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CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
Open accessAbstract
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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“We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines [33].”
From Systematic review of mind‐body interventions to treat myalgic encephalomyelitis/chronic fatigue syndrome (2021) · cites this paper as [33]
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“The study design was guided by the adapted CONSORT checklist for pilot trials [37, 38].”
From It is time to address fear of cancer recurrence in family caregivers: protocol for the feasibility and acceptability of a randomized pilot study of the online version of the Family Caregiver–Fear Of Recurrence Therapy (FC-FORT) (2024) · cites this paper as [38]
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“As reported in the main CONSORT statement, a systematic review has shown that research funded by the pharmaceutical industry is more likely to report findings in its favour, compared with reports of research funded by independent funding bodies.2 61”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials. (2016) · cites this paper as [61]
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“Restricted randomisation is particularly useful in small trials evaluating the effectiveness of an intervention, to ensure balance in certain characteristics between intervention and control groups”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials. (2016) · cites this paper as [61]
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“A quality assessment of each report was carried out to determine if the study followed the Consolidated Standards of Reporting Trials (CONSORT) criteria [42].”
From Patient Engagement with Conversational Agents in Health Applications 2016–2022: A Systematic Review and Meta-Analysis (2024) · cites this paper as [42]
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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 [26]
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“This trial was registered on the ClinicalTrials.gov database (NCT04074681) and will be carried out taking into account the CONSORT 2010 (Consolidated Standards for Reporting Trials; www.consort-statement.org) (Moher et al., 2010) and the CONSORT-EHEALTH guidelines (Consolidated Standards for Reporting Trials of Electronic and Mobile Health Applications and Online TeleHealth) (Eysenbach and CONSORT”
From Efficacy of an internet-based psychological intervention for problem gambling and gambling disorder: Study protocol for a randomized controlled trial (2021) · cites this paper as Moher et al., 2010
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“The results of the study will be reported according to the guidelines of the Consolidated Standards of Reporting Trials (CONSORT) statement [45].”
From HELP@APP: Development and evaluation of a self-help app for traumatized Syrian refugees in Germany- A study protocol of a randomized controlled trial (2019) · cites this paper as [45]
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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 [52]
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“As reported in the main CONSORT statement, a systematic review has shown that research funded by the pharmaceutical industry is more likely to report findings in its favour, compared with reports of research funded by independent funding bodies [2, 61]”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials (2016) · cites this paper as [61]
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“Two reviewers (Zhen Qu and Jiangyi Ju) independently assessed the risk of bias for each included study. The methodological quality of the included studies was assessed via the Cochrane Risk of Bias 2.0 (RoB 2.0) tool (19).”
From Effectiveness of acupuncture in the treatment of chronic sciatica from herniated disks: a systematic review and meta-analysis (2026) · cites this paper as [19]
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“since findings from case studies sometimes fail to be replicated in controlled trials (CONSORT; Moher et al., 2010).”
From THE EFFICACY OF A COMPASSION, ACCEPTANCE AND MINDFULNESS-BASED PILOT INTERVENTION FOR ADOLESCENTS’ TEST ANXIETY: A CASE STUDY USING THE ACADEMIC PROGRAM (2023) · cites this paper as Moher et al., 2010
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“Regarding reporting of adverse events, despite the recommendation of reporting adverse events in clinical trials by the Consolidated Standards of Reporting Trials Group [41], only 1 study [20] reported adverse events.”
From A systematic review of artificial intelligence chatbots for promoting physical activity, healthy diet, and weight loss (2021) · cites this paper as [41]
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“Restricted randomisation is particularly useful in small trials evaluating the effectiveness of an intervention, to ensure balance in certain characteristics between intervention and control groups (see main CONSORT statement) [2, 61].”
From CONSORT 2010 statement: extension to randomised pilot and feasibility trials (2016) · cites this paper as [61]
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Metadata
- 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
- ORCID
- 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
- hybrid
- doi.org
- Licence
- 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
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.
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.
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