broad learning targets. Ask each team to use the matrix shown in slide 8/Figure 3 to identify their current level of: • awareness; • understanding; • knowledge; • skills; • competence. in each of the steps in the IR cycle. You can also refer participants to the more detailed matrix provided in Appendix 1 of the workbook if there are individual steps they are not clear about. Once completed, ask teams to reveal any obvious strengths or weaknesses they identified during the exercise. Listen for, and point out, any clear differences you observe between the relative strengths of the teams, and encourage some teams to identify themselves as a resource for others in relation to a particular step. Implementation Research Toolkit 15 Show this slide and explain each of the five domains using your own words to convey following descriptions: The intervention. The characteristics of the intervention determine whether it will be adopted or ‘fit’ in the local health system. Here the term ‘intervention’ includes the core components and those elements that may be adapted to suit local needs and/or conditions. The characteristics of core components, such as complexity, cost and evidence strength, play a crucial role. Outer setting. This includes the economic, political and social contexts in which an intervention is carried out and that are external to the implementing organization/institution. It is influenced by external policies and incentives – such as bilateral or global funding streams – as well by interactions and peer pressure between organizations. Inner setting. This refers to the context within the implementing organization/institution. It includes the structure of the organization and its culture and networks, as well as internal climate and readiness for change. Individuals involved. These are people who have a direct role in the implementation process. They include health care providers, managers in various parts of the organization/institution, policy- makers and many other stakeholders and beneficiaries. In addition to the traditional concerns regarding capacity to implement, their perceptions and attitudes towards the intervention have an important influence on their commitment to its success and impact. Process for implementation. This incorporates all of the methods and approaches used in to facilitate adoption of the intervention at all levels of the organization, including the planning of strategies and activities. Processes include both those explicitly planned as well as unforeseen developments that emerge during implementation. The audience [slides 13–14] IR involves people with different and complementary skills, experiences and backgrounds addressing an implementation problem and answering questions posed by health care providers, programme managers, implementers and/or other service providers in the execution of their duties. An IR project may therefore include researchers and other stakeholders such as health care providers, programme managers, policy-makers, students, civil society organizations, nongovernmental organizations and any other groups or individuals interested in the IR process and results. The tool kit includes elements relevant to health care providers, researchers, policy-makers/ managers, administrators, the media and members of ethics committees. Ask participants to consider the various audiences and stakeholders listed in slide 10 and suggest which steps of the IR cycle are particularly critical for their respective engagement. You should inform participants that engagement may vary, depending on the context and the nature of the project, and so there is no wrong answer. Once the discussion has taken place, use slide 11 to reveal a typical engagement scenario. This may prompt further discussion, particularly if the participants have significantly different views about engagement. Facilitating Introduction and Basic Orientation 16

FACILITATING MODULE1 CONTEXTUALIZING IMPLEMENTATION RESEARCH ISSUES Implementation Research Toolkit FACILITATING MODULE 1 Learning objectives and expected outcomes This module is designed to emphasize the importance of contextual and environmental factors have IR projects. The module increases understanding of the relationships between the research environment, specific intervention strategies and related ethical considerations. At the end of this module, participant teams will be able to: 1. Analyse the environment in which their IR projects are conducted. 2. Understand and appreciate the context relevant to their proposed/planned intervention. 3. Describe the ethical principles related to have IR project. Key concepts for this module 1. Understanding the IR context The physical, socioeconomic and cultural environments, health systems, stakeholder and institutional culture are key aspects of the research context. Together they contribute to and affect the planning, implementation, monitoring and outcomes of any intervention. During the pre- implementation phase of an IR project, these factors should be analysed. It should be noted that these factors vary considerably from one setting to another, and from one project to the next. 2. Understanding the intervention Interventions such as policy changes, projects, programmes attempt to transfer health innovations that have demonstrated efficacy in the laboratory, clinical trials or small-scale pilot studies to benefit larger populations. The paradox facing IR is that the more rigidly the implementation is controlled to ensure fidelity of a proven intervention, the more likely it is that local contextual factors will reduce its effectiveness. A monitoring system to track changes in the implementation process and check for deviations from the original plan is essential to supporting a ‘logical model’ for the intervention. 3. Ethical considerations in IR From a public health perspective, research ethics should be guided by giving due consideration to the relative risks and benefits to society in addition to the individual research participants. Situations of poverty and limited health care – conditions in which research is frequently conducted in many low- and middle-income countries – often present certain conflicts. 19 Facilitating Module 1 Before you begin… A useful re-cap opportunity of Module 0 (previous day) is provided by asking participants to explain what happens in step 1 of the IR cycle. This serves as a general reminder for participants of the six main stages of an IR project. [Slide 2: IR cycle (without labels)] This should also be followed by reiteration of the four main interacting domains in IR. You can ask participants to explain what is depicted in this slide. [Slide 4: Interacting domains in implementation research] Outline of the presentations [slide 5] Make a general introduction of the module to participants: e.g. Designed to emphasize the importance of contextual and environmental factors surrounding specific IR projects and introduce ethical considerations. (Learning objectives and expected outcomes will be outlined in the next few slides). Emphasize the module’s three key concepts. You can mention that understanding the intervention is important because aligning critical contextual factors and the project is essential for an intervention to have the intended impact. Learning objectives [slide 6] Note that the three parts of the learning objective reflect the key concepts presented in this module. Expected outcomes [slide 7] Serves to translate subject this module is about into new understanding that participants will take away. Therefore, it may be a good to check with participants that they are following the main module ideas at this stage. Key concept 1: Understanding the context [slide 8] Why do we need to understand the context? Probe the participants on this question. Try to get a sense of their appreciation of how an intervention can be affected (positively or negatively) in different contexts. You can also use a simple case study to dig deeper into participants’ views: You are a researcher from the South and have been posted to implement an intervention in the North: Why do you need to understand the context? The physical, socioeconomic and cultural environments, health systems, stakeholder and institutional culture are key aspects of the research context. Together they contribute to and affect the planning, implementation, monitoring and outcomes of any intervention. 20 Proven interventions lose impact in health systems [slide 9] We recognize that interventions that are effective in one setting can have a diluted impact or be ineffective in other contexts. Ask participants why. How can this be possible? Impact/effectiveness is reduced because of the influence of various context- specific factors. (Reveal slide, which has Figure 4 from Workbook) Explain the figure. One of the main purposes of analysing the context (e.g. health system) is to predict how specific considerations might potentially affect the viability and effectiveness of a given intervention. Mention that one important example of such a factor is the health (in)equity in a given setting and the influence of relevant social determinants of health. Analysing the four dimensions of context [slide 10] Emphasize the importance of analysing each of the four key dimensions mentioned. Elaborate on how environment, population, socioeconomic status, culture and politics (i.e. dimension 1) can impact on an intervention (or health system). Illustrative example: In Somali communities, the use of medical face masks presents a challenge for both patients and doctors. The doctor wearing a mask during consultation with a patient creates the perception that the patient has a highly contagious disease, such as TB. With the increased stigma associated with TB, the patient feels humiliated, disrespected and perceives the doctor as arrogant. This often affects the doctor-patient relationship and trust, and impacts the willingness of the patient to return for follow-up consultations or visits. This also presents a safety dilemma for the health worker/doctor. Contextual factors for implementation research [slide 11] This diagram (Figure 1 in workbook) illustrates the complexity and number of factors that can influence IR and the impact of interventions. During the pre-implementation phase of an IR project, the factors presented should be considered and analysed as required. It should be noted that these factors vary considerably from one setting to another, and from one project to the next. Implementation Research Toolkit 21 Facilitating Module 1 At this stage it is helpful to ask a few participants to volunteer how the environment, population, health system, socioeconomic status, culture and/or politics may impact their own project. Illustrative example: Political party affiliations in adjacent communities can impact on the perception/trust of the communities of an intervention. Introducing a new intervention in an election year can make or break the success of the programme (biometric ID cards for example could be associated with plans to rig elections or increase taxation). Analysis of the environment [slide 12] Various aspects of the physical, socioeconomic and cultural context may be relevant depending on the specific intervention. Careful planning must be conducted in order to effectively focus resources on the factors that are most likely to be critical. Health systems [slide 13] When it comes to health-focused interventions, one of the most critical dimensions of context is the health system, typically made up of multiple sub-systems with the primary focus being the promotion, restoration or maintenance of health. Provide a clear explanation of health system and linkage with other sectors. WHO has identified six key ‘building blocks’ that make up health systems: leadership/governance; health care financing; health workforce; medical products, and technologies, information and research, and services delivery (Figure 2). Figure 2: Building blocks of a health system Other factors, such as self and community care, also contribute to health systems. For each component relevant to an IR project, it is helpful to undertake a systematic descriptive analysis to help identify the relevant decision-making agents and the (formal and informal) institutions that govern its operation. System building blocks Leadership / governance Improved health (level and equity) Responsiveness Financial risk protection Access Coverage Quality Safety Health workforce Medical products, technologies Information and research Service delivery Goals/outcomes 22 Stakeholder analysis [slide 14] You should emphasize the importance of involving multiple stakeholders (and their institutions) at the beginning of any IR project (i.e. identifying the problem, defining the research question(s) etc.) and subsequently throughout the entire IR project. Probe participants for their responses to the four questions highlighted: • Who are the most important stakeholders for your project? • Why do you need them? • How can you identify and engage them? • What role should they play in your research project? Stakeholder analysis aims at identifying all relevant stakeholders, assessing how they are likely to be affected by or influence the research, and how they might respond to the research outcome. Draw the attention of participants to the fact that full involvement of the different stakeholders will not happen overnight but will involve painstaking, face-to-face consultation. Stakeholder analysis is one of the most important activities undertaken by researchers in terms of understanding the context of the intervention, and should be done in a systematic and comprehensive way. (Examples of stakeholder analysis are presented in the relevant section of the workbook). Institutional analysis [slide 15] Institutional/organizational analysis (a systematic study of the behaviour of organizations) is another important dimension to consider when planning for IR. This can be achieved through an analysis of strengths, weaknesses, opportunities and threats (‘SWOT’) to establish the factors potentially affecting the success or failure of an intervention. Reflection activity [slide 16] Invite participants to reflect on their own IR projects and identify the environmental factors they should take into account before and during implementation. Encourage them to consider the cultural beliefs and practices, the political structure, the way the health system is organized and the wide range of stakeholders in the environment. Organize a short breakout session (~15 minutes) to allow the teams to individually brainstorm and write down responses to these six questions. Return to plenary to review each question (depending on time available, ask two teams to provide responses to the questions). Give each team 5–10 minutes to present, during which try to encourage participant discussion. Implementation Research Toolkit 23 Facilitating Module 1 Key concept 2: Understanding the intervention [slide 17] Interventions such as policy changes, projects and programmes attempt to transfer health innovations that have demonstrated efficacy in the laboratory, clinical trials or small-scale pilot studies to benefit larger populations. The paradox facing IR is that the more rigidly the implementation is controlled to ensure fidelity of a proven intervention, the more likely it is that local contextual factors will reduce its effectiveness. The more that interventions are adapted to local conditions, the more difficult it will be to argue that findings can be generalized to other localities or populations because outcomes may depend on detailed processes and pathways that may not be well understood. Conduct of meaningful IR requires an in-depth understanding of: (i) the intended intervention; and, (ii) the planned implementation process (with particular attention to modifications driven by a perceived need for adaption to a specific local context). A monitoring system to track changes in the implementation process and check for deviations from the original plan is essential. Such a system can support a ‘logical model’ for the intervention. Such models are commonly required by international donors as a simplified explanation of how a specific intervention is intended to work. Phases in the implementation research process [slide 18] The logical model for an intervention is based on the relationship between sequential phases: • Pre-intervention (i.e. setting research questions and objectives, planning etc. • Implementation • Post-implementation (i.e. evaluation, what happened?) Explain the diagram phase-by-phase. The logic model [slides 19–20] Logic models are also known as ‘logical frameworks’, ‘causal pathways’, ‘theory of change’, or ‘programme matrices’. They are depictions of the logical relationships between the inputs, activities, outputs, outcomes and goal(s)of an intervention. While there are many ways in which logic models can be presented, the underlying purpose of their construction is to assess the ‘if-then’ (causal) relationships between the various intervention elements. Logic model examples • If activities are undertaken then outputs should be produced. • If outputs are produced then outcomes that serve the purpose should result. • If outcomes result then they should contribute towards achieving the goal(s). 24 Those managing an intervention are considered responsible for producing a defined and quantified set of outputs. The output  outcomes step is frequently founded on assumptions about existing evidence and on a thorough contextual understanding. For each step in the logic model to function effectively, relevant assumptions relating to the intervention and the external context must be accurate. More certainty regarding the resilience of individual steps generates more likelihood that overall implementation of the intervention will be successful. Emphasize the fact that there are internal and external factors outside the control of the management, which can impact on the intervention at different levels (activities, outputs, outcomes and goal). Compiling the logic model as a matrix [slide 21] Set aside ~15 minutes to allow each team to complete the matrix according to their own project. Note: You should emphasize that each project’s matrix will be unique to that given project, and should adjust the number of activities, outputs, outcomes and goal(s) accordingly. Mention that assumptions can relate to positive and/or negative factors. An example of a completed matrix is provided in the Participants’ workbook (for guidance only). In plenary, ask one team to talk respectively about their activities, outputs, outcomes and goals. Encourage feedback/comments as appropriate. Complex adaptive systems [slide 22] It has been suggested that many health initiatives give rise to what can be described as ‘complex adaptive systems’ (CAS), in which myriad systems interact with and consequently adapt to the immediate environment. The idea proposes that systems adapt in response to a changing environment – in the current example, particularly in response to changes induced by a given intervention. One common adaptation, for example, might be the formation of new organizational alliances. This partly explains why interventions can succeed in one context and are less effective in another. It also highlights that implementation may not proceed as planned because of changed behaviours etc. The ultimate implications of the CAS notion is that there is no easy way to ‘control’ agent behaviour. CAS are typically and intrinsically unpredictable and unintended responses to interventions are common. Implementation Research Toolkit 25 Facilitating Module 1 Feedback loops in the demand for immunization [slide 23] There are different complex adaptive system behaviours that are relevant to health interventions (path dependency, emergent behaviour and feedback loops). The example shown is on feedback loops in an immunization programme, which can have either positive or negative effects. Let one or more participants volunteer to explain the diagram. Reflection activity [slide 24] This assignment should be given to the participants prior to attending the current module. Ask 2–3 teams to volunteer to present their reflection. Key Concept 3: Ethical considerations in IR [slide 25] Research involving human subjects should be bound by the basic ethical principles to safeguard individuals, communities and society at large against unnecessary risks. In practice, the principles may assume different weights according to the context, but there is universal consensus as far as their validity and the need for use in guiding proposals for research projects. This section outlines the main ethical dilemmas and considers their relevance to IR. Ethical issues and principles in IR [slide 26–27] After introducing this slide and the three principles on ethical issues involving human subjects, discuss with participants some of the ethical dilemmas in IR. For example: language barriers, poverty, low access to health services, conflict of interest etc. Then move on to the following three slides that give details of ethical dilemmas and the principles that were flawed. Case study [slide 28] Present the case study and invite participants to share their opinions and perspectives in relation to ethical dilemmas raised by the case study. Allow 15 minutes for the group work and 5 minutes for presentation. Characteristics of the participants/setting that may undermine ethical principles [slide 29–33] Work through each of these slides with the participants, asking them to suggest the consequences and ethical principles that may be undermined by the participant/setting characteristics that are described. Reflection activity [slide 34] Ask participants to complete this activity using the information presented in slides 26–30 (also reproduced in the participant workbook). Ask for one volunteer to present their conclusions. 26 Application of key concepts [slides 35–36] Shuffle the participants/teams into groups of five. Ask groups to read the case study in the workbook and discuss the three concepts which have been described in Module 1. Each concept should be analysed by one group. Allocate 15 minutes for the group work and 5 minutes for presentation of each concept.. End of Module 1 [slide 37] The following morning before the next session, request two teams to present a summary of: • One thing they learnt. • One thing that was done well. • One thing that could be improved about this module. Implementation Research Toolkit 27 Facilitating Module 1 28

FACILITATING MODULE2 DEVELOPING AN IMPLEMENTATION RESEARCH PROPOSAL Implementation Research Toolkit FACILITATING MODULE 2 Introduction The purpose of this module is to support research teams to develop a high quality implementation research (IR) proposals so they can be competitive in securing research funding. It is longer than other modules in the toolkit, and is intended to support a five-day workshop process, which may be organized as a separate event to the overall IR workshop schedule. Before you begin… A useful re-cap opportunity is provided by asking participants to explain what happens in step 2 of the IR cycle. This serves as a general reminder for participants of the six main stages of an IR project. Explain each step and how they link to one another, including the elements in the inner circle. Remind participants of the varied stakeholders involved in the IR process, including key informants. [Slide 2: IR cycle] At this stage it is useful to point out to participants that although proposal development is a discreet step in the IR cycle, the proposal they are about to develop covers all parts of the cycle and presents their entire IR project. This can also be followed by reiteration of the four main interacting domains in IR. You can ask participants to remind one another what is depicted in this slide. [Slide 3: Interacting domains in implementation research] As a result of the broad coverage of this module, the content and activities provided are organized differently to other modules in the toolkit: as six distinct sessions, with each one addressing specific aspects of proposal development, in a stepwise process. Each session consists of the following elements [slide 4]: • Learning objectives: identifying what teams will accomplish by the end of each session. • Content presentation: providing the information/examples necessary to understand the specific aspects of proposal writing. • Activities: exercises facilitating the understanding of the content and putting theory into practice. • Group work: discussions providing participants with an opportunity to ask questions, and consider specific issues in relation to their individual projects. • Write-shops: provides an opportunity for teams to work together each evening in drafting elements of their proposal, as covered each day. 31 Facilitating Module 2 Pre-module preparation This module is also organized into three separate phases: before, during and after the workshop (Figure 1 and Slide 5). Figure 1. Three stages of the current module Before the workshop, participants/teams should have completed an online component that introduces key IR terminology, IR core concepts, research frameworks, programme components and appropriate IR questions. The online course takes approximately three hours to complete and its specific objectives are: • Identifying characteristics of IR. • Describing implementation/scale up and relating IR to these processes. • Classifying research questions and associated research that falls under the umbrella of IR. • Summarizing framework characteristics and identifying strategies for applying them to IR. • Recognizing how IR is applied to different implementation problems. • Classifying IR priorities for grant applications. • Reviewing the roles of various IR stakeholders and identifying appropriate means for integrating stakeholders in IR planning and in communicating and disseminating results. Teams should have also completed an initial literature review, to enable them to frame their IR problem and goals in a broader context. A pre-module assessment questionnaire should also have been completed by participants. This will be shared with you/other facilitators so that you can assess the level of knowledge of participants prior to starting Module 2. Depending on what you discover from the participant responses, you may decide to adapt the module content to take advantage of the experience of the group and to best meet their needs. This must be decided jointly, and on a case-by-case basis, by the facilitation team. Impact Supplements Introduction Research design Project plan During Workshop What is IR? Who should be on the team? What is our project? Before Workshop After Workshop Literature review Support letters Ethics approval Complete proposal 32 Implementation Research Toolkit Teams will also have specific steps to complete after the workshop, such as additional literature review, finalizing incomplete sections of their proposals, obtaining supporting letters/statements, as well as obtaining ethical approval and other essential clearances for their research. Pre-Work- shop Assessment Questionnaire (Appendix 1). Initial group refresher activity [slide 6] Organize participants into smaller groups, members of each team separated into different groups. Assign each group one of the seven topics (see slide) and ask individual groups to prepare a two- minute presentation summarizing their assigned topic, drawing on content from the pre-workshop online module/previous modules. Each group should choose a spokesperson to present their key points in plenary (in two minutes). Funding an IR proposal [slides 7–9] One of the most fundamental reasons for preparing a high quality proposal is that it allows teams to identify and secure sufficient funding/resources to conduct their research. Explain to participants that while there may be several categories of funders/donors (i.e. multilateral organizations, bilateral government donors, private foundations and trusts [slide 7], the most important dimension of funding/resource mobilization is finding the right ‘fit’ between the proposed research and a donor interested in/willing to find research in a given area [slide 8]. A good fit or compatibility extends beyond the area of interest or traditional support for a given donor, and also includes matching the characteristics of potential donors with the proposed research in several other ways: • Level of team experience: Donors frequently have a preference for very established or up-and- coming research institutions/individuals. • Resources/funds needed: Funders tend to stick to certain ranges of funding requests, to suit their scale of investment and the requirements for administrative engagement by a donor. This is not generally about requests being ‘small enough’ and within the capacity of the funder, as many organizations have minimum limits for applications that they are willing to consider, and that make their administrative investment worthwhile. • Timing and deadlines: Donors often have specific timeframes that apply to specific pools of resources. Projects may need to find funders with a funding cycle that either matches their own research timeline, or that offers a degree of flexibility. For example, completion schedules. • Research location: Most funding mechanisms have some form of geographic criteria. For smaller donors this might be a regional or national support preferences, and for larger ones this might include a specific list of priority countries that are eligible for support. The more preparation/searching that research teams do in order to identify compatible donors/resources, the more likely it is that their research will be funded [slide 9]. Mobilizing the resources needed to conduct a research project is first about how well researchers know their potential donors, and only later dependent on what donors know about them. 33 Facilitating Module 2 What are donors/funders looking for? [slides 10–12] There is one certain way to ensure that research proposals provide what funders require: listen to them and do what they say! Once potential funders have been identified, preparing a proposal should always begin by reading their proposal submission instructions carefully [slide 10]. Work through the list of broad recommendations to participants in slide 10. Remind them that these are more like ‘good professional habits’ for researchers than ‘winning formulas’ that apply only to proposal writing. On a general level, good research proposals look a lot like good research: Rational. Clear. Detailed. Innovative. Coherent. Assuming donor compatibility is good, reviewers are more likely to be receptive to proposals that demonstrate a potential significance and depth of impact. Explain to participants [using slide 11] that these can be communicated through proposals that: • present exciting innovative/ideas; • avoid assuming too much knowledge or familiarity with a subject; • outline realistic aims and timelines – and are not overly ambitious; • limit widely known information; • note the limitations of the study in an honest way; • provide clean, well-written applications with well justified budgets. IR proposals are typically rated on the basis of scientific merit and policy relevance using a specific scale. Just as importantly, you should also review slide 12 with the group in order to highlight some of the pitfalls that a surprising proportion of proposals suffer from. Point out that proposal reviewers are often experienced researchers themselves, and can easily spot such weaknesses. Session 1: Writing the Introduction section This session provides participants with an initial orientation to IR proposals as a whole, before considering the content of the Introduction section in greater detail. Learning objectives and expected outcomes [slide 2] After completing this session, participants will be able to: • Describe the overall components and organization of a typical IR proposal. • Write an introduction to their respective proposals. • Write the research question(s) for their proposals What makes an IR proposal unique? [slides 3 and 4] Slides 3 and 4 are intended to highlight the main differences between a ‘conventional’ research proposal and an IR proposal. First walk through the contents of slide 3, without making this comparison the obvious goal. Highlight the main characteristics of a research proposal. When 34 Implementation Research Toolkit you transition to slide 4, it will make highlighting the unique features of an IR proposal more memorable for participants. Emphasize that the distinctive characteristics of an IR proposal directly reflect the specific features of the IR process, in particular the origin and prioritization of the research problem, and engagement of key stakeholders in the research process. Characteristics of an IR proposal [slides 5–12] The components of an IR proposal vary slightly depending on the preferences outlined by the funding agency to which it is being submitted. Note: As each funding agency has its own format and requirements, some of the elements covered in this session may not be required in every IR proposal and are provided here as a generic guide. The Participant workbook contains a list of the components for an IR proposal with detailed explanations of what each component entails. The overall components of an IR proposal are summarized in Figure 2. This diagram is included in the participants’ workbook, and is presented in slides 7–12 of this session. As you show this sub-set of slides, which outlines the components of an IR proposal, be BRIEF. Each section will be covered in detail within the module – this is just a quick overview of the entire structure to give participants the ‘big picture’. If questions are too detailed, you can place in them in the parking lot for discussion when you get to the session that deals with the specific section in-depth. Present these slides in sequential order, prompting participants to comment and ask questions for clarification in relation to individual proposal elements. Remind participants that more detailed descriptions are provided for each element in their workbooks. If anything is unclear to participants during this general description, they should ask for clarifications from you/other facilitators. A sound understanding of the general structure and purpose of individual proposal elements is essential to the remainder of module 2. Introduction [slides 13–33] In this session, participants take the first steps in writing their proposal by drafting the introduction section. This includes writing two of the most important parts of an IR proposal: an overview of the research problem and corresponding research question(s). The introduction of an IR proposal provides a clear, succinct description of what the research is and a rationale for why the project should be funded. It builds an argument for conducting the study, as based on a need identified by the community, health care providers, programme managers or policy-makers. 35 Facilitating Module 2 The Introduction comprises the following sub-sections: • Title page • Rationale • Statement of the problem • Objectives and research question(s) • Literature review The session aims to provide a combination of definitions and basic descriptions of each element, outlines the purpose and reasoning for each, and provides examples from real-life IR proposals as practical guidance. You should bear in mind that the focus and scope of this session will partly set the tone/mood for the remainder of the module. Before you (and other colleagues) facilitate the session, you should be very familiar with the material presented in slides 13–33, as well as the detailed information and additional resources included in the corresponding section of the participants’ workbook. This includes examples of real proposal texts, which you should select/use to illustrate specific points in the presentation. If helpful, you can also pause the discussion/presentation at a given point, and ask participants to read/consider one or more of these examples in the workbook to reinforce a specific point. This session covers a relatively lengthy series of topics and issues for participants to absorb, and although they will relate them to their own projects to some extent, the group overall will pass through them largely in the abstract. For this reason, as you guide the group through each theme, you should try to refer to some of the examples used in the participants’ workbook to illustrate specific areas. You can also ask the participants to relate each topic/theme to their own projects and/or previous experience, raising real-life experiences as they/you progress. This will help to promote a more varied rhythm to the session. Towards the conclusion of the session, teams will be asked to focus more directly on their own specific projects and proposals, and in particular on the title, the statement of the problem (∼1/2 page), the research questions and the specific objectives. Group activity [slide 34] To bring this session to a close, ask each team to draft their unique statement of the problem their research project sets out to address. This is intended to ensure that respective teams are focused back on their own projects, and that they have fully understood the day’s discussions of the Introduction as a whole. Ask each team to briefly read their statement of the problem and encourage open discussion and clarification. Evening Write-shop briefing [slide 35] After a fairly long session/day, each team will be asked to work into the evening on developing some further short parts of their introduction. You should bear this in mind as you track time progress throughout the day, and ensure that the day concludes so teams have adequate time for a short break before they continue working on these important elements. 36 Implementation Research Toolkit Request the members of each team to work together on the following parts of their Introduction, and be ready to present them briefly at the start of the following day’s meeting: • Working title. • (Complete the draft) Statement of the problem for the proposal (1/2 page). • Research question(s). • Specific project objectives (4 to 6 objectives). Session 2: Research design This session aims to build research team capacities to allow them to determine the specific research design that will be most effective in meeting their research objectives and corresponding research question(s), and build these elements into their proposals. Note: This session is also relatively long and will likely span most of two days. There is only one write-shop, which should be divided into two parts depending upon where you break at the end of the section day – participants should complete as much of the research design section of their proposal as they can on the evening of Day 2. Learning objectives and expected outcomes [slide 2] After completing this session, participants will be able to: • Develop and write up a research design outlining the procedures that will be used to collect and analyse the data in a research project. • Identify and describe the research method (qualitative, quantitative or mixed methods) that will be most effective in attaining the research objectives and answering the corresponding research question(s). • Describe the quality management plan that their team will put in place to ensure quality. • Describe the participants in the research project. Explain the steps they will take to ensure all ethical issues and procedures will be addressed. Research design The Research design section the proposal draws on elements from several stages of the IR process, including: identification of study participants; choosing the most appropriate research methods; as well as data collection and data analysis [slide 3]. The four broad research design options can be defined in relation to the general knowledge gap/ need they each address in the selected community, and the characteristics of the corresponding research approaches. Using slide 4 to guide the discussion, summarize the four types of research design (i.e. before-after series, cross-sectional studies, cluster-randomized controlled trial and direct measurement/observation). Ask participants how they understand the relationship between the needs and design options, and whether they are clear about the best way to make these decisions before they can determine/describing their selected research design. Explain that it is only once the most appropriate research design has been determined, that the methods to be used are apparent and can also then be outlined [slide 5]. 37 Facilitating Module 2 Study participants Because the range of participants is one of the most important distinguishing features of IR projects, it is important that proposals include a full description of the subjects/participants, how they will be selected and criteria that will be used [slide 6]. Group activity [slide 7] Ask the research teams to sit together and briefly share/discuss their selected research designs and outline their range of participants. Encourage groups to share doubts and for all participants to comment/offer helpful critique on design of other projects as they are described. Research methods It is important that the proposal makes a sound and convincing case in relation to the research methods and approaches that will be used as part of the research design. Slide 8 provides useful summary and reminder of the main differences between qualitative and quantitative approaches. Use this slide to discuss each criteria and how they differ between the two methods. To do this, you can ask specific teams to explain what they understand by a given criterion, and how that differs between qualitative and quantitative methods. This gives the individual teams an opportunity to begin discussing and working together with these important concepts. Slides 9–15 and 16–21 then provide the platform to consider qualitative and quantitative research approaches respectively, and in greater detail, before mixed methods are described [slides 22–27]. As you progress through these sub-sets of slides/themes with the group, remind them of the wealth of information that can be obtained using the different data collection strategies and analysis plans, as well as real-life examples that are provided in the participants’ workbook, and that these are related in some detail to the pros and cons of the various research methods. Before facilitating this session, you should make a point to review that section of the workbook yourself, so that you are familiar with the content and the examples that can be referred to in group discussions. Guide research teams to discuss which research design will work best for their IR project. This is similar to the group activity earlier in the same session but now, having reviewed the different research designs and approaches in more detail, a more in-depth and definitive discussion should be possible within individual teams. Some teams may have come to the session with pre-existing ideas about which methods they would use to collect data. Now they may be re-examining those choices and the possibility of adjusting their thinking once more. Teams can use the examples presented in the workbook to help them create a table containing their research objective(s) and research question(s) and identify which data source(s) will be used to collect the data to meet the objectives of the research and answer the research questions determined earlier. Evening Write-shop briefing [slide 29] During the evening, participants should continue to work in their teams to develop the following elements of their team’s project proposal: • Research design. • Research methods including: 38 Implementation Research Toolkit – step-by-step procedures for your data collection; – data analysis; – trustworthiness, validity, reliability; – participants. Teams should be prepared to present their drafts of these proposal sections at the start of the following day. Note: Depending on the time available and your sense of team progress with their own proposal development, you might adjourn the session for the day now or progress to the brief remaining session on quality management. Quality management [slides 30–32] and research ethics Quality management is often an elusive idea to new researchers, and so it is worth stressing that the performance of IR proposals may be significantly affected by not clearly describing how quality management will be achieved in IR projects. Quality management is essential to ensuring that research meets or exceeds scientific, ethical and regulatory standards. In their proposals, participants should outline exactly how they will show that the research team will take consistent, ongoing measures to monitor and evaluate quality and rigour of the research. They should indicate how they will evaluate quality at various stages. Slide 31 provides a useful model/diagram for highlighting where and how quality management is an essential part of the IR process. You can ask different teams to highlight what the quality issues and challenges might be at different stages of the process, what potential solutions might be, and how they would serve to monitor/improve quality. Impress on the teams that attention to quality management expresses a consistent concern for research participants. How their privacy will be protected, for example. What measures will be taken to protect them from harm (e.g. train staff, adhere to ethical standards in the research ethics application etc.)? These are all important influences on proposal review by prospective donors. In closing, use slide 33 to remind participants that similar to quality management, IR proposals should convey a demonstrated commitment to research ethics. Teams should be able to briefly suggest some ways in which the three elements outlined in this slide can be achieved. Evening Write-shop briefing [slide 34] Depending on your decision above re. when to conclude the current session (see note above), you will need to remove either slide 29 or 34 accordingly. 39 Facilitating Module 2 Session 3: Project planning This session participants will work on developing the overall plan for their research projects and incorporating those plans into their proposals. A clear project plan not only conveys the details of the research to potential funders and supporters, it also sends the message that the project has been well thought out from an implementation and activity/resource management perspective. If done well, it can also help demonstrate the feasibility of the project in a very visible way. Learning objectives and expected outcomes [slide 2] After completing this session, teams will be able to: • Develop a project plan (work plan/timeline) to guide the implementation and monitoring of their project. • Develop a work schedule (i.e. GANTT chart) to effectively implement and monitor the project including the tasks and activities to be performed, roles and responsibilities of team members and milestones and deadlines to be met. • Describe the research team (including the knowledge and skills that each team member possesses and how they will contribute to the success of the project). • Develop a realistic, itemized budget linked to the project specific objectives and the project activities. • Provide information required for the justification of various budget items. Planning IR projects [slides 3–5] Project planning includes work scheduling, compiling plans and requirements for the research team, as well as creating and anticipating realistic estimations of resource needs throughout the project [Slide 3]. Work through these general description of a project plan with the group, and ask participants to highlight any points that are not clear. A project plan identifies each task and activity that will be completed throughout the duration of the project. Without a realistic plan, it is impossible to anticipate or identify potential barriers or constraints in adhering to the timetable, implementation and/or completion of the project or to suggest possible solutions. The project plan also establishes the magnitude of the project in order to be able to develop an appropriate budget to carry it out. The plan is a document that also facilitates communication between and among stakeholders, coordinates procedures, teamwork and collaboration. Your research design and procedures will be instrumental in identifying the tasks and activities that need to be completed in your project plan. It is important that participants also appreciate the rationale for their project plans [which are summarized in Slide 4]. A table providing further details of the main activities associated with the three project planning phases [slide 5] are presented in the participant workbook. 40 Implementation Research Toolkit Project timelines [slides 6–8] A project’s total duration should realistically reflect the time needed to carry out each phase of the project plan. This must be clearly and accurately described in any proposal, and has consequences in terms of meeting deadlines for deliverables and the final research report. Clear, feasible timelines reassure funders that projects follow rigorous project management standards. Project plans can be presented in a variety of ways [slides 7 and 8] and teams should choose the most appropriate style for their particular project needs. Research team [slides 9–10] The Research team section of proposal should succinctly describe the team members and the skills/strengths they contribute to the project. This section aims to persuade reviewers that the expertise on a team is sufficient to conduct the proposed research effectively. In IR projects, teams are multidisciplinary and diverse, and proposals need to match backgrounds and experience with the essential project roles and responsibilities as far as possible. Starting with the principal investigator (PI), help the teams to list the names of all individuals who will be involved in their study. Examples in the workbook will offer reminders to participants. Proposals should also include outlines/summaries of the planned research team management structure [slide 10]. Ask participants to compare the example given with their respective team structures. Ask them what this exercise suggests to them in relation to their own human resource planning. Group activity [slide 11] Teams should use the examples from real IR proposals to reflect on the content presented during the past hour or so, and prepare initial drafts of the following sections of their proposals: • The three phases of IR planning. • The work plan/time line of activities. • The research team, including expertise and roles. Budget and justification [slides 12–14] The proposal budget should outline the funds required to be able to effectively conduct the proposed research. Participants/teams need to carefully think through what they realistically need from the funding agency(ies) to carry out the project. If the budget is too low or inflated, it can negatively influence the judging of proposals. Once you have presented/discussed the overall description of a project budget [slide 12], you should ask participants to begin listing/suggesting the various categories of budget elements. They can do this by thinking through the activities they propose to carry out and ask themselves: “What resources/types of resources will we need to carry this work out?” 41 Facilitating Module 2 Once this discussion is partly completed, use slide 13 to remind participants of categories they may have overlooked. Remind participants that once each resource is itemized, the unit cost and total cost for the resource can then be explored and included. It is important to also budget for dissemination and evaluation of related activities and outcomes, which may be overlooked in the early stages of project planning. Finally, explain the budget justification points [slide 14] and why these are critical to bear in mind. Group activity [slide 15] In teams, ask participants to review the sample proposal budget [to be provided by facilitators/ organizers]. Using the information in this session and the example budget as a guide, teams should be able to develop a budget for their team’s proposal. Of all the sections in the proposals, the budget description and justification is likely to change a lot over time, so getting and early draft down on paper is an important step to take. Session 4: Measuring impact IR proposals must clearly demonstrate how research findings will have an impact on the health and/or health care of the communities/populations concerned, policy-making, and on research communities. When developing a typical research/academic proposal, the intent is to generate new knowledge and ideas. Conversely, when developing an IR proposal, the intent is to generate research evidence to improve programme implementation. Why is there such a wide gap between what we know and what we do? The fact that it can take years or even decades for research findings, best practices and guidelines to be implemented into health care workers’ daily practice is one of the stimuli behind the increased focus on an promotion of IR. Despite the growing knowledge base on evidence-based practices in health care, there is a large gap between what is known as a result of research and what is consistently implemented in practice. Scale up of research results and effective access to, and delivery of interventions are the core purposes of IR. Continuous learning and improvement of the health system requires a monitoring and evaluation process to track progress and correct course as necessary. IR proposals have to clearly demonstrate this as a core value and consideration. Learning objectives and expected outcomes [slide 2] After completing this session, teams will be able to develop a monitoring and evaluation plan, a capacity-building plan and a dissemination plan for their IR projects. 42 Implementation Research Toolkit Monitoring and evaluating activities [slides 3–6] First ask participants what they think the main purposes of a monitoring and evaluation plan are. Then reveal slide 3, and allow the group to compare the responses they gave to this list of suggested purposes: • Describes how whether an IR project meets its objectives and delivers what has been promised in the proposal will be assessed. • Informs the prospective funding agency their investment will be/is/was sound. • Facilitates the use of research findings in the health system for improved health outcomes. By definition, it is impossible to conclude an IR project successfully without a rigorous and fully implemented monitoring and evaluation plan. You can use the list on slide 4 to explore whether participants can suggest approaches to monitoring the activities described. By now, the ‘Why monitor?’ question should be obvious, but ‘How? How to monitor such activities is important to consider as the teams begin to formulate their own M&E plans. An evaluation plan should also be included in the proposal. It must outline how an assessment will be made of whether a project meets its research objectives and is ‘successful’, or not. It should also indicate how any changes in the project plan and any problems will be tracked. In general terms, an evaluation plan should consider the following [slide 5]: • Identifies who will use the evaluation findings. • Describes information needed, sources and evaluation methods/instruments. • Examines how the project objectives will be met. • Tracks the expected impact of the intervention. • Demonstrates that the scope of the evaluation is appropriate. Monitoring and evaluation assesses the success and impact at various stages of a project. Evaluation plans should also include a sense of concern for what will follow the conclusion of the funding period, and related sustainability. Building team and local capacities [slide 7] When writing an IR proposal, two specific considerations may help address capacity building: How the project can help improve the research capacity of national and local institutions involved, via training, mentorship, etc. 43 Facilitating Module 2 • How the project, via the process of the implementation, can help increase the capacity to conduct and demand for implementation research within the health system. • These two considerations should be referred to and elaborated as possible in proposals. As you explain these two points, ask participants/teams to consider and comment on how their specific projects contribute towards national and local research capacities, as well as helping to promote the uptake of research outcomes and results. Dissemination plan [slides 8 and 9] Dissemination of research findings is the subject of a dedicated module in this toolkit. This reflects the importance of describing the plan for disseminating information from projects in IR proposals. Most funding agencies are keen to see how their financial support of projects extends to key audiences and stakeholders. Slide 8 provides a useful summary of the main characteristics of a dissemination strategy. You should first walk the group through these points to give them a general orientation. This should be followed by showing slide 9, which asks a series of useful questions that you can use to probe further how the participants’ projects already/should integrate planning for dissemination, who their target audiences might be, and how they can engage stakeholders as early in the research process as possible. You should point out that the dissemination process must be part of the IR project cycle, and not an ‘add-on’ activity conducted at the end of the research. Involving stakeholders in the dissemination process early will enhance greater ownership of the research process and the ultimate uptake of the research findings. The participant workbook includes a series of specific steps that are recommended for research teams as they discuss and identify their dissemination strategies and related needs. This is intended as generic guidance that can be modified and customized for specific projects. The end result should be a context-sensitive strategy designed to disseminate particular research findings to specific audiences. Research teams should focus on the creation of particular information products. This is revisited in greater detail in Module 5. Strong dissemination strategies feature: two-way dialogue; precisely tailored and targeted messages suited to particular audiences; and mechanisms to evaluate relevant indicators, so that the strategy and its products can be revised and improved. 44 Implementation Research Toolkit Group activity [slide 10] Ask the group to review the sample dissemination plan (see workbook) and consider what aspects of this dissemination plan may be helpful to consider for their proposal? What aspects would not be appropriate? Evening Write-shop briefing [slide 11] Instruct teams that during the evening they should develop the following critical parts of their IR proposals: • Monitoring and evaluation plan. • Capacity building plan. • Dissemination plan. They should also make any changes necessary to improve, update, or align all sections of their proposals. Session 5: Supplements In this session teams will develop several of the final sections of their proposals. This includes information on the project summary, table of contents, appendices and researcher CVs. At the end of the session, there will be a final Write-shop to prepare these elements, review existing sections and update/align the overall proposal. Finally, teams will prepare/make a 20-minute presentation and receive feedback on their IR proposals. Learning objectives and expected outcomes [slide 2] By the end of the session, teams will be able to: • Develop a summary for their proposals. • Develop a Table of Contents. • Identify which Appendices need to be included in their proposal. • Develop a template for researcher CVs. • Prepare a 20 minute presentation summarizing their proposal. Project summary [slides 3 and 4] The project summary (also sometimes called an abstract or an executive summary) briefly describes the entire proposal. Researchers often write their summary or abstract last, when they are best able to concisely describe their research proposal. Depending on the requirements of the funding agency, a summary/abstract may be limited to anywhere from 150–200 words (abstract) to a page (summary). 45 Facilitating Module 2 A proposal summary or abstract might be the most important paragraph/ page because it creates the ‘first impression’ with reviewers and may influence whether they choose to fund a given proposal or not. Guide the teams through the description of a project summary [slide 3] and ask them to describe one point each as they review the summary checklist [slide 4]. Table of contents [slide 5] The table of contents organizes the proposal by outlining ‘what’ is in the proposal and where each item can be found. The table of contents presents a convenient list of the proposal topics and sections in a logical sequence ‘at a glance’. Appendices [slide 6] Appendices include those aspects of the project that are of secondary interest to the reader/ reviewer. Appendices assume that the reader can obtain all the necessary information from the body of the proposal and will go to the appendices if they need or want additional information. This may include things such as investigators CVs, research instruments, or letters of support attesting to the capacity of the team to undertake the proposed research or confirming collaboration of a key partner involved in the proposed resaerch. CVs of investigators [slide 7] Teams may want to ensure at least one member has IR experience, a good track record and a strong publication record. Complementary qualities such as credibility in the community are equally important. Evening Write-shop briefing [slides 8 and 9] Instruct teams that they should develop the following aspects of their proposals: • Project Summary (one page). • Title page. • Appendices (make a list of all the appendices and add the ones that are ready). • Researchers’ CVs (create a template of the CV components so that all researchers have a similar look and format). • Review all components of proposals and update/align. As an extension of the Write-shop activity, teams should prepare a 20-minute presentation (slide or poster presentation) covering all elements of their IR proposals. Group presentations [slide 10] Teams will each present their proposals in plenary for 20 minutes. This will be followed by 20 minutes of comments, questions, suggestions and comments from the large group and facilitators. 46 WORKSHOP FORMS This section contains workshop forms. When indicated during the workshop, select and complete the appropriate form. Return the form to the facilitators. Implementation Research Toolkit 47 WORKSHOP FORMS This section contains workshop forms. When indicated during the workshop, select and complete the appropriate form. Return the form to the facilitators. Facilitating Module 2 48 Pre-Workshop Assessment Questionnaire The purpose of this survey is to obtain pertinent information from you that will be used by the pedagogy team to guide the development and delivery of a quality Developing an Implementation Research Proposal. What motivated you to attend the workshop? Are there any personal, cultural or learning characteristics of the participants that need to be considered when designing the workshop? Please elaborate: What are you hoping to learn or gain by participating in the workshop? What specific content would you like to see covered during this workshop? What teaching/learning strategies would you recommend we consider when designing this workshop? Implementation Research Toolkit 49 What support do you feel you (and your colleagues) need to obtain in order to make the workshop successful? Do you have any other comments that may help in the design and delivery of the programme? Thank you Pre-Workshop Assessment Questionnaire The purpose of this survey is to obtain pertinent information from you that will be used by the pedagogy team to guide the development and delivery of a quality Developing an Implementation Research Proposal. What motivated you to attend the workshop? Are there any personal, cultural or learning characteristics of the participants that need to be considered when designing the workshop? Please elaborate: What are you hoping to learn or gain by participating in the workshop? What specific content would you like to see covered during this workshop? What teaching/learning strategies would you recommend we consider when designing this workshop? Facilitating Module 2 50 Proposal Checklist As you work through the course, use this checklist to track your progress. Front Matter � Title � Introduction � Overview of the Problem � Rationale � Statement of the Problem � Research Objectives � Research Question(s) Review of Literature and Referencing � What a review of literature is � Steps to take to conduct a review of literature when I return to my community � Why it is important to reference properly � How to cite references Research Methods � Qualitative � Quantitative � Mixed Methods Implementation Research Toolkit 51 Research Design Describe the Participants and sites Describe Data Collections Procedures Describe Data Analysis Procedures Describe Ethics Procedures Project Plan How to develop a project plan Who to include on the project team and how to describe their assets How to develop and justify a project budget How to develop Quality Standards strategies How to develop a Monitoring and Evaluation Plan How to develop a Capacity Building and Dissemination Plan Impacts How to write an IR proposal Summary (one page) How to develop a Table of contents (use a software package) How to develop the Appendices How to develop the Researchers’ CVs (create a template) How to Prepare a Covering Page How to Write an Abstract IR Proposals & Funding Opportunities Proposal Checklist As you work through the course, use this checklist to track your progress. Front Matter � Title � Introduction � Overview of the Problem � Rationale � Statement of the Problem � Research Objectives � Research Question(s) Review of Literature and Referencing � What a review of literature is � Steps to take to conduct a review of literature when I return to my community � Why it is important to reference properly � How to cite references Research Methods � Qualitative � Quantitative � Mixed Methods Facilitating Module 2 52 Session 1 Evaluation Form Workshop Session 1 – The Components of an IR Proposal Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Implementation Research Toolkit 53 Please provide comments particularly on areas you see in need of improvement; examples, constructive suggestions and ideas are very welcome! 1. What was the most valuable aspect of this workshop session? 2. How could this workshop session be improved? Session 1 Evaluation Form Workshop Session 1 – The Components of an IR Proposal Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Facilitating Module 2 54 Session 2 Evaluation Form Workshop Session 2 – Research Process Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Implementation Research Toolkit 55 Please provide comments particularly on areas you see in need of improvement; examples, constructive suggestions and ideas are very welcome! 1. What was the most valuable aspect of this workshop session? 2. How could this workshop session be improved? Session 2 Evaluation Form Workshop Session 2 – Research Process Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Facilitating Module 2 56 Session 3 Evaluation Form Workshop Session 3 – Project Plan Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Implementation Research Toolkit 57 Please provide comments particularly on areas you see in need of improvement; examples, constructive suggestions and ideas are very welcome! 1. What was the most valuable aspect of this workshop session? 2. How could this workshop session be improved? Session 3 Evaluation Form Workshop Session 3 – Project Plan Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Facilitating Module 2 58 Session 4 Evaluation Form Workshop Session 4 – Impact Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Implementation Research Toolkit 59 Please provide comments particularly on areas you see in need of improvement; examples, constructive suggestions and ideas are very welcome! 1. What was the most valuable aspect of this workshop session? 2. How could this workshop session be improved? Session 4 Evaluation Form Workshop Session 4 – Impact Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Facilitating Module 2 60 Session 5 Evaluation Form Workshop Session 5 – Supplements Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Implementation Research Toolkit 61 Please provide comments particularly on areas you see in need of improvement; examples, constructive suggestions and ideas are very welcome! 1. What was the most valuable aspect of this workshop session? 2. How could this workshop session be improved? Session 5 Evaluation Form Workshop Session 5 – Supplements Please indicate how strongly you agree with each of the following statements regarding the workshop session. Strongly Disagree Disagree Undecided Agree Strongly Agree Not applicable I enjoyed the session O O O O O O I learned useful knowledge and skills about how to write an IR proposal in this session O O O O O O The length of the session was appropriate O O O O O O The topic(s) covered was/were relevant O O O O O O The learning objectives were clear O O O O O O The session was organized O O O O O O The teaching strategies were effective O O O O O O The balance of theory and practical skills was appropriate O O O O O O The facilitator was knowledgeable O O O O O O The facilitator conveyed the information effectively O O O O O O The facilitator was supportive O O O O O O Useful resources were provided O O O O O O The knowledge gained during the teaching session will be useful in my workplace in the future O O O O O O Facilitating Module 2 62

FACILITATING MODULE3 PLANNING AND CONDUCTING AN IMPLEMENTATION RESEARCH PROJECT Implementation Research Toolkit FACILITATING MODULE 3 Make a general introduction of the module to participants. e.g. This module provides information on the essential steps to plan research to conduct a research project, including: applying for ethical review, planning for programme implementation, and implementing good IR principles and practices. These processes will be demonstrated using an IR project as example. Six steps in IR process [slide 2] Before you begin… Reaching Module 3 in the IR workshop, most participants will have already been through the two ‘induction’ modules (i.e. Introduction and Module 1) and many will also have completed Module 2 on preparing a project proposal and secured funds to conduct the project. Nevertheless, it is worth taking a short time to review the overall IR process/framework again as you begin the module. Use the IR cycle diagram in slide 2 to remind participants that Planning and Conducting an Implementation Research is the third step in the cycle. Outline of the presentations [slide 3] Go through the outline with the participants to ensure that they understand what will be covered. This includes the learning objectives, the expected outcomes, the three key concepts of this module (seeking ethical clearance, project implementation process and good practices in IR) and the application of the key concepts in a real life setting. Key concepts for this module 1. Seeking ethical clearance 2. Project implementation process 3. Good practices in implementation research Objective [slide 4] This module is designed to provide information on the various steps to plan for executing the research including: • applying for ethical review; • planning for program implementation; • implementing good IR principles and practices. 65 Facilitating Module 3 Expected outcomes [slide 5] Remind participants that this focuses on the essential steps to plan for the conduct of the research, including: • applying for ethical review; • planning for programme implementation; • implementing good IR principles and practices. These processes will be demonstrated using an IR project as example. By the end of this module participants will be able to: • Describe the ethical requirements and processes required to successfully submit a research project protocol for ethics review. • Describe the related ethical processes in a project cycle. • Systematically describe the steps taken to implement a research project. • Comprehend the value of good practices in the full cycle of a research project. Key concept 1: Seeking ethical clearance IR presents interesting ethical perspectives as it often involves multiple perspectives and interfaces with health services. As such, an implementation researcher may find it difficult to differentiate between routine health care and the research process. When the lines blur between routine heath care and the research process, it may be difficult to identify the potential ethical considerations, especially in the case of participatory research. It is important to consider the ethical aspects of a study right from the initial planning of the project. Experience with ethical review/clearance [slide 6] Begin exploring this key concept by asking participants to share their own experiences with seeking ethical clearances: • What are the institutional review board (IRB) and/or the ethics review committee (ERC) submission requirements in your institution? • How long does it take to receive approval in your institution? What are the possible reasons for not having approval after the first review? • Does your IRB/ERC charge a fee for review? You can also provide an example from your own experience. Research-funding agencies require approval of research proposals by the appropriate ethics review committee before project funds are released. The ethics committee(s) will review the study proposal and require full details of the study plan and procedures. 66 Submission of the research protocol [slide 7] The ethics review process is essential to ensure that the research project will protect subjects’ dignity, rights, safety and well-being. A written approval of the research protocol, written informed consent (preferable in the local language in which it will be administered) and defined recruitment procedures are required. Before you show this slide, ask the participants: “What should the research protocol include?” Then show the list to see if they match. The slide summarizes the documents often required by the IRB/ ERC. Ask participants to add other things that may not have been included in this list. Discuss why the CV of the PI and other team members is important when seeking ethical clearance. Seeking ethical clearance [slide 8] When the ethical committee issues an approval certificate, it will inform the principal investigator (PI) of the need for regular ethical reviews. In IR, the research team continuously monitors and reviews the intervention activities to ensure meaningful and practical outcomes for programme planning and implementation. During this process, unexpected circumstances may arise and consequently changes to the original research plan may be in the best interest of the project and the participants. Illustrative example: When submitting a proposal for ethical review, the research team may indicate that patients be given daily injections by the nurse in charge of the facility. However during the research process, the planned injection process was not effective due to unanticipated problems. One opportunity to update the ethics proposal is during the periodic ethics reviews. In such situations, a number of amendments are likely to be made to the original protocol submitted for ethical review. The IR team must inform the ethical committee of any major changes to the original research protocol or procedures. Ethical issues to be considered during project implementation and clearance may be an ongoing process. Implementation Research Toolkit 67 Elements of an informed consent document [slide 9–10] Ask participants to mention the essential elements/information that must be included in an informed consent form. Ask one of the participants (volunteer) to write these on a flip chart. You can compare this list with the information on the next slide. Informed consent (IC) ensures that individuals can freely make decisions to (or not to) participate according to personal interest, values and priorities. An IC is more than a contractual obligation and should be understood as a process that begins with the initial contact (during the recruitment process), and carries through to the end of participants’ involvement in the project. The IC process requires four basic elements: 1) accurate and appropriate information; 2) understanding the purpose of and procedures in the research process; 3) capacity to consent; 4) voluntary participation. To have an effective consent, it may be necessary to explain the information should be explained in the local language of the participants. The team should be aware of cultural sensitivities. For example, in some countries, specific family members may demand to be involved in the IC process. Example of comments from IRB/ERC [slide 11] Show the participants an example of comments from IRB/IRC. Highlight elements that were discussed in previous slides. Reflection activity [slide 12] A researcher was conducting a study on a patient in a half-way home. The study involved daily visits by a health worker to the half-way home to administer injections. With limited access to transportation, the health worker was unable to make the necessary daily trips to the half-way home. Should the health worker train the researcher to give the daily injections? What are the ethical issues (if any) raised by this situation? How can the issue(s) be addressed? Allow 15 minutes for discussion among members of each group and ask them to report back in plenary. Discuss the ethical angles that relate to this issue, focus in particular on the issue of modifying the protocol without reverting to the ethical committee for approval. Key concept 2: Project implementation Implementing involves conducting and monitoring the proposed activities, as well as updating and revising the research plan accordingly as conditions dictate. The activities include assembling the research team(s), applying for the logistical needs and allocating activities and tasks. Furthermore, the research sites, the timeline for the research activities, and the procedures for the data collection must all be established. This phase also includes closure and evaluation of the project, as well as reporting and dissemination of the research processes and findings. Facilitating Module 3 68 What does implementation include? [slide 13] When the project work plan is complete, agreed by all involved parties and approved by relevant management groups, the implementation of the project may begin. Explain each of the steps outlined in the slide. As you do, ask participants to comment on when/ how stakeholders, partners and frontline workers should be involved in the implementation. What are the specific roles of the team leader during each step? Monitoring the project [slide 14] Show the illustration and emphasise balancing between quality, cost and time. Throughout the project, researchers must measure all three elements, analyse the outcome and respond (react) appropriately in order to increase the quality of the research in balance with cost and time. Regular project monitoring ensures that the team always knows whether or not the project is making progress towards its objectives. Monitoring should be led by the project leader but is a team activity. It allows anticipation and quick response to problems or opportunities and helps to ensure successful implementation. Updating and revising the research plan [slide 15] Plans do not always proceed as intended in IR projects. Therefore adaptations may be required as the implementation process proceeds and more information is obtained. The set procedures (e.g. sampling and data tools) should be reviewed regularly to compare what is happening in practice with the original planned procedure, so that any necessary adjustments can be made. Staff training is a critical part of this process. Implementation research is a dynamic process that often requires adaptations, flexibility and latitude during the course of execution. Such changes/adaptations to the research process must be documented, coordinated and monitored to ensure credibility and fidelity. Implementation Research Toolkit 69 Starting the implementation process [slide 16] The emphasis here should be on the project launch: who should be responsible for the project launch activities, who should attend, clarity on the objectives of the launch and specific roles to be played by team members, stakeholders, partners and frontline workers. Before commencing project implementation, team members should review the project goal, objectives, indicators and work plan. They should address potential issues and set up a mechanism of communication to ensure teamwork during implementation. The team leader/PI must ensure the work begins on time and the agreed standards of performance are followed. The emphasis here should be on the project launch. • Why is the launch important? (ask participants for input) • Who should be responsible for the project launch activities? • Who should attend? There must be clarity on the objectives of the launch and specific roles to be played by each partner. This process should be led by the PI. Key concept 3: Good practices in IR [slide 17] This slide shows the basic good practices – transparency and clarity – as well as good data management in implementation research. Implementation research must generate credible data therefore the documentation process is important. Good research practice can ensure credible data by reducing the risk of obtaining inconclusive results on account of uncertainty about the effectiveness of the intervention itself or because of unclear implementation procedures. Go through the specific questions that should underpin good documentation: • What is happening? • Why is it happening in this way? • Is this expected? It is important to be objective when documenting processes and report both negative and positive experiences. Note: Other considerations listed on this slide are explained in more detail in the participant workbook. Facilitating Module 3 70 Implementation Research Toolkit Application of key concepts [slide 18] Illustrative example project: Key findings from an evaluation of the Mothers2Mothers programme in KwaZulu-Natal, South Africa. Make sure that the teams have read full reference. Ask three teams to present one of each of the three key concepts they have been introduced to and summarize how it was applied in this project. Each team should refer to the detailed descriptions of each key concept (see the Participant workbook) and select the points they feel are most important for presentation. Refer to application of key concepts on the examples in the Participants’ manual (Baek et al, 2007). 71 Facilitating Module 3 72

FACILITATING MODULE4 DATA, ANALYSIS AND PRESENTATION Implementation Research Toolkit FACILITATING MODULE 4 Make a general introduction of the module to participants. The purpose of this module is to outline the fundamentals of IR data analysis and interpretation, which is step 4 in the IR cycle. It also describes design of data analysis, presentation and interpretation for the target audience, with a view to enhancing the uptake and use of research findings. It is not a course in biostatististics or qualitative research methods. Six steps in IR process [slide 2] Take a short time to review the overall IR process/framework again as you start the module. Use the IR cycle diagram in slide 2 to remind participants that Data management, analysis and presentation is the fourth step in the cycle. Before you begin… We assume participants are already familiar with qualitative and quantitative approaches and tools. As a brief reminder, ask participants to describe the main differences between them [slide 3]. Some examples to help prompt discussion/probe participants: • Study objective: Magnitude vs understanding phenomena • Research questions: How many vs why or how • Methodological differences: – Deductive vs inductive – Linear vs iterative – Data analysis: Numbers vs narrative • Emphasize: (i) Qualitative research is concerned with developing explanations to any social phenomenon and (ii) captures the subjective aspects of our world and seeks to answer questions about: – Why the problem/topic is interesting, important or of policy relevance. – What is the aim or specific objectives. During the discussion, remind participants that they will find the differences summarized in Table 1 of their workbook [also slide 4]. 75 Facilitating Module 4 module 4a: Quantitative data management analysis and presentation Presentation outline and key concepts [slide 6] Go through the agenda with participants to ensure that they understand what will be covered in the session. Highlight the key concepts that will be covered in the module. The brief notes below will help you to prompt participants to suggest their own understanding of each one before the session begins. (The learning objectives and expected outcomes are explained in more detail in subsequent slides). Key concepts for this module 1. Data analysis plan Most IR projects use mixed methods in which qualitative and quantitative techniques are combined. Under the right circumstances, a mixed-methods approach can provide a better understanding of the problem than either approach alone. To ensure that the analysis is undertaken in a targeted manner, an analysis plan should first be created. The analysis plan contains a description of the research question and the various steps that will be carried out in the process. 2. Quantitative data analysis In IR, quantitative data analysis may include one or more of the following considerations: • Frequency distribution and summary statistics. • Relationships and confounding variables. • Sub-group analysis. • Statistical models. • Generalizing from samples to populations. • Trend analysis. 3. Data management In order to ensure data quality and integrity, data must be collected and processed using organized, consistent and reproducible procedures and protocols. For example, raw data must be recorded promptly, accurately, legibly and indelibly. Learning objectives and expected outcomes [slide 7] By the end of this module participants will be able to: • Describe data analysis planning processes. • Understand appropriate statistical measures. • Understand data management approaches. 76 Implementation Research Toolkit Key concept 1: Data analysis plan Point out to participants that the main considerations influencing the overall data analysis plan are requirements related to: • stakeholder communication goals; • the anticipated IR study outcomes; • appropriate formats for presenting information. The final analytical approach is a balance between designing analysis for practical use and for purpose. Designing analysis for use [slides 8 and 9] Designing analysis for use in an IR project is based on the premise that the IR aims to: (i) understand the implementation processes, focusing on mechanisms that support or constrain those processes; and (ii) communicate that understanding of the implementation process to multiple stakeholders, who may consequently contribute to the integration of findings into current application and/or future research. It is therefore essential that the analysis and, most importantly, presentation of findings, be carefully considered to avoid potential misinterpretations that could lead to inappropriate conclusions and/ or responses. At slide 9, go through each category of stakeholders and ask participants for inputs on the respective information needs. Emphasise the difference between each one and elaborate on one in particular. Emphasis should be placed on simplicity and interpretability because stakeholders need to both understand the information provided and also be able to interpret it correctly. Designing analysis by purpose [slide 10] An important preliminary consideration when designing data analysis is to clearly define the primary objectives of the analysis by identifying the specific issues to be addressed. Discuss the different terms and emphasise that effectiveness, efficiency, equity and sustainability are elements of the context of interventions. What are the different meanings of, and what makes an intervention: effective, efficient, equitable and sustainable? Use the definitions below to prompt discussion in the group: Effectiveness: Aims to modify implementation procedures in order to improve the generation of benefits. Efficiency: Attempts to assess the implications of possible modifications to the implementation process in order to increase the benefits in relation to resources. Equity: Focuses on distributional issues, i.e. how benefits and resource costs are distributed. 77 Facilitating Module 4 Sustainability: Focuses on identifying essential inputs, potential constraints on their availability and other possible barriers to medium and long-term availability. It is important to remember that data from IR is by nature intended not to simply describe the intervention but also to improve it. Data presentation formats [slides 11 to 27] Data reporting should be presented in both textual and visual formats, such as: • tables • diagrams • graphs • infographics • maps Work steadily through slides 12 to 27 with the group, highlighting the strengths and weaknesses of the various presentation formats and reminding them that selecting presentation formats is part of the data analysis planning. Reflection activity [slide 28] In project teams, ask participants to discuss the results of the study that they need to disseminate and format of data presentation they will use for different groups of stakeholders. Allow 30 minutes for discussion among members of the group and ask for a brief report back. Discuss any questions or challenges that arise. Key concept 2: Quantitative data analysis The form of data analysis used in IR is partly determined by the nature of the research question and the need for descriptive or analytic approaches [slide 29]. Variables in quantitative analysis are usually classified by their level of measurement, as indicated below [slide 30]: • Rational – e.g. weight of child, number of vaccinations. • Interval (based on predetermined equal intervals) – e.g. temperature, some disability measures. • Ordinal (ranks) – e.g. facility levels, quality of life indices. • Nominal (categories) – e.g. district names. Explain the four types of measurement, and ask participants for examples to illustrate their own understanding. In general, regardless of the descriptive/analytic needs determined by the research question, quantitative data analysis focuses on assessment of one or more of the following considerations: • Frequency distribution and summary statistics. • Relationships (and confounding variables). • Sub-group analysis. 78 Implementation Research Toolkit • Statistical models. • Generalizing from samples to populations. • Trend analysis. Before you describe individual approaches, introduce participants to the methods that usually comprise descriptive studies: [slide 31]: • Distributions and summary measures. • Defining intervals for frequency distributions. • Frequency distribution and summary statistics. Introduce each one briefly, and explain that the group will proceed through each one in greater detail [slides 32–38]. Before the session, you can read ahead through the descriptions below for comments/ideas. Distributions and summary measures [slide 32] Quantitative research generates large volumes of data that require organization and summarization. Frequency distributions facilitate a broad understanding of how the data vary or relate to each other. The approach reveals and summarizes distributions of the values of study variables within a study population. Illustrative examples: • The number of children under five years of age in various households in a given population. • Daily outpatient attendance in a health facility. • The birth weights of children born in a particular health facility over a period of time. • Educational levels of mothers of children born in a particular health facility. The use of frequency distributions for this purpose has several advantages: • They are useful for all types of variables. • They are easy to explain and interpret for audiences without specialist knowledge. • They can be presented graphically and in different formats to aid interpretation. Defining intervals for frequency distributions [slide 33] A key decision in constructing a frequency distribution is the choice of intervals. Explain the following three types, using the brief examples presented below: • Ordinal: Level of health facility (e.g. primary, secondary, tertiary). • Interval: Body temperature (e.g. below normal, normal, above normal). • Rational: Body mass index (BMI) (e.g. <25, 25–29, 30+). Highlight these two conflicting objectives when determining the number of intervals: • Limiting the loss of information through the use of a relatively large number of intervals. 79 Facilitating Module 4 • Providing a simple, interpretable and useful summary through the use of a relatively small number of intervals. Distributions based on unequal intervals should be used with caution, as they can be easily misinterpreted, especially when distributions are presented graphically. Summary statistics and frequency distribution [slide 34] Careful examination of the frequency distribution of a variable is a crucial step and can be an extremely powerful and robust form of analysis. Note: It can be tempting to move too quickly to the use of simpler summary statistics that are intended (but often fail) to capture the essential features of a distribution. Summary statistics usually indicate the overall location of a distribution (e.g. how sick, poor or educated a study population is, on average) OR to indicate the extent of variation within a population. The reasons for selecting a particular frequency distribution/summary statistic should relate to the purpose for which it is intended. Suggest that participants read the example presented in their workbook (malnutrition among five year-old children). Use of mean or median [slide 35] The mean is the most commonly used summary measure of location. However, because the mean is simple to calculate and manipulate it is often inappropriately used as the standard measure of central location. The mean is also frequently misinterpreted as the typical value in a population. Illustrative example: The gross domestic product (GDP) of a certain middle-income country was calculated as 3200 US$. Interpreting this as the income of an ‘average’ person in that country does not reflect reality (in fact, the average was closer to 1200 US$). The mean is often unrepresentative when the underlying distribution is skewed. 80 Implementation Research Toolkit The understanding and interpretation of mean and median is significantly influenced according to whether data distribution is skewed [slide 36]. [slide 37] Measures of variation Essentially an assessment of how much variability occurs within a given population. • Low variability: Measures of location can be seen as reasonably representative of the overall population; limited loss of information through aggregation. • High variability: Representative measures of location are less useful; substantial risk of losing information by aggregation (unless the nature of the distribution is well understood). • Explain each measure of variation presented in [slide 38]. Ask participants to suggest examples related to their own experience or projects. Briefly introduce participants to the methods that comprise analytical studies: [slide 39]: • Group comparison. • Association. • Causality. [Slides 40–43] describe the most common approaches in these categories. Group comparison • Explain the different pathways that lead to various forms of group analysis presented [Slide 40]. Association • Explain the data requirements for the correlation analyses described [slide 41]. Causality • In order to highlight the distinction between the various forms of regression analysis [slides 42 and 43], describe the circumstances and instances in which the following approaches should be used: • Linear regression. • Logistic regression. • Cox proportional hazard model. Measures of risk [slide 44] Although measures of risk are widely used in health research, they are frequently misunderstood. For example, risk and odds are often used interchangeably meaning quite different things. 81 Facilitating Module 4 Explain the differences between these constructs: Risk (P): number of people experiencing an event/population exposed to the event. Relative risk (PA/PB): risk in group A compared to risk in group B. Odds: number experiencing versus number not experiencing a particular risk = P/(1-P) Odds ratio: [PA/(1- PA)]/[PB/(1-PB)] Furthermore, ‘reduction in risk’ is not equivalent to ‘reduction in odds’: Use this example to explain the differences: PB (malaria before intervention) = 0.5 PA (malaria after intervention) = 0.1 Reduction in risk = 0.1/0.5 = 0.2 Reduction in odds = (0.1 / 0.9) / (0.5 x 0.5) = 0.11 The ‘denominator problem’ [slide 45] When calculating risk it is essential to know the overall size of the population at risk, which in IR studies is often difficult to determine or reliably estimate. For example, we may have only an estimate of the number of children who should be immunized or should be sleeping under a mosquito net in a given district. Similarly, the catchment population of a facility or actual number of births over a period of time are often unknown. For these reasons, denominators are usually based on projected populations. Because of this uncertainty, it is good practice to provide the estimates of both the numerator and denominator alongside any proportion, percentage or risk estimate and indicate the sources used in the calculation. Sub-group analysis [slide 46] The outcomes of an intervention may vary substantially between different sub-groups of the target population. Sub-group analysis can be complex if the sub-groups are not pre-defined. Data mining (i.e. exploring data sets to discover apparent relationships) is useful to formulate new hypotheses but requires great caution in IR. The context within which this sub-analysis is undertaken should be considered carefully, because relationships between inputs and outcomes may be mediated by contextual variables. Illustrative example: We might assume that it would be useful to undertake an analysis of chronic illness by age group and sex, as shown below (and in Table 7 in the participant Workbook). For meaningful interpretation of the results, the type of chronic illness and the background of the patients experiencing them are important variables to consider. 82 Implementation Research Toolkit Table 7. Background variables of patients with chronic illnesses Age group Chronic illness prevalence Males Females 15–24 0.55 0.80 25–44 1.79 4.01 45–64 4.91 12.28 65 12.86 20.00 All 1.77 4.25 Work through this example with participants so they understand the reasons for caution re. data mining in IR, and the differences between controlled and confounding variables. Reflection activity [slide 47] 15 minute exercise: In project teams, ask participants to discuss the data analysis they intend to conduct in their project and identify whether the data they will collect is suitable for the type of analysis they plan. Encourage teams to identify specific variables that will be analysed and present the selected approach back to the group briefly. Key concept 3: Data management The underlying goal and importance of good overall data management is to ensure, as much as possible, the validity of data generated from a project. Work steadily through slides 48 to 53 with the group, highlighting why it is important to have consistent and rigorous data collection, storage and management, and that data management is required at various research stages, not just the concluding steps. It is also useful to mention that there may be a need to review (or audit) the data after the conclusions have been shared/ published, and that data should be stored and managed with this eventuality in mind. Reflection activity [slide 54] 15 minute exercise: In project teams, ask participants to discuss how to improve the quality of their data management system. Encourage teams to identify specific issues they may encounter and possible solutions. Ask 2–3 team to present their conclusions/challenges back to the group briefly. Conclusion [slide 55] Discuss each of the four main points in this slide with the group, and ask the participants for their interpretation of each point. As you do, it will be useful to refer back to (and verify) the expected outcomes for this sub-module: • Describe data analysis planning processes. • Understand appropriate statistical measures. • Understand data management approaches. 83 Facilitating Module 4 module 4b: Qualitative data collection, analysis and presentation Presentation outline and key concepts [slide 3] Go through the agenda with participants to ensure that they understand what will be covered in the session. Highlight the key concepts that will be covered in the module. The brief notes below will help you to prompt participants to suggest their own understanding of each one before the session begins. Ask participants about their experience with qualitative data and the types of data they mostly intend to collect: qualitative or quantitative? Their responses may help to guide subsequent discussions and emphasis. Also do a quick check in the room of knowledge regarding the use of qualitative methods. Key concepts for this module 1. Qualitative data collection 2. Analysis of data 3. Presentation of data Expected outcomes [slide 4] By the end of this module participants will be able to describe: • Appropriate qualitative data collection techniques and tools. • Data analysis processes in a qualitative study. • Various options for data presentation. Key concept 1: Qualitative data collection Ask participants to explain each of the sampling strategies mentioned [slide 5]. They should also discuss why purposive sampling is used as opposed to probability sampling. Provide feedback and comment on the examples given by participants. Some general definitions/summary notes are included below for your reference. It is important to select your sample in a systematic way so as to ensure that the community/users/external actors see it as a credible and indicative sample. Purposive sampling: This means participants/subjects are intentionally selected because they are likely to generate useful data for the project. 84 Implementation Research Toolkit Convenience sampling: Select whoever is easiest, closest, etc. to save time, money and effort. Information collected generally has very low credibility (e.g. focus groups based on who is available that day at the local community centre, rather than according to predefined criteria). Snowball (chain) sampling: Locate one or two key individuals, and then ask them to name other likely informants. To facilitate the identification of hard-to-find cases (e.g. finding sex workers to interview about experiences of childhood sexual abuse by getting cases referred through friendship networks). Maximum variation sampling: Purposely select a wide range of variation in dimensions of interest. To document diverse variations, it can help to identify common patterns that cut across variations (e.g. researching variations in norms about the acceptability of wife beating by conducting focus groups discussion with: young urban women, old urban women, young rural men, old rural men, women who have been abused, women who have not experienced abuse). Outlier: Cases that have gone extremely right or extremely wrong. Generally considered to be a data point that is far outside the norm for a variable or population. Intensity sampling: To provide rich information from a few select cases that manifest the phenomenon intensely but are not extreme cases (e.g. Interviewing survivors of date rape to learn more about how coerced sex affects women’s sexuality). Homogenous: Small group of similar cases to describe in depth. Used to gain information about a particular group (e.g. single fathers). Before showing the considerations that determine data collection approaches [slide 6], let the participants brainstorm what factors they would consider in order to determine the most appropriate methods of qualitative data collection. As the group considers the general schematic diagram of qualitative data collection [slide 7], remind them about some of the major characteristics of qualitative data: Interviewing: Asking people questions. Observation: Watching (and participating). Existing documents: Official documents, personal writing, movies, songs, etc. Visual data: Photography, film and other forms of visual recording. Proceed left-to-right through each of the layers depicted [slide 7], discussing with the group how collection methods influence the types of data ultimately generated. [Slide 8] highlights the various options for qualitative data collection, and reminds participants that these approaches relate to the implementation step of the IR process. Invite the participants to brainstorm the different methods listed. Using examples from the participants’ projects, discuss the use of qualitative data collection techniques and their appropriateness. 85 Facilitating Module 4 To encourage discussions, use slides 9 to 14. Ask one participant to volunteer to illustrate each method with a real life example. A brief summary of each approach is included below for your reference: In-depth interviews: Qualitative interviewing, at its most basic level, is the process of gathering data by asking people questions. Traditionally interviews involve one-on-one, face-to-face encounters. However, they can also take place on the phone or over the Internet. Structured interviews seek consistency across interviews by using a predetermined set of questions from which the interviewer does not deviate. Unstructured interviews are more like flowing conversations guided by a basic topic of inquiry, usually with open-ended questions and a focus on eliciting stories. Transect walks: These are organized around a given community in order to observe the people, surroundings and resources. They provide an overall view of the community and help it to identify issues that might merit further exploration. They can take as little as an hour or as long as a day, depending on the size of the community and the amount of time available. Transect walks are planned by drawing a ‘transect line’ through a map of the community. The line goes through all zones of the community in order to provide a representative view. Problem tree: Used to understand the basic principles of analysis of problems by identifying major problems and the main causal relationships between them. Vignettes: Short scenarios or stories in written or pictorial form that participants can comment upon. The central feature of this method is to explore participants’ subjective belief systems stories about individuals, situations and structures that can make reference to important points in the study of perceptions, beliefs and attitudes. ns (FGD) [slides 15–19]: All of the methods described above are used as part of qualitative data collection, but probably none so frequently as FGD. Once again, ask one participant to volunteer to describe their experience with a real life example of an FGD. Work steadily through slides 16 to 19 with the group, asking participants to explain their understanding of each one. Reflection activity [slide 20] Consider one of two possible 15 minute exercises: 1. Focus group discussion role play • A group of 8–10 participants is selected from the entire group. • Select the moderator and note taker. • The FGD guide should be ready and discussed with the moderator beforehand. • Select some dominant, docile and controversial characters for participants (these should not be known to the moderator). • The rest of the participants should observe and give constructive feedback/observations at the end of the role play. 2. Problem Tree: group work • List a number of health problems [preferably related to the teams’ projects]. 86 Implementation Research Toolkit • Form groups of 5–7 participants, where two play the role of the researchers and the remainder are the local community members. • Let them develop a problem tree in an FGD setting. • Each group should then present their problem tree conclusion. • Encourage constructive feedback from the participants. Key concept 2: Data analysis Emphasize here that qualitative data generates textual information rather than numbers. To ensure validity and reliability, triangulation (use of multiple qualitative techniques) is essential. The three core requirements of qualitative analysis [slide 21] are: • Detailed description of techniques and methods used to select samples and generate data. • Carefully specified analysis, with attention to issues of validity and reliability. • Triangulation with other data collection methods. Indicate to the participants that they should feel free to use whatever analysis method they are comfortable with. Point out that whatever approach is used, all qualitative analysis involves making sense of large amounts of data, identifying significant patterns and communicating the essence of what the data reveal. [slide 22] Note that in this session you cannot teach participants any of the analysis software referred to [slide 23]. Mention them and generally indicate what the software does: • Atlas-ti deals with large datasets, unstructured coding, mimic paper code and sort. • NVivo handles relatively less data, caters for unstructured coding, finding patterns/relationships in codes. • MaxQDA provides powerful tools for analysing interviews, reports, tables, online surveys, videos, audio files, images, and bibliographical data sets. Analysis of textual material [slides 24–31] Work through these slides with the participants, explaining the main concepts outlined in relation to: • Thematic analysis. • Coding schemes. Slides 32 and 33 summarize the discussion on analysis of qualitative data and provide an opportunity for you to reiterate the basic steps to follow when analysing qualitative data: • Objectives have been met (confirm). • Transcribe (verbatim) all interviews. • Use information from all the techniques/methodologies. 87 Facilitating Module 4 • Incorporate all notes and observations for that particular interview into the transcript. Include background information on respondents or people observed. • Code the main segments using the interview guide. • Recode according to sub-themes. • Produce a matrix. Slides 34–36 provide a brief opportunity to consider the text-based and graphical options for presenting qualitative data. Reflection activity [slide 37] Ask the groups to discuss the specific points highlighted and request three teams to share their conclusions/observations. Encourage other participants to comment. Example [slide 38] Innovative Participatory Health Education (IPHE) in South Sudan An educational initiative solution for improving the life of girls and women worldwide funded by Women Deliver in 2011/12. Stream the video using the URL http://www.youtube.com/watch?v=sHLfGAP0N6k The example summarizes the key concepts of qualitative data: 1. Data collection: observation/in-depth interviews [de-briefing]/FGDs/reflective photography. 2. Data analysis: participatory workshop. 3. Data presentation: health messages [pictures]/song/drama [all developed by the study participants]. 88

FACILITATING MODULE5 DISSEMINATING THE RESEARCH FINDINGS Implementation Research Toolkit FACILITATING MODULE 5 Give a general introduction of the module to participants. The purpose of this module is to use practical examples to highlight and illustrate the key concepts of knowledge translation as relevant to implementation research (IR). It provides structured guidance on preparation of research reports, peer reviewed papers, press releases, conference presentations and policy briefs. Six steps in IR process [slide 2] Take a short time to review the overall IR process/framework again as you start the module. Use the IR cycle diagram in slide 2 to remind participants that Disseminating Implementation Research Findings is the fifth step in the cycle. Presentation outline and expected outcome [slides 3–4] Go through the outline with participants to ensure that they understand what will be covered in the session. Highlight the expected outcomes and key concepts that will be covered in the module. The brief notes below will help you to prompt participants to suggest their own understanding of each key concept before the session begins. Key concepts for this module [slide 5] 1. Knowledge translation (KT) KT is rooted in an ever-shifting context in terms of time, place, and unique situations that its practitioners must always be aware of, anticipate and adjust to. KT techniques can help researchers become more active, context-aware, and collaborative in disseminating the results of research. And by doing so, research results become more relevant, adapted to change, and ultimately more useful. In relation to IR, there are two types of KT activities: end-of-grant and integrated knowledge translation. 2. Dissemination tools A wide variety of dissemination tools is available to research teams to help them promote the uptake of research findings. All these tools should be considered less as individual pieces and more as parts of a whole. The various tools should be used in concert within a larger plan that together produces a complete effective dissemination package or approach. Each tool has different strengths and weaknesses in reaching particular audiences and therefore by using 91 Facilitating Module 5 more than one in combination, the various tools can complement one another to produce a stronger dissemination plan than using any one in isolation. The dissemination tools that will be considered include research reports, peer review papers, press releases, and policy briefs. 3. Dissemination strategy As mentioned above, the dissemination process is an integral part of the IR project cycle. By involving stakeholders in the dissemination process early in the cycle, the greater ownership they will have of the research process and the ultimate uptake of the research findings. Specific steps are recommended for research teams as they discuss and formulate their dissemination strategies and related needs. The end result should be a context-sensitive strategy designed to disseminate particular research findings to given audiences. Key concept 1: Knowledge translation Briefly highlight that knowledge translation (KT) is a two-way process [slide 6] To be effective, it must be disseminated: • using the appropriate tools; • at the appropriate time; • in the appropriate place; • whenever there is an opportunity to engage an audience. Not only is KT aimed ultimately at sharing the results of IR, it also helps researchers to actively engage with stakeholders and research communities, be more aware of the context in which they are working, and encourage collaborative approaches. Stages of KT [slide 7] There are two types of knowledge translations that are commonly practiced: 1. End-of-grant KT 2. Integrated knowledge translation (iKT) End-of-grant KT approaches are more frequently built into research project plans and funding proposals because they comprise the types of sharing approaches that researchers are typically most aware of and adopt. This implies that at the end of a research process, findings/conclusions – new knowledge – are packaged into effective communications tools that are disseminated to a particular audience. These include peer-reviewed papers, guidelines, conference presentations, press releases, radio spot and community dramas. Although such end-of-grant KT activities can be conducted as part of an IR project, they tend to be fairly limited (and relatively expensive). 92 In iKT approaches, researchers and key knowledge users identify research questions, determine methodologies, conduct the research, interpret findings, and then synthesize, disseminate and apply findings – together. Because the ultimate findings reflect the needs of knowledge users, they have a much greater likelihood of being relevant and being implemented. In iKT approaches, knowledge is regarded – from its initial creation to its ultimate application – as a collective, co-productive undertaking. It respects the two-way dynamic that allows research process to be influenced by its contextual surroundings and communities, and for research evidence to be created, shaped and ultimately used by myriad stakeholders. In this way, iKT makes research evidence far more relevant and responsive for practitioners, planners and programme managers. This uniquely positions IR as a tailored, context-sensitive process that actively responds to user needs and demands. Integrated knowledge translation (iKT) is a more innovative approach that is multi-stakeholder and multidisciplinary in its orientation. It is far more dynamic and interactive than end-of-grant approaches. Barriers to uptake of research evidence [slide 8] A wide array of barriers reduces the uptake of research evidence. Many users of research evidence, such as programme managers, operate in an environment with unique pressures and imperatives. Their timelines for action can be very short, and their expertise in applying or balancing different inputs to solve problems may be limited. Ask participants to suggest possible barriers to research uptake. You can use the five brief summaries below to prompt and/or explore individual barriers during the discussion. Potential barriers to research uptake Perception of research evidence by practitioners. How do they balance that evidence with other competing influences? Organizational culture. How does an organization make decisions? How does information flow within an organization? What are its abilities to interact with research evidence? Low skills (especially research or evidence-appraisal skills) among practitioners, either to assess research evidence or to balance it against competing sources of influence (related to no. 2 above). Perceived costs and timelines of research. Given the short time horizons that many practitioners have to make decisions, is research too expensive, or too slow/time-consuming to have real practical value? Information overload. Practitioners, programme managers and implementers may become overwhelmed by the sheer number of information sources. Implementation Research Toolkit 93 Facilitating Module 5 Facilitators of research evidence uptake [slide 9] A similar range of factors can facilitate the uptake of research. Some of these may have come up as you discussed barriers. Once again, ask participants to suggest possible facilitators to research uptake and use the five brief summaries below to prompt and/or explore ideas. At the outset, it might be helpful to suggest that the absence of the barriers mentioned above is not what you are looking for! Potential facilitators to research uptake Researchers reframing practice issues to align with the available evidence. Framing the problem is an essential aspect of many KT activities (e.g. a policy brief) and can bring together many different types of evidence to respond to a particular practice or implementation need. Strengthening the capacity of practitioners to demand appropriate research to address a specific problem. Researchers collaborating with practitioners to generate essential information, encourage active sharing, and jointly identify pressing priorities. Creating targeted messaging emphasizing the role research evidence can play in contributing to better programmes or improved interventions. Researchers networking with practitioners to develop personal contact and trust. Reflection Activity [slide 10] 15 minute exercise: Break into five groups and select two groups to present their conclusions. Ask groups to reflect on a health programme they are familiar with in their country. Is there a policy underpinning this programme? If so, what research evidence was used to formulate this policy? Participants can review the Uganda example presented in their workbooks for inspiration. Key concept 2: Dissemination tools [slide 11] There are many dissemination tools available to research teams that can be used to promote uptake of research findings. The various dissemination tools should be considered less as individual approaches and more as parts of a whole. The various tools should be used in combination within a larger plan, which produces a complete, effective dissemination package. Each tool described has different strengths and weaknesses, and increasing the number of ways that research results reach key audiences increases the chances of uptake and action. Before you begin this sequence of dissemination tool examples, brainstorm the following points among participants: • What are the dissemination tools they are familiar with? • What are the main features of each one? • What are the relative pros and the cons? 94 Four important dissemination tools [slide 12] Detailed summaries of the four tools mentioned in this slide are presented in the participant workbook. Work through the four tools, using some of the following points and notes: Research report • The content of the research report depends on the funder and their requirements. • Ask participants to suggest typical sections (i.e. title; list of authors and preface; acknowledgement; abstract; executive summary; introduction; literature review; research design/methodology; results; discussion; conclusions; and references). • One key question to have in mind when writing report: What other ways can we use or repackage this information? Peer-reviewed paper • Publication in a peer-reviewed journal signals acceptance of the work within the community. • Publication is the beginning of a new cycle of achieving influence. • All journals have different target audiences and varied author instructions. Before writing, identify the intended journal. Press release (an example is given in the workbook) • Mass media is a crucial audience for research findings. Ask participants to suggest why this is important. • A press release is similar to a sheet of ‘take-home messages’, but with its own style and structure that must be followed: – No longer than one page. – Strong and informative headline. – Summarized in several lines – justifying why the research findings deserve publication. • A misleading coverage [slide 13] can be avoided by making a press release available by the media. • This is an example of research information misrepresented. The reporter got the information at a conference and wrote it up with a sensational headline to catch the attention of readers. • Point out to participants that sometimes situations like this are unavoidable BUT the chances of occurring can be reduced by providing a press realease for the media. Policy briefs Policy briefs are short documents that present the findings and recommendations of a research project to a non-specialized audience. • Focused and concise • Evidence-based • Understandable • Accessible content (jargon-free) • Professional Can participants think of other characteristics? Implementation Research Toolkit 95 Facilitating Module 5 Other dissemination tools [slides 14–25] Review each of the slides in this sequence with participants. For each approach, encourage discussion by asking participants to suggest pros/cons of each approach, and to share any related experiences they may have had. Specific considerations/questions to prompt discussion: [slide 15]: Proportions are not consistent/correct. [slide 16]: ‘Slices’ are all same size, even though allocated times vary. [slides 17–20]: Infographics are useful when they are easy to follow, and simplify complex information. Graphs/charts are often used to represent data as part of a larger infographic. [slides 21–24]: Photographs are known to be one of the most powerful tools to convey messages. Photos that accompany targeted messages can be even more powerful. [slide 25] Video: This clip shows the use of interactive video infographics to support the presentation of relatively complex data/evidence in an understandable and interesting way. This TED talk video can be streamed directly if the training facility has reliable internet access. It can also be downloaded ahead of time from http://new.ted.com/talks/hans_rosling_the_truth_about_hiv The data and animation can be downloaded from http://www.gapminder.org/downloads/ gapminder-hiv-presentation Multiple dissemination platforms [slides 26 and 27] IR involves researchers and multiple stakeholders with different capabilities and so different platforms/channels should be used to disseminate research findings. The nature, implications and audience for your findings may suggest a specific channel. Examples of ‘old media’ and ‘new media’ platforms: • Old media is often more familiar (i.e. print media, newspaper, magazine, journals, television and radio). • New media (such as social media) have also become powerful dissemination platforms. Also cost-effective and rapid. Have a brief discussion on the tool(s) best suited for each platform. Key concept 3: Dissemination strategy [slide 28] Developing a dissemination strategy is an established process for all research, and IR is no exception. The dissemination process should be an integral part of the research project cycle. Developing the overall dissemination strategy and planning for its implementation should take place at the start of the research process, and involve all relevant stakeholders. 96 Key approaches [slide 29] Ask participants to explain what they understand by the four key approaches and dissemination strategy considerations (as outlined in this slide). You can use the following points to prompt discussion: • Strong dissemination strategies feature two-way dialogues (not just from the researcher to an audience, but also from the audience to the researcher as well). • Use of appropriate language is central to effectively communicating with and reaching stakeholders. This should consider local language/dialect, and also the extent of local research literacy and familiarity. • Sensitivity to the prevailing context and culture. • Full consideration of the strengths and weaknesses of the dissemination strategies. Step-wise dissemination strategy approach [slide 30] Dissemination strategies must be developed in accordance with the local context and considerations. A generic 9-step process is suggested, which can be adapted and modified to specific settings and IR projects. Walk through each of the nine steps with participants, ask volunteers to describe how they might practically approach each of the steps in relation to their own projects: Step 1: Review past dissemination efforts Begin by looking back at what was done in the past. Step 2: Devise dissemination objectives The team should brainstorm exactly what it hopes to achieve by disseminating the research results (e.g. increase awareness, understanding, action, or support for involvement?). Step 3: Determine primary and secondary audiences The better the research team understands its audiences, the greater the chances for the dissemination approach will achieve its objectives. Step 4: Develop messages Messages should be short, direct and simple, and explain the problem the research sets out to address. Step 5: Decide upon dissemination approaches Considering what might be tight budgets/limited dissemination experience – and the dissemination objectives/audiences – decide what approaches represent the best value and prospect. Step 6: Determine dissemination channels The consideration of optimal channels helps narrow down, in very realistic ways, the types of communications tools that are practical, reach the right audiences and fit into available budgets. Above all, the choice of channel dictates who receives (and therefore who might act upon) the message. Implementation Research Toolkit 97 Facilitating Module 5 Step 7: Review available resources What materials are available for this work? What kinds of skills are available? Is there a defined budget? Will any of these variables change as we execute the dissemination strategy? Step 8: Consider timing and windows of opportunity A dissemination timeline may be obvious. Is there, for example, an upcoming conference at which the research team can distribute several different communications products, deliver a plenary presentation, and convene some face-to- face meetings? Step 9: Evaluate efforts Dissemination requires careful evaluation and feedback, and adjustments may be needed to ensure a maximum return. What will change if the dissemination strategy is completely successful? This question is critical for designing appropriate evaluation metrics, but can also guide the entire dissemination strategy development. Reflection activity [slide 31] In the participant workbook there is an example of a dissemination strategy. The research teams should use this example and the template provided [slide 32] as a guide for developing a first draft of their dissemination strategy. Choose two teams to report back on their strategies to the group. 98

FACILITATING MODULE6 MONITORING AND EVALUATING AN IMPLEMENTATION RESEARCH PROJECT Implementation Research Toolkit FACILITATING MODULE 6 Make a general introduction of the module to participants. e.g. The purpose of this module is to help research teams track their progress against set plans, check compliance to established standards, identify trends and patterns, adapt strategies and inform decisions for project management. The module is also designed to build skills to determine the relevance and fulfilment of objectives, developmental efficiency, effectiveness, impact and sustainability. Six steps in IR process [slide 2] Take a short time to review the overall IR process/framework again as you start the module. Use the IR cycle diagram in slide 2 to remind participants that Monitoring and evaluating an implementation research project is the sixth step in the cycle. Presentation outline and expected outcomes [slides 3–4] Go through the agenda with participants to ensure that they understand what will be covered in the session. Highlight the expected outcomes and key concepts that will be covered in the module. The brief notes below will help you to prompt participants to suggest their own understanding of each key concept before the session begins. Key concepts for this module [slide 5] 1. Monitoring and evaluation (M&E) plan A monitoring and evaluation (M&E) plan is a document that outlines how an implementation research project is monitored and evaluated, and that links strategic information obtained from various data collection systems to decisions about how to improve the project on an ongoing basis. The M&E plan serves several purposes, including: (i) stating how achievements of the programme/project will be measured (ii) documenting consensus, thereby encouraging transparency, accountability and responsibility; (iii) guiding implementation of M&E; and (iv) preserving institutional memory. Each project has different M&E needs, depending on the operating context, implementing agency capacity, donor requirements, and other factors. In preparing an M&E plan, it is important to identify these needs and coordinate the methods, procedures and tools used to meet them; this conserves resources and streamlines M&E planning. 101 Facilitating Module 6 2. Developing an M&E plan Before setting up an M&E plan, teams should define the overall project goals and objectives, understand the context for the study and identify the key players/stakeholders. The most appropriate approach (e.g. M&E framework and data collection methods to conduct M&E) should then be selected. Six key steps should be taken when developing an M&E plan: • Stakeholder consultation and participation • Developing the M&E plan • Determining the M&E methodology • Assigning responsibilities for implementation • Setting targets • Defining reporting system, dissemination and utilization of results 3. Implementing the M&E plan Implementation of the M&E plan occurs in three stages, namely: (i) checking and measuring progress; (ii) analysing the situation; and (iii) reacting to new events, opportunities and issues. Key concept 1: Monitoring & evaluation plan [slide 6] Define the M&E plan as a document that describes the M&E system and links strategic information obtained from various data collection systems to decisions that will improve the project [slide 5]. The M&E plan must address the end users and their information needs in order to facilitate its use. Key components [slide 7] One of the primary purposes of an M&E plan is to describe how achievements of the programme/ project will be measured. In order to stress this basic starting point, begin discussion of this slide by asking participants to describe the changes/impact they expect from their project. You can then ask individual teams to progress through points 2–4 of slide 6, to highlight the four key components that form the foundation upon which an M&E plan should be built. Answering the four corresponding questions is critical to M&E planning. Slide 7 reinforces that any M&E plan is built on the key parameters of a given project. Uses of an M&E plan [slides 8 and 9] Another way to encourage participants to consider the foundations of an M&E plan from a broad perspective is to highlight why such a plan is significant/important. Before progressing to slide 8, encourage a short discussion of this point by asking participants: “What are the uses of an M&E plan?” 102 Uses of an M&E plan: Stating how the project will measure its achievements. Documenting consensus thereby encouraging transparency and responsibility. Guiding M&E implementation. Preserving institutional memory. An M&E plan is built on the key parameters of a project [Slide 10] The major elements of the M&E plan must take into account and be based around overall goals, main beneficiaries and consider limitations of the project such as scope, size and budget of the project. Explain briefly how these parameters act as the practical (and logical) ‘boundary’ inside which the project impact can be assessed. Facilitators of research evidence uptake [slide 11] Usefulness is, however, only one of the critical characteristics of an M&E plan. Remind participants that to be effective an M&E plan must conform to each of the following standards: Utility [see slides 8 and 9]: It must be useful and serve the practical and strategic information needs of the intended users for decision-making purposes, which may range from assessing programme performance to allocating resources, etc. Feasibility: Realistic and practical. Given the general scarcity of resources, the M&E plan should make the best use of existing data collection systems. However, if new data collection systems are involved, resources (cost and technical capacity) must be carefully considered. Ethically sound: Abide by ethical principles with regard to those involved in and affected by the M&E activities. Accuracy: Provide technically accurate and useful information for decision-making and programme improvement. Key concept 2: Setting up or developing an M&E plan [slides 12 and 13] Although already defined in detail earlier in this module, reiterate the main factors/issues that should be considered [slide 12] before setting up an M&E plan (in order to ensure that participants are not placing the plan itself in precedence of these considerations): • The overall project goal. • Understanding the context of the intervention/research. • Identify the key players. • Define the most appropriate approaches (frameworks and methods). Only then should you move on to describe the key steps in developing an M&E plan [slide 13], with the following suggested emphasis: 103 • Stakeholders’ consultation should occur regularly throughout the entire process of developing and implementing the M&E plan. This creates a greater sense of ownership and responsibility, and also increases the probability that the results will be used. • Developing the M&E plan provides a visible linkage and relationship between activities, outputs, outcomes and impact. • How the activities are designed, implemented and monitored translates into how the research problem, goals and objectives can be objectively measured. • It is critical to understand from the outset what factors/variables can be/need to be measured (e.g. resources, service statistics, coverage, quality, etc.), and how the different types of information will be collected and used. • To enable standardization and comparison with other similar projects, the ‘indicators’ should be consistent, as far as possible, with international/national standards. • When considering the optimal methods for collecting and analysing data, capabilities of the existing information systems should be assessed. • The roles and responsibilities of different players should be spelt out, as this will determine how the M&E plan is to be implemented and the reporting system to be adopted. • The reporting system should connect the field to the centre, so those in the centre know what is happening elsewhere. • Target-setting should be done in consultation with all stakeholders to ensure uniform understanding of what the project is committed to achieve. This should focus authentically on what can be realistically achieved given the resources and the environment in which the project is taking place. • The M&E plan should also describe the plan for disseminating and utilizing findings (i.e. in terms of target audiences, frequency/timing of dissemination, and appropriate communication outlets and channels). A case study (based on your experience), which describes the development of a specific M&E plan, can be a useful and intentional way to achieve this broad emphasis. Use slides 19–22 in a flexible way to illustrate some of these key points. Logframe objective [slide 14] Explain how the project inputs, activities are linked to the expected output, outcomes and goal. discuss the indicators at each level. Key steps in setting up M&E plan [slide 15] Emphasize the following to participants: • When considering the appropriate methods by which data for M&E will be collected and analysed, the existing information systems capabilities to address the information needs should be assessed. • The roles and responsibilities of the different players should be spelled out, as this will determine how the M&E plan is to be implemented and the reporting system is adopted. • Targets should be set in consultation with all stakeholders so that everyone understands what the project is committed to achieving. When setting targets, you must focus on answering the 104 question of “what can realistically be achieved given the resources and the environment in which the project is operating”. • The M&E plan should articulate a plan for disseminating and utilizing M&E findings, in terms of the target audience, frequency/timing of the dissemination and appropriate outlets and media channels for communicating M&E data. Evaluation domains & data collection methods [slides 16 and 17] Slide 16 presents an example of a matrix that can be used to map out and assess evaluation domains and data collection methods. Present and explain this example, highlighting the relationship between the selected indicators and data collection methods. Ask participants if they agree with the choice of methods in each case. For the group activity, ask teams to use the same matrix to begin describing the evaluation domains for their own projects, and formulating appropriate indicators and data collection methods. Reflection activity [slide 23] (time to be determined/agreed with participants) First explain the activity and the table. The teams should then create an initial draft of their respective M& E plans (allow up to 30 minutes). A blank template is provided for this activity in the participant workbook. Adapted from Scott G (2008), Monitoring & Evaluation planning Guidelines and tools, American Red Cross Emphasize that the M&E plan helps with systematic operationalization of the M&E activities. Point out that this is just a guideline. Explain how to fill the table. • 2nd Column: insert your pre-determined time-bound objective for project level. • 3rd Column: list the indicators. • 4th Column: insert a performance target for each indicator. • 5th Column: insert the methods to collects data. • 6th Column : insert the frequency of data collection. • 7th Column: insert the name of the person who will be primarily responsible for the activity. • 8th Column : list the resources you require for the activity. • 9th Column : list the conditions that should be in place for you to carry out your activities. • 10th column: List how the information generated will be used for decision-making. Each team should create an initial draft of their project’s M& E plan (give them 10 minutes). Invite two teams to volunteer and present their draft M&E plan (5 minutes for each team). Key concept 3: Implementing the M&E plan [slide 24] The following points regarding the three stages should be highlighted: Checking and measuring progress: Ideally, monitoring focuses on the project’s three main characteristics of quality, time and cost. The project manager coordinates the project team. Analysing the situation: The status of project implementation is compared to the original plan. The causes and impact of potential deviation are identified and documented. 105 Reacting to new events, opportunities and issues: It is important to anticipate and react quickly to new situations, events, opportunities and issues and to identify the necessary actions to be taken. Updating the M&E Plan [slide 25] The entire project team (including key stakeholders/partners) should be involved in the review and adjustment/updating of the plan, and the revised plan should be circulated to all. The M&E plan should be dynamic, involve all team members and document the changes so others know what the changes are. The M&E plan should be seen as a ‘living’ document, which should always reflect reality. Any revisions should be documented accordingly. How well is the M&E plan working? [slide 26] Ask participants to suggest questions that might be considered to assess how well the M&E plan is working in the specified areas. Some examples follow. • Are M&E activities progressing as planned? • Are the evaluation questions being answered sufficiently? • Have other evaluation questions been raised and should they be incorporated into the M&E plan? • Are there any methodological or evaluation design issues that need to be addressed? • Are there any outside factors (e.g. political, environment) that are affecting the M&E plan? • Are appropriate staff and funding still available to implement the M&E plan? • Are M&E findings being disseminated and used by stakeholders for decision-making and programme improvement? Application of key concepts [slide 29] An example is provided to participants (see workbook) that describes the steps taken (by the research team and the implementers) to develop the M&E plan for the use of vouchers for scaling up insecticide-treated nets in the United Republic of Tanzania (2003–2007). Table 1 (see workbook) describes the evaluation domains and data collection methods that were used. The teams should have read the summary (prior to the workshop), if not, they should read it now. The activity comprises an analysis of the steps that were taken by the M&E team to develop the M&E plan for the voucher scheme. Invite two teams to volunteer to present their analysis (~5 minutes for each team). 106 TDR/World Health Organization 20, Avenue Appia 1211 Geneva 27 Switzerland Fax: (+41) 22 791-4854 tdr@who.int www.who.int/tdr The Special Programme for Research and Training in Tropical Diseases (TDR) is a global programme of scientific collaboration established in 1975. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases. TDR is sponsored by the following organizations: World Bank TDR/RCS/14/1 ISBN 978 92 4 150696 0

Workbook Implementation Research Toolkit

Workbook Implementation Research Toolkit WHO Library Cataloguing-in-Publication Data: Implementation research toolkit. Contents: Facilitator guide, Workbook, Brochure and Slides. 1.Research. 2.Delivery of Health Care – methods. 3.Program Development – methods. 4.Translational Medical Research 5.Teaching Materials I.World Health Organization. II.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. ISBN 978 92 4 150696 0 (NLM classification: W 20.5) Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2014 All rights reserved. The use of content from this health information product for all non-commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. 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Editing and design by Inís Communication – www.iniscommunication.com Acknowledgements This Toolkit was developed by the Special Programme for Research and Training in Tropical Diseases (TDR) to strengthen implementation research (IR) capacities of individuals and institutions in low-and middle-income countries where the greatest need exists. It is supported by core contributions to TDR from the following: Belgium, Brazil, China, Cuba, Germany, Ghana, India, the Islamic Republic of Iran, Japan, Luxembourg, Malaysia, Mexico, Netherlands, Nigeria, Norway, Panama, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom of Great Britain and Northern Ireland, the World Bank and Zambia. Specific support was also provided by USAID, and by the Implementation Research Platform, which is based at the World Health Organization and brings together the Alliance for Health Policy and Systems Research; the Special Programme of Research, Development and Research Training in Human Reproduction; the World Health Organization’s Department of Maternal, Newborn, Child and Adolescent Health; and the Partnership for Maternal, Newborn and Child Health and TDR. The toolkit was initiated by Jane Kengeya-Kayondo and Soumya Swaminathan. Henry Lucas, Sandy Campbell, Dirce Guilhem, Boatin Boakye, Yodi Mahendradhata, Colla Jean MacDonald and James Foreit prepared the initial materials for the modules in the toolkit. Guidance and advice on the development process was provided by a steering committee which included the following Miguel Angel Gonzalez Block, Kathleen Handley, Kazi Mizanur Rahman, Wynne E. Norton, Jason B. Smith, Uche V. Amazigo, Linda Kupfer, Shenglan Tang, Isaac K. Nyamongo, Nhan Tran. The Toolkit has benefited from the contributions and advice of many individuals and we wish to thank the following individuals for the input from the compilation and restructuring of the modules through the pilot workshops and final editing: Review and feedback on content: Taghreed Adam, Sam Adjei, Irene Agyepong, Bill Brieger, Effie Espino, Timothy France, Prea Gulati, Jamie Guth, John Gyapong, Adnan Hyder, Regina Kamoga, Barrot Lambdin, Jeff Lazarus, Temina Mandon, Yolanda Ogbolu, Joe Okeibunor, Dimeji Oladepo, Obinna Onwujekwe, Johannes Sommerfeld, Thomas Sukwa, Fabio Zicker. Facilitation of pilot workshops: Ayat Abu Agla, Riris Andono Ahmad, Oladele Akogun, Khaleda Islam, Andres Z. Jaramillo, Baralee Meesukh, Isaac K. Nyamongo, Tuoyo Okorosobo, Martin Ota, Ayo Palmer, Shagufta Perveen, Mike Sanchez, Honam Irene Tsey. Over 200 researchers, academics, disease control programme managers, policy-makers, health administrators, communication scientists and journalists contributed to test and evaluate the toolkit. The following implementers and researchers contributed to the pilots and provided feedback/ comments: Wondwossen Belehu, Paul Bukuluki, Meg C. Doherty, Mary Ellsberg, Katherine Fritz, Meseret Gossa, Nancy Glass, Paul C. Hewett, Elijah Oyaro June, Kuyosh Kadirov, Etienne Karita, Joseph Kariuki Muriithi, Kathleen Kostelny, Jeremias L. Messias, Aragaw Biru Muhammed, Abraham Mukolo, Ester M. Mungure, Tina C. Musuya, Ramadhani S. Mwiru, Edith Nakku-Joloba, Kenneth K. Ngure, Walter O. Obiero, Spallanzani Oduor Ohaga, Eunice A. Omanga, Patrick O. Owiti, Deidra Demeatra Parrish, Nancy A. Perrin, Paul Bitwahiki Ramazani, David Sando, Helen Semu, Anuraj Shankar, Nicholas Shiliya, Helen N. Siril, Amanda C. Tichacek, Rogers Twesigye, Michael Wessells, Olufemi A. Adegoke, Naeemah Abrahams, Nurelign Mohammed Ahmed, Laurence Natacha Ahoua- Leray, Meghan Bishop, Emily Bobrow, Kerry Bruce, Jeanine Condo, Koen Frederix, Khanyisa Gala, Piotr Andrzej Hippner, Andrea Howard, Locunda Erin Higgins Hummert, Mubiana Inambao, John Barton Jemmott, Deyessa Kabeta, Jolly Kamwanga, Amira Karam, Matthew Raymond Lamb, Lebohang Mary Ledikwe, Virginia Letsela, Tonderai Mabuto, Mokgadi Rebecca Malahlela, Abdelhamid Mjidila Charmaine Mlambo, Yael Moverman, Martha Mukaminega, Fhumulani Mavis Mulaudzi, Iris Bongiwe Ndondo, Mathew Ngunga, Bonisile Nhlabatsi, Thobo Matuhogonolo Phologolo, Asta Helen Rau, Letitia Lynn Reason, Mary Pat Selvaggio, Vandana Sharma, Anne Teitelman, Mark Tomlinson, Renay Weiner, Robert Carl Yohnka, Vincent Kudakwashie Zishiri, Abdul Aziz Abdulai, Ismail Adem Abdilahi, Ayat Abu-Agla, Elsheikh Elsiddig Ahmed, Alaaedieen Mokhtar Ali, Wagdy Abdel Moniem Amin, Frank Biney, Peter Chibatamoto, Amel Abdu Gesmalla, Musse Mohamed Hasan, Mirriam Kangwende, Freddy Eric Kitutu, Rugare Abigail Kwakye, Kedibonye Dundu Macha, Talent Maphosa, Matshelo Tina Matlhaga, Chawangwa Modongo, Mohamed Farah Mohamoud, Fadzai N.N. Mutseyekwa, Kwame Shanaube Mwange, Magdy Fawzy Nasrallah, Matsiri Tiroyaone Ogoposte, Sandra Simbeza Sinzala, Henry Wamani, Anisuddin Ahmed, Dhana Raj Aryal, K.C Ashish, Lu Gao, Shaikh A. Shahed Hossian, Khaleda Islam, Nurhuda Binti Ismail, Gamini Jayakody, G.A.J.S.K Jayasooriya, Frederick Dony Jiloris, Pahalagedera Kusumawathie, Huq, Trisasi Lestari, Li Lin, Nafisa Lira, Hammed Oladeji Mogaji, Aftab Ali Akbar Mukhi, Abdul Razak Abdul Muttalif, Shagufta Perveen, Likke Prawidya Putri, Khalid Hussain Shaikh, Raihan Sharif, Ravi Vitrakoti, Nandyan N. Wilastonegoro, Wenti Xu, Quudus Adegboyega Yusuff, Hakeem Abiola Yusuff, Martha Ali Abdullai, Sheila Addei, Enoch Oti Agyekum, Gifty Ofori Ansah, Rahma Eltigani Mohammed Ahmed, Naa Korkor Allotey, Efua Asante, Frank Baiden, Azza Tag Eldin Bashir Babiker, Boniface Denakpo, Eva Engman, Ferrer Blanca Escribano, Lawrence Gyabaa Febir, Boniphace Salustian Jullu, Esther Kyungu, Towela Maureen Maleta, Humphreys Kampila Nsona, Mariam Oke, Mona Babiker Omer, Senga Kali Pemba, Themba B. Phiri, Tatcheme Filemon Tokponnon, Finally, we would like to acknowledge the South African Medical Research Council Durban, College of Health Sciences University of Botswana Gaborone, the International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b) and the TRAction project in Dhaka and the Dodowa Health Research Center of the Ghana Health Services as well as Ayishatu Gibrin and Najoua Kachouri for their contributions in organising the pilot workshops. Responsibility for the views expressed and for any errors of fact or judgment rests with Margaret Gyapong, Edward Kamau, Robinah Najjemba, and Olumide Ogundahunsi, authors of this toolkit. AbbreviAtions ACT artemisinin-combination therapies ANC antenatal care ART antiretroviral therapy BCC behavior change communication BMI body mass index CAS complex adaptive system CHW community health worker CMS Cooperative Medical Scheme COS Community of Science DOT directly-observed therapy ERC ethics review committee FGD focus group discussion HDI Human Development Index HIV human immunodeficiency virus HRP Special Programme of Research, Development and Research Training in Human Reproduction IC informed consent ICF intensified case finding IDRC International Development Research Centre IEC information, education and communication iKT integrated knowledge translation IR implementation research IRB institutional review board IRP Implementation Research Platform KT knowledge translation KZN KwaZulu-Natal LLIN long-lasting insecticide-treated net LOI letter of intent LSHTM London School of Hygiene and Tropical Medicine LTFU loss to follow-up M&E monitoring and evaluation MDR-TB multidrug-resistant tuberculosis NGO nongovernmental organization NSF National Science Foundation NTBCP national TB control programme OER Office of Extramural Research PI principal investigator PLHIV person/people living with the human immunodeficiency virus PMTCT prevention of mother-to-child transmission QDA qualitative data analysis RFP request for proposals SAGE Strategic Advisory Group of Experts SARS severe acute respiratory syndrome SMART specific, measurable, achievable, realistic and timebound SOP standard operating procedure SWOT strengths, weaknesses, opportunities and threats TB tuberculosis TDR Special Programme for Research and Training in Tropical Diseases UNDP United Nations Development Programme UNICEF United Nations Children’s Fund USAID United States Agency for International Development WHO World Health Organization 3 modUle 1 2 modUle modUle contents introdUction And bAsic orientAtion contextUAlizing implementAtion reseArch issUes . . . . . . . 15 Learning objectives. . . . . . . . . 16 Key concepts . . . . . . . . . . . . 16 Understanding the ir context. . . . 16 Understanding the intervention . . 22 ethicaL issUes in research . . . . . 28 appLication of Key concepts . . . . 32 concLUsion . . . . . . . . . . . . . 35 references . . . . . . . . . . . . . 36 additionaL reading . . . . . . . . . 37 developing An implementAtion reseArch proposAl . . . . . . 39 introdUction . . . . . . . . . . . . 40 introdUce yoUr team and research chaLLenge . . . . . . 41 groUp activity: refresher on ir fUndamentaLs . . . . . . . . . 41 fUnding an ir project . . . . . . . . 42 components of an ir proposaL . . . 45 1. Writing the introdUction section. . . . . . . . . . . . . . . 53 Writing the introdUction . . . . . . 53 research qUestion(s) . . . . . . . . 62 revieW of LiteratUre (synthesis of existing KnoWLedge) . . . . . . . 65 2. research design . . . . . . . . . 70 stUdy participants . . . . . . . . . 71 research methods . . . . . . . . . 72 qUaLity management . . . . . . . . 85 research ethics. . . . . . . . . . . 88 3. project pLan . . . . . . . . . . . 91 pLanning the ir project . . . . . . . 91 research team . . . . . . . . . . . 94 bUdget and jUstification . . . . . . 97 4. impact . . . . . . . . . . . . . . .100 monitoring and evaLUation . . . . 100 capacity bUiLding . . . . . . . . . 104 dissemination pLan . . . . . . . . 105 5. sUppLements . . . . . . . . . . .108 project sUmmary . . . . . . . . . 108 references. . . . . . . . . . . . . .111 plAnning And condUcting An implementAtion reseArch project . . . . . . . . . . . 113 introdUction . . . . . . . . . . . 114 Learning objectives. . . . . . . . 114 Key concepts . . . . . . . . . . . 114 seeKing ethicaL cLearance . . . . 114 project impLementation process . 117 good practices in impLementation research . . . . . . . . . . . . . 118 appLication of Key concepts . . . 120 seeKing ethicaL cLearance . . . . 120 project impLementation process . 121 good practices in impLementation research . . . . . 121 concLUsions . . . . . . . . . . . 122 references . . . . . . . . . . . . 123 additionaL reading . . . . . . . . 123 introdUction And bAsic orientAtion . . . . . . . . . . . . 1 Learning objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Key concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is impLementation research? . . . . . . . . . . . . . . . . . . . 2 4 5 6 modUle modUle modUle developing An implementAtion reseArch proposAl . . . . . . 39 introdUction . . . . . . . . . . . . 40 introdUce yoUr team and research chaLLenge . . . . . . 41 groUp activity: refresher on ir fUndamentaLs . . . . . . . . . 41 fUnding an ir project . . . . . . . . 42 components of an ir proposaL . . . 45 1. Writing the introdUction section. . . . . . . . . . . . . . . 53 Writing the introdUction . . . . . . 53 research qUestion(s) . . . . . . . . 62 revieW of LiteratUre (synthesis of existing KnoWLedge) . . . . . . . 65 2. research design . . . . . . . . . 70 stUdy participants . . . . . . . . . 71 research methods . . . . . . . . . 72 qUaLity management . . . . . . . . 85 research ethics. . . . . . . . . . . 88 3. project pLan . . . . . . . . . . . 91 pLanning the ir project . . . . . . . 91 research team . . . . . . . . . . . 94 bUdget and jUstification . . . . . . 97 4. impact . . . . . . . . . . . . . . .100 monitoring and evaLUation . . . . 100 capacity bUiLding . . . . . . . . . 104 dissemination pLan . . . . . . . . 105 5. sUppLements . . . . . . . . . . .108 project sUmmary . . . . . . . . . 108 references. . . . . . . . . . . . . .111 plAnning And condUcting An implementAtion reseArch project . . . . . . . . . . . 113 introdUction . . . . . . . . . . . 114 Learning objectives. . . . . . . . 114 Key concepts . . . . . . . . . . . 114 seeKing ethicaL cLearance . . . . 114 project impLementation process . 117 good practices in impLementation research . . . . . . . . . . . . . 118 appLication of Key concepts . . . 120 seeKing ethicaL cLearance . . . . 120 project impLementation process . 121 good practices in impLementation research . . . . . 121 concLUsions . . . . . . . . . . . 122 references . . . . . . . . . . . . 123 additionaL reading . . . . . . . . 123 dAtA, AnAlysis And presentAtion . . . . . . 125 introdUction . . . . . . . . . . . 126 Key concepts . . . . . . . . . . . 126 data anaLysis pLan . . . . . . . . 126 qUantitative data anaLysis . . . . 127 anaLysis of qUaLitative data. . . . 135 appLication of Key concepts . . . 139 concLUsion . . . . . . . . . . . . 142 references . . . . . . . . . . . . 143 additionaL reading . . . . . . 143 disseminAting the reseArch findings . . . . . . . . . . . 145 introdUction . . . . . . . . . . . 146 Key concepts . . . . . . . . . . . 146 KnoWLedge transLation . . . . . . 146 dissemination tooLs . . . . . . . 149 dissemination strategy . . . . . . 155 concLUsion . . . . . . . . . . . . 161 references . . . . . . . . . . . . 162 additionaL reading . . . . . . 163 monitoring And evAlUAting An implementAtion reseArch project . . . . . . . . . . . 165 introdUction . . . . . . . . . . . 166 Learning objectives. . . . . . . . 166 Key concepts . . . . . . . . . . . 166 monitoring and evaLUation pLan . . . . . . . . . . . . . . . 166 standards for an m&e pLan . . . . 167 Key components of an m&e pLan . . . . . . . . . . . . . . . 167 deveLoping an m&e pLan. . . . . . 167 Key steps in deveLoping an m&e pLan. . . . . . . . . . . . 167 impLementing the m&e pLan . . . . 169 appLication of Key concepts . . . 170 concLUsion . . . . . . . . . . . . 175 references . . . . . . . . . . . . 175 additionaL resoUrces . . . . . . . 175 introdUction And bAsic orientAtion . . . . . . . . . . . . 1 Learning objectives. . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Key concepts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 What is impLementation research? . . . . . . . . . . . . . . . . . . . 2 interacting ir domains . . . . . . . . . . . . . . . . . . . . 4 seLf-assessment exercise. . . . . . . . . . . . . . . . . . . 5 sUmmary of tooLKit modULes . . . . . . . . . . . . . . . . . 6 the aUdience . . . . . . . . . . . . . . . . . . . . . . . . 11 references . . . . . . . . . . . . . . . . . . . . . . . . . 12 additionaL reading . . . . . . . . . . . . . . . . . . . . . 12 appendix 1: seLf-assessment frameWorK for ir cycLe steps . . . . . . . . . . . . . . . 13

introdUction And bAsic orientAtion leArning objectives This introductory module serves as a baseline introduction and a quick reference guide. You will receive an introduction to basic terms and principles, along with an orientation to subsequent toolkit modules and their rationale. By the end of the introduction, you will have a good overall understanding of the following key concepts and their application: 1. What is implementation research (IR)? 2. Key characteristics of IR and the IR cycle. The module is typically combined with an introduction/formal opening ceremony and comprises a half-day workshop/tutorial, slides and materials for further reading. It also includes a self- assessment questionnaire gauging your current IR-related knowledge and understanding. key concepts What is implementation research? The importance of research in identifying solutions and options for overcoming implementation obstacles in health systems and programmes is widely recognized. This form of research addresses implementation bottlenecks, identifies optimal approaches for a particular setting, and promotes the uptake of research findings: ultimately, it leads to improved health care and its delivery. While IR has been defined in various ways by different institutions, common interpretations focus on the systematic approach to understanding and addressing barriers to effective and quality implementation of health interventions, strategies and policies. IR is demand-driven and the research questions are framed based on needs identified together with relevant stakeholders/ implementers in the health system. Key characteristics of IR are summarized in Table 1. The need to address implementation bottlenecks is often greatest in settings where health systems are the weakest or non-existent. Unfortunately, local institutions often have limited knowledge of IR and lack essential capacities to frame relevant research questions, and conduct, manage and interpret research results for programme planning and policy implementation. Academic public health curricula tend not to focus on such research. As a result, most training does not adequately prepare researchers, practitioners, providers or decision-makers for essential partnership and interdisciplinary approaches. This current toolkit comprises seven modules, each providing a participant manual, workshop session slides, and links to relevant further reading and references. The purpose of the toolkit is to help strengthen participant skills in six areas: • Contextualizing implementation research issues. • Developing an implementation research proposal. • Planning to execute implementation research. • Analysing implementation research data. • Communicating the findings and feeding them back into the health system. • Monitoring and evaluating the project. 2 In tro d u c tIo n a n d ba sIc o rIen tatIo n Table 1: Key characteristics of implementation research Characteristic Summary/description Systematic The systematic study of how evidence-based public health interventions are integrated and provided in specific settings, and how resulting health outcomes vary across communities. Balances relevance to real life situations with rigor, strictly adhering to norms of scientific inquiry. Multidisciplinary Analysis of biological, social, economic, political, system and environmental factors that impact implementation of specific health interventions. Interdisciplinary collaborations between behavioural and social scientists, clinicians, epidemiologists, statisticians, engineers, business analysts, policy makers, and key stakeholders. Contextual Demand driven. Framing of research questions is based on needs identified by implementers in the health system. Research is relevant to local specifics and needs, and aims to improve health care delivery in a given context. Generates generalizable knowledge and insights that can be applied across various settings. Mindful of cultural and community-based influences. Complex Dynamic and adaptive. Multi-scale: occurs at multiple levels of health systems and communities. Analyses multi-component programmes and policies. Non-linear, iterative, evolving process. This set of skills is an important element of IR capacity in both individuals and institutions, particularly in low- and middle-income countries, where the greatest need for expanding IR capacity exists. Throughout the capacity-building process there are feedback loops for monitoring, adaptation and improvements, as well as suggestions for ensuring integrated knowledge translation and uptake of results. Implementation research is not a single activity, but a stepwise, cyclical process (Figure 1). The initial step is a clear identification of the intervention problem(s), working with key stakeholders to generate relevant research questions. In this manner, an interdisciplinary team can bring together the relevant skills and backgrounds to develop a detailed proposal, plan, mobilize resources and execute the study. Ultimately it can present the findings in an appropriate format for uptake and use by planners and decision-makers within the health system. 3 Figure 1: The six steps of the implementation research cycle While conducting IR, there must be active and continuous monitoring of activities and regular feedback for necessary changes and amendments. Dissemination of findings in IR should occur continually throughout the cycle as well as after the completion of the research project. The findings must be presented appropriately for each partner and stakeholder, so that the most relevant results are available in a timely manner to influence practice. Interacting IR domains It is instructive to think of IR in terms of the five main interacting ‘domains’ that it encompasses (Figure 2). You will encounter more detailed descriptions of these domains throughout subsequent modules, in addition to the general descriptions outlined here. The intervention. The characteristics of the intervention determine whether it will be adopted or ‘fit’ for the local health system. Here the term ‘intervention’ includes the core components and those elements that may be adapted to suit local needs and/or conditions. The characteristics of core components, such as complexity, cost and evidence strength, play a crucial role. Outer setting. This includes the economic, political and social contexts in which an intervention is carried out and that are external to the implementing organization/institution. It is influenced by external policies and incentives – such as global funding streams – as well as by interactions and peer pressure among organizations. Inner setting. This refers to the context within the implementing organization/institution. It includes the structure of the organization, its culture (internal climate) and networks, as well as readiness for change. Individuals involved. These are people who have a direct role in the implementation process. This includes health care providers, managers in various parts of the organization/institution, policy-makers and many other stakeholders and beneficiaries. In addition to the usual concerns regarding the capacity to implement, their perceptions and attitudes towards the intervention have an important influence on their commitment to its success and impact. 4 1 step step step step step 3 2 4 6 Contextualize challenges Develop a proposal Plan and conduct project MENTORING UPTAKE FEEDBACK CONTINUOUS MONITORING Monitor and evaluate the project step 5 Analyse and present data Disseminate research findings In tro d u c tIo n a n d ba sIc o rIen tatIo n Process for implementation. This incorporates all of the methods and approaches used in facilitating adoption of the intervention at all levels of the organization, including the planning of strategies and activities. Processes include both those explicitly planned and unforeseen ones that emerge during implementation. Self-assessment exercise The team you bring together to tackle a specific IR challenge should be multidisciplinary: members of the team have varied roles, work in diverse sectors, and likely have very different backgrounds. Members may also have diverging ideas about how the elements of IR fit together and what they mean and varying degrees of competence in each area. An IR-focused self-assessment within each team allows you to identify some of those differences in opinion, individual strengths and the distribution of competences within the team. It also allows you to walk at your own pace through the content and focus on the six skill sets the toolkit helps to strengthen, setting your team’s broad learning targets. Using the matrix shown in Figure 3, select your team’s current level of: • awareness • understanding • knowledge • skills • competence in each of the steps in the IR cycle. You can also refer to the more detailed matrix provided in Appendix 1 if there are individual steps you/your team are not clear about at this stage. Each team member should keep a copy of the completed self-assessment matrix, and refer to it during the remainder of the workshop. Figure 2. Interacting domains in implementation research 5 Intervention Outer setting Economic, social and political contexts Inner setting Context within the organization implementing the intervention – Culture, structure, networks etc. Individuals involved Individuals who have a role to play in the implementation process – health care providers, managers, policy makers, beneficiaries, Process for implementation Methods used to facilitate adoption of the intervention at all levels (planned and emergent strategies and activities) Figure 3: Self-assessment framework for IR cycle steps Summary of toolkit modules A brief summary of individual modules and their rationales is presented below. Module 1: Defining and contextualizing implementation research Implementation research is conducted within routine systems and real life settings, removed from the controlled settings associated with other types of scientific research. The prevailing physical, socioeconomic, cultural, health systems, stakeholder and institutional culture are all key aspects of the environment where the research is conducted. Together they contribute to and affect the planning, implementation, monitoring and outcomes of interventions. This module facilitates consideration of the context and engagement of stakeholders in order to help identify bottlenecks and formulate appropriate research questions. The overall objectives of the module are to: • Facilitate engagement between researchers and implementers. • Identify implementation bottlenecks or inefficiencies. • Frame appropriate research questions to address the issues identified. • Highlight the different methodological approaches to generating information. • Consider ethical issues in context. • Facilitate mentorship to ensure sustained IR capacity at all levels. Skill sets 1Some awareness 2 Understanding 3 Knowledge 4 Skills 5 Competence Contextualizing IR issues Developing an IR proposal Planning IR A n al ys in g IR d at a Qualitative Quantitative Communicating IR findings and feeding them back into the health system Monitoring and evaluating the project 6 In tro d u c tIo n a n d ba sIc o rIen tatIo n Over the past decade an half, many efficacious disease control tools, (e.g. bednets and artemisinin- based combination therapy for malaria, praziquantel for schistosomiasis, ivermectin for lymphatic filariasis and onchocerciasis) became available. Studies have demonstrated that these tools can be delivered at the community level. Nevertheless, many have had only limited impact because of inadequate implementation. Once integrated into the in the health system and/or community, an intervention can lose effectiveness or impact due to several factors including, for example, poor uptake of clinical guidelines into practice despite supporting evidence or financial costs to the target population limiting access. Figure 4: Influence of health system factors on intervention effectiveness and impact Figure 4 highlights that in order for a proven and efficacious tool to be effective, it must be accessible to the target group, health care providers must comply with the relevant policies and patients must adhere to the information on use of the tool. However, there are several challenges including inequities that affect the ability of various stakeholders to use the tool as expected eventually rendering the tool ineffective. In order for IR to be successful, the researcher must have an active link with and rapidly respond to the needs of disease control. There must be partnerships and links with other health related ministries or departments and agencies so that relevant findings during the entire process can be taken up and utilized for action as and when it becomes necessary. Because implementation research takes place in real, non-experimental settings and within complex dynamic systems (1), understanding the specific context of the implementation is important. The physical, socioeconomic, cultural and health system, stakeholders, as well as the institutional contexts within which the intervention is taking place affect the planning, design and conduct of the research. Therefore for IR to be relevant, researchers with appropriate stakeholders should interrogate these contexts through situation and institutional analyses. This entails face-to- face interactions, discussions and sharing of documents to ensure that the appropriate questions are asked, addressed in context and have the commitment of all concerned to facilitate uptake of results during and at the end of the research. Efficacious tool - E ff ec ti ve n es s + Accessibility Provider compliance Patient adherence Effectiveness 7 Module 2: Developing an implementation research proposal This module assumes the participants understand the contextual nature of IR, have engaged the right stakeholders, have articulated the problem/barrier to be addressed and have assembled an appropriate and multi-disciplinary team. The underlying principles are presented in the introductory module and module 1. It takes you step-by-step through the process of formulating appropriate research question(s), choosing the appropriate study design to answer the question(s) and preparing an outline of the project activity plan. It covers the following key concepts with examples: • Identifying barriers to implementation and formulating the research question. • Making your case for funding (introduction, rationale and objectives). • Study design and appropriate methodologies. • Planning the project (budget, personnel, timelines, monitoring and evaluation). Regardless of the subject area or study approach, research proposals generally follow a similar outline (Box 1). Box 1 Typical outline of a proposal for implementation research 1. Title This should be a brief statement explaining what the proposal is about. 2. Executive Summary A brief summary of the entire proposal (usually no more than 1 page). 3. Introduction and background An explanation of the issue(s) being examined. 4. Literature review A description of what is already known in the subject area articulating why the background studies are not sufficient. 5. Rationale An explanation of why it is necessary and relevant to conduct the study. 6. Objectives Statement of what will be achieved through the study and when it will be achieved. 7. Methodology/study design A description of how the study would be conducted, what procedures and standards will be followed, the type of data to be collected and the responsible team member. 8. Ethical issues Issues about the autonomy, protection and confidentiality of the subjects abd hiw these will be addressed. 9. Budget/resources An outline of the financial costs involved in implementing the proposed study and any other essential resources. 10. References Acknowledgment of the literature (e.g. research articles, policy papers and documents) used as references for the information provided in the proposal. The difference between an IR proposal and other types of research proposals is the process of identifying the research problem and the involvement of the end users in the research process (2). An IR research project (be it an intervention or analysis of routine data) should achieve the following. Box 1 8 In tro d u c tIo n a n d ba sIc o rIen tatIo n • Better inform health care delivery. • Facilitate the uptake of research results. • The process through which the results were achieved should be generalizable so they can be applied across settings and contexts. • Involve and engage partners across multiple disciplines to address the identified problem. • Lead to the development of policy recommendations for practical solutions (3). Module 3: Planning to conduct the research This section of the toolkit addresses the steps that you will take once resources to support an IR proposal have been secured. It provides information to facilitate planning to conduct the research project, including preparation of the study protocol for an ethical review process. Module 3 covers the following key concepts with examples. • Preparing for ethical review. • Project implementation process. • Good practices in IR. For the successful execution of any project the importance of a good project plan cannot be over-emphasized. The project needs a team where each member has a specific role that is clearly defined and linked to specific outputs. The aims are to: (a) ensure the project has a common goal and (b) provide a clear vision of the project including what needs to be done and at what quality standards, who will do it, when it is to be done, cost of the project, source of funding, milestones and reporting timelines. Planning for IR involves: • defining the scope (consulting stakeholders, agreeing on roles and responsibilities, defining deliverables); • articulating an implementation plan (methods and inputs required); • timelines (Gantt chart); • reporting activities; • estimating resources needs (human and other). Module 4: Data analysis and presentation This module has been designed to help the research team (implementers and researchers): • understand appropriate data analysis procedures for qualitative and quantitative data; • use of statistics in quantitative research; • and describe and document the data analysis processes in a qualitative study. It also employs examples to illustrate the applications of the underlying concepts. In IR, data management and analysis is an ongoing process throughout the project. At all stages (the situation analysis stage prior to, during and following the intervention) data must be collected, managed, analysed and presented in a way that will useful to end users. The type of research problem identified and question asked will determine the type s of analysis to be conducted. Examples of analysis include: • Stakeholder analysis (the process of identifying individuals or groups that are likely to affect or be affected by a proposed action, and sorting them according to their impact on the action and the impact the action will have on them). 9 • SWOT analysis (framework for organizing and using data and information gained from the study of organizations and in monitoring and evaluation of organizations and activities). Institutional analysis (systematic study of the behaviour of organizations). • Other types of analysis include the continuous monitoring and evaluation of the main intervention. At each stage of the process, data collected is either qualitative or quantitative and the standard procedures for analysing such data must be employed (4). It is critical that the researchers do not do this in isolation, but involve all stakeholders in the data management and analysis process to provide the relevant stakeholders the opportunity to use the results as they are generated (5). Module 5: Dissemination of research findings This module has been designed to assist the research team to: • appreciate the concept of knowledge transfer in the uptake and use of research results; • describe the barriers and facilitators of knowledge transfer in relation to a research project; • understand the value of disseminating information throughout the project cycle; • appreciate the value of developing of a comprehensive dissemination strategy in a research project; • appreciate the importance of tailored dissemination tools for the different target audiences. It illustrates the key concepts of knowledge translation with examples and provides structured guidance on preparation of research reports, peer reviewed papers, press releases, conference presentations and policy briefs. Dissemination in IR is not a one-step process. Implementers, working with researchers, take up and use research results as they are generated. The key issue as it relates to IR is that dissemination cannot be deferred until the research is ‘completed’. Dissemination of research findings must be packaged appropriately for each category of stakeholders and key decision-makers. Policy-makers often highlight the failure of researchers to make research results available, while researchers often express frustration that policy-makers do not use research results provided. Brownson et al (6) have used the phrase “travellers in parallel universes” to describe researchers and policy-makers. This disconnect can be avoided by adopting a more comprehensive approach to dissemination. Too often, researchers become aware of the following questions only after the study is completed: • Which stakeholders will benefit from the information to be generated? • What particular questions are these stakeholders seeking to answer? • How do we involve stakeholders in defining and asking the ‘right’ questions? • Who should be targeted in order to get the intervention or finding into action? • How do stakeholders actually absorb research evidence? • Who will be directly or indirectly affected by the outcome of this research? • Is there is a plan for operationalizing the findings, who will support or oppose it? How might we respond to any opposition? Or take advantage of support? • How can we best leverage critical stakeholder insights or allay their objections? These questions should be an integral part of the project planning. If IR is conducted appropriately researchers, implementers and policy-makers should communicate and collaborate throughout the entire journey of the IR cycle. Conventional publication of research findings in peer reviewed 10 In tro d u c tIo n a n d ba sIc o rIen tatIo n journals, written policy briefs and research reports are also essential aspects of dissemination in IR and have their roles. Module 6: Monitoring and evaluation The final module has been designed to help you and the research team track progress in accordance with set plans, check compliance with established standards, identify trends and patterns, adapt strategies and inform decisions for project management. It also helps build skills to determine the relevance and fulfilment of objectives, developmental efficiency, effectiveness, impact and sustainability. On completion of this module, your team will be able to appreciate the process involved in the development of a monitoring as well as evaluation plan and describe the overall implementation process of an IR project. The audience IR involves teamwork. It requires people with different and complementary skills, experiences and backgrounds to come together in order to address an implementation problem and answer questions posed by health care providers, programme managers, implementers and/or other service providers in the execution of their duties. An IR project can therefore include researchers and other stakeholders such as health care providers, programme managers, policy-makers, students, civil society organizations, nongovernmental organizations and any other groups or individuals interested in the IR process and results. Although it is important for everyone involved in an IR project to have an understanding of the entire IR cycle and their role in the project, the modules in this toolkit specifically target health care providers, researchers, policy-makers/managers and administrators. Figure 5 suggests the engagement requirements for the various participants in an IR team. The levels may vary, however, depending on the context and the nature of the project. The IR toolkit is meant for all categories of people listed and other interested parties. Audience Health service providers programme staff Researchers Decision- makers Finance and administration Media Ethics committees Introduction to IR ++ ++ ++ ++ ++ + 1. Contextualizing IR ++ ++ ++ ? + - 2. Proposal development ++ ++ + - - - 3. Planning and executing the research ++ ++ - ++ - - 4. Data analysis and presentation ++ ++ ++ - ? - 5. Dissemination and research findings ++ ++ ++ ? ++ - 6. Monitoring and evaluation ++ ++ - - - - Mentoring and continuous engagement Mandatory ++ Optional ? Desirable + Not required - Figure 5: Suggested participants/audiences and respective critical engagement needs in the various stages of the IR process 11 references 1. Sanders, David, and Andy Haines. “Implementation research is needed to achieve international health goals.” PLoS Medicine 3.6 (2006): e186. 2. Remme, Jan HF, et al. “Defining research to improve health systems.” PLoS medicine 7.11 (2010): e1001000. 3. Damschroder, Laura J., et al. “Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.” Implement Sci 4.1 (2009): 50. 4. McLellan, A. Thomas, Deni Carise, and Herbert D. Kleber. “Can the national addiction treatment infrastructure support the public’s demand for quality care.” Journal of substance abuse treatment 25.2 (2003): 117-121. 5. Kothari, S. P., Xu Li, and James E. Short. “The effect of disclosures by management, analysts, and business press on cost of capital, return volatility, and analyst forecasts: a study using content analysis.” The Accounting Review 84.5 (2009): 1639-1670. 6. Brownson, Ross C., et al. “Researchers and policymakers: travelers in parallel universes.” American journal of preventive medicine 30.2 (2006): 164-172. Additional reading • Peters, David, Nhan Tran, Taghreed Adam, and World Health Organization. “Implementation research in health: a practical guide/edited by David Peters…[et al].” (2013). 12 In tro d u c tIo n a n d ba sIc o rIen tatIo n A pp en di x 1: S el f- as se ss m en t f ra m ew or k fo r IR c yc le s te ps S ki ll se ts 1 S o m e aw ar en es s 2 U n d er st an d in g 3 K n o w le d g e 4 S ki lls 5 C o m p et en ce D efi n in g a n d co n te xt u al iz in g IR is su es W e re ly o n ou r su bj ec tiv e vi ew s of c on te xt W e ar e aw ar e of th e di st in ct iv e co nt ex t o f I R a nd its r an ge /s co pe W e sh ar e a pa rt ia l v ie w o f th e re al IR c on te xt a nd a re fil lin g ga ps in w ha t w e kn ow ab ou t t he fu lle r co nt ex t W e ha ve a fu ll fa ct ua l un de rs ta nd in g of c on te xt an d ar e de ve lo pi ng ad ap ta tio n sk ill s W e in te gr at e co nt ex tu al fa ct or s in to a ll st ep s in th e IR p ro ce ss /c yc le to id en tif y so lu tio ns a nd a da pt IR ap pr oa ch es D ev el o p in g a n IR p ro p o sa l W e ar e fa m ili ar w ith re se ar ch p ro po sa l co m po ne nt s W e ca n di st in gu is h sp ec ifi c re qu ire m en ts o f I R pr op os al s an d pr oj ec ts W e ha ve c om pl et ed o ur IR pr op os al a nd h av e id en tifi ed fu nd in g W e ar e le ar ni ng m or e ab ou t pr op os al d ev el op m en t a s w e im pl em en t o ur p ro je ct an d on go in g M & E W e ar e ab le to g ui de ot he r pr oj ec t t ea m s to u se go od p ra ct ic es in p ro po sa l de ve lo pm en t P la n n in g to ex ec u te IR W e ha ve n ev er p la nn ed IR re se ar ch , s o le ar ni ng a s w e go W e un de rs ta nd th e re qu ire d pl an ni ng p rin ci pl es , b ut y et to a pp ly th em d ire ct ly to o ur pr oj ec t A bl e to a pp ly p la nn in g pr in ci pl es to o ur o w n pr oj ec t W e ar e co nd uc tin g ou r re se ar ch a cc or di ng to g oo d pl an ni ng p rin ci pl es a nd pr ac tic es W e ar e w or ki ng w ith co ns id er ab le p la nn in g an d ar e ab le to m en to r ot he rs A n al ys in g IR d at a W e ar e ne w to r es ea rc h an d/ or d at a m an ag em en t W e ar e aw ar e of d iff er en t da ta c ol le ct io n m et ho ds a nd di st in gu is h qu an tit at iv e an d qu al ita tiv e ap pr oa ch es W e ap pl y ap pr op ria te re se ar ch a nd d at a m et ho ds in o ur w or k W e po ss es s sp ec ifi c da ta an al ys is s ki lls W e ar e ab le to r ea di ly tr an sl at e IR d at a in to ac tio n an d po lic y re co m m en da tio ns C o m m u n ic at in g IR fi n d in g s an d fe ed in g t h em b ac k in to t h e h ea lt h sy st em W e re gu la rly p ub lis h re se ar ch r es ul ts in sp ec ia liz ed jo ur na ls W e ar e fa m ili ar w ith a nd co m pe te nt in e nd -o f- pr oj ec t re su lts d is se m in at io n W e co ns id er d is se m in at io n an d co m m un ic at io n is su es in th e fir st m ee tin gs w ith ke y st ak eh ol de rs W e in te gr at e ou r di ss em in at io n an d co m m un ic at io ns s tr at eg ie s th ro ug ho ut th e IR c yc le W e ha rn es s m ul tip le op po rt un iti es fo r di ss em in at io n sy ne rg y an d co op er at io n am on g pr oj ec t st ak eh ol de rs a nd te am M o n ito ri n g a n d ev al u at in g t h e p ro je ct W e ar e ne w to M & E o f I R W e ar e aw ar e of th e be ne fit s an d re qu ire m en ts of e ffe ct iv e M & E W e un de rs ta nd w ha t ne ed s to b e m on ito re d an d ev al ua te d at th e di ffe re nt st ag es o f o ur p ro je ct W e us e M & E d at a fr om th e pr oj ec t t o co nd uc t p er io di c re vi ew s W e bu ild M & E in to al l s ta ge s of p ro po sa l de ve lo pm en t, pr oj ec t ex ec ut io n an d ad ap ta tio n 13

1 modUle contextUAlizing implementAtion reseArch issUes leArning objectives This module is designed to emphasize the importance of contextual factors surrounding implementation research (IR) projects. The module increases understanding of the relationships between the research environment, specific intervention strategies and related ethical considerations. At the end of this module, your research team will be able to: 1. Analyse the environment in which IR projects are conducted. 2. Understand and appreciate the context relevant to your proposed/planned intervention. 3. Describe the ethical principles related to IR. key concepts Understanding the IR context The physical, socioeconomic and cultural environments, health systems, stakeholder and institutional culture are key aspects of the research context. Together they contribute to and affect the planning, implementation, monitoring and outcomes of any intervention. During the pre- implementation phase of an IR project, the factors presented in Figure 1 should be analysed. It should be noted that these factors vary considerably from one location to another, and from one project to the next. The physical, socioeconomic and cultural context Various aspects of the physical, socioeconomic and cultural context may be relevant depending on the specific intervention. Careful planning must be conducted in order to effectively focus resources on the factors that are most likely to be critical. Physical and demographic factors Attention should be paid to the relevant geographical features: rural/urban location, distance, physical barriers to access (e.g. mountains, rivers), relevant infrastructure such as transport systems, electricity and water supply; demographics (e.g. population size, distribution by location, gender and age). As appropriate, the burden of disease, trends in morbidity and mortality by location and/or population group should be analysed in detail. Figure 1: Contextual factors for implementation research Cultural Intervention Socio- economic Stake- holders Health system Institutional Others Physical factors Political 16 1M ODULE Socioeconomic status Analysis of the general standard of living; the level of inequality, identification of vulnerable groups, socioeconomic status based on income levels, assets, educational status and occupation should be undertaken. In addition, the main types of dwellings (e.g. communal huts, apartments or gated communities), by location, food consumption, nutrition, access to clean water and sanitation e.t.c. should also be analysed. Cultural and political factors Analysis of the cultural beliefs related to health, gender equality, literacy rates, ethnicity/tribal segregation; policy environment and political factors, including level of support for social services and health care services; government capacity to provide services and any other ongoing or recent health interventions should be conducted. The health system Every health system is made up of multiple sub-systems (1) with the primary focus being the promotion, restoration or maintenance of health. The World Health Organization (WHO) has identified six key groups or ‘building blocks’ (2) that make up health systems: leadership/governance; health care financing; health workforce; medical products, technologies; and information and research. These blocks address access to and coverage of health services, as well as quality and safety of services (Figure 2). System building blocks Leadership/governance Improved hralth (level and equity) Responsiveness Financial risk protection Access Coverage Quality Safety Health workforce Medical products, technologies Information and research Service delivery Goals/outcomes Figure 2: Building blocks of a health system 17 Contextualizing im plem entation researCh issues Other factors, such as self and community care, also contribute to health systems. For each component relevant to an IR project, it is helpful to undertake a systematic descriptive analysis to help identify the relevant decision-making agents and the (formal and informal) institutions that govern its operation. Figure 3: Elements of a typical health system 18 1M ODULE In the example summarized below (Box 1), researchers accumulated information about the physical, socioeconomic and cultural factors, as well as health system considerations regarding a study undertaken in KwaZulu-Natal (South Africa). The study involved a review of relevant documents and interaction with the local population. The information comprised baseline data/ indicators for planning and monitoring the research programme in addition to contributing to development of appropriate communication strategies. Example: TB/HIV collaboration in Sisonke District In a study to assess engagement of nongovernmental organizations and community care workers in collaborative tuberculosis (TB)/human immunodeficiency virus (HIV) activities in KwaZulu-Natal (KZN), researchers reviewed the South African health review report with specific emphasis on health and health-related indicators. They established that KwaZulu-Natal is the epicentre of TB and HIV epidemics with a TB-HIV co-infection rate of 75–80% in some settings. They also established that Sisonke District – one of KZN’s 11 districts – was mostly rural with poor roads, an area of 11 128 km2, a population of ~500 000, 79% of whom were unemployed, and poverty levels among the population was 71%. The people of Sisonke District had relatively poor access to basic health services when compared to residents of similar, inland rural districts. Only 33% of Sisonke residents had access to piped water (on or off site), 57% relied on candles for lighting, 74% were reliant on either paraffin or wood for cooking and only 22% had access to good sanitation (i.e. flush or chemical toilets). The most common spoken language was IsiZulu while majority of the district population (53.62%) were females. The antenatal HIV prevalence, which was estimated at 35% compared to 39.5 province-wide in 2008– 2009, was determined through review of the National Antenatal Sentinel HIV and Syphilis Prevalence Survey in South Africa, 2010. New TB cases numbered 1079 per 100 000 population, with an HIV co-infection rate of 81% (compared to 52% overall in South Africa in 2009). At the time of the study (August 2008 to Sept 2009) the health system in the district comprised a total of 32 nongovernmental organizations managing home-based care services, 26 of which were funded by the Department of Health. These 26 nongovernmental organizations employed a total of 414 community health workers (CHW). Another large independent organization managed 402 CHWs. Source: (3) One of the main purposes of analysing the health system is to predict how specific considerations might potentially affect the viability and impact of a given intervention. As a result of a variety of context-specific factors, interventions that may be effective in one setting can have a diluted impact in other contexts (Figure 4). Figure 4. Influence of health system factors on intervention effectiveness and impact Efficacious tool - E ff ec ti ve n es s + Accessibility Provider compliance Patient adherence Effectiveness Box 1 19 Contextualizing im plem entation researCh issues Stakeholder analysis In practice, IR involves various stakeholders who should be identified in the developmental stages of the research project. Stakeholder analysis is one of the most important activities undertaken by researchers in terms of understanding the context of the intervention, and should be done in a systematic and comprehensive way (4–6). Stakeholder analysis aims at identifying all relevant stakeholders, assessing how they are likely to be affected by the research, and how they might respond to the research outcome. Stakeholder identification requires careful judgment, must be neither non-inclusive (limiting breadth of perspectives) nor over-inclusive (diluting essential focus). The process of conducting stakeholder analysis involves: (i) Defining the purpose of the analysis; (ii) Generating the list of stakeholders (an initial list can be constructed by brainstorming relevant issues and further additions to the list can utilize a snowball technique, during which stakeholders identify additional stakeholders); (iii) collecting necessary data (using interview guides semi- structured questionnaires) – it is advisable to book appointments ahead of time, where necessary seek consent and record the interview; (iv) analysing and presenting data in matrices (i.e. type of stakeholder, levels of interest and influence, and the roles they will be or are playing in the implementation of the proposed intervention). Table 3 shows the various stakeholders in an example health project, and the roles they played. Table 3: Examples of typical project stakeholders and respective roles Stakeholder Role ProNet Key nongovernmental organization in policy implementation UNICEF Influential, United Nations agency and represents other nongovernmental organizations at many conferences Ministry of Environment National-level policy formulating and implementing agency Christian Council Represents faith-based groups for policy development Box 2 highlights how stakeholder analysis was used to assess the perceptions, aspirations and expectations of a range of stakeholders in order to assess the policy environment prior to the introduction of a series of health service innovations. Example: Qualitative assessment of stakeholders in Santiago de Chile A study in the Santiago Metropolitan region of Chile used stakeholder analysis to assess the policy environment prior to the introduction of a series of innovations of ambulatory care for acute lower respiratory disease in children (pneumonia and obstructive bronchitis), as well as prevention of stroke. Priority stakeholders were defined according to the knowledge of the researcher about the Chilean health sector. They included policy-makers, doctors, nurses, managers and professions allied to health care. The study mainly involved the collection of qualitative data about the perceptions, aspirations and expectations of a range of stakeholders. It also gathered material on perception of power and authority, as this was seen as likely to affect implementation processes. While this methodology did not permit statistical inference, it was seen as providing understanding of the context and probable responses of stakeholders to the planned innovations. The research was intended to provide data on the negotiation and construction of meanings within social interaction. It considered domains such as experience, knowledge and action. Source: (7). Box 2 20 1M ODULE Institutional analysis Institutional/organizational analysis (a systematic study of the behaviour of organizations) is another important dimension to consider in planning for IR. This can be achieved through an analysis of strengths, weaknesses, opportunities and threats (or ‘SWOT’) to establish the factors with potential impact on the success or failure of an intervention. The example summarized in Box 3 used a SWOT analysis to provide information on various issues affecting the efficiency and sustainability of mosquito control operations in various study settings for a mosquito control programme. Example: Analysis of mosquito control efforts in seven sites Mosquito control programmes at seven urban sites in Costa Rica, Egypt, Israel, Kenya and Trinidad were described and compared. Site-specific urban and disease characteristics, organizational diagrams, and strengths, weaknesses, opportunities and threats (SWOT) analysis tools were used to provide a descriptive assessment of each mosquito control program, and provide a comparison of the factors affecting a reduction in mosquito population. The information for the SWOT analysis was collected from surveys, focus group discussions, and personal communications. The SWOT analysis identified various issues affecting the efficiency and sustainability of mosquito control operations. The main output of the study was the description and comparison of mosquito control operations within the context of each study site’s biological, social, political, management and economic conditions. The issues identified in the study ranged from lack of inter-sectoral collaboration to operational issues of mosquito control efforts. A lack of sustainable funding for mosquito control was a common problem for most sites. Many unique problems were also identified, which included lack of mosquito surveillance, lack of law enforcement, and negative consequences of human behaviour. Identifying common merits and shortcomings of mosquito control operations was seen as very useful in identifying best practices for mosquito control operations, thus leading to better control of mosquito biting and mosquito-borne disease transmission. Source: (8). Reflection activity We have discussed the importance of understanding the environment within which an IR project is planned and implemented. Reflect on your own IR projects and identify the environmental factors that you should take into account before and during implementation. At a very broad level, consider the cultural beliefs and practices, the political structure, the way the health system is organized and the wide range of stakeholders in the environment. Then address the following questions: 1. What are the sociocultural and political systems in your project area? 2. How is the health system structured (public and private)? 3. How might the health system impact your project? 4. Who are the stakeholders? 5. What specific knowledge and (or) skills will each stakeholder bring to the research project? 6. How will the consideration of these factors impact the planning of your project? Box 3 21 Contextualizing im plem entation researCh issues Understanding the intervention Interventions (policy changes, projects, programmes) attempt to scale up health innovations that have demonstrated efficacy in the laboratory, clinical trials or small-scale pilot studies in order to benefit larger populations. Those involved in the development of such innovations promote authentic implementation and often warn that veering from the intended plan may reduce efficacy. They focus on ‘fidelity’ (9, 10). On the other hand, health providers are often more concerned with the effectiveness of the intervention, which they see as being enhanced by appropriate adaptation to the local context. The dilemma facing IR is that the more rigidly the implementation is controlled to ensure fidelity of a proven intervention, the more likely it is that local factors (e.g. resource constraints, cultural factors, infrastructure, etc.) will reduce its effectiveness. The better adapted the interventions are to local conditions, the more difficult it will be to argue that findings can be generalized to other localities or populations. An additional problem in using evidence-based interventions is that there may be considerable uncertainty in the extent to which the intended intervention has been modified in application. The implication is therefore that the claimed fidelity may be substantially lower than actually expected. Furthermore, IR typically involves complex social interventions that result in dependency on the context, which may in turn result in low fidelity. Consequently, the outcomes depend on detailed processes and pathways that may not be well understood. Therefore, to conduct meaningful IR, there is a need for an in-depth understanding of: (i) the intended intervention (for example identifying those elements seen as essential and those that could be modified without undermining the intervention objectives); and, (ii) the planned implementation process, with particular attention to modifications driven by a perceived need for adaption to a specific local context. A monitoring system to track changes in the implementation process and check for deviations from the original plan is essential. Such a system can be a useful starting point to construct (or review if one already exists) a ‘logical model’ for the intervention (11, 12). Such models are commonly required by international donors as a simplified explanation of how a specific intervention is intended to address and achieve its objectives. Intervention Logic This model of the intervention adopts an ‘if–then’ approach (see Figure 4): • If activities are undertaken then outputs should be produced. • If outputs are produced then outcomes that serve the purpose should result. • If outcomes result then they should contribute towards achieving the goal. Those managing the intervention are considered responsible for producing a defined and quantified set of outputs. The output  outcomes step is frequently founded on assumptions about existing evidence and on a thorough contextual understanding. For each step in the logic model to function effectively, relevant assumptions relating to the external context must be accurate. More certainty regarding the robustness of individual steps generates more likelihood that the implementation of the intervention will be successful. 22 1M ODULE Figure 4: The logic model of an intervention (13) The Logic model matrix The logic model can be displayed in a simple matrix format. Objectively verifiable indicators Means of verification Assumptions Goal Outcomes Outputs Activities Inputs The ‘logic’ of the matrix Definitions: Goal: The higher-level objective towards which the intervention is expected to contribute (e.g. reduced infant mortality rate). Outcomes: The ultimate effects or changes anticipated as a consequence of the intervention outputs (e.g. increased child immunization rates). Outputs: Results that can be directly influenced, and for which the implementation management team are responsible (e.g. improved access to immunization). Activities: The activities that will be undertaken in order to produce the intended outputs (e.g. reform of provider incentives). Objectively verifiable indicators One primary purpose of the logic model is to explore and identify how the key implementation activities, outputs and outcomes can be effectively monitored in order to assess the extent to which implementation of a given intervention is progressing as intended. In particular, this process involves generating information and documentation of the expected outputs and outcomes, 23 Contextualizing im plem entation researCh issues although the logical model requires the identification of a set of objectively verifiable indicators at each level: • Goal: Measures to verify the extent to which goal(s) is/are accomplished. • Outcomes: Measures to verify the extent to which outcome targets are achieved. • Outputs: Measures to verify which output targets are achieved. • Activities: Measures of the inputs (i.e. resources) required to undertake the activities. Assumptions The logic model also requires identification of important conditions or events outside the control of the implementation management team that are seen as necessary: • to contribute to the goal; • for the achievement of specific outcomes; • for the production of intended outputs; • for the implementation to begin and continue in a sustained manner. Assumptions are of particular interest for IR because they are of particular relevance in assessment of the possibilities for replicating, scaling up or relocating the intervention. Some key questions to be addressed are: Are the stated assumptions plausible in the existing context? How specific are the assumptions to the research context? • Are there important implicit (unidentified) assumptions? • What consequences might result from incorrect assumptions? • Have any assumptions proved to be incorrect? Possible uses of the logic model in IR • To summarize and test the underlying logic of a given intervention. This should include an initial assessment of plausibility, feasibility and context dependency. • To promote common expectations of the intervention. • To define indicators of success/failure and provide a basis for the design of the monitoring and evaluation framework. • To identify sources of data that can be used to verify implementation failures and accomplishments. • To specify all assumptions that, if incorrect, would have serious adverse consequences for the intervention. • To track significant revisions of the implementation plan over time, and facilitate modification of the logical framework accordingly. 24 1M ODULE Table 4. Example of a completed logic model matrix Objectively verifiable indicators Means of verification Assumptions Goal Eradication of malaria National malaria prevalence National malaria prevalence surveys Other interventions contribute to stated goal Outcome Increased proportion of children under 5 years of age sleeping under a long-lasting insecticide- treated net (LLIN) Number of children sleeping under LLIN Project records Community discussions Mini surveys Communities can be persuaded of benefits of LLINs Output 1 Under-5 children have the means to protect themselves from malaria Mass distribution of LLINs to families with children under 5 Household assessment forms Focus group discussions Adequate funding for the project Families use LLINs for children under-five Output 2 IEC/BCC activities to encourage appropriate LLIN use; early health- seeking behaviour Increase in timely consultations for malaria and use of LLINs by under-five children Health centre records Focus group discussions, Pocket charts Assumes accessibility of health facilities and availability of skilled health workers Activity 1 Identify public health counterparts and training for managers and providers Number of staff identified, training completed Project records Training evaluation Support from local officials, providers and communities Activity 2 Baseline survey of malaria knowledge, LLIN use and health-seeking behaviour Number of focus groups and research sessions held with different groups Data quality/quantity Project records and reports Assumes ability to communicate with target population Activity 3 Identify and train community volunteers to promote LLINs Number of volunteers identified and trained Project records Training evaluations Community action plans Assumes willingness of community to volunteer for these activities Activity 4 Mass distribution of LLINs Number of LLINs distributed Project records Assumes prompt purchase and delivery of nets Activity 5 Production of IEC/BCC materials Number of leaflets and posters produced Project records Availability of IEC* experts and printing facilities Activity 6 Development of reliable information systems Data quality/quantity Project records Community remains committed Health services accessible * (IEC/BCC: Information, education and communication/behaviour change communication) 25 Contextualizing im plem entation researCh issues Complex adaptive systems It has been suggested that many health initiatives give rise to what can be described as ‘complex adaptive systems’ (CAS) (14–17), a theory based on relationships, emergence, patterns and iterations. The premise is that myriad complex systems (weather systems, immune systems, social systems etc.), may interact with and consequently trigger adaptations to the immediate environment. A CAS involves a large number of interacting agents, which have adaptive capabilities. They adapt in response to a changing environment, the context and to changes induced by a given intervention. One common adaptation, for example, is the formation of new organizational alliances. The ultimate implication of the CAS notion that there is no easy way to ‘control’ agent behaviour. CAS are intrinsically unpredictable and unintended responses to interventions often occur. Therefore understanding CAS phenomena is important for better planning, implementation, monitoring and evaluation approaches to scaling up health services. What is the evidence that many health interventions result in CAS? • Due to contextual differences, such as levels of health system development, ecological factors, social and cultural variation, interventions that were successful on a small scale in a controlled research setting, or in one country or region, have often failed when replicated elsewhere or on a larger scale. • In many instances the implementation process rarely proceeds according to plan and often has to be rapidly adapted to suit an alternative and/or changing context. • The ability of implementation managers to exercise control over the behaviour of providers, communities and even their own staff, is in practice often highly constrained by the organizational environment. • Even apparently simple technical interventions can exhibit CAS behaviours when multiple stakeholder groups interact. • Major interventions can sometimes result in very limited outcomes and relatively small inputs can have major positive/negative consequences. CAS behaviour CASs can display unexpected behaviours. Three such behaviour patterns of relevance to health interventions are: feedback loops, path dependence and emergent behaviour. Feedback loops are described in more detail below. Feedback loops occur when the output of a process within the system is fed back as an input into the same system. For example, positive feedback increases the rate of change of a factor in a given direction (i.e. it is self-reinforcing), whereas negative feedback modulates the direction of change (i.e. is balancing). Reflection activity In the last section we reflected upon the complex interactions of cultural beliefs, practices and political structure on health services. Use family planning services as an example of an intervention currently taking place in your project area. What are the environmental and contextual issues that are currently affecting (positively and negatively) the implementation of these services? 26 1M ODULE Example: Feedback loops positively and/or negatively influence demand for immunization services Demand for immunization services is positively influenced (enhanced) by high levels of community awareness about immunization, which is in turn also enhanced by effective community mobilization, high literacy levels of mothers, media campaigns and the extent of health education activities. On the contrary, misconceptions about immunization reduce levels of community awareness about immunization, which will subsequently reduce demand for immunization services. Whereas mothers’ availability increases demand for immunization, family responsibility and low socioeconomic status of the mothers can negatively affect their availability. The quality and availability of health services can affect the demand for immunization services either positively or negatively. Availability of immunization services increases the number of children immunized thereby increasing the herd immunity in the community – which reduces the risk of outbreaks of vaccine preventable diseases. The reduction in morbidities due to vaccine-preventable diseases contributes to an increase in confidence of the community in the immunization programmes and subsequently increases the demand for immunization services. Poor quality health services, for example lack of the vaccines, long waiting hours, children developing abscesses after vaccinations etc. discourage mothers from bringing their children for immunization. This contributes to high dropout rates and unimmunized children in the community, which leads to low immunity and increased risk of outbreaks of vaccine-preventable diseases. The result is lost confidence in the health system, which contributes further to the reduction in demand for the immunization services. Source: Adapted from (14). Box 4 27 Contextualizing im plem entation researCh issues Ethical issues in research The rigour in reviewing research proposals/protocols has steadily increased in the past two decades. A number of initiatives have been implemented to strengthen ethics review capacities and increase awareness among those involved in research. It is difficult, and often inappropriate, to lay down ethical rules that apply to all studies in all places. In terms of ethics, it is important that each study be judged in relation to the context in which it will be conducted. Most ethical issues arise from conflicts between ‘competing’ values. This also suggests that a study that might be deemed ethically unacceptable in one setting may be considered acceptable in another, and both of these might be correct, appropriate judgments. Several guidelines and international standard documents are available with regard to ethical guidelines for human research. Although these will not be discussed in this module, it is worth noting that individual guidelines vary with regard to the scope and level of detail or information to be provided, especially in relation to the consent process, obligations to provide universal standards of care to control groups, the use of placebos and the extent to which research participants have access to health products after the research is completed (18). From a public health perspective, research ethics should be guided by giving due consideration to the relative risks and benefits to society in addition to the individual research participants. Situations of poverty and limited health care – conditions in which research is frequently conducted in many low and middle income countries often present certain conflicts. Those conducting field trials of interventions against diseases associated with poverty are likely, therefore, to be faced with unique and difficult ethical dilemmas. Some of the IR-related ethical issues may be unpredictable and only emerge once the study has begun, and so may not have been addressed in the research protocol presented for ethical review. Ethical issues identified prior to the study and those that emerge in the process of conducting an IR project, should be addressed promptly by the research team. Ethical principles of research involving human subjects Research involving human subjects should abide by the basic ethical principles to safeguard individuals, communities and society at large against unnecessary risks. These principles have been widely discussed as they express different ethical, economic and political theories. In practice, the principles may assume different weights according to the context, but there is universal consensus as far as their validity and the need for use in guiding proposals for research studies go. In large-scale health intervention studies, especially those developed with international partners, moral and ethical issues may transcend national and political interests (19). Low- and middle- income countries have a broad range of health issues and may have limited local capacity to find solutions. In most cases there are limited scientific, managerial, political as well as economic capacities to adequately deliver essential health care. Conducting research under such conditions is both challenging and critical. Three established ethical principles apply to public health research, including IR: 1. Autonomy/respect for persons is based on the ethical conviction that all individuals have a moral value and autonomy and as such should not be used as a means for the benefit of others. Individuals should be treated equally as far as access to the truth, loyalty, privacy and confidentiality are concerned. The two major ethical assumptions derived from this principle are: (i) respect for autonomy of those who are capable of deliberating about their personal choices and for self-determination; and, (ii) protection of persons with diminished autonomy, 28 1M ODULE which requires that those who are dependent or vulnerable be afforded security against harm or abuse (20). 2. Beneficence is concerned with promoting the welfare of individuals as the primary goal of health research by maximising its benefits. Non-maleficence is the bioethics principle of avoiding harm, acting with malice towards individuals or providing ineffective interventions. Causing harm to individuals is not justifiable in any case, even if this may bring benefit to the population – research is only justifiable if there is an appropriate balance between risks and benefits. It is the responsibility of the researcher as well as that of their organization to ensure beneficence. Broader society also shares responsibility for understanding the risks and benefits of any proposed research. 3. Justice refers to the moral obligation of treating people with respect and giving equal opportunity to the participants in both high-risk and beneficial research. Vulnerable populations should be protected and no exclusion of selective groups for reasons unrelated to the research should be applied. Provision of health care to the participants should also be equitable, and local research/health service capacities should be strengthened. Ethical dilemmas in implementation research The ethical and scientific integrity of the researchers is critical for ethical acceptability in IR projects. In the context of IR, specific ethical dilemmas may occur since studies are usually carried out in high-burden and vulnerable populations with limited access to health care. The autonomy and understanding of volunteers in such situations are likely to be limited. Undue expectations of research results and social/authority pressure may lead to forms of forced consent/coercion. In social science research, individual observations or personal interviews are likely to generate psychological distress when sensitive issues are discussed or recorded, or if there is any breach of confidentiality (21). The ethical issues associated with IR can generate controversies. This may involve both quantitative and qualitative research approaches and a range of disciplines and perspectives such as epidemiology, statistics, anthropology, sociology, health economics, health promotion and education, political science etc. Although research protocols are applied in real-life settings and the risks are often minor compared with those encountered in clinical trials, for example, participants in implementation studies may be burdened by loss the of privacy, time spent in interviews and examinations, and by possible adverse psychological effects. Such risks can be minimized by careful attention to study procedures, limiting the length of questionnaires or additional clinical examination and samplings, and considerate timing of observations. Implementation research also poses specific ethical challenges, given that it requires the collection of information from a large number of subjects in diverse situations involving a broad range of stakeholders. Ethics review committees should therefore be well informed about such proposals or protocols and ensure that all perspectives are protected (22). Tables 5 and 6 summarize some of the ethical dilemmas and their consequences, as well as highlighting the relevant ethical principle(s) that may be flawed. 29 Contextualizing im plem entation researCh issues Table 5: Ethical principles flawed by characteristics of the participants/setting Variable Consequences Ethical principles flawed Language barrier Misunderstanding of informed consent Autonomy Family and individual’s role in the community Presence of power relationships and dependence, hindering the individual decision- making process Respect for traditional figures of wisdom and authority including leaders of the community Autonomy Beneficence Justice Traditions and beliefs of healthcare and disease Difference in the respect for traditional healers, doctors/researchers Autonomy Unfamiliar with research Sensitivity to research procedures Autonomy Poverty and low education Difficulty in understanding the information provided by researchers Possibility of exploitation and coercion, inducements, financial benefits Increased burden on research participants Autonomy Justice Low access to health services and goods Possibility of exploitation and coercion, inducements, financial benefits Autonomy Justice Belonging to vulnerable groups Possibility of exploitation and coercion Autonomy Justice Research being carried out from a health facility Interference with public health system Justice Table 6: Ethical principles flawed by the characteristics of the researcher Variable Consequences Ethical principles flawed Language barrier Failure to get informed consent Autonomy Double role: medical assistant and researcher Confusion between research and health care Considering it more important to participate in the research than go without health care Beneficence Justice Conflict of interest Influence the capacity of impartial judgement Autonomy Justice Unjustified intrusion Breach of privacy/confidentiality Autonomy Unclear procedures for participant selection Inequitable selection of participants Justice Failure to explain the benefits of research Raising participants expectations Autonomy 30 1M ODULE Variable Consequences Ethical principles flawed Poor dialogue with legitimate community representatives Failure to communicate with potential participants (due to poor or no skills in local language) Failure to obtain informed consent Failure to determine appropriate/reasonable incentives Failure to use an appropriate dissemination strategy Autonomy Reflection activity Using the information presented in this section and Tables 5 and 6, what are some of the ethical considerations specific to your project? 31 Contextualizing im plem entation researCh issues ApplicAtion of key concepts The examples below describe how the key concepts of understanding the environment, the intervention and the ethical issues can be applied to IR. Example: A case of voluntary male circumcision Background: Although many studies strongly suggest that male circumcision could be important in tackling the continued rise of new HIV infections in Sub-Saharan Africa, in many settings it has proved difficult to translate this research into policy and practice. This has mainly been due to economic, social and ethical considerations. Specific factors should be considered when planning to implement/ scale up voluntary male circumcision as a public health intervention. Below you may find some contextual issues and ethical dilemmas for consideration when planning for male circumcision as an HIV prevention intervention. Key concept 1: Understanding the context The socioeconomic and cultural situations, as well as the health systems where the intervention is to be implemented, should be analysed. For example, the level to which the country is able to afford the costs associated with providing safe circumcision services. Furthermore, the cultural values associated with male circumcision, as well as the organization of available health services should be examined. The organization of the health services has a bearing on decisions regarding the feasibility of either integrating neonatal male circumcision into postnatal services or as a stand-alone service. The existing country’s policies on male circumcision also have an important bearing on the implementation process. For example, is there an age when a child should not be circumcised, are there specialized circumcision surgeons, or places where circumcision takes place? In the analysis of the health services, capacity of existing human resources to provide safe circumcision and other HIV services should also be analysed. Lastly, stakeholders (i.e. policy-makers, ministry of health, health workers, the community and the prospective beneficiaries including spouses) and their respective roles should be assessed. Key concept 2: Understanding the intervention The following contextual issues in relation to the intervention itself should be analysed. This is important because of the different factors that will either facilitate or hinder implementation. Factors involved include the following as cultural acceptability of different male circumcision approaches (i.e. neonatal, preadolescent, adult); the feasibility of integrating the intervention into existing health services; the resources required to provide the intervention; how it could be provided equitably across all the intended beneficiaries; and the social and psychological dimensions of traditional circumcision. Key concept 3: Ethical dilemmas Autonomy – Voluntary male circumcision implies several ethical dilemmas. For one, obtaining consent for a neonatal circumcision operation in the case of minors under the age of consent. What should be done in cases where the child refuses to assent but the parents want the circumcision to take place, or conversely where the child wants circumcision but the parents refuse to provide consent? Furthermore, the very notion of obtaining consent for circumcision may be culturally absent. Justice – The question of who qualifies for the intervention should be closely considered. For example, should populations at risk of HIV acquisition/transmission be targeted for circumcision (e.g. truck drivers, soldiers, migrant workers)? This may lead to subsequent stigmatization if specific populations become associated with HIV and related services. Beneficence – The principle of beneficence is also an important ethical issue that should be considered. For example, deciding the best age at which to implement the intervention; whether male circumcision should be offered only to men who test negative for HIV or should it also be extended to men living with HIV? Source: (23). Box 5 32 1M ODULE Box 6 Example: Improving the coverage of the PMTCT programme in South Africa This intervention comprised a data-driven participatory quality improvement approach implemented in a high HIV prevalence district in South Africa. The design comprised three phases: (i) a participatory assessment phase to build capacity of the local programme managers; (ii) a feedback and planning phase, during which weaknesses in the system were identified and a corresponding intervention was developed; (iii) a 12-month implementation and monitoring phase, during which the intervention to reduce prevention of mother-to-child (PMTCT) HIV transmission took place, and related output indicators were monitored. Data was collected using structured interviews from the managers and counsellors, observation of the health facilities, review of documents and routinely collected PMTCT data. The data showed large improvements in all key PMTCT output indicators. Key concept 1: Understanding the context The population in the study area, the components of the PMTCT programme, the current PMTCT policy, South Africa’s district health system, the referral system and the core activities of the health care providers were described in the background information. The documents reviewed included country health review reports, protocols on PMTCT care, PMTCT programme implementation policy guidelines, and HIV seroprevalence survey reports. The baseline PMTCT indicators were extracted from routine district PMTCT data. The stakeholders included the middle-level managers in the health system (e.g. facility managers, the primary health care supervisors and district programme coordinators) and the community. Their different roles were described accordingly. Key concept 2: Understanding the intervention The conceptual framework used in developing the intervention was based on an expanded health systems approach. (The framework was based on the critical conditions the managers needed to consider to ensure that a programme moves from efficacy to effectiveness). The researchers further acknowledged that the weaknesses identified during the assessment were due to the complex interaction of the clients with the health system factors. The client factors included lack of information and fear of disclosing HIV status, and the health systems factors included lack of ownership of the PMTCT programme among nurses, unclear roles and responsibilities, lack of knowledge of the protocol, as well as poor recording systems and continuity of care. Key concept 3: Ethical dilemmas • This research involved human subjects (the health care providers, children, and caretakers). • Should being part of the routine health care and system qualify the intervention for expedited ethical review? • How to minimize interference with routine health care? • How and at what level of interaction do you draw a line between routine care services and/or research? Source: (24). Further examples of contextual issues impacting IR planning 33 Contextualizing im plem entation researCh issues Box 7 Example: Health worker protection or patient stigma? In Somali communities, the use of medical face masks presents a challenge for both patients and doctors. The doctor wearing a mask during consultation with a patient creates the perception that the patient has a highly contagious disease such as tuberculosis (TB), for example. As a result, and given the stigma associated with TB, the patient may feel humiliated, disrespected and perceives the doctor as arrogant. This often affects the patient–doctor relationship and erodes trust, which may impact willingness to return for follow-up consultations or visits. Additionally, it also presents a safety dilemma for the health worker/doctor. Source: (25). Example: Reproductive health research in Sudan Implementation research on reproductive health issues conducted in Sudan faced ethical and cultural issues because of the mutually different sociocultural contexts of South and East Sudan. The research team had to adapt their approach and team composition to for each context. Ethics: Obtaining appropriate consent for the study South Sudan • Community consent: Given by the chief and religious leaders of the tribe; • Informed consent: Obtained from the participants individually; East Sudan • Community consent: Given by the chief and religious leaders at the village level but some villages will not participate until they have observed the morning sessions from afar. Only after that do the allow members of the tribe to attend sessions and participate in the project. Culture: Optimizing research team composition to ensure acceptance, sustainability and high response rate of the project South Sudan • Project team had equal numbers of men and women. The composition of the team structure was culturally acceptable to the community. East Sudan • The project team composition was changed in response to the cultural context of the community (i.e. closed, complex communities). The team comprised mostly women researchers and this facilitated access to the female participants. The limited number of men in the team interacted with the leaders of the tribe (who are men and are culturally not receptive to directions from women). Research topic and related sensitivities This was seriously considered from project conception and planning to avoid unintentional consequences such as any misconceptions, negative perceptions or misunderstandings that could compromise the success of the project. South Sudan • Community open to discussing intimate reproductive issues and rights. East Sudan • Community closed and certain reproductive issues were considered taboos and as socially unacceptable for discussion. Therefore, designing the research (i.e. the objectives of the research as well as methodology) differed from South Sudan. Source: (26). Box 7 Box 8 34 1M ODULE conclUsion Congratulations on completing Module 1 – Contextualizing Implementation Research Issues. This module was designed to increase your understanding of and knowledge of the environmental issues of IR. The module should also have increased your understanding of intervention strategies and ethical considerations when implementing IR projects. 35 Contextualizing im plem entation researCh issues 1. Bloom, Gerald, and Hilary Standing. “Future health systems: Why future? Why now?.” Social science & medicine 66, no. 10 (2008): 2067-2075. 2. World Health Organization. “Everybody’s business--strengthening health systems to improve health outcomes: WHO’s framework for action.” (2007). 3. Uwimana, Jeannine, Christina Zarowsky, Harry Hausler, and Debra Jackson. “Engagement of non-government organisations and community care workers in collaborative TB/HIV activities including prevention of mother to child transmission in South Africa: Opportunities and challenges.” BMC Health Services Research 12, no. 1 (2012): 233. 4. Varvasovszky, Zsuzsa, and Ruairí Brugha. “A stakeholder analysis.” Health policy and planning 15, no. 3 (2000): 338-345. 5. Brugha, Ruairi, and Zsuzsa Varvasovszky. “Stakeholder analysis: a review.” Health policy and planning 15, no. 3 (2000): 239-246. 6. Hyder, A., S. Syed, P. Puvanachandra, G. Bloom, S. Sundaram, S. Mahmood, M. Iqbal et al. “Stakeholder analysis for health research: case studies from low-and middle-income countries.” public health 124, no. 3 (2010): 159-166. 7. Bedregal, Paula, and Ewan Ferlie. “Evidence based primary care? A multi-tier, multiple stakeholder perspective from Chile.” The International journal of health planning and management 16, no. 1 (2001): 47-60. 8. Impoinvil, Daniel E., Sajjad Ahmad, Adriana Troyo, Joseph Keating, Andrew K. Githeko, Charles M. Mbogo, Lydiah Kibe et al. “Comparison of mosquito control programs in seven urban sites in Africa, the Middle East, and the Americas.” Health Policy 83, no. 2 (2007): 196-212. 9. Carroll, Christopher, Malcolm Patterson, Stephen Wood, Andrew Booth, Jo Rick, and Shashi Balain. “A conceptual framework for implementation fidelity.” Implementation Science 2, no. 40 (2007): 1-9. 10. Pérez, Dennis, Pierre Lefèvre, Marta Castro, Lizet Sánchez, María Eugenia Toledo, Veerle Vanlerberghe, and Patrick Van der Stuyft. “Process-oriented fidelity research assists in evaluation, adjustment and scaling-up of community-based interventions.” Health policy and planning 26, no. 5 (2011): 413-422. 11. Kellogg, W. K. “Logic model development guide.” Michigan: WK Kellogg Foundation (2004). 12. Gasper, D. R. “Logical frameworks’: a critical assessment: managerial theory, pluralistic practice.” ISS Working Paper Series/General Series 264 (1997): 1-46. 13. Contribution of Henry Lucas 14. Paina, Ligia, and David H. Peters. “Understanding pathways for scaling up health services through the lens of complex adaptive systems.” Health Policy and Planning 27, no. 5 (2012): 365-373. 15. Craig, Peter, Paul Dieppe, Sally Macintyre, Susan Michie, Irwin Nazareth, and Mark Petticrew. “Developing and evaluating complex interventions: the new Medical Research Council guidance.” BMJ: British Medical Journal 337 (2008). 16. Rogers, Patricia J. “Using programme theory to evaluate complicated and complex aspects of interventions.” Evaluation 14, no. 1 (2008): 29-48. references 36 1M ODULE 17. Leykum, Luci K., Jacqueline Pugh, Valerie Lawrence, Michael Parchman, Polly H. Noël, John Cornell, and Reuben R. McDaniel. “Organizational interventions employing principles of complexity science have improved outcomes for patients with Type II diabetes.” Implementation Science 2, no. 1 (2007): 28. 18. BIOETHICS, NUFFIELD COUNCIL ON. “The ethics of research related to healthcare in developing countries.” London: Nuffield Council on Bioethics Ed (2002). 19. Beauchamp, T. L., and J. F. Childress. “Principles of Biomedical Ethics Oxford Univ.” (2009). 20. National Commission for the Proptection of Human Subjects of Biomedical and Behavioral Research, Bethesda, MD. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. ERIC Clearinghouse, 1978. 21. Punch, Maurice. “Politics and ethics in qualitative research.” Handbook of qualitative research 2 (1994): 83-98. 22. World Health Organization. Special Programme for Research and Training in Tropical Diseases (TDR). Implementation research for the control of infectious diseases of poverty: Strengthening the evidence base for the access and delivery of new and improved tools, strategies and interventions (2011). 23. Rennie, Stuart, Adamson S. Muula, and Daniel Westreich. “Male circumcision and HIV prevention: ethical, medical and public health tradeoffs in low-income countries.” Journal of medical ethics 33, no. 6 (2007): 357-361. 24. Doherty, Tanya, Mickey Chopra, Duduzile Nsibande, and Dudu Mngoma. “Improving the coverage of the PMTCT programme through a participatory quality improvement intervention in South Africa.” BMC Public Health 9, no. 1 (2009): 406. 25. Contribution of Dr Mohamed Farah, TB Hospital Director, Somaliland. 26. Contributed of Dr Ayat Abu-Agla, National Human Resources for Health Observatory, Khartoum, Sudan. Additional reading • Goodman, Catherine, William Brieger, Alasdair Unwin, Anne Mills, Sylvia Meek, and George Greer. “Medicine sellers and malaria treatment in sub-Saharan Africa: what do they do and how can their practice be improved?.” The American journal of tropical medicine and hygiene 77, no. 6 Suppl (2007): 203. • Verkevisser, M. C., Indra Pathmanathan, and Ann Brownlee. “Designing and Conducting Health System Resaerch Projects: Proposal Development and Field Work.” Health Serv Res 1 (2003). 37 Contextualizing im plem entation researCh issues developing An implementAtion reseArch proposAl 2 modUle developing An implementAtion reseArch proposAl 40 introdUction The purpose of this module is to support you and your team to develop a high quality implementation research (IR) proposal so that you can be competitive in securing research funding. If you are setting out on developing an IR proposal and are not sure where to start, you are not alone! Even defining the research question can at first seem overwhelming. This module has been designed to help team members understand and conduct the basic processes involved in writing an IR proposal. After completing this module, participating research teams will be able to complete their IR proposals. The content and activities in this module are organized into five sessions, with each addressing a specific section of an IR proposal in a stepwise way. Each session consists of the following elements: • Learning objectives: identifying what you will accomplish by the end of each session. • Content presentation: providing you with the information necessary to understand the specific aspects of proposal writing. • Activities: exercises facilitating the understanding of the content and putting theory into practice. • Group work: discussions providing an opportunity to ask questions, and consider specific issues in relation to your specific project. • Write-shops: provides an opportunity to work together each evening in drafting elements of your research proposal, as covered each day. The workshop will be facilitated by researchers experienced in IR, who will guide and support you during the process of developing your team’s IR proposal. The module also provides harmonized guidelines for proposal development to train researchers from different backgrounds. Pre-workshop preparation This module is organized into three stages: before, during and after the workshop (Figure 1). Before the workshop, you should have completed an online component that introduces key terminology, core concepts, research frameworks, programme components and appropriate questions. The onlne course takes approximately three hours to complete and its specific objectives are: • Identifying characteristics of IR. • Describing implementation/scale up and relating IR to these processes. • Classifying research questions and associated research that falls under the umbrella of IR. • Summarizing framework characteristics and identifying strategies for applying them to IR. • Recognizing how IR is applied to different implementation problems. • Classifying IR priorities for grant applications. • Reviewing the roles of various stakeholders and identifying appropriate means for integrating stakeholders in planning and in communicating and disseminating results. The on line component is available on line at https://training.measureevaluation.org/certificate- courses/ir. You should also have completed an initial stakeholders consultation (module 1) as well as literature review to enable you to put your IR problem in to a broader context. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 41 Impact Supplements Introduction Research design Project plan During Workshop What is IR? Who should be on the team? What is our project? Before Workshop After Workshop Literature review Support letters Ethics approval Complete proposal Figure 1. Three stages of the current module Introduce your team and research challenge From earlier modules, you may already have a good understanding of what IR is and how this IR approach can help meet your research objectives. You have also likely identified some of the members of your IR team, established each member’s roles and responsibilities, and identified a research problem for which you would like to develop a proposal. To get started, one member of your team will be asked to briefly describe the research problem/ challenge your team is developing a research project to address. Then invite each member of your team to introduce themselves and explain their ongoing work, as well as roles and responsibilities in your planned project. Group activity: Refresher on IR fundamentals Organize into small groups. Ideally, members of each team should split into different groups. Each group is assigned one of seven topics (see slide). In individual groups, prepare a two-minute presentation summarizing your assigned topic, drawing on content from the pre-workshop online component/ previous modules. Choose a spokesperson to present your key points tin plenary (in two minutes). Funding an IR project There are essentially three types of funding agencies that are potential sources of support for research projects: • Multilateral organizations 42 – e.g. WHO, World Bank, United Nations Children’s Fund (UNICEF), United Nations Development Programme (UNDP), European Commission, and special programmes such as TDR, the Alliance for Health Policy and Systems Research and the Special Programme of Research, Development and Research Training in Human Reproduction (HRP). The Alliance, TDR and HRP, as designated research programmes, periodically issue calls for health research proposals, including those focused on IR. Most multilateral organizations have developed implementation programmes in low- and middle-income countries of which part of programme budget is allocated for monitoring and evaluation, as well as implementation research. • Bilateral donors – e.g. Canada Government, United Kingdom Government (DFID), United States Government (USAID, National Institutes of Health, Fogarty International Center), Norway Government (Norad), Sweden Government (SIDA) Australia Government, and the International Development Research Centre (IDRC). An increasing number of bilateral organizations, such as IDRC, NIH/FIC DFID, USAID, and NORAD have supported implementation research. Almost all the bilateral organizations have aid projects/programmes in low- and middle-income countries of which a certain percentage of the programme budget is allocated for monitoring and evaluation, as well as implementation research. • Private foundations and trusts – e.g. Gates Foundation, Rockefeller Foundation, Ford Foundation, Wellcome Trust. Private foundations and trusts have a tradition of supporting health research, among other issues. Implementation research is one of the areas where some private foundations and trusts have gotten interested in supporting. Note that this list of examples is not exhaustive. National governments in low and middle income countries also fund research to improve access and delivery of interventions within their health systems. Find a match To find a good match for your proposal, consider: • your level of experience; • the resources/funds you need; • timing and deadlines; • your location; • who is interested in the topic. Related resources Government grants: • NIH Office of Extramural Research (OER) Grants Guide (http://grants.nih.gov/grants/guide/ index.html) • National Science Foundation (NSF) • Other individual government agencies • Grants.gov (www.grants.gov) – portal collecting funding/application information from all United States government agencies • Ministries of health • National medical research councils Private associations or foundations 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 43 • Foundation Center Directory (Free Library) • PA Foundation Directory (Free Library) • GrantsNet – from American Association for the Advancement of Science (AAAS) • Bill and Melinda Gates Foundation • Doris Duke Foundation Subscription databases like the ones listed below provide information on sources of research funding. (government and non government) • Community of Science (COS) • InfoEd (Spin/Genius) • Others (IRIS, Egrants) Do your searching… • Go to a library that has good internet access. • Talk to your institution’s Office of Research Administration, if you have one. • Search comprehensive databases such as COS, eRACommons and Spin. • Set up alerts from your database searches. • Search US government grant websites such as OER or Grants.gov, or individual agency websites. • Search association and foundation websites. • Find out what projects related to your area were already funded. This is a very important aspect of your work. If you have some experience in searching databases, you can proceed, otherwise ask for help from a library in or outside of your institution. Whatever approach you take, there are basic steps that you have to follow and several things to consider when deciding where to submit your IR proposal for funding. Find out which funding opportunities are offering research calls or requests for proposals (RFP)/ letters of intent (LOI). This is important as often they call for applications is once a year. Therefore, planning ahead and working back from the application deadline is important. If you miss the deadline it could be a year until another competition or opportunity arises. In implementation research, a 12 month delay is significant. In addition to regular RFP/LOI invitations, some funding agencies may also be interested in supporting IR in accordance with their health research strategies. In other words, researchers from low- and middle-income countries could play a proactive role by sending short research proposals for their consideration. Some funding agencies are more interested to commission or solicit health research proposals, based on their mandates and strategies. You need to ensure a good match between the funding agency and your research project, with regard to research topic, size of grant, geographic region, partners’ eligibility, participating countries, required affiliations etc. Explore research that has already been done on the topic to ensure you are not duplicating existing work. Assess the types of projects the agency has funded in the past, so you can extend or compliment these activities. Demonstrate that you have done your homework and are aware of what exists on the topic, identify the gaps and justify what needs to be done and how the findings will benefit the community. Preparing your application • Read the instructions for submitting a proposal carefully 44 • Refer to pertinent literature • State rationale of proposed investigation • Include clearly presented tables and figures • Present an organized, lucid write-up, including as much detail as possible • Request pre-review from experienced researchers • Use the style and elements required by the funder’s specifications When applying for a research grant, take advantage of the resources available to you. Most universities in Europe and North America have an Office of Research with trained staff to assist researcher with large grant applications This may not be available in institutions and health agencies in low and middle income countries, however there may also be many resources available on the Internet that can be helpful. It is important to visit the website of the funding agency to which you plan to submit your proposal. They will usually have full instructions on what to do and when to submit your proposal. For example: NIH Grant Writing Tips: http://grants.nih.gov/grants/grant_tips.htm. Reviewers will be looking for projects that make a significant impact on the community or state of health care services offered. You can also explore the possibility of communicating with the project manager in the funding agency to obtain more clarity on the application process. Reviewers will look for clear, innovative and exciting ideas, clarity and brevity of writing and realistic objectives and timelines. They will expect a clean, well-written application that promises outcomes that are useful to the population. What reviewers look for • Significance and impact – this is very important in implementation research • Exciting ideas • Ideas they can understand – avoid assuming too much knowledge or familiarity • Realistic aims and timelines – do not be overly ambitious • Stay brief with widely known information • Note the limitations of the study • Prepare and submit a clean, well-written application with a justifiable budget Depending on the funding agency, reviewers may be looking for varied things in different proposals. It is always useful to refer to the instructions in the call for applications before submitting the proposal. In general, IR proposals are typically rated on the basis of scientific merit and policy relevance using a specific scale (e.g. a 1–5 scale, where 1 is high and 5 is low). Ratings for both categories may be averaged together for a final score, which may be one of the main determinants of the funding decision. Specific criteria that are frequently used in each of these categories are outlined below. Scientific merit and policy relevance • Scientific ‘soundness’. • Synthesis of existing knowledge (which could include a literature review) – make it concise; pertinent; complete; appropriate • Research questions – make them appropriate and feasible • Analytical framework – apply as appropriate and make it sound • Proposal should be in accordance with IR principles outlined in the call for proposals 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 45 • Proposal should address issues relevant in the country/community where the research would be conducted • Proposal should fit the specific call for proposals Methodology • Is the design feasible and appropriate? • Are data collection methods and tools appropriate for the design? • What is the sampling method, and size? • How is data management and analysis planned? • Is the overall time plan realistic? Other considerations • Ethical considerations. • Critical assumptions. • Innovation and originality. • Programmatic practicality. Additional critical issues • Is team expertise appropriate for the proposed study? • Could the project findings be scaled up? • How generalizable will the results be? • Is a multidisciplinary approach proposed? • Will the study foster collaboration and team work? • Is the budget appropriate? • Utilization and dissemination possibilities/potential impact on policy and programmes? • Is there potential for research capacity building/strengthening? This could be important to some funders because it could enhance sustainability of an IR culture in the health system. Common problems with applications The following common problems/pitfalls with research proposals should be avoided. • Lack of new or original ideas. • Absence of an acceptable scientific/public health rationale. • Lack of experience in the essential methodology. Lack of sufficient detail on the methodology. • Lack of relevance to policies, programmes and projects. • Diffuse, superficial or unfocused research plan. • Lack of knowledge of relevant published work. • Unrealistic amount of work required. • Uncertainty concerning future directions. • It is helpful to ask the question “So what?” – What difference will the results from the research make to the health system and population if applied. Components of an IR proposal In general, the proposal structure is similar for all research. What is a research proposal? • A document that describes: – the proposed research – why it is being conducted – the research design 46 – the expected impact • A proposal is a requirement for most grant applications, which are typically judged by a committee. To be effective, you need to know: – what you are doing; – why you are doing it; – when you plan to do it; – how you plan to do it. If you have ever written a thesis as part of your studies, you will remember that you were required to write a research proposal and have it ‘approved’ by a thesis committee and your supervisor prior to applying for ethical clearance (if using human subjects) and beginning your data collection. When developing an academic proposal, the intent is to generate new knowledge and ideas. Conversely, when developing an IR proposal the intent is to generate research evidence to inform policy and improve programme implementation. Most grant applications require you to write a research proposal that will be evaluated by a committee to determine if the proposal is worthy of funding. Writing a research proposal is probably one of the most difficult stages of research. In order to write a proposal, you have to know what you are doing, why, when, and how. You need to develop research question(s), a rationale for why the study is necessary and important, and a conceptual framework. You need to conduct a review of existing literature. You need to design the research and specify what research methods you will be using to collect and analyse your data. What is different about an IR proposal IR proposals may differ from conventional research proposals in relation to the: • origin of the research problem • involvement of the end users in the research process These differences arise from the need for IR interventions to help: • better inform health care service quality improvement efforts • facilitate uptake by end users • generate ‘generalizable’ knowledge so it can be applied across settings and contexts • engage multiple sectors, e.g. including epidemiology, social science, anthropology, communi- cation science and health economics • develop policy recommendations and practical solutions Because it can take years for research findings, guidelines and best practices to be completely integrated into practice, researchers, decision-makers and practitioners constantly seek improved knowledge transfer processes. To address this challenge, IR originates with a problem identified and prioritized by end users. Encouraging end-user uptake of research results requires end-user engagement in all steps of the research process, including proposal development. To be effective, IR research findings need to be usable within the available health system framework and implemented appropriately so that end users are able to benefit. IR also aims to produce generalizable knowledge so it can be applied across various settings and contexts (although they may be intervention specific). 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 47 Characteristics of an IR proposal • Each funding agency has its own proposal format and requirements. • Requirements vary and not all agencies will require all components included in this session. • Some agencies may require a letter of intent (LOI) as a preliminary screening to ensure your proposal will align with their needs. • LOI include the same components as a research proposal but with less detail. Additional characteristics may include the following: • Clear distinction between routine disease control and systematic study and analysis of issues. • Indicators to measure outcomes. • A focus on a limited number of priority areas, rather than focusing on a large number of small isolated issues that are unlikely to have significant health impact. • Possibility to extrapolate to other settings and diseases. • Active link to disease control. • Partnership and link up with other ministries, departments and agencies. • Involvement of mentoring train the young and involve the experienced. • Involvement of health professionals from the study setting. • Active dissemination of results at all levels of implementation. The components of a research proposal may vary slightly depending on the purpose outlined by the funding agency to which it is being submitted. Many funding agencies indicate specifically what should be addressed in the proposal. As each funding agency has its own format and requirements, some of the elements covered in this module may not be required in every research proposal. Components of an IR proposal Figure 2. Components of an IR proposal introduction Title page . . Rationale Statement of the problem Research question(s) Literature review research design Research design Research method Data collection Data analysis Participants Quality management Ethics project plan Project plan Research team Budget and justification impact Monitoring and evaluation Capacity building Dissemination plan supplements Project summary Table of contents . . . References Appendices CVs of study team 48 This session has been designed to be general enough so it can be adapted to fit the priorities of different users and funding agency calls for proposals. Below is a list of common components of IR proposals: • Introduction: containing title page, rationale, statement of the problem, objectives and research question(s), and literature review (synthesis of existing knowledge) (Table 1). • Research design: outlining participants, research methods, data collection, data analysis, quality management and ethics (Table 2). • Project plan: containing project plan, research team and budget (Table 3). • Impact: including monitoring and evaluation, capacity building plan and dissemination plan (Table 4). • Supplements: including project summary, table of contents, references, appendices and CVs of investigators (Table 5). Introduction The introduction to your proposal includes the title page, project rationale/summary, table of contents, rationale, statement of the problem, objectives and research question(s), and a review of the literature (synthesis of existing knowledge). Table 1. Sub-components of introduction section Section Description Title page • Four components of a good title: –Use action words. –Reflect implementation and intervention themes. – Include specific target populations (adolescents, children under 5 years of age etc.). – Include specific geographic location(s). Rationale • Outlines what is being studied and why. • Summarizes expected outcomes, including the anticipated impact(s). • Provides clear succinct rationale for why the project should be funded. Statement of the problem • Summarizes the purpose of the study. • Is a paragraph rather than a single statement. • Establishes the direction and captures the essence of the study. • Is clear and concise. • Incorporates your general objectives and uses action words to succinctly outline the purpose of the study. • Reflects the research design of the study. • Leads logically to the research question(s). Objectives and research question(s) • Should be of interest to the research community, researchers, policy- makers; decision-makers, funding agencies, and the health care providers the research will ultimately affect. • Should be answerable. • Are shaped by the problem, and in turn should logically influence the design of the research. • Are clear and specific. • Are feasible. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 49 Section Description • Provides information required to evaluate ongoing interventions or progress. • Analyses possible causes for missed targets in order to find solutions. • Answering the question will result in important information. Literature review • Demonstrates familiarity with the topic. • Summarizes what is not known about the topic. • Establishes credibility. • Places proposed research in a broader context. • Demonstrates relevance by making connections to a body of knowledge. • Integrates and summarizes what is already known about a topic. Research design The research design section includes: research design, research methods, data collection, data analysis, quality management, and participants and ethics. Table 2. Sub-components of research design section Section Description Research design • Describes the nature or structure of the research. • Describes whether it is qualitative, quantitative or mixed methods; between- or within-subjects; experimental or correlational; individual or collective case study etc. Research method • Comprises the various methods you will use to obtain and analyse data. • Justifies what you will do when and how. • Provides a rationale for your research design. • Justifies how your methodology will enable you to produce results that are new or unique. • Comprises a number of sub-sections such as research design, participants, data methods, data collection, and data analysis. Data collection • Explains how you intend to gather the information that will be used to answer the research question(s). • May involve the use of quantitative (e.g. surveys, recording the number of times an incident occurs, laboratory experiments), qualitative (e.g. interviews, observations). Data analysis • Describes exactly how you plan to compile the data you collect and how you will organize and interpret the data to make sense of what you find. • Identifies themes, developing tables and charts, identifying relationships, and/or calculating frequencies. Participants • A full description of the subjects (sample) or participants involved in the research. • How participants will be selected. • Criteria for becoming a participant. 50 Section Description Quality management • System to ensure the quality of the research project. • Helps provide confidence that the conduct of the study and data generated optimally fulfill applicable requirements. • NOT OPTIONAL – You must have a quality management plan. Ethics • You must apply to an ethics board/committee if you will collect information/data from human participants (directly or indirectly). • If you are collecting data in more than one site you may need to apply to more than one board. • Stipulate that you intend to apply for ethics approval. • Ethics approval may take several months to receive, so apply as soon as you submit your proposal for funding. • Most agencies will not release funds until ethics clearance has been received in writing. Project plan The project plan includes: Project plan, research team, and budget. Table 3. Sub-components of project plan section Section Description Project plan • Presents a clear indication of the timeframe for the project and the times when each aspect of the project will be implemented. • Often a work plan or timeline is displayed most effectively in a graphic, table or Excel sheet. • Will help demonstrate the feasibility of the project in a very visible way. • Identifies tasks; when the activity will take place; and by whom. Research team • Describe the members of your team and the experience/assets they contribute to the project. • Team must be multidisciplinary and diverse (depending on the nature of the research, it may include members of the community as well as researchers, healthcare providers and decision makers). • Convince the reviewers you have enough expertise on your team to conduct the proposed research effectively. • Include the role(s) and responsibility of each individual listed on the project. • Indicate whether team members are involved in a full- or part-time basis. Budget and justification • Outlines the resources needed to effectively conduct the proposed research. • Outlines exactly what is realistically needed from the funding agency to carry out the project. • Should be realistic in the context of the research setting. • Outlines how much money is needed in each phase of the project. • Aligns with agency suggested/required budget categories. • The budget should align with the proposed activities in the research design. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 51 Impact The impact section contains the following: monitoring and evaluation, capacity building, and dissemination plan. Table 4. Sub-components of impact section Section Description Monitoring and evalu- ation • Describes exactly how the team will decide whether or not the project meets its objectives. • Informs the prospective funding agency how they will be shown at the end of the project that their investment was a good one. • Facilitates the implementation of evidence-based practice and improved health outcomes. • Examines the difference between the implementation effectiveness and the efficacy of health intervention. Capacity building • How the project can help improve the research capacity of national and local institutions involved, via training, mentorship, etc. • How the project, can help increase capacity for using research evidence for policy or decision-making by key stakeholders, such as government officials, involved in the project. Dissemination plan • The dissemination plan should include intended publications, newsletters, workshops, radio broadcasts, presentations, printed hand-outs, slide shows, training programmes, etc. • Identify key stakeholders target audience and their needs. • Involve stakeholders throughout the process. • Tailor the message accordingly – stakeholder groups vary by their familiarity with research terminology and preferences for receiving information. Supplements Supplements include: Project summary, table of contents, references, appendices, and CVs of members of the project team. Note that the project summary and table of contents are placed at the beginning of your proposal, but are only written after you have completed the other sections. Table 5. Sub-components of supplementary sections Section Description Project summary • Briefly describes the entire proposal. • Although read first, written last. • Includes a description of the problem under investigation, a rationale (situated in the existing literature) for why the research is needed and/or important, the participants, the methodology, and the implications of conducting the research. • Is your ‘first impression’ with reviewers and may influence whether reviewers choose to fund your proposal. • Makes it very easy for reviewers to comprehend and evaluate your proposed project according to the review criteria. 52 Section Description Table of contents • Organizes the proposal by outlining ‘what’ is in it and where each item can be found. • Presents a convenient list of the topics and sections in a logical sequence ‘at a glance’. • Word processors automatically place the headings, sub-headings and page numbers for you in a professional manner. References • Lists all references cited in the text of your proposal (in a recognized referencing style). • If a reference is not cited in the text of your proposal, it should not be listed in your reference list. Appendices • Include those aspects of your project that are of secondary interest to the reader. • Assume the reader can obtain all the necessary information from the body of the proposal. • May include things such as investigators’ CVs, research instruments, or letters of support. • Can provide a place to put additional information you would like the reviewers to have access to, but that the length restrictions prohibit. CVs of members of the project team • Can have an influence on the reviewer’s assessment of your proposal. • Ensure that at least one member of your team has IR experience, a good track record and a strong publication record. • Complementary qualities such as credibility in the community can be equally important. • Agencies usually have a limit of 1–3 pages for an investigator’s short CV. • Develop a template to highlight the most relevant aspects of team members’ CVs to align with the scope of the funding agency. In each of the following sessions, your team will develop and write one section of your research proposal. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 53 1. writing the introdUction section In this session, you will take the first steps in writing your IR proposal by drafting your introduction section. This involves writing an overview of your research problem and conducting a systematic review of existing materials and literature to provide a rationale for why this problem is important and should be addressed. You will also develop general and specific research objectives, a statement of the problem and your research question(s). After completing this session, you will be able to: • Write the introduction for your proposal. • Develop the research question(s) for your proposal. Writing the introduction The introduction to your proposal: • Outlines what is being studied and why (i.e., the rationale). • Builds an argument for the current study. • Includes the statement of the problem, general objectives, specific objectives and research question(s). • Reviews existing literature. • Summarizes expected outcomes, including the impact the results will have. • Provides clear succinct rationale for why the project should be funded. The introduction is essentially a focused review of the pertinent existing knowledge, including published studies, project reports, and other literature. It builds an argument for conducting the study, including general and specific research objectives, the statement of the problem, and research question(s). This argument or rationale might be based on a need identified by the community, policy-makers, and programme managers. In sum, the proposal introduction provides a clear, succinct description of what the research is and a rationale for why the project should be funded. Introduction objectives The introduction provides critical information for funding and community support by accomplishing the following three things: • Provide a foundation for the further development of the proposal (overview of the problem). • Facilitate background information on, and reports from, similar studies (systematic analysis and succinct review of literature). • Systematically state why the proposed IR should be undertaken (rationale), what you hope to achieve (objectives) and expected results (outcomes). Guidelines for writing the introduction • Begin by conducting a systematic analysis about the problem you want to research and why it is important that this research is done. • Once you have your initial ideas clarified, continually edit the introduction as you progress, discuss issues with your team and receive feedback from the larger workshop group and facilitator. 54 The rationale should indicate why the research should be undertaken including the scientific, public health and policy relevance of the problem to be investigated, as well as the magnitude, frequency, affected geographical areas, ethnic and gender considerations of the problem. The introduction should also list other available options to the research problem and make a case as to why the chosen approach should be researched. It should also indicate how the results will be used and why it is likely to affect health care and health systems/policies, and who will ultimately benefit if the project results are used appropriately. What to write about • Overview of the health system and setting (context). • Description of the nature of the problem. • Analysis of the different factors that may influence the problem. • Description of solutions tried (background), and justification for further research. • Information expected from the research and how this information will be used to solve the problem (outcomes). To accomplish this, succinctly write about each of the items listed below. Just start writing, do not worry about how your ideas sound initially or perfecting what you write: you will continually change, elaborate, delete and edit the introduction as you progress with researching and discussing the topic provided. • An overview of the health care system in the country/region/district as these are relevant to the problem. Include illustrative statistics (if and when appropriate and/or available) to describe the context in which the problem occurs. • A description of the nature of the problem. • An analysis of the various factors that may influence the problem – why some factors need to be investigated. • A brief description of any solutions to the problem that have been tried in the past (background), how well they worked and why further research is needed (justification for the study). • A description of the type of information expected to result from the IR study and how this information will be used to solve the problem (outcomes). Developing the title There are four components to a good title: 1. Use ‘action’ words 2. Reflect implementation and intervention themes 3. Include specific target populations (adolescence, children under five year of age, etc.) 4. Include specific geographic location The title of a research proposal should describe the study, be concise and inform the reader what the research is about. It should include key words that would also help to identify appropriate reviewers. The title may not differ significantly from that of any other research proposal, but the topic it addresses will reflect a need identified in the community. It is possible that you may also have “Implementation research” in your proposal title if you are applying for a research grant that is specific to IR. For example: • Identifying gaps in HIV prevention among adolescents in Sub-Saharan Africa: An implementation research study. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 55 • Using implementation research to explore the rise in under-five mortality rates in Cameroon, Central African Republic, Chad, Democratic Republic of the Congo, Kenya and Zambia. Rationale • The introduction must justify why the research problem you have identified is important and worthy of funding. • To provide this justification, begin by providing evidence through a systematic analysis of existing information. Information to support your literature review can be found from a variety of resources and locations including: • local documentation – project progress reports, theses, dissertations, seminar proceedings • programme progress or evaluation reports • medical literature, including reviews that outline gaps in research • scientific meetings and conferences • new ideas/recommendations from previous research • funding agencies’ annual reports • questions asked by programme staff and/or students Example A major challenge for onchocerciasis control is to deliver annual ivermectin treatment to all target communities and to sustain high treatment coverage over a very long period. To achieve this, the African Programme for Onchocerciasis Control (APOC) has adopted the strategy of community-directed treatment (ComDT) with ivermectin. This strategy has proven very effective. Ivermectin treatment is popular and communities have responded enthusiastically to the concept of a community-directed intervention, in which they are themselves in charge of planning and implementation. A recent external evaluation of APOC concluded that ComDT was a timely and innovative strategy. The communities themselves were deeply involved in their own health care on a significant scale. This strategy could be used as a model in developing countries for other community-based health programmes. There is a growing interest at the national and international level to use the approach of ComDT for interventions against other diseases. The current momentum provides an important opportunity to integrate ivermectin treatment with other disease control activities, and to contribute to health care development for some of the poorest populations in Africa. But to ensure that this opportunity is properly exploited, there is an urgent need for good scientific evidence on the effectiveness of the ComDT process for interventions against other diseases, and for integrated disease control at the community level. During its meeting in December 2002, the Joint Action Forum of APOC recommended that the Special Programme for Research and Training in Tropical Diseases (TDR) undertakes, in collaboration with APOC, a multi-country study on the use of ComDT for other diseases. TDR and APOC have responded positively to this request and the multi-country study has now been launched. The research protocol for the multi-country study was developed during a protocol development workshop held from 4–8 November 2002 in Limbe, Cameroon. Because of the complexity of the issues involved, it was decided to prepare the study through a series of consultative meetings with key partners concerned with a multi-disease approach 56 to ComDT, in order to identify the principal research questions to be addressed in the study. An important finding of these consultations was that the attitudes towards ComDT vary widely, ranging from the very positive attitudes of those with experience of ComDT in onchocerciasis control, to doubts of experts in other disease areas who were not always convinced about the potential of the ComDT approach for the diseases they are concerned with. It became very clear that a scientific comparison of community-directed and alternative approaches for delivery of interventions against endemic diseases, including onchocerciasis, is very much needed to provide objective evidence on the advantages and disadvantages of community-directed interventions as compared to other approaches to the delivery of health interventions at the community level in Africa. Statement of the problem • Summarizes the purpose of the study. • Is a paragraph rather than a single statement. • Establishes the direction and captures the essence of the study. • Is clear and concise. • Incorporates general objectives and uses action words to succinctly outline the purpose of the study. • Reflects the research design of the study. • Leads to the research question(s). The term “statement of the problem” may be misleading as it usually comprises a self-contained paragraph, rather than a single statement. • Use words such as “purpose”, “intent” or “objective” to highlight the main idea of the research. • Identify the key concepts being explored. • Identify the research design (e.g. case study, ethnographic study, correlational, experimental). • Identify the unit of analysis in the study (e.g. independent and dependent variables, population, classroom, organization, programme, event); data collection methodologies (e.g. surveys, interviews). Example 1 In the 1990s, the Government of [x country] introduced an economic structural adjustment programme. This meant a reduction in financial allocations to social services and removal of subsidies and consequently a limit of the public health budget. Health sector spending over a percentage of total government spending declined from 5.3% in 1980 to 4.2% by the mid- 1990s. The diminishing resource allocation to the Ministry of Health has seriously affected a variety of programmes, including malaria control. Malaria still ranks among the major health and development challenges in the country and remains one of the major five killer diseases. The 1998 statistics of the country’s 57 districts, 16 showed an incidence rate higher than 100 per 1000 people (Source et al, 1998). Despite the existence of the Medical Care Plan (MCP) in several districts in the country, districts such as y still record one of the highest incidences (885/1000) (Source, 1999). On the other hand, districts such as z located in the same agro-ecological region have managed to reduce the incidence of malaria over the past three years from 575/1000 in 1997 to 305/1000 in 1999. Out of the 57 districts in the country, both y and z are in the top eight poorest districts with a Human Development Index (HDI) of 0.47 (Source 2000). The proposed study will identify factors that have shaped success in malaria control in one district and not the other and draws lessons for 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 57 the development of effective strategies to optimise the use of limited resources in a country that is currently facing an economic crisis. Example 2 Only 5–10% of the Chinese rural population, mostly in the richer eastern coastal areas, were still covered by Cooperative Medical Scheme (CMS) during the 1990s. In Vietnam, after the introduction of user charges in 1989, several provincial health insurance schemes were developed. In the schemes, industrial workers, constituting a minority in the population, were in principle insured on a compulsory basis, while other citizens, including farmers in the rural areas, could join on a voluntary basis. However, less than 2% of the rural target population was enrolled in the voluntary health insurance in 1999. The problem here is the low enrollment in the health insurance scheme and by extension, limited access to health care in the rural population. How to know if the problem is worthy of research To get an indication whether the problem identified would be an appropriate research project, ask the following questions: • Is there a perceived difference or discrepancy between the situation that exists and the ideal or planned situation? • Is there a clear reason for the difference or discrepancy to the problem? • Is there more than one possible answer or solution to the problem? Example Review the following overview of a problem situation: In District Y (population 145 000), sanitary conditions are poor (5% of households have toilets) and diseases connected with poor sanitation such as hepatitis, gastroenteritis and worms infestations are very common. The Department of Health has initiated a sanitary project that aims at increasing the percentage of households with toilets by 15% every year. The project provides materials and the population is expected to provide labour. Two years after the programme began less than half the target was reached. Now review the following questions to understand how to conduct a systematic analysis of the situation and provide a rationale for the need to conduct research to arrive at answers to the problem: • What is the discrepancy? • What factors can explain this difference? – Service-related factors? Failure to inform and involve the community? Bottleneck in the supply of materials? Training and effectiveness of sanitary inspectors? – Population-related factors? Lack of understanding of relationship between disease and sanitation? Poverty? – Physical factors? Ecosystems? Hard soil? Area always flooded? To ensure that you have identified a legitimate problem in need of research and worthy of funding, strategically situate your proposal so that it will: 1. enable researchers and stakeholders to critically evaluate existing knowledge, pool this knowledge and identify gaps that IR projects should fill; 2. clarify the problem and the possible factors that may be contributing to it; 3. facilitate decisions concerning the focus and scope of IR (relate significance to specific aims). 58 These three considerations will be emphasized in the introduction of your proposal and help formulate the rationale for why the research needs to be conducted. Reflecting upon these considerations is also important in helping you first think broadly in order to be able to then narrow your focus to identify research objectives within the broader context. Narrowing the research problem 1. Clarify the viewpoints of all stakeholders. 2. Specify and describe the core problem. 3. Identify the factors that may have contributed to the problem and clarify the relationship of the problem. By now, the research team should be able to develop an overview of the problem and – through a systematic analysis of existing resources and literature – provide a rationale for why conducting the proposed research would provide answers, solutions or alternative strategies to the identified problem. Now follow the steps below to help narrow focus and identify research objectives within the broader research problem: 1. Clarify the viewpoints of all stakeholders. • List all problems • Illustrate the discrepancy Example: Increasing defaulter rate among TB patients • Poor health services management, as identified by policy-makers. • Social stigma associated with TB, as identified by affected communities. • Negative attitudes of health workers, as perceived by service users. 2. Specify and describe the core problem. • Quantify the problem • Describe the problem in detail Example: Increasing defaulter rate among TB patients • How widespread is the observation? Which regions are persistently affected? Are there certain areas that may be potential low compliant areas? • Who is affected the most? • How severe is the problem? What are the consequences? e.g. increasing morbidity, deaths, a waste of resources, development of multidrug resistance. 3. Identify the factors that may have contributed to the problem and clarify the relationships of the problem. Example: Increasing defaulter rate among TB patients • Staff who are poorly trained because there are inadequate materials on TB. • Health educators who have little understanding of patient prescriptions and do not provide systematic advice and counselling to patients. This results in patients not understanding treatment requirements and a high default rate. Research objectives Research objectives should be SMART (i.e. Specific, Measurable, Achievable, Realistic and Timebound). In addition, you need to consider whether the research is: 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 59 • relevant • new or innovative • urgent • politically acceptable • ethical When writing the Research objectives, ensure that the team addresses the following questions: Is the research realistic? Describe the complexity of the proposed research. Are there adequate resources to do the research? Is it feasible to conduct and report the findings in 12 to 36 months? Is the research timely? Provide a rationale for why your research is timely, and convince readers of the urgency for research in this area in order to generate information/solutions to problems affecting a specific community. How is the research relevant? Describe how large or widespread the problem is, and also who is affected, who considers this a problem. Also refer to the potential for the disease/condition to spread/increase if not treated, the potential burden to the health system, and existing or potential economic impacts of the problem on the target population. For example: Both the Chinese and Vietnamese governments have recently recognized the problems of lack of access to health care for the rural population. New policy initiatives are being developed to address the issues. In China, the central government has taken a decision to allocate 10 yuan/ year/person for all the rural population in the central and western parts of China, in order to subsidize the re-establishment of a new Cooperative Medical Scheme, while it has also asked the provincial government to provide the same amount of money to support the schemes. In Vietnam, the government has issued a decree to significantly expand coverage of voluntary health insurance schemes providing the near-poor with subsidized insurance cards. This implies that the governments of the two countries have considered direct financial support to service the demand side (particularly the poor and the near-poor) via health insurance mechanisms, although they continue to allocate certain amounts of money from the government health budget to support the formal health sector. Against this background, the proposed research is expected to support policy initiatives by the governments, by bringing together the resources of experienced researchers from China, Vietnam and three European countries to study, evaluate and draw policy lessons for the ongoing movement to strengthen access to effective healthcare by making health insurance schemes work for the most vulnerable rural population in the two countries. Is the research new or innovative? Point out how the research will add value by doing something new or extend/improve upon something already in existence. You need to convince readers that you are not duplicating something that has already been done. For example: The project will produce innovations in a number of areas through its approaches and activities as follows: 60 • Piloting and testing new rural health insurance arrangements including innovations in: – benefit packages, in particular the development of schemes including primary and outpatient health services in addition to catastrophic health care costs in China; – provider payment mechanisms, in particular options such as capitation for pay for outpatient services at the village and township level health services in China, and commune health stations in Vietnam; – organization and management, including measures to increase accountability and transparency; – government subsidies in both countries. • A participatory approach to involving major stakeholders such as policy-makers and potential/ actual service users at all stages of the research in order to maximize the relevance and impact of the findings. Is the research urgent? Demonstrate how the research results are urgently needed by policy-makers, implementers and health care providers in order to provide evidence to create a change, implement an intervention or put a stop to current practices. For example: During the SARS (severe acute respiratory syndrome) outbreak of 2003–2004, implementation research regarding uptake of SARS protocols was urgent. Is the research politically acceptable? IR projects often address topics of high interest to local and national authorities. It is advisable to involve policy-makers in the project design to ensure political acceptability and facilitate implementation of study results. For example: Undertaking TB research among the prisons in some communist countries may be seen as politically unacceptable. Consulting with and involving the authorities could mitigate this. How will the results and/or recommendations be applicable to the target community? Explain the likelihood of adoption of recommendations resulting from the research and how the findings will be used to improve health and health care. Demonstrate that you have done your homework and are aware of resources available, as well as any additional resources needed to facilitate implementing the recommendations. Is the research ethical? Explain how the research will be beneficial to the members of the community being studied. How will the research findings be shared with the target group? Can informed consent be obtained from the research participants? How will you take into account the condition of the participants? Will the results be shared with those who are being studied? For example: In scaling-up use of GeneXpert TB diagnostic device, more multidrug-resistant tuberculosis (MDR-TB) would be detected. It would be seen as unethical if diagnosed MDR-TB cannot be treated in an appropriate way (e.g. because of lack of technical capacity). 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 61 Overall objectives • List specific and overall objectives. • Outline the purpose for conducting the research. • Clearly state what the study is expected to achieve in general terms. • Align with the broader social, economic and health concerns outlined in the overview of the introduction, and further focus the context of the research down to an essential purpose. Different funding agencies use different terminology (objectives, goals, aims). Sometimes these terms are used interchangeably. The term “general objectives” is sometimes used interchangeably with “purpose of the research” or “overall objectives”. The general objectives should not be unrealistic (reduce morbidity and mortality) but rather reasonable, such as provide programme managers with information useful for improving service delivery. The General objectives outline the purpose for conducting the research. The purpose section may organize the study into clearly defined phases and facilitate the development of the research methodology and data collection to gather information to address the identified problem. The particular research project could contribute in part to the overall objectives, but cannot fully fulfil them, since they may be affected by other factors such as education, manufacturing, etc. On the other hand, the specific objectives must be completely achievable through this project. The specific objectives will be used to measure the success or failure of the project. Example 1 To contribute towards poverty reduction and health improvement for people living in poor rural areas of developing countries; to increase equity in health by making evidence available for health policy-makers for an effective, sustainable and affordable rural healthcare financing system in China and Vietnam. Example 2 To maximize the equity, effectiveness and efficiency of close-to-community services in rural areas and urban slums in six countries. Specific objectives • Specific objectives are a breakdown of general objective(s) into measurable action statements that outline what will be done, where and for what purpose. • Use action verbs when defining specific objectives (e.g. determine, compare, verify, calculate, describe, establish, evaluate). Avoid the use of vague, non-action verbs when writing your Specific objectives (e.g. appreciate, understand or study). Use verbs such as: train, supervize; distribute when describing project activities. Resist the temptation to put too many or over-ambitious specific objectives in your IR proposal that cannot be achieved. After formulating your specific objectives ask yourself the following questions: Are the specific objectives clear, defined in operational terms that can be measured, realistic, and do they demonstrate how the research results will be used to solve the research problem? 62 Good example To determine progress and constraints of visceral leishmaniasis active case detection at the district level using findings from previous years as baseline. Poor examples • To provide patient-focused training programmes to enhance both self-management and peer- management of diabetes as a means to develop leaders. • To study the behaviours of health workers in Uganda. • To develop an implementation strategy for elimination of TB for a national TB control programme in China. Research question(s) • Should be of interest to the researchers, policy-makers; decision-makers, funding agencies, health care providers and the community the research will affect. • Should be answerable. • Are shaped by the problem and in turn shape the design of the research. • Are clear and specific. • Are feasible. • Provide information required to evaluate ongoing interventions and/or progress. • Analyse possible causes for missed targets (in order to find solutions). • Answering the question will result in important information. The research methodology should be designed in such a way that by conducting the research the research question(s) will be answered. IR question(s) • Primarily address the needs of policy-makers, programme managers and health care providers, not only. • Describe the health situation and intervention (include those in place and potential interventions). • Provide information required to evaluate ongoing interventions or progress needed for making adjustments in the intervention. • Analyse possible causes for missed targets (in order to find solutions). IR questions are identified through an analysis of the situation and evidence, not merely based on the instinct of the researcher, policy-makers, programme managers or health care providers. An IR question does one or more of the following: 1. Describes the health situation and intervention (include both situations and interventions in place and potential interventions) • Magnitude of the problem • Distribution of health needs of the population • Risk factors for some problems • People’s awareness of the problem • Utilization patterns of services • Cost-effectiveness of available and potential other interventions 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 63 2. Provides information required to evaluate ongoing interventions or progress needed for making adjustments in the intervention • Coverage of priority health needs • Coverage of target groups • Acceptability of the services • Quality of services • Cost-effectiveness of the intervention • Impact of the programme on health 3. Analyses possible causes for missed targets in order to find solutions • Availability • Acceptability • Affordability • Service delivery problems This information is required to formulate adequate policies, adapt or plan an intervention, and assess progress and the need for adjustments. As your team conducts its own implementation research, remember that the question determines the methods, and the purpose determines the framework. IR questions address the design, implementation and outcomes of programmes. IR also asks: “Are there unintended consequences?” and “Why is it happening as it is?” IR questions are driven by implementation problems and should be designed for action-oriented research in collaboration with stakeholders. Formulating IR questions When formulating an IR question, you should consider the following: • How could it best be answered? • How could it feasibly be answered? • What data is available? What data is needed? • What can be controlled? Once the problem has been identified, the next step is to formulate a question addressing that problem. Your approach depends on context and availability of information. Remember that IR problems are programme embedded – they begin and end in programmes. So, engage programme stakeholders early to formulate IR questions. The way questions are formulated drives research methods. These are helpful sources for formulating IR questions: • Programme progress, annual, or evaluation reports from monitoring and evaluation activities. • Medical literature, meta-analyses, and literature reviews. • Scientific meetings and conferences. • New ideas from previous research or formative qualitative studies (e.g., interviews). • Funding agencies’ annual reports. • Questions asked by programme staff and students. • Local documents – project progress reports, theses, dissertations, seminar proceedings. • Annual review or dissemination meetings. • Geographic information systems (GIS) data that identify geographic location and distribution of problems. 64 Prioritizing IR questions In prioritizing research questions, pay attention to: • relevance • avoiding duplication • urgency of need • political acceptability • feasibility • applicability of results or recommendations • ethical acceptability A programme may generate multiple, simultaneous implementation problems and questions. This can be overwhelming, so it is important to prioritize IR questions, ensuring efficiency and responsible practice of IR. The following seven criteria should help with prioritizing IR questions (Table 6): Table 6. Criteria for prioritizing IR questions Criteria Considerations Relevance • How large or widespread is the problem? • Who is affected by the problem? • How severe is the problem? • If the problem is not checked, is there potential for spread? • Who considers this a problem? • Is this problem a burden to the health system?  How severe is the burden? • What is the economic impact of this problem on the population? Avoidance of duplication • Has this question or problem been researched before? • Are there any interventions that have effectively addressed this problem? • If yes, are there any major questions that deserve further research? • Is my context so different that I cannot use the results of previous intervention research? Urgency of need • How urgently do the policy-makers, implementers and health care providers need results? • Will timeliness impact changing course, taking on new interventions or stopping what they are doing? Political acceptability • It is advisable to do study implementation problems of high interest and those that are supported by local or national authorities. • Study results for salient issues with political support are more likely to be implemented. • Politically accepted implementation problems can likely rely on involvement of the policy makers in the study. Feasibility • How complex is the research? • Are there adequate resources to do the study? • Is it feasible to conduct and report the findings in 12 to 36 months? 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 65 Criteria Considerations Applicability of results or recommendations • What is the likelihood that recommendations will be adopted? • How would the findings be used to improve health and health care? • Are there available resources for implementing the recommendations? Ethical acceptability • How acceptable is the research to those who will be studied? • Does the target group share the implementation problem? • Can informed consent be obtained from the research subjects? • Will the condition of the subjects be taken into account? • Will the results be shared with those who are being studied?   Review of literature (synthesis of existing knowledge) • Involves library searches to find relevant and up-to-date resources, reading and synthesizing the existing information and literature into a succinct overview. • Demonstrates relevance by establishing what is already known about the research problem and how it has been approached in the past. • Provides a rationale for why it is crucial to conduct the research. • Indicates what is not known about the topic. • Helps you refine the statement of the problem. • Provides the ‘state of knowledge’ on the topic and sets up the research question(s) being investigated. • Establishes credibility. The review of literature synthesizes the relevant and most up-to-date information on the proposed research topic and leads to setting up the research question(s) being investigated. A literature review should demonstrate that you have read the existing work in the field with insight, thereby providing the reader with a picture of the state of knowledge and of major questions in the subject area being investigated. By providing an overview of the existing available information, you avoid duplicating existing research by finding out what research has already been done on the topic. Reviewing the existing information will help you refine your statement of the problem, analyse various approaches already used in related studies, and assist in forming convincing arguments related to your research. By reading your overview, readers should be convinced that you are familiar with the topic and you have done extensive background research in the field. In session one ‘Write-shop’, you will strategically situate your research problem in the existing knowledge and literature, in order to establish a rationale for why it is important that your identified problem be researched. Writing your rationale is the first step in developing the synthesis of existing knowledge for your IR proposal. Completing review of literature • Reading and writing can be an iterative process and time consuming. • You are unlikely to complete your synthesis of existing knowledge during the current training. Our goals are to: • ensure you understand what is involved 66 • ensure you are aware of tools available to assist you with this task • provide you with examples of a brief review of literature from IR proposals Conducting a literature review involves reviewing the existing knowledge and doing library searches to find relevant resources (i.e. research articles, research studies, reports, government documents, and white papers), reading, and then organizing and synthesizing the information into a succinct overview of the topic. You may find you need to read about the topic for several days or weeks before beginning to write. At some point, however, you need to begin to write. Often you will find that once you begin to write, the process can feel overwhelming and you need to go back and do some more reading. You need to look for major concepts, read with a purpose, be a critical reader and start to write while still reading. Reading and writing can be an iterative process. As such, developing a comprehensive synthesis of the existing information can be an extremely time- consuming and laborious task. During this workshop you will not have time to produce your review of literature for your research topic to an extent sufficient to support your IR proposal. As indicated earlier in this workbook, it is important to at least read about the problem you have identified before attending the workshop. We will, however, provide an overview of what synthesizing the existing information and literature means, make certain that you are aware of the tools available to assist you with this task and provide you with IR examples of syntheses of the existing knowledge and literature. Once you are back in your communities, you can continue to collect and read articles and develop your review of literature. If you have the resources, you may even want to outsource this task to a consultant who has conducted reviews of literature before. Characteristics of literature review • Presents an argument based on existing information (e.g. published literature; reports, government documents etc.). • Synthesizes information from many sources. • Critiques research studies for methodological shortcomings (when and if appropriate). • Synthesis should support your research question. The review of literature is not merely an expression of the research team’s opinion of an issue or topic, but instead presents an argument based on the existing information, including published literature. An effective synthesis doesn’t depend on, or elaborate upon, one or two studies, but synthesizes the existing information from many sources. It should be well written with one paragraph logically flowing into the next. The review of literature does not just describe or summarize the content of an article but critiques research studies for methodological shortcomings, as appropriate. In the past, it may have been acceptable not to provide a strong synthesis of the existing knowledge due to the research team’s location and lack of access to libraries and resources. However, today anyone who has access to the Internet can find most of the existing literature. Several search engines such as Pubmed (http://www.ncbi.nlm.nih.gov/pubmed), Hinari (http://www.who.int/ hinari/en/) and Google Scholar (http://scholar.google.com) will be helpful in this regard. You can also work with a librarian, orassign a specific member of the project team to help you find and access the information you need. In summary, the synthesis of existing information: • defines and limits the problem or research question(s); 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 67 • demonstrates familiarity with the topic; • establishes credibility; • places the research in context; • demonstrates relevance by making connections to a body of knowledge; • integrates and summarizes what is already known about an area; • helps avoid duplication; • identifies agreement and discrepancies between and among prior research; • helps the researcher select methods and measures; • stimulates new ideas. Referencing • The ideas included in the review of literature should be properly cited. • Software programmes are available to help manage, store and use references effectively. • Improper referencing can hamper your chances of success in your grant application. • Not referencing or referencing improperly can result in plagiarism. • All references cited in the proposal text should be included in the reference list. The ideas included in the review of literature should be properly cited using the reference style required by the agency to which the proposal is being submitted (e.g., APA, MLA, Chicago, Harvard). There are various software programmes available to help manage, store and use references effectively (e.g. EndNote, Mendeley). If possible, install the 30-day trial EndNote software or the free Mendeley software onto your computer. It is essential that you reference properly. Not adhering to the conventions of proper referencing is an indication of sloppy research and consequently will hamper your chances of being successful in your grant application. Moreover, if you do not reference properly, you run the risk of plagiarizing, which can have severe career and academic ramifications. There are programmes that can help you check against plagiarism during your write up. An example is Desktop Plagiarism Checker. All the references cited within your proposal (and only the ones cited in your proposal) must be listed in the references section of your proposal document. Example 1 (well referenced) Following World War II, [Q country] had built an extensive tuberculosis control system that relied on active case-finding using mass-miniature radiography and prolonged inpatient treatment with effective anti-TB drugs (Ref., 1999). The collapse of that country left the burden of TB control on impoverished regional authorities and precipitated a disruption in case finding, diagnostic quality and clinical effectiveness. The emergence of multidrug-resistant TB (MDR-TB) in this region has followed the disruption of effective drug delivery to TB patients (Ref., 1998). Because the international community had judged the Q country’s system of TB control as being too costly, in 1994, the WHO assembled the heads of TB control programmes in this region to promote a standardized framework for TB control later known as ‘DOTS’ (Ref., 2001). In 1998, the Q country Government adopted the DOTS strategy and proceeded to stengthen TB services throughout the country. While a fall in the TB mortality rate has followed the availability of first- line TB drugs and smear microscopy facilities, TB control continues to suffer from at least two limitations: TB patients continue to abandon treatment at a rate of 8% or higher, and more than 5% of newly diagnosed patients have MDR-TB (Ref., 1999). Rates of TB infection have risen in z City and w district during the past decade, as in other parts of the country, and may be 68 associated with poverty and the deterioration of TB control and prevention systems due to a lack of resources. The incidence of other communicable diseases such as diphtheria and hepatitis has also increased (Ref., 1999). The international literature on directly-observed therapy (DOT) suggests that successful community-based TB control programmes depends on some combination of incentives and enablers for patients and health care workers to promote treatment adherence (Ref. et al., 2000). In addition, the medical literature on MDR-TB treatment shows that short-course chemotherapy does not produce acceptable clinical outcomes for patients already resistant to isoniazid and rifampin (Ref., 2000). In settings with highly prevalent MDR-TB, effective TB control will likely require 18- to 24-month courses of individualized treatment regimens that include second-line anti-TB drugs (WHO, 2001). In response to the problems of treatment adherence and MDR-TB, the National Tuberculosis Control Programme and the State Medical University have initiated MDR-TB treatment with second-line drugs in several pilot regions, and have begun to develop an innovative programme of outpatient enhancers and enablers they have termed DOT-flexibility and follow-up (DOT-FF) (Ref., 2001). Example 2 (poorly referenced) Large segments of the world’s rural population remain vulnerable to the full financial cost of illness. Over the past two decades a growing number of developing countries have organized community-based or rural health insurance schemes to improve access to health care for those working in the informal sector. The need to develop and organize health insurance for the rural population and informal sector workers, as well as their dependents, has been linked to two sets of failures in a number of countries: • Government failure to collect taxes and organize public finance, to provide social protection for vulnerable populations, and to exercise oversight of the health sector. • Market failure to offer an effective exchange between supply and demand, partly due to the gap between needs, demand and ability to pay, and partly due to the prevalence of non- monetary transactions in the informal sector. The strengths of health insurance in mobilizing and managing health resources are seen as based on three factors: social capital (safety net formalized by family, friends and community for the low-income groups); pre-existence of some community institutions; and interconnectivity between local communities and external institutions committed to advance the general welfare of society. However, there are also many problems and challenges in developing sustainable health insurance schemes in low- and middle-income countries because of a variety of constraints, including human and financial resources. Group activity: Statement of the problem Now that your team has developed an overview of your research problem(s), a rationale for why the research is justified, and general and specific objectives, you are ready to draft your statement of the problem, which will logically lead you to your research questions. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 69 In your teams, read the example statement of the problem and use it as a guide to discuss the statement of your own research problem. Example [based on a proposal related to malaria control in two different districts in an African country]: In the 1990s, the government of country x introduced an economic structural adjustment programme. This meant a reduction in financial allocations to social services and removal of subsidies and consequently a limit of the public health budget. Health sector spending over a percentage of total government spending declined from 5.3% in 1980 to 4.2% by the mid- 1990s. The diminishing resource allocation to the ministry of health has seriously affected a variety of programmes, including malaria control. Malaria still ranks among the major health and development challenges in the country and remains one of the five major killer diseases. The 1998 statistics of the country’s 57 districts showed an incidence rate higher than 100 per 1000 people in 16 districts (Source, 1998). Despite the existence of the malaria control programme in several districts, some districts (such as y) still record one of the highest incidences (885/1000) (Source, 1999). On the other hand, districts such as z, located in the same agro-ecological region, have managed to reduce the incidence of malaria over the past three years from 575/1000 in 1997 to 305/1000 in 1999. Out of the 57 districts in the country, both y and z are in the top eight poorest districts with a Human Development Index (HDI) of 0.47 (Source, 2000). The proposed studywill identify factors that have shaped success in malaria control in one district and not the other, and draws lessons for the development of effective strategies to optimize the use of limited resources in a country that is currently facing an economic crisis. Write-shop During the evening, work in your teams to develop the following for your team’s project: • Working title • Statement of the problem for your IR proposal (1/2 page) • Research question(s) • Specific objectives for your project (4 to 6 objectives) Be prepared to present your drafts on day 2. Group discussion Each group will give a 10-minute presentation to the group with their results from the previous evening’s write-shop. Propos al 70 2. reseArch design As part of this session, your research team will build capacities that allow you to determine the specific research design that will be most effective in meeting your research objectives and answer your research question(s): • Develop a research design outlining the procedures that will be taken to collect and analyse the data. • Identify the research method (qualitative, quantitative/or mixed) that will be most effective in attaining your research objectives and answering the research question(s). • Describe the quality management plan that your team will put in place to ensure uality. • Describe the participants. • Explain the steps you will take to ensure all ethical protocols and procedures will be addressed. The research design is a blueprint or plan delineating your research methods; the steps or procedures you will take to collect and analyse your data; research sample size and participants; and how you will address ethical considerations. The research design section of your proposal will generally include four sub-sections: • Study participants • Research methods • Data collection • Data analysis There are also four main options of research design, with each one addressing a a different fundamental need in the study setting (Table 7). Table 7. Research design categories and the needs they address Need Design Example Adequacy Before-after or time series Introduction of health insurance in a resource-poor setting, and examination of the impact of health insurance on access to health care. Using before- after or time-series design to collect corresponding data for evaluation. Plausibility Comparison of intervention to control group (pre-post intervention) Cross-sectional studies Introduction of a new approach to the improvement of maternal health care in selected districts. A number of districts with a similar socioeconomic development levels were selected as control sites. The impacts or effects of the new approach were assessed by a comparison of new approach/ intervention to control districts, using the method of ‘differences in differences’, for example. Probability Clusters RCT; pre-post intervention and control sites Using mobile phones as a reminder to increase adherence to TB treatment. Each district is used as a cluster. Among ten districts, a cluster-randomized controlled trial is employed to test the impact of using mobile phones as a reminder in the five districts randomly selected. The other five districts served as control sites. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 71 Need Design Example Explanatory Repeated measures on context and mechanisms Using quantitative, qualitative or mixed methods to understand and examine change in use of health services by pensioners after retirement, and analyse main factors resulting in the changes. Once the overall study design has been determined, it informs the choice of participants, research methods and data collection/analysis approaches that are used/adopted. Study participants The participants section should include a full description of the subjects (sample) or participants who will be involved in the research, along with how they will be selected (purposeful or random sampling) details of the sample size and participant criteria. This allows the reader to make conclusions regarding the generalizability of the study. Criteria for becoming a participant, which may include demographic information such as age and sex, should be specified, along with descriptions of characteristics that are relevant to the research (e.g. years of experience, when they were diagnosed with the disease being researched, level of education etc.). Outline the strategies that will be taken to ensure participants feel free to express their opinions during interviews, focus group discussions and other data collection procedures. For example, are venues private? Are there power dynamics to consider so that participants do not feel intimidated or threatened to say exactly what they are feeling and thinking? For example, if interviewing a patient, they may not feel comfortable expressing their opinion in front of their physician. Or when interviewing health care staff they may not feel comfortable saying how they feel in front of their superiors or managers. Consider how your IR proposal can outline appropriate procedures to ensure that participants feel comfortable and confident to provide honest, reliable responses. The exact structure of the study participant section of your proposal will also be influenced by the selected research methods. Example of Participants section of an IR proposal For the key informant interviews for a study on TB in the prison system of country X, a comprehensive list of officials to be interviewed will be developed based on the stakeholder analysis and on consultations with the national TB control programme (NTBCP) personnel. A preliminary list of officials has been compiled and includes the following: • Minister of health (or his deputy) • Deputy of the minstry of health responsible for epidemiology and infection control • Director of the NTBCP • Chair of the sanitation and epidemiological services committee • Ministry of justice • Deputy of the ministry of justice responsible for the prison system • Chief medical doctor that oversees the prison system • Ministry of internal affairs • Deputy responsible for detention centres 72 • Chief TB medical doctor (detention centres) • Ministry of social security (head administrator) • Ministry of finance (head of budgeting department) • Head of regional political authority • Head of health department of that authority Group activity: Study participants In your research teams discuss who you think your research population will be. Will you have one site or multiple sites? Why will you choose the site(s) you choose? Discuss who you think your participants will be in the study. How many participants will you need? What will be the criteria for becoming a participant? Will you need a variety of participants in order to get different perspectives on an issue (patients, physicians, family members, members of the community)? Will you have a control group of participants? Do you need to choose a representative population for certain aspects of data collection? For example if you are conducting individual interviews do you want your participants to vary in (age, gender, education, experience etc.) in order represent the sample population? Draft an outline of your participant section. You will need a general section describing your participant population. You will also need to estimate how many participants you will want from this population for each data collection method (surveys, focus group discussion, interviews etc.). Research methods There are three general types of research methods qualitative, quantitative or a combination of both (mixed methods), depending on the purpose of the design. Quantitative methods are better for answering the question: What is happening? Qualitative methods are suited for answering the question: Why is it happening? Qualitative methods Qualitative research is generally used to explore values, attitudes, opinions, feelings and behaviours of individuals and understand how these affect the individuals in question. It may also be used to help explain the results of a previous quantitative study. Qualitative researchers are concerned with individuals’ perceptions of specific topics, issues, or situations and the meanings they assign to their lives. This kind of research is important for theory generation, policy development, improving educational practice, justifying change or a particular practice, and illuminating social issues. Qualitative research uses data collection methodologies such as interviewing, observation, and documents (e.g. diaries, historical documents). The results are descriptive or explanatory rather than predictive. For qualitative approaches, your proposal will need to outline the following sections: • Rationale • Data collection • Data analysis • Trustworthiness • Participants • Rationale 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 73 If your research team decides to use qualitative methods in your study, your proposal should describe why qualitative approaches were chosen (explain how qualitative methods will provide information that will help you address your research objectives and research questions). For example, qualitative research may be appropriate because in your research you want to explore values and behaviours of individuals, and to understand how these affect the phenomena in question. Qualitative methods may also be appropriate because it will help further understanding of the results of a previous quantitative study. Qualitative methods may be used because the study aims to generate theory, develop policy, improve health care practice, justify change of a particular practice, or illuminate social issues. Other reasons for using qualitative methods could be to provide context, a deeper understanding of stakeholder’s need, rich data and participants’ perspectives. Qualitative data collection When collecting qualitative data it is preferable to gather data using more than one data collection method. Obtaining information on the same phenomena in a variety of ways allows the researcher to ‘triangulate’ (or cross-check/verify) the data, which adds rigor to the research. The data collection process in qualitative research is emergent. The design is flexible to allow the researcher to investigate themes (findings) in more detail as they emerge. Qualitative methods use data collection methodologies such as interviewing, observation, discussions and review of documents (e.g. diaries, historical documents). The results of qualitative research are descriptive or explanatory rather than predictive, and are typically time-consuming to collect. In your IR proposal, indicate which data collection methods you intend to use and why. The following table may be helpful to you in this process. It provides an overview of qualitative data collection strategies (Table 8). Table 8. Qualitative data collection strategies Strategy Summary and examples Participant observation Researcher participates to some degree in the natural setting over an extended period of time: Systematic observation of verbal and non- verbal actual behaviour in which trained observers use a structured recording form. Data are collected by observing, interviewing, note taking and/or journaling. Researcher develops a relationship with the participants, which may affect the data collected. Proposal example: Semi-structured direct observation will be carried out in selected facilities to assess and compare the behaviour of health staff towards patients who are/not members of the revised schemes in at least two facilities in each study county, such as one township or commune health centre and one county or district general hospital. Non-participant observation The researcher does not participate in any activity in the natural setting. Data are collected by observing, note-taking and/or journaling. Researcher does not develop a relationship with the participants and therefore cannot explore further issues in relation to observations made unless this approach is complemented with a follow up. 74 Strategy Summary and examples Field observation during a transect walk Detailed descriptions of events, actions, behaviours, people and objects in a natural setting. Field observations are written in the form of field notes. In-depth interviews A purposeful conversation directed to the participant by the researcher. The researcher will typically develop an interview guide beforehand. The researcher encourages the participant to talk in-depth, prompting more detail whenever possible without leading the participant to specific answers. Interviews are often recorded and transcribed. The average length of an interview is one hour (or less). Proposal example: It will include in-depth individual interviews with: people suffering from ‘catastrophic illnesses’, including both members and non-members of revised schemes and those who have used and not used services; health policy-makers at national and local levels; and rural health insurance scheme managers. Review of documents and artefacts Records of past events that are written or printed (e.g. letters, anecdotal notes, diaries). Material objects and symbols of a current or past event, groups, organization, or person that reveal social processes, meaning, and value (e.g. diplomas, awards, papers, logos etc.). Video/film/ photographs Media that capture the daily life of an individual, group or event under study. Can be viewed repeatedly to record behaviours. Focus group discussion A 1–2 hour discussion, guided by a trained moderator in which 6 to 10 similar respondents (age, gender, social status) focus on a list of defined topics. The discussion, designed to reveal beliefs, opinions and motives, should take place in an informal setting. Data collection may be enhanced by the interaction between and among participants. Proposal example: This will comprise of focus group discussions using participatory techniques with: members and non-members of the revised schemes (including different age, gender and socioeconomic groups); and health service providers at county/ district levels and below, including general practitioners/ primary care providers, preventive service providers, and out-patient and in-patient providers Plan for qualitative data analysis Qualitative data analysis consists of data management, data reduction and coding of data. In short, the goal is to identify patterns (themes) in the data and links between them. There is no set formula for analysing qualitative data, but the following steps are commonly used in many qualitative research studies and may be helpful to include in your IR proposal: 1. All interviews and discussions are recorded. 2. All recordings have to be transcribed verbatim (i.e. typed out in full, word-for-word). 3. All background information about the participants should be appended to each transcript. 4. In the initial step of the analysis, the researcher will read/re-read the first set of data and write notes, comments and observations in the margin, with regard to interesting data that is relevant to answering the research question(s). 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 75 5. While reading the data, the researchers begin developing a preliminary list of emergent categories into which they will group the notes and comments. These categories are guided by the purpose of the study, the researchers’ knowledge and orientation, and the meanings made explicit by the participants (1). A list of these categories is compiled and attached to the data. 6. The next set of data collected is then carefully read and, with the previously constructed list of categories in mind, notes, comments and observations are once again recorded in the margin. This second data set are then grouped into categories and a list of the categories compiled. The two lists are then compared and merged to create a master list of categories. This list reflects the recurring regularities or patterns in the study. 7. These categories are then given names. Category names may emerge from the researcher, from the participants or from the literature. According to Merriam (1), these categories should be: exhaustive; mutually exclusive; sensitive to what is in the data; conceptually congruent; and, in effect, the answers to the research questions. Category names or codes in data analysis can also be derived from the questions asked in the data collection tools based on the objectives of the study. 8. Once the researchers are satisfied with the categories, the data is assigned to these categories. Taking a clean copy of the data, the researcher organizes the data into meaning units and assigns them to the relevant categories, writing the category code in the margin. 9. The researchers then create separate files for each category and cut and paste the meaning units into the relevant category, creating a file containing all the relevant data. Care should be taken to avoid context stripping by carefully cross-referencing all units and coding them with the participant’s pseudonym, the date of data collection, and the page number (2). 10. The researchers then try to link the categories in a meaningful way. Diagrams can be used to facilitate this process. For example, in a study to determine causes of malaria: Clean dirty gutters Spray your rooms Take intermittent Preventative Treatment (IPT) Sleep under treaded bednet Deworm regularly Avoid eating sweet things Avoid standing in the sun Malaria Prevention Take pain killers 76 11. Researchers can also use several different computer qualitative data analysis (QDA) software to help them manage their data. The term “QDA software” is slightly misleading because the software does not actually analyse the data, but organizes it to make it easier to find and identify themes. Software can also be expensive (up to around US$900 per single user). For these reasons, some researchers prefer analysing data by hand. However, as the software improves, researchers are finding QDA increasingly useful in helping analyse data and save time. Here are some of the more common QDA software names: • AtlasTi (http://www.atlasti.com) • MAXQDA (http://www.maxqda.com) • QSR NVivo (http://www.qsrinternational.com) previously called Nud*ist 6) • EZ-TEXT 3.06C (http://www.cdc.gov/hiv/topics/surveillance/resources/software/ez-text/ index.htm Examples: Qualitative data analysis descriptions 1. Transcripts from key informant interviews and group interviews will be coded and analysed according to emerging themes using Ethnograph software for qualitative analysis. Data will be reported in the form of narratives or frequency tables in addition to standard thick ethnographic descriptions. 2. Coding of focus group interviews, ethnographic field notes and interviews with health workers using Atlas-TI software will allow analysis of emerging themes and presentation of data in the form of narratives or frequency tables. 3. Transcripts from life histories will be coded and analysed according to emerging themes (Ethnograph or Atlas-Ti software). Data will be reported in the form of narratives or frequency tables. In addition, videotaped recordings of patients will be used for national and international advocacy with the permission of interview subjects. Semi-structured, open-ended interviews from patients and family members of patients will be coded and reported as narratives or frequencies of coded responses to better understand the impact of the persistence of MDR- TB in this setting. Trustworthiness IR proposals should stipulate how the research team will ensure scientific rigour in qualitative methods. For example, will your study provide participants with a copy of their interview transcripts to provide them an opportunity to verify and clarify their points of view? Will you use software to help manage your data and increase rigour? Will you conduct member checks (have more than one researcher analyse sections of the data to compare and verify results)? Will you triangulate the data to increase the rigour? Will you report disconfirming evidence? Participants As mentioned above, ensure that numbers of participants, recruitment and selection criteria align with your qualitative methods. You may also have to consider some specific issues: Will you use purposeful sampling? What are the demographics relevant to the study, and characteristics related to the disease of interest. Quantitative methods The three most common designs associated with quantitative methods are: quasi-experimental, correlational, and monitoring evaluation. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 77 Quasi-experimental research Experimental research is the only type of research that can establish cause and effect. Furthermore, it is the only type of research where the researcher attempts to manipulate a particular variable. In experimental research, the researcher is interested in the effect of an independent variable (also known as the experimental or treatment variable) on one or more dependent variables (also known as the criterion or outcome variables). The researcher manipulates the independent variable and measures the dependent variable(s). There are usually two groups of subjects in experimental research: the experimental group, which receives a treatment of some sort (e.g. taught by a new teaching method, or receives a new drug) and the control group, which receives no treatment (e.g. continues to be taught by the old method, or receives a placebo). Sometimes, a comparison group will also be used as well as, or instead of, a control group. The comparison group receives a different treatment from the experimental group. The control and/or comparison groups are critical in experimental research as they allow the researcher to determine whether the treatment had an effect or whether one treatment was more effective than another. When possible, the subjects should be randomly assigned to the treatment and control groups. Correlational research In correlational research, researchers seek to determine relationships between two (or more) variables without trying to influence those variables. The degree to which the variables are related is described by a correlation coefficient, which can take any value from –1 to 1. A positive correlation means that high scores on one variable relate to high scores on the other variable or low scores on one variable relate to low scores on the other variable (i.e. a positive correlation). Conversely, a negative correlation means that high scores on one variable relate to low scores on the other. A correlation coefficient of zero means that there is no relationship between the variables. Contrary to experimental research, correlational research does not establish cause and effect. Not only do researchers use correlational research to describe relationships between variables, but also for prediction. If a strong enough relationship (positive or negative) exists between two variables it is possible to predict a subject’s score on one variable (criterion variable) using their score on the other variable (predictor variable). Monitoring and evaluation research One main objective of monitoring and evaluation (M&E) research is to track implementation progress against the original design, identifying potential weaknesses, testing initial assumptions and adjusting the implementation process if those assumptions fail to hold true. Data collection activities should be carefully justified as addressing the research objective(s). Otherwise there is a risk of wasting scarce resources on data that will never be used. One main source of data can come from the routine health information reporting systems, which often exist in low- and middle-income countries. Community health centres, district and regional hospitals, and other health facilities are usually required to submit their monthly or quarterly reports to local and national health authorities. The information often includes disease patterns, service use and expenditure, and other relevant information. While the data from the routine health information reporting systems can be easily available and collected, the quality of the data may not be reliable, as there has been a tendency of underreporting health problems or service usages, etc. Therefore, special surveys or regular record monitoring arrangements may have to be carried out to collect data required to achieve this objective. These data collection methods include household health interview surveys, health facility surveys (e.g. hospitals, health centres, etc.), and patient surveys. When using these methods for data collection, 78 researchers need to develop instruments and tools, e.g. questionnaires, checklists, and organize visits to selected households and health facilities. In your IR proposal, you should indicate who will be expected to undertake the data collection and whether training will be provided before carrying out the tasks. Appropriate supervision during the process of data collection is also required. For quantitative approaches, your proposal will need to outline the following sections: • A rationale • Data collection • Data analysis • Reliability and validity • Participants Rationale If your research team decides to use quantitative methods in your study, your proposal should describe why quantitative methods are being used (i.e. explain how quantitative methods will provide information that will help you address your research objectives and research questions). For example, quantitative methods may be appropriate because in your research you want to illustrate the cause and effect of the issue or situation being investigated. You may also justify using quantitative methods in order to determine the relationship between variables in a population or explore differences between two groups (e.g. pre-post intervention; different populations). Quantitative data collection Quantitative methods involve the collection and analysis of objective data, often in numerical form. The research design is determined prior to the start of data collection and is not flexible. The research process, interventions and data collection tools (e.g. questionnaires) are standardized to minimize or control possible bias. In your proposal, explain where the data will come from – health centre, district hospital, region (hierarchies for quarterly reports); how surveys will be delivered; who is facilitating delivery; how you will ensure anonymity; time required to complete survey; length of survey; number of questions on survey; sample size; how the survey will be designed; is the survey validated, etc. The data collection tools used (e.g. questionnaire) may be one developed by the researcher or, more preferably, one that has been previously developed. Developing an appropriate and effective instrument takes a lot of time and effort and often requires special skills. If you are developing the tool, specify if you will conduct a pilot. In your IR proposal, indicate what data collection methods you intend to use and why. The following table (Table 9) provides an overview of quantitative data collection strategies and may be helpful to this process. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 79 Table 9. Overview of quantitative data collection strategies Strategy Summary Structured observation The researcher directly observes (watches and listens to) some phenomenon and then systematically records the resulting observations. The researcher pre-determines specific categories of behaviours that will be observed. Questionnaire In a questionnaire, the subjects are required to respond to questions in writing or, more commonly, by marking an answer sheet. In the latter type of questionnaire, response options are often closed lists of responses in the form of yes/no/maybe; strongly disagree/disagree/undecided/agree/ strongly agree; Never/rarely/sometimes/often/frequently etc. Proposal example: Quantitative data will be collected through the use of structured questionnaires. A standardized form will be developed at baseline and will include the following categories: 1) socio-demographic characteristics; 2) economic status; 3) medical and treatment history related to tuberculosis; 4) current health status, including but not limited to assessment of symptoms, smear, culture, weight and height (for calculation of BMI); 5) history of imprisonment or substance abuse; 6) psychosocial status; and 7) knowledge of TB. Performance-based instruments Performance-based instruments are alternative forms of assessment used to demonstrate a skill or proficiency by having the participant create, produce or do something (e.g. write a paper, create a portfolio, do an athletic performance). Although popular in recent years, use of these approaches is fraught with technical difficulties. They are often time- consuming and require equipment or other resources that are not readily available. Source: Adapted from McMillian & Schymacher (3) and Fraenkel & Wallen, (4) Plan for quantitative data analysis It is important to outline a plan for data management and analysis. The methods and models of data analysis should be in accordance with the proposed objectives and types of variables. Quantitative data analysis will involve summarizing the results by calculating frequency and descriptive statistics such as means and standard deviations, and scale alphas for the participants’ responses on the questionnaire items. You should explain how basic descriptive statistics such as means and standard deviations will be calculated from data collected. The tests that you intend to conduct on the data should be explained (e.g. t-tests; hierarchical multiple regression). Specify if you intend to control variables. Indicate if any software will be used in your data analysis). Outline as many of the following that relate to your study: • Demonstrate appropriate analysis procedures. • Provide a general plan for data analysis and justify its technical and theoretical soundness. • Describe what information is needed to complete the analysis, the potential sources for this information and the instruments that will be used for its collection. • Provide sufficient detail to demonstrate the technical soundness of all data collection instruments and procedures. • Identify and justify procedures for analysis, reporting and utilization. 80 • Identify any anticipated constraints on the analysis. • Discuss who will be responsible for analysis, and the roles of the consultants or external personnel. Examples: Quantitative data analysis descriptions Example 1. Patients will be assigned a unique identifier that can be linked with outcome data collected on a quarterly basis. This standardized form will include information on: a) smear and culture conversion; b) current health status, including data on treatment outcome (e.g. cure, abandonment, failure, death); and c) psychosocial status. Some variables on socioeconomic status will also be included in the quarterly assessment form in order to assess changes over time. In addition to the quarterly assessment, drug susceptibility testing will be performed every six months. A separate form will be developed for these results and will be linked using the same unique identifier with information collected at baseline and on a quarterly basis. Three databases will be constructed in Epi2000 for the intake, quarterly and laboratory forms. Prior to data entry, forms will be reviewed for random and systematic error and possible corrections will be made in consultation with the interviewers. Data entry clerks will be given a structured training that also enables them to identify problems with data quality prior to the entry of the forms into the database(s). Subsequent to entry, the databases will be reviewed closely during the first few weeks of entry to ensure that the data are being entered and stored correctly. After this initial intensive phase, the data will be reviewed on a quarterly basis for systematic errors, blank fields, and other problems. Feedback will be provided to data entry clerks and to interviewers on a monthly basis to reduce the likelihood of systematic and random error. Example 2. Descriptive statistics will be generated from the structured questionnaires that will be administered with service providers. Frequencies, means and standard deviations will be calculated where appropriate for a number of health provider variables, including sociodemographic variables (such as gender, age, household size, etc.), socioeconomic status, job satisfaction, relationships with clients, and barriers to providing follow-up care. Example 3. For the cohort study, descriptive statistics will be generated for baseline characteristics of the patients who are enrolled in both retrospective and prospective cohorts. Differences in sociodemographic characteristics will be noted for subsequent multivariate analyses. A description of clinical status and medical history, among other factors collected at baseline, will also be provided for both cohorts by generating frequencies, means, standard deviations and medians, where appropriate. In terms of examining time to smear and culture conversion for both cohorts, Kaplan-Meier survival curves will be constructed. In order to account for confounding variables in the analysis, Cox proportional hazards models will be employed. Linear regression will be used to examine DST outcomes based on number of drugs the patient is resistant to at follow up. Logistic regression will be used for the assessment of binary outcomes, such as treatment outcome (poor versus good), low body mass index, radiographic findings, and occupational status. Poor outcome will be defined as treatment failure, default or death. Interim outcome analysis will be done at the end of year 1 and the final analysis will be performed at the end of the 2-year follow-up period. Biosocial factors related to MDR-TB will also be presented descriptively. In order to examine the association of biosocial factors with MDR-TB emergence, linear regression will be employed 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 81 using the increase in the number of drugs that the patient is resistant to at follow up as the outcome. In terms of persistence of MDR-TB, biosocial factors will be associated with poor treatment outcomes using logistic regression. Confounding variables will be controlled by using multiple regression analysis. Reliability and validity When evaluating a data collection tool for use, it is important to consider its psychometric properties; that is, its reliability and validity. A tool is considered to be valid if it measures what it purports to measure. It is always valid for something specific (e.g. assessing attitude to care); a survey cannot be valid in general. Ideally, any tool used to collect data should have demonstrated validity and reliability for the target population. However, researchers often need to tailor a standardized tool to make it applicable to their research. Adding questions, or amending existing ones, may negatively affect the psychometric properties of the instrument though and so is discouraged. Your proposal should stipulate how your research team will ensure scientific rigour in your quantitative methods. It is important to explain the validity (i.e. how you will be able to draw meaningful inferences from a population) and reliability (i.e. control for stability of instrument scores over time) of the quantitative data. For example, indicate whether the instruments you are using are standardized and whether they have been shown in previous studies and reports to have strong reliability and validity (with respect to content, criterion, and construct). How have you indicated you will ensure scientific rigour (control group, placebo etc.)? Participants Include a section called ‘Participants’ and ensure that your sample size, recruitment and selection criteria align with your quantitative methods. Will you use a random sample? Indicate whether variables are dependent or independent. Describe the study population; selection criteria; provide demographics relative to the study (age, gender, ethnicity, income bracket, etc.) characteristics related to the disease of interest, etc. Mixed methods The majority of proposals use mixed methods in which qualitative and quantitative approaches are combined. Under many circumstances, a mixed methods approach can provide a better understanding of the problem than either a quantitative or qualitative research approach. Nevertheless, one of the main challenges may be to create the optimal combination (and sequence) of the two approaches. The four most common types of mixed methods research design are: sequential explanatory; sequential exploratory; concurrent triangulation; and concurrent embedded (Table 10). 82 Table 10. Main mixed methods research approaches Design type Description Sequential explanatory Collection and analysis of quantitative data in the first phase is followed by the collection and analysis of qualitative data that builds on the results of the first phase. Weight is typically given to the quantitative data. Mixing of the data occurs when the initial quantitative results are used to inform the secondary qualitative data collection. It can be especially useful when unexpected results arise from a quantitative study. The straightforward nature of the design is its strength and so it is easy to implement. The main weakness of the design is the time required to implement since it falls into two phases. Sequential exploratory Collection and analysis of qualitative data in the first phase is followed by the collection and analysis of quantitative data that builds on the results of the first phase. Weight is typically given to the qualitative data. This design tends to be used when the primary purpose is to explore a phenomenon (e.g. testing elements of an emergent theory or determining the distribution of a phenomenon in a given population). It is easy to implement but requires substantial time for data collection. Concurrent triangulation Quantitative and qualitative data are collected simultaneously and then the two datasets are compared to see if there is convergence, differences, or some combination of the two. Ideally, the weight given to the quantitative and qualitative findings is equal but in reality more weight may be given to one methodology over another. Concurrent triangulation is one of the most popular types of mixed methods design. It can, however, be difficult to compare results, particularly if discrepancies arise. It also requires great effort and expertise on the part of the researcher to adequately study a phenomenon using two methods. Concurrent embedded Quantitative and qualitative data are collected simultaneously but there is a primary method that guides the approach. Either quantitative or qualitative data will be used to provide a supportive or supplementary role based on the primary data type. The researcher is able to collect two types of data during a single research phase. Often an embedded design is used to answer different research questions with a study. Since mixed-methods use both qualitative and quantitative methods, mixed method proposals should include: • Rationale (describing type of mixed methods being used) • Data collection • Data analysis • Reliability and validity • Trustworthiness • Participants Rationale If your research team decides to use mixed methods in your study, your proposal should describe why (explain how using qualitative and qualitative methods will provide information that helps you to address your research objectives and research questions). For example, using a mixed methods approach may be appropriate because you want to provide a better understanding of the problem than either a quantitative or qualitative research approach could achieve alone. Your explanation may state that you want to create a design that provides the 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 83 optimal combination and sequence of both approaches. Additional justifications for using a mixed methods approach may be because your project is interdisciplinary involving team members with diverse views or your project will be dealing with complex problems that will benefit from blending qualitative and quantitative data. Mixed methods data collection and analysis There are several elements related to mixed methods research that researchers need to consider for research design: • Timing: Will quantitative and qualitative methods be used simultaneously (concurrent designs) or in two distinct phases (sequential designs)? • Weighting: How much emphasis will be put on the quantitative or qualitative methods? Will they be weighted equally? • Mixing: Data analysis needs to be matched to the design of the study. For example, in a concurrent design, one way of mixing the data is to provide a discussion about the emerging themes from the data and how they support or refute the statistical analysis. Another approach could be to combine the qualitative and quantitative data to arrive at new variables or new themes (5). In a sequential design, for example, a researcher might collect and analyse quantitative data in the first phase of the study and may then select some extreme cases to follow-up in a qualitative phase. • Visual diagrams: An important mixed methods tool that incorporates a notation system and a flow chart of the research process. In your proposal, indicate what data collection strategies and tools you intend to use and why. Use the information outlined in both the qualitative and quantitative sections (above) according to which data collection method you are explaining (for example, if using a focus group discussion, refer to the qualitative methods section – when explaining how you will use a questionnaire, refer to the quantitative methods section). In your proposal it is important that you outline a plan of data management and analysis. The methods and models of data analysis should be in accordance with the proposed objectives and research questions. Trustworthiness, validity and reliability In a mixed methods IR proposal, showing how scientific rigour will be ensured throughout your study is critical. It is important to examine the validity (i.e. being able to draw meaningful inferences from a population) and reliability (i.e. stability of instrument scores over time) of the quantitative data. To ensure qualitative validation, the researcher will use a number of strategies. First, opportunity will be provided for the participants to review the findings and then provide feedback as to whether the findings are an accurate reflection of their experience. Second, triangulation of the data will be used from various sources (transcripts and individual interviews) and from multiple participants. Finally, any ‘disconfirming’ evidence will be reported. This is to ensure that accounts provided by the participants are trustworthy. Refer to the trustworthiness section of qualitative methods and the validity and reliability section of quantitative methods for more detailed information. 84 Group activity: Research design In your research teams discuss which research design will work best for your project. Which methods will you use to collect your data? Use the examples below to help you create a table containing your research objective(s) and research question(s) and identify which data source(s) will be used to collect the data to meet the objectives of the research and answer your research questions. Example (1) For the first objective, the study will analyse qualitative interviews, public discourse from newspapers and decrees, and objective measures of commitment to tuberculosis control in X city. Fifteen key informant interviews and several consensus panel discussions will be used to generate information on national and local policy processes and the translation of national and international guidelines to the behaviour of local health and social security systems in relation to MDR-TB control and ambulatory case-management. This stakeholder analysis will entail interviews with officials at four levels of government: national, region, district and city. (2) For the second objective, the study will employ (a) focus group discussions with health care providers structured by occupation (e.g. nurse, physician); (b) ethnographic assessments carried out by researchers/clinicians trained in ethnographic methods; and (c) structured and open-ended interviews with health care providers responsible for TB control at the district and city levels. (3) Methods for the third objective will include collection of qualitative and quantitative social data, as well as data on clinical and microbiological outcomes as part of a cohort study of patients and providers receiving a package of enablers and incentives termed DOT-FF. (4) For the fourth objective, the study will compare bacteriological and clinical data with quantitative and qualitative social data collected from patients and family members in order to identify biosocial determinants and effects of MDR-TB emergence and persistence. The study will obtain the life histories of patients with MDR-TB and TB on video, if possible. Semi-structured, open-ended interviews will be conducted with patients and family members of patients to better understand the impact of the persistence of MDR-TB in this setting. In addition, the quantitative methods from M3 will help elucidate the biosocial factors potentially related to MDR- TB emergence and persistence (e.g. education, socioeconomic status, lack of social support, sideeffects from second-line anti-tuberculosis drugs as well as HIV and other co-morbidities, such as substance use.) Write-shop During the evening, work in your teams to develop the following for your team’s project: • Research design • Research methods including: – step-by-step procedures for your data collection – data analysis Propos al 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 85 – trustworthiness, validity, reliability – participants Be prepared to present your drafts on day 2. Group discussion Each group will give a 10-minute presentation to the group with their results from the previous evening’s write-shop. Quality management Embedding quality management into your proposal is not an optional step. Quality management is essential to ensuring that research meets or exceeds scientific, ethical and regulatory standards. Quality systems, control and assurance is integral to all research activities. Everyone engaged in the project carries the responsibility of ensuring quality. Quality management should be planned and adhered to in the research design. In your proposal, outline exactly how you will demonstrate that your research team will take consistent, ongoing measures to monitor and evaluate quality and rigour of the research. Indicate how you will evaluate quality at various stages. How will you demonstrate that you will conduct due diligence at all data collection and data analysis steps? If your project lasts more than one year, you may want to stipulate that you intend to have annual quality monitoring evaluations and reports. Discuss a communication plan with all stakeholders to inform them of quality standard procedures to facilitate rapid adjustments and corrections. Quality management should also express a constant and consistent concern for research participants. How will you protect their privacy? What measures will you take to protect them from harm (e.g. train staff, adhere to ethical standards in the research ethics application etc.)? 86 Activities to address quality issues The diagram provides a visual example of how you could plan and ensure continuous and consistent quality management strategies in an IR study. Quality management activities Some of the activities you can integrate into your IR proposal to help manage quality include: • protocol review and approval • standard operating procedures • validation of research instruments • project team training • quality control and monitoring • evaluation of services provided • evaluation of the performance of service providers • review of reports There are many strategies that can be incorporated into your IR proposal to begin the quality standard monitoring process. Monitoring and evaluation strategies that can be implemented to facilitate the quality of your research project include: • Information log: keep track of feedback from stakeholders, news stories published and articles written, and the number of times research has been cited in the academic literature. • A survey: this can be conducted with stakeholders from the target audiences in order to generate feedback. For example, questionnaires can be sent via email six months and one year after a dissemination event or clients attending a family planning clinic can be asked to complete a survey regarding improvements in the quality of care. • A series of key informant interviews with stakeholders at various levels of the health system can provide insight into whether, and how, research was used. Use the table below (Table 11) to get additional ideas about how you can incorporate quality management into your research proposal. Project development phase Planning phase Implementation phase Closure phase Protocol & document development process Planning process Study implement data collections Data management process Data analysis process Report writing process Report Protocol and study documentation review and approval Documentation, monitoring, & auditing Validation Report review and approvalValidation Quality plan, SOPs, training, tools validation, provider’s education 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 87 Table 11. Descriptions of various quality management strategies Strategy Description Protocol review and approval Research rigour includes stipulating how you will protect the rights and welfare of research participants. Protocols may also be established to ensure consistency and diligence in data and collection procedures (standardized instruments, consistent interview protocols); checklists and established protocols to ensure consistency and rigour of data analysis across sites and among researchers. Standard operating procedures A project manager must establish protocol to establish rigour and consistency between and among researchers and research sites. This may include standardizing research collection procedures (establishing a protocol or checklist); creating standardized instruments and interview protocols to be used across sites and among all researchers; constant checks to ensure procedures are diligently adhered to; and holding training sessions with researchers and research assistants. Validation of research instruments Indicate whether research instruments are standardized and whether they have been shown in previous studies and reports to have strong reliability and validity (with respect to content, criteria and construction). Project team training Adequate training and appropriate infrastructure are essential to patient safety, protocol implementation, and quality assurance and improvement – especially in interventional clinical trials. Training of researchers and assistants in data collection procedures to ensure safety of the participants, as well as to ensure consistency and research rigour between and across sites, is essential. Quality control and monitoring Quality control is important to ensure reliable and consistent findings. What procedures will be incorporated into the research design to ensure consistent data collection methods are implemented between and among research sites and among different researchers? The proposed methodology should help investigators identify data quality problems that can be corrected while data are still being collected, and also to identify biases in data collection that might be adjusted for later. Evaluation of services provided Monitoring and evaluating service provision is essential for analysing and, if possible, improving the effectiveness of service regimes. Establish ‘critical limits’ to measure the effectiveness and quality of the services provided to participants/clients/patients. Establish appropriate record-keeping and documentation systems. Make regular site visits to monitor progress and assess impact. Establish corrective actions. Evaluate, with relevant health care workers, achievements made and lessons learnt, and apply any lessons learnt to existing and new arrangements. Evaluation of the performance of service providers Generating and using information on the performance of service providers can lead to substantial enhancement of transparency and accountability, which in turn fosters adherence to higher quality standards in service delivery. Assessment tools rely on external experts measuring quality and performance against a pre-determined set of indicators. Participatory monitoring and evaluation tools seek to engage service users beyond the provision of feedback, to also take an active role in the planning and implementation of the assessment. This helps to build the capacity of the local community to analyse, reflect and take action. Community scorecards envisage active involvement of the group and allow participants themselves to identify indicators of quality and performance. Review of reports Reports should be drafted and shared in sufficient time to provide an opportunity for all researchers and appropriate stakeholders to have the opportunity to read, react to, provide feedback on, edit, revise, and provide input into the report. 88 Research ethics Any research study that collects data from or involving human subjects must undergo an ethics review. You must stipulate that you intend to apply for ethics approval if you have not done so already. You should have an ethics section in your proposal that describes the steps you will take to ensure the protection, dignity, rights and safety of potential research participants before, during and after the research takes place. In addition, your IR proposal should describe how you will ensure that universal ethical values and international scientific standards will be adhered to in terms of local community values and customs in planning, conducting and evaluating the research. If you are collecting data in more than one site you may have to apply to more than one ethics board. Agencies will not distribute funds until ethics clearance has been received in writing. In the ethics section of your proposal, state explicitly how the research will address the following codes of ethics (it may however be worth going to the website of the review board to whom you are submitting your proposal, to make sure you have complied with all their specific requirements): • Balance potential harm to participants against potential benefits. Possible harms fall into several categories such as physical injuries, loss of privileges, inconvenience (including wasted time, psychological injuries (e.g. embarrassment), economic loss, or legal risks). • Maintain privacy, anonymity, and confidentiality: – when health care providers are research participants; – when reviewing medical records; – by maintaining the boundary between researchers and physicians. • Construct the informed consent letter and form (include in proposal appendices). • Where necessary, include a translation of the consent form in appropriate local language(s) as this may be required by some ethical review committees • Obtain voluntary consent of all human subjects/participants. In the case of minors, parental/ guardian consent must be obtained. • Make research results freely available as a public good. • Demonstrate that results cannot be obtained by other methods or means. • Avoid all unnecessary physical and mental suffering and injury. • Risks do not exceed the humanitarian importance of the problem the research will solve. • Cultural diversity considered to ensure participants understand the purpose of the study. • Adequate provisions taken to protect participants. • Involve scientifically qualified, well trained and properly supervised individuals in the research team. • Protocols will be submitted for approval to appropriate ethical and scientific review committees. • Research procedures involving human subjects will be submitted for approval to an independent ethics committee before research begins. • Research and related procedures will be conducted in adherence to the protocol that received scientific and ethical approval. • Any alterations to the protocol will be re-submitted for ethics approval. • Special attention will be paid if the research involves vulnerable subjects. • Subjects will be informed their participation is voluntary and they are at liberty to withdraw from the research at any time without explanation and/or prejudice. • Research will be terminated at any stage if there is any reason to believe harm is being caused to the subjects/participants. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 89 • Participants will be provided with the option to receive the results of the study in which they are participating. • The consent form has two parts: (a) a statement describing the study and the nature of the subject’s involvement in it; and (b) a certificate of consent attesting to the subject’s consent. Both parts should be written in sufficiently large letters and in simple language so that the subject can easily read and understand the contents. As far as possible, medical terminology should be avoided in writing up the consent form. (These should be included in the proposal appendices). • It is not anticipated that any participant could suffer harm in this study. Example In conducting this study, we will follow the key principles of ethical conduct of research. In the current proposal, we propose to conduct an intervention that we are not certain will work at scale, nor are we certain of the impact (i.e. there is equipoise). Therefore, we have incorporated a control group into our research design. Another key ethical concern is beneficence and justice.  The intervention is not invasive and no risks to patients are expected. This intervention may in fact benefit the most vulnerable populations, such as pregnant women and newborn babies. Within this group, it is mainly designed to ensure the poorest can access health care delivery, in case of danger signs, or in case of a sick baby. Efforts will be made to improve health units to support referral in both intervention and control areas. A rigorous consent process will be put in place. Approval will be obtained from the district health teams and from the local communities including community groups, traditional birth attendants (TBAs), and community leaders following a detailed sensitization about the goal and objectives of the study, the implementation strategy and the evaluation processes. For the evaluation component, informed consent will be requested from study subjects and the local community, and confidentiality will be assured. No patient-specific data will be collected apart from aggregated figures (e.g. such as the number of women delivering at health facilities). This data will be collected from registers, which are routinely maintained by health facilities. In addition, such data will be restricted to the medical care staff and the investigators directly involved in the study, and the study team records no names. During the study period, anybody in the community found sick by the study team will be referred appropriately. For the evaluation stage of the intervention, uptake and mortality surveillance consent will not be sought from the subjects. The subjects will be free to accept or refuse, and where necessary, women will be free to consult with their husbands and/or community members before consent. The Safe Deliveries study and the Uganda Newborn Estimated Survival Time (UNEST) already have ethical approval from Makerere University School of Public Health (MUSPH) Institutional Review Board (IRB) and from the Uganda National Council for Science and Technology (UNCST). The current protocol will again be submitted to the same bodies for amendment of ethical approvals. The study will continue using the existing Data Monitoring and Advisory Board, which has been serving both the Safe Deliveries study and UNEST. The DMSB members are local experts, all with PhDs in their respective fields of specialty, and have strong policy linkages. The DSMB will meet annually. The study will be registered as a trial both locally and internationally. Protocols for social science research involving human participants are subject to review, and necessitate approval, of both a local/national institutional review board (IRB) and where the research is funded by WHO, WHO’s Research Ethics Review Committee (ERC), which has 90 the responsibility for reviewing the ethical aspects of proposals for research involving human subjects that are funded or otherwise supported through WHO. ERC’s website can be consulted at http://www.who.int/rpc/research_ethics/en/. Example consent forms Templates for consent forms can be found at the WHO research policy page (http://www.who.int/ rpc/research_ethics/en/). These templates should be adapted to the local situation in which you elicit informed consent. Please make sure that you use the letterhead of your research institution, not that of WHO’s Research Review Ethics Committee. Ethics checklist Checklists and other guidance documents for preparing proposals in the manner recommended by WHO’s Research Ethics Committee (ERC) are available online at http://www.who.int/rpc/ research_ethics/guidelines/en/. Remember to provide all necessary documentation and annexes. The protocol should provide the necessary information and details to comply with the questions proposed in the checklist. Also remember to attach any necessary explanations either in the proposal or relevant accompanying documents. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 91 3. project plAn In this session you will work on your project plan, developing a timeline, describing the research team you need to effectively carry out the research project, and creating and justifying the project budget. After completing this session, your team will be able to: • Develop a project plan (work plan/timeline) to guide the implementation and monitoring of your project. • Develop a work schedule (or GANTT chart) to effectively implement and monitor your project , including the tasks and activities to be performed, roles and responsibilities of team members, as well as main milestones/deadlines to be met. • Describe the research team (including the knowledge and skills that each team member possesses and how they will contribute to the success of the project). • Develop a realistic, itemized budget linked to specific objectives and activities. • Provide information required for the justification of various budget items. Planning the IR project A project plan presents a clear indication of the time frame for the project and when each aspect of the project will be implemented. Often a work plan or timeline is displayed most effectively in a graphic, table or spreadsheet. If done well, your timeline will help demonstrate the feasibility of the project in a very visible way. The work plan will identify tasks (i.e. developing surveys, conducting a needs analysis; administering surveys; conducting interviews; developing curriculum; administering an evaluation); when the activity will take place (often over a time period); and by whom (responsibilities and accountability). Rationale for project plan There are several important reasons for project planning and its value cannot be overstated. A plan establishes a common goal for the project and a clear understanding of the research process. Effective planning: • facilitates the development of a project focus; • ensures consensus around a project development strategy and plan; • ensures ownership of the project; • ensures everyone understands who is doing what, when, and how each action impacts the project as a whole; • enhances teamwork and transparency; • facilitates project monitoring and identification of issues; • facilitates project evaluation and reporting; • provides management/donors with key information for project review. A project plan identifies each task and activity that will be completed throughout the duration of the project. The plan establishes expectations of team members and standards that must be met. Individual team member’s responsibilities are outlined as well as timelines for when each task or activity will be completed. The project plan establishes the magnitude of the project in order to be able to develop an appropriate budget to carry out the plan. It helps anticipate or identify potential barriers or constraints in adhering to the timetable, implementation and/or completion of the project and suggests possible solutions. This is a document that facilitates communication 92 between and among stakeholders, coordinates procedures, teamwork and collaboration. Your research design and procedures will be instrumental in identifying the tasks and activities that need to be completed in your project plan. In summary, the project plan facilitates systematic monitoring of your project. Phases of an IR project plan Project plans are generally presented in three major phases (see Table 12): the planning, implementation and follow-through phases. Table 12. Main activities associated with project planning phases Phase Main activities Planning • Organize the research group and advisory committee • Determine issues or problems to study and frame the research question(s) around these • Develop a research proposal • Obtain ethical clearance • Identify funding sources and obtain support for IR • Establish budget and financial management procedures • Plan for capacity building and technical support Implementation • Monitor the project implementation and maintain quality • Pre-test all research procedures • Establish and maintain data management and quality control • Explore with stakeholders interpretations and recommendations arising from the research findings Follow-through • Develop a dissemination plan • Disseminate results and recommendations • Document any changes in policy and/or guidelines that resulted from the research • Monitor changes in the revised programme • Consider ways of improving the programme that can be tested through further research. Project timelines The project’s total duration should realistically reflect the time needed to carry out each phase of the project plan. Be sure the plan takes into account the time required for staff recruitment and equipment purchases. The project plan should outline: • work schedules; • a description of the tasks to be performed; • schedule and deadlines within tasks; • people assigned to the tasks; • The number of person-days required to complete each task. The duration of a project has serious consequences in terms of meeting deadlines for deliverables and the final report. Project planning must follow rigorous project management standards. There are commercial software packages available to help prepare and monitor the implementation of a work plan. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 93 Project plans can be presented in a variety of ways (Figures 3–5). Choose the most appropriate style for your particular project’s needs, for example: bar chart/Gantt chart. Figure 3. IR project timeline (example) Figure 4. IR project GANTT chart (example) Quality assurance & monitoring Months 1 - 4 Months 5 - 10 Months 8–13 Months 14–18 Planning & design Data collection Data analysis Dissemination 94 Figure 5. IR project GANTT chart (example) Research team The Research team section of your proposal should succinctly describe the members of your team and the assets they contribute to the project. This team will be multidisciplinary and diverse (researchers from academia, health care providers, program implementers, social scientists as well as members of the community). This section should convince the reviewers you have enough expertise on your team to conduct the proposed research effectively. In addition, the proposal needs to include the detailed roles and responsibilities for each of the key team members. Starting with the principal investigator (PI), list the names of all individuals who will be involved in the study. Include all collaborating investigators, community research partners, research assistants, individuals on training, and support staff. The proposal also includes any “to-be- appointed” positions. Identify the experience and expertise of each team member and how their knowledge and/or skill are essential and add value to the effective completion of the project. Finally, include the role and responsibility of each individual listed on the project. The members of the research team usually include: • principle investigator • project manager(s) • multidisciplinary key researcher (public health specialist, statistician, social scientist, etc.) • research assistants • community members • collaborators • advisory committee Task 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 PLANNING & DESIGN Recruit research team Train researchers Select sites Develop/test surveys & interviews IRB approval DATA COLLECTION Facility surveys Parse patient records Provider surveys Patient survey DATA ANALYSIS Quantitative analysis Translate & Transcribe Qualitative analysis MONITORING DISSEMINATION Policy briefs Policy workshops Journal articles Health facility reports Community meetings Targeted media campaign 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 95 Proposals should also include outlines/summaries of the planned research team management structure (see Figure 6 for example) and descriptions of respective roles and responsibilities of team members (see below). Figure 6. Research team management structure (example) Example 1. Team roles and responsibilities Principal investigators: United States (2) • Oversee research conceptualization, design and implementation • Liaise between key collaborators, community leaders and research team • Recruit researchers • Supervise community meetings and policy dialogue workshops Researchers: United States (2)/Tanzania (2) • Analyse data • Train research assistants • Quality assurance • Monitoring and evaluation • Research assistants: Tanzania (10) • Conduct interviews • Collect data for surveys and audits • Enter data into database • In-country coordinators: Tanzania (2) • Administrative assistants: Tanzania (2) European commission Project coordinator Project management office Work package management European partners China & Vietnam partners Project management committee Project technique committee Project advisory committee 96 Example 2. Team roles and responsibilities ABC University School of Public Health is the applying institution and has the overall responsibility for the project including the day-to-day implementation and management. The school has a financial department that will be responsible for all financial management and reporting requirements in collaboration with the Department of Health Policy Planning and Management. In addition, ABC University School of Public Health, in collaboration with the Ministry of Health, will be responsible for organizing dissemination activities and meetings. The School of Public Health has a strong and long-term linkage with policy and the ministry of health and other key partners, such as WHO, UNICEF, USAID, districts, and the local communities, and is the leading public health academic and research institution in Uganda. Research team composition The team comprises a multidisciplinary selection of national and international specialists who will provide the skills that are necessary for the effective design, implementation, evaluation and dissemination of findings that will inform the scale up of maternal, newborn and HIV-related studies, as well as guide the implementation of ongoing programmes. The PI is an epidemiologist who has 10 years’ experience working as a district medical officer/MoH and is currently a PI for the UNEST study and lecturer at the School of Public Health. He has also played a key role in several other health system projects. Other members include Dr Jane Doe, a medical officer for reproductive health in the MOH. She will be the main link to policy and, together with the district medical officers, she will provide technical advice that will be crucial for ensuring that the study is aligned with the country’s priorities, policies and plans. In collaboration with several local NGOs, Dr Doe also plays a role linking the research team with the relevant policy-makers and providing expert advice on aligning the project with the country’s newborn-related priorities. Other team members from Uganda include Mrs Claire Smith, a health economist and maternal health specialist and Dr David Johnson, a health systems expert with over 30 years of experience. They will be jointly responsible for the costing aspect of the study, as well as the designing of the demand-side financing scheme. Dr John Smith, a consultant obstetrician at CDE University, will be responsible for the training and support supervision of health workers. Dr Jane Davis, a statistician, will be responsible for the design and implementation of the baseline and end line survey. Jane Johnson, a communication specialist, will be responsible for ensuring that study findings are communicated to policy-makers appropriately and in a timely way. The international research team members include John Doe (JHU, health systems expert) the director for the Future Health Systems Program Consortium, Jane Smith (JHU, newborn specialist), David Johnson (JHU, maternal health specialist) and Claire Davis (KI, health systems and policy specialists). They will all play the role of providing technical advice to the team during the design, implementation and evaluation of the study. All research team members will participate in the writing of manuscripts. The project will recruit two field coordinators, with priority given to those in existing projects, experience already gained and an excellent rapport with the districts and local communities. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 97 Group activity In teams, use the examples from real IR proposals to reflect on the content presented during the past hour or so, and draft the following sections in relation to your own project: • The three phases of IR planning. • The work plan/time line of activities (you can use a simple flow chart or GANTT chart approach). • The research team, including expertise and roles (a table is one way to display this information effectively). Budget and Justification The budget should outline the funds required to be able to effectively conduct the proposed research. You will need to carefully think through what you realistically need from the funding agency(ies) to carry out the project. If your budget is too low or inflated, it can negatively influence the judging of your proposal. One way to assess this is to ask if it is possible to reduce a budget without compromising the quality of the research. Information such as required funding for each phase of your project is important to outline. Check to see if the funding agency has any restrictions before preparing the budget. Ensure that the budget is presented in the indicated currency, for example. Check with the agency to see if they have suggested/required budget categories that must be used. If the potential funding agency doesn’t have any suggested/required budget categories, organize your budget around a set of meaningful categories that work for your specific project. The types of resources you budget for should align with the proposed activities in the research design. The budget will need to supply the resources necessary to deliver all the proposed research and intervention outputs. Begin by using the project plan to identify the budget you will require for each activity or task. Once each resource is itemized, the unit cost and total cost for the resource can be indicated. Make sure to provide an itemized budget with a detailed breakdown of the funds requested. The budget information should be complete and unambiguous. If the project plans to extend an intervention to a control population after the study, this also needs to be planned and budgeted for. It is important to also budget for dissemination and evaluation of related activities and outcomes. Find out whether there will be any inadmissible items such as overhead costs. Inflation and currency fluctuation in exchange rates and contingency might affect the budget and final available income. It is important to include mechanisms that will help take care of this. Budget categories Categories you may want to consider for itemizing your budget include: • personnel (salary and benefits) • researcher (time, salary and benefits) • training • consultants and/or resource person (salary) • instruction • equipment 98 • supplies (e.g. paper, toner, batteries, publication cost etc.) • communication (telephone/postage/Internet/media)  • materials preparation (software, medical supplies, copying and printing) • travel and subsistence • community liaison • rental of facilities • evaluation • indirect costs (costs that your organization requires you to include) • other expenses (lunches for meetings, interviews etc.) Budget justification Justify each and every budget item, starting with how the budget items were derived in relation to the activities to be undertaken in your research design. Pay particular attention to major or unusual items (some funding agencies might require extra explanation for anything considered to have major cost). Provide details of additional sources of funding available to the organization or principal investigator. If the funds will go to different institutions, indicate allocation of funds by site. Example: Budget justification information Personnel (salary and benefits) Regardless of the number of months being devoted to the project, indicate only the amount of time (usually in days) being requested for each individual listed for each budget period. Provide names (if known), position and salaries, including percentage for fringe benefits if such benefits represent actual costs to the employer. Fringe benefits should follow institutional guidelines and an understanding of what is/not allowable by the sponsor. Also, make sure to include those who are involved in the project but are not paid (or are not being paid out of the proposal budget). If you plan to involve consultants or other outside personnel, make sure to include all associated costs in the budget. Provide the names and organizational affiliations of all consultants (include members of external monitoring or advisory committees). Describe the services to be performed under budget justification (number of days, rate of compensation, travel, per diem and other related costs). Supplies List the costs of the various categories of expendable supplies (e.g. paper, toner, tapes, film, batteries, printing costs, other field supplies). Itemize supplies in separate categories with amount requested. Justify each purchase. Equipment List each equipment item with the amount requested. Include equipment maintenance. Provide justification for each piece of equipment in relation to the work proposed. Identify any piece of equipment considered as major equipment (e.g. major equipment might be any equipment costing more than US$ 1000) and provide additional information if required. Patient (research subjects) costs Explain the nature of the costs (e.g. transportation, drugs for field trials) and method of calculation. It is important to check on limitations linked to the funding organization. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 99 Give details of the locations where patient care will be provided and the budget allocated to each site. Indicate, in detail, the basis for estimating costs, including the number of patients, days of treatment, cost per test or treatment. If both inpatient and outpatient costs are requested, provide information for each separately. If multiple sites are to be used, provide detailed information by site. Include patient travel, patient participation incentives, etc. Travel Itemize each travel item. Provide the purpose and destination of each trip and the number of individuals for whom funds are requested. Include the costs of local transportation and field research expenses necessary for carrying out the proposed research. List separately the costs of transportation, subsistence allowance (indicate the scale paid by the institution) and any other costs (specify). Check on limitations linked to the funding organization. Also, some organizations might require separate international and national/local travels cost. Include lodging and subsistence expenses for field workers. Justify the number of trips per year and relate them to individual’s tasks. If samples will need to be transported from the field to a lab, indicate how this will happen and the costs involved. Field costs Indicate whether there will be a need for renting or purchasing a vehicle and provide detailed justification for why a vehicle is needed. Also make sure to include associated fuel, insurance and maintenance costs. In case a vehicle will be purchased, indicate what will happen to it once the project ends. Overhead Find out whether the funding organization will cover overhead costs and include this in the budget accordingly. Other expenditures Itemize any other expenditure required for the proposed research to be carried out. This might include things such as insurances cost, outsourcing, publication costs, computer charges, rental and leases, service contracts and communication costs, especially if the work involves many countries/institutions. It is important to note that some organizations do not provide funding for things listed as miscellaneous or other. Make sure to clarify this with the funding organization before submitting the budget. Group activity In your IR teams, review the sample IR proposal budget provided by the facilitator(s). Using the information covered in Session 3 and the example budget as a guide, develop a budget for your team’s IR proposal. 100 4. impAct In this session, the sections of your IR proposal that address measures to ensure quality standards in your research project will be reviewed. Specifically, after completing this session you will develop: • monitoring and evaluation plan for your IR project • capacity-building plan • dissemination plan Considerable effort must be made to ensure that your proposal clearly demonstrates how your research findings will have an impact on the health and/or health care of the communities/ populations concerned, policy-making, and on research communities. For example, how will your proposal demonstrate that your research team has: • Acknowledged, monitored and planned for competing priorities, limited logistic capacity, a lack of political will, and/or inadequate infrastructure and resources – all of which could affect health care packages from being delivered to those who need them most? • Planned for developing and maintaining capacity building in your IR project to facilitate the adoption of evidence-based health interventions in developing countries? • Demonstrated that you will disseminate your research findings to ensure your project will generate research evidence to inform policy and programme implementation? When developing a typical research/academic proposal, the intent is to generate new knowledge and ideas. Conversely, when developing an IR proposal, the intent is to generate research evidence to inform policy and programme implementation. Despite the growing knowledge base on evidence-based practices in health care, there is a large gap between what is known as a result of research and what is consistently implemented in practice. Why is there such a wide gap between what we know and what we do? The fact that it can take years or even decades for research findings, best practices and guidelines to be implemented into health care workers’ daily practice is one of the stimuli behind the IR ‘movement’. Utilization of research results is the core purpose of IR. Translating evidence into health care practice requires a monitoring and evaluation process to ensure quality and improve health outcomes. Your proposal should demonstrate that your project will facilitate the adoption and integration of evidence-based health interventions and change practice patterns, particularly in developing countries. In order to be convincing, your proposal should demonstrate that you have considered the complexity of the situation and environments where the research will take place. Monitoring and Evaluation A monitoring and evaluation plan: • Describes exactly how it will be assessed whether or not the project meets its objectives and delivers what has been promised in the proposal. • Informs the prospective funding agency their investment is/was sound. • Facilitates the use of research findings for implementation of evidence-based practice and thus improves health outcomes. • Examines the difference between the implementation effectiveness and efficacy of health intervention. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 101 Monitoring activities Monitoring activities in your proposal include: steps you will take to assess the progress of the project (e.g. recruitment rate, the extent to which timelines are being adhered to, deadlines concerning required reports to donors etc.) so that any problems or issues can be detected early and any essential changes or interventions can be made as soon as possible. Monitoring activities include identifying aspects of the project that need to be observed, who is responsible for the various activities and the organization of the monitoring activities. Such monitoring activities are usually associated with specific milestones or timeline events within your project. When identifying your project timeline, consider including your specific monitoring activities. For example, at milestone X you will report on Y. A description of the monitoring component should include the following: • Identifying the resources needed for the project, including staff, equipment, supplies, logistics support and funds, and the precautions you will take to ensure these resources will be appropriately used. • Adherence to the research design procedures to ensure they are being followed correctly and in a timely manner. This includes how you intend to monitor the roles, responsibilities and activities of each team member in relation to the project as a whole in order to ensure the work plan will be carried out as envisaged. Measures that will be taken to identify delays or difficulties. • Connections between the intervention and quality of data. • Plans for how the research team intends to communicate and coordinate with the study population, other collaborating groups and/or funding authorities. Evaluation plan An evaluation plan should be included in your proposal, outlining exactly how you will demonstrate whether or not your project meets its objectives and was ‘successful’. Many research proposal criteria stipulate that approximately 10% of total budget should be designated to evaluation. Often research teams hire a consultant to conduct their evaluation. In your IR proposal, indicate whether the evaluation will be conducted by an internal team member or an external consultant. The evaluation plan demonstrates how the research objectives will be met and indicates how you intend to keep close track of changes in the project plan and problems encountered and solved (or not solved), so you can inform the stakeholders and include this information in the preliminary report. An evaluation plan should also consider the following: • Identifies who will use the evaluation findings. • Describes information needed, sources and evaluation methods/instruments. • Examines how the project objectives will be met. • Tracks the expected impact of the intervention. • Demonstrates that the scope of the evaluation is appropriate. The evaluation plan will indicate to the prospective funding agency how you will demonstrate that their investment in you will be a good one. If you plan to use a survey or questionnaire to help evaluate the success of your project, include a draft of your evaluation tools in the appendices. Monitoring and evaluation assesses the success and impact at various stages of the project. Various approaches have been used to measure how well a treatment, programme, or service has been effectively implemented. Some evaluation strategies infer implementation success by measuring clinical outcomes at the client or patient level, while other studies measure the actual 102 targets of the implementation, quantifying for example the desired provider behaviours associated with delivering the newly implemented treatment. Proctor et al. (6) define implementation outcomes as the effects of deliberate and purposive actions to implement new treatments, practices and services. They propose incorporating the following eight conceptually distinct implementation outcomes into the evaluation plan: acceptability, adoption, appropriateness, feasibility, fidelity, implementation cost, penetration and sustainability. Include both a concern for formative or process evaluation (evaluation while the project is being conducted) and summative evaluation or product evaluation (evaluation that is conducted during/ at the end of the project to demonstrate the project fulfilled what was originally proposed). If your project is more than one year long, you may want to stipulate that you intend to have annual evaluations and reports. Make direct reference to your research objectives in your evaluation plan, in order to highlight consistency within your proposal. Your evaluation plan should include a sense of concern for what goes on following the conclusion of the funding period. How will the initiatives that have been started under your project be sustained in the future? How will other cooperating agencies assist in continuing the project after the conclusion of the funding period? To facilitate uptake of your research findings, your proposal should indicate how you intend to inform all stakeholders of your research findings at all stages of the research. Monitoring and evaluation tools Monitoring and evaluation strategies that can be implemented to facilitate the quality of your research project include: • Information log: keeps track of feedback from stakeholders, related news stories reported and articles written, and the number of times research has been cited in the academic literature. • A survey: conducted with stakeholders from the target audiences to provide feedback. For example, questionnaires can be sent via email six months and one year after a dissemination event, or clients attending a family planning clinic can be asked to complete a survey regarding improvements in the quality of care. • A series of key informant interviews with stakeholders at various levels of the health system can provide insight into if and how research was used. One way to display an evaluation plan is to use a table outlining the research objectives or research question(s) and evaluation strategies to evaluate if the objective has been met. Research objective How it will be measured Objective 1 Focus group interview to … Pre-post surveys Objective 2 Individual interviews with key stakeholders Example: Evaluation of intervention process and impact Objectives 1. To evaluate the extent to which the revised rural health insurance schemes in the study areas were implemented as planned. 2. To explain why or why not implementation occurred as planned. 3. To evaluate the impact of the revised health insurance schemes implemented on: improving equity in access to/use of health care; reduction of financial burdens due to expensive medical 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 103 bills; equity and extent of scheme coverage; member satisfaction; and financial viability and sustainability of the schemes. Description of work This work package includes a number of work tasks (WT), which aim to undertake a comprehensive evaluation of the intervention impacts, according to the research objectives. The evaluation will include both a process and an impact evaluation. Parts of the data collection and analysis for the process evaluation will begin simultaneously with the interventions. This is to ensure that effective monitoring of the process of intervention will enable the majority of problems encountered in implementation to be identified and addressed as quickly as possible. Data from a rapid household health survey, qualitative studies, and the management information system operated in the intervention counties and districts, will be used. WT 1. The first work task is to refine the evaluation frameworks (Figures x and y), which will be used to guide the collection of data for the evaluation. Key researchers and the members of the project advisory committee will use one of the project meetings (to be held at the end of year 2) to discuss how to refine the evaluation framework and finalize it before the completion of the interventions. WT 2. The research team will also repeat the household health survey using the same methods, the same study counties/districts, and the same population sample as in the situation analysis and baseline survey. The survey will be conducted after completing 18 months of intervention. The questionnaire may be modified to reflect changes made during the intervention period. However, the overall contents of the questionnaire will be the same, covering household general information (e.g. family size, income, insurance membership, etc.), perceived illness (including 1–2 tracer studies – TB suspects/chronic cough patients and diarrhoea patients) and service utilization and expenditure, and reasons for not using services needed, as well as patient satisfaction with services. After completing the survey, all the questionnaires will be entered for analysis based on the evaluation framework developed. WT 3 Qualitative data will also be collected and analysed, including: focus group discussions using participatory techniques and in-depth individual interviews (with the same social groups in the target population as those consulted in the situation analysis); focus group discussions and in-depth interviews with health service providers at county/ district levels and below, health policy-makers at national and local levels, rural health insurance scheme managers and relevant non-health policy-makers at local levels; semi-structured direct observation will be carried out in selected facilities to assess and compare the behaviour of health staff towards patients who are members/non-members of the revised schemes WT 4 The relevant data from the management information system operated in the designated health facilities and the insurance fund management organizations will be collected and analysed in line with the evaluation framework. Deliverables • Evaluation framework finalized • Report on impact evaluation of the interventions in the two countries 104 Milestones Finalising the evaluation framework by project month (PM) 20 and writing up the evaluation report by PM 46. Expected results More equitable and sustainable health insurance schemes tested in the study areas upon which policy recommendations can be made for the governments of two countries. Capacity building Restricted research capacity has been identifies as one of the constraints toaddressing health care priorities in low- and middle-income countries (7). Generating appropriate, trustworthy evidence depends on the existence of good research organizations. Capacity-strengthening strategies need to focus on the comprehensive needs of institutions, including overall skills and career development, development of leadership, governance and administrative systems, and strengthening networks among the research community, both nationally and internationally. When writing your IR proposal, two specific considerations may help address capacity building: • How the project can help improve the research capacity of national and local institutions involved, via training, mentorship, etc. • How the project, via the process of the implementation, can help increase the capacity of using research evidence for policy- or decision-making by key stakeholders, such as government officials. Example: Research capacity development The development and strengthening of research capacity for both partners from China/Viet Nam and Europe will be a continuous process throughout the implementation of the project. The following are key activities aimed for research capacity development. Each partner should analyse its current situation of research capacity and the gap between what research skills and capacity are required and what are available. A strategy for research capacity building for all the partners involved will then be developed and approved in the first meeting of the project management committee. In light of this strategy, a detailed plan for research capacity building will be developed in the first half of Year 1. The plan will include a system of mentoring and supervision for junior researchers from both developing countries and European countries, and exchange of visiting researchers between Chinese/Vietnamese partners and European partners. The issue of gender will be taken into account in developing such a plan. A number of appropriate strategies will be used to build up research capacity, particularly for the two developing countries during the project implementation. Researchers from thosecountries will be invited to visit European partners during the period of the development of study design and research instruments, and data analysis and report/paper writing. While they are with the European partners, these junior researchers will attend a programme aimed at developing their skills in research techniques relevant to the project and analytical issues related to health system development in general and health insurance in particular. Wherever possible, junior researchers will be encouraged to register as Masters/PhD students in their own institutions, with joint supervision by senior researchers from China/Viet Nam and European partners. Junior researchers from European partners will also be encouraged to spend adequate time working in the study field to gain direct experience of undertaking research in developing countries. Junior 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 105 researchers from all the partners will also be encouraged to be involved in project management activities in order to enhance capacity of research project management. The strengthening of research capacity of EU partners will ensure a common understanding of key elements of the research, including gender-specific qualitative and quantitative methods and data analysis, health policy analysis, health economics models, etc. Dissemination plan An important aspect of your proposal will be the plan for disseminating information of/from the project. Most funding agencies are interested in seeing how their financial support of your project will extend to other audiences. Therefore, your proposal should include a section on Dissemination and will include the kind of dissemination you plan to carry out, and where you intend to disseminate your research findings. Information dissemination strategy • To ensure you communicate research information, plans and findings most effectively to stakeholders, answer the following questions: • What are the objectives of the dissemination strategy? • Who are the target audiences? • What are appropriate channels of communication? • How will you assess information uptake and use? • What are the most useful tools or products? (e.g. policy briefings, research reports) Dissemination activities typically include: • Presentation of research findings at national and international conferences. • Publication of research findings in national and international peer-reviewed journals. • Meetings with local and national stakeholders to discuss research findings. • Policy advocacy briefs. • Use of life history interviews of patients in advocacy work (with the permission of interview subjects). • Annual reports. • Media (e.g. radio broadcasts, press releases, newspaper articles etc.). This section of the proposal should include: • An estimate of the number of refereed and professional publications you intend to develop during each year of the project (including the names of journals you will submit to and professional journals, newsletters, printed hand-outs, policy reports and other publications intended); • The number and names of the academic and professional conferences you intend to attend each year; • Educational or informal community presentations you propose to make during each year of the project (including workshops or training programs; information sessions; policy briefings; press conferences; slide shows etc). It is often better to ‘under-promise and over-deliver’ in this regard. Proposals that make elaborate claims (especially without similar track records to support such a publication or dissemination record) tend to lose credibility with reviewers. 106 Too often, research findings are published in relatively esoteric /highly specialised journals intended for or likely to be understood by only a small number of people with a specialized knowledge or interest and, that are largely only read by other researchers. Disseminating the research findings to all stakeholders in a format suitable for the target audience (key messages) is essential to ensure better use and uptake of research findings. Group activity Review the sample dissemination plan (below). What aspects of this dissemination plan may be helpful to consider for your IR proposal? What aspects would not be appropriate? Example: Consulting with, and disseminating findings to, national policy-makers The involvement of regional/provincial and national policy-makers throughout the research process is a crucial factor for the success of the project because attaining the expected strategic impact of the research depends critically on them taking up the research recommendations. The following methods will be used to identify key policy-makers, consult with them and communicate the final project conclusions and recommendations to them: • A stakeholder analysis will be conducted at the beginning of the project and involve the following: • A project workshop in Project Month 2. • Key stakeholders identified will be invited to attend joint research planning workshops between both study countries, including the situation analysis and study baseline design workshop in Project Month 4 (see WP 2). • A workshop to discuss the findings of the situation analysis and discuss possible revisions to existing schemes in Project Month 12 (see WP 3). • A workshop to present and discuss the preliminary findings of the evaluation of the revised schemes in Project Month 42 (see WP 6). • A workshop presenting the final study findings in Project Month 47. Policy briefs will be developed, and aimed at policy-makers and managers at different levels, including regional and national policy-makers. Consultations with primary stakeholders will occur, and they will be provided with full project findings in due course. The primary project stakeholders are the target population, providers of health care and providers of health insurance in the study sites. These groups will be consulted and informed of the findings in the following ways: • Representatives of primary stakeholder groups such as farmer’s associations, and grassroots women’s groups will be invited to join the initial project start-up workshop. • Further consultation will be carried out with these groups prior to the redesign of health insurance schemes through qualitative data collection as part of the situation analysis. • The preliminary findings of the evaluations of the pilot schemes will be disseminated to representatives of these stakeholder groups through a workshop in month x to enable them to comment on the findings and appropriate recommendations. • The final study findings will be communicated to these stakeholders through the development and dissemination of appropriate materials such as radio broadcast slots and newsletters. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 107 • Consulting with and disseminating the project findings to international policy-makers and researchers. • In order to inform the design and implementation of more sustainable, equity-oriented health insurance schemes internationally, it will be important to ensure that the study methodology will produce information on the specific questions and indicators of concern to international policy.makers. The project will involve representatives of international policy makers and their advisers on the technical advisory committee, which will meet twice a year to discuss plans and review results. The study results will be disseminated more widely through a number of mechanisms, including: • Submission of academic papers for publication in national, regional and international high impact peer-reviewed journals. • The production of policy briefings for international policy-makers. • The presentation of papers at relevant regional and international conferences attended by the health research and policy making community. • Submission of the final research report to the EU. • Web-based dissemination of project findings through a project website and submission of the project findings to research dissemination websites such as ID21. • Presentation to community members, academia, district and regional health teams and other relevant stakeholders. Write-shop During the evening, work in your teams to develop the following aspects of your team’s IR proposal: • Monitoring and evaluation plan • Capacity building plan • Dissemination plan • Make any changes necessary to improve, update, or align all sections of your proposal Propos al 108 5. sUpplements In this session you will develop several of the final sections of your proposal. Specifically, information on the project summary, table of contents, appendices, and your researcher CVs will be covered. You will have a write shop to prepare these aspects, and review all the previous components and update and align your entire proposal. Finally, you will prepare a 20-minute presentation and present and receive feedback on your IR proposal. By the end of the session, participants will be able to: • Develop a proposal summary • Develop a table of contents • Identify which appendices need to be included • Develop a template for your CVs • Prepare a 20 minute presentation summarizing your IR proposal Project summary An IR project summary (sometimes called an abstract or an executive summary) briefly describes the entire proposal. Researchers often write their summary or abstract last, when they are best able to concisely describe their research proposal. The summary should include a description of the problem under investigation, a rationale for why the research is needed or important (situated in the literature), the participants, the methodology, the research activities to be undertaken and the expected outcomes or implications of conducting the research. Depending on the requirements of the funding agency, your summary/abstract may be limited to anywhere from 150–200 words (abstract) to a page (summary). Like a research report or journal article, your proposal summary or abstract might be the most important paragraph/page of your proposal because it will be the first thing most reviewers come into contact with when reviewing your proposal. The summary will create the ‘first impression’ with reviewers and may influence whether reviewers choose to fund your proposal or not. Example: IR project summary Proposal title: Bringing health care to the vulnerable – developing equitable and sustainable rural health insurance in China and Viet Nam Proposal acronym: RHINCAV Overall objective: The goal of the project is to contribute towards poverty reduction and health improvement for people living in poor rural areas of developing countries. The overall objective of the project is to promote equity in health by making evidence available for health policy-makers for an effective, sustainable and affordable rural health care financing system in China and Viet Nam. Specific objectives 1. To carry out a situation analysis of perceived needs for rural health insurance and strengths and weaknesses of existing schemes. 2. To develop and implement pilot rural health insurance schemes that are feasible and meet the perceived needs of their target populations. 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 109 3. To monitor and evaluate the effects of the new schemes from the perspectives of equitable coverage, user satisfaction, efficient service utilization and provision, poverty reduction and sustainability. 4. To support the design and implementation of sustainable, equity-oriented rural health insurance schemes by effective dissemination of the research findings. Abstract A growing number of developing countries are developing health insurance schemes to protect people, particularly the poor, from financial catastrophe caused by expensive medical care. Among them are China and Viet Nam, which have experienced rapid economic development and dramatic social changes over the past two decades. All these changes have had profound implications for every aspect of people’s lives. Health care financing reforms in the two countries have led health facilities to rely increasingly on user charges, which have resulted in greater financial difficulties in accessing health care, especially for the rural poor. Although the central governments of both countries have promoted the development of rural health insurance for many years, the population coverage has been far from satisfactory, due to many political, socioeconomic and managerial factors. The proposed research will promote equitable health care financing mechanisms in the two countries by developing and disseminating an evidence base for the design and implementation of sustainable and acceptable rural health insurance schemes. The research project will adopt a case study approach in which a number of study counties and districts where rural health insurance schemes already exist will be selected for implementing revised schemes that are feasible and meet the perceived needs of their target population. It will monitor and evaluate the effects of the schemes from the perspectives of equitable coverage, user satisfaction, efficient service use and provision, poverty reduction and sustainability. It is expected that the final project results (good practice and lessons learnt) will be disseminated to a wide audience and used to inform relevant policies on rural health insurance in China, Viet Nam and other developing countries. Project summary checklist The summary should be informative to those working in the same or related fields. A good summary makes it very easy for reviewers to comprehend and evaluate your proposed project according to the review criteria. Although the criteria for a research proposal will vary depending on the funding agency, a summary typically will include a brief description of each of the following: • The problem (what problem are you trying to solve?). • A convincing rationale for why this problem is important (i.e. how the proposed research will advance knowledge, improve health care practice etc.). • Where the research will take place and with whom (sites and participants). • How the data will be collected and analysed. • The extent to which the proposed research is innovative. • The expected results or the impact of conducting the research. • How the findings will be disseminated. • The implications (change policy, improve health care practice etc. and who will benefit). Table of contents The table of contents organizes the proposal by outlining what is in the proposal and where each item can be found. It presents a convenient list of the topics and sections in a logical sequence ‘at a glance’. 110 Word processing software such as Microsoft Word and Open Office, have the ability to automatically generate a table of contents. You can tag your headings with the appropriate heading style (e.g. Heading 1, Heading 2, Heading 3) and use the Insert > Table of contents features. Appendices Appendices include those aspects of your project that are of secondary interest to the reader. The reader should be able to obtain all the necessary information from the body of the proposal and will go to the appendices if they need or want additional information. Appendices may include things such as the CVs of members of the research team, research instruments, or letters of support. This is also a place to put additional information you would like the reviewers to have access to but the length restrictions prohibit space for them to be included in the body of the proposal. CVs of investigators The CVs of investigators have an influence on the reviewer’s assessment of your proposal. You may want to ensure at least one member of your team has IR experience, a good track record and a strong publication record. Complementary qualities such as credibility in the community are equally important. Usually agencies have a limit of 1–3 pages for an investigator’s short curriculum vitae. So investigators will need to shorten their CVs to highlight the most relevant aspects of their professional/academic life to the project and to align with the scope of the funding agency. A template can help investigators to shorten their CVs and to keep them uniform. Write-shop In your teams develop the following aspects of your team’s IR proposal: • Project summary (one page). • Title page. • Appendices (make a list of all the appendices and add the ones that are ready). • Researchers’ CVs (create a template of the CV components so that all researchers have a similar look and format). • Review all components of your proposal and update and align. Group activity: Proposal presentation Prepare a 20-minute presentation (slide or poster presentation) including the following aspects of your IR proposal • Title • Rationale • Statement of the problem • Research question(s) • Research design • Research method Propos al 2M ODULE D ev elo pin g a n im plem en tatio n resea rc h pro po s a l 111 • Data collection • Data analysis • Quality management • Participants • Ethics • Project plan • Research team • Budget and justification • Monitoring and evaluation plan • Capacity building plan • Dissemination plan Group presentation Present your team’s proposal to the large group in 20 minutes. This will be followed by 20 minutes of comments, questions, suggestions and comments from the large group and facilitators. references 1. Merriam, S. B. (1998). Qualitative research and case study applications in education (2nd ed). San Francisco: Jossey-Bass 2. Maxwell, J. A. (2012). Qualitative research design: An interactive approach (Vol. 41). Sage publications. 3. McMillan, J.H., & Schumacher, S. (2010). Research in education: Evidence-based inquiry (7th ed.). Boston: Pearson/Allyn and Bacon. 4. Fraenkel, J, & Wallen, N. (2009). How to design and evaluate research in education (7th ed.). Boston: McGraw-Hill Higher Education. 5. Creswell, J. W. (2009). Editorial: Mapping the field of mixed methods research. Journal of Mixed Methods Research, 3(2), 95-108. 6. Proctor, E., Silmere, H., Raghavan, R., Hovmand, P., Aarons, G., Bunger, A., ... & Hensley, M. (2011). Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Administration and Policy in Mental Health and Mental Health Services Research, 38(2), 65-76. 7. Travis, P., Bennett, S., Haines, A., Pang, T., Bhutta, Z., Hyder, A. A., ... & Evans, T. (2004). Overcoming health-systems constraints to achieve the Millennium Development Goals. The Lancet, 364(9437), 900-906.

3 modUle plAnning And condUcting An implementAtion reseArch project 114 introdUction This module addresses the immediate steps that take place once funding/resources for an IR proposal is secured. It provides information on planning for conduct of the research project, including preparation of the study protocol for ethical review. It covers the following key concepts with examples: • Preparing and applying for ethical review. • Planning for project implementation. • Implementing good IR principles and practices. leArning objectives The Planning and conducting an implementation research project module provides information on the essential steps of research execution, including: applying for ethical review, planning for programme implementation, and implementing good IR principles and practices. These processes will be illustrated using the example of an IR project. By the end of this module your research team will be able to: • Describe the ethical requirements and processes required to successfully submit a research project protocol for ethics review. • Describe the related ethical processes in a project cycle. • Systematically describe the steps needed to implement a research project. • Appreciate the value of good practices in the full cycle of a research project. key concepts Seeking ethical clearance Implementation research offers unique ethical perspectives in that it involves, in most cases multiple perspectives and interfaces with health services. As such, IR implementers may find it difficult to differentiate between routine health care and the research process. When the lines blur between routine heath care and the research process, it may be difficult to identify the potential risks associated with the research, especially participatory research. Research funding agencies require the approval of research proposals by the appropriate ethics review committee before project funds are released. Depending on the circumstances, ethical review may be required from more than one such committee. For example, ethics approval may be required from an institutional as well as a national ethics review committee, or by more than one research or health institution in case of collaborative projects. The ethics committee(s) will review the study proposal and require full details of the study plan and procedures. The committee(s) pay particular attention to how consent will be obtained from potential study participants, and carefully scrutinize all informed consent documents. Any changes in the study, such as adding new objectives, extending the study catchment area, adding or removing inclusion or exclusion criteria will require additional approval by the ethics committee(s). It is important to consider the ethical aspects of a research study right from the initial stage planning of the project. However, due to the fact that IR is conducted in real-life settings, sometimes certain unforeseen circumstances not considered before the project was presented for ethical review may arise. 3M ODULE Pla n n in g a n d c o n d u c tin g a n im Plem en tatio n resea rc h Pro jec t 115 Submission of the research protocol for ethical review The ethics review process is essential to ensure that the research project will protect research subjects’ dignity, rights, safety and well-being. Therefore, before initiating a study, a written approval of the protocol, written informed consent (preferably in the local language in which it will be administered) and defined recruitment procedures are required. The principal investigator is responsible for complying with the study protocol as agreed by the sponsor and regulatory authority (if appropriate), and approved by the scientific and ethical committees. Table 1 outlines the documents generally required to be submitted to research ethics committees. The requirements may vary between committees so it is important to check the specific documentation and protocol requirements with the ethics committee(s) to whom you are applying. Table 1. Documents to be submitted to the institutional review board (IRB) and/or the ethics review committee (ERC) Cover letter briefly describing the research proposal and ethical issues involved, if any. Full research protocol including rationale, research problem, review of literature, methodology, data collection tools, procedures and expected outcomes. Analysis of potential risks and benefits, including protection of privacy and confidentiality. Detailed subject recruitment process and target population. Informed consent or assent for minors available in the local language. Process of communicating the research findings to participants and communities. Plan for addressing post-study obligations such as: • improvements in health care and facilities; • provision of new-proven interventions to participants; • long-term surveillance; • strengthening of local research expertise. Curriculum vitae of the principal investigator and the research team members. Proposed dissemination of the study results. Ethical issues to be considered during project implementation Ethical principles of autonomy, risk/beneficence and justice (as described in Module 1) should be adhered to during the implementation and post-implementation phases of IR projects. In this section, issues regarding informed consent, privacy and confidentiality will be discussed. Seeking informed consent Informed consent (IC) is recognized as a fundamental ethical requirement for conducting research involving human subjects (1). Informed consent ensures that individuals can freely make decisions to participate according to personal interest, values and priorities. The IC is more than a contractual obligation and should be understood as a process that begins with the initial contact (during the recruitment process), and carries through to the end of participants’ involvement in the project. The establishment of the process requires four basic elements: 1) accurate and appropriate information; 2) understanding the purpose of and procedures in the research process; 3) capacity to consent; 4) voluntary participation. 116 To have an effective consent, full information should be explained in the local language of the participants. Furthermore local/simplified words (i.e. rather than scientific and professional jargon) should be used. The consent form should also include information about the research and the procedure as well as the consent certificate (Table 2). Table 2. Elements in an informed consent document Part 1: Information sheet Introduction of the investigator and his/her institution. Purpose of the research. Type of research intervention. Participant selection. Voluntary participation. Procedures (interview, focus group discussions (FGD), where interview will take place, privacy and confidentiality issues). Duration of the procedures/interview, the length of the intervention including follow-up. Anticipated risks. Benefits at different levels (individual, community or society). Reimbursements (if necessary). Confidentiality (note: FGDs provide particular challenge to confidentiality, because once something is said in the group, it becomes common knowledge). Sharing of results (process that will be used to share the research results). Right to refuse or withdraw. Who to contact (e.g. for any additional information). Part 2: Certificate of consent This section must be written in the first person. Should include a few brief statements about the research and be followed by a statement, indicating that the participant has read or the information has been read to him/her, they understand and are participating voluntarily. If the participant is illiterate, but provides oral consent, a witness must sign. The researcher or person going over the informed consent must sign each consent form. Privacy, confidentiality, anonymity Protecting the anonymity and confidentiality of research participants is another practical component of research ethics. Disclosure of personal information may, in some circumstances pose a risk of discrimination or prejudice. Protecting the privacy and confidentiality of participants is the investigator’s duty (2). Protecting the anonymity and confidentiality of research participants involves adhering to ethical procedures during data collection, storage and analysis as well as during the publication process. During data collection, the participant should be accorded as much privacy as possible to ensure that the information being provided is not shared with other individuals. Unless the respondent gives permission, at no time should the identity of the respondent be disclosed to any third party during data collection, storage or analysis, or 3M ODULE Pla n n in g a n d c o n d u c tin g a n im Plem en tatio n resea rc h Pro jec t 117 during dissemination or publication. Identity of the respondents may be associated with Plan anonymous identifiers which cannot be linked to individuals. Seeking ethical clearance during implementation of the project When the ethical committee(s) issues an approval certificate it will inform the principal investigator (PI) of the need for regular reviews as described in the section below. In most study designs, the original research protocol is followed precisely. However in IR, the research team continuously monitors and reviews the intervention activities to ensure meaningful and practical outcomes for programme planning and implementation. During this process, unexpected circumstances may arise leading to changes in the original research plan (in the best interest of the project and/or the participants). In such situations, a number of amendments are likely to be made to the original proposal submitted for ethical review. The IR team must inform the ethical committee of any major changes to the original research protocol or procedures. For example when submitting a proposal for ethical review, the research team may indicate that patients be given daily injections by the nurse in charge of the facility. However during the research process, the planned injection process was not effective due to unanticipated problems. The ethics committee must be informed of any change(s) in procedure including those dues to unanticipated problems. This can be done during periodic ethical reviews of the project. Periodic reviews may be requested since most ethics committees require follow up to ensure compliance with procedure, to evaluate any protocol deviation, or to follow up with medical intercurrence during a study. The committee proposes the frequency and procedures for follow- up and review of operations and data on a case-by-case basis. Interim ethical review may be needed in special circumstances due to significant change in the study design or when information used for the original approval of the proposal has changed. Final ethical review is a process whereby the project PI communicates to the ethical committee the conclusion of the project, through a progress report since last approval, a summary of study results and the future disseminations plans. Reflection activity An anthropologist was conducting an ethnographic study on Buruli ulcer patients in a half-way home. The study was designed such a way that a health worker was to make a daily visit to the half-way home to administer injections. However due to the distance between the half-way home and the nearest health facility, the health worker was unable to make the necessary daily trips. Should the health worker train the researcher to give the daily injections? Project implementation process Implementing the project involves the process of conducting and monitoring the proposed activities, as well as updating and revising the research plan accordingly as conditions dictate. The activities include assembling the research team(s), applying for the logistical needs and allocation of activities and tasks. Furthermore, the research sites, the timeline for the research activities, and the procedures for the data collection must all be established. This phase also includes closure and evaluation of the project, as well as reporting and disseminating the processes and findings of the research. In the following section, the process involved in starting 118 the implementation process and ensuring quality data is described. Monitoring is a process that is interwoven throughout the implementation process of any IR project. Starting the implementation process When the project work plan is complete, agreed by all involved parties and approved by relevant management groups, the implementation of the project may begin. It can be very helpful to include the entire research team (including stakeholders, partners and frontline workers) in the launching of the project. The team members review the project goal, objectives, indicators and work plan. They address potential issues and set up a mechanism of communication to ensure teamwork during implementation. The team leader must ensure that the work begins on time and the agreed standards of performance are followed within the approved budget limits. Good practices in implementation research Implementation research must generate credible data. Good research practice can ensure credible data by reducing the risk of obtaining inconclusive results on account of uncertainty. Uncertainty arises when the intervention is ineffective or the implementation procedures are unclear (3). Documentation of processes Implementation research is a dynamic process that often requires adaptations, flexibility and latitude during the course of execution. Such changes/adaptations to the research process must be documented, coordinated and monitored to ensure credibility and fidelity. The following questions should underpin the documentation: • What is happening? • Why is it happening in this way? • Is this expected? It is important to be objective when documenting processes and report both negative and positive experiences. This will facilitate learning and evidence to support previously anecdotal reports. Documentation of the various processes, adaptations, revisions and experiences that occurred and impacted the research will ensure that programme planners and policy-makers do not only receive the results of the study but understand the process by which the results are obtained. Training of the implementers Plans do not always proceed as intended in IR projects. Therefore adaptations may be required as the implementation process proceeds and more information is obtained. The set procedures (e.g. sampling and data tools) should be reviewed regularly to compare what is happening in practice with the original planned procedure, so that any necessary adjustments can be made. Staff training is a critical part of this process in order to ensure that the procedures are understood and adhered to. Training for all essential procedures should be standardized and targeted to all the key staff. To ensure a continuous learning process, training should be followed by mentoring and/or supervision activities. Researchers need to ensure that the set procedures are adhered to during training using the prescribed materials and the most up-to-date versions of the data collection tools and instruments. In IR, there is the possibility of adverse events or unintended consequences of the intervention. Adverse events can have a negative impact on the adoption and sustainability of the intervention, 3M ODULE Pla n n in g a n d c o n d u c tin g a n im Plem en tatio n resea rc h Pro jec t 119 particularly when these events occur during the initial stage of implementation. Resistance to change, inertia and investment in the status quo – coupled with the inherently difficult and complex new task – may affect the adoption of a new practice. Pre-testing In any research, a pre-test is usually conducted to check the validity and reliability of a data collection tool. Pre-testing allows the research team to check whether the research instructions and questions are clear, adequate time is provided to administer the questionnaire, etc. Since data management is critical to the success of the research, the data management team should be available during the discussion that follows the pre-test to incorporate changes into the final design of the tool and facilitate incorporation of appropriate checks into the data entry system. This stage includes designing the forms for recording measurements, developing programmes for data entry, management and analysis; and planning dummy tabulations to assure the appropriate variables are collected. Note All study instruments (qualitative and quantitative) should be tested. Data management Collection and storage/documentation of accurately recorded and retrievable results are essential for any research. Good data collection practices will ensure that data can be traced to their source and originality (i.e. the raw data that constitutes the first recording of the observation). To ensure these characteristics, raw data must be recorded: • Promptly: After a specific task is completed. Delaying data recording will reduce data quality as memory may fail or be inaccurate. • Accurately: Inaccurate data recording will reduce the reliability of the data collected, and is therefore a critical part of the integrity of the study. • Legibly: Hand-written data should be clearly written, electronic records should not be difficult to decipher. • Indelibly: Handwritten raw data should be recorded in permanent ink. Any changes to the raw data should not obscure the previous entry. The date, reason for the change and signature of the person responsible for the change should be added. Clear and regularly checked data flow prevents data loss. As IR collects different types of data (i.e. patient, organizational and surveillance-related data) from various sources (i.e. human subjects, medical records, health services and laboratory registers, surveillance systems, and administrative systems) a detailed chart should be made describing the critical pathway(s) to be used for the data collection process in handling questionnaires, coding, data entry, data verification, cleaning and storage of hard copies and back-up of data files. Storage or archiving of data means that recorded data are appropriately stored for future use. The WHO Good Clinical Practice Guideline recommends that data and essential documents should be for at least two years after the research project has ended. Data should be kept in secured storage areas or locked cabinets. 120 ApplicAtion of key concepts Example project: Key findings from an evaluation of the Mothers2Mothers programme in KwaZulu-Natal, South Africa (4) Background: Mothers2Mothers (M2M) is a peer support programme that aims to provide education and psychosocial support to HIV-positive pregnant women and new mothers, help women access existing health care services to prevent mother-to-child transmission (PMTCT) of HIV, and follow up with mothers and babies to ensure they receive appropriate medical care after delivery. While there has been much interest in innovative psychosocial support programmes that complement PMTCT clinical services, only a few such programs exist, and there is very little data about their effectiveness. Although M2M is a well-known programme with anecdotal accounts of successfully supporting HIV-positive women, it has yet to undergo an external evaluation. The Horizons Program of the Population Council, in collaboration with Health Systems Trust, completed the first evaluation of M2M as part of its introduction in KwaZulu-Natal Province, in South Africa. Study design and methods The researchers used a pre–post, quasi-experimental study design to assess programme effectiveness. There were three evaluation sites in the Pietermaritzburg area of KwaZulu-Natal. These sites drew women from urban and peri-urban settings. The eligibility criteria for the study included being between the ages of 18 and 49, knowing one’s HIV status, and either 6–9 months pregnant or 12 weeks or less postpartum. Two cross-sectional surveys were conducted. At baseline data collection in 2005, before M2M was introduced, 183 HIV-positive pregnant women and 178 HIV-positive postpartum women were interviewed using a structured questionnaire. At follow-up data collection in 2006, one year after M2M was introduced, 345 HIV-positive pregnant women and 350 HIV-positive postpartum women were interviewed using the same questionnaire but with additional questions about programme exposure and interaction. Concept 1: Seeking ethical clearance • The evaluation protocol was approved by the Population Council’s IRB, USAID, and the University of Stellenbosch in South Africa. The Horizons Program obtained ethical approval in the United States, while Health Systems Trust obtained in-country approval. • The questionnaire was translated into isiZulu and translated back into English. • The study’s interviewers were trained on the importance of following ethical guidelines, including maintaining confidentiality. • Written informed consent was obtained from all women interviewed. • Participants were compensated 40 Rand (approximately US$6) in recognition of costs such as travel, child care, and other expenses associated with participation in the study. • Interviews were conducted in a private space at the clinics. • All of the interviewers were female as it was deemed culturally appropriate to have only women in the health facilities conducting the interviews. • Participants were not asked to give their names except to sign the written informed consent form. • These forms were stored in a locked office, and kept separately from the data, which were in an electronic format. 3M ODULE Pla n n in g a n d c o n d u c tin g a n im Plem en tatio n resea rc h Pro jec t 121 Concept 2: Project implementation process The programme implementation period was 2005–2006 and the M2M project activities included: • Health talks by the site coordinators and mentor mothers on days when there are appointments for antenatal clinics and/or maternal and child health services. • Counselling and support groups by mentor mothers and site coordinators on a daily basis. • Daily visits by the mentor mothers to the labour and delivery wards to speak with expectant mothers or newly delivered mothers awaiting discharge. • Regular support group meetings within the clinic, providing nutritious lunches to the women who visit the site. • Community outreach by mentor mothers and site coordinators. • Pre–post, quasi-experimental study design to assess programme effectiveness. Changes in programme implementation Due to slight delays in obtaining the necessary approvals for conducting the research activities at the sites, and the need to start programme activities, there was some overlap of baseline data collection with intervention activities. Concept 3: Good practices in implementation research Protocol Development The evaluation protocol and instruments were jointly developed by the principal investigators from the Horizons Program and Health Systems Trust, and were further reviewed by the staff from M2M. During programme implementation 1. The m2m project employed experienced health care professionals as program managers to oversee local programs based in the individual health care facilities. 2. Mentor mothers participated in two weeks of training using a standard curriculum which covered basic medical knowledge about HIV infection and antiretroviral therapy (ART), behaviours that prevent mother-to-child transmission. 3. To ensure a continuous learning process, the site coordinator (a mentor mother who has participated in the programme) supervised the delivery of care provided by mentor mothers. Good practices in data collection and data management 1. Staff from the Horizons Program and Health Systems Trust jointly conducted the training of interviewers. 2. Health Systems Trust recruited university graduates with previous work experience as interviewers. 3. The interviewers completed two weeks of training prior to each round of data collection. 4. The questionnaire was pre-tested to ensure that the study population understood the questions, and that culturally appropriate phrases were used. 5. Participants’ responses were recorded electronically using Perseus Mobile Survey software operating on a Dell Azim x51 handheld computer (this programme allowed for all of the questionnaire’s skip patterns and range checks to execute automatically during the interview). 6. On a daily basis, after the interviews were completed, the data manager uploaded the data to a desktop computer then converted the data to SPSS software for quality control, management, analysis and storage. 7. Backup files were encrypted and emailed offsite daily to the research team, who were the only ones who had access to the data. 122 conclUsions Congratulations on completing Module 3 Planning and conducting an implementation research project. This module provided information on the various steps to plan for to conduct the research including: applying for ethical review, planning for programme implementation, and implementing good IR principles and practices. An example of these processes was demonstrated through the use of an authentic IR project. 3M ODULE Pla n n in g a n d c o n d u c tin g a n im Plem en tatio n resea rc h Pro jec t 123 references 1. Neff, Margaret J. “Informed consent: what is it? Who can give it? How do we improve it?.” Respiratory care 53, no. 10 (2008): 1337-1341. 2. Giordano, James, Michelle O’Reilly, Helen Taylor, and Nisha Dogra. “Confidentiality and autonomy: The challenge (s) of offering research participants a choice of disclosing their identity.” Qualitative Health Research 17, no. 2 (2007): 264-275 3. WHO/TDR. “Handbook: Good laboratory practice.” United Nations Development Programme (UNDP)/World Bank/World Health Organization. Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland: (2001). http://www.who.int/tdr/publications/quality_ practice/en/index.html Accessed 11 February 2014. 4. Baek, Carolyn, Vuyiswa Mathambo, Sibongile Mkhize, Irwin Friedman, Louis Apicella, and Naomi Rutenberg. “Key findings from an evaluation of the mothers2mothers program in KwaZulu-Natal, South Africa,” Horizons Final Report. Washington, DC: Population Council. (2007) Additional reading • Kass, Nancy E., Ruth R. Faden, STEVEN N. GooDMAN, P. E. T. E. R. PRoNoVoST, S. E. A. N. TuNiS, and ToM L. BEAuCHAMP. “The Research Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.” Hastings Center Report 43, no. s1 (2013): S4-S15. • Faden, Ruth R., Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. “An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.” Hastings Center Report 43, no. s1 (2013): S16-S27.

4 modUle dAtA, AnAlysis And presentAtion 126 introdUction The purpose of this module is to outline the fundamentals of IR data analysis and interpretation, (step 4 in the IR cycle). It also describes design of data analysis, presentation and interpretation for the target audience, with the objective of enhancing the uptake and use of research findings. Upon completion of this module, you will be able to: • Describe appropriate data analysis planning processes for both quantitative and qualitative data. • Understand the appropriate measures for statistical analysis in quantitative research. • Describe the data analysis processes in a qualitative study. The module is divided into two main sections: the first focuses on quantitative data management, analysis and presentation, and the second one qualitative data management, analysis and presentation. Before we begin… We assume you are already familiar with these two approaches and tools of data collection (from Module 2). As a brief reminder you will be asked by the facilitator to identify some of the main differences between them (Table 1). Table 1. Comparing qualitative and quantitative approaches Qualitative Quantitative Social theory Action Structure Methods Observation, interview Experiment, survey Question What is x? How? Why? (classification) How many xs? (enumeration) Reasoning Inductive Deductive Sampling Theoretical Statistical Strength Validity Reliability key concepts Data analysis plan Most IR proposals use mixed methods in which qualitative and quantitative techniques are combined. Under the right circumstances, a mixed-methods approach can provide a better understanding of the problem than either approach alone. To ensure that the analysis is undertaken in a systematic manner, an analysis plan should be created first. The analysis plan contains a description of the research question and the various steps that will be carried out in the process. Designing analysis for use Designing analysis for use in an IR project is based on the premise that the IR aims to: (i) understand the implementation processes, focusing on mechanisms that support or constrain those processes; and (ii) communicate that understanding of the implementation process to multiple stakeholders, who may consequently contribute to the integration of findings into current and/or future research. 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 127 Few of the stakeholders in the IR project team are likely have specialized knowledge of both quantitative or qualitative research methods. It is therefore essential that the analysis and most importantly, the presentation of findings, be carefully considered to avoid potential misinterpretations that could lead to inappropriate conclusions and/or responses. Emphasis should be placed on simplicity and interpretability because stakeholders need to both understand the information provided and also be able to interpret it correctly (1). Data analysis should take place along with the data collection process. This continual data analysis process facilitates regular sharing and discussion of findings. Emphasis on quantitative analysis should be on simple summary statistics, such as changes in: • counts, means, medians, ranges, percentiles; • rates, trends, ratios and (for some stakeholders) risks; • frequency distributions, proportions and percentages. Designing analysis by purpose An important preliminary consideration when designing data analysis plan is to clearly define the primary objectives of the analysis by identifying the specific issues to be addressed. It is important to remember that data from IR is by nature intended not to simply describe the intervention but also to improve it. For example, IR research may focus on: • Effectiveness: Aims to modify implementation procedures in order to improve the generation of benefits. • Efficiency: Attempts to assess the implications of possible modifications to the implementation process in order to increase the benefits in relation to resources. • Equity: Focuses on distributional issues, i.e. how benefits and resource costs are distributed. • Sustainability: Focuses on identifying essential inputs, potential constraints on their availability and other possible barriers to medium and long-term sustainability. Quantitative data analysis In IR, quantitative data analysis will include one or more of the following considerations: • Frequency distribution and summary statistics. • Relationships and confounding variables. • Sub-group analysis. • Statistical models. • Generalizing from samples to populations. • Trend analysis. Variables in quantitative analysis are usually classified by their level of measurement, as indicated below. • Rational – e.g. weight of child, number of vaccinations. • Interval (based on predetermined equal intervals) – e.g. temperature, some disability measures. • Ordinal (ranks) – e.g. facility levels, quality of life indices. • Nominal (categories) – e.g. district names. 128 Distributions and summary measures Quantitative research generates large volumes of data that require organization and summarizing. These operations facilitate a better understanding of how the data vary or relate to each other. The data reveals distributions of the values of study variables within a study population. For example: • The number of children under five years in various households in a given population. • Daily outpatient attendance in a health facility. • The birth weights of children born in a particular health facility over a period of time. • Educational levels of mothers of children born in a particular health facility. Analysis of the type of data described above essentially involves the use of techniques to summarize these distributions and estimate the extent to which they relate to other variables. For example, in a sample of newborns we might summarize the distribution of birth weights by calculating the frequency of low, normal and high birth weights, classifying as normal those in some standard range. If we also calculated the frequency of different education levels for the mothers of those newborns, we could then estimate the strength of a possible relationship between these two variables. The use of frequency distributions for this purpose has several advantages: • useful for all types of variables. • easy to explain and interpret for audiences without specialist knowledge. • can be presented graphically and in different formats to aid interpretation (e.g. tables, bar charts, pie chart, graphs, etc.). Defining intervals for frequency distributions A key decision in constructing a frequency distribution relates to the choice of intervals. For example: • Ordinal: Level of health facility (e.g. primary, secondary, tertiary). • Interval: Body temperature (e.g. below normal, normal, above normal). • Rational: Body mass index (BMI) (e.g. <25, 25–29, 30+). There are two conflicting objectives when determining the number of intervals: • Limiting the loss of information through the use of a relatively large number of intervals. • Providing a simple, interpretable and useful summary through the use of a relatively small number of intervals. Distributions based on unequal intervals should be used with caution, as they can be easily misinterpreted, especially when distributions are presented graphically. Data presentation formats Data reporting should be presented in both textual and visual formats (such as diagrams, maps, graphs, tables). Organizing and displaying the data in visual formats is useful in identifying trends and forecasts. The example below presents the same data in a variety of formats (e.g. table of frequencies, table of proportions/percentages, bar chart, pie chart, etc.). 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 129 Table 2: Provider education expressed as frequency table (example) Level of education of private providers Frequency Illiterate 106 Basic literacy 74 Primary school certificate 57 Secondary school certificate 11 Higher level qualification 2 Total 250 Figure 1: Provider education expressed as a bar chart (example) Table 3: Provider education presented as proportion, percentage and cumulative percentage (example) Level of education Proportion Percentage Cumulative percentage Illiterate 0.424 42.4 42.4 Basic literacy 0.296 29.6 72.0 Primary school certificate 0.228 22.8 94.8 Secondary school certificate 0.044 4.4 99.2 Higher level qualification 0.008 0.8 100.0 Total 1.000 100.0 0 20 40 60 80 100 120 Illiterate Basic literacy Primary school certificate Secondary school certificate Higher level qualification Level of education 130 Figure 2: Provider education presented as a pie chart (example) Table 4: Joint frequency distributions for two or more variables (example) Highest level Men Women All Illiterate 42 64 106 Basic literacy 45 29 74 Primary school certificate 32 25 57 Secondary school certificate 8 3 11 Higher level qualification 1 1 2 Total 128 122 250 Table 5: Row percentages (example) Highest level Men Women All Illiterate 39.6 60.4 100.00 Basic literacy 60.8 39.2 100.00 Primary school certificate 56.1 43.9 100.00 Secondary school certificate 72.7 27.3 100.00 Higher level qualification 50.0 50.0 100.00 Total 51.2 48.8 100.00 Illiterate Secondary school certificate Higher level qualification Basic Literacy Primary school certificate 1% 4% 23% 30% 42% 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 131 Table 6: Column percentages (example) Highest level Men Women All Illiterate 32.8 52.5 42.4 Basic literacy 35.2 23.8 29.6 Primary school certificate 25.0 20.5 22.8 Secondary school certificate 6.3 2.5 4.4 Higher level qualification 0.8 0.8 0.8 Total 100.00 100.00 100.00 Figure 3: Bar chart for two variables (example) Summary statistics and frequency distribution Careful examination of the frequency distribution of a variable is a crucial step and can be an extremely powerful and robust form of analysis. There can be a tendency to move too quickly to the calculation of simpler summary statistics that are intended (but often fail) to capture the essential features of a distribution. Summary statistics usually focus on deriving the measure indicating the overall location of a distribution (e.g. how sick, poor or educated a study population is, on average) OR to indicate the extent of variation within a population. However, the reasons for selecting a particular summary statistic should relate to the purpose for which it is intended. Illiterate Basic literacy Primary school certificate Secondary school certificate Higher level qualification 60 50 40 30 20 10 0 Men Women 132 Example: Summary statistics and frequency distribution To find out if a recently implemented intervention reduced the problem of malnutrition among five year- old children in a given village, a researcher may ask: “Which summary statistic is most appropriate?” • Change in mean or median daily calorie intake of all five year-olds in village? • Change in proportion of five year-olds in village falling below predetermined minimum calorie requirement? The criteria for making such choices include: 1. Face validity (i.e. is the statistic relevant to the specific concern?). 2. Whether stakeholders understand how the data was derived. 3. Whether stakeholders are able to interpret the findings as intended. Use of mean or median The mean, or average, is the most commonly used summary measure of location. However, it is often inappropriately used as the standard measure of central location because the mean is simple to calculate and manipulate. For example, it is straightforward to combine the mean of sub- populations to calculate the overall population mean. The mean is also frequently misinterpreted as the typical value in a population. For example, the GDP of a certain middle-income country was calculated as 3200 US$. Interpreting this as the income of an ‘average’ person in that country does not reflect reality (in fact, it was closer to 1200 US$). The mean is often unrepresentative when the underlying distribution is skewed. The median, defined as the middle value, is relatively easy to explain. The magnitudes of other values are irrelevant. For example, if the largest value in a given range increases or the smallest value decreases, the median remains unchanged. When a data set is not skewed (or when data are distributed ‘normally’), the mean and the median will be the same (Figure 4). Figure 4: Normal distribution: The mean is the measure of central location 70 60 50 40 30 20 10 0 3 4 5 6 7 Birth Weight Birth Weight (Ibs) Pr op or tio n of B irt hs 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 180 160 140 120 100 80 60 40 20 0 Distribution of land holdings Size of land holding N um be r o f f ar m er s Box 1 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 133 Figure 5: Skewed distribution In a skewed distribution, the mean is more difficult to interpret. Measures of risk Although measures of risk are widely used in health research, they are not always well understood. For example, risk and odds are often used interchangeably however do not mean the same thing. • Risk (P): number of people experiencing an event/population exposed to the event. • Relative risk (PA/PB): risk in group A compared to risk in group B. • Odds: number experiencing versus number not experiencing = P / (1-P) • Odds ratio: [PA/(1- PA)] / [PB/(1-PB)] Furthermore, reduction in risk is not equivalent to reduction in odds: • PB (malaria before intervention) = 0.5 • PA (malaria after intervention) = 0.1 • Reduction in risk = 0.1/0.5 = 0.2 • Reduction in odds = (0.1 / 0.9) / (0.5 x 0.5) = 0.11 The ‘denominator problem’ When calculating risk, it is essential to know the overall size of the population at risk. In implementation studies, it is often difficult to calculate or reliably estimate these summary statistics because the denominator is not reliably known. For example, we may only have an estimate of the number of children who should be immunized or should be sleeping under a mosquito net in a given district. Similarly, the catchment population of a facility or actual number of births over a period of time are often unknown. For these reasons, denominators are usually based on projected populations resulting in reported coverage of over 100% in some instances. Because of this uncertainty, it is good practice to provide the estimates of both the numerator and denominator alongside any proportion, percentage or risk estimate and indicate the sources used in the calculation. 70 60 50 40 30 20 10 0 3 4 5 6 7 Birth Weight Birth Weight (Ibs) Pr op or tio n of B irt hs 8 9 10 11 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 180 160 140 120 100 80 60 40 20 0 Distribution of land holdings Size of land holding N um be r o f f ar m er s 134 Measures of variation How much variability occurs in a given population? • Low variability: Measures of location can be seen as reasonably representative of the overall population; there is limited loss of information through aggregation. • High variability: Representative measures of location are less useful; there is a substantial risk of losing information by aggregation unless the nature of the distribution is well understood. Choice of measures Variances, standard deviations and coefficients of variation are widely used in statistical analysis. As with the mean, this is not because they are always the best measures of variability (they can be easily interpreted for normally distributed variables but not for other distributions), but mainly because they can be readily calculated and manipulated. For example, given the variances of two population sub-groups it is easy to combine them to calculate the overall population variance. However, while they may have technical advantages, these measures have serious limitations in terms of policy application. Alternative measures More readily interpreted measures include quartiles and percentiles. Quartiles: divide data into four quarters (Q1 to Q4) – 25% in each: 1. Q2 is the median. 2. Q1 is the median of the data points below the median. 3. Q3 is the median of the data points above the median. 4. Q3-Q1 is the inter-quartile range, comprising the middle 50% of a population. Percentiles divide the data into two parts: • p percent have values less than the percentile. • (100 – p) percent have greater values. • 50th percentile = median; 25th percentile = first quartile. • Other common percentiles: – 20th (which defines the first quintile group). – 10th (which defines the first decile group). Sub-group analysis The outcomes of an intervention may vary substantially between different sub-groups of the target population. Sub-group analysis can be complex if the sub-groups are not pre-defined. Investigating a relationship within a sub-group because it appears interesting could bias the findings. Data mining (i.e. exploring data sets to discover apparent relationships) is useful in formulating new hypotheses but requires great caution in IR. The context within which this sub-analysis is undertaken should be considered carefully, because relationships between inputs and outcomes may be mediated by contextual variables. For example, we might assume that it would be useful to undertake an analysis of chronic illness by age group and sex, as shown in Table 7. For meaningful interpretation of the results, the type of chronic illness and the background of the patients experiencing them are important variables to consider. 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 135 Table 7. Background variables of patients with chronic illnesses Age group Chronic illness prevalence Males Females 15–24 0.55 0.80 25–44 1.79 4.01 45–64 4.91 12.28 65 12.86 20.00 All 1.77 4.25 Controlled and confounding variables In the example of chronic illness (Table 7), we often describe such an analysis as one that assesses the relationship between inputs and outcomes by controlling for age group and sex. However, we know that in practice, a very large number of other factors may influence this relationship, for example occupation, level of education, socioeconomic status, household size, type of dwelling, rural/urban location, etc. Random allocation of subjects to intervention and control groups would allow us to argue that the potentially confounding effects of such variables average out. If that is not possible, we should find some way to control for these effects. Because IR takes place in real life and within complex adaptive systems, these effects may be difficult to control, however they must be considered. Analysis of qualitative data There are many traditions of qualitative research and it has been argued that “there cannot and should not be a uniform approach to qualitative methods (2). Similarly, there are few “agreed-on” canons for qualitative data analysis, in the sense of shared ground rules for drawing conclusions and verifying sturdiness (3). Many qualitative studies adopt an iterative strategy – collect some data, construct initial concepts and hypotheses, test against new data, revise concepts and hypotheses, etc. This approach implies that data collection and analysis are embedded in a single process and undertaken by the same individuals. However, with the increasing use of qualitative research in epidemiology and health research, objectives are pre-defined prior to data collection. Qualitative data analysis can be done manually or with proprietary software like the examples listed below: • Atlas-ti deals with large data sets, unstructured coding, mimic paper code and sort. • NVivo handles relatively less data, caters for unstructured coding, find patterns/relationships in codes. • MaxQDA provides powerful tools for analysing interviews, reports, tables, online surveys, videos, audio files, images and bibliographical data sets. There is a considerable range of choice in software for analysing qualitative data. Researchers should feel free to use whatever analysis method (with or without software) they are comfortable with. Whatever approach is used, all qualitative analysis involves making sense of large amounts of data, identifying significant patterns and communicating the essence of what the data reveal. The three core requirements of qualitative analysis are: 1. Detailed description of techniques and methods used to select samples and generate data. 2. Carefully specified analysis, with attention to issues of validity and reliability. 3. Triangulation with other data collection method. 136 Validity and reliability in qualitative research Validity in qualitative studies focuses on internal validity, with researchers seeking an in-depth understanding that will allow them to counter alternative explanations for their findings. Qualitative studies often rely on purposive sampling, which tend to detract from claims for external validity (generalizability). In quantitative studies, ‘reliability’ means repeatability and independence of findings from the specific researchers generating those findings. The term reliability is most often associated with quantitative research. However in qualitative research, reliability implies that given the data collected, the results are dependable and consistent (4). The strength of qualitative research lies in validity (closeness to the truth). Good qualitative research, using a selection of data collection methods, should touch the core of what is going on rather than just skimming the surface (4). 4. Analysis of textual material The basic process for the analysis of text derived from qualitative interviews or discussions is relatively straightforward and includes: 1. Identification of similar phrases, themes and relationships between themes. 2. Identification of similarities and differences between population sub-groups (e.g. men/women, rural/urban, young/old, richer/poorer, etc.). 3. Initial attempts to generalize by identifying consistent patterns across or within sub-groups. 4. Critical review and revision of generalizations, paying particular attention to contradictory evidence and outliers. Example: Focus group discussions As far as possible, outputs of focus group discussions (FGD) should be verbatim records. The notes taken by the recorder should be compared to a recording of the discussion. The recorder and moderator should agree on a final transcript. The transcripts (from multiple FGDs) should provide the material for systematic analysis. FGD analysis will typically address a number of specific research topics and sub-topics, such as eliciting additional topics of local concern, which can be used to define the broad domains for analysis. These can be sub-divided further into themes, sub-themes, etc. and allocated systematic codes. The initial descriptive analysis should also capture: (i) most common themes mentioned; (ii) less common themes; (iii) common associations between themes; and (iv) similarities and difference between sub-groups. The critical review and revision should: (i) review original text to assess the extent to which it conforms to the above analysis; and (ii) pay particular attention to any contradictory evidence, minority viewpoints, etc. Domain /theme analysis One relatively simple approach is based on the identification of key topics, referred to as ‘domains’, and the relationships between them (2). There are four stages in domain /theme analysis: 1. Identify main issues raised by the interviewees – the domains /themes. 2. Group more detailed topics within each of these domains to construct a taxonomy of sub-categories. 3. Specify what was actually said, the components within each sub-category. 4. Exploration of interrelationships between the various domains. Box 2 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 137 Domain /theme identification • Index texts, identifying topics line-by-line. • Collate these topics across all interviews to identify a preliminary list. • Some will recur more frequently than others and some of the latter can be classified as sub-topics. • Systematically combine related topics to develop a list of just a few fairly broad domains. Example of an initial list of topics and sub-topics (6): • Getting and being pregnant: Signs of pregnancy, danger signs, physical problems. • Feelings during pregnancy: Anxiety, anger/fright, worries, embarrassment, inconvenience, impressions. • Family planning: Methods. • Advice/activities to promote health: Exercise, activities, smoking, self-care, advice sources, information sources. • Birth and miscarriage: Previous experiences, place, signs, caesarean/normal, birth weight. • Antenatal care: Staff, place, experiences, meetings, tests, distance/cost, logistics, waiting time. • General background: Family, employment, geography. Initial list of potential domains /themes From the above example, the following broad domains were identified: • Motivations for antenatal care. • Medical process (experiences of antenatal care and evaluation of that care). • Risks during pregnancy. • Reproductive histories. • Socioeconomic background. Figure 6. Taxonomy of sub-categories (from Atkinson and AbuEl Haj, 1996) WHY ATTEND ANTENATAL CARE? Health check [Fear of risks, positive reassurance] Health promotion Material gain [food, milk] Insurance [sterilization, good birth] WHAT HAPPENS AT ANTENATAL CARE? Take information Vaccinate Give information Refer Physical Examination Send for tests Sterilization DIMENSIONS OF USERS EVALUATIONS Organization Interpersonal behaviour Technical practice Information Sub-categoriesThemes Motivators Medical process Positive Negative [EVALUATIONS] 138 After listing the domains (Figure 6), it is useful to start arranging the actual segments of text into the primary domains. This process groups actual phrases together and allows the sub-categories to emerge directly from the interviewees’ own words. Relationships between domains /themes This stage involves identifying relationships between the domains or topics to build up an overall picture. Within the collection of actual quotations from respondents, the researcher should identify statements that relate one topic to another. For example, in the study described above, researchers were able to establish associations between the domains that linked women’s previous experiences, risk perceptions and socioeconomic situation to their evaluations of health services. Figure 7. Relationship between domains (from Atkinson and AbuEl Haj, 1996) Coding schemes Following an initial analysis to gain an overall understanding of the main features of the data, many analysts apply a systematic coding procedure. The researchers determine the most appropriate way to conduct a systematic analysis, uncovering and documenting links between topics, themes and sub-themes (3). These codes are assigned to specific occurrences of words or phrases, highlighting patterns within the text while preserving their context, as in Table 8. 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 139 Table 8. Matrix of perceived cause and signs of malaria Focus group discussion Village A women Village A men Village B women Village B men Malsign Hot body Yellow eyes White lips Bloody stool Hot body Yellow Eyes Hot body White lips Yellow eyes Bloody Stool Hot body Yellow eyes White lips Malcause Mosquitoes Fresh mangoes Mosquitoes Standing in the heat Fresh mangoes Mosquitoes Standing in the heat Eating fresh mangoes Mosquitoes Reflection activity We have discussed the need for an analysis plan including various methods of and tools for analysing and presenting the data. • In your research team, discuss how you plan to analyse and present your data. • How will you ensure validity and reliability of your data? • What kind of analysis will you/your team undertake? • Will you be using any software for your data analysis? • Discuss the reasons for your decision to use (or not use) software for your analysis. • How will you present your data? ApplicAtion of key concepts The example below describes thematic analysis, presentation and interpretation of FGD data. Example: Njeru et al. 2011 (7) Practicing provider-initiated HIV testing in high prevalence settings: Consent concerns and missed preventive opportunities Background: A population-based survey was conducted among adults in the three study districts (Malindi, Mbarali & Kapiri Mposhi) in Kenya. Two HIV counselling models were compared: Model 1: Client-initiated HIV counselling and testing is commonly referred to as voluntary counselling and testing (VCT) and Model 2: Provider-initiated testing, in contrast to the client-initiated testing, is recommended by a health provider to people attending a health facility. In-depth interviews and focus group discussions were employed to explore informants’ experiences and perceptions of the HIV testing services with an emphasis on experiences with the provider- initiated testing model. The groups consisted of: female outpatients, male outpatients, pregnant women attending antenatal clinics and youths aged 18 to 24 years. Analysis was conducted through the use of a framework analysis. Data analysis for all data sets involved five main steps: familiarization, identification of a framework, indexing, charting and interpretation. Box 3 140 Below are some of the results presented as verbatim quotations from the respondents and the made by the researchers’ interpretation. Objective: to explore respondents’ perceptions and experiences with counselling during HIV testing Main theme: The value of counselling Sub Theme: The Preventative Aspect Opportunities for HIV prevention provided by counseling emerged as important issues in our interviews and discussions. • “The importance of counselling emerges when a person who has not been infected gets advice and follows it, because s/he will not get this disease.” (Female 26 years old, urban Malindi). “Counselling is very important because if you are counselled you get the courage or the strength to prevent being infected as you are told the way forward.”(Female youth, FGD, urban Malindi) • “As for me I was tested at the VCT. There they really counselled me on HIV and on how I can protect my life.” (Male adults, FGD, urban Malindi) Sub theme: The support dimension The need for counselling as an important dimension in supporting those already infected with HIV was a point that was brought up in both the IDIs and the FGDs across the three districts. Both male and female informants from the three countries expressed the view that sufficient post-test counselling has the potential to reduce worry, fear and blame as illustrated in the quotations below: • “Because if you have been made aware through counselling, even if you tested positive, there will be no fear, that’s why some people declare that they are HIV positive, they had seminars where they were counselled and that is why they have that courage. But if one discloses his status as positive here people will talk about him; some will even deny him drinking water because of fear”. (Male adults, FGD, Mbarali) Sub theme: The time dimension The need for sufficient time during counselling to clearly convey messages emerged as vital in the testing services. In order to fully conceptualise and understand the information presented more time was identified as needed before embarking on the testing. In this manner, so that one would be prepared to receive the test results whatever the outcome might be. • “When I say we need education, I mean we need counselling, we need counselling that is offered step by step until we are ready to test.” (Male adults, FGD, Mbarali) • “When you enter the facility and after the counselling you are immediately asked if you are ready for the test. No! That also can cause a lack of willingness to test. The counsellor should counsel me and tell me I have the right to go for testing. Therefore, if the time for counselling is increased, I see that as an improvement.” (Female adult, FGD, rural Malindi) 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 141 Major Theme: Challenges Experienced with the Imp lementation of the PITC Model in HIV Testing Sub theme: Threat to counselling • “During the second pregnancy we were not given a choice. It was a must to get tested on HIV and then (after that) on the pregnancy. We were not asked; you enter in the room for HIV testing and then you go for other tests. To tell you the truth, some there got quite scared that day when we were suddenly tested. People panicked a lot. So people were not happy, but it was a must that they do it.” (Female 35 years old, urban Malindi) • “It was said that according to the rules of the hospital if someone reaches the time of delivery and does not have HIV results she is not received.” (Female 35 years old, urban Malindi) • “If you refuse to test they don’t examine your stomach. So when it is time for delivery they don’t accept you.” (Female pregnant, FGD, Urban Malindi) Sub theme: HIV testing as mandatory In Malindi our informants reported that the HIV test within PMTCT was no longer voluntary. A common phrase that was used to describe the new testing model was “it is a must”, a point noted by both female and male respondents: • “I was not tested at a VCT centre, but at that place for women (ANC clinic). Because when you are pregnant, you are tested on many things, but first they must test you for AIDS.” (Female pregnant 40 years old, urban Malindi) • “Here let’s say women and men go for (HIV) testing, but a majority of them are women because the woman must be tested when she goes to the clinic.” (Male 34 years old, urban Malindi) Sub theme: The expressed burden on women • These counsellors should be many to help us because we are wives, and when you ask your husband to go to test himself he stays quiet refusing to talk. He tells you ‘you get tested, if you are found to be ok, I am also ok’. He does not go.” (Female pregnant, FGD, urban Malindi) • “You know also there are many incidents which have come up because you find that when a woman is heavy (pregnant) it’s like the husband forces the wife to go for testing, you see? If anything bad arises (meaning if she is HIV positive) he starts questioning the wife, and asks ‘where did it come from?” (Female pregnant, FGD, rural Malindi) 142 conclUsion Congratulations on completing Module 4 Data Analysis and Presentation. This module provided you with an outline of the basics of IR data analysis and interpretation. It also described the design of data analysis, and data presentation and interpretation for the target audience to enhance uptake of the findings. We hope that you have enjoyed this module and have increased your knowledge and understanding of data analysis and presentation. We encourage you to continue with Module 5 entitled, Communicating the findings and feeding them back into the health system. 4M ODULE IN TRO D U C TIO N /Q U IC K REFEREN C E 143 references 1. Walker, Neff, Jennifer Bryce, and Robert E. Black. “Interpreting health statistics for policymaking: the story behind the headlines.” The Lancet 369, no. 9565 (2007): 956-963. 2. Bradley, Elizabeth H., Leslie A. Curry, and Kelly J. Devers. “Qualitative data analysis for health services research: developing taxonomy, themes, and theory.” Health services research 42, no. 4 (2007): 1758-1772. 3. Miles, Matthew B., and A. Michael Huberman. “Qualitative data analysis: An expanded sourcebook. 1994.” Beverly Hills: Sage Publications (1994). 4. Lincoln, Yvonna S. “Guba, eG 1985: Naturalistic inquiry.” (8). 5. Greenhalgh, Trisha, and Rod Taylor. “Papers that go beyond numbers (qualitative research).” BMJ: British Medical Journal 315, no. 7110 (1997): 740. 6. Atkinson, Sarah, and Monica Abu el Hap. “Domain analysis for qualitative public health data.” Health Policy and Planning 11, no. 4 (1996): 438-442. 7. Njeru, Mercy K., Astrid Blystad, Elizabeth H. Shayo, Isaac K. Nyamongo, and Knut Fylkesnes. “Practicing provider-initiated HIV testing in high prevalence settings: consent concerns and missed preventive opportunities.” BMC health services research 11, no. 1 (2011): 87. Additional reading • Goldstein, Harvey, William Browne, and Jon Rasbash. “Multilevel modelling of medical data.” Statistics in medicine 21, no. 21 (2002): 3291-3315. • Patton, Michael Quinn. Qualitative research. John Wiley & Sons, Ltd, 2005. • Robson, Colin. Real world research: A resource for social scientists and practitioner- researchers. Vol. 2. Oxford: Blackwell, 2002.

5 modUle disseminAting the reseArch findings 146 introdUction The purpose of this module is to illustrate the key concepts of knowledge translation (KT) as relevant to implementation research (IR). It provides structured guidance on preparation of research reports, peer reviewed papers, press releases, conference presentations and policy briefs. Upon completion of this module, you will be able to: • Appreciate the value of continuous stakeholder engagement for dissemination and utilization of research results. • Appreciate the value of developing of a comprehensive dissemination strategy as an integral part of a research project. • Understand the importance of tailored dissemination tools for various target audiences. key concepts Knowledge translation KT techniques can help researchers become more active, context-aware, and collaborative in disseminating the results of research. Application of these techniques help make. research results more relevant to the target audience, and ultimately more useful. KT activities There are essentially two types of KT activities: end-of-grant and integrated knowledge translation (iKT). End-of-grant activities is often built into funding proposals (1). As the name suggests, such activities are typically conducted at the end of the knowledge creation process. They are focused on translating knowledge into effective communication tools and disseminating those to a particular audience. These include peer-reviewed papers, guidelines, conference presentations, press releases, radio spots, community dramas, and so on. These activities essentially present completed findings. Although end-of-grant KT activities can be conducted as part of IR, it is a limited (and relatively expensive) activity (2, 3). By its nature, it lags behind the research and findings may not be available in time to address the problem. Integrated KT approaches allow more innovation and are effective in providing timely solutions to implementation problems. This approach is a mixture of art and science, and in many ways illustrates the core features of IR itself. For example, it is multi-stakeholder and multidisciplinary, as well as dynamic and interactive (4). The integrated approach requires researchers and key knowledge end- users to collaborate and jointly conduct many of the essential steps, identify research questions; determine methodologies; conduct the research; interpret findings; disseminate and apply the findings – together. Because the findings reflect the needs of knowledge users, they have a much higher likelihood of being acknowledged and used. iKT also includes activities such as priority setting, development of policy briefs, facilitation of dialogues, and the development of knowledge translation platforms/rapid response services. Integrated approaches do not treat knowledge as something that can be generated, disseminated and then applied (as it is sometimes simplistically envisioned in end-of-grant KT). Rather, iKT views research knowledge – from its creation through to its application – as a collective, co-productive undertaking (5). It respects a two-way dynamic, in which research evidence is created, shaped and ultimately used by many different stakeholders. In some ways, this approach reverses the usual ‘authority’ of researchers, who no longer possess exclusive control of research evidence. In order to make research evidence more relevant and 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 147 responsive, iKT approaches involve practitioners, planners and programme managers (among others) in the process of identifying, designing and conducting research. This uniquely positions research as a tailored, context-sensitive input responding to user needs and demands. Example: IR evidence uptake and use for policy-making This project addressed scaling up of zinc for young children (SUZY) in Bangladesh. The integrated KT approaches aided policy-makers to integrate IR outcomes into making decisions on the treatment of childhood diarrhoea. Various stakeholders were involved throughout the entire project cycle. Collaboration between policy- makers and researchers facilitated the sharing of tacit knowledge, policy positions and the setting of common priorities and goals. Whereas some stakeholders had not been considered during the conceptualization of the project, they were brought on board later to expedite the scale-up process. The other lesson from the collaborative approach was the adoption of best delivery methods. For example, the use of existing community health systems [i.e. community health workers whose primary focus was family planning] was initially contemplated as a channel to scale up the intervention. However, this was discontinued when they realized it would not be feasible (an additional task for the community health workers). Zinc products were available over-the-counter, and could be administered easily, physicians (especially paediatricians) were identified as key players in promoting and prescribing it. The outcome of these findings enabled the project to embark on training within medical colleges and of public health physicians at the district and sub-district levels. Some 8000 village doctors acted as trainers for more than 200 000 informal providers. Research conclusions: • In order to effectively implement evidence-informed policy, policy-makers and researchers should learn together and work in partnership to improve access and delivery. • Steps should be taken to increase the demand for research use and KT through sustainable partnerships and mechanisms, including KT platforms (at the district, provincial and national levels), which promote the early involvement of policy-makers, managers, health care providers and patients, and serve as the basis for capacity-strengthening activities. Source: (6) Barriers and facilitators to uptake of research evidence There are various barriers and facilitators to the uptake of research evidence. Many users of research evidence (e.g. programme managers and implementers) operate in an environment with unique pressures and imperatives. Their timelines for action can be very short, and their expertise in applying or balancing different inputs to solve problems may be limited. Barriers to research evidence uptake 1. Perception of research evidence by practitioners: How do practitioners balance evidence with other competing influences? (7). This can include practitioners lacking a clear idea of where to access relevant, tailored information to suit their needs, how to distinguish quality of evidence sources, and how to ultimately use it (8). After all, “evidence speaks with many voices,” and any one piece of evidence might have multiple different (and even contradictory) implications (9). Findings may also be ambiguous and lack precise estimates of intended effects (10). 2. Organizational culture. How does an organization make decisions? How does information flow within an organization? What are its abilities to interact with research evidence? (11, 12). ‘Groupthink’ or ‘how we do things around here’ can also slow or distort the use of research evidence. The prevailing administrative context may also shield programme managers, Box 1 148 implementers or technical officers from a researchers’ advocacy, and they may feel no accountability to the research community (8). 3. The low skills (especially research or evidence-appraisal skills) among practitioners, either to assess research evidence or to balance it against competing sources of influence (8). 4. The perceived cost and timelines of research. Given the short time horizons that many practitioners have to make decisions, research could be considered too expensive, too time- consuming or too much of a luxury to have real practical value (13). 5. Information overload. Practitioners, programme managers and implementers may become overwhelmed by the sheer number of information sources; or become persuaded by other influences (e.g. lobbyists or other interest groups who have financial resources, abilities, and/or insider knowledge on advancing a particular agenda) (10). Facilitators of research evidence uptake Facilitators leading to wider adoption of the research evidence may include: 1. Researchers reframing practice issues to align with the existing evidence base (8). Framing the problem is an essential step in many KT activities (e.g. a policy brief) and can bring together many different types of evidence to respond to a particular practice or implementation need. 2. Strengthening the capacity of practitioners to: demand research evidence that responds to and supports their needs; and to access, assess, adapt and apply research evidence in their daily work (14). 3. Researchers collaborating with practitioners to generate essential information, to encourage active sharing, and identify pressing priorities (8). 4. Creating targeted messaging (e.g. policy briefs, press releases) emphasizing the role that research evidence can play in contributing to better programmes or improved interventions (12, 15). Research evidence can be communicated more effectively by turning them into compelling stories. For example, by contrasting ‘the costs of action versus those of inaction’ the likelihood of evidence influencing decision-making may be much higher (10). 5. Researchers pursuing personal contact with practitioners and developing trust (16). Trust built from personal relationships can be a vital ingredient connecting the worlds of research and practice. 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 149 Example: Research translation to inform national health policies. Learning from multiple perspectives in Uganda Background: Research and evidence can have an impact on policy and practice, resulting in positive outcomes. However, research translation is a complex, dynamic and non-linear process. Although universities in Africa play a major role in generating research evidence, their strategic approaches to influence health policies and decision- making are generally weak. This study was conducted with the aim of understanding the process of translating research into policy in order to guide the strategic direction of Makerere University College of Health Sciences (MakCHS) and similar institutions in their quest to influence health outcomes nationally and globally. Methods: A case study approach using 30 in-depth interviews with stakeholders involved in two HIV prevention research projects was purposively selected. The study sought to analyse the research-to- policy discourses for the prevention of mother-to- child transmission (PMTCT) of HIV. The analysis sought to identify entry points, strengths and challenges by interviewing three major groups of stakeholders in Uganda: researchers (8), policy-makers (12) and media practitioners (12). Results: Among the factors that facilitated PMTCT policy uptake and continued implementation were: Shared platforms for learning and decision-making among stakeholders; implementation pilots to assess feasibility of the intervention; the emergence of agencies to undertake operations research; and the high visibility of policy benefits to child survival. Implication: For effective uptake of IR findings, all stakeholders should be involved throughout the entire process of the research project in order to enhance the learning and decision-making processes among various stakeholders. Source: (17). Reflection activity Taking a cue from the Uganda example above, reflect on a health programme you are familiar with in your country. Is there a policy underpinning this programme? What research evidence was used to formulate this policy? Dissemination tools Various dissemination tools are available to research teams pursuing the uptake of research findings. All these tools should be considered less as individual pieces and more as parts of a whole. The various tools should be used in concert within a larger plan that together produces a complete effective dissemination package. Each tool has different strengths and weaknesses in reaching audiences and therefore by using more than one, the tools complement one another to produce a strong dissemination plan. In many cases, the work that goes in the development of one tool can be replicated or modified into the development of another. Increasing the number of ways that research findings reach key audiences increases the chances of uptake and action. The dissemination tools considered in this module will include, research reports, peer review papers, press releases, and policy briefs. Research reports At the conclusion of any IR project, funders expect reports from the grantees. The content of the research report depends on the funder and their specific requirements. A review of the initial Box 2 150 grant agreement is therefore the obvious place to start when deciding on the structure and content of the report. If the funder has provided a report template with sections that need to be followed, then the exercise of writing a research report is relatively straightforward. The following sections are typical of many research reports, and peer-reviewed papers: title; list of authors and institutional affiliations; acknowledgement; abstract; executive summary; introduction; literature review; research design/methodology; results; discussion; conclusions; and references. However it is essential to follow guidelines from respective funders and/or journal publishers/editors. Other uses of research reports One key question to have in mind throughout the process of writing the report is: What other ways can we use or present this information? A research report can be the source of information and insights for various kinds of additional products. The tables and charts can become the major visuals of a conference presentation. The executive summary can contribute to a page of take- home messages, to a press release, or suggest the argument of a policy brief. And most of all, the research report can be a template for peer-reviewed papers, a way of ordering thought and simplifying very complex processes into phrases suited for digestion by the wider research community. Many parts of the report can be lifted, often with only moderate adjustments, straight into a peer-reviewed paper. Peer-reviewed papers For many researchers, publication in a peer-reviewed journal is a peak achievement. It signals acceptance of the work within the community, a visible contribution to the field and a reward for many years of work. Although publication is extremely important, it is by no means the end of the implementation research process. Instead, the publication should be considered as the beginning of a new cycle of achieving influence. The big limitations of peer- reviewed publications, is that key audiences (for instance, practitioners and programme implementers) tend not to read them extensively if at all. Although the structure of a peer-reviewed paper can be very similar to a report, itsaudience differ. Every journal has specific requirements and formats for submitted articles, a preferred style (e.g. length of abstracts, reference style, etc.), and particular guidelines to be followed by all authors. Therefore, before writing a paper, the logical first step is to identify the intended journal. Browsing back issues (most make some content available online) to see the types of articles to published is a useful place to begin. Choose a journal that routinely publishes content related to your study and follow the instructions for authors closely. Journals that accept IR research include: Health Policy and Planning; Tropical Medicine and International Health; Social Science and Medicine; Human Resources for Health; Global Public Health; Community Health Education; and The Bulletin of the World Health Organization. Publication in an “Open Access” journal (i.e. a journal that permits unrestricted access and reuse of the published article) is encouraged by many funders of research. Upon selecting a journal, locate the submission guidelines on the journal web site. Examples of abstracts for peer-reviewed papers Example 1: Intensified tuberculosis case finding among people living with the human immunodeficiency virus in a hospital clinic in Ethiopia. Assefa et al., International Journal of Tuberculosis and Lung Disease. 2011 Mar;15 (3):411–3. 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 151 Abstract Intensified tuberculosis case finding (ICF) is used in people living with the human immunodeficiency virus (PLHIV) to reduce the burden of tuberculosis (TB). We conducted a retrospective study in 300 PLHIV attending an HIV care clinic in Ethiopia to assess ICF performance during a 12-month period. Between 80% and 95% of patients were screened for TB at enrolment and at each 3-month follow-up visit. Thirty-four (11%) patients were diagnosed with TB, of whom 27 (79%) were identified in the first 6 months. This study assessed serial ICF in routine settings, showing that TB screening had its largest diagnostic yield in the first 6 months. Example 2: Identification of losses to follow-up in a community-based antiretroviral therapy clinic in South Africa using a computerized pharmacy tracking system. Nglazi et al., BMC Infectious Diseases. 2010 Nov 15;10:329. Abstract Background: High rates of loss to follow-up (LTFU) are undermining rapidly expanding antiretroviral treatment (ART) services in sub-Saharan Africa. The intelligent dispensing of ART (iDART) is an open-source electronic pharmacy system that provides an efficient means of generating lists of patients who have failed to pick-up medication. We determined the duration of pharmacy delay that optimally identified true LTFU. Methods: We conducted a retrospective cross-sectional study of a community-based ART cohort in Cape Town, South Africa. We used iDART to identify groups of patients known to be still enrolled in the cohort on the 1st of April 2008 that had failed to pick-up medication for periods of ≥ 6, ≥ 12, ≥ 18 and ≥ 24 weeks. We defined true LTFU as confirmed failure to pick up medication for three months (since last attendance). We then assessed short-term and long-term outcomes using a prospectively maintained database and patient records. Results: On the date of the survey, 2548 patients were registered as receiving ART but of these 85 patients (3.3%) were found to be true LTFU. The numbers of individuals (proportion of the cohort) identified by iDART as having failed to collect medication for periods of ≥ 6, ≥ 12, ≥ 18 and ≥ 24 weeks were 560 (22%), 194 (8%), 117 (5%) and 80 (3%), respectively. The sensitivities of these pharmacy delays for detecting true LTFU were 100%, 100%, 62.4% and 47.1%, respectively. The corresponding specificities were 80.7%, 95.6%, 97.4% and 98.4%. Thus, the optimal delay was ≥ 12 weeks since last attendance at this clinic (equivalent to eight weeks since medication ran out). Pharmacy delays were also found to be significantly associated with LTFU and death one year later. Conclusions: The iDART electronic pharmacy system can be used to detect patients potentially LTFU and who require recall. Using a short a cut-off period was too non-specific for LTFU and would require the tracing of very large numbers of patients. Conversely prolonged delays were too insensitive. Of the periods assessed, a ≥ 12 weeks delay appeared optimal. This system requires prospective evaluation to further refine its utility. Press release The media is a crucial audience for research findings because it is both a target for and disseminator of research evidence. The media can reach stakeholders that research teams cannot. They can popularize findings, press governments for change, and highlight inequities or programmes that are not working. However, researchers must be aware that the media can be sensational with bold headlines, while the actual reporting may lack important facts. For these reasons, one of the best 152 ways to reach media organizations is through a press release. This is similar in many regards to a sheet of take-home messages, but a press release has its own style and structure which should be followed. In general, press releases are: • No longer than one page. It may feature a photograph and/or logo of the research institution; other than this it comprise text. • Topped by a strong and informative headline. Newspapers, depend upon a catchy ‘hook’ (the title) to convince people to read their articles, and a press release is no different. This is no simple task – to use ten words or less to capture the essence of a research project is very challenging. For a non-specialist audience you can focus on the most compelling/shocking and/or fascinating aspect of the project. Brainstorming on this might help to find the ten words that really capture what the project is about and why people should care about the results/ conclusions. • Summarized in several lines – justifying why the research findings deserve publication (dissemination /sharing). A small photograph or graphic may be helpful in reducing complexity to a simple but powerful image. Have a two-paragraph body that answers the who, what, where, why and how questions for a lay audience. The media typically structures its articles to begin with the most important information and end with the least important. End with a section containing more information about the research institution or principal investigator. Also include contact information so that the newspaper or journalist can follow up if need be. Example: Yellow fever vaccination booster not needed News release 17 May 2013 | Geneva – The yellow fever ‘booster’ vaccination given ten years after the initial vaccination is no longer necessary, according to WHO. An article published in WHO’s Weekly Epidemiological Record (WER) reveals that the organization’s Strategic Advisory Group of Experts (SAGE) on Immunization has reviewed the latest evidence and concluded that a single dose of vaccination is sufficient to confer life-long immunity against yellow fever disease. Since yellow fever vaccination began in the 1930s, only 12 known cases of yellow fever post-vaccination have been identified, after 600 million doses have been dispensed. Evidence showed that among this small number of ‘vaccine failures’, all cases developed the disease within five years of vaccination. This demonstrates that immunity does not decrease with time. Important news for yellow fever endemic countries and travellers “The conventional guidance has been that the yellow fever vaccination has had to be boosted after ten years,” says Dr Helen Rees, chair of the SAGE. “Looking at really very good evidence, it was quite clear to SAGE that in fact a single dose of yellow fever vaccine is effective. This is extremely important for countries where yellow fever is endemic, because it will allow them to reconsider their vaccine scheduling. It is also important for travellers.” Yellow fever is an acute viral haemorrhagic disease transmitted by infected mosquitoes that is endemic to 44 countries in tropical areas of Africa and the Americas. Infection with the yellow fever virus causes varying degrees of disease, from mild symptoms to severe illness with bleeding, jaundice and fatal outcomes. Box 3 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 153 Estimated 200 000 new cases each year There are an estimated 200 000 cases of yellow fever worldwide each year. About 15% of people infected with yellow fever progress to a severe form of the illness, and up to half of those will die, as there is no cure for yellow fever. Treatments are aimed simply at reducing patients’ discomfort. The vast majority of reported cases and deaths occur in sub-Saharan Africa. In endemic regions of Africa, yellow fever natural immunity is acquired with age, putting children at highest risk of infection. Over the past two decades, the number of yellow fever cases worldwide has increased due to declining population immunity to infection, deforestation, urbanization, population movement and climate change. Vaccination is the most effective measure Vaccination is considered to be the most important and effective measure against yellow fever. Protective immunity develops within 30 days for 99% of people receiving the vaccination. For routine immunization programmes in Africa, home to 31 of the 44 yellow fever-endemic countries, the vaccine costs about $0.82 per dose. SAGE is the principal advisory group to WHO for vaccines and immunization. It is charged with advising WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunization and its linkages with other health interventions. SAGE is concerned with all vaccine-preventable diseases including childhood vaccines and immunization. For more information please contact: Communications Officer/spokesperson Telephone: +41 22 791 mail: @who.int Policy brief Policy briefs are short documents that present the findings and recommendations of a research project to a non-specialized audience. It is a stand-alone document, focused on a single topic and no more than 2–4 pages (~1500 words). Jones and Walsh (18) have observed that: “Policy briefs, if carefully designed, can be a powerful tool for communicating research findings to development policy audiences.” Because policy-makers are constrained by time and overwhelmed by various sources of information, they are likely to make quick decision by selecting the ‘evidence’ most appropriate to their political leanings. Furthermore, in practice, research evidence is considered through the lens of policy-makers’ experience, expertise and judgment, contextual pragmatics, available resources and the policy context, as well as the habits, values and traditions of policy-makers, and the influence of lobbyists and pressure groups. Increasing the usage of evidence in policy-making therefore requires a communication approach that is informed by an understanding of and engagement with these competing influences. Key ingredients of effective policy briefs (19) To effectively serve its intended purpose a policy brief should be (19): 1. Focused on achieving the intended goal of convincing the target audience. 2. Professional (i.e. not academic). The typical audience for a policy brief is not interested in the research/analysis procedures conducted to generate the evidence, but rather the writer’s perspective on the problem and potential solutions based on the new evidence. 3. Evidence-based. The policy brief is a communication tool. The audiences not only expect a rational argument but will only be convinced by arguments supported by evidence that the problem exists and the consequences of (or not) adopting a particular course of action. 154 4. Limited to a particular problem or specific aspect of a given problem. 5. Concise. Typical audiences often do not have the time or inclination to read an in-depth, 20-page argument on a policy problem. Therefore, it is expedient that policy briefs do not exceed a maximum of 6–8 pages. 6. Understandable. Use clear and simple language (i.e. not jargon and concepts of an academic discipline). 7. Accessible to the intended target audience. 8. Promotional. i.e. should catch the eye of the intended audience through use of colour, logos, photographs, slogans and illustrative quotes. 9. Practical and feasible. It must provide arguments based on what is actually happening in practice with a particular policy and propose recommendations that are realistic and feasible to the target audience. Common structural elements of a policy brief Policy briefs directly reflect the range of roles that policy analysts fill (from researcher to advocate). The IR projects that policy briefs typically focus on are from the more action-oriented, advocacy end of the continuum. Although there is much variation even at this end of the scale, the most common elements of policy briefs are: title of the document; executive summary; context and importance of the problem; critique of policy option(s); policy recommendations; appendices and sources consulted or recommended. Example: Policy brief on support for scaling up ACTs in treatment of simple P. falciparum malaria in Burkina Faso Policy issues The resistance of P. falciparum to conventional antimalarial drugs is well attested by a number of studies throughout the world, including in Burkina Faso. The efficacy of artemisinin-combination therapies (ACTs) has also been proven in various studies and the large-scale use of ACT is recommended by WHO. Like other countries, Burkina Faso opted to change its drugs strategy for treatment of simple malaria by substituting ACT for chloroquine treatment in February 2005. At the time of writing, this scaling up of ACTs has not been applied to all age groups. Scale of the problem Malaria is a major public health problem in Burkina Faso, with more than 2 million recorded cases and over 4000 deaths every year, especially among children under 5 years of age. The majority of medical consultations, hospital admissions and deaths are malaria-related. Proper management of malaria requires the use of effective treatment. However, the socioeconomic status of the population, limited public resources and poor health service infrastructure prohibit large parts of the population from accessing this life-saving treatment. Policy options Given this situation, there is an urgent need for policies to improve universal and equitable access to ACTs for treatment of non-complicated malaria. These policy options are: • Urge private-sector stakeholders (pharmacies, clinics and surgeries) to comply with national directives on subsidized pricing of ACTs. • Motivate community health workers responsible for home-based management of simple malaria. • Withdraw the antimalarial drugs used in monotherapy to treat simple malaria. Box 4 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 155 Implementation considerations To implement any of these three policy options, it is essential to: • Provide information/raise awareness of the principal malaria control stakeholders. • Ensure that ACTs adapted to each age group are available countrywide. • Train the staff tasked with dispensing ACTs. • Review certain regulatory arrangements relating to policy implementation. Source: Personal communication, EVIPNet Team in Burkina Faso. Using multiple dissemination platforms IR involves researchers and multiple stakeholders with different capabilities and access to different dissemination platforms or channels. The nature and implications of your findings may suggest a particular channel. For example, if the major audience of a study is a group of patients in a rural clinic, then creating a community drama may be an effective channel, as might printing up a very simple brochure for patients awaiting care, or the use of colorful cartoon/animations for young children. The Internet also offers various platforms to disseminate your team’s work, such as social media platforms or blogs. Dissemination strategy Developing a dissemination strategy The dissemination process must be part of the IR project cycle. Involving stakeholders in the dissemination process early will enhance greater ownership of the research process and the ultimate uptake of the research findings. Specific steps are recommended for research teams as they discuss and identify their dissemination strategies and related needs. This is intended as generic guidance that can be modified and customized for specific projects. The end result should be a context-sensitive strategy designed to disseminate particular research findings to specific audiences. The overall approach The research team could be tempted to focus on the creation of particular information products. For example, there have been instances where a research project has created videos featuring a visual component to the research and feature interviews with the researchers and other major stakeholders. However, single one-way products do not constitute a dissemination strategy. Strong dissemination strategies feature: two-way dialogues (not just from the stakeholders/ researchers to an audience, but also feedback and responses from the audience); precisely tailored and targeted messages suited to particular audiences; and mechanisms to evaluate relevant indicators, so that the strategy and its products can be revised and improved. 156 Steps in developing a dissemination strategy The figure below highlights nine separate steps research teams should consider in developing a dissemination strategy. Step 1: Review past dissemination efforts When developing a dissemination strategy, it is prudent to begin by looking at what was done in the past. How did the research team disseminate information in the past? What products were created? Which ones worked? How did particular audiences respond? This can be done as an internal brainstorming exercise, review of relevant documents, or as a survey (formal or informal) with stakeholders who received the team’s communications in the past. Alternatively, a formal audit of previous dissemination efforts (often conducted by a third party) can assess performance and, more importantly, gauge perceptions that key stakeholders have of the team’s research, and of the climate surrounding the research. This type of information can significantly influence the selection of future tools and dissemination channels. Step 2: Devising dissemination objectives The research team should brainstorm around what it hopes to achieve by disseminating IR results. Why does the team wish to communicate processes or findings to particular audiences? Is the purpose of the dissemination to increase awareness, understanding, action, or to support local involvement? Below are examples of dissemination objectives for a youth HIV prevention campaign: Example: By the end of 2013, the project will provide the youth with information on: • HIV prevention strategies • The life skills to prevent/mitigate HIV infection 1. Review past dissemination efforts 2. Devise dissemination objectives 3. Determine audiences 4. Develop messages 5. Decide on dissemination approaches 6. Determine dissemination channels 7. Review available resources 8. Consider timing and windows of opportunity 9. Evaluate efforts Figure 1. Steps in developing a dissemination strategy Box 5 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 157 Step 3: Determining primary and secondary audiences Determining the primary and secondary audiences for the information being disseminated is a critical aspect of the dissemination strategy. The research team must understand who the audience is, how they absorb research evidence, their timelines, needs, etc. This will greatly increase the likelihood that the dissemination approach will meet its objectives. Every IR project has multiple audiences with unique abilities and needs. Messages must be appropriately tailored taking these into consideration. One tested way to ensure your team addresses the needs of all stakeholders in the dissemination process is to classify them into primary and secondary audiences. Primary audiences are those who need to make a decision or a change. Secondary audiences are those in a position to influence the decisions or actions of the primary audience. The level of audience (primary or secondary) is determined by the dissemination objectives. Example: In an intervention to perform safe male circumcisions for HIV prevention, where you are aiming to persuade the men to come for circumcision, the primary audiences are men who are at risk of HIV infection in relation to safe male circumcision (e.g. the uncircumcised men and sexually active circumcised men). Secondary audiences would include health workers, opinion leaders, caretakers of uncircumcised boys and female sexual partners. Each audience requires its own targeted communication strategy. However, in the same intervention, if the objective of the dissemination is rather to seek support of the policy-makers to incorporate circumcision policies into existing national health policy, then the ministry of health officials and legislatures, plus other opinion leaders, would be the primary audience. Step 4: Developing messages Messages are at the heart of any dissemination product. Messages should be direct, simple, and explain the problem the research sets out to address. In addition, the solution the research may have generated, the particular implications of the research findings, and/or what might be expected of different audiences as a consequence of those findings should be captured in the message. IR projects often result in three to five key messages. While of course this does not represent the research in its totality, these messages can convey the essence of the research and its implications in a few concise words and phrases. Messages should be written exclusively for one audience, bearing in mind the audience’s needs and abilities with respect to the research evidence. A member of this audience should be able to read (or watch or listen to) those key messages in two minutes or less. Step 5: Deciding on dissemination approaches One way of choosing dissemination approaches is by initiating several stages of ‘conversation’ with a specific audience. The CHSRF’s ‘graded-entry’ approach (14) offers one such idea. As an initial outcome of this approach, the research team develops a short document (i.e. 1 page or less) for a major audience. The document should focus exclusively on the most important findings for that audience and their major implications. Assuming the audience’s positive reaction, a more detailed 3-page document could then follow, providing more detail about the research project itself, and positioning the implications against the context and other scientific evidence, etc. This could then be followed by a 25 page document (and/or a peer-reviewed paper) that explains technical matters such as the methodology. Box 6 158 Step 6: Determining dissemination channels No matter how good the dissemination product, it will have very little impact if it is not disseminated via the most relevant channels. For example, a beautifully produced DVD with videos and photographs that capture the magnitude of a research project impact is useless if members of the intended audience do not have DVD players or even reliable electricity supply. Relying on the Internet as a channel for dissemination obviously assumes user connectivity, access to certain minimum bandwidth and sufficient skills to be able to find and use the research team’s work. The consideration of appropriate channels is an essential step as it helps to narrow down, in very realistic ways, the types of communications tools that are practical, reach the right audiences and within the available budgets. Above any other consideration, the choice of channel(s) dictates who receives (and therefore who might act upon) messages. Step 7: Reviewing available resources It is important to consider the resources available for the dissemination activities. What materials are available for this work? Who can do it and what kinds of skills do they have? How much funding is available to create and implement this strategy? Will any of these variables change as we implement the strategy? One reason why research teams tend not to be adept at sharing their findings is because dissemination can be expensive to carry out. Some forms of dissemination require significant resources as well as a high level of capacity. Communication products can also carry hidden costs, such as translation of materials into multiple languages, or costs for specialized skills such as graphic design, etc. The more realistic and precise the team can be about all of these costs the more realistic the expectations for this work will be. This is best achieved by drawing up detailed budgets for each product from the outset. Step 8: Considering timing and windows of opportunity A timeline for developing and disseminating information/communication products may be obvious but worth reiterating. There may be, for instance, an upcoming conference or other event at which the research team can distribute several different communication products, deliver a plenary presentation, and/or arrange some face-to-face meetings. Given some of these suggestions for a staged approach, the research team must pay attention to issues of timing. This involves being aware of shifts within an audience (suggesting greater receptivity to your team’s work), windows of strategic opportunity that might suddenly open to which your team must respond quickly, and the activities of like-minded researchers and institutions, whose actions may help in advancing your team’s agenda. Step 9: Evaluating dissemination efforts As with all aspects of the IR process, dissemination of results and implications also requires careful evaluation and feedback. Dissemination should be carefully planned so that the intended audience(s) are reached. During implementation, adjustments may be needed to ensure a maximum return on investment and attention. One question that can usefully guide the entire approach to dissemination is: What will change if communications are completely successful? You don’t just want to get your findings into the public domain, you want specific audiences to receive them and act upon them. What kind of action then, among key audiences, equates with success? 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 159 Assessing budgetary implications is also important. Recognizing the effort that goes into successful dissemination, you need to be clear that you have used the right tools, struck the right balance among available tools, and received sufficient user feedback. This can be collected via some formal surveying and key informant interviews, and be invaluable of planning future strategies. An ‘impact log’ (20) can be another way to accumulate feedback on your communications strategies. Usually done informally, an impact log documents stakeholder reactions , media references, peer review references, etc.; media references to the work; peer-review references, etc. The research team can then synthesize all of this information into a lessons learnt or best-practice document. In some cases, the feedback may immediately shift or alter some of the products to ensure they reach the right audiences with the right messages. Reflection Activity Below is an example of a dissemination strategy. Use this example and the template provided to guide your team in developing a first draft of your dissemination plan. 160 Dissemination channels/tools Target audiences Project X’s dissemination strategy Dissemination objectives Providing general information Announcing news Informing ethical bodies Improving communication between different stake holders Improving collaboration between different multi site study teams Technical issues Societal issues Ethical issues Personnel/organizational issues Dissemination content • Community meetings • Interpersonal communication • Local events • Web sites • Email messages • Project team conference/meetings • Policy briefs • Dissemination workshops • Technical reports • Scientific seminars • Mass media • Scientific publication • Community • Implementing team • Policy-makers/MoH officials • Research community • Ethical review committees 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 161 Dissemination channels/tools Target audiences Project X’s dissemination strategy Dissemination objectives Dissemination content conclUsion Congratulations on completing Module 5 Dissemination of Research Findings. This module illustrates the key concepts of knowledge translation that relate to IR. This module also described the value of continuous stakeholder engagement for discussion and utilization of research results, the value of developing of a comprehensive dissemination strategy in a research project, and the importance of tailored dissemination tools for the different target audiences. We hope that you found enjoyed this module helpful and have increased your knowledge and understanding of dissemination of results and research findings. We encourage you to continue with Module 6 entitled, Monitoring and evaluation. 162 references 1. Graham, Ian D., Jo Logan, Margaret B. Harrison, Sharon E. Straus, Jacqueline Tetroe, Wenda Caswell, and Nicole Robinson. “Lost in knowledge translation: time for a map?.” Journal of continuing education in the health professions 26, no. 1 (2006): 13-24. 2. Bero, Lisa A., Roberto Grilli, Jeremy M. Grimshaw, Emma Harvey, Andrew D. Oxman, and Mary Ann Thomson. “Getting research findings into practice: closing the gap between research and practice: an overview of systematic reviews of interventions to promote the implementation of research findings.” BMJ: British Medical Journal 317, no. 7156 (1998): 465. 3. McGrath, Patrick J., Patricia Lingley-Pottie, Debbie Johnson Emberly, Cathy Thurston, and Cathy McLean. “Integrated knowledge translation in mental health: family help as an example.” Journal of the Canadian Academy of Child and Adolescent Psychiatry 18, no. 1 (2009): 30. 4. Lapaige, Véronique. ““Integrated knowledge translation” for globally oriented public health practitioners and scientists: Framing together a sustainable transfrontier knowledge translation vision.” Journal of multidisciplinary healthcare 3 (2010): 33. 5. Lomas, Jonathan. “Using research to inform healthcare managers’ and policy makers’ questions: from summative to interpretive synthesis.” Healthcare Policy 1, no. 1 (2005): 55-71. 6. Panisset, Ulysses, Tracey Pérez Koehlmoos, Ahmad Hamdi Alkhatib, Tomás Pantoja, Prabal Singh, Jane Kengey-Kayondo, and Ben McCutchen. “Implementation research evidence uptake and use for policy-making.” Health Res Policy Syst 10 (2012): 20. 7. Orton, Lois, Ffion Lloyd-Williams, David Taylor-Robinson, Martin O’Flaherty, and Simon Capewell. “The use of research evidence in public health decision making processes: systematic review.” PLoS One 6, no. 7 (2011): e21704. 8. Jewell, Christopher J., and Lisa A. Bero. ““Developing Good Taste in Evidence”: Facilitators of and Hindrances to Evidence Informed Health Policymaking in State Government.” Milbank Quarterly 86, no. 2 (2008): 177-208. 9. Klein, Rudolf. “Evidence and policy: interpreting the Delphic oracle.” Journal of the Royal Society of Medicine 96, no. 9 (2003): 429-431. 10. Brownson, Ross C., Charles Royer, Reid Ewing, and Timothy D. McBride. “Researchers and policymakers: travelers in parallel universes.” American journal of preventive medicine 30, no. 2 (2006): 164-172. 11. Bowen, Shelley, and Anthony B. Zwi. “Pathways to “evidence-informed” policy and practice: a framework for action.” PLoS medicine 2, no. 7 (2005): e166. 12. Dobbins, Maureen, Steven E. Hanna, Donna Ciliska, Steve Manske, Roy Cameron, Shawna L. Mercer, Linda O’Mara, Kara DeCorby, and Paula Robeson. “A randomized controlled trial evaluating the impact of knowledge translation and exchange strategies.” Implement Sci 4, no. 1 (2009): 61. 13. Kothari, Anita R., Julia J. Bickford, Nancy Edwards, Maureen J. Dobbins, and Mechthild Meyer. “Uncovering tacit knowledge: A pilot study to broaden the concept of knowledge in knowledge translation.” BMC health services research 11, no. 1 (2011): 198. 14. Dobbins, Maureen, Helen Thomas, Mary Ann O’Brien, and Melissa Duggan. “Use of systematic reviews in the development of new provincial public health policies in Ontario.” International journal of technology assessment in health care 20, no. 04 (2004): 399-404. 5M ODULE D IS SEM IN ATIO N O F RESEA RC H FIN D IN G S 163 15. Innvær, Simon, Gunn Vist, Mari Trommald, and Andrew Oxman. “Health policy-makers’ perceptions of their use of evidence: a systematic review.” Journal of Health Services Research & Policy 7, no. 4 (2002): 239-244. 16. Ssengooba, Freddie, Lynn Atuyambe, Suzanne N. Kiwanuka, Prasanthi Puvanachandra, Nancy Glass, and Adnan A. Hyder. “Research translation to inform national health policies: learning from multiple perspectives in Uganda.” BMC international health and human rights 11, no. Suppl 1 (2011): S13. 17. Jones, Nicola, and Cora Walsh. Policy briefs as a communication tool for development research. Overseas development institute (ODI), 2008. 18. Young E. and Quinn L. Writing Effective Public Policy Papers: Guide for Policy Advisers in Central and Eastern Europe. Budapest, Local Government and Public Service Reform Initiative; 2002. 19. Hovland, Ingie. Making a Difference: M&E of Policy Research, London, Overseas Development Institute (ODI). working paper 281, 2007. Additional reading • Assefa, D., Z. Melaku, T. Gadissa, A. Negash, S. G. Hinderaker, and A. D. Harries. “Intensified tuberculosis case finding among people living with the human immunodeficiency virus in a hospital clinic in Ethiopia [Notes from the field].” The International Journal of Tuberculosis and Lung Disease 15, no. 3 (2011): 411-413. • Is Research Working for You? Hamilton: National Collaborating Centre for Methods and Tools; (2009). (http://www.nccmt.ca/registry/view/eng/35.html, accessed 5 February 2014). • Nglazi, Mweete D., Richard Kaplan, Robin Wood, Linda-Gail Bekker, and Stephen D. Lawn. “Identification of losses to follow-up in a community-based antiretroviral therapy clinic in South Africa using a computerized pharmacy tracking system.” BMC infectious diseases 10, no. 1 (2010): 329. • Schober, Jane E., Andy Farrington, and Anne Lacey. Presenting and disseminating research. NHS Executive, Trent, 1998. • Bennett, Gavin, and Nasreen Jessani, eds. The knowledge translation toolkit: Bridging the know-do gap: A resource for researchers. IDRC, 2011. • Implementation research for the control of infectious diseases of poverty: Strengthening the evidence base for the access and delivery of new and improved tools, strategies and interventions. Geneva: Special Programme for Research and Training in Tropical Diseases; 2011. (http://www.who.int/tdr/publications/tdr-research- publications/access_report/en/index. html, accessed 5 February 2014). • Datta, Ajoy, and Arnaldo Pellini. “Communicating Research.” (2011)

6 modUle monitoring And evAlUAting An implementAtion reseArch project introdUction This module has been designed to help your research team track progress against your set plans, check compliance to established standards, identify trends and patterns, adapt strategies and inform decisions for project management. The module is also designed to build skills to determine the relevance and fulfilment of objectives, developmental efficiency, effectiveness, impact and sustainability. It covers the following key concepts with examples: • Monitoring and evaluation (M&E) plan • Developing an M&E plan • Implementing the M&E plan leArning objectives Upon completion of this module, your research team will be able to: 1. Appreciate the process involved in the development of a monitoring and evaluation plan. 2. Describe the implementation process of a monitoring and evaluation plan. key concepts Monitoring and evaluation plan A monitoring and evaluation (M&E) plan is a document that outlines how an implementation research project is monitored and evaluated, and that links strategic information obtained from various data collection systems to decisions about how to improve the project on an ongoing basis. The M&E plan serves several main purposes, including: (i) stating how achievements of the programme/project will be measured; (ii) documenting consensus, thereby encouraging transparency, accountability and responsibility; (iii) guiding implementation of M&E; and (iv) preserving institutional memory. An M&E plan is built on the key parameters of a project, which include the: • overall goal or desired change or effect; • main beneficiaries or audience of the project; • hypotheses or assumptions that link the project objectives to specific interventions or activities; • project scope and size; • extent of participation in and capacity for M&E; • project duration; and • overall project budget. Each project has different M&E needs, depending on the operating context, implementing agency capacity, donor requirements, and other factors. In preparing an M&E plan, it is important to identify these needs and coordinate the methods, procedures and tools used to meet them; this conserves resources and streamlines M&E planning. 166 6M ODULE M o n ito rin g a n d eva lu atin g a n iM pleM en tatio n resea rc h pro jec t Standards for an M&E plan An effective M&E plan should conform to the following standards: Utility: It must be useful and serve the practical and strategic information needs of the intended users for decision-making purposes, these may range from assessing programme performance to allocating resources, etc. Feasibility: Be realistic and practical. Given the scarcity of resources, the M&E plan should make the best use of existing data collection systems. However, if new data collection systems are involved, resources (cost and technical capacity) must carefully be considered. Ethically sound: Abide by ethical principles with regard to those involved in and affected by the M&E activities. Accuracy: Provide technically accurate and useful information for decision-making and programme improvement. Key components of an M&E plan There are four key components that form the foundation upon which the M&E plan should be built. Answering these four corresponding questions is critical to M&E planning: What does the project want to change and how? (ii) What are the specific objectives that are designed to achieve this change? (iii) What are the indicators and how will they will be measured, and, (iv) How the M&E data will be collected and analysed? Developing an M&E plan Before you set up an M&E plan, the team should define the overall project goals and objectives, understand the context for the study and identify the key players/stakeholders (the details of understanding the intervention and identifying the stakeholders were described in detail in Modules 1 and 2). The most appropriate approach (e.g. M&E framework and data collection methods to conduct M&E) should also be selected. The frameworks (logic model, logical framework) and data collection methods were also explained in Modules 1 and 2 respectively. Below are the key steps that should be taken when developing an M&E plan. It should be noted that these steps are not necessarily independent from each other, and may actually overlap quite substantially. Many of these steps may be developed or need to be considered in conjunction with others. Key steps in developing an M&E plan Stakeholder consultation and participation Stakeholder consultations and participation should be regular occurrences throughout the entire process of developing and implementing your M&E plan. These consultations ensure dialogue, a clear understanding of the project goals and objectives, and how these will be assessed. They also ensure that various perspectives are understood and integrated, and that authentic needs are being met. Stakeholder participation in the design of the M&E plan facilitates the selection of appropriate and useful M&E indicators. Furthermore, taking extra measures to promote stakeholder participation creates a sense of ownership and responsibility among partners. Stakeholder involvement increases the probability that the information and results guided by the M&E plan will be consistent with their expectations. 167 Developing the M&E plan One of the first tasks in developing your M&E plan is translating your project’s research problem, goals and objectives into variables that can be objectively measured. Specific M&E plans highlight and refer to the conceptual foundation upon which the project as a whole is built. It is essential to understand the differences between project inputs, outputs, outcomes, and impact, since the indicators to be measured under the M&E plan will most likely reflect this hierarchy. Consensus should be reached on key questions in the following areas: “What do we want to know at the end of the project?” and “What do we expect to change by the end of the project?” Again, answering the question of what you expect your project to change will guide decisions about what strategic information is needed for project management decisions as well as what elements should be monitored and evaluated in order to assess progress. The rigor and scope of your M&E plan will depend on what you commit to and what results or outcomes your project is accountable for. Developing the M&E plan provides your team with a clear picture of the following: • How project activities are linked to expected outputs, outcomes and population-level impacts. • How different types of information will be collected and used by different levels of the health system. • What elements need to be measured (e.g. resources, service statistics, coverage and quality, costs, and outcomes associated with the project). • Appropriate indicators to be selected. To enable standardization and comparison with other similar projects, indicators should be consistent with international/national standards. They should also be feasible and realistic to collect. The data sources identified must provide the information needed to measure the indicators. Determining the M&E methodology Once your team has developed the M&E plan, defined the indicators, and identified the data sources necessary, the appropriate methods by which data can be collected and analysed should be determined. For example, your team should determine whether you will use existing data collection systems or if new systems need to be developed. Your team must also determine how information will be recorded, analysed and reported. Furthermore your team should also carefully consider the resources available in terms of technical competencies, costs, and time when determining the methods and tools to be used. Assign responsibilities for implementation After developing the M&E plan, the roles and responsibilities of the different stakeholders should be described clearly. This step will determine how the M&E plan will be specifically implemented and what reporting system will be adopted. The implementation of the plan should include the data collection plan (i.e. who is responsible for collection of specific data; ensuring quality control at each stage; how often the data will be collected; format of the data (e.g. raw, summary); what resources will be required at each stage; who will analyse the data) and the dissemination plan. Setting targets Target should be set in consultation with all stakeholders so that everyone understands what the project has committed to achieve. By setting targets, you will have a concrete measure by which to judge whether the project is progressing as expected. The process of target setting, must focus on answering the question: “What can realistically be achieved given the resources and the 168 6M ODULE M o n ito rin g a n d eva lu atin g a n iM pleM en tatio n resea rc h pro jec t environment in which the project is operating?” The factors to consider include: baseline levels; past trends; expert opinions; research findings; what has been achieved elsewhere; client expectations; and the capacity and logistics to achieve targets. When setting specific project targets, you must also decide the direction of any potential changes that may be indicated over time. Defining reporting system, dissemination and utilization of results Throughout the process of developing the M&E plan, the end users’ information needs must be addressed to ensure utilization of the findings from the research project. In the M&E plan, your team should clearly articulate a plan for disseminating and utilizing M&E findings (see also Module 5). Preliminary findings should be prepared and presented during strategically timed user meetings and/or workshops. The information should be tailored to the specific stakeholders’ interests and needs. Relevant information will solicit input and feedback that could affect decision-making and project improvement. Below are some practical considerations in planning information reporting and utilization planning: • Design the M&E dissemination plan around the information needs of the users. It is important to be mindful that the content and format of data reports will vary according to their intended use. For example, is the M&E required to monitor processes? To conduct strategic planning? To comply with requirements? Help identify problems? Justify a funding request? Or to conduct an impact evaluation? • Identify the frequency of data reporting needs. For example, project managers may want to review M&E data frequently to assess project progress and make planning decisions, whereas donors may need data only once or twice a year to ensure accountability. • Tailor the reporting formats to the intended audience. Since reporting may entail different levels of complexity and technical language, the report format and media should be tailored to specific audiences and different methods used to solicit feedback. • Identify appropriate outlets and media channels for communicating M&E data. This should consider both internal reporting, such as regular project reports, to management and progress reports to donors, as well as external reporting, such as public forums, news releases, briefings, and websites. Implementing the M&E plan Implementation of the M&E plan occurs in three stages, namely: (i) checking and measuring progress; (ii) analysing the situation; and (iii) reacting to new events, opportunities and issues. These are described in detail below. Checking and measuring progress Ideally, monitoring focuses on the project’s three main characteristics of quality, time and cost. The project manager coordinates the project team and should always be aware of the status of the project. When checking and measuring progress, the project manager should communicate with all team members to find out whether planned activities are implemented on time and within the agreed quality standards and budget. The achievement of milestones is measured and reflects the progress of the project. 169 Analysing the situation The second stage of monitoring consists of analysing the situation. The status of project development is compared to the original plan, and causes and impact of potential deviation are identified. Actions are identified to address these causes and the impacts of any deviations. Reacting to new events, opportunities and issues It is important to anticipate and react quickly to new situations, events, opportunities and issues, and to identify the possible actions to be taken. If appropriate, various options are considered and discussed with the project team and a decision is taken regarding the most appropriate path to pursue. Adjustments to/updating the M&E plan The M&E plan should be seen as dynamic and should always reflect the reality of what is known and understood. Each time a deviation from the original M&E plan is identified, whether or not it requires any further action, the M&E plan should be revised and changes documented accordingly. The revised plan reflects the new situation and should demonstrate the impact of the deviation on the whole research project. This is crucial for effective implementation and good communication with the project team, donors and all stakeholders. Adapting the M&E plan also facilitates the management of the project budget and finances. Updating the M&E plan involves including the entire project team (key stakeholders/partners) in the decision-making process; revising the work plan (including costs) as and when necessary; and meticulously documenting all adjustments. Circulate the revised plan to all stakeholders including the relevant Ethical Review Board(s) and Institutional Review Board(s), highlighting the changes and their impact on the project. Your team must obtain approval for the plan amendments from all relevant parties as appropriate. Below are examples of questions that can be considered to help your team assess how well the M&E plan is working. • Are M&E activities progressing as planned? • Are the evaluation questions being answered sufficiently? • Have new evaluation questions been raised and, if so, should they be incorporated into the M&E plan? • Are there any methodological or evaluation design issues that need to be addressed? • Are there any outside factors (political, environment) that are affecting the M&E plan? • Are appropriate staff and funding still available to implement the M&E plan? • Are M&E findings being disseminated and used by stakeholders for decision-making and programme improvement? ApplicAtion of key concepts The example below describes the six steps taken by the research team and the implementers to develop the M&E plan for the use of vouchers for scaling up insecticide-treated nets in the United Republic of Tanzania (2003–2007). Example: Hanson et al (2008) (1). Step 1: Stakeholder consultation and participation The M&E strategies were developed during scheduled meetings of Tanzania National Voucher Scheme (TNVS) partners. The stakeholders included officers from the National Malaria Control 170 6M ODULE M o n ito rin g a n d eva lu atin g a n iM pleM en tatio n resea rc h pro jec t Programme, groups involved in implementing insecticide-treated net (ITN) distribution activities in Tanzania, and researchers from the Ifakara Health Research and Development Centre (IHRDC) and the London School of Hygiene and Tropical Medicine (LSHTM). Following broad-based consultation and participation, a comprehensive and multidisciplinary approach to monitoring and evaluation was agreed upon to cater for novelty and complexity of the intervention, involving multiple partners and depending on both the health system and the retail sector. Step 2: Developing the M&E plan The researchers and stakeholders developed an M&E plan. This was to investigate the programme effects over five main domains: (1) ITN coverage among target groups; (2) provision and use of reproductive and child health (RCH) services; (3) ‘leakage’ of vouchers (i.e. in terms of non-target groups receiving vouchers, and vouchers being used to purchase items other than ITNs); (4) the commercial ITN market; and (5) cost and overall cost-effectiveness of the scheme. They also developed the indicators to measure the progress. The indicators were agreed upon by the Global Fund to fight AIDS, TB and Malaria (GFATM), which funded the project. Table 1 below shows the evaluation domains, the core indicators, and the data sources for each. Step 3: Determining the M&E methodology The team used the principle of triangulation, in which data was collected from multiple sources. These included household, facility and exit surveys, focus group discussions (FGD) and in-depth interviews, a retail audit for data on ITN availability, retail prices at the shops, voucher tracking as well as cost analysis. Reflection activity Using the information from the table above as a reference, complete the template below (Table 2) and create an initial draft of your rproject M&E plan. Step 4: Assign responsibilities for implementation Independent researchers from IHRDC and LSHTM conducted the M&E activities. Activities involved collecting and analysing data, and reporting findings to the implementers who included the National Malaria Control Programme and groups involved in implementing ITN M&E activities in the country. Sometimes it may be appropriate to contract M&E activities out. However, if the research team is implementing the intervention, it would be appropriate for the entire team to be involved in monitoring of the activities. Step 5: Setting targets Targets for the effects of the voucher programme included: • Measuring the effect of the voucher scheme on ITN use among pregnant women and children under five years of age. • Use of RCH services including the voucher scheme. • Effect of the scheme on RCH service provision. • Pregnant mothers’ use of RCH services, their voucher knowledge and use, ITN use and knowledge of malaria in pregnancy. 171 Ta b le 1 . E va lu at io n d o m ai n s an d d at a co lle ct io n m et h o d s E va lu at io n d o m ai n In d ic at o r( s) S u rv ey s F D G s an d in -d ep th in te rv ie w s R et ai l ce n su s Vo u ch er tr ac ki n g C o st an al ys is H o u se - h o ld Fa ci lit y E xi t C ov er ag e of ta rg et g ro up s (o w ne rs hi p, u se ) • H ou se ho ld o w ne rs hi p of a t l ea st o ne n et /IT N ; • In di vi du al s le pt u nd er a n et /IT N o n th e ni gh t pr io r to th e su rv ey X X X P ro vi si on a nd us e of R C H se rv ic es , i nc lu di ng vo uc he r sc he m e • C ur re nt ly /r ec en tly p re gn an t w om an * at te nd ed A N C ; • M ea n w ee ks o f g es ta tio n at ti m e of fi rs t A N C vi si t; • R ec ei ve d a vo uc he r; • R ec ei ve d 1 do se o f S P a s IP T p; • R ec ei ve d 2 do se s of S P a s IP T p X X X X X Le ak ag e of vo uc he rs • % o f v ou ch er r ec ip ie nt s w ho c ou ld b e id en tifi ed , i nt er vi ew ed , a nd c on fir m ed th ey re ce iv ed a v ou ch er X X Im pa ct o n IT N m ar ke t • % o f w ar ds w ith a t l ea st o ne r et ai l s ou rc e of IT N s, in se ct ic id e X X C os t a nd c os t- ef fe ct iv en es s • C os t p er v ou ch er • D el iv er ed ; • C os t p er IT N d el iv er ed X X In di ca to rs o f v ou ch er c ov er ag e w er e ca lc ul at ed fo r bo th c ur re nt ly p re gn an t w om en a nd fo r w om en w ho h ad a li ve b ir th in th e 12 m on th s pr ec ed in g th e su rv ey . IT N = in se ct ic id e- tr ea te d ne t; R C H = r ep ro du ct iv e an d ch ild h ea lth ; A N C = a nt en at al c ar e; S P = s ul ph ad ox in e- py rim et ha m in e; IP T p = in te rm itt en t p re ve nt iv e tr ea tm en t i n pr eg na nc y 172 6M ODULE M o n ito rin g a n d eva lu atin g a n iM pleM en tatio n resea rc h pro jec t • Community and provider perspectives on the scheme. • ITN availability and retail prices at selected shops. • Degree of ‘leakage’ of vouchers. • Economic and financial costs of the voucher scheme. The scope of the M&E and the targets set were based on available resources. For example, whereas this was a national programme, activities were in a representative sample of 21 focal districts. The health impact of the programme (in terms of mortality and morbidity prevented) was not measured. More importantly, health impact of ITN use on morbidity, mortality and anaemia had been demonstrated under effectiveness conditions in an earlier study in the country and were therefore considered unnecessary in this intervention. Table 2. Template for evaluation domains and data collection methods Evaluation domain Indicator (s) Level of data collection* Data collection technique Data collection technique Data collection technique Data collection techniquee.g House- hold e.g. Facility Indicate level(s) of data collection relevant to your project 173 Step 6: Define reporting system, utilization and dissemination of results (a) Reporting system and dissemination of results Results from the various segments of research were presented to TNVS partners at scheduled meetings in the first two years. Table 3 outlines result reporting dates for each of the main data collection methods. Table 3. Schedule of reporting dates for specific, by data collection method Data collection method Time of reporting results Household and facility surveys November 2005 Retail audit January 2006 Voucher tracking April 2006 Key informant interviews and FGDs August 2006 Household survey and costing November 2006 Retail audit and voucher tracking August 2007 Household and facility surveys November 2007 (b) Utilization of the findings Regular feedback regarding the research findings helped implementers identify problems early in the project. Identifying problems allowed the research team to revisit and modify their M&E strategies where necessary, as outlined in Table 4. Table 4. Ongoing and emerging issues and corresponding responses Issue identified Evaluation response Implementer response Relatively low levels of voucher coverage Qualitative investigation with facility staff to identify reasons for not distributing vouchers Redevelop training messages for facility workers Stock-outs of vouchers and antenatal cards required for issuing of voucher In-depth facility level analysis Work with the Medical Supplies Division and MEDA to improve supply chains Relatively low levels of voucher coverage in most geographically isolated clusters Survey instruments modified in subsequent rounds to include questions about use of outreach services for ANC, and the interventions received Develop mechanisms for outreach providers to distribute vouchers Relatively low levels of retreatment of ITNs Qualitative investigation to identify what voucher recipients understand about retreatment kits Amend insecticide treatment messages to respond to user knowledge and perceptions Low knowledge of voucher value Qualitative investigation into understanding of the value of the value Develop IEC materials to address voucher value and top-up 174 6M ODULE M o n ito rin g a n d eva lu atin g a n iM pleM en tatio n resea rc h pro jec t conclUsion Congratulations on completing Module 6 Monitoring and Evaluation. This final module provided you with an outline of how to help your research team track your progress against your set plans, check compliance to established standards, identify trends and patterns, adapt strategies and inform decisions for project management. This module also described the process involved in the development and implementation process of a monitoring and evaluation plan. references 1. Hanson K et al. (2008). Vouchers for scaling up insecticide-treated nets in Tanzania: methods for monitoring and evaluation of a national health system intervention. BMC Public Health. 2008;8(1):205. (http://www.ncbi.nlm.nih.gov/pubmed/18544162, accessed 17 February 2014). Additional resources • Chaplowe SG. Monitoring and Evaluation Planning.” American Red Cross/CRS M&E Module Series. Washington, DC and Baltimore, MD. American Red Cross and Catholic Relief Services (CRS). 2008 • Developing a monitoring and evaluation plan. Wantirna. National Centre of Sustainability at Swinburne University of Technology. 2011. (http://evaluationtoolbox.net.au/index. php?option=com_content&view=article&id=20&Itemid=159, accessed 17 February 2014). • James T and Miller J. Developing a monitoring and evaluation plan for ICT for education. In: Monitoring and evaluation of ICT in education projects: A handbook for developing countries. Wagner DA et al, editors. Washington, D.C. infoDev (The World Bank). 2005. (http://www. infodev.org/articles/monitoring-and-evaluation-ict-education-projects, accessed 17 February 2014). • Developing and Implementing a monitoring and Evaluation plan PPT presentation Chapel Hill. Measure Evaluation (University of North Carolina). 2006. (http://www.cpc.unc.edu/measure/ training/materials/phn/m-e-of-population-health-and-nutrition-programs/course-modules/ week-2/How%20to%20Develop%20%20Implement%20an%20M-E%20Plan%20170706.ppt, accessed 17 February 2014). 175

ISBN 978 92 4 150696 0 TDR/World Health Organization 20, Avenue Appia 1211 Geneva 27 Switzerland Fax: (+41) 22 791-4854 tdr@who.int www.who.int/tdr The Special Programme for Research and Training in Tropical Diseases (TDR) is a global programme of scientific collaboration established in 1975. Its focus is research into neglected diseases of the poor, with the goal of improving existing approaches and developing new ways to prevent, diagnose, treat and control these diseases. TDR is sponsored by the following organizations: World Bank TDR/RCS/14/1

实施研究工具包 导师手册 主译 李 慧 谢润生 夏 萍 Published by the World Health Organization in 2014 Implementation research toolkit © World Health Organization 2014 The World Health Organization has granted translation and publication rights for an edition in Chinese to the Key Research Office of Standardization of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences (Guangdong Provincial Hospital of Chinese Medicine; The Second Affiliated Hospital of Guangzhou University of Chinese Medicine), which is solely responsible for the quality and faithfulness of Chinese version. In the event of any inconsistency between the English and the Chinese version, the original English version shall be the binding and authentic version. © Key Research Office of Standardization of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences (Guangdong Provincial Hospital of Chinese Medicine; The Second Affiliated Hospital of Guangzhou University of Chinese Medicine) 2021 Authors/Editors of the translated version: Hui LI, Runsheng XIE, Ping XIA, Miaochun CAI, Yanxi LU, Gang ZHENG, Changrui OU, Chumin YE 实施研究工具包 © 广东省中医药科学院（广东省中医院、广州中医药大学第二附属医院） 中医药标准化重点研究室 2021 年 主译 李 慧 谢润生 夏 萍 译者 蔡淼纯 卢彦熹 郑 港 欧昌睿 叶楚民 著者 World Health Organization, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases 世界卫生组织授权广东省中医药科学院（广东省中医院、广州中医药大学第 二附属医院）中医药标准化重点研究室翻译和出版本手册的中文版，并由后者对 本手册的中文版负责。 致 谢 本工具包由热带病培训研究特别规划署（TDR）开发，旨在加强有着极大需求的中低收 入国家中个人和机构开展实施研究的能力。 TDR 得到了以下国家的大力支持：比利时、巴西、中国、古巴、德国、加纳、印度、伊 朗、日本、卢森堡、马来西亚、墨西哥、荷兰、尼日利亚、挪威、巴拿马、西班牙、瑞典、 瑞士、泰国、土耳其、英国、世界银行和赞比亚。 美国国际开发署和实施研究平台也提供了特别支持，该平台总部设在世界卫生组织，联 合了：卫生政策和系统研究联盟；人类生殖研究、发展和研究培训特别规划署；世界卫生组 织孕产妇、新生儿、儿童和青少年卫生部；孕产妇、新生儿和儿童健康伙伴关系；TDR。 本工具包是由 Jane Kengeya-Kayondo 和 Soumya Swaminathan 共同发起。Henry Lucas、 Sandy Campbell、Dirce Guilhem、Boatin Boakye、Yodi Mahendradhata、Colla Jean MacDonald 和 James Foreit 为工具包中的各个单元准备了原始材料。指导委员会对开发过程提供了指导 和建议，该委员会包括以下人员：Miguel Angel Gonzalez Block, Kathleen Handley, Kazi Mizanur Rahman, Wynne E. Norton, Jason B. Smith, Uche V. Amazigo, Linda Kupfer, Shenglan Tang, Isaac K. Nyamongo, Nhan Tran. 本工具包得益于许多人的贡献和建议，我们要特别感谢以下人士，他们通过试点研讨会 和最后的编辑，为各单元的结构调整和汇编提供了宝贵意见： 内容审查和反馈：Taghreed Adam, Sam Adjei, Irene Agyepong, Bill Brieger, Effie Espino, Timothy France, Prea Gulati, Jamie Guth, John Gyapong, Adnan Hyder, Regina Kamoga, Barrot Lambdin, Jeff Lazarus, Temina Mandon, Yolanda Ogbolu, Joe Okeibunor, Dimeji Oladepo, Obinna Onwujekwe, Johannes Sommerfeld, Thomas Sukwa, Fabio Zicker. 推动试点研讨会的举行。Ayat Abu Agla, Riris Andono Ahmad, Oladele Akogun, Khaleda Islam, Andres Z. Jaramillo, Baralee Meesukh, Isaac K. Nyamongo, Tuoyo Okorosobo, Martin Ota, Ayo Palmer, Shagufta Perveen, Mike Sanchez, Honam Irene Tsey。 超过 200 名研究人员、学者、疾病控制规划管理人员、政策制定者、卫生行政人员、通 信科学家和记者为本工具包的测试和评估做出了贡献。以下实施者和研究人员为试点工作做 出了贡献，并提供了反馈/评论： Wondwossen Belehu, Paul Bukuluki, Meg C. Doherty, Mary Ellsberg, Katherine Fritz, Meseret Gossa, Nancy Glass, Paul C. Hewett, Elijah Oyaro June, Kuyosh Kadirov, Etienne Karita, Joseph Kariuki Muriithi, Kathleen Kostelny, Jeremias L. Messias, Aragaw Biru Muhammed, Abraham Mukolo, Ester M. Mungure, Tina C. Musuya, Ramadhani S. Mwiru, Edith Nakku-Joloba, Kenneth K. Ngure, Walter O. Obiero, Spallanzani Oduor Ohaga, Eunice A. Omanga, Patrick O. Owiti, Deidra Demeatra Parrish, Nancy A. Perrin, Paul Bitwahiki Ramazani, David Sando, Helen Semu, Anuraj Shankar, Nicholas Shiliya, Helen N. Siril, Amanda C. Tichacek, Rogers Twesigye, Michael Wessells, Olufemi A.Adegoke, Naeemah Abrahams, Nurelign Mohammed Ahmed, Laurence Natacha Ahoua- Leray, Meghan Bishop, Emily Bobrow, Kerry Bruce, Jeanine Condo, Koen Frederix, Khanyisa Gala, Piotr Andrzej Hippner, Andrea Howard, Locunda Erin Higgins Hummert, Mubiana Inambao, John Barton Jemmott, Deyessa Kabeta, Jolly Kamwanga, Amira Karam, Matthew Raymond Lamb, Lebohang Mary Ledikwe, Virginia Letsela, Tonderai Mabuto, Mokgadi Rebecca Malahlela, Abdelhamid Mjidila Charmaine Mlambo, Yael Moverman, Martha Mukaminega, Fhumulani Mavis Mulaudzi, Iris Bongiwe Ndondo, Mathew Ngunga, Bonisile Nhlabatsi, Thobo Matuhogonolo Phologolo, Asta Helen Rau, Letitia Lynn Reason, Mary Pat Selvaggio, Vandana Sharma, Anne Teitelman, Mark Tomlinson, Renay Weiner, Robert Carl Yohnka, Vincent Kudakwashie Zishiri, Abdul Aziz Abdulai, Ismail Adem Abdilahi, Ayat Abu-Agla, Elsheikh Elsiddig Ahmed, Alaaedieen Mokhtar Ali, Wagdy Abdel Moniem Amin, Frank Biney, Peter Chibatamoto, Amel Abdu Gesmalla, Musse Mohamed Hasan, Mirriam Kangwende, Freddy Eric Kitutu, Rugare Abigail Kwakye, Kedibonye Dundu Macha, Talent Maphosa, Matshelo Tina Matlhaga, Chawangwa Modongo, Mohamed Farah Mohamoud, Fadzai N.N. Mutseyekwa, Kwame Shanaube Mwange, Magdy Fawzy Nasrallah, Matsiri Tiroyaone Ogoposte, Sandra Simbeza Sinzala, Henry Wamani, Anisuddin Ahmed, Dhana Raj Aryal, K.C Ashish, Lu Gao, Shaikh A. Shahed Hossian, Khaleda Islam, Nurhuda Binti Ismail, Gamini Jayakody, G.A.J.S.K Jayasooriya, Frederick Dony Jiloris, Pahalagedera Kusumawathie, Huq, Trisasi Lestari, Li Lin, Nafisa Lira, Hammed Oladeji Mogaji, Aftab Ali Akbar Mukhi, Abdul Razak Abdul Muttalif, Shagufta Perveen, Likke Prawidya Putri, Khalid Hussain Shaikh, Raihan Sharif, Ravi Vitrakoti, Nandyan N. Wilastonegoro, Wenti Xu, Quudus Adegboyega Yusuff, Hakeem Abiola Yusuff, Martha Ali Abdullai, Sheila Addei, Enoch Oti Agyekum, Gifty Ofori Ansah, Rahma Eltigani Mohammed Ahmed, Naa Korkor Allotey, Efua Asante, Frank Baiden, Azza Tag Eldin Bashir Babiker, Boniface Denakpo, Eva Engman, Ferrer Blanca Escribano, Lawrence Gyabaa Febir, Boniphace Salustian Jullu, Esther Kyungu, Towela Maureen Maleta, Humphreys Kampila Nsona, Mariam Oke, Mona Babiker Omer, Senga Kali Pemba, Themba B. Phiri, Tatcheme Filemon Tokponnon, 最后，我们要感谢南非医学研究委员会德班分会、博茨瓦纳大学哈博罗内分校健康科学 学院、孟加拉国国际腹泻病研究中心和达卡的 TRAction 项目以及加纳卫生局的 Dodowa 健 康研究中心，以及 Ayishatu Gibrin 和 Najoua Kachouri 在组织试点研讨会方面的贡献。 本工具包的作者 Margaret Gyapong、Edward Kamau、Robinah Najjemba 和 Olumide Ogundahunsi 对所表达的观点以及任何事实或判断的错误负责。 缩略语 ACT artemisinin-combination therapies 青蒿素联合疗法 ANC antenatal care 产前护理 ART antiretroviral therapy 抗逆转录病毒治疗 BCC behavior change communication 行为改变交流 BMI body mass index 身体质量指数 CAS complex adaptive system 复杂适应系统 CHW community health worker 社区卫生工作者 CMS Cooperative Medical Scheme 合作医疗方案 COS Community of Science 科学共同体 DOT directly-observed therapy 直接观察疗法 ERC ethics review committee 伦理审查委员会 FGD focus group discussion 焦点小组讨论 HDI Human Development Index 人类发展指数 HIV human immunodeficiency virus 人类免疫缺陷病毒 HRP Special Programme of Research, Development and Research Training in Human Reproduction 人类生殖研究、发展和研究培训特 别规划署 IC informed consent 知情同意书 ICF intensified case finding 强化个案调查 IDRC International Development Research Centre 国际发展研究中心 IEC information, education and communication 信息、教育和交流 iKT integrated knowledge translation 整合型知识转化 IR implementation research 实施研究 IRB institutional review board 机构审查委员会 IRP Implementation Research Platform 实施研究平台 KT knowledge translation 知识转化 KZN KwaZulu-Natal 夸祖鲁-纳塔尔省 LLIN long-lasting insecticide-treated net 经长效杀虫剂处理过的蚊帐 LOI letter of intent 意向书 LSHTM London School of Hygiene and Tropical Medicine 伦敦卫生与热带医学院 LTFU loss to follow-up 失访 M&E monitoring and evaluation 监测和评估 MDR-TB multidrug-resistant tuberculosis 耐多药肺结核 NGO nongovernmental organization 非政府组织 NSF National Science Foundation 美国国家科学基金会 NTBCP national TB control programme 国家结核病防治规划 OER Office of Extramural Research 院外研究处 PI principal investigator 项目负责人 PLHIV person/people living with the human immunodeficiency virus 艾滋病病毒感染者和艾滋病病人 PMTCT prevention of mother-to-child transmission 预防母婴传播 QDA qualitative data analysis 定性数据分析 RFP request for proposals 需求建议书 SAGE Strategic Advisory Group of Experts 战略专家咨询组 SARS severe acute respiratory syndrome 严重急性呼吸综合征 SMART specific, measurable, achievable, realistic and timebound 具体、可衡量、可实现、现实性和 时限性 SOP standard operating procedure 标准操作规程 SWOT strengths, weaknesses, opportunities and threats 强弱危机分析 TB tuberculosis 结核病 TDR Special Programme for Research and Training in Tropical Diseases 热带病培训研究特别规划署 UNDP United Nations Development Programme 联合国开发计划署 UNICEF United Nations Children’s Fund 联合国儿童基金会 USAID United States Agency for International Development 美国国际开发署 WHO World Health Organization 世界卫生组织 目 录 实施研究工具包的背景和介绍 1 第一部分：计划和组织研讨会 4 第二部分：开展各个单元所需的详细信息和材料 8 内容介绍和基本定位 11 促进单元 1 情境化实施研究问题 15 促进单元 2 制定实施研究计划书 24 促进单元 3 计划开展实施研究项目 53 促进单元 4 数据、分析和展示 60 单元 4a：定量数据管理，分析和呈现 62 单元 4b：定性数据收集，分析和呈现 71 促进单元 5 传播研究结果 76 促进单元 6 监测和评估实施研究项目 85 1 实施研究工具包的背景和介绍 一、总体目标和理论依据 有效的实施研究“需要一个广泛的、系统的（因此也是多学科的）方法，它跨越公共和 私人部门，它需要来自生物医学、制药、社会科学、公共卫生和卫生经济学部门的研究人员 共同合作。这些研究人员必须考虑到当地卫生系统的背景因素，倡导政治承诺，最重要的是 必须以卫生保健提供者、疾病控制规划实施者和决策者的需求为导向。识别这些背景条件并 将其纳入到研究过程中是至关重要的。此外，实施研究必须解决国家、区域和全球层面上越 来越复杂的创新进程。”（世界卫生组织 2011 年）。 本工具包旨在加强有着极大需求的低收入和中等收入国家中的个人和机构开展实施研 究的能力。其侧重于以需求为导向的研究问题，这些研究问题是基于卫生系统中利益相关者 /实施者的需求而提出的。它涵盖实施研究的过程，重点强调了利益相关者在识别问题、制 定适当的研究问题、项目设计的团队合作、数据收集和分析、项目的监测和评估以及在系统 内反馈和吸收研究成果方面的中心范式。 二、意向参与人和受益者 实施研究是一种团队合作，需要具有不同技能、经验和背景的人聚集在一起来提出一个 实施问题，然后回答由卫生保健提供者、项目管理者、实施者或其他服务提供者在其履行职 责中所提出的问题。因此，一个实施研究项目小组可根据其项目的内容和性质决定是否纳入 研究人员、卫生保健提供者、项目管理人员、决策者、学生、民间社会组织和非政府组织。 该工具包可作为实施研究团队培训工具，也可改编为公共卫生学校的实施研究教学材料。 计划和组织研讨会 理想情况下，研讨会将贯穿项目的始终，分为 7 个单元进行。包括了定义实施研究问题 并确定其背景、制定研究计划书、计划开展研究、收集和分析数据、向卫生系统传达和反馈 结果、并最终监测和评估项目。研讨会应尽可能将相关活动组织在一起。例如，项目规划单 元应在项目资金得到保障后、在开展实地工作前开展，数据收集和分析单元应在开始数据收 集等工作前开展。 应至少在研讨会开始前两周，给研讨会学员提供参考资料、案例研究和反思练习的材料。 每个单元的建议时长见于本手册的第 12 页。 三、预期研究结果 卫生系统薄弱或不存在卫生系统的地区往往是最需要解决实施瓶颈问题的地方。遗憾的 2 是，正是在这样的环境下，实施研究的知识和必要的技能才会受到限制。从而无法制定适当 的研究问题，难以开展、管理、解释和利用研究结果以进行方案规划和政策实施。一般而言， 公共卫生学术规划课程并不会专注于现实生活背景下的研究，而这往往是实施研究所关注的 重点。这种培训始终没有为卫生系统的研究人员、从业人员、服务提供者和决策者针对解决 实施的障碍而采取的合作关系（团队方法）和跨学科方法做好充分准备。 这个工具包的使用将促进把实施研究理解为一种团队合作，这种团队合作采取了系统性 的方法来理解和解决有效和高质量实施卫生干预措施、战略和政策的障碍。实施研究团队和 卫生系统将能够开展和利用研究成果来改善或优化需求最大区域的卫生保健和系统。 四、工具包材料 这个工具包的开发和设计主要是为了在研讨会环境中应用。这是一个动态和互动的项目， 导师在学习过程中会积极参与团队合作。一系列的材料和学习方法已经被精心开发和研制， 这将会以一种有效且有趣的方式展开。 学员手册 每一个单元都有相应的学员手册。这些是为了在研讨会期间提供学员需要的信息，包括 每个单元的幻灯片。值得强调的是研讨会的学员不需要复制或记下幻灯片的内容。这些内容 将在学员手册的不同章节中会提及。 每本学员手册还列出了参考文献和提供了建议阅读材料的链接，以及其他更详细地介绍 特定主题的资源。 幻灯片 每个单元都有一组幻灯片。幻灯片的内容特意保持简短，主要是为了鼓励研讨会期间的 讨论和批判性思维（以及避免导师和学员“照念”幻灯片，而不进行思考）。幻灯片可以适 应特定的研讨会环境或学员。在每次研讨会之前，导师都应该检查相关的幻灯片，以便做出 最后的修改。 导师手册 本手册为组织者和导师提供了计划和实施研讨会的基本信息。它包括： • 关于计划和筹备研讨会的资料； • 教学和学习方法的概述； • 每个单元的详细说明。 注意：为了避免产生任何的混淆，本导师手册中所有对图形、表格和方框的引用都与学员手册中使用 的数字相匹配。这意味在本手册中有些引用的序号可能存在错误。 3 本手册包括以下两部分： 第一部分 计划和组织研讨会 1. 设计研讨会的结构、时间表和内容：包含对研讨会的结构和内容所提出的建议。 2. 邀请学员和其他嘉宾：就邀请学员和其他嘉宾参加研讨会提出建议，具体建议如下： • 利用专家的专业知识。 • 策划正式的开幕式和闭幕式。 • 纳入来自各个国家不同部门的团队成员。 3. 主要的教学方法：讨论研讨会的便利性，以及所使用的教学方法。 • 选择导师的标准。 • 导师的角色。 • 参与式培训的基本规则。 • 计划和运行各个单元。 4. 计划开展实施研究的研讨会：包含实施研究的计划和准备清单（例如设施及设备）。 5. 评价方法：提供研讨会评价方法的概述： • 衡量学员的观点及其反应。 • 评估学员知识的变化。 • 对研讨会本身的反馈或促进。 • 采用随访调查问卷来促进对学员实践行为变化的了解。 第二部分 开展各个单元所需的详细信息和材料 这个部分包括研讨会的时间表和进行每一环节的步骤说明。它还提供了开展各个单元所 需的所有支持材料，例如带有谈话要点的幻灯片、白板及其内容，以及可能会提出的关于带 有注释的案例研究材料。最后，它还包括一些提示帮助您回答学员可能会提出的问题、识别 和解决那些敏感性问题。 4 第一部分 计划和组织研讨会 一、设计研讨会的框架结构、时间和内容 实施研究研讨会包括七个核心要素。学员研究项目的发展阶段和团队的经验决定了研讨 会的结构和重点。应根据他们的实施研究的概念或问题邀请研讨会的学员作为一个同质的小 组。将项目处于不同发展阶段的学员混合在一起是无法有效规划的。 二、选择或邀请学员和其他嘉宾 研讨会的学员应组队成为研究小组，每队最少 3 人，最多 5 人。团队中所代表的规程将 取决于要处理的研究问题的性质，但在所有情况下，每个团队必须包括至少一个实施者。团 队领导应该列出项目中的成员和他们的角色，以确保他们在整个研讨会期间能够参加。选择 标准应该清楚地说明。 尽可能选择熟悉学员当地、国家或地区背景的导师。导师应该对所涉及的主题有丰富的 经验，最好是积极的实施者或研究者。这增加了使用图表的可能性，通过图表的应用可以使 学员加强概念的吸收。在开展研讨会之前，导师应该花时间检查材料并增加适当的图表。 三、对研讨会进行计划 预算：住宿、餐饮、材料、旅费和任何其他有关费用是研讨会所要考虑的重要因素。在 邀请学员参加研讨会之前，必须提供充足的资金。 在研讨会开始之前，与学员建立良好的沟通是非常重要的。以下是学员需要提前了解的 问题举例：研讨会的目标、日期、地点、学员的职责，包括他们在研讨会期间的出席、完成 课前作业。行程安排应允许学员在研讨会前一天到达。在整个研讨会期间，学员最好都待在 同一地点。这将有助于小组学习和在一天结束时完成任务。 每个研讨会单元应该在相应的研究活动之前完成（例如项目规划单元应该在项目开始之 前完成）。在第一次研讨会上使用以下检查清单： 1. 学员和导师分别自我介绍。 2. 在研讨会开始时，所有人都同意基本的行为准则（基本规则，如尊重、礼貌、称呼 方式、清晰发言、轮流发言等）。 3. 安排一名学员作为研讨会的时间管理员。 4. 指派小组或学员回顾和介绍单元（每天——最好是第二天早上的第一件事）。已学 的知识、进展顺利的事项以及需要改进之处是回顾时应该关注的重点。 导师每日应对研讨会活动的进度进行回顾，并做出相应的调整。 5 四、学习重点或学习注意事项 你应该在开始指导课程之前阅读这部分内容。 准备你的课程 • 非常重要的是，您必须彻底熟悉工具包的材料以及每一单元的思路。这是必要的， 即使你是一个经验丰富的导师或你已经对实施研究非常了解。 • 通读所有的单元，而不是只关注那些你将要展示的单元。了解不同的会议是如何结 合在一起的，这将帮助你专注于每一次会议的信息，而不用重复后面课程将会介绍的材料。 • 阅读本手册中的会议目标，提醒自己课程的目标是什么。 • 与其他导师协调，可以考虑将一些课程分配给其他导师，特别是那些涉及不同活动 主题的长课程。 • 请始终随身携带本手册，并在整个课程的准备、授课和后续阶段需要时进行参考。 关键概念 本工具包使用关键概念来强调具体的重点领域和行动原则。每个单元所涵盖的关键概念 都被清楚地概括（贯穿所有材料），可通过重复书写、引用、用它们来上课和演讲、口头多 次重复使用这些概念从而使得这些关键概念在整个课程中得到强化（由导师或学员）。在接 下来的每一天开始的时候，都要回顾和加强前几天的关键概念。 提升授课技巧 • 说话要自然生动。最好是用对话方式来陈述信息，而不是逐字逐句地读出陈述笔记 的内容。尽可能避免从屏幕上阅读。 • 说话要清晰，语速要慢，声音要突出，这样所有的学员都能听明白你在说什么。 • 演讲时要面对听众，与听众保持眼神交流。在房间里四处走动，让学员参与进来。 • 向学员详细解释每个幻灯片或图片的内容，并清楚地强调他们应该从中学习的要点。 • 记住，幻灯片和白板只是简化的视觉辅助工具；不要期望学员能在没有你的引导下 从这些工具中学习。 参与到学员之中 • 不断观察各小组学员的情绪和小组气氛。是否每个人都参与其中？他们看起来是否 感兴趣？ • 如果你觉得氛围不够活跃，可以开展一些破冰活动和做一些暖场活动。如果学员看 起来疲惫不堪或无法接受大量的信息，可以考虑进行短暂的休息。 • 鼓励全员参与。使用语言和非语言的方法来鼓励学员参与。直接提问那些沉默不语 6 的学员，但注意不要让他们感到尴尬。 • 确保学员有一次发言的机会；如果有必要的话，给他们一个发言的顺序。如果人们 知道有机会说话，他们就不太可能打断别人。 • 鼓励相互尊重地进行讨论和分享想法和经验。建立在学员已经知道或经历的基础上 的学习会更为有效。 • 通过积极的参与来鼓励团队合作和营造归属感。 • 确保讨论不仅由某一两个人主导，并确保所有学员都有机会提出和回答问题。 • 感谢所有学员的回应，以鼓励持续参与。 • 鼓励简明扼要地回答，积极点评那些简短且切中要点的学员回答。 • 请学员在回答问题时合上学员手册，以便思考可能的答案，而非阅读手册的信息。 • 在整个课程期间对定期提出的问题进行重新总结。 • 识别需要跟进的问题或观察结果。 导师的基本要求和成人学习原则 根据成人学习的主要原则，导师的目标应是： • 有热情和欢迎的态度，能够对学员表示赞同和接受。 • 能够与团队建立良好的关系。 • 对话题充满热情。 • 能够创造一个互动的环境，例如提问、在房间里走动、总是对所有人讲话、避免关 注某个小组或某人。 • 确保对学员采取非评判性的方式（即使你不赞同他们的观点）。 • 能够在不妨碍参与的情况下领导。 • 随机应变。 你还需要： • 确保可视化材料已准备好，如白板、幻灯片或投影仪可用。 • 保持视觉辅助工具简单易读。 • 定期检查学员是否理解所呈现的信息。 • 使用互动技巧（例如提出开放式问题，请学员详细阐述他们的理解）。 • 给学员真正的机会，让他们自行发现每个课程中问题的答案。这些问题的提出是为 了让学员们能够通过查看所展示的相关图表，或根据他们自己的经验，或从之前的研讨会中 讨论过的材料中得出适当的答案。 • 有时，学员在寻找答案时可能需要额外的帮助；在这种情况下，你可以考虑给他们 一个提示。在其他情况下，你可能会发现用不同的方式再问一遍这个问题会有帮助。 7 导师技巧的快速检查清单 动作 站在中心舞台；避免站在角落或桌子后面。 面对听众；说话时不要面对黑板或屏幕。 避免挡住听众的视线。 与每个位置的听众进行眼神交流。 使用自然的手势和面部表情，同时保持一定的文化敏感性。 在房间里走动；接近学员来引起他们的注意，并鼓励他们的参与。 演讲 说话要清楚，语速要慢，声音要大到每个人都能听见；自然热情；适当地改变你 的语调。 在活动挂图板上写下难以理解的新名词；读出发音并做出解释。 请注意，一些听众可能因为文化背景不同而对一些表达方式和图例感觉陌生。 互动 与所有学员互动和接触；适当地称呼他们的名字。 提问手册中建议的问题；询问不同的学员；鼓励沉默不语的学员积极发言。 给予学员回答的时间；不要太快给出答案；如有需要，可给予提示。 对所有的回答都给予鼓励和积极的回应；用机智和灵敏纠正错误。 避免离题或分散注意力的讨论；如有必要，可以将这类讨论推迟。对学员提出的 问题给予满意的回答，或者说明以后再答复。 可视化辅 助工具 准备所需的辅助工具和设备；在上课前检查并安排好。 确保每个人都能看清楚；安排好空间和位置，让他们能很好地看到演讲者和屏幕。 适当地指出你在投影仪或屏幕上所讲的内容。 如果使用海报或白板，请用大而清晰的字体书写。 盖上、关闭或移除不再使用的视觉辅助工具。 使用材料 准确和完整地遵循课程计划；使用你的手册。 充分准备；事先阅读并获得你需要的任何材料。 在课程前准备好你的助手（例如，角色扮演）；如果可能的话可以事先进行练习。 不要死记硬背；虽然要遵循手册，但更要用自己的语言表达。 时间管理 强调重点；尽量避免重复，除非真的有用。 请给出一些当地的例子；避免引入过多的额外内容。 如果有必要阅读手册，要时不时看一下听众。 注意时间：放慢节奏；定期对团队进行评估以确保你的行动不会太快或太慢；课 程的开始部分不要花太长时间。熟悉演讲的内容、幻灯片转换和演讲的持续时间。 五、评估方法 使用匿名自填问卷进行评估。最初的评估应该在研讨会开始时进行。这项评估的目的是 建立关于学员在工具包的七个单元方面的知识、技能和能力的基线资料。从这一评估中获得 的信息将指导导师在课程中需要更加重视的部分。在研讨会结束时发放一份相同的问卷，以 评估学员的知识变化。 为了评估学员对单元（内容、传递）和导师的看法和反应，在每个单元的最后会发放一 份自填问卷。这些反馈可以用来改进课程，也可以用来更好地规划未来的课程。 8 第二部分 开展各个单元所需的详细信息和材料 一、工具包单元：快速参考 实施研究工具包研讨会单元由内容介绍和六个核心部分组成： 单元 题目 建议时长 备注 入门 内容介绍和基本定位 0.5 天 通常与内容介绍、开幕式和第 1 单元相结合 1 情境化实施研究问题 1.0 天 2 制定实施研究计划书 5.0 天 独立的 3 计划开展实施研究项目 0.5 天 可以和第 4 单元相结合 4 数据分析和展示 1.5 天 可以和第 3 单元结合 5 传播研究结果 1.0 天 可以和第 6 单元相结合 6 监测和评估实施研究项目 1.0 天 可以和第 5 单元相结合 二、研讨会单元的概要描述 实施研究工具包研讨会由入门单元和六个核心单元组成。 内容介绍和基本定位 入门单元为学员提供基本的介绍和快速参考（对于新的引导者也很有用）。它提供了 6 个核心单元的概要，它们的基本原理，基本术语和原则，并描述如下： • 什么是实施研究？ • 实施研究关键特征及实施研究循环。 • 为学员提供以实施研究为重点的自我评估。 该单元通常与内容介绍或正式开幕仪式相结合，包括一个为期半天的研讨会（附有教程、 演示幻灯片以及可供进一步阅读的材料）。 单元 1：情境化实施研究问题 单元 1 旨在帮助研究人员、实施者和决策者认识到实施研究的价值，并提高他们对实施 研究和一般干预措施所处环境的理解。此外，该单元还介绍了实施研究项目的伦理问题。该 单元包括以下关键概念及其应用程序和示例： • 理解环境和情境。 • 理解干预措施。 • 实施研究的伦理和道德问题。 9 单元 2：制定实施研究计划 本单元建立在理解实施研究所处情境、让合适的利益相关者参与进来、阐明需要解决的 问题或障碍，以及组建一个适当的多学科的团队的前提之上（即单元 1 中涉及的内容）。 • 识别实施的障碍并提出研究问题。 • 说明申请资助的理由（内容介绍、理论依据和目标）。 • 研究设计和适当的方法。 • 规划项目（预算、人员、时间表、监测和评估）。 该单元帮助学员思考和完成制定一项研究计划所需的必要步骤。 单元 3：计划开展实施研究项目 单元 3 阐述了获得开展实施研究的资源后应采取的步骤。它提供了计划研究项目所需的 信息，包括为伦理审查过程而准备的研究方案。单元 3 涵盖以下关键概念，并附有实例。 • 准备伦理审查。 • 项目实施过程。 • 实施研究的良好实践。 单元 4：数据分析和展示 本单元旨在帮助研究团队、实施者和研究人员了解对定性和定量数据的适当数据分析程 序；了解在定量研究中适当地使用统计学；并在定性研究中描述和记录数据分析过程。本单 元将通过一些例子来说明如何应用这些基本概念。 单元 5：传播研究结果 本单元旨在协助研究小组： • 领会在吸收和使用研究成果时的知识转移概念。 • 描述与研究项目有关的知识转移的障碍和促进因素。 • 理解在整个项目周期中传播信息的价值。 • 认识到在研究项目中制定一项全面的传播战略的价值。 • 认识到为不同目标受众量身定制传播工具的重要性。 本单元举例说明了知识转化的关键概念，并为准备研究报告、同行评议论文、新闻稿、 会议报告和政策摘要提供结构化的指导。 单元 6：监测和评估实施研究项目 最后一个单元的设计目的是帮助研究团队根据既定计划跟踪进度，检查是否符合已建立 的标准，确定趋势和模式，调整策略并为项目管理提供决策依据。本单元内容还有助于培养 技能，以确定目标的相关性和实现、发展效率、效果、影响和可持续性。完成本单元后，研 究小组将能够了解制订监测和评估研究计划所涉及的过程，并描述实施研究项目的实施过程。 10 内容介绍和基本定位 11 内容介绍和基本定位 一、学习目标和预期结果 [幻灯片 3-4] 本介绍性单元作为基本介绍和快速参考指南，介绍了基本术语和原则，以及介绍其他单 元及其理论依据。本单元结束时，学员应对以下关键概念及其应用有全面了解： 1. 什么是实施研究？ 2. 实施研究的关键特征和实施研究循环。 本单元通常与内容介绍或正式开幕式相结合，包括一个为期半天的研讨会（附有教程、 演示幻灯片以及可供进一步阅读的材料）。包括给予学员对于目前实施研究相关知识和理解 进行自我评估的时间。 二、什么是实施研究？ [幻灯片 5-7] 在这入门课程中，主要目标是确保所有学员理解实施研究与健康和生命科学领域中其他 形式的调查研究之间的根本区别。 研究确定解决办法和备选办法以克服卫生系统、疾病控制规划和提供保健服务方面的实 施障碍的重要性已得到广泛认可。实施研究解决了这种实施瓶颈，确定了针对特定环境的最 佳方法，并促进吸收研究成果：最终，它将改善卫生保健及其服务提供。 卫生系统薄弱或不存在卫生系统的地区（包括在低收入和中等收入国家），往往是最需 要解决实施瓶颈问题的地方。遗憾的是，地方机构往往对实施研究的知识有限，缺乏制定相 关研究问题以及为方案规划和政策执行开展、管理和解释研究结果的基本能力。学术性的公 共卫生课程往往并不关注这类研究。 导致的结果是，大多数培训始终没有为卫生系统的研究人员、从业人员、服务提供者和 决策者针对解决实施的障碍而采取的团队协作和跨学科方法做好充分准备。本实施研究工具 包的编写正是为了帮助填补这一空白。 不同的机构对实施研究有着不同的定义。常见的解释为这是一种侧重于系统地了解和应 对阻碍有效和高质量实施卫生干预措施、战略和政策的研究。实施研究是以需求为导向，研 究问题是根据卫生系统中利益相关者或实施者确定的需求而提出。 请用这两张幻灯片来讨论和说明实施研究与生物医学或其他研究的不同之处。给学员足 够的时间解释清楚什么是实施研究，让他们充分考虑这些差异。以问题或例子探讨如何在社 区层面实施干预措施，以及当地居民如何获得该干预措施。 根据对这些关键问题的理解和掌握情况的评估，你可以花更多的时间来强调实施研究的 具体特征，如表 1 所示。所有的导师都应该在内容介绍单元开始前仔细回顾这个表格。邀请 或鼓励学员分享参与实施研究所获得的经验，分享或讨论彼此的观点。 12 表 1：实施研究的关键特征 特征 总结或描述 系统性 ⚫ 系统性研究是基于证据的公共卫生干预措施如何在特定环境中进行整合和提 供，以及由此产生的健康结局如何因社区而变化。 ⚫ 严格遵守科学研究的规范，以严谨的态度平衡相关性。 多学科 性 ⚫ 分析生物、社会、经济、政治、系统和影响特定健康干预措施实施的环境因素。 ⚫ 行为和社会科学家、临床医生、流行病学家、统计学家、工程师、商业分析师、 政策制定者和关键利益相关者之间的跨学科合作。 情境性 ⚫ 以需求为导向。研究问题的框架是由卫生系统实施者识别的需求来确定的。 ⚫ 研究与当地实际情况和需求有关，旨在特定情境下改善卫生保健服务的提供。 ⚫ 形成可应用于不同环境的普适性知识和见解。注意不同文化和不同群体对实施 研究的影响。 复杂性 ⚫ 动态性和适应性。 ⚫ 多层次：发生在卫生系统和不同群体的多个层面。 ⚫ 分析多组成部分的方案和政策。 ⚫ 非线性的，迭代的和不断演变的过程。 注：实施研究有时被称为“运筹学”，或“实施科学” 三、相互影响的实施研究领域 [幻灯片 8] 作为整个工具包内容介绍的一部分，其还有助于启发学员结合实施研究中五个主要的相 互影响的“领域”来进行思考（见学员手册的图 2）。 四、实施研究循环的六个步骤 [幻灯片 9-10] 要是学员能很好地掌握实施研究的内涵，接下来关键是要让他们要明白实施研究循环中 的每个步骤都需要哪些具体技能和知识。当描述实施研究循环的六个步骤时，你可以笼统地 概述开展实施研究时所需的技能和知识（包括通过本工具包传授的知识）。 使用没有标签或文字的实施研究循环图（幻灯片 4），与学员一起探索这六个步骤所代 表和包含的内容。然后切换到带标签或文字的实施研究循环图（幻灯片 5），更详细地解释 每一个步骤，突出各个步骤之间的链接。 在讲解实施研究循环步骤的过程中，不断参考和强调： • 内圈中的每一个元素； • 关键利益相关者如何参与每一步，包括关键消息提供者。 在介绍及详细讨论了实施研究循环的六个步骤后，请提醒学员实施研究工具包旨在促进 形成与该循环六个步骤相匹配的技能或能力。 13 五、自我评估框架 [幻灯片 11-12] 为应对特定的实施研究挑战而组成的团队应该是个多学科团队：具有不同的角色，在不 同的领域工作，并且往往有着很不一样的背景。 以实施研究为中心的自我评估可以有效地揭示出每个团队中的一些差异。其还允许团队 识别他们自身的相对优势和劣势（包括与参加研讨会的其他团队的关系），并为团队设定广 泛的学习目标。 请每个团队使用幻灯片 8 或图 3 所示的矩阵来确定他们当前的水平： • 略懂； • 理解； • 知识； • 技能； • 能力。 在实施研究循环的每个步骤中。如果学员不清楚个别步骤，可以让他们详细参考学员手 册附录 1 中的矩阵图。 完成评估后，请各团队展示他们在练习中发现的明显的优点或缺点。倾听并指出你观察 到的团队间相对实力的明显差异，并鼓励一些团队在特定步骤中将自身视为其他团队的资源。 展示这张幻灯片，用你自己的语言逐一描述和解释这五个领域： 干预措施。干预措施的特点决定了干预措施是否会被采用。这里，“干预措施”一词包 括核心组成部分和那些可以适应当地需要和条件的要素。核心组成部分的复杂性、成本和证 据强度等特征发挥了关键作用。 外部环境。这包括实施干预措施的经济、政治和社会情境因素，这些因素反映实施组织 或机构的外部环境。它受到外部政策和激励——例如双边或全球资金流动——以及组织之间 的相互作用和同行压力的影响。 内部环境。这指的是实施组织或机构所处的情境。它包括组织的结构、文化和网络，以 及内部气候和变化的准备情况。 个人参与。这些个体在实施过程中有直接作用。他们包括卫生保健提供者、组织或机构 各部门管理者、决策者和其他利益相关者和受益者。除了对实施能力的常规关注外，他们关 于干预措施的看法和态度对其对于所承诺的项目成功实施和带来的影响都是至关重要的。 实施过程。这包括所有用于促进各级组织采取干预措施的方法和途径策略，包括策略和 活动的规划。过程包括那些明确计划的以及在实施过程中出现的难以预见的情况。 14 六、受众 [幻灯片 13-14] 实施研究涉及到一些具有不同和互补的技能、经验与背景的人员，解决实施问题并回答 卫生保健提供者、项目管理者、实施者和其他服务提供者在执行其职责时提出的问题。因此， 实施研究项目可包括研究人员和其他利益相关者，如卫生保健提供者、项目管理者、决策者、 学生、民间社会组织、非政府组织以及对实施研究过程和结果感兴趣的任何其他团体或个人。 工具包包括与保健提供者、研究人员、决策者和管理人员、行政人员、媒体和伦理委员 会成员有关的内容。 请学员基于幻灯片 10 中列出的各类受众和利益相关者，列出他们分别参与到实施研究 循环中的哪些步骤是尤为重要的。您应该告知学员，由于项目间的情境和性质不同，参与情 况可能会有所不同，因此没有错误的答案。 讨论开始后，使用幻灯片 11 来展示一个典型的参与场景。这可以促进学员们的讨论， 特别是他们对于参与情况存在明显不同的看法。 15 1 促进 单元 情境化实施研究问题 16 促进单元 1 一、学习目标和预期成果 本单元旨在强调情境和环境因素对实施研究项目的重要性。本单元增加了对研究环境、 具体干预策略和相关伦理考虑之间关系的理解。在本单元结束后，学员团队将能够： 1. 分析他们开展的实施研究项目所处的环境。 2. 理解和重视与他们提议或计划实施干预措施相关的情境。 3. 描述与实施研究项目相关的伦理原则。 二、本单元的关键概念 1. 理解实施研究情境 自然、社会经济和文化环境、卫生系统、利益相关者和制度文化是研究情境的关键因素。 它们共同促进并影响每个干预措施的计划、实施、监测和结果。在实施研究项目的前期实施 阶段，应该分析这些因素。需要注意的是，这些因素在不同的环境、不同的项目中都有很大 的差异。 2. 理解干预措施 政策改变、项目和规划等干预措施试图将已在实验室、临床试验或小规模试点研究中证明有 效的健康创新进行转移，造福更多人。实施研究面临的困境是，越是严格控制实施以确保已证实 的干预措施的保真度，当地的情境因素就越有可能降低其效果。 一个监测系统可以跟踪实施过程中的变化，并检查其与原计划的偏差，这对于支持干预的“逻 辑模型”至关重要。 3. 实施研究中的伦理考虑 从公共卫生的角度来看，研究伦理应该以适当考虑社会的相对风险和获益为指导，而不 是每个研究参与者个体。研究常常在那些贫穷和卫生保健水平都十分有限的中低收入国家中 开展，在这种条件下往往会造成某些冲突。 在开始授课前…… 请学员解释实施研究循环的第一步是做什么。这是对实施研究项目的六个主要阶段的 提醒，也是一个复习入门单元（前一天）内容的好机会。 幻灯片 2：实施研究循环（不带标签）。 随后，你还应重申实施研究中的四个主要交互领域。你可以让学员解释这张幻灯片所 描述的内容。 幻灯片 4：实施研究中的交互领域。 17 三、演讲大纲 [幻灯片 5] 对学员进行单元的总体介绍：例如，旨在强调特定实施研究项目的情境和环境因素的重 要性，并介绍伦理方面的考虑（学习目标和预期成果将在接下来的几张幻灯片中进行概述）。 强调本单元的三个关键概念。你可以提到，深入理解干预措施是很重要的。因为将关键 的情境因素和项目结合起来，对于干预措施产生预期的影响是至关重要的。 四、学习目标 [幻灯片 6] 请注意，学习目标的三个部分反映了本单元中提出的关键概念。 五、预期成果 [幻灯片 7] 将本单元所涉及的主题转化为学员将会学到的新知识。因此，导师最好在这个阶段与学 员确认他们是否掌握了本单元的核心知识。 关键概念 1：理解实施研究情境 [幻灯片 8] 为什么我们需要理解情境？可以就这个问题提问学员们。试着让他们了解在不同的情境 下干预措施是如何被（积极或消极地）影响。 你也可以用一个简单的案例研究来深入挖掘学员的观点：假如你是一名来自韩国的研究 人员，被派往朝鲜实施干预措施：为什么你需要了解相关的情境因素？ 经过验证的干预措施失去了对卫生系统的影响力 [幻灯片 9] 我们认识到，在某个环境下有效的干预措施在其他情境下的影响可能会被淡化甚至无法 产生效果。向学员提问：原因是什么？怎么会这样？ 显示幻灯片，当中含有来自学员手册里的图 4（解释图表）。分析情境（如卫生系统） 的主要目的之一是预测具体考虑因素会如何潜在地影响特定干预措施的可行性和效果。 关于这种因素的一个重要例子是在特定环境下的医疗公平或医疗不公平和健康的相关 社会决定因素带来的影响。 自然、社会经济和文化环境、卫生系统、利益相关者和制度文化 是研究情境的关键因素。它们共同促进并影响每个干预措施的计划、 实施、监测和结果。 由于各种特定情境因素的作用，降低了干预措施的影响/效果。 18 分析情境的四个维度 [幻灯片 10] 强调分析上述四个关键维度的重要性。详细说明环境、人口、社会经济状况、文化和政 治（即：维度 1）如何影响干预措施（或卫生系统）。 实施研究的情境因素 [幻灯片 11] 这张图（学员手册中的图 1）说明了实施研究影响因素的复杂性和数量，以及给干预措 施带来的冲击。在实施研究项目的预实施阶段，应根据需要考虑和分析所提出的因素。 在这个阶段，询问一些自愿阐述环境、人口、卫生系统、社会地位、文化和/或政治是 如何影响他们项目的人或许会比较有帮助。 分析环境 [幻灯片 12] 自然、社会经济和文化背景的各个方面可能是相关的，这取决于具体的干预措施。必须 进行仔细的规划，以便有效地将资源集中在最可能成为最关键的因素上。 卫生系统 [幻灯片 13] 当涉及到以健康为重点的干预措施时，其中最关键的情境维度是卫生系统，其通常由多 个子系统组成，主要重点是促进、恢复或维护健康。 明确说明卫生系统及其与其他部门的联系。 世界卫生组织确定了构成卫生系统的六个关键“基石”：领导/执政能力；卫生筹资；卫 生人力资源；医疗产品和技术；信息和研究；服务提供（图 2）。 举例说明：在索马里社区中，使用医用口罩对病人和医生都是 一项挑战。医生在与病人会诊时戴口罩会让人觉得病人患有高度传 染性疾病，如结核病。随着与结核病相关的病耻感增加，患者感到 羞辱，不被尊重，并认为医生很傲慢。这往往会影响医患关系和信 任，也会影响患者复诊或就诊的意愿。这也给卫生工作者和医生带 来了一个安全难题。 要注意的是，这些因素在不同的环境、不同的项目中都有很大的差异。 说明性的例子：相邻社区的政党从属关系会影响社区对干预措 施的感知和信任。在选举年引入一种新的干预措施，可以促进或阻 碍该计划的成功（例如，生物识别身份证可能与操纵选举或增加税 收的计划相关联)。 19 图 2：卫生人力资源 卫生系统的基石 其他因素亦有益于卫生系统，如自我护理和社区护理。对于与实施研究项目相关的组成 部分，进行系统的描述性分析利于识别相关决策主体和管理其运作的（正式和非正式）机构。 利益相关者分析 [幻灯片 14] 你应该强调，在任何实施研究项目开展前（即识别实施障碍、定义研究问题等）以及随 后贯穿整个实施研究项目的过程中，让多个利益相关者（及其机构）参与进来的重要性。 提问学员以下四个问题： • 谁是项目最重要的利益相关者？ • 你为什么需要他们？ • 你如何识别并吸引他们？ • 他们在你的研究项目中应该扮演什么角色？ 利益相关者分析旨在识别所有利益相关者，评估他们可能会如何受到研究的影响或如何 影响研究，以及他们对于研究结果的反应是如何的。提醒学员留意，想让不同利益相关者都 充分参与进来并非一朝一夕的事，需要进行艰苦的、面对面的磋商。 （学员手册的相关部分提供了利益相关者分析的例子）。 机构分析 [幻灯片 15] 机构或组织分析（系统研究组织行为）是在规划实施研究时需要考虑的另一个重要方面。 可通过强弱危机分析（“SWOT”）实现，从而确定影响干预措施成功或失败的潜在因素。 卫生系统的基石 目标或结果 卫生筹资 领导/执政能力 卫生人力资源 医疗产品和技术 信息和研究 服务提供领导/执政能力 改善健康状况（水平和质量） 反应性 财政风险保护 促进效率 获取 覆盖 质量 安全 利益相关者分析是研究人员在了解干预措施情境因素方面进行的 最重要的活动，而且应该系统、全面地进行。 20 思考活动 [幻灯片 16] 邀请学员对自己的实施研究项目进行思考，并确定在实施前和实施过程中应该考虑的环 境因素。鼓励他们考虑文化信仰和实践、政治结构、卫生系统的组织方式以及环境中广泛的 利益相关者。 组织简短讨论（约 15 分钟），让团队单独进行头脑风暴，并写下对这六个问题的回答。 通过全体会议回顾每个问题（根据可用的时间，请两个小组回答提问）。给每个小组 5-10 分钟的发言时间，在此期间尽量鼓励学员讨论。 关键概念 2：理解干预措施 [幻灯片 17] 政策改变、项目和规划等干预措施试图将已在实验室、临床试验或小规模试点研究中证 明有效的健康创新进行转移，造福更多人。实施研究面临的困境是，越是严格控制实施以确 保已证实的干预措施的保真度，当地的情境因素就越有可能降低其效果。干预措施越适应当 地条件，就越难将已证实的研究结果可以推广到其他地区或人群，因为结果取决于可能尚未 被很好理解的详细过程和途径。 一个能跟踪实施过程中的变化并检查是否偏离原定计划的监测系统是必不可少的。这样 的系统可以支持干预措施的“逻辑模型”。国际捐助者通常需要这样的模型，以简化对具体 干预措施如何发挥作用的解释。 实施研究过程中的阶段 [幻灯片 18] 干预措施的逻辑模型是基于连续阶段之间的关系： • 预干预阶段（即设置研究问题和目标、计划等）。 • 实施阶段 • 实施后阶段（即评估，发生了什么？） 分阶段地解释图表。 逻辑模型 [幻灯片 19-20] 逻辑模型也被称为“逻辑框架”、“因果路径”、“变化理论”或“项目矩阵。它们描述了一 项干预措施的输入、活动、输出、结果和目标之间的逻辑关系。虽然逻辑模型可以通过多种 方式呈现，但其构建的根本目的是评估各种干预元素之间的“如果-那么”（因果）关系。 开展有意义的实施研究需要深入了解：①预期的干预措施；以及 ②计划的实施过程（特别注意需要适应当地特定情境因素而做出修改）。 21 逻辑模型实例 • 如果进行了活动，那么应该会有产出。 • 如果形成了产出，那么应该会有符合目的的结果。 • 如果产生了结果，那么他们应该有助于实现目标。 那些管理干预措施的人被认为负责形成一组可定义的和可量化的产出。产出结果步骤经 常建立在对现有证据的假设和对情境因素的透彻理解上。 强调存在一些管理层控制之外的内部和外部因素，这些因素可以在不同层面（活动、产 出、结果和目标）对干预措施产生影响。 将逻辑模型编译为矩阵 [幻灯片 21] 留出 15 分钟，让每个团队根据自己的项目完成矩阵。 在全体会议上，请一个小组分别谈论他们的活动、产出、结果和目标。你应该对其进行 适当的鼓励反馈或评论。 复杂适应系统 [幻灯片 22] 有学者认为，许多健康倡议产生了所谓的“复杂适应系统”（CAS），在这种系统中，无 数系统与直接环境相互作用并因此适应环境。该思想提出，系统适应变化的环境——在当前 的例子中，特别是响应由给定的干预措施引起的变化。例如，一个常见的适应可以是形成了 新的组织联盟。 这部分解释了为什么干预措施可以在一种情况下成功，而在另一种情况下效果较差。它 还强调，由于行为的改变等原因，实施可能无法按计划进行。 为使逻辑模型中的每个步骤更为有效，与干预措施和外部情境因 素有关的假设必须是准确的。更好地把握个别步骤的弹性，就更有可 能使干预措施的整体实施获得成功。 注意：你应该强调每个项目的矩阵对于给定的项目来说都是独一 无二的，并且应该相应地调整活动、产出、结果和目标的数量。应提 到，假设可以与积极和/或消极因素相关。在学员的工作手册中提供了 一个完整的矩阵示例 （仅供参考)。 复杂适应性系统概念的基本内涵是，没有简单的方法可以“控制” 主体的行为。复杂适应性系统通常具有内在的不可预测性，对干预措 施的意外反应是普遍的。 22 免疫接种需求的反馈循环 [幻灯片 23] 与健康干预相关的是不同的复杂适应系统行为（路径依赖、突发行为和反馈循环）。所 展示的例子是免疫规划中的反馈循环，它可能产生积极或消极的影响。 让一个或多个学员自告奋勇地解释图表。 思考活动 [幻灯片 24] 这个作业应该在参加当前单元之前交给学员。请 2-3 个小组自告奋勇地提出自己的看法。 关键概念 3：实施研究中的伦理考虑 [幻灯片 25] 以人为研究对象的研究应受到基本伦理原则的约束，以保护个人、社区和整个社会免受 不必要的风险。 在实践中，这些原则可能会根据不同的情境而承担不同的权重，但在其有效性和用于指 导研究项目建议的必要性方面存在普遍的共识。 本节概述了主要的伦理困境，并考虑了它们与实施研究的相关性。 实施研究中的道德问题和原则 [幻灯片 26-27] 在介绍这张幻灯片和涉及人类受试者的伦理问题的三个原则后，与学员讨论实施研究中 的一些伦理困境。例如：语言障碍、贫困、获得保健服务的机会少、利益冲突等。接下来的 三张幻灯片详细介绍了伦理困境和存在缺陷的原则。 案例学习 [幻灯片 28] 展示案例研究，并邀请学员分享他们对案例研究所提出的伦理困境的看法和观点。为小 组工作留出 15 分钟，为陈述留出 5 分钟。 可能被研究对象/环境的特征影响的伦理原则 [幻灯片 29-33] 与学员共同浏览每张幻灯片，请他们提出可能被所描述的研究对象/环境特征影响的道 德原则和造成的后果。 思考活动 [幻灯片 34] 请学员使用幻灯片 26-30 中的信息来完成这个活动（在学员手册中也有复制）。请一名 志愿者陈述他们的结论。 23 关键概念的应用 [幻灯片 35-36] 把学员/团队分成五组。请各小组阅读学员手册中的案例研究，并讨论单元 1 中描述的 三个概念。每个概念应由一组人分析。 小组讨论 15 分钟，每个概念展示 5 分钟。 单元 1 的结尾 [幻灯片 37] 在下一次课程的前一天上午，请两个小组介绍以下内容的摘要： • 他们学习到的一样东西。 • 完成较好的一件事。 • 这个单元需要改进的一些方面。 24 2 制定实施研究计划书 促进 单元 25 促进单元 2 一、简介 本单元的目的是支持研究团队制定高质量的实施研究计划书，使他们在获得研究资金方 面具备竞争力。本单元的建议学习时间比工具包中的其他单元要长，旨在支持为期五天的研 讨会进程，本单元亦可作为一个单独的活动安排到整个实施研究研讨会的时间表中。 由于本单元的覆盖面很广，所提供的内容和活动的组织方式与工具包中的其他单元不同： 作为五节不同的课程，每节课对应解决计划书制定过程中的一个具体方面的问题。每一节课 程都由以下内容组成 [幻灯片 4]： • 学习目标：确定各小组在每节课程结束前将完成哪些工作。 • 内容介绍：提供必要的信息/示例，以理解撰写计划书的具体内容。 • 活动：通过练习来促进对内容的理解，将理论付诸实践。 • 小组讨论：通过讨论为学员创造提问机会，并考虑与他们个人项目相关的具体问题。 • 写作坊：为团队提供了一个机会，让他们每晚一起写作，撰写他们的计划书的内容。 二、单元前准备 这个单元也被分为了三个独立的阶段：研讨前，研讨中，研讨后（图 1 和幻灯片 5）。 在开始之前…… 我们可通过询问学员关于实施研究循环第二步的内容，从而提供了一个很好的复习机会。 这可以作为学员们对于整个实施研究项目中六个主要阶段的一个常规提醒。阐述每一个步骤 以及它们是如何相互连接的，包括核心圈的要素。提醒学员参与实施研究过程中涉及的不同 利益相关者，包括一些关键消息提供者。 [幻灯片 2：实施研究循环] 在这个阶段有必要向学员指出，虽然计划书的制定在整个实施研究循环中是一个独立步 骤，但即将制定的计划书涵盖了整个周期中的所有部分，并展示了整个实施研究项目。 这也可以通过重复实施研究中的四个主要的相互作用领域来实现。你可以请学员互相提 醒这张幻灯片所描述的内容。 [幻灯片 3：实施研究中的相互作用领域] 26 图 1. 本单元的三个阶段 在研讨会之前，学员/团队应完成一个线上部分，内容包括介绍关键的实施研究术语、 实施研究核心概念、研究框架、研究方案组成部分和适当的实施研究问题。在线课程大约需 要三个小时才能完成，其具体目标是： • 识别实施研究的特征。 • 描述实施/规模扩大，并将实施研究与这些过程联系起来。 • 将属于实施研究范畴的研究问题和相关研究进行分类。 • 总结框架特征并确定将其应用于实施研究的策略。 • 认识到如何将实施研究应用于不同的实施问题。 • 为资助申请而对实施研究的优先级进行分类。 • 审查各种实施研究利益相关者的作用，并确定适当的方法，将利益相关者整合到实 施研究规划和交流和传播结果中。 团队还应该完成初步的文献综述，以使他们能够在更广泛的背景下构建他们的实施研究 问题和目标。 学员还应填写一份单元前评估问卷。分享给您或其他导师，以便您可以在单元 2 开始前 评估学员的知识水平。根据学员回答中发现的内容，您可以充分利用导师团队经验进行单元 内容的调整，使其能够最大程度地满足学员需要。这必须由导师团队根据具体情况共同决定。 在研讨会结束后，各小组还需要完成一些具体的步骤，如补充文献综述、完成计划书中 不完整的部分、获得支持信/声明，以及获得伦理审查许可和其他必要的研究许可。单元前 评估问卷（见附录 1）。 研讨前 研讨中 导言 研究设计 研讨后 什么是实施研究？ 我们的团队应该有谁？ 我们的项目是什么？ 项目计划 影响 文献综述 支持信 伦理审查许可 完成计划书 附件 27 三、初始小组复习活动 [幻灯片 6] 将学员组织成较小的小组，每个团队的成员分到不同的小组。给每组分配七个主题中的 一个（见幻灯片），并要求每个小组准备一个约两分钟的汇报用于总结他们所分配的主题， 可借鉴研讨会前的在线单元或先前单元的内容。 每组应选择一名发言人在全体会议上来陈述他们的要点（两分钟）。 四、基金资助一项实施研究计划 [幻灯片 7-9] 编写高质量研究计划书的一个最根本的原因是，它可以让团队获得足够的资金或资源来 开展他们的研究。 这里要向学员解释的是，虽然可能有若干类别资助者/捐助者（例如，多边组织、双边 政府捐助者、私人基金会和信托基金 [幻灯片 7]），资金/资源调动的最重要方面是：在拟进 行的研究和对某一领域的研究感兴趣/愿意找到研究的捐助者之间找到正确的“匹配”[slide8]。 好的匹配或兼容性超出了对给定捐助者的兴趣领域或传统支持的领域，还包括通过其他几种 方式将潜在捐赠者的特征与拟进行的研究进行匹配： • 团队经验水平：捐助者往往倾向于非常成熟或积极进取的研究机构/个人。 • 所需资源/基金：资助者倾向于坚持一定范围的资助请求，以适应其投资规模和捐助 者的行政参与要求。这并不是说在资助者的能力范围内申请资金越少越好，因为许多组织对 愿意考虑的申请有最低限度的要求，以促使他们的投资管理更有意义。 • 时间和期限：捐助者通常有适用于特定的资源池的具体时间框架。项目可能需要找 到资金周期与他们自己的研究时间表相匹配的资助者，或者有一定程度的灵活性。例如，完 全时间表。 • 研究地点：大多数资助机制都有某种形式的地理标准。对较小的捐助者来说，这可 能是地区性或全国性的资助偏好，对于较大的捐助者，这可能包括一份有资格获得资助的优 先国家的具体名单。 五、捐助者/资助者在寻找什么？ [幻灯片 11-12] 有一种方法可以确保研究计划书满足资助者的要求：倾听他们的意见，并按照他们的要 研究团队为了确定合适的捐助者/资源而做的准备/调查越多，他们 的研究就越有可能获得资金 [幻灯片 9]。调动开展一个研究项目所需 的资源，首先是取决于研究人员对其潜在捐助者的了解程度，然后才 取决于捐助者对他们的了解。 28 求去做！一旦确定了潜在的资助者，在准备计划书时，应该首先仔细阅读他们对于计划书的 提交说明[幻灯片 10]。 通过幻灯片 10 中向学员提出广泛建议清单。提醒他们，清单里这些建议对研究人员来 说更像是“良好的职业习惯”，而不是只适用于撰写计划书的“成功准则”。 假设捐助者的兼容性很好，评审人更有可能接受那些具有潜在重大影响的计划书。向学 员解释[使用幻灯片 11]，这些信息可以通过计划书的内容来传达： • 提出激动人心的创新点/想法； • 避免假定评审人十分熟悉某一主题或对其具有充足的知识储备； • 列出现实的目标和时间表-不要过于雄心勃勃 • 限制出现过多众所周知的信息 • 实事求是地列出研究局限性； • 提供一份简洁明了的、文笔好的申请，并提供合理的预算。 一般是根据科学价值和政策相关性，采用特定的量表对实施研究计划书进行评级。 同样重要的是，您也应该与小组一起回顾幻灯片 12，以便强调一些出现在计划书中的 并且占有惊人比例的缺陷。提醒他们，计划书评审人往往本身就是经验丰富的研究者，因此 可以很容易地发现这些不足。 第一节课：撰写导言部分 本节课为学员们提供了对整个实施研究计划书的初步介绍，然后再进一步探讨导言部分 的内容细节。 学习目标和预期成果 [幻灯片 2] 在完成本节课后，学员将能够： • 描述典型的实施研究计划书的总体组成部分和组织结构。 • 为各自的计划书撰写一份导言。 • 为他们的计划书撰写研究问题。 什么使得实施研究计划书与众不同？ [幻灯片 3 和 4] 幻灯片 3 和 4 旨在突出“传统”研究计划书与实施研究计划书之间的主要区别。先浏览幻 灯片 3 的内容，不用将这种比较作为明确的教学目标。突出研究计划书的主要特点。当你切 换到幻灯片 4，强调实施研究计划书的独有特点，这样会让学员印象加深。 一般情况下，一份良好的研究计划书看起来就像是一项不错的研 究：合理、清晰、详细、创新、连贯。 29 强调实施研究计划书的鲜明特征，直接反映实施研究过程的具体特征，特别是研究问题 的起源和优先次序，以及研究过程中关键利益相关者的参与。 实施研究计划书的特征 [幻灯片 5-12] 实施研究计划书的组成部分略有不同，这取决于提交该计划书的供资机构的偏好。 学员手册包含了实施研究计划书的组成部分列表，并且对每个组成部分所涵盖的内容有 详细的解释。 图 2 总结了实施研究计划书的总体组成部分。此图包含在学员手册中，并在本节课的幻 灯片 7-12 中展示。当您展示这组概述了实施研究计划书组成部分的幻灯片时，务必要简明 扼要地介绍。本单元中每节课程的内容都有详细介绍——这只是为了给学员一个全局图，从 而对整个结构的一个快速概览。如果问题太详细，当你深入到课程的特定部分时，可以把它 们留在课后进行讨论。 按顺序展示这些幻灯片，鼓励学员就个别计划书中的要素发表评论、提出问题，并弄清 楚这些疑问。提醒学员，可以在他们的学员手册中查阅关于每个要素的详细描述。 如果在这个总体描述中学员有觉得任何不清楚的地方，他们应向您或其他导师寻求解答。 对每个计划书的元素的大致结构和目的有全面理解，这对单元 2 的其余部分至关重要。 导言 [幻灯片 13-33] 在本节课上，学员者通过起草导言部分来开始撰写他们的计划书的第一步。这包括撰写 实施研究计划书的两个最重要的部分：研究问题的概述和相应的研究问题。 导言包括以下分节： • 标题页 • 理论依据 • 问题陈述 • 目标和研究问题 • 文献综述 注：由于每个供资机构都有自己的格式和要求，本节课所涵盖的 一些内容可能并不是每一项实施研究计划书中都需要的，这里提供的 是一个通用指南。 一份实施研究计划书的导言会清楚、简洁地描述该研究是什么， 以及资助该项目的理由。它根据社区、卫生保健提供者、项目管理人 员或决策者所确定的需求，为开展这项研究建立了立项依据。 30 课程的目的是将每个要素的定义和基本描述结合为一体，概述每个要素的目的和理由， 并提供真实的实施研究策划案例作为实践指导。请您谨记，这节课的重点和范围将在一定程 度上为本单元的其余部分打下基础。 在您（和其他同事）讲授这节课之前，您应该要非常熟悉幻灯片 13-33 中的材料，以及 在学员手册中的相关章节中的详细的信息和额外的资源。还包括真实计划书文本的示例，您 应该选择或使用这些示例来说明演讲中的具体要点。如果有帮助的话，您还可以在某个给定 的节点上暂停讨论或演示，并让学员阅读或思考学员手册中的一个或多个示例，以此来强化 特定的知识点。 本节课涵盖了一系列相对较冗长的主题和问题，供学员吸收学习。他们能在一定程度上 将这些主题和问题与自己的项目联系起来，理论上整个小组应该能够完成的。出于这个原因， 当您在指导小组完成每个主题时，您应该尽量参考学员手册中的一些示例来说明具体领域。 您还可以将学员每个话题或主题与他们自己的项目和/或先前的经验联系起来，在他们/您的 进程中提高实践经验。这将有助于为课堂带来更多样化的节奏。 针对本节课的总结，要求团队们更直接地把重点放在各自的具体项目和计划书上，特别 是标题、问题陈述（1-2 页）、研究问题和具体目标。 小组活动 [幻灯片 34] 为了结束本节课，请每个小组就他们的研究项目着手解决的问题，起草一份特别陈述。 这是为了确保每个团队都将注意力集中在自己的项目上，并确保他们已经充分理解了当天对 整个导言部分的讨论。 请每个小组简要阅读他们的问题陈述，鼓励公开讨论和阐明这些问题。 晚间写作坊 [幻灯片 35] 在经历相当长的课程会议/一天之后，每个小组将被要求在晚上进一步形成关于导言的 简要部分。当你追踪一天的时间进度时，你应该记住这一点，并确保这一天结束后，团队有 足够的时间进行短暂的休息，然后再继续处理这些重要要素。 要求每个小组的成员就其导言的部分共同完成以下工作，并准备好在第二天会议开始时 做简要的汇报： • 项目标题。 • 完成计划书的问题陈述草稿（1-2 页）。 • 研究问题。 • 具体的项目目标（4-6 个目标）。 31 第二节课：研究设计 这节课旨在培养研究团队的能力，使他们能够确定具体的研究设计，从而最有效地实现 其研究目标和回答相应的研究问题，并将这些要素纳入到他们的计划书。 注：这一节课也相对较长，可能会持续两天时间。只有一个写作训练，但应该根据当天 课程结束时的休息情况分为两个部分--学员应该在第二天晚上尽可能地完成自己计划书的 研究设计部分。 学习目标和预期成果 [幻灯片 2] 在本节课结束之后，学员将能够： • 制定和撰写研究设计，概述研究项目中将用于收集和分析的数据的程序。 • 确定和描述研究方法（定性、定量或混合方法），这将最有效地实现研究目标并回 答相应的研究问题。 • 描述研究团队将用以确保研究质量的质量管理计划。 • 描述研究项目的研究对象。 解释他们将采取哪些步骤来确保所有伦理问题和程序都得到解决。 研究设计 计划书的研究设计部分借鉴了实施研究过程的几个阶段的要素，包括：确定研究对象； 选择最合适的研究方法；以及数据收集和数据分析 [幻灯片 3]。 四种常见的研究设计方案可以根据所选社区中的一般知识差距/需求以及相应研究方法 的特点来定义。用幻灯片 4 来指导讨论，总结四种类型的研究设计（例如，前后序列、横断 面研究、整群随机对照试验和直接测量/观察）。询问学员如何理解需求和研究设计之间的关 系，以及他们是否可以在确定/描述他们选定的研究设计之前清楚地了解做出这些决定的最 佳方法。 只有确定了最合适的研究设计后，才能确定相应方法，然后才能进行概述 [幻灯片 5]。 研究对象 由于研究对象的范围是实施研究项目最重要的明显特征之一，因此很重要的一点是，计 划书中应包含对研究对象的完整描述，如何选择研究对象和选择标准 [幻灯片 6]。 小组活动 [幻灯片 7] 请各研究团队坐在一起，简要地分享/讨论他们选定的研究设计，并概述他们的研究对 象范围。鼓励各小组分享他们的疑惑，并让所有学员对其他项目的研究设计进行评论或提出 有益的批评。 32 研究方法 重要的是，计划书就研究设计中将会使用的研究方法和途径提出了合理而且令人信服的 理由。幻灯片 8 展示了关于定性方法和定量方法之间主要区别的总结和提示。使用此幻灯片 来讨论每种标准以及这些标准在这两种方法之间的不同之处。要做到这一点，您可以要求某 些研究团队解释他们对给定标准的理解，以及定性和定量方法之间的区别。这使得各个团队 有机会围绕这些重要的概念开展讨论和团队合作。 然后，幻灯片 9-15 和 16-21 分别提供了挑选定性和定量的研究方法的平台，并在描述 混合方法之前更详细地介绍这些方法 [幻灯片 22-27]。 当您与小组一起浏览这些幻灯片/主题时，提醒他们使用不同的数据收集策略和分析计 划可以获得的丰富信息，以及在学员手册中提供的实际的例子，这些都与各种研究方法的优 缺点有一些详细的关系。在上这节课之前，您应该先回顾学员手册中的这一部分，以便熟悉 在小组讨论的内容和参考示例。 指导研究团队讨论哪些研究设计将最适合他们的实施研究项目。这类似于之前的课程中 的小组活动，但现在，在更详细地回顾了不同的研究设计和方法之后，各个研究团队之间应 该可以进行更深入和明确的讨论。一些研究团队可能带着预先存在的想法来参与课程，即关 于他们将使用哪些方法来收集数据。但现在，他们可能需要重新审视那些选择，并有可能再 次调整他们的想法。 团队可以使用学员手册中的示例来帮助他们创建一个包含其研究目标和研究问题的表 格，并确定将使用哪些数据来源来收集数据，以实现研究目标并回答先前确定的研究问题。 晚间写作坊 [幻灯片 29] 在晚上，学员应该继续他们的团队作业，以开发他们团队的项目计划书的以下要素： • 研究设计。 • 研究方法包括： – 数据收集的逐步过程； – 数据分析； – 可信度、有效性、可靠性； – 研究对象。 各研究团队应准备好在第二天开始时展示出计划书的这些部分的草案。 质量管理和研究伦理 [幻灯片 30-32] 质量管理对于新晋研究人员来说往往是一个难以捉摸的概念。因此需要注意，如果没有 清楚地描述如何在实施研究项目中实现质量管理，那么可能会严重影响实施研究项目的成效。 注：根据可用的时间和您对团队计划书进度的感觉，您可以暂时 休课一天，或者在开始剩下的课程，进入质量管理部分。 33 在他们的计划书中，学员应该详细说明他们将如何显示研究团队将采取一致的、持续的 措施来监测和评估研究的质量和严谨性。它们应说明它们将如何在不同阶段评估质量。 幻灯片 31 提供了一个有用的模型/图表，用以突出质量管理如何成为实施研究过程中必 不可少的一部分。你可以要求不同的团队指出在整个过程中的不同阶段会有遇到什么样的质 量问题和挑战，有哪些潜在的解决方案，以及它们将如何有助于监测/提高质量。 使团队牢记一点，对质量管理的关注就是代表着对研究对象的持续关注。例如，他们的 隐私将如何得到保护。将采取哪些措施保护他们免受伤害（例如，培训员工，遵守研究伦理 申请中的道德标准等）？ 这些都是影响潜在捐助者评审研究计划书的重要因素。 最后，通过幻灯片 33 提醒学员，与质量管理类似，实施研究计划书应传达对研究伦理 的明确承诺。各研究团队应该能够简要地提出一些方法来实现本幻灯片中概述的三个要素。 晚间写作坊 [幻灯片 34] 根据您上面关于何时结束本节课程的决定（见上面的注释），您将需要相应地删除第 29 或第 34 张幻灯片。 第三节课：项目计划 本节课上学员将努力制定其研究项目的总体计划，并将这些计划纳入其计划书中。一个 明确的项目计划不仅向潜在的资助者和支持者传达了研究的细节，它还传达出这样的信息： 该项目已经从实施和活动/资源管理的角度做出了详尽的考虑。如果完成得好，将有助于用 非常明显的方式证明项目的可行性。 学习目标和预期成果 [幻灯片 2] 在完成本节课之后，团队将能够： • 制定项目计划（工作计划/时间表），以指导项目的实施并监测项目。 • 制定工作时间表（例如，甘特图），以有效地开展和监测项目，包括要执行的任务 和活动，团队成员的角色和责任，以及要达到的里程碑和截止日期。 • 描述研究团队（包括每个团队成员所拥有的知识和技能，以及他们将如何为项目的 成功做出贡献）。 • 制定切合实际且与项目的具体目标和项目活动挂钩的分项预算。 • 为各种预算项目的测算理由提供必要的信息。 计划实施研究项目 [幻灯片 3-5] 项目计划包括工作安排、编制研究团队的计划和要求，以及构建和预测整个项目的现实 质量管理对于确保研究符合或超过科学、道德和监管标准至关重要。 34 资源需求估计[幻灯片 3]。与小组一起完成对项目计划的总体描述，并要求学员标出任何不 清楚的地方。 项目计划确定了在整个项目期间将完成的每一项任务和活动。 计划也是一份有助于利益相关者之间的沟通、协调、团队协作的文件。您的研究设计和 步骤将有助于确定您的项目计划中需要完成的任务和活动。 重要的是，学员们也要理解他们项目计划的理论依据 [在幻灯片 4 中有总结]。在学员 手册中有一个表格，更详细地列出了与三个项目规划阶段有关的主要活动[幻灯片 5]。 项目时间表 [幻灯片 6-8] 项目的研究周期应真实地反映执行项目计划的每个阶段所需的时间。在任何计划书中都 需要清楚和准确地描述研究周期，它会产生影响成果产出和完成最终研究报告的截止日期。 清晰、可行的时间表使资助者相信该项目遵循了严格的项目管理标准。 项目计划可以多种方式呈现[幻灯片7和8]，团队应该选择最适合具体项目需求的方式。 研究团队 [幻灯片 9-10] 计划书的研究团队部分应该简洁地描述团队成员和他们为项目贡献的技能/力量。本节 旨在说服评审人，团队的专业知识足以有效地开展所策划的研究。在实施研究项目中，团队 是跨学科和多样化的，计划书需要尽可能将背景和经验与基本的项目角色和责任相匹配。 从项目负责人开始，帮助各研究团队列出所有即将参与其研究的研究者姓名。学员手册 中的示例将为学员提供参考。 计划书还应包括计划中的研究团队管理结构的概要/摘要[幻灯片 10]。让学员将给出的 示例与各自的团队结构进行比较。提问他们这项练习对他们自己的人力资源规划有何启发。 小组活动 [幻灯片 11] 各小组应利用真实的实施研究计划书示例，反思过去一小时左右提及的内容，并撰写计 划书的以下几个部分的初稿： • 实施研究计划的三个阶段。 • 工作计划/活动时间表。 • 研究团队，包括专业知识和角色。 如果没有一个现实的计划，就不可能预测或确定在遵守项目时间 表、执行和/或完成项目的潜在障碍或制约因素，也不可能提出合理的 解决方案。项目计划还确定了项目的规模，以便能够制定适当的预算 来执行。 35 预算和测算理由[幻灯片 12-14] 计划书的预算应概述有效开展拟进行的研究所需的资金。 学员/团队需要仔细考虑他们实际上需要从资助机构获得些什么来支撑项目的开展。如 果预算过低或夸大，可能会对计划书的评审产生负面影响。 在你介绍/讨论了项目预算的总体描述后[幻灯片 12]，您应该让学员开始列出/展示的不 同类型的预算要素。他们可以通过拟计划开展的研究活动来思考：我们需要哪些资源或哪些 类型的资源来完成这项工作？ 讨论部分完成后，使用幻灯片 13 提醒学员们一些可能被忽略了的预算要素类型。 提醒学员，逐项列出每个资源后，就可以着手探讨和纳入这些资源的单位成本和总成本。 相关活动和成果的传播与评估的预算编制也很重要，但这在项目规划的早期阶段可能会被忽 视。最后，解释一下预算测算理由的要点[幻灯片 14]，以及为何需要牢记这些要点。 小组活动 [幻灯片 15] 在小组中，请学员回顾计划书预算模板 [由导师/组织者提供]。使用本节课中的信息和 预算示例作为指南，小组应该能够为他们团队的计划书制定预算。计划书的各个部分中，预 算的描述和测算理由可能会随着时间的推移发生很大的变化，因此将早期草稿记录下来是一 个重要的步骤。 第四节课：测量影响 实施研究计划书必须清楚地表明研究结果将如何对有关社区/人群的健康和/或卫生保健、 决策和研究社区产生影响。 在制定一个典型的研究/学术计划书时，其目的是产生新的知识和想法。相反，在制定 实施研究计划书时，目的是收集研究证据，以改进方案的实施。 为什么我们知道的和我们做的有这么大的差距？事实上，研究结果、最佳实践和指南需 要数年甚至几十年才能落实到卫生保健工作者的日常实践中，这也是促使人们更加关注和推 广实施研究的原因之一。 卫生系统的持续学习和改进需要一个监测和评估过程，以跟踪进展并在必要时纠正方向。 这应该作为核心价值和重点考虑因素明确体现在实施研究计划书中。 尽管关于卫生保健中的循证实践知识越来越丰富，但研究结果和 在实践中持续实施的内容之间仍存在巨大差距。扩大研究成果、有效 获得和提供干预措施是实施研究的核心目的。 36 学习目标和预期成果 [幻灯片 2] 在完成本节课之后，各小组将能够为其实施研究项目制定监测和评价计划、能力建设计 划和传播计划。 监测和评估活动 [幻灯片 3-6] 首先提问学员，他们认为监测和评估计划的主要目的是什么。然后展示幻灯片 3，让小 组成员将他们的答案与这份推荐目的清单进行比较： • 描述将如何评估实施研究项目是否达到其目标并实现了计划书中承诺的内容。 • 告知潜在的资助机构，他们投资的研究项目过去、现在和将来都是可靠的。 • 促进研究结果在卫生系统中的利用，以改善健康结局。 您可以使用幻灯片 4 中的清单，探讨学员们是否能提出监督所描述的活动的方法。到目 前为止，“为什么要监督？”这个问题的答案是显而易见的，但问题在于“如何监督？” 重要的是，在研究团队开始制定监测和评估计划时，就需要考虑如何监测这些活动。 计划书中还应列入评估计划。它必须概述如何评估一个项目是否达到其研究目标和是否 “成功”。当中还应该指出如何跟踪项目计划中出现的所有变化和各种问题。 一般来说，评估计划应考虑以下几点 [幻灯片 5]： • 明确谁将使用评估结果 • 描述所需的信息、来源和评估方法/工具 • 审查如何实现项目目标。 • 跟踪干预措施的预期影响。 • 阐明评价范围适宜性。 评估计划还应关注资助期满后的情况以及相关的可持续性。 团队能力和当地能力建设 [幻灯片 7] 在撰写实施研究计划书时，有两个具体的考虑因素可能有助于解决能力建设问题： • 该项目如何通过培训、指导等方式帮助提高国家和当地有关机构的研究能力。 • 该项目如何通过实施的过程，帮助提高卫生系统内开展实施研究的能力和需求。 顾名思义，如果没有严格和充分实施的监测和评估计划，就不可 能成功地完成一个实施研究项目。 监督和评估是对项目各个阶段的成功和影响做出评价。 37 • 应在计划书中尽可能提及和阐述这两点考虑。 当你在解释这两点时，请学员/团队思考和评价他们的具体项目如何促进国家和当地的 研究能力，以及如何有助于促进研究成果和结果的吸收利用。 传播计划 [幻灯片 8 和 9] 传播研究成果是该工具包中一个特定单元的主题。这反映了在实施研究计划书中描述项 目信息传播计划的重要性。大多数供资机构都热切希望看到他们对项目的财政支持如何延伸 到关键受众和利益相关者。 幻灯片 8 对传播策略的主要特征做出了很好的总结。你应该先让小组成员通过了解这些 要点找到一个大致的方向。 接下来应该展示幻灯片 9，该幻灯片提出了一系列很好的问题。你可以利用这些问题来 进一步探讨学员的项目已经/应该如何整合传播计划，谁是他们可能的目标受众，以及他们 如何能够在研究过程中尽早让利益相关者参与进来。 您应该指出，传播过程必须是实施研究项目周期的一部分，而不是在研究结束时进行的 “附加”活动。让利益相关者尽早参与传播进程，将加强对研究进程的自主权，并最终吸收 采纳研究成果。 学员手册包含一系列具体步骤，以供研究团队在讨论和确定其传播策略和相关需求时使 用。本手册系一个通用性指南，使用者可以根据具体项目进行修改和定制。最终结果应是一 项具有情景敏感性的策略，旨在向特定受众传播特定的研究结果。 研究团队应该专注于创造特定的信息产品。单元 5 中将重新详细讨论这一点。 小组活动 [幻灯片 10] 请小组回顾传播计划的示例（见学员手册），并考虑该传播计划的哪些方面可能有助于 他们的计划书？哪些方面是不合适的？ 晚间写作坊 [幻灯片 11] 指导团队在晚间制定他们的实施研究计划书的以下关键部分： • 监测和评估计划 • 能力建设计划 • 传播计划 它们还应做出任何必要的修改，以改进、更新或调整其计划书的所有部分。 强有力的传播策略的特点是：双向对话；适合特定受众的精确定 制的且有针对性的信息；评估相关指标的机制，以便对策略及其产品 进行修订和改进。 38 第五节课：附件 在本节课上，小组将撰写其计划书的最后几节。这包括项目摘要、目录、附录和研究人 员简历有关的信息。 在本节课结束时，将有一个最后的“课间写作”来准备这些内容，回顾现有章节，并更 新/调整整个计划书。 最后，各团队将准备/制作约 20 分钟的汇报，并接收对他们计划书的反馈意见。 学习目标和预期成果 [幻灯片 2] 在本次课程结束之际，团队将能够： • 为他们的计划书做一个总结。 • 制定目录列表。 • 确定在他们的计划书中需要包括哪些附录材料。 • 为研究人员简历设置一个模板。 • 准备 20 分钟的汇报，总结他们的计划书。 项目摘要 [幻灯片 3 和 4] 项目摘要（有时也称为摘要或执行摘要）简要描述了整个计划书。研究人员通常最后再 撰写总结或摘要，因为这时他们最能简明扼要地描述他们的研究计划书。 根据供资机构的要求，总结/摘要可能被限于 150-200 字（摘要）到一页（总结）。 指导团队完成对项目摘要的描述[幻灯片 3]，并让他们在回顾摘要清单时[幻灯片 4]，分 别描述一个要点。 目录 [幻灯片 5] 目录通过概述计划书中的内容以及每个条目的位置来组织计划书。目录按照逻辑顺序一 目了然地展示了计划书的主题和各个章节。 附录 [幻灯片 6] 附录包含了项目中的一些读者/评审人次要感兴趣的方面。附录假设读者可以从计划书 正文中获得所有的必要信息，如果他们需要或想要额外的信息，他们可查看附录。附录可能 包括研究人员简历、研究工具或证明团队进行所策划的研究或与参与研究的关键合作伙伴达 成合作的证明信件。 计划书的总结或摘要可能是最重要的段落/页，因为它会使评审人 留下“第一印象”，并可能影响他们是否选择资助该项研究。 39 研究人员简历 [幻灯片 7] 团队可能希望确保至少有一个成员有实施研究经验，良好的业绩和论文发表记录。诸如 社区信誉等补充性优良品质同样重要。 晚间写作坊 [幻灯片 8 和 9] 指导小组成员根据以下方面撰写自己的计划书： • 项目摘要（一页）。 • 标题页。 • 附录（列出所有附录的列表，并添加准备好的附录）。 • 研究人员的简历（创建简历组件的模板，以便所有研究人员都有相同的格式）。 • 检查计划书的所有组成部分并更新/调整。 • 作为写作活动的延伸，小组应准备一份 20 分钟的汇报（幻灯片或海报演示），涵盖 其实施研究计划书的所有内容。 小组汇报 [幻灯片 10] 各小组将在全体会议上对其计划书作 20 分钟的汇报展示。随后将有 20 分钟来供大组和 导师发表评论、提问、建议和意见。 40 研讨会表格 此部分包含一些研讨会表格。在研讨会期间，根据指示选择并完成适当的表格。完成后将表格交 回给导师。 41 学前评估问卷 本调查的目的是从您那里获得相关的信息，这些信息将被教学团队用于指导学员撰写和 完成一项高质量的实施研究计划书。 是什么促使你来参加本课程？ 设计该课程时，是否需要考虑参与课程的学员们的个人、文化或学习特征？请详细说明： 你希望通过参加该课程学习或获得什么？ 你想在这个课程中看到什么特定的内容？ 在设计这个研讨会时，你会建议我们考虑哪些教学/学习策略？ 为了使研讨会成功进行，你（和你的同事）需要获得什么样的支持？ 您是否有其他可能有助于方案设计和实施的意见？ 感谢！ 42 计划书清单 当你在课程中工作时，使用这个清单来跟踪你的进展。 前言 标题 导言 问题概述 理论依据 问题陈述 研究目的 研究问题 文献和参考文献综述 文献综述是什么 当回到自己所在社区时进行文献综述需要采取的步骤 为什么正确引用很重要 如何引用参考文献 研究方法 定性方法 定量方法 混合方法 研究设计 描述研究对象和场所 描述数据收集程序 描述数据分析程序 描述伦理道德程序 项目计划 如何制定项目计划 项目团队中应该包括哪些成员，以及如何描述他们的作用 如何制定和证明项目预算 如何制定质量标准策略 如何制定监测和评估计划 影响 如何制定能力建设和传播计划 如何撰写实施研究计划书的总结（一页） 如何编制目录（使用软件包） 如何编制附录 如何编制研究人员的简历（创建模板） 如何准备封面 如何写摘要 实施研究计划书&资助机会 43 第一节课 评价表 第一节课 实施研究计划书的组成部分 请指出你对以下关于研讨会课程的陈述的同意程度 强 烈 不同意 不同意 尚未决定 同意 强烈同意 不适用 我很享受这个课程 O O O O O O 在这课程中，我学到了关于如何 写撰写研究计划书的知识和技巧 O O O O O O 课程的时间长度很合适 O O O O O O 课程涵盖的主题具有相关性 O O O O O O 学习目标很明确 O O O O O O 课程安排得当 O O O O O O 教学策略是有效的 O O O O O O 理论和实践技能的平衡很恰当 O O O O O O 导师知识渊博 O O O O O O 导师有效地传达了信息 O O O O O O 导师起到了支持作用 O O O O O O 课程提供了有用的资源 O O O O O O 在教学过程中获得的知识将对我 未来的工作有所帮助 O O O O O O 44 请提供意见，特别是你认为有需要改善的地方；欢迎举例说明，提出建设性提议和想法！ 本次研讨会课程中最有价值的方面是什么？ 如何改进这个研讨会课程？ 45 第二节课 评价表 第二节课 研究过程 请指出你对以下关于研讨会课程的陈述的同意程度 强烈 不同意 尚未决定 同意 强烈同意 不适用 不同意 我很享受这个课程 O O O O O O 在这课程中，我学到了关于如何 写撰写研究计划书的知识和技巧 O O O O O O 课程的时间长度很合适 O O O O O O 课程涵盖的主题具有相关性 O O O O O O 学习目标很明确 O O O O O O 课程安排得当 O O O O O O 教学策略是有效的 O O O O O O 理论和实践技能的平衡很恰当 O O O O O O 导师知识渊博 O O O O O O 导师有效地传达了信息 O O O O O O 导师起到了支持作用 O O O O O O 课程提供了有用的资源 O O O O O O 在教学过程中获得的知识将对我 未来的工作有所帮助 O O O O O O 46 请提供意见，特别是你认为有需要改善的地方；欢迎举例说明，提出建设性提议和想法！ 本次研讨会课程中最有价值的方面是什么？ 如何改进这个研讨会课程？ 47 第三节课 评价表 第三节课——研究计划 请指出你对以下关于研讨会课程的陈述的同意程度 强烈 不同意 尚未决定 同意 强烈同意 不适用 不同意 我很享受这个课程 O O O O O O 在这课程中，我学到了关于如何 写撰写研究计划书的知识和技巧 O O O O O O 课程的时间长度很合适 O O O O O O 课程涵盖的主题具有相关性 O O O O O O 学习目标很明确 O O O O O O 课程安排得当 O O O O O O 教学策略是有效的 O O O O O O 理论和实践技能的平衡很恰当 O O O O O O 导师知识渊博 O O O O O O 导师有效地传达了信息 O O O O O O 导师起到了支持作用 O O O O O O 课程提供了有用的资源 O O O O O O 在教学过程中获得的知识将对我未 来的工作有所帮助 O O O O O O 48 请提供意见，特别是你认为有需要改善的地方；欢迎举例说明，提出建设性提议和想法！ 本次研讨会课程中最有价值的方面是什么？ 如何改进这个研讨会课程？ 49 第四节课 评价表 第四节课——影响 请指出你对以下关于研讨会课程的陈述的同意程度 强烈 不同意 尚未决定 同意 强烈同意 不适用 不同意 我很享受这个课程 O O O O O O 在这课程中，我学到了关于如何 写撰写研究计划书的知识和技巧 O O O O O O 课程的时间长度很合适 O O O O O O 课程涵盖的主题具有相关性 O O O O O O 学习目标很明确 O O O O O O 课程安排得当 O O O O O O 教学策略是有效的 O O O O O O 理论和实践技能的平衡很恰当 O O O O O O 导师知识渊博 O O O O O O 导师有效地传达了信息 O O O O O O 导师起到了支持作用 O O O O O O 课程提供了有用的资源 O O O O O O 在教学过程中获得的知识将对我未 来的工作有所帮助 O O O O O O 50 请提供意见，特别是你认为有需要改善的地方；欢迎举例说明，提出建设性提议和想法！ 本次研讨会课程中最有价值的方面是什么？ 如何改进这个研讨会课程？ 51 第五节课 评价表 第五节课——附件 请指出你对以下关于研讨会课程的陈述的同意程度 强烈 不同意 尚未决定 同意 强烈同意 不适用 不同意 我很享受这个课程 O O O O O O 在这课程中，我学到了关于如何 写撰写研究计划书的知识和技巧 O O O O O O 课程的时间长度很合适 O O O O O O 课程涵盖的主题具有相关性 O O O O O O 学习目标很明确 O O O O O O 课程安排得当 O O O O O O 教学策略是有效的 O O O O O O 理论和实践技能的平衡很恰当 O O O O O O 导师知识渊博 O O O O O O 导师有效地传达了信息 O O O O O O 导师起到了支持作用 O O O O O O 课程提供了有用的资源 O O O O O O 在教学过程中获得的知识将对我未 来的工作有所帮助 O O O O O O 52 请提供意见，特别是你认为有需要改善的地方；欢迎举例说明，提出建设性提议和想法！ 本次研讨会课程中最有价值的方面是什么？ 如何改进这个研讨会课程？ 53 3 促进 单元 计划开展实施研究项目 54 促进单元 3 一、简介 向学员们介绍本单元的概况。例如：本单元主要论述的是：计划、开展实施研究项目的 关键步骤，包括：申请伦理审查，制定实施方案以及良好的实施研究原则和实践。这些流程 将以一个具体的实施研究项目作为范例进行展示。 二、实施研究的六个步骤 [幻灯片 2] 三、本单元的关键概念 • 寻求伦理许可 • 项目实施进程 • 实施研究中的良好实践 四、演讲大纲 [幻灯片 3] 与学员一起阅读演讲大纲，确保他们了解大纲所涵盖的内容。其中包括学习目标、预期 成果、本单元的三个关键概念（寻求伦理许可，项目实施进程和实施研究中的良好实践）以 及在现实生活中对这些关键概念的应用。 五、学习目标 [幻灯片 4] 本单元旨在提供有关开展研究的各个步骤的信息，包括： • 申请伦理审查； • 项目实施规划； • 实施良好的实施研究原则和实践。 在开始之前...... 进入第三单元前，大多数学员已经学习了两个“入门”单元（例如：背景介绍和单元 1）， 并且很多人也完成第二单元，学习了如何准备项目计划书和获得开展项目的资金。 但尽管如此，我们认为有必要让学员花些许时间在开始该单元时再次回顾整个实施研究 的流程/框架。使用幻灯片 2 中的实施研究循环图提醒学员：计划和开展实施研究是第三步。 55 六、预期成果 [幻灯片 5] 提醒学员（本模块）着重于计划研究如何进行的基本步骤，包括： • 申请伦理审查； • 项目实施规划； • 实施良好的实施研究原则和实践。 这些流程将会被展示，以一个（具体的）实施研究项目作为范例。在本单元结束时，学 员将能够： • 描述伦理要求和过程。这有助于他们顺利提交用于伦理审查的研究项目方案。 • 在一个项目周期中描述相关伦理流程。 • 系统性地描述实施一项研究项目的步骤。 • 理解良好实践在所研究项目的整个周期中的价值。 关键概念 1：寻求伦理许可 实施研究提出让人感兴趣的伦理道德观点，因为它经常涉及多方面问题并与卫生服务相 衔接。因此，实施研究者可能会发现难以区分常规医疗保健和研究过程。当两者的界线变得 模糊时，可能难以确定潜在的伦理考虑因素，尤其是在参与式研究的情况下。从项目初始计 划部分就开始考虑研究的伦理问题是十分重要的。 关于伦理审查/许可的经验 [幻灯片 6] 我们通过要求学员分享寻求伦理许可的经验来开始探索这一关键概念： • 你机构中的机构审查委员会和/或伦理审查委员会的提交要求是什么？ • 在你机构中获得批准需要多长时间？第一次审核后未获批准的原因可能是什么？ • 机构审查委员会和伦理审查委员会是否会收取审查费用？ 你还可以根据的自身经验提供示例。 研究资助机构要求在发放项目资金之前，项目研究计划书需要获 得相应的伦理审查委员会批准。伦理审查委员会将会审核研究计划书 并要求研究者提供有关于研究计划和步骤完整的细节。 56 提交研究方案 [幻灯片 7] 伦理审查程序对于确保研究项目对研究对象的尊严、权利、安全和福祉至关重要。需要 有该研究方案的书面批准、书面知情同意书（最好采用当地语言）和明确的招募程序。 在你展示这张幻灯片之前，请询问学员：“研究方案应该包含什么内容？” 然后向学员展示研究方案的内容清单，看看学员的答案与内容清单是否匹配。该幻灯片 总结了机构审查委员会/伦理审查委员会经常需要的文件。除此之外，我们还需要学员添加 该清单中可能未包含的其他内容。 讨论在寻求伦理许可时，为什么项目负责人和其他成员的简历是重要的。 寻求伦理许可 [幻灯片 8] 当伦理委员会签发批准证书时，将会告知项目负责人后续需要定期进行伦理审查。在实 施研究中，研究团队持续对其干预行为进行监控和审查，以确保与项目计划和实施有关的结 果是有意义的并且符合实际。由于在此过程中可能会出现意外情况，因此，对原研究计划的 改变可能更符合该项目和研究对象的最佳利益。 在这种情况下，我们可能会对用于伦理审查的原始研究方案进行一些修改。注意，实施 研究团队对于任何有关于原始研究方案或步骤做出的重要改变之前，必须先通知伦理委员会。 知情同意书的内容 [幻灯片 9-10] 询问学员在知情同意书中必须要包含哪些基本要素或信息。请其中一位学员（志愿者） 将这些内容写在图上，以便你将这些内容与下一幻灯片的信息做比较。 知情同意确保个人可以根据自身兴趣、价值观和偏好来自由决定是否参与到该项目中。 说明性示例：提交伦理审查计划书时，研究团队可能会指定由该 机构的护士每天为患者进行注射。然而在研究过程中由于出现某些不 可预测的情况，使得原计划中的注射流程变得低效。这时，研究团队 可在进行定期进行伦理审查时把握机会更新伦理计划书。 在项目实施和伦理审批过程中需要持续不断地去考虑各种伦理问题。 57 知情同意不仅仅是一种合同义务，其更应被理解为一个从研究对象最初接触到该项目（招募 过程）到该项目结束的全部过程。 该过程的建立需要四个基本要素：1）准确且合适的信息。2）理解该研究的目的和步骤。 3）研究对象的接受程度。4）自愿参与。 为了确保研究对象的同意是有效的，团队应使用研究对象的当地语言来解释相关信息。 团队需注意文化敏感性。比如，在某些国家，某些家属可能会要求参与到知情同意的过程中。 机构审查委员会/伦理审查委员会评论的实例 [幻灯片 11] 向学员展示机构审查委员会/伦理审查委员会评论的实例。标出那些在之前幻灯片中已 讨论过的要素。 思考活动 [幻灯片 12] 曾经有一名研究员对在“中途之家”（为出狱者、出院病人等提供社会适应服务的场所） 的患者进行研究。这项研究提到健康工作者每天要前往“中途之家”来执行注射。由于交通 不便，导致这些工作人员无法每天都来到“中途之家”。那么，这些工作人员应该训练研究 人员去执行日常注射吗？ 这种情况会引发什么伦理问题（如果有的话）？如何解释这个（些）问题？ 给每一组成员 15 分钟的讨论时间，然后让他们进行全面汇报。从伦理角度来讨论该问 题，特别是要关注如何在不需要重新向伦理委员会申请批准的情况下修改研究方案。 关键概念 2：项目实施进程 项目实施包括对既定活动的开展和监测，并依据情况更新和修改研究计划。这些活动包 括：组建研究团队、申请后勤需要以及分配活动和任务。 此外，必须明确研究地点、项目活动时间表和数据收集步骤。这个阶段还包括项目的结 题和评估，以及研究过程和结果的报告和传播。 实施包括哪些内容？ [幻灯片 13] 当完成项目工作计划，并得到所有相关方的同意和有关管理团队的批准之后，即可开始 项目的实施。 58 解释幻灯片中所概述的每个步骤。与此同时，请让学员对以下问题进行评论：利益相关 方、合作伙伴和一线工作者应该在何时以及如何参与到实施工作中。团队领导者在每个步骤 中需发挥哪些具体作用？ 项目监测 [幻灯片 14] 向学员展示插图，并强调质量、成本和时间之间达到平衡。在整个项目当中，研究者必 须对该三个要素进行测量、对其结果进行分析并做出适当的响应，以在时间和成本之间取得 平衡，从而提高研究质量。 更新和修订研究计划 [幻灯片 15] 实施研究项目并不总按预期计划进行。因此，随着实施进程的推移和更多信息的获取， 可能需要对项目进行调整。应定期检查事先设定好的程序（比如：抽样和数据工具），将实 际情况与原定计划的步骤进行比较，以便进行任何必要的调整。员工培训是这一过程的关键 部分。 开始实施进程 [幻灯片 16] 这里的重点应放在项目启动上：谁应该负责项目启动的相关活动，谁应该参加，明确启 动的目标以及项目成员、利益相关者、合作伙伴和一线工作者各自的角色。 在开始项目实施之前，团队成员应该回顾项目的目标、目的、指标和工作计划。他们应 该解决潜在的问题并建立沟通机制，以确保实施过程中的团队合作。 团队领导者/项目负责人必须确保项目按时开始，并遵守已商定的绩效标准。 定期的项目监测可以确保团队始终知道项目是否在朝着目标进行 着。监测工作应该由项目负责人领导，但这也是一项团队活动。其可 对问题或机会进行预测和快速响应，并有助于确保成功实施。 实施研究是一个动态的过程，在开展过程中往往需要调整、灵活 和宽容。对研究过程的这种变化/调整必须加以记录、协调和监督，以 确保可信度和保真度。 59 这里的重点应放在项目启动上。 • 为什么项目启动重要？（请学员回答） • 谁应该负责项目启动的相关活动？ • 谁应该参加？ 明确启动的目标以及项目成员、利益相关者、合作伙伴和一线工作者各自的角色。这一 过程应由项目负责人主导。 关键概念 3：实施项目中的良好实践[幻灯片 17] 这张幻灯片展示了实施研究中基本的良好实践-透明和清晰-以及良好的数据管理。 实施研究所收集的数据必须可靠，所以记录过程很重要。良好的研究实践可以确保获得 可靠的数据，减少由于干预措施本身的有效性存在不确定性或者实施步骤不清晰而获得不确 定结果的风险。仔细阅读以下问题，这些问题应作为良好记录的基础： • 正在发生什么？ • 为什么会以这样的方式发生？ • 这是我们所预期的吗？ 在记录过程中必须保持客观性，并报告正面和负面经验。 关键概念的应用 [幻灯片 18] 确保各团队成员已阅读了完整的参考资料。 请三个团队分别介绍先前他们所了解的三个关键概念中的其中一个概念，并概括其在项 目中的应用。每个团队应参考每个关键概念的详细描述（见学员手册），从中选择他们认为 最重要的概念进行介绍。 请参考学员手册中关于应用关键概念的实例（Beak 等，2007）。 注意：本幻灯片中列出的其他考虑因素在学员手册中会有更详细的解释。 示例项目：南非夸祖鲁-纳塔尔省“Mothers2Mothers”计划评估的 主要发现。 60 4 数据、分析和展示 促进 单元 61 促进单元 4 一、简介 向学员们介绍本单元的概况。本单元旨在概述实施研究的数据分析和解释的基本原理 （这是实施研究循环中的第四步）。本单元还描述了针对目标受众而设计的数据分析、呈现 和解释，以期更好地吸收理解并利用研究结果。这个单元并不是一门关于生物统计学或定性 研究方法的课程。 二、实施研究过程中的六个步骤 [幻灯片 2] 当你讲授本单元时，请先简短地再次回顾整个实施研究流程/框架。使用幻灯片 2 中的 实施研究循环图来提醒学员：数据管理、分析和呈现是该循环的第四步。 在你开始之前...... 我们假定学员已经熟悉定性和定量两种数据收集方法和工具。简要提醒一下，请要求学 员们描述一下两者的主要区别 [幻灯片 3]。 以下是一些可用于促进学员们讨论/探索的示例： • 研究目标：数量规模 vs 理解现象？ • 研究问题：有多少 vs 为什么或怎么样 • 方法学差异： – 演绎法 vs归纳法 – 线性 vs 迭代 – 数据分析：数量 vs叙述 • 强调：①定性研究关注对各种社会现象的发展解释；②定性研究捕捉世界的主观观念， 并试图回答以下问题： – 为什么这个问题/主题能引起人的兴趣，它为什么重要或者为什么它与政策相关。 – 目的或具体目标是什么？ 在讨论过程中，提醒学员们可在学员手册表 1 中找到关于这些差异的总结 [也包括幻灯 片 4]。 62 单元 4a： 定量数据管理，分析和呈现 一、演讲大纲和关键概念 [幻灯片 6] 与学员们一起仔细阅读议程，以确保他们了解本次课程的内容。强调本单元将涉及的关 键概念。下面的简要说明将会帮助你促使学员在会议开始之前说出他们对于每个概念的理解。 （学习目标和预期结果将在随后的幻灯片中详细说明。） 二、本单元的关键概念 1. 数据分析计划 大部分实施研究项目使用混合方法，将定性和定量技术结合在一起。在合适的情况下， 混合方法比单独使用其中一种方法能更好地理解问题。 为了确保数据分析能按照计划进行，应首先制作一份数据分析计划。该计划包含对研究 问题的描述，以及此过程中将要进行的各个步骤。 2. 定量数据分析 在实施研究，定量数据分析应包括以下至少一个考虑因素： • 频率分布和汇总统计。 • 关系和混杂变量。 • 亚组分析。 • 统计模型。 • 从样本到总体的概括。 • 趋势分析。 3. 数据管理 为了确保数据质量和完整，必须使用有组织的、一致性的和可复制的程序和方案来收集 和处理数据。例如，原始数据的记录必须及时、准确、清晰且能永久保存。 三、学习目标和预期成果 [幻灯片 7] 本单元结束时，学员将能够： • 描述数据分析计划流程。 • 了解合适的统计方法。 • 了解数据管理方法。 63 关键概念 1：数据分析计划 向学员指出影响整个数据分析计划的主要考虑因素是与以下方面有关的要求： • 利益相关者的沟通目标； • 预期的实施研究成果； • 适当的信息展示的格式。 最终的分析方式的确定是在按实际需求设计数据分析和按目的设计分析之间做平衡。 根据实际使用设计数据分析 [幻灯片 8 和 9] 按实施研究需求来设计数据分析的前提是实施研究旨在：①了解实施过程，重点关注那 些支持或限制这些过程的机制。②将对实施过程的理解与各利益相关者进行交流，这些利益 相关者可能会因此将相关结果纳入当前和/或今后的研究中。 因此，必须仔细考虑分析，最重要的是展示研究发现，以避免对研究结果产生错误的理 解，从而导致不合适的结论和/或反应的产生。幻灯片 9 中详细介绍各类利益相关者，请学 员就各自的信息需求发表意见。强调每个类别之间的区别，并选其中一类进行详细阐述。 按目的设计数据分析 [幻灯片 10] 在设计数据分析时，一个重要的初步考虑是通过确定要解决的具体问题来明确定义数据 分析的主要目标。 讨论不同的术语，并强调有效性、效率、公平性和可持续性是干预措施的情境要素。那 么一项干预措施有哪些不同含义？以及如何能做到效率高、有作用、强调公平并具有可持续 性？请参考以下定义，并在小组中进行讨论： 有效性：旨在修改实施过程，以改善收益的产生。 效率：尝试评估对实施过程可能进行的修改的影响，以提高与资源相关的收益。 公平：关注分配问题，即收益和资源成本的分配方式。 可持续性：着重于识别必要的投入、识别对其可用性的潜在限制，并识别其他可能限制中长期可 持续发展的因素。 应该强调简单性和可解释性，因为利益相关者既要理解所提供的 信息，也要能够正确地解释它。 64 数据展示格式 [幻灯片 11 到 27] 数据报告应该以文本和视图的格式来呈现，比如： • 表格 • 流程图 • 曲线图 • 信息图 • 地图 请向学员们仔细介绍幻灯片 12 到 27 页，着重强调不同的呈现格式的优缺点，并提醒他 们：如何选择呈现格式也是数据分析计划的一部分。 思考活动 [幻灯片 28] 在项目团队中，请学员讨论两个内容：他们需要传播的研究结果以及用于不同利益相关 者群体的数据呈现格式。 给予组员 30 分钟讨论时间并要求其提供简要报告。组员还需分析在讨论期间内产生的 问题或挑战。 关键概念 2：定量数据分析 实施研究中数据分析的形式部分取决于研究问题的性质和对描述或分析方法的需求 [幻灯片 29]。 定量分析中的变量通常按其衡量尺度分类，如下所示 [幻灯片 30]：。 • 连续型数值变量-例如孩子的体重，疫苗接种数量。 • 离散型数值变量（基于预定的相等间隔）-例如，温度，一些伤残测量指标。 • 有序分类变量（排名）-例如，设施水平，生活质量指标。 • 名义变量（类别）-例如地区名称。 请解释该四种测量类型，并请学员通过例子来发表自己的见解。 通常来说，无论对由研究问题决定的描述或分析方法的需求如何，定量数据分析都关注 需要谨记，实施研究的数据本质上不是为了简单地描述干预措施，而 是为了改进干预措施。 65 以下至少一个考虑因素： • 频率分布和汇总统计。 • 关系（和混杂变量）。 • 亚组分析。 • 统计模型。 • 从样本到总体的概括。 • 趋势分析。 在描述个别方法前，请向学员介绍描述性研究中常见的方法 [幻灯片 31]： • 分布和汇总方法。 • 确定频率分布的间距。 • 统计摘要和频率分布。 简要介绍每个方法，并向学员们说明它们会在 [幻灯片 32-38]被更详细地介绍。在本次 课程之前，你可以阅读下面的说明以获取一些意见或想法。 分布和汇总方法 [幻灯片 32] 定量研究会产生大量需要整理和汇总的数据。频率分布有助于更好地了解数据是如何变 化或者相互关联。该方法揭示并总结了在一个研究总体中所研究变量的数值分布。 基于此目的而使用的频率分布有几个优点： • 适用于所有类型的数据。 • 即使是对于没有专业知识背景的听众来说，频率分布也很容易被解释和理解。 • 可以通过图表和其他不同的格式来呈现数据，以帮助解释。 说明性示例： • 特定人群内，不同家庭中 5 岁以下儿童的数量。 • 卫生机构每日门诊人数。 • 在一段时间内，某医疗机构新生儿的出生体重。 • 某医疗机构新生儿的母亲的教育水平。 66 确定频率分布的间距 [幻灯片 33] 构建频率分布的一个关键决策是对间距的选择。例如： • 有序分类变量：卫生机构水平（例如：一级、二级、三级）。 • 离散型数值变量：体温（例如：低于正常、正常、高于正常）。 • 连续型数值变量：身体质量指数（BMI）（例如，<25，25-29，30+）。 决定间隔数量时，请着重强调以下两个相互矛盾的目标： • 通过使用相对较多的间距来限制信息丢失。 • 通过使用相对较少的间距来提供一个简单、可解释的和有用的总结。 统计摘要和频率分布 [幻灯片 34] 仔细检查变量的频率分布是至关重要的一步，这会是一种极其强大且稳健的分析形式。 统计摘要通常着重于获得能够显示出分布的总体位置的方法（例如，所调查人群的平均 患病程度，贫困程度或者受教育的程度），或者显示出总体的变异程度。 建议学员阅读其学员手册中介绍的示例（五岁儿童群体中的营养不良情况）。 平均值或中位数的使用 [幻灯片 35] 平均数（均值）是最常用的汇总性位置测量方法。但是，由于均值易于计算和操作，团 队经常会不恰当地将其用作集中程度的标准方法。均值也经常被误解为一个总体中的典型值。 应谨慎使用基于不等距的分布，因为它们很容易被误解，特别是 当分布是以图形形式呈现时。 注意：过快地使用较简单的统计摘要可能是很诱人的，尽管这些 统计旨在（但往往不能）捕捉分布的基本特征。 频率分布/统计摘要的选择应该与其目的相关。 67 [幻灯片 37] 变异程度的测量 其本质上是对某个特定总体内发生了多大程度的变异的评估。 • 变异程度低：分布位置的测量可以合理地代表总体；汇总后丢失的信息有限。 • 变异程度高：分布位置的测量的不太具有代表性；存在因汇总而丢失信息的巨大风 险，除非团队对该分布的性质有充分的了解。 • 解释 [幻灯片 38]中所介绍的关于变异程度的测量。请学员结合自身经验或项目来 举例。 向学员简要介绍构成分析性研究的方法： [幻灯片 39] • 分组比较。 • 关联分析。 • 因果关系。 [幻灯片 40-43]描述了这些类别中最常见的方法。 分组比较 • 说明会导致群体分析中出现各种形式的不同途径 [幻灯片 40]。 关联分析 • 说明中描述的关联分析的数据要求 [幻灯片 41]。 例如：某一个中等收入国家的人均国内生产总值计算为 3200美元。 将此解释为该国“普通人”的收入并不能反映现实情况（实际上，均 数接近 1200 美元）。当基本分布存在偏移时，均值通常不具有代表性。 数据分布是否偏态，明显影响着对平均数和中位数的理解和解释 [幻灯片 36]。 68 因果关系 为了突出回归分析中不同形式的区别 [幻灯片 42 和 43]，描述了以下方法应该在什么情 况和实例中使用： • 线性回归。 • Logistic 回归。 • Cox 比例风险回归模型。 风险测量 [幻灯片 44] 尽管风险测量在健康研究中被广泛使用，但它们并不总是被很好地理解。例如，风险和 几率经常互换使用，但是两者并不指同一件事。 此外，“降低风险”并不等于“降低比值”： 分母问题 [幻灯片 45] 在计算风险时，重要的是要知道处于风险中的人口的总体规模。在实施研究中，计算或 得到这些概要统计量的可靠估值通常是很难的。例如，我们只能估算某一地区应接种疫苗或 应在蚊帐下睡觉的儿童数量。同样，一个机构设施所覆盖人口或某一段时间内的实际出生人 口通常也是未知的。 出于这些原因，分母通常作为基于预测的人口。 解释这些基础理念的区别： 风险（P）：经历某事件的数量或暴露于该事件的人群。 相对风险（PA/PB)：A 组的风险与 B 组的相比。 比值：发生该事件的数量与未发生该事件的数量之比 = P/(1-P) 比值比：[PA/(1- PA)]/[PB/(1-PB)] 使用此示例来说明两者之间的区别： PB（干预前的疟疾发病率) = 0.5 PA（干预后的疟疾发病率) = 0.1 风险降低程度 = 0.1/0.5 = 0.2 比值降低程度 = (0.1/0.9) / (0.5×0.5) = 0.11 69 由于存在这种不确定性，那么较好的做法是同时提供分子和分母在任意比例中的估计值、 百分比或风险的估计值，并给出计算中使用的来源。 亚组分析 [幻灯片 46] 干预措施的结果在目标人群的不同亚组之间可能会有很大差异。如果没有预先定义亚组， 那亚组分析可能会很复杂。 数据挖掘（即：探索数据集以发现表层关系）在提出新的假设时很有用，但在实施研究 中需要格外谨慎地使用。应该仔细考虑亚组分析所处的环境，因为投入和产出之间的关系可 能受到情景变量的影响。 表 7. 慢性病患者的背景变量 年龄组 慢性病患病率 男性 女性 15-24 0.55 0.80 25-44 1.79 4.01 45-64 4.91 12.28 65 12.86 20.00 合计 1.77 4.25 和学员仔细阅读该例子从而让他们了解在实施研究中为何要谨慎地进行重新数据挖掘， 以及控制变量和混杂变量之间的区别。 思考活动 [幻灯片 47] 练习 15 分钟：在项目团队中，请学员讨论他们打算在项目中开展的数据分析，并确定 他们将收集的数据是否适合他们所计划的分析类型。 鼓励团队去确定他们将用于分析的具体变量，并向简短地介绍将选择的方法。 说明性示例：我们可以假定按年龄组和性别来划分慢性病患者并 进行分析是有用的（在学员手册的表 7 中）。为了对结果进行更有意义 的解释，慢性病的分类和这些患者的背景都是被考虑的重要变量。 70 关键概念 3：数据管理 好的整体数据管理的主要目标和重要性是尽可能多地确保从项目中产生的数据的效度。 与小组一起跟着幻灯片 48 到 53 页进行操作，强调为什么数据收集、存储和管理要保证一致 和严格的重要性，以及不仅仅只是在总结的步骤，各个研究阶段都需要数据管理。值得一提 的是，在结论被分享/发表之后数据可能还需要被审查（或审核），数据也应被存储和管理好， 以时刻能够应对这种可能性的发生。 思考活动 [幻灯片 54] 练习 15 分钟：在项目团队中，请学员讨论如何提高他们数据管理系统的质量。 鼓励团队确定他们可能遇到的特定问题以及可能的解决方案。请两到三组简要地向自己 组展示他们的结论/挑战。 结论 [幻灯片 55] 与小组讨论此幻灯片中的四个要点，并请学员解释每个要点。在此过程中，回顾（并验 证）这个子单元的预期结果将会非常有用： • 描述数据分析计划流程。 • 了解适当的统计方法。 • 了解数据管理方法。 71 单元 4b：定性数据收集，分析和呈现 一、演讲大纲和关键概念 [幻灯片 3] 和学员仔细浏览整个大纲，以确保他们了解这一节将会有什么内容。重点标出这个单元 将会出现的关键概念。下面的简要说明将会帮助你提示学员在开课之前每个人都能提出自己 对内容的理解。 向学员提问关于定性数据的经历和他们最倾向于去收集的数据类型：定性还是定量？他 们的回答可能会对接下来的讨论和重点的指导有所帮助。 除此之外，可快速测试一下关于使用定性方法的知识。 二、本单元的关键概念 • 定性数据收集 • 数据分析 • 数据呈现 三、预期成果 [幻灯片 4] 在本单元结束之前，学员将能够对以下知识进行描述： • 合适的定性数据收集工具和技巧。 • 定性研究中的数据分析过程。 • 数据演示的各种选择。 关键概念 1：定性数据收集 请学员解释所提到的每一种抽样策略 [幻灯片 5]。他们也应该讨论为什么使用立意抽 样而不是随机抽样。对学员所给出的例子予以反馈。以下是一些常规的定义/总结说明供你 参考。 重要的是，要以系统的方式选择你的样本，以确保社区/用户/外部参 与者将其视为一个可信的、有参考价值的样本。 72 立意抽样：有意地选择参与者/研究对象，因为他们有可能会产生对项目有用的数据。 方便抽样：选择最容易，最邻近（等等）的人，以节省时间，金钱和精力。所收集的信 息通常不可靠（例如：焦点小组成员是从当天当地社区中心中有空的人中挑选出来的，而不 是根据预先确定的标准）。 雪球（链型）抽样：定位到一两个关键个体，然后让他们去给出其他可能的消息提供者。 这是为了便于查明难以发现的案例（例如，寻找性工作者去采访她们童年性虐待的经历，这 是通过朋友圈而得到的案例）。 最大变异采样：故意在自己感兴趣的方面选择一个大范围的差异。为了记录不同的差异， 这个方法可以帮助我们识别跨越差异的普遍的模式（例如，研究有关殴打妻子的行为的可接 受性的规范差异，通过与以下人群进行焦点小组讨论：市区年轻女性，市区年老女性，郊区 年轻男人，郊区年老男人，曾遭受虐待的妇女，未遭受虐待的妇女。 离群值：极端正确或错误的案例。通常被认为是远远超出变量或总体标准的数据点。 强度抽样：从一些能集中表现出这种现象但又不是极端的案例中提供丰富的信息（例如： 采访约会强奸的幸存者，以了解更多有关强迫性行为是如何影响女性性欲的信息）。 同质性：深入描述一小群体类似的案例。常用于从某个特定群体中得到信息（例如：单 亲父亲）。 在展示决定数据收集方法的考虑因素之前 [幻灯片 6]，请学员头脑风暴一下：他们会考 虑哪些因素来确定用于收集定性数据的最佳方法？ 当小组对定性数据收集的一般示意图进行思考时 [幻灯片 7]，提醒他们有关定性数据的 一些主要特征： 采访：向人们提问。 观察：看（和参与）。 现有文件：正式文件，个人文章，电影，歌曲，等等。 可视化数据：摄影，电影和其他可视记录的格式。 从左往右依次浏览所示的每个图层 [幻灯片 7]，与小组讨论收集方法是如何影响最终生 成的数据类型。 [幻灯片 8]重点介绍了定性数据收集的各种选择，并提醒学员这些方法和实施研究流程 中的实施步骤有联系。邀请学员对列表中不同的方法进行头脑风暴。使用学员项目中的例子， 讨论定性数据收集方法的使用以及这些方法是否合适。 73 幻灯片 9 到 14 可以用于鼓励学员进行讨论。请一名学员自愿用自己的实际生活的例子 来阐明每个方法。以下是每种方法的简要，供你参考： 深度访谈：从最基本的层面讲，定性访谈是通过向人们提问这一方式来收集数据的过程。 传统意义上的采访为一对一、面对面的接触。但是，我们也可以在电话或线上进行采访。结 构访谈通过使用一组预定的问题（采访者的提问不会偏离这些问题）来寻求访谈的一致性。 非结构访谈更像是以询问一个基本主题为基础的流畅对话，通常带有开放式问题，并注重故 事的引入。 横断面走访调查：我们围绕一个既定的社区组织了这些走访，目的是观察人员、周围环 境和资源。其能够提供了社区的整体情况并帮助社区发现可能需要进一步探索的问题。根据 社区的规模和可用时间的长短，我们最少可以花一小时，最长也可以花一天时间走完。横断 面步行的规划是通过在社区地图上绘制“横断面路线”而完成的。这条路线经过该社区所有 区域，以提供具有代表性的视图。 问题树：通过识别主要问题和问题间的主要因果关系，用于了解分析问题的基本原则。 小插图：一种以文字或图片的形式呈现出来的小场景或事件，学员可以对此进行评论。 学员这种方法的主要特点是探索学员的主观信念系统，即关于个体、情境和结构的事件，这 些事件可以为知觉、信念和态度的研究提供重要的参考。 焦点小组讨论 [幻灯片 15-19]：上述所有的方法都被视为定性数据收集方法的一部分， 但可能没有一个方法会像焦点小组讨论一样被用的如此频繁。 再次请一名学员自愿以其在实际生活例子来描述其参与了焦点小组讨论的经历。 和小组仔细跟着幻灯片 16 到 19 进行操作，请学员对每一个方法做出他们自己的解释。 思考活动 [幻灯片 20] 采取以下两个 15 分钟练习的其中一个： 1. 焦点小组讨论的角色扮演： • 从所有小组中选出 8-10 名学员。 • 选择主持人和会议记录者。 • 应该有一份讨论指南，并事先与主持人对该指南进行讨论。 • 在学员中挑出一些主导型角色、顺从型角色和反对型角色（主持人并不知情）。 • 其余学员应该在讨论过程中进行观察，并在本次角色扮演结束时给予建设性的反馈 和观察结果。 74 2. 问题树：小组工作： • 列出一系列健康问题（最好与团队项目有关）。 • 由 5-7 名学员组成的小组，其中两名扮演研究人员，剩余的皆为当地社区成员。 • 让他们以焦点小组讨论的方式来制作一个问题树。 • 每组随后都应该给出问题树结论。 • 鼓励学员提供具有建设性的反馈。 关键概念 2：数据分析 在此强调，定性数据产生的是文本信息，而不是数字。为了确保信效度，三角论证方法 （使用多种定性方法）是必不可少的。 定性分析的三个核心要求是 [幻灯片 21]： • 选择样本和生成数据的技术和方法的详细说明。 • 仔细说明分析过程，注意信效度的问题。 • 使用三角定位法，与其他数据收集方法进行对比。 向学员表示他们应使用自己认为适合的任何分析方法。 [幻灯片 22] 要注意：这一节可你不会将 [幻灯片 23]中任一个分析软件教给学员。提到这些方法并 介绍软件的功能： • Atlas-ti 可处理大数据集，非结构化编码，模拟纸质代码和排序。 • NVivo 可处理相对较少的数据，以适应非结构化编码，在代码中找到模式/关系。 • MaxQDA 为多种数据形式的分析（例如：采访、报告、表格、网络调查、视频、 音频、图像和文献数据集）提供了强大的工具。 文本资料分析 [幻灯片 24-31] 和学员一起跟着这些幻灯片进行操作，解释与以下内容有关的主要概念： 指出无论使用的方法是什么，所有定性分析都涉及到对大量数据的理 解、对潜在重要模式的发现，以及对数据所揭露的本质的传达。 75 • 主题分析。 • 编码方案。 幻灯片 32 到 33 总结了有关定性数据分析的讨论，并给你机会去重申分析定性数据时应 遵循的基本步骤： • 目标已经实现（确认）。 • 逐字逐句地抄录所有采访内容。 • 通过所有的技术/方法论工具去使用这些信息。 • 所有关于那一次采访的笔记和观察进行合并，生成文字记录，并包括受访者和被观 察的人的背景资料。 • 使用采访指南对主要部分进行编码。 • 根据子主题进行重新编码。 • 生成一个主题矩阵。 幻灯片 34-36 提供了一个简短的机会来考虑基于文本和图像的定性数据展示方式。 思考活动 [幻灯片 37] 请小组讨论被高亮的具体要点，并请三个团队分享他们的结论/观察结果。鼓励其他学 员积极发表意见。 实例 [幻灯片 38] 南苏丹共和国的创新参与式健康教育项目（IPHE） 这是一项旨在为改善世界上未成年和成年女性的生活水平而提出的教育创新解决方案， 在 2011 至 2012 年由“妇女分娩”组织提供资金援助。 可通过该网址观看项目相关视频：http://www.youtube.com/watch?v=sHLfGAP0N6k 该范 例总结了定性数据的关键概念： 1. 数据收集：观察/深度访谈[完成后需给出报告]/关键小组讨论/能引发思考的图像 收集。 2. 数据分析：参与式研讨会。 3. 数据呈现：健康信息[以图片的形式呈现]/歌曲/情景剧[所有内容都有研究的学员 承办。 76 5 促进 单元 传播研究结果 77 促进单元 5 一、简介 向学员们介绍本单元的概况。本单元旨在使用实例来强调和说明与实施研究相关的知识 转化的关键概念。它为准备研究报告、同行评审论文、新闻稿、会议报告和政策简报提供了 结构化指南。 二、实施研究的六个步骤 [幻灯片 2] 当你讲授本单元时，请先简短地再次回顾整个实施研究流程/框架。使用幻灯片 2 中的 实施研究循环图来提醒学员，传播实施研究结果是循环的第五步。 三、演讲大纲和预期结果 [幻灯片 3-4] 与学员一起仔细阅读大纲，以确保他们了解课程内容。强调本单元将涉及的预期成果和 关键概念。下面的概要将帮助你在课程开始前鼓励学员们提出他们对每个关键概念的理解。 四、本单元的关键概念 [幻灯片 5] 1. 知识转化 知识转化根植于不断变化的时间、地点和独特的环境中，从业者必须时刻意识到、预测 和适应这些环境。知识转化技术可以帮助研究人员在传播研究结果时变得更为主动、更具情 境感知和更加协作。通过这样做，研究结果变得更具相关性，更能适应变化，最终变得更加 有用。就实施研究而言，知识转化活动有两种类型：EOG 知识转化和整合型知识转化。 2. 传播工具 研究团队可以使用各种各样的传播工具来帮助他们促进对研究结果的吸收利用。所有这 些工具都应该被看作是一个整体的一部分，而不是一个单独的部件。各种工具应在一个更大 的计划内协调使用，共同形成一套完整有效的传播工具包或方法。在接触特定受众方面，每 种工具都有不同的长处和短处，因此，通过结合使用多种工具，各种工具可以相互补充，形 成比单独使用任何一种工具更强有力的传播计划。 将考虑的传播工具包括研究报告、同行评审论文、新闻稿和政策简报。 78 3. 传播策略 如上所述，传播过程是实施研究项目循环中不可分割的一部分。让利益相关者尽早参与 传播进程，将加强对研究进程的自主权，并最终吸收采纳研究成果。 建议研究团队在讨论和制定其传播策略和相关需求时形成具体步骤。最终结果应是一项 具有情境敏感性的策略，旨在向特定的受众传播特定的研究结果。 关键概念 1：知识转化 简要强调知识转化是一个双向的过程 [幻灯片 6] 为了产生效果，必须进行传播： • 使用适当的工具； • 在适当的时间； • 在适当的地方； • 只要有机会吸引受众。 知识转化的类型 [幻灯片 7] 有两种类型的知识转化通常被实践： • EOG 知识转化 • 整合型知识转化 EOG 知识转化方法更频繁地被纳入研究项目计划和资助计划书中，因为其包含了研究 人员最为了解和常用的共享方法类型。这意味着在研究过程结束时，研究结果/结论-新知识 -将被打包到有效的传播工具中，并传播给特定的受众。这些包括经过同行评审的论文、指 南、会议报告、新闻稿、广播节目和社区戏剧。虽然这种 EOG 知识转化活动可以作为实施 研究项目的一部分进行，但它们往往是相当有限的（并且相对昂贵）。 在整合型知识转化方法中，研究人员和关键知识用户一起识别研究问题、确定研究方法、 开展研究、解释研究结果，然后汇总、传播和应用研究结果。由于最终结果反映了知识用户 的需求，因此它们具有更大的相关性和被实施的可能性。 知识转化不仅最终的目的是分享是实施研究的结果，它还帮助研究人员 与利益相关者和研究团体积极互动，从而更加了解他们工作的情境，并鼓励 协作。 79 在整合型知识转化方法中，知识从最初的创造到最终的应用都被视为一种集体的、共同 生产的事业。它尊重双向动态，使研究过程受到其周边情境和社区的影响，并使研究证据被 无数利益相关者创造、塑造和最终使用。通过这种方式，整合型知识转化使研究证据对从业 者、规划者和项目管理者更具相关性和响应性。这独特地将实施研究定位为一个量身定制的、 具有情境敏感性的过程，可以积极响应用户的需求和要求。 研究证据应用过程中的阻碍因素 [幻灯片 8] 各种各样的阻碍因素减少了对研究证据的应用。许多研究证据的使用者，例如项目管理 者，是在一个有着独特的压力和要求的环境中进行工作。他们的行动时间表可能非常短，而 且他们在应用或平衡不同投入以解决问题方面的能力可能有限。 请学员提出研究结果应用过程中可能存在的阻碍因素。你可以在讨论中使用下面的五个 简短摘要来提示和/或探讨个别阻碍因素。 研究证据应用过程中的促进因素 [幻灯片 9] 有一系列类似的因素可以促进研究结果应用。在此前讨论阻碍因素时，其中一些因素可 能已有提及。 再次请学员提出研究结果应用过程中可能存在的促进因素，并使用下面的五个简短摘要 来提示和/或探讨各种想法。开始时，可以提醒他们这些因素都是需要加以考虑的。 整合型知识转化是一种多利益相关者、多学科的创新方法。它比 EOG 知识转化的方法更具活力和互动性。 研究结果应用过程中的潜在阻碍因素 ①从业人员对研究证据的感知。他们如何平衡这些证据和其他证据相互竞争的影响？ ②组织文化。一个组织如何做决策？信息如何在组织内流动？它与研究证据相互作用的 能力是什么？ ③从业人员缺乏技能（特别是研究或证据评估技能），无论是评估研究证据，还是平衡 其与竞争的影响来源（与上面第二点相关）。 ④研究的预期成本和时间表。许多从业人员必须在短时间内做出决定，无法认真考虑 研究是否过于昂贵，或过于缓慢/耗时而没有真正的实际价值？ ⑤信息超载。从业人员、项目管理者和实施者可能会被大量的信息来源搞得不知所措。 80 思考活动 [幻灯片 10] 15 分钟练习：分成五组，选出两组来表达他们的结论。请各小组回想他们熟悉的本国 健康规划。是否有相关政策支撑这项规划？如有，制定这项政策时采用了哪些研究证据？学 员可以回顾他们的学员手册中介绍的乌干达案例以获得灵感。 关键概念 2：传播工具 [幻灯片 11] 研究团队可以使用各种传播工具来推广研究成果。 描述的每种工具都有不同的优点和缺点，增加将研究结果传达给关键受众的方式的数量， 可以增加获取和行动的机会。 在你开始一系列传播工具示例之前，请学员集体讨论以下几点： • 他们所熟悉的传播工具是什么？ • 每个工具的主要特点是什么？ • 每个工具相对的优点或缺点是什么？ 四种重要的传播工具 [幻灯片 12] 幻灯片中提到的四种工具的详细概要见学员手册。使用四种工具有以下要点和注意事项： 研究结果应用过程中的潜在促进因素。 ①研究人员重新构建实践问题，以符合现有证据。构建问题是许多知识转化活动（如政 策简报）的重要方面，可以汇集许多不同类型的证据，以响应特定实践或实施需求。 ②加强从业人员开展适当研究解决具体问题的能力。 ③研究者与从业人员协作，产生重要信息，鼓励积极分享，并共同确定紧迫的优先事项。 ④建立有针对性的消息传递，强调研究证据在形成更好的方案或改进干预措施中可以发 挥的作用。 ⑤研究者与从业人员紧密联系，发展人际关系和建立信任。 各种传播工具不应视为单独的方法，而应视为整体的一部分。各种工 具应在更大的计划内结合使用，以便产生一套完整、有效的传播工具包。 81 研究报告 研究报告的内容取决于资助者及其具体要求。 请学员说出具有哪些常见部分（如标题；作者和机构隶属关系列表；致谢；摘要；执行 摘要；介绍；文献综述；研究设计/方法；结果；讨论；结论；和参考文献。） 写报告时要考虑的关键问题是：我们还有哪些方法可以使用或重新包装这些信息？ 同行评审论文 在同行评审的期刊上发表，标志着该研究工作在社会上被接受。发表论文是获得影响力 的新周期的开始。 所有期刊都有不同的目标读者和作者指南。在写论文之前，应先确定你的目标期刊。 新闻稿（学员手册展示了一个示例） • 大众传媒是研究成果的重要受众。要求学员提出为什么这很重要。 • 新闻稿类似于一张关键信息表，但新闻稿有自己的风格和结构，必须予以遵循： – 不要超过一页。 – 强而有力、信息丰富的标题。 – 用几句话概括-说明研究结果值得发表的原因。 • 可以通过媒体发布新闻稿来避免有误导性的报道 [幻灯片 13]。 • 这是一个研究信息被歪曲的案例。为了吸引读者的注意，记者在一个会议上获得这 个信息后选用了耸人听闻的标题进行报道。 • 向学员指出，有时这样的情况是不可避免的，但可以通过向媒体提供新闻实况来减 少发生的机会。 政策简报 政策简报是向非专业读者展示研究项目的发现和建议的简短文件。 • 重点突出、简明扼要。 • 以证据为基础。 • 易于理解。 • 无障碍内容（无术语）。 • 专业。 学员们还能想到其他特征吗？ 82 其他传播工具 [幻灯片 14-25] 与学员一起回顾这个系列中的每张幻灯片。对于每种方法，请学员说出每种方法的优缺 点，并分享他们的相关经验来促进讨论。促进讨论的具体考虑事项/问题： [幻灯片 15]：比例不一致/不正确。 [幻灯片 16]：“间隔”都是相同大小的，即使分配的时间不同。 [幻灯片 17-20]：信息图表很有用，因为它们很容易理解，并且可以简化复杂的信息。 图形/图表通常用于将数据表示为较大信息图的一部分。 [幻灯片 21-24]：众所周知，照片是传达信息的最有力的工具之一。有针对性的信息附 带的照片甚至可以更强大。 [幻灯片 25]：这个片段展示了交互式视频信息图表的使用，并以一种易于理解和有趣的 方式支持相对复杂的数据/证据的呈现。如果培训机构有稳定可靠的网络，可以直接播放这 段 TED 演讲视频。可从 http://new.d.com/talks/hans_rosling_the_truth_about_hiv 提前下载。 数据和动画可从 http://www.gapminder.org/downloads/gapminder-hiv-presentation 下载。 多样化传播平台 [幻灯片 26 和 27] 实施研究涉及研究者和多个具有不同能力的利益相关者，因此应该使用不同的平台/渠 道来传播研究成果。根据研究结果的性质、含义和受众选择特定的传播渠道。 “旧媒体”和“新媒体”平台的一些例子： • 传统媒体广为人知（即印刷媒体、报纸、杂志、期刊、电视和广播）。 • 新媒体（如社交媒体）已成为强大的传播平台，而且具有成本效益、传播速度快。 简单讨论一下最适合每个平台的工具。 关键概念 3：传播策略 [幻灯片 28] 制定传播策略是所有研究的必备过程，实施研究也不例外。 传播过程应该是研究项目周期的一个组成部分。制定项目的总体传播 战略和实施计划应在研究过程开始时进行，并让所有相关的利益相关者都 参与进来。 83 关键方法 [幻灯片 29] 请学员阐述他们对于四种关键方法和传播策略的理解（如幻灯片所述）。你可以用以下 几点来促进讨论： • 强而有力的传播策略的特点是双向对话（从研究者到受众，也从受众到研究者）。 • 使用适当的语言对与利益相关者进行有效地沟通和联系至关重要。这应该考虑到当 地的语言/方言，以及当地的研究素养和熟悉程度。 • 对当时的情境和文化的敏感性。 • 充分考虑传播策略的优势和劣势。 分阶段传播策略方法 [幻灯片 30] 传播策略必须根据当地的情境和因素制定。建议采用通用的九步流程，可根据特定环境 和实施研究项目进行调整和修改。与学员一起浏览九个步骤中的每一个步骤，邀请志愿者描 述他们如何实际地将每个步骤与他们自己的项目联系起来： 第一步：回顾过去的传播工作 从回顾过去已完成的工作开始。 第二步：制定传播目标 研究团队应该进行头脑风暴，明确希望通过传播研究结果实现什么目标（例如：提高认 知、理解、行动或支持参与） 第三步：确定主要受众和次要受众 研究团队越了解其受众，传播方法实现其目标的机会就越大。 第四步：开发信息 信息应该简短、直接、简单，并解释研究要解决的问题。 第五步：确定传播方式 考虑有限的预算/传播经验——以及传播目标/受众——决定最具价值和前景的方法。 第六步：确定传播渠道 对最佳传播渠道的考虑有助于以非常现实的方式缩减实用的通信工具类型，使其能够接 触到合适的受众，并符合现有的预算。最重要的是，传播渠道的选择决定了谁接收消息（以 及谁会采取行动）。 第七步：评估可用资源 什么材料可以用于这项工作？有哪些技能可用？是否有明确的预算？当我们执行传播 84 策略时，这些因素会有所变化吗？ 第八步：考虑时机和机会窗口 传播时间线可能是显而易见的。例如，是否有一个即将召开的会议，在这个会上研究团 队可以分发几种不同的通讯产品，进行一次全体演示，并召开一些面对面的会议？ 第九步：评估工作 传播需要仔细评估和反馈，可能需要为了确保获得最大的回报而进行调整。 如果传播策略完全成功，将会带来什么变化？这个问题对于设计适当的评价指标至关重 要，也可以用于指导整个传播策略的制定。 思考活动 [幻灯片 31] 在学员手册中有一个传播策略的案例。研究团队应该使用这个案例和提供的模板 [幻灯 片 32]作为制定其传播策略初稿的指南。 选择两个研究团队向小组汇报他们的传播策略。 85 6 促进 单元 监测和评估实施研究项目 86 促进单元 6 一、简介 向学员们介绍本单元的概况。本单元旨在帮助研究团队根据既定的计划跟踪其进展、检 查对既定标准的遵守情况、识别趋势和模式、调整策略并为项目管理提供决策依据。本单元 还旨在培养技能，以确定目标的相关性和实现情况、发展效率、效力、影响和可持续性。 二、实施研究过程中六个步骤 [幻灯片 2] 当你讲授本单元时，请先简短地再次回顾整个实施研究流程/框架。使用幻灯片 2 中的 实施研究循环图来提醒学员，监测和评估实施研究项目是该循环中的第六步。 三、演讲大纲和预期结果 [幻灯片 3-4] 与学员一起仔细阅读大纲，以确保他们了解课程内容。强调本单元将涉及的预期成果和 关键概念。下面的概要将帮助你在课程开始前鼓励学员们提出他们对每个关键概念的理解。 四、本单元的关键概念 [幻灯片 5] 1. 监测和评估计划 监测和评估计划是一份概述如何监测和评估实施研究项目，并将从各种数据收集系统获 得的策略信息与如何持续改进项目的决策联系起来的文件。监测和评估计划有几个主要目的， 包括：①说明如何评估规划/项目的成果；②记录共识意见，从而鼓励透明度、问责制和责 任感；③指导监测和评估的实施；④保存机构记忆。 每个项目都有不同的监测和评估需求，这取决于运行情境、实施机构能力、捐赠者需求 和其他因素。在准备一项监测和评估计划时，识别这些需求并协调用于满足这些需求的方法、 程序和工具是很重要的；这可以节省资源并简化监测和评估计划。 2. 制定一项监测和评估计划 在你建立一个监测和评估计划之前，团队应该定义整个项目的目标和目的，理解研究的 情境，并识别关键的参与者/利益相关者。还应选择最适当的方法（如监测和评估框架，进 行监测和评估的数据收集方法）。在制定监测和评估计划时，应采取六个关键步骤： 87 • 利益相关者的协商和参与 • 制定监测和评估计划 • 确定监测和评估的方法 • 指定实施职责 • 设定目标 • 定义报告系统，传播和利用结果 3. 实施监测和评估计划 监测和评估计划的实施分为三个阶段，即：①检查和评估进度；②现状分析；和③对新 事件、机遇和问题做出反应。 关键概念 1：监测和评估计划[幻灯片 6] 将监测和评估计划定义为描述监测和评估系统并将从各种数据收集系统获得的策略信 息与改进项目的决策联系起来的文件 [幻灯片 5]。 关键要素 [幻灯片 7] 监测和评估计划的主要目的之一是说明如何评估规划/项目的成果。为了强调这个基本 的出发点，在开始讨论这张幻灯片时，请学员描述他们期望从项目中获得的变化/影响。然 后，你可以要求各个团队通过完成幻灯片 6 中的第 2-4 点，来强调组成监测和评估计划基础 的四个关键要素。 幻灯片 7 强调了任何监测和评估计划都是建立在给定项目的关键因素之上的。 监测和评估计划的应用 [幻灯片 8 和 9] 另一种鼓励学员从更广泛的角度来考虑监测和评估计划的基础的方法是强调为什么这 样计划是有意义的/重要的。在进入幻灯片 8 之前，通过询问学员：“监测和评估计划有何用 监测和评估计划必须满足终端用户和他们的信息需求，以方便其使用。 回答这四个问题是监测和评估计划的关键。 88 途？”来推动学员就这一点进行简短讨论。 一项监测和评估计划建立在项目的关键因素之上 [幻灯片 10] 监测和评估计划的主要要素必须考虑到并围绕总体目标、主要受益者，并考虑项目的局 限性，如项目的范围、规模和预算。 请简要解释这些参数是如何作为实际上（和逻辑上）的“边界”来评估项目的影响。 研究证据应用过程中的促进因素 [幻灯片 11] 然而，有用性只是监测和评估计划的关键特征之一。提醒学员，监测和评估计划要有效 果，必须符合下列各项标准： 实用性 [见幻灯片 8 和 9]：它必须是有用的，并满足预期用户用于制定决策目的的实际 和策略信息需求，这可能包括评估方案执行情况和分配资源等。 可行性：实事求是。考虑到资源的稀缺，监测和评估计划应该充分利用现有的数据收集 系统。但是，如果涉及新的数据收集系统，则必须仔细考虑资源（费用和技术能力）。 符合道德规范：遵守与监测和评估活动相关和受其影响的道德原则。 准确性：为决策制定和方案改进提供技术上准确和有用的信息。 关键概念 2：建立或制定一项监测和评估计划 [幻灯片 12 和 13] 虽然在前面已经给出详细定义，但请重申在建立一项监测和评估计划之前应该考虑的主 要因素/问题（为了确保学员没有将计划本身置于这些考虑之外） [幻灯片 12]： • 项目的总体目标 • 理解干预/研究的情境。 • 识别关键人物。 • 定义最合适的方法（框架和方式）。 监测和评估计划的应用： ①说明项目将如何评估其成果。 ②记录共识意见，从而鼓励透明度和责任感。 ③指导监测和评估的实施。 ④保存机构记忆。 89 然后你才能继续描述制定监测和评估计划的关键步骤 [幻灯片 13]，建议强调如下重点： • 在制定和实施监测和评估计划的整个过程中，应定期与利益相关者进行协商。这能 让人产生了更多的主人翁意识和责任感，也增加了结果被使用的可能性。 • 制定监测和评估计划提供了活动、产出、结果和影响之间的明显联系和关系。 • 如何设计、实施和监测活动转化为如何客观地衡量研究问题、目标和目的。 • 从一开始就了解哪些因素/变量可以/需要被测量（例如资源、服务统计、覆盖面、 质量等），以及不同类型的信息将如何被收集和使用至关重要。 • 为了实现标准化并与其他类似项目进行比较，各项“指标”应尽可能与国际/国家 标准保持一致。 • 在考虑收集和分析数据的最佳方法时，应评估现有信息系统的能力。 • 应明确不同参与者的角色和责任，因为这将决定监测和评估计划将如何实施和报告 系统将如何采用。 • 报告系统应将现场与中心连接起来，以便中心人员了解其他地方的情况。 • 在制定目标时，应与所有利益相关者进行协商，以确保对项目承诺实现的目标有统 一的理解。应该真正地关注于在既定的资源和环境的情况下，项目能够实际实现些什么。 • 监测和评估计划还应描述传播和利用研究结果的计划（即根据目标受众、传播频率 /时间，以及适当的传播出口和渠道）。 案例研究（基于你的经验）描述了特定监测和评估计划的制定，可以是实现这一广泛重 点的有用和有意的方式。灵活地使用幻灯片 19-22 来说明其中的一些关键点。 逻辑框架目标 [幻灯片 14] 解释项目的投入、活动是如何与预期的产出、结果和目标相联系的，进而讨论各级指标。 建立监测和评估计划的关键步骤 [幻灯片 15] 向学员强调以下几点： • 在考虑收集和分析监测和评价数据的适当方法时，应评估现有信息系统满足信息需 要的能力。 • 应阐明不同参与者的角色和责任，因为这将决定监测和评估计划将如何实施和报告 系统将如何采用。 • 目标应该在与所有利益相关者协商后确定，以便每个人都了解项目要实现的目标。 在设定目标时，你必须专注于回答这个问题：“在项目运作的资源和环境下，实际能达到什 么目标？” • 监测和评估计划应明确传播和利用监测和评估结果的计划，包括目标受众、传播频 率/时间、传播监测和评估数据的适当出口和媒体渠道。 90 评估领域和数据收集方法 [幻灯片 16 和 17] 幻灯片 16 展示了一个矩阵的例子，它可以用于规划和评估评估领域和数据收集方法。 给出并解释这个例子，强调所选指标与数据收集方法之间的关系。询问学员是否同意每种情 况下的方法选择。 对于小组活动，要求团队使用相同的矩阵来开始描述他们自己项目的评估领域，并制定 适当的指标和数据收集方法。 思考活动 [幻灯片 23] （应与学员确定/商定时间） 首先解释活动和表格。然后，团队应该创建他们各自的监测和评估计划的初稿（最多 30 分钟）。在学员手册中有该活动提供的一个空白模板。改编自 Scott G（2008），监测和评 估规划指南和工具，美国红十字会。 强调监测和评估计划有助于监测和评估活动的系统化运作。指出这只是一个指导原则。 解释如何填写表格： • 第二栏：为项目级别插入预先确定的有时间限制的目标。 • 第三栏：列出指标。 • 第四栏：为每个指标插入绩效目标。 • 第五栏：插入收集数据的方法。 • 第六栏：插入数据采集频率。 • 第七栏：插入活动主要负责人的姓名。 • 第八栏：列出活动所需的资源。 • 第九栏：列出你开展活动所应具备的条件。 • 第十栏：列出如何将产生的信息用于决策。 每个团队都应该创建一个他们项目的初始监测和评估计划草案（给他们 10 分钟时间）。 邀请两组志愿者展示他们的监测和评估计划草案（每组 5 分钟）。 关键概念 3：实施监测和评估计划 [幻灯片 24] 关于这三个阶段，应强调下列各点： 检查和测量进度：理想情况下，监控关注于项目的三个主要特征：质量、时间和成本。 项目管理者负责协调项目团队。 现状分析：将项目实施情况与原计划进行比较。识别并记录潜在偏差的原因和影响。 对新事件、机遇和问题做出反应：对新情况、事件、机会和问题做出预测并迅速做出反 应，并确定需要采取的必要行动是很重要的。 91 更新监测和评估计划 [幻灯片 25] 整个项目团队（包括主要利益相关者/合作伙伴）应参与计划的评审、调整/更新，并将 修订后的计划分发给所有人。监测和评估计划应该是动态的，包括所有团队成员并记录变动， 以便其他人知道变动了什么。 监测和评估计划的效果如何？ [幻灯片 26] 让学员提出评估检测与评估计划在特定领域的效果如何可能被考虑的问题。（以下）是 一些例子。 • 监测和评估活动是否按计划进行？ • 评估问题是否得到了充分的回答？ • 是否提出其他评估问题，是否应将其纳入监测和评估计划？ • 是否有需要解决的方法或评估设计问题？ • 是否有任何外部因素（如政治、环境）影响监测和评估计划？ • 是否仍有合适的员工和资金来实施监测和评估计划？ • 监测和评估结果是否被利益相关者传播并用于决策和方案改进？ 关键概念的应用 [幻灯片 29] 向学员提供了一个例子（见学员手册），说明了（研究小组和实施者）为在坦桑尼亚联 合共和国（2003-2007 年）为扩大使用驱虫蚊帐代金券制定监测和评估计划所采取的步骤。 表 1（参见学员手册）描述了所使用的评估领域和数据收集方法。团队应该阅读摘要（在研 讨会之前），如果没有，他们现在就应该阅读它。该活动包括分析检测与评估团队为制定代 金券计划检测与评估计划而采取的步骤。 邀请两组志愿者展示他们的分析（每组 5 分钟）。 监测和评估计划应该被视为一份“动态”文件，它应该总是反映现实。 任何修改都应相应记录下来。 Implementation Research Toolkit Facilitators’ guide

实施研究工具包 学员手册 主译 李 慧 谢润生 夏 萍 Published by the World Health Organization in 2014 Implementation research toolkit © World Health Organization 2014 The World Health Organization has granted translation and publication rights for an edition in Chinese to the Key Research Office of Standardization of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences (Guangdong Provincial Hospital of Chinese Medicine; The Second Affiliated Hospital of Guangzhou University of Chinese Medicine), which is solely responsible for the quality and faithfulness of Chinese version. In the event of any inconsistency between the English and the Chinese version, the original English version shall be the binding and authentic version. © Key Research Office of Standardization of Chinese Medicine, Guangdong Provincial Academy of Chinese Medical Sciences (Guangdong Provincial Hospital of Chinese Medicine; The Second Affiliated Hospital of Guangzhou University of Chinese Medicine) 2021 Authors/Editors of the translated version: Hui LI, Runsheng XIE, Ping XIA, Miaochun CAI, Yanxi LU, Gang ZHENG, Changrui OU, Chumin YE 实施研究工具包 © 广东省中医药科学院（广东省中医院、广州中医药大学第二附属医院） 中医药标准化重点研究室 2021 年 主译 李 慧 谢润生 夏 萍 译者 蔡淼纯 卢彦熹 郑 港 欧昌睿 叶楚民 著者 World Health Organization, UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases 世界卫生组织授权广东省中医药科学院（广东省中医院、广州中医药大学第 二附属医院）中医药标准化重点研究室翻译和出版本手册的中文版，并由后者对 本手册的中文版负责。 致 谢 本工具包由热带病培训研究特别规划署（TDR）开发，旨在加强有着极大需求的中低收 入国家中个人和机构开展实施研究的能力。 TDR 得到了以下国家的大力支持：比利时、巴西、中国、古巴、德国、加纳、印度、伊 朗、日本、卢森堡、马来西亚、墨西哥、荷兰、尼日利亚、挪威、巴拿马、西班牙、瑞典、 瑞士、泰国、土耳其、英国、世界银行和赞比亚。 美国国际开发署和实施研究平台也提供了特别支持，该平台总部设在世界卫生组织，联 合了：卫生政策和系统研究联盟；人类生殖研究、发展和研究培训特别规划署；世界卫生组 织孕产妇、新生儿、儿童和青少年卫生部；孕产妇、新生儿和儿童健康伙伴关系；TDR。 本工具包是由 Jane Kengeya-Kayondo 和 Soumya Swaminathan 共同发起。Henry Lucas、 Sandy Campbell、Dirce Guilhem、Boatin Boakye、Yodi Mahendradhata、Colla Jean MacDonald 和 James Foreit 为工具包中的各个单元准备了原始材料。指导委员会对开发过程提供了指导 和建议，该委员会包括以下人员：Miguel Angel Gonzalez Block, Kathleen Handley, Kazi Mizanur Rahman, Wynne E. Norton, Jason B. Smith, Uche V. Amazigo, Linda Kupfer, Shenglan Tang, Isaac K. Nyamongo, Nhan Tran. 本工具包得益于许多人的贡献和建议，我们要特别感谢以下人士，他们通过试点研讨会 和最后的编辑，为各单元的结构调整和汇编提供了宝贵意见： 内容审查和反馈：Taghreed Adam, Sam Adjei, Irene Agyepong, Bill Brieger, Effie Espino, Timothy France, Prea Gulati, Jamie Guth, John Gyapong, Adnan Hyder, Regina Kamoga, Barrot Lambdin, Jeff Lazarus, Temina Mandon, Yolanda Ogbolu, Joe Okeibunor, Dimeji Oladepo, Obinna Onwujekwe, Johannes Sommerfeld, Thomas Sukwa, Fabio Zicker. 推动试点研讨会的举行。Ayat Abu Agla, Riris Andono Ahmad, Oladele Akogun, Khaleda Islam, Andres Z. Jaramillo, Baralee Meesukh, Isaac K. Nyamongo, Tuoyo Okorosobo, Martin Ota, Ayo Palmer, Shagufta Perveen, Mike Sanchez, Honam Irene Tsey。 超过 200 名研究人员、学者、疾病控制规划管理人员、政策制定者、卫生行政人员、通 信科学家和记者为本工具包的测试和评估做出了贡献。以下实施者和研究人员为试点工作做 出了贡献，并提供了反馈/评论： Wondwossen Belehu, Paul Bukuluki, Meg C. Doherty, Mary Ellsberg, Katherine Fritz, Meseret Gossa, Nancy Glass, Paul C. Hewett, Elijah Oyaro June, Kuyosh Kadirov, Etienne Karita, Joseph Kariuki Muriithi, Kathleen Kostelny, Jeremias L. Messias, Aragaw Biru Muhammed, Abraham Mukolo, Ester M. Mungure, Tina C. Musuya, Ramadhani S. Mwiru, Edith Nakku-Joloba, Kenneth K. Ngure, Walter O. Obiero, Spallanzani Oduor Ohaga, Eunice A. Omanga, Patrick O. Owiti, Deidra Demeatra Parrish, Nancy A. Perrin, Paul Bitwahiki Ramazani, David Sando, Helen Semu, Anuraj Shankar, Nicholas Shiliya, Helen N. Siril, Amanda C. Tichacek, Rogers Twesigye, Michael Wessells, Olufemi A.Adegoke, Naeemah Abrahams, Nurelign Mohammed Ahmed, Laurence Natacha Ahoua- Leray, Meghan Bishop, Emily Bobrow, Kerry Bruce, Jeanine Condo, Koen Frederix, Khanyisa Gala, Piotr Andrzej Hippner, Andrea Howard, Locunda Erin Higgins Hummert, Mubiana Inambao, John Barton Jemmott, Deyessa Kabeta, Jolly Kamwanga, Amira Karam, Matthew Raymond Lamb, Lebohang Mary Ledikwe, Virginia Letsela, Tonderai Mabuto, Mokgadi Rebecca Malahlela, Abdelhamid Mjidila Charmaine Mlambo, Yael Moverman, Martha Mukaminega, Fhumulani Mavis Mulaudzi, Iris Bongiwe Ndondo, Mathew Ngunga, Bonisile Nhlabatsi, Thobo Matuhogonolo Phologolo, Asta Helen Rau, Letitia Lynn Reason, Mary Pat Selvaggio, Vandana Sharma, Anne Teitelman, Mark Tomlinson, Renay Weiner, Robert Carl Yohnka, Vincent Kudakwashie Zishiri, Abdul Aziz Abdulai, Ismail Adem Abdilahi, Ayat Abu-Agla, Elsheikh Elsiddig Ahmed, Alaaedieen Mokhtar Ali, Wagdy Abdel Moniem Amin, Frank Biney, Peter Chibatamoto, Amel Abdu Gesmalla, Musse Mohamed Hasan, Mirriam Kangwende, Freddy Eric Kitutu, Rugare Abigail Kwakye, Kedibonye Dundu Macha, Talent Maphosa, Matshelo Tina Matlhaga, Chawangwa Modongo, Mohamed Farah Mohamoud, Fadzai N.N. Mutseyekwa, Kwame Shanaube Mwange, Magdy Fawzy Nasrallah, Matsiri Tiroyaone Ogoposte, Sandra Simbeza Sinzala, Henry Wamani, Anisuddin Ahmed, Dhana Raj Aryal, K.C Ashish, Lu Gao, Shaikh A. Shahed Hossian, Khaleda Islam, Nurhuda Binti Ismail, Gamini Jayakody, G.A.J.S.K Jayasooriya, Frederick Dony Jiloris, Pahalagedera Kusumawathie, Huq, Trisasi Lestari, Li Lin, Nafisa Lira, Hammed Oladeji Mogaji, Aftab Ali Akbar Mukhi, Abdul Razak Abdul Muttalif, Shagufta Perveen, Likke Prawidya Putri, Khalid Hussain Shaikh, Raihan Sharif, Ravi Vitrakoti, Nandyan N. Wilastonegoro, Wenti Xu, Quudus Adegboyega Yusuff, Hakeem Abiola Yusuff, Martha Ali Abdullai, Sheila Addei, Enoch Oti Agyekum, Gifty Ofori Ansah, Rahma Eltigani Mohammed Ahmed, Naa Korkor Allotey, Efua Asante, Frank Baiden, Azza Tag Eldin Bashir Babiker, Boniface Denakpo, Eva Engman, Ferrer Blanca Escribano, Lawrence Gyabaa Febir, Boniphace Salustian Jullu, Esther Kyungu, Towela Maureen Maleta, Humphreys Kampila Nsona, Mariam Oke, Mona Babiker Omer, Senga Kali Pemba, Themba B. Phiri, Tatcheme Filemon Tokponnon, 最后，我们要感谢南非医学研究委员会德班分会、博茨瓦纳大学哈博罗内分校健康科学 学院、孟加拉国国际腹泻病研究中心和达卡的 TRAction 项目以及加纳卫生局的 Dodowa 健 康研究中心，以及 Ayishatu Gibrin 和 Najoua Kachouri 在组织试点研讨会方面的贡献。 本工具包的作者 Margaret Gyapong、Edward Kamau、Robinah Najjemba 和 Olumide Ogundahunsi 对所表达的观点以及任何事实或判断的错误负责。 缩略语 ACT artemisinin-combination therapies 青蒿素联合疗法 ANC antenatal care 产前护理 ART antiretroviral therapy 抗逆转录病毒治疗 BCC behavior change communication 行为改变交流 BMI body mass index 身体质量指数 CAS complex adaptive system 复杂适应系统 CHW community health worker 社区卫生工作者 CMS Cooperative Medical Scheme 合作医疗方案 COS Community of Science 科学共同体 DOT directly-observed therapy 直接观察疗法 ERC ethics review committee 伦理审查委员会 FGD focus group discussion 焦点小组讨论 HDI Human Development Index 人类发展指数 HIV human immunodeficiency virus 人类免疫缺陷病毒 HRP Special Programme of Research, Development and Research Training in Human Reproduction 人类生殖研究、发展和研究培训特 别规划署 IC informed consent 知情同意书 ICF intensified case finding 强化个案调查 IDRC International Development Research Centre 国际发展研究中心 IEC information, education and communication 信息、教育和交流 iKT integrated knowledge translation 整合型知识转化 IR implementation research 实施研究 IRB institutional review board 机构审查委员会 IRP Implementation Research Platform 实施研究平台 KT knowledge translation 知识转化 KZN KwaZulu-Natal 夸祖鲁-纳塔尔省 LLIN long-lasting insecticide-treated net 经长效杀虫剂处理过的蚊帐 LOI letter of intent 意向书 LSHTM London School of Hygiene and Tropical Medicine 伦敦卫生与热带医学院 LTFU loss to follow-up 失访 M&E monitoring and evaluation 监测和评估 MDR-TB multidrug-resistant tuberculosis 耐多药肺结核 NGO nongovernmental organization 非政府组织 NSF National Science Foundation 美国国家科学基金会 NTBCP national TB control programme 国家结核病防治规划 OER Office of Extramural Research 院外研究处 PI principal investigator 项目负责人 PLHIV person/people living with the human immunodeficiency virus 艾滋病病毒感染者和艾滋病病人 PMTCT prevention of mother-to-child transmission 预防母婴传播 QDA qualitative data analysis 定性数据分析 RFP request for proposals 需求建议书 SAGE Strategic Advisory Group of Experts 战略专家咨询组 SARS severe acute respiratory syndrome 严重急性呼吸综合征 SMART specific, measurable, achievable, realistic and timebound 具体、可衡量、可实现、现实性和 时限性 SOP standard operating procedure 标准操作规程 SWOT strengths, weaknesses, opportunities and threats 强弱危机分析 TB tuberculosis 结核病 TDR Special Programme for Research and Training in Tropical Diseases 热带病培训研究特别规划署 UNDP United Nations Development Programme 联合国开发计划署 UNICEF United Nations Children’s Fund 联合国儿童基金会 USAID United States Agency for International Development 美国国际开发署 WHO World Health Organization 世界卫生组织 1 目 录 内容介绍和基本定位 1 单元 1 情境化实施研究问题 13 单元 2 制定实施研究计划书 33 单元 3 计划开展实施研究项目 104 单元 4 数据、分析和展示 114 单元 5 传播研究结果 134 单元 6 监测和评估实施研究项目 153 1 内容介绍和基本定位 2 内容介绍和基本定位 一、学习目标 本单元作为基本介绍和快速参考指南，介绍了基本术语和原则，以及其他单元及其理论 依据。本单元结束时，学员应对以下关键概念及其应用有全面了解： 1. 什么是实施研究？ 2. 实施研究的关键特征和实施研究循环。 本单元通常与内容介绍或正式开幕式相结合，包括一个为期半天的研讨会（附有教程、 演示幻灯片以及可供进一步阅读的材料）。包括学员对于目前实施研究相关知识和理解进行 自我评估的时间。 二、主要概念 什么是实施研究？ 研究解决和备选办法以克服卫生系统、疾病控制规划和提供保健服务等方面实施障碍的 重要性已得到广泛认可。实施研究解决了这种实施瓶颈，确定了针对特定环境的最佳方法并 促进其吸收研究成果。最终，它将改善卫生保健及其服务提供。 不同的机构对实施研究有着不同的定义。常见的解释为这是一种侧重于系统地了解和应 对阻碍有效和高质量实施卫生干预措施、战略和政策的研究。实施研究以需求为导向，研究 问题是根据卫生系统中利益相关者或实施者确定的需求而提出。实施研究关键特征见表 1。 卫生系统薄弱或不存在卫生系统的地区（包括在低收入和中等收入国家），往往是最需 要解决实施瓶颈问题的地方。遗憾的是，地方机构往往对实施研究的知识有限，缺乏制定相 关研究问题以及为方案规划和政策执行、管理和解释研究结果的基本能力。学术性的公共卫 生课程往往并不关注这类研究。导致的结果是，大多数培训始终没有为卫生系统的研究人员、 从业人员、服务提供者和决策者针对解决实施的障碍而采取的团队协作和跨学科方法做好充 分准备。 本工具包由七个单元组成，每个单元都提供了学员手册、研讨会幻灯片以及相关的阅读 和参考资料的链接。本工具包旨在帮助学员强化以下六个方面的技能： • 情境化实施研究问题。 • 制定实施研究计划书。 • 计划开展实施研究项目。 • 分析实施研究数据。 • 交流研究结果并将其反馈给卫生系统。 • 监测和评估项目。 3 表 1：实施研究的关键特征 特征 总结或描述 系统性 ⚫ 系统性研究是基于证据的公共卫生干预措施如何在特定环境中进行整合和提 供，以及由此产生的健康结局如何因社区而变化。 ⚫ 严格遵守科学研究的规范，以严谨的态度平衡相关性。 多学科性 ⚫ 分析生物、社会、经济、政治、系统和影响特定健康干预措施实施的环境因素。 ⚫ 行为和社会科学家、临床医生、流行病学家、统计学家、工程师、商业分析师、 政策制定者和关键利益相关者之间的跨学科合作。 情境性 ⚫ 以需求为导向。研究问题的框架是由卫生系统实施者识别的需求来确定的。 ⚫ 研究与当地实际情况和需求有关，旨在特定情境下改善卫生保健服务的提供。 ⚫ 形成可应用于不同环境的普适性知识和见解。注意不同文化和不同群体对实施 研究的影响。 复杂性 ⚫ 动态性和适应性。 ⚫ 多层次：发生在卫生系统和不同群体的多个层面。 ⚫ 分析多组成部分的方案和政策。 ⚫ 非线性的，迭代的和不断演变的过程。 这套技能是个人和机构实施研究能力的重要组成部分，特别是在那些有着极大需求扩大 实施研究能力的中低收入国家。在整个能力建设过程中，有监测、适应和改进的反馈循环， 亦有确保综合知识转化和成果吸收的建议。 实施研究不是一个单一的活动，而是一个逐步循环的过程(图 1)。第一步是明确干预问 题，与关键利益相关者合作，提出相关的研究问题。通过这种方式，一个跨学科的团队可以 集合相关的技能和背景来制定一个详细的申请书、计划，调动资源和开展研究。最终通过适 当的形式展示研究结果，供卫生系统内的规划人员和决策者采纳和使用。 图 1：实施研究循环的六个步骤 监测和评估项目 6 步骤 传播研究结果 5 步骤 数据分析和展示 4 步骤 计划开展项目 3 步骤 制定计划书 2 步骤 情境化实施挑战 1 步骤 吸收 持续监测 指导 反馈 4 开展实施研究时，必须积极和持续地监测各项活动，并定期反馈必要的更改和修订。实 施研究成果的传播应在整个循环过程中以及研究项目完成后持续地进行。研究结果必须要适 当地展示给每位合作伙伴和利益相关者，以便及时获取相关性最强的结果，从而影响实践。 相互影响的实施研究领域 从实施研究中五个主要的相互影响的“领域”来思考实施研究有助于启发学员（图 2）。 除了此处的概述内容外，您将在后续单元中看到对这些领域更为详细的描述。 干预措施。干预措施的特点决定了干预措施是否会被采用。这里，“干预措施”一词包 括核心组成部分和那些可以适应当地需要和条件的要素。核心组成部分的复杂性、成本和证 据强度等特征发挥了关键作用。 外部环境。这包括实施干预措施的经济、政治和社会情境因素，这些因素反映实施组织 或机构的外部环境。它受到外部政策和激励——例如双边或全球资金流动——以及组织之间 的相互作用和同行压力的影响。 内部环境。这指的是实施组织或机构所处的情境。它包括组织的结构、文化和网络，以 及内部气候和变化的准备情况。 个人参与。这些个体在实施过程中有直接作用。他们包括卫生保健提供者、组织或机构 各部门管理者、决策者和其他利益相关者和受益者。除了对实施能力的常规关注外，他们关 于干预措施的看法和态度对其对项目的成功实施和产生的作用都是至关重要的。 实施过程。这包括所有用于促进各级组织采取干预措施的方法和途径策略，包括策略和 活动的规划。过程包括那些事先计划明确的以及在实施过程中出现的难以预见的情况。 图 2：相互影响的实施研究领域 个人参与 在实施过程中担任 角色的个体——卫 生保健提供者、管 理者、政策制定者。 内部环境 实施机构的内部情 境因素——文化、 组织架构、网络等。 干预措施 外部环境 经济、社会和政治等情境因素。 实施过程 用于促进各层面干预措施采用的方法 （计划的和紧急的策略和活动） 5 自我评估练习 为应对特定的实施研究挑战而组成的团队应该是个多学科团队：具有不同的角色，在不 同的领域工作，并且往往有着显著差异的背景。团队成员们可能对于实施研究要素的组合方 式、意义和其在每个领域的能力程度有不同的看法。在每个团队中进行以实施研究为中心的 自我评估，可以让你识别出在观点、个人优势和团队内部能力分布方面的一些差异。你还可 按照自己的节奏浏览内容，并专注于工具包所需要的六项技能组合，为您的团队设定广泛的 学习目标。 请使用图 3 所示的矩阵来确定你们团队当前的水平： • 略懂； • 理解； • 知识； • 技能； • 能力。 在实施研究循环的每个步骤中，如果您和您的团队在这一阶段中不清楚个别步骤，可以 详细参考本手册中附录 1 的矩阵图。每个团队成员都应该保存一份已完成的自我评估矩阵， 并在接下来的研讨会中作为参考。 技能组合 1 略懂 2 理解 3 知识 4 技能 5 能力 情境化实施研究问题 制定实施研究计划书 计划开展实施研究项目 分 析 实 施 研 究 数 据 定性 定量 交流实施研究结果并将 其反馈给卫生系统 监测和评估项目 图 3：实施研究循环中各步骤的自我评估框架 6 工具包各单元总结 下面简要介绍各个单元及其理论依据。 单元 1：情境化实施研究问题 实施研究是在常规系统和现实生活环境中进行的，与其他类型的科学研究相关的控制设 置有所不同。当前的自然、社会经济、文化、卫生系统、利益相关者和体制文化都是开展研 究的重要环境因素。它们共同促进和影响干预措施的规划、实施、监测和结局。该单元促进 了关于情境因素的考虑、利益相关者的参与，从而帮助识别实施瓶颈和提出适当的研究问题。 该单元的总体目标是： • 促进研究者和实施者之间的交流。 • 识别实施瓶颈或效率低下的情况。 • 提出适当的研究问题以解决所发现的问题。 • 强调产生信息的不同方法。 • 结合实际情境背景考虑伦理问题。 • 促进老师和学生的关系，以确保各层面上具备持续的实施研究能力。 在过去的十年中，许多有效的疾病控制工具逐渐可以获取（例如蚊帐和以青蒿素为基础 的治疗疟疾的联合疗法，吡喹酮治疗血吸虫病，伊维菌素治疗淋巴系统和盘尾丝虫病）。 研究表明，这些工具可以在社区提供。然而，由于实施不力，使得许多工具产生的效果 有限。一项干预措施一旦纳入卫生系统或社区，可能会由于若干因素而失去效力或影响，例 如，尽管有证据支持，但临床指南在实践中没有得到充分利用，或着是目标人群的经济成本 限制了其使用。 图 4：卫生系统因素对干预措施效果和作用的影响 图 4 强调，为使已证明有效的工具发挥作用，其必须被目标群体所使用，同时卫生保健 提供者必须遵守相关政策，患者必须遵守有关工具的使用信息。然而，目前存在着不少挑战， 包括一些不平等现象，这将影响不同利益相关者按计划使用该工具的能力，从而最终导致该 工具无法发挥作用。 + 效 果 - 有效工具 有效工具 可及性 提供者的符合度 提供者的符合度 患者的依从性 患者的依从性 效果 7 为了使实施研究成功开展，研究人员必须和疾病控制的需求保持积极联系并迅速做出反 应，还必须与其他与卫生有关的部门和机构建立伙伴关系和联系，以便在必要时利用整个过 程中的相关研究结果并采取行动。 因为实施研究是在真实的、非实验性的环境中进行的，并且是在复杂的动态系统中进行 的 (1)，所以理解实施的具体情境是很重要的。自然、社会经济、文化和卫生系统、利益相 关者以及正在进行干预的机构背景等情境因素影响着研究的规划、设计和开展。因此，研究 者和合适的利益相关者应该通过情境和制度分析来判断实施研究开展的情境。这需要面对面 的互动、讨论和文件的共享，以确保在研究过程中提出合适的问题，并在特定的情境下解决 问题，以及确保所有相关人员在研究期间和研究结束时对结果充分吸收利用。 单元 2：制定实施研究计划 本单元建立在理解实施研究所处情境、让合适的利益相关者参与进来、阐明需要解决的 问题或障碍，以及组建一个适当的多学科的团队的前提之上（即单元 1 中涉及的内容）。基 本原理在介绍性单元和单元 1 中已经作了讲解。接下来将带你一步一步地形成合适的研究问 题，选择适当的研究设计来回答该问题，并撰写项目活动计划的大纲。将围绕以下关键概念， 并结合实例加以说明： • 识别实施的障碍并提出研究问题。 • 说明申请资助的理由（内容介绍、理论依据和目标）。 • 研究设计和适当的方法。 • 规划项目（预算、人员、时间表、监测和评估）。 • 无论研究领域或研究方法如何，研究计划书通常遵循相似的大纲（方框 1）。 实施研究计划书和其他类型的研究计划书区别在于识别研究问题的过程和最终用户参 与研究过程 (2)。一个实施研究项目（无论是关于干预措施，还是关于常规数据的分析）应 该做到以下几点： • 更好地为医疗服务提供信息。 • 促进对研究结果的理解。 • 获得研究结果的过程应该是普适性的，这样它们就可以应用在不同环境和情境。 • 使多个学科的合作伙伴参与进来，以解决所识别的问题。 • 制定实际解决方案的政策建议 (3)。 8 方框1 实施研究计划书的典型提纲 1. 题目 应有一个关于计划书内容的简要陈述。 2. 执行摘要 应有一个关于整个计划书的简要总结（通常不超过1页）。 3. 介绍和背景 围绕拟研究的问题进行阐释。 4. 文献回顾 对研究领域中已知内容进行描述，清楚说明现有研究存在的不足。 5. 理论依据 解释开展研究的必要性与相关性。 6. 目标 说明通过研究将能实现什么目标以及何时实现。 7. 方法或研究设计 描述研究将如何进行、遵循哪些程序和标准、需要收集的数据类型和团队成员职责。 8. 伦理问题 关于研究对象的自主权，保护措施和保密性以及这些问题的解决方法。 9. 预算或资源 开展研究所涉及的财务费用以及其他必要的资源概要 10. 参考文献 鸣谢为计划书提供信息的参考文献（例如研究文章、政策文件及文档）。 单元 3：计划开展实施研究项目 单元 3 阐述了获得开展实施研究的资源后应采取的步骤。它提供了计划研究项目所需的 信息，包括为伦理审查过程而准备的研究方案。单元 3 涵盖以下关键概念，并附有实例。 • 准备伦理审查。 • 项目实施过程。 • 实施研究的良好实践。 对于任何一个成功执行的项目，一个好的计划的重要性怎么强调都不过分。项目需要一 个团队，其中每个成员都有明确定义的角色，并与特定的产出相关联。目标是：①确保项目 有一个共同的目标；②提供一个清晰的项目愿景，包括需要完成的内容以及需要符合怎样的 质量标准，由谁去完成，项目的完成时间，项目的花费、资金来源、时间表和报告时间。 9 实施研究的计划包括了： • 界定范围（咨询利益相关者，商定角色和职责，确定可交付成果）； • 阐明实施计划（所需的方法和投入）； • 时间表（甘特图）； • 报道活动； • 评估资源需求（人力和其他）。 单元 4：数据分析和展示 本单元旨在帮助研究团队（实施者和研究者）： • 了解适合定性和定量数据的数据分析程序； • 在定量研究中使用统计学； • 并在定性研究中描述和记录数据分析过程。 本单元将通过一些例子来说明如何应用这些基本概念。在实施研究中，数据管理和分析 在项目中是持续进行的。各阶段的数据都必须收集、管理、分析，并以一种有用的方式向最 终使用者进行展示。所确定的研究问题和提出问题的类型将决定要进行的分析类型。分析的 例子包括： • 利益相关者分析（识别可能影响或被实施方案行动影响的个人或群体，并根据他们 对行动的影响和行动对他们的影响对他们进行分类的过程）。 • 强弱危机分析（即 SWOT 分析，是统筹和使用从组织中的研究里获得的数据和信 息以及监测和评估组织和活动的框架）。制度分析（对组织行为的系统研究）。 • 其他类型的分析包括对主要干预措施的持续监测和评估。 在该过程的每一阶段，所收集的数据要么是定性的，要么是定量的，必须采用标准的程 序来分析这些数据 (4)。至关重要的是，研究人员不能孤立地这样做，而是要让所有利益相 关者都参与数据管理和分析过程，以便在产生结果时为利益相关者提供使用结果的机会 （5）。 单元 5：传播研究结果 本单元旨在协助研究小组： • 领会在吸收和使用研究成果时的知识转移概念。 • 描述与研究项目有关的知识转移的障碍和促进因素。 • 理解在整个项目周期中传播信息的价值。 • 认识到在研究项目中制定一项全面的传播战略的价值。 • 认识到为不同目标受众量身定制传播工具的重要性。 本单元举例说明了知识转化的关键概念，并为准备研究报告、同行评议论文、新闻稿、 10 会议报告和政策简报提供结构化的指导。 实施研究的传播不是一个一步到位的过程。实施者与研究人员一起工作，在研究结果产 生时接受并使用它们。与实施研究相关的关键问题是，在研究“完成”之前不能推迟传播。 研究结果的传播必须为每一类利益相关者和关键决策者进行适当的包装。 决策者经常强调研究人员未能提供研究结果，而研究人员经常对决策者没有使用所提供 的研究结果表示失望。Brownson 等 (6)曾使用“平行宇宙中的旅行者”一词来描述研究人员 和政策制定者。这种脱节可以通过采用更全面的传播方法来避免。在很多情况下，研究人员 在研究完成之后才逐渐意识到以下的问题： • 哪些利益相关者从将要产生的信息中获益？ • 这些利益相关者想要回答的具体问题是什么？ • 我们如何让利益相关者参与界定和提出“正确的”问题？ • 为了使干预措施或研究结果变成具体行动，应该以谁为目标对象？ • 利益相关者实际上如何吸收研究证据？ • 谁将直接或间接地受到本研究结果的影响？ • 是否有将研究结果付诸实施的计划，谁将支持或反对?我们将如何回应任何反对意 见?或者充分利用支持？ • 我们如何才能最大化地利用关键利益相关者的洞察力或减轻他们的反对意见？ 这些问题应该是项目规划中不可分割的一部分。要想实施研究开展顺利，研究人员、实 施者和政策制定者应该在实施研究循环的整个过程中不断进行沟通和合作。在同行评议中发 表研究成果，撰写政策简报和研究报告也是在实施研究及他们扮演的角色中基本的传播方式。 单元 6：监测和评估 最后一个单元的设计目的是帮助研究团队根据既定计划跟踪进度，检查是否符合已建立 的标准，确定趋势和模式，调整策略并为项目管理提供决策依据。本单元内容还有助于培养 技能，以确定目标的相关性和实现、发展效率、效果、影响和可持续性。完成本单元后，研 究小组将能够了解制订监测和评估研究计划所涉及的过程，并描述实施研究项目的实施过程。 受众 实施研究涉及到一些具有不同和互补的技能、经验与背景的人员，解决实施问题并回答 卫生保健提供者、项目管理者、实施者和其他服务提供者在执行其职责时提出的问题。因此， 实施研究项目可包括研究人员和其他利益相关者，如卫生保健提供者、项目管理者、决策者、 学生、民间社会组织、非政府组织以及对实施研究过程和结果感兴趣的任何其他团体或个人。 尽管参与实施研究项目的每个人对于整个实施研究循环及其在项目中的作用的了解是 重要的，但在该单元中，强调的是卫生保健提供者、研究人员、决策者或管理人员和行政人 11 员对实施研究的理解。 图 5 显示了实施研究团队中不同参与者的参与需求。然而，根据项目的内容和性质，参 与需求可能会有所不同。实施研究工具包适用于列出的所有类别的人员和其他感兴趣的团体。 受众 卫生服务提 供者 研究人员 决策制定者 财务及 行政 传媒 伦理委员会 实施研究简介 ++ ++ ++ ++ ++ ++ 情境化实施研究 ++ ++ ++ ？ + - 制定实施研究计划书 ++ ++ + - - - 计划开展实施研究项目 ++ ++ - ++ - - 数据分析和展示 ++ ++ ++ - ？ - 传播研究结果 ++ ++ ++ ？ ++ - 监测和评估 ++ ++ - - - - 指导和持续参与 必须++ 可选择？ 建议+ 不作要求- 图 5：建议的参与者或受众，以及对实施研究过程中不同阶段的参与需求 参考文献 1. Sanders, David, and Andy Haines.“Implementation research is needed to achieve international health goals.” PLoS Medicine 3.6 (2006): e186. 2. Remme, Jan HF, et al. “Defining research to improve health systems.” PLoS medicine 7.11 (2010): e1001000. 3. Damschroder, Laura J., et al. “Fostering implementation of health services research findings into practice: a consolidated framework for advancing implementation science.” Implement Sci 4.1 (2009): 50. 4. McLellan, A. Thomas, Deni Carise, and Herbert D. Kleber. “Can the national addiction treatment infrastructure support the public’s demand for quality care.” Journal of substance abuse treatment 25.2 (2003): 117-121. 5. Kothari, S. P., Xu Li, and James E. Short. “The effect of disclosures by management, analysts, and business press on cost of capital, return volatility, and analyst forecasts: a study using content analysis.” The Accounting Review 84.5 (2009): 1639-1670. 6. Brownson, Ross C., et al. “Researchers and policymakers: travelers in parallel universes.” American journal of preventive medicine 30.2 (2006): 164-172. 补充阅读 • Peters, David, Nhan Tran, Taghreed Adam, and World Health Organization. “Implementation research in health: a practical guide/edited by David Peters…[et al].” (2013). 12 附录 1:实施研究循环步骤的自我评估框架 技能组合 1 略懂 2 理解 3 知识 4 技能 5 能力 定义和情境化实施研究 问题 我们依赖于我们对环境的 主观看法 我们了解实施研究的独特 背景及其范围 我们对真实的实施研究背 景的部分看法是一致的， 并且填补了我们对更完整 背景的了解 我们对环境有完全真实的 理解，并且正在发展适应 技能 我们将背景因素整合到实 施研究过程或循环的所有 步骤中，以确定解决方案 并调整实施研究方法 提出实施研究的方案 我们熟悉研究提案的组成 部分 我们可以区分实施研究方 案和项目的具体要求 我们已经完成了实施研究 计划，并确定了资助 在实施项目和持续监督和 评估时，我们不断学习更 多关于方案制定的知识 我们能够指导其他项目团 队在方案制定中使用良好 的实践 计划开展实施研究项目 我们从未计划过实施研 究，所以边做边学 我们了解所需的规划原 则，但尚未将它们直接应 用到我们的项目中 我们能够将规划原则应用 到我们自己的项目中 我们根据良好的规划原则 和实践进行研究 我们对工作进行了充足的 计划，并能够指导他人 分析实施研究数据 我们是研究或数据管理方 面的新手 我们了解不同的数据收集 方法，并区分定量和定性 方法 我们在工作中使用适当的 研究和数据方法 我们拥有特定的数据分析 技能 我们能够迅速地将实施研 究数据转化为行动和政策 建议 交流实施研究结果并将 其反馈给卫生系统 我们定期在专业期刊上发 表研究成果 我们熟悉并胜任项目结束 后的成果传播 我们在与主要利益相关者 的第一次会议中考虑传播 和沟通问题 我们在整个实施研究循环 中整合我们的传播策略和 沟通策略 我们利用多种机会在项目 利益相关者和团队之间传 播、协同和合作 监测和评估项目 我们对实施研究的管理是 新手 我们清楚有效监督和评估 的好处及要求 我们了解在项目的不同阶 段需要监督和评估什么 我们使用来自项目的监督 和评估数据来进行周期性 检查 我们将监督和评估整合到 方案制定、项目执行和调 整的各个阶段 13 1 单元 情境化实施研究问题 14 单元 1 情境化实施研究问题 一、学习目标 本单元旨在强调情境和环境因素对实施研究项目的重要性。本单元增加了对研究环境、 具体干预策略和相关伦理考虑之间关系的理解。在本单元结束后，学员团队将能够： 1. 分析他们开展的实施研究项目所处的环境。 2. 理解和重视与他们提议或计划实施干预措施相关的情境。 3. 描述与实施研究项目相关的伦理原则。 二、关键概念 1. 理解实施研究情境 自然、社会经济、文化环境、卫生系统、利益相关者和制度文化是研究情境的关键因素。 它们共同促进并影响干预措施的计划、实施、监测和结果。在实施研究项目的前期实施阶段， 应该分析这些因素。需要注意的是，这些因素在不同的环境、不同的项目中都有很大的差异。 自然、社会经济和文化背景 自然、社会经济和文化背景的各个方面可能是相关的，这取决于具体的干预措施。必须 进行仔细的规划，以便有效地把资源集中在最可能成为关键的因素上。 ①自然和人口因素 应注意相关的地理特征：农村或城市的位置、距离、进入的自然障碍（例如山区、河流）、 相关的基础设施(例如交通系统、电力和供水）；人口统计（例如人口规模、按地点、性别和 年龄分布）。应根据情况详细分析按地点或人口类别分列的疾病负担、发病率和死亡率趋势。 ②社会经济状况 分析一般生活水平；应研究不平等程度、确定脆弱群体、根据收入水平、资产、教育状 况和职业确定社会经济地位。此外，不同类型的住房(如公共小屋、公寓或封闭式社区)，也 应按照位置、食物消费、营养、获得干净的水和卫生等因素进行分类和分析。 ③文化和政治因素 分析与健康、两性平等、识字率、种族或部落隔离有关的文化信仰；政策环境和政治因 素，包括对社会服务和保健服务的支持水平；应当进行政府提供服务的能力以及任何其他正 在进行的或近期进行的卫生干预措施。 15 图 1 实施研究中的情境因素 卫生系统 每一个卫生系统是由多个子系统构成的（1），其主要重点是促进、恢复或维持健康。世 界卫生组织已经确定了构成卫生系统的六个关键群组或“基石”（2），包括了领导/执政能力； 卫生筹资；卫生人力资源；医疗产品和技术；信息和研究；服务提供。这些基石涉及卫生保 健服务的获取和覆盖，以及服务的质量和安全（图 2）。 图 2：卫生系统的基石 其他因素亦有益于卫生系统，如自我护理和社区护理。对于与实施研究项目相关的组成 部分，进行系统的描述性分析利于识别相关决策主体和管理其运作的（正式和非正式）机构。 卫生系统的基石 目标或结果 卫生筹资 领导/执政能力 卫生人力资源 医疗产品和技术 信息和研究 服务提供 改善健康状况（水平和质量） 反应性 财政风险保护 促进效率 获取 覆盖 质量 安全 例如：信仰、 伦理道德、 传统 文化 政治 社会 经济 自然 因素 其他 利益相 关者 卫生 系统 干预 制度 例如：权力关系、 政治背景、政府结 构 例如：地形、 距离、河流 任何其他的 影响干预的 因素 例如：教育、 人口、居住 例如：非政府 组织、学校、 女性团体 健康、信息、 服务提供、劳 动力 机构文化和风 格 16 图 3：典型的卫生系统要素 在下面总结的例子（方框 1）中，研究人员积累了关于在夸祖鲁-纳塔尔省（南非）进 行的一项研究的自然、社会经济和文化因素以及卫生系统考虑因素的信息。该研究包括审查 相关文件和与当地居民的互动。这些资料包括用于规划和监测研究方案的基线数据或指标， 并有助于制订合适的传播战略。 分析卫生系统的主要目的之一是，预测具体因素如何潜在地影响某一特定干预措施的可 行性和作用。由于各种特定的情境因素，在某个环境中可能有效的干预措施在其他情境下的 影响可能会被削弱（图 4）。 17 方框 1 案例：Sisonke区的结核病/艾滋病合作项目 在一项评估非政府组织和社区护理工作者参与夸祖鲁-纳塔尔省结核病及人类免疫缺陷病 毒（HIV）合作活动的研究中，研究人员审查了南非卫生审查报告，特别强调了健康和与健康 相关的指标。他们确定夸祖鲁-纳塔尔省是结核病和HIV流行的中心，在某些环境中结核病及 HIV联合感染率为75-80%。他们还确定夸祖鲁-纳塔尔省的11个区之一Sisonke区主要是农村， 道路很差，面积为11128平方公里，人口约50万，79%的人失业，人口中的贫困水平为71%。 与类似的内陆农村地区的居民相比，Sisonke地区的居民获得基本保健服务的机会相对较差。 只有33%的Sisonke居民能够获得自来水（在现场或现场外），57%依靠蜡烛照明，74%依靠石 蜡或木材做饭，只有22%能够获得良好的卫生设施（即冲水或化学厕所）。最常见的语言是伊 斯苏鲁语，大部分地区人口为女性（53.62%)）。产前HIV流行率估计为35%，而2008年至2009 年全省HIV流行率为39.5%，这是通过审查2010年南非全国产前哨点HIV和梅毒现况调查确定 的。每10万人中有1079例新结核病例，HIV合并感染率为81%（2009年南非总体为52%）。 在进行研究时（2008年8月至2009年9月），该地区的卫生系统由32个管理家庭护理服务的 非政府组织组成，其中26个组织由卫生部资助。这26个非政府组织共雇用了414名社区卫生工 作者。另一个大型独立组织管理着402名社区卫生工作者。 资料来源：（3） 图 4：卫生系统因素对干预措施效果和作用的影响 利益相关者分析 在实践中，实施研究涉及到各种各样的利益相关者，应该在研究项目的发展阶段对他们 加以识别。利益相关者分析是研究人员在理解干预措施情境因素方面进行的最重要的活动之 一，其应该以系统和全面的方式进行（4-6）。利益相关者分析旨在识别所有利益相关者，评 估研究可能对他们造成的影响以及他们对于研究结果的反应。利益相关者的识别需要仔细的 判断，必须既不能不包容（限制观点的广度），也不能过于包容（淡化基本的焦点）。 + 效 果 - 有效工具 有效工具 可及性 提供者的符合度 提供者的符合度 患者的依从性 患者的依从性 效果 18 利益相关者分析过程包括:（1）明确分析的目的；（2）生成利益相关者列表（可以通过 头脑风暴来构建初始列表，继而利用滚雪球的方法完善列表，在此期间，可以识别更多的利 益相关者）；（3）收集必要的资料（使用访谈指南半结构式问卷）——建议提前预约，必要 时征求同意并记录访谈；（4）以矩阵形式分析和提出数据（即利益相关者的类型、利益和影 响的程度，以及他们在实施拟采用的干预措施中将要发挥或正在发挥的作用）。表 3 显示了 健康项目案例中的各种利益相关者，以及他们所扮演的角色。 表 3 项目利益相关者和各自角色的典型案例 利益相关者 角色 ProNet 政策实施中的重要非政府组织 联合国儿童基金会 有影响力的联合国机构，并代表其他的非政府组织参加各种会议 环境部机构 国家级政策制定与实施 基督教委员会会体 代表以信仰为基础的团体 方框 2 强调了如何利用利益相关者分析评估一系列利益相关者的看法、愿望和期望，以 便在推出一系列卫生服务创新之前评估政策环境。 制度分析 制度或组织分析（组织行为的系统性研究）是计划实施研究需考虑的另外一个重要因素。 可以通过分析强弱危机分析（SWOT 分析）实现，以确定影响干预成功或失败的潜在因素。 方框 3 中案例使用了 SWOT 分析，提供了有关影响蚊子控制方案的各种研究环境中蚊 子控制行动的效率和可持续性的各种问题的信息。 方框 2 案例：对智利圣地亚哥的利益相关者进行质量评估 智利圣地亚哥大都会地区的一项研究采用利益相关者分析，评估儿童急性下呼吸道疾病 （肺炎和阻塞性支气管炎）的门诊护理以及预防中风的系列创新举措在引入前的政策环境。 根据研究人员对智利卫生部门的了解，确定了重点利益相关者。他们包括决策者、医生、 护士、管理人员和与卫生保健有关的专业人员。 这项研究主要涉及收集有关一系列利益相关者的看法、愿望和期望的定性数据。该研究 还收集了关于权力和权威的看法的材料，因为这被认为可能会影响实施过程。 虽然这种方法不能进行统计推断，但它被视为向利益相关者提供关于计划中的创新举措 的情境理解和可能反应。本研究旨在为构建有意义的社会互动与协商提供数据。其考虑了经 验、知识和行为等领域。 资料来源:（7） 19 方框 3 案例：七个地点的蚊虫控制工作分析 对哥斯达黎加、埃及、以色列、肯尼亚和特立尼达等七个城市的蚊虫控制规划进行了 描述和比较。特定的城市和疾病特征、组织图表、SWOT分析工具用于对每个蚊子控制程 序进行描述性评估，并对影响减少蚊子数量的因素进行比较。 SWOT分析的信息来源于调查、焦点小组访谈以及个人交流。SWOT分析确定了影响 蚊虫控制行动效率及其可持续性的各种问题。研究的主要成果是对蚊虫控制行动中每个研 究地点的生物、社会、政治、管理和经济条件进行描述及比较。 研究发现的问题包括从缺乏跨部门合作到蚊虫控制工作的操作问题。缺乏可持续的蚊 虫控制资金是大多数场所的共同问题。还有许多特殊问题，包括缺乏蚊虫监测、缺乏执法， 以及人类行为的负面影响。 识别蚊虫控制行动的共同优点和缺点，有助于确定蚊虫控制行动的最佳实践，从而更 好地控制蚊虫叮咬和蚊虫疾病的传播。 资料来源：（8） 思考活动 • 项目范围内的社会文化和政治制度是什么？ • 卫生系统是如何构成的（公立和私立）？ • 卫生系统可能如何影响你的项目？ • 谁是利益相关者？ • 每个利益相关者将为研究项目带来哪些具体的知识和技能？ • 对这些因素的考虑将如何影响你项目的计划？ 2. 理解干预措施 政策变化、项目和规划等干预措施试图将已在实验室、临床试验或小规模试点研究中证 明有效的健康创新进行转移，造福更多人。参与这类创新开发的人群促进了真正的实施，并 经常警告说偏离计划可能会降低效率。他们关注的是“保真度”（9,10）。而卫生保健提供者 往往更关心干预措施的效果，他们认为根据当地情况进行适当调整可以提高干预措施的效果。 实施研究面临的困境是，越是严格控制实施以确保已证实的干预措施的保真度，当地的 情境因素（如资源约束、文化因素、基础设施等）就越有可能降低其效果。使用循证干预措 施的另一个问题是，预期的干预措施在应用中被修改的程度可能存在相当大的不确定性。因 此，这就意味着所说的保真度可能大大低于实际预期。 我们已经讨论了了解实施研究项目规划和实施的环境的重要性。反思 自己的实施研究项目，并确定在项目实施前和实施过程中应考虑的环境因 素。站在一个更为广泛的层面上，考虑文化信仰和习俗、政治结构、卫生 系统的组织方式以及环境中广泛的利益相关者。然后回答以下问题： 20 此外，实施研究通常涉及复杂的社会干预措施，其依赖于研究所处的情境，这反过来可 能会导致低保真度。因此，结果取决于可能尚未被很好理解的详细过程和各种途径。 因此，要进行有意义的实施研究，就需要深入了解：①预期的干预(例如，确定那些被 认为是必要的因素，以及那些可以在不破坏干预目标的情况下进行修改的因素)；②计划的 实施过程，特别注意由于认为有必要适应当地的具体情况而做出的修改。 一个能跟踪实施过程中的变化并检查是否偏离原定计划的监测系统是必不可少的。这样 的系统可以作为一个有用支点来构建（或者审查，如果已经存在）干预的“逻辑模型”（11,12）。 国际捐助者通常需要这样的模型，以简化解释具体的干预措施如何处理和实现其目标。 干预逻辑模型 这种干预模型采用了“如果-那么”的方法（见图 4）： • 如果进行了活动，那么应该会有产出。 • 如果形成了产出，那么应该会有符合目的的结果。 • 如果产生了结果，那么他们应该有助于实现目标。 关于外部情境因素监测和评价的假设 图 4：一项干预措施的逻辑模型 那些管理干预措施的人被认为负责形成一组可定义的和可量化的产出。产出结果步骤经 常建立在对现有证据的假设和对情境因素的透彻理解上。 为使逻辑模型中的每个步骤更为有效，与干预措施和外部情境因素有关的假设必须是准 确的。更好地把握个别步骤的弹性，就更有可能使干预措施的整体实施获得成功。 逻辑模型矩阵 逻辑模型可以采用简单的矩阵格式显示。 可验证的客观指标 验证的方法 假设 目标 结果 产出 活动 投入 在实施管 理的控制 之下 超出实 施管理 的控制 投入 活动 产出 结果 目标 21 矩阵的“逻辑” 定义： 目标：干预有助于实现的更高层次的目标（例如：降低婴儿死亡率）。 结果：干预措施的结果所预期的最终影响或变化（例如：增加儿童免疫接种率）。 产出：可直接影响并由实施管理小组负责的结果（例如：改善获得免疫接种的机会）。 活动：为产生预期产出而进行的活动（例如：提供者激励机制的改革）。 可验证的客观指标 该逻辑模型的一个主要目的是探讨和确定如何有效地监测关键的实施活动、产出和结果， 以评估某项干预措施按计划实施的完成程度。特别是，这一过程涉及产生预期产出和结果的 信息和文件，逻辑模式要求在每一级确定一套可验证的客观指标： • 目标：验证目标完成程度的措施。 • 结果：验证成果目标实现程度的措施。 • 产出：验证哪些产出目标已实现的措施。 • 活动：对开展活动所需投入（即资源）的衡量。 假设 逻辑模型还需要识别在实施管理团队控制之外的、被认为是必备的重要条件或事件： • 用于实现目标； • 用于实现具体结果； • 用于形成预期产出； • 用于开始和持续实施。 研究假设对实施研究来说特别重要，因为它们在评估重复、扩大或重新部署干预措施的 可能性方面特别重要。一些需要解决的关键问题是： 在现有的背景下，上述假设是否可信？ 这些假设对于研究背景有多大的针对性？ • 是否有重要的隐含（未确认的）假设？ • 不正确的假设可能会导致什么后果？ • 有任何假设被证明是错误的吗？ 逻辑模型在实施研究中的可能用途 • 总结和测试给定干预措施的基本逻辑。包括合理性、可行性和情境因素的初步评估。 • 促进对干预措施的共同期望。 • 界定成功/失败的指标，并为设计监测和评估框架提供基础。 • 确定可用于验证实现失败和成功的数据源。 • 明确所有研究假设，如果不正确，将对干预措施产生严重的不利后果。 • 随着时间的推移，跟踪实施计划的重大修订，并相应地促进逻辑框架的修改。 22 表 4.一个完整的逻辑模型矩阵的案例 客观的可验证的指标 验证的方法 假设 目标 根除疾病 国家疟疾患病率 全国疟疾流行情况 调查 其他有助于实现既定 目标的干预措施 结果 使用长效杀虫剂处理过的 蚊帐(LLIN)睡觉的5岁以 下儿童比例增加 睡在长效杀虫剂处理 过的蚊帐的孩子数量 项目记录 社区讨论 小调查 社区可以被说服接受 长效杀虫剂处理过的 蚊帐的好处 产出 1 5岁以下儿童拥有保护自 己不受疟疾侵害的手段 5岁以下儿童家庭中 使用长效杀虫剂处理 过的蚊帐的大量分布 家庭评估形式 焦点小组讨论 为这个项目提供充足 的资金；家庭给五岁 以下儿童使用长效杀 虫剂处理过的蚊帐 产出 2 信息、教育和沟通或行为 改变沟通活动来鼓励适当 的使用长效杀虫剂处理过 的蚊帐；早期求医行为 对5岁以下儿童的疟 疾问题和长效杀虫剂 处理过的蚊帐的使用 问题增加及时咨询 健康中心的记录 焦点小组讨论, 口袋式图表 假定有卫生设施和熟 练的卫生工作者 活动 1 确定公共卫生对口单位， 并对管理人员和提供者进 行培训 已确认的工作人员人 数，完成的培训 项目记录 培训评估 来自当地官员、提供 者、社区的支持 活动 2 疟疾知识、长效杀虫剂处 理过的蚊帐使用和求医行 为基线调查 与不同小组举行的焦 点小组和研究会议的 数目； 数据质量或数量 项目记录及报告 具备与目标人群沟通 的能力 活动 3 寻找和训练社区义工来推 广长效杀虫剂处理过的蚊 帐 确定和训练的志愿者 数量 项目记录 培训评估 社区行动计划 假定社区愿意自愿参 加这些活动 活动 4 长效杀虫剂处理过的蚊帐 的大量分布 LLINs长效杀虫剂处 理过的蚊帐的数量分 布 项目记录 假定立即购买和交付 蚊帐 活动 5 信息、教育和沟通或行为 改变沟通的载体 印制的传单和海报数 目 项目记录 信息、教育和交流的 可用性 活动 6 开发可靠的信息系统 数据数量或质量 项目记录 社区承诺 健康服务可及性 * （IEC/BCC:信息、教育及传播或行为改变传播） 23 复杂适应系统 有学者认为，许多健康倡议产生了所谓的“复杂适应系统”（CAS）（14-17），这是一种 基于关系、产生、模式和迭代的理论。前提是，无数复杂系统（天气系统、免疫系统、社会 系统等）可能会相互作用，从而触发对当前环境的适应。 复杂适应系统涉及大量具有自适应能力的相互作用主体。它们会根据不断变化的环境、 环境和特定干预所引起的变化做出适应。例如，一个常见的适应可以是形成了新的组织联盟。 复杂适应系统概念的最终含义是没有简单的方法来“控制”主体行为。复杂适应系统在 本质上是不可预测的，对干预措施的意外反应经常发生。因此，了解复杂适应系统现象对于 更好地规划、实施、监测和评估扩大卫生服务的方法非常重要。 许多健康干预产生复杂适应系统的证据是什么？ • 由于环境差异，如卫生系统发展水平、生态因素，社会和文化差异，在条件受限制 的研究环境中或者在某个国家或地区中获得小规模成功的干预措施，想要向其他地方进行推 广或者扩大规模时往往会遭遇失败。 • 实施过程往往很少按照计划进行，通常需要迅速做出调整来适应不断变化的情境。 • 实施管理者对提供者、社区甚至他们自己员工行为进行控制的能力，在实践中经常 受到组织环境的高度限制。 • 看似很简单的技术干预在利益相关者群体互动时也会出现复杂适应系统行为。 • 重大的干预有时会产生非常有限的结果，相对较小的投入也可能产生重大的积极或 消极后果。 复杂适应系统行为 复杂适应系统会表现出意想不到的行为。与卫生干预措施相关的三种行为模式是:反馈 循环、路径依赖和突发行为。下面将更详细地描述反馈循环。 当系统内某个进程的输出被反馈到同一个系统中时，反馈循环就发生了。例如，正反馈 增加了某一因素在给定方向上的变化率（即自我强化），而负反馈调节了变化方向（即平衡）。 思考活动 目前影响这些服务实现的环境和情境问题是什么（积极的和消极的影响）？ 上一节中，我们回顾了关于健康服务的文化信仰、做法和政治结 构的复杂相互作用。请以计划生育服务为例，说明目前在你的项目区 域内正在进行的干预。 24 例子:反馈循环对免疫接种服务的需求产生积极或消极影响 社区对免疫接种的高度认识对免疫接种服务的需求产生了积极的影响(加强)，而有效 的社区动员、母亲的高识字率、媒体宣传和健康教育活动的程度也提高了对免疫接种服 务的认识。相反，对免疫接种的误解降低了社区对免疫接种的认识水平，从而降低了对 免疫接种服务的需求。 尽管母亲的可获得性增加了对免疫接种的需求，但母亲的家庭责任和社会经济地位 低下可能对其可获得性产生负面影响。 保健服务的质量和可得性可以积极或消极地影响对免疫服务的需求。免疫服务的提 供增加了接受免疫接种的儿童数量，提高了社区的群体免疫力，从而疫苗降低了可预防 疾病的暴发风险。疫苗可预防疾病的低发生率有助于提高社区对免疫接种方案的信心， 从而增加对免疫接种服务的需求。 卫生服务质量差，例如缺乏疫苗、等待时间长、接种疫苗后儿童出现脓肿等，使母 亲不愿带子女参加免疫接种。这导致社区儿童辍学率高和未接种疫苗的发生，从而导致 免疫力低下，增加了疫苗可预防疾病暴发的风险。其结果是对卫生系统失去信心，这进 一步减少了对免疫接种服务的需求。 方框4 认知水平 其他的相互 竞争的利益 动员的 有效性 放弃 免疫接种 免疫接种的 需求 母亲的 可及性 对卫生系统 的信任水平 服务的 可及性 正反馈 负反馈 25 3. 实施研究中的伦理考虑 在过去的 20 年里，审查研究提案/协议的严格程度稳步提高。已经实施了一些举措，以 加强伦理审查能力和提高参与研究人员的认识。制定适用于各个地方所有研究的伦理规则是 困难的，而且常常是不恰当的。重要的是，每项研究都要根据其所处的情境来判断伦理方面 的问题。大多数伦理道德问题源于“相互竞争”的价值观之间的冲突。这也表明，在一种环 境中可能被认为是伦理上不可接受的研究，在另一种环境下可能被认为是可以接受的，这两 种判断都可能是正确的，适当的。 关于人类研究的伦理准则，有一些准则和国际标准文件可供参考。虽然本单元不会讨论 这些准则，但值得注意的是，每个准则在提供的细节或信息的范围和水平方面有所不同，特 别是在知情同意程序、向对照组提供常规标准护理服务的义务、安慰剂的使用以及研究参与 者在研究结束后获得健康产品的程度（18）。从公共卫生的角度来看，研究伦理应该考虑适 当社会的相对风险和利益，而不是以研究对象个人为导向。在许多中低收入国家，面对着贫 穷和有限的医疗卫生条件，研究工作往往会遭遇一些困难。因此，那些对与贫穷有关的疾病 进行干预措施实地试验的人可能会面临特殊且困难的伦理困境。与实施研究相关的一些伦理 问题可能是不可预测的，并且只有在研究开始时才会出现，因此可能没有在提交伦理审查的 研究方案中得到解决。在研究之前发现的伦理问题以及在进行实施研究项目过程中出现的伦 理问题，应由研究团队迅速解决。 以人为研究对象的伦理原则 以人为研究对象的研究应受到基本伦理原则的约束，以保护个人、社区和整个社会免受 不必要的风险。 这些原则被广泛讨论，因为它们表达了不同的伦理、经济和政治理论。在实践中，这些 原则可能会根据不同的情境而承担不同的权重，但在其有效性和用于指导研究项目建议的必 要性方面存在普遍的共识。 在大规模的卫生干预研究中，特别是在与国际伙伴合作开展的研究中，道德和伦理问题 可能超越国家和政治利益（19）。低收入和中等收入国家有广泛的卫生问题，而当地找到解 决方案的能力十分有限。在大多数情况下，充分提供基本保健的科学、管理、政治和经济能 力都很有限。在这样的条件下进行研究既具有挑战性又至关重要。 三项既定伦理原则应用于公共卫生研究，包括实施研究： 1. 自主权/尊重他人是基于伦理信念，即每个人都有道德观和自主权，因此不应被用作造 福他人的手段。在了解真相、忠诚、隐私和保密方面，个人应该被平等对待。从这一原 则衍生出的两个主要伦理假设是：①对那些能够做个人选择和自我决定的人给予充分尊 重；②保护自主权被减弱的人，要求那些依赖他人或易受伤害的人得到安全保障，免受 伤害或虐待。 26 2. 效益是将促进个人福利作为健康研究的首要目标，最大限度地扩大其收益。非恶意是指 避免伤害、恶意对待个人或提供无效干预的生物伦理学原则。在任何情况下，对个人造 成伤害都是不合理的，即使这可能给人群带来利益——只有在风险和利益之间有适当的 平衡时，研究才是合理的。研究人员及其组织的责任是确保效益。更广泛的社会也有责 任了解任何拟议研究的风险和好处。 3. 公正是指在高风险和有益的研究中，尊重他人，给予参与者平等机会的道德义务。弱势 群体应得到保护，不应因与研究无关的理由而排除特定群体。向参与者提供健康服务也 应是公平的，并应加强地方研究或保健服务能力。 实施研究中的伦理困境 研究人员的伦理和科学诚信对国际合作项目的伦理可接受性至关重要。在实施研究的背 景下，可能会出现特定的伦理困境，因为研究通常是在医疗卫生条件有限的高负担和脆弱人 群中进行的。在这种情况下，志愿者的自主权和理解能力可能是有限的。对研究结果的过高 期望社会压力和权威压力可能导致各种形式的强迫同意或胁迫。在社会科学研究中，当讨论 或记录敏感问题，或违反保密原则时，个人观察或个人访谈都可能产生心理困扰（21）。 表 5：由于参与者或环境的特点而存在缺陷的伦理原则 变量 结果 伦理原则缺陷 语言障碍 权力关系和依赖的存在，阻碍了个体的决策过程 自主权 家庭和个人在社会中 的角色 尊重有智慧和权威的传统人物，包括社区领袖 自主权 效益 公正 医疗保健和疾病的传 统和信仰 对传统治疗师、医生或研究人员的尊重差异 自主权 不熟悉的研究 对研究程序的敏感性 自主权 贫穷和低教育水平 难以理解研究人员提供的信息 自主权 公正 获得保健服务和商品 的机会低 剥削和胁迫，引诱，经济利益的可能性 自主权 公正 属于弱势群体 剥削和胁迫的可能性 自主权 公正 在卫生机构进行研究 干扰公共卫生系统 公正 27 与实施研究相关的伦理问题会引发争议。这可能涉及定量和定性研究方法以及一系列学 科和观点，如流行病学、统计学、人类学、社会学、卫生经济学、健康促进和教育、政治学 等。尽管研究方案是应用在现实生活环境中的，其风险往往比在临床试验中遇到的风险小， 例如，实施研究的参与者可能会因失去隐私、花费在访谈和检查上的时间以及可能产生的消 极心理影响而感受到负担。这些风险可以通过仔细关注研究程序，限制问卷的长度或额外的 临床检查和抽样，以及考虑观察的时间来实现风险的最小化。实施研究还提出了具体的伦理 挑战，因为它需要从涉及广泛利益相关者的不同情况下的大量受试者中收集信息。因此，伦 理审查委员会应充分了解此类提案或协议，并确保所有观点都得到保护（22）。 表 5 和表 6 总结了一些伦理困境及其后果，并强调了可能有缺陷的相关伦理原则。 表 6:因研究人员的特点而存在缺陷的伦理原则 变量 结果 伦理原则缺陷 语言障碍 未能获得知情同意 自主权 双重角色：医疗助理 和研究员 认为参与研究比没有医疗保健更重要 效益 公正 利益冲突 影响公正判断的能力 自主权 公正 不正当的入侵 违反隐私保密 自主权 不清楚参与者选择的 程序 不公平的参与者选择 公正 未能解释研究的好处 提高参与者的期望 自主权 与合法的社区代表对 话不畅 未能与潜在参与者沟通（由于缺乏当地语言技能） 未能获得知情同意 未能确定适当或合理的激励措施 没有使用适当的传播策略 自主权 思考活动 使用本节和表 5 和表 6 中提供的信息，思考一下你的项目有哪些 伦理问题特别注意？ 28 三、关键概念的应用 下面的例子描述了如何将理解环境、干预和伦理问题的关键概念应用到实施研究中。 方框 5 案例：一例自愿接受包皮环切手术的男性 背景:尽管许多研究强烈建议，在撒哈拉以南非洲，男性包皮环切术在应对新艾滋病毒感染 的持续上升方面非常重要，但许多情况证明很难将这项研究转化为政策和实践。这主要是由于 经济、社会和伦理方面的考虑。在计划实施或扩大男性自愿接受包皮环切作为公共卫生干预措 施时，应考虑具体因素。以下是在计划将男性包皮环切作为一个艾滋病预防干预时，可能会发 现的一些相关的问题和伦理困境。 关键概念1：理解情境 应当分析社会经济和文化状况，以及实施干预措施的卫生系统。例如，该国能够支付与提 供安全割礼服务有关的费用水平。此外，应当审查与男性包皮环切有关的文化价值观以及现有 保健服务的组织。保健服务的组织对将新生儿男性包皮环切术纳入产后服务或作为一项单独服 务的可行性有决定性影响。现行国家关于男性包皮环切的政策也对实施进程有重要影响。例如， 是否某些年龄段的孩子不应该接受割礼，是否有专门的割礼外科医生，或者实施割礼的地方？ 在分析保健服务时，还应分析现有人力资源提供安全包皮环切和其他艾滋病毒服务的能力。最 后，应评估利益相关者（即决策者、卫生部、卫生工作者、社区和包括配偶在内的潜在受益者） 及其各自的作用。 关键概念2:理解干预 应分析以下与干预措施本身有关的背景问题。这一点很重要，因为有不同的因素会促进或 阻碍实施。相关因素包括:不同男性包皮环切方法的文化可接受性（即新生儿、青春期青少年、 成人）；将干预措施纳入现有保健服务的可行性；提供干预所需的资源；如何在所有预期受益人 中公平地提供；以及传统割礼的社会和心理层面。 关键概念3:伦理困境 自主权——自愿的男性包皮环切意味着几个伦理困境。其一，在未达到同意年龄的未成年 人的情况下，获得新生儿包皮环切手术的同意。如果孩子不同意但父母想要割礼，或者反过来 孩子想要割礼但父母拒绝同意，该怎么办？此外，获得包皮环切手术同意的概念在文化上可能 是不存在的。 公正——谁有资格进行干预的问题应予以密切考虑。例如，是否应该针对有感染或传播艾 滋病毒风险的人群（如卡车司机、士兵、移徙工人）实施包皮环切?如果特定人群与HIV和相关 服务有关联，这可能导致随后的污名化。 效益——效益原则也是需要考虑的重要伦理问题。例如，决定实施干预的最佳年龄；男性 包皮环切手术是否应该只提供给HIV检测呈阴性的男性，还是也应该推广到艾滋病毒携带者？ 资料来源：（23） 29 还有更多的情境性问题影响实施研究计划的案例 案例:增大南非预防母婴传播方案的覆盖面 这一干预措施包括在南非一个艾滋病毒高发地区实施的数据驱动的参与式质量改进方法。 设计包括三个阶段:（1）建立一个参与性评价阶段以培养当地方案管理人员能力；（2）反馈和 规划阶段，在此期间查明系统的弱点并制订相应的干预措施；（3）为期12个月的实施和监测阶 段，在此期间进行了减少艾滋病毒母婴传播预防的干预措施，并监测了有关的产出指标。 通过对管理人员和顾问进行结构化访谈、观察卫生设施、审查文件和例行收集预防母婴传 播的数据。数据显示，所有关键的母婴传播预防产出指标都有很大改善。 关键概念1:理解情境 背景资料中介绍了研究地区的人群、预防母婴传播方案的组成部分、目前的预防母婴传播 政策、南非的地区卫生系统、转诊系统和保健提供者的核心活动。所审查的文件包括国家卫生 审查报告、预防母婴传播护理议定书、预防母婴传播方案实施政策指导方针和艾滋病毒血清流 行情况调查报告。基线预防母婴传播指标是从常规地区预防母婴传播数据中提取的。利益相关 者包括卫生系统的中层管理人员（如:设施管理人员、初级保健监督员和地区方案协调员）和社 区。它们的不同作用也作了相应的说明。 关键概念2:理解干预 用于制定干预措施的概念框架是基于扩大的卫生系统方法（该框架是基于管理者必须考虑 的关键条件而制定的，确保一个项目从效力转向效果）。研究人员进一步确认，评估过程中发现 的弱点是由于客户与卫生系统因素的复杂交互作用造成的。客户因素包括缺乏信息和害怕披露 HIV状况，卫生系统因素包括护士对预防母婴传播计划缺乏所有权、角色和责任不明确、缺乏对 议定书的了解，以及糟糕的记录系统和护理连续性。 关键概念3:道德困境 • 这项研究以人为研究对象（卫生保健提供者、儿童和看护者）。 • 作为常规医疗保健和系统的一部分，让干预措施有资格获得快速伦理审查？ • 如何尽量减少对日常卫生保健的干扰？ • 您如何在常规护理服务和研究之间划清界限，以及在哪种层次上划清界限？ 资料来源：（24） 方框 6 30 方框7 案例：卫生工作者保护还是患者病耻感？ 在索马里社区，使用医用口罩对病人和医生都是一项挑战。医生在与病人会诊时戴口罩会 让人觉得病人患有高度传染性疾病（例如结核病）。因此，考虑到与结核病有关的病耻感，患者 可能会感到羞辱、不尊重，并认为医生傲慢。这往往会影响医患关系，损害信任，从而可能影 响回访的意愿。此外，它还为卫生工作者或医生提出了一个安全难题。 资料来源：（25） 方框 8 案例:苏丹的生殖健康研究 由于苏丹南部和东部的社会文化背景不同，在苏丹开展的关于生殖健康问题的实施研究面 临伦理和文化问题。研究团队必须根据不同的背景调整他们的方法和团队组成。 伦理：获得本研究的适当同意 苏丹南部 • 社区同意：由部落的酋长和宗教领袖给予； • 知情同意：从参与者个人处获得； 苏丹东部 • 社区同意：由村级的领袖和宗教领袖最后落实，但是一些村庄的领导只有在远程观看会议 后才能决定是否参加。只有在那之后，他们才会允许部落成员参加会议并参与项目。 • 企业文化：优化研究团队组成，确保项目的可接受性、可持续性和高回复率。 苏丹南部 项目组男女人数相等。团队结构的组成在文化上为社会所接受。 苏丹东部 • 项目团队的组成根据社区的文化背景进行了改变。（如封闭的、复杂的社区)。该小组主 要由女性研究人员组成，这使得会有更多的女性参与者加入。团队中少数人男性会与部落 中的领导互动（在文化上这些男性并不善于接受女性的指示）。 • 研究主题及相关的敏感性 • 从项目概念和计划方面认真考虑以避免意外的后果，如任何可能危及项目成功的误解、负 面看法或误解。 苏丹南部 社区开放讨论亲密的生殖问题和权利。 苏丹东部 社区封闭和某些生殖问题被认为是禁忌以及在社会上不可讨论的问题。因此，设计研究（即 研究的目标以及方法）与苏丹南部不同。 资料来源：（26） 四、结论 祝贺完成了单元 1 情境化实施研究问题。本单元旨在增加学员对实施研究的环境问题的 理解和相关知识。该单元还应该促进你在实施研究项目时对干预策略和伦理考虑的理解。 8 31 五、参考文献 1. Bloom, Gerald, and Hilary Standing. “Future health systems: Why future? Why now?.” Social science & medicine 66, no. 10 (2008): 2067-2075. 2. World Health Organization. “Everybody’s business--strengthening health systems to improve health outcomes: WHO’s framework for action.” (2007). 3. Uwimana, Jeannine, Christina Zarowsky, Harry Hausler, and Debra Jackson. “Engagement of non-government organisations and community care workers in collaborative TB/HIV activities including prevention of mother to child transmission in South Africa: Opportunities and challenges.” BMC Health Services Research 12, no. 1 (2012): 233. 4. Varvasovszky, Zsuzsa, and Ruairí Brugha. “A stakeholder analysis.” Health policy and planning 15, no. 3 (2000): 338-345. 5. Brugha, Ruairi, and Zsuzsa Varvasovszky. “Stakeholder analysis: a review.” Health policy and planning 15, no. 3 (2000): 239-246. 6. Hyder, A., S. Syed, P. Puvanachandra, G. Bloom, S. Sundaram, S. Mahmood, M. Iqbal et al. “Stakeholder analysis for health research: case studies from low-and middle-income countries.” public health 124, no. 3 (2010): 159-166. 7. Bedregal, Paula, and Ewan Ferlie. “Evidence based primary care? A multi-tier, multiple stakeholder perspective from Chile.” The International journal of health planning and management 16, no. 1 (2001): 47-60. 8. Impoinvil, Daniel E., Sajjad Ahmad, Adriana Troyo, Joseph Keating, Andrew K. Githeko, Charles M. Mbogo, Lydiah Kibe et al. “Comparison of mosquito control programs in seven urban sites in Africa, the Middle East, and the Americas.” Health Policy 83, no. 2 (2007): 196-212. 9. Carroll, Christopher, Malcolm Patterson, Stephen Wood, Andrew Booth, Jo Rick, and Shashi Balain. “A conceptual framework for implementation fidelity.” Implementation Science 2, no. 40 (2007): 1-9. 10. Pérez, Dennis, Pierre Lefèvre, Marta Castro, Lizet Sánchez, María Eugenia Toledo, Veerle Vanlerberghe, and Patrick Van der Stuyft. “Process-oriented fidelity research assists in evaluation, adjustment and scaling-up of community-based interventions.” Health policy and planning 26, no. 5 (2011): 413-422. 11. Kellogg, W. K. “Logic model development guide.” Michigan: WK Kellogg Foundation (2004). 12. Gasper, D. R. “Logical frameworks’: a critical assessment: managerial theory, pluralistic practice.” ISS Working Paper Series/General Series 264 (1997): 1-46. 13. Contribution of Henry Lucas 14. Paina, Ligia, and David H. Peters. “Understanding pathways for scaling up health services through the lens of complex adaptive systems.” Health Policy and Planning 27, no. 5 (2012): 365-373. 15. Craig, Peter, Paul Dieppe, Sally Macintyre, Susan Michie, Irwin Nazareth, and Mark Petticrew. “Developing and evaluating complex interventions: the new Medical Research Council guidance.” BMJ: British Medical Journal 337 (2008). 16. Rogers, Patricia J. “Using programme theory to evaluate complicated and complex aspects of 32 interventions.” Evaluation 14, no. 1 (2008): 29-48. 17. Leykum, Luci K., Jacqueline Pugh, Valerie Lawrence, Michael Parchman, Polly H. Noël, John Cornell, and Reuben R. McDaniel. “Organizational interventions employing principles of complexity science have improved outcomes for patients with Type II diabetes.” Implementation Science 2, no. 1 (2007): 28. 18. BIOETHICS, NUFFIELD COUNCIL ON. “The ethics of research related to healthcare in developing countries.” London: Nuffield Council on Bioethics Ed (2002). 19. Beauchamp, T. L., and J. F. Childress. “Principles of Biomedical Ethics Oxford Univ.” (2009). 20. National Commission for the Proptection of Human Subjects of Biomedical and Behavioral Research, Bethesda, MD. The Belmont report: Ethical principles and guidelines for the protection of human subjects of research. ERIC Clearinghouse, 1978. 21. Punch, Maurice. “Politics and ethics in qualitative research.” Handbook of qualitative research 2 (1994): 83-98. 22. World Health Organization. Special Programme for Research and Training in Tropical Diseases (TDR). Implementation research for the control of infectious diseases of poverty: Strengthening the evidence base for the access and delivery of new and improved tools, strategies and interventions (2011). 23. Rennie, Stuart, Adamson S. Muula, and Daniel Westreich. “Male circumcision and HIV prevention: ethical, medical and public health tradeoffs in low-income countries.” Journal of medical ethics 33, no. 6 (2007): 357-361. 24. Doherty, Tanya, Mickey Chopra, Duduzile Nsibande, and Dudu Mngoma. “Improving the coverage of the PMTCT programme through a participatory quality improvement intervention in South Africa.” BMC Public Health 9, no. 1 (2009): 406. 25. Contribution of Dr Mohamed Farah, TB Hospital Director, Somaliland. 26. Contributed of Dr Ayat Abu-Agla, National Human Resources for Health Observatory, Khartoum, Sudan. 六、补充阅读 • Goodman, Catherine, William Brieger, Alasdair Unwin, Anne Mills, Sylvia Meek, and George Greer. “Medicine sellers and malaria treatment in sub-Saharan Africa: what do they do and how can their practice be improved?.” The American journal of tropical medicine and hygiene 77, no. 6 Suppl (2007): 203. • Verkevisser, M. C., Indra Pathmanathan, and Ann Brownlee. “Designing and Conducting Health System Resaerch Projects: Proposal Development and Field Work.” Health Serv Res 1 (2003). 33 2 制定实施研究计划书 单元 34 单元 2 制定实施研究计划书 简介 本单元旨在支持您和您的团队开发出高质量的实施研究计划书，以让您在获取研究基金 时更具竞争力。如果您正在着手写一份实施研究计划书，并且不确定从哪里开始（这样的情 况其实是普遍存在的）。即使是对研究问题的定义，一开始也似乎是压倒性的困难。本单元 的设计是为了帮助团队成员理解和执行实施研究计划书撰写所涉及的基本过程。 在完成这一单元之后，参与的研究的团队将能够完成他们的实施研究计划书。本单元的 内容和活动分为五节课，并逐步针对每个具体的部分对应解决计划书制定过程中的问题。每 节课包括以下这些内容： • 学习目标：确定在每节课程结束前将完成哪些工作 • 内容介绍：提供必要的信息，以理解撰写计划书的具体内容 • 活动：通过练习来促进对学习内容的理解，将理论付诸实践 • 小组讨论：通过讨论来为组员提供提问的机会，并思考与其项目有关的具体问题 • 写作坊：为团队提供一个每晚共同写作的机会，用于撰写团队计划书的内容 研讨会将由有实施研究经验的研究人员来协助，他们将在您的团队制定实施研究计划书 的过程中给予您指导和支持。 本单元还提供统一的计划书撰写指导，培训来自不同背景的研究人员。 研讨会前的准备工作 本单元分为三个阶段：研讨前，研讨中，研讨后（图 1）。 在研讨会之前，您应该完成一个线上部分，该部分介绍了关键术语核心概念、研究框架、 项目组成和适当的问题。在线课程大约需要三个小时才能完成，其具体目标是： • 识别实施研究的特征。 • 描述实施/规模扩大，并将实施研究与这些过程联系起来。 • 将属于实施研究范畴的研究问题和相关研究进行分类。 • 总结框架特征并确定将其应用于实施研究的策略。 • 认识到如何将实施研究应用于不同的实施问题。 • 对实施研究的优先级进行分类。 • 审查各种实施研究利益相关者的作用，并确定适当的方法，将利益相关者整合到实 施研究规划、交流和传播结果中。 35 线上部分可浏览 https://training.measureevaluation.org/certificatecourses/ir.。您还应该完成 一个初始利益相关者咨询（单元 1）以及文献综述，这能使您把实施问题置于更广阔的背景。 图 1. 本单元的三个阶段 介绍您的团队和研究的挑战 在前面的单元中，您可能已经很好地理解了什么是实施研究，以及这种实施研究方法如 何帮助您实现研究目标。您可能也已经确定了您的实施研究团队的一些成员，设定了每个成 员的角色和责任，并确定了一个研究问题且为此制定一份计划书。 开始时，需要请您团队的一位成员来简要描述您的团队开发研究项目所要解决的研究问 题/挑战。然后邀请您的团队的每个成员自我介绍并解释他们正在进行的工作，以及在您所 计划的项目中的角色和责任。 小组活动：复习实施研究的基本知识 分成小组。理想情况下，每个团队的成员应该分成不同的组。每组分配七个主题中的一 个（见幻灯片）。在每个小组中，准备两分钟的报告来总结指定的主题，可借鉴研讨会之前 的线上部分/前几个单元的内容。 选择一位发言人在全体会议上来展示要点（两分钟内）。 研讨前 研讨中 导言 研究设计 研讨后 什么是实施研究？ 我们的团队应该有谁？ 我们的项目是什么？ 项目计划 影响 文献综述 支持信 伦理审查许可 完成计划书 附件 36 实施研究项目的资助 主要有三类供资机构，作为支持研究项目的潜在来源： ①多边组织 – –例如，世界卫生组织（WHO）、世界银行、联合国儿童基金会（UNICEF）、联 合国开发计划署（UNDP）、欧盟委员会（European Commission），以及一些特 殊项目，如 TDR、卫生政策和系统研究及特殊项目研究联盟、以及人类生殖研 究、发展和研究培训特别规划署（HRP）。 卫生政策和系统研究及特殊项目研究联盟、TDR 和 HRP，作为指定的研究项目，定期 对卫生健康研究计划书进行招标，包括那些实施研究。大多数多边组织在低收入和中等收入 国家制定了执行方案，其中部分方案预算被分配到监测和评估以及实施研究。 ②双边捐赠者 – 例如，加拿大政府、英国政府（英国国际发展署）、美国政府（美国国际开发 署，国立卫生研究院，福加蒂国际中心）、挪威政府(挪威开发合作署）、瑞典 政府（瑞典国际发展合作署）、澳大利亚政府和加拿大国际发展研究中心。 越来越多的双边组织，如加拿大国际发展研究中心、美国国立卫生研究院/Fogarty 国际 中心，英国国际发展署，美国国际开发署和挪威开发合作署，都资助过实施研究。几乎所有 的双边组织在低收入和中等收入国家都有援助项目，其中一定比例的方案预算用于监测和评 估，以及实施研究。 ③私人基金会和信托 – 例如，盖茨基金会，洛克菲勒基金会，福特基金会，惠康信托。 相比于其他问题，私人基金会和信托基金有支持健康研究的传统。实施研究是一些私人 基金会和信托基金有兴趣支持的领域之一。请注意，上述所列举的并非详尽无遗。一些低收 入和中等收入国家的政府也会资助研究，以改善其卫生系统内干预措施的获取和提供。 寻找匹配 为给您的计划书找一个合适的匹配，需要考虑： • 您的经验水平； • 您需要的资源/基金； • 时间和截止日期； • 您的地理位置； • 谁会对这个主题感兴趣。 37 相关资源 政府资助： • 美国国立卫生研究院院外研究处指南 (http://grants.nih.gov/grants/guide/index.html) • 国家科学基金会 • 其他个人/政府机构 • Grants.gov(www.grants.gov)-从所有美国政府机构收集资金/申请信息的门户网站 • 卫生部 • 国家医学研究理事会 私人协会或基金会： • 基金会中心目录（免费图书馆） • PA 基金会目录（免费图书馆） • 赠款网-来自美国科学促进协会（AAAS） • 比尔·盖茨和梅林达·盖茨基金会 • Doris Duke 基金会订阅数据库 下面列出的数据库，提供了关于研究资金来源的信息（政府和非政府） • 科学社区 • InfoEd（Spin/Genius） • 其他（IRIS，Egrants） 如何搜索...... • 去一个互联网接入良好的图书馆。 • 如果你有的话，和你所在机构的研究管理办公室谈谈。 • 搜索综合数据库，如科学社区、eRACommons 和 Spin。 • 从数据库搜索中设置提醒。 • 搜索美国政府赠款网站，如院外研究处或 Grants.gov，或个别机构网站。 • 搜索协会和基金会的网站。 • 查明那些与你所在领域有关的并且已经获得资助的项目。 这是您工作中一个非常重要的方面。如果您在搜索数据库方面有一定的经验，您可以继 续进行，否则可以向您所在机构或机构外的图书馆寻求帮助。不管你采取什么方法，决定在 哪里提交实施研究计划书申请资金时，您必须遵循基本的步骤并考虑一些事情。 38 寻找哪些基金愿意为研究计划书/意向书提供资助机会。 这一点很重要，因为他们通常 要求每年申请一次。因此，提前规划并从申请截止日期开始往回做计划工作是很有必要的。 如果你错过了最后期限，可能要等上一年才会有另一轮招标或机会出现。在实施研究中，12 个月的延迟是很严重的。此外，对于定期的研究计划书/意向书申请，一些供资机构也可能 有兴趣根据其健康研究战略来支持开展实施研究。换句话说，来自中低收入国家的研究人员 可以发挥积极作用，发送简短的研究计划书来供其审议。一些资助机构会基于他们的任务和 战略，更有可能委托或征求卫生健康研究计划书。 需要确保资助机构和研究项目之间的良好匹配，包括研究主题、资助规模、地理区域、 合作伙伴资格、参与国家、要求的附属机构等。探索已经在这个主题上做过的研究，以确保 你没有重复现有的工作。评估机构过去资助的项目类型，你可以扩展这些活动。做好充分准 备，了解该主题的现有内容，识别差距并证明需要做哪些工作，以及这些发现将如何使社区 受益。 准备你的申请 • 仔细阅读提交研究计划书的说明 • 参考相关文献 • 说明拟开展调查研究的理论依据 • 提出一个有组织的、清晰的报告，包含尽可能多的细节 • 请求有经验的研究人员预先审查 • 使用资助者所要求的风格和元素 在申请研究基金时，要充分利用可获得的一切资源。 欧洲和北美的大多数大学都有研 究办公室，配备训练有素的工作人员，以协助研究人员进行大规模的基金申请，低收入和中 等收入国家的学校或卫生健康机构可能没有这些资源。然而，互联网上也可能有许多有用的 资源。访问所要提交计划书的资助机构的网站是很重要的。他们经常会对该做什么和何时提 交计划书有详细的指示。 例如：美国国立卫生研究院资助写作小贴士：http://grants.nih.gov/grants/grant_tips.htm。 审查员将寻找对所提供的社区或国家卫生保健服务产生重大影响的项目。 此外，可以探索与资助机构的项目经理沟通的可能性，以便更清楚地了解申请过程。审 稿人一直关注那些具有清晰、创新和令人振奋的想法，以及同时具备现实的目标、时间表和 文笔清晰简洁的项目。他们希望看到一个清晰、编写良好，并承诺会产生实际作用的申请书。 39 评审人所关注的内容 • 意义和影响——这在实施研究中非常重要 • 令人振奋的想法 • 他们可以理解的想法——避免假设基于过多复杂的知识 • 避免假定评审人十分熟悉某一主题或对其具有充足的知识储备 • 列出现实的目标和时间表-不要过于雄心勃勃 • 限制出现过多众所周知的信息 • 列出研究局限性 • 提供一份简洁明了的、文笔好的申请，并提供合理的预算 根据供资机构的不同，审查员可能会在不同的计划书中寻找不同的点。在提交计划书之 前，参考申请通知中的说明总是很有用的。 一般来说，实施研究计划书是根据科学价值和政策相关性，使用特定的量表来评级的(例 如，一个 1-5 的量表，其中 1 是高，5 是低)。这两个类别的评级可以平均在一起得出最终得 分，这可能是资助决定的主要决定因素之一。下文概述了每一类中经常使用的具体标准。 科学价值和政策的相关性 • 科学可靠 • 综合现有知识（可包括文献综述）——使其简洁、中肯、完整、适当 • 研究问题——使之恰当且可行 • 分析框架——酌情适用并使其健全 • 计划书应符合招标通知中概述的实施研究原则 • 计划书应解决将进行研究的国家/社区的相关问题 • 计划书应该适合具体的招标通知 方法 • 设计是否可行且适当？ • 数据收集方法和工具是否适合研究设计？ • 抽样方法是什么，样本量是多少？ • 数据管理和分析是如何计划的？ • 总体时间计划是否符合实际？ 40 其他考虑 • 道德考虑。 • 关键假设。 • 创新性和原创性。 • 方案实用性。 其他关键问题 • 团队的专长是否适合拟进行的研究？ • 能否扩大项目结果的规模？ • 结果将具有多大的普适性？ • 是否提出了一种多学科方法？ • 研究是否会促进协作和团队合作？ • 预算是否适当？ • 应用和传播的可能性/对政策和方案的潜在影响？ • 是否有建设/加强研究能力的潜力？这可能对一些资助者很重要，因为它可以提高 卫生系统中实施研究文化的可持续性。 应用中的常见问题 应避免以下与研究提案有关的常见问题/陷阱。 • 缺乏有新意或原创的想法。 • 缺乏被认可的科学/公共卫生理论依据。 • 缺乏基本方法方面的经验。方法论上缺乏足够的细节。 • 缺乏与政策、方案和项目的相关性。 • 分散、肤浅或没有重点的研究计划。 • 缺乏对相关已发表工作的了解。 • 工作量不切实际。 • 未来方向的不确定性。 • “那又怎样？”是很有用的提问——研究结果如果被应用，会对卫生系统和人口产 生什么影响？ 实施研究计划书的组成内容 一般而言，所有的研究计划书的结构都是相似的。 41 什么是研究计划书？ • 一份描述了以下内容的文档： – 拟开展的研究 – 开展研究的原因 – 研究设计 – 预期影响 • 计划书是大多数资助申请的必要条件，通常会由一个委员会来评审。为了提高效率， 你需要知道： – 在做什么； – 为什么做； – 计划什么时候做； – 打算怎么做。 如果你曾经在研究中写过论文，你要记住，在申请伦理许可(如果涉及人类受试者)和开 始数据收集之前，你需要写一份研究计划，并得到论文委员会和你的导师的“批准”。 在制定学术计划书时，目的是产生新的知识和想法。相反，在制定实施研究计划书时， 目的是产生研究证据，为政策提供信息，并改进方案的执行。 大多数资助申请都要求你写一份研究计划书，将会由一个委员会评估，以确定该计划书 是否值得资助。 撰写研究计划书可能是研究中最困难的阶段之一。为了写计划书，你必须知道你在做什 么，为什么做，什么时候做，以及怎么做。您需要提出研究问题，解释研究的重要性和必要 性，以及给出一个概念框架。您需要对现有文献进行综述。需要设计研究，并详细说明你将 使用什么研究方法来收集和分析数据。 实施研究计划书的不同之处 实施研究计划书可能与传统的研究计划书不同： • 研究问题的由来 • 终端用户参与研究过程 这些差异产生于对实施研究干预的需要，用以来帮助 • 更好地报告保健服务质量改善成果。 42 • 促进终端用户的应用。 • 产生“普适性”知识，以便将其应用于不同的环境和背景。 • 多学科参与，例如，包括流行病学、社会科学、人类学、传播学和卫生经济学。 • 提出政策建议和实际解决方案。 由于研究结果、指导方针和最佳实践可能需要数年时间才能完全融入实践，研究人员、 决策者和实践者不断寻求改进的知识转移过程。 为了应对这一挑战，实施研究源于终端用户所发现并赋予优先级的问题。鼓励终端用户 应用研究结果，要求终端用户参与研究过程的所有步骤，包括计划书的制定。 为了有效，实施研究结果需要在现有卫生健康系统框架范围内可用，并适当实施，从而 使终端用户能够受益。实施研究还旨在产生普适性知识，以便它可以应用于各种环境和背景 （即使它们可能是特定的干预措施）。 实施研究计划书的特征 • 每个资助机构都有自己的计划书格式和要求。 • 要求各不相同，且并非所有机构都需要本节课里所讲到的所有组成部分。 • 一些机构可能需要一封意向书作为初步筛选，以确保您的计划书将符合他们的需要。 • 意向书包含与实施研究计划书相同的内容，但细节较少。 其他特点可能包括以下方面： • 明确区分常规疾病的控制和问题的系统研究和分析。 • 衡量成果的指标。 • 注重有限数量的优先领域，而不要关注不太可能对健康产生重大影响的大量孤立的 小问题。 • 可外推到其他环境和疾病。 • 与疾病控制的积极联系。 • 与其他部委、部门和机构建立伙伴关系和联系。 • 辅导和培训新人和有经验的人。 • 研究中卫生专业人员的参与。 • 在各级执行工作中积极传播成果。 43 研究计划书的组成部分可能略有不同，这取决于所提交计划书的供资机构所概述的目的。 许多供资机构都明确指出了在计划书中应该解决的问题。 由于每个供资机构都有自己的格式和要求，本模块所涵盖的一些要素可能不是在每一项 研究计划书中都需要。 实施研究计划书的组成内容 图 2. 实施研究计划书的组成内容 这节课的设计足够有普适性，因此可以根据不同对象的优先事项和供资机构对计划书的 要求加以调整。下面是实施研究的常见组成部分列表： • 导言：包含标题页、理论依据、问题陈述、目标和研究问题，以及文献综述（综合现 有知识）（表 1）。 • 研究设计：概述研究对象、研究方法、数据收集、数据分析、质量管理和伦理（表 2）。 • 项目计划：包含项目计划、研究团队和预算（表 3）。 • 影响：包括监测和评估、能力建设计划和传播计划（表 4）。 • 附件：包括项目摘要、目录、参考资料、附录和研究人员简历（表 5）。 导言 标题页 . . 理论依据 问题陈述 研究问题 文献综述 研究设计 研究设计 研究方法 数据收集 数据分析 研究对象 质量管理 伦理 项目计划 项目计划 研究小组 预算和测算理由 影响 监测和评估 能力建设 传播计划 附件 项目摘要 目录 . . 参考文献 附录 研究团队简历 44 导言 你的计划书的导言包括标题页、理论依据/摘要、目录、理论依据、问题陈述、目标和 研究问题、文献综述（综合现有知识）。 表 1. 导言部分的次级组成内容 部分 描述 标题页 • 一个好标题由四个部分组成： -使用表示行动的词汇。 -反映实施和干预的主题。 -包含特定的目标人群（青少年、5岁以下儿童等）。 -包含具体的地理位置。 理论依据 • 概述正在研究的内容和原因。 • 总结预期成果，包括预期影响。 • 提出简洁明了的理由，说明该项目为何应该被资助。 问题陈述 • 总结研究目的。 • 应是一个段落而不是一句陈述。 • 确定研究方向并抓住研究的实质。 • 清晰简洁。 • 纳入研究的总体目标，使用表示行动的词汇简洁概述研究目的。 • 反映出研究设计。 • 逻辑清晰地引出研究问题。 目标和研究问题 • 应该研究最终影响的研究社区、研究者、政策制定者、决策者、供资 机构和医疗保健提供者等所感兴趣的问题。 • 问题应该是可回答的。 • 由问题形成的，反过来又应在逻辑上影响研究设计。 • 明确且具体。 • 具有可行性。 • 提供评估正在进行的干预或项目进展所需的信息。 • 分析未达到目标的可能原因，以便找到解决办法。 • 回答这个问题将获得重要的信息。 文献综述 • 表明熟悉这一主题。 • 总结对该主题所未知的内容。 • 建立可信度。 • 将拟进行的研究放在更广泛的背景下。 • 通过建立与知识体系的联系来证明相关性。 • 整合和总结关于某主题的已知内容。 45 研究设计 研究设计部分包括：研究设计，研究方法，数据收集，数据分析，质量管理，以及研究 对象和伦理。 表 2. 研究设计的次级组成内容 部分 描述 研究设计 • 描述研究的性质或结构。 • 采用定性、定量还是混合方法；关注研究对象之间或研究对象内部； 实验性研究或相关性研究；个案研究或群体案例研究等。 研究方法 • 包括用来获取和分析数据所使用的各种方法。 • 说明要做什么，什么时候，怎么做。 • 为研究设计提供理论依据。 • 证明研究方法如何产生新的或与众不同的结果。 • 包括一些次级部分，如研究设计、研究对象、数据方法、数据收集和 数据分析。 数据收集 • 解释如何收集用于回答研究问题的信息。 • 可能涉及使用定量数据（例如，调查、记录事件发生次数、实验室实 验），定性数据（例如，访谈、观察）。 数据分析 • 详细描述如何汇总收集的数据，以及如何组织和解读数据，以理解研 究发现。 • 确定主题，编制表格和图表，确定关系，计算频率。 研究对象 • 对研究中的对象（样本）或参与者的完整描述。 • 如何选择研究对象。 • 成为研究对象的标准。 质量管理 • 确保研究项目质量的制度。 • 有助于保障研究开展和产生的数据能够最佳地满足要求。 • 必选项——必须有质量管理计划。 伦理 • 如果从人类受试者（直接或间接）收集信息/数据，你必须向伦理委 员会/专委会申请。 • 如果在多个地点收集数据，则可能需要向多个委员会申请。 • 保证申请伦理许可。 • 伦理批准可能需要几个月的时间才能收到，所以一旦提交了计划书 就要马上着手申请。 • 大多数机构在收到书面形式的伦理审查声明前是不会发放资金的。 46 项目计划 项目计划包括：项目计划、研究团队和预算。 表 3. 研究计划的次级组成内容 部分 描述 项目计划 • 明确说明项目的时间框架和项目各方面实施的时间。 • 工作计划或时间表通常在图表、表格或Excel表中最能有效显示。 • 将有助于以非常明显的方式证明项目的可行性。 • 确定任务；活动何时进行；由谁执行。 研究团队 • 描述团队成员以及他们为项目贡献的经验。 • 团队必须是多学科和多样化的（取决于研究的性质，它可能包括社区 成员以及研究人员、医疗保健提供者和决策者）。 • 说服评审专家，团队有足够的专业知识有效地运行拟开展的研究。 • 项目列出每个成员的角色和责任。 • 说明团队成员是全职还是兼职参与。 预算 • 概述有效运行拟开展研究所需的资源。 • 准确地说明开展项目实际上需要供资机构提供什么。 • 在研究情境下应能反映现实情况。 • 说明项目每个阶段需要多少资金。 • 与机构的建议/要求的预算类别保持一致。 • 预算应与研究设计中的拟开展的活动相一致。 影响 影响部分包括以下内容：监测和评估、能力建设和传播计划。 表 4. 影响部分的次级组成内容 部分 描述 监测和评估 • 准确描述团队将如何判定项目是否达到其目标。 • 告知潜在的资助机构，项目结束时将如何向他们证明这是个好投资。 • 促进循证实践的实施和健康结局的改善。 • 评估实施效果与健康干预措施效力之间的差异。 能力建设 • 该项目将如何通过培训、指导等方式帮助提高国家和当地相关机构的 研究能力。 • 该项目将如何帮助参与的关键利益相关者（如政府官员）来提高利用 研究证据制定政策或进行决策的能力。 传播计划 • 传播计划应包括预期的出版物、通讯稿、研讨会、无线电广播、演讲、 印刷品、幻灯片、培训方案等。 • 确定主要利益相关者的目标受众及其需求。 • 让利益相关者参与整个进程。 • 相应地调整信息-利益相关者群体因对研究术语的熟悉程度和偏好的 不同而对信息的接收程度各不相同。 47 附件 附件包括：项目摘要、目录、参考资料、附录和项目组成员的简历。 请注意，项目摘要和目录放在计划书的开头，但只有在你完成了其他部分后才能写。 表 5. 附件部分的次级组成内容 部分 描述 项目摘要 • 简要描述整个计划书。 • 先读后写。 • 包括对所调查的问题的描述、为什么需要做这项研究和/或这项研究 的重要性（基于现有文献）、研究对象、方法学和进行这项研究的意义。 • 是评审专家对项目的“第一印象”，可能会影响他们是否选择资助。 • 使评审专家很容易根据评审标准理解和评估您拟开展的项目。 目录 • 通过概述内容和每个可以找到出处的条目来组织计划书内容。 • 按逻辑顺序展示主题和章节列表，使之一目了然。 • 文字处理程序会以专业的方式自动为您设置标题、副标题和页码。 参考资料 • 列出计划书中引用的所有参考资料（使用公认的参考文献格式）。 • 如果计划书中没有引用某一参考资料，则不应在参考文献中列出。 附录 • 包括项目中对读者而言是次要方面的内容。 • 假设读者可以从计划书正文中获得所有必要的信息。 • 可能包括调查人员的简历、研究工具或支持信等。 • 放置希望审查员可以看到但是受计划书字数限制的内容。 项目组成员的简历 • 可以使审查员对计划书的评估产生影响。 • 确保团队中至少有一位成员具有实施研究经验、良好的业绩和论文 发表记录。 • 诸如社区信誉等补充性优良品质也同样重要。 • 机构通常对一个调查员的简历内容限制在1-3页。 • 制定一个模板，突出团队成员简历中最相关的方面，应与供资机构 的范围保持一致。 在以下每一节课中，您的团队将撰写和形成研究计划书的其中一个部分。 48 第一节课：撰写导言部分 本节课，您将通过起草导言部分开启撰写实施研究计划书的第一步。当中涉及撰写研究 问题概述，并对现有的材料和文献进行系统综述，以提供理论依据来说明为什么这个问题是 重要的并且亟待解决。将制定总体和具体的研究目标，问题的陈述和研究问题。 在完成本节课后，你将能够： • 为计划书撰写一份导言 • 为计划书撰写研究问题 撰写导言 计划书导言： • 概述所研究的内容和原因（即理论依据） • 对研究现状的论述 • 包括问题陈述，总体目标，具体目标和研究问题 • 对已有文献的综述 • 总结预期结果，包括结果将产生的影响 • 提供清晰简洁的理由，说明项目为何应该得到资助 导言基本上是对现有相关知识的综述，包括已发表的研究报告、项目报告和其他文献。 它为开展研究建立了一个论点，包括一般和具体的研究目标、问题的陈述和研究问题。这一 论点或理论依据可能基于社区、政策制定者和项目管理者所确定的需要。总之，计划书的导 言对研究内容提供了明确、简洁的说明，并解释了项目为何应该得到资助。 导言的目的 导言通过完成以下三件事为资金和社区支持提供了关键信息： • 为计划书的进一步完善提供基础（问题概述） • 通过类似研究来背景信息（对文献进行系统分析和简要综述） • 系统论述为何进行实施研究（理论依据），希望实现的（目标）和预期结果（成果） 导言撰写指南 • 首先，系统分析想要研究的问题，以及分析完成这项研究的重要性 • 一旦理清了初步想法，随着进程不断编写导言，与团队讨论问题，并从更大的研讨 会小组和导师那里得到反馈 理论依据应说明为何开展研究，包括研究问题的科学性、公共卫生和政策相关性，以及 调查的规模和频率，地理区域，种族和性别因素的问题。导言还应列出研究问题的其他可用 选项，并说明为何采用所选择的方法，还应说明将如何使用这些结果，以及为何这些结果能 影响卫生健康和卫生健康系统/政策，以及如果项目结果得到适当应用，谁将最终受益。 49 写什么内容 • 卫生系统和环境（情境）概述 • 问题性质描述 • 分析可能影响问题的不同因素 • 对可使用的解决方案的描述（背景），以及进一步研究的理由 • 从研究中期望得到的信息以及这些信息将如何用于解决问题（结局） 为了完成这一部分，要简洁地写出下面列出的每一个项目。只要开始写作，就不要担心 最初的想法如何，或者想要写得很完美：随着您对主题的研究和讨论的进展，将不断更改、 详细说明、删除和编辑导言。 概述国家/区域/地区的卫生系统，因为这些系统与问题有关。包括说明性统计数据（如 果适当和/或可用的话）来描述问题发生的背景。 • 问题性质的描述 • 分析可能影响问题的不同因素 • 简要描述尝试过的任何解决问题的方案(背景)，它们的效果如何，以及需要进一步 研究的原因（开展研究的理由） • 描述预期从实施研究中产生的信息类型，以及如何使用这些信息来解决问题（结局） 形成标题 好的标题由四个部分组成： 1. 使用表示行动的词汇 2. 反映实施和干预的主题 3. 包含特定的目标人群(如青少年、五岁以下儿童等) 4. 包含特定的地理位置 研究计划书的标题应能描述研究，简明扼要地告知读者研究是关于什么。它应该包括关 键词，这些关键词可以帮助找到合适的评审专家。 标题与任何其他研究计划书的标题可能 没有很大的不同，但它所涉及的主题将反映出社区的需求。如果在申请实施研究经费，则尽 可能在您的计划书标题中也写有“实施研究”的字眼。 例如： • 撒哈拉以南非洲青少年在预防艾滋病毒方面的差距测定：一项实施研究 • 利用实施研究探讨喀麦隆、中非共和国、乍得、刚果民主共和国、肯尼亚和赞比亚 等五岁以下儿童死亡率的上升 理论依据 • 导言必须证明为什么你提出的研究问题是重要的，并且是值得资助的 • 为了证明这一点，首先要通过系统分析现有信息来提供证据 50 可以从各种资源和途径找到支持进行文献综述的信息，包括： • 当地文件——项目进度报告，论文，学位论文，研讨会记录 • 方案进展或评价报告 • 医学文献，包括概述研究差距的评论 • 来自先前研究的新想法/建议 • 供资机构的年度报告 • 方案工作人员和/或学生提出的问题 案例： 控制盘尾丝虫病的主要挑战是每年要向所有目标社区提供伊维菌素治疗，并在很长一段 时间内保持高治疗覆盖率。为实现这目标，非洲盘尾丝虫病控制规划（APOC）采用了伊维 菌素面向社区的治疗战略（ComDT）。事实证明，该策略非常奏效。伊维菌素治疗很受欢迎， 社区对由自己负责规划和实施的以社区为导向的干预概念反响良好。APOC 最近的一项外部 评估得出结论，ComDT 是一个及时和创新的战略。社区本身在很大程度上深入参与了自己 的卫生保健工作。这一战略可作为发展中国家其他社区卫生保健方案的模式。 在国家和国际层面，人们对使用 ComDT 的方法来作为其他疾病的干预措施的兴趣越来 越大。目前的良好势头提供了一个重要机遇，可以将伊维菌素治疗与其他疾病控制活动结合 起来，并促进非洲一些最贫穷人口的卫生保健发展。但是，为了确保这一机会得到适当利用， 迫切需要有良好的科学证据来证明 ComDT 过程在防治其他疾病的干预措施方面的效果，以 及在社区层面上综合疾病控制的效果。 在 2002年 12月的会议上，APOC的联合行动论坛建议热带病培训研究特别规划署（TDR） 与 APOC 合作进行一项关于使用 ComDT 治疗其他疾病的多国研究。TDR 和 APOC 积极响 应了这一要求，多国研究现已启动。2002 年 11 月 4 日至 8 日在喀麦隆林贝举行的方案制定 研讨会上，制定了多国研究的研究方案。 由于所涉及问题的复杂性，研究者决定通过与关注 ComDT 多病种方法的主要合作伙伴 举行一系列磋商会议来准备这项研究，以确定研究中需要解决的主要研究问题。 磋商中的重要的发现是，人们关于 ComDT 的态度差异很大,有的专家对 ComDT 在盘尾 丝虫病控制方面的经验持非常积极的态度，而一些其他疾病领域的专家对ComDT表示怀疑， 并不相信 ComDT 方法有助于他们所关注的疾病。非常明确的是，十分需要对社区指导的干 预措施和其他干预措施进行科学比较，包括盘尾丝虫病。通过提供客观证据，用以说明社区 指导的干预措施与其他在非洲社区层面提供保健干预措施的方法相比的优势和劣势。 问题陈述 • 总结研究目的 • 注意应该是一个段落，而不是单一的陈述 • 确立方向，抓住研究的本质 51 • 清晰简洁 • 应包含总体目标，并使用表示行动的词汇简洁地概述研究目的 • 反思研究设计 • 引出研究问题 “问题陈述”一词可能具有误导性，因为它通常包括一个自成一体的段落，而不是一句 话的陈述。 • 使用“目的”、“意图”或“目标”等词来突出研究的主要思路 • 确定所要研究的关键概念 • 确定研究设计（例如，案例研究，民族志研究，相关性研究，实验） • 确定研究中的分析单位（例如，自变量和因变量、人口、课堂、组织、方案、事件)； 数据收集方法(例如，调查，访谈） 案例 1 在 20 世纪 90 年代，X 国政府推出了经济结构调整方案。这意味着减少了对社会服务方 面的财政拨款，取消了补贴，从而限制了公共卫生预算。卫生部门的支出占政府总支出的比 例从 1980 年的 5.3%下降到 1990 年代中期的 4.2%。分配给卫生部的资源不断减少，严重影 响了包括疟疾控制在内的各个计划。疟疾仍然是该国主要的健康和发展挑战之一，并且仍然 是五大致命疾病之一。1998 年的统计数据显示，在全国 57 个地区中，有 16 个地区的发病 率高于每 1000 人 100 例（资料来源：1998 年）。 尽管全国几个区都配套有医疗计划，但 Y 区的发病率（885/1000）仍然是最高的区域之 一（资料来源：1999）。另一方面，位于同一农业生态区的 Z 区在过去三年里成功地将疟疾 的发病率从 1997 年的 575/1000 降至 1999 年的 305/1000。在全国 57 个区中，Y 区和 Z 都是 最贫穷的八个区，人类发展指数为 0.47（资料来源：2000 年）。拟开展的研究将识别在某个 区的疟疾控制中取得成功的因素，吸取经验并制定有效的实施策略，以便在一个目前面临经 济危机的国家优化使用有限的资源。 案例 2 在 20 世纪 90 年代，中国只有 5-10%农村人口，且大部分都是富裕的东部沿海地区，被 合作医疗方案覆盖。在越南，在 1989 年实行参保人收费后，制定了几项省级健康保险计划。 在这些计划中，工业工人在人口中占少数，原则上由公司投保。而其他公民，包括农村地区 的农民，基于自愿投保。然而，1999 年自愿参加健康保险的农村目标人口不到 2%。这里的 问题是，医疗保险的使用率很低。因此，农村人口获得医疗保健的机会有限。 如何知道这个问题是否值得研究 为了说明所确定的问题是否是一个适当的研究项目，请回答以下问题： • 存在的情况与理想或计划的情况之间是否存在感知差异或差异？ 52 • 问题的不同或差异是否有明确的原因？ • 这个问题是否有多个可能的答案或解决方案？ 案例 回顾以下问题的相关情况概述： 在 Y 区域（145000 人口)，卫生条件差（仅 5%的家庭配备厕所），并且与卫生条件有关 的疾病，如肝炎、胃肠炎和蠕虫感染是非常常见的。卫生部发起了一个卫生项目，旨在让配 备厕所的家庭比例每年提高 15%。由于该项目提供物资，预期区域内的人口将提供劳动力。 但在该方案开始两年之后，实现的目标仍不到一半。 现在回顾以下问题，了解如何对情况进行系统分析，并为需要进行研究以得出问题答案 提供理论依据： • 什么是差异？ • 什么因素可以解释这种差异？ – 服务相关因素？社区不知情且参与不足？物资供应瓶颈？卫生检查人员的培 训及其有效性？ – 与人口有关的因素？对疾病与卫生的关系缺乏了解？贫穷？ – 自然因素？生态系统？硬化的土地？洪灾泛滥的区域？ 为了确保您已经确定了一个需要研究并值得资助的合理问题，要战略性地定位您的计划 书，以便它能够： 1. 使研究人员和利益相关者能够批判性地评估现有知识，汇集这些知识，并确定实施 研究项目应填补的空白； 2. 阐明问题和可能导致问题的因素； 3. 促进关于实施研究重点和范围相关的决定（与具体目标有关的意义）。 这三个考虑因素需要在你的计划书的导言中强调，以帮助你明确表达为什么需要进行研究的 理由。反思这些考虑因素对于帮助你先进行广泛思考也有重要作用，以便能够缩小你的关注 点范围，在更广泛的背景下确定研究目标。 缩小研究问题 1. 阐明所有利益相关者的观点。 2. 指定并描述核心问题 3. 找出可能导致问题的因素，明确其与问题的关系。 到目前为止，研究团队应该能够对研究问题进行概述，并通过对现有资源和文献的系统 分析，从而为进行研究提供理论依据，用于说明拟开展的研究为何能够针对所确定的问题提 供答案、解决方案或替代策略。现在请遵循以下步骤来帮助缩小重点，并在较宽泛的研究问 题内确定研究目标： 53 1. 阐明所有利益相关者的观点。 • 列出所有问题 • 说明差异 案例：结核病患者的不规则服药率不断上升 • 政策制定者表明，卫生健康服务管理不善 • 受影响社区表明，与结核病有关的社会病耻感 • 服务使用者，卫生健康工作者的消极态度 2. 指定并描述核心问题。 • 量化问题 • 详细描述问题 案例：结核病患者的不规则服药率不断上升 • 观察范围有多广泛？哪些地区持续受到影响？是否有某些区域可能是潜在的低依 从性区域？ • 谁受影响最大？ • 问题有多严重？后果是什么？例如，发病率、死亡率升高，浪费资源，形成多重药 耐性等。 3. 找出可能导致问题的因素，并阐明其与问题的关系。 案例：结核病患者的不规则服药率不断上升 • 由于缺乏有关结核病的物资，工作人员缺乏培训。 • 健康教育者对病人处方知之甚少，未对病人提供系统的建议和咨询，这导致患者不 理解治疗要求，从而造成高不规则服药率。 研究目标 研究目标应该 SMART（即具体、可衡量、可实现、现实性和时限性）。另外，需要考 虑该研究是否： • 有相关性 • 有创新性 • 亟待解决 • 政治上的可接受性 • 符合伦理 在撰写研究目标时，要确保团队解决以下问题： ①研究是否具有现实性？ 描述所开展研究的复杂性。是否有足够的资源进行研究？在 12 至 36 个月内开展并报告 54 调查结果是否具有可行性？ ②研究是否具有时效性？ 描述这个问题有多宽泛，以及谁会受到影响，以及谁会将其视作问题。也指如果不加以 应对，疾病/情况将有传播/恶化的潜在风险，卫生健康系统负担增加的潜在风险，以及该问 题对目标人群的现有或潜在经济影响。 ③研究如何具有相关性？ 描述这个问题有多宽泛，以及谁会受到影响，以及谁会将其视作问题。也指如果不加以应对， 疾病/情况将有传播/恶化的潜在风险，卫生健康系统负担增加的潜在风险，以及该问题对目 标人群的现有或潜在经济影响。 案例 中国和越南政府最近都认识到农村人口缺乏医疗保健的问题。为了解决这些问题，正在 制定新的政策举措。在中国，中央政府已经决定为中西部地区的所有农村人口每人每年分配 10 元补贴，为了重新建立新的合作医疗计划提供补贴，同时还要求省政府提供同样数额的 资金支持该计划。政府颁布了一项法令，大幅扩大自愿医疗保险计划的覆盖范围，向近贫困 人口提供补贴保险卡。这意味着，两国政府考虑通过医疗保险机制为需求方（特别是贫困户 和接近贫困户）提供直接财政支助，尽管它们继续从政府卫生预算拨出一定数额的资金支持 正规的卫生部门。在此背景下，拟开展的研究预计将支持政府的政策举措，由 BRI 汇集来 自中国、越南和三个欧洲国家的经验丰富的研究人员的资源，为正在进行的加强电子访问的 运动研究、评估和吸取政策教训有效的医疗保健，使两国最脆弱的农村人口提供有效的医疗 保健。在此背景下,该研究预计将支持政府的政策举措,，通过汇集来自中国、越南和三个欧 洲国家的经验丰富的研究人员的资源进行研究，为正在进行的改革做评估并吸取政策教训以 有效加强医疗保健的可及性，使医疗保险计划对这两个国家最脆弱的农村人口发挥作用。 ④研究是否具有创新性？ 指出研究将如何通过做一些新的或扩展/改进已经存在的东西来增加价值。你需要让读 者相信你不是在重复做一些已经被做过的工作。 案例： 该项目将通过以下方法和活动在若干领域产生创新： • 新农村医疗保险试点和测试，包含以下创新点： – 福利，尤其是包含中国的初级和门诊医疗服务和灾难性卫生支出的计划； – 卫生服务提供者的支付机制，特别是诸如在中国的乡村和乡镇一级的卫生服务 和越南的社区卫生站收取门诊费用等备选方案； – 组织和管理，包括加强问责制和透明度的措施； – 两个区域的政府补贴。 采取参与式的方法，让决策者和潜在/实际服务用户等主要利益相关者参与研究的各个 阶段，以便最大限度地发挥研究结果的相关性和影响力。 55 ⑤研究是否是当务之急？ 论证政策制定者、实施者和卫生健康提供者如何迫切需要研究结果，以便提供证据来改 变现状、实施干预或停止目前的做法。 案例： 在 2003-2004 年严重急性呼吸综合征（SARS）爆发期间，迫切需要对 SARS 方案的实施 进行研究。 ⑥这项研究是否在政治上可被接受? 实施研究项目往往涉及地方和国家当局利益高度关注的专题。 最好让决策者参与项目 设计，以确保政治上的可接受性并促进研究结果的推行实施。 案例： 在一些共产主义国家，监狱中进行结核病研究在政治上可能是不可接受的。与当局协商 并让其参与其中可以缓解这种情况。 ⑦结果和/或建议将如何适用于目标社区？ 解释采纳研究结果建议的可能性，以及如何利用这些发现来改善卫生保健。证明你已经 完成了你的工作并且获知可用的资源，以及促进实施该建议所需的任何额外资源。 ⑧研究是否合乎伦理？ 解释研究如何有利于被研究社区的成员。如何与目标群体分享研究结果？是否能获得研 究对象的知情同意？你将如何考虑研究对象的状况？这些结果是否将与被研究人群分享？ 案例： 在扩大使用 GeneXpert 结核病诊断装置时，将检测到更多的多重耐药结核病（MDR-TB）。 如果诊断出的多重耐药结核病不能得到合适的治疗，这将被视为不道德的行为（例如，因为 缺乏技术能力）。 总体目标 • 列出具体和总体目标 • 概述开展研究的目的 • 用通用术语明确说明该研究的预期成果 • 在导言部分的概述中将更广泛的社会、经济和健康问题结合，并进一步将研究的背 景集中到一个基本的目的 不同的供资机构使用不同的术语（目的、目标、宗旨）。有时这些术语可以互换使用。 “总体目标”一词有时与“研究目的”或“整体目标”交替使用。总体目标不应不切实际（减 少发病率和死亡率），而应该是合理的，例如向项目管理人员提供有助于改进服务的信息。 总体目标概述了进行研究的目的。目的部分可以将研究分为明确界定的阶段，并促进研究方 法的发展和数据收集，以汇集信息来解决已确定的问题。 特定的研究项目可以促进总体目标的部分，但不能充分实现这些目标，因为它们可能受 到教育、制造业等其他因素的影响。另一方面，具体的目标必须通过这个项目可以完全实现。 具体目标将用于衡量项目的成败。 56 案例 1： 帮助发展中国家贫困农村地区的人民减少贫困并改善健康状况；通过向卫生决策者提供 证据，以在中国和越南建立一个有效、可持续和负担得起的农村卫生保健筹资体系，提高卫 生公平性。 案例 2： 在六个国家的农村地区和城市贫民窟，最大限度地促进社区服务公平性、有效性和效率。 具体目标 • 具体目标是将总体目标细分为可衡量的行动声明，概述了将做什么和在哪里做。 • 在定义特定目标时使用表示行动的词汇（例如，确定、比较、验证、计算、描述、 建立、评估）。 在写你的具体目标时，避免使用模糊的、非动作的动词（例如，欣赏、理解或研究）。 在描述项目活动时使用表示行动的词汇，如：训练，监督，分配。抵制住诱惑，不要把太多 或过于雄心勃勃的但无法实现的具体目标放入您的实施研究计划书。在制定你的具体目标后， 问自己以下问题：具体目标是否明确，是否以专业术语定义，是否可测量并有现实意义，以 及是否说明了研究结果将如何用于解决研究问题？ 正面案例： 以前几年的调查结果为基线，确定区域层面利什曼病活动性病例检测的促进和阻碍因素。 反面案例： • 提供以病人为中心的培训方案，以加强糖尿病的自我管理和病友管理，作为培养领 导者的手段。 • 研究乌干达卫生工作者的行为。 • 为中国国家结核病控制计划制定一个消除结核病的实施战略。 研究问题 • 应该对研究人员、政策制定者、决策者、供资机构、医疗保健提供者以及受研究影 响的社区都有意义。 • 应该是可回答的。 • 由问题形成的，反过来影响研究设计。 • 都是明确具体的。 • 是可行的。 • 提供评估正在进行的干预和/或进程的必要信息。 • 分析未达到目标的可能原因（以找到解决办法） • 回答这个问题将产生重要信息。 研究方法的设计应以这样的方式来设计：通过开展研究，研究问题将得到解答。 57 实施研究问题 • 主要解决政策制定者、项目管理员和卫生保健提供者的需要，但不仅限于此。 • 描述健康状况和干预措施（包括已施加的和潜在的干预措施）。 • 提供必要的信息，以评估正在进行的干预或在干预中做出调整所需的进程。 • 分析未达到目标的可能原因（以便找到解决办法）。 实施研究问题是通过对情况和证据的分析来确定的，而不仅仅是基于研究人员、政策制 定者、项目管理人员或卫生保健提供者的直觉。 一个实施研究问题会研究以下一项或多项： 1. 描述健康状况和干预措施（包括现有的情况和干预措施以及潜在的干预措施） • 问题的严重性 • 人口健康需求分布情况 • 一些问题的危险因素 • 人们对问题的认认知 • 服务的利用模式 • 现有的和潜在的其他干预措施的成本效益 2. 提供必要的信息，以评估正在进行的干预或在干预过程中需要做出的调整 • 覆盖优先健康需求 • 目标群体的覆盖范围 • 服务的可接受性 • 服务质量 • 干预的成本效益 • 该方案对健康的影响 3. 分析未达到目标的可能原因，以便找到解决办法 • 可及性 • 可接受性 • 可负担 • 服务提供问题 这些信息需要用来制定适当的政策，调整或策划干预措施，以及评估项目进展和项目调 整的必要性。 当您的团队开展自己的实施研究时，请记住“问题决定方法，目的决定框架”。实施研 究的问题涉及方案的设计、实施和成果产出。实施研究还会提出：“是否有意想不到的后果？” 和“为什么会这样？”。实施研究的研究问题是由实施问题驱动的，并且应该与利益相关者 合作，来设计出以行动为导向的研究。 58 制定实施研究问题 在制定实施研究问题时，您应该考虑以下问题： • 如何能最好地回答？ • 如何能可行地回答？ • 有哪些数据可用？需要什么数据？ • 什么是可以控制的？ 一旦发现了实施难题，下一步就是提出解决这个难题的研究问题。您的方法取决于所处 情境和信息的可及性。请记住，实施研究问题是方案嵌入式的——它们始于方案也终于方案。 因此，尽早让方案的利益相关者参与制定实施研究问题。问题的制定方式决定研究方法。这 些都是有助于制定实施研究问题的来源： • 方案进展情况，年度报告，或监测和评估活动中产生的评估报告 • 医学文献，Meta 分析，文献综述 • 学术会议 • 从先前的研究或形成性的定性研究中产生的新想法（例如，访谈） • 供资机构的年度报告 • 项目工作人员和学生提出的问题 • 当地文件-项目进度报告，学位论文，论文，研讨会记录 • 年度总结或宣传会议 • 能确定问题的地理位置和分布的地理信息系统数据 实施研究问题的优先排序 在对研究问题进行优先排序时，要注意： • 相关性 • 避免重复 • 紧急程度和需要等级 • 政治上的可接受性 • 可行性 • 结果或建议的适用性 • 伦理上的可接受性 一个方案可能会同时产生多个实施问题和研究问题。这可能是无法避免的，因此考虑实 施研究问题的优先顺序，确保实施研究的效率和实践是很重要的。以下七项标准应有助于确 定实施研究问题的优先次序（表 6）： 59 表 6. 实施研究问题的优先排序标准 标准 考虑因素 相关性 • 这个问题有多大多广泛？ • 谁会受到问题的影响？ • 问题有多严重？ • 如果问题未解决，是否有扩大的可能性？ • 谁将其视作问题？ • 这个问题是卫生系统的负担吗？ 负担有多重？ • 这个问题对人口的经济影响是什么？ 避免重复 • 这个研究问题或实施问题以前研究过吗？ • 是否存在有效地解决这一问题的干预措施？ • 如果有，是否存在值得进一步研究的主要问题？ • 背景不同，是否能使用先前干预研究的结果？ 紧急程度和需要等 级 • 政策制定者、执行者和卫生保健提供者有多迫切需要取得成果？ • 及时性是否会影响改变的进程、新的干预措施的采用或停止他们正在 做的事情。 政治许可 • 最好研究地方或国家当局高度关注和支持的实施问题。 • 对具有政治支持的突出问题的研究结果更有可能得到落实。 • 政治上被接受的实施问题可能取决于政策制定者参与研究。 可行性 • 研究有多复杂？ • 是否有足够的资源来做这项研究？ • 是否能在 12 至 36 个月内开展并报告调查结果？ 结果或建议的适用 性 • 建议被采纳的可能性如何？ • 如何利用这些发现来改善卫生保健？ • 是否有可用的资源来实施这些建议？ 伦理许可 • 被研究人群对该研究的接受程度如何？ • 目标群体是否都存在实施研究问题？ • 是否可以获得研究对象的知情同意？ • 是否会考虑研究对象的情况？ • 研究结果是否会被分享给被研究人群？ 文献综述（综合现有知识） • 包括图书馆搜索以找到最新的相关资源，阅读并整合现有的信息和文献形成一个简 要的概述 • 通过确定已知的研究问题以及过去的处理方法来论证相关性 • 提供理由来说明为什么进行研究是至关重要的 • 指出研究主题中尚不得知的内容 • 帮助你完善问题的陈述 • 提供关于该主题的“知识状况”，并设定正在研究的研究问题 • 建立可信度 60 文献综述整合了所提出的研究课题的最新相关信息，并提出了正在调查的研究问题。文 献综述应该证明你已经阅读并深入了解了该领域现有的工作，从而向读者提供正在调查的主 题领域的知识状况和主要问题的情况。 通过对现有的可获得的信息的概述，您可以找出在该主题上已经做过的研究来避免重复 现有的研究。回顾现有的信息将帮助你完善你对问题的陈述，分析在相关研究中已经使用的 各种方法，并有助于形成与研究相关的有说服力的论点。通过阅读你的综述，读者应该能相 信，你熟悉这个主题并且在这个领域做过广泛的背景研究。 在第一节课的“写作坊”中，您将战略性地将研究问题定位在现有的知识和文献中，以 便建立一个理论依据，来说明为何您研究的既定问题之很重要的。撰写您的理论依据是您的 实施研究计划书中整合现有知识的第一步。 完成文献综述 • 阅读和写作是一个反复的过程，并且耗时 • 您在目前的培训中不太可能会完成对现有知识的整合 我们的目标是： • 确保您理解所涉及的内容 • 确保您知道有可用的工具来帮助您完成此任务 • 向您提供从实施研究计划书中摘取的文献综述示例 进行文献综述涉及回顾现有知识和进行图书馆检索以找到相关资源(即研究文章，研究 报告，政府文件和白皮书)，阅读，然后组织和整合信息，成为一个简洁的主题概述。你可 能会发现，在开始写作之前，你需要就主题进行几天或几周的阅读。然而，在某些时候，你 需要开始写作。通常你会发现，你需要寻找主要的概念，有目的地阅读，成为一个具有批判 性思维的读者，并开始写的时候，仍然要阅读。阅读和写作可以是一个反复的过程。因此， 对现有信息进行全面整合可能是一项极其费时费力的任务。 在这个研讨会中，你将没有时间为你的研究主题进行文献综述，因此无法在足够的程度 上支持你的实施研究计划书。正如工作手册前面所指出的那样，在参加该课程之前至少就您 所确定的问题做一些阅读，这是很重要的。 总而言之，我们将概述整合现有的信息和文献的意义，确保您知道有哪些可用的工具可 以帮助您完成这项任务，并为您提供现有知识和文献整合的实施研究案例。在你完成研讨会 的学习后，你可以继续收集和阅读文章，并撰写你的文献综述。如果您有足够的资源，您甚 至可以把这个任务外包给曾经进行过文献综述的顾问。 文献综述的特点 • 提出基于现有信息的论点（例如，出版的文献、报告、政府文件等） • 整合多个来源的信息 • 批判研究方法缺陷（如果合适的话） • 文献综述应该支持你的研究问题 61 对文献的综述不仅是研究小组对一个问题或主题的意见的表达，而是根据现有的信息 （包括已发表的文章）提出一个论点。一个有效的文献综述并不取决于或详细说明一两项研 究，而是整合许多来源的信息。它应该写得很好，从一个段落有逻辑地衔接到下一个段落。 文献综述不仅描述或总结了一篇文章的内容，还会酌情批评研究方法上的缺陷。 过去，由于研究小组所处的位置以及缺乏对图书馆资源的利用，没能对既往知识进行有 力的综合分析是可以接受的。然而，今天任何人在网上都能找到大部分文献。一些搜索引擎 会有所帮忙，如 PubMed（http://www.ncbi.nlm.nih.gov/pubmed）、Hinari（http://www.who.int/ hinari/en/）和 Google 学术（http://scholar.google.com）。你也可以与图书馆员合作，或指派项 目组的特定成员帮助你寻找和获取你需要的信息。综上所述，整合现有资料能够： • 定义并限制问题或研究问题 • 表明对主题的熟悉程度 • 建立可信度 • 将研究置于其情境中 • 通过与一组知识的连接来证明相关性 • 整合并总结已知的某个领域的东西 • 有助于避免重复 • 确定与先前研究之间的相同之处和差异 • 帮助研究者选择方法和措施 • 激发新的想法 参考文献 • 文献综述中包含的思想应适当引用 • 软件程序可以帮助有效地管理、存储和使用引文 • 不恰当的参考文献会阻碍你申请资金成功的机会 • 不引用或引用不当可能会造成剽窃 • 计划书的文中引用的所有参考资料应列入参考文献列表 文献综述中所包含的想法应使用提交计划书的机构所要求的参考风格加以适当引用（例 如，APA, MLA, Chicago, Harvard）。有各种软件程序可以帮助有效地管理、存储和使用参考 文献（例如，EndNote, Mendeley）。如果可能的话，将 30 天试用的 EndNote 软件或免费的 Mendeley 软件安装到您的计算机上。 你必须适当地引用。不遵守正确参考文献的惯例是研究不严谨的表现，因此会妨碍你申 请资助时获得成功的可能性。此外，如果你不正确地引用，你就会面临剽窃的风险，这可能 会产生严重的职业和学术影响。有一些程序可以帮助你在你的写作中检查是否抄袭。举个例 子：桌面抄袭检查器。 62 案例 1（引用良好） 在第二次世界大战之后，Q 国家建立了一个广泛的结核病控制系统，该系统依赖于使用 大规模微型 X 线影像进行积极的病例发现，并使用有效的抗结核药物进行长期的住院治疗 （参考文献，1999 年）。 该国的崩溃给贫困的地区当局留下了结核病控制的负担，并导致 了病例发现、诊断质量和临床有效性的中断。伴随着对结核病患者有效药物输送的中断，该 地区出现多药耐药结核病（MDR-TB）（参考文献，1998 年）。 由于国际社会认为 Q 国的结核病控制系统投入过大，1994 年，世界卫生组织召集了该 地区结核病控制方案的负责人，以促进形成结核病控制的标准框架，后来被称为“DOTS” （参考文献，2001 年）。1998 年，Q 国政府通过了 DOTS 战略，并开始在全国加强结核病服 务。虽然随着一线结核病药物和涂片镜检设施的供应，结核病死亡率有所下降，但结核病控 制仍然受到至少两个限制：结核病患者继续以 8%或更高的速率放弃治疗，超过 5%的新诊 断患者患有 MDR-TB（参考文献，1999 年）。在过去的十年中，z 市和 w 区的结核病感染率 有所上升，就像全国其他地区一样，并且可能与贫困和由于缺乏资源而导致结核病控制和预 防系统恶化有关。白喉和肝炎等其他传染病的发病率也大幅增加（参考文献，1999 年）。 关于直接观察治疗（DOT）的国际文献表明，基于社区的结核病控制方案的成功取决于 激励患者和医护人员的因素组合，从而促进患者的治疗依从性（参考文献，2000 年）。此外， 关于 MDR-TB 治疗的医学文献表明，短期化疗不能为已经对异烟肼和利福平耐药的患者产 生可接受的临床结果（参考文献，2000 年）。在 MDR-TB 高度流行的环境中，有效的结核病 控制可能需要 18 至 24 个月的个体化治疗方案，包括二线抗结核药物（世界卫生组织，2001 年）。针对治疗依从性和 MDR-TB 的问题，国家结核病控制方案和国立医科大学已在几个试 点地区开始使用二线药物治疗 MDR-TB 并已开始制定一项创新的门诊增强和使能方案，他 们称之为柔性 DOT 和随访 DOT（参考文献，2001 年）。 案例 2（引用较差） 世界上大部分农村人口仍然容易遭受疾病带来的财务费用影响。在过去 20 年中，越来 越多的发展中国家组织了基于社区或农村的健康保险计划，以改善在非正规部门工作的人获 得医疗保健的机会。为农村人口和非正规经济部门工人及其受抚养人制定和组织健康保险的 必要性与一些国家的两组失败因素有关： • 政府未能征税和组织公共财政，未能为弱势群体提供社会保护，未能监督卫生部门。 • 市场未能提供供求之间的有效交换，部分是由于需求、需求和支付能力之间的差距， 部分是由于非正规部门中非货币交易的普遍存在。 健康保险在调动和管理健康资源方面的优势被视为基于三个因素：社会资本（(由家庭、 朋友和社区为低者正式确定的安全网-收入群体）；一些社区机构的存在；地方社区与致力于 促进社会普遍福利的外部机构之间的相互联系。但是，由于各种限制，包括人力和财政限制， 中低收入国家在制定可持续健康保险计划方面也存在许多问题和挑战资源。 63 小组活动：问题陈述 现在，你的团队已经对你们的研究问题，研究的理论依据， 以及一般和具体的目标进行了概述，你要准备好起草你的问题 陈述，这将从逻辑上引导你提出你的研究问题。 在你的团队中，阅读案例中的问题陈述，并将其作为指导来讨论你们自己的问题陈述。 案例[基于某个非洲国家两个不同地区疟疾控制的计划书]： 1990 年代，X 国政府推出了经济结构调整规划。这意味着减少对社会服务的财政拨款， 取消补贴，从而取消公共卫生预算。卫生部门支出占政府总支出的比例从 1980 年的 5.3%下 降到 1990 年代中期的 4.2%。分配给卫生部的资源日益减少，严重影响了包括疟疾防治在内 的各种规划。疟疾仍然是该国健康和发展方面的主要挑战之一，仍然是五大致命疾病之一。 1998 年全国 57 个区的统计数据显示，16 个区的发病率高于 100/千人（资料来源，1998 年）。 尽管在一些地区制定了疟疾控制方案，但一些地区（如 Y 区）仍然是发病率最高的地 区之一（885/1000）（资料来源，1999 年）。另一方面，位于同一农业生态区的 Z 区等地区 在过去三年里设法将疟疾发病率从 1997 年的 575/1000 减少到 1999 年的 305/1000。在该国 的 57 个区中，Y 区和 Z 区都是最贫穷的 8 个区之一，人类发展指数为 0.47（资料来源，2000 年）。拟进行的研究将确定在一个地区成功控制疟疾的因素，并吸取经验教训，制定有效战 略，从而在目前面临经济危机的国家进行有限资源的优化利用。 写作坊 在晚上，为你们团队的项目制定以下内容： • 项目标题 • 实施研究计划书的问题陈述（1-2 页） • 研究问题 • 具体你的项目目标（4-6 个目标） 请准备好在第二天提交你的草稿。 小组讨论 各小组将有约 10 分钟，展示前一天晚上写作的结果。 64 第二节课：研究设计部分 作为本节课的一部分，您的研究团队将建立能力，使您能够确定最有效地满足您的研究 目标的具体研究设计，并回答您的研究问题： • 制定一项研究设计，概述收集和分析数据的程序。 • 确定最能有效地实现您的研究目标并回答研究问题的研究方法（定性、定量/或混合) • 描述您的团队将制定的质量管理计划，以确保有效性。 • 描述研究对象。 • 解释您将采取的步骤，以确保所有伦理协议和程序将得到解决。 研究设计是描绘您的研究方法的蓝图或计划；收集和分析数据的步骤或程序；研究样本 大小和研究对象；以及你将如何解决伦理问题。计划书研究设计部分通常包括四个小节： • 研究对象 • 研究方法 • 数据收集 • 数据分析 研究设计主要有四种选择，每一种都针对不同研究环境中的基本需求（表 7）。 表 7. 研究设计类别及其所需满足的需求 一旦确定了总体研究设计，它就会影响研究对象选择，以及所使用/采纳的研究方法和 据收集/分析方法。 需求 设计 示例 充分性 前后对照或时间序列 在资源贫乏的情况下引入健康保险，并测试健 康保险对获得医疗保健的影响。使用前后对照或时 间序列设计来收集相应数据进行评估。 合理性 干预与对照组比较 （干预前-干预后）， 横断面研究 在选定的地区采用一种改善产妇保健的新方法。 一些社会经济发展水平相似的地区被选定为对照点。 新方法的影响或效果是通过对照地区的新的方法/干预 措施的比较，使用“双重差分法”的方法来评估的。 可能性 集群随机对照试验； 干预前-干预后和对 照点 使用手机作为提醒，以增加对结核病治疗的依从 性。每个区作为一个集群。 在十个区中，采用分组随 机对照试验，在五个区随机测试使用手机作为提醒的 影响当选。其他五个区作为对照点。 解释性 关于情境和机制的重 复测量 采用定量、定性或混合方法，了解和研究退休人 员在使用卫生保健服务方面的变化，并分析导致变化 的主要因素。 65 研究对象 研究对象部分应包括对将受试者（样本）或研究涉及的研究对象的完整描述，以及如何 选择研究对象(目的抽样或随机抽样)样本大小和研究对象标准的详细内容。这使读者能够就 研究的普适性做出结论。成为研究对象的标准，可能包括年龄和性别等人口资料，以及与研 究有关的特征（如，工作年限，确诊时间，教育水平等）。 概述将采取哪些策略，以确保研究对象在访谈、小组讨论和其他数据收集过程期间能够 畅所欲言。例如，场地是否私密？是否有考虑权力动态性，这样研究对象就不会感到害怕或 威胁，从而说他们真实的感受和想法？例如，如果采访病人，如果是在医生面前，他们表达 表达自己的意见可能会不太舒服。或者在采访医护人员时，让他们在上级或经理面前的说他 们的感受可能也会让他们觉得不舒服。考虑一下您的实施研究计划书如何列出适当的程序， 以确保研究对象感到舒适和自信，以提供真实、可靠的回复。 您的计划书中的研究对象部分的具体结构也将受到所选择的研究方法的影响。 实施研究计划书中研究对象部分的示例 为研究 X 国监狱系统结核病而进行的关键人物访谈，将根据利益相关者的分析和与国 家结核病控制规划人员的协商，制定一份待访谈的官员综合名单。初始名单包含： • 卫生部长（或副部长） • 负责流行病学和感染控制的卫生部副部长 • 国家烟草控制计划主任 • 卫生和流行病学服务委员会主席 • 司法部 • 司法部负责监狱系统的代表 • 主管监狱系统的首席医生 • 内务部部长 • 负责拘留中心的副处长 • 结核病首席医生（拘留中心） • 社保部（主管管理员） • 财政部（预算编制部门负责人） • 区域政治当局负责人 • 该机构卫生部门负责人 小组活动：研究对象 在你的研究团队中讨论：你认为你的研究人群是谁。你会 有一个研究地点或多个研究地点吗？你为什么会选择你选择的 研究地点？讨论你认为在你的研究中研究对象将会是谁。你需 66 要多少研究对象？成为研究对象的标准是什么？你是否需要不同类型的研究对象来获得对一个 问题的不同观点（病人、医生、家庭成员、社区成员）？你有对照组的研究对象吗？ 数据收集 的某些方面是否需要选择具有代表性的人群？例如，如果你正在进行个体采访，你是否希望你的 研究对象在（年龄、性别、教育、经验等)上有所不同，以此代表样本总体？ 为你的研究对象部分起草一份大纲。当中需要一个描述研究对象人群的部分，还需要估计每 个数据收集方法下，将要从这个总体中抽取多少研究对象(调查、焦点小组讨论、访谈等)。 研究方法 一般有三种类型的研究方法，定性方法、定量方法或两者的组合（混合方法），取决于 设计的目的。定量方法更适合回答的问题：发生了什么？ 定性方法适合于回答的问题：为 什么会发生这种情况？ 定性方法 定性研究通常用于探讨个体的价值观、态度、意见、感受和行为，并了解这些如何影响 所涉个人。也可以用来解释先前定量研究的结果。 定性研究人员关注个体对特定主题、问题或情况的看法，以及他们赋予生活的意义。这 种研究对于理论形成、政策制定、改进教育实践、证明变革或某一特定实践的正确性，阐明 社会问题都具有重要意义。定性研究使用数据收集方法，如访谈、观察和文件（例如，日记， 历史文件）。结果是描述性的或解释性的，而不具有预测性。 对于定性方法，您的计划书将需要概述以下章节： • 理论依据 • 数据收集 • 数据分析 • 可信度 • 研究对象 基本原理 如果你的研究团队决定在你的研究中使用定性方法，你的计划书应该说明为什么选择定 性方法（说明定性方法将如何提供信息来帮助你达成研究目标并解决研究问题）。 例如，定性研究可能是合适的，因为在你的研究中，你想探索个体的价值观和行为，并 了解这些价值观和行为是如何影响相关现象的。定性方法可能合适的原因，还因为它将有助 于进一步了解先前定量研究的结果。 使用定性方法，可能是因为研究的目的是形成理论，制定政策，改进卫生健康实践，证 明改变某一特定做法是合理的，或者阐明社会问题。使用定性方法的其他原因可以是用来提 供情境因素、对利益相关者的需要的更深层理解、丰富的数据和研究对象的观点。 67 定性数据收集 在收集定性数据时，最好使用一种以上的数据收集方法收集数据。以各种方式获得关于 相同现象的信息可以使研究人员对数据进行“三角测量”（或交叉检查/验证），这增加了研 究的严谨性。定性研究中的数据收集过程具有涌现性。 因此设计要灵活，才能让研究者在 研究主题（结果）涌现的时候更详细地进行调查。 定性方法使用的数据收集方法，如访谈、观察、讨论和审查文件（例如，日记、历史文 件）。定性研究的结果是描述性的或解释性的，而不是预测性的，通常收集起来很耗时。 在你的实施研究计划书中，说明您打算使用哪些数据收集方法以及原因。下表可能在此 过程中对你有所帮助。它概述了定性数据的收集策略（表 8）。 表 8. 定性数据收集策略 策略 总结和示例 研究对象调查 研究人员在一定程度上参与了长时间处于一种自然环境：对语言和 非语言实际行为的系统观察，受过培训的观察员使用结构化的记录表格。 通过观察、访谈、记录和/或记录收集数据。研究人员如果与研究对象建 立了某种关系，可能会影响收集到的数据。 计划书示例：将在选定的机构中进行半结构化的直接观察，在每个 研究县评估和比较至少两个机构卫生工作人员对属于/不属于修订计划 成员的患者的行为。如乡镇或公社卫生中心和县或地区综合医院。 非研究对象调查 研究者不参与自然环境中的任何活动。数据通过观察、记录和/或记 录收集。研究人员不与研究对象建立关系，因此不能探讨与所作观察有 关的进一步问题，除非这种方法得到后续行动的补充。 在横断面过程中的现 场观察 详细描述自然环境中的事件、行动、行为、人和物体。 实地观察以 实地笔记的形式撰写。 深度访谈 研究者针对研究对象的有目的地谈话。研究人员通常会事先制定采 访指南。研究人员鼓励研究对象深入交谈，尽可能地促进更多的细节， 而不引导研究对象得到具体的答案。访谈通常要被记录和转录。访谈的 平均时间是一小时（或更短）。 计划书示例：包括深入的个人访谈：患有“灾难性疾病”的人，包 括属于/不属于修订计划成员以及曾使用过/未使用服务的人士；国家和 地方各级卫生政策制定者；农村医疗保险计划管理人员。 审查文件和文物 书面誊写或打印的过去事件的记录。（如，书信、轶闻录、日记）。 揭示社会过程、意义和价值的当前或过去事件、群体、组织或人的物质 对象和符号（如文凭、奖项、报纸、标识等）。 视频/影像/照片 捕捉被研究的个体、群体或事件的日常生活的媒体。可以被反复查 看的行为记录。 焦点小组讨论 一次1-2小时的讨论，由一名训练有素的主持人指导，其中6至10名 类似的受访者（年龄、性别、社会地位）重点讨论一系列确定的主题。 这场讨论旨在揭示信仰、观点和动机，应该在非正式的环境中进行。研 究对象者之间的互动可以有助于数据收集。 计划书示例：使用参与式技术的焦点小组讨论将包括：使用参与技 术与修订计划成员和非修订计划成员（包括不同年龄、性别和社会经济 群体）；县/区及以下各级卫生健康服务提供者，包括全科医生/初级卫 生保健提供者、预防服务提供者以及门诊和住院服务提供者。 68 定性数据分析计划 定性数据分析由数据管理、数据归约和数据编码组成。简而言之，目标是识别数据中的 模式（主题）和它们之间的链接。分析定性数据没有固定的公式，但以下步骤在许多定性研 究中常用，将其纳入您的实施研究计划书可能会有帮助： 1. 所有访谈和讨论都有记录。 2. 所有录音必须逐字转录（即，完整地打印出来，逐字逐句）。 3. 每一份文字记录上都应该附有研究对象有关的所有背景资料。 4. 在分析的最初步骤中，研究人员将阅读/重新阅读第一组数据，在页边空白处写下 涉及回答研究问题相关的有意思的数据的笔记、评论和观察。 5. 在阅读数据的同时，研究人员开始制定一个紧急情况类别的初步列表，并将注释和 评论分组。这些类别是由研究的目的、研究人员的知识和方向以及研究对象的明确的含义为 指导的。这些类别的列表会被编译并附在数据上。 6. 然后仔细阅读下一组收集的数据，并考虑到先前构建的类别列表，注释、评论和观 测再次记录在页边空白处。然后，第二个数据集将被分组进入到类别表和编译的类别列表。 然后对这两个列表进行比较和合并，以创建一个类别主列表。这份列表反映了研究中反复出 现的规律或模式。 7. 然后赋予类别名称。类别名称可能来自研究者、研究对象或文献。根据 Merriam（1）， 这些类别应该：详尽无遗；相互排斥；对数据中的内容敏感；概念上一致；能成为研究问题 的答案。数据分析中的类别名称或代码也可以基于研究的目标，从数据收集工具中提出的问 题中得出。 8. 若研究人员对这些类别感到满意，就将数据分配到这些类别。取一份干净的数据副 本，研究者将数据整理成更有意义的单元，并将其分配给相关类别，将类别代码写在空白处。 9. 然后，研究人员为每个类别创建单独的文件，并将意义单位剪切并粘贴到相关类别 中，创建一个包含所有相关数据的文件。应该小心避免上下文剥离，仔细交叉引用所有单位， 并使用研究对象的化名进行编码，数据收集日期，和页码（2）。 10. 然后，研究人员试图以一种更有意义的方式将这些类别联系起来。图可以用来促进 这个过程。例如，在一项确定疟疾原因的研究中： 11. 研究人员还可以使用几种不同的计算机定性数据分析(QDA)软件来帮助他们管理数 据。“QDA 软件”一词有点误导人，因为该软件实际上不分析数据，而是整理数据，方便找 数据，更容易确定主题。软件也可能有些贵（每个用户可达 900 美元）。由于这些原因，一 些研究人员更喜欢手动分析数据。然而，随着软件的改进，研究人员发现 QDA在帮助分析数 据和节省时间方面作用越来越大。以下是一些比较常见的 QDA软件： • AtlasTi (http://www.atlasti.com) • MAXQDA (http://www.maxqda.com) • QSR NVivo (http://www.qsrinternational.com) previously called Nud*ist 6) • EZ-TEXT 3.06C (http://www.cdc.gov/hiv/topics/surveillance/resources/software/ez-text/ index.htm 69 案例：定性数据分析描述 1. 关键人物访谈和小组访谈的文字记录将根据新出现的主题进行编码和分析，使用民 族志软件进行定性分析。除了标准民族志描述，数据还将以叙述或频率表的形式来报告。 2. 使用 Atlas-TI 软件对焦点小组访谈、人类学田野笔记和对卫生健康工作者的访谈 进行编码，将有助于分析新出现的主题，并以叙述或频率表的形式展示数据。 3. 来自生活史的文字记录将根据新出现的主题进行编码和分析（民族志或 Atlas-Ti 软件）。数据将以叙述或频率表的形式报告。此外，在访谈对象的许可下，患者的录像将用 于国家和国际宣传。对患者和患者家属的半结构化、开放式的访谈将被编码，并以叙述或频 率的形式报告，以更好地理解在这种情况下 MDR-TB持续存在的影响。 可信度 实施研究计划书应规定研究小组如何确保定性方法的科学严谨性。例如，你的研究是否 会为研究对象提供一份他们的采访的文字记录，为他们提供一个证明和阐明他们观点的机会。 您是否会使用软件来帮助管理您的数据使其更严谨？您是否会进行成员检查（让多名研究人 员分析数据的多个部分，以比较和验证结果）？你会对数据进行三角测量以增加严谨性吗？ 你是否会报告并不成立的证据？ 清理脏水沟 避免阳光 避免吃甜食 定期除虫 服用止疼药 睡在蚊帐里 间歇性预防 打扫房间 预防疟疾 70 研究对象 如上所述，确保研究对象的数量、招聘和选择标准与您的定性方法相一致。你可能还需 要考虑一些具体的问题：你是否会使用目的抽样方法？与研究相关的人口学统计数据是什么， 以及与所研究的疾病相关的特征。 定量研究方法 与定量方法相关的三种最常见的设计是：准实验研究、相关性研究、监测和评估研究。 准实验研究 实验研究是唯一能够建立因果关系的研究类型。此外，这是研究人员试图控制特定变量 的唯一的一种研究类型。在实验研究中，研究者对自变量（也称为实验或治疗变量）对一个 或多个因变量的影响感兴趣（也称为标准或结果变量）。研究者控制自变量并测量因变量。 在实验研究中通常有两组研究对象：实验组，接受某种处理（如，用一种新的教学方法教学， 或接受一种新药）；对照组，不接受处理（如，继续用旧的方法教学，或接受安慰剂）。有时， 也会使用比较组，或者对照组。 对照组接受与实验组不同的处理。对照和/或比较组在实验 研究中是至关重要的，他们能使研究者确定治疗是否有效果，或者一种治疗是否比另一种治 疗更有效。在可能的情况下，研究对象应随机分配到治疗组和对照组。 相关性研究 在相关性研究中，研究人员试图确定两个（或多个）变量之间的关系，而不试图影响这 些变量。变量相关的程度用相关系数来描述，它可以从-1 到 1 取任意值。正相关意味着一 个变量上的高分与另一个变量上的高分有关，或者一个变量上的低分与另一个变量上的低分 有关（如，正相关）。相反，负相关意味着一个变量的高分与另一个变量的低分有关。相关 系数为零意味着变量之间没有关系。与实验研究相反，相关性研究没有建立因果关系。 研究人员不仅使用相关性研究来描述变量之间的关系，而且还用于预测。如果两个变量 之间存在足够强的关系（正或负)，则可以使用一个变量(标准变量)的得分来预测一个研究对 象在这个变量(标准变量）上的得分变量（预测变量）。 监测和评估研究 监测和评估研究的一个主要目标是根据最初的设计跟踪实施进度，找出潜在的弱点，测 试最初的假设，如果这些假设不成立，则调整实施过程。数据收集活动应仔细论证，以达到 研究目标。否则就有将稀缺资源浪费在永远不会使用的数据上的风险。 一个主要的数据来源可以来自通常存在于中低收入国家的常规卫生信息报告系统。通常 要求社区卫生中心、地区和区域医院以及其他卫生机构向地方和国家卫生当局提交的月度或 季度报告。信息通常包括疾病模式、服务使用和支出以及其他相关信息。 虽然可以很容易地获取和收集来自常规健康信息报告系统的数据，但数据的质量可能不 71 可靠，因为存在漏报的趋势健康问题或服务用途等。因此，可能需要进行特别调查或定期记 录监测安排，以收集实现目标所需的数据。这些数据收集方法包括家庭健康访谈调查、卫生 机构调查(例如，医院、卫生中心等)和患者调查。在使用这些方法收集数据时，研究人员需 要开发一些工具，例如，问卷、核对表，组织访问选定的家庭和卫生机构。 在你的实施研究计划书中，你应该指出谁将承担数据收集工作，以及在执行任务之前是 否将提供培训。期间还需要对数据收集过程进行适当的监督。 对于定量方法，您的计划书将需要概述以下章节： • 理论依据 • 数据收集 • 数据分析 • 信度和效度 • 研究对象 理论依据 如果你的研究团队决定在你的研究中使用定量方法，你的计划书中应该描述为什么使用 定量方法（如，解释定量方法将如何提供信息，以帮助您解决您的研究目标和研究问题）。 例如，在您的研究中定量方法是合适的，因为您想说明正在调查的问题或情况的原因和 影响。您也可以说明使用定量方法是为了确定群体中变量之间的关系或探索两组之间的差异 （如，干预前-干预后比较；不同人群)。 定量数据收集 定量方法涉及客观数据的收集和分析，通常是以数值形式进行的。研究设计是在数据收 集开始之前确定的，没有灵活性。研究过程、干预措施和数据收集工具（例如，问卷）是标 准化的，以尽量减少或控制可能的偏倚。 在你的计划书中，解释数据从何处所得-卫生中心、地区医院、区域（季度报告的等级）； 如何进行调查；由谁来协助实施；将如何确保匿名性；完成调查所需的时间；调查的长度； 调查问题的数量；样本量大小；调查将如何设计；调查是否经过验证等。 所使用的数据收集工具(例如，问卷)可以是由研究者开发的，或者更好的是之前已经开 发过的。开发一种适当并有效的工具需要大量的时间和精力，往往需要特殊的技能。如果您 正在开发该工具，请明确您是否会进行预调查。 在您的实施研究计划书中，请说明您打算使用哪些数据收集方法以及原因。下表（表 9） 概述了定量数据收集策略，可能对这个过程会有帮助。 72 表 9. 定量数据收集策略概述 策略 总结 结构化观察 研究者直接观察(看和听)一些现象，然后系统地记录所得到的观 察结果。研究人员预先确定将被观察的行为的特定类别。 问卷调查 在问卷调查中，研究对象被要求以书面形式回答问题，更常见的方 式是在答题栏做标记。在后一种类型的问卷中，回答选项通常是封闭 的回答列表，形式是“是”/“否”/“可能”；非常不同意/不同意/ 尚未决定/同意/非常同意；从不/很少/有时/经常/频繁，等。 计划书示例： 定量数据将通过结构化问卷收集。我们会在基线水平上开发一份标 准化格式，包括以下类别：1) 人口社会学特征；2)经济地位；3)与 肺结核有关的病史和治疗史；4)目前的健康状况，包括但不限于症状、 痰涂片、痰培养、体重和身高的评估(用于计算BMI)；5)有监禁或滥 用药物史;6)社会心理状态;和7)结核病知识 绩效评价工具 绩效评价工具是另一种评估形式，通过让研究对象创造、制作或做 某事来展示技能或熟练程度（例如，写论文，写简历，做运动表演）。 尽管近年来很流行，但使用这些方法有技术上的困难。这些方法通常 很耗时，并且需要一些非现成的设备或其他资源。 资料来源：改编自 McMillian & Schymacher (3) and Fraenkel & Wallen, (4) 定量数据分析计划 做一份简要的数据管理和分析计划是很重要的。数据分析的方法和模型应符合所提出的 目标和变量的类型。 定量数据分析将包括通过计算频率和描述性统计，如均值和标准差，以及问卷条目的阿 尔法值。您应该解释如何从收集到的数据中计算基本的描述性统计值，如均值和标准差。 您需要说明您将要对数据进行的检验（例如，t-检验；分层回归分析）。详细说明您是 否要控制变量。如有使用任何软件来进行数据分析您也需要加以说明。 概述以下与您的研究相关的诸多内容： • 展示适当的分析程序 • 提供数据分析的总体计划，并证明其技术和理论合理性。 • 描述完成分析所需的信息、这些信息的潜在来源以及将用于收集这些信息的工具。 • 提供足够的细节，以证明所有数据收集仪器和程序的技术可靠性。 • 确定分析、报告和利用的程序。 • •明确分析过程中可能存在的制约因素 • 讨论谁将负责分析，以及顾问或外部人员的角色。 73 案例：定量数据分析描述 案例 1：病人将被分配一个唯一的标识符，可以与每季度收集的结果数据联系起来。这 份标准化表格将包括以下信息：a)痰涂片和痰培养；b)目前的健康状况，包括治疗结果的数 据（例如，治愈、放弃、失败、死亡）；c)心理社会状况。关于社会经济地位的一些变量也 将列入季度评估表，以评估随着时间的推移而发生的变化。 除每季度评估外，每半年进行一次药敏试验。将为这些结果编制一份单独的表格，并使 用相同的唯一标识符进行链接，将其与在基线收集的季度数据信息连接起来。 将在 Epi2000 中建立三个数据库，用于接收季度的实验室表格。在数据输入之前，将对 表格进行随机和系统误差的审查，并与审查员协商做出可能的更正。并对数据录入员进行结 构化培训，使他们能够在表格输入数据库之前发现数据质量问题。 在输入之后，将在头几周对数据库进行密切审查，以确保数据输入和存储正确。在这一 初始密集阶段之后，将每季度对数据进行审查，以了解系统错误、空白字段和其他问题。每 月向数据录入员和审查员提供反馈，以减少系统和随机误差的可能性。 案例 2：从服务提供者管理的结构化问卷中生成描述性统计数据。适当情况下，将计算 一些卫生保健服务提供者变量的频率、平均值和标准差，包括人口社会学变量（如性别、年 龄、家庭规模等）、社会经济地位、工作满意度、与客户的关系，以及提供后续护理的障碍。 案例 3：对于队列研究，将对被纳入回顾性和前瞻性队列的病人的基线特征进行描述性 统计。随后的多元分析将显示其人口社会学特征的差异。除基线收集的其他因素外，对每个 队列的临床状况和病史的描述也将通过频率，均值，标准差和中位数来产生。在检查两个队 列的痰涂片和痰培养方面，将构建 Kaplan-Meier 生存曲线。为了解释分析中的混杂变量， 将采用 Cox 比例风险模型。线性回归将用于检查 DST 的结果，根据病人在随访时抵抗的药 物数量。Logistic 回归将用于评估二元结果，如治疗结果（差与好）、低体重指数、放射学发 现和职业状况。不良结局将被定义为治疗失败、不规则服药或死亡。中期结果分析将在第一 年年底进行，最终分析将在之后为期 2 年的接续期结束时进行。 还将介绍与 MDR-TB 有关的生物社会因素。为了研究生物社会因素与 MDR-TB 的出现 之间的关系，将采用线性回归的方法，以随访时患者出现耐药情况数量增加作为结局。就 MDR-TB 的持久性而言，使用 Logistic 回归，将生物社会因素与不良治疗结果进行相关。混 杂因素将通过多元回归分析来控制。 信度和效度 在评估所使用的数据收集工具时，必须考虑其心理测量学特性；即其信度和效度。测量 74 工具用于测量其所要测量的东西时，应当是有效的。它总是对具体的东西有效（例如，评估 对护理的态度）；调查一般来说是无效的。 理想情况下，用于收集数据的任何工具都应证明其对于目标人群的有效性和可靠性。 然 而，研究人员往往需要定制一个标准化的工具来使其适用于他们的研究。添加问题或修改现 有问题可能会对工具的心理测量特性产生负面影响，因此不鼓励。 你的计划书应该规定你的研究团队将如何确保你的定量方法科学严谨。解释说明定量数 据的效度（如，你将如何能够从一个群体中得出有意义的推论）和信度（如，随着时间的推 移，控制仪器分数的稳定性）均很重要。 举个例子，说明您使用的仪器是否标准化，以及它们是否在以前的研究和报告中显示具 有较强的信度和效度（在内容、标准和结构效度方面）。 你如何说明你能确保科学严谨（对照组、安慰剂等）？ 研究对象 包括一个名为“研究对象”部分，并确保你的样本量、研究对象招募和选择标准与你的 定量方法保持一致。你会进行随机抽样吗？指出变量是因变量还是自变量。描述研究人群； 选择标准；提供研究相关的人口统计数据（年龄、性别、种族、收入水平等）；与所研究的 疾病有关的特征等。 混合方法 大多数计划书采用混合方法，将定性和定量方法结合起来。在许多情况下，混合方法可 以比定量或定性研究方法更好地解决问题。然而，主要的挑战之一可能是创造两种方法的最 佳组合（和顺序）。 混合方法研究设计最常见的四种类型是：顺序性解释设计；顺序性探究设计；并行三角 设计；并行嵌套设计（表 10）。 由于混合方法同时使用定性和定量方法，混合方法计划书应包括： • 理论依据（描述正在使用的混合方法的类型） • 数据收集 • 数据分析 • 信度和效度 • 可信度 • 研究对象 75 表 10. 主要的混合方法研究方法 策略 总结 顺序性解释 在第一阶段收集和分析定量数据之后，在第一阶段的结果的基础 上收集和分析定性数据。权重通常是给定量数据赋予的。当初始定量 结果用于报告二次定性数据收集时，就会发生数据的混合。当定量研 究产生意想不到的结果时，它尤其能发挥作用。该设计的直截了当的 本质是它的优势，也因此它很容易实现。该设计的主要缺点是其实施 所需的时间，因为它要分为两个阶段。 顺序性探究 在第一阶段收集和分析定性数据之后，将定量数据的收集和分析 建立在第一阶段结果之上。通常会给定性数据赋予权重。当主要目的 是探索一种现象时，往往会使用这种设计（例如，测试一项新兴的理 论的要素或确定某一现象在特定人群中的分布）。这种设计很容易实 现，但需要大量的时间来收集数据。 并行三角 定量数据和定性数据同时收集，然后比较两个数据集，看看是否 有趋同，差异，或两者的某种组合。理想情况下，定量和定性结果的 权重是相等的，但在现实中，一种方法可能比另一种方法更受重视。 并行三角是混合方法设计中最流行的一种。然而，比较结果可能会很 困难，特别是在出现差异的情况下。这也需要研究人员的努力和专业 知识，使用两种方法来充分研究一个现象。 并行嵌套 定量和定性数据是同时收集的，但有一个主要的方式来指导这个 方法。根据主要数据类型，将使用定量或定性数据来提供支持或补充 作用。研究人员能够在一个研究阶段收集两种类型的数据。通常一种 嵌入式设计被用来回答不同的研究问题。 由于混合方法同时使用定性和定量方法，混合方法计划书应包括： • 理论依据（描述正在使用的混合方法的类型） • 数据收集 • 数据分析 • 信度和效度 • 可信度 • 研究对象 理论依据 如果你的研究团队决定在你的研究中使用混合方法，你的计划书应该描述原因（阐明使 用定性和定性方法将如何提供信息，帮助您完成您的研究目标并解决研究问题）。 例如，因为你希望能更好地解决问题，而比起单独使用定量或定性的研究方法，使用混 合方法可能是更合适的。你可能需要解释说明，您希望创建一种设计，将两种方法进行最佳 76 组合和排序。使用混合方法的其他理由可能是因为您的项目是跨学科项目，涉及具有不同观 点的团队成员，或者您的项目将处理复杂的问题，需要将定性和定量数据混合。 混合方法数据收集和分析 在研究设计中，有几个与混合方法研究有关的要素需要研究人员在研究设计中加以考虑： • 时间：定量和定性方法同时使用（并行设计）或两个不同的阶段使用（顺序设计）？ • 权重：对定量或定性方法的重视程度如何？它们的加权是否相等？ • 混合：数据分析需要与研究的设计相匹配。例如，在并行设计中，混合数据的一种 方法是讨论数据中出现的主题，以及它们如何支持或驳斥统计分析。另一种方法可以是将定 性和定量数据结合起来，得出新的变量或新的主题（5）。例如，在顺序设计中，研究人员可 以在研究的第一阶段收集和分析定量数据，然后选择一些极端的病例进行定性随访。 • 可视化图表：是一种重要的混合方法工具，它包含符号系统和研究过程的流程图。 在计划书中，请说明您打算使用哪些数据收集策略和工具以及选择的原因。根据您所使 用的数据收集方法，使用定性和定量部分（上述提及）中概述的信息。（例如，如果使用焦 点小组讨论，请参考定性方法部分——当解释如何使用问卷时，请参考定量方法部分）。 在你的计划书中，概述数据管理和分析计划很重要。 数据分析的方法和模型应符合所 提出的目标和研究问题。 可信度，信度和效度 在一个混合方法实施研究计划书中，说明如何在整个研究过程中确保科学严谨是至关重 要的。检验定量数据效度（如，能够从人口中提取有意义的推论）和信度（如，仪器多次测 量分数的稳定性）是很重要的。 为了确保定性验证，研究者将使用一些策略。首先，将为研究对象提供机会审查调查结 果，然后就调查结果是否准确地反映了他们的经验提供反馈。第二，使用数据的三角测量， 数据来自于各种渠道（文本记录和个人访谈）和多个研究对象。最后，任何“证明假设不成 立”的证据都要报告出来。这是为了确保研究对象提供的解释是可信的。 有关更详细的信息，请参阅定性方法的可信度部分和定量方法的信度和效度部分。 小组活动：研究设计 在你的研究团队中，讨论哪些研究设计将最适合你的项目。 你将使用哪些方法来收集你的数据？使用下面的示例帮助你 创建一个包含你的研究目标和研究问题的表格，并确定将使用 哪个数据源收集数据以满足研究目标，并回答你的研究问题。 77 案例 （1）对于第一个目标，本研究将分析 X 市的定性访谈、报纸和法令的公开论述以及对 结核病控制所承诺的客观措施。将通过 15 个关键人物访谈和几次协商小组讨论，来产生相 关国家和地方的政策进程的信息，以及一些国家和国际上关于地方卫生和社会保障系统在 MDR-TB 控制和流动病例管理方面的行为准则的译文。利益相关者分析将需要采访四个级别 的政府官员：国家级、区域级、省级和市级。 （2）对于第二个目标，研究将采用①与按职业划分的保健提供者进行焦点小组讨论（例 如，护士、医生）；②由接受过民族志方法培训的研究人员/临床医生进行的民族志评估；③ 对区和市两级负责结核病控制的卫生保健提供者进行结构化和开放式访谈。 （3）第三个目标的方法将包括收集定性和定量的社会数据，以及临床和微生物学结果 的数据，这也是患者和医疗服务提供者接受一系列激励措施的队列研究的一部分。 （4）为了实现第四个目标，本研究将比较细菌学和临床数据与从患者及其家庭成员收 集的定量和定性社会数据，以确定 MDR-TB 出现和持续的生物社会决定因素和影响。如果 可能的话，这项研究将通过视频获取 MDR-TB 和结核病患者的生活历史。将对患者和患者 家属进行半结构化、开放式访谈，以更好地了解在这种情况下 MDR-TB 持续存在的影响。 此外，M3的定量方法将有助于阐明可能与MDR-TB出现和持续相关的生物社会因素（例如， 教育、社会经济地位、缺乏社会支持、二线抗结核药物的副作用以及艾滋病毒和其他共病， 如药物滥用）。 写作坊 在晚上，为你们团队的项目制定以下内容： • 研究设计 • 研究方法包括： – 收集资料的逐步程序 – 数据分析 – 可信度、信度、效度 – 研究对象 请准备好在第二天展示你的草案。 小组讨论 各小组将有约 10 分钟，展示前一天晚上写作的结果。 78 质量管理 将质量管理嵌入到您的计划书中是不可或缺的步骤。质量管理对于确保研究符合或超过 科学、道德和监管标准至关重要。质量系统、控制和保证是所有研究活动的组成部分。每个 从事本工程的人都负有保证质量的责任。质量管理应在研究设计中做出计划并始终坚持。 在您的计划书中，详细说明您将如何证明您的研究团队将采取一致的、持续的措施来监 测和评估研究的质量和严谨性。指出你将如何在不同的阶段评估质量。您将如何证明您将在 所有数据收集和数据分析步骤中尽职调查？ 如果您的项目持续一年以上，您可能想要规定每年进行质量监测评估和报告。与所有利 益相关者讨论沟通计划，告知他们质量标准程序，以促进快速调整和纠正。 质量管理也应表达对研究研究对象的持续和一致的关注。将如何保护他们的隐私？将采 取什么措施来保护他们免受伤害（例如，人员培训，在研究伦理应用中坚持伦理标准等）？ 解决质量问题的活动 上方示例可视化地展示了如何在实施研究中规划和确保连续和一致的质量管理策略。 质量管理活动 您可以将一些活动整合到您的实施研究计划书中，将有助于管理质量，其中包括： • 协议审查和批准 • 标准化操作规程 • 研究工具的验证 • 项目团队培训 • 质量控制和监测 • 对所提供的服务的评估 • 对服务提供者的绩效评估 • 审查报告 方案和研究文件 的审查和批准 文献记录，监 测&审计 验证 协议和文件开发过程 计划过程 实施 数据 收集 数据 管理 过程 数据 分析 过程 报告 撰写 过程 质量计划，sop，培 训，工具校验，供应 商培训教育 验证 报告和审批 项目 开发 阶段 计划 阶段 实施阶段 完成阶段 报告 79 有许多策略可以纳入您的实施研究计划书中，以开展质量标准监测。为促进您的研究项 目质量所能实施的监测和评估策略包括： • 信息日志：跟踪来自利益相关者的反馈，发表的新闻故事和撰写的文章，以及学术 文献中引用的研究次数。 • 调查：这可以针对目标受众中的利益相关者开展，以产生反馈。例如，在传播活动 后的半年或一年，通过电子邮件发送问卷。再如，要求参加计划生育的客户完成一项关于提 高护理质量的调查。 • 对卫生系统各级利益相关者进行的一系列关键人物访谈，可以深入了解研究是否被 应用，或如何被应用。 使用下表（表 11）获得更多关于如何将质量管理纳入您的实施研究计划书的想法。 表 11. 各种质量管理策略的描述 策略 总结 协议审查和批准 研究严谨性包括规定如何保护研究对象的权利和福利。还可以制定 议定书，以确保数据和数据收集程序的一致性和严格性（标准化的仪器， 一致的访谈协议）；检查清单和既定协议，以确保在不同地点和不同研 究人员之间的数据分析的一致性和严谨性。 标准化操作规程 指出研究仪器是否标准化，以及它们是否在以前的研究和报告中显 示出较强的信度和效度（内容、标准和结构效度）。 项目团队培训 充分的培训和适当的基础设施对于病人的安全、协议的实施以及质 量保证和改进至关重要-特别是在介入临床试验中。 必须对研究人员和助理进行数据收集程序培训，以确保研究对象的 安全，并确保站点之间和站点之间的一致性和研究的严谨性。 质量控制和监测 质量控制对于确保可靠和一致的发现很重要。研究设计将纳入哪些 程序，以确保在研究地点之间和研究地点之间以及不同研究人员之间实 施一致的数据收集方法？拟采用的方法应有助于调查人员查明在数据仍 在收集时可以纠正的数据质量问题，并查明数据收集中的偏差，以便以 后加以调整。 评估所提供的服务 监测和评估服务的提供对于研究分析，以及提高服务体制的有效性 是至关重要的。制定“关键限制”，以衡量向研究对象/客户/患者提供 的服务的有效性和质量。 建立适当的记录和文件系统。定期实地视察，以监督进度及评估影 响。建立纠偏措施。与相关卫生健康工作者一起评估取得的成就和吸取 的教训，并将其应用于现有的和新的安排中。 评估服务提供者的 绩效 对服务提供者进行绩效评价并使用绩效评价信息可以大幅提高透明 度和促进问责制，这反过来又促进了对服务提供的更高质量标准的坚持。 评估工具依靠外部专家根据预先确定的一套指标来衡量质量和绩效。参 与式的监测和评估工具寻求的是服务用户参与，而不仅仅是提供反馈， 并让服务用户积极参与评估的策划和实施工作。这有助于建立当地社区 分析、反思和采取行动的能力。社区记分卡设想了团体的积极参与，并 允许研究对象自己确定质量和绩效的指标。 报告的审查 报告应该在足够的时间内起草并共享，提供机会让所有研究人员和 适当的利益相关者来阅读，做出反应，提出反馈，进行编辑，修订，以 及为报告注入新内容。 80 研究伦理 任何从人类受试者收集数据或涉及人类受试者的研究都必须接受伦理审查。如果您还没 有进行伦理审查，您必须保证自己是打算要申请伦理批准的。您的实施研究计划书中应该有 一个伦理部分，描述您将采取的步骤，以确保在研究进行之前、研究期间和之后潜在研究对 象的保护、尊严、权利和安全。此外，您的实施研究计划书应说明你们将如何确保在规划、 开展和评估该研究时，会根据当地社区的价值观和习俗，遵循普遍的伦理价值和国际科学标 准。如果您在一个以上的地点收集数据，您可能需要向不止一个伦理委员会申请。在收到书 面的伦理道德许可之前，机构不会分配资金。 在你的计划书的伦理部分，明确说明该研究将如何处理下列伦理准则（值得一做的是， 访问您提交计划书的审查委员会网站，以确保您符合他们的所有具体要求）： • 平衡对研究对象的潜在危害和潜在利益。可能的伤害可以分为几类，如身体伤害、 特权丧失、造成不便，包括浪费时间、心理伤害（如尴尬）、经济损失或法律风险 • 保持隐私、匿名性和保密性： – 当卫生保健提供者是研究对象时； – 在审查病历时； – 保持研究者和医生之间的界限 • 编写知情同意书和表格（包括在提案附录中）。 • 如有必要，添加一份知情同意书的当地语言翻译，因为某些伦理审查委员会可能会 要求这样做。 • 获得所有受试者/研究对象的自愿同意。若是未成年人，必须获得父母/监护人同意。 • 将研究结果作为公共品免费提供。 • 避免一切不必要的身体和精神上的痛苦和伤害。 • 风险不超过该研究将解决的问题的人道主义重要性。 • 考虑文化多样性，以确保研究对象理解研究的目的。 • 采取充分的措施保护研究对象。 • 在研究团队中加入有科学资格、受过良好训练和适当监督的人员。 • 方案将提交给适当的伦理和科学审查委员会批准。 • 涉及人体受试者的研究程序要在研究开始前提交给一个独立的伦理委员会批准。 • 任何对方案的修改将要被重新提交伦理审批。 • 如果研究涉及到脆弱的研究对象，要特别注意。 • 研究对象将被告知他们的参与是要出于自愿的，他们可以在任何时候自由退出研究， 不需要解释且/或不会受到偏见。 • 无论在何阶段，若有任何理由相信会对受试者/研究对象造成伤害，研究都将会终止。 81 实例 进行研究时，我们坚持科学研究的伦理原则。目前计划书中，我们建议进行干预，但我 们不确定是否会大规模地发挥作用，也不确定其影响（即存在平衡）。因此，我们在研究设 计中加入了对照组。另一个关键的伦理问题是有力和公正。这种干预是非侵入性的，对患者 没有风险。这一干预措施实际上可能有利于最脆弱的人群，如孕妇和新生儿。在这一群体中， 在这一群体中，其主要目的是确保最贫穷的人能够获得保健服务，如有危险迹象人群，或生 病婴儿。我们将会努力改进保健单位，以支持干预和控制领域的转诊工作。 我们会严格执行知情同意程序。详细宣传研究目标、实施战略和评价过程后，将得到地 区保健小组和包括社区团体在内的地方社区、传统助产士和社区领导人的批准。在评估部分， 将要求获取研究对象和当地社区的知情同意，并将确保保密。除汇总数据外，不会收集任何 特定患者的数据（例如在卫生保健机构分娩的妇女人数）。这些数据将从卫生保健机构例行 维护的登记册中收集。此外，这些数据将仅限于医护人员和直接参与研究的调查人员，研究 小组不记录姓名。研究期间，研究小组在社区内发现的任何病人都将被适当地转诊。 在干预的评估阶段，不会征求研究对象的接受和死亡率监测同意。研究对象可自由接受 或拒绝，必要时，妇女在同意之前可以与其丈夫和/或社区成员商量。 安全分娩研究和乌干达新生儿估计生存时间项目（UNEST）已经获得了 Makerere 大学 公共卫生学院机构审查的伦理批准委员会和乌干达国家科学技术理事会的批准。方案将再次 提交给相同机构进行伦理审批修订。这项研究将继续利用现有的数据监测和咨询委员会，该 委员会一直在为 UNEST 提供服务。DMSB 每年举行一次会议，成员均为当地专家，都是各 自专业领域的博士，政策关联性较强。这项研究将在当地和国际上作为试验进行注册。 涉及人类受试者的社会科学研究的规程必须得到地方/国家机构审查委员会和由世界卫 生组织资助的伦理审查委员会（ERC）的审查，并必须得到批准。世界卫生组织研究伦理审 查委员会，有责任审查由世界卫生组织资助或以其他方式支持的涉及人体受试者的研究计划 书的伦理方面问题。ERC 的网站是：http://www.who.int/rpc/research_ethics/en/。 知情同意书格式示例 同意书模板可在世卫组织研究政策页面(http://www.who.int/ rpc/research_ethics/en/)上找 到。这些模板应该适应你获得知情同意的当地情况。请确保使用您的研究机构的信笺，而不 是世卫组织研究审查伦理委员会的信笺。 伦理道德检查表 以世卫组织研究伦理委员会建议的方式准备计划书的检查表表和其他指导文件可在 http://www.who.int/rpc/research_ethics/guidelines/en/网站上获得。记得提供所有必要的文件和 附件。方案应提供必要的信息和细节，以符合检查表中提出的问题。此外，请记住在计划书 或相关附带文件内附上一切必要的解释。 82 第三节课：项目计划部分 在这节课中，你将根据你的项目计划，制定时间表，描述有效执行研究项目所需的研究 团队，并编制和论证项目预算。完成此阶段后，你的团队将能够： • 制定项目计划（工作计划/时间表），以指导项目的实施并监测项目。 • 制定工作时间表（例如，甘特图），以有效地开展和监测项目，包括要执行的任务 和活动，团队成员的角色和责任，以及要达到的里程碑和截止日期。 • 描述研究团队（包括每个团队成员所拥有的知识和技能，以及他们将如何为项目的 成功做出贡献）。 • 制定切合实际且与项目的具体目标和项目活动挂钩的分项预算。 • 为各种预算项目的测算理由提供必要的信息。 策划实施研究项目 一个项目计划展示了清晰明了的项目时间范围以及项目的每个方面将在什么时候执行。 往往一个工作计划或时间表会最有效地被显示在图形、表格或电子表格中。如果做得好，你 的时间表将有助于以非常明显的方式证明项目的可行性。工作计划将确定任务（即开展调查， 进行需求分析；管理调查；进行访谈；制定课程；管理评价）；活动何时开展（往往在一段 时间内）；以及由谁开展（责任和义务）。 项目计划的理论依据 项目计划有几个重要原因，其价值怎么强调都不为过。一个计划为项目确立了共同的目 标，并对研究过程有了清晰的认识。有效的计划： • 促进项目重点的制定； • 确保围绕项目发展策略和计划达成共识； • 确保项目的所有权； • 确保每个人都了解谁在做什么，什么时候做，以及每个行动如何影响整个项目； • 加强团队合作和透明度； • 促进项目监测和识别问题； • 促进项目评估和报告； • 向管理者/捐赠者提供项目审查所需的关键信息。 项目计划确定了在整个项目期间将完成的每项任务和活动。计划建立了团队成员的期望 和必须满足的标准。每个团队成员的职责以及完成每项任务或活动的时间线都被列出。项目 计划确定了项目的规模，以便能够制定适当的预算来执行计划。它有助于预测或识别在遵守 时间表、实施和/或完成项目方面的潜在障碍或制约因素，并提出可能的解决方案。这是一 个促进利益相关者之间的沟通，协调程序，团队协作的文件。 83 你的研究设计和程序将有助于确定项目计划中需要完成的任务和活动。总之，项目计划 有利于系统监测你的项目。 实施研究项目计划的各个阶段 项目计划一般分为三个主要阶段（见表 12）：规划阶段、实施阶段和后续阶段。 表 12. 与项目计划阶段相关的主要活动 项目时间表 项目的总持续时间应该真实地反映执行项目计划的每个阶段所需的时间。确保该计划考 虑到员工招聘和设备采购所需的时间。项目计划应概述： • 工作时间表； • 对将要执行的任务的描述； • 任务时间表和截止日期； • 被分配任务的人员； • 完成每项任务所需的人日数； 项目的持续时间对交付成果和最终报告的完成期限有严重的影响。项目计划必须遵循严 格的项目管理标准。有可供使用的商业软件包，可以帮助编制和监测工作计划的执行情况。 项目计划必须遵循严格的项目管理标准。有可供使用的商业软件包，可以帮助编制和监 测一个工作计划的执行情况。 阶段 主要活动 规划 • 组织研究小组和咨询委员会。 • 确定事件或状况来研究，并围绕这些来框定研究问题。 • 制定一份研究计划。 • 获得伦理许可。 • 确定实施研究的资金来源并获得支持。 • 建立预算和财务管理程序。 • 制定能力建设和技术支持计划。 实施 • 监测项目实施并保证质量。 • 对所有研究程序进行预试验。 • 建立并保证数据管理和质量控制。 • 与利益相关者探讨研究结果产生的解释和建议。 后续 • 制定传播计划。 • 传播成果和建议。 • 记录研究引起的政策和/或方针的所有变化。 • 监测订正方案的变化。 • 考虑可通过进一步研究加以检验的改进方案的方法。 84 图 3. 实施研究项目时间表（示例） 年份 月份 活动 责任 监督/ 支持 1 2 3 4 5 12 1.准备 1.1 伦理许可 1 1.2 落实 TSA 1 1.3 招募研究人员，审核任务分配 1 1.4 仪器开发 1 1.5 招聘现场人员 1 1.6 向研究现场人员及主管部门通报情况 1 /3 1.7 当地审批会议 1 /3 1.8 建立银行账户和现场财务程序 1 1.9 培训现场人员和当地支持 2,3 /7,8 1.10 预试验研究 2 3/7 1.11 仪器的最终精化 1 /2 2. 数据的收集、整理和分析 2.1 国家和区域政策和卫生服务评估 2.1.1 档案记录研究 3 1/ 2.1.2 重要访谈 3 1/ 2.2 当地卫生服务需求 2.2.1 档案记录研究 3 1/ 2.2.2 重要访谈 3 1/ 2.3 环境/水管理研究 4，5 /8 图 4. 实施研究项目甘特图（示例） 1-4个月 5-10个月 规划与设计 数据收集 8-13个月 数据分析 14-18个月 传播 质量保证与监控 85 任务 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 规划与设计 招募研究团队 培训研究人员 选择地点 开发/测试调查和访谈 伦理委员会批准 数据收集 机构调查 分析患者记录 提供者调查 患者调查 数据分析 定量分析 翻译和转录 定性分析 监测 传播 政策简报 政策研讨会 期刊文章 医疗机构报告 社区会议 有针对性的媒体活动 图 5. 实施研究项目甘特图（示例） 研究团队 你计划书的研究团队部分应该简明扼要地描述你的团队成员以及他们对项目的贡献。这 个团队将是多学科和多样化的（来自学术界的研究人员，卫生保健提供者，项目实施人员， 社会科学家以及社区成员）。这个部分应该使评审人员相信你在你的团队中有足够的专业知 识来有效地进行拟开展的研究。此外，计划书需要包括每个关键团队成员的详细角色和职责。 从项目负责人开始，列出所有将参与研究的人员的姓名。包括所有合作调查员、社区研 究伙伴、研究助理、受训人员和支持人员。包括所有合作调查员、社区研究伙伴、研究助理、 受训人员和支持人员。该计划书还包括“待任命”职位。确定每个团队成员的经验和专业知 识，以及他们的知识和/或技能对于有效完成项目的重要性和如何为其增加价值。最后，包 括项目中列出的每个人的角色和责任。研究团队成员通常包括： • 项目负责人 • 项目管理者 • 多学科核心研究人员（公共卫生专家、统计学家、社会科学家等） • 研究助理 • 团体成员 • 合作者 • 咨询委员会 计划书还应包括计划的研究团队管理结构的大纲/摘要（例如，见图 6）和团队成员各自 角色和职责的描述（见下文）。 86 图 6. 研究团体管理结构（示例） 案例 1. 团队角色和职责 项目负责人：美国（2） • 监督研究的概念化、设计和实施 • 主要合作者、社区领导人和研究团队之间的联络 • 招募研究人员 • 监管社区会议和政策对话研讨会 研究人员:美国（2）/坦桑尼亚（2） • 分析数据 • 培训研究助理 • 质量保证 • 监测和评估 • 研究助理:坦桑尼亚（10） • 进行访谈 • 为调查和审计收集数据 • 将数据输入数据库 • 国内协调员:坦桑尼亚（2） • 行政助理:坦桑尼亚（2） 欧盟委员会 项目协调员 项目管理 委员会 项目技术 委员会 项目咨询 委员会 项目管理办公室 工作包管理 欧洲合作 伙伴 中越合作 伙伴 87 案例 2. 团队角色和职责 ABC 大学公共卫生学院是申请机构，全面负责该项目，包括日常实施和管理。学校设 有财务部门，将与卫生政策规划管理部协作，负责所有财务管理和报告要求。此外，ABC 大学公共卫生学院将与卫生部合作，负责组织传播活动和会议。公共卫生学院与政策、卫生 部以及世界卫生组织、联合国儿童基金会、美国国际开发署、各地区和当地社区等其他主要 合作伙伴有着牢固和长期的联系，是乌干达主要的公共卫生学术和研究机构。 研究团队组成 该小组由多学科的国内和国际专家组成，他们将提供有效设计、实施、评估和传播研究 结果所必需的技能，为扩大孕产妇、新生儿和 HIV 相关研究提供信息，并指导正在进行的 方案的实施。项目负责人是一名流行病学家，有 10 年的地区医疗官员/卫生部工作经验，目 前是 UNEST 研究的项目负责人和公共卫生学院的讲师。他还在其他几个卫生系统项目中发 挥了关键作用。其他成员包括卫生部生殖健康医疗官员 Jane Doe 博士。她将与政策主要联 系起来，并与地区医务官员一起提供技术咨询，对于确保研究与国家的优先事项、政策和计 划保持一致至关重要。Doe 博士还与一些地方非政府组织合作，将研究团队与相关政策制定 者联系起来，并就如何使项目与国家的新生儿优先事项相一致提供专家意见。 来自乌干达的其他小组成员包括卫生经济学家和孕产妇保健专家克 Claire Smith 夫人和 有 30 多年经验的卫生系统专家 David Johnson 博士。他们将共同负责研究的成本方面，以及 需求侧融资方案的设计。CDE 大学产科顾问 John Smith 博士将负责对医护人员的培训和支 持监督。统计学家 Jane Davis 博士将负责基线和终线调查的设计和实施。沟通专家 Jane Johnson 将负责确保研究结果及时、恰当地传达给政策制定者。国际研究小组成员包括未来 卫生系统方案联合会主任 John Doe（JHU，卫生系统专家）、Jane Smith（JHU，新生儿专家）、 David Johnson（JHU，专家）和 Claire Davis（KI，卫生系统和政策专家）。他们都将在研究 的设计、实施和评估过程中为研究团队提供技术建议。所有研究小组成员将参与稿件的撰写。 该项目将聘请两名现场协调员，优先聘请现有项目中已取得经验和与地区和当地社区关 系良好的协调员。 小组活动：研究设计 在团队中，使用实施研究计划书中的实例来重新思考过去 一个小时左右的内容，并根据你自己的项目撰写以下部分： • 实施研究计划的三个阶段。 • 工作计划/活动时间线（你可以使用一个简单的流程图或甘特图） • 研究团队，包括专业知识和角色（表格是有效显示这些信息的一种方式） 88 预算和测算理由 预算应列出能够有效地进行拟开展研究所需的资金。需要仔细考虑实际需要从资金机构 那里得到什么来执行这个项目。如果预算过低或过高，可能会对计划书产生负面影响。评估 这一点的一个方法是询问是否有可能在不损害研究质量的前提下削减预算。 重要的是，列出项目每个阶段所需的资金等信息。在准备预算之前，检查一下资助机构 是否有任何限制。例如，确保预算以指定货币呈现。与机构核对，看是否有必须使用的建议 /要求的预算类别。 如果潜在的资助机构没有任何建议/要求的预算类别，按照一组对你的具体项目有意义 的类别来组织你的预算。、预算的资源类型应该与研究设计中拟开展活动相一致。预算将需 要提供交付所有拟开展的研究和干预产出所必需的资源。从项目计划开始，确定每个活动或 任务所需的预算。一旦每个资源被逐项列出，就可以指出该资源的单位成本和总成本。务必 提供分项预算，对所要求的资金进行详细的分解。预算信息应该是完整和明确的。 如果项目计划在研究后对控制人群进行干预，这也需要进行计划和预算。对相关活动和 成果的传播和评价也要进行预算。查明是否有不允许的项目，如管理费用。通货膨胀和汇率 的货币波动以及意外情况可能会影响预算和最终可用收入。重要的是要包括有助于解决这一 问题的机制。 预算类别 你可能想要考虑的分项预算包括： • 职员（工资和福利） • 研究人员（时间、工资和福利） • 培训 • 顾问和/或专家（薪水） • 教学 • 设备 • 消耗品（如纸张、碳粉、电池、出版费用等） • 通讯（电话/邮费/互联网/媒体） • 材料准备（软件、医疗用品、复印和打印） • 差旅费和津贴 • 社区联络 • 设施租赁 • 评估 • 间接成本（组织要求你计入的成本） • 其他费用（会议午餐、面试等） 89 预算测算理由 证明每一个预算项目的合理性，首先从预算项目是如何与你的研究设计中要进行的活动 相关的开始。特别注意重大或不寻常的项目（一些资助机构可能会要求额外解释所有被认为 有重大成本的事情）。提供组织或项目负责人可获得的其他资金来源的详细资料。如果资金 会流向不同的机构，则注明按地点分配资金。 案例：预算测算理由信息 ①职员（工资和福利） 不管在项目上花费了多少个月的时间，只指出在每个预算期间列出的每个人所需要的时 间（通常以天为单位）。提供姓名（如果知道的话）、职位和薪金，包括附加福利的百分比， 如果这些福利代表雇主的实际成本。附加福利应遵循机构方针，并了解主办机构允许或不允 许的福利。同时，确保包括那些参与项目但没有得到报酬（或者没有从计划书预算中得到报 酬）的人。如果你打算让顾问或其他外部人员参与，请确保将所有相关费用列入预算。 提供所有顾问（包括外部监测或咨询委员会成员）的姓名和组织隶属关系。说明在预算 范围内需要提供的服务（日数、补偿率、差旅费、每日津贴和其他有关费用）。 ②消耗品 列出各类消耗性用品的费用(例如纸张、墨粉、胶带、胶卷、电池、印刷费用、其他现 场用品)。将消耗品按要求的金额分别归类。每购买一件都要说明。 ③设备 列出每一项设备所需的金额。包括设备维护。为每件设备提供与拟开展工作相关的证明。 确定被认为是主要设备的所有设备（例如，主要设备可能是所有成本超过 1000 美元的设备）， 并在需要时提供额外信息。 ④患者（研究对象）费用 解释成本的性质（例如运输、现场试验药品）和计算方法。重要的是检查与资助组织有 关的限制。详细说明将提供病人护理的地点和分配给每个地点的预算。详细说明估算费用的 依据，包括患者人数、治疗天数、每次检查或治疗的费用等。如果同时要求住院和门诊费用， 则分别提供各自的信息。如果要使用多个地点，请按地点提供详细信息。包括患者转移、患 者参与激励等。 ⑤差旅费 逐项列出每个差旅项目。提供每次差旅的目的地和目的地，以及申请资金的人数。包括 进行拟开展研究所需的当地运输费用和实地研究费用。分别列出交通费、生活津贴（说明机 构支付的数额）和所有其他费用（具体说明）。检查与筹资组织有关的限制。还有，一些组 织可能需要单独的国际和国家/地方差旅费。包括现场工作人员的住宿和生活费用。说明每 年出差的次数，并将其与个人任务联系起来。如果需要将样本从现场运送到实验室，请说明 将如何运送以及所涉及的费用。 ⑥现场费用 说明是否需要租用或购买车辆，并提供需要车辆的详细理由。还要确保包括相关的燃料、 90 保险和维护费用。如果要购买车辆，说明一旦项目结束将会发生什么。 ⑦管理费 查明资助机构是否会支付管理费用，并相应地将其列入预算。 ⑧其他支出 请列出拟开展研究所需的所有其他开支。这可能包括保险成本、外包、出版成本、电脑 费用、租金和租赁、服务合同和通讯成本，特别是当工作涉及许多国家/机构时。需要指出 的是，有些组织没有为列为杂项或其他事项提供资金。在提交预算前，一定要与资助机构明 确这一点。 小组活动：研究设计 在实施研究团队中，回顾由导师提供的实施研究计划书预 算模板。使用第 3 节课中包含的信息和预算案例作为指导，制 定你们团队的实施研究计划书预算。 91 第四节课：影响 在本节课中，你的实施研究计划书中涉及确保研究项目质量标准的措施的部分将被审查。 具体来说，在完成这节课后，你将： • 为你的实施研究项目制定监测和评估计划 • 能力建设计划 • 传播计划 你必须努力确保你们的计划书清楚地表明，你们的研究结果将如何对有关社区/人群的 健康或保健、政策制定和研究界产生影响。例如，你的计划书将如何证明你的研究团队已有： • 承认、监测和计划相互竞争的优先事项、有限的后勤能力、缺乏政治意愿和/或基础 设施和资源不足——所有这些都可能影响向最需要的人提供的卫生保健计划？ • 计划在项目中发展和维持能力建设，以促进发展中国家采用循证卫生干预措施？ • 表明将传播研究成果，以确保项目将为政策和项目实施提供信息而产生研究证据？ 当制定一个典型的研究/学术计划书时，其目的是产生新的知识和想法。相反，在制定 实施研究计划书时，其目的是产生研究证据，为政策和规划实施提供信息。尽管卫生保健循 证实践的知识基础日益增长，但所谓的研究结果与实践中一贯实施的做法之间仍存在巨大差 距。为什么我们知道的和我们做的之间有这么大的差距？研究发现，最佳实践和指导方针可 能需要数年甚至数十年的时间才能落实到卫生保健工作者的日常实践中，这是实施研究“运 动”背后的刺激因素之一。 研究成果的利用是实施研究的核心目的。将证据转化为卫生保健实践需要一个监测和评 估过程，以确保质量和改善健康结果。你的计划书应表明，你们的项目将促进采用和整合循 证卫生干预措施，并改变做法模式，特别是在发展中国家。为了让人信服，你的计划书应该 表明你已经考虑了研究将要发生的情况和环境的复杂性。 监测和评估 一项监测和评估计划： • 准确地描述如何评估项目是否满足其目标并传达计划书中所承诺的内容。 • 告知潜在的融资机构他们的投资是/曾经是合理的。 • 促进研究结果的使用，实施循证实践，从而改善健康结局。 • 检查卫生干预措施的实施效果与效力之间的差异。 92 监测活动 你的计划书中的监测活动包括：你评估项目的进展（例如招募率、遵守时间表的程度， 有关向捐赠者提交所需报告的截止日期等）将采取的步骤，以便及早发现问题或事件，并尽 快做出所有必要的改变或干预。 监测活动包括确定项目中需要观察的方面、由谁负责各种活动以及监测活动的组织。此 类监测活动通常与项目中的特定节点或时间轴事件相关联。在确定项目时间表时，考虑包括 特定的监测活动。例如，在节点 X，你将报告 Y。对监测部分的描述应包括以下内容： • 确定项目所需的资源，包括人员、设备、用品、后勤支持和资金，以及你将采取的 预防措施，以确保这些资源将得到适当的使用。 • 遵守研究设计程序，以确保正确和及时地遵循这些程序。这包括你打算如何监控与 项目相关的每个团队成员的角色、职责和活动，以确保工作计划按照设想得到执行。为确定 延误或困难而采取的措施。 • 干预与数据质量之间的联系。 • 研究团队打算如何与研究对象、其他合作团体和/或资助机构沟通和协调的计划。 评估计划 在计划书中应该包括一份评估计划，详细列出将如何证明项目是否达到了目标，是否“成 功”。许多研究计划书标准的规定是，指定总预算的约 10%用于评估。研究团队通常会聘请 顾问进行评估。在实施研究计划书中，指出评估将由内部团队成员还是外部顾问进行。 评估计划展示了研究目标将如何实现，并表明打算如何密切跟踪项目计划中的变更以及 遇到和解决（或未解决）的问题，因此可以告知利益相关者并将这些信息包含在初步报告中。 评估计划还应考虑以下几点： • 确定谁将使用评估结果 • 描述所需信息、来源和评估方法/工具 • 检查项目目标将如何实现 • 跟踪干预的预期影响 • 证明评估的范围是合适的 评估计划将向潜在的资助机构表明，你将如何证明他们对你的投资是个好投资的。如果 你计划使用调查或问卷来帮助评估项目的成功，请在附录中包括评估工具的草稿。 93 监测和评估评估项目在各个阶段的成功和影响、已经使用了各种方法来衡量治疗、规划 或服务的有效执行情况。一些评价策略通过在客户或患者层面衡量临床结果来推断实施成功， 而其他研究则衡量实施的实际目标，例如量化与提供新实施的治疗有关的预期提供者行为。 Proctor 等人（6）将实施结局定义为实施新的治疗、实践和服务的故意和有目的的行动的效 果。他们建议将以下 8 个概念上截然不同的实施结果纳入评估计划：接受度、采用率、适当 性、可行性、保真度、实施成本、覆盖范围和可持续性。 既包括形成性评价或过程性评价（项目正在进行时的评价），也包括终结性评价或产品 性评价（评价是在项目结束时进行的，以论证项目完成了最初提出的内容）。如果你的项目 超过一年，你可以规定进行年度评估和报告。在评价计划中直接参考自己的研究目标，以便 突出计划书内容的一致性。 你的评估计划应该体现对资助期结束后发生的事情的关注。在你的项目下已经开始的计 划将如何在未来持续下去?在资助期结束后，其他合作机构将如何协助继续进行该项目?为了 促进你的研究成果的利用，你的计划书应表明你打算如何在研究的各个阶段将你的研究成果 告知所有利益相关者。 监测和评估工具 为提高研究项目的质量，可以实施的监测和评估策略包括: • 信息日志：跟踪利益相关者的反馈、相关新闻报道和文章的撰写、研究被学术文献 引用的次数。 • 调查：与目标受众的利益相关者一起进行，提供反馈。例如，可以在传播活动 6 个 月和 1 年后通过电子邮件发送问卷，或要求计划生育门诊患者完成关于改善护理质量的调查。 • 对卫生系统各级利益相关方进行的一系列关键信息访谈可以深入了解研究是否以 及如何被使用。 展示评估计划的一种方式是使用一个表格来概述研究目标或研究问题和评估策略，以评 估目标是否已经实现。 研究目标 如何评估 目标1 焦点小组访谈 前后调查 目标2 与主要利益相关者单独面谈 94 案例：干预过程和影响评估 目标 1. 评估研究地区经修订的农村医疗保险计划按计划实施的程度。 2. 解释原因或为什么没有按计划实现。 3. 评估实施的修订健康保险计划对以下方面的影响:改善获得/使用保健服务的公平 机会；减轻昂贵的医疗账单造成的经济负担；公平和计划覆盖范围；成员的满意度;以及这 些计划的财务可行性和可持续性。 工作描述 本工作包括多项工作任务，旨在根据研究目标对干预影响进行综合评估。评估将包括过 程评价和影响评估。过程评价的部分数据收集和分析将与干预措施同时开始。这是为了确保 对干预过程进行有效监测使在执行过程中遇到的大多数问题能够尽快查明和解决。将使用来 自快速家庭健康调查、定性研究和在干预县和区运行的管理信息系统的数据。 工作任务 1：第一个工作任务是定义评估框架（图 x 和 y），这些框架将用于指导评估数 据的收集。主要研究人员和项目咨询委员会成员将利用一次项目会议（将在第 2 年年底举行） 讨论如何在干预措施完成之前完善评估框架并最后确定它。 工作任务 2：研究团队还将重复采用与现状分析和基线调查相同的方法、相同的研究县 /区、相同的人口样本进行家庭健康调查。调查将在完成干预的 18 个月后进行。问卷可以修 改，以反映干预期间所作的变化。但问卷的总体内容将相同，涵盖家庭一般资料（如家庭规 模、收入、保险成员等）、疾病感知（包括 1-2 项示踪研究——结核病疑似患者/慢性咳嗽患 者和腹泻患者）和服务利用与支出、不使用所需服务的原因以及患者对服务的满意度等。问 卷调查完成后，根据制定的评估框架将所有问卷录入分析。 工作任务 3：定性数据也将收集和分析，包括：使用参与式技术的焦点小组讨论和深入 的个人访谈（与在现状分析中咨询的目标人群中的相同社会群体）；与县/区及以下各级卫生 服务提供者、国家和地方各级卫生政策制定者、农村医疗保险计划管理人员和地方各级有关 非卫生政策制定者进行焦点小组讨论和深入访谈;将在选定的设施中进行半结构化直接观察， 以评估和比较保健工作人员对修订计划成员/非成员患者的行为。将根据评估框架收集和分 析指定保健设施和保险基金管理组织运行的管理信息系统的相关数据。 95 可交付成果 • 确定评估框架 • 关于两国干预措施影响评估的报告 节点 20 个项目月（PM）完成评估框架，46 个项目月（PM）完成评估报告。 预期结果 在可以向两国政府提出政策建议的研究领域尝试更公平和可持续性的健康保险计划。 能力建设 研究能力受限已被确定为低收入和中等收入国家处理卫生保健优先事项的制约因素之 一（7）。生成恰当、可信的证据依赖于良好的研究组织的存在。能力提升策略需要关注机构 的综合需求，包括整体技能和职业发展，领导、治理和行政系统的发展，以及加强国内外研 究共同体之间的网络。在撰研究计划书时，有两个具体考虑可能有助于解决能力建设问题： • 该项目如何通过培训、指导等方式帮助提高国家和地方有关机构的研究能力。 • 该项目如何通过实施过程帮助提高诸如政府官员等关键利益相关方利用研究证据 制定政策或决策的能力。 案例：研究能力发展 发展和加强中国/越南和欧洲两个伙伴的研究能力将是整个项目实施过程中的一个持续 过程。以下是旨在发展研究能力的主要活动。每个合作伙伴应分析其研究能力的现状，以及 需要哪些研究技能和能力与现有能力之间的差距。 随后将在项目管理委员会第一次会议上拟订并核准为所有参与的伙伴建立研究能力的 策略。根据这一策略，研究能力建设的详细计划将在第一年的上半年制定。该计划将包括一 个对来自发展中国家和欧洲国家的青年研究人员进行指导和监督的系统，以及中国/越南合 作伙伴和欧洲合作伙伴之间的访问研究人员交流。在制订这一计划时将考虑到性别问题。 将使用一些适当的策略来提高研究能力，特别是在项目实施期间为两个发展中国家提高 研究能力。在研究设计和研究工具的开发、数据分析和报告/论文撰写期间，这些国家的研 究人员将被邀请访问欧洲合作伙伴。这些初级研究员与欧洲伙伴在一起时，将参加一个方案， 96 其目的是发展他们在与项目有关的研究技术和与一般保健系统发展特别是健康保险有关的 分析问题方面的技能。若有可能，将鼓励初级研究人员在自己的机构注册为硕士/博士，由 中国/越南和欧洲合作伙伴的高级研究人员联合监督。还将鼓励来自欧洲伙伴的初级研究员 花足够的时间在研究领域工作，以获得在发展中国家进行研究的直接经验。还将鼓励所有合 作伙伴的初级研究员参与项目管理活动，以提高研究项目管理的能力。加强欧盟伙伴的研究 能力将确保对研究的关键要素达成普遍认识，包括针对性别的定性和定量方法以及数据分析、 卫生政策分析、卫生经济学模型等。 传播计划 你们计划书的一个重要方面将是传播项目信息的计划。大多数资助机构都想知道他们对 你的项目的资金支持将如何延伸到其他受众。因此，你的计划书应该包括一个关于传播的部 分，将包括你计划进行的传播类型，以及你打算在哪里传播你的研究结果。 信息传播策略 • 为确保你最有效地向利益相关者传达研究信息、计划和结果，请回答以下问题： • 传播策略的目标是什么？ • 谁是目标受众？ • 什么是合适的沟通渠道？ • 你将如何评估信息的吸收和使用？ • 最有用的工具或产品是什么？（例如政策简报、研究报告） 传播活动通常包括： • 在国内和国际会议上发表研究成果。 • 在国内和国际同行评议期刊上发表研究成果。 • 与当地和全国利益相关方开会讨论研究结果。 • 政策倡导简报。 • 在宣传工作中使用患者的生活史访谈（征得访谈对象的同意）。 • 年度报告。 • 媒体（如电台广播、新闻发布、报纸文章等）。 97 计划书的这一部分应包括： • 在项目进行的每一年，你拟撰写的参考文献和专业出版物的数量（包括你拟提交的 期刊名称，以及专业期刊、通讯稿、印刷讲义、政策报告和其他拟发表的出版物）； • 每年你打算参加的学术和专业会议的数量和名称； • 你计划在项目的每一年进行的教育或非正式的社区演讲（包括研讨会或培训计划; 课程信息；政策简报；新闻发布会；幻灯片等等）。 在这方面，“少承诺，多兑现”往往更好。做出详细声明的计划书（特别是没有类似的 跟踪记录来支持此类出版物或传播记录的计划书）往往会失去评审人的信任。 通常，研究结果发表在相对深奥/高度专业化的期刊上，只为少数具有专业知识或兴趣 的人或可能理解，而且大部分只有其他研究人员阅读。以适合目标受众（关键信息）的形式 将研究结果传播给所有利益相方对于确保更好地利用和吸收研究结果至关重要。 小组活动 回顾传播计划案例（如下）。这个传播计划的哪些方面可 能有助于考虑你的实施研究计划书？哪些方面是不合适的？ 例如:与国家政策制定者协商并向他们传播研究结果 在整个研究过程中，区域/省和国家政策制定者的参与是项目成功的关键因素，因为要 实现预期的研究战略影响，关键取决于他们采纳研究建议。将使用下列方法来确定主要的政 策制定者，同他们协商，并向他们通报最后的项目结论和建议： • 在项目开始时将进行利益相关者分析，包括以下内容： • 第 2 个项目月的项目研讨会。 • 将邀请确定的主要利益相关方参加两个研究国之间的联合研究规划讲习班，包括第 4 个项目月的现状分析和研究基线设计讲习班（见 WP2）。 • 在第 12 个项目月举行研讨会，讨论现状分析的结果，并讨论对现有方案的可能修 订（见 WP3）。 • 在第42个项目月举办一个研讨会，介绍和讨论修订方案评估的初步结果（见WP6）。 • 在第 47 个项目月研讨会中提出最后研究结果。 将编制政策简报，针对不同级别的政策制定者和管理人员，包括区域和国家政策制定者。 98 将与主要利益相关方进行协商，并将在适当时候向他们提供全面的项目研究结果。项目的主 要利益相关方是研究地点的目标人群、卫生保健提供者和健康保险提供者。研究结果将通过 以下方式咨询这些小组并告知他们： • 农民协会等主要利益相关方团体和基层妇女团体的代表将被邀请参加最初的项目 启动研讨会。 • 在重新设计医疗保险计划之前，将与这些群体进行进一步协商，方法是收集定性数 据，作为现状分析的一部分。 • 试点方案评估的初步结果将通过 x 月的研讨会传播给这些利益相关者群体的代表， 使他们能够对评估结果和适当的建议发表评论。 • 最后的研究结果将通过编制和派发适当的材料，如无线电广播时段和通讯，传达给 这些利益相关方。 • 与国际政策制定者和研究人员协商并向他们传播项目结果。 • 为了在国际上设计和实施更可持续、更公平的健康保险计划，必须确保研究方法能 够产生国际政策制定者关注的具体问题和指标信息。该项目将包括国际政策制定者的代表及 其技术咨询委员会的顾问，该委员会将每年举行两次会议，讨论计划和审查结果。 研究结果将通过若干机制更广泛地传播，包括: • 提交学术论文，在国家、地区和国际高影响力的同行评议期刊上发表。 • 为国际政策制定者制作政策简报。 • 在卫生研究和政策制定界参加的相关区域和国际会议上呈现论文。 • 向欧盟提交最终研究报告。 • 通过项目网站以网络方式传播项目研究结果，并将项目研究结果提交给 ID21 等研 究传播网站。 • 向社区成员、学术界、地区和区域卫生小组以及其他利益相关方介绍情况。 写作坊 在晚上，为你们团队的项目制定以下内容： • 监测和评估计划 • 能力建设计划 • 传播计划 • 做出必要的更改，以改进、更新或调整你的计划书的所有部分 99 第五节课：附件 在这节课中，你将扩展你的计划书的几个最后部分。具体来说，包括项目概要、目录、 附录和你的研究人员简历等信息。 你将有一个晚间写作准备这些方面，并审查所有以前的组成部分，更新和调整你的整个 计划书。最后，你将准备一个 20 分钟的演示，并展示和接收你的实施研究计划书的反馈。 在课程结束时，参与者将能够： • 制定一份计划书摘要。 • 制定一个目录。 • 确定哪些附录需要包括在内。 • 为你的简历制作一个模板。 • 准备一个 20 分钟的报告，总结你的实施研究计划书。 项目概要 实施研究项目概要（有时称为摘要或执行摘要）简要地描述整个计划书。研究人员通常 在他们最能简明地描述他们的研究计划的时候，把他们的概要或摘要写在最后。概要应包括 对所调查问题的描述、为何需要或重要进行研究的理由（位于文献中）、参与者、方法、要 开展的研究活动以及开展研究的预期结果或启示。根据资助机构的要求，你的概要/摘要可 以限制在 150-200 字（摘要）到一页（概要）之间。就像研究报告或期刊文章一样，你的计 划书概要或摘要可能是你的计划书中最重要的一段/一页，因为它将是大多数审阅者在审阅 你的计划书时首先接触到的东西。概要将给审阅者留下“第一印象”，并可能影响审阅者是 否选择资助你的计划书。 案例：实施研究项目概要 计划书标题：为弱势群体提供卫生保健—在中国和越南发展公平和可持续农村医疗保险。 计划书缩写：RHINCAV 总目标：该项目的目标是为发展中国家贫困农村地区的人民减少贫困和改善健康做出贡 献。该项目的总体目标是通过向卫生政策制定者提供证据，在中国和越南建立有效、可持续 和负担得起的农村卫生保健融资系统，促进卫生公平。 具体目标 1. 对农村医疗保险的需求以及现有计划的优缺点进行现状分析。 100 2. 制定和实施可行的试点农村医疗保险计划，满足其目标人口的预期需求。 3. 从公平覆盖范围、使用者满意程度、有效利用和提供服务、减少贫穷和可持续发展 的角度，监测和评估新计划的效果。 4. 通过有效传播研究结果，支持设计和实施可持续的、注重公平的农村医疗保险计划。 摘要 越来越多的发展中国家正在制定健康保险计划，以保护人民，特别是穷人，免受昂贵的 医疗保健造成的财政灾难。其中包括中国和越南，它们在过去二十年中经历了快速的经济发 展和剧烈的社会变化。所有这些变化对人们生活的各个方面都产生了深刻的影响。这两个国 家的卫生保健筹资改革导致卫生设施越来越依赖用户收费，这导致在获得卫生保健方面，特 别是对农村穷人而言，出现了更大的财政困难。 尽管两国中央政府多年来一直在推动农村医疗保险的发展，但由于政治、社会经济和管 理等诸多因素，农村医疗保险的人口覆盖率一直不尽如人意。拟开展的研究将通过为设计和 实施可持续和可接受的农村医疗保险计划建立和传播证据基础，促进这两个国家的公平医疗 保健筹资机制。该研究项目将采用个案研究方法，选择一些已经存在农村医疗保险计划的研 究县和区，实施可行的、满足其目标人口预期需求的修订计划。它将从公平覆盖、用户满意、 有效使用和提供服务、减少贫穷和可持续性等方面监测和评价这些计划的效果。预计项目的 最终成果（良好实践和经验教训）将向广泛的受众传播，并用于为中国、越南和其他发展中 国家的有关农村医疗保险政策提供信息。 项目概要清单 该概要应该对在相同或相关领域工作的人提供信息。一个好的概要可以使评审人员很容 易根据评审标准理解和评估你拟开展的项目。虽然研究计划的标准会因资助机构的不同而有 所不同，但概要通常会包括以下每一项的简要描述： • 问题（你想解决什么问题？） • 令人信服的理由，为什么这个问题是重要的（即拟申请的研究将如何促进知识，改 善卫生保健实践等）。 • 研究将在哪里进行，与谁（场所和参与者）一起进行。 • 如何收集和分析数据。 • 拟开展研究的创新性程度。 101 • 进行研究的预期结果或影响。 • 研究结果将如何传播。 • 影响（改变政策、改善保健做法等，世界卫生组织将从中受益）。 目录 目录通过概述计划书中的内容以及每一项内容可以在哪里找到来组织计划书。它以‘一 目了然’的逻辑顺序呈现了一个主题和章节的简便列表。 文字处理软件，如 Microsoft Word 和 open office，能够自动生成目录。你可以使用适当 的标题样式（例如标题 1、标题 2、标题 3）标记标题，并使用“插入”>“目录”功能。 附录 附录包括那些对读者来说是次要兴趣的项目方面。读者应该能够从计划书的主体中获得 所有必要的信息，如果他们需要或想要额外的信息，可以去看附录。附录可能包括研究小组 成员的简历、研究工具或推荐信等内容。这也是放置你希望审阅人员能够访问但由于长度限 制禁止在计划书正文中提及的附加信息的地方。 调查人员的简历 调查人员的履历对审查员对你的计划书的评估有影响。你可能希望确保团队中至少有一 名成员具有实施研究经验，有良好的履历记录和较强的发表记录。社区公信力等辅助能力同 样重要。通常机构限制调查人员的简短简历为 1-3 页。因此，调查人员需要缩短简历，突出 他们的职业/学术生活中与项目最相关的方面，并与资助机构的范围保持一致。模板可以帮 助调查人员缩短简历并保持简历的统一。 写作坊 在晚上，为你们团队的项目制定以下内容： • 项目概要（一页）。 • 标题页。 • 附录（列出所有的附录，并添加那些已经准备好的）。 • 研究人员简历（创建一个简历模板，以便所有的研究人员都有相似的外观和格式）。 • 检查你的计划书的所有组成部分，并更新和调整。 102 小组活动：展示计划书 准备一个 20 分钟的报告（幻灯片或海报），你的实施研究 计划书包括以下方面： • 标题 • 理论依据 • 问题陈述 • 研究问题 • 研究设计 • 研究方法 • 数据收集 • 数据分析 • 质量管理 • 研究对象 • 伦理道德 • 项目计划 • 研究团队 • 预算和测算理由 • 监控和评估计划 • 能力建设计划 • 传播计划 小组汇报 各小组将在 20 分钟内展示你们的计划书。随后，导师 和大组成员会提出讨论、问题、建议和意见（20 分钟）。各 小组将在全体会议上对其计划书作 20 分钟的汇报展示。 103 参考文献 1. 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The Lancet, 364(9437), 900-906. 104 3 单元 计划开展实施研究项目 105 单元 3 计划开展实施研究项目 一、简介 本单元将介绍实施研究项目在资金/资源到位后采取的步骤，以及如何计划和开展一个 研究项目，其中包括了准备用于伦理审查的研究简介。本单元通过示例来介绍以下关键概念： • 准备和申请伦理审查 • 规划项目实施 • 借鉴良好的实施研究原则和做法，并用于实际工作当中 二、学习目标 本单元提供了有关研究执行的基本步骤的信息，包括：申请伦理审查，规划项目实施， 为实施研究制定良好的原则并付诸实践。这些流程将以具体的实施研究项目范例进行展示。 在本单元结束时，参与者将能够： • 描述有助于研究计划方案顺利通过伦理审查所需的伦理要求和流程 • 在一个项目周期中描述相关伦理流程 • 系统性地描述实施一项研究项目的步骤 • 重视良好实践在所研究项目的整个周期中的价值 三、关键概念 1 寻求伦理许可 实施研究在伦理方面提供了独一无二的观点，因为在大多数情况下，实施研究涉及了多 种观点并且与卫生服务对接。就其本身而言，参与实施研究的成员可能会觉得常规的医疗流 程和研究中所设计的流程难以区分，如果区分两者的界线变得模糊，成员可能难以识别与研 究相关的潜在风险，尤其是参与式研究。 研究资助机构要求在发放项目资金之前，相应的伦理审查委员会需批准研究计划。根据 具体情况，可能不止有一个这样的委员会要求研究小组配合完成伦理审查工作。例如，项目 可能需要得到某个机构或国家的伦理审查委员会的伦理批准；如果是合作项目，则可能需要 多个研究或卫生机构的批准。这些伦理委员会将会对研究方案进行审核，并要求提供有关于 研究计划和步骤的完整细节。除此之外，委员会特别注意研究小组是如何获取潜在的研究对 象的同意的，并仔细审查所有知情同意书。关于研究中所有的更改，例如添加新目标，扩展 研究范围，添加或移除准入或者排除标准，这些更改都需要伦理委员会的额外批准。另一方 面，从项目初始的计划部分就考虑研究的伦理部分是十分重要的。但是，考虑到实施研究是 106 在现实环境中进行的，因此有时候可能会出现某些不可预见的情况，这些情况在进行伦理审 查之前都未被团队考虑。 提交用于伦理审查的研究方案 伦理审查程对于确保研究项目对研究对象的尊严、权利、安全和健康/福祉至关重要。 因此，在开始一项研究之前，需要有该研究方案的书面批准，知情同意书（最好采用当地语 言）和明确的招募程序。项目负责人有责任去遵循由赞助者和监管部门批准的（如适用）以 及科学委员会和伦理委员会批准的研究方案。 表 1 概括了需要提交给研究伦理委员会的一般性文件。不同委员会对此类文件的要求不 同，因此我们有必要了解清楚我们所申请的伦理委员会的具体文件与方案要求。 表 1. 提交给机构审查委员会和/或伦理审查委员会的文件。 申请信：简要描述了研究计划和所涉及的道德因素，如果有的话。 完整的研究计划，其中包括了必要性原则、研究问题、文献综述、方法学、数据 收集工具、研究流程以及期望结果。 分析潜在风险和利益，包括隐私保护和保密性。 详细的项目研究对象准入流程和目标人群介绍。 知情同意书，为照顾少数人，知情同意书将使用当地的语言。 将研究结果传达给研究对象和社区的过程。 • 履行研究结束后义务的计划，例如： • 卫生服务和机构的改善； • 向研究对象提供新型成熟的干预措施； • 长期监管； • 加强当地的专业研究知识。 项目负责人和团队成员的简历 研究结果的传播建议 项目实施期间应考虑的道德因素 在实施研究过程中以及研究完成后，应遵守自主原则、风险效益原则和公平原则（详见 单元 1）。在这一部分，将讨论有关于知情同意、隐私、保密的问题。 获得知情同意 知情同意被认为是涉及到人的研究中的一项基本伦理要求（1）。知情同意确保个人可以 根据自身兴趣、价值观和偏好来决定是否参与到该项目中。知情同意不仅仅是一个合同中的 义务，其更应被理解为贯穿于研究对象参与项目的全部过程（从研究对象被招入至研究项目 中开始到项目结束）。该过程的建立需要四个基本要素：1）准确且合适的信息。2）理解该 107 研究的目的和步骤。3）研究对象接受程度。4）自愿参与。 为了确保研究对象的同意有效，团队应使用研究对象的当地语言来解释完整信息。而且 应使用当地常用的或者是简化的表述（相较于科学用于和专业术语）。知情同意书还应包括 有关研究和研究步骤的知情告知信息以及同意签字页（表 2）。 表 2. 知情同意书中的要素 第一部分：知情告知页 研究者和其所处机构的介绍 研究目的 研究干预类型 研究对象选择 自愿参与 步骤（访谈，焦点小组讨论，访谈将在哪里进行，研究对象隐私和保密问题）。 各项步骤/访谈的持续时间，干预的时间（包括随访）。 可预见的风险 不同层级的利益（个人、社区或者全社会） 报销（如有必要） 保密（注意：焦点小组讨论会对保密产生极大的挑战，因为一旦有人在小组里说了些什么，这 将变成众所周知的内容）。 结果分享（用于分享研究结果的流程）。 拒绝或撤销的权利。 联系人（比如：当需要获取其他信息时，可以联系的人）。 第二部分：同意签字页 本部分必须以第一人称写成。 应该包含研究对象关于该研究的一些简短陈述，该陈述显示研究对象已阅读了相关信息，他们 已理解这项研究的内容并同意自愿参与该研究项目。 如果研究对象阅读能力较差，但提供口头同意，则必须有公证人签字。 研究人员在检查知情同意书的时候必须在每一份知情同意书上签字。 隐私、保密、匿名 保护研究对象的匿名权和保密权是研究伦理中的另外一个客观存在的部分。在某些情况 下，个人信息的暴露可能会让研究对象受到被歧视和受人偏见的风险。保护研究对象的隐私 权和保密权是研究者的义务（2）。保护研究对象的匿名权和保密权涉及到：在数据收集、存 储、分析和发布过程中遵循伦理程序。在数据收集过程中，我们应尽可能给予研究对象的隐 私足够多的保护，以确保他们所提供的信息不会被其他人分享。除非被调查者允许，任何时 108 候被调查者的身份都不应暴露给第三方，包括在数据收集、存储、分析和发布过程中。被调 查者的身份可通过“计划匿名标识符”而得到保护，这些标识符和他们的身份没有联系。 在项目实施过程中寻求伦理许可 当伦理审查委员会签发批准证书时，它将会通知项目负责人有关于常规伦理审查的事项， 详见以下部分。在大多数研究设计中，都严格遵循原始研究方案。但在实施研究中，研究团 队持续对其干预行为进行监控和审查，以确保与项目计划和实施有关的结果是有意义的并且 符合实际。在此过程中意想不到的结果可能会出现，并导致原始研究计划的改变（这些改变 是符合该项目和/或研究对象的最大利益的）在这些情况下，我们可能会对用于伦理审查的 原始研究方案进行一些修改。实施研究团队在做任何有关于原始研究计划或步骤的主要改变 之前，必须通知伦理审查委员会。例如，在提交研究计划书至伦理委员会之后，研究团队中 的护士长会每天为患者打针，但是计划中的注射流程会由于不可预测的因素而变得低效。研 究团队必须告知伦理审查委员会任何一个研究步骤上的改变，即便是因为未知的问题而导致 的。这可以在项目的定期伦理审查期间完成。 为了确保（团队）严格遵循了研究步骤，评估是否存在方案偏差，或者在研究过程中跟 进医疗介入措施，大部分伦理审查委员会都可能要求定期的伦理审查。委员会根据具体情况 提出跟进和审查业务和数据的频率和步骤。 在特殊情况下，由于研究设计发生了重大变化或原始批准的标书信息发生更改，可能需 要临时伦理审查。 最终的伦理审查是一个过程，项目负责人要向伦理审查委员会报告关于自上一次审批通 过以来的项目进展情况、研究结果总结和将来的传播计划。 思考活动 一个人类学家曾对“中途之家”（又称重返社会训练所，是为出狱者、 出院病人等提供社会适应服务的场所）里患有布鲁里溃疡患者进行人种学 研究。根据该研究设计，医护人员每天都要到“中途之家”为患者打针。 但由于最近的卫生机构到“中途之家”的距离过远，医护人员无法做到每 日执勤。那么，医护人员应否对其他研究人员进行培训，让他们代为进行 每日注射？ 109 2 项目实施进程 项目实施工作涉及设立和监测既定活动的过程，并且根据具体情况更新和修订研究计划。 这些活动包括：组建研究团队，申请后勤需要以及分配活动和任务。此外，研究地点、项目 活动时间表和数据收集步骤必须确定。这一部分还包括项目的结束和评估以及项目流程和结 果的报告和发表。在以下部分中，将描述项目实施工作的启动和质量数据的确认的过程。项 目监测是与任何实施研究的实施过程交织在一起的。 开始实施工作 当项目工作计划完成，并得到有关方和相关管理小组的批准和同意之后，项目的实施工 作就可以开始了。将整个研究团队（包括利益相关者、合作伙伴和一线工作人员）纳入项目 的启动是非常有帮助的。团队成员需检查项目的宏观目标、微观目标、指标和工作计划。他 们还需要解决潜在问题并建立沟通机制，以确保实施过程中的团队合作。团队负责人必须确 保工作按时开始，并在批准的预算范围内遵循已商定的绩效标准 3 实施研究的良好实践 实施研究必须生成可靠的数据。良好的研究做法可以通过减少由于不确定因素而导致非 决定性结果的风险来获得可靠的数据。当干预措施低效或者实操流程（步骤）不清晰，不确 定性即会产生。 过程记录 实施研究是一个动态的过程，在执行过程中往往需要进行调整，具备灵活性和自由度。 需要记录、协调和监控对于研究过程中的这些改变/调整，以确保可靠性和保真度。 下列问题应作为记录文件的主体： • 正在发生什么？ • 为什么会以这样的方式发生？ • 是我们所预期的吗？ 在过程记录时保持客观是很重要的，要报告对正面经历和负面经历。这将有助于学习这 些记录和佐证支撑以往的传闻性报告。 记录在研究中出现的并对研究产生影响的各种进程、调整、修订和经验，这不仅确保项 目规划者和政策制定者接收到研究结果，还能让他们了解获得这些结果的过程。 实施者培训 计划并非总是如实施研究项目所想的一样进行着。随着实施流程的进行和更多信息的获 取，可能需要调整。应该定期检查既定的步骤（例如：采样和数据工具），以将实际发生的 情况与原始计划内容进行比较，以至于在必要的时候，可以进行任何调整。员工培训是该过 程的关键部分，这是为了确保这些步骤能被理解并遵守。所有必要步骤的培训都必须标准化 110 并且覆盖到所有关键成员。为确保持续的学习过程，培训后应进行指导和/或监督活动。 研究人员需要使用规定的材料和最新版本的数据收集工具和仪器，确保在培训期间遵守 既定步骤。在实施研究中，可能会出现不良事件或者在干预后出现意外后果。不良事件会对 干预措施的采用和持续性产生负面影响，尤其是当这些事件发生在实施的初期。对于变革的 抗拒，惰性和对现状的投入——再加上固有的困难和复杂的新任务——这些都可能会影响到 新措施的采用。 预测试 各类研究通常会进行预测试以检查数据收集工具的信效度。预测试能够让研究团队知道 研究操作和问题条目是否清晰，以及是否有足够的时间管理调查问卷等。由于数据管理是一 项研究成功的关键，数据管理团队应该参与到预测试之后的讨论当中，修订最终版并对数据 输入系统进行适当的检查。这一阶段包括设计记录测量资料的表格以及建立用于数据输入、 数据管理和数据分析的程序；除此之外，还有虚拟表格的设计，以确保能收集到合适的变量。 笔记 应检验所有研究工具（定量和定性）。 数据管理 对于任何研究来说，对准确记录且可检索到的结果的收集和存储/记录都是必不可少的。 好的数据收集实践能确保数据可以追溯到其源头（即在观察过程中第一手记录的原始数据） 为确保这些特性，原始数据的记录必须有以下特点： • 及时性：完成具体任务之后，没有及时记录数据会降低数据质量，因为记忆可能会有 错乱或者不准确。 • 准确性：数据记录不准确会降低所收集数据的信度，因此这是研究完整性的关键部分。 • 数据清晰明了：手写数据应书写清晰，电子记录应容易被译解。 • 能被永久保存：手写原始数据应使用永久型墨水书写。对原始数据的任何更改都不能 掩盖先前输入的条目。日期，更改理由和更改负责人签名都应该添加。 清晰且定期检查的数据流可防止数据丢失。当实施研究从各种来源（例如：人类受试者、 病历、卫生机构和实验室登记簿，监测系统和行政系统的数据）收集不同类型的数据（即患 者，组织和与监视相关的数据），应制作详细的记载关键路径的图表，其用于数据收集过程 中，包括处理调查问卷、编码、数据输入、数据确认以及清理和储存数据备份和打印件。 数据的存储或归档意味着这些所记录的数据能够被合理储存，以防未来不时之需。世界卫生 组织的药品临床实验管理规范建议：数据和基本文件应在研究项目结束后至少保留两年。数 据应保存在安全的存储区域或者上锁的机柜中。 111 四、关键概念的应用 案例项目：南非夸祖鲁-纳塔尔省“Mothers2Mothers”项目评估的主要发现（4） 背景：Mothers2Mothers（M2M）是一个同伴支持计划，其旨在为 HIV 阳性孕妇和新妈 妈提供教育和社会心理支持，帮助妇女获得现有医疗保健服务以防止艾滋病母婴传播 （PMTCT），并跟进母亲和婴儿以确保在分娩后两者能得到合适的医疗保健服务。 尽管人们对于作为 PMTCT 临床服务的补充的创新性的心理社会支持项目非常感兴趣， 但目前只有少数项目现存，并且其有效性的数据也很少。虽然 M2M 是一项著名的项目，亦 有一些关于其成功支持了 HIV 阳性妇女的报导，但尚未进行外部评估。人口理事会的“地 平线计划”与卫生系统信托基金合作，完成了对 M2M 的首次评估，并将其引入南非夸祖鲁 -纳塔尔省。 研究设计和方法 研究人员使用了前-后测、准实验性的研究设计来评估项目的有效性。在夸祖鲁-纳塔尔 省的彼得马里茨堡地区有三个评估点。这些评估点吸引了来自城市和郊区的妇女。这项研究 的纳入排除标准包括：18-49 岁、知道自己的艾滋病毒感染状况、目前状态：怀孕 6-9 月或 者产后不超过 12 个月。进行了两次横断面调查。在 M2M 被引进之前，在 2005 年的基线数 据收集的过程中，研究人员使用结构化调查问卷对 183 名 HIV 阳性的孕妇和 178 名 HIV 阳 性的产后妇女进行访谈。在 2006 年随访数据收集的过程中，有 345 名 HIV 阳性的孕妇和 350HIV 阳性的孕后妇女接受了研究人员的访谈，且使用了与 2005 年第一次访谈相同的调查 问卷，但增加了有关项目暴露和相互作用的问题。 关键概念 1：寻求伦理许可 • 评估方案已获得人口理事会的机构审查委员会（IRB）、美国国际开发署和南非斯泰 伦博斯大学的批准。“地平线”计划在美国获得了伦理许可，而卫生系统信托基金获得了国 内许可。 • 问卷被翻译为祖鲁语，然后再翻译成英语。 • 研究采访者接受了有关遵守伦理准则（包括保密）的重要性的培训。 • 获得了所有接受访谈的妇女的书面知情同意。 • 参与者有 40 南非兰特（约合 6 美元）的补偿，用于补助其费用，例如交通、育儿 以及与其参与研究相关的其他费用。 • 访谈是在诊所的私人场地进行。 • 所有采访者都是女性，因为从文化层面来看，只有在卫生机构中工作的女性来担任 面试者是合适的。 • 除了签署知情同意书以外，不要求参与者提供姓名。 • 这些表格存储在一个上锁的办公室，与电子格式的数据分开存放。 112 关键概念 2：项目实施进程 该计划的执行期为 2005-2006 年，M2M 项目活动包括： • 现场协调员和导师母亲在预约产前诊所和/或孕妇和儿童健康服务的当天对妈妈进 行指导。 • 由导师母亲和现场协调员组成日常辅导和支持小组。 • 导师母亲日常去分娩病房探视，与准妈妈或临产的母亲交谈。 • 诊所内的定期支持小组会议，并为参与现场的妇女提供营养午餐。 • 导师母亲和现场协调员进行社区外展活动。 • 经前-后测、准实验的研究设计，这样做可对项目的有效性进行评估。 项目实施中的变化 由于获得研究现场活动所需的必要批准在时间上略有延迟，以及出于项目活动的启动工 作需要，基线数据收集与干预措施可能会同时进行。 关键概念 3：实施研究的良好实践 方案开发 评估方案和工具由“地平线”计划和卫生系统信托基金的项目负责人共同制定，并由 M2M 计划的员工进行进一步的审查。 项目实施期间 1. M2M项目雇用了经验丰富的医疗专家作为项目管理人员，以单独的卫生保健措施为 基础，去监督当地项目。 2. 导师母亲参与了为期两个星期的训练，使用标准课程，该课程涵盖了有关 HIV感染 和抗逆转录病毒疗法（ART）的基本医学知识，以及防止母婴传播。 3. 为确保持续的学习过程，现场协调员（已经参加过该计划的一名导师母亲）监督了 导师母亲提供的护理服务。 数据收集和数据管理中的良好实践 1. “地平线计划”和卫生系统信托基金中的成员共同对采访者进行培训。 2. 卫生系统信托基金招募了有工作经验的大学毕业生作为采访者。 3. 在每轮数据收集之前，采访者完成了两周的培训。 4. 对问卷进行了预测试，以确保被研究人员能够理解问题，并确保问卷使用了符合文 化习惯的短语。 5. 在 Dell Azim x51 掌上电脑运行 Perseus Mobile Survey软件，以电子方式记录参 与者的回答（该程序使所有问卷的“跳过”模式和范围检查在访谈期间自动执行）。 6. 日常期间，在访谈结束后，数据管理元将数据上传到笔记本电脑，然后将数据转换 为 SPSS软件，以进行质量控制、管理、分析和存储。 7. 每天备份文件加密后发送电子邮件给研究团队，该团队是唯一可以访问数据的小组。 113 五、结论 恭喜您完成了单元 3：计划开展实施研究项目。这一单元提供了有关计划如何进行研究 的各个步骤的信息，包括：申请伦理审查、项目实施规划和采取良好的实施研究原则和做法。 我们通过真实的实施研究项目作为例子去展示这些过程。 六、参考文献 1. Neff, Margaret J. “Informed consent: what is it? Who can give it? How do we improve it?.” Respiratory care 53, no. 10 (2008): 1337-1341. 2. Giordano, James, Michelle O’Reilly, Helen Taylor, and Nisha Dogra. “Confidentiality and autonomy: The challenge (s) of offering research participants a choice of disclosing their identity.” Qualitative Health Research 17, no. 2 (2007): 264-275 3. WHO/TDR. “Handbook: Good laboratory practice.” United Nations Development Programme (UNDP)/World Bank/World Health Organization. Special Programme for Research and Training in Tropical Diseases, Geneva, Switzerland: (2001). http://www.who.int/tdr/publications/quality_ practice/en/index.html Accessed 11 February 2014. 4. Baek, Carolyn, Vuyiswa Mathambo, Sibongile Mkhize, Irwin Friedman, Louis Apicella, and Naomi Rutenberg. “Key findings from an evaluation of the mothers2mothers program in KwaZulu-Natal, South Africa,” Horizons Final Report. Washington, DC: Population Council. (2007) 七、补充阅读 • Kass, Nancy E., Ruth R. Faden, STEVEN N. GooDMAN, P. E. T. E. R. PRoNoVoST, S. E.N. TuNiS, and ToM L. BEAuCHAMP. “The Research Treatment Distinction: A Problematic Approach for Determining Which Activities Should Have Ethical Oversight.” Hastings Center Report 43, no. s1 (2013): S4-S15. • Faden, Ruth R., Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp. “An ethics framework for a learning health care system: a departure from traditional research ethics and clinical ethics.” Hastings Center Report 43, no. s1 (2013): S16-S27. 114 4 数据、分析和展示 单元 115 单元 4 数据、分析和展示 一、简介 本单元旨在概述实施研究的数据分析和解释的基本原理（这是实施研究循环中的第四 步）。本单元还描述了针对目标受众而设计的数据分析、呈现和解释，以期更好地吸收理解 并利用研究结果。完成本单元后，您将能够： • 在定性和定量数据层面，展示合适的数据分析规划过程。 • 理解适用于定量研究的数据分析方法。 • 在定性研究中描述数据分析的过程。 本单元分为两个主要部分：第一部分侧重于定量数据管理、分析和展示，第二部分侧重 于定性数据管理、分析和展示。 在课程开始之前...... 我们假定你已经熟悉定性和定量两种数据收集方法和工具（来自单元 2）。简要提醒一 下，导师会要求你描述一下两者的主要区别（表 1）。 表 1. 定量和定性方法的比较 二、关键概念 1 数据分析计划 大多数实施研究的计划书使用混合方法，将定性和定量方法结合在一起。在适当的情况 下，混合的方法比单独使用其中一种方法能更好地理解问题。 为了确保系统地进行分析，应首先制作一份数据分析计划。该计划包含对研究问题的描 述以及该过程中将要执行的各个步骤。 定性方法 定量方法 社会理论 注重行动 注重结构 方法 观察，访谈 实验，调查 问题 X是什么？如何发生？为何发生？（分类） 有多少个 X？（计算） 论证方法 归纳法 演绎法 采样方法 理论性的 统计性的 优势 效度 信度 116 根据实际使用设计数据分析 对在实施研究项目中使用的数据分析进行设计是基于一系列实施研究的目标：①了解实 施过程，重点关注那些支持或约束这些过程的机制。②将对实施过程的理解传达给各个利益 相关者，他们随后可能会对今后研究发现的整合产生影响。 在实施研究团队中，只有很少的利益相关者有可能掌握了关于定性和定量研究方法的知 识。因此，应仔细考虑数据分析工作（最重要的是研究发现的呈现），以避免可能导致错误 结论和/或错误响应的潜在误解。 重点应放在简单性和可解释性上，因为利益相关者不仅需要理解所提供的信息，而且还 必须能够正确地对其进行解释（1）。数据分析应与数据收集过程一起进行。这种持续的数据 分析过程有助于定期的调查结果的共享和讨论。 定量分析应侧重于简单的汇总统计，例如： • 计数，平均数，中位数，极差，百分位数 • 率，趋势，比率和（对于某些利益相关者的）风险 • 频率分布，占比和百分比 按目的设计数据分析 在设计数据分析计划的时候，一个重要的初步考虑因素是通过确定要解决的具体问题来 明确定义数据分析的主要目标。需谨记：实施研究中的数据并不仅用于简单地描述干预措施， 还要用于改善干预措施。 例如，实施研究可能专注于： • 效果：旨在修改实施步骤，以改善收益的产生 • 效率：尝试评估实施过程中可能发生的修改的含意，以提高与资源相关的收益 • 公平：关注分配问题，即收益和资源成本的分配方式 • 可持续性：着重于确定必要的投入，对这些投入的可用性的限制和其他可能限制中 长期可持续发展的因素 2 定量数据分析 在实施研究中，定量数据分析将包括以下一项或多项注意事项： • 频率分布和汇总统计 • 关系和混杂变量 117 • 亚组分析 • 统计模型 • 从样本概括到总体 • 趋势分析 定量分析中的变量通常按其衡量尺度分类，如下所示。 • 连续型数值变量-例如孩子的体重，疫苗接种数量 • 离散型数值变量（基于预定的相等间隔）-例如，温度，一些伤残测量 • 有序分类变量（排名）-例如，设施水平，生活质量指标 • 名义变量（类别）-例如，地区名称 分布和汇总方法 定量研究会产生大量需要整理和汇总的数据。这些操作有助于更好地了解数据如何变化 或者相互关联。数据揭示了在一个研究总体中所研究变量值的分布。例如： • 特定人群内，不同家庭中 5 岁以下儿童的数量 • 卫生机构每日门诊人数 • 在一段时间内，某医疗机构新生儿的出生体重 • 某医疗机构新生儿的母亲的教育水平 对上述数据类型的分析主要涉及到通过使用数据分析方法来概括这些分布和评估他们 与其他变量的关联程度。例如，在新生儿样本中，我们可以在一些标准的范围内将新生儿体 重水平分为低、正常和高，然后我们可通过计算这三个水平的频率来概括新生儿体重的分布。 如果我们还计算了那些新生儿母亲的不同教育水平的频率，我们就可以对这两个变量之间可 能存在的关联的程度进行评估。基于此目的而使用的频率分布有几个优点： • 适用于所有类型的数据。 • 即使是对于没有专业知识背景的听众来说，频率分布也很容易被解释和理解。 • 可以通过图表和其他不同的格式来呈现数据，以帮助解释（例如表格，条形图，饼 图，其他图形等）。 确定频率分布的间距 构建频率分布的一个关键决策与间距的选择有关。例如： • 定序变量：卫生机构水平（例如：一级、二级、三级） 118 • 定距变量：体温（例如：低于正常、正常、高于正常) • 连续变量：身体质量指数（例如，<25, 25-29, 30+） 确定要多少个间距的时候，有两个相互矛盾的目标： • 通过使用相对大量的间距来限制信息丢失 • 通过使用相对少量的间距来提供一个简单，可解释的和有用的摘要 基于不等间隔的分布应谨慎使用，因为这些分布很容易被错误理解，尤其是当以图形方 式来呈现分布的时候。 数据呈现格式 数据报告应该以文本和视图的格式来呈现（比如流程图，地图，条形图，表格等）。以 视图的格式来组织和展现数据对趋势和预报的识别是有帮助的。下面的实例以多种格式显示 相同的数据（例如频率表，占比/百分比表，条形图，饼图等）。 表 2：以频率表表示的提供者教育水平（示例） 私人提供者的教育水平 频数 未受过教育 106 具备基本素养 74 小学毕业 57 中学毕业 11 高等教育 2 合计 250 图 1：以条形图表示的提供者教育水平 （示例） 119 表 3：以比例、百分比和累计百分比表示的提供者教育水平（示例） 图 2：以饼图表示的提供者教育水平（示例） 表 4：两个或多个变量的联合频数分布（示例） 最高（教育）水平 男性 女性 总计 未受过教育 42 64 106 具备基本素养 45 29 74 小学毕业 32 25 57 中学毕业 8 3 11 高等教育 1 1 2 合计 128 122 250 表 5：行百分比（示例） 教育水平 占比 百分比 累计百分比 未受过教育 0.424 42.4 42.4 具备基本素养 0.296 29.6 72.0 小学毕业 0.228 22.8 94.8 中学毕业 0.044 4.4 99.2 高等教育 0.008 0.8 100.0 总计 1.000 100.0 120 最高（教育）水平 男性 女性 总计 未受过教育 39.6 60.4 100.00 具备基本素养 60.8 39.2 100.00 小学毕业 56.1 43.9 100.00 中学毕业 72.7 27.3 100.00 高等教育 50.0 50.0 100.00 合计 51.2 48.8 100.00 表 6：列百分比（示例） 最高（教育）水平 男性 女性 总计 未受过教育 32.8 52.5 42.4 具备基本素养 35.2 23.8 29.6 小学毕业 25.0 20.5 22.8 中学毕业 6.3 2.5 4.4 高等教育 0.8 0.8 0.8 合计 100.00 100.00 100.00 图 3：两个变量的条形图（示例） 121 统计摘要和频率分布 仔细检查变量的频率分布是至关重要的一步，这会是一种极其强大且稳健的分析形式。 这可能会带来一种趋势：出于找到该分布的根本特征（但常常失败）的原因，团队可能会过 早地进入到更加简单的统计摘要的计算工作中。 统计摘要通常着重于获得能够显示出一个分布（例如，所调查人群的平均患病程度，贫 困程度或者受教育的程度）总体位置的方法，或者显示出总体的变异程度。但是，选择概要 统计量的原因应与预期目标有关。 平均值或中位数的使用 平均值（或平均数）是最常用的汇总性位置测量方法。但是，由于均值易于计算和操作， 团队经常会不恰当地将其用作集中程度的标准方法。例如，结合子人群的均值去计算总体人 群的均值是非常直接的。均值也经常被误解为一个总体中的典型值。例如，某一个中等收入 国家的 GDP 计算为 3200 美元。将此解释为该国“普通”人的收入并不能反映现实（实际上， 这一数字接近 1200 美元）。当基础分布偏移时，平均值通常不具有代表性。 中位数，定义为位于数据中间的值，相对容易解释。其他值的大小无关紧要。例如，如 果给定范围内的最大值增加或最小值减小，中位数保持不变。 当数据集为非偏态分布时（或为正态分布时），均值和中位数将相同（图 4）。 方框 1 案例：统计摘要和频率分布 为了弄清最近实施的干预措施是否可以减少某村庄五岁以下儿童的营养不良问题，研究人员可 能会问：“哪个汇总统计量最合适？” • 村庄中所有五岁儿童每日平均卡路里摄入量平均值或中位数的变化？ • 村庄中所有五岁儿童中低于预先确定的最低卡路里摄入需求的比例？ 做出此类选择的标准包括： 1. 表面效度（即：统计量是否与特定关注点相关？）。 2. 利益相关者是否了解数据的来源。 3. 利益相关者是否能够按预期解释结果。 122 图 4：正态分布：均值处于测量的中间位置 图 5：偏态分布 偏态分布中，均值更加难以解释整个数据。 风险测量 尽管风险测量在健康研究中被广泛使用，但它们并不总是被很好地理解。例如，风险和 几率经常互换使用，但是两者并不指同一件事。 • 风险（P）：经历某事件的数量或暴露于该事件的人群。 • 相对风险（PA/PB)：A 组的风险与 B 组的相比。 • 比值：发生该事件的数量与未发生该事件的数量之比 = P/(1-P) • 比值比：[PA/(1- PA)]/[PB/(1-PB)] 123 此外，降低风险并不等于降低几率： • PB（干预前的疟疾发病率) = 0.5 • PA（干预后的疟疾发病率) = 0.1 • 风险降低程度 = 0.1/0.5 = 0.2 • 比值降低程度 = (0.1/0.9) / (0.5×0.5) = 0.11 “分母问题” 在计算风险时，重要的是要知道处于风险中的人口的总体规模。在实施研究中，计算或 得到这些概要统计量的可靠估值通常是很难的。，因为分母未知，且可信度低。例如，我们 只能估算某一地区应接种疫苗或应在蚊帐下睡觉的儿童数量。同样地，一个机构设施所覆盖 人口或某一段时间内的实际出生人口通常也是未知的。出于这些原因，分母通常作为基于预 测的人口，因此在某些情况下报告的覆盖率超过 100%。 由于存在这种不确定性，那么较好的做法是同时提供分子和分母在任意比例中的估计值、 百分比或风险的估计值，并给出计算中使用的来源。 变异程度的测量 一个总体中发生了多大程度的变异？ • 变异程度低：位置的测量可以合理地代表总体；通过聚合，信息的丢失程度会减小 • 变异程度高：位置测量的代表性没有多大用处；存在因汇总而丢失信息的巨大风险， 除非团队对该分布的性质有充分的了解 测量方法的选择 方差，标准差和变异系数在数据分析中被广泛使用。就像平均值一样，这并不是因为它 们始终是测量变异程度的最佳方法（在正态分布中，它们可以很容易就被解释清楚，但其他 分布就不行），而主要是因为它们可以易于计算和操作。 例如，给定两个总体亚组的方差，那么结合这两个方差去计算总体人群的方差是非常容 易的。但是，尽管它们有技术上的优点，这些测量方法在政策应用上存在严重的限制性。 124 其他测量方法 更容易被理解的测量方法包括四分位数和百分位数。 四分位数：将数据分成四个部分（Q1 到 Q4）-每一个占 25%。 1. Q2 是中位数。 2. Q1 是低于中位数的数据点的中位数。 3. Q3 是高于中位数的数据点的中位数。 4. Q3-Q1 是四分位数之间的范围，占总体的中间 50%。 百分位数将数据分为两部分： • 有 p%的值小于该百分位数。 • 有(100-p)%的值小于该百分位数。 • 第 50 个百分位数 = 中位数; 第 25 个 百分位数 = 第一个四分位数. • 其他常见百分位数： –第 20 个百分位数（第一个五等分群体）。 –第 10 个百分位数（第一个十分位组）。 亚组分析 干预结果在目标人群的不同子人群间可能会有很大差异。如果未预先定义亚组，那亚组 分析可能会很复杂。研究亚组中的关系（因为它引起人的关注）可能会对研究发现产生偏倚。 数据挖掘（即：探索数据集以发现表层关系）在提出新的假设时很有用，但在实施研究 中需要格外谨慎地使用。应该仔细考虑亚组分析所处的环境，因为投入和产出之间的关系可 能由情境变量来调节。例如，我们可能认为按年龄组和性别来划分慢性病患者并进行分析是 有用的，如表 7 所示。为了对结果的解释更具有意义，慢性病的分类和这些患者的背景都是 被考虑的重要变量。 表 7. 慢性病患者的背景变量 年龄组 慢性病患病率 男性 女性 15-24 0.55 0.80 25-44 1.79 4.01 45-64 4.91 12.28 65 12.86 20.00 合计 1.77 4.25 125 控制变量和混杂变量 在慢性病（表 7）这个范例中，我们经常将这种分析描述成一种通过控制年龄组和性别 两个变量来评估投入与产出之间关系的分析。但是在实际操作过程中我们知道会有很多其他 因素会影响这个关系，例如职业、教育水平、社会经济地位、家庭规模、居住类型、城市/ 农村位置等。将目标人群随机分配为干预组和对照组，可以认为这些变量的潜在混杂效应最 终达到组间均衡。如果这不可能发生，我们应找到其他能够控制这些效应的方法。因为实施 研究发生在现实生活中和复杂适应系统中。这些效应虽然难以被控制，但是必须予以考虑。 3 定性数据分析 定性研究的领域中存在许多传统，有人认为“不能也不应该采用统一的定性研究方法” （2）。类似地，从一些用于定下结论和检验研究稳健程度的共同基本原则的意义上来讲，用 于定性数据分析的“已商定”标准很少（3）。许多定性研究采取一种迭代策略——收集一些 数据，构建出事概念和假设，接受新数据的检验，修改概念和假设，等等。这一方法意味着 数据收集和分析工作被嵌入到单个过程中，并由同一个人执行。 但是，随着定性研究在流行病学和健康研究中的使用越来越多，研究目的是在收集数据 的工作开始之前预先确定的。定性数据分析可以手动完成，也可以使用专业软件进行，例如： • 可处理大数据集，非结构化编码，模拟纸质代码和排序。 • NVivo 可处理相对较少的数据，以适应非结构化编码，在代码中找到模式/关系。 • MaxQDA 为多种数据形式的分析（例如：访谈、报告、表格、网络调查、视频、 音频、图像和文献数据集）提供了强大的工具。 有很多用于分析定性数据的软件供我们选择。研究人员应使用自己认为适合的任何方法 （无论是使用还是不使用软件）。无论使用的方法是什么，所有定性分析都涉及到对大量数 据的理解，对潜在重要模式的发现，以及数据所揭露的本质的传达。 定性分析的三个核心要求是： 1. 选择样本和生成数据的技术和方法的详细说明。 2. 仔细说明分析过程，注意信效度的问题。 3. 使用三角论证方法，与其他数据收集方法进行对比。 126 定性研究中的信效度 定性研究中的效度侧重于内部效度，这是由于研究人员寻求深入的了解，这有助于他们 推翻研究发现中的备择解释。定性研究通常依赖于立意抽样，但该方法有降低外部效度（普 适性）的倾向。 在定量研究中，“效度”指研究发现的可重复性和独立性。该术语最常于定量研究相联 系。但是在定性研究中，效度指：对于已收集的数据，结果是可靠且一致的（4）。定性研究 的优势在于效度（与事实的接近程度）。一个使用多种数据收集方法进行的高质量定性研究， 应该弄清楚目前正发生的事情的本质，而不是仅仅略懂于表面（4）。 文本材料分析 从定性访谈或讨论中得出的文本分析的基本过程相对简单，包括： 1. 识别相似的句段、主题以及主体之间的联系。 2. 确定总体中各子群体之间的异同（例如：男性/女性，城市/乡村，年轻/老年，富 有/贫穷，等等） 3. 通过识别组间或组内一致的模式，来初步尝试概括。 4. 对总结结果进行述评和修改，尤其关注矛盾的证据和异常值。 方框 2 案例：焦点小组讨论 焦点小组讨论的内容应尽可能完整地被记录。记录员的文字笔记应与会议录音作比对。 记录员和主持人应就最终副本达成一致。多个座谈会的副本可为系统分析提供材料。 关于焦点小组讨论的分析通常会涉及到许多特定的研究主题和子主题，例如抽出其余能 够引起本地关注的主题，这些主题可用于定义广泛的分析领域。这些可以进一步细分为主题， 子主题等，并为其分配系统代码。 最初的描述性分析还应包括：①提到的最常见的主题；②不太常见的主题；③主题之间 常见的关联；④亚组之间的异同。 分析的述评和修订环节应：①审查原文，评估其符合上述分析的程度；②特别注意任何 有矛盾的证据，少数派的观点，等等。 127 领域/主题分析 这是一种相对简单的方法，其基于关键主题（又称为“领域”）及主题之间关系的识别 （2）。领域/主题分析有四个阶段： 1. 确定受访者提出的主要问题——领域/主题。 2. 将在每个领域中更详细的主题进行分组，以构建一个亚类的分类法。 3. 详述每个子主题中的“成分”，即实际所说的内容。 4. 探索各个领域之间的相互联系。 领域/主题的识别 • 索引文本，逐行阅读并试图找到主题。 • 在所有访谈中整理出这些主题，从而确定一个初始清单。 • 有些主题会比其他主题出现地更加频繁，后者中的一部分主题则可以被归为子主题。 • 系统地结合相关主题，从而列出一个仅有几个涵盖范围相当大的领域的列表。 以下是一个包括主题和子主题的初始清单的例子（6）： • 将要怀孕和已怀孕的阶段：怀孕迹象，危险迹象，身体问题。 • 怀孕期间的感觉：焦虑，愤怒/惊吓，担忧，尴尬，麻烦，消沉。 • 家庭计划：方法 • 提高健康水平的建议/活动：锻炼，活动，抽烟，自我照顾，建议来源，信息来源。 • 出生和分娩：既往经历，（出生/分娩）地点，体征，剖腹产/顺产，出生体重。 • 产前护理：出诊医生，地点，经历，会议，测试，距离/成本，后勤，等候时间。 • 一般背景：家庭，是否有工作，地域。 潜在领域/主题的初始列表 从以上示例中，我们可以确定的大领域如下： • 产前护理的动机 • 医疗过程（产前护理的经验和评估） • 怀孕期间的风险 • 生育史 • 社会经济背景 128 图 6. 亚类的分类法（Atkinson 和 AbuEl Haj，1996 年） 列出了领域之后（图 6），我们就可以开始对基础领域中实际的文本片段进行排列，这 是有用的。这个流程将实际的短语分组在一起，并使得亚类都直接来源于被采访者的话中。 领域/主题之间的关系 这个阶段涉及到：通过对领域或主题之间联系的识别，建立整体图景。在对采访者的真 实引证的收集中，研究人员应识别出一个主题与另外一个主题的关系的陈述。例如，在上述 研究中，研究者能够在与妇女过往经历、风险感知和社会经济情况相关的领域和他们对健康 服务的评估之间建立联系。 编码方案 经过初步分析，以对数据的主要特征有了一个整体的理解之后，许多分析人员会应用一 个系统性的编码程序。研究人员的工作是确定最合适去进行系统分析的方式，发现并记录主 题和子主题之间的关系（3）。这些编码被分配给特定的单词或短语，突出显示文本中的模式， 同时保留其语境，如表 8 所示。 129 图 7. 领域之间的关系（来自 Atkinson 和 AbuEl Haj，1996 年 表 8. 疟疾的感知原因和体征 焦点小组讨论 A村妇女 A村男子 B村妇女 B村男子 不良体征 身体发热 眼睛发黄 嘴唇发白 血便 身体发热 眼睛发黄 身体发热 嘴唇发白 眼睛发黄 血便 身体发热 眼睛发黄 嘴唇发白 不良原因 蚊子 新鲜芒果 蚊子 在高温中站着 新鲜芒果 蚊子 在高温中站着 吃新鲜的芒果 蚊子 风险 既往经验 影响 动机 社会经济因素 描述 医疗过程 评价 内容 喜欢/不喜欢 信息 技术 人际行为 组织 特殊主题 建议 解释 信息 检查 疫苗 维他命 药物 健谈 兴趣 礼貌 耐性 职员 连续性 预约 拥挤 130 思考活动 我们已经讨论了对分析计划的需求，包括用于分析和展示数据的 各种方法和工具。 • 在您的研究团队中，讨论您是如何去分析和呈现数据？ • 您将如何确保数据的信效度？ • 您/您的团队采取何种分析？ • 您会将统计软件应用于您的数据分析中吗？ • 讨论您做出用（或不用）软件进行分析的决定的原因。 • 您将如何呈现您的数据？ 三、关键概念的应用 下面的示例描述了焦点小组讨论数据中的主题分析，呈现和解释。 方框 3 案例：Njeru 等. 2011（7） 在高患病率地区实施由提供者发起的HIV检测：知情同意问题和错失的预防机会。 背景：研究人员对肯尼亚三个研究地区中（马林迪，姆巴拉里和卡皮里姆波希）的 成年人进行基于人群的研究，比较了两种HIV咨询模型：模型1：以客户为起点的HIV咨 询和检测一般被认为是自愿咨询检测（VCT）；模型2：以提供者为起点，不同于以客户 为发起点的检测，模型2是一个健康服务提供者对前往健康卫生机构的人所推荐的。 我们进行了深度访谈和焦点小组讨论，以探索被采访者和讨论人员关于HIV测试服 务的经历和感知，重点是由提供者发起的测试模型的经历。这些组包括：女性门诊病人， 男性门诊病人，到产前诊所就诊的孕妇和18岁到24岁的青年。 使用结构分析法来进行分析。所有数据集的数据分析涉及五个主要步骤：（对数据 的）熟悉，确定框架，建立索引，绘制图表和解释。 131 以下展示的是以被采访者的言语引证和研究人员对其的解释而得出的结果。 目的：在艾滋病毒检测过程中探索受访者对咨询的感知和经历。 主要主题：咨询的价值 子主题：预防方面 在访谈和讨论过程中，通过咨询所提供的 HIV 预防机会成为了重要问题。 • “当没有被感染的人得到建议并遵循建议时，咨询的重要性就显现出来了，因为她 /他将不会感染这种疾病。”（女性，26 岁，马林迪市区）。“咨询很重要，因为如果你被告知 了，您将有勇气或有能力去预防，因为你被告知了如何去做到这些的方法。”（女性，青年， 焦点小组讨论，马林迪市区） • “就我而言，我在 VCT 中接受了测试。在那里，他们真的对我进行有关 HIV 知识 的辅导以及建议我如何保护自己生命。”（成年男性，焦点小组讨论，马林迪市区） 子主题：支持维度 在三个地区中的进行了深度访谈和焦点小组讨论的人都提出了咨询的重要性，因为这是 作为支持那些已经感染了 HIV 的人的重要方面。这三个国家的男女性消息提供者均认为， 在测试后充分的辅导有可能减少研究对象的担忧，恐惧和责备，如下文所示： • “因为通过咨询让你意识到，即便 HIV 检测结果为阳性，你也不会感到恐惧，这 就是为什么有些人会声称自己 HIV 检测呈阳性，他们在研讨会上接受了劝告，这就是为什 么他们能鼓起勇气。但一旦有人在这里透露了他的阳性检测结果，人们就会开始讨论他；有 些人甚至会出于恐惧而禁止他喝水.”（成年男性，焦点小组讨论，姆巴拉里） 子主题：时间维度 在咨询过程中需要足够的时间清楚地传达信息，这在检测服务中显得至关重要。在开始 检测之前，根据实际需要可给予更多时间，以便为了让研究对象充分概念化和理解所提供的 信息。在这种情况下，无论检测结果如何，人们都会做好准备。 • “当我说我们需要教育时，我的意思是我们需要咨询，我们需要一步步来进行辅导， 直到我们准备好进行检测。（成年男性，焦点小组讨论，姆巴拉里） • “当你进入医疗机构并进行咨询，你马上就会被问到你是否准备好接受检测。不！ 那也可能使得接受检测的意愿较弱。咨询师应该对我进行辅导并告知我有权利去做检测。因 此，如果咨询时间增加，我认为这会是一种改进。”（成年女性，焦点小组讨论，马林迪郊区） 132 主要主题：在 HIV 检测中实施 PITC 模型所遇到的挑战 子主题：对咨询的威胁 • “在第二次怀孕期间，我们没有选择的余地。我们必须做 HIV 检测，然后（之后） 对妊娠进行检测。我们没有被提问；你仅仅是进入到做 HIV 检查的房间然后你就去做另外 的检查。说实话，那天我们突然要求做检查的时候，在那里的一些人感到非常恐惧。人们非 常恐慌。所以人们并不快乐，但是他们必须要这样做。”（女性，35 岁，马林迪市区。） • “据说，按照医院的规定，如果有人到了分娩时间，但又没有 HIV 检测结果，医 院就不会接收她。”（女性，35 岁，马林迪市区） • “如果你拒绝检查，他们不会检查你的胃。所以到了分娩的时候，他们也不会接收 你。“（女性孕妇，焦点小组讨论，马林迪市区） 子主题：强制进行 HIV 测试 在马林迪，提供给我们信息的人报告说，在 PMTCT 内的 HIV 检测已经不再是自愿做 的了。用于描述新测试模型的一个常用短语是“这是必须的”，女性和男性受访者均指出了 这一点： • “我没有在 VCT 中心接受过检测，而是在那个妇女诊所（ANC 诊所）。因为在怀孕 时，你要接受很多方面的检查，但首先他们必须要对你做艾滋病检测。”（孕妇，40 岁，马 林迪市区） • “的确男性和女性都得去做（HIV）检测，但这其中大部分人都是女性，因为女性 在去诊所的时候必须接受检测。“（男性，34 岁，马林迪市区） 子主题：女性所表达出的负担 • “应该有很多咨询师来帮助我们，因为我们是妻子，当你要求你的丈夫，让他自己 去做检查的时候，他会保持安静，拒绝讲话。他会对你说‘你都做过检查了，如果你没事， 我也没事’。于是他就不去了。”（孕妇，焦点小组讨论，马林迪市区） • “你还知道发生了许多已经发生的事件，因为你发现：如果当一个女人变重了（怀 孕了），丈夫就会强制他们的妻子去做检查，你明白吗？如果有什么不好的事情发生了（意 味着她是 HIV 阳性），丈夫就会开始责问妻子，问她这艾滋病是从哪得来的？”（孕妇，焦 点小组讨论，马林迪郊区） 133 四、结论 恭喜您完成了单元 4：数据、分析和展示。本单元为您提供了对实施研究的数据分析和 解释的基础的概述。其还描述了数据分析的设计，以及对数据的呈现和解释，为了加强目标 受众对研究发现的吸收和理解。我们希望您能喜欢这一单元并增加您对数据分析和呈现的知 识和理解。我们鼓励您继续学习关于“交流研究结果，并将其反馈至卫生系统”的第 5 单元。 五、参考文献 1. Walker, Neff, Jennifer Bryce, and Robert E. Black.“Interpreting health statistics for policymaking: the story behind the headlines.” The Lancet 369, no. 9565 (2007): 956-963. 2. Bradley, Elizabeth H., Leslie A. Curry, and Kelly J. Devers. “Qualitative data analysis for health services research: developing taxonomy, themes, and theory.” Health services research 42, no. 4 (2007): 1758-1772. 3. Miles, Matthew B., and A. Michael Huberman. “Qualitative data analysis: An expanded sourcebook. 1994.” Beverly Hills: Sage Publications (1994). 4. Lincoln, Yvonna S. “Guba, eG 1985: Naturalistic inquiry.” (8). 5. Greenhalgh, Trisha, and Rod Taylor. “Papers that go beyond numbers (qualitative research).” BMJ: British Medical Journal 315, no. 7110 (1997): 740. 6. Atkinson, Sarah, and Monica Abu el Hap. “Domain analysis for qualitative public health data.” Health Policy and Planning 11, no. 4 (1996): 438-442. 7. Njeru, Mercy K., Astrid Blystad, Elizabeth H. Shayo, Isaac K. Nyamongo, and Knut Fylkesnes. “Practicing provider-initiated HIV testing in high prevalence settings: consent concerns and missed preventive opportunities.” BMC health services research 11, no. 1 (2011): 87. 六、补充阅读 • Goldstein, Harvey, William Browne, and Jon Rasbash. “Multilevel modelling of medical data.” Statistics in medicine 21, no. 21 (2002): 3291-3315. • Patton, Michael Quinn. Qualitative research. John Wiley & Sons, Ltd, 2005. • Robson, Colin. Real world research: A resource for social scientists and practitioner- researchers. Vol. 2. Oxford: Blackwell, 2002. 134 5 单元 传播研究结果 135 单元 5 传播研究结果 一、简介 本单元旨在阐明与实施研究相关的知识转化（KT）的关键概念。它为准备研究报告、 同行评审论文、新闻稿、会议报告和政策简报提供了结构化指南。学习此单元后，你将能够： • 认识到利益相关者持续参与传播和利用研究结果的价值。 • 认识到制定全面的传播战略作为研究项目的一个组成部分的价值。 • 了解针对不同目标受众量身定制的传播工具的重要性。 二、关键概念 1 知识转化 知识转化技术可以帮助研究人员在传播研究结果时变得更为主动、更具情境感知和更加 协作。这些技术的应用有助于使研究成果与目标受众更相关，最终变得更有用。 知识转化活动 知识转化活动形式基本上有两种类型：EOG 知识转化和整合型知识转化。EOG 知识转 化活动经常被纳入资金标书中。顾名思义，这些活动通常在知识创造过程的最后进行。它们 的重点是将知识转化为有效的交流工具，并将其传播给特定的受众。这些内容包括同行评议 的论文、指南、会议报告、新闻稿、广播节目、社区戏剧等等。这些活动基本上存在已完成 的结果中。虽然 EOG 知识转化活动可以作为实施研究的一部分进行，但它是一项有限的（且 相对昂贵的）活动（2，3）。就其性质而言，它研究滞后，结果可能无法及时解决这个问题。 整合型知识转化方法允许进行更多的创新，并且能够有效地为解决问题提供及时的解决 方案。这种方法是艺术和科学的结合，在许多方面说明了实施研究本身的核心特征。例如， 它是多利益相关者、多学科的，也是动态的、交互的（4）。整合型方法要求研究人员和关键 知识的终端用户合作和共同进行许多基本步骤，识别研究问题，确定研究方法，实施研究， 解释研究结果，最后传播和应用研究结果。由于研究结果反映了知识使用者的需求，它们被 承认和使用的可能性要高得多。整合型知识转化还包括确定优先事项、制定政策简报、促进 对话和开发知识转化平台/快速反应服务等活动。整合型方法并没有把知识视为可以产生、 传播和应用的东西（正如它有时被简单地设想为 EOG 知识转化）。相反，整合型知识转化 136 将研究知识——从它的创造到它的应用——视为一种集体的、协同的任务（5）。它尊重一种 双向动态，在这种动态中，研究证据被许多不同的利益相关者创造、塑造并最终使用。在某 些方面，这种方法颠覆了研究人员一贯的“权威性”，使他们不再拥有对研究证据的独家控 制权。为了使研究证据更具相关性和响应性，整合型知识转化方法让从业人员、规划人员和 项目管理人员（除其他外）参与确定、设计和开展研究的过程。这使研究工作具有独特的定 位，成为了响应用户需求和要求而量身定制的、具有情境敏感性的一项投入。 获取研究证据的障碍和促进因素 在获取研究证据方面存在各种障碍和促进因素。许多研究证据的使用者（例如项目管理 者和实施者），是在一种独特的压力和迫切需要的环境中工作的。他们的行动时间表可能非 常短，而且他们在应用或平衡不同投入以解决问题方面的能力可能有限。 方框 1 案例：实施研究证据的获取和决策使用 该项目旨在提高孟加拉国儿童锌的摄入率。整合型知识转化方法帮助政策制定者将实 施研究结果纳入关于“儿童腹泻”治疗的决策中。 在整个项目周期中，各种利益相关者都参与其中。政策制定者和研究人员之间的合作 促进了隐性知识、政策立场的共享和共同优先事项和目标的确定。尽管在项目的概念化过 程中没有考虑到一些利益相关者，但是他们后来被引入董事会以加速扩大进程。合作方式 的另一个启示是采用最好的服务提供方法。例如，使用现有的社区卫生系统[即最初以计划 生育为重点的社区卫生工作者]作为最初扩大干预措施的渠道。然而，当他们意识到这是不 可行的时候，这项工作就中止了（因为这是社区卫生工作者的一项额外任务）。锌制品可 以在柜台上买到，而且容易管理，医生（尤其是儿科医生）被认为是推广和开处方的关键 角色。这些发现的结果使该项目能够在医学院、区级和区级以下的范围内开展公共卫生医 生的培训。大约8000名全科医生担任了20万多名非正式医疗服务提供者的培训师。 研究结论： • 为有效实施循证政策，政策制定者和研究者应共同学习，合作改善服务获取和提供。 • 应采取通过可持续的伙伴关系和机制，包括知识转化平台（在区级、省级和国家级 层面）等步骤，增加对研究用途和知识转化的需求，促进决策者、管理者、卫生保健提供 者和患者的早期参与，并作为能力建设活动的基础。 资料来源：（6） 137 获取研究证据的障碍 1. 从业者对研究证据的感知：他们如何平衡这些证据和其他相互竞争的影响？（7） 这可能包括从业人员缺乏明确的概念，即在何处获取相关的定制信息以满足他们的需求，如 何区分证据来源的质量，以及如何最终使用这些信息（8）。毕竟，“证据有多种声音”，任何 一项证据都可能有多种不同的（甚至是相互矛盾的）含义（9）。研究结果可能也模棱两可， 缺乏对预期效果的精确估计（10）。 2. 组织文化：一个组织如何做决策？信息如何在组织内流动?它与研究证据相互作用 的能力是什么？(11，12)“群体思维”或“我们在这里如何做事”也会减缓或扭曲研究证据 的使用。普遍的行政情境也可能使项目管理者、实施者或技术官员不了解研究人员的主张， 他们可能会觉得无需对研究团体负责任（8）。 3. 从业人员缺乏技能（特别是研究或证据评估技能），无论是评估研究证据，还是平 衡其与竞争的影响来源（8）。 4. 研究的预期成本和时间表。许多从业人员必须在短时间内做出决定，研究可能被认 为太昂贵、太耗时或太奢侈，没有真正的实用价值（13）。 5. 信息超载。从业人员、项目管理人员和实施人员可能会被大量的信息来源搞得不知 所措；或被其他势力所说服（例如游说者或其他利益集团，他们有财力、能力和/或内部知 识来推进某一特定议程）。 获取研究证据的促进因素 促使研究证据得到更广泛采纳的因素可能包括： 1. 研究人员重新构建实践问题，以符合现有的证据基础（8）。在许多知识转化活动（如 政策简报）中，提出问题是必不可少的一步，可以汇集多种不同类型的证据，以满足特定的 实践或实施需要。 2. 加强从业人员的能力：需要能够回应和支持他们需求的研究证据;以及在日常工作 中获取、评估、调整和应用研究证据（14）。 3. 研究人员与从业人员合作，以产生必要的信息，鼓励积极分享，并确定紧迫的优先 事项（8）。 4. 建立有针对性的消息传送（例如政策简报，新闻稿），强调研究证据在促进更好的 计划或改进的干预措施中可以发挥的作用（12,15）。通过将研究证据转化为令人信服的故事， 可以更有效地传达。例如，通过对比“行动成本与不行动成本”，证据影响决策的可能性会 高得多（10）。 5. 研究人员寻求与从业人员接触并建立信任（16）。建立在个人关系上的信任是连接 研究和实践世界的重要因素。 138 思考活动 从乌干达例子中得到启示，思考一下在你的国家你熟悉的一个卫生 项目。是否有政策支持该计划？制定该政策时使用了哪些研究证据？ 2 传播工具 研究团队可以使用各种传播工具来推广研究成果。所有这些工具都应该被看作是一个整 体的一部分，而不是一个单独的部件。各种工具应在一个更大的计划内协调使用，共同形成 一套完整有效的传播工具包。在接触特定受众方面，每种工具都有不同的长处和短处，因此， 通过结合使用多种工具，各种工具可以相互补充，形成比单独使用任何一种工具更强有力的 传播计划。在许多情况下，开发一种工具的工作可以复制或改造为另一种工具的开发。增加 将研究结果传达给关键受众的方式的数量，可以增加获取和行动的机会。本单元考虑的传播 工具将包括研究报告、同行评审论文、新闻稿和政策简报。 方框 2 案例：为国家卫生政策提供信息研究转化，多视角学习乌干达的经验。 背景：研究和证据可以对政策和实践产生影响，从而产生积极的结果。然而，科研转 化是一个复杂的、动态的、非线性的过程。尽管非洲的大学在产生研究证据方面发挥了重 要作用，但它们在制定卫生政策和决策方面的战略方法普遍较弱。本研究旨在了解将研究 转化为政策的过程，以指导马克雷大学健康科学学院及其他类似机构的战略方向，以期在 全国和全球范围内影响健康结局。 方法：有目的地选择了一种案例研究方法，即对参与两个HIV预防研究项目的利益相关 者进行30次深度访谈。该研究试图分析预防艾滋病毒母婴传播（PMTCT）的研究到政策的论 述。该分析试图通过访问乌干达的三个主要利益相关者群体:研究人员(8)、政策制定者(12) 和媒体工作者(12)来确定切入点、优势和挑战。 结果：促进PMTCT政策的采纳和持续实施的因素包括：利益相关方之间共享学习和决策 平台；评估干预措施的可行性的试点推行；开展业务研究的机构的出现；以及对儿童生存 有利的政策的高度可见性。 意义：为了有效地推广实施研究结果，所有利益相关者都应参与研究项目的整个过程， 以加强各利益相关者之间的学习和决策过程。 资料来源：（17） 139 研究报告 在任何实施研究项目结束时，资助者都希望得到被资助者的研究报告。研究报告的内容 取决于资助者及其具体要求。因此，在决定报告的结构和内容时，显然最开始是回顾最初的 约定协议。如果资助者提供了一个报告模板，其中包含需要遵循的部分，那么撰写研究报告 的练习就相对简单了。以下部分是许多研究报告和同行评审论文的典型部分：标题；作者和 机构隶属关系列表；致谢；摘要；执行摘要；介绍；文献综述；研究设计/方法；结果；讨 论；结论；和参考文献。然而，必须遵循各自的资助者和/或期刊出版商/编辑的撰写指南。 撰写报告的整个过程中需要牢记的关键问题是：我们还可以通过哪些其他方式使用或呈 现这些信息？一份研究报告可以是各种附加产品的信息和见解的来源。表格和图表可以成为 会议演示的主要视觉效果。执行摘要可以作为一页重点信息，也可以作为一份新闻稿，或者 作为政策简报的论点的建议。最重要的是，研究报告可以成为同行评审论文的模板，是一种 理清思路、将非常复杂的过程简化为适合更广泛研究团队接受的短语的方式。该报告的许多 部分可以被删除，通常只需要进行适度的调整，就可以直接形成一篇同行评审的论文。 同行评审论文 对许多研究人员来说，在同行评审的期刊上发表论文是一项最高成就。它标志着社会对 这项工作的接受程度，是对该领域的有形贡献，也是多年工作的回报。尽管论文发表非常重 要，但它绝不是实施研究过程的终点。相反，论文的发表应该被视为取得影响力的新周期的 开始。同行评审的出版物的最大限制是，关键读者（例如，从业人员和项目实施者）往往不 会广泛阅读它们。 尽管一篇同行评审论文的结构可能与一篇报告非常相似，但其读者却有所不同。每个期 刊都有特定的要求和文章格式，偏好的风格（例如摘要的长短、参考的格式等等），以及所 有作者都要遵循的特定指南。因此，在写论文之前，逻辑上的第一步是确定目标期刊。浏览 以往的文章（大多数都是在线提供一些内容）来查看要发布的文章类型是一个很好的开始。 选择一份定期发表与你的研究相关内容的期刊，并严格遵循作者须知。接受实施研究的期刊 包括：Health Policy and Planning（卫生政策与规划）、Tropical Medicine and International Health （热带医学与国际卫生）、Social Science and Medicine（社会科学与医学）、Human Resources 140 for Health（卫生人力资源）、Global Public Health（全球公共卫生）、Community Health Education （社区卫生教育）和 The Bulletin of the World Health Organization（世界卫生组织公报）。许 多研究资助者鼓励在“Open Access”期刊（即允许不受限制地访问和重复使用已发表的文 章的期刊）上发表文章。选择期刊后，可在期刊网站上找到投稿指南。 同行评审论文的摘要示例 案例 1： 在埃塞俄比亚一家医院门诊部对人类免疫缺陷病毒感染者的强化结核病病例发现。 Assefa et al., International Journal of Tuberculosis and Lung Disease. 2011 Mar;15 (3):411-3. 摘要：强化结核病病例的发现（ICF）用于感染人类免疫缺陷病毒（PLHIV）的人群， 以减轻结核病（TB）的负担。我们对埃塞俄比亚一家 HIV 护理诊所的 300 名 PLHIV 患者进 行了回顾性研究，以评估 ICF 在 12 个月内的表现。80%到 95%的患者在登记时和每次 3 个 月的随访中都进行了结核病筛查。34 名患者(11%)被诊断为结核病，其中 27 名患者(79%)是 在最初 6 个月内确诊的。这项研究在常规环境中评估了一系列 ICF，表明结核病筛查在最初 6 个月的诊断量最大。 案例 2： 使用计算机化药房跟踪系统，确定在南非的一个社区抗逆转录病毒疗法诊所中的失访偏 倚。Nglazi et al., BMC Infectious Diseases.2010 Nov 15;10:329. 摘要 背景：高失访偏倚率（LTFU）正在破坏撒哈拉以南非洲迅速扩大的抗逆转录病毒治疗 （ART）服务。ART 智能配药（iDART）是一个开源的电子药房系统，它提供了一种能够 生成未能取药的患者名单的有效方法。我们决定使用该系统来更好地确定真实 LTFU 的药房 延迟时间。 方法：我们对南非开普敦一个以社区为基础的 ART 群组进行了回顾性横断面研究。我 们使用 iDART 来确定在 2008 年 4 月 1 日仍被纳入队列的患者组，这些患者在≥6、≥12、 ≥18 和≥24 周的时间内仍未接受药物治疗。我们将真正的 LTFU 定义为有三个月确认无法 获得药物治疗（自上次就诊以来）。然后，我们使用前瞻性维护的数据库和患者记录评估短 期和长期结果。 141 结果：调查期间，2548 名患者登记接受抗逆转录病毒治疗，但其中 85 名患者（3.3%） 被认为是真正的 LTFU。iDART 确定的未接受药物治疗≥6、≥12、≥18 和≥24 周的人数（占 队列比例）分别为 560（22%）、194（8%）、117（5%）和 80（3%）。这些药物延迟对检测 真正 LTFU 的敏感性分别为 100%、100%、62.4%和 47.1%。其特异性分别为 80.7%、95.6%、 97.4%和 98.4%。因此，最佳延迟时间为自上次就诊起≥12 周（相当于药物用完后的 8 周）。 药房延误也被发现与 LTFU 和一年后死亡显著相关。 结论：iDART 电子药房系统可用于检测潜在 LTFU 和需要返回医院的患者。对于 LTFU 而言，使用较短的截止时间太不具体了，需要对大量的患者进行追踪。相反，长时间的延迟 也太不敏感了。在评估的周期中，≥12 周的延迟是最佳的。这个系统需要前瞻性的评价来 进一步改进它的效用。 新闻稿 媒体是研究成果的重要受众，因为它既是研究证据的目标受众，也是研究证据的传播者。 媒体可以接触到利益相关者，而研究团队无法做到这一点。他们可以推广研究结果，向政府 施压要求改革，并强调不公平或无效的计划。然而，研究人员必须意识到，媒体可以通过大 胆的报道引起轰动标题，而实际的报道可能缺乏重要的事实。由于这些原因，接触媒体的最 佳方式之一是通过新闻稿。这在很多方面与一份关键信息表，但新闻稿有自己的风格和结构， 必须予以遵循。一般来说，新闻稿包括： • 不要超过一页。可附有该研究机构的照片及/或标志；除此之外，还可包括文本。 • 以有力而有信息的标题为主。报纸，依靠一个吸引人的标题来说服人们阅读他们的 文章，新闻稿也不例外。这不是一个简单的任务——用十个或更少的词来抓住一个研究项目 的本质是非常具有挑战性的。对于非专业受众，你可以关注项目中最引人注目/令人震惊和/ 或最吸引人的方面。在这个问题上进行头脑风暴可能有助于找到十个真正能抓住项目内容以 及为什么人们应该关心结果/结论的词。 • 用几行进行总结-证明为什么研究结果值得发表（推广/分享）。一张小照片或图片 可能有助于把复杂的东西简化为简单而有力的图像。 准备一个两段的正文，回答非专业受众关于何人、何事、何地、何因和如何等问题。媒 体通常以最重要的信息开头，以最不重要的信息结尾。最后以包含更多关于研究机构或主要 研究者信息的部分结束。还包括联系信息，如果需要以便报纸或记者可以跟进。 142 方框 3 案例:没有必要加强黄热病疫苗接种 新闻稿 2013 年 5 月 17 日|日内瓦– 据世界卫生组织说，在初次接种疫苗十年后，不再需要 黄热病“增强”疫苗。世界卫生组织《流行病学周报》上发表的文章显示，该组织免疫 战略咨询专家组（SAGE）审查了最新证据，并得出结论认为，单剂疫苗接种足以使人获 得对黄热病的终生免疫。自 20 世纪 30 年代开始接种黄热病疫苗以来，在分发了 6 亿剂 疫苗后，只发现了 12 例已知的黄热病接种后病例。证据显示，在这一小部分“疫苗失败” 病例中，所有病例都是在接种疫苗五年内发病的。这表明，免疫力不会随时间而降低。 对于黄热病流行国家和旅行者来说，一个重要的消息 “一般的指导方针是十年后必须加强黄热病疫苗接种，”SAGE主席Helen Rees博士 说。“从非常好的证据来看，SAGE非常清楚，事实上，一剂黄热病疫苗是有效的。这对 黄热病流行的国家极为重要，因为这将使它们能够重新考虑其疫苗计划。这对旅行者来 说也很重要。” 黄热病是一种由受感染的蚊子传播的急性病毒性出血病，在非洲和美洲热带地区的 44个国家流行。感染黄热病病毒可导致不同程度的疾病，从轻微症状到伴有出血、黄疸 和死亡结果的严重疾病。 估计每年有20万新病例 全世界每年估计有20万黄热病病例。约15%的黄热病感染者会发展为重症，其中多达 一半将死亡，因为没有治愈黄热病的方法。治疗的目的仅仅是减少病人的不适。 绝大多数报告的病例和死亡发生在撒哈拉以南非洲。在非洲流行地区，随着年龄的 增长，人们可以获得黄热病的自然免疫力，这使儿童面临着最高的感染风险。在过去20 年里，由于人口对感染免疫力下降、森林砍伐、城市化、人口流动和气候变化，全世界 黄热病病例数量有所增加。 接种疫苗是最有效的措施 疫苗接种被认为是预防黄热病最重要和最有效的措施。99%接受疫苗接种的人在30天 内产生保护性免疫。44个黄热病流行国家中有31个是非洲国家，就非洲的常规免疫规划 而言，每剂疫苗的价格约为0.82美元。 SAGE是WHO疫苗和免疫方面的主要咨询小组。它负责就发展、提供免疫及其与其他卫 生干预措施的联系提供咨询意见。SAGE是WHO关于全球总体政策和战略的组织，涉及疫苗 和技术、研究以及所有可通过疫苗预防的疾病，包括儿童疫苗和免疫接种。 如需更多资料，请联络： 通讯员/发言人 电话:+41 22 791 电子邮件:@who.int 143 政策简报 政策简报是向非专业读者展示研究项目结果和建议的简短文件。这类独立文件聚焦于某 个主题，篇幅不超过 2-4 页（约 1500 字）。Jones 和 Walsh（18）观察到：“政策简报如果经 过精心设计，可以成为传播研究结果的有力工具来发展政策受众。由于决策者受到时间的限 制和各种信息来源的压力，他们很可能会选择最符合其政治倾向的“证据”来迅速做出决定。 此外，在实践中，研究证据是通过政策制定者的经验、专业知识和判断、情境语用学、 可用资源和政策背景，以及政策制定者的习惯、价值观和传统，以及游说者和压力集团的影 响来考虑的。因此，在政策制定过程中增加证据的使用需要一种沟通方式，这种沟通方式应 以对这些竞争影响的理解和参与为基础。 有效政策简报的主要内容（19） 为了有效地达到预期目的，政策简报应是（19）： 1. 专注于达到说服目标受众的预期目标。 2. 专业的（即非学术的）。政策简报的典型读者对产生证据的研究/分析程序不感兴趣， 而是对作者基于新证据对问题的审视和潜在的解决方案感兴趣。 3. 以证据为基础。政策简报是一种沟通工具。受众不仅期待一个合理的论据，而且只 会被有证据证明问题存在的论据和采取（或不采取）某一特定行动的后果所说服。 4. 局限于某一特定问题或某一特定问题的特定方面。 5. 简洁。典型的读者通常没有时间或兴趣去阅读一篇关于政策问题的长达 20 页的深 入论述。因此，政策简报的篇幅最好不要超过 6-8页。 6. 可理解的。使用清晰和简单的语言(即不要使用专业术语和概念)。 7. 易被预期目标受众访问的。 8. 易宣传推广。即应通过使用色彩、标志、照片、标语和说明性引用来吸引目标观众 的眼球。 9. 实用和可行的。它必须根据某一特定政策在实践中实际发生的情况提出论点，并提 出对目标受众切实可行的建议。 政策简报的共同结构要素 政策简报直接反映了政策分析人员（从研究人员到倡导者）的角色范围。政策简报通常侧重 于更加注重行动的、倡导性的实施研究项目。即使在结尾的规模也有很大的差别，但政策简 报最常见的内容是:文件的标题;执行摘要;问题的背景和重要性;政策措施的批判;政策建议; 参考或推荐的附录和来源。 144 方框 4 案例:关于支持在布基纳法索扩大以青蒿素为基础的联合疗法治疗简单恶性疟原虫疟疾的 政策简报 政策问题 恶性疟原虫对传统抗疟药物的耐药性得到了包括布基纳法索在内的世界各地的一些 研究的充分证明。各种研究也证实了青蒿素联合疗法（ACTs）的疗效，世界卫生组织建 议大规模使用ACTs。与其他国家一样，布基纳法索于2005年2月选择改变其治疗简单疟疾 的药物战略，以青蒿素替代氯喹治疗。在编写本报告时，这种扩大的行为并没有适用于 所有年龄组。 问题的规模 疟疾是布基纳法索的一个主要公共卫生问题，每年有200多万病例记录在案，死亡人 数超过4000人，特别是年龄5岁以下儿童。大多数医疗咨询、住院和死亡都与疟疾有关。 政策措施 在这种情况下，迫切需要制定政策，改善能够普遍和公平地获得用于治疗非复杂疟 疾的青蒿素类药物的情况。这些政策措施包括： • 敦促私营部门的利益相关方(药房、诊所和外科手术)遵守国家关于ACTs补贴定价 的指示。 • 激励社区卫生工作者，负责以家庭为基础的简单疟疾管理。 • 停止使用单一疗法治疗单纯性疟疾的抗疟药物。 实施注意事项 要实施这三种政策措施中的任何一种，必须： • 提供信息/提高疟疾控制主要利益相关方的认识。 • 确保在全国提供适合每个年龄组的ACTs。 • 培训负责青蒿素联合疗法配药的工作人员。 • 审查与政策实施有关的某些监管安排。 资料来源：个人通讯，布基纳法索的EVIPNet小组。 使用多样化传播平台 实施研究涉及多个能力不同的研究人员和利益相关者，因此应该使用不同的平台/渠道 来传播研究成果。你的研究结果的性质和含义可能暗示了一个特定的渠道。例如，如果一项 研究的主要受众是农村诊所的一群患者，那么创作社区戏剧可能是一个有效的渠道，也可以 为等待治疗的患者打印一本非常简单的小册子，或者对幼儿使用五颜六色的卡通/动画。 互联网还提供了各种平台来传播团队的信息，比如社交媒体平台或博客。 145 3 传播策略 制定传播策略 传播过程是实施研究项目循环中不可分割的一部分。尽让利益相关者尽早参与传播进程， 将加强对研究进程的自主权，并最终吸收采纳研究成果。建议研究团队在讨论和制定其传播 策略和相关需求时形成具体步骤。最终结果应是一项具有情境敏感性的策略，旨在向特定的 受众传播特定的研究结果。 整体方法 研究团队可能会倾向于专注特定信息产品的创建。例如，有这样的例子：一个研究项目 制作了一个视频，其中包含了研究的视觉组成部分，并对研究人员和其他主要利益相关者进 行了专题访谈。但是，单一的单向产品并不构成传播策略。 强有力的传播策略特色：双向对话（不只是利益相关者/研究者与受众之间的对话，还 包括受众的反馈和回应）；针对特定受众量身定制、有针对性的信息;以及评估相关指标的机 制，以便对战略及其产品进行修订和完善。 制定传播策略的步骤 下图强调了研究小组在制定传播策略时应考虑的 9 个单独步骤。 图 1. 制定传播策略的步骤 1.回顾过去的传播工作 2.制定传播目标 3.确定受众 4.形成信息 5.确定传播方式 6.确定传播渠道 7.评估可用资源 8.考虑时机与机会 9.评估工作 146 步骤 1：回顾过去的传播工作 在制定传播策略时，谨慎的做法是先看看过去做了什么。研究小组过去是如何传播信息 的？创造了什么产品？做了哪些工作？特定的观众有何反应？这可以作为一次内部的头脑 风暴练习，查看相关文档，或者作为对过去收到团队交流的利益相关者的调查（正式的或非 正式的）。或者，对以前的传播工作的正式审计（通常由第三方进行）的正式审计可以评估 绩效，更重要的是，可以评估主要利益相关者对团队研究以及研究周围环境的看法。这类信 息可以对今后工具和传播渠道的选择产生重大影响。 步骤 2：制定传播目标 应通过头脑风暴讨论研究团队希望通过传播实施研究结果实现什么目标。为何团队希望 将研究过程或结果传达给特定受众？传播目的是提高认识、理解、行动，还是支持地方参与？ 以下是青年预防 HIV 运动的传播目标的例子： 方框 5 案例：到2013年底，该项目将向青年提供以下信息： • HIV预防策略 • 预防/减轻HIV感染的生活技能 步骤 3：确定受众 确定所传播的信息的主要和次要受众是传播战略的一个关键方面。研究团队必须了解受 众是谁，他们如何接收研究证据，他们的时间表、需求等等。这将大大增加传播方法将满足 其目标的可能性。每个实施研究项目都有多个具有独特能力和需求的受众。考虑到这些因素， 信息必须进行适当的调整。 其中一种经过测试的方法可以确保团队在传播过程中满足所有利益相关者的需求，那就 是将他们分为主要受众和次要受众。主要受众是那些需要做出决定或改变的人。次要受众是 指那些能够影响主要受众的决策或行动的受众。受众的水平（主要或次要）由传播目标决定。 方框 6 案例： 在为预防HIV而进行的安全男性包皮环切手术干预中，你的目标是说服男性来进行 包皮环切手术，主要受众是与安全男性包皮环切手术相关的有感染HIV风险的男性(例如 未割包皮的男性和性行为活跃的割过包皮的男性)。次要受众将包括卫生工作者、意见领 袖、未割包皮男孩的监护者和女性性伴侣。每个受众都需要自己的针对性传播策略。 然而，在同样的干预中，如果传播的目标是寻求决策者的支持，以便将割礼政策纳入 现有的国家卫生政策，那么卫生部官员和立法机构以及其他意见领袖将是主要受众。 147 步骤 4：形成信息 信息是任何传播产品的核心。信息应该是直接的，简单的，并且解释研究要解决的问题。 此外，研究可能产生的解决方案，研究结果的特定含义，以及/或作为这些结果对不同受众 的期望，都应该在信息中体现出来。实施研究项目通常会产生三到五个关键信息。当然，这 并不代表研究的整体，这些信息可以在几个简洁的词和短语中传达研究的本质和它的含义。 步骤 5：确定传播方式 选择传播方式的其中一种方法是与特定的受众开展多阶段的“对话”。加拿大卫生服务 研究基金会的“逐级进入”方法（14）就提供了这样一个思路。研究小组将为主要受众形成 一份简短的文件（即 1 页或更少）作为初步结果。该文件专门关注对该受众而言最重要的调 查结果及其主要影响。假若受众反响积极，那么接下来可能会有一份更详细的 3 页文件，提 供关于研究项目本身的更多细节，并将其含义与上下文和其他科学证据进行对比。然后再写 一份 25 页的文件（和/或一篇同行评议的论文），解释诸如方法等技术问题。 步骤 6：确定传播渠道 再好的传播产品，如果不通过最相关的渠道传播，影响也微乎其微。例如，如果目标受 众没有 DVD 播放机，甚至没有可靠的电力供应，那么制作精美的带有视频和照片的 DVD 的研究项目就毫无用处。依靠互联网作为传播渠道显然是假设用户具有连通性，能够获得一 定的最小带宽和足够的能力，以便能够发现和使用研究团队的研究结果。考虑适当的渠道是 至关重要的一步，因为它有助于以非常现实的方式缩小在现有预算范围内、能够接触到适当 受众的实用通讯工具的种类。在任何其他考虑因素之上，渠道的选择决定了谁接收（因此谁 可能采取行动）消息。 步骤 7：评估可用资源 着重考虑可用于传播活动的资源。什么材料可以用于这项工作？谁能做，他们有什么技 能？有多少资金可用来创建和实施该策略?在实施策略的过程中，这些变量会发生变化吗？ 研究团队往往不善于分享他们的研究发现，其中一个原因是传播成本很高。某些形式的 传播需要大量的资源和高水平的能力。通讯产品也可能带来隐性成本，如将材料翻译成多种 语言，或是专门技能（如平面设计等）的成本。团队对所有这些成本越是现实和精确，对这 项工作的期望就越现实。最好从一开始就为每种产品制定详细的预算。 148 步骤 8：考虑时机与机会窗口 开发和传播信息/通讯产品的时间表可能很明显，但值得重申。例如，可能会有一个即 将举行的会议或其他活动，研究团队可以在其中分发几种不同的通讯产品，进行全体演示， 和/或安排一些面对面的会议。 鉴于上述一些关于分阶段方法的建议，研究团队必须注意时机问题。这包括了解受众内 部的变化（表明对团队工作的接受程度更高）、可能突然打开的战略机遇之窗（你的团队必 须对此做出快速反应），以及志同道合的研究人员和机构的活动，他们的行动可能有助于推 进你团队的议程。 步骤 9：评估工作 与实施研究过程的所有方面一样，传播结果和影响也需要仔细评估和反馈。应仔细规划 传播策略，以便能够接触到预期的受众。在实施过程中，可能需要进行调整，以确保得到最 大的投资回报和关注。一个可以有效地指导整个传播方法的问题是：如果传播完全成功，将 会带来什么变化？你不只是想让你的研究发现进入公共领域，你还想要特定的受众接受它们 并据此采取行动。那么，在关键受众中，采取什么样的行动才算是成功呢？ 评估所涉预算问题也很重要。为了认识到成功传播的成果，你需要清楚地知道你是否已 经使用了正确的工具，并在可用的工具之间取得了正确的平衡，以及收到了足够多的用户反 馈。上述信息可以通过一些正式的调查和关键的线人访谈来收集，这对于规划未来的战略是 非常有价值的。“影响日志”（20）可以是积累你沟通策略反馈的另一种方式。影响日志通常 以非正式的方式记录利益相关者的反应、媒体参考资料、同行评审参考资料等;媒体工作的 参考资料；同行评审参考等。然后研究团队可以将所有信息综合成一份经验教训或最佳实践 文件。在某些情况下，反馈可能会立即转变或改变某些产品，以确保它们能以准确的信息传 递给合适的受众。 思考活动 下面是一个传播策略的例子。使用此示例和提供的模板指导你的 团队制定你传播计划的初稿。 149 150 三、结论 祝贺完成单元 5：传播研究结果的学习。本单元还描述了利益相关者持续参与讨论和利 用研究成果的价值，在研究项目中制定全面传播策略的价值，以及针对不同目标受众量身定 制传播工具的重要性。我们希望这个单元对你有所帮助，并且增加了你对传播研究成果和研 究发现的知识和理解。我们鼓励你继续学习单元 6“监测和评估”。 151 四、参考文献 1. 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(http://www.who.int/tdr/publications/tdr-research- publications/access_report/en/index. html, accessed 5 February 2014). • Datta, Ajoy, and Arnaldo Pellini. “Communicating Research.” (2011) 153 6 单元 监测和评估实施研究项目 154 单元 6 监测和评估实施研究项目 一、简介 本单元旨在帮助研究团队根据既定的计划跟踪其进展、检查对既定标准的遵守情况、识 别趋势和模式、调整策略并为项目管理提供决策依据。本单元还旨在培养技能，以确定目标 的相关性和实现情况、发展效率、效力、影响和可持续性。包括以下关键概念，并附有实例： • 监测和评估计划 • 制定监测和评估计划 • 实施监测和评估计划 二、学习目标 学习本单元后，你的研究团队将能够： 1. 理解监测和评估计划的制定过程。 2. 描述监测和评估计划的实施过程。 三、关键概念 监测和评估计划 监测和评估计划是一份概述如何监测和评估实施研究项目，并将从各种数据收集系统获 得的策略信息与如何持续改进项目的决策联系起来的文件。监测和评估计划有几个主要目的， 包括：①说明如何评估规划/项目的成果；②记录共识意见，从而鼓励透明度、问责制和责 任感；③指导监测和评估的实施；④保存机构记忆。 一项监测和评估计划建立在项目关键决定因素的基础上，其中包括： • 总体目标或预期的变化或效果； • 项目的主要受益者或受众； • 将项目目标与特定干预或活动联系起来的假设或假定； • 项目范围和规模； • 监测与评估的参与程度和能力； • 项目持续时间； • 项目总体预算。 每个项目都有不同的监测和评估需要，这取决于运作环境、实施机构能力、捐赠者需求 和其他因素。在撰写监测和评估计划时，重要的是要确定这些需求并协调用于满足这些需求 的方法、程序和工具;这可以节省资源，简化监测和评估计划。 155 监测和评估计划的标准 一项有效的监测和评估计划应该符合以下标准： 实用性：它必须是有用的，并能满足目标用户在制定决策目的的实际和战略信息需求， 这些需求可能包括评估方案执行情况和资源分配等等。 可行性：实事求是。考虑到资源的稀缺，监测和评估计划应该充分利用现有的数据收集 系统。但是，如果涉及新的数据收集系统，则必须仔细考虑资源（费用和技术能力）。 符合道德规范：遵守与监测和评估活动相关和受其影响的道德原则。 准确性：为决策制定和方案改进提供技术上准确和有用的信息。 监测和评估计划的关键要素 构建监测和评估计划的关键要素有四个。回答以下四个问题是监测和评估计划的关键： ①项目想要改变什么，怎么改变？②为实现这一变化而设计的具体目标是什么？③指标 是什么，将如何衡量这些指标；④如何收集和分析监测和评估的数据? 制定监测和评估计划 在你建立一个监测和评估计划之前，团队应该定义整个项目的目标和目的，理解研究的 情境，并识别关键的参与者/利益相关者（单元 1 和单元 2 详细描述了理解干预和确定利益 相关者的细节）。还应选择最适当的方法（如监测和评估框架，进行监测和评估的数据收集 方法）。在单元 1 和单元 2 中分别对框架（逻辑模型、逻辑框架）和数据收集方法进行说明。 以下是制定监测和评估计划时应该采取的关键步骤。需要注意的是，这些步骤不一定相 互独立，实际上可能会有很大程度的重叠。其中许多步骤可能需要开发或需要与其他步骤一 并综合考虑。 制定一项监测和评估计划的关键步骤 利益相关者的协商和参与 利益相关者的协商和参与应该经常发生在制定和实施你的监测和评估计划的整个过程 中。这些协商确保对话，明确了解项目目标和目的，以及如何评估这些目标。他们还确保不 同的观点得到理解和整合，并确保真实的需求得到满足。利益相关者参与监测和评估计划的 156 设计，有利于选择适当和有用的监测和评估指标。此外，采取额外措施促进利益相关者的参 与，能在合作伙伴之间创造了一种所有权和责任感。利益相关者的参与增加了监测和评估计 划所指导的信息和结果与他们的期望一致的可能性。 制定监测和评估计划 制定你的监测和评估计划的首要任务之一就是将项目的研究问题、目标和目的转化为可 以客观衡量的变量。具体的监测和评估计划强调并参考整个项目所建立的概念基础。理解项 目投入、产出、结果和影响之间的差异是至关重要的，因为在监测和评估计划下要衡量的指 标将最有可能反映这个层次。 要在以下几个关键问题上达成共识:“在项目结束时，我们想知道什么？”以及“到项 目结束时，我们期望发生什么变化？”同样，回答关于你期望你的项目能改变什么的这一问 题，将指导项目管理决策需要什么战略信息以及为了评估进展应该监测和评估哪些内容的决 策。你的监测和评估计划的严谨程度和范围，将取决于你所承诺的内容以及你的项目要对哪 些结果或成果负责。 制定监测和评估计划可以让你的团队清楚地了解以下情况： • 项目活动如何与预期产出、结果和人群层面的影响相联系。 • 不同级别的卫生系统如何收集和使用不同类型的信息。 • 需要测量的内容（例如，资源、服务量统计、覆盖率和质量、成本、项目相关结果）。 • 选择适当的指标。为了标准化并与其他类似项目进行比较，各项指标应与国际/国家 标准一致。指标数据的收集也应该是可行的和符合实际的。所确定的数据来源必须提供衡量 这些指标所需的信息。 确定监测和评估的方法 当你的团队制定了监测和评估计划、定义了指标、确定了必要的数据源后，就应该把相 应的数据收集和分析方法也确定下来。例如，你的团队应该确你是否将使用现有的数据收集 系统，或者是否需要开发新的系统。你的团队还必须确定如何记录、分析和报告相关信息。 此外，在确定要使用的方法和工具时，你的团队还应该仔细考虑技术能力、成本和时间方面 有哪些可用资源。 157 指定实施职责 在制定监测和评估计划之后，应该清楚地描述不同利益相关者的角色和责任。这一步骤 将决定如何具体实施监测和评估计划，以及采用何种报告体系。计划的实施应包括数据收集 计划（即由谁负责收集具体数据；确保各阶段的质量控制;收集数据的频率；数据的格式（例 如原始数据、摘要）；在每个阶段需要哪些资源;谁来分析数据）和传播计划。 设定目标 目标应该在与所有利益相关者协商后确定，以便每个人都了解项目承诺要实现的目标。 通过设定目标，你将有一个具体的衡量标准，通过它来判断项目是否按照预期进行。在设定 目标的过程中，必须着重回答以下问题：“鉴于项目所处的资源和环境条件下，该项目实际 上能达到什么目标？”需要考虑的因素包括：基线水平；既往趋势；专家意见；研究结果； 在其他地方已取得的成就；客户的期望；以及实现目标所需的能力和后勤保障。在设定具体 的项目目标时，你还需要对任何可能随着时间推移而出现的潜在变化方向做出判断。 定义报告系统，传播和利用结果 制定监测和评估计划的整个过程中，必须满足终端用户的信息需要，以确保研究项目的 结果得到利用。在监测和评估计划中，你的团队应该阐明传播和利用监测和评估结果的计划 （参见单元 5）。初步结果应在具有战略意义的用户会议和/或研讨会上准备和展示。信息应 根据特定利益相关者的利益和需求进行调整。相关信息将征集可能影响决策和项目改进的意 见和反馈。以下是计划信息报告及利用的一些切实考虑： • 围绕用户的信息需要设计监测和例如，是否需要监测和评估来监测流程?进行策略 规划?遵守要求?帮助识别问题?申请资金是否合理?或者进行影响评估?评估传播计划。需要注 意的是，数据报告的内容和格式将根据其预期用途而有所不同。 • 确定数据报告需求的频率。例如，项目管理者可能希望经常回顾监测和评估数据， 以评估项目进展并形成决策计划，而捐赠者可能一年只需要一次或两次数据，以确保责任。 • 针对目标受众定制相应的报告格式。由于报告可能涉及不同程度的复杂性和技术语 言，报告格式和媒体应根据特定的受众和不同的方法来征求反馈。 • 确定合适的渠道来传播监测和评估数据。既应考虑向管理部门提交定期项目报告和 向捐赠者提交进度报告等内部报告，也应考虑公共论坛、新闻稿、简报和网站等外部报告。 158 实施监测和评估计划 监测和评估计划的实施分为三个阶段，即：①检查和评估进度；②现状分析；和③对新 事件、机遇和问题做出反应。下面将对此作详细说明。 检查和测量进度 理想情况下，监测关注于项目的三个主要特征:质量、时间和成本。项目管理者负责协 调项目团队，并且应该时刻注意项目的状态。在检查和测量进度时，项目管理者应与所有团 队成员进行沟通，以查明计划的活动是否按时、在商定的质量标准和预算范围内得到实施。 衡量里程碑成果并反映项目的进展。 现状分析 监测的第二阶段包括现状分析。将项目发展状态与原计划进行比较，识别潜在偏差的原 因和影响。确定解决这些原因和任何偏差的影响的措施。 对新事件、机遇和问题做出反应 对新情况、新事件、新机遇和新问题进行预测并迅速做出反应，重点确定可能采取的行 动。可以的话，请考虑各种选择并与项目团队进行讨论，然后决定出最合适的路径。 调整/更新监测和评估计划 监测和评估计划应是动态的，并应始终反映已知和理解的事实。每当发现与原计划的偏 差时，无论是否需要采取进一步的措施，都应修订监测和评估计划，并将相应的变化记录在 案。修订后的计划应反映新情况，并应说明偏差对整个研究项目的影响。这对于有效实施和 与项目团队、捐赠者和所有利益相关者的良好沟通至关重要。调整监测和评估计划还有助于 项目预算和财务的管理。更新监测和评估计划包括将整个项目团队（关键利益相关者/合作 伙伴）纳入制定决策过程；在必要时修订工作计划（包括成本）；以及仔细记录所有调整。 将修订后的计划分发给所有利益相关者，包括相关的伦理审查委员会和机构审查委员会，强 调变更及其对项目的影响。你的团队必须在适当的情况下获得所有相关方对计划修改的批准。 下面是一些示例问题，可以帮助你的团队评估监测和评估计划的效果。 • 监测和评估活动是否按计划进行？ • 评估问题是否得到了充分的回答？ • 是否提出了新的评估问题，如果提出，是否应将其纳入监测和评估计划？ • 是否有需要解决的方法或评估设计问题？ • 是否有任何外部因素（政治、环境）影响监测和评估计划？ • 是否有合适的人员和资金来实施监测和评估计划？ • 监测和评估结果是否被利益相关者传播并用于决策和方案改进？ 159 四、关键概念的应用 下面的例子描述了研究团队和实现者在坦桑尼亚联合共和国（2003-2007年）制定扩大 使用驱虫蚊帐代金券的监测和评估计划所采取的 6个步骤。 案例：Hanson et al (2008) (1). 第一步:利益相关者咨询和参与 监测和评估战略是为坦桑尼亚国家补助计划合作伙伴安排的会议期间制定的。这些利益 相关方包括来自国家疟疾控制方案的官员、参与在坦桑尼亚开展驱虫蚊帐（ITN）分发活动 的团体以及来自 Ifakara 卫生研究和发展中心和伦敦卫生和热带医学学院的研究人员。在广 泛的协商和参与之后，商定了一项全面和多学科的监测和评估方法，以适应干预措施的新颖 性和复杂性，这涉及多个合作伙伴，并取决于卫生系统和零售部门。 第二步:制定监测和评估计划 研究人员和利益相关者制定一项监测和评估计划。目的是调查项目在五个主要领域的效 果：①在目标群体中的 ITN 覆盖率；②提供和使用生殖和儿童保健服务；③代金券“滥用” （即非目标群体收到代金券，以及代金券被用于购买 ITNs 以外的物品）；④驱虫蚊帐的贸 易市场；⑤方案的费用和总成本效益。他们还制定了衡量进展的指标。这些指标是由资助该 项目的全球抗击艾滋病、结核病和疟疾基金（GFATM）商定的。表 1 显示了各评估领域、 核心指标和数据来源。 第三步:确定监测和评估方法 该团队使用了三角测量的原理，即从多个来源收集数据。这些调查包括家庭、机构和离 境调查、焦点小组讨论和深度访谈、对 ITN 可用性数据的零售审计、商店零售价格、代金 券跟踪以及成本分析。 思考活动 使用表中的信息作为参考，完成下面的模板（表 2）并创建你项目 监测和评估计划的初始草案。 第四步:指定实施职责 由 IHRDC（Ifakara 卫生研究和发展中心）和 LSHTM（伦敦卫生和热带医学学院）的 独立研究人员进行监测和评估活动。行动包括收集和分析数据，并向实施者报告调查结果， 实施者包括国家疟疾控制方案和在该国参与实施 ITN 监测和评估活动的团体。有时，将监 测和评估活动外包出去可能是合适的。但是，如果研究团队正在实施干预措施，则整个团队 参与监测活动将是合适的。 160 表 1.评估领域和数据收集方法 评估领域 指标 调查 焦点小组访谈和 深度访谈 零售 普查 代金券 追踪 成本 分析 家庭 机构 离境 目标群体的覆盖范 围（所有权、使用） • 家庭拥有至少一个蚊帐/经杀虫剂处理的蚊帐； • 调查前，每晚睡在蚊帐下的人数。 X X X 生殖和儿童保健服务的 提供和使用，包括代金 券计划 • 目前/最近怀孕的妇女*参加生殖和儿童保健服 务； • 首次访视生殖和儿童保健服务时的平均妊娠周 数； • 收到代金券； • 接受1剂SP作为妊娠期间歇性预防治疗； • 接受2剂SP作为妊娠期间歇性预防治疗。 X X X X X 代金券外泄 • 能够确认、面谈并确认收到代金券的接收人的 百分比 X X 对ITN市场的影响 • 至少有一个经杀虫剂处理的蚊帐、杀虫剂零售 来源的地区的百分比 X X 成本和成本效益 • 每张代金券的成本； • 交付； • 每交付ITN的成本。 X X 计算了目前怀孕妇女和调查前 12 个月内活产的妇女的代金券覆盖率指标。 ITN=经杀虫剂处理的蚊帐；RCH=生殖和儿童健康;ANC=产前保健；SP=磺胺嘧啶；IPTp=妊娠期间歇性预防治疗 161 表 2. 评估领域和数据收集方法的模板 指出与项目相关的数据收集标准 第五步：设定目标 代金券项目的效果目标包括： • 测量代金券计划对孕妇及五岁以下儿童使用驱虫蚊帐的影响。 • 代金券计划中生殖和儿童保健服务的使用。 • 该计划对提供生殖和儿童保健服务的影响。 • 孕妇生殖和儿童保健服务的使用情况、代金券认识和使用情况、驱虫蚊帐使用情况 和孕期疟疾知识。 • 社区和供应商对该计划的看法。 • ITN 供应情况和指定商店的零售价格。 • 代金券“滥用”的程度。 • 代金券计划的经济和财政成本。 监测和评估的范围和确定的指标是根据现有资源确定的。例如，虽然这是一个国家项目， 但行动是在 21 个重点地区的代表性样本内进行的。没有衡量该项目对健康的影响（就预防 的死亡率和发病率而言）。更重要的是，在该国较早的一项研究中，在有效条件下证明了使 用 ITN 对发病率、死亡率和贫血的健康影响，因此认为在这种干预中没有必要。 评估 领域 指标 数据收集标准* 数据收 集技术 数据收 集技术 数据收 集技术 数据收 集技术 家庭 机构 162 第六步：定义报告系统，利用和传播结果 ①报告系统和传播结果 在前两年安排的会议上，向坦桑尼亚国家补助计划合作伙伴介绍了研究的各个部分的结 果。表 3 列出了每种主要数据收集方法的结果报告日期。 表 3. 按数据收集方法列出的具体报告日期一览表 ②研究结果的利用 关于研究结果的定期反馈有助于实施者在项目的早期发现问题。识别问题使研究团队能 够在必要时重新审视和修改其监测与评价战略，如表 4 所述。 表 4. 当前和新出现的问题及相应对策 识别问题 评估响应 实施者响应 代金券覆盖率相对较低 与后勤员工进行定性调查，以确定不 分发代金券的原因 为后勤员工重新制定培训 信息 代金券发放所需的产前卡和 代金券缺货 深度机构水平分析 与医疗用品司和MEDA合 作，改善供应链 在大多数地理上孤立的区域 中，代金券覆盖率相对较低 在随后的几轮调查中修改了调查工 具，包括关于产前保健外展服务的使 用和所接受的干预措施的问题 制定外展服务提供者分发 代金券的机制 ITN再治疗水平相对较低 进行定性调查，以确定接受代金券的 人对再治疗包的了解 修改杀虫剂处理信息，以 响应用户的知识和看法 对代金券价值认识不足 定性调查了解价值的价值 开发IEC材料以解决代金 券价值和充值问题 数据收集方法 报告结果时间 家庭及机构调查 2005年11月 零售审计 2006年1月 代金券追踪 2006年4月 关键线人访谈和焦点小组访谈 2006年8月 家庭调查及成本计算 2006年11月 零售审计及代金券追踪 2007年8月 家庭及机构调查 2007年11月 163 五、结论 祝贺完成单元 6 监测和评估的学习。最后一个单元为你提供了如何帮助你的研究团队根据既 定计划跟踪您的进度，检查是否符合既定标准，确定趋势和模式，调整策略并为项目管理提 供决策依据。本单元还描述了监测和评估计划的制定和实施中所涉及的过程。 六、参考文献 1. Hanson K et al. (2008). Vouchers for scaling up insecticide-treated nets in Tanzania: methods for monitoring and evaluation of a national health system intervention. BMC Public Health. 2008;8(1):205. (http://www.ncbi.nlm.nih.gov/pubmed/18544162, accessed 17 February 2014). 七、补充阅读 • Chaplowe SG. Monitoring and Evaluation Planning.” American Red Cross/CRS M&E Module Series. Washington, DC and Baltimore, MD. American Red Cross and Catholic Relief Services (CRS). 2008 • Developing a monitoring and evaluation plan. Wantirna. National Centre of Sustainability at Swinburne University of Technology. 2011. (http://evaluationtoolbox.net.au/index. php?option=com_content&view=article&id=20&Itemid=159, accessed 17 February 2014). • James T and Miller J. Developing a monitoring and evaluation plan for ICT for education. In: Monitoring and evaluation of ICT in education projects: A handbook for developing countries. Wagner DA et al, editors. Washington, D.C. infoDev (The World Bank). 2005. (http://www. infodev.org/articles/monitoring-and-evaluation-ict-education-projects, accessed 17 February 2014). • Developing and Implementing a monitoring and Evaluation plan PPT presentation Chapel Hill. Measure Evaluation (University of North Carolina). 2006. (http://www.cpc.unc.edu/measure/ training/materials/phn/m-e-of-population-health-and-nutrition-programs/course-modules/ week-2/How%20to%20Develop%20%20Implement%20an%20M-E%20Plan%20170706.ppt, accessed 17 February 2014). Implementation Research Toolkit Workbook