The extent of Patient and Public Involvement and Engagement in Sequential Multiple Assignment Randomised Trials: A scoping Review.
TL;DR
PPIE reporting in SMARTs is inadequate, which hinders efforts to advance this design and develop acceptable interventions, and it is recommended that researchers embed and comprehensively report PPIE using frameworks such as GRIPP2-SF, that funders require and monitor it, and that journals implement the new CONSORT 2025 involvement item.
Abstract
Background
Sequential Multiple Assignment Randomised Trials (SMARTs) offers a robust methodology for developing adaptive, personalised interventions, but their unfamiliarity may limit accessibility for patients and the public. Patient and public involvement and engagement (PPIE) makes research more relevant, acceptable and impactful, yet its integration into these trials remains unclear. We aimed to map the extent, nature and quality of PPIE reporting in published SMARTs.
Methods
We conducted a scoping review following the Joanna Briggs Institute methodology and reported according to the PRISMA-ScR. We assessed 60 completed SMARTs: 35 identified through a prior review (to June 2024) and 25 through an updated search in five databases (Scopus, Medline, Web of Science, PubMed, and PsycINFO) up to June 2026. For each trial, we also searched associated protocols and registry entries. Data were extracted using a charting form developed with input from two public contributors and guided by the GRIPP2-SF (Guidance for Reporting Involvement of Patients and Public) checklist.
Results
Only five of 60 SMARTs (8.3%) reported any PPIE, and in three, it appeared in the protocol only. All five trials were conducted in the USA, three in psychiatric disorders, one each in cancer and HIV prevention and were publicly. Involvement was described in varied terms, including community advisory boards, consumer consultants, and youth advisory council. PPIE occurred almost entirely during design and development; none reported involving contributors in analysis or interpretation, dissemination or co-authorship. No trial fully met GRIPP2-SF, formally evaluated PPIE's affect or reflected critically on involvement process.
Conclusions
PPIE reporting in SMARTs is inadequate, which hinders efforts to advance this design and develop acceptable interventions. We recommend that researchers embed and comprehensively report PPIE using frameworks such as GRIPP2-SF, that funders require and monitor it, and that journals implement the new CONSORT 2025 involvement item.