研究动态
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Kaplan-Meier 曲线中报告的“真实”患者与通过 IPDfromKM 方法估计的“重建”患者之间统计分析的比较:评估室性心动过速导管消融的八项试验的分析。

A Comparison of Statistical Analysis Between "Real" Patients Reported in Kaplan-Meier Curves and "Reconstructed" Patients Estimated Through the IPDfromKM Method: Analysis of Eight Trials Evaluating Catheter Ablation of Ventricular Tachycardia.

发表日期:2023 Oct
作者: Andrea Messori, Valeria Fadda, Maria R Romeo, Sara Veneziano, Sabrina Trippoli
来源: CLINICAL PHARMACOLOGY & THERAPEUTICS

摘要:

事件发生时间终点在肿瘤学中应用最广泛,在心脏病学中应用也较少。在这种情况下使用的典型统计参数包括总生存期、无进展生存期和无复发生存期。结果的图形表示基于 Kaplan-Meier 图。当 Kaplan-Meier 曲线包含在荟萃分析中时,典型的方法是一种简化的方法,因为每个试验的结果(以及荟萃分析本身的结果)都是通过 2x2 意外事件来表达的;方法上的简化在于分析中省略了后续操作,因此也省略了 Kaplan-Meier 曲线。 IPDfromKM 方法于 2021 年开发,是一种专为在这些情况下使用的人工智能算法。根据该方法,为了在荟萃分析中保留Kaplan-Meier曲线,每条曲线都被转换成个体患者的数据库(其被表示为“重建的”个体患者)。这样,为了荟萃分析的目的,统计方法是基于个体患者(如临床试验的统计方法),因此不能排除Kaplan-Meier曲线,并且随访的效果可以,因此,予以调查。该技术报告描述了 IPDfromKM 方法的所有操作细节。为了介绍该方法,我们以一项研究导管消融预防室性快速心律失常 (VT) 效果的荟萃分析为例。最初的荟萃分析于 2023 年 2 月发布,其中包括 9 项对照试验,并采用了基于 2x2 列联表的简化方法。我们使用 IPDfromKM 方法重新分析了这些试验。总体而言,标准二元荟萃分析和 IPDfromKM 方法均表明消融可显着降低 VT 复发(二元荟萃分析的风险比为 0.820,而 IPDfromKM 方法的风险比为 0.728)。相比之下,虽然二元方法没有发现异质性,但 IPDfromKM 发现了显着的异质性,这一点通过 Kaplan-Meier 曲线的目视检查得到了证实。这表明 IPDfromKM 方法的结果更准确,因为它们包括随访对患者结果的影响。总之,我们的重新分析证实了消融所带来的显着益处,但也发现了更明显的试验间异质性。最后需要强调的是,在荟萃分析领域之外,IPDfromKM方法还适用于对从未在真实临床试验中进行过比较的治疗方法进行间接比较。在这种情况下,通过进行模拟比较试验来分析重建患者。版权所有 © 2023,Messori 等人。
Time-to-event endpoints are most widely used in oncology and, to a lesser extent, in cardiology. Typical statistical parameters employed in this context include overall survival, progression-free survival, and recurrence-free survival. The graphical presentation of the results is based on the Kaplan-Meier plot. When Kaplan-Meier curves are included in a meta-analysis, the typical methodological approach is a simplified one because the results of each trial (as well as those of the meta-analysis itself) are expressed through a 2x2 contingency; the methodological simplification is that the follow-up is left out from the analysis and, consequently, the Kaplan-Meier curves are omitted as well. The IPDfromKM method, developed in 2021, is an artificial intelligence algorithm designed to be used in these situations. According to this method, to keep the Kaplan-Meier curves in the meta-analysis, each curve is converted into a database of individual patients (which are denoted as "reconstructed" individual patients). In this way, for the purposes of the meta-analysis, the statistical methods are based on individual patients (like those of clinical trials) so that the Kaplan-Meier curves must not be excluded, and the effect of the follow-up can, therefore, be investigated. This technical report describes the IPDfromKM method in all of its operational details. To present the method, a meta-analysis investigating the effects of catheter ablation to prevent ventricular tachyarrhythmia (VT) has been taken as an example. The original meta-analysis, which included nine controlled trials, was published in February 2023 and adopted the simplified approach based on 2x2 contingency tables. We have reanalyzed these trials by using the IPDfromKM method. Overall, both the standard binary meta-analysis and the IPDfromKM method showed that ablation significantly reduces VT recurrence (hazard ratio, 0.820 for binary meta-analysis vs 0.728 for the IPDfromKM method). By contrast, while no heterogeneity was found by the binary method, the IPDfromKM found significant heterogeneity, which was confirmed by visual inspection of the Kaplan-Meier curves. This suggests that the results of the IPDfromKM method are more accurate because they include the effect of the follow-up on patients' outcomes. In conclusion, our reanalysis confirms the significant benefit determined by ablation, but a more pronounced degree of between-trial heterogeneity has been found. Finally, it should be stressed that, outside the field of meta-analysis, the IPDfromKM method is also applicable to carry out an indirect comparison between treatments that have never been compared in real clinical trials. In this case, reconstructed patients are analyzed by conducting a simulated comparative trial.Copyright © 2023, Messori et al.