Returning Incidental Research Findings From 18F-Fluorodeoxyglucose-Positron Emission Tomography/Computed Tomography to Participants: A Survey of Investigators From a Clinical Trial of Rheumatoid Arthritis.

Abstract

There are limited data on researchers' attitudes and beliefs on returning and managing incidental research findings from whole body 18F-fluorodeoxyglucose-positron emission tomography/computed tomography (FDG PET/CT) imaging. Site principal investigators (PIs) who enrolled participants for the Treatments Against Rheumatoid Arthritis and Effect on FDG PET/CT (TARGET) trial were surveyed. Of the 28 TARGET site PIs eligible for the study, 18 consented to participate (response rate: 64%). Many site PIs returned incidental findings to participants (61%), and the most common finding that was returned was serious (but not life-threatening) and treatable (54.5%). More than half of the investigators believed that adequacy of clinical follow up (58.8%) and legal liability if incidental findings are not disclosed (55.6%) were extremely important factors in returning incidental research findings from whole body FDG PET/CT. All investigators felt very obligated to return incidental research findings if scans revealed a treatable, high-risk medical condition. Most investigators felt very obligated to disclose incidental findings with important health implications (94.4%), for which proven preventive or therapeutic interventions exist (77.8%), that provide early detection of a health problem (72.2%), if participants ask for their incidental findings (72.2%), and if scans have established validity for a particular medical condition (61.1%). Although it is recommended that researchers report and manage incidental research findings, our data show differing views and uncertainties on what and how to return, and the extent of follow up needed to manage, incidental findings from whole body FDG PET/CT; this highlights the need for more specific and standardized guidance.