Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review.
OBJECTIVE
To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran.


METHODS
Systematized review.


METHODS
We included RCTs conducted on diabetes mellitus in Iran. Animal studies, educational interventions, and non-randomized trials were excluded. We excluded duplicated publications reporting the same groups of participants and intervention. Two independent reviewers identify all eligible articles specifically designed data extraction form. We searched through international databases; Scopus, ProQuest, EBSCO, Science Direct, Web of Science, Cochrane Library, PubMed; and national databases (In Persian language) such as Magiran, Scientific Information Database (SID) and IranMedex from January 1995 to January of 2013 Two investigators assessed the quality of reporting by CONSORT 2010 (Consolidated Standards of Reporting Trials) checklist statemen.t,. Discrepancies were resolved by third reviewer consulting.


RESULTS
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.


CONCLUSIONS
The findings of this study show that the quality of RCTs conducted in Iran in diabetes research seems suboptimal and the reporting is also incomplete however an increasing trend of improvement can be seen over time. Therefore, it is suggested Iranian researchers pay much more attention to design and methodological quality in conducting and reporting of diabetes RCTs.
Knowledge Utilization Research Center, Tehran University of Medical Sciences, Tehran, Iran.
Faeze
F
Gohari
Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, 1449614535 Iran.
Hamid Reza
HR
Baradaran
Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, 1449614535 Iran.
Morteza
M
Tabatabaee
Endocrine Research Center, Institute of Endocrinology and Metabolism, Iran University of Medical Sciences, Tehran, 1449614535 Iran.
Shabnam
S
Anijidani
Department of Neurology, Boston Children's Hospital, Harvard Medical School, 1 Autumn St, Boston, MA 02115 USA.
Fatemeh
F
Mohammadpour Touserkani
Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran, Iran.
Rasha
R
Atlasi
Iran University of Medical Sciences, Tehran, Iran.
Maryam
M
Razmgir
Diabetes; Iran; Randomized controlled trials; Systematized review