A 360 Degree Qualitative Ethical Assessment of Reporting Patient Reported Outcomes

While guidelines exist for returning genetic, biomarker, and radiologic research results, there is little guidance regarding the return of patient-reported outcome (PRO) research results. As a supplement to an ongoing trial of palliative care for Parkinson's disease, we conducted thirty qualitative, semi-structured interviews of persons with Parkinson's disease, their carepartners, community neurologists, primary care physicians, and researchers to elicit their perceptions of returning PRO research data to persons with Parkinson's disease and carepartners. Interviews were audio-taped, transcribed, double-coded, and analyzed for themes. Participants supported returning tailored PRO research results when feasible. Clinicians wanted clinically-actionable results. Researchers thought that returning aggregate results should be standard practice. However, our persons with Parkinson's disease and carepartners reported privacy concerns. Clinicians had mixed reactions about receiving non-actionable research results. Researchers worried whether returning individual results during a study could impact research integrity. Additional research is needed to develop optimal guidelines for future research studies.