Patient and public involvement and engagement in the ASCEND PLUS trial: reflections from the design of a streamlined and decentralised clinical trial
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Summary
This summary is machine-generated.Patient and Public Involvement and Engagement (PPIE) was crucial for the ASCEND PLUS trial, optimizing its decentralized design and ensuring participant accessibility for the large-scale study on type 2 diabetes and cardiovascular events.
Area Of Science
- Clinical Trials
- Patient-Centered Research
- Diabetes Management
Background
- The ASCEND PLUS trial is a large-scale randomized controlled trial in the UK.
- It investigates oral semaglutide for cardiovascular event prevention in approximately 20,000 individuals with type 2 diabetes.
- The trial utilizes an innovative decentralized model for participant interaction, minimizing physical site requirements.
Purpose Of The Study
- To detail the process and outcomes of Patient and Public Involvement and Engagement (PPIE) activities within the ASCEND PLUS trial.
- To assess the impact of PPIE on trial design and execution.
- To identify lessons learned for future clinical trial implementations.
Main Methods
- Central coordination of PPIE activities, including six focus groups and a Public Advisory Group (PAG).
- Strategic recruitment for PPIE groups to ensure diversity among adults with type 2 diabetes across the UK.
- Online meetings for focus groups, PAG, and Steering Committee, supplemented by hybrid workshops.
Main Results
- PPIE significantly influenced the trial's design, offering participants choices for screening and consent (online or via calls).
- Development of concise information leaflets and review of all participant-facing materials for clarity and accessibility by the PAG.
- PAG input was vital in selecting quality-of-life assessment tools.
Conclusions
- Patient and Public Involvement and Engagement is fundamental to the ASCEND PLUS trial's ongoing success.
- PPIE has been critical in optimizing trial design, securing approvals, and facilitating trial conduct.
- The insights gained will inform future PPIE strategies in clinical research.
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