Discovery and informing research participants of incidental findings detected in brain magnetic resonance imaging studies: Review and multi‐institutional study

Abstract

BackgroundBrain imaging studies using magnetic resonance imaging (MRI) sometimes reveal incidental findings (IFs) that might be relevant to some of the health issues in research participants. Although professional communities have discussed how to manage these IFs, there is no global consensus on the concrete handling procedures including how to inform participants of IFs.MethodsFirst, this study reviewed previous studies for the number of IFs discovered in brain imaging studies using MEDLINE. Second, a multi‐institutional study determined the number of IF discoveries and evaluated the method of informing participants at multiple institutions, which participated in a national brain science project in Japan.ResultsBoth the review and multi‐institutional study showed that IFs with a high urgency level were discovered in 0–2.0% of participants, including healthy volunteers, and that the rate of IF discovery in general was higher in studies conducted in elderly population. Moreover, multi‐institutional study suggested the criteria used to judge whether or not to inform participants of IFs may differ by institution.ConclusionsOur results suggest that in order to ensure informing the participants of high urgency IFs, physicians who are capable of interpreting brain images clinically should review all brain images, and the establishment of a support system is required for brain imaging studies at nonmedical institutions. Since the method of informing participants of IFs might affect their understanding and acceptance of IFs, which are related to managing risks of false “clean bill of health” or psychological impacts of informing IFs, further research focusing on communication of IFs is needed.

Prevalence and outcomes of incidental imaging findings: umbrella review

“…We included 20 systematic reviews from 7098 references identified from our database search (fig 1). 7 8 9 28 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 These 20 systematic reviews included 240 primary studies and 627 073 patients. Fifteen systematic reviews provided data to quantify the prevalence of detecting incidentalomas7 8 9 28 30 31 32 33 34 35 36 37 38 39 45 (table 1), whereas 18 provided data to quantify the outcomes of incidentalomas7 8 9 28 30 31 32 33 34 35 38 39 40 41 42 43 44 45 (table 2) (13 provided both).…”

“…We did not conduct meta-analyses for malignancy on data from three systematic reviews8 34 38 because incidentalomas were not stratified by malignancy (either stratified by “urgency level”34 or “significant findings”38) or the diagnosis of incidentalomas was inconsistently or not reported in primary studies 8. One of these systematic reviews quantified the outcome of brain incidentalomas 34. Of 2082 patients with brain incidentalomas, around half (n=1146, 55%) did not require a referral, whereas 815 (39%) were routinely referred for follow-up.…”

Potentially serious incidental findings on brain and body magnetic resonance imaging of apparently asymptomatic adults: systematic review and meta-analysis

“…In the recent umbrella review mentioned above, researchers reported a prevalence of incidental findings on brain MRI of 22% (95% confidence interval 14% to 31%), about 10 times higher than our pooled prevalence estimate for brain MRI. 8 56 57 Most of this difference is likely to be due to the umbrella review’s inclusion of all reported incidental findings, regardless of their potential clinical significance, whereas we focused on potentially serious incidental findings. Some of the difference might also be due to different study inclusion criteria (reflecting the different focus of the umbrella review, which had broader inclusion criteria, including studies of patients as well as apparently asymptomatic people), as well as a difference in meta-analytical methods.…”

Incidental Findings on Brain MRI in People with HIV Infection

“…In this study, we found a rate of 33.3% in the HIV cohort, 27% in the controls. Such a wide range of prevalence has been hypothesized to be due to varying methods, populations, and sample sizes 9,15,16 . Furthermore, there is evidence that the prevalence of incidental finding detection is more likely using high-resolution MRI sequences 17 .…”