Reporting of randomised factorial trials: development of extensions to the CONSORT 2010 and SPIRIT 2013 guidance statements

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CONTEXTRandomised trials provide the strongest evidence available about the effectiveness of health care interventions. Standards exist for reporting randomised trials so that users of evidence may clearly see strengths or deficiencies in study design or conduct that could affect the validity of the results. Widely adopted and evidence-based, SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) and CONSORT (Consolidated Standards of Reporting Trials) statements provide minimum recommendations for reporting protocols and results of randomised trials.Factorial randomised trials represent the potential for efficient evaluation of more than one intervention in the same study without the need for a larger sample size. In its simplest 2x2 form to test two interventions (A and B), participants are randomised to receive either no intervention, A alone, B alone or both A and B. Factorial trials have specific design and analysis considerations in addition to standard items specified in SPIRIT and CONSORT guidance. While extensions to SPIRIT and CONSORT exist for methodological variations, including different trial designs, interventions and types of data, extensions do not yet exist for factorial trials.AIMThe aim of this study is to develop extensions for reporting factorial randomised trials to the SPIRIT and CONSORT statements.METHODSWe will adopt similar methods as used previously to develop SPIRIT and CONSORT main statements and extensions. We will first conduct a scoping review of the literature to draw up a long list of items that we consider may be useful in reporting factorial trials. The scoping review will be completed prior to starting the present study and does not form part of the request for funding, but is included here for completeness.We will then conduct a Delphi study comprising (1) an online survey, and (2) a consensus meeting. For the online survey, we will contact stakeholders including clinical trials researchers with experience in the design/conduct/analysis/reporting of factorial trials, knowledge users, representatives from funding bodies, journal editors, and PPI (patient and public involvement) representatives. We will identify individuals from relevant publications and through research networks such as the MRC-NIHR Trials Methodology Research Partnership.As there is no formal method for estimating required sample size for a Delphi survey, we will aim to recruit the largest sample in the time available. Previous experience suggests that up to 130 individuals will be invited. Participants will be asked to complete two survey rounds in which they indicate importance of including items identified in the scoping review in a final list. They can also suggest new items in round 1. In round 2, they are presented with their own score from round 1 as well as summary scores from other participants. After survey round 2, we will use pre-defined criteria to define each item as 'consensus in', 'consensus out', or 'no consensus'.Following the survey, items defined as 'consensus out' will be discarded and all others will be taken forward for discussion at a consensus meeting. Participants at the meeting (approximately 30) will comprise stakeholders represented in the survey. Each item will be discussed and voted on for inclusion in the final list of items for SPIRIT and CONSORT extension.The final phase of the study involves writing and disseminating SPIRIT and CONSORT extension guidance and checklists, and a shared Explanation and Elaboration document.BENEFITSThe outputs of this research will provide investigators with a comprehensive framework for the design, conduct, analysis, interpretation and dissemination of factorial randomised trials. CONSORT and SPIRIT extensions will aid in critical appraisal and interpretation for grant reviewers, funding bodies, trial methodologists, journal editors, reviewers, and readers.