Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2019

Open Access 01-12-2019 | Commentary

Introducing the new CONSORT extension for stepped-wedge cluster randomised trials

Authors: Karla Hemming, Monica Taljaard, Jeremy Grimshaw

Published in: Trials | Issue 1/2019

Login to get access

Abstract

The use of the stepped-wedge cluster randomised trial (SW-CRT) is on the increase, and although there are still relatively few SW-CRTs currently published its use is bound to show an increase in the near future. An extension of the CONSORT reporting guideline for SW-CRTs has recently been developed. By making reporting guidelines for this innovative design available relatively early in its development, it is possible that the methodological conduct and reporting of future SW-CRTs will not be at the same risk of low-quality of reporting as is the case with many other study designs. We provide a brief overview of this reporting guideline and encourage authors to use it appropriately; and for journal editors to endorse its use.
Literature
1.
Caille A, Kerry S, Tavernier E, Leyrat C, Eldridge S, Giraudeau B. Timeline cluster: a graphical tool to identify risk of bias in cluster randomised trials. BMJ. 2016;354:i4291.CrossRefPubMed
2.
Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–7.CrossRefPubMedPubMedCentral
3.
Campbell MK, Piaggio G, Elbourne DR, Altman DG, for the CONSORT Group. Consort 2010 Statement: extension to cluster randomised trials. BMJ. 2012;345:e5661.CrossRefPubMed
4.
Copas AJ, Lewis JJ, Thompson JA, Davey C, Baio G, Hargreaves JR. Designing a stepped wedge trial: three main designs, carry-over effects and randomisation approaches. Trials. 2015;16:352.CrossRefPubMedPubMedCentral
5.
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64.
6.
Girling AJ, Hemming K. Statistical efficiency and optimal design for stepped cluster studies under linear mixed effects models. Stat Med. 2016;35(13):2149–66.CrossRefPubMedPubMedCentral
7.
Grayling MJ, Wason JM, Mander AP. Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features. Trials. 2017;18(1):33.CrossRefPubMedPubMedCentral
8.
9.
Hemming K, Taljaard M, McKenzie JE, Hooper R, Copas A, Thompson JA, Dixon-Woods M, Aldcroft A, Doussau A, Grayling M, Kristunas C, Goldstein CE, Campbell MK, Girling A, Eldridge S, Campbell MJ, Lilford RJ, Weijer C, Forbes AB, Grimshaw JM. Reporting of stepped wedge cluster randomised trials: extension of the CONSORT 2010 Statement with explanation and elaboration. BMJ. 2018;363:k1614.CrossRefPubMedPubMedCentral
10.
Li A, Garg A, Prakash V, Grimshaw J, Taljaard M, Mitchell J, Matti D, Linklater S, Naylor K, Dixon S, Faulds C, Bevan R, Getchell L, Knoll G, Kim J, Sontrop J, Bjerre L, Tong A, Presseau J. Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 Trial): study protocol for a pragmatic stepped-wedge cluster randomized controlled registry trial. Trials. 2017;18:610.CrossRefPubMedPubMedCentral
11.
12.
Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332.CrossRefPubMedPubMedCentral
13.
Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, et al. Improving the reporting of pragmatic trials: an extension of the CONSORT Statement. BMJ. 2008;337:a2390.CrossRefPubMedPubMedCentral
14.
Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better reporting of interventions: template for intervention description and replication (TIDieR) Checklist and guide. BMJ. 2014;348:g1687. https://​doi.​org/​10.​1136/​bmj.​g1687 PubMed PMID: 24609605.CrossRefPubMed
15.
Piaggio G, Elbourne DR, Pocock SJ, Evans SJW, Altman DG, for the CONSORT Group. Reporting of noninferiority and equivalence randomized trials. Extension of the CONSORT 2010 statement. JAMA. 2012; 308(24): 2594-2604.
Metadata
Title
Introducing the new CONSORT extension for stepped-wedge cluster randomised trials
Authors
Karla Hemming
Monica Taljaard
Jeremy Grimshaw
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-018-3116-3

Other articles of this Issue 1/2019

Trials 1/2019 Go to the issue

Study protocol

Smoking cessation opportunities in severe mental illness (tobacco intensive motivational and estimate risk — TIMER—): study protocol for a randomized controlled trial

Study protocol

Evaluation of intravenous lidocaine in head and neck cancer surgery: study protocol for a randomized controlled trial

Study protocol

A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial

Study protocol

Converting habits of antibiotic use for respiratory tract infections in German primary care – study protocol of the cluster-randomized controlled CHANGE-3 trial

Study protocol

Holistic care program for elderly patients to integrate spiritual needs, social activity, and self-care into disease management in primary care (HoPES3): study protocol for a cluster-randomized trial

Study protocol

Effects of transcranial direct current stimulation on the rehabilitation of painful shoulder following a stroke: protocol for a randomized, controlled, double-blind, clinical trial