Council of Europe, Committee of Ministers, Recommendation No. R (94) 11

Council of Europe, Committee of Ministers, Recommendation No. R (94) 11 on Screening as a Tool of Preventive Medicine (Oct. 10, 1994).

The Committee of Ministers,

Considering that the aim of the Council of Europe is to achieve a greater unity between its members and that this aim may be pursued, inter alia, by the adoption of common action in the public health field;

Noting that chronic diseases are the major causes of death and a high social and economic burden in developed countries;

Considering that screening for the early detection of some of these diseases, could in principle provide a method for their control;

Considering that, as yet, there is no absolute proof of the value of screening and early treatment in most diseases;

Considering that few, if any, diseases can at the present time be regarded as fulfilling all the desirable criteria for screening, and that the recommended evaluative procedures are not often carried out in full;

Recognising that the implementation of widespread screening programmes raises major ethical, legal, social, medical, organisational and economic problems which require initial and ongoing evaluation;

Taking into account the provisions of the Convention of Human Rights and of the European Social Charter;

Bearing in mind the Convention for the protection of individuals with regard to automatic processing of personal data of 28 January 1981, as well as the provisions of Recommendation No. R (81) 1 on regulations for automated medical banks and Recommendation No. R (83) 10 on the protection of personal data used for purposes of scientific research and statistics,

Recommends to governments of member states that they take account in their national health planning regulations and legislation of the conclusions and recommendations set out in the appendix to this recommendation.

Appendix to Recommendation No. R (94) 11

1. Introduction

1.1. For the purposes of this recommendation, screening means applying a test to a defined group of persons in order to identify an early stage, a preliminary stage, a risk factor or a combination of risk factors of a disease. In any case it is a question of detecting phenomena, which can be identified prior to the outbreak of the disease.

1.2. The object of screening as a service is to identify a certain disease or risk factor for a disease before the affected person spontaneously seeks treatment, in order to cure the disease or prevent or delay its progression or onset by (early) intervention.

1.3. The value of existing forms of screening for infectious diseases is fully acknowledged but these established methods are not considered in detail in this recommendation. Emphasis is made on screening for chronic degenerative non-communicable disorders.

1.4. Screening is only one method of controlling disease. It should be viewed in the whole context of reducing the burden of ill health to the individual and the community by, for example, socio-economic, environmental measures, health education and improvement of existing health care and disease prevention systems.

1.5. Environmental factors are recognized as important contributors to disease, but inherited factors may also play an important role. With the advent of new genetic knowledge, an increasing number of genetic diseases and genetic risk factors for disease will be identified and offer the possibility for new screening procedures. As the procedures for genetic screening are not fully established nor fully evaluated, they have not been included in this recommendation.

1.6. The present position is that the implementation of screening in European countries is fragmentary, with few national screening programmes for the total population but many screening schemes restricted to population groups.

1.7. Because there are differences in health needs and health services, as well as in ethical values and in legal norms and rules between countries, the decision to implement a particular screening programme should be taken in co-operation with the medical profession by each country. Nevertheless there are common general principles and problems which are equally relevant to all systems.

1.8. Screening is a tool which is potentially capable of improving the health of the population but it also has adverse effects. Constant care should be taken to ensure that in any screening programme the advantages prevail over the disadvantages.

1.9. The general benefits of screening are often described. It is, however, also important to be aware of the adverse effects which can be :

- stigmatisation and/or discrimination of (non) participants;

- social pressure to participate in the screening and undergo the intended treatment/intervention;

- psychological distress where there is no cure for the disease or where the treatment and/or intervention is morally unacceptable to the individual concerned;

- exposure to physical and psychological risks with limited health gains;

- creation of expectations which probably cannot be fulfilled;

- individuals who are positively screened might experience difficulties such as access to insurance, employment, etc.;

- severe side effects of invasive clinical diagnosis of false positives;

- delay in diagnosing false negatives;

- unfavourable cost-benefit relationship of a screening programme.

1.10. The various problems which are encountered in the introduction and provision of screening services are interrelated.

Nevertheless a distinction may be made between those concerned with:

i. ethical and legal issues;

ii. selection of diseases (medically) suitable for screening;

iii. economic aspects and evaluation of screening;

iv. quality assurance;

v. organisation of a screening programme;

vi. scientific research.

2. Ethical and legal values

2.1. Effectiveness is a necessary prerequisite for the screening to be ethical. It should nonetheless be kept in mind that screening can be effective and still unethical.

2.2. Advantages and disadvantages of screening for the target population and the individual must be well balanced, taking into account social and economic costs, equity as well as individual rights and freedoms.

2.3. Failure to make known information on the positive and negative aspects of the screening is unethical and infringes the autonomy of the individual.

2.4. The decision to participate in a screening programme should be taken freely. The diagnoses and treatments which may follow the screening should also require a free and separate consent. No pressure should be used to lead somebody to undergo any of these procedures.

2.5. The right to privacy requires that the results of the tests as a general rule are not communicated to those who do not wish to be informed, are collected, stored, and handled confidentially, and adequately protected. It is preferable not to screen individuals who do not wish to be informed of the results of the screening.

2.6. Neonatal screening can only be justified if the intervention is of direct health benefit to the child. Otherwise screening should be postponed until the child can decide for itself.

2.7. No personal data derived from the screening should be communicated to third parties unless the data subject has given consent to it or in accordance with national law.

2.8. When a screening programme is provided as a service and conducted also for research purposes, the decision to make available personal medical data stemming from the screening programme for research purposes should be taken freely, without undue pressure.

The decision not to take part in the research should not in any way prevent the individual from participating in the screening programme.

3. Criteria for selecting diseases suitable for screening

3.1. The disease should be an obvious burden for the individual and/or the community in terms of death, suffering, economic or social costs.

3.2. The natural course of the disease should be well-known and the disease should go through an initial latent stage or be determined by risk factors, which can be detected by appropriate tests. An appropriate test is highly sensitive and specific for the disease as well as being acceptable to the person screened.

3.3. Adequate treatment or other intervention possibilities are indispensable. Adequacy is determined both by proven medical effect and ethical and legal acceptability.

3.4. Screening followed by diagnosis and intervention in an early stage of the disease should provide a better prognosis than intervention after spontaneously sought treatment.

4. Economic aspects

4.1. The increasing financial burden of health care makes it necessary to assess the economic aspects of screening. However these aspects should not be the overriding consideration. In all screening programmes human consideration regarding the value and quality of life, life expectancy as well as respect for individual rights are of prime importance.

4.2. Economic assessments are necessary to enable rational decisions to be made on the priority to be given to alternative ways of using health resources.

4.3. Measurement of the economic aspects of screening is not fully mastered. Early detection and treatment may be less expensive than late treatment. However, available studies relate only to present screening costs and further work is necessary to determine possible cost control in the long term.

4.4. Non systematic screening or spontaneous screening results in high marginal costs. Only systematic screening is able to provide means for controlling cost. Therefore, constant care should be taken to ensure that in any screening programme the allocated resources are used in an optimal way.

5. Quality assurance

5.1. Screening should aim at the highest possible standards of quality from the medical and organisational point of view.
5.2. Because of the expectations that screening creates as well as its adverse effects, screening should meet the highest quality assurance standards in all its aspects.

5.3. An assessment of the scientific evidence of the effectiveness of screening in the control of a disease should be made by experimental studies before introducing a screening programme as a service. The practical arrangements for a mass screening, which are directly linked to the health structures and systems, should obtain the same effectiveness as that obtained in the randomised trial.

5.4. Having implemented a screening programme, it should be subjected to continuous independent evaluation. Evaluation will facilitate adaptation of the programme, correction of deficiencies noted and verification of achievement of objectives. The adverse effects of the screening programme should not be ignored in the evaluation which should be carried out by independent public health experts.

5.5. If quality assurance standards are not met in the long term it should be possible for the screening programme to be corrected, and, if this is not possible, stopped.

5.6. The programme must evaluate participation, and the percentage of people screened in the target population, the technical quality of testing and the quality of diagnosis and treatment provided as a follow-up for persons with a positive test result.
Severe side effects of false positives should be revealed and evaluated.

5.7. There is a need for more teaching of medical students in epidemiology and its application to measuring the effects of screening. Similarly post-graduate education in this field is also needed to enable practising doctors to understand the principles and evaluation of screening.

5.8. Provision of screening programmes requires that training in techniques and interpretation of screening tests is included in undergraduate and post-graduate medical teaching programmes.

5.9. A screening programme requires resources in both staff and technical facilities for carrying out the screening tests. In many instances tests can be performed by non medical staff. Provision should be made for initial and further training of the medical and technical staff who will be involved in performing the screening tests and interpreting their results. Technical methods, including automated techniques, are useful in screening for some diseases. Quality of screening methods should be monitored.

6. Organisation

6.1. The organising body of a screening programme should be held responsible throughout the programme. The organisation of a screening programme should comply with what is described in national guidelines and protocols.

6.2. Within the organisational framework the target population should be defined (by age or otherwise) as well as the frequency of screening tests and the general and specific objectives and quality assurance guidelines.

6.3. It must be stressed that screening cannot succeed without co-operation between preventive and curative systems. Organisation must be tailored to the structures of the health system. If appropriate structures in the curative health care system are lacking, screening should not be implemented until they are developed (pilot programmes, for example). There are various degrees to which screening services may be integrated with curative services or develop as a separate speciality. The advantages and disadvantages of these should be assessed separately in different health care systems.

6.4. Provisions should be made for the financing of the programme, the cost of organising and evaluating the structure, the cost of testing, the cost of quality assessment and monitoring, and the cost of the follow-up care of those people who screen positively.

6.5. Process and outcome indicators should be constantly evaluated.

6.6. Systematic collection of data is required in screening programmes to serve the needs of the individual and of the health service. To that end, data should be collected on the target population, on persons screened (with dates and the results of the test carried out), and on the results of eventual diagnostic examinations. Access to a morbidity register considerably facilitates evaluation.

6.7. Adequate protection of all data collected by means of a screening programme should be guaranteed.

6.8. Participation of the public in screening programmes is determined by personal factors (for example attitudes, motivation and anxiety) and by situational factors (waiting time and efficient organisation, for example). These can be influenced for instance by health education and by good organisation of the screening procedure.

6.9. In order to ensure optimal participation by the target population, the best possible information should be widely provided and awareness-raising and education programmes should be organised for both the target population and the health professionals.

6.10. Invitations should be accompanied by written information on the purposes and effectiveness of the programme, on the test, on potential advantages and disadvantages, on the voluntary nature of participation and on how data will be protected. An address should be provided for those who require further information.

6.11. Participants should be informed on how, when and where their test results will be available or will be communicated to them.

6.12. The positive results found at screening should always be confirmed by subsequent diagnostic tests before commencing a treatment/intervention, unless the screening test is a diagnostic test. It is absolutely essential that adequate diagnostic facilities are available to confirm or reject the screening finding as soon as possible. Similarly, treatment facilities must be available and easily accessible to the confirmed cases. The work load placed on the health services by screening can be very large, especially since most screening programmes also lead to incidental pathological findings unrelated to the disease at which the programme is aimed.

6.13. Combining screening for several diseases into a multiple screening procedure may seem to be convenient to the individual and economic to the programme, but such a "package deal" may negatively influence the extent to which most of the criteria for screening including age limit and frequency would be met.

7. Research

7.1. Research into new, more effective, screening tests must be encouraged and the long-term effects of the various methods of treatment and provision for positive subjects studied. Research must be further developed to answer the numerous social, ethical, legal, medical, organisational and economic questions as well as psychological problems raised by screening, on which evidence is incomplete.

7.2. Quality assurance concerning research programmes should be conducted into the effectiveness of the various screening tests, the practical arrangements for screening, the measures to increase participation, the means of improving test efficiency, follow-up to and provisions for screened positive assessment process and all the economic aspects.

7.3. Information gathered during screening should be available for the purpose of scientific research, for the improvement of health services, and for the benefit of future screening, taking into account full respect of autonomy and confidentiality and the protection of personal privacy.

8. General remarks

8.1. It is particularly important that political decision-makers and target groups should be kept informed of the current state of knowledge about the value of screening for particular diseases. Improved communication should be encouraged.

8.2. Governments should promote the research and evaluation necessary for assessing the value of both new and existing programmes. This form of research necessarily means large-scale research which, in some instances, may be designed as international collaborative studies. Scientific evaluation is the only way in which the positive and negative effects of screening can be assessed in order that a rational decision can be taken on whether a screening programme should be implemented and what resources should be allocated.

Quality assurance (as defined by World Health Organisation) :

"All those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service (ISO 6215-198O). Satisfactory performance in service implies the optimum quality of the entire diagnostic process i.e., the consistent production of adequate diagnostic information with minimum exposure of both patients and personnel."

Quality control (as defined by World Health Organisation) :

"The set of operations (programming, co-ordinating, carrying out) intended to maintain or to improve [...] (ISO 3534-1977). As applied to a diagnostic procedure, it covers monitoring, evaluation and maintenance at optimum levels of all characteristics of performance that can be defined, measured, and controlled."