PDF(Pubmed)
Abstract：
Direct oral anticoagulants (DOACs) revolutionized the management of thromboembolic disorders. Clinical care may be further improved as Factor XIs undergo large-scale outcome trials. What role can non-randomized database studies play in expediting understanding of these drugs in clinical practice? The RCT-DUPLICATIVE Initiative emulated the design of eight DOAC randomized clinical trials (RCT) using non-randomized claims database studies. RCT study design parameters and measurements were closely emulated by the database studies and produced highly concordant results. The results of the single database study that did not meet all agreement metrics with the specific RCT it was emulating were aligned with a meta-analysis of six trials studying similar questions, suggesting the trial result was an outlier. Well-designed database studies using fit-for-purpose data came to the same conclusions as DOAC trials, illustrating how database studies could complement RCTs for Factor XI inhibitors-by accelerating insights in underrepresented populations, demonstrating effectiveness and safety in clinical practice, and testing broader indications.
摘要：
直接口服抗凝剂（DOAC）彻底改变了血栓栓塞性疾病的管理。随着因子XIs进行大规模结果试验，临床护理可能会得到进一步改善。非随机数据库研究在促进临床实践中对这些药物的理解方面可以发挥什么作用？RCT-DUPLICATIVE计划使用非随机索赔数据库研究模拟了8项DOAC随机临床试验（RCT）的设计。数据库研究密切模拟了RCT研究设计参数和测量，并产生了高度一致的结果。单一数据库研究的结果不符合与它所模拟的特定RCT的所有一致指标，与六个研究类似问题的试验的荟萃分析相一致。表明试验结果是一个异常值。使用适合目的数据的精心设计的数据库研究得出了与DOAC试验相同的结论，说明数据库研究如何通过加速对代表性不足的人群的洞察来补充因子XI抑制剂的随机对照试验，在临床实践中证明有效性和安全性，并测试更广泛的适应症。
