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

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dc.contributor.authorHopewell, S.
dc.contributor.authorClarke, M.
dc.contributor.authorMoher, D.
dc.contributor.authorWager, E.
dc.contributor.authorMiddleton, P.
dc.contributor.authorAltman, D.
dc.contributor.authorSchulz, K.
dc.contributor.editorvon Elm, E.
dc.date.issued2008
dc.description.abstractBACKGROUND: 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.
dc.description.statementofresponsibilitySally Hopewell, Mike Clarke, David Moher, Elizabeth Wager, Philippa Middleton, Douglas G. Altman, Kenneth F. Schulz, and the CONSORT Group
dc.identifier.citationPLoS Medicine, 2008; 5(1):48-56
dc.identifier.doi10.1371/journal.pmed.0050020
dc.identifier.issn1549-1277
dc.identifier.issn1549-1676
dc.identifier.orcidMiddleton, P. [0000-0002-8573-338X]
dc.identifier.urihttp://hdl.handle.net/2440/43052
dc.language.isoen
dc.publisherPublic Library of Science
dc.rightsCopyright © 2008 Hopewell et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
dc.source.urihttps://doi.org/10.1371/journal.pmed.0050020
dc.subjectCONSORT Group
dc.subjectWriting
dc.subjectAbstracting and Indexing
dc.subjectPublishing
dc.subjectCongresses as Topic
dc.subjectPeriodicals as Topic
dc.subjectRandomized Controlled Trials as Topic
dc.titleCONSORT for Reporting Randomized Controlled Trials in Journal and Conference Abstracts: Explanation and Elaboration
dc.typeJournal article
pubs.publication-statusPublished

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