Background: Clear, transparent, and sufficiently detailed conference abstracts and abstracts of journal articles are important for reporting randomized trials. Readers often base their assessment of a trial solely on information in the abstract.
Objectives: To extend the CONSORT (Consolidated Standards of Reporting Trials) Statement by developing a checklist of essential items to be included in any conference or journal abstract reporting a randomized trial.
Methods: We generated a list of possible checklist items from existing quality assessment tools. A three-round, modified-Delphi process was used to select and reduce the number of possible checklist 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 one-day meeting involving 26 participants in Canada, in January 2007. This was part of a three-day meeting of the CONSORT group as a whole. Proposed checklist items, resulting from the Delphi survey, were discussed as to whether they should be included, excluded or modified in the final checklist. Following the meeting, the checklist was revised and sent to the CONSORT Steering Committee and meeting participants to ensure that it reflected the discussions.
Results: CONSORT for Abstracts consists of a 17-item checklist; reports of abstracts should be described in a structured format. The checklist items include details of the contact author; trial design; trial participants; interventions intended for each randomized group; trial objectives; primary outcome; method of allocation; blinding of trial personnel; numbers of participants randomized and analysed; trial status; results for the primary outcome; harms; trial conclusions; trial registration number and name of registry; and source of funding. We recommend the checklist is used in conjunction with its explanatory document, which includes examples of good reporting, rationale, and evidence, when available, for inclusion of each item.
Conclusions: CONSORT for Abstracts aims to improve reporting of randomized trials in abstracts of journal articles and in abstracts of conference proceedings. We hope it will help authors of these abstracts to provide the necessary detail and clarity, to allow users of these abstracts to do so more effectively and to assess the validity of the research more effectively.
Reference: 1. Moher D, Schulz KF, Altman DG. (2001) The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials, Lancet, 357(9263):1191-1194.