Cited by 1,022Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsDelphi Technique in Research

The DOI matches its Crossref record; 39 of the 40 references it cites were found in a registry or an index; none of the 21 sources its claims cite is checked for support yet.

CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.

Open access
Schulz, Kenneth F., Altman, Douglas G., Moher, David·2010·Journal of Clinical Epidemiology

Abstract

Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions. However, randomised trials can yield biased results if they lack methodological rigour [1]. To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings. Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [2–4].

Overview

AI snapshot

Written from the paper’s full text.

TL;DR

CONSORT 2010 updates the reporting guideline for parallel group randomised trials, comprising this paper, a 25-item checklist, and a flow diagram. The revision is described as evolutionary, based on accumulated methodological evidence and experience since the 2001 statement.

Key findings

  • CONSORT 2010 provides a 25-item checklist and flow diagram for reporting individually randomised, two-group, parallel trials, the most common design, which the paper says accounts for over half of trials in the literature.
  • The revision made evolutionary changes: the flow diagram was not modified except for one word; existing items kept previous numbers except for some renumbering of items 2 to 5; new items/sub-items included trial registration, protocol availability, funding, changes to outcomes after trial start, and why the trial ended or was stopped.
  • More than 400 journals explicitly support the CONSORT statement, and more than 700 studies comprise the CONSORT database underpinning the initiative.
  • The statement solely addresses reporting, not designing, conducting, or analysing trials, and is not intended as an instrument to evaluate trial quality or to construct a “quality score.”

Methods

  • Thirty-one members of the CONSORT 2010 Group met in Montebello, Canada, in January 2007 to update the 2001 statement; participants aggregated and synthesised evidence on checklist items, and only items deemed absolutely fundamental to reporting a randomised controlled trial were kept.
  • After the meeting, the CONSORT Executive convened teleconferences and meetings; after seven major iterations, a revised checklist was distributed for feedback, the executive met twice in person, and a final iterative process produced the CONSORT 2010 Explanation and Elaboration.
  • The update drew on new methodological evidence and accumulating experience since 2001, with the CONSORT database of more than 700 studies providing empirical evidence.

Limitations

  • The paper states a potential drawback: a reporting guideline might encourage some authors to report fictitiously the information suggested by the guidance rather than what was actually done; authors, peer reviewers, and editors should guard against this.
  • The paper states that CONSORT 2010 does not include recommendations for designing and conducting randomised trials, is not intended to evaluate trial quality, and is not appropriate for constructing a “quality score.”
  • The paper states that CONSORT 2010 focuses predominantly on the two-group, parallel randomised controlled trial; other trial designs, such as cluster randomised and noninferiority trials, require additional information and separate CONSORT extensions. Evident from the text: the statement is a consensus reporting guideline and reports no prospective validation of the 2010 checklist itself.

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Integrity signals

Registry

Crossref · 10.1016/j.jclinepi.2010.02.005

Cites

39 of 39 references verified0 citation errors · 0 not checkable

Statistics

Nothing to recompute.

Verification

Claims the paper makes

13 Not checked yet · 9 Own interpretation · 6 No basis given

Verify all 21 references — free account
  • Probably not a substantial claim. 16
  • It may state two separate claims as one. 7
18 of 18
  • The paper relies on this without support.

    Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions.

    “Randomised controlled trials, when appropriately designed, conducted, and reported, represent the gold standard in evaluating healthcare interventions.”
  • The paper relies on this without support.

    To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings.

    “To assess a trial accurately, readers of a published report need complete, clear, and transparent information on its methodology and findings.”
  • The paper relies on this without support.

    New methodological evidence and additional experience has accumulated since the last revision in 2001.

    “Furthermore, new methodological evidence and additional experience has accumulated since the last revision in 2001.”
  • The paper relies on this without support.

    Conclusions in papers frequently misrepresented the actual analytical results and harms were ignored or marginalised.

    “However, the CONSORT Group expressed concerns that conclusions in papers frequently misrepresented the actual analytical results and that harms were ignored or marginalised.”
  • The paper relies on this without support.

    Diligent adherence by authors to the checklist items facilitates clarity, completeness, and transparency of reporting.

    “Diligent adherence by authors to the checklist items facilitates clarity, completeness, and transparency of reporting.”
  • The paper relies on this without support.

    Many journals expect authors to complete a CONSORT checklist indicating where in the manuscript the items have been addressed.

    “Many journals expect authors to complete a CONSORT checklist indicating where in the manuscript the items have been addressed.”
6 of 6

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Citations

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Metadata

Authors
Schulz, K. F., Altman, D. G., & Moher, D.
Affiliations
  • Family Health International 360 (US)
  • University of Oxford (GB)
  • University of Ottawa (CA)
Corresponding author
Schulz, Kenneth F.
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2010-08
Volume
63
Issue
8
Pages
834-840
ISSN
0895-4356 (ISSN-L)
OpenAlex
W2571766406
Cited by
1,022
References
40
Citations by year
2026: 67 · 2025: 85 · 2024: 78 · 2023: 61 · 2022: 66 · 2021: 70 · 2020: 90 · 2019: 76 · 2018: 64 · 2017: 69 · 2016: 58 · 2015: 43 · 2014: 61 · 2013: 54 · 2012: 41
FWCI
43.32
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Epidemiology (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
Funders
  • University of Pennsylvania
  • Johns Hopkins University
  • University of Ottawa
  • Ottawa Hospital Research Institute
  • McMaster University
  • Janssen Scientific Affairs
  • Cancer Research UK
  • National Institute for Health and Care Research
  • University of Oxford
  • Institut National de la Santé et de la Recherche Médicale
  • Johns Hopkins Bloomberg School of Public Health
  • University of California, Irvine
  • Canadian Institutes of Health Research
  • Medical Research Council
Topics
  • Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
  • Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
  • Social Sciences › Sociology and Political Science › Delphi Technique in Research
Keywords
CONSORT 2010, reporting guidelines, trial reporting quality, methodological quality
MeSH terms
Publishing, Research Design, Randomized Controlled Trials as Topic

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