The Quality of Reporting of Randomized Controlled Trials in Korean Medical Journals Indexed in KoreaMed: Survey of Items of the Revised CONSORT Statement

ABSTRACT

BACKGROUND: The revised Consolidated Standards for Reporting of Trials (CONSORT) were developed to improve the reporting of Randomized Controlled Trials. We studied to survey the extent to which RCTs report items included in the revised CONSORT recommendations. METHODS: A descriptive survey of RCTs enrolled in 2005 at KoreaMed, which is a representative database in Korea was done. The main outcome measures were the proportion of RCTs that reported each of 22 checklist items of CONSORT. RESULTS: We identified 125 RCTs from 26 journals. Random sequence implementation (0%), estimated effect size and its precision (0%), sample size determination (8.9%), method of random sequence generation (7.3%), allocation concealment (3.2%), participant flow (4.8%) and any other analysis (7.3%), generalizability of the trial findings (0.8%) were pooly reported. CONCLUSION: The proportions of following the CONSORT recommendations in Korean medical journals were very low. An effort to improve the reporting of RCTs by application and recommendation of CONSORT statement is required.