Peter Hegedüs1, Oyunbileg von Stackelberg2, Christoph Neumann3, Sonja Selder4, Nicole Werner5, Pia Erdmann6, Anja Granitza6, Henry Völzke5, Fabian Bamberg7, Rudolf Kaaks3, Robert C Bertheau2, Hans-Ulrich Kauczor2, Christopher L Schlett2,7, Sabine Weckbach2. 1. Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Neuenheimer Feld 110, 69120, Heidelberg, Germany. hegedues.peter@med.uni-heidelberg.de. 2. Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Neuenheimer Feld 110, 69120, Heidelberg, Germany. 3. Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany. 4. Institute of Clinical Radiology, Ludwig-Maximilian-University Hospital, Munich, Germany. 5. Institute of Community Medicine, SHIP/Clinical-Epidemiological Research, University of Greifswald, Greifswald, Germany. 6. Faculty of Theology, Systematic Theology, University of Greifswald, Greifswald, Germany. 7. Department of Diagnostic and Interventional Radiology, Medical Center - University of Freiburg, Freiburg, Germany.
Abstract
OBJECTIVES: In the German National Cohort (GNC), 30,000 individuals are examined with whole-body MRI (wbMRI), of which about 3000 participants are expected to receive an incidental finding (IF) disclosure. In order to get feedback from participants and to evaluate the IF-management procedure of the wbMRI substudy, a follow-up questionnaire was developed. This single-center pilot trial was aimed to get a first impression on feasibility reproducibility and validity of such a survey in order to take necessary adjustments before initiating the survey among several thousand participants. METHODS: The questionnaires were sent out in test-retest manner to 86 participants who received a wbMRI examination in January-February 2016 at the imaging center in Neubrandenburg. The ratio of participants with and without IF notification was 1:1. Descriptive statistics was performed. RESULTS: A first response of 94% and completion proportion of 99% were achieved. Participants were satisfied with the examination procedure. Ninety-five percent of participants considered it very important to receive notification of IFs. Participants reported minimal stress levels while waiting for a possible IF notification letter, but high stress levels when an IF letter was received. Phrasing of the IF reports was rated in 97% as well understandable and in 55% as beneficial to health status. CONCLUSIONS: This questionnaire will serve researchers within the GNC as a fundamental instrument not only for quality management analyses but also for the investigation of still unacknowledged scientific and ethical questions contributing to evidence-based guidelines concerning the complex approach to IFs in future population-based imaging. KEY POINTS: • Evidence-based guidelines for reporting incidental findings in population whole-body MRI are lacking. • Pilot-testing of a questionnaire for the evaluation of practical and ethical aspects of the procedure to report incidental findings in the German National Cohort shows a high level of acceptance and high return rate by participants. • Participants reported minimal stress levels while waiting for a possible incidental finding notification letter, which increased significantly, when such a letter was received.
OBJECTIVES: In the German National Cohort (GNC), 30,000 individuals are examined with whole-body MRI (wbMRI), of which about 3000 participants are expected to receive an incidental finding (IF) disclosure. In order to get feedback from participants and to evaluate the IF-management procedure of the wbMRI substudy, a follow-up questionnaire was developed. This single-center pilot trial was aimed to get a first impression on feasibility reproducibility and validity of such a survey in order to take necessary adjustments before initiating the survey among several thousand participants. METHODS: The questionnaires were sent out in test-retest manner to 86 participants who received a wbMRI examination in January-February 2016 at the imaging center in Neubrandenburg. The ratio of participants with and without IF notification was 1:1. Descriptive statistics was performed. RESULTS: A first response of 94% and completion proportion of 99% were achieved. Participants were satisfied with the examination procedure. Ninety-five percent of participants considered it very important to receive notification of IFs. Participants reported minimal stress levels while waiting for a possible IF notification letter, but high stress levels when an IF letter was received. Phrasing of the IF reports was rated in 97% as well understandable and in 55% as beneficial to health status. CONCLUSIONS: This questionnaire will serve researchers within the GNC as a fundamental instrument not only for quality management analyses but also for the investigation of still unacknowledged scientific and ethical questions contributing to evidence-based guidelines concerning the complex approach to IFs in future population-based imaging. KEY POINTS: • Evidence-based guidelines for reporting incidental findings in population whole-body MRI are lacking. • Pilot-testing of a questionnaire for the evaluation of practical and ethical aspects of the procedure to report incidental findings in the German National Cohort shows a high level of acceptance and high return rate by participants. • Participants reported minimal stress levels while waiting for a possible incidental finding notification letter, which increased significantly, when such a letter was received.
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