A patient and public involvement (PPI) toolkit for meaningful and flexible involvement in clinical trials – a work in progress

摘要: Funders of research are increasingly requiring researchers to involve patients and the public in their research. Patient involvement (PPI) can potentially help make sure that design is relevant, it participant friendly ethically sound. Using sharing PPI resources benefit those involved undertaking PPI, but existing not used consistently this lead duplication effort. This paper describes how we developing a toolkit support clinical trials teams unit. The will provide key ‘off shelf’ resource trial with limited resources, PPI. Key activities further maintaining to: ● listen views experience both patient contributors who use tools; modify tools based on our using them; identify need for future update any newly identified come light; raise awareness work collaboration others either develop or test out order reduce Background funder requirement due potential benefits friendly, sound available leading undertake effective meaningful Methods first phase was describe which should be considered pathway at what stage these take place. informed through review type timing within coordinated by Clinical Trials Research Centre previously described areas impact trials. In second phase, websites around identification opportunistically, e.g. conversation other trialists social media, were resources. Tools developed where gaps existed. Results A flowchart describing point happen. Three domains identified: planning PPI; supporting recording evaluating Four main corresponding under PPI: plan; identifying contributors; allocating appropriate costs; managing expectations. information sheets. These tools, require summary characteristics circumstances clarify requirements expectations review. For planned interventions monitored terms impact, tool monitor contributor development. Conclusions provides use;