The DOI matches its Crossref record; 22 of the 22 references it cites were found in a registry or an index.
The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
Open accessAbstract
To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goal can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improvement. Investigators and editors developed the original CONSORT (Consolidated Standards of Reporting Trials) statement to help authors improve reporting by using a checklist and flow diagram. The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist includes 22 items selected because empirical evidence indicates that not reporting the information is associated with biased estimates of treatment effect or because the information is essential to judge the reliability or relevance of the findings. We intended the flow diagram to depict the passage of participants through an RCT. The revised flow diagram depicts information from four stages of trial (enrollment, intervention allocation, follow-up, and analysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have performed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
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“The RCT was conducted in accordance with the CONSORT 2010 Statement [51] and the CONSORT-EHEALTH guidelines [52,53] to study the efficacy of two experimental conditions: 1) In Vivo Exposure and 2) Augmented Reality Exposure (see S1 CONSORT Checklist).”
From In Vivo versus augmented reality exposure in the treatment of small animal phobia: A randomized controlled trial (2016) · cites this paper as [51]
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“For this protocol, we will follow the CONSORT statement (Consolidated Standards of Reporting Trials, http://www.consort-statement.org) (25, 26) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Interventional Trials (27, 28).”
From Spanish Adaptation of Meaning-Centered Psychotherapy for Participants With Cancer: Study Protocol of a Randomized Control Trial (2022) · cites this paper as [25]
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Meta-analysis of Observational Studies in Epidemiology<SUBTITLE>A Proposal for Reporting</SUBTITLE>
Stroup, D. F. (2000) · JAMA · doi:10.1001/jama.283.15.2008 · Cited by 20,623
Schulz (1995) · doi:10.1001/jama.1995.03520290060030 · Cited by 5,634
Self-citationMoher, D., Cook, D. J., Eastwood, S., Olkin, I., Rennie, D., & Stroup, D. F. (1999) · The Lancet · doi:10.1016/s0140-6736(99)04149-5 · Cited by 4,826
Self-citationMoher, D., Pham, B., Jones, A., Cook, D. J., Jadad, A. R., Moher, M., Tugwell, P., & Klassen, T. P. (1998) · The Lancet · doi:10.1016/s0140-6736(98)01085-x · Cited by 3,560
Self-citationImproving the Quality of Reporting of Randomized Controlled Trials: The CONSORT Statement
Begg, C. (1996) · JAMA · doi:10.1001/jama.1996.03540080059030 · Cited by 3,127
What is meant by intention to treat analysis? Survey of published randomised controlled trials
Hollis, S., & Campbell, F. (1999) · BMJ · doi:10.1136/bmj.319.7211.670 · Cited by 2,160
Recommendations for Reporting Cost-effectiveness Analyses
Siegel, J. E. (1996) · JAMA: The Journal of the American Medical Association · doi:10.1001/jama.1996.03540160061034 · Cited by 1,147
The scandal of poor medical research.
Altman, D. G. (1994) · BMJ · doi:10.1136/bmj.308.6924.283 · Cited by 897
Self-citationBetter reporting of randomised controlled trials: the CONSORT statement
Altman, D. G. (1996) · BMJ · doi:10.1136/bmj.313.7057.570 · Cited by 614
Self-citationGuidelines for Statistical Reporting in Articles for Medical Journals
Bailar, J. C., & MOSTELLER, F. (1988) · Annals of Internal Medicine · doi:10.7326/0003-4819-108-2-266 · Cited by 387
Research works printed but not linked: 4
- Egger, Ju ni The value of patient flow charts in reports of randomized controlled trials : bibliographic study The CONSORT Group In press, JAMA
- Moher, Use of the CONSORT statement and quality of reports of randomized trials : a comparative before and after evaluation ? The CONSORT Group In press, JAMA
- Moher, Use of the CONSORT statement and quality of reports of randomized trials : a comparative before and after evaluation ? The CONSORT Group In press, JAMA
- Egger, Ju ni The value of patient flow charts in reports of randomized controlled trials : bibliographic study The CONSORT Group In press, JAMA
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Thabane, L., Ma, J., Chu, R., Cheng, J., Ismaila, A., Rios, L. P., Robson, R., Thabane, M., Giangregorio, L., & Goldsmith, C. H. (2010) · BMC Medical Research Methodology · doi:10.1186/1471-2288-10-1 · Cited by 3,384
Sampson, H. A., van Wijk, R. G., Bindslev‐Jensen, C., Sicherer, S. H., Teuber, S. S., Burks, A. W., Dubois, A. E. J., Beyer, K., Eigenmann, P., Spergel, J. M., et al. (2012) · Journal of Allergy and Clinical Immunology · doi:10.1016/j.jaci.2012.10.017 · Cited by 751
Single-case experimental designs: a systematic review of published research and current standards
Smith, J. D. (2012) · Psychological Methods · doi:10.1037/a0029312 · Cited by 630
Early intervention for psychosis
Marshall, M., & Rathbone, J. (2011) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd004718.pub3 · Cited by 531
Metadata
- Authors
- Moher, D., Schulz, K. F., & Altman, D. G.
- Affiliations
- University of Ottawa (CA)
- University of North Carolina at Chapel Hill (US)
- University of Oxford (GB)
- Venue
- Journal of the American Podiatric Medical Association
- Publisher
- MDPI AG
- Published
- 2001-09
- Volume
- 91
- Issue
- 8
- Pages
- 437-442
- ISSN
- 1930-8264 (ISSN-L)
- 8750-7315
- OpenAlex
- W2082317966
- Cited by
- 193
- References
- 22
- Citations by year
- 2026: 1 · 2025: 3 · 2024: 7 · 2023: 10 · 2022: 12 · 2021: 7 · 2020: 15 · 2019: 9 · 2018: 13 · 2017: 6 · 2016: 9 · 2015: 8 · 2014: 9 · 2013: 8 · 2012: 6
- FWCI
- 3.76
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of the American Podiatric Medical Association (publishedVersion)
- PubMed (publishedVersion)
- Funders
- Abbott Laboratories
- U.S. National Library of Medicine
- 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 › Library and Information Sciences › Academic Publishing and Open Access
- Keywords
- CONSORT statement, reporting quality, reporting checklist, flowcharts, intention-to-treat analysis, bias in treatment effect estimation, clinical trial transparency
- MeSH terms
- Humans, Publishing, Quality Control, Research Design, Reproducibility of Results, Randomized Controlled Trials as Topic
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