Dataset Information

A practical approach to incidental findings in neuroimaging research.

ABSTRACT:

Objective

We describe the systematic approach to incidental findings (IFs) used at the Mind Research Network (MRN) where all MRI scans receive neuroradiologist interpretation and participants are provided results.

Methods

From 2004 to 2011, 8,545 MRI scans were acquired by 45 researchers. As mandated by MRN's external institutional review board, all structural sequences were evaluated by a clinical neuroradiologist who generated a report that included recommendations for referral if indicated. Investigators received a copy of their participants' reports, which were also mailed to participants unless they specifically declined. To better understand the impact of the radiology review process, a financial analysis was completed in addition to a follow-up phone survey to characterize participant perceptions regarding receiving their MRI scan results.

Results

The radiologist identified IFs in 34% of the 4,447 participants. Of those with IFs (n = 1,518), the radiologist recommended urgent or immediate referral for 2.5% and routine referral for 17%. For 80.5%, no referral was recommended. Estimated annual cost for this approach including support for the neuroradiologist, medical director, and ancillary staff is approximately $60,000 or $24/scan. The results of the retrospective phone survey showed that 92% of participants appreciated receiving their MRI report, and the majority stated it increased their likelihood of volunteering for future studies.

Conclusions

Addressing IFs in a cost-effective and consistent manner is possible by adopting a policy that provides neuroradiology interpretation and offers participant assistance with clinical follow-up when necessary. Our experience suggests that an ethical, institution-wide approach to IFs can be implemented with minimal investigator burden.

SUBMITTER: Shoemaker JM

PROVIDER: S-EPMC3235350 | biostudies-literature | 2011 Dec

REPOSITORIES: biostudies-literature

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Publications

A practical approach to incidental findings in neuroimaging research.

Shoemaker J M JM Holdsworth M T MT Aine C C Calhoun V D VD de La Garza R R Feldstein Ewing S W SW Hayek R R Mayer A R AR Kiehl K A KA Petree L E LE Sanjuan P P Scott A A Stephen J J Phillips J P JP

Neurology 20111130 24

<h4>Objective</h4>We describe the systematic approach to incidental findings (IFs) used at the Mind Research Network (MRN) where all MRI scans receive neuroradiologist interpretation and participants are provided results.<h4>Methods</h4>From 2004 to 2011, 8,545 MRI scans were acquired by 45 researchers. As mandated by MRN's external institutional review board, all structural sequences were evaluated by a clinical neuroradiologist who generated a report that included recommendations for referral ...[more]

PMID: 22131543

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Project description: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.

Dataset Information

A practical approach to incidental findings in neuroimaging research.

Objective

Methods

Results

Conclusions

Publications

A practical approach to incidental findings in neuroimaging research.

Similar Datasets

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