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Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

Michael J Grayling¹, James M S Wason², Adrian P Mander²

¹MRC Biostatistics Unit Hub for Trials Methodology Research, Cambridge Institute of Public Health, University Forvie Site, Robinson Way, Cambridge, CB2 0SR, UK. mjg211@cam.ac.uk.

|January 23, 2017

Abstract

Background:

The stepped wedge (SW) cluster randomized controlled trial (CRCT) design is being used with increasing frequency. However, there is limited published research on the quality of reporting of SW-CRCTs. We address this issue by conducting a literature review.

Methods:

Medline, Ovid, Web of Knowledge, the Cochrane Library, PsycINFO, the ISRCTN registry, and ClinicalTrials.gov were searched to identify investigations employing the SW-CRCT design up to February 2015. For each included completed study, information was extracted on a selection of criteria, based on the CONSORT extension to CRCTs, to assess the quality of reporting.

Results:

A total of 123 studies were included in our review, of which 39 were completed trial reports. The standard of reporting of SW-CRCTs varied in quality. The percentage of trials reporting each criterion varied to as low as 15.4%, with a median of 66.7%.

Conclusions:

There is much room for improvement in the quality of reporting of SW-CRCTs. This is consistent with recent findings for CRCTs. A CONSORT extension for SW-CRCTs is warranted to standardize the reporting of SW-CRCTs.

Keywords:

Cluster randomized controlled trial Reporting quality Review Stepped wedge

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