Cited by 1,858Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsClinical practice guidelines implementation

CONSORT 2010 Explanation and Elaboration: Updated guidelines for reporting parallel group randomised trials

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Moher, David, Hopewell, Sally, Schulz, Kenneth F., Montori, Victor, Gøtzsche, Peter C., Devereaux, P.J., Elbourne, Diana, Egger, Matthias +1 more·2010·Journal of Clinical Epidemiology

Abstract

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias. A group of scientists and editors developed the CONSORT (Consolidated Standards of Reporting Trials) statement to improve the quality of reporting of RCTs. It was first published in 1996 and updated in 2001. The statement consists of a checklist and flow diagram that authors can use for reporting an RCT. Many leading medical journals and major international editorial groups have endorsed the CONSORT statement. The statement facilitates critical appraisal and interpretation of RCTs. During the 2001 CONSORT revision, it became clear that explanation and elaboration of the principles underlying the CONSORT statement would help investigators and others to write or appraise trial reports. A CONSORT explanation and elaboration article was published in 2001 alongside the 2001 version of the CONSORT statement. After an expert meeting in January 2007, the CONSORT statement has been further revised and is published as the CONSORT 2010 Statement. This update improves the wording and clarity of the previous checklist and incorporates recommendations related to topics that have only recently received recognition, such as selective outcome reporting bias. This explanatory and elaboration document-intended to enhance the use, understanding, and dissemination of the CONSORT statement-has also been extensively revised. It presents the meaning and rationale for each new and updated checklist item providing examples of good reporting and, where possible, references to relevant empirical studies. Several examples of flow diagrams are included. The CONSORT 2010 Statement, this revised explanatory and elaboration document, and the associated website (www.consort-statement.org) should be helpful resources to improve reporting of randomised trials.

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Authors
Moher, D., Hopewell, S., Schulz, K. F., Montori, V., Gøtzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G.
Affiliations
  • Ottawa Hospital (CA)
  • University of Oxford (GB)
  • Family Health International 360 (US)
  • Rigshospitalet (DK)
  • McMaster University (CA)
  • London School of Hygiene & Tropical Medicine (GB)
  • University of Bern (CH)
Corresponding author
Moher, David
Venue
Journal of Clinical Epidemiology
Publisher
Elsevier BV
Published
2010-08
Volume
63
Issue
8
Pages
e1-e37
ISSN
0895-4356 (ISSN-L)
OpenAlex
W4235092737
Cited by
1,858
References
303
Citations by year
2026: 42 · 2025: 88 · 2024: 132 · 2023: 107 · 2022: 146 · 2021: 153 · 2020: 179 · 2019: 146 · 2018: 121 · 2017: 122 · 2016: 132 · 2015: 140 · 2014: 120 · 2013: 83 · 2012: 81
FWCI
74.73
Type
journal article
Language
en
Open access
Locations
  • Journal of Clinical Epidemiology (publishedVersion, cc-by-nc)
  • PubMed (publishedVersion)
  • Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
  • LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
Funders
  • University of Pennsylvania
  • Johns Hopkins University
  • Ottawa Hospital Research Institute
  • McMaster University
  • 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
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
  • Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
Keywords
CONSORT 2010, reporting quality, randomized controlled trials, reporting bias, selective outcome reporting, flowcharts, trial reporting checklist, critical appraisal
MeSH terms
Humans, Publishing, Quality Control, Randomized Controlled Trials as Topic, Guidelines as Topic

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