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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. and Langan, Sinéad M. , et al. (2021) In The BMJ 373.
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 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... (More)

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 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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
in
The BMJ
volume
373
article number
n857
publisher
BMJ Publishing Group
external identifiers
  • pmid:33926904
  • scopus:85105172374
ISSN
0959-8146
DOI
10.1136/bmj.n857
language
English
LU publication?
yes
id
27d9aeba-b7bb-457a-9688-06989e745070
date added to LUP
2021-05-20 12:07:29
date last changed
2024-06-16 13:56:50
@article{27d9aeba-b7bb-457a-9688-06989e745070,
  abstract     = {{<p>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 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.</p>}},
  author       = {{Kwakkenbos, Linda and Imran, Mahrukh and McCall, Stephen J. and McCord, Kimberly A. and Fröbert, Ole and Hemkens, Lars G. and Zwarenstein, Merrick and Relton, Clare and Rice, Danielle B. and Langan, Sinéad M. and Benchimol, Eric I. and Thabane, Lehana and Campbell, Marion K. and Sampson, Margaret and Erlinge, David and Verkooijen, Helena M. and Moher, David and Boutron, Isabelle and Ravaud, Philippe and Nicholl, Jon and Uher, Rudolf and Sauvé, Maureen and Fletcher, John and Torgerson, David and Gale, Chris and Juszczak, Edmund and Thombs, Brett D.}},
  issn         = {{0959-8146}},
  language     = {{eng}},
  month        = {{04}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{The BMJ}},
  title        = {{CONSORT extension for the reporting of randomised controlled trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) : Checklist with explanation and elaboration}},
  url          = {{http://dx.doi.org/10.1136/bmj.n857}},
  doi          = {{10.1136/bmj.n857}},
  volume       = {{373}},
  year         = {{2021}},
}