Application of the justification principle/ Survey about the situation in Europe regarding the use of CT[1] on asymptomatic individuals outside screening programs

On 27 June 2013, on the occasion of the 11th meeting of the association HERCA which brings together the Heads of European Radiological protection Competent Authorities, HERCA has approved the document Survey about the situation in Europe regarding the use of CT on asymptomatic individuals outside screening programs. The aim of the report is to present an overview of the use of CT on asymptomatic individuals in Europe for individuals undergoing “on request” exams with no clinical indication (no symptoms/clinical signs) and thus often occurring as a result of an individual request.

The issues with unjustified exposures in medicine have been accentuated by recent developments in imaging procedures, especially in preventive health care or procedures claiming to belong to it. Normally, imaging procedures are performed on patients presenting with symptoms of some sort in a typical setting of curative medicine. This is not the case in preventive health care, where the persons examined are not characterized as patients (literally: persons who “suffer”) nor do they present any symptoms. These persons are often referred to as “asymptomatic individuals”.

There is a European and international focus on this group of individuals and both the European Commission (EC) and the International Atomic Energy Agency (IAEA) have proposed requirements to get regulatory control of medical exposure of asymptomatic individuals. Lack of regulatory control of this group, especially with CT-examinations, may result in a significant contribution to the collective dose to the population. In this framework, it is important to differentiate formal screening programmes from more informal arrangements usually denoted as individual health assessment (IHA). In the case of IHA there is no, or insufficient medical evidence with regard to the potential “net benefit” of the procedure, and thus questions related to justification arise. As opposed to official screening programs, the application of quality assurance is not guaranteed.

Faced with this situation, in July 2012, HERCA WG Medical Applications launched a survey about the situation in Europe regarding the use of CT on asymptomatic individuals outside screening programs. The approved report on the occasion of the 11th HERCA meeting presents the results of the survey containing the answers of 21 European countries.

The survey has revealed among other issues that:

• CT examinations on asymptomatic individuals outside screening programmes are performed in at least eight European countries. The number is assumed to be higher, since only five countries actively search for the existence of these practices.
• Most countries indicate that examinations on asymptomatic individuals outside screening programmes are not allowed from a legal point of view even though the fact that asymptomatic individuals are not directly mentioned in most countries legislation. Most national radiation protection regulations can regulate this practice by means of their general justification paragraph, since exposure of asymptomatic individuals outside screening programmes is generally found not justified.
• Despite that justification of any exposure to x-rays of individuals is mandatory, companies or hospitals in at least nine countries advertise for IHA by use of CT examinations. Only few countries have some kind of reimbursement of CT examinations on asymptomatic individuals outside screening programmes and, in most cases, only if some sort of individual justification is observed.
• Even though CT examinations on asymptomatic individuals are not common practice in the majority of the European countries, it is important with increased focus on this practice to reduce its implementation. The survey collected several proposals on how to increase awareness among the public and the performing institutions, in order to reduce the level of IHA examinations with CT. In addition to an increased level of awareness, there is a need for a more active involvement from the authorities from a legal point of view. This can be done by reacting on unjustified examinations and by strengthening the regulation in future revisions.

HERCA Working Group on Medical Applications has identified a need for further work with respect to IHA to reduce the already current practice and prevent it to get established in more countries.

[1] Computerized tomography