Quality of Randomized Clinical Trial Reports Published by Iranian Researchers in the Obstetrics and Gynecology Level 1 Journals: Using CONSORT

Document Type : Original Article

Authors

1 Associate Professor, Department of Physiology, Women's Reproductive Health Research Center, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.

2 M.Sc. of Midwifery, School of Nursing and Midwifery, Tabriz University of Medical Sciences, Tabriz, Iran.

3 Medical Student, Medical Philosophy and History Research Center, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran.

4 M.Sc. of Health Services Management, Tabriz Health Services Management Research Center, School of Management and Medical Informatics, Tabriz University of Medical Sciences, Tabriz, Iran.

Abstract

Introduction: Studies of randomized controlled trials are one of the most important studies in medical sciences. So, the report quality of these studies is very important. This study was conducted to evaluate the quality of clinical trials published by Iranian researches in level 1 journals of obstetrics and gynecology.
Methods: In this cross sectional study, articles of Randomized Controlled Trials (RCTs) published by Iranian researchers in field of obstetrics and gynecology in English journals indexed in first level valid bases (ISI, Pubmed, Web of Knowledge) during 1999 to 2012 were evaluated by two researchers using CONSORT tool. Data were analyzed using descriptive statistics tests and SPSS software version 16.
Results: Results of evaluation of 141 articles showed that totally the main part of failures were in methods and materials part and among 17 items of this part, the most part of weaknesses and shortcomings are in: determining sample size, method used for the order of randomized allocation of participants in study, details of any kind of randomization (for example categorization, block formation) and blinding method. Overall average of scores was equal to 31.35±5.67 from minimum and maximum of 19-37.
Conclusion: The most common weakness of researchers in reporting the results of studies were in materials and methods part which could be improved by more education on these topics, using specialists of statistics and methodology, and also using standard tools for self evaluation of articles.
 

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