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Abstract
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.
Acknowledgments
This work was supported in part by the Department of Anesthesia at McMaster University. The funders had no role in the study design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. Dr. Olga Gajic-Veljanoski is supported by Hamilton Health Sciences Foundation.
Author contributions
AT, BBD, JP, OGV, and LT conceived the research question and developed the protocol for this systematic review. AT and BBD completed an initial literature search to inform the background of this review as well as designed the electronic search strategy. Data extraction forms will be developed and pilot tested by AT and BBD. AT, BBD, JP, OGV, and LT developed the statistical analysis plan. BBD, AT, JP, OGV, and LT contributed equally to writing and revision of the manuscript. The final version of the protocol submitted to Clinical Epidemiology has been read and approved by all authors. All authors contributed toward data analysis, drafting and critically revising the paper and agree to be accountable for all aspects of the work.
Disclosure
The authors report no conflicts of interest in this work.