CEN Workshop Agreement 16624 Health Care Services – Quality Criteria for Health Checks

Key Contextual Factors

• No contextual limitations, the aim is to provide a basic set of quality criteria.
• Comments or suggestions from the users of the CEN Workshop Agreement are welcome and should be addressed to the CEN-CENELEC Management Centre.
• Quality criteria for health checks is mainly aimed at providers of health checks and policy makers. Providers might learn what defines a responsible health check service and improve their services accordingly. Policy makers might learn to decide about the need for policy or regulations for all or specific health checks, or providers. Quality criteria for health checks will help consumers to make informed choices.
• CEN Workshop Agreement is publicly available as a reference document from the National Members of The following countries: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia.
• Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

Key Components/Steps

The set of generic criteria are applied in these steps:

• Information.
• Communication and informed consent.
• Condition and target population.
• Test procedure.
• Test clinical validity.
• Results.
• Follow-up.
• Quality and safety management and legal environment.

Health checks CWA was used as a background material in development of European wide survey of barriers to early diagnosis, a Work Package 5 milestone 5.1 in March 2019 in the framework of the Joint action Innovative Partnership for Action Against Cancer iPAAC, ending in December 2021.

Main Impacts / Added Value

• On individual level consumers can make more informed choices on health checks. Some tests may carry risks in themselves, such as invasive tests or imaging techniques conducted with radiation.
• Early diagnosis and prevention may be strengthened if health checks are applied with quality criteria. It is equally important to note that health checks incorporate a serious risk of unnecessary medical procedures and may lead to an unwanted rise in medical expenses, due to a high number of false positive results.

Lessons Learned

The health checks can be potentially interesting programmatic services for finding cancer earlier. Quality criteria will advance good planning of the balance of harms and benefits.

• The balance between advantages and disadvantages is often precarious, due to lack of appropriate evidence. Health checks can provide interesting links with early diagnosis of cancer where similar balance of harms and benefits needs to be explored.
• Early diagnosis of cancer can take place in systematic population-based programmes; based e.g. on clinical examination of breast cancer symptoms in order to improve access to cancer services and improve prognosis. It is worthwhile considering in the EU context also early diagnosis in the usual patient-oriented clinical setting when and individual patient seeks for diagnostic confirmation and treatment.
• Health check have various services providers in different settings; such as schools, military service, occupational healthcare; enabling initialization of the diagnostic pathways based on interviews and clinical examination of possible symptoms.

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