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Hegedues, Peter; Stackelberg, Oyunbileg von; Neumann, Christoph; Selder, Sonja; Werner, Nicole; Erdmann, Pia; Granitza, Anja; Voelzke, Henry; Bamberg, Fabian; Kaaks, Rudolf; Bertheau, Robert C.; Kauczor, Hans-Ulrich; Schlett, Christopher L.; Weckbach, Sabine (2019): How to report incidental findings from population whole-body MRI: view of participants of the German National Cohort. In: European Radiology, Vol. 29, No. 11: pp. 5873-5878
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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.