Governance of a Learning Health Care System for Oncology: Patient Recommendations

Abstract

QUESTION ASKED: What are patients' opinions about how to govern users and uses of learning health care system (LHS) data? SUMMARY ANSWER: Beyond robust approaches to individual informed consent, the involvement of trained, informed patients in decision making at the level of system governance is essential. Those considering enrolling patients in LHSs should select LHSs that include patient representation on governing boards; provide transparency regarding users, uses, and outcomes (including the requirement that users publish their findings as a way to earn and maintain patient trust); and ensure surveillance and ongoing oversight of for-profit users. WHAT WE DID: We conducted democratic deliberation sessions with patients along with focused discussions on ethical issues associated with CancerLinQ, a real-world oncology LHS. WHAT WE FOUND: Patients were concerned that profit-driven users might manipulate LHS data in ways that could burden or exploit patients, hinder medical decisions , or compromise patient-provider communication. They recommended restricted access, user fees, and penalties to prevent users, especially for-profit entities, from misusing data. BIAS, CONFOUNDING FACTORS, REAL-LIFE IMPLICATIONS: The results of this study might not be generalizable to a broader patient population. Patients who have been diagnosed with cancer may be more likely to see a clear link between research, medical advances, and their own quality of care and well-being, and thus may support access to their data more so than those who have never been diagnosed. abstract PURPOSE The learning health care system (LHS) was designed to enable real-time learning and research by harnessing data generated during patients' clinical encounters. This novel approach begets ethical questions regarding the oversight of users and uses of patient data. Understanding patients' perspectives is vitally important. MATERIALS AND METHODS We conducted democratic deliberation sessions focused on CancerLinQ, a real-world LHS. Experts presented educational content, and then small group discussions were held to elicit viewpoints. The deliberations centered around whether policies should permit or deny certain users and uses of secondary data. De-identified transcripts of the discussions were examined by using thematic analysis. RESULTS Analysis identified two thematic clusters: expectations and concerns, which seemed to inform LHS governance recommendations. Participants expected to benefit from the LHS through the advancement of medical knowledge, which they hoped would improve treatments and the quality of their care. They were concerned that profit-driven users might manipulate the data in ways that could burden or exploit patients, hinder medical decisions, or compromise patient-provider communication. It was recommended that restricted access, user fees, and penalties should be imposed to prevent users, especially for-profit entities, from misusing data. Another suggestion was that patients should be notified of potential ethical issues and included on diverse, unbiased governing boards. CONCLUSION If patients are to trust and support LHS endeavors, their concerns about for-profit users must be addressed. The ethical implementation of such systems should consist of patient representation on governing boards, transparency, and strict oversight of for-profit users.