Comments, Suggestions and Criticisms of the PRECIS-2 Design Tool: A Citation Analysis.

The Pragmatic Explanatory Continuum Indicator Summary (PRECIS) tool, initially published in 2009 and revised in 2015, was created to assist trialists to align their design choices with the intended purpose of their randomised controlled trial (RCT): either to guide real-world decisions between alternative interventions (pragmatic) or to test hypotheses about intervention mechanisms by minimising sources of variation (explanatory). There have been many comments, suggestions and criticisms of PRECIS-2. This summary will be used to facilitate the development of to the next revision, PRECIS-3. We used Web of Science to identify all publication types citing PRECIS-2, published between May 2015 and July 2023. Citations were eligible if they contained 'substantive' suggestions, comments or criticism of the PRECIS-2 tool. We defined 'substantive' as comments explicitly referencing at least one PRECIS-2 domain, or a concept directly linked to an existing or newly proposed domain Two reviewers independently extracted comments, suggestions and criticisms, noting their implications for the update. These were discussed amongst authors to achieve consensus on the interpretation of each comment and its implications for PRECIS-3. The search yielded 885 publications, and after full-text review, 89 articles met the inclusion criteria. Comments pertained to new domains, changes in existing domains, or were relevant across several or all domains. Proposed new domains included assessment of the comparator arm and a domain to describe blinding. There were concerns about scoring eligibility and recruitment domains for cluster trials. Suggested areas for improvement across domains included the need for more scoring guidance for explanatory design choices. Published comments recognise PRECIS-2's success in aiding trialists with pragmatic or explanatory design choices. Enhancing its implementation and widespread use will involve adding new domains, refining domain definitions, and addressing overall tool issues. This citation review offers valuable user feedback, pivotal for shaping the upcoming version of the PRECIS tool, PRECIS-3.

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