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Methodological Reporting Quality of Randomized Controlled Trials in 3 Leading Diabetes Journals From 2011 to 2013 Following CONSORT Statement: A System Review

机译:在CONSORT声明后,2011年至2013年间3种领先的糖尿病期刊的随机对照试验的方法学报告质量:系统综述

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To appraise the current reporting methodological quality of randomized clinical trials (RCTs) in 3 leading diabetes journals. We systematically searched the literature for RCTs in Diabetes Care , Diabetes and Diabetologia from 2011 to 2013. Characteristics were extracted based on Consolidated Standards of Reporting Trials (CONSORT) statement. Generation of allocation, concealment of allocation, intention-to-treat (ITT) analysis and handling of dropouts were defined as primary outcome and “low risk of bias.” Sample size calculation, type of intervention, country, number of patients, funding source were also revealed and descriptively reported. Trials were compared among journals, study years, and other characters. A total of 305 RCTs were enrolled in this study. One hundred eight (35.4%) trials reported adequate generation of allocation, 87 (28.5%) trials reported adequate concealment of allocation, 53 (23.8%) trials used ITT analysis, and 130 (58.3%) trials were adequate in handling of dropouts. Only 15 (4.9%) were “low risk of bias” trials. Studies at a large scale (n > 100) or from European presented with more “low risk of bias” trials than those at a small scale (n ≤ 100) or from other regions. No improvements were found in these 3 years. This study shows that methodological reporting quality of RCTs in the major diabetes journals remains suboptimal. It can be further improved to meet and keep up with the standards of the CONSORT statement.
机译:为了评估目前在3种领先糖尿病期刊上报告随机临床试验(RCT)的方法学质量。我们系统地检索了2011年至2013年糖尿病护理,糖尿病和糖尿病患者的RCT文献。根据综合报告标准(CONSORT)声明提取了特征。分配的产生,分配的隐藏,意向性治疗(ITT)分析和辍学处理被定义为主要结果和“偏见风险低”。样本量计算,干预类型,国家,患者人数,资金来源也被披露并描述性报告。在期刊,研究年份和其他角色之间比较了试验。本研究共纳入305个RCT。一百零八(35.4%)个试验报告了足够的分配产生,八十七(28.5%)个试验报告了足够的分配隐藏,53个(23.8%)试验使用了ITT分析,而130个(58.3%)试验足以处理辍学。只有15个(4.9%)是“低偏见风险”试验。与小规模(n≤100)或其他地区相比,大规模(n> 100)或来自欧洲的研究呈现出更高的“低偏倚风险”试验。这三年没有发现任何改善。这项研究表明,主要糖尿病杂志中RCT的方法学报告质量仍然欠佳。可以对其进行进一步改进,以符合并保持CONSORT声明的标准。

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