CONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomized Trials
Annals of Internal MedicinePublished 1 June 2010
Kenneth F. Schulz, Douglas G. Altman, David Moher, for the CONSORT Group*
Citations3,864
SJR quartileQ1
SJR score3.38
SNIP3.27
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
The latest version of the CONSORT statement, CONSORT 2010, is described, which updates the reporting guideline based on new methodological evidence and accumulating experience.
Abstract
The CONSORT (Consolidated Standards of Reporting Trials) statement is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
Keywords
Decision SciencesMedicineEconomics, Econometrics and Finance
BMJPreferred reporting items for systematic reviews and meta-analyses: the PRISMA statement
83,276 Citations2009David Moher, A. Liberati +3 more
PubMedPreferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement.
45,120 Citations2009David Moher, Alessandro Liberati +2 more
Annals of Internal MedicinePreferred Reporting Items for Systematic Reviews and Meta-Analyses: The PRISMA Statement
37,262 Citations2009David Moher, Alessandro Liberati +3 more
PLoS MedicineThe Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies
21,612 Citations2007Erik von Elm, Douglas G. Altman +5 more
The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study, resulting in a checklist of 22 items that relate to the title, abstract, introduction, methods, results, and discussion sections of articles.
Annals of Internal MedicineThe Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies
17,239 Citations2007Erik von Elm, Douglas G. Altman +5 more
The STROBE Statement is a checklist of items that should be addressed in articles reporting on the 3 main study designs of analytical epidemiology: cohort, casecontrol, and cross-sectional studies; these recommendations are not prescriptions for designing or conducting studies.
BMC MedicineCONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
13,537 Citations2010the CONSORT Group, Kenneth F. Schulz +2 more
BMJCONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials
9,055 Citations2010David Moher, Sally Hopewell +7 more
JAMAEmpirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials
5,580 Citations1995Klaus‐Peter Schulz
Empirical evidence is provided that inadequate methodological approaches in controlled trials, particularly those representing poor allocation concealment, are associated with bias.
The LancetThe CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials
5,372 Citations2001David Moher, Kenneth F. Schulz +1 more
The revised CONSORT statement presented here incorporates new evidence and addresses some criticisms of the original statement to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
The LancetDoes quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?
3,591 Citations1998David Moher, Ba’ Pham +6 more
Study of low methodological quality in which the estimate of quality is incorporated into the meta-analyses can alter the interpretation of the benefit of intervention, whether a scale or component approach is used in the assessment of trial quality.
BMJConsort 2010 statement: extension to cluster randomised trials
3,418 Citations2012Marion Campbell, Gilda Piaggio +3 more
This paper provides updated and extended guidance, based on the 2010 version of the CONSORT statement and the 2008consORT statement for the reporting of abstracts, on how to report the results of cluster randomised controlled trials.
JAMAImproving the quality of reporting of randomized controlled trials. The CONSORT statement
3,343 Citations1996Colin B. Begg
BMJAssessing the quality of controlled clinical trials
3,334 Citations2001Peter Jüni, Douglas G Altman +1 more
The concept of study quality and the methods used to assess quality are discussed and the methodology for both the assessment of quality and its incorporation into systematic reviews and meta-analysis is discussed.
JAMAImproving the Quality of Reporting of Randomized Controlled Trials
3,138 Citations1996Colin B. Begg
BMC Medical Research MethodologyThe CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials
2,754 Citations2001David Moher, Kenneth F. Schulz +1 more
The revised 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.
BMJCONSORT statement: extension to cluster randomised trials
2,547 Citations2004Marion Campbell, Diana R Elbourne +1 more
New guidance is presented, based on the 2001 revision of the CONSORT statement, on reporting parallel group randomised trials in which individual participants are randomly assigned to study groups.
JAMAThe CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
2,530 Citations2001David Moher
The revised CONSORT statement presented in this paper incorporates new evidence and addresses some criticisms of the original statement to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.
JAMAReporting of Noninferiority and Equivalence Randomized Trials
2,357 Citations2012Gilda Piaggio, Diana R Elbourne +4 more
An updated extension of the CONSORT checklist for reporting noninferiority and equivalence trials is presented, based on the 2010 version of theconsORT Statement and the 2008 CONSORT Statement for the reporting of abstracts, and illustrative examples and explanations for those items that differ from the main 2010consORT checklist are provided.
Annals of Internal MedicineExtending the CONSORT Statement to Randomized Trials of Nonpharmacologic Treatment: Explanation and Elaboration
2,237 Citations2008Isabelle Boutron, David Moher +4 more
This elaboration and explanation document is developed from a review of the literature to provide examples of adequate reporting in trials of nonpharmacologic treatments and should help to improve the reporting of RCTs performed in this field.
BMJPharmaceutical industry sponsorship and research outcome and quality: systematic review
2,163 Citations2003Joel Lexchin, Lisa A Bero +2 more
Investigating whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support found systematic bias favours products which are made by the company funding the research.
BMJWhat is meant by intention to treat analysis? Survey of published randomised controlled trials
2,130 Citations1999S. Hollis, Fiona Campbell
Assessment of reports of randomised controlled trials published in 1997 found that intention to treat was used, but handling of deviations from randomised allocation varied widely and methods used to deal with this were generally inadequate, potentially leading to bias.
BMJImproving the reporting of pragmatic trials: an extension of the CONSORT statement
1,829 Citations2008Merrick Zwarenstein, Shaun Treweek +7 more
Eight CONSORT checklist items for reporting of pragmatic trials are recommended, including the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings.
JAMAEmpirical Evidence for Selective Reporting of Outcomes in Randomized Trials
1,806 Citations2004An‐Wen Chan, Asbjørn Hróbjartsson +3 more
The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
Annals of Internal MedicineBetter Reporting of Harms in Randomized Trials: An Extension of the CONSORT Statement
1,522 Citations2004John P. A. Ioannidis, Stephen J.W. Evans +6 more
This work searched MEDLINE, EMBASE, Web of Science, and the Cochrane Library using a wide array of terms related to harms and identified pertinent evidence and made recommendations on the appropriate reporting of harms in RCTs.
PLoS ONESystematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias
1,506 Citations2008Kerry Dwan, Douglas G. Altman +12 more
There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.
Annals of Internal MedicineThe CONSORT Statement: Revised Recommendations for Improving the Quality of Reports of Parallel-Group Randomized Trials
1,441 Citations2001David Moher, Kenneth F. Schulz +2 more
New England Journal of MedicineClinical Trial Registration: A Statement from the International Committee of Medical Journal Editors
1,211 Citations2004Catherine De Angelis, Jeffrey M. Drazen +11 more
JAMAReporting of Noninferiority and Equivalence Randomized Trials
1,122 Citations2006Gilda Piaggio, Diana R Elbourne +4 more
An adaptedconsORT checklist for reporting noninferiority and equivalence trials is presented and illustrative examples and explanations for those items amended from the original CONSORT checklist are provided, enabling readers to assess the validity of their results and conclusions.
The LancetBlinding in randomised trials: hiding who got what
939 Citations2002Kenneth F. Schulz, David A. Grimes
The Medical Journal of AustraliaDoes the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review
853 Citations2006Amy C. Plint, David Moher +5 more
Whether the adoption of the CONSORT checklist is associated with improvement in the quality of reporting of randomised controlled trials (RCTs) is investigated.
Data Archiving and Networked Services (DANS)Towards complete and accurate reporting of studies of diagnostic accuracy: The STARD Initiative
697 Citations2003
PubMedRandomized trials stopped early for benefit: a systematic review.
696 Citations2005Víctor M. Montori, P.J. Devereaux +20 more
RCTs stopped early for benefit are becoming more common, often fail to adequately report relevant information about the decision to stop early, and show implausibly large treatment effects, particularly when the number of events is small, which suggests clinicians should view the results of such trials with skepticism.
PLoS MedicineCONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration
659 Citations2008Sally Hopewell, Mike Clarke +6 more
A minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract, is developed to improve reporting of abstracts of RCTs published in journal articles and conference proceedings.
BMJWhat is missing from descriptions of treatment in trials and reviews?
593 Citations2008Paul Glasziou, Emma Meats +2 more
Replicating non-pharmacological treatments in practice depends on how well they have been described in research studies, as well as on the quality of the treatments themselves.
Annals of Internal MedicineReporting Randomized, Controlled Trials of Herbal Interventions: An Elaborated CONSORT Statement
566 Citations2006Joel Gagnier, Heather Boon +5 more
This study elaborated on the 22-item checklist of the Consolidated Standards of Reporting Trials (CONSORT) statement to help authors and editors improve reporting of RCTs of herbal interventions and emphasized minimizing item elaborations and additions and basing elaborations on evidence whenever possible.
BMJThe quality of reports of randomised trials in 2000 and 2006: comparative study of articles indexed in PubMed
505 Citations2010Sally Hopewell, Susan Dutton +3 more
Reporting of several important aspects of trial methods improved between 2000 and 2006; however, the quality of reporting remains well below an acceptable level.
The LancetEpidemiology and reporting of randomised trials published in PubMed journals
475 Citations2005An‐Wen Chan, Douglas G. Altman
The epidemiology and reporting of methodological details for all 519 PubMed-indexed randomised trials published in December, 2000 were assessed, and power calculation, primary outcomes, random sequence generation, allocation concealment, and handling of attrition were each adequately described.
The LancetCONSORT for reporting randomised trials in journal and conference abstracts
437 Citations2008Sally Hopewell, Mike Clarke +5 more
Journals and conference organisers should provide instructions about the key elements of a trial that authors should report, within the space limitations of an abstract (typically, 250–300 words), and preliminary work shows that all the checklist items can be fi tted within such word limits.
JAMAA Proposal for Structured Reporting of Randomized Controlled Trials
310 Citations1994Erik Andrew
A RANDOMIZED controlled trial (RCT) is the most reliable method of assessing the efficacy of health care interventions and reports of RCTs should provide readers with adequate information about what went on in the design, execution, analysis, and interpretation of the trial.
Annals of Internal MedicineClinical Trial Registration: A Statement from the International Committee of Medical Journal Editors
275 Citations2004Catherine De Angelis, Jeffrey M. Drazen +11 more
The International Committee of Medical Journal Editors (ICMJE) proposes comprehensive trials registration as a solution to the problem of selective awareness and announces that all 11 ICMJE member journals will adopt a trials-registration policy to promote this goal.
JAMAReporting Number Needed to Treat and Absolute Risk Reduction in Randomized Controlled Trials
234 Citations2002Jim Nuovo
The frequency of explicit reporting of the number needed to treat (NNT) and the absolute risk reduction (ARR) in RCTs was examined and few authors expressed their findings in terms of NNT or ARR.
The LancetCONSORT 2010 changes and testing blindness in RCTs
145 Citations2010Kenneth F. Schulz, Douglas G. Altman +2 more
JAMAReporting Randomized Controlled Trials
81 Citations1995Drummond Rennie
It is found that when the treatment allocation was inadequately concealed from study participants and investigators, when the effect of a therapy was thwarted if allocation of patients is not random.
Annals of Internal MedicineWhat's in Placebos: Who Knows? Analysis of Randomized, Controlled Trials
60 Citations2010Beatrice A. Golomb, Laura C. Erickson +4 more
Because the nature of the placebo can influence trial outcomes, placebo formulation should be disclosed in reports of placebo-controlled trials.
