Involving Patients in Hospital-Based Health Technology Assessment of Innovative Medical Devices: Adapting to a Specific Local Context and Lessons Learned From the Assessment of an Ex Vivo Perfusion System of Human Donor Hearts.

introductionA demand from the cardiac surgery and heart transplantation department of a French (Lyon) university hospital to adopt an ex-vivo perfusion system of human donor hearts was a chance to actively involve patients in our hospital-based health technology assessment (HB-HTA) process. MATERIAL AND

methodsWe selected an existing framework for patient involvement in HB-HTA and involved patients at two stages of the HB-HTA process: evaluation and dissemination. Firstly, we conducted a consultation-oriented workshop to gather patient perspectives on the introduction of the technology in our hospital, based on their significant experience of healthcare. Secondly, we organized an information-oriented workshop to communicate the HB-HTA results to the patients consulted, after the decision had been taken.

resultsWe modified the framework for patient involvement to suit the local decision-making context, the HB-HTA methodology, and the type of technologies assessed in our institution. Patients perceived the ex-vivo perfusion system as a promising technology to facilitate access to heart transplantation. They emphasized the importance of a tailored information provided to patients about the potential use of the technology in their healthcare trajectories, and suggested involvement of patients to facilitate its implementation in hospitals. DISCUSSION: Modifying existing frameworks for patient involvement to fit specific local contexts should be encouraged, and has to address the need of timely information for decision-makers and patient recruitment issues. Decision to incorporate patient perspectives and experiences should be made on a project-by-project basis, and focus on innovative medical devices with expected significant impact on patient quality of life. Effective and transparent communication and prospective feedbacks from HB-HTA producers to patients are essential for a successful process. PATIENT OR PUBLIC CONTRIBUTION: Three patients with a lived experience of heart transplantation, or another transplant procedure, or more broadly procedures involving innovative medical devices (specialists) and two patients recruited for societal issues and legitimacy of a collective voice were involved (generalists).