Cargando…

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

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 interventi...

Descripción completa

Detalles Bibliográficos
Autores principales: Hemming, Karla, Taljaard, Monica, McKenzie, Joanne E, Hooper, Richard, Copas, Andrew, Thompson, Jennifer A, Dixon-Woods, Mary, Aldcroft, Adrian, Doussau, Adelaide, Grayling, Michael, Kristunas, Caroline, Goldstein, Cory E, Campbell, Marion K, Girling, Alan, Eldridge, Sandra, Campbell, Mike J, Lilford, Richard J, Weijer, Charles, Forbes, Andrew B, Grimshaw, Jeremy M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group Ltd. 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6225589/
https://www.ncbi.nlm.nih.gov/pubmed/30413417
http://dx.doi.org/10.1136/bmj.k1614
_version_ 1783369809675681792
author Hemming, Karla
Taljaard, Monica
McKenzie, Joanne E
Hooper, Richard
Copas, Andrew
Thompson, Jennifer A
Dixon-Woods, Mary
Aldcroft, Adrian
Doussau, Adelaide
Grayling, Michael
Kristunas, Caroline
Goldstein, Cory E
Campbell, Marion K
Girling, Alan
Eldridge, Sandra
Campbell, Mike J
Lilford, Richard J
Weijer, Charles
Forbes, Andrew B
Grimshaw, Jeremy M
author_facet Hemming, Karla
Taljaard, Monica
McKenzie, Joanne E
Hooper, Richard
Copas, Andrew
Thompson, Jennifer A
Dixon-Woods, Mary
Aldcroft, Adrian
Doussau, Adelaide
Grayling, Michael
Kristunas, Caroline
Goldstein, Cory E
Campbell, Marion K
Girling, Alan
Eldridge, Sandra
Campbell, Mike J
Lilford, Richard J
Weijer, Charles
Forbes, Andrew B
Grimshaw, Jeremy M
author_sort Hemming, Karla
collection PubMed
description 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.
format Online
Article
Text
id pubmed-6225589
institution National Center for Biotechnology Information
language English
publishDate 2018
publisher BMJ Publishing Group Ltd.
record_format MEDLINE/PubMed
spelling pubmed-62255892018-11-23 Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration Hemming, Karla Taljaard, Monica McKenzie, Joanne E Hooper, Richard Copas, Andrew Thompson, Jennifer A Dixon-Woods, Mary Aldcroft, Adrian Doussau, Adelaide Grayling, Michael Kristunas, Caroline Goldstein, Cory E Campbell, Marion K Girling, Alan Eldridge, Sandra Campbell, Mike J Lilford, Richard J Weijer, Charles Forbes, Andrew B Grimshaw, Jeremy M BMJ Research Methods & Reporting 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. BMJ Publishing Group Ltd. 2018-11-09 /pmc/articles/PMC6225589/ /pubmed/30413417 http://dx.doi.org/10.1136/bmj.k1614 Text en Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
spellingShingle Research Methods & Reporting
Hemming, Karla
Taljaard, Monica
McKenzie, Joanne E
Hooper, Richard
Copas, Andrew
Thompson, Jennifer A
Dixon-Woods, Mary
Aldcroft, Adrian
Doussau, Adelaide
Grayling, Michael
Kristunas, Caroline
Goldstein, Cory E
Campbell, Marion K
Girling, Alan
Eldridge, Sandra
Campbell, Mike J
Lilford, Richard J
Weijer, Charles
Forbes, Andrew B
Grimshaw, Jeremy M
Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
title Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
title_full Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
title_fullStr Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
title_full_unstemmed Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
title_short Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 statement with explanation and elaboration
title_sort reporting of stepped wedge cluster randomised trials: extension of the consort 2010 statement with explanation and elaboration
topic Research Methods & Reporting
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6225589/
https://www.ncbi.nlm.nih.gov/pubmed/30413417
http://dx.doi.org/10.1136/bmj.k1614
work_keys_str_mv AT hemmingkarla reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT taljaardmonica reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT mckenziejoannee reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT hooperrichard reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT copasandrew reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT thompsonjennifera reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT dixonwoodsmary reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT aldcroftadrian reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT doussauadelaide reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT graylingmichael reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT kristunascaroline reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT goldsteincorye reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT campbellmarionk reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT girlingalan reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT eldridgesandra reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT campbellmikej reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT lilfordrichardj reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT weijercharles reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT forbesandrewb reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration
AT grimshawjeremym reportingofsteppedwedgeclusterrandomisedtrialsextensionoftheconsort2010statementwithexplanationandelaboration