CONSORT: An Important Step toward Evidence-Based Health Care

The recent publication of the Consolidated Standards of Reporting Trials (CONSORT) guidelines lines for the reporting of randomized trials [1] marks a welcome convergence of advice from the Standards of Reporting Trials (SORT) Group [2] and the Asilomar Working Group on Recommendations for the Reporting of Clinical Trials in the Biomedical Literature, which examine clinical efficacy [3]. Authors who submit papers to Annals are now being asked to adhere to the principles embodied in the sensible recommendations from these two similar but until recently largely independent projects [4]. The Lancet, JAMA, and BMJ are also adopting these recommendations. The goal of the guidelines is to improve the reporting of clinical trials. This, in turn, should enhance the interpretation and further analysis of the results of existing trials and encourage high standards in the design and conduct of future trials.

The CONSORT guidelines provide a coherent statement of standards for the practice and reporting of randomized trials-a statement that is particularly welcome for its brevity and clarity. The recommendations highlight the importance of the fundamental building blocks that minimize bias and provide the scientific rigor needed to make meaningful clinical inferences from trials. These building blocks include adequately describing the hypotheses to be tested, the sample studied, and the process of randomization; accounting for all randomly assigned participants; and providing information on either primary end points for binary outcomes or estimates of mean and variance for continuous data.

If widely implemented, the CONSORT guidelines should go …