The revised CONSORT statement for reporting randomized trials: Explanationand elaboration

Overwhelming evidence now indicates that the quality of reporting of random ized, controlled trials (RCTs) is less than optimal. Recent methodologic an alyses indicate that inadequate reporting and design are associated with bi ased estimates of treatment effects. Such systematic error is seriously dam aging to RCTs, which boast the elimination of systematic error as their pri mary hallmark. Systematic error in RCTs reflects poor science, and poor sci ence threatens proper ethical standards. A group of scientists and editors developed the CONSORT (Consolidated Stand ards of Reporting Trials) statement to improve the quality of reporting of RCTs. The statement consists of a checklist and flow diagram that authors c an use for reporting an RCT. Many leading medical journals and major intern ational editorial groups have adopted the CONSORT statement. The CONSORT st atement facilitates critical appraisal and interpretation of RCTs by provid ing guidance to authors about how to improve the reporting of their trials. This explanatory and elaboration document is intended to enhance the use, u nderstanding, and dissemination of the CONSORT statement. The meaning and r ationale for each checklist item are presented. For most items, at least on e published example of good reporting and, where possible, references to re levant empirical studies are provided. Several examples of flow diagrams ar e included. The CONSORT statement, this explanatory and elaboration document, and the a ssociated Web site (http://www.consort -statement.org) should be helpful re sources to improve reporting of randomized trials.