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Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration.

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posted on 2019-08-12, 15:25 authored by K Hemming, M Taljaard, JE McKenzie, R Hooper, A Copas, JA Thompson, M Dixon-Woods, A Aldcroft, A Doussau, M Grayling, C Kristunas, CE Goldstein, MK Campbell, A Girling, S Eldridge, MJ Campbell, RJ Lilford, C Weijer, AB Forbes, JM Grimshaw
This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for the stepped wedge cluster randomised trial (SW-CRT). The SW-CRT involves randomisation of clusters to different sequences that dictate the order (or timing) at which each cluster will switch to the intervention condition. The statement was developed to allow for the unique characteristics of this increasingly used study design. The guideline was developed using a Delphi survey and consensus meeting; and is informed by the CONSORT statements for individual and cluster randomised trials. Reporting items along with explanations and examples are provided. We include a glossary of terms, and explore the key properties of the SW-CRT which require special consideration in their reporting.

Funding

This research was funded by the Australian National Health and Medical Research Council (NHMRC) project grant (1108283) and also partly funded by the UK NIHR Collaborations for Leadership in Applied Health Research and Care West Midlands initiative. MDW is funded by a Welcome Trust Senior Investigator award WT097899. JAT is funded by the Medical Research Council Network of Hubs for Trials Methodology Research (MR/L004933/1-P27). JMG holds a Canada Research Chair in Health Knowledge Transfer and Uptake. CW holds a Canada Research Chair. JEM holds an NHMRC Australian Public Health Fellowship (1072366). KH holds an NIHR Senior Research Fellowship (SRF-2017-002).

History

Citation

BMJ, 2018;363:k1614

Author affiliation

/Organisation/COLLEGE OF LIFE SCIENCES/School of Medicine/Department of Health Sciences

Version

  • VoR (Version of Record)

Published in

BMJ

Publisher

BMJ Publishing Group

eissn

1756-1833

Acceptance date

2018-03-20

Copyright date

2018

Available date

2019-08-12

Publisher version

https://www.bmj.com/content/363/bmj.k1614

Notes

Online at version of record, see DOI: Supplementary materials: Supplementary figures S1, S2, and S3 Supplementary materials: Supplementary table S1, S2, and S3

Language

en

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