Value of Flow Diagrams in Reports of Randomized Controlled Trials

Abstract

The Consolidated Standards for Reporting of Trials (CONSORT) criteria were published in 1996¹ to assist authors in reporting randomized controlled trials (RCTs). The CONSORT statement consists of a checklist for items in the methods, results, and discussion sections of a trial report and a diagram to show the flow of participants through the various stages of the trial (Figure 1, A). The CONSORT statement has been endorsed by an increasing number of journals,^2-5 but it is unclear whether the use of CONSORT has improved the quality of reports of RCTs. We examined to what extent 5 leading medical journals adopted flow diagrams, analyzed the information contributed by these diagrams, and assessed completeness of reporting overall. The results guided our attempt to improve the design of the flow diagram (Figure 1, B).