Efthimiou Orestis, Mavridis Dimitris, Debray Thomas P A, Samara Myrto, Belger Mark, Siontis George C M, Leucht Stefan, Salanti Georgia
Department of Hygiene and Epidemiology, University of Ioannina School of Medicine, Ioannina, Greece.
Department of Primary Education, University of Ioannina, Ioannina, Greece.
Stat Med. 2017 Apr 15;36(8):1210-1226. doi: 10.1002/sim.7223. Epub 2017 Jan 12.
Non-randomized studies aim to reveal whether or not interventions are effective in real-life clinical practice, and there is a growing interest in including such evidence in the decision-making process. We evaluate existing methodologies and present new approaches to using non-randomized evidence in a network meta-analysis of randomized controlled trials (RCTs) when the aim is to assess relative treatment effects. We first discuss how to assess compatibility between the two types of evidence. We then present and compare an array of alternative methods that allow the inclusion of non-randomized studies in a network meta-analysis of RCTs: the naïve data synthesis, the design-adjusted synthesis, the use of non-randomized evidence as prior information and the use of three-level hierarchical models. We apply some of the methods in two previously published clinical examples comparing percutaneous interventions for the treatment of coronary in-stent restenosis and antipsychotics in patients with schizophrenia. We discuss in depth the advantages and limitations of each method, and we conclude that the inclusion of real-world evidence from non-randomized studies has the potential to corroborate findings from RCTs, increase precision and enhance the decision-making process. Copyright © 2017 John Wiley & Sons, Ltd.
非随机研究旨在揭示干预措施在现实临床实践中是否有效，并且将此类证据纳入决策过程的兴趣与日俱增。当目的是评估相对治疗效果时，我们评估现有方法，并提出在随机对照试验（RCT）的网络荟萃分析中使用非随机证据的新方法。我们首先讨论如何评估这两种证据之间的兼容性。然后，我们介绍并比较一系列允许在RCT的网络荟萃分析中纳入非随机研究的替代方法：单纯数据合成、设计调整合成、将非随机证据用作先验信息以及使用三级分层模型。我们在两个先前发表的临床实例中应用了其中一些方法，比较了经皮干预治疗冠状动脉支架内再狭窄和精神分裂症患者使用抗精神病药物的情况。我们深入讨论了每种方法的优缺点，并得出结论，纳入来自非随机研究的真实世界证据有可能证实RCT的结果，提高精确度并加强决策过程。版权所有© 2017约翰威立父子有限公司。
