Mixed-methods study to develop extensions to the SPIRIT and CONSORT statements for factorial randomised trials: the Reporting Factorial Trials (RAFT) study.

ABSTRACT:

Background

Extensions 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.

Objective

To develop SPIRIT and CONSORT extensions for factorial trials.

Design and participants

A 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.

Results

In phase 1, the scoping review identified 31 reporting recommendations, which formed

SUBMITTER: Hall SS 

PROVIDER: S-EPMC11836851 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature