The Adequacy of Reporting Randomized, Controlled Trials in the Evaluation of Antidepressants

OBJECTIVE: To evaluate the adequacy of the reports of methodological and statistical aspects of randomized, controlled trials that evaluate antidepressant medications and the degree to which their results can be used in subsequent metaanalyses. DATA SOURCES: Randomized, controlled trials published in English that compared 2 antidepressant drugs with a placebo were reviewed. Papers were located using Medline and reference lists. DATA EXTRACTION: Each paper was evaluated using a checklist, and 3 summary criteria scores were derived: minimal, ideal, and overall. RESULTS: Only 9 of the 69 papers met the minimal criteria to be included in a metaanalysis (which would report the final sample size and an estimate of the mean and of the standard deviation); and 0 met all of the ideal criteria for reporting clinical trials. Out of a possible 100 points, the mean score for the articles was 51, and the highest score was 80. Scores were not related to the citation impact factor of the journal in which they appeared. CONCLUSIONS: Researchers must become more aware of the criteria for reporting clinical trials, and editors must insist more strenuously that these criteria be satisfied.