A guide to implementation research in the prevention and control of noncommunicable diseases

W HO /A nd re w Es ieb o A guide to implementation research in the prevention and control of noncommunicable diseases A guide to implementation research in the prevention and control of noncommunicable diseases A guide to implementation research in the prevention and control of noncommunicable diseases ISBN 978-92-4-151180-3 © World Health Organization 2016 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercial-Share- Alike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no sug- gestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Com- mons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the media- tion rules of the World Intellectual Property Organization (http://www.wipo.int/amc/en/mediation/rules). Suggested citation. A guide to implementation research in the prevention and control of noncommunicable diseases. Geneva: World Health Organization; 2016. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third- party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omis- sions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use. iii A guide to implementation research in NCDs Contents Acknowledgements ------------------------------------------------------------------------------------------------ iv Abbreviations --------------------------------------------------------------------------------------------------------v Executive summary ------------------------------------------------------------------------------------------------ vi 1. Introduction ------------------------------------------------------------------------------------------------1 1.1 Burden of noncommunicable disease --------------------------------------------------------------------- 1 1.2 Global response to NCDs ----------------------------------------------------------------------------------- 1 1.3 Purpose and objectives of this guide ---------------------------------------------------------------------- 1 1.4 Target audience ---------------------------------------------------------------------------------------------- 2 1.5 Achieving national goals and targets in relation to NCDs: The evidence-implementation gap -- 2 2. Implementation research -------------------------------------------------------------------------------5 2.1 What is implementation research? ------------------------------------------------------------------------ 5 2.2 Why is implementation research important? ------------------------------------------------------------ 6 2.3 Implementation and the implementation research cycle ----------------------------------------------- 6 3. Practical steps on how to undertake implementation research -----------------------------11 3.1 Identifying evidence-based policies and interventions that are appropriate to your local context ----------------------------------------------------------------------------------------11 3.1.1 Situation analysis: ascertaining the need for a policy or intervention ----------------------11 3.1.2 Knowledge synthesis: formally identifying and assessing relevant evidence --------------12 3.2 Adapting and piloting the policy or intervention -------------------------------------------------------19 3.2.1 Social validity: how acceptable is the policy or intervention in your local context? ------21 3.3 Evaluating the implementation of a policy or intervention -------------------------------------------22 3.3.1 What research questions should the implementation evaluation be asking? -------------22 3.3.2 What are implementation outcomes? -----------------------------------------------------------23 3.3.3 What are the moderators of the implementation of the policy or intervention? ----------25 3.3.4 Implementation strategies -------------------------------------------------------------------------25 3.3.5 How effective is the policy or intervention? ----------------------------------------------------26 3.3.6 How do you assess costs associated with implementation? ---------------------------------26 3.3.7 How do you use data for quality assurance and improvement? -----------------------------27 3.3.8 How to improve sustainability --------------------------------------------------------------------28 3.4 Scaling up a policy or intervention -----------------------------------------------------------------------29 4. Conclusions -----------------------------------------------------------------------------------------------33 Appendix 1. The PICO Framework for developing objectives and guiding knowledge synthesis ----------34 Appendix 2. Example of a matrix for the synthesis of relevant evidence ------------------------------------- 35 Appendix 3. Assessing the social validity of a policy or intervention ------------------------------------------ 36 Appendix 4. Assessing fidelity --------------------------------------------------------------------------------------- 37 Appendix 5. Decision support data system ------------------------------------------------------------------------ 40 References ------------------------------------------------------------------------------------------------------------ 41 A guide to implementation research in NCDs iv Acknowledgements This Guide was prepared by Fabrizio D’Esposito, Emma Thomas, and Brian Oldenburg of The University of Melbourne, Australia, under the coordination of Ruitai Shao and Cherian Varghese with the assistance of Yuxi Zhang, and with guidance from Alison Harvey and Etienne Krug, Department for the Management of Noncommunicable Diseases, Disability, Violence and Injury Prevention, World Health Organization (WHO). The following people provided helpful comments, expert technical review and case studies included in the guide: Professor Ross Brownson, Washington University in St. Louis, United States of America; Dr Nathan Grills, The University of Melbourne, Australia; Professor Liming Li, Chair of Board and Executive Vice President, Chinese Academy of Medical Sciences, Beijing, China; Dr Elezebeth Mathews and Professor KR Thankappan, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram, India; Dr Mark Miller, National Institutes of Health, Bethesda, USA; Professor Nihal Thomas and Dr Riddhi Dasgupta, Christian Medical College, Vellore, India and Dr Jacqui Webster, the George Institute for Global Health, Sydney, Australia. Valuable guidance to the development of this document was provided by the following experts: Dr Sania Nishtar, Professor David Peters, Professor Pekka Puska, Professor Srinath Reddy and Dr Cuilin Zhang. As participants in a WHO Ad Hoc Technical Meeting to Support the Work of the WHO Secretariat in Implementing Action 54 (research) of the WHO Global NCD Action Plan 2013–2020, 7–8 May 2015, these experts discussed the structure of the guide and provided inputs and suggestions during the process of developing this guide. Staff from WHO regional offices and headquarters reviewed the draft and provided technical support: Douglas Bettcher, Edouard Tursan D’espaignet, Albert Francis E. Domingo, Ophira Ginsburg, Andre Ilbawi, Belinda Loring, Bente Mikkelsen, Armando Peruga, Leanne Riley, Hai-Rim Shin, Nhan Tran, Menno Van Hilten and Temo Waqanivalu. WHO also acknowledges Ms Naima Reza in UK for technical editing of this guide, and Mr Jean-Claude Fattier in Switzerland for the cover design and layout. vA guide to implementation research in NCDs Abbreviations ACP Academias das Cidades de Pernambuco AS Academia da Saude CDC Centers for Disease Control and Prevention COTPA The Cigarettes and Other Tobacco Products Act FCTC Framework Convention on Tobacco Control GRADE Grading of Recommendations, Assessment, Development and Evaluation GRC Guidelines Review Committee GUIA Guide for Useful Interventions for Physical Activity in Brazil and Latin America HIC High-income country KDPP The Kerala Diabetes Prevention Program LMIC Low- and middle-income country MeSH Medical subject heading M-PACE Method for Program Adaptation through Community Engagement NCD Noncommunicable disease NPDCS The National Programme for Prevention and Control of Diabetes, Cardiovascular diseases and Stroke PICO Population, Intervention, Comparison, Outcome PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses T2DM Type 2 diabetes mellitus WHO World Health Organization A guide to implementation research in NCDs vi Executive summary Implementation research remains relatively new to population-based health programmes and is an area in which language and terminology are still being developed. In this guide implementation research is defined as “the scientific study of the processes used to implement policies and interventions and the contextual factors that affect these processes”. In other words, implementation research investigates the various factors that affect how a new policy or intervention may be used (or implemented) in real-life settings. As well as providing some context and introducing terminology, the guide covers the various steps needed to carry out implementation research, from the initial situation analysis (which ascertains the need for a policy or intervention) and knowledge synthesis (formally identifying and assessing relevant evidence) through to the four key parts of the implementation research cycle: identification of an appropriate policy or intervention; adaptation and piloting of the policy or intervention; implementing the policy or intervention and evaluating this; and finally, scaling up the policy or intervention. The guide explores the way in which the interplay between a policy or intervention and its local context (e.g. culture and language) can affect implementation. The importance of social validity and other key aspects of implementation, known as implementation outcome variables (reach, adoption, fidelity, implementation cost and sustainability), are discussed. Programmes are said to have social validity when they address problems considered relevant by consumers in a suitable way and have outcomes that are considered valuable. This social validity can be assessed qualitatively, e.g. through surveys and questionnaires. Programmes with poor social validity may need some adaptation, where elements of the policy or intervention other than key evidence-based kernels are modified. Reach is a combination of both the number of people reached by a policy or intervention and how representative they are of the target population. Better reach, in general, will lead to better impact. Adoption reflects willingness to initiate a programme (policy or intervention) and will differ with contexts and implementers as it is affected by the availability of resources and expertise etc. Meanwhile, implementation fidelity indicates how close the implementation of a policy or intervention is to that developed by the programme’s developers. Implementation costs include direct labour costs (associated with consumer- or implementer- contact), indirect labour costs (associated with the consumers and implementers but do not require direct contact) and non-labour costs (e.g. building space, printing of resources, etc.). Finally, the guide touches on sustainability and scale-up strategies, referring to a nine step guide for developing a scaling-up strategy. Overall this document aims to provide guidance, tools and examples for implementation research that support the effective implementation of NCD policy options and cost-effective interventions as proposed in the Global Action Plan for the Prevention and Control of Noncommunicable Diseases 2013–2020.1 1 For further information, visit: http://www.who.int/nmh/events/ncd_action_plan/en/ vii A guide to implementation research in NCDs Introduction 1 WHO /Andrew Esiebo 1A guide to implementation research in NCDs 1. Introduction 1.1 Burden of noncommunicable disease Noncommunicable diseases (NCDs) are noninfectious health conditions typically caused by genetic and/or environmental and lifestyle factors. As NCDs tend to be long-lasting or recurrent, they are sometimes also referred to as chronic diseases (1). Currently, NCDs account for almost two-thirds of deaths globally (2). Four main diseases account for the majority of deaths from NCDs: cardiovascular disease, chronic respiratory disease, cancer and diabetes. Importantly, these four NCDs share common behavioural risk factors including tobacco use, unhealthy diet, physical inactivity and harmful use of alcohol (2). 1.2 Global response to NCDs In 2011, the World Health Organization (WHO) published A prioritized research agenda for the prevention and control of noncommunicable diseases (3), which identified key areas of research relating to the prevention and control of NCDs. In September of that year, participants at the United Nations High-level Meeting on Noncommunicable Disease Prevention and Control recognized the existence of cost-effective interventions regarding the preventability of NCDs and the numerous opportunities for global action, and subsequently The Sixty-sixth World Health Assembly endorsed the Global Action Plan for the prevention and control of noncommunicable diseases 2013–2020 (4). This called upon international partners to take coordinated action to attain nine voluntary global NCD targets by 2025 – including a 25% reduction in premature mortality due to NCDs. One of the Global action plan’s main objectives focuses on research. This objective calls on stakeholders to promote and support: n national capacity for high-quality research related to the prevention and control of NCDs (and so increase the knowledge base for national, regional and global action); n the translation of high-quality NCD basic research into practice; n development for the prevention and control of NCDs. 1.3 Purpose and objectives of this guide Although some practical tools for facilitating the use of implementation research for the prevention and control of disease already exist, these mainly focus on communicable diseases.2 None exist specifically for NCDs. The main purpose of this guide is to provide practical guidance, tools and examples for implementation research so as to support effective implementation of NCD policy options and cost-effective interventions. Specific objectives of this guide are to: n raise awareness about the purpose and potential impact of implementation research; n assist countries to capture, collate and analyse information and to translate and adapt evidence-based policy options and interventions to local contexts; n help identify barriers to the implementation of policies and interventions; n help identify the best approaches to implementation research. 2 One such tool is the Implementation research toolkit, which was developed by the Special Programme for Research and Training in Tropical Diseases (TDR). The TDR is hosted by the WHO and the toolkit can be found at: http://www.who.int/tdr/publications/topics/ir-toolkit/en/ (accessed 14 October 2016). A guide to implementation research in NCDs 2 In this guide we provide an introduction to basic implementation research terms and concepts and briefly outline what implementation research involves. We have collated and summarized recent relevant evidence and provide links to resources for further information on many of the topics covered. The guide also includes case studies that showcase examples of the implementation of NCD prevention and control policies and interventions. At the end of the guide we provide some practical tools to support the implementation research process. 1.4 Target audience This guide has been written for programme implementers, health professionals (including researchers) and national health policy-makers who are involved in the selection and implementation of policies and interventions for the prevention and control of NCDs around the world. 1.5 Achieving national goals and targets in relation to NCDs: The evidence-implementation gap A major challenge in the prevention and control of NCDs has been that despite a wide range of global, regional and national plans, initiatives, policies and interventions, the impact on health outcomes still needs to be increased significantly. There is still a very notable ‘evidence-into-implementation (or action)’ gap. This translation gap – between research evidence and practice – is now very well recognized in many health fields (5-7). For example, a review of healthcare delivered to adults from the USA shows that up to 45% of patients fail to receive treatments that have been shown to be effective (7), while 11% receive treatments that are not needed or potentially harmful (7). Reducing the gap between evidence and practice is associated with reductions in morbidity and mortality (8-10) and reduced healthcare costs (11). Therefore, in recent years there has been increased attention on barriers to the translation of research and on how to develop evidence-informed implementation in order to improve patient outcomes (12-14). Evidence is now also needed on effective implementation of primary prevention of NCDs in different contexts through policies and intersectoral health promotion. 3A guide to implementation research in NCDs 2 Implementation Research WHO / WPRO /Nomin Lkhagvasuren 5A guide to implementation research in NCDs 2. Implementation Research 2.1 What is implementation research? Implementation research investigates the various factors that affect how a new policy or intervention may be used (or implemented) in real-life settings. Such research remains relatively new to population-based health programmes, so a common language and terminology are still being developed. For reference, key terms used in this guide are outlined below. Defined as… Further details Implementation A specified set of activities de- signed to put into practice a policy or intervention of known dimensions (15) Implementation processes are: n purposeful n described in sufficient detail to allow inde- pendent observers to detect the presence and quality of the specific set of implementation- related activities (16) Implementation research The scientific study of the pro- cesses used to implement poli- cies and interventions and the contextual factors that affect these processes (17) Investigates all aspects of implementation, including: n the uptake of evidence-based policies and interventions n activities used to put these into practice n factors that influence these activities n impact of factors on health outcomes Implementer(s) An individual (or group of indi- viduals) responsible for manage- ment of the implementation process Some examples: n policy-makers n health professionals n community-based organizations Consumers The group(s) of individuals that are targeted by an intervention, programme or a policy Typically, they: n are at high risk of developing NCDs, or n have a high prevalence of NCDs Context The setting within which a policy or intervention is to be imple- mented Includes all characteristics of said setting, for example: n stakeholders n social, economic and political environment n geographical setting n epidemiologic profile Knowledge synthesis The identification, assessment and collation of evidence This process: n relates to existing policies and interventions n aims to achieve a desired outcome Knowledge exchange The process of collaborative problem-solving This occurs throughout the implementation process be- tween: n researchers n decision-makers (including policy-makers) n consumers n other relevant stakeholders Knowledge translation The process by which relevant research information is made accessible and available Through interactive engagement with audiences, this is used for: n practice n planning n policy making A guide to implementation research in NCDs 6 Questions addressed by implementation research include: n Which policy or intervention is best for a new context? n What is the best way to implement it? n How can the target population be reached? n What factors might affect implementation and adoption? n How can the costs of implementation be minimized? n How can uptake and health outcomes be improved? 2.2 Why is implementation research important? One of the purposes of implementation research is to support the successful selection of policies and interventions that have been shown to be efficacious (16). It also helps identify how to implement these policies and interventions in contexts where populations and/or resources may differ from that where they were initially formulated and evaluated, and helps identify which components of a policy or intervention are needed to obtain intended outcomes. Moreover, when prevention and control efforts fail, implementation research can help identify whether failure was due to a policy/intervention being ineffective in the setting (intervention failure) or whether a so called good policy/intervention was deployed incorrectly (implementation failure) (18). In effect, implementation research is about learning how to optimize implementation, scale up promising strategies, evaluate impact and, importantly, how to sustain these strategies over the long term. Notably, implementation research has the potential to bridge the evidence-into-action gap. 2.3 Implementation and the implementation research cycle There is a growing number of theories and models describing implementation and the implementation research process (19-22). Implementation typically involves a stepwise, cyclical process (Fig. 1). The first step is to work with key stakeholders in order to define the specific health need and then identify an appropriate policy or intervention to address that need. The second step is adaptation of the selected policy or intervention to the local context and undertaking some piloting. The third step involves implementation of the adapted policy or intervention. The fourth and final step is assessing if the adapted policy or intervention can be more widely implemented or scaled up and, if so, defining the resources and further steps that will be required to achieve this (23, 24). In practice, the path from selection (step 1) through to scale up (step 4) is rarely direct, as it is usually determined by multiple stakeholders, the availability of resources and other contextual factors. Instead, it normally has numerous iterations involving going back and forth between two or more process steps. 7A guide to implementation research in NCDs 3 For further information, visit http://ktclearinghouse.ca/knowledgebase/knowledgetoaction STEP 4 SCALE-UP OF POLICY OR INTERVENTION STEP 1 IDENTIFICATION OF APPROPRIATE POLICY OR INTERVENTION STEP 3 EVALUATION OF THE IMPLEMENTATION OF POLICY OR INTERVENTION STEP 2 ADAPTATION AND PILOTING OF POLICY OR INTERVENTION Is the policy intervention appropriate for new contexts? What resources need to be mobilized for scale up and how will these be mobilized? How will knowledge be translated and exchanged effectively? How will appropriate policies and interventions be selected? How will relevant evidence be identified and assessed? How will a policy and intervention for a new setting be refined and translated? How acceptable is the policy or intervention? What are the barriers and facilitators of implementation? What is the reach of the policy or intervention? What is the adoption? How well is it implemented? What are the moderators of implementation? How effective is implementation? This cyclical process is often depicted in implementation models and frameworks. One commonly used framework is the Knowledge to Action Cycle outlined by Graham et al. (25). The KT Clearinghouse provides a range of resources, tools and information about this model.3 Figure 1. Implementation and the implementation research cycle 9A guide to implementation research in NCDs 3 Practical steps on how to undertake implementation research WHO/ Patrick Brown 11 A guide to implementation research in NCDs 3. Practical steps on how to undertake implementation research 3.1 Identifying evidence-based policies and interventions that are appropriate to your local context Before a policy or intervention is selected and implemented it is important to ascertain that there is a need for it and that there is enough high quality evidence to suggest that it will be effective in the local context. This process is outlined in the following subsections. 3.1.1 Situation analysis: ascertaining the need for a policy or intervention The selection of policies and interventions for NCD prevention and control typically starts with a situational analysis. This is an information-gathering process that helps understand the specifics of the NCD burden in a particular area (e.g. health needs, risks and local context).4 The situational analysis also provides an opportunity to garner intersectoral collaboration. The first stage of a situational analysis is usually to establish a group of relevant stakeholders – this includes implementers, potential consumers and other appropriate parties. The exact point at which this group is established and its composition depends on the local context; in some instances, the individuals who set up the situational analysis will have already done work on the topic and a group may already exist. The stakeholder group should then engage in knowledge exchange activities; this means that they should discuss the health problem and also collate and discuss evidence about environmental, behavioural and personal determinants related to the health problem. This stage helps identify which factors are modifiable and could be prioritized as targets of policies and interventions. The group should also discuss and clearly identify expected outcomes – such as changes in mortality, morbidity or prevalence of risk factors in a target population. Case study 1 (below) gives an example of a situational analysis carried out in India in relation to diabetes prevention. Case study 1: Situational analysis – Diabetes prevention, India Why this case study? This illustrates how a situational analysis was carried out in the state of Kerala, India in order to assess the need to implement a diabetes prevention programme. The situational analysis laid the foundation for the adaptation of diabetes prevention programmes from Europe, the USA and Australia to the local context. Title Carrying out a situational analysis for the implementation of NCD prevention and con- trol policies and interventions Source Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, India Health issue Type 2 diabetes mellitus Setting Trivandrum region in Kerala, India Target population Men and women at high risk of developing diabetes 4 It is beyond the scope of this guide to describe the situational analysis process and the establishment of multisectoral collaborations in detail. However, WHO has published a comprehensive resource on this process which can be found at: http://www.who.int/nmh/action-plan-tools/en/ (accessed 14 October 2016). A guide to implementation research in NCDs 12 Background India has approximately 65 million individuals with type 2 diabetes mellitus (T2DM) – the second-largest number for a single country in the world. This number is expected to double by 2030 (26, 27). Studies estimate that T2DM affects between 9% and 20% of the country’s adult population (28, 29). Kerala has the highest prevalence of T2DM, with up to 20% of adults estimated to have the disease in parts of the state (30, 31). Description of policy or intervention The Kerala Diabetes Prevention Program (KDPP) is a lifestyle intervention aimed at in- dividuals in rural areas of Kerala at high risk of developing diabetes. The programme is designed to reduce the risk of developing diabetes through a series of peer-led sessions held within local communities. Following training on diabetes prevention and group facilitation, peer leaders identified from within the community conduct small group sessions focused on increasing knowledge about diabetes and on prevention strate- gies. Sessions are supplemented with community-wide activities such as yoga, walking and gardening which help participants to put into practice the learning from the group sessions. What took place? A situational analysis was carried out prior to the development of the KDPP by triangu- lating evidence from: (i) previous research on the prevalence and control of diabetes in India and elsewhere; (ii) policy and other programme documents relevant to diabetes prevention specific to Kerala or India and (iii) a collection of novel qualitative data in Kerala through engagement with local stakeholders (including consumers) (32). Relevant published research was retrieved following PubMed searches using medical subject heading (MeSH) terms related to diet, physical activity, tobacco and health pro- motion interventions conducted in India. The search engines of relevant government department websites (e.g. of the Ministry of Health & Family Welfare) were used to retrieve relevant policy and programme docu- ments (including guidelines at both the state and national level on NCD prevention and control, diet, physical activity and tobacco and alcohol use). The qualitative research component consisted of focus groups (with pre-diabetic in- dividuals from rural areas of Kerala, identified from the database of an earlier survey (33) that explored perceptions and attitudes towards T2DM and its prevention). These group discussions helped to identify specific needs for cultural adaptation and for de- livery of the programme to target communities. What was learnt? The National Programme for Prevention and Control of Diabetes, Cardiovascular Dis- eases and Stroke (NPDCS) – with recommendations on diet and physical activity – only launched recently in India. This contrasts to the situation in high income countries (HICs), where most diabetes prevention programmes were implemented almost a de- cade ago. Despite the large burden of NCDs in the state and across the country, the situational analysis revealed gaps in NCD research and policy in Kerala/India. A review of epide- miological studies revealed a higher prevalence of risk factors for T2DM in Kerala than in the rest of the country (29), with some risk behaviours (such as smoking) higher than the national average. Adult physical inactivity during leisure time was also high (34). The focus groups highlighted the important role of families and cultural norms in mak- ing lifestyle choices in India. This underpinned the importance of developing a more integrated approach to behaviour change interventions than used in HICs. Multiple strategies involving family and community empowerment were called for – as corrobo- rated by other studies in India (32, 35-36). 3.1.2 Knowledge synthesis: formally identifying and assessing relevant evidence Implementing a policy or intervention that has only been shown to be effective in one research study can be problematic. Few studies by themselves are persuasive enough to change policy or practice; in fact, individual studies may even be misleading due to chance or bias (37). Therefore, after carrying out the situational analysis and identifying the health need and desired outcomes, implementers need to perform a formal synthesis of evidence on potential policies and interventions – termed a knowledge synthesis. 13 A guide to implementation research in NCDs Failure to use such a knowledge synthesis can lead to delays between the generation of research evidence about an intervention and the time when clinical experts make recommendations in line with research findings. For example, Antman observed a 15 year gap between the time when meta-analysis could have demonstrated the effectiveness of a particular method to treat myocardial infarction and widespread recommendations for its use (38). Stages of knowledge synthesis There is a growing range of methods for knowledge synthesis; most involve an initial review of existing literature. Depending on time, resources available, and other constraints, this literature review can be rapid or involve a lengthier meta-analytical process. These issues are explored in more details later in this guide; in this section, we highlight the common stages in knowledge synthesis (see Fig. 2) based on published frameworks (39, 40, 41). Fig. 2. The stages of knowledge synthesis Stage 1. Stating the objectives of the policy or intervention to be implemented Stage 2. Defining the eligibility criteria for evidence to be assessed Stage 3. Defining a search strategy to identify relevant evidence Stage 4. Searching for relevant evidence Stage 5. Assessing the quality of evidence found Stage 6. Assembling and analysing the most complete data set feasible Stage 7. Making an informed decision based on a structured report of the research Stage 1: Stating the objectives of the policy or intervention to be implemented The first stage in the knowledge synthesis process is to formulate the objectives of the synthesis; this is arguably the most important stage in the process and is partially informed by the situational analysis described earlier in Section 3.1.1. The more explicit the objectives (for example, in terms of how specifically the population or the intervention is defined), the more you will limit available evidence. On the other hand, making the objectives broader is likely to require more resources as there will be more evidence to sift through and assess. One method for devising objectives is summarized by the acronym PICO: n Population n Intervention n Comparison n Outcome For example, your objectives may be to identify evidence on approaches to the prevention of secondary heart attacks (outcome) in elderly men and women who live in rural areas (population). These are very A guide to implementation research in NCDs 14 broad objectives, so you may refine these based on information gathered during the situational analysis. For instance, the situational analysis may have revealed that the majority of people in your target population have access to mobile phones; you may therefore want to narrow your objectives by stating that you are seeking evidence on mHealth programmes (interventions) and their effectiveness compared with face-to- face secondary prevention services (comparison). The PICO model is very widely used and it is recommended by Cochrane (previously The Cochrane Collaboration) as a strategy for formulating questions and search strategies and for characterizing clinical studies or meta-analyses.5 Appendix 1 provides an example of PICO and a template to apply this to your context. Stage 2: Defining the eligibility criteria for evidence to be assessed In the second stage you should set the criteria that will determine whether you retain (and assess) a particular piece of evidence that you identify or whether you should discard it. This stage is partially guided by the objectives outlined earlier. First, you need to specify the characteristics of the evidence (e.g. research studies) that are to be included in your knowledge synthesis – in effect, the ‘eligibility criteria’. The following are typical: n the nature of what was studied (e.g. specific policies or interventions); n the context (in other words setting and population – e.g. adults; ethnic groups); n the date of research (e.g. ever; since 1920; since 1990); n the research methods (e.g. all methods; only empirical; only certain designs); n the language of report (e.g. English only; French only; both). Taking forward the scenario mentioned in stage 1 above, you might want to limit your search to ‘evidence on interventions that use information and communication technology for secondary prevention of heart attacks in men and women living in rural areas’. Ideally, you would also limit your search to evidence from your own country, although this may not always be possible as the evidence available may be too limited or nonexistent. In that case you may wish to look for evidence from the region (e.g. South Asia if you are based in Bangladesh; sub-Saharan Africa if you are based in Uganda; and so on). You also have to decide if you only wish to search for recent evidence (often the case, to ensure relevance) and if you want to include peer-reviewed studies that use randomized controlled designs only, or whether you also want to include grey literature.6 Stage 3: Defining a search strategy to identify relevant evidence After you have set the objectives for the knowledge synthesis, and after you have decided which evidence you will assess, you need to prepare the search strategy. This specifies the detailed method for conducting the search; it outlines exactly which terms (in a structured list) you will search for in databases, how these terms will be linked and what databases you will use. The search strategy should be grounded in the research question and should be recorded in detail. Your choice of key terms will be guided by the objectives. Bear in mind that the same concept may be referred to in a number of ways (e.g. self-esteem might be referred to as self-worth elsewhere). You therefore need to examine each of your concepts and develop a list of the different ways in which they could appear in the literature. You will also need to think about how your search terms may be linked. 5 For further information about PICO, visit: http://linkeddata.cochrane.org/pico-ontology (accessed 14 October 2016). 6 Grey literature is information that is unpublished or not published commercially; its value has been formally acknowledged by prestigious evidence- based research organizations, including Cochrane. Examples include (but are not limited to) conference papers, reports, policy statements, government documents, statistics, interviews and focus groups reports. Grey literature is particularly useful when the literature relating to polices and interventions of interest is limited in quantity and/or has limited applicability to the local context. 15 A guide to implementation research in NCDs Searches are usually conducted online, using existing research literature and/or policy databases. Key databases that are useful in the identification of relevant evidence include: n Cochrane Library: http://www.thecochranelibrary.com n The Joanna Briggs Institute Database of Systematic Reviews and Implementation Reports: http://joannabriggslibrary.org/index.php/jbisrir/index n Database of Abstracts of Reviews of Effects (DARE): http://www.crd.york.ac.uk/CRDWeb/ HomePage.asp n NICE Evidence Services: https://www.evidence.nhs.uk n PubMed Health: https://www.ncbi.nlm.nih.gov/pubmedhealth n WHO Library Database (WHOLIS): http://dosei.who.int Different databases work in different ways, so you may need to adapt your search strategy to each database that you use. This process is often referred to as ‘tailoring’ your search. You may also decide to develop separate search strategies for different aspects of your research. Note that implementers do not all always have access to all databases or to the evidence identified through the databases. This underpins the importance of establishing an intersectoral collaborative team from the outset (as mentioned in Section 3.1.1); ideally, this team will include academic researchers who will typically have access to most online databases and sources of evidence. When searching for relevant evidence there is a trade-off between sensitivity and specificity; specificity decreases as sensitivity increases. Searches that are highly sensitive will identify all or most of the relevant literature, however they will also likely identify literature that is not relevant. Searches that are highly specific will exclude all or most of the literature that is not relevant, however they may also exclude some of the literature that is relevant. The more sensitive the search, the more time needs to be spent sifting out irrelevant studies. Given that implementers are often time-constrained or resource-limited, some sensitivity may have to be sacrificed in the knowledge that some potentially relevant evidence may be missed. Defining a search strategy will benefit from the expertise of an information specialist. They can provide guidance on defining search terms that will help balance sensitivity and specificity. Stage 4: Searching for relevant evidence (applying the search strategy) This stage involves searching for all relevant evidence using the selection criteria identified and the predetermined search strategy for a specific database(s). The search will aim to identify as much of the literature that meets the inclusion criteria as possible. If time and resources allow, it is a good idea to have more than one person performing the same search independently, and then comparing the evidence identified to make sure that findings are consistent and there is no bias in the way that searches are made and evidence is selected. When searching for research evidence, it is important to ensure you consider which study design will best answer your research question. For example, a systematic review of randomized control trials is ideal if you wish to determine the best type of intervention to prevent or manage a condition. However, if you are wishing to know how common the problem is, then local and current random sample surveys (or censuses) would be more appropriate. The Oxford Centre of Evidence Based Medicine (OCEBM) provides a hierarchy of evidence depending on the research question.7 7 For further information, visit the OCEBM website: http://www.cebm.net/ocebm-levels-of-evidence/ (accessed 14 October 2016). A guide to implementation research in NCDs 16 Stage 5: Assessing the quality of evidence found The quality of evidence is likely to vary considerably. Therefore, you must decide on explicit criteria for appraising studies in order to separate those of higher quality from those of lower quality. Three main dimensions considered when appraising the quality and relevance of studies (41) are: n the methodological quality of the study; n the relevance of that research design to the objectives; n the relevance of the study focus to addressing the objectives. Checklists such as the Jadad scale (also known as the Oxford quality scoring system) are commonly used for assessing the methodological quality of trails (41). The Joanna Briggs Institute provides a range of different checklists to critical appraise other study designs.8 WHO uses the GRADE (Grading of Recommendations, Assessment, Development and Evaluation) approach to assess the quality of a body of evidence. WHO uses this approach as it represents internationally agreed standards for making transparent recommendations. Detailed information on GRADE is available through the WHO Guidelines Review Committee (GRC) secretariat and on the following websites: n GRADE working group: www.gradeworkinggroup.org n GRADE online training modules: http://cebgrade.mcmaster.ca n GRADE profile software: http://www.cochrane.org Other sources of information can also help you in assessing evidence: n The Trip Database9 is a medical search engine that allows you to search for evidence based on PICO and to find out about evidence by study design, relevance and timeline. n The Critical Appraisal Skills Programme (CASP)10 provides a range of training, workshops and tools to help you critically evaluate the quality, results and relevance of research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) is another widely used method to assess an evidence-based minimum set of items for reporting in systematic reviews and meta-analyses. PRISMA focuses on the reporting of reviews evaluating randomized trials, but can also be used as a basis for reporting systematic reviews of other types of research, particularly evaluations of interventions.11 Assessing evidence and developing evidence summaries using GRADE (or otherwise) is a specialized task that is best done by a methodological expert, so it may be prudent to enlist such help. This is especially important if you are assessing evidence for large scale NCD prevention and control policies. Nevertheless, if appropriate it is possible to assess the evidence more rapidly and in-house using the three dimensions listed above with existing online resources. Stage 6: Assembling and analysing the most complete data set feasible After assessing the evidence, you will have to collate and analyse all your assessments to determine if there are sufficient grounds to implement the policy or intervention that you are interested in. This is likely to be the stage that implementers, particularly policy officials, are most interested in. You should therefore ensure that output from the knowledge synthesis is presented in a clear format that meets their needs (for example, by drawing out policy implications). 8 For further information, visit: http://joannabriggs.org/research/critical-appraisal-tools.html 9 For further information, visit the Trip Database website: http://www.tripdatabase.com (accessed 14 October 2016). 10 For further information, visit the CASP website: http://www.casp-uk.net (accessed 14 October 2016). 11 For further information, visit the PRISMA website: http://prisma-statement.org/Default.aspx (accessed 14 October 2016). 17 A guide to implementation research in NCDs There are various approaches to collating, analysing and presenting the evidence you found; in Appendix 2 we provide a mock matrix which you can use to collate and rank evidence. Stage 7: Making an informed decision based on a structured report of the research Only when all available evidence has been collated and assessed, and evidence for the effectiveness has been ranked, is it possible to select a policy or intervention for adaptation to and implementation in your local context. Systematic reviews and other approaches to knowledge synthesis The guidance provided above is sufficient to identify and assess evidence relevant to the effectiveness of policies and interventions for an outcome of interest within a relatively short amount of time and with limited resources. A more rigorous approach to identifying, assessing and synthesizing evidence from numerous sources is to carry out a systematic review. Systematic reviews bring the same level of rigour to reviewing research evidence as should have been used in producing that research evidence in the first place. Using the systematic review approach, however, is time and resource consuming and is not usually possible in the circumstances where most programme implementers are seeking to implement a new policy or intervention (or to implement an existing policy or intervention in a new setting). A faster approach is that of rapid evidence assessment, which uses targeted literature searches to produce a report in a relatively short period of time. This is less rigorous than a full systematic review, but more so than an ad hoc search.12 It is well aligned with the approach described here. Case study 2 (below) provides an example of knowledge synthesis in practice. Case study 2: Knowledge synthesis – Tobacco-related NCDs and plain packaging policies, India Why this case study? This showcases knowledge synthesis in preparation for the implementation of to- bacco plain packaging policies and interventions in India. The case study also illustrates that, although there may be evidence for a policy or intervention’s effectiveness, it is important to take account of local context. Title Knowledge synthesis on plain packaging to assess existing evidence to promote the selection of evidence based policies and interventions for implementation in India Source Nossal Institute for Global Health, The University of Melbourne, Melbourne, Australia Health issue Respiratory diseases and other NCDs caused by tobacco Setting India Target population Individuals who use tobacco products Background Tobacco is responsible for 25% of deaths from respiratory diseases in India (42), which is the world’s second largest consumer of tobacco (smoking and smokeless forms) (43). The prevalence of tobacco use is 48% in males and 20% in females, with many others exposed to second-hand smoke (44, 45). Tobacco attributable deaths in India are expected to rise to 1.5 million annually by 2020 (46). It has been suggested that the cost of respiratory diseases attributable to tobacco in India in 2011 was US$ 600 million (47). In 2003 the Indian government, consistent with the WHO Framework Convention on Tobacco Control (FCTC) (48), passed The Cigarettes and Other Tobacco Products Act (COTPA). This prohibited tobacco-related advertising and sponsorship and specified health warnings on tobacco packs (49). However, the impact of these measures was limited (50), prompting the Indian Government to consider larger, more effective pictorial health warnings (4, 51-56). The next step would be plain packaging, for which there is growing international evidence. 12 The UK Government has developed and made available online a toolkit which provides additional information on rapid evidence assessment. This tool can be found at: http://www.civilservice.gov.uk/networks/gsr/resources-and-guidance/rapid-evidence-assessment/how-to-do-a-rea (accessed 28 November 2016). A guide to implementation research in NCDs 18 Description of policy or intervention Plain packaging entails the removal of all branding (colours, imagery, corporate logos and trademarks), with brand names mandated a uniform size and font and placed to- gether with current or enhanced graphic health warnings on the tobacco packaging. Plain packaging would apply to packaging of all forms of tobacco; in India this in- cludes beedis and chewed forms of tobacco as well as conventional cigarettes. The aim of plain packaging is to decrease the attractiveness of the package, enhance the effect of pictorial health warnings on the package, increase thoughts about quit- ting and promote negative attitudes towards tobacco use. Plain packaging of tobacco products has a significant evidence base from a number of countries (54, 57-60) – especially from Australia where it was first introduced. However, evidence on such packaging in rapidly developing countries such as India is relatively scant (61, 62). What took place? A joint Indian and Australian taskforce was convened with support from a small grant from the Australia India Institute. Following a comprehensive knowledge synthesis project, the taskforce produced a report on the possibility of plain packaging in India (60). The report included evidence from other jurisdictions, local market research on plain packages (63) and results from a stakeholder analysis undertaken with legal experts, policy-makers and tobacco control experts. It summarized all the behavioural, politi- cal and legal evidence and provided graded recommendations as to the way forward. The report was launched at a high level event attended by politicians from India, WHO representatives, leading tobacco control experts and legal experts. In response, a private members bill on plain packaging was introduced to the Indian parliament in 2013 and a follow up international conference was also held at which the Indian health minister and health secretary gave presentations. However, a number of contextual barriers have slowed progress on plain packaging. These include a change of government and health ministers, a demand for local evi- dence and opposition from a significant tobacco farming industry in India. Further research is planned to respond to these concerns and produce additional local evi- dence. What have we learnt? While external (international) evidence and the input of international experts is a helpful start in formulating policies, it is not sufficient for successful policy change. To increase the chances of the knowledge synthesis leading to a change in policy, the following points are useful: n It is important to know the specific audience for whom the knowledge synthesis is being undertaken. n Research needs to take account of the policy-making timetable – e.g. regulatory committee meetings or election cycles. n A mechanism is needed to ensure the knowledge synthesis is fed to the appro- priate groups to inform debate and policy. In particular, a clear communication strategy is needed to reach decision-makers. n The knowledge synthesis team need to involve credible figures to maximize the likelihood of evidence reaching decision-makers. (In this example, two coinves- tigators sat on government advisory committees). n Contextual information can often result in a need to include and/or produce unique evidence in addition to that available from other jurisdictions. (For ex- ample, in this case the tobacco products and industries of Australia and India were very different, so further information was needed). Finally, note that while the stages of knowledge synthesis outlined above will help to identify policies and interventions that may be pursued in the prevention and control of NCDs, they may not provide information about transferability of these to new and different contexts. Approaches to the assessment of suitability and adaptation of policies and interventions to new contexts are discussed later in the guide. 19 A guide to implementation research in NCDs 3.2 Adapting and piloting the policy or intervention The interplay between a policy or intervention and its local context can impact both its implementation and its effectiveness (64, 65). For example, differences in culture, language, age and socioeconomic status of the target population can – and often do – influence successful implementation of a policy or intervention either positively or negatively (66). This means that a policy or intervention may need some adaptation. Adapting a policy or intervention to the context in which it will be delivered is a delicate balancing act: on the one hand adaptation is crucial to ensure relevance to the local context, improve feasibility, increase local pertinence and adoption, encourage fidelity, foster sustainability and maximize effectiveness; on the other hand, one has to be careful not to modify the policy or intervention so much that fidelity to some of the core components of the policy or intervention is lost and effectiveness is threatened. Guidelines on the adaptation of interventions typically share the following steps: n identifying differences between the population for which the policy or intervention was initially designed and the new target population; n identifying which component(s) of a policy or intervention need to be adapted; n making modifications to the policy or intervention; n piloting the modified policy or intervention. The Method for Program Adaptation through Community Engagement (M-PACE) developed by Chen et al. (66) outlines a way of systematically adapting interventions to a new setting. This involves convening an adaptation steering committee (including experts who can advise on whether an element of a policy or intervention can be changed without reducing effectiveness) and then exposing a limited group of participants to the unadapted intervention. This is followed by collecting participant and instructor feedback after each implementation session (if appropriate), or conducting a pilot through individual interviews and then conducting focus groups with participants and instructors at the end of the intervention (or pilot). Further details about M-PACE can be found in reference (66). When adapting a policy or intervention it is important to know that certain elements are essential for desired outcome(s). These elements are known as evidence-based kernels and can be likened to a drug’s active ingredients, without which its effects would be lost (66). Therefore, as far as possible, these kernels should not be modified. However, methodically determining the kernels of a policy or intervention is not typically feasible – it requires the same intervention to be implemented multiple times, with the presumed kernel being changed each time the intervention is reimplemented while other variables are kept constant. Although research teams have successfully articulated and validated the kernels of some programmes (63, 67-70), there are few adequately defined programmes in the research literature. The amount of evidence for evidence-based kernels in different fields should grow with increasing recognition of the importance of implementation research. The case study below gives an example for how an intervention was adapted to the local context. Case study 3: Adapting interventions – Hypertension, Mongolia Why this case study? This case illustrates the importance of adapting interventions to the local context and piloting them prior to scale up. The case study also highlights some of the barriers and facilitators to the adaption and piloting process and proposes ways in which to address these. Title Adapting policies and interventions to new contexts Source The George Institute for Global Health, Sydney, Australia Health issue Hypertension and comorbidities A guide to implementation research in NCDs 20 Setting Mongolia Target population General population of Ulaanbaatar (Mongolia’s capital city) Background Population-wide salt reduction programmes are widely viewed as one of the most cost-effective interventions for the prevention of hypertension and associated NCDs. The number of such national programmes has almost doubled between 2010 and 2014 and programmes are now being implemented in most regions of the world. However, to date, most of those that have demonstrated an impact are from HICs. There is some way to go to translate the lessons from these countries to low and me- dium income countries (LMICs). Description of policy or intervention Successful salt reduction programmes identify the main sources of salt in the diet and then develop a strategy to reduce them. The Ministry of Health in Mongolia (MMoH) implemented a pilot intervention to re- duce population salt intake in Ulaanbaatar during 2012–2013. The results of this pilot, combined with a series of other initiatives, informed the development of a National Salt Reduction Strategy. What took place? The MMoH established an intersectoral working party and organized a two-week national consultation and training programme on salt reduction. Actions arising in- cluded implementation of a pilot salt reduction intervention. The main objective of the pilot intervention was to reduce salt intake of the em- ployees of three factories, based on the notion that simply telling people what they should/should not eat does not work – the food environment also needs to change. Adapting this to the Mongolian context, implementation strategies included training employees on the negative health impact of salt and on consuming a healthy diet, as well as actually reducing salt levels in the food served in company canteens/kitchens. Pre- and post-intervention monitoring showed that salt intake reduced between 2011 and 2013. The number of people that did not know which foods were high in salt also declined substantially during the same period. These activities demonstrated the potential for action and helped to convince policy- makers to scale up the policy to national level, resulting in the Mongolian National Salt Reduction Strategy being endorsed by the government in 2015 – with the ultimate goal to reduce population salt intake in Mongolia by 30%. What have we learnt? Success of the pilot intervention and scaling up of the policy to national level was pos- sible for a number of reasons: n The importance of multisectoral action was recognized from the outset. n The project emerged from consultation and training on salt reduction and raised awareness of the health impacts of salt. n The approach started by trying to understand the main sources of salt in the diet and how best to reduce them (rather than simply replicating salt reduction initia- tives from other countries). Lessons for other countries: n Do not just replicate other programmes. A good understanding of how consump- tion patterns are contributing to salt intake in the country of interest is also need- ed. n Do ensure that your strategy is multifaceted, combining a change of the food en- vironment together with programmes to change consumer behaviour. n Do continue with advocacy programmes to ensure strong government support and adequate financing. n Do establish effective multisectoral stakeholder engagement, community partici- pation and training procedures from the outset. n Do, where possible, implement pilot interventions. n Do not leave evaluation until the end of the programme. Regular monitoring en- sures programmes are on track to achieve targets. 21 A guide to implementation research in NCDs 3.2.1 Social validity: How acceptable is the policy or intervention in your local context? Despite a policy or intervention being highly effective at achieving a desired outcome, its implementers and/or consumers may consider it inappropriate for a particular setting. In order for a policy or intervention to achieve intended outcomes in the practice setting, it must be both effective and socially valid. A programme is said to have social validity when it addresses problems considered relevant by consumers, it does so in a manner that consumers can enjoy or at least tolerate, and it produces outcomes that are considered valuable (71). A social validity assessment can provide information regarding how well specific elements of a policy or intervention are liked or disliked. Most current approaches define three elements of a policy or intervention that can be assessed for their social validity. These are: (i) the social significance of the goals of policy or intervention, (ii) the social appropriateness and acceptability of the policy or intervention’s procedures and (iii) the social importance of the effects or the outcomes produced by policy or interventions. Most methods for assessing social validity ask parties other than policy-makers or researchers about their opinions on policies and interventions (71) and use questionnaires/rating scales and focus groups or interviews (72). One common approach with questions on each of the three elements of social validity (73) is provided in Appendix 3. This qualitative approach can be combined with quantitative data collection (e.g. by survey) if necessary. Case study 4: Establishing acceptability – Respiratory diseases, Senegal Why this case study? This illustrates the negative consequences of implementing an effective intervention without first assessing acceptability in a new context. Title The importance of establishing acceptability Source Beltramo T, Levine DI. The effect of solar ovens on fuel use, emissions and health: Re- sults from a randomised controlled trial (74). Health issue Respiratory diseases Setting Senegal Target population Households where cooking is conducted using solid fuels Background Traditional stoves for cooking and heating in LMICs are frequently fuelled with dung, coal and wood. The smoke resulting from burning such solid fuels pollutes the air and has been linked to a range of respiratory and other diseases. Improved stoves have the potential to reduce exposure to household air pollution and so improve health outcomes. One such improved stove is the solar oven. During laboratory testing in highly controlled contexts, solar ovens frequently show positive results and do not emit any emissions. However, studies in real-world contexts are far less promising. Description of policy or intervention A phased, randomized controlled trial to test the effects of a solar oven called ‘the HotPot’ was carried out in Senegal. What took place? The solar oven was provided to 465 households. After six months, the intervention group had just as high carbon monoxide exposure as the control group and there was no reduction in self-reported health symptoms. In the laboratory these stoves were shown to be effective – so what went wrong? The study showed poor levels of adoption of the HotPot, with households using the stove very infrequently. A major reason for this was that the solar oven was far too small for the majority of households in the study. Other studies (75) indicated additional reasons for solar oven unacceptability to com- munities: cooking could take longer, the ovens could not be used for heating and light, and the oven might need be used outdoors during sunlight. What have we learnt? Adoption of new technologies is challenging and interventions must be tailored to the needs and preferences of communities in order to succeed (76). A guide to implementation research in NCDs 22 3.3 Evaluating the implementation of a policy or intervention Typically, evaluation efforts have focused on assessing how effective NCD policies and interventions are at achieving health improvement at the individual or population level. Assessing the effectiveness of a policy or intervention, however, is not sufficient. Planning and focused efforts to evaluate the implementation of NCD policies and interventions must also be in place. Thus, the evaluation should look at the implementation of policies and interventions as well as their effectiveness. Put simply, the focus of an evaluation of the implementation process is on the types and quantities of policies and interventions delivered, the beneficiaries of those policies and interventions, the  resources used to deliver the policies and interventions, the practical problems encountered, and the ways in which such problems were resolved. The steps involved in planning an evaluation of the implementation process are analogous to those for planning an evaluation of effectiveness. Evaluation of the implementation process must be addressed early in a programme’s planning process, or else the collection of relevant data could be compromised or even missed. Public Health Ontario has devised ten steps for conducting an evaluation (77); we have adapted these below so that they are inclusive of implementation processes and effectiveness:1. Clarify what is to be evaluated.2. Engage stakeholders.3. Determine your evaluation questions.4. Develop an evaluation framework.5. Determine appropriate methods of measurement and procedures.6. Develop an evaluation plan.7. Collect data.8. Process data and analyse results.9. Interpret and disseminate results.10. Apply evaluation findings. 3.3.1 What research questions should the implementation evaluation be asking? Key questions should be designed in order to assess implementation research or to report on implementation research. For example: n What specific policy or intervention was put into place by the implementers in order to address the NCD issue being tackled? n To what extent was the policy or intervention implemented as intended? n To what extent was the policy or intervention adopted by implementers? n What are the factors that can influence how well a policy or intervention is implemented? n To what extent did these factors influence how well a policy or intervention is implemented? n What is the association between the health outcomes (i.e. effectiveness) of a policy or intervention and how well this is implemented? n Was the implementation approach that was used cost effective? 23 A guide to implementation research in NCDs Peters et al (78) have developed a useful table which can help develop the research questions for evaluations.13 3.3.2 What are implementation outcomes? In implementation research studies, implementation outcomes describe the intentional actions to deliver a policy or an intervention (18, 78); they are distinct from, but related to, health outcomes. Implementation outcome variables include: acceptability, reach, adoption, fidelity, implementation cost and sustainability. Acceptability has been covered in Section 3.2.1; cost and sustainability are discussed later in Sections 3.3.6 and 3.3.8, respectively. In the following subsections we will focus on reach, adoption and fidelity. What is the reach of the policy or intervention? Reach is defined as the absolute number, proportion and representativeness of a study sample (79). Population impact is a function of how well a policy or intervention is implemented, its effectiveness at the individual level and its reach. For example, the population impact of a smoking cessation programme depends both on how many smokers are reached and try to stop smoking, and what the average success rate is. Research indicates that in this example the reach of the programme has much greater impact, since the success rate seems to vary less. Reach is a combination of both the number of people reached by a policy or intervention and how representative they are of the target population. Most studies report the size of the study sample and the proportion of individuals who are willing to participate, but few report on representativeness (which indicates the similarities and/or differences between those who participate in the study and those who are eligible but do not). The representativeness is important, as generalization of an intervention into real-world settings is likely to have better impact if sample representativeness – and therefore reach – is good. Comparisons for representativeness should be based on basic demographic characteristics and, when possible, on primary outcomes. Case study 5 (below) explores the issue of reach. Case study 5: Considering reach – Diabetic foot, India Why this case study? This illustrates the importance of assessing reach to ensure that populations with the greatest health need are reached by a new policy or intervention. Title Why do we need to assess reach as well as effectiveness? Source Christian Medical College, Vellore, Tamil Nadu, India Health issue Diabetic foot Setting Integrated Diabetes Foot Clinic, Department of Endocrinology, Diabetes and Metabo- lism, Christian Medical College, Vellore, Tamil Nadu, India Target population Type 2 diabetes mellitus patients affected with diabetic foot problems Background Diabetic foot problems are the most common reason for hospitalization of diabetic patients and absorb some 20% of the total healthcare costs of the disease, more than all other diabetic complications put together. Treatment involves footwear modifica- tion and offloading (i.e. reducing pressure on affected areas of the foot). 13 The table can be found here: http://www.bmj.com/content/347/bmj.f6753 (accessed 14 October 2016). A guide to implementation research in NCDs 24 Description of policy or intervention An Integrated Diabetes Foot Clinic was set up in 2008 at the Christian Medical College in Vellore, India, with a core team of endocrinologists, diabetes nurse educators, vas- cular surgeons, physiotherapists and orthotists. The clinic was equipped with tools for the diagnosis and treatment of diabetic foot, and radiological investigations were completed and reviewed within the same day. Meanwhile, patient-specific footwear was developed at the Prosthetics and Orthotics Centre. In 2015, a retrospective study was carried out on 138 patients to assess the utility of low-cost footwear modifications (such as anterior rocker modifications) in reducing ulcer healing time. What took place? Over half of the group of patients using the anterior rocker modification had healed fully within 8–12 weeks; those noncompliant with or without anterior rocker foot- wear had a prolonged healing time of 4–6 months. What have we learnt? Adequate foot care and offloading techniques remain inaccessible for a significant proportion of diabetic patients due to socioeconomic factors and lack of awareness, leading to amputations and healthcare expenditure. So, although treatments may be effective their reach may be limited. The care provided at the clinic had a greater reach. The study indicates that use of simple diagnostic criteria and development of cost-effective modifications such as the anterior rocker significantly reduced healing time and hence reduced economic burden. What is the adoption of the policy or intervention? Adoption has been defined as the absolute number, proportion and representativeness of settings (contexts) and intervention agents (implementers) that are willing to initiate a programme (policy or intervention) (79). Different contexts (e.g. worksites, medical offices, schools, communities, etc.) and implementers (e.g. health practitioners, policy-makers, government staff, researchers, etc.) can differ in their adoption of a policy or intervention, as this is affected by the availability of resources, the level of expertise and the commitment to programmes. Researchers seldom report on issues of adoption, but understanding how adoption varies among different contexts and implementers is critical to the impact of a policy or intervention. The approach to measuring adoption should change depending on the policy or intervention, as well as on whether adoption at the context level or implementer is of interest. Providing detailed guidance on the many tools and approaches for the assessment of adoption is beyond the scope of this guide. The National Institutes of Health in the United States of America, however, maintains the Grid-Enabled Measures Database14 – a database of measures that are used to assess adoption (as well as other implementation outcomes). What is the fidelity of the policy or intervention? Implementation fidelity refers to the extent to which a policy or intervention is delivered as intended by its developers and in line with the programme model (80). Evaluation of implementation fidelity is important because it may affect the relationship between an intervention and its outcomes. It may also: n prevent potentially false conclusions from being drawn about an intervention’s effectiveness in achieving the intended health outcomes; n help in the achievement of improved outcomes; n give primary researchers confidence in attributing health outcomes to the intervention; n give evidence-based practitioners confidence that they are implementing the chosen intervention properly; n give secondary researchers more confidence when synthesizing studies (81). 14 Please see: https://www.gem-measures.org/public/ConstructDetail.aspx?cat=1&cid=1193&tab=1 (accessed 14 October 2016). 25 A guide to implementation research in NCDs Two aspects of interventions affect fidelity (81) – structural and dynamic. n Structural aspects – e.g. adherence to basic programme elements such as hiring high-quality staff or providing participants with the recommended service dosage and duration. n Dynamic aspects – these relate to quality and content of the relationship between the implementer and the consumer. There are also two primary components to implementation fidelity – initial and ongoing fidelity. n Initial fidelity – reflects the implementer’s ability to meet the initial requirements for implementing a new policy or intervention in a new site, e.g. compliance with all training requirements. n Ongoing fidelity – reflects the implementer’s ability to maintain the implementation and reporting standards of the intervention once a particular site is operational, e.g. the ability to consistently implement an intervention. Assessment of the dynamic aspects of fidelity may require the development of unique fidelity criteria that relate to the components of policies and interventions being evaluated. These should be objective and measurable (82, 83). Appendix 4 provides templates for the development of tools for the assessment of structural and dynamic fidelity. 3.3.3 What are the moderators of the implementation of the policy or intervention? As already mentioned, the interplay between a policy or intervention and the context within which it is implemented is complex. Various moderating factors – moderators – can affect the fidelity with which a policy or intervention is implemented; the effect can be positive or negative. Moreover, these moderators interact with each other, and the effect of one moderator on fidelity might be influenced by another moderator. Factors identified as potential moderators of effective programme implementation include: complexity of the intervention, facilitation strategies, quality of delivery, consumer characteristics and responsiveness (81, 84, 85) as well as individual practitioner characteristics (86-88), organizational supports for innovation (19, 96, 100) and implementation support strategies (64, 86, 87). Active and integrated approaches by those developing/supporting the implementation process (15, 64) and the broader context may also influence implementation (89-91). Therefore, social systems, interorganizational linkages and historical/concurrent events should be taken into account when assessing programme implementation (89). 3.3.4 Implementation strategies Implementation strategies can be defined as methods to enhance the adoption, implementation and sustainability of a policy or intervention (92, 93). For example, they can include methods for training implementers, intervention-specific toolkits, checklists and algorithms as well as formal practice protocols and guidelines. It is crucial that implementation strategy-related efforts are assessed when evaluating implementation. For example, the training of healthcare workers may be an implementation support strategy when implementing a community-based intervention to control hypertension; in this case the evaluation protocol would assess the training provided (e.g. its frequency, duration, perceived quality), its effect on workers’ knowledge and skills, and other contextual factors such as pre-existing skills. Successful implementation strategies have been identified in a review on ways to improve health service delivery in LMICs (94); a list of these can be downloaded from here: http://hdl.handle.net/10986/12335. A guide to implementation research in NCDs 26 Frameworks are available to enable you to systematically determine the barriers and enablers of implementation. One such commonly used framework is the Theoretical Domains Framework. The framework assesses 14 broad domains including: ‘knowledge’, ‘skills’, ‘social/professional roles’, ‘environmental contexts and resources’ and ‘social influences’(95). 3.3.5 How effective is the policy or intervention? Indicators used to assess the effectiveness of a policy or intervention are determined by the anticipated health outcome. For example, effectiveness of a diabetes prevention intervention is determined by assessing diabetes incidence in the population of interest, while the effectiveness of a new policy to encourage physical activity in schools may be determined by assessing the levels of high intensity exercise carried out by students. Given the huge variety of health outcomes assessed in NCD prevention and control, and given the objectives of this guide, it is beyond the scope of this guide to explore the wide range of tools and methods for the assessment of health outcomes. Note that effectiveness is affected by implementation. Therefore, when assessing the effectiveness of a policy or intervention we are not assessing the intervention’s absolute effectiveness – but are only assessing its effectiveness as implemented. As such, it is inadequate to conclude that a policy or intervention is effective per se without providing information about its implementation; the same policy or intervention could be implemented elsewhere with very different health outcomes. Also note that implementation outcomes differ from clinical treatment outcomes, and both should be assessed (15, 95, 97). Implementation outcomes have three important functions. First, they serve as indicators of the implementation success. Second, they are proximal indicators of implementation processes. And third, they are key intermediate outcomes (86) in relation to service system or clinical outcomes in treatment effectiveness and quality of care research. 3.3.6 How do you assess costs associated with implementation? Economic evaluation within healthcare generally compares two or more intervention options in relation to their cost and consequences. Commonly used methods include cost effectiveness, cost-utility and cost- benefit analysis. Assessing the economics of an implementation strategy poses slightly different questions. An implementation strategy generally comes with additional costs. Therefore, the key economic question is whether the relative costs associated with the implementation strategy lead to a justifiable level of enhanced outcome as compared to usual/routine methods (98). If enhanced implementation can be shown to lead to improved service delivery and also result in improved client outcomes, then these may be more cost effective than usual care. Such information is crucial for policy- and decision-makers, managers and service providers. The total costs of the intervention are estimated as a ratio of the outcome. This has been described using the following ratio (98): Implementation Cost  effectiveness  ratio = Cost!"#$%"%&'(')*&  !"#$"%&'   − Cost!"#$%  !"#$"%&' Outcome!"#$%"%&'(')!"  !"#$"%&'   − Outcome!"#$%  !"#$"%&'   Implementation Cost  effectiveness  ratio = Cost!"#$%"%&'(')*&  !"#$"%&'   − Cost!"#$%  !"#$"%&' Outc m !"#$%"%&'(')!"  !"#$"%&'   − Outcome!"#$%  !"#$"%&'   27 A guide to implementation research in NCDs ‘Cost’ may include: n direct labour costs – costs associated with consumer- or implementer- contact (e.g. the time cost of having a clinician coach a consumer through a new health app or deliver a training programme to service delivery staff); n indirect labour costs – additional costs associated with the consumers and implementers which do not require direct contact (e.g. developing resources or planning for the intervention); n non-labour costs – additional overheads and resource costs associated with the intervention (e.g. building space, printing of resources, etc.). ‘Outcome’ may include: n consumer-level health outcomes; n implementer-level outcomes – associated with the intervention (e.g. enhanced communication, collaboration and/or service delivery). Additional benefits may be seen in the timeliness of care. Systematic implementation incurs costs above that of the intervention itself, with the bulk of this cost currently being borne by implementers (e.g. provider organizations). However, economic evaluation is relatively new to the field of implementation and there is a paucity of literature on the topic. The research base around economic evaluation of implementation therefore needs to be developed. If studies reveal added benefits of a particular implementation strategy above usual practice, then policy- and decision- makers will need to think about getting additional resources to successfully implement the strategy (98). 3.3.7 How do you use data for quality assurance and improvement? Collecting and utilizing data: n guides quality assurance; n provides information on the implementation and effectiveness of a policy or programme as implemented; n builds on the evidence available to other implementers. The following need to be in place to effectively collect, utilize, and share data: n an adequate decision support data system; n adequate capacity among programme implementers to use, interpret and translate data appropriately. Decision support data systems are sources of information used to help make good decisions internal to an organization. They are an important part of continuous quality improvement for policies and interventions. When setting up a decision support data system it is important to be clear about the data to be collected, where the data will be sourced from, and who will be responsible for data collection. It is also important to establish how the data available will be used for quality assurance and improvement. If the feedback loops (staff performance evaluations and decision support data systems) indicate that changes are needed, then the organization adjusts the integrated system to improve effectiveness and efficiency. A template for guidance through some of these issues is provided in Appendix 5. A guide to implementation research in NCDs 28 3.3.8 How to improve sustainability In order to maximize the health impact of NCD research, effective policies and interventions must be well implemented and well sustained. Too often, effective policies or interventions suffer from a so called innovation–evaporation effect – where they are not sustained after the initial implementation period (99). The following are all factors for failure to sustain a policy or intervention (98): n not adapting intervention approaches to the local context n resisting the introduction of new practices due to capacity constraints n a lack of human resources n intervention costs (and other economic factors) n insufficient investment in implementation infrastructure (including in training, monitoring and evaluation systems) n staff recruitment and staff turnover n lack of political will Important elements of successfully sustained interventions include: n Sustainability planning: l It is crucial that sustainability and long-term continuation of the intervention is planned for and considered during all aspects of implementation. l Requires a well-defined scale-up strategy. l Includes developing strategies for integration into existing services. n Leadership and engagement: l A key ingredient for the long term success of NCD policies and interventions is strong and sustained political leadership at the highest national and international levels. l Government sectors besides health all have to be part of the government response – e.g. finance, agriculture, justice, education, urban design, transport, foreign affairs and trade; civil society and the private sector also have a part to play (101). l Implementers need to be able to understand and manage competing interests and stakeholders and to avoid the rise of conflicts of interest. n Communicate the ongoing impact of the change to stakeholders. This requires: l an effective communication strategy; l strong advocacy (there should be tools/organization links for this); l establishment of monitoring and evaluation systems. n Formalize and standardize the change: l Embed the change within organizational structures and processes (e.g. within policies). l Remove old ways of doing things. n Training / capacity building / linking with other organizations: l This needs infrastructure to support implementation – e.g. training, delivery systems and technical resources. n Keep the intervention simple: l In this way, key stakeholders and the target audience are more readily able to understand, engage and scale up the intervention (98). 29 A guide to implementation research in NCDs 3.4 Scaling up a policy or intervention An approach to working with country teams to scale-up strategies has been developed by ExpandNet15 in collaboration with WHO. This approach entails a nine step guide for developing a scaling-up strategy16:1. Planning actions to increase the scalability of the innovation2. Increasing the capacity of the user organization to implement scaling up3. Assessing the environment and planning actions to increase the potential for scaling-up success4. Increasing the capacity of the resource team to support scaling up5. Making strategic choices to support vertical scaling up (institutionalization)6. Making strategic choices to support horizontal scaling up (expansion/replication)7. Determining the role of diversification8. Planning actions to address spontaneous scaling up9. Finalizing the scaling-up strategy and identifying next steps Please refer to the guide for further information. Some other useful sustainability planning tools can be found here: n Program Sustainability Assessment Tool developed by the Centre for Public Health Systems Science at George Warren Brown School of Social Work: https://sustaintool.org/assess (accessed 14 October 2016). n Ontario Health: Implementing and sustaining changes: http://www.hqontario.ca/Portals/0/documents/qi/qi-implementing-and-sustaining-changes-primer- en.pdf (accessed 14 October 2016). n NHS: Sustainability Model and Guide: http://www.qualitasconsortium.com/index.cfm/programs-services/sustainability/sustainability- master-scoring-system/ (accessed 14 October 2016). n McGrath KM, Bennett DM, Ben-Tovim DI, Boyages SC, Lyons NJ, O’Connell TJ. Implementing and sustaining transformational change in health care: lessons learnt about clinical process redesign. Med J Aust. 2008; 188 (6):32. n Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist (102): http://www.bmj.com/content/352/bmj.i1174 15 ExpandNet is a global network of representatives from international organizations, nongovernmental organizations, academic and research institutions, ministries of health and specific projects who seek to advance the science and practice of scaling up. More information can be found here: http://www.expandnet.net/home.htm (accessed 14 October 2016). 16 Nine steps for developing a scaling-up strategy: http://www.expandnet.net/PDFs/ExpandNet-WHO%20Nine%20Step%20Guide%20published.pdf (accessed 14 October 2016). A guide to implementation research in NCDs 30 Case study 6: Scaling up – Physical activity interventions, Brazil Why this case study? This illustrates the importance of engaging different sectors for the scale up of effec- tive interventions. It also highlights challenges to scale up – such as changes in policies and funding mechanisms. Title Scaling up of physical activity interventions at the national level in Brazil: An effective solution to increase physical activity at the population level Source Washington University in St. Louis, St Louis, Missouri, United States of America Health issue Inadequate levels of physical activity and the need to address health disparities in the population of Brazil Setting Community (Brazil) Target population Brazil (adults and older adults from the general community) Background In Brazil, guidelines on physical activity suggest a minimum of 150 minutes of moder- ate or vigorous physical activity per week. However, the most recent national survey showed that nearly half the adult population did not reach this level of activity, with approximately 15% being completely inactive. The most commonly cited barriers to engaging in physical activity include lack of time and work/family responsibilities. Community-based interventions that make use of readily available resources (i.e. parks, trails, community centres), while providing professional guidance can be a promising strategy to increase physical activity at the population level (103, 104). Project GUIA (Guide for Useful Interventions for Physical Activity in Brazil and Latin America)17 (105) is a cross-national collaboration funded by the Prevention Research Centers programme (run by the Centers for Disease Control and Prevention (CDC)); it sets out to evaluate a programme taking place in Brazil for over a decade (106). Description of policy or intervention The programme ‘Academia da Cidade’ or ‘City Gym’ started in Recife, Pernambuco in the north-east of Brazil, and was institutionalized in 2002. It is carried out at a number of points of intervention or so called polos – new spaces or re-engineered and beauti- fied public spaces. Physical and cultural activities are provided by professional instructors and include: dancing, aerobics, strength training, flexibility and other health enhancing activities. What took place? In 2008, Project GUIA evaluated the Academia da Cidade programme using a combi- nation of qualitative and quantitative methods including a phone survey, systematic direct observation, historical evaluation, logic models and qualitative interviews of coordinators, staff and users (107-111). Results from the evaluation showed that the programme was effective in increasing and maintaining physical activity levels of the population and helped meet the guide- lines for physical activity. The evaluation also assessed reach, showing that women, older adults, and lower in- come people were the segments of the population that benefited the most from the programme (112). What have we learnt? Two significant events took place after results from the evaluation were shared with Project GUIA stakeholders:1. In early 2011, the government of the state of Pernambuco created the Aca- demias das Cidades de Pernambuco (ACP), a programme that aimed to ex- pand the basic offering of Academia da Cidade (113).2. Later in 2011, the ministry of health created the Academia da Saude (AS), a national programme with added nutritional and social development com- ponents (113). Changes in the supportive policies and in the funding mech- anisms have represented challenges for implementation at a large scale and for sustainability. The experience and lessons learned in Brazil show the challenge of scaling up physical activity interventions and the need to consider long-term political and financial support (113). 17 For more information about Project GUIA, visit: http://www.projectguia.org/ (accessed 14 October 2016). 31 A guide to implementation research in NCDs 4 Conclusions WHO/ Atul Loke 33 A guide to implementation research in NCDs 4. Conclusions Implementation research involves the scientific study of the processes used to implement policies and interventions and the contextual factors that affect these processes. Implementation research can help identify the most efficient and cost-effective methods of implementation, thereby helping to bridge the evidence-into-implementation (action) gap and improving health outcomes. Implementation research should be embedded in all stages involving the selection, adaptation and evaluation of policies or interventions for the prevention and control of NCDs. It is also important for the knowledge created to be shared among policy-makers, implementers and researchers through cross- country and cross-sectoral platforms and collaborations. A guide to implementation research in NCDs 34 Appendix 1. The PICO Framework for developing objectives and guiding knowledge synthesis The PICO headings will help you to breakdown your objectives and it will assist in devising the question that will guide your knowledge synthesis. PICO is not a rigid framework and there may be questions that do not need to cover all four aspects of PICO. Define your objective: Describe your objective in as few words as possible e.g. To find a policy or intervention to reduce the burden of hypertension in China Population: Define in detail the population that you are interested in e.g. For Chinese urban populations Intervention: Define the type of intervention that you are interested in e.g. economic incentive measures such as increasing taxes of unhealthy food Comparison: What comparison group are you using to compare the outcomes from the inter- vention against? e.g. Controls (i.e. that receive no intervention) Outcome: What outcome measure(s) are you interested in? e.g. Reduction in the consumption of processed foods Refine your objective: Now rewrite your objective e.g. To find an effective policy for the reduction of consumption of salt from processed foods in ur- ban populations in China Using the refined objective above to guide your knowledge synthesis should produce a manageable amount of focused evidence. The selection of the policy or intervention should be based on the results of a comprehensive situation analysis and/or conducted by expert advisors. Otherwise you may want to broaden your objective to identifying any policies or interventions (e.g. any policies or interventions for the prevention of hypertension in China). Similarly, if you are not satisfied with the quality and/or amount of evidence you identify, you may wish to broaden your search by using a less specific population (e.g. Chinese groups as a whole, or even other countries in the region). 35 A guide to implementation research in NCDs A p p en d ix 2 . E xa m pl e of a m at rix fo r t he sy nt he sis o f r el ev an t e vid en ce Be lo w is a sa m pl e m at rix th at yo u m ay w ish to u se to su m m ar ize fi nd in gs fr om th e kn ow le dg e sy nt he sis a ct iv iti es a nd to in fo rm th e se le ct io n of a n ev id en ce -b as ed p ra ct ice or in te rv en tio n. Y ou c an a da pt th is m at rix b y m od ify in g so m e of th e ex ist in g co lu m ns o r b y ad di ng n ew c ol um ns so th at th e m at rix is c us to m ize d to a dd re ss th e ob je ct iv es yo u se t o ut fo r t he k no w le dg e sy nt he sis u sin g th e PI CO fr am ew or k. N ot e: Th e sa m pl e m at rix b el ow u se s a fic tit io us s tu dy fo r d em on st ra tio n pu rp os es o nl y. PI CO : Synth es is of e vi de nc e fo r t he e ffe ct iv en es s o f h yp er te ns io n pr ev en tio n pr og ra m m es in p ri m ar y he al th ca re ce nt re s i n ur ba n ce nt re s i n Ch in a St u d y re fe re n ce D es ig n N o. o f p ar ti ci p an ts O u tc o m es O ut co m e re po rt ed in re su lts M ea su re s Li st to ol s Eff ec t: Po st in te rv en tio n re su lts Fo llo w u p Lo ng es t p oi nt o f fo llo w u p (i. e. 6 m on th s; 1 y ea r) Q u al it y o f ev id en ce In di ca te o n a sc al e fr om o ne to fiv e* In te rv en ti o n C o n tr o l R el at iv e eff ec t (9 5% C I) A b so lu te eff ec t P va lu e Fi rs t A ut ho r e t a l 20 15 Jo ur na l 1 (1 ):1 - 10 Cl us te r R an do m iz ed Co nt ro l T ria l 10 07 In ci de nc e of hy pe rt en - si on Cl in ic al a s- se ss m en t by p rim ar y he al th ca re ce nt re n ur se 8. 4% 11 .0 % 0. 76 (0 .7 –0 .8 1) 2. 6% 0. 03 5 1 ye ar fo llo w u p 4 So di um c on - su m pt io n U rin e bi o- m ar ke rs fr om sa m pl es co lle ct ed b y pa rt ic ip an ts ov er 2 4 ho ur s 18 0 m Eq /L / da y 20 0 m Eq /L / da y n/ a 20 m Eq /L / da y 0. 07 2 1 ye ar fo llo w u p Ph ys ic al a c- tiv ity Ti m e us e di ar y 90 m in /w ee k 70 m in / w ee k n/ a 20 m in / w ee k 0. 04 1 1 ye ar fo llo w u p *Y ou w ill h av e to b e cl ea r a bo ut h ow y ou a ss es s a nd ra nk q ua lit y of e vi de nc e. A guide to implementation research in NCDs 36 Appendix 3. Assessing the social validity of a policy or intervention Below is a proposed structure:A. Social significance of goals These questions should seek to understand whether potential consumers feel that the goals of the policy or intervention are important to them and/or their community. As far as possible, it is important to ask questions that are not leading. Questions relating to an intervention aiming to reduce salt consumption to prevent hypertension could be: 1. What are some of the main health problems you think are common in this community? 2. Which of these problems do you think are important? 3. Have you heard of hypertension before? If so, what do you know? 4. If someone has hypertension, do they need to do anything about it?B. Socially acceptable procedures These questions should seek to understand whether potential consumers feel that the procedures used in an intervention are acceptable. Questions relating to community health workers providing hypertension education could be:1. How do you feel about seeking health advice from your community health worker?2. How good or bad are community workers as a source of knowledge about your health?3. How do you feel about information sessions organized and presented by your local commu- nity health worker?C. Social importance of effects These questions should seek to understand whether consumers feel that an intervention or policy is achieving its intended outcomes and whether these are of any importance. Accordingly, these questions can only be asked after the policy or intervention has already been implemented. Following on from the example above – i.e. a community health worker led intervention for the reduc- tion of salt consumption to prevent and control hypertension – some questions could be:1. What did you think of the health information sessions?2. Have you or your family acted upon the information received?3. Have you noticed a difference in how you feel? Have you spoken to your relatives and friends about it?4. Now that you have attended the sessions, would you recommend them to others in your com- munity? 37 A guide to implementation research in NCDs Appendix 4. Assessing fidelity The table below provides an example of the type of indicators and data that you may consider collecting to assess structural and dynamic fidelity of implementation. The table also provides suggestions for when data should be collected and which tools may be used. Before collecting this data, it is important to clearly describe the ideal values for each indicator. The closer the data you collect is to the ideal value, the higher the level of fidelity. Take, for example, the first indicator, ‘Organizational structure’. If you were aiming to deliver a nutritional education programme through maternal and child health centres, then your ideal values for the organizational structure may be ‘A maternal and child health centre that is (i) well established in the community – e.g. has been in existence for at least five years and has three permanent staff; (ii) receives ongoing funding and (iii) delivers health promotion programmes in addition to a core maternal and child health programme. The definition of the ideal values should, as far as possible, be guided by evidence (e.g. there may be evidence for the ideal organizational context within which to deliver a nutritional programme). It may not always be feasible to engage the ideal implementers, however collecting data about these values prior to beginning delivery of an intervention will provide invaluable information for the analysis of fidelity, effectiveness and moderators of effectiveness. STRUCTURAL FIDELITY INDICATORS TIMING TOOL Implementer level – Descriptive data Organizational structure of implementer (e.g. school, hospital, community organization, etc.) Baseline Implementer profile form Primary funding source of implementer Baseline Implementer profile form Usual health focus of implementer Baseline Implementer profile form Implementer level – Demographic characteristics of staff Gender Baseline Implementer staff demographics form Age Baseline Implementer staff demographics form Date of hire Baseline Implementer staff demographics form Date of certification or completion of model-specific training Baseline Implementer staff demographics form Role Baseline Implementer staff demographics form Education Baseline Implementer staff demographics form Prior experience in implementing similar policies or in- terventions Baseline Implementer staff demographics form A guide to implementation research in NCDs 38 Termination date Monthly (as needed) Implementer – staff demographics form Implementer level – Intervention/policy delivery data Implementer delivery load derived from: - e.g. number of individuals who receive an interven- tion from a staff at a community based organization - e.g. employment time fraction of staff at a commu- nity based organization Monthly (as needed) Intervention session forms Training sessions dosage – derived from: - training sessions completed - duration of training sessions completed Monthly (as needed) Training records Consumer level – Intervention/policy delivery data Dosage – derived from: - intervention sessions completed - duration of intervention sessions Monthly (as needed) Intervention session forms Duration of intervention – derived from: - date of commencement of intervention - date of completion of intervention Monthly (as needed) Intervention session forms 39 A guide to implementation research in NCDs DYNAMIC FIDELITY (Collected regularly – e.g. once every six weeks) INDICATORS RESPONSE Process These questions should seek to understand whether the implementers followed the appro- priate processes when implementing a policy or intervention. E.g. The community health worker told us about the intervention, what they would do and what we need to do in a way that I un- derstood – Strongly disagree – Disagree – Neither – Agree – Strongly Agree Principles These questions should seek to understand whether the implementers followed the appro- priate principles when implementing the policy or intervention E.g. The community health worker showed respect for my culture – Strongly disagree – Disagree – Neither – Agree – Strongly Agree Outcomes These questions should seek to understand whether the consumers feel that the policy or interventions are helping them achieve the intended outcome(s). E.g. The skills I have learnt from the interven- tion are helping me manage my hyperten- sion – Strongly disagree – Disagree – Neither – Agree – Strongly Agree A guide to implementation research in NCDs 40 Appendix 5. Decision support data system When planning for the implementation of a new policy or intervention it is crucial to be clear about what decision support data systems will be used. The question and table below will help you think through some of the important aspects of the decision support data system. n Who will be responsible for collecting and analysing performance assessment data? n Who will be responsible for supporting the quality of the data collection, analysis, and report preparation processes (support, guidance, oversight)? n Who else plays a role? At which level (e.g. team, district, regional, state)? n How important is data collection, analysis, and report preparation in achieving the desired outcomes for the selected innovation? What are the right next steps for activating the decision support data system? Activities Time frame Person(s) responsible Resources needed 41 A guide to implementation research in NCDs References1. World Health Organization, Global status report on noncommunicable diseases 2010, A. Al- wan, Editor. 2010, The World Health Organization.2. World Health Organization, Global status report on noncommunicable diseases 2014, S. Mendis, Editor. 2014, World Health Organization.3. World Health Organization, Prioritized research agenda for prevention and control of non- communicable diseases, S. Mendis and A. Alwan, Editors. 2011, World Health Organization: Geneva.4. World Health Organization, Global action plan for the prevention and control of noncommu- nicable diseases 2013-2020. 2013, World Health Organization: Geneva.5. Cochrane, L.J., et al., Gaps between knowing and doing: Understanding and assessing the barriers to optimal health care. Journal of Continuing Education in the Health Professions, 2007. 27(2): p. 94-102.6. Grol, R., Successes and failures in the implementation of evidence based guidelines for clinical practice. Medical Care, 2001. 39(8): p. SII46-54.7. McGlynn, E.A., et al., The quality of health care delivered to adults in the United States. New England Journal of Medicine, 2003. 348(26): p. 2635-45.8. McCullough, M.L., et al., Following cancer prevention guidelines reduces risk of cancer, car- diovascular disease, and all-cause mortality. Cancer Epidemiol Biomarkers, 2011. 20(6): p. 1089-97.9. Komajda, M., et al., Adherence to guidelines is a predictor of outcome in chronic heart failure: The MAHLER survey. European Heart Journal, 2005. 26(16): p. 1653-9.10. Saslow, D., et al., American cancer society, American society for colposcopy and cervical pa- thology, and American society for clinical pathology screening guidelines for the prevention and early detection of cervical cancer. CA: A Cancer Journal for Clinicians, 2012. 62(3): p. 147-72.11. Shapiro, D., et al., Containing costs while improving quality of care: The role of profiling and practice guidelines. Annual Review of Public Health, 1993. 14(1): p. 219-41.12. Grol, R. and M. Wensing, What drives change? Barriers to and incentives for achieving evi- dence-based practice. Medical Journal of Australia, 2004. 180(6): p. S57.13. Harrison, M.B., et al., Adapting clinical practice guidelines to local context and assessing barri- ers to their use. Canadian Medical Association Journal, 2010. 182(2): p. E78-84.14. Rainbird, K., R. Sanson-Fisher, and H. Buchan, Identifying barriers to evidence uptake. 2006, National Institute of Clinical Studies: Melbourne, Australia.15. Fixsen, D.L., et al., Implementation research: A synthesis of the literature. 2005, University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementa- tion Research Network: Tampa, FL.16. National Implementation Research Network. Implementation defined. Learn Implementa- tion 2013 [cited 2015 December 5th]; Available from: http://nirn.fpg.unc.edu/learn-imple- mentation/implementation-defined.17. Peters, D.H., M.T. Tran, and A. Taghreed, Implementation research in health: A practical guide. 2013, Alliance for Health Policy and Systems Research, World Health Organization: Geneva, Switzerland. A guide to implementation research in NCDs 42 18. Proctor, E.K., et al., Outcomes for implementation research: Conceptual distinctions, measure- ment challenges, and research agenda. Administration and Policy in Mental Health and Mental Health Services Research, 2011. 38(2): p. 65-76.19. Davies, P., A.E. Walker, and J.M. Grimshaw, A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation of the results of rigorous evaluations. Implementation Science, 2010. 5: p. 1-6.20. Michie, S., et al., Specifying and reporting complex behaviour change interventions: The need for a scientific method. Implementation Science, 2009. 4: p. 40.21. Damschroder, L.J., et al., Fostering implementation of health services research findings into practice: A consolidated framework for advancing implementation science. Implementation Science, 2009. 4: p. 50.22. McDonald, K.M., I.D. Graham, and J. Grimshaw, Toward a theoretical basis for quality im- provement interventions, in Closing the quality gap: A critical analysis of quality improvement strategies, K.G. Shojania, et al., Editors. 2004, Agency for Healthcare Research and Quality: Rockville, MD.23. TDR Special Programme for Research and Training in Tropical Diseases, Implementation research toolkit. 2014: World Health Organization.24. Proctor, E.K., et al., Writing implementation research grant proposals: Ten key ingredients. Implementation Science, 2012. 7: p. 96.25. Graham, I. D., Logan, J., Harrison, M. B., Straus, S. E., Tetroe, J., Caswell, W. and Robinson, N. (2006), Lost in knowledge translation: Time for a map?. J. Contin. Educ. Health Prof., 26: 13–24. doi:10.1002/chp.4726. Shaw, J.E., R.A. Sicree, and P.Z. Zimmet, Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract, 2010. 87(1): p. 4-14.27. Ramachandran, A., R.C. Wan Ma, and C. Snehalatha, Diabetes in Asia. Lancet, 2009. 375(9712): p. 408-18.28. Thankappan, K.R., et al., Risk factor profile for chronic non-communicable diseases: Results of a community-based study in Kerala, India. Indian Journal of Medical Research, 2010. 131: p. 53-63.29. Menon, V.U., et al., Prevalence of known and undetected diabetes and associated risk factors in central Kerala - ADEPS. Diabetes Research and Clinical Practice, 2006. 74(3): p. 289-94.30. Raman, K.V., A. Joseph, and C.R. Soman, High prevalence of type 2 diabetes in an urban settlement in Kerala, India. Ethnicity and Health, 1999. 4(4): p. 231-9.31. Daivadanam, M., et al., Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial. BMC Public Health, 2013. 13: p. 95.32. Soman, C.R., et al., Cohort profile: the PROLIFE study in Kerala, India. Int J Epidemiol, 2011. 40(1): p. 10-4.33. Sugathan, T.N., C.R. Soman, and S. K, Behavioural risk factors for non communicable diseases among adults in Kerala, India. The Indian Journal of Medical Research, 2008. 127(6): p. 555- 63.34. Krishnan, A., et al., Evaluation of community-based interventions for non-communicable dis- eases: Experiences from India and Indonesia. Health Promotion International, 2011. 26(3): p. 276-89.35. Kumar, M.S., P.S. Sarma, and K.R. Thankappan, Community-based group intervention for tobacco cessation in rural Tamil Nadu, India: A cluster randomized trial. Journal of Substance Abuse Treatment, 2012. 43(1): p. 53-60. 43 A guide to implementation research in NCDs 36. Mohan, V., et al., Community empowerment - A successful model for prevention of noncom- municable diseases in India - The Chennai Urban Population Study (CUPS-17). The Journal of the Association of Physicians of India, 2006. 54(858-62).37. Grimshaw, J.M., et al., Knowledge translation of research findings. Implementation Science, 2012. 7: p. 50.38. Antman, E.M., et al., A comparison of results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. The Journal of the American Medical Association, 1992. 268(2): p. 240-8.39. Chalmers, I., Trying to do more good than harm in policy and practice: The role of rigorous, transparent, up-to-date evaluations. The Annals of the American Academy of Political and Social Science, 2003. 589: p. 22-40.40. Pope, C., N. Mays, and J. Popay, Synthesizing qualitative and quantitative health research. 2007, Berkshire, UK: Open University Press.41. Jadad, A.R.; Moore R.A.; Carroll D.; Jenkinson C.; Reynolds D.J.M.; Gavaghan D.J.; McQuay H.J. (1996). “Assessing the quality of reports of randomized clinical trials: Is blinding necessary?”. Controlled Clinical Trials. 17(1): 1–12. doi:10.1016/0197-2456(95)00134-4. PMID 8721797.42. World Health Organization, WHO global report: mortality attributable to tobacco, W. Press, Editor. 2012: Geneva.43. Jhanjee, S., Tobacco Control in India – Where are we now? Delhi Psychiatry Journal, 2011. 14(1): p. 26.44. Ministry of Health and Family Welfare India, Tobacco use among students and teachers. Findings from the Global Youth Tobacco Survey and Global School Personnel Survey India. 2010: New Delhi.45. International Institute for Population Sciences & MoHFW India, Global Adult Tobacco Sur- vey (GATS) India 2009-2010. New Delhi.46. ITC Project, TCP India National Report. Findings from the Wave 1 Survey (2010-2011). 2013, University of Waterloo, Canada; Healis-Sekhsaria Institute for Public Health, India.47. Ministry of Health and Family Welfare (Government of India), Economic Burden of Tobacco Related Diseases in India. Executive Summary. 2014, New Delhi: PHFI and WHO Country Of- fice for India.48. World Health Organization, WHO Framework Convention on Tobacco Control. 2003: Geneva.49. Ministry of Health and Family Welfare India, The Cigarettes and Other Tobacco Products (Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution) Act, 2003. 2009: New Delhi.50. Arora, M., Tewari A, Nazar PN, Gupta K, Shrivastav R,, Ineffective pictorial health warnings on tobacco products: lessons learnt from India. Indian Journal of Public Health, 2012. 56(1): p. 61-64.51. Yadav, A., India: New Warnings to Cover 85% of Packs. Tobacco Control, 2015. 24(1): p. 3.52. Moodie, C., et al., Plain tobacco packaging: A systematic review. UK Centre for Tobacco Con- trol Studies, 2012.53. Wakefield, M.A., et al., Introduction effects of the Australian Plain Packaging policy on adult smokers: a cross-sectional study. BMJ open, 2013. 3(7): p. e003175.54. Lok Sabha Secretariat, Fourth Report on the Cigarettes and other Tobacco Products (Prohibi- tion of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distri- bution) Act, 2003, C.o.S. Legislation, Editor. 2015, Government of India Press: New Delhi. A guide to implementation research in NCDs 44 55. White V, Australian Secondary Students’ Alcohol and Drug (ASSAD), Centre for Behavioural Research in Cancer (CBRC), Editor. 2015, Department of Health Canberra.56. Hammond D, Health warning messages on tobacco products: a review Tobacco Control, 2011. 20(327).57. Arora M, T.A., Grills N, Nazar GP, Sonrexa J, Gupta VK, Moodie R, Reddy KS., Exploring per- ception of Indians about Plain Packaging of tobacco products. Frontiers in Public Health, 2013. 1: p. 35.58. Dunlop, S., et al., Impact of Australia’s introduction of tobacco plain packs on adult smokers’ pack-related perceptions and responses. BMJ Open, 2014. 4: p. e005836.59. Hammond, D., Standardized packaging of tobacco products: evidence review. 2014, Irish De- partment of Health.60. Australia India Institute, Report of the AII Taskforce on Tobacco Control: Plain Packaging of tobacco products. 2012: Melbourne 61. Hughes N, Grills N, and Aurora M, Effect of plain packaging of tobacco products in low and middle income settings: A systematic review of the literature. Currently under reviewed, 2015.62. Jann W and Werich K, Theories of policy change, in Handbook of Public Policy Analysis: Theo- ry, Politics, and Methods, Fischer F and Miller GJ, Editors. 2007, Taylor and Francis group.63. Henggeler, S.W., et al., Transporting efficacious treatments to field settings: The link between supervisory practices and therapist fidelity in MST programs. Journal of Clinical Child & Ado- lescent Psychology, 2002. 31(2): p. 155-67.64. Greenhalgh, T., et al., Diffusion of innovations in service organizations: Systematic review and recommendations. Milbank Quarterly, 2004. 82(4): p. 581‐629.65. Oldenburg, B., et al., The spread and uptake of diabetes prevention programs around the world: a case study from Finland and Australia. Transl Behav Med, 2011. 1(2): p. 270-282.66. Chen, E.K., et al., Tailoring evidence-based interventions for new populations: A method for program adaptation through community engagement. Evaluation & the Health Professions, 2013. 36(1): p. 73-92.67. Embry, D. and A. Biglan, Evidence-based kernels: Fundamental units of behavioral influence. Clinical Child and Family Psychology Review, 2008. 11(3): p. 75-113.68. Blase, K. and D. Fixsen, Core intervention components: Identifying and operationalizing what makes programs work. 2013, Office of the Assistant Secretary for Planning and Evaluation.69. Chamberlain, P., The Oregon Multidimensional Treatment Foster Care Model: Features, out- comes, and progress in dissemination. Cognitive and Behavioral Practice, 2003. 10: p. 303- 12.70. Forgatch, M.S., R. Patterson, and D.S. DeGarmo, Evaluating fidelity: Predictive validity for a measure of competent adherence to the Oregon model of parent management training (PMTO). Behavior Therapy, 2005. 36: p. 3-13.71. Carter, S., The social validity manual. 2009, London, UK: Academic Press.72. Schwartz, I.S. and D.M. Baer, Social validity assessment: Is current practice state of the art? Applied Behavior Analysis, 1991. 24(2): p. 189-204.73. Gresham, F.M. and M.F. Lopez, Social validation: A unifying concept for school-based consul- tation research and practice. School Psychology Quarterly, 1996. 11(3): p. 204-27.74. Beltramo, T. and D.I. Levine, The effect of solar ovens on fuel use, emissions and health: Re- sults from a randomised controlled trial. Journal of Development Effectiveness, 2013. 5(2): p. 178-207. 45 A guide to implementation research in NCDs 75. Otte, P.P., Solar cookers in developing countries-What is their key to success? Energy Policy, 2013. 63: p. 375-381.76. Thomas, E., et al., Improved stove interventions to reduce household air pollution in low and middle income countries: a descriptive systematic review. BMC Public Health, 2015. 15: p. 650.77. Ontario Agency for Health Protection and Promotion (Public Health Ontario), At a glance: The ten steps for conducing an evaluation. 2015: Toronto, ON.78. Peters, D.H., et al., Implementation research: what it is and how to do it. British Journal of Sports Medicine, 2014. 48(8): p. 731-736.79. Glasgow, R.E. and L.A. Linnan, Evaluation of theory-based interventions, in Health behavior and health education: Theory, research, and practice, K. Glanz, B.K. Rimer, and V.K. Jossey- Bass, Editors. 2008, Jossey-Bass: San Francisco, CA. p. 487-508.80. Breitenstein, S.M., et al., Measuring implementation fidelity in a community-based parenting intervention. Nursing Research, 2010. 59(3): p. 158-65.81. Carroll, C., et al., A conceptual framework for implementation fidelity. Implementation Sci- ence, 2007. 2: p. 40.82. Koball, H., et al., Supporting evidence-based home visiting to prevent child maltreatment: Overview of the cross-site evaluation. 2009, Department of Health and Human Services, Administration for Children and Families, Children’s Bureau: Washington, DC.83. McGrew, J.H., et al., Measuring the fidelity of implementation of a mental health program model. Journal of Consulting and Clinical Psychology, 1994. 62(4): p. 670-8.84. Aarons, G., Measuring provider attitudes toward evidence‐based practice: Consideration of organizational context and individual differences. Child & Adolescent Psychiatric Clinics of North America, 2005. 14(2): p. 255‐viii.85. Aarons, G., D. Sommerfeld, and C. Walrath‐Greene, Evidence‐based practice implementa- tion: The impact of public versus private sector organization type on organizational support, provider attitudes, and adoption of evidence‐based practice. Implementation Science, 2009. 4: p. 83.86. Correnti, R. and B. Rowan, Opening up the black box: Literacy instruction in schools partici- pating in three comprehensive school reform programs. American Educational Research Journal, 2007. 44(2): p. 298‐338.87. Frambach, R. and N. Schillewaert, Organizational innovation adoption: A multi‐level frame- work of determinants and opportunities for future research. Journal of Business Research Special Issue: Marketing Theory in the Next Millennium, 2002. 55(2): p. 163‐76.88. Rogers, E., Diffusion of innovations. 4th ed. 1995, New York, NY: The Free Press.89. Lipsey, M. and D. Cordray, Evaluation methods for social intervention. Annual Review of Psy- chology, 2000. 51: p. 345‐75.90. Pettigrew, A., The character and significance of strategy process research. Strategic Manage- ment Journal, 1992. 13: p. 5‐16.91. Pettigrew, A., What is a processual analysis? Scandinavian Journal of Management, 1997. 13: p. 337‐48.92. Curran, G.M., et al., Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical Care, 2012. 50(3): p. 217-26. A guide to implementation research in NCDs 46 93. Proctor, E.K., B.J. Powell, and J.C. McMillen, Implementation strategies: Recommendations for specifying and reporting. Implementation Science, 2013. 8: p. 139.94. Peters, D., et al., Improving health service delivery in developing countries: From evidence to action. 2009, World Bank: Washington, DC.95. French, Simon D., et al. “Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework.” Implementation Science 7.1 (2012): 1.96. Glasgow, R.E., eHealth evaluation and dissemination research. American Journal of Preven- tive Medicine, 2007. 32(5S): p. S119–26.97. Proctor, E.K., et al., Implementation research in mental health services: An emerging science with conceptual, methodological, and training challenges. Administration and Policy in Mental Health and Mental Health Services Research, 2009. 36(1): p. 24–34.98. Raghavan, R., The role of economic evaluation in dissemination and implementation research, in Dissemination and implementation research in health: Translating science in practice, R. Brownson, G.A. Colditz, and E.K. Proctor, Editors. 2012, Oxford University Press: New York, NY.99. National Health Service UK, NHS Institute Sustainability and its relationship with spread and adoption. 2007, NHS Institute for Innovation and Improvement: Coventry.100. Milat, A.J., A. Bauman, and S. Redman, Narrative review of models and success factors for scaling up public health interventions. Implementation Science, 2015. 10: p. 113.101. Beaglehole, R., et al., Priority actions for the non-communicable disease crisis. Lancet, 2011. 377(9775): p. 1438-47.102. Smisha Agarwal., et al, Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist. BMJ 2016;352:i1174 103. Hoehner, C.M., et al., Physical activity interventions in Latin America: a systematic review. Am J Prev Med, 2008. 34(3): p. 224-233.104. Hoehner, C.M., et al., Physical activity interventions in Latin America: expanding and classify- ing the evidence. Am J Prev Med, 2013. 44(3): p. e31-40.105. Paez, D.C., et al., Bridging the gap between research and practice: an assessment of external validity of community-based physical activity programs in Bogota, Colombia, and Recife, Bra- zil. Transl Behav Med, 2015. 5(1): p. 1-11.106. Pratt, M., et al., Project GUIA: A model for understanding and promoting physical activity in Brazil and Latin America. J Phys Act Health, 2010. 7 Suppl 2: p. S131-4.107. Parra, D.C., et al., Assessing physical activity in public parks in Brazil using systematic observa- tion. Am J Public Health, 2010. 100(8): p. 1420-6.108. Simoes, E.J., et al., Effects of a community-based, professionally supervised intervention on physical activity levels among residents of Recife, Brazil. Am J Public Health, 2009. 99(1): p. 68-75.109. Hallal, P.C., et al., Association between perceived environmental attributes and physical activ- ity among adults in Recife, Brazil. J Phys Act Health, 2010. 7 Suppl 2: p. S213-22.110. Hallal, P.C., et al., Evaluation of the Academia da Cidade program to promote physical activity in Recife, Pernambuco State, Brazil: perceptions of users and non-users. Cad Saude Publica, 2010. 26(1): p. 70-8. 47 A guide to implementation research in NCDs 111. Soares, J., et al., Cross-sectional associations of health-related quality of life measures with selected factors: a population-based sample in recife, Brazil. J Phys Act Health, 2010. 7 Suppl 2: p. S229-41.112. Reis, R.S., et al., Assessing participation in community-based physical activity programs in Brazil. Med Sci Sports Exerc, 2014. 46(1): p. 92-8.113. Parra, D.C., et al., Scaling up of physical activity interventions in Brazil: how partnerships and research evidence contributed to policy action. Glob Health Promot, 2013. 20(4): p. 5-12. W HO /A nd re w Es ieb o A guide to implementation research in the prevention and control of noncommunicable diseases

实施性研究在慢性病防控 中的应用指导 原著 世界卫生组织（World Health Organization） 主审 邵瑞太（世界卫生组织总部） 吴　静（中国疾病预防控制中心慢性非传染性疾病 　　　　预防控制中心） 马吉祥（山东省疾病预防控制中心） 主译 张　娟（中国医学科学院　北京协和医学院群医学 　　　　及公共卫生学院） 宫恩莹（墨尔本大学人口与全球健康学院　世界 　　　　卫生组织慢性非传染性疾病实施研究合作 　　　　中心） 中国协和医科大学出版社 　 北　京 ˚Ø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`a!<bOcd P ef & ghij . K) kl # !"#$%&'()*+ & !"!"KA! ONIEHQRS GR GTBRQ GABB! GJ O " 8 #Y * $ 8 #e * %g * & 8 #mT45 G 45no G 23 G cp ' 8 # UAQQ GB! O !"*,qrs DNV tuvw !!"!"" x !ARJJJ y OOO 23456,7489:;<=>?@ A OO ! ! 234567 B OO C ! e O f O ghi DE.F ! z O p G-HI ! ;JKLMNOPG-Q ! kl{|}~|€ Q y O ‚ƒ A""RJ"O „… "A" GBT!B"WJA" R OO S ! ---89;>.98.,> T OO U ! †‡rˆ‰ˆklŠ‹Œ V OO W ! klŽ‘’m“ X OO Y ! RSR XA"Q!OAPJ! V OO Z ! JKRT ) OO 0 ! WR ”w - OO [ ! !"!" • A! –x A * V OO [ ! !"!" • A! –x A —˜ \ OO ] ! W"K"" ™ NIEHQRS R TBRQ ABB! J " -#^_ $ `#a6 $ b_Vcdefg $ hYQHIijk # 实施性研究在慢性病 防控中的应用指导 译者名单 主审 邵瑞太　世界卫生组织总部 吴　静　中国疾病预防控制中心慢性非传染性疾病预 防控制中心 马吉祥　山东省疾病预防控制中心 主译 张　娟　中国医学科学院　北京协和医学院群医学及 公共卫生学院 宫恩莹　墨尔本大学人口与全球健康学院 　　　　世界卫生组织慢性非传染性疾病实施研究合作 　　　　中心 中文版审校 阎丽静　昆山杜克大学 田懋一　乔治全球健康研究院 翻译团队 闫睿杰　中国医学科学院　北京协和医学院群医学及 公共卫生学院 张竞雯　中国医学科学院　北京协和医学院群医学及 公共卫生学院 胡奕娈　中国医学科学院　北京协和医学院群医学及 公共卫生学院 热娜提·肉孜　中国医学科学院　北京协和医学院阜 外医院 尚小絮　中国医学科学院　北京协和医学院护理学院 董丽丽　中国医学科学院　北京协和医学院护理学院 张行易　中国医学科学院　北京协和医学院阜外医院 致谢 Brian Oldenburg　墨尔本大学人口与全球健康学院 　　　　　　　 世界卫生组织慢性非传染性疾病实施 　　　　　　　 研究合作中心 贺馨柔　墨尔本大学 1序 序 很高兴看到《实施性研究在慢性病防控中的应用指导》 （后称《指导》）一书经张娟等人的努力第一次被翻译成中文。 中风、缺血性心脏病和肺癌等慢性病是我国居民过早 死亡的主要原因，也是影响我国社会经济发展的一个重要 因素。尽管近年来，相关的研究证据、指南和政策不断涌 现，却难以达到预期效果。包括我国在内的发展中国家， 迫切需要将那些符合成本效益的干预措施在各自的社会经 济文化环境下有效实施以产生相应效果。如何形成最佳实 践，使这些政策真正落地，必须全面考虑实施过程中的现 实条件，实施性研究成为解决这一问题的必要手段。 实施性研究是针对上述问题应运而生的一个应用科学 研究领域，立足于不同社会经济文化环境这个复杂的适应 性系统，研究内容涵盖实施过程的方方面面，是一门以用 户为导向的科学。在实施性研究中，具体情境因素起着核 心作用，其中，利益相关方的参与和支持至关重要，以灵 活调整实施策略。此外，实施性研究对实施过程和干预效 果进行双重评价，通过定性、定量和混合方法对评价结果 实施性研究在慢性病防控中的应用指导 2 进行解释，使策略能更好地在真实世界得以实施。 本《指导》针对卫生健康领域的实施者、专业人员和 卫生健康政策制定者，旨在提高对实施性研究目的和潜在 影响的认识；帮助研究者获取、整理和分析信息，因地制 宜地将基于循证的政策和干预措施进行转化；帮助识别政 策和干预措施实施过程中面临的障碍；帮助确定开展实施 性研究的最佳方法。 本书注重实用性，整理并总结了最新的研究证据，提 供资源链接从而涵盖与主题相关的更多信息。全书正文 共 4章，前 2章为概括性内容，大体介绍了慢性非传染性 疾病实施性研究的基本术语和概念，简要概述了实施性研 究所涉及的内容，其中包括实施性研究的周期。第 3章重 点介绍实施性研究的实用性步骤：第一步，提出适合当地 情境的循证政策和干预措施，涵盖了所需的形势分析、知 识汇总及知识转化等，以及实施性研究的方法和相关资 源；第二步，调整并试行政策或干预措施；第三步，评估 政策或干预措施的实施，包括实施结局指标（可接受性、 覆盖面、采纳度、保真度、实施的成本和可持续性）、调 节因素和实施策略等；第四步，政策或干预措施的推广， 其中包括制定推广策略的 9个步骤。最后，第 4章归纳 总结。在《指导》最后，还提供了支持实施性研究的实用 工具。更值得称道的是，该《指导》还通过案例来展示慢 性病防控政策和干预的实施，娓娓道来，引人入胜。 3序 近年来，实施性研究在国外蓬勃发展，对推动慢性病 防控从政策到实践发挥了重要作用，而我国目前尚处于初 步阶段。充分学习国际上关于实施性研究的先进理论、框 架、模型、研究设计方法及实践案例，有利于加快我国慢 性病防控的步伐并提升效果。基于此，作为实施性研究应 用于慢性病防控的入门之作，本书的翻译出版即为一次努 力尝试。希望本书能为我国学者和慢性病防控专业人员开 展慢性病防控相关实施性研究提供指导，推动我国慢性非 传染性疾病相关政策和具有成本效益的干预措施有效实施， 弥合证据与实施之间的裂痕。 本书的中文版在尊重原版的基础上，结合WHO和国 内外专家的意见，对一些术语和表达方式做了较好的本土 化，使全文通俗易懂，保证了较高的翻译质量。 中国医学科学院　北京协和医学院 群医学及公共卫生学院执行院长 2020年 11月 8日

1致　　谢 本指导是在世界卫生组织（WHO）非传染性疾病、伤 残、暴力和伤害预防管理司的艾利森·哈维（Alison Harvey） 和艾蒂安·克鲁格（Etienne Krug）的指导下，邵瑞太（Ruitai Shao）和 Cherian Varghese的协调及 Yuxi Zhang的协助下， 由澳大利亚墨尔本大学的 Fabrizio D’Esposito， Emma Thomas， Brian Oldenburg等人撰写而成的。 以下人员为该指导的撰写提供了建设性意见、专业技 术支持和具体案例研究：美国圣路易斯华盛顿大学的 Ross Brownson教授，澳大利亚墨尔本大学的 Nathan Grills教 授，中国医学科学院原党委书记、常务副院长李立明教授， 印度 Sree Chitra Tirunal 医学科学和技术研究所 Elezebeth Mathews博士和 KR Thankappan教授，美国国立卫生研究 院Mark Miller教授，印度基督教医学院 Nihal Thomas 教授 和 Riddhi Dasgupta博士，澳大利亚悉尼乔治全球健康研究 院 Jacqui Webster博士。 以下专家为本指导的编制提供了宝贵意见：Sania Nishtar博士、David Peters教授、Pekka Puska教授、Srinath 实施性研究在慢性病防控中的应用指导 2 Reddy教授和 Cuilin Zhang博士。上述专家作为WHO特设 技术会议 1的参会者，参与讨论了本指导的结构，并在编写 指导的过程中提供了建议。 以下WHO各区域办事处和总部的工作人员审查了初 稿并提供了技术支持：Douglas Bettcher，Edouard Tursan D’espaignet，Albert Francis E. Domingo，Ophira Ginsburg， Andre Ilbawi，Belinda Loring，Bente Mikkelsen，Armando Peruga，Leanne Riley，Hai-Rim Shin，Nhan Tran，Menno Van Hilten和 Temo Waqanivalu。 WHO也非常感谢英国 Naima Reza女士对于本指导的 编辑，以及瑞士的 Jean-Claude Fattier先生设计和排版英文 版指导封面。 1　本次会议于 2015 年 5 月 7～8 日召开，旨在帮助 WHO 实施“预 防和控制慢性非传染性疾病全球行动计划 2013-2020”第 54 号行动 （研究）。 1英 -中文缩略词对照表 ACP Academias das Cidades de Pernambuco 伯南布哥州城市健身项目 AS Academia da Saude 健康健身项目 CDC Centers for Disease Control and Prevention 美国疾病预防控制中心 COTPA The Cigarettes and Other Tobacco Products Act 香烟和其他烟草制品法 FCTC Framework Convention on Tobacco Control 烟草控制框架公约 GRADE Grading of Recommendations， Assessment， Development and Evaluation 证据推荐分级的评估、制订与评价 GRC Guidelines Review Committee 指南审查委员会 GUIA Guide for Useful Interventions for Physical Activity in Brazil and Latin America 巴西与拉丁美洲体育锻炼干预指导 实施性研究在慢性病防控中的应用指导 2 HIC High-income country 高收入国家 KDPP The Kerala Diabetes Prevention Program 喀拉拉邦糖尿病预防项目 LMIC Low- and middle-income country 中低收入国家 MeSH Medical subject heading 医学主题词 M-PACE Method for Program Adaptation through Com- munity Engagement 社区参与式项目调整法 NCD Noncommunicable disease 慢性非传染性疾病 NPDCS The National Programme for Prevention and Control of Diabetes， Cardiovascular diseases and Stroke 国家预防和控制糖尿病、心血管疾病和中风 的计划 PICO Population， Intervention，Comparison， Outcome 目标人群、干预措施、对照组和结局指标 PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses 系统综述和荟萃分析优先报告条目 3T2DM Type 2 diabetes mellitus 2型糖尿病 WHO World Health Organization 世界卫生组织 英 -中文缩略词对照表

1概　　要 “实施性研究（implementation research）”对于以人群 为基础的卫生项目来说还是一个比较新的概念，目前该领 域的有关概念与术语尚处在发展研究阶段。本指导中对实 施性研究的定义为“针对实施政策和干预措施的过程，以 及影响这些过程的情境因素的科学研究”。换句话说，实施 性研究就是探究影响一项新政策或干预措施在真实世界中 实施的各类因素的研究。 本指导除了提供一些情境和相关术语之外，还提出 开展实施性研究所需的主要步骤，即形势分析（situation analysis，明确政策或干预措施的必要性），知识汇总 （knowledge synthesis，正式确定并评估相关证据），以及实 施性研究周期中的 4个关键要素：确定合适的政策或干预 措施；调整并试行政策或干预措施；实施并评估政策或干 预措施；推广政策或干预措施。 同时，探讨了政策或干预措施与当地情境（如文化 或语言）之间的相互作用，及其如何影响政策或干预措 施的实施。该指导进一步讨论了政策或干预措施实施的 实施性研究在慢性病防控中的应用指导 2 社会效度（social validity），以及政策或干预措施实施的 其他重要方面，即实施结局指标（implementation outcome variables），如覆盖率、采纳度、保真度、实施成本和可持 续性。 实施项目若能用合理方式解决与受众相关的问题并能 带来有价值的结局，这一项目便被认为具有社会效度。社 会效度可以通过定性的方法如调查或问卷来评价。社会效 度较差的项目需要完善除关键的循证核心内容之外的因素 来调整政策或干预措施的实施。 覆盖面（reach）既包含政策或干预措施惠及的人数又 强调这些人在目标人群中的代表性。总体来说，一项政策 或干预措施如果覆盖面较好将会带来更好的影响。 采纳度（adoption）反映启动一个项目（如政策或干预 措施）的意愿，亦会因当地情境不同、政策不同或干预措 施实施方不同而有所不同，因为实施意愿本身常常会受到 当地资源和实施者专业水平等因素的制约。 同时，实施的保真度（fidelity）反映政策或干预措 施的实施与其制定者的设计初衷的接近程度。实施成本 （implementation cost）包括直接人力成本（与受众或实施者 直接相关的费用），间接人力成本（与受众和实施者间接相 关的费用）和非人力成本（如场地、印刷材料等）。 最后，本指导谈到了项目可持续性（sustainability）和 推广策略，并给出了制定推广策略的 9步指导方针。总而 3言之，本指导旨在为实施性研究提供参考、工具以及实例， 从而促进“预防和控制慢性非传染性疾病全球行动计划 2013—2020”1中提出的慢性非传染性疾病相关的政策和具 有成本效益的干预措施的有效实施。 1　更多信息请点击 http://www.who.int/nmh/events/ncd_action_plan/en/ 概　要

1目　录 目　　录 　1　导论　 1．导论 ………………………………………………………3 1.1　慢性非传染性疾病的疾病负担 ………………………3 1.2　慢性非传染性疾病的全球应对 ………………………3 1.3　本指导目标 ……………………………………………4 1.4　本指导受众 ……………………………………………5 1.5　实现本国慢性病防控目标：证据与实施之间的差距 6 　2　实施性研究　 2．实施性研究 ………………………………………………9 2.1　什么是实施性研究？ …………………………………9 2.2　为什么实施性研究很重要？ ……………………… 11 2.3　实施与实施性研究周期 …………………………… 12 实施性研究在慢性病防控中的应用指导 2 　3　实施性研究步骤　 3．实施性研究步骤 ……………………………………… 17 3.1　提出适合当地情境的循证政策和干预措施 ……… 17 3.1.1　形势分析：明确政策或干预的必要性…………… 17 3.1.2　知识汇总：识别并评估相关证据………………… 21 3.2　调整并试行政策或干预措施 ……………………… 33 3.2.1　社会效度：政策和干预措施在本地的可接受 　　　程度如何？………………………………………… 38 3.3　评估一项政策或干预的实施 ……………………… 40 3.3.1　实施的评估应该提出哪些研究问题？…………… 41 3.3.2　实施结局是什么？………………………………… 42 3.3.3　实施政策或干预措施的调节因素是什么？……… 47 3.3.4　实施策略…………………………………………… 47 3.3.5　如何评价政策或干预措施的效果？……………… 48 3.3.6　如何评价政策或干预措施的实施成本？………… 49 3.3.7　如何用数据确保并提高实施的质量？…………… 51 3.3.8　如何提高政策或干预措施的可持续性？………… 51 3.4　政策或干预措施的推广 …………………………… 53 3目　录 　4　总　结　 4．总结 …………………………………………………… 61 附　件……………………………………………………… 63 附件 1．用于制定目标和指导知识汇总的 PICO 框架 … 65 附件 2．用于相关证据整合的模板样例 ………………… 67 附件 3．评估政策或干预措施的社会效度 ……………… 69 附件 4．实施保真度的评估 ……………………………… 71 附件 5．决策支持数据系统 ……………………………… 75 参考文献…………………………………………………… 77 1 导　论

31　导　论 1.导论 1.1　慢性非传染性疾病的疾病负担 慢性非传染性疾病（noncommunicable diseases，NCDs, 以下简称慢性病）通常是指由遗传和 / 或环境以及生活方式引起 的不具有传染性的健康状态，往往影响持久或具有复发性［1］。 目前，慢性病导致的死亡约占全球死亡人数的三分之 二［2］，主要来源为 4 大疾病，即心血管疾病、慢性呼吸道 疾病、癌症和糖尿病。重要的是，这 4 种慢性病具有共同 的行为危险因素——烟草使用、不健康饮食、身体活动不 足和有害饮酒［2］。 1.2　慢性非传染性疾病的全球应对 2011 年，世界卫生组织（World Health Organization， WHO）发布了《预防和控制慢性非传染性疾病的优先研 究议程（A prioritized research agenda for the prevention and control of noncommunicable diseases）》［3］，议程确定了预防 和控制慢性病有关的关键研究领域。同年 9 月，联合国慢 性非传染性疾病预防与控制高层会议的与会者们认识到预 4实施性研究在慢性病防控中的应用指导 防慢性病是一项具有成本效益的干预措施，并有全球行动 的巨大机会。随后的第 66 届世界卫生大会批准了“预防 和控制慢性非传染性疾病全球行动计划 2013-2020（the Global Action Plan for the Prevention and Control of Noncom- municable Diseases 2013-2020）”［4］。该计划呼吁国际合作伙 伴联合起来，到 2025 年实现 9 项全球慢性非传染性疾病自 愿目标——包括将慢性病导致的过早死亡率降低 25%。 全球行动计划的主要目标之一是关注研究。该目标呼 吁利益相关方推动和支持以下行动： ◆ 在预防和控制慢性病领域开展高质量研究的国家能 力建设（并借此加强国家、地区和全球行动的知识 基础）； ◆将高质量的慢性病研究证据转化为实践行动； ◆发展慢性病预防和控制。 1.3　本指导目标 虽然我们已有一些与疾病预防和控制相关的实施性研 究的实用工具，但这些工具主要针对传染性疾病 1。目前尚 1　其中一个工具是实施性研究工具包，该工具包由热带病研究和 培 训 特 别 项 目（the Special Programme for Research and Training in Tropical Diseases，TDR）制定。TDR 由 WHO 主持，工具包可以在 以下网址找到：http://www.who.int/tdr/publications/topics/ir-toolkit/en/ （获取于 2016 年 10 月 14 日）。 51　导　论 无针对慢性病实施性研究的实用工具。本指导的主要目的 是为实施性研究提供实用指南、工具和样例，用以支持慢 性病政策和具有成本效益的干预措施的有效实施；具体目 标包括： ◆提高对实施性研究目的和潜在影响的认识； ◆ 帮助各国研究者获取、整理和分析信息，因地制宜， 将基于循证的政策和干预措施进行转化； ◆帮助识别实施政策和干预措施的障碍； ◆帮助确定实施性研究的最佳方法。 本指导将会介绍实施性研究的基本术语和概念，并简 要概述实施性研究所涉及的内容。我们整理并总结了最新 的研究证据，并提供资源链接，从而涵盖与主题相关的更 多信息。指导还包括了案例研究，展示了慢性病预防和控 制政策、干预的实施案例。在指导最后，我们还提供了支 持实施性研究的实用工具。 1.4　本指导受众 本指导是为选择和实施全球慢性病预防和控制相关 政策及干预措施的项目实施者、卫生健康领域的专业人员 （包括研究人员）和国家卫生政策制定者编写的。 6实施性研究在慢性病防控中的应用指导 2 实施性研究 1.5　实现本国慢性病防控目标：证据与实施之间的 差距 尽管在全球、区域和国家范围内有很多计划、倡议、 政策和干预措施，然而这些手段对健康结局的影响仍需加 强，这也是慢性病预防和控制的一个主要挑战。“证据 - 实 施（或执行）”之间的差距仍值得关注。目前在许多健康领 域都存在研究证据和实践之间的转化差距［5-7］。例如，一 篇为美国成年人提供医疗服务的综述表明，高达 45% 的患 者未能接受已经证明有效的治疗［7］，而 11% 的患者接受了 非必要的治疗或者具有潜在伤害的治疗［7］。 缩小证据与实施之间的差距将有效地降低发病率和死 亡率［8-10］及医疗成本［11］。因此，近年来，人们越来越关 注研究转化中的障碍，以及如何开展以循证为基础的实践 来改善患者预后［12-14］。同时也需要更多的证据支持，在不 同情境下，通过政策及跨部门合作的健康促进，慢性病一 级预防能够有效实施。 2 实施性研究

92　实施性研究 2．实施性研究 2.1　什么是实施性研究？ 实施性研究（implementation research）探究影响一项 新政策或干预措施在真实世界中实施的各类因素。这类研 究对以人群为基础的卫生项目来说仍是一种比较新的概念 和方法，相关概念与术语尚在发展阶段。作为参考，本指 导所使用的主要的术语都在下表中列出。 表 1　实施性研究术语 定义 具体细节 实施（implemen- tation） 将政策或者干 预在指定规模 下付诸实践的 一系列具体 活动［15］ 实施过程： ·具有目的性 ·描述详尽，使独立观察者能 够发觉是否存在特定的实施 相关活动及其质量［16］ 实施性研究 （implementation research） 针对实施政策 和干预措施的 过程，及影响 这些过程的情 境因素的科学 研究［17］ 调查实施性研究的各方面因素， 包括： ·循证政策和干预措施的采纳 ·将政策和干预措施付诸实践 的活动 ·影响这些活动的因素 ·对于健康结局的影响 10 实施性研究在慢性病防控中的应用指导 定义 具体细节 实施者 ［implementer(s)］ 管理和负责实 施过程的个人 （或群体） 例如： ·政策制定者 ·卫生专业人员 ·基层社区机构 受众 （consumers） 干预措施或政 策的目标人群 通常包括： ·慢性病的高危人群 ·慢性病患病率较高的人群 情境 （context） 政策或者干预 措施实施的特 定场景 包括场景的所有特征，例如： ·利益相关方 ·社会、经济和政治环境 ·地理场景 ·疾病流行情况 知识汇总 （knowledge synthesis） 证据的识别、 评估和汇总 这个过程： ·与现存的政策和干预措施 相关 ·以实现一个确切结局为目标 知识交流 （knowledge exchange） 合作解决问题 的过程 发生在整个实施过程中的各方 人员之间，包括 ·研究者 ·决策者（包括政策制定者） ·受众 ·其他利益相关方 知识转化 （knowledge translation） 促进研究信息 可及性和可利 用性的过程 通过与受众互动实现，该过程 可用在实践、计划和制定政策 等方面 续表 11 2　实施性研究 实施性研究回答的问题包括： （1）什么是新情境下的最佳政策或干预措施？ （2）实施干预措施的最佳方法是什么？ （3）如何覆盖目标受众？ （4）哪些因素会影响干预措施的实施和采纳 ? （5）如何使实施干预措施的成本最小化？ （6）如何提高干预措施的采纳率和健康结局？ 2.2　为什么实施性研究很重要？ 实施性研究的目的之一是帮助决策者选择一项有效的 政策或干预措施［16］。同时，实施性研究可以帮助确定如何 在与初始情境不同的人群和资源中实施这些政策和干预措 施，并找出达到预期结果所必需的政策和干预措施如果干 预措施并没有达到理想的效果，实施性研究有助于判断失 败是由政策或者干预措施本身导致（失败的干预），还是由 于错误的实施方式导致（失败的实施）［18］。 实际上，实施性研究就是了解如何优化干预措施的实 施，如何推广有前景的策略，如何评估影响，更为重要的 是如何使这些策略长时间、可持续地推广。显然，实施性 研究有潜力成为行动和证据之间的桥梁。 12 实施性研究在慢性病防控中的应用指导 2.3　实施与实施性研究周期 如今越来越多的理论和模型被用于描述实施性研究的 过程［19-22］。实施通常是一个步步递进、循环往复的过程 （图 1）。第一步是与利益相关方合作，确定具体的健康需 求和问题，以及明确解决该需求的恰当的政策或干预措施。 第二步是根据当地情境调整所选择的政策或干预措施，并 进行一些试点。第三步是实施调整后的政策或干预措施。 第四步是评估调整后的政策或干预是否可以在更大的范围 内被实施或推广，如果可以，需确定实现这一目标所需的 资源和步骤［23，24］。 在实践中，从选择（步骤 1）到推广（步骤 4）的路径 通常由多个利益相关方、资源的可用性和其他情境因素共 同来决定，并非一蹴而就。因而，实施的过程通常历经多 次迭代，在两个或多个流程步骤之间反复。 13 2　实施性研究 图 1　实施和实施性研究循环 第二步： 调整并试行政策 或者干预措施 第一步： 确定合适的政策 或者干预措施 第四步： 推广政策或者 干预措施 第三步： 评估政策或干预 措施的效果 如何选择合适的政策 或者干预措施？ 如何识别和评估相关 的证据？ 如何修改和调整政策或干预措施 从而适用于新的场景？ 政策或干预措施的可接受性如何？ 政策或者干预措施实施的 阻碍和促进因素是什么？ 政策或 者干 预措 施的 覆盖范 围 如何？ 政策或者干预措施的采纳度如何？ 实施的质量如何？ 政策或者干预措施实施过程 中的调节因素是什么？ 政策或者干预措施实施 的效果如何？ 这个干预措施或者政策 是否适合新的情境？ 为了推广政策或者干预措施需 要动员哪些资源？又该如何动 员这些资源？ 如何有效地进行知识转化和知 识交换？ 这个循环过程经常会出现在各种实施性研究的模型 和框架中，其中，由 Graham 等人概括的“知识 - 行动闭 3 实施性研究步骤 环（knowledge to action cycle）”框架被广为使用［25］。知 识转化交换中心（knowledge tranlation clearinghouse，KT Clearing house）提供了关于此框架的一系列资源、工具和 信息 1。 1　更多信息请点击 http://ktclearinghouse.ca/knowledgebase/knowled getoaction 3 实施性研究步骤

17 3　实施性研究步骤 3．实施性研究步骤 3.1　提出适合当地情境的循证政策和干预措施 在选定一项政策或干预措施之前，必须明确是否有必 要实施该政策或干预措施，并且是否有足够多的高质量证 据证明该政策或干预措施在当地情境下会有效。以下内容 将对此过程进行概述。 3.1.1　形势分析：明确政策或干预的必要性 慢性病防控政策或干预措施的选择通常从形势分析 （situation analysis）开始。这是一个信息收集过程，有助于 了解特定地区的慢性病负担（例如健康需求，风险和当地 情境）1。形势分析也可为跨部门合作提供机会。 形势分析的第一阶段通常是组建一个利益相关方小 组——包括实施者、潜在受众和其他相关的利益方。这个 1　详细描述形势分析过程和多部门协作的建立超出了本指导准 则的范围。然而，WHO 已发布了关于这一进程的综合资源，可查 阅 http://www.who.int/nmh/action-plan-tools/en/（获取于 2016 年 10 月 14 日）。 18 实施性研究在慢性病防控中的应用指导 小组的建立及其构成取决于当地情境；在某些情况下，组 织形势分析的成员已经完成了与主题相关的工作；工作组 也可能已经存在。 利益相关方小组随之应参与到知识交流活动中；这 意味着他们应该讨论健康问题，并整理和讨论与健康问题 有关的环境、行为和个人决定因素方面的证据。这一阶段 有助于确定哪些因素可以干预，并可以考虑作为政策和干 预的优先目标。该小组还应讨论并明确预期结局——例 如，目标人群死亡和发病数的变化，或者危险因素的流行 情况。 以下给出了一个在印度进行的与糖尿病预防相关的形 势分析的案例。 案例研究 1：形势分析——印度的糖尿病预防项目 （表 2） 表 2　印度的糖尿病预防项目 为什么选择 这个案例？ 该案例旨在展示如何在印度喀拉拉邦进行形势分析， 以评估实施糖尿病预防项目的必要性。 形势分析为把糖尿病预防项目从欧洲，美国和澳大利 亚引入到当地奠定了基础 标题 为慢性病防控政策和干预措施的实施进行形势分析 来源 印度特里凡得琅 Sree Chitra Tirunal 医学科技研究所 健康问题 2 型糖尿病 19 3　实施性研究步骤 地点 印度喀拉拉邦特里凡得琅地区 目标人群 糖尿病高风险人群 背景 印度有大约 6500 万人患有 2 型糖尿病，是世界上糖 尿病患病人数第二多的国家。预计到 2030 年这个数 字将翻一番［26，27］。研究估计，2 型糖尿病将影响该 国 9% 至 20% 的成年人口［28，29］。 喀拉拉邦有最高的 2 型糖尿病患病率，据估计，该州 部分地区有高达 20% 的成年人患有该病［30，31］ 政策或干预 措施的描述 喀拉拉邦糖尿病预防项目（Kerala Diabetes Prevention Program，KDPP）是一项面向喀拉拉邦农村地区糖尿 病高危人群的生活方式干预项目。该计划旨在通过当 地社区举办的一系列由患病同伴主导的讨论活动来降 低患糖尿病的风险。从社区中挑选出的同伴领袖组织 在接受糖尿病预防和团体促进培训后，开展小组活动， 重点普及有关糖尿病和预防策略的知识。小组活动辅 以社区范围的活动，如瑜伽、健步走和园艺等，帮助 参与者将小组活动学习的知识付诸实践 我们做了 什么？ 在开发 KDPP 之前进行形势分析，通过以下方式对 证据进行测量：（Ⅰ）关于印度和其他地方糖尿病患 病率和控制率的既往研究；（Ⅱ）与喀拉拉邦或印度 特有的糖尿病预防相关的政策和其他项目文件；以及 （Ⅲ）通过与当地利益相关方（包括受众）的接触， 在喀拉拉邦收集新的定性数据［32］。 通过 PubMed 平台搜索有关印度的饮食、身体活动、 烟草和健康促进干预项目的医学主题词（MeSH）， 检索已发表的相关研究 续表 20 实施性研究在慢性病防控中的应用指导 我们做了 什么？ 使用相关政府部门网站（例如卫生和家庭福利部）的 检索引擎检索相关政策和计划文件（包括州和国家层 面的关于慢性病防控、饮食、身体活动、烟草和酒精 使用方面的指南）。 定性研究部分由专题小组组成（专题小组成员为来自 喀拉拉邦农村地区的糖尿病前期的个体，组员名单从 早期一项探讨对 2 型糖尿病及其预防的看法和态度的 研究的数据库［33］中确定）。这些小组讨论有助于明 确在适应当地文化以及向目标社区提供项目过程中的 具体需求 我们学到了 什么？ 国家预防和控制糖尿病心血管疾病和脑卒中计划 （National Programme for Prevention and Control of Diabetes，Cardiovascular diseases and Stroke， NPDCS）中关于饮食和身体活动的建议近期才在印度 推出。这与高收入国家（high-income country，HIC） 的情况形成对比，高收入国家的大多数糖尿病预防计 划几乎在十年前已经实施。 尽管该邦和全国的慢性病负担都很重，但形势分析显 示喀拉拉邦和印度全国的慢性病研究和政策之间存在 差距。一项流行病学研究综述显示，喀拉拉邦的 2 型 糖尿病危险因素的流行率高于全国其他地区［29］，其 中一些危险行为（如吸烟）高于全国平均水平。成年 人空闲时间身体活动缺乏的流行率也很高［34］。 专题小组强调了印度家庭和文化规范对生活方式选择 方面的重要作用。这说明了相比高收入国家，在印度 倡导更加综合的行为改变干预方法的更为重要。正如 印度其他研究所证实的那样，新的干预手段需要涉及 家庭和社区赋能的多种综合策略［32，35-36］ 续表 21 3　实施性研究步骤 3.1.2　知识汇总：识别并评估相关证据 实施一项仅在单一研究中显示有效的政策或干预可能 会产生问题。很少有研究本身具有足够的说服力来改变政 策或实践；事实上，由于巧合或偏倚，个别研究甚至可能 有误导性［37］。因此，在进行形势分析并确定健康需求和预 期结局后，实施者需要对潜在政策和干预措施进行正式的 证据整合——这就是知识汇总。 如果不使用知识汇总，可能会导致某项干预的研究证 据产生与临床专家作出符合该研究发现的推荐之间的延迟。 例如，安特曼（Antman）观察到一种治疗心肌梗死的特定 方法的有效性从被荟萃分析证明到被广泛建议使用之间存 在 15 年的间隔［38］。 知识汇总的阶段 知识汇总的方法越来越多；大多数涉及对现有文献的 初步检索。根据时间、可用资源和其他限制因素，这种文 献综述既可以很快，也可以涉及较长的荟萃分析过程。本 指导后面将详细介绍这些内容；在本节中，我们基于已发 布的框架［39～41］重点介绍知识汇总的常见阶段（图 2）。 22 实施性研究在慢性病防控中的应用指导 图 2　知识汇总的阶段 第 1 阶段：　提出要实施的政策或干预的目标 第 2 阶段：　确定要评估的证据的选择标准 第 3 阶段：　定义检索策略以找出相关证据 第 4 阶段：　检索相关证据 第 5 阶段：　评估发现的证据质量 第 6 阶段：　集成和分析可用的最完整的数据集 第 7 阶段：　根据研究形成的结构化报告做出明智的决定 第 1阶段：提出要实施的政策或干预的目标 知识汇总过程的第 1 阶段是确定知识汇总的目标；这可 以说是该过程中最重要的阶段，在前面“3.1.1　形势分析： 明确政策或干预的必要性”章节中已经涉及一部分的信息。 目标越明确（例如，目标人群或干预措施的定义越具 体），能检索到的证据数量越少。另一方面，目标越宽泛， 可能需要投入更多的时间和人力来筛选和评估证据。 下文是一种制定目标的方法，首字母可缩写为 PICO： 23 3　实施性研究步骤 ◆ P- 目标人群（population）； ◆ I- 干预措施（intervention）； ◆ C- 对照组（comparison）； ◆ O- 结局指标（outcome）。 例如，项目目标可能是识别在农村地区的老年男性和 女性（目标人群）中预防心脏病二次发作（结局指标）方 法的证据。这个目标非常宽泛，研究者可以根据形势分析 期间收集的信息对这目标进行优化。例如，形势分析可能 表明目标人群中的大多数人都可以使用手机；因此，可缩 小目标范围，查找移动医疗项目（干预措施）的证据，并对 比其与面对面二级预防服务（对照组）在有效性上的差异。 PICO 模型使用非常广泛，Cochrane（考科蓝，以前称 为 Cochrane 协作组）推荐将其作为构建问题和检索策略、 并用于描述临床研究或荟萃分析 1。附录 1 提供了 PICO 的 示例和模板，可用于形势分析中。 第 2阶段：确定要评估的证据的选择标准 在第 2 阶段，您应该设定标准，以确定是否应该涵盖 （并评估）已发现的特定证据还是应舍弃该证据。这一阶段 部分主要由前面概述的目标来指导。 首先，需要明确要纳入知识汇总过程中的证据的特征 （例如调查研究）——实际上是“选择标准”。 以下是一些 1　获取更多关于 PICO 框架的信息，请访问：http://linkeddata.co- chrane.org/pico-ontology（获取于 2016 年 10 月 14 日） 24 实施性研究在慢性病防控中的应用指导 典型示例： ◆所研究内容的性质（例如具体政策或干预措施）； ◆情境（即地点和人群——例如成年人、某个民族）； ◆研究时间（例如自 1920 年以来、自 1990 年以来）； ◆ 研究方法（例如所有方法、仅试验性的、仅某些试 验设计）； ◆报告语言（例如仅限英语、仅限法语、两者都有）。 继续上述第 1 阶段提到的情境，检索范围可以限制 在“使用信息和通信技术对农村地区的男性和女性进行心 脏病发作二级预防的证据”。理想情况下，检索范围可限 制在研究所在国家，但这样并非总是可行，因为可用的证 据可能极少或根本不存在。在这种情况下，可以将寻找证 据的范围扩大至区域（例如，如果目标在孟加拉国，则检 索南亚地区；如果目标是乌干达，则为撒哈拉以南非洲地 区等）。 还必须决定是否只检索近期的证据（通常采用这种方 式以确保相关性），以及是否要纳入仅使用随机对照设计 的同行评议研究，或者是否也考虑纳入未正式发表的灰色 文献 1。 1　灰色文献是指尚未公开或不公开发表的信息，其价值已得到包 括Cochrane在内的著名的循证研究组织的正式认可。包括（但不限于） 会议论文，报告，政策声明，政府文件，统计数据，访谈和专题小 组报告。当与政策和相关干预措施有关的文献数量有限和 / 或对当地 情境的适用性有限时，灰色文献尤其有用。 25 3　实施性研究步骤 第 3阶段：定义检索策略以识别相关证据 在确定了知识汇总的目标以及要评估的证据之后，需 要准备检索策略。检索策略指的是进行检索的详细方法； 它列出了将使用哪些（结构化列表中的）词条在数据库中 进行检索，这些词条如何关联以及将使用哪些数据库。检 索策略应基于研究问题，并详细记录下来。 关键词的选择应以研究目标为导向。请记住，同一个 概念可能有多种表述方式（例如，自尊在其他地方可能被 表述为自我价值）。因此，需要明确每个概念，并把它们在 文献中可能出现的不同方式列一个清单，还需要考虑检索 词如何关联。 检索通常使用现有的研究文献和 / 或政策数据库在线 进行。有助于发现相关证据的重要数据库包括： ◆ Cochrane 图书馆：http://www.thecochranelibrary.com ◆ Joanna Briggs Institute 系统评价和实施报告数据库： http://joannabriggslibrary.org/index.php/jbisrir/index ◆效果综述摘要数据库（DARE）： 　 http://www.crd.york.ac.uk/CRDWeb/ HomePage.asp ◆ NICE 证据服务：https://www.evidence.nhs.uk ◆ PubMed Health：https://www.ncbi.nlm.nih.gov/ pubmedhealth ◆ 世界卫生组织图书馆数据库（WHOLIS）：http://dosei. who.int 26 实施性研究在慢性病防控中的应用指导 不同的数据库检索逻辑不同，因此可能需要修改检索 策略以适应每个数据库。此过程通常被称为“定制”检索。 也可能决定针对研究的不同方面制定单独的检索策略。 请注意，实施者并非总是能够访问所有数据库或通过 数据库找到证据。这体现了从一开始就建立跨部门协作团 队的重要性（如章节 3.1.1 所述）；理想情况下，该团队 应包含可以访问大多数在线数据库和证据来源的学术研究 人员。 在寻找相关证据时，需要在敏感性和特异性之间进行 权衡；敏感性增加时，特异性降低。高敏感性的检索能发 现所有或大多数相关文献，但是也可能找出不相关的文献。 高特异性的检索能排除所有或大部分不相关的文献，但是 也可能排除一些相关的文献。检索越敏感，就需要花费更 多的时间来筛选不相关的研究。鉴于实施者通常时间或资 源有限，因此只能牺牲一些敏感性，从而导致遗漏一些可 能相关的证据。定义检索策略将受益于信息学专家的专业 知识。他们可以提供检索词限定的指导来平衡敏感性和特 异性。 第 4阶段：检索相关证据（应用检索策略） 该阶段涉及使用所选定的选择标准和针对特定数据库 的预定检索策略来检索所有相关证据。检索旨在尽可能多 地发现符合纳入标准的文献。 如果时间和资源允许，最好让多个人独立执行相同的 27 3　实施性研究步骤 检索，然后比较筛选后的证据，以确保结果一致，并且在 检索和选择证据的过程中没有偏倚。 在寻找研究证据时，重要的是要考虑哪种研究设计 能够最好地回答研究问题。例如，如果希望确定预防或 控制某种疾病的最佳干预类型，则针对随机对照试验的 系统综述最为理想。但是，如果希望了解问题的流行程 度，那么本地和当前的随机抽样调查（或人口普查）将 更为合适。牛津循证医学中心（Oxford Centre of Evidence Based Medicine，OCEBM）提供了一个基于研究问题的证 据等级 1。 第 5阶段：评估发现的证据质量 证据质量可能差异很大。因此，必须确定评估研究的 明确标准，以便区分质量较高的研究与质量较低的研究。 在评估研究的质量和相关性时考虑的 3 个主要方面 [41] 是： ◆研究的方法学质量； ◆研究设计与目标的相关性； ◆研究重点与实现目标的相关性。 诸如 Jadad 量表（也称为牛津质量评分系统）的检查 清单通常用于评估临床试验方法的质量［41］。乔安娜·布里 格斯研究所（Joanna Briggs Institute）也提供了一系列针对 1　获取更多信息，请访问 OCEBM 官方网站：http://www.cebm.net/ ocebm-levels-of-evidence/（获取于 2016 年 10 月 14 日） 28 实施性研究在慢性病防控中的应用指导 不同研究设计的检查清单 1。 WHO 使用“证据推荐分级的评估、制订与评价”工具 （Grading of Recommendations，Assessment，Development and Evaluation，GRADE）来评估证据的质量，作为制定 简明建议的国际通用标准。GRADE 的详细信息，可通 过 WHO 指南审查委员会（Guidelines Review Committee， GRC）秘书处和以下网站获取： ◆ GRADE 工作组：www.gradeworkinggroup.org ◆ GRADE 在线培训模块：http：//cebgrade.mcmaster.ca ◆ GRADE 简介软件：http：//www.cochrane.org 其他信息来源也可以用于评估证据： ◆ Trip Database2是一个医学检索引擎，允许根据 PICO 检索证据，也可以通过搜索研究设计、相关性和时 间查找证据。 ◆ 关键评估技能计划（Critical Appraisal Skills Programme， CASP）3提供一系列培训、研讨会和工具，帮助批 判性地评估研究的质量、结果和相关性。 系统综述和荟萃分析优先报告条目（Preferred Reporting 1　 获 取 更 多 信 息， 请 访 问：http://joannabriggs.org/research/criti- cal-appraisal-tools.html 2　获取更多信息，请访问 Trip Database 官方网站：http://www.trip- database.com（获取于 2016 年 10 月 14 日） 3　获取更多信息，请访问CASP官方网站：http://www.casp-uk.net（获 取于 2016 年 10 月 14 日） 29 3　实施性研究步骤 Items for Systematic Reviews and Meta-Analyses，PRISMA） 是另一种被广泛使用的方法，用于评估系统综述和荟萃分 析中基于证据的最小条目集。PRISMA 侧重于报告评估随 机试验的综述，但也可作为指导基础，用于报告其他类型 研究的系统综述，尤其是干预措施的评估 1。 使用 GRADE（或其他方式）评估证据和撰写证据汇 总报告是一项专业任务，最好由方法学专家完成。如果研 究者正在评估大规模慢性病防控政策的证据，这一点尤为 重要。当然，在合适情况下，也可以通过使用上面列出的 三个方面和现有的在线资源，更快速地在组织内部完成证 据的评估。 第 6阶段：集成和分析可用的最完整的数据集 在评估证据后，需要整理和分析所有评估结果，以确 定是否有足够的理由来实施研究者感兴趣的政策或干预措 施。这可能是实施者，特别是政策官员最感兴趣的阶段。 因此，应确保知识汇总阶段的结果能以清晰的形式呈现， 从而能够满足这些人的需求（例如，通过提出政策可能引 发的后果）。 有多种方法可以整理、分析和展示找到的证据；在附 录 2 中，我们提供了一个模板样例，研究者可以使用它来 整理和排列证据。 1　获取更多信息，请访问 PRISMA 官方网站：http://prisma-state- ment.org/Default.aspx（获取于 2016 年 10 月 14 日） 30 实施性研究在慢性病防控中的应用指导 第 7阶段：根据研究形成的结构化报告做出明智的决定 只有对所有可用证据进行整理、评估并对证据的有效 性进行排序后，才有可能选出适合当地情境的政策或干预 措施。 系统综述和其他知识汇总方法 上述指导足以帮助研究者在相对较短的时间内和资源 有限的情况下识别和评估您感兴趣的政策和干预措施的有 效性相关的证据。从众多来源中识别、评估和综合证据的 更严格的方法是进行系统综述。类似于在最初产生研究证 据的阶段，系统综述在审查研究证据时同样严格。然而， 使用系统综述方法要花费时间和资源，且通常无法满足大 多数项目实施者正在寻求的实施新政策或干预措施（或在 新环境中实施现有政策或干预）的需求。 更快捷的方法是快速证据评估法，它使用有针对性 的文献检索，在相对较短的时间内生成报告。快速证据评 估法不像完整的系统综述那么严苛，但比临时检索更为严 格 1。快速证据评估可与本章节描述的方法相辅相成。 以下提供了实践中知识汇总的一个案例。 案例研究 2：知识汇总——印度与烟草有关的非传染 性疾病和简易包装政策（表 3） 1　英国政府已经开发并在线共享了一个能够提供更多快速证据评 估有关信息的工具包，可在以下网址找到：http://www.civilservice. gov.uk/networks/gsr/resources-and-guidance/rapid-evidence-assessment/ how-to-do-a-rea（获取于 2016 年 11 月 28 日） 31 3　实施性研究步骤 表 3　印度与烟草有关的非传染性疾病和简易包装政策 为什么选择 这个案例 这个案例展示了为印度实施烟草简易包装政策和干预 做准备知识汇总的过程。 这个案例研究表明，即使有证据表明政策或干预措施 有效，考虑当地情境仍然非常重要 标题 关于“简易包装”的知识汇总，以便选择能够在印度 实施的具有循证证据的政策和干预措施 来源 澳大利亚墨尔本大学 Nossal 全球健康研究所 健康问题 烟草引起的呼吸道疾病和其他慢性病 地点 印度 目标人群 烟草制品使用者 背景 印度是世界第二大烟草消费国（吸烟和嚼烟形式）［42］， 死于呼吸系统疾病的人中，25 人是由烟草造成的［43］。 吸烟率在男性中为 48%，在女性中为 20%，同时还有 其他很多人暴露于二手烟［44，45］。预计到 2020 年，印 度由烟草导致的死亡人口数将增加到每年 150万人［46］。 据估计，2011 年烟草引起的呼吸系统疾病的费用在印 度达到 6 亿美元［47］。 2003 年，印度政府遵循 WHO 烟草控制框架公约 （Framework Convention on Tobacco Control，FCTC）［48］ 通过了“香烟和其他烟草制品法”（Cigarettes and Other Tobacco Products Act，COTPA）。这一法案禁止了与 烟草有关的广告和赞助以及规定了烟草包装上的特定 健康警告［49］。然而，这些措施的影响有限［50］，因此 促使了印度政府考虑引入更大、更有效的图片健康警 语［4，51-56］。下一步计划是推行有越来越多国际证据支 持的简易包装 32 实施性研究在慢性病防控中的应用指导 政策或干预 措施的描述 简易包装需要删除所有品牌信息（颜色、图像、公司 徽标和商标），品牌名称要求统一尺寸和字体，并与 烟草包装上现有或增强的图形健康警告一起放置。 简易包装适用于所有形式烟草的包装；在印度，这包 括线扎手卷烟和咀嚼形式的烟草以及传统卷烟。 简易包装的目的是降低包装的吸引力，增强图案健康 警告对包装的影响，增加戒烟的想法，促进形成对烟 草使用的负面态度。 烟草制品的简易包装这一干预手段有来自许多国 家［54，57-60］的重要证据作为基础——尤其是首次引入 简易包装的澳大利亚。 然而，像印度这样的快速发展 的发展中国家，此类包装证据相对较少［61，62］ 我们做了 什么？ 印度和澳大利亚联合工作组在澳大利亚印度研究所的 一笔小额基金的支持下开展工作。在一个全面的知识 汇总项目之后，该工作组编写了一份关于印度简易包 装可能性的报告［60］。 该报告包括来自其他地区的证据，关于简易包装的当 地市场研究［63］以及与法律专家、政策制定者和烟草 控制专家进行利益相关方分析的结果。它总结了所有 行为，政策和法律方面的证据，提供了关于发展方向 的分级建议。 该报告是在由印度政治家、WHO 代表、主要烟草控制 专家和法律专家参加的高级别活动中发布的。作为回 应，一份关于简易包装的私人法案于 2013 年在印度议 会提交，后续并举行了一场国际会议，印度卫生部长 和秘书长在会上作了发言。 然而，许多实施情境的障碍减缓了简易包装的推进。 其中包括政府和卫生部长的变动、对本地证据的需求 以及来自印度有影响力的烟草种植产业的反对。未来 计划进一步开展研究、并产生更多的本地证据来回应 这些顾虑 续表 33 3　实施性研究步骤 我们学到了 什么？ 虽然外部（国际）证据和国际专家的投入在制定政策 方面是一个有益的开端，但它不足以成功地改变政策。 为了增加知识汇总促使政策变化的可能性，以下几点 非常有用： ·了解正在进行的知识汇总的特定受众至关重要。 ·研究需要考虑政策制定时间表，例如监管委员会会 议或选举周期。 ·需要一种机制来确保将知识汇总提供给适当的群体， 以便为辩论和政策提供信息。特别是，需要一个明 确的沟通策略来接触决策者。 ·知识汇总团队需要包括可靠的成员，以最大限度地 提高证据到达决策者层面的可能性（在这个例子中， 两个共同研究者是政府咨询委员会成员）。 ·除了可从其他地区获得的证据之外，情境信息通常 还需要引入和 / 或提供一些当地所独具的证据。（例 如，在这种情况下，澳大利亚和印度的烟草制品和 工业非常不同，因此需要更多信息） 最后，请注意，虽然上文概述的知识汇总阶段将有助 于确定在预防和控制慢性病方面可能采取的政策和干预措 施，但它们可能无法提供该干预措施在新的和不同情境下 的可推广性的信息。本指导稍后将讨论评估政策和干预措 施在新情境下的适合性和适应性的方法。 3.2　调整并试行政策或干预措施 政策或干预措施与当地情境的相互作用可以同时影响 续表 34 实施性研究在慢性病防控中的应用指导 政策或干预措施的实施和效果［64，65］。例如，目标群体在文 化、语言、年龄和社会经济地位上的差异可以并常常会给 一个政策或干预措施的成功执行带来积极或消极的影响［66］。 这说明政策或者干预措施可能需要一些调整。 调整一项政策或干预使其适应情境需要精妙权衡：一 方面，调整是必不可少的，因为通过适当的调整可以确保 政策或干预措施与当地情境的相关性，提高可行性，增加 与当地的针对性和采纳度，促进保真度，促进可持续性并 使干预效果最大化；另一方面，需要注意避免政策或干预 调整过大以至于影响某些核心成分的实施并且危及其效果。 调整干预措施的指导方针通常包括以下步骤： ◆ 确认初始政策或干预措施针对的人群与新目标人群 之间的差异； ◆确认政策或干预中需要调整的部分； ◆对政策或干预进行调整； ◆试行调整后的政策或干预。 社区参与式项目调整法（Method for Program Adaptation through Community Engagement，M-PACE）［66］概述了一种 系统地调整干预措施以适应新实施环境的方法。该方法包 括召集一个干预调整的指导委员会（包括可以提出建议的 专家，能在不影响项目或干预措施的情况下对某一要素进 行调整）并让一小部分参与者接受未调整的干预措施。如 果合适的话，在每个实施阶段收集参与者和指导者的反馈 意见，或通过个人访谈来进行试点，然后在干预（或试点） 后开展由参与者和指导者参与的焦点小组座谈。M-PACE 的 35 3　实施性研究步骤 更多细节可以在参考文献［66］中找到。 在调整一项政策或干预措施时，了解预期结果的某些 特定干预元素至关重要。这些元素被认为是基于证据的核 心，可以类比为药物的活性成分，若没有这些成分，药物 的效果将会丧失［66］。所以，尽可能不要改变这部分核心内 容。然而，系统地确定一项政策或干预措施的核心元素通 常是不可行的——其需要将同样的干预实施数次，每次实 施干预时，保持其它元素不变，仅改动假定的核心元素。 尽管研究队伍已经成功地表述并证实了一些项目的核心内 容［63，67-70］，但在研究文献里很少有成分界定的项目。随着 人们对实施性研究的意识的提高，不同领域中基于循证的 核心元素的证据应当随之增加。 以下案例展示了如何调整干预措施以适应当地情境 （表 4）。 案例研究 3：调整干预措施——蒙古的高血压试点干 预（表 4） 表 4　蒙古的高血压试点干预 为什么选择这 个案例 这个案例说明了根据当地情境调整干预措施并在扩 大规模前进行试点的重要性。 这个案例研究同时强调了调整和试点过程中的障碍 和促进因素，并提出的解决这些障碍和促进因素的 方法 标题 使政策与干预措施适应新情境 来源 澳大利亚悉尼乔治全球健康研究院 36 实施性研究在慢性病防控中的应用指导 健康问题 高血压与合并症 地点 蒙古 目标人群 乌兰巴托（蒙古首都）的普通人群 背景 以人群为基础的减盐项目被广泛地认为是对高血压 和相关慢性病预防的最有经济效益的干预措施之一。 相关全球项目的数量在 2010～2014 年间几乎翻了 两倍，目前全球大多数区域实施这种项目。然而， 到目前为止，大多数成效显著的项目来自高收入国 家。将这些来自于高收入国家的经验转化为适用于 中低收入国家（low-and medium-income countries， LMICs）的措施是需要过程的 政策或干预措 施的描述 成功的减盐项目识别饮食中盐的主要来源并制定一 个方案来减少摄入。在 2012～2013 年，蒙古卫生部 （Ministry of Health in Mongolia，MMoH）施行了一 个试点干预来减少乌兰巴托人群的盐摄入。这一试 点的结果与其他一系列举措相结合，为制定国家减 盐战略提供信息 我们做了 什么？ 蒙古卫生部创立了一个多部门的工作组，并组织了 一个为期两周的全国减盐咨询和培训项目。所采取 的行动包括一个试点减盐干预措施的实施。 试点干预的主要目的是减少 3 个工厂员工的盐摄入， 该干预是基于 1 个理念——单纯地告诉人们他们应 该吃什么 / 或不吃什么是无效的，也应改变饮食环 境。根据蒙古的当地情境，实施过程中稍有调整， 干预内容包括培训员工们了解过量食盐摄入的危害 以及采用更健康饮食的好处，同时也减少了公司餐 厅 / 厨房里提供的食物的盐含量 续表 37 3　实施性研究步骤 我们做了 什么？ 干预前及干预后的监测表明盐摄入在 2011 年和 2013 年间减少了。同时期，不了解哪种食物盐含量 高的人数也减少了。 这些活动展示了采取行动的潜力并帮助政策制定者 们将政策扩大到全国范围，2015 年，蒙古政府采用 了《蒙古国家减盐战略》——其最终的目标是将人 群盐摄入量减少 30% 我们学到了 什么？ 试点干预的成功以及政策推广到全国水平的原因有 以下几点： ·在干预开始时就认识到跨部门行动的重要性； ·此项目以减盐的咨询和培训为起点，提高了人们 对盐的健康效应的认知； ·此方法从了解当地饮食中盐的主要来源和减少它 们的最好方法入手（而不是简单复制其他国家最 初的减盐方法）。 对其它国家的经验： ·不要只是复制其他项目，也需要很好地理解目标 国家的有关盐摄入的饮食模式； ·确保策略是多方面的，要将改变饮食环境和改变 受众行为的项目结合起来； ·要不断宣传项目以确保政府的有力支持和足够的 资金； ·要建立多部门人员的有效参与，自开始就要有社 区参与和培训项目； ·要在条件允许的情况下实施试点干预； ·不要只在项目结束时开展评估，要频繁监测以确 保实现项目目标的方向无误 续表 38 实施性研究在慢性病防控中的应用指导 3.2.1　社会效度：政策和干预措施在本地的可接受程度如何？ 尽管一项政策或干预措施可对于实现预期结果非常有 效，但实施者和 / 或受众可能认为其并不适用于特定环境。 为了让一项政策或干预措施在实践环境中达到预期结果， 其必须既有效果又有社会效度（social validity）。项目若能 用合理的方式解决与受众相关的问题、并以一种受众可以 享受或至少接受的方式带来有价值的结局，这一项目便被 认为具有社会效度［71］。 社会效度评价可以对一项政策或干预措施的某个部分 的受欢迎程度提供信息。大多数现行的方法是在一项政策 或干预措施中界定出三个可以检测其社会效度的元素，包 括：（1）政策或干预目标的社会意义，（2）政策或干预过 程的社会适宜性和可接受性（acceptability），（3）由政策或 干预措施产生的结果或影响的社会意义。 大多数检测社会效度的方法是通过使用问卷 / 量表和 专题小组或访谈［72］询问除了政策制定者或研究者以外的 各方对政策或干预的意见［71］。在附录 3 中提供了一个对社 会效度的三个要素中每部分都提出问题的常用方法［73］。如 有必要，这个定性的方法可与定量的数据收集（如通过调 查问卷）相结合。 案例研究 4：确定可接受性——塞内加尔的呼吸系统 疾病项目（表 5） 39 3　实施性研究步骤 表 5　塞内加尔的呼吸系统疾病项目 为什么选择 这个案例 此案例举例说明了在没有首先评估新情境中的可接受 性就施行一个有效干预的不良后果 标题 确定可接受性的重要性 来源 太阳能灶对燃料使用、排放与健康的影响：一个随机 对照试验的结果［74］ 健康问题 呼吸系统疾病 地点 塞内加尔 目标人群 使用固体燃料烹饪的家庭 背景 在中低收入国家，用来烹饪和加热的原始火炉通常使 用粪便，煤和木材作为燃料。燃烧这样的固体燃料产 生的烟雾会污染空气，并与一系列呼吸系统疾病和其 他疾病有关 改进后的火炉有可能减少室内空气污染，从而改善健 康结局。太阳能灶是改进的火炉中的一种。在高度控 制的实验情境测试时，太阳能灶经常显示积极的结果 并不排放任何排放物。然而，在真实世界情境中的研 究却没有这么理想 政策或干预 措施的描述 在塞内加尔，开展了一个分阶段的随机对照试验来检 测名为“火锅”的太阳能灶效果 我们做了 什么？ 太阳能灶被提供给了 465 个家庭。六个月后，干预组 的一氧化碳暴露水平与控制组一样高，并且自我报告 的身体健康症状没有减少。 在实验室里这些太阳能灶被证明有效，所以哪里出 错了？ 研究表明由于“火锅”的使用率很低，这些干预家庭 很少使用太阳能灶。其中一个主要原因是太阳能灶对 研究中的大多数家庭来说太小了 40 实施性研究在慢性病防控中的应用指导 我们做了 什么？ 其它研究［75］指出了关于太阳能灶对社区不可接受的 其他原因：烹饪可能会花费更长时间，炉灶不能用来 加热或照明，并且太阳能灶可能需要在有阳光的室外 使用 我们学到了 什么？ 对新技术的采纳具有挑战性，干预措施必须适应社区 的需求和偏好才能成功［76］ 3.3　评估一项政策或干预的实施 通常，人们以评估慢性病政策和干预措施是否能在个 人或人群层面改善健康效果作为评估工作的重点。然而， 只进行政策或干预的效果评估是不够的，还需要制定计划 并集中力量来评估这些政策和干预措施的实施情况。因此， 评估工作应既关注政策和干预措施的有效性，也关注政策 和干预措施的实施情况。 简而言之，评估实施过程的重点应放在所实施的政策 和干预措施的类型和数量、政策和干预措施的受益者，用 于实施政策和干预措施的资源，遇到的实际问题以及解决 这些问题的方式上。 计划开展实施过程评估的步骤类似于计划一项评估项 目有效性的过程。设计项目实施过程的评估必须要在项目 计划的早期开始，否则可能无法完整地收集相关的数据或 者完全错过数据收集。 续表 41 3　实施性研究步骤 加拿大安大略省公共卫生部门设计了 10 个开展评估的 步骤［77］，我们对这些内容进行了如下调整以便使这些评估 步骤可以同时包含对实施流程和实施效果的评估： 1．明确要评估的内容； 2．让利益相关方参与； 3．确定评估问题； 4．制定评估框架； 5．确定适当的测量方法和流程； 6．制定评估计划； 7．收集数据； 8．处理数据并分析结果； 9．解释和传播结果； 10．应用评估结果。 3.3.1　实施的评估应该提出哪些研究问题？ 评估实施性研究或报告实施性研究的成果需要设计一 些关键的研究问题，例如： ◆采用了哪些具体的政策或干预措施来控制慢性病？ ◆政策或干预措施在多大程度上是按照预期开展实施？ ◆实施者对政策或干预措施的采纳程度如何？ ◆有哪些因素会影响政策或干预措施的实施情况？ ◆ 这些因素在多大程度上影响了政策或干预措施的 实施？ 42 实施性研究在慢性病防控中的应用指导 ◆ 政策或干预措施所带来的健康结局（例如有效性） 与实施情况之间是什么关系？ ◆所用的实施方法是否具有成本效益？ Peters 等人［78］开发了一个表格可以帮助我们提出评估 相关的研究问题 1。 3.3.2　实施结局是什么？ 在实施性研究中，实施结局（implementation outcomes） 指的是针对一项政策或干预措施采取的有意识的行 动［18，78］；与健康结局相关但两者不同。实施结局指标包 括：可接受性、覆盖面（reach）、采纳度（adoption）、保 真度（fidelity）、实施成本（implementation cost）和可持续 性（sustainability）。可接受性已经在 3.2.1 节介绍；实施成 本和可持续性将分别在 3.3.6 和 3.3.8 介绍。在下述的几个 章节，我们将重点关注覆盖面、采纳度和保真度。 政策或干预的覆盖面是什么？ 政策或干预措施的覆盖面可以定义为研究样本的绝对 数量、比例和其人群的代表性［79］。政策或干预措施在人群 层面的效果取决于政策或干预措施的实施情况、在个体层 面的效果，以及其覆盖面。例如，一项戒烟项目在人群层 面的效果将取决于参与项目并尝试戒烟的吸烟者数量和平 1　表格参考： http://www.bmj.com/content/347/bmj.f6753（获取于 2016 年 10 月 14 日） 43 3　实施性研究步骤 均戒烟成功率。该研究表明，由于成功率的差异较小，这 个例子中项目的覆盖面将对项目效果有较大的影响。 覆盖面既包含政策或干预措施惠及的人数又强调了这 些人在目标人群中的代表性。很多研究报告了研究样本的 大小、愿意参与项目的个体比例，但较少报告人群的代表 性（人群的代表性反映参与研究的人群和那些符合条件但 没有参与的人群之间的相似性和 / 或差异）。 人群代表性尤为重要，因为如果参与实施的人群具有 代表性，覆盖面好，那么将干预措施推广到真实世界环境 也将可能会产生更好的效果。代表性的比较应基于基本的 人口统计特征，在可能的情况下基于主要结局指标。以下 案例探讨了与覆盖面相关的问题。 案例研究 5：将覆盖面纳入考虑——印度的糖尿病足 项目（表 6） 表 6　印度的糖尿病足项目 为什么选择 这个案例？ 这一研究案例阐述了评估覆盖面在确保新的政策或干 预措施可以惠及健康需求最大的人群的重要作用 标题 为什么我们需要评估覆盖面和有效性？ 来源 印度泰米尔纳德邦 Vellore 基督教医学院 健康问题 糖尿病足 地点 印度泰米尔纳德邦 Vellore 基督教医学院综合糖尿病足 诊所内分泌科糖尿病与代谢系统 目标人群 患有糖尿病足的 2 型糖尿病患者 44 实施性研究在慢性病防控中的应用指导 背景 糖尿病足问题是导致糖尿病患者住院的最常见原因， 约占该疾病总医疗费用的 20%，超过所有其他糖尿病 并发症的费用总和。糖尿病足的治疗包括鞋类的改造 和减压（即减轻脚部受影响区域的压力） 政策或干预 措施的描述 糖尿病足综合诊所于 2008 年在印度 Vellore 的基督教 医学院成立，该诊所拥有一个由内分泌学家、糖尿病 护理教育工作者、血管外科医生、物理治疗师和矫形 师组成的综合团队。 该诊所配备了诊断和治疗糖尿病足的设备，放射学检 查也可在就诊同一天内完成。与此同时，假肢和矫正 中心开发了针对患者情况的设计的专用鞋。 2015 年开展了一项包含 138 名患者的回顾性研究，以 评估低成本鞋类改造（如鞋前底改造）在减少溃疡愈 合时间的效用 我们做了 什么？ 使用鞋前底改造的患者中，有超过一半的人在 8～12 周 内溃疡完全愈合；而那些没有坚持穿或没有穿被改造 的鞋的患者的愈合时间长达 4～6 个月 我们学到了 什么 由于社会经济因素和缺乏意识，相当大比例的糖尿病 患者无法获得足够的足部护理和足部减压技术，从而 导致截肢和医疗保健支出。因此，尽管此类治疗可能 有效，但其覆盖面依然有限。 诊所提供的服务有更大的覆盖面。该研究表明，使用 简单的诊断标准、开发具有成本效益的改进措施（如 鞋前底改造）可显著缩短溃疡愈合时间，从而减轻经 济负担 政策或干预的采纳度是什么？ 采纳度被定义为愿意开展项目（政策或干预措施）的 续表 45 3　实施性研究步骤 地点（情境）和干预机构（实施者）的绝对数量、比例、 和代表性［79］。 不同的情境（例如工作场所、诊室、学校、社区等） 和不同的实施者（例如医疗从业人员、政策制定者、政府 工作人员、研究人员等）对政策或干预措施的采纳度可能 会有所差异，因为政策的采纳会受到可及的资源、专业知 识水平和对项目的承诺程度的影响。研究人员很少报告采纳 度相关的信息，但是了解不同情境和实施者对政策或干预措 施采纳度的差异对于了解政策或干预的实施效果尤为重要。 测量项目采纳度的方法应根据政策或干预本身、采纳 的情境或实施者的兴趣等因素而改变。提供对评估采纳程 度的更多的工具和方法的详细指导超出了本指导的范围。 但是美国国立卫生研究院（National Institutes of Health， NIH）拥有一个网格化测量数据库（Grid-Enabled Measures Database）1，该数据库涵盖了用于评估采纳度（以及其他实 施结局）的测量方法。 什么是政策或干预措施的保真度？ 实施的保真度是指政策或干预措施的实施与其开发人 员的意图和项目模型的一致程度［80］。评估实施的保真度十 分必要，因为保真度可能会影响干预与其效果之间的关系。 评估保真度还可能： 1　参见：https://www.gem-measures.org/public/ConstructDetail.aspx? cat=1&cid=1193&tab=1（获取于 2016 年 10 月 14 日） 46 实施性研究在慢性病防控中的应用指导 ◆ 避免得出对干预措施在实现预期健康结局方面的有 效性的潜在错误结论； ◆有助于改善结局； ◆ 让初级研究人员树立干预措施可改善健康结局的 信心； ◆ 让基于证据的实践者相信他们正在恰当地实施所选 择的干预措施； ◆让研究人员在使用二手数据整合研究时更有信心［81］。 干预从两方面影响实施的保真度［81］——结构层面和 动态层面。 ◆ 结构层面——例如，遵守项目的基本要素，如雇佣 高水平的员工或为参与者提供符合推荐剂量和持续 时间的服务。 ◆ 动态层面——通常与实施者和受众之间关系的质量 和内容有关。 实施的保真度有两个主要组成部分——初始保真度和 持续保真度。 ◆ 初始保真度——反映实施者在一个新的环境下能够 满足实施一项新政策或干预最初要求的能力，例如 符合所有培训要求。 ◆ 持续保真度——反映了实施者在一个项目已经开始 实施后能够保持实施质量和汇报标准的能力，例如 持续实施干预的能力。 从动态层面来说，进行评估可能需要制定与所评估的 47 3　实施性研究步骤 政策和干预措施的组成部分相关的、独特的保真度标准。 这些标准需要客观且可测量［82，83］。附录 4 提供了用于开发 评估项目结构性保真度和动态性保真度工具的模板。 3.3.3　实施政策或干预措施的调节因素是什么？ 如前所述，政策或干预措施与其实施情境之间的相互 作用较为复杂。各种调节因素可以影响政策或干预实施的 保真度，且影响效果可以是积极的或消极的。此外，这些 调节因素彼此交互、一个调节因素对于实施保真度的影响 可能受其他调节因素的影响。 影响项目有效实施的可能调节因素包括：项目的复杂程 度、促进策略、实施的质量、受众特征和响应能力［81，84，85］， 以及个体参与者的特征［86-88］、组织对创新的支持［19，96，100］、 支持实施的策略［64，96，87］等。开展 / 支持实施过程［15，64］ 的积极和整合的方法，以及实施的大环境也可能影响实 施［89-91］。因此，在评估项目实施时应充分考虑社会系统、 组织间联系和历史 / 并发事件［89］。 3.3.4　实施策略 实施策略（implementation strategies）可以定义为增加 政策或干预措施的采纳、实施和可持续性的方法［92，93］。例 如实施者培训、干预工具包、检查表、算法以及正式实施 的方案和指南等方法。 在评估实施时，评估与实施策略相关的工作至关重要。 48 实施性研究在慢性病防控中的应用指导 例如，医务人员的培训可能是在实施基于社区开展高血压 控制的干预时的实施支持策略；在这种情况下，评估方案 需要包含评估所提供的培训（例如，培训频率、持续时间、 感知质量）及其对医疗工作者知识和技能的影响，以及其 他情境因素如预先存在的技能。 已有综述回顾了关于改善中低收入国家卫生服务提 供方面的成功实践策略［94］，这一列表可以从此网址下载： http://hdl.handle.net/10986/12335。 研究框架可以帮助研究人员系统性地决定实施过程中 的阻碍和促进因素。其中一个常用的框架是理论领域框架 （Theoretical Domains Framework）。该框架评估了 14 个广 泛的领域，包括：“知识”“技能”“社会 / 专业角色”“环境 背景和资源”和“社会影响”［95］。 3.3.5　如何评价政策或干预措施的效果？ 用于评估政策或干预措施有效性的指标取决于预期的 健康结局。例如，通过评估研究目标人群的糖尿病发病率 来确定糖尿病预防干预措施的有效性；通过评估学生进行 的不同水平的高强度锻炼来反映在学校中的开展促进体育 活动的新政策的有效性。鉴于慢性病预防和控制中评估的 健康结局的巨大差异，探索用于评估健康结局的各种工具 和方法超出了本指导的范畴。 需要注意的是政策或干预的有效性会受到实施的影响。 49 3　实施性研究步骤 因此，在评估政策或干预措施的有效性时，我们并不是在 评估干预措施的绝对有效性，而只是评估其实施的有效性。 因此，如果没有提供有关项目实施的信息，我们是不足以 得出某个政策或干预措施是有效的这一结论；同样的政策 或干预措施可以在其他地方实施并产生截然不同的健康结 局。还要注意的是实施结局与临床治疗结果不同，两者都 应进行评估［15，95，97］。 实施结局有三个重要功能。第一，它们是实施成功与 否的指标。第二，它们是实施过程的近端指标。第三，它 们是与治疗效果和服务质量研究中服务系统或临床结局相 关的重要中间结局［86］。 3.3.6　如何评价政策或干预措施的实施成本？ 医疗保健中的经济学评价通常比较两种或多种干预方 案的成本和结果。常用的方法包括成本效果、成本效用和 成本效益分析。 在评估实施策略的经济性方面提出的问题稍有不同。 实施策略通常会带来额外的成本。因此，主要的经济学评 估问题是与通常 / 常规方法相比，实施策略所产生的相对 成本是否能够带来足够水平的结果增强［98］。如果加强实施 能够改善服务提供并提升服务对象的结局，那么这些实施 策略可能比常规手段更具有成本效益。此类信息对政策制 定者、决策者、管理者和服务提供者至关重要。 50 实施性研究在慢性病防控中的应用指导 干预的总成本以结果的比率来估计，见下述比率计算［98］： 成本效果比＝ 实施策略的成本 -常规措施的成本 实施策略的效果 -常规措施的效果 “成本”可能包括： ◆ 直接人力成本——与受众或实施者相关的成本（例 如，让临床医师通过新的健康软件指导患者或向服 务提供人员提供培训项目的时间成本）； ◆ 间接人力成本——与受众和实施者相关但不需要与 他们直接接触所带来的额外成本（例如开发资源或 计划干预）； ◆ 非人力成本——与干预相关的额外费用和资源成本 （例如建筑空间、资料印刷等）。 “结局”可能包括： ◆受众层面的健康结局； ◆ 实施者层面的结局——与干预相关（例如加强沟通、 合作和 / 或服务提供）。 其他效益可能来自于服务的时效性。 系统性实施所产生的成本高于干预本身的成本，目前， 其中大部分成本由实施者（例如提供者组织）承担。然而， 经济学评价对于实施领域来说相对较新，而且关于该主题 的文献较少。因此，与实施相关的经济学评价的研究基础 仍需加强。如果研究能够揭示某些实施策略比常规实践将 带来更多效益，那么政策制定者和决策者需要考虑获取额 外的资源来成功实施这些策略［98］。 51 3　实施性研究步骤 3.3.7　如何用数据确保并提高实施的质量？ 收集和利用数据以实现： ◆指导质量控制； ◆ 提供已实施的政策或项目在实施和有效性层面的 信息； ◆为其他实施者建立可及的证据基础。 需要采用以下措施以便有效地收集、利用和共享数据： ◆足够的决策支持数据系统； ◆计划实施者能正确使用、解读和转化数据。 决策支持数据系统是用于帮助组织内部做出正确决策 的信息来源。它们是政策和干预措施持续性质量改善的重 要组成部分。在建立决策支持数据系统时，我们需要明确 要收集哪些数据，数据的来源是什么以及由谁来负责数据 收集。确定这些数据将如何用于质量控制和质量改善也很 重要。 如果反馈路径（员工绩效评估和决策支持数据系统） 表明需要进行变更，那么组织需要调整、整合系统以提高 效率和效果。附录 5 部分提供了对于该问题的指导及模板。 3.3.8　如何提高政策或干预措施的可持续性？ 为了最大限度地发挥慢性病研究对健康的影响，有效 的政策和干预措施不但要很好地实施，而且需要能够长期 维持。有效的政策或干预措施往往受到所谓的“创新 - 蒸 52 实施性研究在慢性病防控中的应用指导 发”效应的影响，在初始实施期后不能够持续［99］。 以下是未能维持政策或干预措施的因素［98］： ◆干预方式不适应当地情境； ◆当地由于能力限制而拒绝引入新的措施； ◆缺乏人力资源； ◆干预成本（和其他经济因素）； ◆ 对实施的基础设施（包括培训、监测和评估系统） 的投资不足； ◆员工招募和员工流动； ◆缺乏政治意愿。 促使干预成功地持续实施的重要因素包括： ◆可持续性规划 ●充分考虑实施的各个方面和规划干预的可持续性及 长期实施。 ●有明确的项目扩展策略。 ●包括制定融入现有医疗服务的发展战略。 ◆领导和参与 ●国家和国际最高层面强有力且持续的政治领导是慢 性病政策和干预措施长期成功的关键因素。 ●卫生以外的政府部门都必须成为政府响应行动的一 部分——例如财政、农业、司法、教育、城市设计、 交通、外交和贸易；民间社会组织和私营部门也需 要发挥作用［101］。 53 3　实施性研究步骤 ●实施者需要能够理解和管理竞争利益和利益相关方， 避免利益冲突。 ◆将变化的持续影响传达给利益相关方。这需要 ●有效的沟通策略； ●强有力的倡导（应有相应的工具 / 组织链接）； ●建立监测和评估系统。 ◆将改变形式化、标准化 ●将改变嵌入组织结构和流程（如纳入政策内）； ●剔除旧的做事方式。 ◆培训 / 能力建设 / 与其他组织的连接 ●项目的实施需要基础架构来支持——例如通过培训、 服务提供系统和技术资源。 ◆保持干预的简化 ●简单的干预设计可以让关键的利益相关方和目标受 众更容易理解、参与和推广［98］。 3.4　政策或干预措施的推广 ExpandNet1与 WHO 合作，开发了与各国团队合作推 广（scaling up）政策或干预措施的策略。 1　ExpandNet 是一个全球网络，由来自国际组织、非政府组织、学 术和研究机构、卫生部门和特定项目的代表组成，致力于推动推广 的科学和实践。更多信息可以在这里找到：http://www.expandnet.net/ home.htm（获取于 2016 年 10 月 14 日）。 54 实施性研究在慢性病防控中的应用指导 该方法提出了制定推广策略的九个指导步骤 1。 1．计划行动来增加创新的可推广性； 2．增强用户组织的能力从而实施推广； 3．评估环境以及规划行动以增加推广成功的潜力； 4．提高资源团队的能力以支持推广； 5．开展战略性选择以支持纵向（制度化）推广； 6．开展战略性选择以支持横向（扩张 / 复制）推广； 7．确定多样化的作用； 8．规划行动来处理自发性推广； 9．确定最终推广策略并确定下一步措施。 如需更多信息请参照指导。 一些其他有用的可持续性规划工具： ◆ 由圣路易斯华盛顿大学布朗社会工作学院公共卫生 体系中心（the Center for Public Health System at George Warren Brown School of Social Work）所开发的项目 可持续性评估工具： https://sustaintool.org/assess（获取于 2016 年 10 月 14 日） ◆安大略健康（Ontario Health）：实施和保持改变： http://www.hqontario.ca/Portals/0/documents/qi/qi-imp 1　制定推广策略的九个步骤：http://www.expandnet.net/PDFs/Expand Net-WHO%20Nine%20Step%20Guide%20published.pdf（获取于 2016 年 10 月 14 日） 55 3　实施性研究步骤 lementing-and-sustaining-changes-primer-en.pdf（获取 于 2016 年 10 月 14 日） ◆ 英国国民医疗服务体系（National Health Service， NHS）：可持续模型和指南： http://www.qualitasconsortium.com/index.cfm/programs- services/sustainability/sustainability-master-scoring- system/（获取于 2016 年 10 月 14 日）. ◆ McGrath KM，Bennett DM，Ben-Tovim DI，Boyages SC，Lyons NJ，O’Connell TJ．Implementing and sustaining transformational change in health care: lessons learnt about clinical process redesign．Med J Aust．2008; 188(6): 32. ◆ Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth) evidence reporting and assessment (mERA) checklist［102］: http://www.bmj.com/content/352/bmj.i1174 案例研究6：推广——巴西身体活动的干预措施（表7） 表 7　巴西推广身体活动的干预措施 为什么选择 这个案例 这个案例阐明了不同部门的参与对推广有效干预的重 要性，强调了推广面临的挑战——比如改变政策和筹 资机制 标题 在巴西全国范围内推广身体活动干预：一项有效的增 加大众的身体活动的方案 56 实施性研究在慢性病防控中的应用指导 来源 美国密苏里州圣路易斯圣路易斯华盛顿大学 健康问题 巴西人群身体活动不足以及解决健康不平等的需要 地点 社区（巴西） 目标人群 来自普通巴西社区的成人和老年人 背景 在巴西，关于身体活动的指南建议：每周至少进行 150 分钟的中等或高强度身体活动。然而，最近全国 调查显示将近一半的成人没有达标，其中 15% 的人完 全没有中高强度身体活动。缺少时间以及工作 / 家庭 职责是参加身体活动的主要障碍。 基于社区，利用现有可用资源（如公园、人行道、社 区中心），同时提供专业指导是在人群层面提高身体 活动的潜在有效干预策略［103，104］。 巴西与拉丁美洲体育锻炼干预指导项目（Guide for Useful Interventions for Physical Activity in Brazil and Latin America，GUIA）1［105］是由美国疾病预防控制中 心（Centers for Disease Control and Prevention，CDC） 运行的“预防研究中心计划”资助的一个跨国合作项目； 其目的是评估在巴西开展超过十年的项目［106］ 政策或干预 措施的描述 城市健身项目（Academia da Cidade）开始于巴西东北 部的 Recife，Pernambuco 地区，在 2002 年被制度化。 该计划开展了数个干预点（polos）——新的场所或经 过重新设计和美化的公共空间。 由专业指导员提供身体和文化活动指导，包括：舞蹈、 有氧运动、力量训练、灵活度和其它增进健康的身体 活动 续表 57 3　实施性研究步骤 我们做了 什么？ 2008 年，GUIA 项目采用定性和定量结合的方法评估 城市健身项目，包括电话调查、系统性直接观察、历 史评价、逻辑模型及对协调人员、工作人员和用户的 定性访谈［107-111］ 我们做了 什么？ 评估结果表明，该项目有效提高并维持人群达到推荐 的身体活动水平。 覆盖面评估发现，女性、老年人和低收入人群是从项 目中获益最多的人群［112］ 我们学到了 什么？ 评估结果与 GUIA 项目利益相关方分享后，发生两件 重要的事情： 1．2011 年前期，伯南布哥州政府设立了伯南布哥州城 市健身项目（Academias das Cidades de Pernambuco， ACP），方案旨在扩大城市健身项目［113］。 2．2011 年后期，健康部设立了健康健身项目（Academia da Saude，AS），一个加入了营养和社会发展元素的 全国性项目［113］。支持政策和筹资机制发生了改变， 对大规模实施和可持续性构成了挑战。 巴西的经验教训表明，推广促进身体活动的干预项目 具有挑战性，需要考虑长期的政治和财政支持［113］ 1　获取更多关于 GUIA 项目的信息，请访问：http://www.projectguia. org/（获取于 2016 年 10 月 14 日）。 续表 4 总　结 4 总　结

61 4　总　结 4．总结 实施性研究是针对实施政策和干预措施的过程，以及 影响这些过程的情境因素的科学研究。 实施性研究有助于发现最有效和最具成本效益的实施 方法，从而有助于弥合从证据到实施（执行）之间的差距， 并改善健康结局。 实施性研究应该被纳入到慢性病防控政策和干预措施 的选择、调整以及评估过程的所有阶段。重要的是，通过 跨国和跨部门的平台与合作，政策决策者、实施者以及研 究者可以共享实施性研究所创造的知识。

附　件

65 附　件 附件 1．用于制定目标和指导知识汇总的 PICO框架 PICO 框架有助于目标的分解和问题的设计，并指导知 识汇总。PICO 不是一个严格的框架，一些问题不需要涵盖 PICO 框架所有四个方面。 明确目标：尽可能用精简的语言描述目标 例如：制定一项政策或干预措施来减轻中国高血压疾病负担 目标人群：详细界定感兴趣的人群 例如：中国城市人群 干预措施：明确感兴趣的干预措施类型 例如：经济刺激手段，如增加不健康食品税 对照组：选择一个什么样的对照组来比较干预措施的结局？ 例如：控制组（即不接受干预措施） 66 实施性研究在慢性病防控中的应用指导 结局指标：感兴趣的结局指标是什么？ 例如：加工食品消费量的减少程度 优化目标：现在重写目标 例如：制定一项有效的政策，减少中国城市人群从加工食品中摄入 的盐含量。 以上面优化后的目标为指导，进行知识综合，形成数 量可控且集中的证据。 政策或干预措施的选择应该基于综合形势分析的结果 和 / 或专家们的指导意见。否则，可能需要扩大目标范围 以识别任何可能的政策或干预措施（例如，对中国居民高 血压预防有效的政策或干预措施）。同样，如果研究者对所 发现的证据质量或数量不满意，不妨扩大界定的人群范围 （如整个中国人群，甚至该地区的其他国家）来扩大搜索 范围。 67 附　件 附件 2．用于相关证据整合的模板样例 下面是一个模板样例（表 8），研究者可以用它来总结 知识汇总的结果，并为选择一项基于证据的实践或干预措 施提供信息。研究者可以通过修改一些现有的列或添加新 的列来调整模板，通过定制模板来实现使用 PICO 框架进 行知识汇总的目标。 注意：下面模板样例仅用于示范。 PICO：中国城市初级卫生保健中心高血压预防项目有 效性的证据整合 68 实施性研究在慢性病防控中的应用指导 表 8　 用 于 相 关 证 据 整 合 的 模 板 样 例 研 究 文 献 结 局 测 量 效 果 ： 干 预 结 果 随 访 证 据 质 量 设 计 在 结 果 中 报 告 的 结 局 工 具 列 表 干 预 组 对 照 组 相 对 效 果 （ 95 % C I） 绝 对 效 果 P 值 随 访 最 长 时 间 （ 例 如 ， 6 个 月 ； 1 年 ） 用 1 到 5 来 表 明 证 据 质 量 * 样 本 量 Fi rs t A ut ho r et a l 20 15 J ou rn al 1（ 1） : 1 - 10 高 血 压 的 发 病 率 初 级 保 健 中 心 护 士 的 临 床 评 估 8. 4% 11 .0 % 0. 76 （ 0. 7～ 0. 81 ） 2. 6% 0. 03 5 随 访 1 年 4 整 群 随 机 对 照 试 验 钠 摄 入 量 收 集 受 试 者 24 小 时 尿 液 ， 测 量 尿 液 生 物 标 志 物 18 0m m ol / L× da y△ 20 0m m ol / L× da y△ n/ a 20 m m ol / L× da y△ 0. 07 2 随 访 1 年 10 07 身 体 活 动 水 平 每 日 运 动 时 间 每 周 90 分 钟 每 周 70 分 钟 n/ a 每 周 20 分 钟 0. 04 1 随 访 1 年 * 研 究 者 必 须 清 楚 如 何 评 估 证 据 质 量 等 级 。 △ 原 文 单 位 为 m Eq /L × da y。 69 附　件 附件 3．评估政策或干预措施的社会效度 建议的评估结构如下（表 9）： 表 9　政策或干预措施社会效度的评估结构 A．目标的社会意义 这些问题应该设法了解潜在受众是否认为政策或干预措施的目标对 他们或者他们居住的社区有意义。 尽可能问一些不具有导向性的问题。 与旨在减少盐消费量以预防高血压的干预措施相关的问题可包括： 1．您认为这个社区常见的主要健康问题有哪些？ 2．这些健康问题中，您认为哪一些是最重要的？ 3．您之前听说过高血压吗？如果听说过，您了解多少？ 4．如果有人患有高血压，他们需要做些什么？ B.社会可接受的程序 这些问题应该设法了解潜在受众是否认为干预措施的实施过程是可 接受的。 有关社区工作者提供高血压健康教育的问题可包括： 1．您如何看待向社区健康工作人员寻求健康建议？ 2．您认为社区工作者作为你健康知识的来源有什么利弊？ 3．您如何看待由您所居住的社区的健康工作者组织或提供的健康 知识宣讲？ 70 实施性研究在慢性病防控中的应用指导 C.效果的社会重要性 这些问题应该设法了解受众是否认为一项干预措施或者政策正在实 现其预期的结局，以及结局是否有意义。因此，这些问题只有在政 策或干预措施实施之后才能提出。 根据上面例子，即关于社区健康工作者实施“减少盐消费，预防高 血压”的干预措施，可以包括以下问题： 1．您觉得健康知识宣讲怎么样？ 2．您和您的家人在获得信息后是否有采取行动？ 3．您注意到自己有什么变化吗？您会向您的亲戚和朋友宣传这些 健康知识吗？ 4．参加宣讲后，您会把它推荐给社区里的其他人吗？ 71 附　件 附件 4．实施保真度的评估 表 10 和表 11 提供了在评估实施结构性和动态性保真 度时可以考虑收集的指标类型和数据的例子。该表还提供 了何时以及使用哪些工具进行数据收集的建议。 在收集数据之前，描述清楚每一个指标的理想值至关 重要。研究者收集的数据越接近理想值，实施的保真度越 高。以评估的第一个指标“组织结构”为例。如果研究者 想通过妇幼保健中心提供营养教育项目，那么组织结构的理 想情境为符合以下条件的妇幼保健中心：①在社区中建设良 好——例如，已建成至少五年，并且有三名长期员工；②有 持续不断的资金支持；③除了核心的妇幼保健项目外，还提 供健康促进项目。理想情形的定义应该尽可能基于证据（例 如，可能有证据表明某个机构是开展营养教育项目的理想组 织）。总是能找到理想的实施机构来开展实施常常是不现实 的，但是在开展干预措施之前收集一些相关的数据将会为分 析保真度、有效性以及有效性的调节因素提供宝贵的信息。 表 10　结构保真度 指标 时间节点 工具 实施者层面 - 描述性数据 实施的组织结构（例如，学校、医院、 社区等） 基线 实施表格 72 实施性研究在慢性病防控中的应用指导 指标 时间节点 工具 实施方案主要资金来源 基线 实施表格 实施者关注的健康问题 基线 实施表格 实施者层面 - 员工的人口学特征 性别 基线 职工人口学特 征表格 年龄 基线 职工人口学特 征表格 雇用日期 基线 职工人口学特 征表格 认证或完成某种培训的日期 基线 职工人口学特 征表格 职称 基线 职工人口学特 征表格 教育 基线 职工人口学特 征表格 有执行类似政策或干预措施的经验 基线 职工人口学特 征表格 截止日期 每月（根据需 求而定） 职工人口学特 征表格 实施者层面 - 干预措施 / 政策实施时记录的数据 实施者记录的数据包括： ·例如：接受社区工作人员干预的 人数 ·例如：社区工作人员的工作时间 比例 每月（根据需 求而定） 干预措施记录 表格 续表 73 附　件 指标 时间节点 工具 培训课程量来自： ·已完成的培训课程 ·已完成课程的培训时间 每月（根据需 求而定） 培训记录 受众层面 - 干预措施 / 政策实施时记录的数据 完成量包括： ·已完成的干预课程 ·已完成课程的培训时间 每月（根据需 求而定） 干预措施记录 表格 干预持续的时间，来自： ·干预开始的时间 ·干预完成的时间 每月（根据需 求而定） 干预措施记录 表格 表 11　动态保真度（定期收集数据——如每 6周 1次） 指标 回答 流程 应该询问这些问题以了解实施者在实施政 策或干预时是否遵循了适当的流程 例如：社区健康工作者以我们可以理解的 方式向我们讲解了干预措施，包括他们在 做什么以及我们需要做什么 ·非常不同意 ·不同意 ·不知道 ·同意 ·非常同意 原则 应该询问这些问题以了解实施者在实施政 策或干预措施时是否遵循原则 例如：社区卫生工作者尊重我的（当地） 文化 ·非常不同意 ·不同意 ·不知道 ·同意 ·非常同意 续表 74 实施性研究在慢性病防控中的应用指导 指标 回答 结局 应该询问这些问题以了解受众是否认为政 策或干预措施有助于他们实现预期结局 例如：我从干预措施中学到的技巧能够帮 助我控制高血压 ·非常不同意 ·不同意 ·不知道 ·同意 ·非常同意 续表 75 附　件 附件 5．决策支持数据系统 在规划新的政策或干预措施时，明确将使用什么样的 决策支持数据系统至关重要。下面的问题和表 12 有助于了 解决策支持数据系统的一些重要方面。 ◆谁将负责收集和分析绩效评估数据？ ◆ 谁将负责保障（支持、指导、监督）数据收集、分 析、报告撰写过程中的质量？ ◆ 在各个层级（例如团队、地区、区域、州）还有谁 在扮演角色？ ◆ 数据收集、分析、报告撰写对于实现所选择的创新 性的干预措施的预期结局有多重要？ 表 12　激活决策支持数据系统的正确后续步骤是什么？ 活动 时间框架 负责人 所需资源 参考文献 参考文献

79 参考文献 参考文献 ［1］World Health Organization, Global status report on noncommunicable diseases 2010, A. Alwan, Editor. 2010, The World Health Organization. ［2］World Health Organization, Global status report on noncommunicable diseases 2014, S. Mendis, Editor. 2014, World Health Organization. ［3］World Health Organization, Prioritized research agenda for prevention and control of noncommunicable diseases, S. Mendis and A. Alwan, Editors. 2011, World Health Organization: Geneva. ［4］World Health Organization, Global action plan for the prevention and control of noncommunicable diseases 2013- 2020. 2013, World Health Organization: Geneva. ［5］Cochrane, L. J., et al., Gaps between knowing and doing: Understanding and assessing the barriers to optimal health care. Journal of Continuing Education in the Health Professions, 2007. 27(2): p. 94-102. ［6］Grol, R., Successes and failures in the implementation of evidence based guidelines for clinical practice. Medical Care, 2001. 39(8): p. SII46-54. 80 实施性研究在慢性病防控中的应用指导 ［7］McGlynn, E. A., et al., The quality of health care delivered to adults in the United States. New England Journal of Medicine, 2003. 348(26): p. 2635-45. ［8］McCullough, M. L., et al., Following cancer prevention guidelines reduces risk of cancer, cardiovascular disease, and all-cause mortality. Cancer Epidemiolgy Biomarkers & Prevention, 2011. 20(6): p. 1089-97. ［9］Komajda, M., et al., Adherence to guidelines is a predictor of outcome in chronic heart failure: The MAHLER survey. European Heart Journal, 2005. 26(16): p. 1653-9. ［10］Saslow, D., et al., American cancer society, American society for colposcopy and cervical pathology, and American society for clinical pathology screening guidelines for the prevention and early detection of cervical cancer. CA: A Cancer Journal for Clinicians, 2012. 62(3): p. 147-72. ［11］Shapiro, D., et al., Containing costs while improving quality of care: The role of profiling and practice guidelines. Annual Review of Public Health, 1993. 14(1): p. 219-41. ［12］Grol, R. and M. Wensing, What drives change? Barriers to and incentives for achieving evidence-based practice. Medical Journal of Australia, 2004. 180(6): p. S57. ［13］Harrison, M. B., et al., Adapting clinical practice guidelines to local context and assessing barriers to their use. 81 参考文献 Canadian Medical Association Journal, 2010. 182(2): p. E78-84. ［14］Rainbird, K., R. Sanson-Fisher, and H. Buchan, Identifying barriers to evidence uptake. 2006, National Institute of Clinical Studies: Melbourne, Australia. ［15］Fixsen, D. L., et al., Implementation research: A synthesis of the literature. 2005, University of South Florida, Louis de la Parte Florida Mental Health Institute, The National Implementation Research Network: Tampa, FL. ［16］National Implementation Research Network. Implementation defined. Learn Implementation 2013 [cited 2015 December 5th]; Available from: http://nirn. fpg. unc. edu/ learn-implementation/implementation-defined. ［17］Peters, D. H., M. T. Tran, and A. Taghreed, Implementation research in health: A practical guide. 2013, Alliance for Health Policy and Systems Research, World Health Organization: Geneva, Switzerland. ［18］Proctor, E. K., et al., Outcomes for implementation research: Conceptual distinctions, measurement challenges, and research agenda. Administration and Policy in Mental Health and Mental Health Services Research, 2011. 38(2): p. 65-76. ［19］Davies, P., A. E. Walker, and J. M. Grimshaw, A systematic review of the use of theory in the design of guideline dissemination and implementation strategies and interpretation 82 实施性研究在慢性病防控中的应用指导 of the results of rigorous evaluations. Implementation Science, 2010. 5: p. 1-6. ［20］Michie, S., et al., Specifying and reporting complex behaviour change interventions: The need for a scientific method. Implementation Science, 2009. 4: p. 40. ［21］Damschroder, L. J., et al., Fostering implementation of health services research findings into practice: A consolidated framework for advancing implementation science. Implementation Science, 2009. 4: p. 50. ［22］McDonald, K. M., I. D. Graham, and J. Grimshaw, Toward a theoretical basis for quality improvement interventions, in Closing the quality gap: A critical analysis of quality improvement strategies, K. G. Shojania, et al., Editors. 2004, Agency for Healthcare Research and Quality: Rockville, MD. ［23］TDR Special Programme for Research and Training in Tropical Diseases, Implementation research toolkit. 2014: World Health Organization. ［24］Proctor, E. K., et al., Writing implementation research grant proposals: Ten key ingredients. Implementation Science, 2012. 7: p. 96. ［25］Graham, I. D., Logan, J., Harrison, M. B., Straus, S. E., Tetroe, J., Caswell, W. and Robinson, N. (2006), Lost in knowledge translation: Time for a map?. Journal of Continuing 83 参考文献 Education in Health Prof fessions, 26: 13–24. doi:10. 1002/chp. 47. ［26］Shaw, J. E., R. A. Sicree, and P. Z. Zimmet, Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Research Clinic Practia, 2010. 87(1): p. 4-14. ［27］Ramachandran, A., R. C. Wan Ma, and C. Snehalatha, Diabetes in Asia. Lancet, 2009. 375(9712): p. 408-18. ［28］Thankappan, K. R., et al., Risk factor profile for chronic non-communicable diseases: Results of a community- based study in Kerala, India. Indian Journal of Medical Research, 2010. 131: p. 53-63. ［29］Menon, V. U., et al., Prevalence of known and undetected diabetes and associated risk factors in central Kerala——ADEPS. Diabetes Research and Clinical Practice, 2006. 74(3): p. 289-94. ［30］Raman, K. V., A. Joseph, and C. R. Soman, High prevalence of type 2 diabetes in an urban settlement in Kerala, India. Ethnicity and Health, 1999. 4(4): p. 231-9. ［31］Daivadanam, M., et al., Lifestyle change in Kerala, India: needs assessment and planning for a community-based diabetes prevention trial. BMC Public Health, 2013. 13: p. 95. ［32］Soman, C. R., et al., Cohort profile: the PROLIFE study in Kerala, India. International Journal of Epidemiology, 2011. 40(1): p. 10-4. 84 实施性研究在慢性病防控中的应用指导 ［33］Sugathan, T. N., C. R. Soman, and S. K, Behavioural risk factors for non communicable diseases among adults in Kerala, India. The Indian Journal of Medical Research, 2008. 127(6): p. 55563. ［34］Krishnan, A., et al., Evaluation of community-based interventions for non-communicable diseases: Experiences from India and Indonesia. Health Promotion International, 2011. 26(3): p. 276-89. ［35］Kumar, M. S., P. S. Sarma, and K. R. Thankappan, Community-based group intervention for tobacco cessation in rural Tamil Nadu, India: A cluster randomized trial. Journal of Substance Abuse Treatment, 2012. 43(1): p. 53-60. ［36］Mohan, V., et al., Community empowerment——A successful model for prevention of noncommunicable diseases in India——The Chennai Urban Population Study(CUPS-17). The Journal of the Association of Physicians of India, 2006. 54(858-62). ［37］Grimshaw, J. M., et al., Knowledge translation of research findings. Implementation Science, 2012. 7: p. 50. ［38］Antman , E . M. , e t a l . , A compar i son o f results of meta-analyses of randomized control trials and recommendations of clinical experts. Treatments for myocardial infarction. The Journal of the American Medical Association, 1992. 268(2): p. 240-8. 85 参考文献 ［39］Chalmers, I., Trying to do more good than harm in policy and practice: The role of rigorous, transparent, up-to-date evaluations. The Annals of the American Academy of Political and Social Science, 2003. 589: p. 22-40. ［40］Pope, C., N. Mays, and J. Popay, Synthesizing qualitative and quantitative health research. 2007, Berkshire, UK: Open University Press. ［41］Jadad, A. R. ; Moore R. A. ; Carroll D. ; Jenkinson C. ; Reynolds D. J. M. ; Gavaghan D. J. ; McQuay H. J. (1996). “Assessing the quality of reports of randomized clinical trials: Is blinding necessary?”. Controlled Clinical Trials. 17(1): 1–12. doi:10. 1016/0197-2456(95)00134-4. PMID 8721797. ［42］Jhanjee, S., Tobacco Control in India – Where are we now? Delhi Psychiatry Journal, 2011. 14(1): p. 26. ［43］World Health Organization, WHO global report: mortality attributable to tobacco, W. Press, Editor. 2012: Geneva. ［44］Ministry of Health and Family Welfare India, Tobacco use among students and teachers. Findings from the Global Youth Tobacco Survey and Global School Personnel Survey India. 2010: New Delhi. ［45］International Institute for Population Sciences & MoHFW India, Global Adult Tobacco Survey(GATS)India 2009-2010. New Delhi. 86 实施性研究在慢性病防控中的应用指导 ［46］ITC Project, TCP India National Report. Findings from the Wave 1 Survey(2010-2011). 2013, University of Waterloo, Canada; Healis-Sekhsaria Institute for Public Health, India. ［47］Ministry of Health and Family Welfare(Government of India), Economic Burden of Tobacco Related Diseases in India. Executive Summary. 2014, New Delhi: PHFI and WHO Country Office for India. ［48］World Health Organization, WHO Framework Convention on Tobacco Control. 2003: Geneva. ［49］Ministry of Health and Family Welfare India, The Cigarettes and Other Tobacco Products(Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution)Act, 2003. 2009: New Delhi. ［50］Arora, M., Tewari A, Nazar PN, Gupta K, Shrivastav R, , Ineffective pictorial health warnings on tobacco products: lessons learnt from India. Indian Journal of Public Health, 2012. 56(1): p. 61-64. ［51］Yadav, A., India: New Warnings to Cover 85% of Packs. Tobacco Control, 2015. 24(1): p. 3. ［52］Moodie, C., et al., Plain tobacco packaging: A systematic review. UK Centre for Tobacco Control Studies, 2012. 87 参考文献 ［53］Wakefield, M. A., et al., Introduction effects of the Australian Plain Packaging policy on adult smokers: a cross- sectional study. BMJ open, 2013. 3(7): p. e003175. ［54］Lok Sabha Secretariat, Fourth Report on the Cigarettes and other Tobacco Products(Prohibition of Advertisement and Regulation of Trade and Commerce, Production, Supply and Distribution)Act, 2003, C. o. S. Legislation, Editor. 2015, Government of India Press: New Delhi. ［55］White V, Australian Secondary Students’ Alcohol and Drug(ASSAD), Centre for Behavioural Research in Cancer(CBRC), Editor. 2015, Department of Health Canberra. ［56］Hammond D, Health warning messages on tobacco products: a review Tobacco Control, 2011. 20(327). ［57］Arora M, T. A., Grills N, Nazar GP, Sonrexa J, Gupta VK, Moodie R, Reddy KS., Exploring perception of Indians about Plain Packaging of tobacco products. Frontiers in Public Health, 2013. 1: p. 35. ［58］Dunlop, S., et al., Impact of Australia’s introduction of tobacco plain packs on adult smokers’ pack-related perceptions and responses. BMJ Open, 2014. 4: p. e005836. ［59］Hammond, D., Standardized packaging of tobacco products: evidence review. 2014, Irish Department of Health. ［60］Australia India Institute, Report of the All Taskforce 88 实施性研究在慢性病防控中的应用指导 on Tobacco Control: Plain Packaging of tobacco products. 2012: Melbourne ［61］Hughes N, Grills N, and Aurora M, Effect of plain packaging of tobacco products in low and middle income settings: A systematic review of the literature. Currently under reviewed, 2015. ［62］Jann W and Werich K, Theories of policy change, in Handbook of Public Policy Analysis: Theory, Politics, and Methods, Fischer F and Miller GJ, Editors. 2007, Taylor and Francis group. ［63］Henggeler, S. W., et al., Transporting efficacious treatments to field settings: The link between supervisory practices and therapist fidelity in MST programs. Journal of Clinical Child & Adolescent Psychology, 2002. 31(2): p. 155-67. ［64］Greenhalgh, T., et al., Diffusion of innovations in service organizations: Systematic review and recommendations. Milbank Quarterly, 2004. 82(4): p. 581-629. ［65］Oldenburg, B., et al., The spread and uptake of diabetes prevention programs around the world: a case study from Finland and Australia. Translatimed Behavioral Medicine, 2011. 1(2): p. 270-282. ［66］Chen, E. K., et al., Tailoring evidence-based interventions for new populations: A method for program 89 参考文献 adaptation through community engagement. Evaluation & the Health Professions, 2013. 36(1): p. 73-92. ［67］Embry, D. and A. Biglan, Evidence-based kernels: Fundamental units of behavioral influence. Clinical Child and Family Psychology Review, 2008. 11(3): p. 75-113. ［68］Blase, K. and D. Fixsen, Core intervention components: Identifying and operationalizing what makes programs work. 2013, Office of the Assistant Secretary for Planning and Evaluation. ［69］Chamberlain, P., The Oregon Multidimensional Treatment Foster Care Model: Features, outcomes, and progress in dissemination. Cognitive and Behavioral Practice, 2003. 10: p. 30312. ［70］Forgatch, M. S., R. Patterson, and D. S. DeGarmo, Evaluating fidelity: Predictive validity for a measure of competent adherence to the Oregon model of parent management training(PMTO). Behavior Therapy, 2005. 36: p. 3-13. ［71］Carter, S., The social validity manual. 2009, London, UK: Academic Press. ［72］Schwartz, I. S. and D. M. Baer, Social validity assessment: Is current practice state of the art? Applied Behavior Analysis, 1991. 24(2): p. 189-204. ［73］Gresham, F. M. and M. F. Lopez, Social validation: 90 实施性研究在慢性病防控中的应用指导 A unifying concept for school-based consultation research and practice. School Psychology Quarterly, 1996. 11(3): p. 204-27. ［74］Beltramo, T. and D. I. Levine, The effect of solar ovens on fuel use, emissions and health: Results from a randomised controlled trial. Journal of Development Effectiveness, 2013. 5(2): p. 178-207. ［75］Otte, P. P., Solar cookers in developing countries- What is their key to success? Energy Policy, 2013. 63: p. 375- 381. ［76］Thomas, E., et al., Improved stove interventions to reduce household air pollution in low and middle income countries: a descriptive systematic review. BMC Public Health, 2015. 15: p. 650. ［77］Ontario Agency for Health Protection and Promotion (Public Health Ontario), At a glance: The ten steps for conducing an evaluation. 2015: Toronto, ON. ［78］Peters, D. H., et al., Implementation research: what it is and how to do it. British Journal of Sports Medicine, 2014. 48(8): p. 731-736. ［79］Glasgow, R. E. and L. A. Linnan, Evaluation of theory-based interventions, in Health behavior and health education: Theory, research, and practice, K. Glanz, B. K. Rimer, and V. K. JosseyBass, Editors. 2008, Jossey-Bass: San 91 参考文献 Francisco, CA. p. 487-508. ［80］Breitenstein, S. M., et al., Measuring implementation fidelity in a community-based parenting intervention. Nursing Research, 2010. 59(3): p. 158-65. ［81］Carroll, C., et al., A conceptual framework for implementation fidelity. Implementation Science, 2007. 2: p. 40. ［82］Koball, H., et al., Supporting evidence-based home visiting to prevent child maltreatment: Overview of the cross-site evaluation. 2009, Department of Health and Human Services, Administration for Children and Families, Children’s Bureau: Washington, DC. ［83］McGrew, J. H., et al., Measuring the fidelity of implementation of a mental health program model. Journal of Consulting and Clinical Psychology, 1994. 62(4): p. 670-8. ［84］Aarons, G., Measuring provider attitudes toward evidence-based practice: Consideration of organizational context and individual differences. Child & Adolescent Psychiatric Clinics of North America, 2005. 14(2): p. 255-viii. ［85］Aarons, G., D. Sommerfeld, and C. Walrath-Greene, Evidence-based practice implementation: The impact of public versus private sector organization type on organizational support, provider attitudes, and adoption of evidence-based practice. Implementation Science, 2009. 4: p. 83. 92 实施性研究在慢性病防控中的应用指导 ［86］Correnti, R. and B. Rowan, Opening up the black box: Literacy instruction in schools participating in three comprehensive school reform programs. American Educational Research Journal, 2007. 44(2): p. 298-338. ［87］Frambach, R. and N. Schillewaert, Organizational innovation adoption: A multi-level framework of determinants and opportunities for future research. Journal of Business Research Special Issue: Marketing Theory in the Next Millennium, 2002. 55(2): p. 163-76. ［88］Rogers, E., Diffusion of innovations. 4th ed. 1995, New York, NY: The Free Press. ［89］Lipsey, M. and D. Cordray, Evaluation methods for social intervention. Annual Review of Psychology, 2000. 51: p. 345-75. ［90］Pettigrew, A., The character and significance of strategy process research. Strategic Management Journal, 1992. 13: p. 5-16. ［91］Pettigrew, A., What is a processual analysis? Scandinavian Journal of Management, 1997. 13: p. 337-48. ［92］Curran, G. M., et al., Effectiveness-implementation hybrid designs: Combining elements of clinical effectiveness and implementation research to enhance public health impact. Medical Care, 2012. 50(3): p. 217-26. 93 参考文献 ［93］Proctor, E. K., B. J. Powell, and J. C. McMillen, Implementation strategies: Recommendations for specifying and reporting. Implementation Science, 2013. 8: p. 139. ［94］Peters, D., et al., Improving health service delivery in developing countries: From evidence to action. 2009, World Bank: Washington, DC. ［95］French, Simon D., et al. “Developing theory-informed behaviour change interventions to implement evidence into practice: a systematic approach using the Theoretical Domains Framework. ” Implementation Science 7. 1(2012): 1. ［96］Glasgow, R. E., eHealth evaluation and dissemination research. American Journal of Preventive Medicine, 2007. 32(5S): p. S119–26. ［97］Proctor, E. K., et al., Implementation research in mental health services: An emerging science with conceptual, methodological, and training challenges. Administration and Policy in Mental Health and Mental Health Services Research, 2009. 36(1): p. 24–34. ［98］Raghavan, R., The role of economic evaluation in dissemination and implementation research, in Dissemination and implementation research in health: Translating science in practice, R. Brownson, G. A. Colditz, and E. K. Proctor, Editors. 2012, Oxford University Press: New York, NY. 94 实施性研究在慢性病防控中的应用指导 ［99］National Health Service UK, NHS Institute Sustainability and its relationship with spread and adoption. 2007, NHS Institute for Innovation and Improvement: Coventry. ［100］Milat, A. J., A. Bauman, and S. Redman, Narrative review of models and success factors for scaling up public health interventions. Implementation Science, 2015. 10: p. 113. ［101］Beaglehole, R., et al., Priority actions for the non- communicable disease crisis. Lancet, 2011. 377(9775): p. 1438-47. ［102］Smisha Agarwal., et al, Guidelines for reporting of health interventions using mobile phones: mobile health (mHealth)evidence reporting and assessment(mERA)checklist. BMJ 2016;352:i1174 ［103］Hoehner, C. M., et al., Physical activity interventions in Latin America: a systematic review. American Journal of Preventive Medicine, 2008. 34(3): p. 224-233. ［104］Hoehner, C. M., et al., Physical activity interventions in Latin America: expanding and classifying the evidence. American Journal of Preventive Medicine, 2013. 44(3): p. e31-40. ［105］Paez, D. C., et al., Bridging the gap between research and practice: an assessment of external validity of community- based physical activity programs in Bogota, Colombia, and Recife, Brazil. Translational Behavioral Medicine, 2015. 5(1): p. 1-11. 95 参考文献 ［106］Pratt, M., et al., Project GUIA: A model for understanding and promoting physical activity in Brazil and Latin America. Journal of Physical Activity and Health, 2010. 7 Suppl 2: p. S131-4. ［107］Parra, D. C., et al., Assessing physical activity in public parks in Brazil using systematic observation. American Journal of Public Health, 2010. 100(8): p. 1420-6. ［108］Simoes, E. J., et al., Effects of a community-based, professionally supervised intervention on physical activity levels among residents of Recife, Brazil. American Journal of Public Health, 2009. 99(1): p. 68-75. ［109］Hallal, P. C., et al., Association between perceived environmental attributes and physical activity among adults in Recife, Brazil. J Phys Act Health, 2010. 7 Suppl 2: p. S213-22. ［110］Hallal, P. C., et al., Evaluation of the Academia da Cidade program to promote physical activity in Recife, Pernambuco State, Brazil: perceptions of users and non-users. Cad Saude Publica, 2010. 26(1): p. 70-8. ［111］Soares, J., et al., Cross-sectional associations of health-related quality of life measures with selected factors: a population-based sample in recife, Brazil. Journal of Physical Activity and Health, 2010. 7 Suppl 2: p. S229-41. ［112］Reis, R. S., et al., Assessing participation in community- 96 实施性研究在慢性病防控中的应用指导 based physical activity programs in Brazil. Medicine Science Sports Exerciy, 2014. 46(1): p. 92-8. ［113］Parra, D. C., et al., Scaling up of physical activity interventions in Brazil: how partnerships and research evidence contributed to policy action. Global Health Promotion, 2013. 20(4): p. 5-12.