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

被引:7
作者
Gohari F. [1 ]
Baradaran H.R. [2 ]
Tabatabaee M. [2 ]
Anijidani S. [2 ]
Mohammadpour Touserkani F. [3 ]
Atlasi R. [4 ]
Razmgir M. [5 ]
机构
[1] Tehran University of Medical Sciences, Knowledge Utilization Research Center, Tehran
[2] Iran University of Medical Sciences, Endocrine Research Center, Institute of Endocrinology and Metabolism, Tehran
[3] Department of Neurology, Boston Children's Hospital, Harvard Medical School, 1 Autumn St, Boston, 02115, MA
[4] Tehran University of Medical Sciences, Endocrinology and Metabolism Research Institute, Tehran
[5] Iran University of Medical Sciences, Tehran
关键词
Diabetes; Iran; Randomized controlled trials; Systematized review;
D O I
10.1186/s40200-016-0258-2
中图分类号
学科分类号
摘要
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. © 2016 The Author(s).
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  • [1] Global status report on noncommunicable diseases 2014, (2012)
  • [2] Danaei G., Et al., National, regional, and global trends in fasting plasma glucose and diabetes prevalence since 1980: systematic analysis of health examination surveys and epidemiological studies with 370 country-years and 2.7 million participants, Lancet, 378, 9785, pp. 31-40, (2011)
  • [3] Dagenais G.R., Et al., Variations in diabetes prevalence in Low-, middle-, and high-income countries: results from the prospective urban and rural epidemiology study, Diabetes Care, (2016)
  • [4] Esteghamati A., Et al., Prevalence of diabetes and impaired fasting glucose in the adult population of Iran national survey of risk factors for non-communicable diseases of Iran, Diabetes Care, 31, 1, pp. 96-98, (2008)
  • [5] Guyatt G.H., Oxman A.D., Vist G.E., Et al., GRADE: an emerging consensus on rating quality of evidence and strength of recommendations, BMJ, 336, 7650, pp. 924-926, (2008)
  • [6] Moher D., Pham B., Jones A., Et al., Does quality of reports of randomised trials affect estimates of intervention efficacy reported in meta-analyses?, Lancet, 352, 9128, pp. 609-613, (1998)
  • [7] Pildal J., Chan A.W., Hrobjartsson A., Forfang E., Altman D.G., Gotzsche P.C., Comparison of descriptions of allocation concealment in trial protocols and the published reports: cohort study, BMJ, 330, 7499, pp. 1049-1052, (2005)
  • [8] Begg C., Cho M., Eastwood S., Et al., Improving the quality of reporting of randomized controlled trials. The CONSORT statement, JAMA, 276, 8, pp. 637-639, (1996)
  • [9] Moher D., Schulz K.F., Altman D.G., The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials, Lancet, 357, 9263, pp. 1191-1194, (2001)
  • [10] Schulz K.F., Altman D.G., Moher D., CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials, BMJ, 340, (2010)