Evaluating the utility of a patient and public involvement and engagement (PPIE) end-of-trial event to re-engage with cell-based therapy participants.

Abstract

Aims: Although research in cell-based therapy is expanding, little is known about patient experience in cell therapy trials to-date. This study explores the experience and attitudes of participants involved in the ASCOT randomized controlled trial, a long-term orthopedic study comparing different cell therapies for the treatment of knee articular cartilage defects.

Methods: The clinical and rehabilitation experience of participants, and their attitudes relating to i) patient and public involvement (PPIE) in research and ii) future research on cellular therapy and clinical trials were explored through questionnaires. To gather this information, the utility of an end-of-trial event to reengage participants was evaluated.

Results: Despite the anticipated high burden, overall trial experience was reported as highly positive. Communication and ongoing engagement between patients and both the clinical and research teams may have contributed to this. Key challenges identified for future research include the need for early and transparent communication regarding trial results, and greater support to facilitate active PPIE involvement. The end-of-trial engagement event demonstrated feasibility and value as a model to gather this important PPIE data for future studies.

Conclusions: This study highlights the importance of integrating participant perspectives to optimize trial design and delivery in future cell therapy research.