Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

Trials. 2017 Jan 21;18(1):33. doi: 10.1186/s13063-017-1783-0.


Background: The stepped wedge (SW) cluster randomized controlled trial (CRCT) design is being used with increasing frequency. However, there is limited published research on the quality of reporting of SW-CRCTs. We address this issue by conducting a literature review.

Methods: Medline, Ovid, Web of Knowledge, the Cochrane Library, PsycINFO, the ISRCTN registry, and were searched to identify investigations employing the SW-CRCT design up to February 2015. For each included completed study, information was extracted on a selection of criteria, based on the CONSORT extension to CRCTs, to assess the quality of reporting.

Results: A total of 123 studies were included in our review, of which 39 were completed trial reports. The standard of reporting of SW-CRCTs varied in quality. The percentage of trials reporting each criterion varied to as low as 15.4%, with a median of 66.7%.

Conclusions: There is much room for improvement in the quality of reporting of SW-CRCTs. This is consistent with recent findings for CRCTs. A CONSORT extension for SW-CRCTs is warranted to standardize the reporting of SW-CRCTs.

Keywords: Cluster randomized controlled trial; Reporting quality; Review; Stepped wedge.

Publication types

  • Review
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Data Accuracy
  • Guidelines as Topic
  • Humans
  • Quality Control
  • Randomized Controlled Trials as Topic / methods*
  • Randomized Controlled Trials as Topic / standards
  • Research Design* / standards