Ye Fangshu, Wang Chong, O'Connor Annette M
Department of Statistics, Iowa State University, Ames, IA, United States.
Department of Veterinary Diagnostic and Production Animal Medicine, Iowa State University, Ames, IA, United States.
Front Pharmacol. 2023 Apr 27;14:1157708. doi: 10.3389/fphar.2023.1157708. eCollection 2023.
To achieve higher power or increased precision for a new trial, methods based on updating network meta-analysis (NMA) have been proposed by researchers. However, this approach could potentially lead to misinterpreted results and misstated conclusions. This work aims to investigate the potential inflation of type I error risk when a new trial is conducted only when, based on a -value of the comparison in the existing network, a "promising" difference between two treatments is noticed. We use simulations to evaluate the scenarios of interest. In particular, a new trial is to be conducted independently or depending on the results from previous NMA in various scenarios. Three analysis methods are applied to each simulation scenario: with the existing network, sequential analysis and without the existing network. For the scenario that the new trial will be conducted only when a promising finding (-value ) is indicated by the existing network, the type I error risk increased dramatically (38.5% in our example data) when analyzed with the existing network and sequential analysis. The type I error is controlled at 5% when analyzing the new trial without the existing network. If the intention is to combine a trial result with an existing network of evidence, or if it is expected that the trial will eventually be included in a network meta-analysis, then the decision that a new trial is performed should not depend on a statistically "promising" finding indicated by the existing network.
为了在新试验中获得更高的检验效能或更高的精度,研究人员提出了基于更新网络荟萃分析(NMA)的方法。然而,这种方法可能会导致结果被误解和结论被错误陈述。本研究旨在探讨当仅在基于现有网络比较的P值发现两种治疗之间存在“有前景”的差异时进行新试验时,I型错误风险的潜在膨胀情况。我们使用模拟来评估感兴趣的场景。特别是,在各种场景下独立进行新试验或根据先前NMA的结果进行新试验。对每个模拟场景应用三种分析方法:使用现有网络、序贯分析和不使用现有网络。对于仅在现有网络表明有前景的发现(P值)时才进行新试验的场景,在使用现有网络和序贯分析时,I型错误风险显著增加(在我们的示例数据中为38.5%)。在不使用现有网络分析新试验时,I型错误被控制在5%。如果打算将试验结果与现有证据网络相结合,或者预计该试验最终将纳入网络荟萃分析,那么进行新试验的决定不应依赖于现有网络表明的统计学上“有前景”的发现。