PDF(Pubmed)
Abstract：
UNASSIGNED: Evaluate methodological quality of type 2 diabetes RCTs conducted in Iran and cited in clinical practice guidelines and systematic reviews and meta-analyses.
UNASSIGNED: We conducted a descriptive methodological quality review, analyzing 286 Randomized Controlled Trials (RCTs) on diabetes mellitus published in Iran from July 2004 to 2021. We searched six databases systematically and evaluated eligible articles using the CONSORT 2010 checklist for abstracts. Two investigators assessed the data using a 17-item checklist derived from CONSORT. Additionally, we examined the citations of each RCT in 260 clinical practice guidelines, with a specific focus on the adequate reporting of outcomes.
UNASSIGNED: Out of 6667 articles, 286 analyzed. Poor reporting and failure to meet criteria observed. Only 3.8% cited in guidelines. Reporting rates: primary outcomes (41.9%), randomization (61.8%), trial recruitment (12.6%), blinding (50.8%). 27.9% cited in systematic reviews, 50.34% in systematic reviews and meta-analyses, 26.57% in meta-analyses. 67.8% of papers cited in systematic reviews. Adherence highest for participants, objective, randomization, intervention, outcome; lowest for recruitment, trial design, funding source, harms, and reporting primary outcomes.
UNASSIGNED: Poor methodological reporting and adherence to CONSORT checklist in evaluated RCTs, especially in methodological sections. Improvements needed for reliable and applicable results in guidelines, reviews, and meta-analyses. Inadequate outcome reporting challenges researchers, clinicians, and policymakers, impacting evidence-based decision-making. Urgent improvements in RCT registration necessary.
UNASSIGNED: We conducted a descriptive methodological quality review, analyzing 286 Randomized Controlled Trials (RCTs) on diabetes mellitus published in Iran from July 2004 to 2021. We searched six databases systematically and evaluated eligible articles using the CONSORT 2010 checklist for abstracts. Two investigators assessed the data using a 17-item checklist derived from CONSORT. Additionally, we examined the citations of each RCT in 260 clinical practice guidelines, with a specific focus on the adequate reporting of outcomes.
UNASSIGNED: Out of 6667 articles, 286 analyzed. Poor reporting and failure to meet criteria observed. Only 3.8% cited in guidelines. Reporting rates: primary outcomes (41.9%), randomization (61.8%), trial recruitment (12.6%), blinding (50.8%). 27.9% cited in systematic reviews, 50.34% in systematic reviews and meta-analyses, 26.57% in meta-analyses. 67.8% of papers cited in systematic reviews. Adherence highest for participants, objective, randomization, intervention, outcome; lowest for recruitment, trial design, funding source, harms, and reporting primary outcomes.
UNASSIGNED: Poor methodological reporting and adherence to CONSORT checklist in evaluated RCTs, especially in methodological sections. Improvements needed for reliable and applicable results in guidelines, reviews, and meta-analyses. Inadequate outcome reporting challenges researchers, clinicians, and policymakers, impacting evidence-based decision-making. Urgent improvements in RCT registration necessary.
摘要：
■评估在伊朗进行的2型糖尿病随机对照试验的方法学质量，并在临床实践指南以及系统评价和荟萃分析中引用。
■我们进行了描述性方法学质量审查，分析2004年7月至2021年在伊朗发表的286项糖尿病随机对照试验（RCT）。我们系统地搜索了六个数据库，并使用CONSORT2010摘要清单评估了符合条件的文章。两名调查人员使用来自CONSORT的17项清单评估了数据。此外,我们检查了260个临床实践指南中每个RCT的引用，特别注重充分报告成果。
■在6667篇文章中，286分析报告不佳，未达到观察到的标准。指南中引用的仅为3.8％。报告率：主要结果（41.9%），随机化（61.8%），试验招募(12.6%)，致盲（50.8%）。27.9%在系统评价中被引用，50.34%的系统评价和荟萃分析，元分析中26.57%。67.8%的论文在系统评价中被引用。参与者的依从性最高，目标,随机化，干预，结果；招聘最低，试验设计,资金来源,危害,并报告主要结果。
■在评估的RCT中，方法报告和对CONSORT检查表的依从性差，尤其是在方法论部分。准则中可靠和适用的结果所需的改进，reviews,和荟萃分析。不充分的结果报告挑战研究人员，临床医生,和政策制定者，影响循证决策。迫切需要改进RCT注册。
■我们进行了描述性方法学质量审查，分析2004年7月至2021年在伊朗发表的286项糖尿病随机对照试验（RCT）。我们系统地搜索了六个数据库，并使用CONSORT2010摘要清单评估了符合条件的文章。两名调查人员使用来自CONSORT的17项清单评估了数据。此外,我们检查了260个临床实践指南中每个RCT的引用，特别注重充分报告成果。
■在6667篇文章中，286分析报告不佳，未达到观察到的标准。指南中引用的仅为3.8％。报告率：主要结果（41.9%），随机化（61.8%），试验招募(12.6%)，致盲（50.8%）。27.9%在系统评价中被引用，50.34%的系统评价和荟萃分析，元分析中26.57%。67.8%的论文在系统评价中被引用。参与者的依从性最高，目标,随机化，干预，结果；招聘最低，试验设计,资金来源,危害,并报告主要结果。
■在评估的RCT中，方法报告和对CONSORT检查表的依从性差，尤其是在方法论部分。准则中可靠和适用的结果所需的改进，reviews,和荟萃分析。不充分的结果报告挑战研究人员，临床医生,和政策制定者，影响循证决策。迫切需要改进RCT注册。
