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  1. Azadeh Aletaha1,
  2. Hamid Reza Baradaran2,
  3. Akbar Soltani1,
  4. Amir Ramezani3
  1. 1Tehran University of Medical Sciences, Endocrinology &Metabolism Research Institute Iran, Tehran, Iran
  2. 2Associate Professor of Clinical Epidemiology Iran University of Medical Sciences, Tehran, Iran
  3. 3Iran University of Medical Sciences, Tehran, Iran.


Background and aims: To determine the quality of randomized controlled clinical trial reports in diabetes research in Iran and their presence in domestic and foreign credible guidelines which can imply whether randomized controlled trial articles in the field of diabetes are of good quality or not with respect to their high level of received citations, quality and credibility.

Method: We included RCTs conducted on Diabetes mellitus in Iran. Animal studies, educational, interventions, and non-randomized trials were excluded. This was a bibliographic study examining published journal articles involving RCTs in diabetes research from Iranian authors. A systematic search of ten databases(ISI Web of science, Scopus, PubMed, Science Direct, The Cochrane Library, Taylor & Francis Online, Biomed Central, EBSCO, ProQuest and OVID)were undertaken from July 2004–2014. We excluded duplicated publications reporting the same groups of participants and intervention two independent reviewers identify all eligible articles specifically designed data extraction form. Two reviewers assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statement and also evaluate each article with Scientometry tools in 260 valid English diabetes guidelines.

Result: Overall, we included 185 RCTs on diabetes mellitus, One hundred and eight five (185) studies were included and appraised. Half of them (55.7%) were published in Iranian journals. Most (89.7%) were parallel RCTs, and being performed on type2 diabetic patients (77.8%). Less than half of the CONSORT items (43.2%) were reported in studies, totally. The reporting of randomization and blinding were poor. A few studies 15.1% mentioned the method of random sequence generation and strategy of allocation concealment. And only 34.8% of trials report how blinding was applied. From 185 articles, twelve articles (10%) are presented in 260 Guidelines.

Conclusion: The reporting quality of abstracts of RCTs on Diabetes mellitus still should be improved. After the publication of CONSORT for abstracts guideline, the RCT abstracts reporting quality were improvement to some extent. The presence of RCTs on diabetes mellitus in guidelines was poor. This indicates that RCTs on diabetes mellitus need substantial improvement. In order to present an adequate reporting of the randomized controlled trial results, it is necessary that comprehensive information be given about the study's design, implementation, included groups, and method of data analysis and interpretation of the results.

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