title: Reporting quality of stepped wedge design randomized trials: a systematic review protocol.
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.
  
  
  OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Life Sciences Program, Queen's University, Kingston, ON, Canada; Department of Anesthesia, McMaster University Hamilton ON.
authors.forename: Alex
authors.initials: A
authors.lastname: Thabane
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; St. George's University of London, London England, UK.
authors.forename: Brittany B
authors.initials: BB
authors.lastname: Dennis
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; Department of Medicine, McMaster University, Hamilton ON, Canada; Hamilton Health Sciences, St. Peter's Hospital, Hamilton, ON Canada.
authors.forename: Olga
authors.initials: O
authors.lastname: Gajic-Veljanoski
authors.affiliation: Department of Anesthesia, McMaster University Hamilton ON; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada.
authors.forename: James
authors.initials: J
authors.lastname: Paul
authors.affiliation: Department of Anesthesia, McMaster University Hamilton ON; Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton ON, Canada; Population Health Research Institute, Hamilton Health Sciences; Department of Pediatrics, McMaster University, Hamilton, ON, Canada; Centre for Evaluation of Medicine; Biostatistics Unit, Father Sean O'Sullivan Research Centre, St Joseph's Healthcare, Hamilton, ON, Canada.
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
keywords: cluster randomized trial; quality of reporting; randomized controlled trial; stepped wedge; stepped wedge design; systematic review