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PMID: 18215107 Published · ppublish English Consensus Development Conference Guideline Journal Article Research Support, Non-U.S. Gov't

CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration.

PLoS medicine ·Vol. 5 ·No. 1 ·2008-01-22 ·Pages e20

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, CONSORT Group

Abstract

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. 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. 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.

MeSH Terms
Abstracting and Indexing/standards Congresses as Topic Periodicals as Topic/standards Publishing/standards Randomized Controlled Trials as Topic Writing/standards
Authors & Affiliations
8 authors, click to expand affiliations / ORCID
Hopewell Sally
UK Cochrane Centre, Oxford, United Kingdom. [email protected]
Clarke Mike
Moher David
Wager Elizabeth
Middleton Philippa
Altman Douglas G
Schulz Kenneth F
CONSORT Group
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Article Info
Journal
PLoS medicine
Abbr.
PLoS Med
ISSN
1549-1676
DOI
10.1371/journal.pmed.0050020
Email
[email protected]
Published
2008-01-22
Pages
e20
Language
English
Region
United States
NLM ID
101231360
PMCID
PMC2211558
Subset
IM
External Links
PubMed source DOI: 10.1371/journal.pmed.0050020 PMC Full Text View journal details
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