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

Lookup NU author(s): Dr Michael GraylingORCiD, Professor James WasonORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).


Abstract

© 2017 The Author(s).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.


Publication metadata

Author(s): Grayling MJ, Wason JMS, Mander AP

Publication type: Review

Publication status: Published

Journal: Trials

Year: 2017

Volume: 18

Online publication date: 21/01/2017

Acceptance date: 03/01/2017

ISSN (electronic): 1745-6215

Publisher: BioMed Central Ltd.

URL: https://doi.org/10.1186/s13063-017-1783-0

DOI: 10.1186/s13063-017-1783-0


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