WHO (the World Health Organisation) and the EC (the European Commission) recommend national programmes of screening in adults for cervical-, breast- and colorectal cancer. For these programmes evidence based guidelines are available that ensure quality and safety.
Health checks and (periodic) health examinations are emerging for any diseases. For many of these checks the evidence base is lacking, and many other long established quality criteria for screening are not met.
Effectively implemented health checks can prevent disability and death and improve quality of life. The poor prognosis for people with diseases that are diagnosed at an advanced stage can make early detection and intervention a worthwhile strategy.
The benefits are straightforward. Early and accurate diagnosis and intervention will lead to an improved prognosis for some patients. At this stage treatment may need to be less radical. Scarce health services resources will be saved by treating diseases before they progress, and those with true-negative test results can be reassured.
The disadvantages are more complex. There will be longer periods of morbidity for patients whose prognosis is unchanged and there may be overtreatment of non-serious conditions or abnormalities identified. There are also resource costs in finding more illness both in terms of the tests themselves, the personnel costs and the subsequent management of whatever is found. There is the unpalatable certainty that some individuals with false-negative results will be given unfounded reassurance and that some with false-positive results will experience, at the very least, unnecessary anxiety and, at the worst, inappropriate treatment. Finally, there is the possibility of hazard from the screening test itself.
Screening adults is potentially big business. The challenge regarding health checks is to find a balance between the right-to-know and the autonomy of clients versus the need to safeguard these clients against the risks of screening by regulating quality and safety; to maximize benefit and minimize harm.
Screening services provided by national health services, such as the national screening programmes for cervical cancer and breast cancer, may not be perfect but are introduced on the basis of sound scientific evidence, are subject to ongoing scrutiny and provide continuity of care and follow-up. This is not necessarily the case in the private sector (WHO 2006).
In 2008 the Health Council in the Netherlands (Gezondheidsraad, 2008) reported that a fresh approach is needed to encourage sensible screening and to protect individuals against the risks of unsound screening. A key element would be to establish a quality-mark for responsible health checks, based on scientific assessments of new developments and aimed at promoting responsible provision and responsible choices.
As a follow up to the report NEN, in cooperation with the Netherlands Ministry of Health, Welfare and sports, inventorised screening criteria at European level. The inventory concluded that:
- Wide variety of screening practices coexist in Europe.
- Wilson and Jungner principles of 1968 still remain valid. Many general quality criteria are developed on the basis of these principles, eg the UK National Screening Committee appraisal criteria for screening programmes (NHS, 2009).
- There is a lot of discussion on quality criteria for national population screening programmes. The cancer screening programmes dominate the discussion. Less heated debates are going on regarding the screening programmes that do not use radiation tests in the screening methodology.
- For some diseases the screening criteria can be met and evidence based national programmes can be developed. WHO has listed these diseases (WHO, 2006).
- The Netherlands (1992) and Belgium (2008) have acts to prevent harmful screening practices. The control on the implementation of these acta is difficult for certain forms of private sector screening practices, especially when the screening services do not explicitly state the diseases they are screening for, like ‘total body scans’.
- A set of quality criteria for those screening services outside the national programmes has not been identified.
- A group of interested stakeholders is interested to continue working on the subject, both from the respondents from this inventory as well as from the European Partnership. In the Netherlands as well as in the UK initiatives are being developed to address this issue. These initiatives can be used as inputs for the Joint Action discussions.
In 2011 the Executive Agency for Health and Consumers of the European Commission has decided to award a grant for the action entitled 'European Partnership for Action Against Cancer'. The proposal 'Developing initial quality criteria for health checks at European level' is included in the work package 'Screening and early diagnosis'.
This Joint Action will result in a CEN Workshop Agreement (CWA) on ‘Quality criteria for health checks’.
CEN Workshop Agreement
Health checks are single or periodic medical examinations offered to people to prevent or early detect one or more diseases or risk factors or poor health outcomes. The Workshop aims to achieve consensus on basic principles of quality criteria for health checks and will further elaborate on the definition of health checks.
Quality criteria for health checks aim:
- to encourage good practice in prevention and early detection of health risks;
- to protect individuals against the risks of unsound health checks;
- to allow clients to make responsible choices about health checks.
Outside the scope of the project are:
a) screening services covered by the recommendation of the Council of the EU on cancer screening (e.g., screening for breast-, colorectal and cervical cancer and screening using potential new tests, e.g. screening for prostate cancer);
b) health checks or other preventive and prophylactic services already regulated by national or EU legislation and rules (e.g. the statutory German health check-up);
c) products such as self- tests already covered by national or EU legislation and rules (e.g. covered by directive 98/79/EG).
CEN Workshop Status
The kick-off meeting of the workshop took place on Friday 02 December 2011 in The Hague (NL).
The CEN Workshop Agreement was published by CEN on 12 June 2013 as CWA 16642:2013 ‘Quality criteria for health checks’. In accordance with an agreement between CEN and the EPAAC project, the document is freely available from the EPAAC website.
Ms A. Cecile J.W. Janssens
Professor of translational epidemiology
Erasmus Medical Centre
Department of Epidemiology
PO Box 2040 (room Ee 21-40b)
NL-3000 CA Rotterdam
Ms Annemarieke Rendering
Public Health Department
Ministry of Health, Welfare and Sports
NL-2511 VX Den Haag
Tel: +31 70 3405112
NEN – Dutch Standardization Institute
Ms Ir Marlou Bijlsma
NL-2623 AX Delft
Tel: +31 15 2690264
CEN-CENELEC Management Centre
Mr Alexandre della Faille de Leverghem
Sustainability and Services
Avenue Marnix, 17
Tel: +32 2 550 0931