Development of a guideline for reporting the results of randomised Studies Within A Trial

Evidence to support decisions on trial processes is minimal. A Study Within A Trial (SWAT) can however be used to test trial processes or explore methodological uncertainties. The replication of SWATs is required to ensure sufficient power and broad applicability of findings. Prompt reporting is therefore essential; however, SWAT publications are often the first to be abandoned in the face of other time pressures. Although guidelines for the reporting of trials methodology research such as SWATs do exist, they are unfortunately not widely used. Development of a simple and concise guideline was therefore warranted to aid authors and journals to produce timely reports of randomised SWATs. This webinar presented the process of development of a straightforward, concise, CONSORT compliant, reporting standard for SWATs. Catherine Arundel is a Research Fellow at York Trials Unit (University of York) and has extensive experience designing, conducting, and managing large scale randomised controlled trials. She also has an interest in methodological research specifically in relation to trial process evaluation and has undertaken a reported several studies within a trial primarily focused on trial recruitment and retention methods. She was previously involved in the delivery of the PROMoting THE USe of SWATs (PROMETHEUS) programme, is a member of the Trial Forge SWAT Centre based at the University of York through which she leads the Trial Forge SWAT Network.