The CONSORT statement: Revised recommendations for improving the quality of reports of parallel-group randomized trials

To comprehend the results of a randomized, controlled trial (RCT), readers must understand its design, conduct, analysis, and interpretation. That goa l can be achieved only through complete transparency from authors. Despite several decades of educational efforts, the reporting of RCTs needs improve ment. Investigators and editors developed the original CONSORT (Consolidate d Standards of Reporting Trials) statement to help authors improve reportin g by using a checklist and flow diagram. The revised CONSORT statement pres ented in this paper incorporates new evidence and addresses some criticisms of the original statement. The checklist items pertain to the content of the Title, Abstract, introduc tion, Methods, Results, and Discussion. The revised checklist includes 22 i tems selected because empirical evidence indicates that not reporting the i nformation is associated with biased estimates of treatment effect or becau se the information is essential to judge the reliability or relevance of th e findings. We intended the flow diagram to depict the passage of participa nts through an RCT. The revised flow diagram depicts information from four stages of a trial (enrollment, intervention allocation, follow-up, and anal ysis). The diagram explicitly includes the number of participants, for each intervention group, that are included in the primary data analysis. inclus ion of these numbers allows the reader to judge whether the authors have pe rformed an intention-to-treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RC T, enabling readers to understand a trial's conduct and to assess the valid ity of its results.