WHO meeting on community control of stroke and hypertension: Geneva, 6-13 December 1973: control of stroke in the community: methodological considerations and protocol of WHO stroke register

• WORLD HEALTH ORGANIZATION ORGANISATION MONDIALB DB LA SANl'a WHO MEETING ON CCIOOJNITY CONTROL OF STROKE AND HYPERI'iNSION Geneva. 6-p December 1973 CVD/s/73.6 l!NGLISH ONLY C~TROL OF STROKE IN 'lHE C<»MJNITY Methodological considerations and protocol of WHO Stroke Register by s. Hatano Medical Officer Cardiovascular Diseases The iaaue of this document does not constitute formal publication. It should not be reviewed, abstracted or quoted without the agreement of the World Health Organization. Authors alone are responsible for views expreeaed in signed articles. Ce document ne constitue pas une publication. II ne dolt faire l'objet d'aucun compte rendu ou r68umt§ ni d'aucune citation sans l'autorisation de !'Organisation Mondiale de la Santt§. Les opinions exprlmt§es dans les articles signt§s n'engagent que leurs auteurs. CVD/s/73.6 page 2 The present document is the result of a cooperative effort. It is based on the discussions that took place in two WHO meetings, held in 1971 and 1972. The following investigators participated in these meetings, Dr K. Aho, Tapiola, Finland Dr S. Dogan, Zagreb, Yugoslavia Dr N. Dondog, Ulan Ba.tor, Mongolia Dr L. Oeltner, Zerifin, Israel Dr P. Hannsen, Goteborg, Sweden Dr K. Kondo, Tokyo, Japan Dr J. Marquardsen, Copenhagen, Denmark Dr T. Omae, Fukuoka, Japan Dr B. O. Osuntokun, Ibadan, Nigeria Dr z. Poljakovic, Zagreb, Yugoslavia Dr P. Puska, Kuopio, Finland Dr A. Radie, Dublin, Ireland Dr V. E. Smirnov, Moscow, USSR Dr o. Tibblin, Goteborg, Sweden Mr K. Uemura, Chief, Health Statistical Methodology, WHO, Geneva Chronic Diseases Unit, EURO, Copenhagen 1. • 2. 3. 4. 5. 6. CVD/S/73.6 page 3 CONTENTS INTRODUCTI 00 • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 1.1 1.2 1.3 Role of stroke register in general health services •••••••••••••••••• Pilot study ••••••••••.•.•••••••.••••.•••.•.••••••••• • ••..••••.••• • .•• Objectives of the stroke register••••••••••••••••••••••••••••••••••• ESTABLISHMENT OF STROKE REGISTER ••••••••••••••••••••••••••••• ~ •••••••••••• 2.1 2.2 2.3 Selection of a study population•••••••••••••••••••••••••••··~··~····· Regis tey Centre •••••••••••••••••••.••••••••••••••••••••••••••••••••• Organization of source of notification ••••••••••• ~ ••••••••••••• ~- •••• CRITERIA FOR Rm ISTRA. TI ON' • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 3.1 3.2 3.3 3.4 3.5 Definition of stroke ••••••••••••••••••••••••••.•.••••••••••.•••••••• Criteria for inclusion •••••••••••••••••••••••••••••••••••••••••••••• Age and sex ••••••••••••••••••••••••••••••••••••••••••••••••••••••••• Clinical criteria ................................................... Identification of residence and of employment ....................... PROCEDURES FOR INCLUSION IN THE REGISTER •••••••••••••••••••••••••••••••••• 4.1 4.2 4.3 4.4 4.5 Case finding •••••••••••••.••••••.•••.•.••••••.•••••.••.••••••••••••• Ini t1al interview ••••••••••••••••••••••.••.••••.••••.•••••••..•.•••• Follow-up Recurrent Report ot ........................................................... stroke •••••••••••.••••••••••••••••••••••••••••..•.•••••••• death •••••.••••••..•...•••••.•••••••.•••.•.•.••.•••••.•.•• UNIFOJl,1 COUECTI~ OF DATA •••••••••••••••••••••••••••••••••••••••••••••••• 5.1 5.2 5.3 5.4 Content ••••••..••••.•••••••••.••..•••..••••.•••••••••.•••.•.•.•••••• Record fonns and data transfer sheets •••••••••••••••••••••••• , •••••• Instructions for completing record fonns •••••••••••••••••••••••••••• Test for unifor,n record.ing ••••••••••••••••••••.••••••••••••.•..••••• cmTRAL POOUNO AND ANALYSIS •••••••••••••••••••••••••••••••••••••••••••••• Assessment of Progranune Operation ................................... ROLE OF WHO ............................................................... Page 5 6 6 7 7 7 11 13 15 15 15 15 15 16 17 17 17 17 18 18 19 19 22 22 22 23 23 25 CVD/s/73.6 page 4 Page 8. FUTURE OF THE STROKE REGISTER • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 25 8.1 Duration of the stroke register ••••••••••.••.••••••.••.•..•....••••••• 25 8.2 Stimulus to epidemiology and public health action ••.••.•.•.••••••••••• 26 8. j Aid to clinical research • , .••.••••.••. , . . • . . • . • . • • . • . . • . . • . • . . • • • • • . • • 26 ~.4 Inclusion of other cardiovascular diseases and expansion of control programme • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 ANNEX I Stroke Register Record Forms • • • • • • . • . • . • • . . . . . . • • . • . . • . . • . • . • . . . • . . . • • 27 ANNEX II Instructions for completing WHO Stroke Register Forms •••.•••..•.•••..• 35 ANN.EX. III Occupation Code . • • . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . • . . . . . . . . 49 ANNEX IV Collaborating centres in the WHO Stroke Register •••••.••.•••••••.••.•• 52 • cvo/s/73.6 page 5 1. INTRODUCTIOO Nobody would deny the significance of medical, social and economical impact of cerebrovascular diseases. According to national mortality statistics available to WHO, more than 10% of the causes of death are attributed to vascular disease affecting the central nervous system. The number of victims is increasing as longevity increases. Occupancy of beds in chronic hospitals by disabled patients who had stroke, and loss of otherwise usable manpower absorbed by caring for stroke patients, are growing and pending problems. Reliable information on the magnitude of the stroke problem in the community is, however, scarce. For instance, mortality statistics, particularly those on various types of stroke, have been an easy target for criticism because of low reliability and low accuracy. Carefully collected epidemiological data cover a few selected areas only and data are often not comparable with each other. '!he lack of information hampers systematic planning of stroke control at the community level. The magnitude of cerebrovascular disease and its control measures were discussed at a WHO meeting held in Monaco in 19701• In this context, the term "control" means organized effort to fight a disease, and includes all aspects of prevention, treatment, rehabilitation, education, and also evaluation. In view of the lack of knowledge on the problem of stroke in the community, the setting up of a register for stroke patients in a standardized way was recommended. This should supply basic information for planning and evaluation of a stroke control programme, and also allow international comparison. Priority was also given to initiating a feasibility study of hypertension control in the community, this being considered the most effective way of preventing stroke and other cardiovascular complications. A meeting of investigators on stroke and hypertension control was subsequently convened in Geneva in February 19712 to work out concrete programmes. Record forms and the operating protocol for a stroke register were agreed upon. Basic guidelines of a hypertension control programme were also worked out. A pre-pilot stroke register was then started in Copenhagen, Goteborg, and some other places. Based on the experience obtained during the pre-pilot study, the above items were revised and finalized at a meeti~ on control of stroke and hypertension in the community, held in Ooteborg in November 1971. The purpose of the present paper is to introduce the methodology worked out by the WHO collaborative group for planning, establishing and running a stroke register. Data can be used for epidemiological research, as well as for developing a stroke control programme, only if they are collected in a uniform manner. Another important preventive aspect - hypertension control programme - is dealt with in another paper. 1 Cerebrovascular Diseases= Prevention, Treatment and Rehabilitation - Report of a WHO meeting held in Monaco in May 1970, Wld Hlth Org. techn. Rep. Ser., No. 469, Geneva, 1971. 2 Control of Stroke and Hypertension in the Community - Report of a WHO meeting held in Geneva in February 1971 (Intemal Document cvo/71.3) 3 Community Control of Stroke and Hypertension - Report of a WHO meeting held in Ooteborg, November/December 1971 (Internal Document CVD/72.1) cvn/s/73.6 page 6 1.1 Role of stroke register in general health services The stroke register is an inseparable part of a stroke control programme, providing basic information for planning, implementing, and evaluating the programme. In turn, the stroke control programme is a part of a more comprehensive programme for cardiovascular diseases with interrelated etiology and pathogenesis, and therefore with common approach in a disease control. A practical process would be to start from one or a few programmes· and gradually build up a more comprehensive cardiovascular disease control programme, which is again a part of the general health care system. Existing organizations, such as the anti-tuberculosis campaign, and experience from other programmes, such as the cancer register, can be mobilized for use in the stroke register, and vice versa. For the selection of a stroke control programme in particular, consideration should be given to: 1) Whether stroke is a public health problem in the area. 11) Whether local interest exists, or whether interest can be raised and maintained. 111) Whether an active centre and personnel is available, and whether clinical, epidemiological and statistical competence are present. The next consideration is whether it should be started as a single programme or should it be combined with other programmes, such as a community hypertension control or a myocardial infarction register. Combining with a hypertension control programme is desirable, since hypertension control is the most potent way of preventing stroke while a stroke register is the best way of evaluating the hypertension control programme. Simultaneous implementation requires more energy but results are readily correlated. In the WHO collaborating centres a variety of approaches, alone or in combination, are followed according to local needs and available resources. Once it has been decided to start a stroke control programme, collection of basic information is needed. Out of various approaches to obtain such information, a community stroke register can provide the most comprehensive data. 1.2 Pilot study What is the practical scale: in a small or a large community, in selected areas or nationwide? Before expansion of a programme, we need to study whether the same format can be used in different countries or in different groups of population, and to assess the constraints or difficulties, the reliability of data, the relevance of information, the way of data linkage between other existing registers, etc. The WHO programme started on a limited scale, i.e. in small communities in several countries. Fifteen groups from ten countries have now been working under the coordination of WHO. The programme has been adjusted for wider use in areas with different systems of medical care. We hope that this programme, as it is at present, can be used in many places for several years. Each centre should start with a feasibility study by organizing an information network first and then by establishing a suitable operation of daily work. When experience is gained in running a pilot study, and feasibility and usefulness of the study is demonstrated, the programme can be expanded in either of two directions: spreading the programme to other areas or countries, or combining other programmes to build a more comprehensive health care system in the same area. 1.3 Objectives of the stroke register cvo/s/73.6 page 1 The stroke register is a systematic collection of basic infonnation from all stroke patients in a defined population. It will be used for epidemiological studies, for planning local medical services, for the evaluation of the stroke control progranne and of the hypertension control programme, for the study of natural history of stroke, and for evaluating the efficacy of· rehabilitation services and of other specific treatments. Results will be compared with previous experience in the same area, and with results from other centres. Data obtained from the stroke register can be used for promoting interest and cooperation among public health administration, physicians and the public on stroke control. The objectives of the stroke register are swmnarized: 1) Collecting more accurate 1nfonnat1on on: (a) the magnitude of stroke in the community (b) social and clinical profile of stroke patients {c) preventive measures, diagnostic procedures and rehabilitation applied to the patient (d) natural history of stroke 11) Developing methodology for standardized data collection 111) Analysis and comparison of data iv) Application of obtained knowledge for stroke control. 2. ESTABLISHMENT OF STROKE FlEGISTER 2.1 Selection of a study population A register can be established either in a defined geographical area or in an occupational group. A long-tenn control programme can also be applied to the same populations. Several points are considered as a guide for selecting a population for study. 2.1.1 Type of population Various populations can be chosen according to the purpose of the stroke register. 1) General survey: In order to review the magnitude of problems related to stroke in the community for planning purposes, the sample population must be a representative one. Distribution of age, sex, social classes in the study population should be similar to the target population at large. The results and conclusion can thus be extrapolated and generalized. CVD/S/7j.6 page 8 2.1.2 11) Evaluation of intervention programme: Obviously, the population under the intervention programme should be covered. Secular changes should be monitored before, during, and after the programme. Inherent weakness in observation of secular change is an unknown magnitude of contribution of other factors, e.g. improvement of economical and sanitary conditions, progress in medical practice in general, etc. It is desirable to study, simultaneously, a similar population group which has not undergone the special programme and compare the two populations. 111) Epidemiology: According to the design of the study, either 1) or ii) above can be used for epidemiology. Special population groups, which have extremely high or low mortality or other contrasting characteristics, are also of interest for epidemiological studies. iv) Hospitalized patients: Where a large majority of stroke patients are hospitalized, a hospital case study, which can be carried out more accurately with much less effort, may be used as a substitute for the total population study. With this approach, however, one can never know how many patients are treated at home or how many die without reaching hospital. The catchment area is influenced by many factors and hospital patients usually do not represent all the stroke patients from the population under study. This approach is therefore not recommended except for the initial exploratory survey. Stability of population In order to obtain reliable figures on the size or feature of the stroke problem it is desirable that the population does not change during a study period. If the annual inflow is 15% without outflow, in five years half of the total population will consist of newcomers. If, on the other hand, the annual outflow is 1)% without inflow, the original population will have decreased by half in five years. If the mobile sector of the population has character- istics identical to those of the remaining sector no change will result; however, this is generally not the case. Population movement is unavoidable in a modern society. In an occupational group, turnover of members is a rule. In order to avoid erroneous interpretation, changes in the background population should be known. Since many factors change at the same time, it is often difficult to identify relevant factors to the changes in stroke. For these reasons, it is preferable to complete a study in a shorter period, covering a larger population. 2.1.3 Availability of demographic data It has frequently been reported that stroke is common among young people in some countries, where the majority of the population are young and only a small fraction of the population lives beyond 60 years of age. Without reliable age breakdowns of the population, it cannot be concluded whether the incidence rate of stroke among the young is really higher than in other countries or it is simply a reflection of the population composition. The availability of recent demographic data on the study population is therefore important. cvo/s/73.6 page 9 2.1.4 Adequate size of population In order to obtain the incidence rate or the prevalence of certain characteristics, which can be extrapolated to the colllllunities of similar make-up, the size of the study population must be large enough. In general. the ad.equate size of the sample is determined by two factorsa 1) the desired precision of measurement 11) expected frequency of the event or phenomenon. '!be higher the precison required, and the lower the frequency, the larger must be the size of the sample. (a) Precision We can arbitrarily set the level of precision. It can be expressed by the range (confidence interval) in which the true value is likely to fall with a given probability. Measurement with a high (low) precision thus means that the value is estimated within a narrow (wide) range under a given probability. For example, estimation with±~ is obviously more precise than estimation with ±20,,C. The confidence interval is usually determined at a probability of~ or~ level: the probability for the true value to fall outside the stated range will then be ~ (o(. • 0.01) or ~ ( oe. • 0.05), respectively. (b) Expected frequency To estimate the frequency is indeed our objective. We must. however, have a rough estimation of this figure, based on the existing knowledge or on a small scale pilot survey, in order to estimate the necessary size of population to be studied. The following tablel shows the approximate size of sample we need at a given precision ('!5% to ±100,:) for a different frequency value expected (0.1% to 50,:) at a probability level of~ (d-.. = 0.05). 1 Approximate size* of random samples required for estimation of frequency with desired precision (o<. • 0.05) Precision of estimation* Expected (relative to the expected frequency) frequency !~ ±10,: ±20,: ±50,: ±1oo,; o.~ ;:>100.000 ..::>100.000 7100,000 20.000 6,000 o.2',C ;;;>100,000 ;::;,,100.000 60.000 10.000 2.500 0.5% 7100,000 90.000 20,000 3,500 1.000 1% .7100,000 40,000 10.000 2,000 500 5% 3(),000 7~000 2,000 400 L.100 10,: 20,000 4.000 900 200 ..::::: 60 20,: 10.000 2,000 400 70 <. 30 50,: .}.OOO 400 100 .c::.30 ~30 * Expected errors are not distributed. equally between plus and minus side. because of variability of binomial distribution. Original table for precise confidence interval is provided by WHO document HSM/73.1: Adequacy of sample size CVD/s/73.6 page 10 According to the preliminary analysis of the WHO collaborative study the annual incidence rate for the age group 55-64 is around 0.5% to 0.1% in most places. If this population is assumed to be a random sample from an infinite number of the same type of populations, and we are going to estimate the incidence rate of the latter, we can use this table as follows. In order to estimate the incidence rate within a confidence interval of !50% relative to the estimated value (i.e. it is estimated with a confidence interval of 0.25% to 0.75% or 0.05% to 0.15%). we need a sample population of 3,500 to 20,000 in this age group. If we require a higher precision, e.g. of !20%, we need from 20,000 to more than 100.000. Where the incidence rate is about 1%, as in rural Japan, a smaller number such as 2,000 or 10,000 suffices for the requirement of the same precision of !5Q% or ±2()% respectively. A small population group will suffice if a longer period is spent on the study. If we take an age-specific group, such as aged 55-64, which may account for 10% of the total population of 100,000, we shall be able to estimate the annual incidence rate of 0.1%, 0.2%. 0.5% or 1%, with precision of !5()%, in 2, 1, 1/3, and 1/5 years, and with precision of !2~ in more than 10,' 6, 2, and 1 years respectively. Incidence rate itself, interest, or personnel may change with time; continuation of a study for longer than five years would be practically prohibitive. {c) Power of detecting difference The above principle applies not only to the estimation of incidence rate, but also to the comparison of frequency. The probability that the estimated difference is real increases with the precision of measurement. For instance, if we have two g:coups of 100 stroke patients each, the difference between the observed frequency of 10% and 25% cannot be significant at a probability level of 95%. but if we have 200 patients we can conclude that the difference is significant, i.e. such a difference is unlikely to occur by chance {less than 5 times out of 100 samples)l. For these reasons the size of the study population should be sufficiently large, within a manageable limit, in order to obtain accurate information. A population of at least 100,000 was reco11111ended as necessary to obtain an incidence rate for the total population with reasonable accuracy. From a population of this size, we can distinguish the difference in incidence rate between O.J..%. 0.2% and 0.-:;/, at a probability level of 95'1,. About 500 stroke patients may be registered during two years and we can distinguish the difference in frequency of various characteristics, for instance between 1%, 5% and 10% at 95% probability level. 2.1.5 Acceptance by the community For case detection and follow-up, help from the local medical services, patients, and patients' families is essential. Support from the government, and local administration facilitates the operation of the register. Continued effort is needed for strengthening a cooperative atmosphere. The register is more acceptable when it is a part of a stroke control programme, which supplies information on, and services in, prevention and rehabilitation to the public, and eases access to facilities for diagnosis, hospitalization and rehabilitation to the general practitioner. Lectures, conferences and meetings for both the general public and 1 WHO Document HSM/73.1: Adequacy of sample size cvo/s/73.6 page 11 medical practitioners, explaining the aims of the stroke register, its relation to the methods of controlling stroke, are necessary, particularly during the preparatory period. There are a number of pamphlets, booklets and audio-visual material available for the education of the public. The.periodical circulation of a newsletter on the progress of the programme has been proved to be useful to maintain people's interest and cooJ)eration~· 'If there is a large central hospital or a teaching hospital, it is highly desirable that such a hospital takes the responsibility for providing educational and medical services,. material, and personnel. 2.2 Registry Centre 2.2.1 Location The registry centre is not an office but a functioning unit. It is often situated in a central hospital, in a department of medicine or neurology, or a school of public health, but may also be located separately in another building. Wherever the location is, it should be convenient for connnun1cating with medical services and patients in the study. area. ·, ... ~.2.2 Personnel There are three types of duties required in the registry centre. 1) Director (should be a physic1an)a overall coordination of work; establishment of stroke register; organizing sources of notification; cooperation with public health administrators, hospitals, medical. societies, and medical universities; maintenance of activities; analysis of data; issue of newsletters and other publications; contact with other centr-es and with WHO. 11) Clerk (may be a clerk, secretary, or librar1an)a checking and sorting records; arranging follow-up; preparing letters and educational material; assisting the Director. 111) Interviewer (may be a trained nurse or social worker)t to visit hospitals, practitioners, and patients; to collect information; to interview and examine the patients; to fill in record forms; to guide the patient in his rehabilitation and occupation. These Job allocations should be flexible according to the local situation. Practitioners may be more accessible by a physician than a nurse interviewer, and practitioners may or may not welcome guidance given to their patients by the third person. The clerk may be shared with another registry, such as myocardial infarction register. The Director should, however, be fully responsible for the stroke register, and it is desirable that he be full-time. It depends on his initiative whether the register functions actively and efficiently. If he does not keep an eye on the daily running of the register, the register is likely to become dull, routine desk work, alternated with paroxysmal bursts of data transfer. The minimum staff number for the centre would be two persons, i.e. Director and interviewer, both sharing the functions of the clerk, and both working full-time on the register. The optimum number would be three to five persons, which would thus reduce the workload of individuals. It is not desirable to have too many workers as efficiency and responsibility of work would diminish and more effort would be absorbed in coordination of their work and maintenance of uniform reporting. CVD/s/73.6 page 12 In addition it is useful to have a statistician and allied personnel available to the registry centre: their duties involve checking and editing record forms; programming, punching, storing data; data retrieval and analysis; consultations on data processing. In the WHO collaborative study, the Health Statistics Methodology Unit is working as such a statistical centre. Facilities and personnel for data processing must be contacted and involved.starting from the initial planning stage. 2.2.3 Equipment No special equipment is necessary, but efficiency of work is augmented by certain provisions, e.g. an automated tape recorder connected to a telephone to receive notification by telephone at night or during absence. For the follow-up of stroke patients, transport facilities ought to be readily available. A car is useful for visits to the patient's home and medical services, soon after notification or on scheduled dates. A copying or printing machine is helpful for the production of newsletters and other information to be distributed to the cooperating physicians and other people. 2.2.4 Other aids Registry centres in the WHO group are devising and using various means to facilitate and stimulate daily work. 1) A map showing geographical distribution of patients is of epidemiological interest and is also helpful to recognize insufficient notification from some parts. By using colour markers, distribution and subclassification of patients, e.g. patients who were notified to the centre after death, the ones who died within three weeks, and surviving patients, can be clearly illustrated. 11) Filing and indexing cases in chronological order, and also filing and indexing patients' names in alphabetical order is absolutely necessary. A list of patients with expected date of follow-up interview, date when interview has actually taken place, date of completion of record forms, and date of sending these to WHO if applicable; such a list facilitates the smooth daily running of the work. 111) A monthly record of the number of notified patients from each information source is useful for detecting insufficient or irregular reporting. iv) In one centre, a copy of all death certificates issued in the study area is regularly received and has been useful for review. I t I 2.3 Organization of source of notification cvo/s/73.6 page 13 The role of a medical service differs from place to place. The local administrative body should be well infonned about the programme. On special occasions, local legislation for obligatory reporting may be possible and helpful. The cooperation of major hospitals is essential. A patient from the study area may visit a physician or hospital outside, as the stroke could occur outside the study area, and in many places a. patient is free to choose their consultant physician. It is therefore common practice to keep in contact with all major hospitals in the entire city or district in order not to miss a patient being treated outside the study area. The support of the local.association of physicians is influential on the attitude of general practitioners who have a decisive role in reporting stroke patients. Other institutions and organizations which facilitate the case register should be contacted, and an appropriate procedure for reporting should be devised for each source. Various sources are being used in the WHO stroke register, and completeness of data collection for each source has been estimated by each centre, whose experiences are mentioned below. (a) Hospitals The most important source of infonnation which generally provides an extensive record of the patient's condition. It is easier to collect information where there is only one major hospital available in the area. Stroke patients are usually hospitalized either in a medical or neurological ward, but may sometimes be 88lt to a neuroaurgical or psychiatric department; they should not be missed. In WHO study areas, where there are many hospitals, weekly contact by a physician or a trained nurse, has secured 90 to looJ; reporting. (b) Emergency services This is the first step for all acutely 111 patients in some places. Patients are referred to hospital care, ambulatory care or home care only from this service. In such a place, daily contact with the emergency service offers a very high coverage of stroke patients. (c) General practitioners, outpatient clinic: They are the first front of medical services which have everyday contact with stroke patients. They play a decisive role in the areas where stroke patients are traditionally cared for at home. Where stroke, major or minor, is generally referred to a hospital, the yield from practitioners is small. However, non-hospitalized patients fonn a special group and should not be neglected. Existing weekly or monthly meetings of physicians, for any purpose, may be used for cqlllllU.nication and reporting. A weekly or occasional telephone call to a physician is another approach. To supplement these, monthly reminders and newsletters may be helpful. By these methods, 70 to 10°-' of stroke patients have been notified. (d) Nursing homes, old peoples' homes, chronic hospitals including mental hospitalss These are non-existent in some comnunities, whereas in other communities there are many, including non-authorized private nursing homes. Stroke among people in these institutions is not infrequent. Diagnosis is often inaccurate and available infonnation insufficient. Notification of stroke patients is not easy but this group should be contacted. Estimated completeness has differed from 30 to looJ; in the WHO collaborating centres. CVD/S/73.6 page 14 (e) Death certificate: Death certificates should be reviewed periodically. The common practice is a review every two weeks or a month. A longer interval will decrease the accuracy of infonnation. A few deceased patients who were not hospitalized or who were missed can be traced from this source. Completeness of detection has been l<>O..'. If we simply collect a cause of death given on the death certificate, the stroke register may turn out as a copy of the national mortality statistics, the quality of which is not satisfactory. For example, a stroke which occurred a long time ago but leaving disability until death may be listed as one of the contributing causes of death, but this is not an incidence of stroke to be registered (see criteria). Loss of consciousness prior to death, sudden death, or even suicide, may sometimes be recorded as stroke for convenience. The death certificate is an important source of case detection, but a further search into the clinical evidence by contacting the certifying physician and the family should be made. If the diagnosis of stroke cannot be substantiated, it should not be accepted. (f) Autopsy record; medico-legal autopsies: An autopsy offers decisive infonnation on the cause of death and regular contact with pathological and medico- legal departments must be kept. In many places, the results of an autopsy appears on the death certificate, but this is not always the case. (g) Social insurance records; sick leave records: Their usefulness depends on local conditions. These form a supplementary source in some population groups, and may be the only practical tool in an occupational group. Delayed notification is inevitable with this approach, and the quality of information is poor. Before accepting a diagnosis of stroke, further information for validation should be sought. (h) Other sources: An interviewer should be alert to seek information on new patients during rounds. A patient is often known by neighbours, particularly by a family in which a member has the same disease. A new stroke victim has often been found by an interviewer before a physician notifies the case to the centre. Where circumstances are favourable, a voluntary laymen's association for control of cardiovascular disease in the conununity may be fanned, and information about stroke patients in the vicinity may also be gathered from this source. (1) Mass screening examination; questionnaire: This is an excellent way for detecting missing patients, and is the only way to find a patient who did not seek medical care. This is, however, an undertaking with its own purpose. A prevalence study of stroke can be added to other population studies, whenever such a survey is going to take place in the same, or part of the population. A special survey in a random sample may be carried out to assure completeness of the register. 3. CRITERIA FOR REDISTRATIOO 3.1 Definition of stroke CVD/S/73.6 page 15 Stroke is defined as rapidly developed clinical signs of focal (or global1 ) disturbance of cerebral function, lasting more than 24 hours or leading to death, with no apparent cause other than a vascular origin; it includes patients presenting clinicai signs and symptoms suggestive of sub&rachnoid haemorrhage, intracerebral haemorrhage, or cerebral ischaemic necrosis. It does not include transient cerebral ischaemia. 3.2 Criteria for inclusion In order to be entered into the register, (a) a patient must fulfil the clinical criteria for stroke, (b) a patient must be resident in the area or belong to the occupational group selected for the study, and (c) stroke must have occurred during the study period. 3.3 Age and sex All stroke patients. of both sexes and of any age, should be included. Where the aim of the stroke register is limited to the evaluation of a hypertension control programme, observation may be limited to the corresponding age group. ).4 Clinical criteria Patients may die without being seen by a physician, with or without neurological· deficits observed by the family, and with or without diagnosis of stroke on a death certificate. Supplementary explanations are given in order to meet the objectives of the stroke register and to collect data in a uniform way. The general rule is to base registration on clinical diagnosis, rather than patho- logical confirmation. Patients who are suspected as having stroke, with reasonable grounds, are included. (a) Living patients All living patients who had suspected. stroke should be included in the register. A delay of a few days from onset is allowed to decide whether the patient should be registered. This is a safeguard to avoid unnecessary load on the register due to apparently false diagnosis of stroke, e.g.841.te alcoholism, drug intoxication, etc. Other patients are referred to an emergency service with a label of stroke to facilitate hospitalization, but such an incorrect label is usually detected within a few days. Patients who were not diagnosed as having stroke at the beginning, but who were later found to have stroke, should be registered as soon as the diagnosis of stroke is established. l 'Global' - applied to patients with subarachnoid haemorrhage and to some patients in deep coma, but does not include systemic circulatory failure, e.g. shock, Stokes-Adams syndrome, or hypertensive encephalopathy. CVD/S/73.6 page 16 (b) Deceased patients "Stroke" stated on the death certificate should not be accepted automatically. In such a case, a search for available clinical information (from medical documents and/or observations about the patient by the family) should follow. Where there was suggestive evidence of stroke of recent onset, the deceased patient is included in the register and the required record forms should be completed retrospectively as far as possible. Where there was no suggestive evidence, or the stroke occurred before the starting date of the register, the patient should not be included. (c) Autopsied patients When other diagnosis is established based on autopsy finding for a patient who was clinically diagnosed as, or suspected to have had, stroke before autopsy, the patient should remain in the register and the required record forms completed. When recent, significant, cerebrovascular lesions were found at autopsy and clinical history was indicative of stroke, the patient should be included in the register. On the other hand, if clinical history was incompatible with stroke, the patient should be excluded, irrespective of the autopsy finding. 3.5 Identification of residence and of employment Subjects officially registered as being inhabitants of the defined area (if no official population register exists, subjects who usually live in the defined area) are included irrespective of the site where stroke occurred, i.e. both outside and inside the defined area. However, persons residing outside the study area who had a stroke inside this area, or who were hospitalized in the area and accordingly notified to the centre should be excluded. A patient whose residence could not be identified should be excluded. Determination of the person's residence is based on the list of inhabitants provided by the city or village authorities, where available. The same principle is applied to an occupational group. Employment status at the time of onset of stroke is taken. Stroke which occurred during the patient's official travel or during sick leave is included, a registered patient should be followed up even when he retired or changed occupation after stroke. Stroke which occurred after retirement or change of occupation does not cause inclusion in the register. 4. PROCEDURES FOR INCLUSIW IN THE REGISTER 4.1 Case finding CVD/s/73.6 page 17 Stroke patients should be notified to the registry by any doctor who is called to see them. In each area a careful study will be required of the different ways in which patients may first come into contact with the medical services. Each of these ways must be covered by a system of notification to the registry and by a system of checking by the registry staff. The value of the register depends on including the highest possible proportion of cases arising in the population under study, all suspected stroke cases should be registered; as many routes of case finding as are practicable should be used; effort should be made to cover especially patients treated at home, in a nursing home or in mental hospitals. Notification to the registry must be as simple as possible and should involve the minimum infonnation, such as name and address of doctor; name, age, sex and address of the patient; date of consultation and the tentative diagnosis. Notification will be made by personal contact, telephone, or the mailing of a (pre-paid) letter containing a simple fonn distributed to the possible sources of notification. Experience has shown that it is not helpful to request notifying doctors and others to fill in elaborate fo:nns; their assistance should be concentrated on inmediate notification of stroke patients they have seen. 4.2 Initial interview On notification of a stroke patient, the registry doctor checks available information to decide whether the patient satisfies the criteria for inclusion. The clerk checks the name (or personal identification number if existing) of the patient with the registration list to see whether it is a new stroke case or one registered previously. If new, the patient is placed on the register by entering all available information on the Initial Record Fonn ( p 27). If registered previously, the procedure for the Recurrence Record Fonn ( p 31 ) is followed. The clerk fixes the dates of initial and subsequent follow-up visits to the patient. An interviewer from the centre visits the patient in the hospital or at home and collects the required information using the WHO record fonns according to the procedure outlined in the instruction manual (see Annex1I). If possible, the record fonns should be completed during the interview. In some cases additional visits may be necessary to obtain reliable informat~on. It is strongly reconmended that all the data be recorded by the registry personnel. It was found to be unsatisfactory to allow information to be recorded by anyone outside the registry. 4.3 Follow-up All cases registered, except when death occurred before registration, must be kept under observation until the first follow-up at three weeks after the onset. Stroke is usually stabilized and a clinical diagnosis is detennined at this point in the majority of patients. Those who are diagnosed as stroke should be kept on the further follow-up schedule. The second and third follow-up is carried out at three months and one year after the onset. Each follow-up is recorded on a separate Follow-up Record Fonn (p 28-29). CVD/s/73.6 page 18 Patients who are diagnosed as not having stroke at three weeks should not be withdrawn from the register, and first Follow-up Record Form at three weeks should be completed mentioning the correct diagnosis, and the patients need not be followed up further. Those who were diagnosed as stroke at three weeks but later diagnosed as "not stroke", an Exclusion Record Form (p 32) is completed and follow-up is terminated. Further follow-up may be continued optionally every six-month interval after one year. In this case, the same observation periods for follow-up should be applied to all patients·. The procedure for following up patients will depend on local circumstances. Methods to be used are: (a) visits to or by the patient; (b) visits to consulting physician and review of medical documents; and (c) contact with the family and patient by telephone. This last approach may only be used at the second and later follow-ups but should not be used for the first follow-up. If at any follow-up, the patient cannot be traced the Follow-up Record Form should be completed with as much information as can be obtained, and final disposition is recorded as "unknown". 4.4 Recurrent stroke It is likely that some patients will develop attacks of suspected or actual stroke on more than one occasion. To avoid confusion and difficulty in the registration and docu- mentation of such episodes, the following conventions should be observed. Any episode of suspected acute stroke is considered to continue for a period of three weeks after the time of onset. If recurrence(s) occur during the three-week period this should be regarded as a continuation of the initial attack and is not coded as recurrence. This convention is introduced so as to avoid difficulty in determining whether a later development of neurological symptoms is a recurrence or a slow progression of the initial attack. If a patient who has previously been registered suffers a further episode of suspected stroke after the three-week period following the acute attack (either initial or recurrent) the infonnation should be entered on a Recurrence Record Form and given the same registration number, so that recurrence in the same patient can be identified. If two or more suspected attacks have been registered for one patient, only the initial attack should be followed up at the intervals laid down. Each recurrence, however, requires a follow-up after three weeks. If a patient dies as a result of recurrence, both Recurrence and Death Record Forms should be completed. 4.5 Report of Death Whenever the death of a patient with stroke, or with suspected stroke, is notified, a Death Record Fann is filled in. All deaths during the observation period of patients who have been registered previously, irrespective of the cause of death, must be reported. If the patient died before registration, then an Initial Record Form should be com- pleted as far as possible. In the case of delayed notification, a patient who died more than three weeks after onset, the three-week Follow-up Record Form should also be completed. The completion of further interim Follow-up Record Form, to provide the latest information on the patient's status prior to death, is not required. 5. UNIFOJllt COLLECTIC!l OF DATA CVD/S/TJ.6 page 19 The use of the same terminology and of the same procedure for collecting and recording infonnation on the same items is an obvious necessity for comparison and/or pooling of data. 5.1 Content One is often tempted to collect as much available infonnation as possible. However, it is better to collect a limited amount of information with more attention and accuracy. A number of items were initially proposed, chosen, tested, and only the essential ones retained in the WHO stroke register. The criteria for selection of items are: (a) relevance to the objectives of the stroke register (b) clear definition with least possibility of misunderstanding (c) availability from the majority of patients in the majority of centres (d) avoiding duplication 'nle following items are finally included in the WHO stroke register (for details, see record fonns and instructions). Initial record Identification and registration centre registration number date of completion of record fonn date of birth sex state of patient at time of notification preliminary diagnosis by notifying source Personal conditions prior to stroke civil status living conditions working conditions occupation Previous medical history stroke acute myocardial infarction acute myocardial infarction register No., if any other heart disease arterial hypertension hypertension register No., if any treatment for raised blood pressure immediately prior to stroke diabetes mellitus cvo/s/73.6 page 20 Patient's capability of self care before stroke self care control of bladder Early stages of present attack date of onset or detection admission to hospital date of admission to hospital Clinical state at time of maximum impairment within the first 24 hours level of consciousness motor deficit of limbs speech disturbances blood pressure (first measurement after stroke) Follow-up Identification Initial registration number centre code date of completion of record form date of birth type of follow-up Diagnosis (at j-week follow-up only) diagnosis by registry examinations performed blood pressure at the interview Transfer of the patient since previous interview location of the patient at the previous interview transfer(s) date(s) of transfer(s) Personal conditions at time of interview current living conditions current working conditions help for self care Medical history since previous regular follow-up recurrent stroke acute myocardial infarction acute myocardial infarction registration number anti-hypertensive treatment hypertension registration number rehabilitation by qualified person Clinical state at time of follow-up level of consciousness motor deficit of limbs speech disturbances bed or pressure sores Joint contracture Activity of dailY living bed-fast/chair-fast and must be carried control of bladder self care walking Death record Identification Initial registration number date of death date of birth place of death Autopsy autopsy brain autopsy Causes of death clinical autopsy centre code Examinations perfo:nned, if died within three weeks of onset Recurrence record Identification Initial registration number date of completion of the fo:nn date of birth centre code Clinical state at time of maximum impainnent within 24 hours level of consciousness motor deficit of limbs speech disturbances Ea~lY stage of present recurrence date of onset or detection admission to hospital date of admission to hospital preliminary diagnosis by attending physician CVD/S/TJ.6 page 21 CVD/S/73.6 page 22 Exclusion record Identification Initial registration number date of first follow-up Diagnosis date of completion of form diagnosis by registry 5.2 Record forms and data transfer sheets centre code Record forms containing precoded items were prepared in WHO for the Initial, Follow-up, Death, RecuITence and Exclusion Record Forms (pp 27-32). Only an English version is available. Centres are requested to send originals to WHO and keep carbon copies for their own use and reference. In the centres where the English version is inappropriate, the same format in their own language should be provided. Some of these centres wish to use a simple recording sheet to transfer data from their own original record for central analysis. Two kinds of condensed data sheets with precoded boxes are available for this purpose. One contains information from one set of Initial, Follow-up, and Death Record For.ms (p 33). For the second and later follow-ups, another transfer sheet of the same fonnat is used for each interview. The other data transfer sheet is for recurrence, three-week follow-up after recurrence, and exclusions (p 34). 5.3 Instructions for completing record forms Record forms have been designed as much as to be self-explanatory. Furthermore, for unifonn understanding of the terms in the record forms, detailed explanations about the terms and procedures have been prepared and are being used. These are given as Annex II. 5.4 Test for uniform recording In spite of the above precautions, it would be too optimistic to assume that the understanding and interpretation of the stroke register is secured simply by documentation, however detailed it is. Test case histories, which include all necessary information for recording, were distributed by WHO from time to time to each centre, where each interviewer completed the record forms independently and these were sent to WHO. This exercise revealed points where frequent misunderstanding occu?Ted and its causes. Possible source of errors, and problems inherent to items or descriptions were thus recognized and measures have been taken to improve the comparability and accuracy of information collected. Another teat was also carried out to find out if stroke is diagnosed in a uniform manner in each centre. A powerful tool to objectively ascertain the diagnosis of acute myocardial infarction is the determination of the concentration of enzymes released from necrotic myocardial cells in the blood and the evaluation of ECG changes. Unfortunately, there are no such objectively measurable parameters to ascertain the diagnosis of stroke, and the diagnosis of stroke is only based upon the interpretation of clinical information. Particularly in the two extreme conditions (e.g. severe stroke which resulted in early death in deep coma, and mild stroke such as with slight dysphasia or motor deficit in the face or cvo/s/73.6 page 23 tongue only) the diagnosis is sometimes not easy and the patient may be diagnosed differently in a different place at a different time. This may introduce false difference in the incidence of stroke as well as in the clinical profile of stroke patients. In order to study the possible discrepancy in the diagnosis of stroke, problematic case histories were sent to WHO from each centre and were circulated.to the participating centres, and thei~ decisions on inclusion/exclusion on the stroke register were compared to check whether registration is done uniformly. 6. CENTRAL POOLING AND ANALYSIS In order to develop a widely applicable methodology for different places in the world and to shed light on the local situation by comparing with other places, the WHO stroke register was started as an international cooperative undertaking. For both purposes, pooling and analysis of information in WHO is convenient. After completing record forms as fully as possible, and after careful checking to ensure that all available infonnation is recorded correctly, each collaborating centre sends the record forms or the data transfer sheets to WHO in Geneva. These are reviewed in the Cardiovascular Diseases Unit (CVD) and Health Statistics Methodology Unit (HSM) at WHO. Record forms with missing data, mistakes and controversial data are returned to the :responsible centre for correction. Both visual and computer checks are made in WHO. Cleared data are transferred to punch cards and on tape, are stored and tabulated. Basic and accurate information on the stroke problem is being collected from different areas of the world, for the first time, in a uniform manner. These data can be used for comparison, by other centres who are not directly involved in the WHO study but who investi- gate the stroke problem with the same procedure. Assessment of Programme Operation Usually there are gaps among centres in the progress of the :register. Some are related to local factors such as cooperation of hospitals and general practitioners or hospitalization rate, etc., which cannot be controlled immediately. There are other factors which are influenced by the attitude of the centre. In a cooperative programme, it is helpful for the coordinating centre to monitor such factors. Operational condition of a centre may be assessed by the followings (a) Establishment of the registra~ion centre For the programme to be successful, there must be a permanent director who is watching the daily programme operation. The presence of many physicians whose responsibility is on a part-time basis, without a fully responsible director represents weakness of the centre. CVD/s/73.6 page 24 (b) Regular data acquisition and transfer The longer the time span after the attack, the lower becomes the reliability of memory. In order to maintain the interest and cooperation of notifying sources, the centre should always be alert and receptive. In such circumstances, completion, checking, sorting, and transfer of data to WHO can be carried out monthly or bi-monthly. This again helps the smooth operation of data processing. A paroxysmal, e.g. once or twice, supply of information cannot supplement fading interest and memory and should be avoided. (c) Precision of date of follow-up D.le to many interfering factors, follow-up cannot always be carried out on a definite date. In delayed notification, the fonn has to be filled in with retrospective inquiry. However, when the programme is under regular operation, a delay of follow-up can be kept to a minimum. (d) Missing information and errors When a register is watchful, these can be minimized. (e) Consistency of data When the number of stroke is small, more fluctuation of data is expected. There may be seasonal variation and a shift in one or another direction. However, monthly incidence and frequency of various characteristics of stroke patients would remain within a limited range. (f) Other activities Collected data should be used for improving the stroke control programme in the corrmunity. From time to time dissemination of acquired knowledge by issuing newsletters and pamphlets, holding educational meetings on prevention, and by intensifying rehabilitation services, are examples. These activities invite cooperation of the medical profession and the public, and facilitate the operation of the stroke register. The range of activities depends upon the scale and scope of the stroke register; development from a small stroke register to a comprehensive stroke control programme should be promoted as much as possible. 7. ROLE OF WHO cvn/s/73.6 page 25 Cooperation and communications between the centres are enhanced by various means by WHO. News on the progress in each centre and information on other studies of a similar nature are disseminated to and from the involved centres and also other interested centres on request, through a periodical newsletter. ~ueries are clarified by direct col!ll'lunication between the participating centres and WHO. An interchange visit of investigators has been arranged to help mutual understanding and learning on the spot. WHO has been holding an annual meeting of investigators to provide a chance of close discussion for improving methodology and review of the results. Programme operation is also assisted by WH01 record fonns and data transfer sheets are being supplied, tests for securing comparability are being carried out, data are being collected, edited and analyzed and results have been distributed, discussed and will be published. A token amount of WHO funds often facilitates support from local government and medical services, and an introduction of local research funds into the study. WHO thus plays an important catalyzing function to promote stroke control programme. WHO does not intend to increase the number of cooperating centres, but intends to test and improve methodology and to demonstrate the applicability of analyzed results to the stroke control programme. WHO is willing to support a similar undertaking at any place in the world, and to supply further technical infonna.tion on request. All enquiries should be addressed to1 Cardiovascular Diseases Unit World Health Organization 1211 Geneva gz Switzerland (Telegrams1 Telephone: Telex1 UNISANTE - Geneva Geneva 34 60 61 22335 8. FUTURE OF '!HE STROKE RFDISTER 8.1 Duration of the stroke register The pilot study will be terminated when its goal is achieved, i.e. when information on a sufficient number of stroke patients is gathered, analyzed and used for assessing the present situation of stroke control in the community and for indicating how to improve it. In the majority of WHO-collaborating centres, a pilot operation for half a year, continuation of two full years, and at least one year follow-up of all the registered patients are thought to be a reasonable time schedule. By this time, about 300 to 750 stroke patients are expected to be registered in each centre and this number would suffice for simple cross tabulations and comparisons between centres. cvo/s/73.6 page 26 Further continuation of the stroke register is expected as a part of a comprehensive cardiovascular disease control programme, such as a hypertension control programme etc. 8.2 Stimulus to epidemiology and public health action Data collected from various population groups will show if differences exist in the incidence, case fatality, clinical feature or complications of patients. These differences may be partly attributed to the uneven development of stroke control in the community, and partly due to known and unknown etiological factors. Comparison of results will thus suggest points of actions in promoting control measures against stroke, and also give a hint on possible etiological and prognostic factors in epidemiological research. 8.j Aid to clinical research Evaluation of various preventive, diagnostic, therapeutic, and rehabilitative methods is less biased when tested in non-selected patients from the community than when tested in hospitalized patients. An established network of case finding, and friendly cooperation with local physicians would provide a basis for such a study. Socio-economical aspects of the stroke problem can be investigated only in the frame of the community. 8.4 Inclusion of other cardiovascular diseases a.nd expansion of control programme The principle of community approach may be expanded to the control of rheumatic heart disease, ischaemic heart disease, or any other programme, according to the local circumstances. Experience and organization obtained during the stroke register can be applied. Success in one area will encourage another area to start. During this process of expansion, other operational problems would emerge, and a new strategy and methodology may thus be required. Cardiovascular disease control programme will thus contribute to and eventually be integrated into improved general health services. ANNEX I cvn 1cJr1~ 11. page 27 WHO STROKE REGISTER - Initial Record Form Study! Pj 1 j1 I Identification and Registration Registration number: Centre code: I I I I I I [I] 4-8 9-10 Previous Medical H istory Stroke: l=no, 2=yes, 9=unknown (3=optional code) D 37 A cute myocardial infarction: Oas· Date of completion of record form ~ D]month 19fTl 11-16 L..lJ L..lJ A MI Registration No. , if any: I I I I I 139-43 N ame of interviewer: N ame of patient: _____________________ _ Present home address: ------ _ -------- _____ Tel. no.-------- Date of birth: ~month~ LJ_j [D IL.l_LJ 17-23 C ode for data processing G24 Sex: !•male, 2•female 025 026 State of patient at time of notification: !•alive, 2"'dead Preliminary diagnosis by notifying source {IC D code): I I I 1 I I 27-31 Personal Conditions Prior to Stroke Civil starus: !•single, 2=married, 3<:divorced, 4-widowed. 5•separated, 0 6•other, 9=unknown 32 Living conditions: l•in private household, alone 2-in private household, not alone 3•permanently living in instirution 9=unknown Working conditions: l•in gainful work 2-retlred because of ill health a-retired because of age 4ahousewlfe S-other 9sunknown Occupation (2-digit ILO code): X4"'no gainful work X 9sunknown WHO/CVD 5164 - 2/12 [Da5-36 A ny other heart diseases: D 44 Arterial hypertension: O 45 Hypertension Register No., if any:I ... __.! ___ .... I_ ... ,_ ... I__.I 46-50 Treatment for raised blood pressure immediately prior to stroke: Diabetes mellitus: Patient's Capablllty of Self Care Before Stroke Self care: !=independent 2•partially dependent 3=-totally dependent 9"'Unknown Control of bladder: l•not disturbed, 2=disturbed ~unknown Early Stages of Present Attack day D ate of onset or detection: [I] Admission to hospital: l=no, 2=yes a-stroke occurred in hospital, 9=unknown Date of admission to hospital: Clinical state at time of Maximum Impairment Level of consciousness: l"'fully conscious, 2•somnolent, 3=serni-coma, 4•coma, 9sunknown R 051 052 month rn 55-58 month rn60-63 Molor deficit of limbs: l•no deficit 2=weakness/paralysis 3=not assessable Arm Leg 0 0 L 065-66 067-68 Speech disturbances: l=no, 2=yes, 3=not assessable Blood pressure: mmHg (lst measurement after onset) Systolic Diastolic 069 I I I 170-72 I I I 173-75 CVD/S/73.6 page 28 WHO STROKE REGISTER - Follow-up Record Form Identification Initial registration number: I I I I I I 4-8 Centre code: [I] 9-10 day month year Date of Cl>DlD letion of record torm [D []] 1CTJ 11-16 N ame of interviewer: N ame of patient: Present home address: Tel. no. Date of birth: rnrn rrn 1~17-23 Type of follow-up 1 = regular, 3 weeks 2 = regular, 3 months 3" regular, 1 year 4 • at recutrence Optional 6 = regulai; I. Syears 7 = regular, 2 years 5 = recutrence, 3 weeks To be recorded at 3 weeks follow-up only ICD code Diagnosis by Registry ( causing entry into Register} I I I 1 I I 2s-29 Were any of the following examinations performed? 1 s: no, 2 "' yes, 9 • unlmown Examination by physician Examination by neurologist Lumbar pwicture A ngiography Electroencephalogram Brain scan Echo-encephalography Electrocardiogram Blood pressure at Systolic this interview: mm Hg Diastolic I n•A '""'"' I!!' ~ft:. Dao Oa1 Oa2 Oaa 034 Oas 036 037 I I I I I l 138-40 141-43 Page 1 for Reg. No. Transfer of the Patient since previous interview Institution code: 1 • hospital1 2 • nursing home 3 = home, 4 • other, 9 • unknown. Where was the patient at time of previous interview? Transferred to:(if not transferred, write •no transfer• and leave boxes blank) 1) ___________________ Code _ _ _ _ _ _ _ _ date IT] 1 mof th 119[1] 46-51 2) ________ _ Code _________ date []] [JJ19[JJ 53-58 3) _____________________ Code D5!J ---------- date [I] [I]l9[D 60-65 4) ---- _________________ Code date Personal Conditions at Time of Interview Current living conditions: 1 • in private household, alone 2 • in private household,not alone 3 = in hospital or nursing home 9,. unknown Current working conditions : If in gainful work before the stroke, 1 .. working as much as before 2 = working less than before 3 = not working 9= 1mknown If not m gainful work before the stroke, 4 = domestic activities as before 5 ,. domestic activities less than before 6 = no domestic activities 9 • unknown If help is needed in personal care, help is given by: 1 = family 2 = others (unpaid) 3 • paid domestic help 4 = staff in hospital or nursing home 5 = no help available 6 = no help needed 9 = unknown Card No. ~80 (T o continue to page 2) CVD/S/13.6 page 29 WHO STROKE REGISTER - Follow-up Record Form Study j P! 1! 2 ! Page 2 for Reg. No: Medical History Since Previous Regular Interview Recuaent stroke(s) (more than 3 weeks after onset): 1 • no. 2 • yes, 9 = unknown (3 = optional coae) Acute myocardial infarction: 1 • no. 2 • yes. 9 • unknown (3 = optional cocle) 026 If •yes•. AM I Registration No: (leave blank if not applicable) I I I I I I 27-31 Antihypertensive treatment: 1 ,. no. 2 • yes. 9 • unknown (3 = optional code) Hypertension Registration No: (leave blank if not applicable) 032 I I I I I I a3-37 Rehabilitation given by qualified person: 1 • no. 2 • yea. 9 • unknown (3 = optional code) Clinical State (at time of interview) Level of consciousness: 1 • fully conscious 2 .. consciousnea disturbed 9,. unknown Motor deficit of limbs: 1 • no deficit 2 • weaknea/paralysl.s 3 • not aaeaable Speech disturbances: l • no 2 • yes 3 • not assessable Bed or pressure sores: l • no 2 • yes 9 • unknown Joint contracture: 1 .. no 2 • yes 9 • unknown WHO/CVD 5165 page 2 R L 040-41 042-43 Activity of Daily Uving Bed·fast/chalr·fast and must be carried? l • no 2 • yes 9• unknown Control of bladder: 1 • not disturbed 2 • disturbed 9 • unknown Self care: 1 • independant 2 • partially dependant 3 • totally dependant 9= unknown Walking: 1 • without help of other person 2 • with help of other penon 3 • not at all 9 = unknown Dso Card No. 0 80 CVD/S/73.6 page 30 WHO STROKE REGISTER - Death Record Form Study ! P! 1 !3 ! Initial registration number. I I I I I I [I] Centre code: day month year Date of death: [I] [IJ19[IJ Name of data collector: Name of patient: ____________________ _ Home address: Tel.no. ------------------- ------ D ate of birth: ITJ[jj1[L[J 4-8 9-10 11-16 17-23 Code for data processing ~ 24 Place of death: l=home, 2-hospital. 3=nuning home, o 25 4-other, 9'=unknown (boxes 26-36 are reserved for local option) Autopsy performed?1 l"'llo, 2-yes. in hospital 3=yes, medico-legal a-unknown 037 WHO/CVD 5166 - 12/72 Cause of death: ICD code ______________ __! I 111 -----------------' I 111 _________________ I I I 1 I 138-42 143-47 148-52 __________________ ! I I 1 I ____________________ .11111 ! 53-57 158-62 163-67 ___________ -------' I I l I If death occurred within 3 weeks of stroke, were any of the following examinations performed? lsno, 2'"}'es1 9"11.lnknown Examination by physician Examination by neurologist Lumbar puncture Angiography Electroencephalogram Brain scan Echo-encephalogram Elecaocardiogram Brain autopsy performed? 1 = no, 2 = yes, 9 = unknown 068 069 010 0 71 012 073 074 075 076 cvo1sns.6 page 31 WHO STROKE REGISTER • Recurrence Record Form Study I P I 1 I • I ldem1flcatloo Clllllcal lt&te at dine of maximum lmpaftment within 24 hours Centre code: Date of completion of I I I I ·I I DJ 1-10 ma [I]month IT] record form 19 11 ·16 Name of interviewer: ----------------------------------------- Name of patlent1 ____________________________________________ _ Praent home adclrem -----------------·--------------------------· tel·. no. -------.------------ Date of bllth1 Code far data procemng Level of COIIICioumem 1 • fully COIIIC1oua 2 • lffel of CODICf.olunell reduced 9 • unknown Moret deficit of llmbl: 1 • DO deficit 2 • wealcnem/paralym 3•not .... ble Speech d&turbancer. Early eses of pneent recurrence 025 R L Anno 026-27 Leg D 028-29 Oso day moncb. Dace of omec or detecdoD.: [I] [I]s1-M Adm1eCoa to botptUb 1 • no 2• yes 3 • taolce occmred In holp1tal 9 • unknown Dace of adm1.aoa to bolpltal: ICD code day month [I] [I]ss-sa CVD/S/73.6 page 32 WHO STROKE REGISTER • Ezcluaion Record Form (To be used when the exclulion occurred later than 3 weeks after onset of attack) ldendflcadoo. Dtaposll lnidal registration numbers Cemre code: Date of first follow-up Name ·)f interviewer: Study IP I R I 2 I I I I I I I [D rn rn l9rn --------------------------------------- N a:ne of patient:---------------------------------------------------- Prelentbonie address: •••••••••••••••••••••••••••••••••••••••••••••••• TeL no. Data proceal.ng code 4-8 9·10 11-16 Date of completion of the forms day moada year DJ [D u[D &5·'10 ICD code I I I I I I 71-75 Data proceal.ng code ~ 80 IIRO/C'ID 5195 12/72·500 .... .... ~ Q > u ' 0 :r ~ WHO STROKE REGISTER Transfer Sheet Initial Record Fonn: 1-3 4-8 9-10 P 1 1 Date of birth Registration number Centre Date of completion code 25 26 27-31 Diagnosis Follow-up Record Fonn: ICD Examinations Syst. BP Date 52 53-58 59 60-65 4 Inst Date nst Date ansfer 2 ansfer 3 [ - _!-_3 __ _1__ T __ i_:,8 __ -- _ I _9_-JQ 1 ______ lJ:lJ_,.. __ , ___ L, -,--T-11:a:J_ -.- _T _ J_uJ I I I I I I t I 1 t I I I I I I I t p I l I 2 I I I I I I I I I I I I I I I I I I I I I I - ·--· _J __ • __ • __ 1 __ • __ • __ • - ·-- • - • __ , - ·--· --·--·--· -· - ·--· - ·- ·--' C V D /S/?3. 6 page 33 80 0 O.rd No. 25 26 27-31 32 33-37 38 39 40-41 42-43 44 5 46 47 48 49 50 80 AMI Reg. No. H ypt Reg. No. a,nRLRL Ann Leg Death Record Fonn: 1 3 _____ 4-8 ____ L9-10 11-16 ______ n-i3 __ "T ___ fi I I I I I I I I I t I I I I I I I I I I I I I 6 R~~~~;n \;~;..,i ~;·~_._D_a..._t_e_o..._f_d_ea._th_.._ .... __ !. - .1.D~; ~/birt°ii - -•- - --, code 25 26 27-31 32-36 37 38-42 43-47 48-52 ICD ICD Aty IC D, clinical ICD, clinical ICD, clinical 53-57 58-62 63-67 76 ICD, autopsy ICD, autopsy ICD, autopsy Examinations ra· CVD/S/73.6 page 34 WHO STROKE REGISTER - Transfer Sheet Recurrence Record Form 1·3 4-8 9-10 P 1 4 Initial Centre Reg1strat1on number code 25 26-27 28·29 30 31-34 35 11-16 Date of completion of the form 36-39 Con R L Arm R L Spc Date of onset Hsp Date of hosp. Leg or detect I on Follow-up Record Form: 17-23 Date of birth 40-44 Prehm.D1agnos1" 24 4 od 25-29 30-37 38-40 41-43 ~4 45 46-51 ICD Examinations Syst. BP Diasl. BP Pre Inst Date 52 53-58 59 60-65 Ins Date Inst Date Transfer 2 Transfer 3 66 67-72 Date Transfer 4 Inst Transfer 1 73 74 75 Liv Wk Co Con p: 1 : 2: : : : : : : : ! : : : : : : : : ; ; I : : [ ... T!:~ .. -- · T ·-·r · · "T ~~~ .. --- .. · · · J. -~-,.1~.i ·· -..-· .. /!;!~-r-· ·r··· .i.· ·r ·· -,---~~=~~ · -· r · ··• · ... J}.~J I I ' , I I I I I I I 1 1 I I I • I I 1 1 I I I - --L-- .1..- . .L ....... - .t.. - -..L.- •• L ... • ..L, ·--&. .. -. 4 •.• ..I. •• • .1.. - ••'- ••• .&. .... .1. ·- • .a .... J. •• • L ..... J..- . .1. ••• 1. .... .1. .... J. ..... .I. 25 26 27-31 32 33-37 Re M AMI Reg. No. Hy Hypt Reg. No. trk I trt Exclusion Record Form 1·3 4-8 9-10 p ·R 2 Registration number Centre Date of 65-70 Date of completion nf thf' tnrm code 71-75 Di agnos I s by R,..oi'-ttrv 38 39 40-41 42-43 44 45 46 47 48 49 Reh Con R L R L Spc Bed Jnt Bed Bib Self Arm Leg so con fast are 11-16 24 1 I st follow-up od 80 2 cod 50 Wik 80 0 Card No. 80 GJ Card No. cvo/s/73.6 page 35 ANNEX II INSTRUCTIONS FOR COMPLETING WHO'STROKE RmISTER F0Jlt1S In order to obtain comparable data, these instructions should be strictly followed at each cooperating centre. Whenever a problem arises concerning the te:nninology, the inter- pretation of patient's answer and the way of completing record forms. this must be taken up with the programme director at the centre, or where necessary with WHO. The interviewer questions the patient directly. If the patient is seriously 111 or mentally deteriorated, or dead, a family member or neighbour who is living in close contact with the patient is questioned. Identification and Registration 4-8 Registration number: 9-10 Centre code: 11-16 Date of completion of record fonn: Name of interviewer: Name of patient: Present home address and telephone number: INITIAL RECORD FORM A serial case number is given by each registry, starting from 00001. In order to avoid double registration of recurrent cases who are already in the register, the name of the patient, sex and date of birth (or personal identification number where available) should be checked before giving a new registration number to any patient being notified to the register centre. The recu?Tence record fo:nn is used for recurrences for whom an initial record fonn has been completed by the register center. (This procedure differs from acute myocardial infarction registers.) For a registered patient whose attack proved not to be a stroke, but in whom stroke occurred later, a new registration number should be given. The centre code will be assigned for each centre by WHO. Date when the patient or his family is interviewed by the centre. and subsequently 1•ecord fo:nn is com- pleted. For a patient who is notified at a later date or after death, no direct interview at early stage of stroke is possible. Therefore this date means date of registration and completion of record fonn. I'tem not coded. Item not coded. Item not coded. cvo/s/73.6 page 36 17-2j Date of birth: 24 26 State of patient: .:.7-31 Preliminary diagnosis: Personal Conditions Prior to Stroke j2 Civil status: 35 Living conditions: 54 Working conditions: )5-)6 Occupation (optional): Day and month are entered using two· digit nu~bers. The last three digits of the year are coded. Item has a fixed code 'O'. This box is used to facilitate data processing work. The state "at time of notification" should be: entered. If dead, a death record form should also be filled in, and if death occurred after j deeks from onset of stroke a follow-up record form at 3 weeks should also be filled in retrospectively. If alive, regular follow-ups are planned either prospectively or retrospectively, depending upon the timing of notification after onset of stroke . Clinical diagnosis given by the doctor who first saw the patient. Diagnoses are coded according to the !CD (1965 Revision) which are composed of j to 4 digits. One additional digit is provided fur optional use by the centre, though this last digit is not taken for analysis at WHO. All these conditions denote those at time of attack. The status in an "official" record is accepted. Code 3 refers to a stroke occurring in a person already under longterm care in an institution, but not to short-term hospitalization. "Household" is defined as: a person living alone or a group of persons living together partaking of meals prepared in common and benefitting from common housekeeping. Code 1 refers to any type of gainful work and to the working status of the patient and not to that of the household. Housewife is coded as 2, but if she participates in gainful part time work, which offers substantial income, code l should be entered. Sick leave expected to be temporary should be coded as 1 = working. This is an optional item. Simplified !LO classification (1968 version) expressed with two digits (see pages 49-51) is used. Only the present occupation if working is entered. When the patient is engaged in more than one type of work, the major source of income is taken. A housewife doing her own domestic work only is coded as X4; a housewife doing additional gainful work should be given the code for the gainful work. (See Annex III, pp 49-51). Previous Medical Historx 37 Strokes cvo/s/73.6 page 37 Wherever the patient seems to have a good memory, he is questioned on past events; if this is doubtful, then the family is also questioned. If neither of these is possible, than a consulting doctor is contacted and medical records are sought. Questions to the patient and fami+v should be expressed in narrative fonn but not with medical tenns. Some examples are shown in this manual. Try to explain what the disease in question means, but without influencing the patient's replies. Questions must not be given in a hurry, and the patient (or other respondent) should have time to think quietly. It is preferable to postpone asking these questions until patient's condition is better and stabilized. This part much depends on memory, medical attention and level of medical knowledge of the patient, and also on the attitude of the interviewer, but this will still be useful in the assessment of the make- up of the patients at different times and in different areas. Confirmation by medical record is not obligatory since it is not thought to be an efficient way of validation. However, optional code "3 • yes, confinned by medical documents" is provided for the centres who wish to verify patients' verbal remarks by seeking medical documents for confirmation. This optional code will be taken for analysis if a centre decides to do this for all the registered patients. Code 112 • yes" therefore means "yes, but not confinned", conunon to all centres. For all questions in this section (37-52), except registration numbers, answer codes area l • the patient did not have the disease in question; 2 • the patient had the disease in the past; and 9 • "don't know" or "not sure". An example of questions to be used: l. Have you ever had a "stroke"? Use lay term in local language if available. It 'yes', ask whether patient consulted a doctor. If 'yes', ask what the diagnosis was (see 4). If a doctor was not con- sulted or diagnosis is not known, ask what the symptoms were. If the patient does not seem to understand the tenn, proceed to questions a - d below in 2, cvo/s/73.6 page 38 Acute Myocardial Infarction: 2. Symptoms suggestive of stroke are the following: a. Sudden unexplained weakness or loss of strength in ann, leg, or both? b. Sudden unexplained numbness, clumsiness, loss or reduction of sense of touch, warm or cold in the face, ann, or leg? c. Sudden difficulty in speech: (1) Trouble in finding the right words used daily for no attributable reason or difficulty in under- standing such words written or spoken? (11) Speech becoming thick due to difficulty in moving tongue, lips or throat? d. Trouble with sight? (1) Sudden blindness in one or both eyes? (11) Sudden half-blindness in one or both eyes? (111) Things seen double when there was only one object? j. When the answer is positive, ask how long the symptoms lasted. If any symptom lasted for more than 24 hours, without other diagnosis than that described below, it is accepted as stroke. 4. Any diagnosis by a doctor in ICD code for acute cerebrovascular diseases, even when patient cannot explain the symptoms. These are: 430 - subarachnoid haemorrhage; 431 - cerebral haemor- rhage; 4)2 - occlusion of precerebral arteries; 4)3 - cerebral thrombosis; 434 - cerebral embolism; and 436 - acute but ill-defined cerebrovascular disease. 455, 437 and 458 should not be considered as stroke. This refers to the presence of history of typical pain. Typical history: when it was characterized by retrosternal pain with the following charac- teristics: 1. diffusion through the chest, anteriorly or generally which may remain localized in the chest or radiate to the shoulder, anns, Jaws or abdomen on one or both sides; 2. resistance to nitroglycerine; 3. duration of more than 20 minutes; 4. usually severe and at times of agonizing intensity. 39-43 AMI Register numbers 44 Any other heart diseases: 45 Arterial hypertension: 46-50 Hypertension register number: 51 Treatment for high blood pressure: 52 Diabetes mellitus: cvn/s/73.6 page 39 This category corresponds to either "Definite" or "Possible" acute myocardial infarction in the Acute Myocardial Infarction (AMI) Register. A centre wishing to distinguish "Definite AMI" in the AMI Register from "Possible AMI" can use the optional code 11 3 • yes, confirmed" instead of the code 2. If an AMI register exists in the same community referral to the AMI register centre should be made. Questions such as "Have you ever had heart disease?" could be used and narrative descriptions of symptoms or diagnoses obtained from the patient by an interviewer are used as information for a physician in the registry, who Judges whether or not it was heart disease. Clinical diagnosis is optional. Minor ECG abnormalities detected by screening are not generally considered as a disease. Example of question: "Have you ever been told that your blood pressure is elevated?" Put the answer, irrespective of the actual blood pressure level of the patient. If a hypertension register exists in the same community referral to the hypertension register centre should be made. If "yes" to the question 45, ask whether the patient has been following the instruction of the doctor i11111ediately prior to the study. "Treatment" here is used in its widest sense meaning all indications given, i.e. general advice for diet, rest, regular use of drugs, etc. If the physician's instruction has been followed only temporarily or partially, enter 1 • no. No specific criteria are used. Example of questions "Have you ever been told that you have diabetes mellitus?". Pre-clinical diabetes is excluded. CVD/S/73.6 page 40 Patient's Capability of Self Care before Stroke 53 Self-care: 54 Control of bladder: Early Stages of Present Attack 55-58 Date of onset or detection: 59 Admission to hospital: 60-63 Date of admission: "Independent" means complete independence in daily self-care such as feeding. dressing. washing and toilet, irrespective of speed and skill of per- formance or need of supportive devices. "Partially dependent" means that the patient required aid of another person in some of the daily self-care. "Totally dependent" means that the patient required aid of another person with all the above activities. "Disturbed" means urinary incontinence or when urinary catheterization has been applied. The onset means the initial feeling of abnormality, which is then followed by major symptoms of stroke. The onset of disease is usually sudden and clear- cut. If. however, the onset occurred during sleep and the abnormality was found in the morning. the date of detection instead of onset of the abnorma- lity is entered. Admission to a hospital, because of the present stroke, is asked. If a stroke happened during hospitalization for any reason. code 3 is entered. The date can be before the onset of stroke. if a stroke occurred in hospital (code j to the preced- ing question). If not hospitalized. leave blank. Clinical State at Time of Maximum Impairment (within the First 24 Hours) Levels of consciousness: Information pertaining to the maximum imoa.irment within the first 24 hours from the onset of attack is entered. Although delayed aggravation will often happen in cerebral infarction. impairment after the first 24 hours should not be entered. Information on later deterioration is sacrificed in order to maintain comparability between centres. Information is obtained both from medical records and from direct interview. Four grades of consciousness are distinguished: 1. fully conscious - normal response; 2. somnolent - not fully awake, but can respond to verbal stimuli; j. semi-coma - response to powerful stimuli. such as pain, but not to verbal ones; 65-68 Motor deficit of limbs: 69 Speech disturbance: 70-75 Blood pressures CVD/S/73.6 page 41 4. co"'8, - no response even with the most powerful stimulus. If disturbance of consciousness was noticed without testing the grade by either verbal or stronger stimuli at the time of maximum impairment and if the patient was already recovered at the time of int_er- view, retrospective determination of the level of consciousness is usually impossible. In such circumstances, code the milder level out of possible ones. In patients who had coma, or in some of the patients with decreased level of consciousness, motor deficit (boxes 65-68) and speech disturbances (box 69} can be coded as 3 • not assessable. Any weakness noted by an interviewer or a doctor is ticked according to site and side of body. No distinction is ma.de whether it has existed since before the attack and was aggravated after the attack. Differentiation between paralysis and paresis is not made. Ocular and facial paralysis is not coded here. If a limb was amputated, put code 'O'. If no record is obtainable in retro- spective search, code 9 is entered. No distinction is attempted between dysarthria and dysphasia. Either one should be recorded as positive. Blood pressure level at "first measurement after onset" is taken from available medical records. The interviewer needs to contact the doctor(s} who saw the patient. If it was not recorded, then the blood pressure level measured by the interviewer is entered. Blood pressure measurement for this initial record form is taken on the right arm in the supine position, as is the usual practice in early stages of stroke, so far as it is possible. Diastolic pressure is determined at phase 5 (disappearance of Korotkoff sounds} but phase 4 (muffling of sounds} is taken as the diastolic pressure value if ~orotkoff sounds persist until O or thereabouts. CVD/S/73.6 page 42 FOLLOtl-UP RECORD FOR-1 This fonn is used for regular follow-ups, as well as at three weeks after recurrence, either prospectively, or retrospectively in delayed notification. Card 1 Identification 4-8 Initial registration number: 11-16 Date of completion of record form: l'(-2) Date of birth: 24 Type of follow-up: To be recorded at 3 weeks follow-up only 25-4) This section is completed in the same manner as.for the Initial Record Fonn. The identical registration number as used in the Initial Record Fonn is used throughout all follow- ups and recurrences. The actual date when a follow-up interview (or retrospective review of medical record) is carried out and subsequently record form is completed, not the expected or planned date. This is used for identification of the patient. Enter the corresponding type of present follow-up for which the form is being used. For those centres who continue follow-up at one-and-a-half years and at two years, optional codes 6 and 7 are provided. This section is completed at 3 weeks after initial stroke and 3 weeks after recurrence (code 1 or 5 in box 24). The clinical diagnosis is usually determined at this time, based on clinical and various laboratory examinations. ICD Code is entered by the registry centre. In autopsied cases the clinical diagnosis may not be confirmed by autopsy. Nevertheless, the original clinical diagnosis should be recorded here, irrespective of autopsy findings. Various di~gnostic procedures enumerated here do not imply any general recommendations. The purpose of this section is (1) to ascertain how many of these diagnostic measures reach the stroke patients at the community level in different areas; (2) to give a rough measure of the diagnostic procedures carried out in the registry centre, and of the reliability of the diagnosis entered in boxes 25-29; and (3) to serve for planning detailed studies where need arises. 38-43 Blood pressures Transfer of Patient 44-72 44 Where was the patient at time of previous interview 45-72 Patient was transferred to: Personal Conditions at Time of Follow-up 73 Current living conditionst cvo/s/73.6 page 43 Casual blood pressure is measured in the same way as described in the Initial Record Fonn (boxes 70- 75, Pl.l) but in a sitting position. This data is referable to the WHO hypertension control programme. Por detailed instructions refer to WHO Technical Report Series No. 231. Enter the names of the institutions so that any miscoding can be detected and reclassification be arranged if the need arises. Hospitals establishment pennanently staffed by at least one physician, which can offer in-patient accommodation and provides medical and nursing care. Nursing homes establishment providing accommodation principally for nursing, but not for medical care. Enter the code of the institution (or home) which was mentioned last in the previous record, so that the sites of the patient's care can be traced continuously. Space for noting four transfe?Sis provided, each with the date of transfer. Transfer within an institution (between different departments or wards of different discipline) should not be listed separately. All transfers between different institutions (irrespective of whether the type of institutions fall into the same category) or between institutions and home, should be listed. The last one mentioned should be the accorrmodation at time of interview. When the patient cannot be found for follow-up, code 9 • Unknown is entered. Conditions of scheduled time of follow-up (three weeks, three months, one year ••• ) are entered, but not the conditions at time when interview or review of medical record takes place. This dis- tinction is necessary, particularly in the case of delayed and retrospective notification. Codes are self-explanatory. For definition of household, see box 33 of the Initial Record Fonn, Pl.l. CVD/s/73.6 page 44 '(4 Current working conditions: 75 Self-care: If the patient had any gainful work prior to the stroke which was registered in the Initial Record Form (boxes 34-)6, Pl.l): whether the patient is working as much as before (code 1) either in the previous Job or in a new one; working less than before (code 2) i.e. either working less in the previous Job or change of Job to a lighter one; or not working at all (code 3). If the patient had no gainful work, such as the case of a retired person or a housewife: whether the patient carries out domestic activities (cleaning, preparation of meals) to the same degree (including none at all) as before the stroke (code 4), to a limited degree (code 5), or not at all (code 6). It should be noted that in a patient who did not carry out dom- estic activities both before and after the stroke, code 4 is used. With a hospitalized patient either code 3 or code 6 is used, depending upon whether or not he had gainful work, If the patient is totally or partially dependent in self-care (feeding, dressing, washing and toilet), who is giving help? Irrespective of the location of the patient, either hospital or at home, the person who is giving the most substantial help for the daily life of the pa~ient is entered. Code 11 1 = family": the family member who was residing with patient at time of attack, and helps the patient. The relative who is mobilized after patient's attack, in order to provide supportive care, should belong to code 2. Code 11 2 = unpaid": payment for the help is not obligatory, such as aid given by relatives, friends, or by other social services, free of charge. Code 11 ) = paid help": help given by any person who is receiving payment, regardless of~ is paying for the services (the patient, private insurance system, social security, etc). Code "4 = institution": permanent nursing staff home. If supplementary the major one is coded. self-care is done by of the hospital or nursing help from outside is used, Code "5 = no help available": the presumably rare case where no help is available. Code "6 = no help needed": if patient is fully independent in self-care and the question is not applicable, For all boxes 47-50 of card 2, code 1 is entered.) Card 2 CVD/s/73.6 page 45 Medical Historx Since Previous Regular Interview 25 Recurrent stroke(s)t 26-31 Acute myocardial infarctions) ) 32 Antihypertensive treatments) 38 Rehabilitation: Clinical State 39 40-43 44 45 Level of consciousness, Motor deficit of limbs:) ) Speech disturbances, ) Bed or pressure sores: ) Joint contracturet ) Activities of Daiiy Living 47 Bed-ridden/chair-ridden: 48 Control of bladders) ) 49 Self-caret ) Optional code "3 • yes, confinned" can be used for boxes 25, 26, 32 and 38 as in the Initial Record Fonn. Recurrence within 3 weeks of the onset is regarded as a continuation of the first attack, and is not coded. This item is therefore not applicable at the first (3 weeks) follow-up, and use code 11 1 ... no" at the first follow-up. When any recurrence of stroke is noted, check date, available medical records, and whether additional recording in the registry is required. Definition as in the Initial Record Form (boxes 38 and 51 of Pl.l). "Qualified person" means any medical or paramedical person who had special training in rehabilitation. If rehabilitation has been carried out regularly under the guidance of a qualified person. this is accepted as 'yes'. Only 2 grades are distinguished at the time of follow-up. Same as in Initial Record Fonn (boxes 65-69 of Pl.l). If any type of these, irrespective of the cause, exists at the time of follow-up, it should be recorded. "Frozen shoulder" is not a contracture. No dis- tinction between major contractures such as hips and knees, and minor ones such as fingers or wrists is attempted. Where the patient cannot leave bed or chair by his own means, irrespective of reason, and must be carried. Same as in Initial Record Fonn (boxes 53 and 54, Pl.1). CVD/S/73.6 page 46 50 Walking: 4-8 Initial registration numbert 9-10 Centre Code: 25 Place of death: 56-67 Cause(s) of death: Whether patient actually walks indoors or outside, without (code 1) or with some (code 2) help from another person, regardless of use of supportive devices. Do not ask patient's opinion as to whether he can or cannot walk. DEA'lll RECORD FORM Same as in Initial Record Fonn. Same as in Initial Record Fonn. Definition - same as described in Follow-up Record Fonn in section on "Transfer of Patient" (boxes 44-72, Card 1, of Pl.2). Clinical diagnosis is used for general comparison between centres, and also for assessment of accuracy of clinical diagnosis. Therefore, not a diagnosis written on the death certificate, but the best clinical diagnosis using all available infonnation from medical documents and family's observation, and which guided treatment of the patient prior to death, without knowing the results of the post- mortem examination should be recorded in the section(s) marked "clinical". The condition directly leading to death is recorded first. This condition may be a complication or consequence of pre-existing or underlying conditions, or may itself represent the underlying cause of death. If the latter is the cause, then no other cause need be entered. But if the i11111ediate condition causing death is a complication or a consequence of an underlying condition, this underlying con- dition should be recorded next. If this in turn arose from a further underlying condition, then this latter should in turn be recorded next; thus the underlying cause of death or the condition initiating the fatal sequence is recorded last. When the results of post-mortem examinations are available, the section on cause(s) of death (autopsy) should be completed. The finding which is most significant as a cause of death according to a pathologist's opinion is entered first. Pathological lesion in the brain should be recorded whenever available. Associated causes of death need not be recorded. 68-75 Examinations perfonned before death: 76 Brain autopsy perfonned: CVD/S/73.6 page 47 This section is used only for patients who died within 3 weeks of the initial stroke or recurrence, and whose follow-up record fonn is not completed. This is the same as in the Follow-up Record Fonn (boxes 30-37 of Card 1, Pl.2) and is provided to obtain infonnation on diagnostic examinat!~ns used. For deaths occurring later than 3 weeks after initial stroke or recurrence, this section is left blank. Enter whether or not the brain is taken out and examined. Disregard methods of examination. RECURRENCE RECORD FORtt This form is used for recurrences after three weeks from onset of the initial attack or of the previous recurrent attack. 4-8 Initial registration number: 9-10 Centre Code1 11-16 Date of completion of record form: 17-23 Date of birth: 25-30 Clinical state at time of maximum impainnent within 24 hours1 31-44 Date of onset or detection: Same as Initial Record Fann. Same as in Initial Record Form. Same as in Initial Recor1. Fonn. This is used for identification of the patient. Same as in Initial Record Fonn (boxes 64-69), except that the level of consciousness is graded into two categories only. Interval between this date and the date of either the initial attack or the previous recurrent attack must not be shorter than three weeks. Recurrence which happened within three weeks are regarded as continuation of the previous attack and are not recorded. EXCLUSION RECORD FORtt This fonn is used for a registered patient suspected of having had a stroke but for whom another diagnosis is given at a date later than three weeks after the onset of the attack. If another diagnosis is ma.de within three weeks, the first Follow-up Record Fonn is used. If another diagnosis is given by autopsy, the Death Record Fann is used. If another delayed diagnosis is given while the patient is alive, the final clinical diagnosis is entered in this Exclusion Record Fann, and follow-up is tenninated. CVD/s/75.6 page 48 11-16 Date of first follow-up: 65-70 Date of completion of the form: 71-75 Diagnosis by registry: This item is included in order to facilitate the computer programming. This is the date when the form is actually entered but not the date when diagnosis of stroke was changed to another. The new diagnosis which meets with the exclusion criteria is entered, using ICD code. • OCCUPATION CODE cvo/s/13.6 page 49 ANNEX III (Adapted from the International Standard. Classification of Occupations, ILO, 1968) Professional, technical and related workers 01 Physical scientists and related technicians 02 Architects, engineers and related technicians 04 Aircraft and ships' officers 05 Life scientists and related technicians 06 Medical, dental, veterinary and related workers 08 Statisticians, mathematicians, systems analysts and related technicains 09 Economists 11 Accountants 12 Jurists 13 Teachers 14 Workers in religion 15 Authors, Journalists and related writers 16 Sculptors, painters, photographers and related creative artists 17 Composers and perfonning artists 18 Athletes,. sportsmen and related workers 19 Professional, technical and related workers not elsewhere classified Administrative and managerial workers 20 Legislative officials and government administrators 21 Managers Clerical and related workers 30 Clerical supervisors 31 Government executive officials 32 Stenographers, typists and card and tape-punching machine operators 33 Book-keepers, cashiers and related workers 34 Computing machine operators 35 Transport and conununications supervisors 36 Transport conductors 37 Mail distribution clerks 38 Telephone and telegraph operators 39 Clerical and related workers not elsewhere classified Sales workers 40 Managers (wholesale and retail trade) 41 Working proprietors (wholesale and retail trade) 42 Sales supervisors and buyers 4) Technical salesmen, commercial travellers and manufacturers' agents 44 Insurance, real estate, securities and business services salesmen and auctioneers 45 Salesmen, shop assistants and related workers 49 Sales workers not elsewhere classified CVD/S/73.6 page 50 50 51 52 55 54 55 56 57 58 59 Service workers Managers (catering and lodging services) Working proprietors (catering and lodging services) Housekeeping and related service supervisors Cooks, waiters, bartenders and related workers Maids and related housekeeping service workers not elsewhere classified Building caretakers, charworkers, cleaners and related workers Launderers, dry-cleaners and pressers Hairdressers, barbers, beauticians and related workers Protective service workers Service workers not elsewhere classified Agricultural, animal husbandry and forestry workers, fishermen and hunters 60 Farm managers and supervisors 61 Farmers 62 Agricultural and animal husbandry workers 63 Forestry workers 64 Fishermen, hunters and related workers 70 71 72 7) '(4 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 Production and related workers, transport equipment operators and labourers Production supervisors and general foremen Miners, quarrymen, well drillers and related workers Metal processers Wood preparation workers and paper makers Chemical processers and related workers Spinners, weavers, knitters, dyers and related workers Tanners, fellmongers and pelt dressers Food and beverage processers Tobacco preparers and tobacco product makers Tailors, dressmakers, sewers, upholsterers and related workers Shoemakers and leather goods makers Cabinetmakers and related woodworkers Stone cutters and carvers Blacksmiths, toolmakers and machine tool operators Machinery fitters, machine assemblers and precision instrument makers (except electical) Electrical fitters and related electrical and electronics workers Broadcasting station and sound equipment operators and cinema projectionists Plumbers, welders, sheet metal and structural metal preparers and erectors Jewellery and precious metal workers Glass formers, potters and related workers Rubber and plastics product makers Paper and paperboard products makers Printers and related workers 93 Painters 94 Production and related workers not elsewhere classified 9'5 Bricklayers, carpenters and other construction workers 96 Stationary engine and related equipment operators 9'( Material handling and related equipment operators, dockers and freight ha.ndlers 98 Transport equipment operators 99 Labourers not elsehwere classified • ... • ) Xl X2 X3 X4 X9 Workers not classifiable bY occupation New workers seeking employment CVD/S/TJ.6 page 51 Workers reporting occupations unidentifiable or inadequately described Wor.kers not reporting any occupation Persons without gainful work Persons unkb.own if gainfully employed If any investigator uses more than two digits of the ISC in the ori'g1rtal" :rtecord;- ·the- · ·. - ·· first t~o digits should be entered in the WHO record fonns. Slight discrepancies may then · arise f'rdm the code listed above. For example the three digit code fo.r, a nurse is 071 and hence if this code is abridged, code <rr will be entered in the WHO fonn and not 06 as listed above. - These'" minor differences are acceptable in central processing. CVD/S/73.6 page 52 ANNEX IV Country Denmark Finland Ireland Israel Japan Mongolia COLLABORATING CENTRES IN THE WHO STROKE REGISTER Study Area Copenhagen (Frederiksberg) Espoo and Kauniainen North Karella Character of Study Area and Population* Mainly residential & commercial, and light industry Developing neighbour town to Helsinki. Commerce, services & industry Mainly agricultural, much emigration continued Size of Population Total Po 1 ti Other Related pu a on Studies** xl,000 over 65 102.0 103.5 182.5 % 21.0 5.1 8.6 Comprehensive CVD prevention including HT control & AMI register Dublin Mainly residential 142.3 6.9 AMI register (southern part) Ramle and Rehovot Akita Fukuoka Japanese Nat. Railways Osaka Saku Urban & rural. 50% Afro-Asian and 50% 218.0 Euro-American origin Rural agriculture and commerce Urban part of Fukuoka City + 3 towns, age up to 65 Male employees of a company in Tokyo region, age up to 59 Semi-urban. Commuter area to Osaka. Ser- vices, agriculture and commerce 36.1 40.4 Rural. Mainly agri- culture+ commerce & 108.5 light industry Ulan Bator ',~ Urban 261.3 6.8 0 4.7 8.5 4.4 HT control HT control HT control HT control HT control in a limited area HT control * Unless s~ecially mentioned - all ages and both sexes ** HT = hypertension; AMI= acute myocardial infarction --~ Principal Investigator J.Marquardsen K. Aho P. Puska K. Salmi A. Radie L. Geltner s. Kojima T. Omae Y. Fukuda Y. Komachi K. Isomura N. Dondog ' CVD/s/73.6 page 53 Size of Population Character of Study Total Po ulation Other Related Principal Country Study Area Area and Population* P 65 Studies** Investigator xl,000 over ' ~ Nigeria Epe (and Mostly agriculture 0.0.Akinkugbe > Ibadan) + traders, fishery, 14.o HT control B.O.Osuntokun factory workers Sweden Ooteborg Urgan, age up to 65 450.1 9.6 Multifactorial prevention. P. Harmsen AMI Register USSR Moscow Urban 221.0 HT control in V.E.Smirnov (Tushino) selected age group Yugoslavia Zagreb Urban 85.5 13.2 ProspectiTe z. Poljakovic (part) epidemiological study '