The PRO-CAR-T™ study: achieving excellence in patient and public involvement and engagement

Patient and Public Involvement and Engagement (PPIE) is advocated in Patient Reported Outcome (PRO) research, but implementation remains inconsistent and often suboptimal. Many barriers exist, including a lack of understanding about how to apply the principles of PPIE in practice. This paper offers an example of how PPIE can be meaningfully integrated into the development of a digital PRO system within the complex and rapidly evolving field of advanced therapies. The aims are to offer practical insights about how PPIE was conceptualised and operationalised in the context of this study, and use the lessons learned to inform future PPIE strategies for PRO research.

Co-produced strategy and delivery plans for PPIE were developed by stakeholders, including patients, carers and members of the public, and drawing on national standards and best practice guidelines. This was followed by activities to recruit additional Patient and Public Partners, provide training, identify opportunities for PPIE and map these to key decision points in the research plan. The success of these strategies and activities was evaluated using a range of reflective and assessment methods, in which personal experiences and formal feedback were combined to assess impact and identify areas for improvement.

Evaluation revealed that PPIE was successfully integrated across project management, study conduct, and dissemination, generating both research value and personal benefits. However, several conceptual, methodological, and practical challenges were encountered. Three key themes emerged: (i) the challenges of distinguishing between research and PPIE in PRO studies (ii) the factors that shape meaningful PPIE and research impact and (iii) areas for improvement. Early planning, finding the right people, and working co-productively were identified as critical facilitators.

Integrating excellent PPIE is achievable in PRO research, even in challenging contexts that involve life-threatening conditions and complex emerging therapies. Although barriers exist, our experience suggests many can be addressed and several actionable recommendations and resources are offered to strengthen PPIE in future PRO research.