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处理网络荟萃分析中真实世界证据相关出版物:多发性硬化症的案例研究。

Handling related publications reporting real-world evidence in network meta-analysis: a case study in multiple sclerosis.

机构信息

Evidera Inc., Waltham, MA 02451, USA.

Evidera Inc., Saint-Laurent, QC H4S 1V3, Canada.

出版信息

J Comp Eff Res. 2023 Aug;12(8):e220132. doi: 10.57264/cer-2022-0132. Epub 2023 Jul 29.

Abstract

The presence of two or more publications that report on overlapping patient cohorts poses a challenge for quantitatively synthesizing real-world evidence (RWE) studies. Thus, we evaluated eight approaches for handling such related publications in network meta-analyses (NMA) of RWE studies. Bayesian NMAs were conducted to estimate the annualized relapse rate (ARR) of disease-modifying therapies in multiple sclerosis. The NMA explored the impact of hierarchically selecting one pivotal study from related publications versus including all of them while adjusting for correlations. When selecting one pivotal study from related publications, the ARR ratios were mostly similar regardless of the pivotal study selected. When including all related publications, there were shifts in the point estimates and the statistical significance. An hierarchy should guide the selection among related publications in NMAs of RWE. Sensitivity analyses modifying the hierarchy should be considered for networks with few or small studies.

摘要

存在两个或多个报告重叠患者队列的出版物会给定量综合真实世界证据 (RWE) 研究带来挑战。因此,我们评估了在 RWE 研究的网络荟萃分析 (NMA) 中处理此类相关出版物的八种方法。进行贝叶斯 NMA 以估计多发性硬化症中疾病修正治疗的年化复发率 (ARR)。NMA 探讨了在层次上从相关出版物中选择一项关键研究与同时包含所有这些研究并调整相关性的影响。当从相关出版物中选择一项关键研究时,ARR 比值大多相似,而与选择的关键研究无关。当包含所有相关出版物时,点估计和统计显著性会发生变化。在 RWE 的 NMA 中,层次结构应指导相关出版物的选择。对于研究数量较少或较小的网络,应考虑修改层次结构的敏感性分析。

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