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Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review

Research output: Contribution to journalArticle

  • K. Hemming
  • K. Carroll
  • J. Thompson
  • A. Forbes
  • M. Taljaard
  • S.J. Dutton
  • V. Madurasinghe
  • K. Morgan
  • B. Stuart
  • K. Fielding
  • V. Cornelius
  • E.L. Turner
  • R. Hooper
  • B. Giraudeau
  • P.T. Seed
  • A. Nicklesshttp://orcid.org/0000-0001-8534-116X
  • M. Grayling
  • M. Prague
  • S. Kerry
  • L. Bell
  • E. Watson
  • R. Gafoor
  • N. Marlin
  • E. Yorganci
  • L. Smith
  • M. Mbekwe
  • S. Teerenstra
  • C. Chan
  • M. Moerbeek
  • P. Jacobsen
  • S. Bond
  • B. Jones
  • J. Preisser
  • M. Kanaan
  • C. Hewitt
  • C. Easter
  • T. Pellatt-Higgins
  • L. Pankhurst
  • S.C. Agbla
  • S. Eldridge
  • R.G. Lerner
  • C. Leyrat
  • M. Pilling
  • J.R. Forman
  • I. Bhattacharya
  • N. Magill
  • J. Candlish
  • C. McDowell
  • J. Martin
  • C. Kristunas
  • E. Allen
  • N. Seward
  • E. Nicholls
  • B.D. Franklin
Original languageUndefined/Unknown
Pages (from-to)77-88
JournalJournal of Clinical Epidemiology
Volume107
Early online date28 Nov 2018
DOIs
DateAccepted/In press - 19 Nov 2018
DateE-pub ahead of print - 28 Nov 2018
DatePublished (current) - 1 Mar 2019

Abstract

Objectives
The Consolidated Standards of Reporting Trials extension for the stepped-wedge cluster randomized trial (SW-CRT) is a recently published reporting guideline for SW-CRTs. We assess the quality of reporting of a recent sample of SW-CRTs.

Study Design and Setting
Quality of reporting was asssessed according to the 26 items in the new guideline using a novel crowd sourcing methodology conducted independently and in duplicate, with random assignment, by 50 reviewers. We assessed reliability of the quality assessments, proposing this as a novel way to assess robustness of items in reporting guidelines.

Results
Several items were well reported. Some items were very poorly reported, including several items that have unique requirements for the SW-CRT, such as the rationale for use of the design, description of the design, identification and recruitment of participants within clusters, and concealment of cluster allocation (not reported in more than 50% of the reports). Agreement across items was moderate (median percentage agreement was 76% [IQR 64 to 86]). Agreement was low for several items including the description of the trial design and why trial ended or stopped for example.

Conclusions
When reporting SW-CRTs, authors should pay particular attention to ensure clear reporting on the exact format of the design with justification, as well as how clusters and individuals were identified for inclusion in the study, and whether this was done before or after randomization of the clusters, which are crucial for risk of bias assessments. Some items, including why the trial ended, might either not be relevant to SW-CRTs or might be unclearly described in the statement.

Documents

Documents

  • CONSORT Extension for SW-CRTs R1 CleanVersion

    Accepted author manuscript, 115 KB, Word-document

    Embargo ends: 27/12/19

    Request copy

    Licence: CC BY-NC-ND

DOI

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