CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE): checklist with explanation and elaboration
Kwakkenbos, Linda; Imran, Mahrukh; McCall, Stephen J; McCord, Kimberly A; Fröbert, Ole; Hemkens, Lars G; Zwarenstein, Merrick; Relton, Clare; Rice, Danielle B; Langan, Sinéad M; Benchimol, Eric I; Thabane, Lehana; Campbell, Marion K; Sampson, Margaret; Erlinge, David; Verkooijen, Helena M; Moher, David; Boutron, Isabelle; Ravaud, Philippe; Nicholl, Jon; Uher, Rudolf; Sauvé, Maureen; Fletcher, John; Torgerson, David; Gale, Chris; Juszczak, Edmund; Thombs, Brett D
(2021) BMJ (Clinical research ed.), volume 373
(Article)
Abstract
Randomised controlled trials are increasingly conducted as embedded, nested, or using cohorts or routinely collected data, including registries, electronic health records, and administrative databases, to assess if participants are eligible for the trial and to facilitate recruitment, to deliver an embedded intervention, to collect trial outcome data, or a combination
... read more
of these purposes. This report presents the Consolidated Standards of Reporting Trials (CONSORT) extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE). The extension was developed to look at the unique characteristics of trials conducted with these types of data with the goal of improving reporting quality in the long term by setting standards early in the process of uptake of these trial designs. The extension was developed with a sequential approach, including a Delphi survey, a consensus meeting, and piloting of the checklist. The checklist was informed by the CONSORT 2010 statement and two reporting guidelines for observational studies, the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement and the REporting of studies Conducted using Observational Routinely collected Data (RECORD) statement. The extension includes eight items modified from the CONSORT 2010 statement and five new items. Reporting items with explanations and examples are provided, including key aspects of trials conducted using cohorts or routinely collected data that require specific reporting considerations.
show less
Download/Full Text
Keywords: Checklist/standards, Cohort Studies, Humans, Randomized Controlled Trials as Topic/standards, Research Design/standards, General Medicine, Research Support, Non-U.S. Gov't, Journal Article
ISSN: 1756-1833
Publisher: BMJ Publishing Group
Note: Funding Information: Funding: The development of the CONSORT extension for randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) was funded by grants from the Canadian Institutes of Health Research (PI BDT, Co-Is OF, CR, LK, and EJ, No PJT-156172; PI BDT, Co-I LK, No PCS-161863) and from the United Kingdom National Institute of Health Research (NIHR) Clinical Trials Unit Support Funding (PI EJ, Co-PI CG, supported salary of SJM). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. DBR was supported by a Vanier CIHR Graduate Scholarship. SML was supported by a Wellcome Senior Clinical Fellowship in Science (205039/Z/16/Z). EIB was supported by a New Investigator Award from the Canadian Institutes of Health Research, Canadian Association of Gastroenterology, and Crohn’s and Colitis Canada. He was also supported by the Career Enhancement Program of the Canadian Child Health Clinician Scientist Program. DM was supported by a University Research Chair (uOttawa). RU was supported by the Canada Research Chairs Program (Award No 231397). CG was supported by the UK Medical Research Council through a Clinician Scientist Fellowship. BDT was supported by a Tier 1 Canada Research Chair. Funding Information: “The registry is financed by the Swedish government and the Association of Local Authorities and Regions (the public health care provider), and is supported by the Swedish Heart Association, the National Board of Health and Welfare and the Swedish Heart and Lung Foundation. Participating hospitals are not reimbursed by the registry and costs of local data entry are borne by their internal budget [35, supplement]. The trial sponsor was the Karolinska Institutet.”35 Publisher Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY. No commercial re-use. See rights and permissions. Published by BMJ.
(Peer reviewed)
