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Dr. Birgit Keller, (Federal Ministry for the Environment, Nature Conservation and Nuclear Safety, Germany)

As in other industrialised countries, many people in Germany are increasingly interested in the early detection of diseases. There is a general growing awareness of health issues in the population and, as a consequence, the urge to lead a healthier lifestyle. Preventive measures which are intended to prevent the outbreak of diseases are the top priority of health protection and should be supported.

In addition to purely preventive measures, many people want diseases to be detected as early as possible so that they can be cured. In many cases early detection requires an examination which makes use of ionising radiation.

So, how do we deal with this trend among patients? Is their desire for early detection (or their fear of becoming ill) sufficient to justify the use of ionising radiation for the purpose of early detection? Or do we need a stringent legal framework? How do we deal with self-referral and self-presentation of asymptomatic individuals? What role do doctors play here? In the following, I would like to discuss these issues in some more detail.

Legal situation in Germany

In Germany, the requirements for using radioactive substances or ionising radiation on human beings for medical purposes are laid down in the Radiation Protection Ordinance and the X-ray Ordinance. Only a radiological practitioner with adequate training (technical competence) in radiation protection is authorised to perform X-ray examinations or treatments. In addition, any such application must serve a medical purpose, i.e. there must be reasonable suspicion of disease. The radiological practitioner must furthermore carry out an individual justification, i.e. he has to review whether the health benefits for the use of X-rays outweigh the radiological risk, and whether there are other options with comparable health benefits with no or lesser radiation exposure.

Besides these regulations which refer to healthcare, there are certain prerequisites for the use of ionising radiation for screening purposes. However, this kind of application is only admissible for approved health screening programmes. In Germany, these screening programmes need to be approved by health authorities in the respective states. This general approval of a screening programme takes the place of the justification for the individual application of X-rays by the radiological practitioner. Currently, there is only one approved health screening programme, the breast cancer screening programme X-ray mammography for women between 50 and 69.

Criteria for the approval of health screening programmes

Which criteria must be met for the approval of health screening programmes using X-rays?

  1. The examination should have a sufficiently high positive predictive value as well as a sufficiently high negative predictive value.
  2. The examination is acceptable for the patient (exposure, costs).
  3. There is no other procedure for examination available with a lower risk than that of ionising radiation.

In addition, the following prerequisites relevant for effective secondary preventive measures for early detection of diseases should be met:

  1. The individual risk profile is known or can be precisely defined.
  2. The severity of the suspected disease justifies an early detection measure.
  3. The disease to be detected in an asymptomatic stage must have a sufficiently high prevalence to ensure the effectiveness of the examination.
  4. The disease must be at a stage in which it does not yet show symptoms but can be detected.
  5. Effective therapies, which improve the prognosis when applied at an early stage and/or the quality of life of the patient, exist in principle for this disease and are available within the health care system.

Since a health screening programme uses ionising radiation on asymptomatic persons, the requirements for technological quality assurance and the quality of the assessment are particularly stringent. This procedure therefore requires a consistent quality assurance regarding:

  1. Advice and clarification for interested persons,
  2. Distinguishing between persons suitable for an examination and those who do not benefit from it,
  3. Standards for equipment,
  4. Examination,
  5. Assessment of the examination including validation,
  6. Recommendations for further diagnostic measures to confirm and classify diagnosis (clarification) and for suitable treatment where necessary,
  7. Documentation and evaluation.

In our opinion, health screening programmes can only be considered as appropriate if these criteria are fulfilled.

European regulations

The provisions stipulated by German law are in accordance with the current Medical Exposure Directive. Individual early detection, however, is also an issue in the proposal for the European Basic Safety Directive which says: "Any medical radiological procedure on an asymptomatic individual, intended to be performed for early detection of disease shall be part of a health screening programme or shall require specific documented justification for that individual by the practitioner, in consultation with the referrer, following guidelines from relevant professional bodies and competent authorities."

In contrast to earlier regulations, this directive allows more scope for early detection on asymptomatic persons, albeit following guidelines from relevant professional bodies and competent authorities, and in consultation with the referrer.

Individual health assessment

Between an approved screening programme and the individual application of X-rays within healthcare, individual health assessment takes place in a legal grey area – sometimes even referred to as wellness screening. Current German law does not allow for such early detection measures. There is major concern that the radiation risks or undesired consequences of ill-considered early detection measures are not taken sufficiently into account. This is even more true if these early detection measures are chosen by the persons themselves.

Individual health assessment occurs particularly often with regard to mammography screening. Why, for example, is the breasts cancer screening program rejected so often? Reasons are, for instance, that many women do not feel comfortable with a uniform, perhaps even impersonal procedure, or that physicians reject this treatment out of their own interest.

At this point I would like to stress that, in this context, we do not reject early detection measures on an individual base for women with a family history of the disease or with other sever risk factors. In this case, suspicion of disease can be considered as high enough to justify the application of X-rays within healthcare.

Patients choosing their own treatment

We think, that a justification for the use of ionising radiation for the early detection of a disease cannot be issued solely on the wish of the individual person, as the individual person usually lacks the expertise to balance the benefits and disadvantages of an examination. An indication may only be established according to the latest medical knowledge and in line with agreed recommendations and guidelines of scientific expert bodies and following a review of all relevant factors.

Medically untrained persons often wrongly assess their personal risk profile as well as the benefits and disadvantages of an early diagnosis and/or treatment of a disease. Therefore, before individual early detection measures are taken, the patient should get comprehensive advice based on agreed guidelines regarding the individual risk of disease. This should not only include a detailed description of the respective examination but also any possible benefits and disadvantages of positive or negative findings.

These issues, which also play a significant role for organised mass examinations, are of particular importance here.

Potential advantages include:

  1. Improved probability of cure or survival of patients through treatment at an early stage,
  2. Improved quality of life for patients through an early-stage treatment that imposes less strain,
  3. Reassurance in the case of (correct) negative findings and improved quality of life (exclusion diagnosis).

Potential disadvantages include:

  1. Overdiagnosis, i.e. early detection of a disease that will not cause medical problems during the patient's lifetime.
  2. Reducing quality of life if a diagnosis or treatment is simply brought forward without offering a better prognosis or quality of life,
  3. Incorrect positive findings causing unnecessary anxiety and unnecessary further diagnostic measures and treatments, including their side effects and complications,
  4. Incorrect negative findings providing false reassurance and potential delay of new diagnosis if symptoms occur,
  5. Potential harm to health through radiation exposure.

In general, patients should be informed not only about the respective examination, but also about the follow-up measures which might be the result of uncertain or positive findings.

It is necessary to provide interested persons with scientifically founded information on early detection measures.

The aim should be to enable patients to assess the benefits and disadvantages of early detection examinations with ionising radiation. They should also be aware of the examination procedure and be advised that the findings may lead to further measures. This information is necessary so that the patient can not only decide for or against a certain examination, but is also aware of the range of measures that may follow.I

Under which circumstances could individual early detection be permissible? (The following comments are based on a position paper by the Commission on Radiological Protection, an advisory body on radiation protection issues for the German government.)

Ultimately, we must ask to what extent the wishes of patients should be taken into account. Who should take the decision concerning the use of ionising radiation on patients?

This problem is currently being discussed in Germany. There is agreement that a patient's wishes cannot be the decisive factor here. However, the notion is growing stronger that a patient's opinion should be given more consideration. However, this must be embedded in a general and individual justification.

From the radiation protection point of view, examinations of asymptomatic persons within the framework of individual early detection should only be possible for exactly defined uses. Lists could be drawn up in cooperation with medical expert bodies. The following uses might be options:

  1. CT or MR colonography (virtual colonoscopy),
  2. Low dose CT of lung for smokers,
  3. X-ray mammography for women outside approved screening programmes.

In addition, the justification of an individual health assessment has to be based on:

  • The medical history of the person and, if necessary, physical examination,
  • Drawing up an individual risk profile,
  • Comprehensive information and advice on benefits, risks and undesired side effects as well as diagnostics for clarification where necessary,
  • Severity and course of suspected disease, options for valid diagnostics and treatment,
  • Highest quality standards regarding implementation, findings and decision on further procedures,
  • Comprehensive documentation of measures,
  • Accompanying evaluation of examination.

To sum up:

An individual health assessment using X-rays for the early detection of severe diseases should be carried out exclusively on the basis of agreed guidelines of scientific expert bodies, which take into account the above-mentioned criteria.