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

Sally Hopewell, Mike Clarke, David Moher, Elizabeth Wager, Philippa Middleton, Douglas G. Altman, Kenneth F. Schulz, Virginia Barbour, Jesse Berlin, Isabelle Boutron, P. J. Devereaux, Kay Dickersin, Diana Elbourne, Susan Ellenberg, Val Gebski, Steven Goodman, Peter C. Gøtzsche, Trish Groves, Steven Grunberg, Brian HaynesAstrid James, Peter Juhn, Don Minckler, Victor M. Montori, Cynthia Mulrow, Stuart Pocock, Drummond Rennie, David Schriger, Iveta Simera

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Pages (from-to)48-56
Number of pages9
JournalPLoS Medicine
Volume5
Issue number1
DOIs
StatePublished - Jan 2008

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Randomized Controlled Trials
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ASJC Scopus subject areas

  • Medicine(all)

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Hopewell, S., Clarke, M., Moher, D., Wager, E., Middleton, P., Altman, D. G., ... Simera, I. (2008). CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration. PLoS Medicine, 5(1), 48-56. https://doi.org/10.1371/journal.pmed.0050020

CONSORT for reporting randomized controlled trials in journal and conference abstracts : Explanation and elaboration. / Hopewell, Sally; Clarke, Mike; Moher, David; Wager, Elizabeth; Middleton, Philippa; Altman, Douglas G.; Schulz, Kenneth F.; Barbour, Virginia; Berlin, Jesse; Boutron, Isabelle; Devereaux, P. J.; Dickersin, Kay; Elbourne, Diana; Ellenberg, Susan; Gebski, Val; Goodman, Steven; Gøtzsche, Peter C.; Groves, Trish; Grunberg, Steven; Haynes, Brian; James, Astrid; Juhn, Peter; Minckler, Don; Montori, Victor M.; Mulrow, Cynthia; Pocock, Stuart; Rennie, Drummond; Schriger, David; Simera, Iveta.

In: PLoS Medicine, Vol. 5, No. 1, 01.2008, p. 48-56.

Research output: Contribution to journalArticle

Hopewell, S, Clarke, M, Moher, D, Wager, E, Middleton, P, Altman, DG, Schulz, KF, Barbour, V, Berlin, J, Boutron, I, Devereaux, PJ, Dickersin, K, Elbourne, D, Ellenberg, S, Gebski, V, Goodman, S, Gøtzsche, PC, Groves, T, Grunberg, S, Haynes, B, James, A, Juhn, P, Minckler, D, Montori, VM, Mulrow, C, Pocock, S, Rennie, D, Schriger, D & Simera, I 2008, 'CONSORT for reporting randomized controlled trials in journal and conference abstracts: Explanation and elaboration', PLoS Medicine, vol. 5, no. 1, pp. 48-56. https://doi.org/10.1371/journal.pmed.0050020
Hopewell, Sally ; Clarke, Mike ; Moher, David ; Wager, Elizabeth ; Middleton, Philippa ; Altman, Douglas G. ; Schulz, Kenneth F. ; Barbour, Virginia ; Berlin, Jesse ; Boutron, Isabelle ; Devereaux, P. J. ; Dickersin, Kay ; Elbourne, Diana ; Ellenberg, Susan ; Gebski, Val ; Goodman, Steven ; Gøtzsche, Peter C. ; Groves, Trish ; Grunberg, Steven ; Haynes, Brian ; James, Astrid ; Juhn, Peter ; Minckler, Don ; Montori, Victor M. ; Mulrow, Cynthia ; Pocock, Stuart ; Rennie, Drummond ; Schriger, David ; Simera, Iveta. / CONSORT for reporting randomized controlled trials in journal and conference abstracts : Explanation and elaboration. In: PLoS Medicine. 2008 ; Vol. 5, No. 1. pp. 48-56.
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AU - Hopewell, Sally

AU - Clarke, Mike

AU - Moher, David

AU - Wager, Elizabeth

AU - Middleton, Philippa

AU - Altman, Douglas G.

AU - Schulz, Kenneth F.

AU - Barbour, Virginia

AU - Berlin, Jesse

AU - Boutron, Isabelle

AU - Devereaux, P. J.

AU - Dickersin, Kay

AU - Elbourne, Diana

AU - Ellenberg, Susan

AU - Gebski, Val

AU - Goodman, Steven

AU - Gøtzsche, Peter C.

AU - Groves, Trish

AU - Grunberg, Steven

AU - Haynes, Brian

AU - James, Astrid

AU - Juhn, Peter

AU - Minckler, Don

AU - Montori, Victor M.

AU - Mulrow, Cynthia

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