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.
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Abbreviations
- FU:
-
Follow-up
- GNC:
-
German National Cohort
- IF:
-
Incidental findings
- KORA:
-
Kooperative Gesundheitsforschung in der Region Augsburg
- SHIP:
-
Study of Health in Pomerania
- wbMRI:
-
Whole-body magnetic resonance tomography
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Funding
The GNC is funded by the Federal Ministry of Education and Research (BMBF) (funding code 01ER1301A and 01ER1801) and the participating federal states and supported by the Helmholtz Association as well as by the participating universities and institutes of the Leibniz Association.
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The scientific guarantor of this publication is Prof. Dr. Sabine Weckbach.
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The authors of this manuscript declare no relationships with any companies, whose products or services may be related to the subject matter of the article.
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One of the authors has significant statistical expertise.
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Written informed consent was obtained from all subjects (patients) in this study.
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• cross sectional study
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Hegedüs, P., von Stackelberg, O., Neumann, C. et al. How to report incidental findings from population whole-body MRI: view of participants of the German National Cohort. Eur Radiol 29, 5873–5878 (2019). https://doi.org/10.1007/s00330-019-06077-z
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DOI: https://doi.org/10.1007/s00330-019-06077-z