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

Hemming, Karla; Carroll, Kelly; Thompson, Jennifer; Forbes, Andrew; Taljaard, Monica; Dutton, Susan J.; Madurasinghe, Vichithranie; Morgan, Katy; Stuart, Beth; Fielding, Katherine; Cornelius, Victoria; Turner, Elizabeth L.; Hooper, Richard; Giraudeau, Bruno; Seed, Paul T.; Nickless, Alecia; Grayling, Michael; Prague, Melanie; Kerry, Sally; Bell, Lauren; Watson, Eila; Gafoor, Rafael; Marlin, Nadine; Yorganci, Emel; Smith, Lesley; Mbekwe, Murielle; Teerenstra, Steven; Chan, Claire; Moerbeek, Mirjam; Jacobsen, Pamela; Bond, Simon; Jones, Ben; Preisser, John; Kanaan, Mona; Hewitt, Catherine; Easter, Christina; Pellatt-Higgins, Tracy; Pankhurst, Laura; Agbla, Schadrac C.; Eldridge, Sandra; Lerner, Robin G.; Leyrat, Clémence; Pilling, Mark; Forman, Julia R.; Bhattacharya, Indrani; Magill, Nicholas; Candlish, Jane; McDowell, Cliona; Martin, James; Kristunas, Caroline; Allen, Elizabeth; Seward, Nadine; Nicholls, Elaine; Franklin, Bryony Dean

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.

Citation

Hemming, K., Carroll, K., Thompson, J., Forbes, A., Taljaard, M., Dutton, S. J., Madurasinghe, V., Morgan, K., Stuart, B., Fielding, K., Cornelius, V., Turner, E. L., Hooper, R., Giraudeau, B., Seed, P. T., Nickless, A., Grayling, M., Prague, M., Kerry, S., Bell, L., …Franklin, B. D. (2019). Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review. Journal of clinical epidemiology, 107, 77-88. https://doi.org/10.1016/j.jclinepi.2018.11.017

• Journal Article Type: Review
• Acceptance Date: Nov 19, 2018
• Online Publication Date: Nov 28, 2018
• Publication Date: 2019-03
• Deposit Date: Jan 27, 2020
• Journal: Journal of Clinical Epidemiology
• Print ISSN: 0895-4356
• Publisher: Elsevier
• Peer Reviewed: Peer Reviewed
• Volume: 107
• Pages: 77-88
• DOI: https://doi.org/10.1016/j.jclinepi.2018.11.017
• Keywords: Epidemiology; Stepped-wedge cluster randomized trial; Quality of reporting; CONSORT; Reliability
• Public URL: https://hull-repository.worktribe.com/output/3393631
• Related Public URLs: https://ora.ox.ac.uk/objects/uuid:3ec280ed-7419-4ded-967a-2ea53d5e26c6
• Additional Information: This article is maintained by: Elsevier; Article Title: Quality of stepped-wedge trial reporting can be reliably assessed using an updated CONSORT: crowd-sourcing systematic review; Journal Title: Journal of Clinical Epidemiology; CrossRef DOI link to publisher maintained version: https://doi.org/10.1016/j.jclinepi.2018.11.017; Content Type: article; Copyright: © 2018 Elsevier Inc. All rights reserved.