How CONSORT began
In 1993, 30 experts comprised of medical journal editors, clinical trialists, epidemiologists, and methodologists met in Ottawa, Canada with the aim of developing a new scale to assess the quality of randomized controlled trial (RCT) reports. However, during preliminary discussions, participants felt that many of the suggested scale items were irrelevant because they were not regularly reported by authors. In fact, there was accumulating evidence that the quality of reports of RCTs was less than optimal (1,2). Therefore, unanimous agreement steered the remainder of the workshop to focus on ways to improve the reporting of RCTs.
Participants nominated items to be included in the checklist for which there was evidence, whenever possible, that not adequately reporting this information could lead to biased estimates of the benefits of the intervention under investigation. One outcome of the meeting was the Standardized Reporting of Trials (SORT) statement (3). This statement consisted of a 32-item checklist and flow diagram in which investigators were encouraged to report on the various aspects of how RCTs were conducted.
Concurrently, and independently, another group of experts, the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature, convened in Asilomar (California), USA, were working on a similar mandate. This group also published a proposal which included a checklist of recommended items for authors to consider when reporting RCTs (4).
At the suggestion of Drummond Rennie, Deputy Editor of JAMA, representatives from both groups met in 1996, in Chicago, USA. The remit of this group was to merge the best of the SORT and Asilomar proposals into a single, coherent evidence-based recommendation. It was felt that a single recommendation would have a better likelihood of appealing to journals and thus improve dissemination. The meeting resulted in the Consolidated Standards of Reporting Trials (CONSORT) Statement, which was first published in 1996 (5).
Further meetings of the Group in 1999 and 2000 led to the publication of the revised CONSORT Statement in 2001. Following a meeting in January 2007, a further revision is underway.
References
1. Pocock SJ, Hughes MD, Lee RJ. Statistical problems in the reporting of clinical trials. A survey of three medical journals. N Engl J Med. 1987;317:426-32. [PMID: 0003614286]
2. Altman DG, Doré CJ. Randomisation and baseline comparisons in clinical trials. Lancet. 1990;335:149-53. [PMID: 0001967441]
3. The Standards of Reporting Trials Group. A proposal for structured reporting of randomized controlled trials. The Standards of Reporting Trials Group. JAMA. 1994;272:1926-31. [PMID: 0007990245]
4. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Call for comments on a proposal to improve reporting of clinical trials in the biomedical literature. Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Ann Intern Med. 1994;121:894-5. [PMID: 0007978706]
5. Begg C, Cho M, Eastwood S, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276:637-9. [PMID: 0008773637]
Page last edited: 02 April 2008
