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

Abstract

ObjectiveTo determine the quality of randomized controlled clinical trial (RCT) reports in diabetes research in Iran.DesignSystematized review.MethodsWe 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.ResultsOne 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.ConclusionsThe 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 materialThe online version of this article (doi:10.1186/s40200-016-0258-2) contains supplementary material, which is available to authorized users.

Compliance of published randomized controlled trials on the effect of physical activity on primary dysmenorrhea with the consortium's integrated report on clinical trials statement: A critical appraisal of the literature

“…The possible reason for the higher quality in the aforementioned study is appraising the RCTs published only in 2017 in Indian medical journals, and it seems that overal compliance with the CONSORT tool has increased over time. [ 51 ],[ 57 ],[ 58 ] Regarding our findings, most of the RCTs did not mention the phrase of “randomized trial in the title” (1a). This finding is in contrast with some studies[ 51 ],[ 55 ] and is in line with another study.…”

A tutorial on methodological studies: the what, when, how and why

“…Any study that describes or analyzes methods (design, conduct, analysis or reporting) in published (or unpublished) literature is a methodological study. Consequently, the scope of methodological studies is quite extensive and includes, but is not limited to, topics as diverse as: research question formulation [11]; adherence to reporting guidelines [12][13][14] and consistency in reporting [15]; approaches to study analysis [16];…”

“…Any study that describes or analyzes methods (design, conduct, analysis or reporting) in published (or unpublished) literature is a methodological study. Consequently, the scope of methodological studies is quite extensive and includes, but is not limited to, topics as diverse as: research question formulation [ 11 ]; adherence to reporting guidelines [ 12 – 14 ] and consistency in reporting [ 15 ]; approaches to study analysis [ 16 ]; investigating the credibility of analyses [ 17 ]; and studies that synthesize these methodological studies [ 18 ]. While the nomenclature of methodological studies is not uniform, the intents and purposes of these studies remain fairly consistent – to describe or analyze methods in primary or secondary studies.…”

“…For example, Mbuagbaw et al described the reporting of research recommendations in Cochrane HIV systematic reviews [ 30 ]. Gohari et al described the quality of reporting of randomized trials in diabetes in Iran [ 12 ]. Methodological studies that are analytical Some methodological studies are analytical wherein “analytical studies identify and quantify associations, test hypotheses, identify causes and determine whether an association exists between variables, such as between an exposure and a disease.” [ 89 ] In the case of methodological studies all these investigations are possible.…”

“…For example, Mbuagbaw et al described the reporting of research recommendations in Cochrane HIV systematic reviews [ 30 ]. Gohari et al described the quality of reporting of randomized trials in diabetes in Iran [ 12 ].…”