ارزشيابي كيفيت كارآزماييهاي باليني منتشرشده در مجلات علوم پزشكي ايران در فاصله سالهاي 82-1380

AN EVALUATION OF THE QUALITY OF PUBLISHED CLINICAL TRIALS IN IRANIAN MEDICAL JOURNALS DURING 2001-2004

BACKGROUND AND OBJECTIVE: A clinical trial cannot be adequately interpreted without information about the methods used in the design of the study and the analysis of the results. The goal of this study was to assess the quality of published clinical trials in the Iranian medical journals. METHODS: In this cross sectional study, all 227 randomized clinical trials published in the 25 Iranian Medical Journals were surveyed. In these trials, the methods of randomization, determination of sample size, blinding and ethical issues were examined. FINDINGS: Results showed that only 14(6.2%) out of 227 published clinical trials reported the sample size calculations. The information about the type of randomization and the methods of blinding were reported in 3(1.3%) and 113 (49.8%) respectively. Of these figures, 27(11.9%) were single-blind and 86 (37.9%) double-blind. One hundred ninety three (85%) of the trials reported the statistical methods used. Finally, the issue of the informed consent was reported in 92(40.5%) trials. CONCLUSION: Published clinical trials are poorly designed and reported in Iranian medical journals. Therefore, it is recommended that editors, reviewers and authors should improve the standards of reporting clinical trials using a standard protocol.