CONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration

By Sally Hopewell, Mike Clarke, David Moher, Elizabeth Wager, P. Middleton, Douglas G. Altman, K. F. Schulz. PLoS Medicine, 2008

615 citations recorded by the source corpus.

Background Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles related to randomized controlled trials (RCTs) are important, because readers often base their assessment of a trial solely on information in the abstract. Here, we extend the CONSORT (Consolidated Standards of Reporting Trials) Statement to develop a minimum list of essential items, which authors should consider when reporting the results of a RCT in any journal or conference abstract. Methods and Findings We generated a list of items from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. In all, 109 participants were invited to participate in an electronic survey; the response rate was 61%. Survey results were presented at a meeting of the CONSORT Group in Montebello, Canada, January 2007, involving 26 participants, including clinical trialists, statisticians, epidemiologists, and biomedical editors. Checklist items were discussed for eligibility into the final checklist. The checklist was then revised to ensure that it reflected discussions held during and subsequent to the meeting. CONSORT for Abstracts recommends that abstracts relating to RCTs have a structured format. Items should include details of trial objectives; trial design (e.g., method of allocation, blinding/masking); trial participants (i.e., description, numbers randomized, and number analyzed); interventions intended for each randomized group and their impact on primary efficacy outcomes and harms; trial conclusions; trial registration name and number; and source of funding. We recommend the checklist be used in conjunction with this explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for the inclusion of each item. Conclusions CONSORT for Abstracts aims to improve reporting of abstracts of RCTs published in journal articles and conference proceedings. It will help authors of abstracts of these trials provide the detail and clarity needed by readers wishing to assess a trial's validity and the applicability of its results.

Subfields: Pharmacology, Public Health, Environmental and Occupational Health, Statistics and Probability

View Paper: https://www.semanticscholar.org/paper/003a794a746b573a22699e2b1706daceefc6ccdd

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Citations in the corpus

The CARE guidelines: consensus-based clinical case reporting guideline development (2013, positive): “There is substantial empirical evidence that reporting guidelines improve the completeness of published scientific reports eg, see references [13,24,25].”
CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. (2012, background): “For speciﬁc guidance see CONSORT for abstracts [45,65].”
The CARE Guidelines: Consensus-based Clinical Case Report Guideline Development (2013, positive): “There is substantial empirical evidence that reporting guidelines improve the completeness of published scientific reports (e.g., see Turner et al., 2012; Hopewell et al., 2008; and Hopewell, Ravaud, Baron, & Boutron, 2012).”
PRISMA for Abstracts: Reporting Systematic Reviews in Journal and Conference Abstracts (2013, methodology): “" Membership of the PRISMA for Abstracts Group is provided in the Acknowledgments.”
CONSORT 2025 statement: updated guideline for reporting randomised trials. (2025, neutral): “43 Other extensions include non-pharmacological treatments, 27 outcomes, 25 patient reported outcomes, 44 surrogate outcomes, 45 social and psychological interventions, 46 harms, 24 abstracts, 47 and health equity.”
Guidance for Developers of Health Research Reporting Guidelines (2010, methodology): “The CONSORT group has started using a Delphi consensus method [25] to achieve this goal.”
CARE guidelines for case reports: explanation and elaboration document. (2017, background): “The abstract also aids indexing and identification of case reports in electronic databases [21].”