CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.

By David Moher, Sally Hopewell, K. F. Schulz, Victor M. Montori, P. Gøtzsche, P. Devereaux, Diana Elbourne, Matthias Egger, Douglas G. Altman. International Journal of Surgery, 2012

3,604 citations recorded by the source corpus.

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.

Subfields: Economics and Econometrics, Public Health, Environmental and Occupational Health, Statistics and Probability

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Citations in the corpus

Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials: combined analysis of meta-epidemiological studies. (2012, neutral): “Contributing meta-analysesa Contributing trials Contributing high-risk trials (%) Contributing meta-analysesa Contributing trials Contributing unclear-risk trials (%) Sequence generation All 48 (17) 453 81 (18) 100 (57) 906 648 (72) Mortality 3 (2) 26 7 (27) 12 (8) 83 59 (71) Objective 22 (6) 175 32”
Strategy for intention to treat analysis in randomised trials with missing outcome data (2011, background): “The intention to treat principle requires all participants in a clinical trial to be included in the analysis in the groups to which they were randomised, regardless of any departures from randomised treatment.”
Effect size measures for mediation models: quantitative strategies for communicating indirect effects. (2011, background): “…with scientific oversight, including the National Center for Education Statistics (NCES, 2003), the International Committee of Medical Journal Editors (via the Consolidated Standard of Reporting Trials [CONSORT; Moher et al., 2010]), and the American Educational Research Association (AERA, 2006).”
How to Do a Systematic Review: A Best Practice Guide for Conducting and Reporting Narrative Reviews, Meta-Analyses, and Meta-Syntheses. (2019, background): “There are a number of guidelines outlining how to report systematic reviews and meta-analyses, including many that are methodology specific (e.g., CONSORT guidelines for reporting randomized controlled trials; see Moher et al. 2010).”
Data Statements for Natural Language Processing: Toward Mitigating System Bias and Enabling Better Science (2018, methodology): “…specialists in clinical trial methodology, and others to improve reporting of randomized, controlled trials.17 They include a checklist for authors to use to indicate where in their research reports each item is handled and a statement explaining the rationale behind each item (Moher et al., 2010).”