CONSORT Statement 2001
The CONSORT Statement is a continually evolving instrument, needing to be regularly updated in light of experience and new empirical evidence. Participants in the CONSORT Group and their degree of involvement vary over time. Key members meet regularly to review the need to further refine the CONSORT Statement.
At a meeting in May 1999, 13 participants of the CONSORT Group decided that there was a need to revise the original CONSORT checklist and flow diagram. The Group discussed the merits of including each item in light of current evidence, and determined, by consensus, the changes to be made in the revision.
As in developing the original CONSORT Statement, the intention was to keep only those items deemed fundamental to reporting standards for an RCT. Some items, which were not regarded as essential, could well be highly desirable and should still be included in a report of a randomized controlled trial even though they are not included in CONSORT. Such items included approval of an institutional ethics review board, sources of funding for the trial, and a trial registry number - e.g., the International Standard Randomized Controlled Trial Number (ISRCTN) used to register the RCT at its inception (1).
The revised CONSORT Statement was published in 2001, without precedent, simultaneously in three prestigious international medical journals (2-4).
References
1. Chalmers I. Current Controlled Trials: an opportunity to help improve the quality of clinical research. Curr Control Trials Cardiovasc Med 2000;1:3-8 [PMID: 11714397]
2. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT
statement: revised recommendations for improving the quality of reports of
parallel group randomized trials. Ann Intern Med. 2001;134:657-62. [PMID: 11304106]
3. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. JAMA. 2001;285:1987-91. [PMID: 11308435]
4. Moher D, Schulz KF, Altman DG, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports parallel group randomized trials. Lancet. 2001;357:1191-94. [PMID: 11323066]
Page last edited: 02 April 2008
