Journal des soins pharmaceutiques et des systèmes de santé
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Compliance to the CONSORT Statement on Participant Flow Diagrams in Infectious Disease Randomized Clinical Trials

Onyeka P Godwin, Brandon Dyson, Paul S Lee, Soon Park and Euni Lee

Background: The Consolidated Standard of Reporting Trials (CONSORT) Guidelines were developed to support adequate reporting of randomized controlled trials (RCTs). Method: A systematic review was conducted including RCTs of infectious diseases published in the top general medical and infectious disease journals in 2010. The level of compliance to flow diagram and its association with the CONSORT endorsement by the journals were evaluated. Results: A total of 67 studies were included in the analysis and a half of the studies were HIV/AIDS RCTs. About 78% of the studies included the flow diagram and 66% of the studies described an intention-to-treat approach. However, explicit descriptions of the study populations were the most lacking during the follow-up stage. The journals that endorsed the CONSORT statement had significantly lower odds of including the CONSORT flow diagram as compared with non-endorsing journals (OR=0.144; 95% CI 0.036-0.575, p<0.05). Conclusions: About one out of four published RCTs in the top medical- and infectious disease journals did not include the CONSORT diagram in 2010, and inconsistency in the reporting of the study population was observed. Clear and complete description of the attrition, especially on the follow-up process, can enhance valid interpretations of the findings by clinical pharmacists.