Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the...

Area of Science:

• Clinical Trial Methodology
• Reporting Guidelines
• Interventional Research

Background:

• Factorial trials require specific reporting standards beyond existing guidelines.
• The Reporting Factorial Trials (RAFT) group aimed to address this gap.
• Existing SPIRIT and CONSORT guidelines needed extensions for factorial trial designs.

Purpose of the Study:

• To develop extensions for the SPIRIT and CONSORT reporting guidelines tailored for factorial trials.
• To ensure comprehensive and transparent reporting of factorial trial methodology and results.

Main Methods:

• A four-phase consensus-based approach was employed.
• This included a scoping review, a multi-round Delphi survey with 104 respondents, a consensus meeting with 15 experts, and checklist finalization.
• Iterative refinement and expert review ensured the development of specific reporting items.

Main Results:

• The scoping review identified 31 recommendations, leading to 50 concepts for guideline development.
• A Delphi survey refined these concepts, with 49 reaching consensus.
• The process resulted in 9 SPIRIT extension items and 17 CONSORT extension items.

Conclusions:

• Adoption of the developed SPIRIT and CONSORT extensions will enhance the conduct, understanding, and interpretation of factorial trials.
• Transparency in the development process promotes best practices for creating future reporting guidelines.
• These extensions aim to improve the quality and consistency of reporting for complex factorial trial designs.