The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials

To comprehend the results of a randomised controlled trial (RCT), readers m ust understand its design, conduct, analysis, and interpretation. That goal can be achieved only through total transparency from authors. Despite seve ral decades of educational efforts, the reporting of RCTs needs improvement . Investigators and editors developed the original CONSORT (Consolidated St andards of Reporting Trials) statement to help authors improve reporting by use of a checklist and now diagram. The revised CONSORT statement presente d here incorporates new evidence and addresses some criticisms of the origi nal statement. The checklist items pertain to the content of the Title, Abs tract, Introduction, Methods, Results, and Discussion. The revised checklis t includes 22 items selected because empirical evidence indicates that not reporting this information is associated with biased estimates of treatment effect, or because the information is essential to judge the reliability o r relevance of the findings. We intended the flow diagram to depict the pas sage of participants through an RCT. The revised flow diagram depicts infor mation from four stages of a trial (enrolment, intervention allocation, fol lowup, and analysis). The diagram explicitly shows the number of participan ts, for each intervention group, included in the primary data analysis. Inc lusion of these numbers allows the reader to judge whether the authors have done an intention-to-treat analysis. In sum, the CONSORT statement is inte nded to improve the reporting of an RCT, enabling readers to understand a t rial's conduct and to assess the validity of its results.