The extent of Patient and Public Involvement and Engagement in Sequential Multiple Assignment Randomised Trials: A...

Area of Science:

• Clinical Trials Methodology
• Health Services Research
• Patient and Public Involvement and Engagement (PPIE)

Background:

• Sequential Multiple Assignment Randomised Trials (SMARTs) are advanced methods for personalized interventions.
• Patient and Public Involvement and Engagement (PPIE) enhances research relevance and impact.
• The integration of PPIE in SMARTs is not well understood.

Purpose of the Study:

• To map the extent, nature, and quality of PPIE reporting in published SMARTs.
• To identify gaps in PPIE integration within SMART methodology.
• To inform best practices for PPIE in adaptive clinical trial designs.

Main Methods:

• A scoping review methodology was employed, following the Joanna Briggs Institute guidelines.
• Sixty completed SMARTs were assessed, including protocols and registry entries.
• Data extraction utilized a charting form developed with public contributor input and the GRIPP2-SF checklist.

Main Results:

• Only 8.3% of SMARTs reported any PPIE, often limited to the protocol stage.
• PPIE was primarily involved in the design and development phases, with no reporting of involvement in analysis, interpretation, or dissemination.
• No trial fully met the GRIPP2-SF criteria, formally evaluated PPIE's impact, or critically reflected on the involvement process.

Conclusions:

• Reporting of PPIE in SMARTs is currently inadequate.
• Comprehensive PPIE integration and reporting are essential for advancing SMART methodology and developing acceptable interventions.
• Recommendations include embedding PPIE using frameworks like GRIPP2-SF, requiring funder monitoring, and implementing CONSORT 2025 guidelines.