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

The CONSORT (CONsolidated Standards Of Reporting Trials) statement was designed to help authors improve the reporting of randomised controlled trials (RCTs) on human patients. The statement was revised in a publication in The Lancet in 2001 and is also described in a paper in the British Medical Journal. 

The CONSORT statement consists of a checklist and flow diagram for reporting an RCT. For convenience, the checklist and diagram together are called simply CONSORT. They are primarily intended for use in writing, reviewing, or assessing reports of simple two-group parallel RCTs.

The checklist relating to a paper's Title, Abstract, Introduction, Methods, Results, and Discussion. The revised checklist 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 or relevance of the findings.

The publication includes a revised flow diagram depicting information from four stages of a trial (enrolment, intervention allocation, followup, and analysis). The diagram explicitly shows the number of participants, for each intervention group, included in the primary data analysis. Inclusion of these numbers allows the reader to judge whether the authors have done an intention-to- treat analysis. In sum, the CONSORT statement is intended to improve the reporting of an RCT, enabling readers to understand a trial's conduct and to assess the validity of its results.

Reference

CONSORT 2010 statement: extension to randomised pilot and feasibility trials (October 2016)