The Committee of Ministers, under the terms of Article 15.b of the Statute of the Council of Europe,

Considering that the aim of the Council of Europe is to achieve greater unity between its members and this aim can be furthered by the adoption of common measures in the health field;

Aware of the importance of identifying causes and risk factors in epidemiology more accurately with the aim of understanding patterns of disease, and of the need for preventive measures, health care planning and research on available epidemiological data in the interest of improved health care as well as better use of resources;

Noting that epidemiological data should be collected with clearly defined objectives while ensuring the close involvement of the personnel who participate in the process of collection as well as of the individuals and groups who form the object of the data collection;

Convinced of the importance of improving classification systems for diagnoses and recourse to care in the field of primary health care as well as the harmonisation of medical records;

Mindful of the improvements required in the training of health care personnel in this field and of the importance of such training in maintaining the quality of data;

Calling to mind the need to feed information back to the level where data are collected;

Recognising the need to apply strict rules of confidentiality to the collection, storage and processing of personal data;

Mindful of the variations between countries in the types of epidemiological data collected;

Bearing in mind in this regard the principles laid down in Recommendation No. R (83) 10 on the Protection of Personal Data used for Scientific Research and Statistics,

Recalling however that the collection of epidemiological data should be planned so as to make it compatible whenever possible with internationally agreed indicators,

Believing in the importance of continuing European collaboration and information exchange as an essential tool in the development of appropriate systems of data collection,

Recommends that the governments of member States promote by all means at their disposal the application of the strategy described in the appendix to this Recommendation, drawing the principles embodied in it to the attention of all the relevant authorities, services and institutions within their respective territories.

APPENDIX TO RECOMMENDATION NO. R (89) 4

COLLECTION OF EPIDEMIOLOGICAL DATA IN PRIMARY HEALTH CARE

INTRODUCTION - Legal and Ethical Issues

i. Attention should be paid to the legal and ethical issues raised by the collection of personal data for the purposes referred to in Chapter 1 as well as by their subsequent storage and processing. For this purpose the collection of personal data, as well as their subsequent storage and processing, should be carried out in conformity with the principles contained in the Committee of Ministers' Recommendations No. R (81) 1 on Regulations for Automated Medical Data Banks and No. R (83) 10 on the Protection of Personal Data used for Scientific Research and Statistics, as well as the European Science Foundation statement concerning the Protection of Privacy and the use of Personal Data for Research.

ii. Data subjects should be guaranteed the right to information about the nature and objectives of the data collection, and the methods to be used, as well as their rights in regard to the data stored and processed subsequent to collection. In particular, and subject to the existence of other effective safeguards laid down by domestic law, the express and informed consent of the data subjects should be sought before data can be collected and used for any of the purposes stated in Chapter 1.

iii. Personal data relating to health should be collected, stored and processed in conditions of strict confidentiality, by qualified individuals who are well informed about the principles of medical confidentiality and of professional secrecy in general.

iv. Computerised data bases relating to health should be designed so as to ensure maximum security in terms of the accessibility of personal data. Whenever possible only unidentified data should be used. Where personal data are needed, as is sometimes the case for research purposes, it is necessary to develop systems for treating such data in coded form and to ensure that the code is completely confidential.

v. For some purposes data needs to be personalised only at local level, eg in the clinic or health centre, whereas unidentified data can be delivered to a central statistical unit and used in large scale analyses. Optimal use should be made of the possibilities offered by computer technology to differentiate accessibility to personal data and to use codified data.

vi. The principles set out above also apply to transborder flows of personal data collected and stored for the purposes referred to in Chapter I.

I. PURPOSES FOR WHICH DATA ARE COLLECTED

i. The collection of any epidemiological data should have a well- defined purpose, which will normally fall into one of the four following categories:

. patient/client oriented purpose
. planning purpose
. public health purpose
. research purpose

The evaluation of the collection of any epidemiological data is a continuous task. The collection of data, even if for specific purposes has to be adapted to the actual needs in the country.

The evaluation of care and clinical audit is another important purpose which carries elements of all four previously mentioned purposes.

ii. The personnel involved in the collection of data should be fully informed about the main purpose of the collection, the methods employed and the proposed use of the data.

iii. Collection of epidemiological data at community level should be based on local participation by policy making bodies and relevant community interest groups, especially in the planning stage of major epidemiological surveys.

iv. There should be regular feedback of the information generated to the level where the data are collected, to the personnel involved in the data collection, health personnel and the population to which the data relate, subject to the need to protect the confidentiality of the data.

v. An important objective of the collection of epidemiological data at primary health care level should be to serve as a basis for planning which is directly related to the needs of the community.

II. SOURCES OF DATA

i. The epidemiological data collected should include classic morbidity and mortality indicators, in particular the causes of mortality according to sex and age and data on mother and child health and family health in general.

ii. Data collection should also focus on socio-economic conditions, occupational situation, behavioural risk and psychological factors, and appropriate methods of collection should be further developed.

iii. Household surveys and health interview surveys at community level cannot generally be carried out regularly, but should be encouraged on an ad hoc basis. The problems involved in using data from national or regional surveys at community level should be taken into account.

National surveys should be carried out regularly, to allow the monitoring of epidemiological trends.

III. THE COLLECTION OF EPIDEMIOLOGICAL DATA

i. When collecting and processing epidemiological data, attention should be paid to the selection of an appropriate denominator for the measurements of the incidence and prevalence of disease. The denominator should be selected according to the purpose and design of the study. In primary health care, a geographically defined community will often be the most natural denominator.

ii. The community denominator is generally provided by census data in anonymous form. Census data should therefore be easily accessible at community level.

iii. Besides the purpose of providing the epidemiological denominator, census data and vital statistics are important for planning purposes. For this reason they should be regularly broken down and made easily accessible at community level.

iv. In cases where a specific catchment area is difficult to define, the total number of patients registered at a given primary health care centre can, for some purposes, be used as a denominator, but attention should be paid to the possibility that the representativeness of findings will be distorted by patient selection.

v. The personnel involved in the collection of data - doctors, nurses, physiotherapists, technical and administrative staff - should be adequately trained for the task. The training should focus on the purposes of data collection, classification systems and problems related to quality of data. Health staff should not only care for individuals but also play a vital role in the epidemiological support of community health and should be involved in the completion of findings. Education in these matters should be included in medical and other health care curricula.

vi. The quality of the data collected should be maintained by continuing education in methods of use in epidemiology (as well as in new classification systems), by self-evaluation wherever possible, and by activities designed to increase motivation (eg regular feedback of data).

IV. INDICATORS ON HEALTH AND SOCIAL CONDITIONS

i. The collection of epidemiological data should be planned so as to make it compatible with internationally agreed indicators, such as the World Health Organisation indicators for Health for All 2000 and the Organisation for Economic Co-operation and Development list of social indicators.

V. DATA ON PATIENT ENCOUNTERS IN PRIMARY HEALTH CARE

i. Data on the use of primary health care services are important for several of the purposes enumerated above, and more systematic registration of such data is recommended.

ii. Further development in diagnostic classification systems in primary health care should be encouraged. It is important that any such diagnostic classifiation should be compatible with the International Classification of Diseases system.

iii. Further development of reason-for-visit classifications (reasons for which patients use the health services) should be encouraged. Classification of reasons for visit should not be made regularly, but rather on an ad hoc basis, and with regular evaluation of the system used.

iv. The use of a "health booklet", "carnet de santé", for each individual might facilitate the collection of data in primary health care. An extended use of such systems may be tested, and in particular the possibilities for international comparison should be considered.

v. Data from mother and child care services and school health services are important in the epidemiological perspective, as well as in the health care and planning perspectives, and should also be related to data from the primary health care services.

vi. Efforts should be made to harmonise the format and content of medical records in primary health care. While allowing for flexibility to meet the needs of any specific primary health care centre, the importance of high quality of medical records should be recognised.

vii. While the concept of a standardised minimum basic data set has been shown to be useful when collecting data on hospital care, in the field of primary health care, existing systems (eg International Classification of Primary Care) should be further tested and evaluated before being recommended for general use.

VI. THE NEED FOR EUROPEAN CO-OPERATION
i. European co-operation in the collection and analysis of epidemiological data should be encouraged. It is recommended that the processed data be collected and treated so as to facilitate international comparison, for example by using the World Health Organisation's Health for All 200 indicators.

ii. Collaborative activities in Europe in relation to medical records, diagnostic classification, reason for visit classification, and other topics related to recording of primary health care data should be supported. The experience gained from these activities should be widely diffused so as to obtain maximum harmonisation of methods of data collection in primary health care.

iii. Projects relating to international networks of data bases for information sharing in primary health care - literature data banks, electronic communication, "sentinel" networks, etc - should be encouraged in the form of a small scale research and development projects, but with the aim of creating systems appropriate for extended use in a context of European co-operation.