Enhanced Reporting of Randomized, Controlled Trials: The CONSORT Statement

Excerpt

Well-performed, randomized, controlled, clini cal trials produce the best evidence for the superiority, equivalence, or inferiority of one clinical intervention compared with another. They require careful planning and are a lot of work. This planning and work often are wasted when trials are not adequately reported. In 1995 a group of scientists and statisticians met to address the problem of poor reporting of randomized, controlled trials. Most of the attendees were members of two existing groups concerned with the reporting of clinical trials: the Standards of Reporting Trials (SORT), and the Asilomar Working Group on Recommendations for Reporting of Clinical Trials in the Biomedical Literature. Each of these groups had already made recommendations, but their combined conference produced an important standard for authors, editors, and readers: the CONSORT Statement.1,2 The CONSORT (Consolidated Standards of Reporting Trials) Statement has been endorsed by the World Association of Medical Editors, the International Committee of Medical Journal Editors, and the Council of Science Editors. In 2003 it was mentioned in the “Instructions to Authors” in 22 percent of a sample of the top medical journals.3 As of this edition of Diseases of the Colon & Rectum, the Consort Statement will be included in the Instructions to Authors and compliance will be mandatory for authors submitting randomized, controlled trials. …