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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].
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.
Model-written summary. Check it against the paper before relying on it.
Integrity signals
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Cites
Statistics
Verification
Claims the paper makes
0 of 21 cited sources checked · 0 supported · 0 flagged
None of the sources cited for this claim have been checked yet.
In the paper
“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].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 6. Implications and limitations
What the sources say
- Not checked yetcites [16] Moher, 2009, Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement, BMJ source
- Not checked yetcites [17] Bossuyt, 2003, Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative, BMJ source
- Not checked yetcites [18] von Elm, 2007, Strengthening the reporting of observational studies in epidemiology (STROBE) statement: guidelines for reporting observational studies, BMJ source
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIn the paper
“However, randomised trials can yield biased results if they lack methodological rigour [1].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 1. Introduction
What the sources say
- Not checked yetcites [1] Jüni, 2001, Systematic reviews in health care: assessing the quality of controlled clinical trials, BMJ source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesA conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Nevertheless, CONSORT does indirectly affect design and conduct.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 2. Intent of CONSORT 2010
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“CONSORT 2010 focuses predominantly on the two group, parallel randomised controlled trial, which accounts for over half of trials in the literature [2].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 6. Implications and limitations
What the sources say
- Not checked yetcites [2] Chan, 2005, Epidemiology and reporting of randomised trials published in PubMed journals, Lancet source
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIn the paper
“While those statements improved the reporting quality for some randomised controlled trials [9,10], many trial reports still remain inadequate [2].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 1. Introduction
What the sources say
- Not checked yetcites [2] Chan, 2005, Epidemiology and reporting of randomised trials published in PubMed journals, Lancet source
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesNone of the sources cited for this claim have been checked yet.
In the paper
“Empirical evidence suggests that authors often ignore, in the conduct and reporting of their trial, what they stated in the protocol [4,22].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > Box 1. Noteworthy general changes in CONSORT 2010 Statement
What the sources say
- Not checked yetcites [4] Dwan, 2008, Systematic review of the empirical evidence of study publication bias and outcome reporting bias, PLoS ONE source
- Not checked yetcites [22] Chan, 2004, Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles, JAMA source
Load-bearingStrength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“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].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 3. Background to CONSORT
What the sources say
- Not checked yetcites [14] Schulz, 1995, Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials, JAMA source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIn the paper
“That support seems warranted: when used by authors and journals, CONSORT seems to improve reporting [9].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 3. Background to CONSORT
What the sources say
- Not checked yetcites [9] Plint, 2006, Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review, Med J Aust source
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesNone of the sources cited for this claim have been checked yet.
In the paper
“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].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > Box 1. Noteworthy general changes in CONSORT 2010 Statement
What the sources say
- Not checked yetcites [4] Dwan, 2008, Systematic review of the empirical evidence of study publication bias and outcome reporting bias, PLoS ONE source
- Not checked yetcites [22] Chan, 2004, Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles, JAMA source
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesNone of the sources cited for this claim have been checked yet.
In the paper
“While those statements improved the reporting quality for some randomised controlled trials [9,10], many trial reports still remain inadequate [2].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 1. Introduction
What the sources say
- Not checked yetcites [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 yetcites [10] Hopewell, 2010, The quality of reports of randomised trials in 2000 and 2006: a comparative study of articles indexed by PubMed, BMJ source
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
- Probably not a substantial claim. 16
- It may state two separate claims as one. 7
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“More than 700 studies comprise the CONSORT database (located on the CONSORT website), which provides the empirical evidence to underpin the CONSORT initiative.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 3. Background to CONSORT
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Other prominent editorial groups, the Council of Science Editors and the World Association of Medical Editors, officially support CONSORT.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 3. Background to CONSORT
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“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).”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 5. Changes in CONSORT 2010
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“Experience with the checklist noted pragmatic difficulties when an item comprised multiple elements.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > Box 1. Noteworthy general changes in CONSORT 2010 Statement
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“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).”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 3. Background to CONSORT
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
The paper states this without a source or data behind it here, so there is nothing to check it against. The quote shows it is in the paper.
In the paper
“More than 400 journals, published around the world and in many languages, have explicitly supported the CONSORT statement.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 3. Background to CONSORT
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Other trial designs, such as cluster randomised trials and noninferiority trials, require varying amounts of additional information.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 2. Intent of CONSORT 2010
What the sources say
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
None of the sources cited for this claim have been checked yet.
In the paper
“Indeed, SORT [19] tried a rigid format, and it failed in a pilot run with an editor and authors [20].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 6. Implications and limitations
What the sources say
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
None of the sources cited for this claim have been checked yet.
In the paper
“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].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 1. Introduction
What the sources say
- Not checked yetcites [5] Begg, 1996, Improving the quality of reporting of randomized controlled trials. The CONSORT statement, JAMA source
- Not checked yetcites [6e8]
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“CONSORT 2010 relieves obfuscations and forces authors to provide page numbers in the checklist for both eligibility and settings”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > Box 1. Noteworthy general changes in CONSORT 2010 Statement
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Rests on an assumption: Many journals expect authors to complete a CONSORT checklist indicating where in the manuscript the items have been addressed.
In the paper
“Unfortunately, attempted assessments frequently fail because authors of many trial reports neglect to provide lucid and complete descriptions of that critical information [2e4].”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 1. Introduction
What the sources say
- Not checked yetcites [2e4]
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Transparent reporting reveals deficiencies in research if they exist.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 2. Intent of CONSORT 2010
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 6. Implications and limitations
Strength:hedged· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Moreover, CONSORT can help researchers in designing their trial.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 2. Intent of CONSORT 2010
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably not a substantial claim.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Poor reporting allows authors, intentionally or inadvertently, to escape scrutiny of any weak aspects of their trials.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 6. Implications and limitations
Tests✓ Asserted: passes✗ Checkable: fails✓ Load-bearing: passes✗ Based: failsProbably not a substantial claim. It may be too vague to check against evidence. The paper may give no reason why it holds.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The ensuing scrutiny rewards well conducted trials and penalises poorly conducted trials.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > Box 1. Noteworthy general changes in CONSORT 2010 Statement
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✗ Checkable: fails✗ Load-bearing: fails✗ Based: failsProbably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it. The paper may give no reason why it holds. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“That emerging reality should provide impetus to improved trial design and conduct in the future, a secondary indirect goal of our work.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > 2. Intent of CONSORT 2010
Strength:plain· not yet calibratedCausal:conditional· not yet calibratedTests✓ Asserted: passes✗ Checkable: fails✗ Load-bearing: fails✓ Based: passesProbably not a substantial claim. It may be too vague to check against evidence. The paper’s conclusions may not depend on it.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Any support for the earlier version accumulated from journals or editorial groups will automatically extend to this newer version, unless specifically requested otherwise.”
§ CONSORT 2010 Statement: Updated guidelines for reporting parallel group randomised trials > Box 1. Noteworthy general changes in CONSORT 2010 Statement
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✗ Based: failsProbably not a substantial claim. The paper’s conclusions may not depend on it. The paper may give no reason why it holds.
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?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredIn the citing paper
“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]
Citations
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Self-citationMoher, D., Hopewell, S., Schulz, K. F., Montori, V., Gotzsche, P. C., Devereaux, P. J., Elbourne, D., Egger, M., & Altman, D. G. (2010) · BMJ · doi:10.1136/bmj.c869 · Cited by 8,883
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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
- 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
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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.
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