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Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review

View Article: PubMed Central - PubMed

ABSTRACT

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.

Electronic supplementary material: The online version of this article (doi:10.1186/s40200-016-0258-2) contains supplementary material, which is available to authorized users.

No MeSH data available.


CONSORT flow diagram
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Fig1: CONSORT flow diagram

Mentions: Based on defined search strategy for this study, 414 articles identified. One hundred and seventy seven articles in first screening and fifty two articles in second screening were excluded. Finally, 185 articles fulfilled eligibility criteria and assessed for this systematic assessment (Fig. 1).Fig. 1


Quality of reporting randomized controlled trials (RCTs) in diabetes in Iran; a systematic review
CONSORT flow diagram
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC5015251&req=5

Fig1: CONSORT flow diagram
Mentions: Based on defined search strategy for this study, 414 articles identified. One hundred and seventy seven articles in first screening and fifty two articles in second screening were excluded. Finally, 185 articles fulfilled eligibility criteria and assessed for this systematic assessment (Fig. 1).Fig. 1

View Article: PubMed Central - PubMed

ABSTRACT

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.

Electronic supplementary material: The online version of this article (doi:10.1186/s40200-016-0258-2) contains supplementary material, which is available to authorized users.

No MeSH data available.