M Jamalian, S Kheiri,
Volume 14, Issue 4 (Vol.14, No.4, 2019)
Abstract
Background and Objectives: Randomization is one of the principles of correct clinical trial. The aim of this study was to determine the quality of randomization in the published articles of clinical trials in the Persian-language journals indexed in Scopus.
ed in Scopus D
Methods: In this cross-sectional study, all clinical trials published in Persian journals indexed in Scopus during 2013-2017 were evaluated in terms of randomization using the Jadad scale. The score of the randomization item of this scale ranges from 0 to 2, with 0, 1, and 2 indicating poor, moderate, and good quality.
Results: A total of 452 articles were evaluated. Random allocation was indicated in 423 articles (93.6%). Simple random assignment and blocked methods were used in 42.8% and 22% of randomizations, respectively. The randomization method was unknown in 34% and an incorrect method was used for randomization in 5.3% of the articles. According to the Jadad scale, 56.4% of the articles had good, 36.9% had moderate, and 6.6% had poor quality in terms of randomization. Methodologists were consulted in 40.7% of the articles, and their contributions led to increased transparency in the randomization report (P = 0.007).
Conclusion: The randomization method and its report are missing in many clinical trials. Therefore, considering the importance of randomization in validating the results of these studies, journals editors and researchers should pay attention to the quality of randomization and its report.
