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Reporting quality of stepped wedge design randomized trials: a systematic review protocol

Authors Thabane A, Dennis B, Gajic-Veljanoski O, Paul J, Thabane L

Received 24 December 2015

Accepted for publication 31 March 2016

Published 8 July 2016 Volume 2016:8 Pages 261—266

DOI https://doi.org/10.2147/CLEP.S103098

Checked for plagiarism Yes

Review by Single-blind

Peer reviewers approved by Dr Colin Mak

Peer reviewer comments 3

Editor who approved publication: Professor Henrik Toft Sørensen


Alex Thabane,1,2 Brittany B Dennis,3,4 Olga Gajic-Veljanoski,3,9,10 James Paul,2,3 Lehana Thabane2,3,5-8

1Life Sciences Program, Queen’s University, Kingston, ON, Canada; 2Department of Anesthesia, McMaster University Hamilton ON, 3Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; 4St. George’s University of London, London England, UK; 5Population Health Research Institute, Hamilton Health Sciences, 6Department of Pediatrics, McMaster University, Hamilton, ON, Canada; 7Centre for Evaluation of Medicine, 8Biostatistics Unit, Father Sean O’Sullivan Research Centre, St Joseph’s Healthcare, Hamilton, ON, Canada; 9Department of Medicine, McMaster University, Hamilton ON, Canada; 10Hamilton Health Sciences, St. Peter’s Hospital, Hamilton, ON Canada

Background: Stepped wedge design (SWD) is a cluster randomized controlled trial (RCT) design that sequentially rolls out intervention to all clusters at varying time points. Being a relatively new design method, reporting quality has yet to be explored, and this review will seek to fill this gap in knowledge.
Objectives: The objectives of this review are: 1) to assess the quality of SWD trial reports based on the CONSORT guidelines or CONSORT extension to cluster RCTs; 2) to assess the completeness of reporting of SWD trial abstracts using the CONSORT extension for abstracts; 3) to assess the reporting of sample size details in SWD trial reports or protocols; 4) to assess the completeness of reporting of SWD trial protocols according to SPIRIT guidelines; 5) to assess the consistency between the trial registration information and final SWD trial reports; and 6) to assess the consistency of what is reported in the abstracts and main text of the SWD trial reports. We will also explore factors that are associated with the completeness of reporting.
Methods:
We will search MEDLINE, EMBASE, Web of Science, CINAHL, and PsycINFO for all randomized controlled trials utilizing SWD. Details from eligible papers will be extracted in duplicate. Demographic statistics obtained from the data extraction will be analyzed to answer the primary objectives pertaining to the reporting quality of several aspects of a published paper, as well as to explore possible temporal trends and consistency between abstracts, trial registration information, and final published articles.
Discussion:
Findings from this review will establish the reporting quality of SWD trials and inform academics and clinicians on their completeness and consistency. Results of this review will influence future trials and improve the overall quality and reporting of SWD trials.

Keywords:
randomized controlled trial, stepped wedge design, stepped wedge, cluster randomized trial, quality of reporting, systematic review

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