Use of the CONSORT Statement and Quality of Reports of Randomized Trials: A Comparative Before-and-After Evaluation

Moher, David; Jones, Alison; Lepage, Leah; for the CONSORT Group

doi:10.1001/jama.285.15.1992

Cited by 1,027Meta-analysis and systematic reviewsStatistical Methods in Clinical TrialsAcademic Publishing and Open Access

Use of the CONSORT Statement and Quality of Reports of Randomized Trials: A Comparative Before-and-After Evaluation

Moher, David, Jones, Alison, Lepage, Leah, for the CONSORT Group·2001·JAMA

DOI 10.1001/jama.285.15.1992

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Abstract

CONTEXT: The Consolidated Standards for Reporting of Trials (CONSORT) statement was developed to help improve the quality of reports of randomized controlled trials (RCTs). To date, a paucity of data exists regarding whether it has achieved this goal. OBJECTIVE: To determine whether use of the CONSORT statement is associated with improvement in the quality of reports of RCTs. DESIGN AND SETTING: Comparative before-and-after evaluation in which reports of RCTs published in 1994 (pre-CONSORT) were compared with RCT reports from the same journals published in 1998 (post-CONSORT). We included 211 reports from BMJ, JAMA, and The Lancet (journals that adopted CONSORT) as well as The New England Journal of Medicine (a journal that did not adopt CONSORT and was used as a comparator). MAIN OUTCOME MEASURES: Number of CONSORT items included in a report, frequency of unclear reporting of allocation concealment, and overall trial quality score based on the Jadad scale, a 5-point quality assessment instrument. RESULTS: Compared with 1994, the number of CONSORT checklist items in reports of RCTs increased in all 4 journals in 1998, and this increase was statistically significant for the 3 adopter journals (pre-CONSORT, 23.4; mean change, 3.7; 95% confidence interval [CI], 2.1-5.3). The frequency of unclear reporting of allocation concealment decreased for each of the 4 journals, and this change was statistically significant for adopters (pre-CONSORT, 61%; mean change, -22%; 95% CI, -38% to -6%). Similarly, 3 of the 4 journals showed an improvement in the quality score for reports of RCTs, and this increase was statistically significant for adopter journals overall (pre-CONSORT, 2.7; mean change, 0.4; 95% CI, 0.1-0.8). CONCLUSION: Use of the CONSORT statement is associated with improvements in the quality of reports of RCTs.

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Journal endorsement of CONSORT is associated with better reporting of randomised trials.
“Some evidence shows that journal endorsement of CONSORT is associated with better reporting and that reporting is improving over time [2,13–15].”
From CONSORT 2025 statement: Updated guideline for reporting randomised trials (2025) · cites this paper as [15]
The CONSORT statement has demonstrated a substantial positive impact on the quality of RCT reports.
“Over the past two decades, it has undergone two updates and has demonstrated a substantial positive impact on the quality of RCT reports6,7.”
From Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI extension (2020) · cites this paper as [6]
Earlier trials published before 2001 might not reflect current standards and/or feature incomplete reporting of methodological details introduced with CONSORT, increasing scope in biased risk assessments and heterogeneity.
“This means that these earlier trials might not reflect the current standards and/or feature incomplete reporting of methodological details that was introduced with the CONSORT guidelines and checklist, therefore increasing scope in biased risk assessments and heterogeneity.22 90”
From Exercise as medicine for depressive symptoms? A systematic review and meta-analysis with meta-regression (2023) · cites this paper as [90]

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Authors: Moher, D., Jones, A., Lepage, L., & for the CONSORT Group
Affiliations: Children's Hospital of Eastern Ontario (CA)
ORCID: Moher, David
Jones, Alison
Venue: JAMA
Publisher: American Medical Association (AMA)
Published: 2001-04-18
Volume: 285
Issue: 15
Pages: 1992
ISSN: 0002-9955 (ISSN-L)
0098-7484
DOI: 10.1001/jama.285.15.1992
OpenAlex: W2049321668
Cited by: 1,027
References: 13
Citations by year: 2026: 9 · 2025: 20 · 2024: 32 · 2023: 29 · 2022: 21 · 2021: 36 · 2020: 68 · 2019: 35 · 2018: 35 · 2017: 30 · 2016: 35 · 2015: 43 · 2014: 51 · 2013: 59 · 2012: 40
FWCI: 64.71
Type: journal article
Language: en
Open access: closed
Locations: JAMA (publishedVersion)
PubMed (publishedVersion)
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 › Decision Sciences › Information Systems and Management › Academic Publishing and Open Access
Keywords: CONSORT statement, reporting quality, randomized controlled trials, allocation concealment, Jadad scale, trial quality assessment, reporting guidelines, before-and-after evaluation
MeSH terms: Publishing, Quality Control, Randomized Controlled Trials as Topic

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Use of the CONSORT Statement and Quality of Reports of Randomized Trials: A Comparative Before-and-After Evaluation

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