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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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(2018) Reporting of stepped wedge cluster randomised trials : extension of the CONSORT 2010 statement with explanation and elaboration. BMJ Open, 363 . k1614. doi:10.1136/bmj.k1614
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Official URL: https://doi.org/10.1136/bmj.k1614
Abstract
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.
| Item Type: | Journal Article | ||||||||||||
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| Subjects: | R Medicine > R Medicine (General) | ||||||||||||
| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences > Population, Evidence & Technologies (PET) Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Clinical trials , Clinical trials -- Reporting , Clinical trials -- Quality control, Systematic reviews (Medical research) , Evidence-based medicine | ||||||||||||
| Journal or Publication Title: | BMJ Open | ||||||||||||
| Publisher: | BMJ | ||||||||||||
| ISSN: | 2044-6055 | ||||||||||||
| Official Date: | 9 November 2018 | ||||||||||||
| Dates: |
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| Volume: | 363 | ||||||||||||
| Article Number: | k1614 | ||||||||||||
| DOI: | 10.1136/bmj.k1614 | ||||||||||||
| Status: | Peer Reviewed | ||||||||||||
| Publication Status: | Published | ||||||||||||
| Access rights to Published version: | Open Access | ||||||||||||
| Funder: | 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 Seni, Canada Research Chairs (CRC) | ||||||||||||
| Grant number: | 1108283 (NHMR) ; 1072366 (NHMR) | ||||||||||||
| RIOXX Funder/Project Grant: |
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