Finding the Ethical Path Forward: A Bioethical and Stakeholder-driven Investigation on the Sharing of Palliative-related Survey Results with Patients, Caregivers and Community Clinicians

University Of Rochester, Rochester NY

Investigators

Linked publications, trials & patents

Abstract

PROJECT SUMMARY/ABSTRACT Despite growing advocacy to make health data available to patients a standard in clinical care, clinical research data are often not shared with participants despite the potential for this data to improve care and real- world outcomes. The literature shows that most participants want to receive research results. However, there is no clear guidance or consensus on how to ethically and effectively return individual non-genetic research results (IRR). Notably, efforts for increasing transparency in clinical research have been largely limited to genomics with few studies looking at the much more common, and potentially actionable, patient reported outcomes (PRO) collected in the course of clinical research. In this supplement, we focus on return of these patient-reported outcomes to patients, family carepartners, and community clinicians from the perspectives of these key stakeholders, as well as researchers and bioethics. The proposed project is a one-year Bioethics Supplement that leverages an ongoing R01-funded pragmatic trial of community-based palliative care for people living with Parkinson's disease (PD) and Lewy Body Dementia (an NIH-designated Alzheimer Disease Related Disorder; ADRD). Stakeholder participants for this supplement will include our community clinician partners, as well as patients and family carepartners who have completed their final data collection for the parent trial. By making available PROs, it is possible that researchers may increase engagement of participants, convey respect for participants' autonomy, and empower participants' personal decision-making processes. There are also risks, such as increasing anxiety or distress, providing information that is not actionable, interfering in the patient's relationship with their community provider, and contaminating research results if this information leads to changes in health behaviors. There are also privacy concerns regarding what information is shared between patients and family carepartners and between the clinician and the carepartner. It is thus critical to understand what, when, and how to share IRRs. The Specific Aims of this supplement are to: 1) Elicit input from key stakeholders (patients, caregivers, community clinicians, and investigators) to understand views, concerns, and preferences on returning patient- and caregiver-reported outcomes using mixed methods; and, 2) Engage an interdisciplinary committee of bioethicists, palliative care researchers, community clinicians, carepartners, and individuals with PD in a review of the key findings to develop preliminary recommendations about the return of PROs. Lessons learned through this research will inform our future work in PD and palliative care research, including building capacity to incorporate returning patient reported outcome (PRO) results to participants in an ethically sound manner. We anticipate this work will have implications for clinical research outside of palliative care and neurology and may set a foundation for future studies looking to ethically integrate return of PROs and other non-genomic IRRs into trial design.