DOI: 10.6084/m9.figshare.30913478
title: Evaluating the utility of a patient and public involvement and engagement (PPIE) end-of-trial event to re-engage with cell-based therapy participants

description: 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. 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. 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. This study highlights the importance of integrating participant perspectives to optimize trial design and delivery in future cell therapy research. Research and delivery of cell-based therapies is growing quickly. Cell-based therapies use living cells, often to repair or replace damaged tissues. For these treatments to become widely available, they have to be tested in clinical trials. However, we still know little about what it is like for patients to take part in clinical trials using cell-based therapies. This study explored the experiences and attitudes of people involved in the ASCOT trial, a long-term study comparing different cell therapies for repairing damaged cartilage. Participants were asked about their experience of taking part in the study, their rehabilitation experiences and to share their views on future cell therapy trials. Information about how to best design and deliver future research which embeds patient and public involvement (known as PPIE) was also gathered. To collect this feedback, the research team tested whether an end-of-trial event would be a good way to reconnect with participants. Although the clinical trial required significant time and effort, including long follow-up time and completion of many follow-up questionnaires, participants reported very positive experiences overall. Participants also highlighted opportunities for improvement in future trials, such as providing earlier and more transparent updates on trial results and offering better support to help patients take an active role in PPIE. The study showed that an end-of-trial event is a useful and practical way to gather this kind of feedback. Overall, the findings emphasize how important it is to include participant perspectives when designing and running future cell-therapy research.