Aletaha Azadeh, Malekpour Mohammad-Reza, Keshtkar Abbas Ali, Baradaran Hamid Reza, Sedghi Shahram, Mansoori Yasaman, Hajiani Mehdi, Delavari Somayeh, Habibi Farzaneh, Razmgir Maryam, Saeedi Saeedeh, Soltani Akbar, Nemati-Anaraki Leila
Department of Medical Library and Information Science, School of Health Management and Information Sciences, Iran University of Medical Sciences, Tehran, Iran.
Evidence Based Medicine Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
J Diabetes Metab Disord. 2023 Oct 19;23(1):101-114. doi: 10.1007/s40200-023-01328-9. eCollection 2024 Jun.
Evaluate methodological quality of type 2 diabetes RCTs conducted in Iran and cited in clinical practice guidelines and systematic reviews and meta-analyses.
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.
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.
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.
评估在伊朗开展并被临床实践指南、系统评价及荟萃分析引用的2型糖尿病随机对照试验（RCT）的方法学质量。
我们进行了一项描述性方法学质量评价，分析了2004年7月至2021年在伊朗发表的286项关于糖尿病的随机对照试验。我们系统检索了六个数据库，并使用CONSORT 2010摘要清单对符合条件的文章进行评估。两名研究人员使用源自CONSORT的17项清单评估数据。此外，我们检查了260项临床实践指南中每项RCT的引用情况，特别关注结果的充分报告。
在6667篇文章中，分析了286篇。观察到报告不佳且未达到标准。只有3.8%被指南引用。报告率：主要结局（41.9%）、随机化（61.8%）、试验招募（12.6%）、盲法（50.8%）。27.9%被系统评价引用，50.34%被系统评价和荟萃分析引用，26.57%被荟萃分析引用。67.8%的论文被系统评价引用。参与者、目标、随机化、干预、结局的依从性最高；招募、试验设计、资金来源、危害和主要结局报告的依从性最低。
在评估的RCT中，方法学报告和对CONSORT清单的依从性较差，尤其是在方法学部分。需要改进以在指南、评价和荟萃分析中获得可靠且适用的结果。结局报告不足对研究人员、临床医生和政策制定者构成挑战，影响基于证据的决策。迫切需要改进RCT注册。
