Management of Incidental Findings in the German National Cohort

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.