ArticleBMJ open2025
Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
2 citing papers in PubMed.
- Development of a tic service model for children and young people in England: a Delphi study.BMJ open · 2026Article
- Reporting of dog-assisted intervention trials: extension of the SPIRIT 2025 and CONSORT 2025 statement.BMC medical research methodology · 2026Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundExtensions to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting recommendations specifically for factorial trials have been developed by the Reporting Factorial Trials (RAFT) study group. This article describes the processes and methods used to develop the extensions.
objectiveTo develop SPIRIT and CONSORT extensions for factorial trials. DESIGN AND
participantsA four-phase, consensus-based approach was used: phase 1: scoping review, phase 2: Delphi survey (n=104 respondents in round 1), phase 3: consensus meeting (n=15 members) and phase 4: checklist finalisation.
resultsIn phase 1, the scoping review identified 31 reporting recommendations, which formed a long list of 50 concepts (19 applied to the SPIRIT extension and 31 applied to the CONSORT extension) to include in the guideline development. In phase 2, a three-round Delphi survey resulted in two new concepts being added and ended with 49 concepts (19 applied to SPIRIT and 30 applied to CONSORT) reaching consensus to remain, with only three concepts meeting the exclusion criteria. In phase 3, the concepts were further refined and translated into specific extension item wording, through an extensive review process conducted by the core RAFT team and leading trial experts, who attended a 2-day hybrid meeting. The resulting 9 SPIRIT items and 17 CONSORT items were further evaluated and developed through an iterative process in phase 4, to promote user acceptance and uptake.
conclusionUptake of the CONSORT and SPIRIT extensions will improve the conduct of factorial trials, as well as understanding and interpretation of such trials. By reporting on how these extensions were developed, we promote transparency of this process and share learning experiences to develop best practice when developing reporting guidelines.
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