The CONSORT Group is pleased to announce the publication of a new extension to the CONSORT Statement for reporting randomized controlled trials (RCTs) in journal and conference abstracts.[1,2] Clear, transparent, and sufficiently detailed abstracts of conferences and journal articles are important, because readers often base their assessment of a trial solely on information in the abstract. We have extended the CONSORT Statement to develop a minimum list of essential items that authors should consider when reporting the main results of a RCT in any journal or conference abstract.
In developing this checklist, a list of items was generated from existing quality assessment tools and empirical evidence. A three-round, modified-Delphi process was used to select items. One hundred and nine 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. Potential checklist items were discussed for inclusion into the final checklist. The wording of the checklist items 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 encourage authors to use the CONSORT for Abstracts checklist in conjunction with its explanation and elaboration publication. We encourage journals, and conference organisers (chairs) to endorse the use of CONSORT for Abstracts by modifying their ''Instructions to Authors'' and by drawing their readers' attention to this reporting guidance, perhaps through an editorial, or by including a link to the checklist on the conference website and by notifying the CONSORT coordinator (MOcampo@cheo.on.ca) to include their journal or conference to the list of CONSORT endorsers. The most important benefit will be to enable readers to use abstracts more effectively and to aid assessment of the validity of the research.
We are grateful for the financial support provided by the American Society of Clinical Oncology, BMJ, Canadian Institutes of Health Research, Johnson & Johnson, The Lancet, Nordic Cochrane Centre, PLoS Medicine, UK Cochrane Centre, UK National Co-ordinating Centre for Research Methodology to convene a meeting of the CONSORT Group in Montebello, Canada, in January 2007.
1. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF and the CONSORT Group (2008) CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med 5(1): e20. doi:10.1371/journal. pmed.0050020.
2. Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF and the CONSORT Group (2008) CONSORT for reporting randomised trials in journal and conference abstracts. Lancet: 371:281-283.