Impact of detecting potentially serious incidental findings during multi-modal imaging

Abstract

There are limited data on the impact of feedback of incidental Background findings (IFs) from research imaging. We evaluated the impact of UK Biobank's protocol for handling potentially serious IFs in a multi-modal imaging study of 100,000 participants (radiographer 'flagging' with radiologist confirmation of potentially serious IFs) compared with systematic radiologist review of all images.: Brain, cardiac and body magnetic resonance, and dual-energy x-ray Methods absorptiometry scans from the first 1000 imaged UK Biobank participants were independently assessed for potentially serious IFs using both protocols. We surveyed participants with potentially serious IFs and their GPs up to six months after imaging to determine subsequent clinical assessments, final diagnoses, emotional, financial and work or activity impacts.: : Compared with systematic radiologist review, radiographer Conclusions flagging missed some serious diagnoses, but avoided adverse impacts for many participants with non-serious diagnoses. While systematic radiologist review may benefit some participants, UK Biobank's responsibility to avoid both unnecessary harm to larger numbers of participants and burdening of publicly-funded health services suggests that radiographer flagging is a justifiable approach in the UK Biobank imaging study. The potential scale of non-serious final diagnoses raises questions relating to handling IFs in other settings, such as commercial and public health screening.

Factors associated with potentially serious incidental findings and with serious final diagnoses on multi-modal imaging in the UK Biobank Imaging Study: A prospective cohort study

“…Brain and body imaging is increasingly used for research, diagnostic and screening purposes and is accompanied by the risk of identifying abnormalities which are unrelated to the purposes of the imaging, so-called incidental findings (IFs) [1]. Since very few IFs turn out to represent serious disease [2], it is of limited value to feedback clearly non-serious IFs. Therefore, we focus on potentially serious IFs (PSIFs), defined as those which indicate the possibility of a condition which, if confirmed, would carry a real prospect of seriously threatening life span, or of having a substantial impact on major body functions or quality of life [2].…”

The UK Biobank imaging enhancement of 100,000 participants: rationale, data collection, management and future directions

“…In light of these findings from the pilot and with additional advice from UKB's independent Ethics and Governance Council, we concluded that the proposed UKB imaging incidental findings protocol to use radiographer flagging (and not systematic radiologist review) provides an acceptable balance of benefit versus harm to the participants, as detailed elsewhere 12 .…”

The Duty to Look for Incidental Findings in Imaging Research

“…Compared to radiographer flagging, the overall balance of harms and benefits of systematic radiologist review was ultimately considered uncertain. 42 If it turns out that systematic radiologist review (or other strategies aimed at increasing the yield of incidental findings) would produce more harm than good, then we should not adopt them. However, this is not because researchers do not have a duty to look.…”

“…Although we think that there are important unresolved questions regarding the kinds of findings that should be communicated to participants, this article takes no position on what range of incidental findings ought to be disclosed to them; we are merely arguing in favor of looking for incidental findings that should be reported to participants, whatever that range is determined to be. The German National Cohort MRI Study 20 and the U.K. Biobank Imaging Study 21 have already developed lists of potentially serious findings to report to participants. These lists were jointly developed by radiologists, clinicians, ethicists, and epidemiologists, and they are subject to ongoing review.…”

“…These false positives caused needless anxiety and unnecessary clinical assessment, which had negative impacts on some participants' finances, access to insurance, and emotional well‐being. Compared to radiographer flagging, the overall balance of harms and benefits of systematic radiologist review was ultimately considered uncertain 42 . If it turns out that systematic radiologist review (or other strategies aimed at increasing the yield of incidental findings) would produce more harm than good, then we should not adopt them.…”