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How to report incidental findings from population whole-body MRI: view of participants of the German National Cohort

European Radiology volume 29, pages 5873–5878 (2019)Cite this article

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

References

  1. The Royal College of Radiologists (2011) Management of incidental findings detected during research imaging. The Royal College of Radiologists, London, p 2011. Available via: https://www.rcr.ac.uk/system/files/publication/fieldpublicationfiles/BFCR%2811%298_ethics.pdf. Accessed 18 Jan 2019

  2. Presidential Commission for the Study of Bioethical Issues (2013) Anticipate and communicate. Ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumercontexts. Available via https://bioethicsarchive.georgetown.edu/pcsbi/sites/default/files/FINALAnticipateCommunicatePCSBI0.pdf. Accessed 18 Jan 2019

  3. Erdmann P (2017) Incidental findings – ethical aspects. In: Weckbach S (ed) Incidental radiological findings. Springer, London, pp 9–24

    Google Scholar 

  4. German National Cohort C (2014) The German National Cohort: aims, study design and organization. Eur J Epidemiol 29:371–382

    Article  Google Scholar 

  5. Bamberg F, Kauczor HU, Weckbach S et al (2015) Whole-body MR imaging in the German National Cohort: rationale, design, and technical background. Radiology 277:206–220

    Article  Google Scholar 

  6. Bertheau RC (2016) Management of incidental findings in the German National Cohort. In: Weckbach S (ed) Incidental Radiological Findings. Springer, London, pp 57–70

    Chapter  Google Scholar 

  7. Schlett CL, Hendel T, Weckbach S et al (2016) Population-based imaging and radiomics: rationale and perspective of the German National Cohort MRI study. Rofo 188:652–661

    CAS  Article  Google Scholar 

  8. Wolf SM, Lawrenz FP, Nelson CA et al (2008) Managing incidental findings in human subjects research: analysis and recommendations. J Law Med Ethics 36:219–248 211

    Article  Google Scholar 

  9. Erdmann P (2015) Zufallsbefunde aus bildgebenden Verfahren in populationsbasierter Forschung. Münster (mentis)

  10. Schmidt CO, Hegenscheid K, Erdmann P et al (2013) Psychosocial consequences and severity of disclosed incidental findings from whole-body MRI in a general population study. Eur Radiol 23:1343–1351

    Article  Google Scholar 

  11. Bamberg F, Hetterich H, Rospleszcz S et al (2017) Subclinical disease burden as assessed by whole-body MRI in subjects with prediabetes, subjects with diabetes, and normal control subjects from the general population: the KORA-MRI study. Diabetes 66:158–169

    CAS  Article  Google Scholar 

  12. Schmidt GP, Reiser MF, Baur-Melnyk A (2007) Whole-body imaging of the musculoskeletal system: the value of MR imaging. Skeletal Radiol 36:1109–1119

    Article  Google Scholar 

  13. Laible M, Schoenberg SO, Weckbach S et al (2012) Whole-body MRI and MRA for evaluation of the prevalence of atherosclerosis in a cohort of subjectively healthy individuals. Insights Imaging 3:485–493

    CAS  Article  Google Scholar 

  14. Weckbach S, Schoenberg SO (2009) Whole body MR imaging in diabetes. Eur J Radiol 70:424–430

    Article  Google Scholar 

  15. Cieszanowski A, Maj E, Kulisiewicz P et al (2014) Non-contrast-enhanced whole-body magnetic resonance imaging in the general population: the incidence of abnormal findings in patients 50 years old and younger compared to older subjects. PLoS One 9:e107840

    Article  Google Scholar 

  16. Goehde SC, Hunold P, Vogt FM et al (2005) Full-body cardiovascular and tumor MRI for early detection of disease: feasibility and initial experience in 298 subjects. AJR Am J Roentgenol 184:598–611

    Article  Google Scholar 

  17. Gibson L.M., Sellors J., Sudlow C.L.M. (2016) Management of Incidental Findings on Multimodal Imaging in UK Biobank. In: Weckbach S. (eds) Incidental Radiological Findings. Medical Radiology. Springer, Cham

  18. Lo GG, Ai V, Au-Yeung KM, Chan JK, Li KW, Chien D (2008) Magnetic resonance whole body imaging at 3 Tesla: feasibility and findings in a cohort of asymptomatic medical doctors. Hong Kong Med J 14:90–96

    PubMed  Google Scholar 

  19. Weckbach S, Schlett CL, Bertheau RC, Kauczor HU (2014) [Incidental radiological findings]. Internist (Berl) 55:1019–1025

  20. Hegenscheid K, Seipel R, Schmidt CO et al (2013) Potentially relevant incidental findings on research whole-body MRI in the general adult population: frequencies and management. Eur Radiol 23:816–826

    Article  Google Scholar 

  21. Petersen SE, Matthews PM, Bamberg F et al (2013) Imaging in population science: cardiovascular magnetic resonance in 100,000 participants of UK Biobank - rationale, challenges and approaches. J Cardiovasc Magn Reson 15:46

    Article  Google Scholar 

  22. Teuber A, Sundermann B, Kugel H et al (2017) MR imaging of the brain in large cohort studies: feasibility report of the population- and patient-based BiDirect study. Eur Radiol 27:231–238

    Article  Google Scholar 

  23. Hoffmann M (2013) Two basic ethical problems of incidental findings in population-based, non-intervening magnetic resonance imaging (MRI) research. J Eval Clin Pract 19:427–432

    Article  Google Scholar 

  24. Royal JM, Peterson BS (2008) The risks and benefits of searching for incidental findings in MRI research scans. J Law Med Ethics 36:305–314, 212

    Article  Google Scholar 

  25. Appelbaum PS, Lidz CW, Grisso T (2004) Therapeutic misconception in clinical research: frequency and risk factors. IRB 26:1–8

    Article  Google Scholar 

  26. Kirschen MP, Jaworska A, Illes J (2006) Subjects’ expectations in neuroimaging research. J Magn Reson Imaging 23:205–209

    Article  Google Scholar 

  27. Vernooij MW, Ikram MA, Tanghe HL et al (2007) Incidental findings on brain MRI in the general population. N Engl J Med 357:1821–1828

    CAS  Article  Google Scholar 

  28. Cole C, Petree LE, Phillips JP, Shoemaker JM, Holdsworth M, Helitzer DL (2015) ‘Ethical responsibility’ or ‘a whole can of worms’: differences in opinion on incidental finding review and disclosure in neuroimaging research from focus group discussions with participants, parents, IRB members, investigators, physicians and community members. J Med Ethics 41:841–847

    Article  Google Scholar 

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Acknowledgements

We acknowledge the continuous advice and support of the ethics committee of the German National Cohort. Moreover, we would like to thank all investigators of the German National Cohort MRI Study (see online Appendix [5]).

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.

Author information

Affiliations

  1. Department of Diagnostic and Interventional Radiology, University Hospital Heidelberg, Neuenheimer Feld 110, 69120, Heidelberg, Germany

    Peter Hegedüs, Oyunbileg von Stackelberg, Robert C. Bertheau, Hans-Ulrich Kauczor, Christopher L. Schlett & Sabine Weckbach

  2. Division of Cancer Epidemiology, German Cancer Research Center, Heidelberg, Germany

    Christoph Neumann & Rudolf Kaaks

  3. Institute of Clinical Radiology, Ludwig-Maximilian-University Hospital, Munich, Germany

    Sonja Selder

  4. Institute of Community Medicine, SHIP/Clinical-Epidemiological Research, University of Greifswald, Greifswald, Germany

    Nicole Werner & Henry Völzke

  5. Faculty of Theology, Systematic Theology, University of Greifswald, Greifswald, Germany

    Pia Erdmann & Anja Granitza

  6. Department of Diagnostic and Interventional Radiology, Medical Center - University of Freiburg, Freiburg, Germany

    Fabian Bamberg & Christopher L. Schlett

Authors
  1. Peter Hegedüs
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  2. Oyunbileg von Stackelberg
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  3. Christoph Neumann
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  4. Sonja Selder
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  5. Nicole Werner
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  6. Pia Erdmann
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  7. Anja Granitza
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  8. Henry Völzke
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  9. Fabian Bamberg
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  10. Rudolf Kaaks
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  11. Robert C. Bertheau
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  12. Hans-Ulrich Kauczor
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  13. Christopher L. Schlett
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  14. Sabine Weckbach
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Corresponding author

Correspondence to Peter Hegedüs.

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Guarantor

The scientific guarantor of this publication is Prof. Dr. Sabine Weckbach.

Conflict of interest

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.

Statistics and biometry

One of the authors has significant statistical expertise.

Informed consent

Written informed consent was obtained from all subjects (patients) in this study.

Ethical approval

Institutional Review Board approval was obtained.

Methodology

• prospective

• cross sectional study

• performed at one institution

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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

Keywords

  • Questionnaire design
  • Incidental discovery
  • Epidemiology
  • Tomography