Communicating incidental and reportable findings from research MRIs: considering factors beyond the findings in an underrepresented pediatric population

Kiley B Vander Wyst,Kiri Olsen,Lee Seabrooke,Armando Peña,Janiel Pimentel,Gabriel Q Shaibi,Micah L Olson,Smita S Bailey,Robert B Rosenberg,Mitchell Shub,Jeffrey Miller,Ana Martinez Valencia

doi:10.1186/s12874-021-01459-8

Abstract

BackgroundThe application of advanced imaging in pediatric research trials introduces the challenge of how to effectively handle and communicate incidental and reportable findings. This challenge is amplified in underserved populations that experience disparities in access to healthcare as recommendations for follow-up care may be difficult to coordinate. Therefore, the purpose of the present report is to describe the process for identifying and communicating findings from a research MRI to low-income Latino children and families.MethodsLatino adolescents (n = 86) aged 12–16 years old with obesity and prediabetes underwent a research MRI (3 Tesla Philips Ingenia®) as part of a randomized controlled diabetes prevention trial. The research MRIs were performed at baseline and 6 months to assess changes in whole-abdominal fat distribution and organ fat in response to the intervention. An institutional pathway was developed for identifying and reporting findings to participants and families. The pathway was developed through a collaborative process with hospital administration, research compliance, radiology, and the research team. All research images were reviewed by a board-certified pediatric radiologist who conveyed findings to the study pediatrician for determination of clinical actionability and reportability to children and families. Pediatric sub-specialists were consulted as necessary and a primary care practitioner (PCP) from a free community health clinic agreed to receive referrals for uninsured participants.ResultsA total of 139 images (86 pre- and 53 post-intervention) were reviewed with 31 findings identified and 23 deemed clinically actionable and reportable. The only reportable finding was severely elevated liver fat (> 10%, n = 14) with the most common and concerning incidental findings being horseshoe kidney (n = 1) and lung lesion (n = 1). The remainder (n = 7) were less serious. Of youth with a reportable or incidental finding, 18 had a PCP but only 7 scheduled a follow-up appointment. Seven participants without a PCP were referred to a safety-net clinic for follow-up.ConclusionsWith the increased utilization of high-resolution imaging in pediatric research, additional standardization is needed on what, when, and how to return incidental and reportable findings to participants, particularly among historically underrepresented populations that may be underserved in the community.Trial registrationPreventing Diabetes in Latino Youth, NCT02615353

Highlights

The application of advanced imaging in pediatric research trials introduces the challenge of how to effectively handle and communicate incidental and reportable findings
With the increased utilization of high-resolution imaging in pediatric research, additional standardization is needed on what, when, and how to return incidental and reportable findings to participants, among historically underrepresented populations that may be underserved in the community
The aims of the current report are: 1) describe the process for identifying and returning findings from a research MRI to low-income Latino children and families participating in a randomized clinical trial with an imaging component, 2) characterize the number, type, and potential implications of findings on follow-up management, and 3) present key lessons learned throughout the process

Summary

Introduction

The application of advanced imaging in pediatric research trials introduces the challenge of how to effectively handle and communicate incidental and reportable findings. This challenge is amplified in underserved populations that experience disparities in access to healthcare as recommendations for follow-up care may be difficult to coordinate. Incidental findings (IFs) add further disclosure challenges for researchers as they often represent a discovery unrelated to the purpose of the study but may be valid and medically actionable [2, 3]. Communication of IFs may be further complicated among underserved and otherwise underrepresented pediatric populations who experience a disproportionate burden of disease due to social determinants of health [7, 8]. As efforts are made to increase the diversity of clinical trial populations by enrolling underrepresented and underserved groups [21], it is critical for researchers to consider contextual and structural factors that are operational within socially disadvantaged populations so that research participation does not exacerbate existing heath disparities

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