TY - JOUR
T1 - Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran
T2 - a systematic review
AU - Gohari, Faeze
AU - Baradaran, Hamid Reza
AU - Tabatabaee, Morteza
AU - Anijidani, Shabnam
AU - Mohammadpour Touserkani, Fatemeh
AU - Atlasi, Rasha
AU - Razmgir, Maryam
N1 - Acknowledgements
The authors wish to thank Professor Khamseh for his valuable comments to
prepare this article.
Funding
This study was part of Dr Shabnam Anjidani’s thesis for her medical doctorate
degree and also was granted by Tehran University of Medical Sciences number
91-04-102-20579.
PY - 2016/9/7
Y1 - 2016/9/7
N2 - Objective: To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Design: 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.
AB - Objective: To determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran. Design: 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.
KW - Diabetes
KW - Iran
KW - Randomized controlled trials
KW - Systematized review
UR - http://www.scopus.com/inward/record.url?scp=84986207056&partnerID=8YFLogxK
U2 - 10.1186/s40200-016-0258-2
DO - 10.1186/s40200-016-0258-2
M3 - Article
AN - SCOPUS:84986207056
VL - 15
JO - Journal of Diabetes and Metabolic Disorders
JF - Journal of Diabetes and Metabolic Disorders
SN - 2251-6581
IS - 1
M1 - 36
ER -