CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials.
Open accessAbstract
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].
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.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
0 of 21 cited sources checked · 0 supported · 0 flagged
- Premisecitation
The evidence based approach used for CONSORT served as a model for development of other reporting guidelines (systematic reviews/meta-analyses, diagnostic studies, observational studies).
“The evidence based approach we have used for CON-SORT also served as a model for development of other reporting guidelines, such as for reporting systematic reviews and meta-analyses of studies evaluating interventions [16], diagnostic studies [17], and observational studies [18].”
Quote in the paperNot a substantial claim0 of 3 sources checked- cites [16] Moher, 2009, Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, BMJ source
Not checked in the free run.
- cites [17] Bossuyt, 2003, Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative, BMJ source
Not checked in the free run.
- cites [18] von Elm, 2007, Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies, BMJ source
Not checked in the free run.
- Premisecitation
Randomised controlled trials can yield biased results if they lack methodological rigour.
“However, randomised trials can yield biased results if they lack methodological rigour [1].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [1] Jüni, 2001, Systematic reviews in health care: assessing the quality of controlled clinical trials, BMJ source
Not checked in the free run.
- Interpretationreasoning
CONSORT indirectly affects design and conduct.
“Nevertheless, CONSORT does indirectly affect design and conduct.”
Quote in the paperSubstantial claim - Premisecitation
Two group, parallel randomised controlled trial accounts for over half of trials in the literature.
“CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature [2].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [2] Chan, 2005, Epidemiology and reporting of randomised trials published in PubMed journals, Lancet source
Not checked in the free run.
- Premisecitation
Many trial reports still remain inadequate.
“While those statements improved the reporting quality for some randomised controlled trials [9,10], many trial reports still remain inadequate [2].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [2] Chan, 2005, Epidemiology and reporting of randomised trials published in PubMed journals, Lancet source
Not checked in the free run.
- Premisecitation
Authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol.
“Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol [4,22].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [4] Dwan, 2008, Systematic review of the empirical evidence of study publication bias and outcome reporting bias, PLoS ONE source
Not checked in the free run.
- cites [22] Chan, 2004, Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles, JAMA source
Not checked in the free run.
- Premisecitation
Some poorly conducted or poorly reported aspects of trials are associated with bias.
“Researchers had shown for many years that authors reported such trials poorly, and empirical evidence began to accumulate that some poorly conducted or poorly reported aspects of trials were associated with bias [14].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [14] Schulz, 1995, Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials, JAMA source
Not checked in the free run.
- Premisecitation
When used by authors and journals, CONSORT seems to improve reporting.
“That support seems warranted: when used by authors and journals, CONSORT seems to improve reporting [9].”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [9] Plint, 2006, Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review, Med J Aust source
Not checked in the free run.
- Premisecitation
Authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (selective outcome reporting).
“This followed from empirical evidence that authors frequently provide analyses of outcomes in their published papers that were not the prespecified primary and secondary outcomes in their protocols, while ignoring their prespecified outcomes (that is, selective outcome reporting) [4,22].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [4] Dwan, 2008, Systematic review of the empirical evidence of study publication bias and outcome reporting bias, PLoS ONE source
Not checked in the free run.
- cites [22] Chan, 2004, Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles, JAMA source
Not checked in the free run.
- Premisecitation
The CONSORT statements improved reporting quality for some randomised controlled trials.
“While those statements improved the reporting quality for some randomised controlled trials [9,10], many trial reports still remain inadequate [2].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [9] Plint, 2006, Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review, Med J Aust source
Not checked in the free run.
- cites [10] Hopewell, 2010, The quality of reports of randomised trials in 2000 and 2006: a comparative study of articles indexed by PubMed, BMJ source
Not checked in the free run.
- Classified as probably not a substantial claim. 16
- May combine two claims. 7
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingnone givenMore than 700 studies comprise the CONSORT database, which provides the empirical evidence to underpin the CONSORT initiative.
“More than 700 studies comprise the CONSORT database (located on the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenOther prominent editorial groups (Council of Science Editors and World Association of Medical Editors) officially support CONSORT.
“Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingnone givenThe revision process resulted in evolutionary, not revolutionary, changes to the checklist, and the flow diagram was not modified except for one word.
“The revision process resulted in evolutionary, not revolutionary, changes to the checklist (Table 1), and the flow diagram was not modified except for one word (Fig. 1).”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
FindingreasoningExperience with the checklist noted pragmatic difficulties when an item comprised multiple elements.
“Experience with the checklist noted pragmatic difficulties when an item comprised multiple elements.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
FindingreasoningThousands more journals have implicitly supported CONSORT through the ICMJE endorsement.
“Moreover, thousands more have implicitly supported it with the endorsement of the CONSORT statement by the International Committee of Medical Journal Editors (www.icmje.org).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingnone givenMore than 400 journals have explicitly supported the CONSORT statement.
“More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Premisenone givenOther trial designs, such as cluster randomised trials and noninferiority trials, require varying amounts of additional information.
“Other trial designs, such as cluster randomised trials and noninferiority trials, require varying amounts of additional information.”
Quote in the paperNot a substantial claim0 of 2 sources checkedMay combine two claims.
PremisecitationSORT tried a rigid format, and it failed in a pilot run with an editor and authors.
“Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors [20].”
Quote in the paperSubstantial claim0 of 2 sources checked- cites [19] Standards of Reporting Trials Group, 1994, A proposal for structured reporting of randomized controlled trials, JAMA source
Not checked in the free run.
- cites [20] Rennie, 1995, Reporting randomized controlled trials. An experiment and a call for responses from readers, JAMA source
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
PremisecitationThe original CONSORT statement was developed in 1996 and revised five years later.
“That lack of adequate reporting fuelled the development of the original CONSORT (Consolidated Standards of Reporting Trials) statement in 1996 [5] and its revision five years later [6e8].”
Quote in the paperNot a substantial claim0 of 2 sources checked- cites [5] Begg, 1996, Improving the quality of reporting of randomized controlled trials. The CONSORT statement, JAMA source
Not checked in the free run.
- cites [6e8]
Not checked in the free run.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
InterpretationreasoningCONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings.
“CONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings”
Quote in the paperNot a substantial claim- Rests on an assumption: Many journals expect authors to complete a CONSORT checklist indicating where in the manuscript the items have been addressed.
May combine two claims.
PremisecitationMany trial reports neglect to provide lucid and complete descriptions of critical information, causing attempted assessments to fail.
“Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [2e4].”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [2e4]
Not checked in the free run.
Probably not a substantial claim: may not pass S2 (checkable).
Interpretationnone givenTransparent reporting reveals deficiencies in research if they exist.
“Transparent reporting reveals deficiencies in research if they exist.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Interpretationnone givenA reporting guideline might encourage some authors to report fictitiously the information suggested by the guidance rather than what was actually done.
“However, as 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.”
Quote in the paperNot a substantial claimClassified as probably not a substantial claim.
InterpretationreasoningCONSORT can help researchers in designing their trial.
“Moreover, CONSORT can help researchers in designing their trial.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S2 (checkable), S4 (based).
Interpretationnone givenPoor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials.
“Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing), S4 (based). May combine two claims.
Interpretationnone givenThe ensuing scrutiny rewards well conducted trials and penalises poorly conducted trials.
“The ensuing scrutiny rewards well conducted trials and penalises poorly conducted trials.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing).
InterpretationreasoningThat emerging reality should provide impetus to improved trial design and conduct in the future.
“That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing), S4 (based).
Interpretationnone givenAny support for the earlier version accumulated from journals or editorial groups will automatically extend to this newer version, unless specifically requested otherwise.
“Any support for the earlier version accumulated from journals or editorial groups will automatically extend to this newer version, unless specifically requested otherwise.”
Quote in the paperNot a substantial claim
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.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Results will be analyzed and reported according to the CONSORT statement.
“Results will be analyzed and reported according to the CONSORT statement [66].”
From Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial (2023) · cites this paper as [66]
The Introduction identifies CONSORT as a guideline for reporting randomized trials, supporting the plan to report results according to it. Section 6 (Implications and limitations) says CONSORT does not recommend how trials should be conducted; the paper does not establish it as a standard for performing the results analysis. Page numbers are unavailable in our copy. (LLM, conf=0.87)
Experimental — accuracy not yet measuredHeteroscedasticity may suggest a need to specify further the eligibility criteria or search for an additive scale.
“Otherwise, heteroscedasticity may suggest a need to specify further the eligibility criteria or search for an additive scale 25, 29.”
From Does evidence support the high expectations placed in precision medicine? A bibliographic review (2019) · cites this paper as [29]
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Grönstedt, H. K., Frändin, K., Bergland, A., Helbostad, J. L., Granbo, R., Puggaard, L., Andresen, M., & Hellström, K. (2012) · Gerontology · doi:10.1159/000345416 · Cited by 95 · see citing works
- 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
- hybrid
- doi.org
- Licence
- 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
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Claims read by deepseek-v4.1-flash under definition version 3 (extract-v3) on 2026-10-08.
Classified by jev-1.13-20260917 (gold-guideline-v0.2) on 2026-10-08.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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