15-17 October 2014, BfS Neuherberg. WHO International Consultation:

Transcription

1 15-17 October 2014, BfS Neuherberg WHO International Consultation: Justification of the Use of CT in Medical Imaging for Individual Health Assessment of Asymptomatic People - Individual Health Assessment (IHA) for the Purpose of this Meeting - Jürgen Griebel Federal Office for Radiation Protection (BfS), Germany

2 Principle of Justification: International BSS Medical exposures shall be justified by weighing the diagnostic or therapeutic benefits depending on prevalence of disease severity of disease impact on individual's outcome of disease Benefit Risk a sufficient net benefit against the radiation detriment depending on exposure level age life expectancy vs. latency period with account taken of the benefits and risks of available alternative techniques that do not involve medical exposure.

3 Medical Exposures: Scenarios Scenario #1: an individual patient: symptomatic individual high prevalence of disease undergoing X-rays as part of his own medical treatment healthcare Scenario #2: a target population: group of asymptomatic individuals low prevalence of disease undergoing X-rays as part of an approved health screening programme breast cancer screening programmes Scenario #3: an individual person: asymptomatic individual low prevalence of disease undergoing X-rays for the early detection of severe diseases individual health assessment (IHA): CT-screening exams of lung, colon, heart or whole body ( manager check-up ) generic term: opportunistic screening

4 Scenario #3: Individual Health Assessment presenting referring person: asymptomatic individual low prevalence of pathology medical practitioner: clinical history physical examination other clinical testing radiological practitioner: individual health assessment by CT

5 Scenario #3: Individual Health Assessment presenting person: asymptomatic individual low prevalence of pathology self-presentation referring medical practitioner any common interest between both self-referral problem: financial incentive radiological practitioner justification for an individual medical exposure: how to be carried out? what to be claimed for? scientific evidence: how to be assessed? prospective randomized controlled trials: if they exist: not applicable population based studies: not available

6 Scenario #3: Individual Health Assessment Why has particular care to be taken in justifying radiological procedures to be performed as part of a screening? 1.) Due to the typically low prevalence of serious diseases in an asymptomatic population, the vast majority of individuals undergoing screening is not affected by the disease. 2.) These individuals do not derive a direct health effect, but can only be harmed - either by radiation induced cancer - or by adverse health effects such as false-positive results and overdiagnosis. valid for all kinds of screening valid even for approved health screening programmes valid in particular for individual health assessment

7 Basic Safety Standards It represents remarkable progress, that both the International Basic Safety Standards (2014), and the Euratom Directive on Basic Safety Standards (2014), clearly address the justification of individual health assessment.

8 International-Basic Safety Standards Requirement 37: Justification of medical exposures Any radiological procedure on an asymptomatic individual that is intended to be performed for the early detection of disease, but not as part of an approved health screening programme, shall require specific justification for that individual by the radiological medical practitioner and the referring medical practitioner, in accordance with the guidelines of relevant professional bodies or the health authority. As part of this process, the individual shall be informed in advance of the expected benefits, risks and limitations of the procedure.

9 Requirements for IHA Justification: HERCA European approach from a regulator s perspective

10 Requirements for IHA Justification: HERCA the individual health assessment is - based on consensus guidelines of scientific societies, - embedded in a well-established screening algorithm, clearly defined risk profiles exist, a demanding quality assurance programme is established along the whole screening chain, a demanding programme concerning training and education is well established, adequate measures concerning documentation and evaluation are set in place, and population based studies adequate information about both potential benefit and potential risk and harm is provided to the individual,

11 Requirements for IHA Justification: HERCA further requirements concerning: ethical issues, socio-economic issues, reimbursement, self-referral, self-presentation.

12 scientific evidence of benefit Summary high Breast Cancer Screening Program Individual Health Assessment Healthcare low low Opportunistic Screening asymptomatic individual definition of requirements for justification increase of scientific evidence by population based studies prevalence of disease symptomatic patient high

13 scientific evidence of benefit Objective of the Workshop high Breast Cancer Screening Program Individual Health Assessment Healthcare to discuss these claims in a world wide view low low Opportunistic Screening asymptomatic individual definition of requirements for justification increase of scientific evidence by population based studies prevalence of disease symptomatic patient high

14 Thank you for your attention!

15

16 Medical Exposures: Scenarios Scenario #1: Healthcare presenting referring patient: symptomatic individual high prevalence of pathology medical practitioner radiological practitioner justification of an individual medical exposure: to be carried out by means of consultation between the medical practitioner and the radiological practitioner (3.157 International BSS) benefit to an individual patient: getting evidence in favour of, or against, a suspected diagnosis, planning the therapy of a known disease, monitoring the progress of a known disease

17 Medical Exposures: Scenarios Scenario #2: Screening Programme participating independent invitation system clearly defined target population: asymptomatic individuals low prevalence of pathology justification of the whole screening programme: to be carried out by health authorities screening unit benefit to target population: reduction in disease related mortality in the target population prospective randomized controlled trials: available

18 Medical Exposures: Scenarios Scenario #3: Individual Health Assessment (IHA) presenting referring person: asymptomatic individual low prevalence of pathology medical practitioner: clinical history physical examination other clinical testing radiological practitioner: individual health assessment by CT

19 Medical Exposures: Scenarios Scenario #3: Individual Health Assessment (IHA) presenting person: asymptomatic individual low prevalence of pathology self-presentation referring medical practitioner any common interest between both self-referral justification of IHA: how to be carried? what to be claimed? problem: financial incentive radiological practitioner benefit to individual person: how to be assessed? population based studies on IHA: not yet available