Rigorous Reporting of Stepped Wedge Cluster Randomised Controlled Trials: Development of a Flow Diagram Template

Background: Stepped wedge cluster randomised controlled trials (SW-CRCT) are increasingly used in rehabilitation research. Current Consolidated Standards for Reporting Trials (CONSORT) diagram templates are unsuited to depicting the flow of participants through this trial design. Thus, reporting to CONSORT standards is challenging. A recent systematic review highlighted the poor-quality reporting of SW-CRCTs, identifying that 33.3% failed to include a CONSORT flow diagram.

Aim: To develop a SW-CRCT flow diagram template with capacity to accurately depict participant movement (patients and staff) through study phases and across sites in the Stroke Oral healthCare pLan Evaluation (SOCLE II; NCT01954212).

Methods: Following ethical approval we recruited 325 patients and 112 staff across four study sites and collected data during usual care, intervention and enhanced care study phases. Working collaboratively, a team of experienced rehabilitation researchers, trial methodologists and statisticians, explored various approaches to inform the development of a unique flow diagram. We sought to develop a template that was flexible enough to accommodate the reporting of complex pragmatic SW-CRCTs, but which also enabled selective filtering of information to support the reporting of specific aspects of the trial.

Results: Our SW-CRCT CONSORT flow diagram template elucidates the patients and staff in SOCLE II that were: screened; consented; withdrawn (and later returned); discharged; trained; transferred and contributed to data collection at specific time points.

Conclusion: Using Microsoft Visio 2010 software our flow diagram template can be adapted by other rehabilitation researchers to enhance the quality of their analysis and trial reporting to CONSORT standards.