Randomized clinical trials (CONSORT)]

It has been repeatedly shown that the information supplied in publications of clinical trials is frequently insufficient or inaccurate and that some methodologic problems are associated with exaggerated estimates of the effect of healthcare interventions. To improve the quality of reports of clinical trials, a group of scientists and editors developed the CONSORT statement (Consolidated Standards of Reporting Trials), a 22-item checklist (plus flow diagram), that can be used by authors, editors, reviewers, and readers. After publication in 1996, CONSORT was adopted by several journals and editorial groups. In 1999, a second version was drawn up, which was published in 2001. This article presents the Spanish translation of the two elements integrating the revised CONSORT, the flow diagram and the 22-item checklist, and provides a short comment on each of them. Previous publications of the CONSORT statement and other useful resources such as examples of what are considered good communications may be obtained from the CONSORT web site (http://www.consort-statement.org).