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Management of Incidental Findings in the German National Cohort

  • Robert C. Bertheau
  • Oyunbileg von Stackelberg
  • Sabine Weckbach
  • Hans-Ulrich Kauczor
  • Christopher L. Schlett
Chapter
Part of the Medical Radiology book series (MEDRAD)

Abstract

The German National Cohort is a long term, multicenter, population-based cohort study currently undertaken in Germany with the goal of investigating the development of common chronic diseases. As part of this investigation, 30.000 out of the total of 200.000 participants are being subjected to a whole-body 3-Tesla MR imaging without contrast agents. To help with the implementation of national and international ethical guidelines a system was developed to classify and report incidental findings that might be detected on imaging and possibly pose a risk to the participant’s health. This system focuses on guiding radiologists in the decision of reporting or not-reporting a finding in an attempt to balance the risk of over- and under-reporting, and thus, to minimize false positives and false negatives. The cornerstone of that process is a list specifying findings and separating them into report-worthy and not-report-worthy. For defining incidental findings, study specific limitations and confounders had to be taken into account. This book chapter details the necessary steps to develop such a system, illustrates the particular challenges and summarizes the ethical dilemmas with such a system. Further, technical and quality assurance tools are presented to guarantee high quality and consistency for incidental finding reporting in long-term, multicenter studies such as the German National Cohort.

Keywords

Primary Care Physician Incidental Finding Ethical Framework Image Viewer Additional Protocol 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. Abeloos L, Lefranc F (2011) What should be done in the event of incidental meningioma? Neurochirurgie 57(2):78–81CrossRefPubMedGoogle Scholar
  2. Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2007). Council of Europe Steering Committee on Bioethics, StrasbourgGoogle Scholar
  3. Al-Shahi Salman R (2007) W.N. Whiteley, and C. Warlow, screening using whole-body magnetic resonance imaging scanning: who wants an incidentaloma? J Med Screen 14(1):2–4CrossRefPubMedGoogle Scholar
  4. Atalay MK et al (2011) The prevalence and clinical significance of noncardiac findings on cardiac MRI. AJR Am J Roentgenol 196(4):W387–W393CrossRefPubMedGoogle Scholar
  5. Ballantyne C (2008) To know or not to know. Nat Med 14(8):797Google Scholar
  6. Bamberg F et al (2015) Whole-body MR imaging in the German national cohort: rationale, design, and technical background. Radiology 277(1):206–220CrossRefPubMedGoogle Scholar
  7. Beigelman-Aubry C, Hill C, Grenier PA (2007) Management of an incidentally discovered pulmonary nodule. Eur Radiol 17(2):449–466CrossRefPubMedGoogle Scholar
  8. Bender R et al (1998) Variation of sensitivity, specificity, likelihood ratios and predictive values with disease prevalence by H. Brenner and O. Gefeller, statistics in medicine, 16, 981-991 (1997). Stat Med 17(8):946–948CrossRefPubMedGoogle Scholar
  9. Berland LL et al (2010) Managing incidental findings on abdominal CT: white paper of the ACR incidental findings committee. J Am Coll Radiol 7(10):754–773CrossRefPubMedGoogle Scholar
  10. Berlin L (2011) The incidentaloma: a medicolegal dilemma. Radiol Clin North Am 49(2):245–255CrossRefPubMedGoogle Scholar
  11. Boland GW et al (2008) Incidental adrenal lesions: principles, techniques, and algorithms for imaging characterization. Radiology 249(3):756–775CrossRefPubMedGoogle Scholar
  12. Booth TC et al (2012) Management of incidental findings during imaging research in “healthy” volunteers: current UK practice. Br J Radiol 85(1009):11–21CrossRefPubMedPubMedCentralGoogle Scholar
  13. Borra RJ, Sorensen AG (2011) Incidental findings in brain MRI research: what do we owe our subjects? J Am Coll Radiol 8(12):848–852CrossRefPubMedGoogle Scholar
  14. Bradley AJ, Lim YY, Singh FM (2011) Imaging features, follow-up, and management of incidentally detected renal lesions. Clin Radiol 66(12):1129–1139CrossRefPubMedGoogle Scholar
  15. Childs DD, Leyendecker JR (2008) MRI of the pelvis: a guide to incidental findings for musculoskeletal radiologists. Semin Musculoskelet Radiol 12(1):83–103CrossRefPubMedGoogle Scholar
  16. Chow A, Drummond KJ (2010) Ethical considerations for normal control subjects in MRI research. J Clin Neurosci 17(9):1111–1113CrossRefPubMedGoogle Scholar
  17. Convention for the protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. (1999). Council of Europe, Strasbourg CedexGoogle Scholar
  18. Cordell S (2011) The biobank as an ethical subject. Health Care Anal 19(3):282–294CrossRefPubMedGoogle Scholar
  19. Cramer SC et al (2011) A system for addressing incidental findings in neuroimaging research. Neuroimage 55(3):1020–1023CrossRefPubMedPubMedCentralGoogle Scholar
  20. de Rave S, Hussain SM (2002) A liver tumour as an incidental finding: differential diagnosis and treatment. Scand J Gastroenterol Suppl 236:81–86CrossRefGoogle Scholar
  21. Erdogan D et al (2007) Management of liver hemangiomas according to size and symptoms. J Gastroenterol Hepatol 22(11):1953–1958CrossRefPubMedGoogle Scholar
  22. Esmaili A, Munden RF, Mohammed TL (2011) Small pulmonary nodule management: a survey of the members of the society of thoracic radiology with comparison to the fleischner society guidelines. J Thorac Imaging 26(1):27–31CrossRefPubMedGoogle Scholar
  23. German National Cohort (GNC) Consortium (2014) The German national cohort: aims, study design and organization. Eur J Epidemiol 29(5):371–382CrossRefGoogle Scholar
  24. Gore RM et al (2011) Hepatic incidentalomas. Radiol Clin North Am 49(2):291–322CrossRefPubMedGoogle Scholar
  25. Gross MD et al (2010) Incidentally-discovered adrenal masses. Discov Med 9(44):24–33PubMedGoogle Scholar
  26. Hartwigsen G et al (2010) Incidental findings are frequent in young healthy individuals undergoing magnetic resonance imaging in brain research imaging studies: a prospective single-center study. J Comput Assist Tomogr 34(4):596–600CrossRefPubMedGoogle Scholar
  27. Hegenscheid K et al (2013) Potentially relevant incidental findings on research whole-body MRI in the general adult population: frequencies and management. Eur Radiol 23(3):816–826CrossRefPubMedGoogle Scholar
  28. Hoggard N et al (2009) The high incidence and bioethics of findings on magnetic resonance brain imaging of normal volunteers for neuroscience research. J Med Ethics 35(3):194–199CrossRefPubMedGoogle Scholar
  29. Illes J (2008) Brain screening and incidental findings: flocking to folly? Lancet Neurol 7(1):23–24CrossRefPubMedGoogle Scholar
  30. International Ethical Guidelines for Biomedical Research Involving Human Subjects. (2002). Council for International Organizations of Medical Sciences (CIOMS), GenevaGoogle Scholar
  31. Irwin RB et al (2013) Incidental extra-cardiac findings on clinical CMR. Eur Heart J Cardiovasc Imaging 14(2):158–166CrossRefPubMedGoogle Scholar
  32. Johnson PT et al (2011) Common incidental findings on MDCT: survey of radiologist recommendations for patient management. J Am Coll Radiol 8(11):762–767CrossRefPubMedGoogle Scholar
  33. Kamath S et al (2009) Incidental findings on MRI of the spine. Clin Radiol 64(4):353–361CrossRefPubMedGoogle Scholar
  34. Khosa F et al (2011) Prevalence of noncardiac findings on clinical cardiovascular MRI. AJR Am J Roentgenol 196(4):W380–W386CrossRefPubMedGoogle Scholar
  35. Ladd SC (2009) Whole-body MRI as a screening tool? Eur J Radiol 70(3):452–462CrossRefPubMedGoogle Scholar
  36. Lee S, Joo KB, Ryu JA (2011) Subjective incidental findings of the lumbar spine at MRI. Am J Roentgenol 197(6):W1168–W1168CrossRefGoogle Scholar
  37. Legmann P (2009) Adrenal incidentaloma: management approaches: CT – MRI. J Radiol 90(3 Pt 2):426–443CrossRefPubMedGoogle Scholar
  38. Lumbreras B, Donat L, Hernandez-Aguado I (2010a) Incidental findings in imaging diagnostic tests: a systematic review. Br J Radiol 83(988):276–289CrossRefPubMedPubMedCentralGoogle Scholar
  39. Lumbreras B et al (2010b) Unexpected findings at imaging: predicting frequency in various types of studies. Eur J Radiol 74(1):269–274CrossRefPubMedGoogle Scholar
  40. Lund-Johansen M (2013) Expect the unexpected: incidental findings on brain magnetic resonance imaging. World Neurosurg 80(5):e119–e120CrossRefPubMedGoogle Scholar
  41. MacMahon H et al (2005) Guidelines for management of small pulmonary nodules detected on CT scans: a statement from the fleischner society. Radiology 237(2):395–400CrossRefPubMedGoogle Scholar
  42. Maia AC Jr et al (2012) Incidental demyelinating inflammatory lesions in asymptomatic patients: a Brazilian cohort with radiologically isolated syndrome and a critical review of current literature. Arq Neuropsiquiatr 70(1):5–11CrossRefPubMedGoogle Scholar
  43. Matsusue E et al (2006) White matter changes in elderly people: MR-pathologic correlations. Magn Reson Med Sci 5(2):99–104CrossRefPubMedGoogle Scholar
  44. McKenna DA, Laxpati M, Colletti PM (2008) The prevalence of incidental findings at cardiac MRI. Open Cardiovasc Med J 2:20–25CrossRefPubMedPubMedCentralGoogle Scholar
  45. Megibow AJ et al (2011) The incidental pancreatic cyst. Radiol Clin North Am 49(2):349–359CrossRefPubMedGoogle Scholar
  46. Milstein AC (2008) Research malpractice and the issue of incidental findings. J Law Med Ethics 36(2):356–360, 214CrossRefPubMedGoogle Scholar
  47. Morin SHX et al (2009) Incidental findings in healthy control research subjects using whole-body MRI. Eur J Radiol 72(3):529–533CrossRefPubMedGoogle Scholar
  48. Morris Z et al (2009) Incidental findings on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ 339:b3016Google Scholar
  49. Nelson CA (2008) Incidental findings in magnetic resonance imaging (MRI) brain research. J Law Med Ethics 36(2):315–319, 213CrossRefPubMedPubMedCentralGoogle Scholar
  50. Orme NM et al (2010) Incidental findings in imaging research: evaluating incidence, benefit, and burden. Arch Intern Med 170(17):1525–1532CrossRefPubMedPubMedCentralGoogle Scholar
  51. Pierce SR et al (2009) Incidental findings during functional magnetic resonance imaging: ethical and procedural issues. Am J Phys Med Rehabil 88(4):275–277CrossRefPubMedGoogle Scholar
  52. Puls R, Hamm B, Hosten N (2010) MRI without radiologists–ethical aspects of population based studies with MRI imaging. Rofo 182(6):469–471CrossRefPubMedGoogle Scholar
  53. Radiologists, T.R.C.o., Management of Incidental Findings detected during Research Imaging (2011). The Royal College of Radiologists, LondonGoogle Scholar
  54. Richardson HS (2008) Incidental findings and ancillary-care obligations. J Law Med Ethics 36(2):256–270, 211CrossRefPubMedPubMedCentralGoogle Scholar
  55. Robinson PJ (1997) Radiology’s Achilles’ heel: error and variation in the interpretation of the Rontgen image. Br J Radiol 70(839):1085–1098CrossRefPubMedGoogle Scholar
  56. Royal JM, Peterson BS (2008) The risks and benefits of searching for incidental findings in MRI research scans. J Law Med Ethics 36(2):305–314, 212CrossRefPubMedPubMedCentralGoogle Scholar
  57. Shoemaker JM et al (2011) A practical approach to incidental findings in neuroimaging research. Neurology 77(24):2123–2127CrossRefPubMedPubMedCentralGoogle Scholar
  58. Subhas N et al (2009) Incidental tumor and tumor-like lesions around the knee. Semin Musculoskelet Radiol 13(4):353–370CrossRefPubMedGoogle Scholar
  59. van der Lugt A (2009) Incidental findings on brain magnetic resonance imaging. BMJ 339:b310Google Scholar
  60. Vanel D et al (2009) The incidental skeletal lesion: ignore or explore? Cancer Imaging 9(Spec No A):S38–S43CrossRefPubMedPubMedCentralGoogle Scholar
  61. Vernooij MW et al (2007) Incidental findings on brain MRI in the general population. N Engl J Med 357(18):1821–1828CrossRefPubMedGoogle Scholar
  62. Weiner C (2014) Anticipate and communicate: ethical management of incidental and secondary findings in the clinical, research, and direct-to-consumer contexts (December 2013 report of the presidential commission for the study of bioethical issues). Am J Epidemiol 180(6):562–564CrossRefPubMedGoogle Scholar
  63. Wichmann HE et al (2012) The German national cohort. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 55(6-7):781–787CrossRefPubMedGoogle Scholar
  64. Zarzeczny A, Caulfield T (2012) Legal liability and research ethics boards: the case of neuroimaging and incidental findings. Int J Law Psychiatry 35(2):137–145CrossRefPubMedGoogle Scholar

Copyright information

© Springer International Publishing Switzerland 2016

Authors and Affiliations

  • Robert C. Bertheau
    • 1
  • Oyunbileg von Stackelberg
    • 1
  • Sabine Weckbach
    • 1
  • Hans-Ulrich Kauczor
    • 1
  • Christopher L. Schlett
    • 1
  1. 1.Department of Diagnostic and Interventional RadiologyUniversity Hospital HeidelbergHeidelbergGermany

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