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.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
References
Abeloos L, Lefranc F (2011) What should be done in the event of incidental meningioma? Neurochirurgie 57(2):78–81
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2007). Council of Europe Steering Committee on Bioethics, Strasbourg
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):2–4
Atalay MK et al (2011) The prevalence and clinical significance of noncardiac findings on cardiac MRI. AJR Am J Roentgenol 196(4):W387–W393
Ballantyne C (2008) To know or not to know. Nat Med 14(8):797
Bamberg F et al (2015) Whole-body MR imaging in the German national cohort: rationale, design, and technical background. Radiology 277(1):206–220
Beigelman-Aubry C, Hill C, Grenier PA (2007) Management of an incidentally discovered pulmonary nodule. Eur Radiol 17(2):449–466
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):946–948
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):754–773
Berlin L (2011) The incidentaloma: a medicolegal dilemma. Radiol Clin North Am 49(2):245–255
Boland GW et al (2008) Incidental adrenal lesions: principles, techniques, and algorithms for imaging characterization. Radiology 249(3):756–775
Booth TC et al (2012) Management of incidental findings during imaging research in “healthy” volunteers: current UK practice. Br J Radiol 85(1009):11–21
Borra RJ, Sorensen AG (2011) Incidental findings in brain MRI research: what do we owe our subjects? J Am Coll Radiol 8(12):848–852
Bradley AJ, Lim YY, Singh FM (2011) Imaging features, follow-up, and management of incidentally detected renal lesions. Clin Radiol 66(12):1129–1139
Childs DD, Leyendecker JR (2008) MRI of the pelvis: a guide to incidental findings for musculoskeletal radiologists. Semin Musculoskelet Radiol 12(1):83–103
Chow A, Drummond KJ (2010) Ethical considerations for normal control subjects in MRI research. J Clin Neurosci 17(9):1111–1113
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 Cedex
Cordell S (2011) The biobank as an ethical subject. Health Care Anal 19(3):282–294
Cramer SC et al (2011) A system for addressing incidental findings in neuroimaging research. Neuroimage 55(3):1020–1023
de Rave S, Hussain SM (2002) A liver tumour as an incidental finding: differential diagnosis and treatment. Scand J Gastroenterol Suppl 236:81–86
Erdogan D et al (2007) Management of liver hemangiomas according to size and symptoms. J Gastroenterol Hepatol 22(11):1953–1958
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):27–31
German National Cohort (GNC) Consortium (2014) The German national cohort: aims, study design and organization. Eur J Epidemiol 29(5):371–382
Gore RM et al (2011) Hepatic incidentalomas. Radiol Clin North Am 49(2):291–322
Gross MD et al (2010) Incidentally-discovered adrenal masses. Discov Med 9(44):24–33
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):596–600
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):816–826
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):194–199
Illes J (2008) Brain screening and incidental findings: flocking to folly? Lancet Neurol 7(1):23–24
International Ethical Guidelines for Biomedical Research Involving Human Subjects. (2002). Council for International Organizations of Medical Sciences (CIOMS), Geneva
Irwin RB et al (2013) Incidental extra-cardiac findings on clinical CMR. Eur Heart J Cardiovasc Imaging 14(2):158–166
Johnson PT et al (2011) Common incidental findings on MDCT: survey of radiologist recommendations for patient management. J Am Coll Radiol 8(11):762–767
Kamath S et al (2009) Incidental findings on MRI of the spine. Clin Radiol 64(4):353–361
Khosa F et al (2011) Prevalence of noncardiac findings on clinical cardiovascular MRI. AJR Am J Roentgenol 196(4):W380–W386
Ladd SC (2009) Whole-body MRI as a screening tool? Eur J Radiol 70(3):452–462
Lee S, Joo KB, Ryu JA (2011) Subjective incidental findings of the lumbar spine at MRI. Am J Roentgenol 197(6):W1168–W1168
Legmann P (2009) Adrenal incidentaloma: management approaches: CT – MRI. J Radiol 90(3 Pt 2):426–443
Lumbreras B, Donat L, Hernandez-Aguado I (2010a) Incidental findings in imaging diagnostic tests: a systematic review. Br J Radiol 83(988):276–289
Lumbreras B et al (2010b) Unexpected findings at imaging: predicting frequency in various types of studies. Eur J Radiol 74(1):269–274
Lund-Johansen M (2013) Expect the unexpected: incidental findings on brain magnetic resonance imaging. World Neurosurg 80(5):e119–e120
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):395–400
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):5–11
Matsusue E et al (2006) White matter changes in elderly people: MR-pathologic correlations. Magn Reson Med Sci 5(2):99–104
McKenna DA, Laxpati M, Colletti PM (2008) The prevalence of incidental findings at cardiac MRI. Open Cardiovasc Med J 2:20–25
Megibow AJ et al (2011) The incidental pancreatic cyst. Radiol Clin North Am 49(2):349–359
Milstein AC (2008) Research malpractice and the issue of incidental findings. J Law Med Ethics 36(2):356–360, 214
Morin SHX et al (2009) Incidental findings in healthy control research subjects using whole-body MRI. Eur J Radiol 72(3):529–533
Morris Z et al (2009) Incidental findings on brain magnetic resonance imaging: systematic review and meta-analysis. BMJ 339:b3016
Nelson CA (2008) Incidental findings in magnetic resonance imaging (MRI) brain research. J Law Med Ethics 36(2):315–319, 213
Orme NM et al (2010) Incidental findings in imaging research: evaluating incidence, benefit, and burden. Arch Intern Med 170(17):1525–1532
Pierce SR et al (2009) Incidental findings during functional magnetic resonance imaging: ethical and procedural issues. Am J Phys Med Rehabil 88(4):275–277
Puls R, Hamm B, Hosten N (2010) MRI without radiologists–ethical aspects of population based studies with MRI imaging. Rofo 182(6):469–471
Radiologists, T.R.C.o., Management of Incidental Findings detected during Research Imaging (2011). The Royal College of Radiologists, London
Richardson HS (2008) Incidental findings and ancillary-care obligations. J Law Med Ethics 36(2):256–270, 211
Robinson PJ (1997) Radiology’s Achilles’ heel: error and variation in the interpretation of the Rontgen image. Br J Radiol 70(839):1085–1098
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, 212
Shoemaker JM et al (2011) A practical approach to incidental findings in neuroimaging research. Neurology 77(24):2123–2127
Subhas N et al (2009) Incidental tumor and tumor-like lesions around the knee. Semin Musculoskelet Radiol 13(4):353–370
van der Lugt A (2009) Incidental findings on brain magnetic resonance imaging. BMJ 339:b310
Vanel D et al (2009) The incidental skeletal lesion: ignore or explore? Cancer Imaging 9(Spec No A):S38–S43
Vernooij MW et al (2007) Incidental findings on brain MRI in the general population. N Engl J Med 357(18):1821–1828
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):562–564
Wichmann HE et al (2012) The German national cohort. Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz 55(6-7):781–787
Zarzeczny A, Caulfield T (2012) Legal liability and research ethics boards: the case of neuroimaging and incidental findings. Int J Law Psychiatry 35(2):137–145
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2016 Springer International Publishing Switzerland
About this chapter
Cite this chapter
Bertheau, R.C., von Stackelberg, O., Weckbach, S., Kauczor, HU., Schlett, C.L. (2016). Management of Incidental Findings in the German National Cohort. In: Weckbach, S. (eds) Incidental Radiological Findings. Medical Radiology(). Springer, Cham. https://doi.org/10.1007/174_2016_63
Download citation
DOI: https://doi.org/10.1007/174_2016_63
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-319-42579-5
Online ISBN: 978-3-319-42581-8
eBook Packages: MedicineMedicine (R0)