tteICE：一个用于在双臂试验中估计伴有并发事件的生存时间结局治疗效果的R包
tteICE: An R Package for Estimating Treatment Effects on Time-to-Event Outcomes with Intercurrent Events in Two-Arm Trials
- Kobe University（神户大学）
- Shanghai University of International Business and Economics（上海对外经贸大学）
- Chinese Academy of Medical Sciences & Peking Union Medical College（中国医学科学院 北京协和医学院）
机构由 AI 辅助整理，请以论文原文为准。
AI总结：
本文介绍R包tteICE，用于在存在并发事件（如治疗中断或竞争事件）的双臂试验中，通过五种策略估计生存时间结局的治疗效果，支持非参数和半参数估计，并提供绘图和Shiny界面。
AI中文摘要：
在具有生存时间结局的临床试验中评估治疗效果因并发事件（ICEs）而变得复杂，例如治疗中断或竞争事件。虽然ICH E9（R1）附录概述了应对这些挑战的五种策略，但实施这些方法的可用软件有限。本文介绍了用于R语言的\pkg{tteICE}包，该包实现了五种策略，以促进存在ICEs时的有效因果推断。\pkg{tteICE}使研究人员能够在治疗和对照条件下，以非参数或半参数方式高效估计潜在累积发生函数。通过对比这些函数来评估治疗效果，并使用逐点置信区间和$p$-值量化统计不确定性。该包支持来自随机对照试验和观察性研究的数据，包括存在竞争风险和半竞争风险的情况。为降低应用研究人员的门槛，\pkg{tteICE}集成了绘图函数和配套的交互式Shiny应用程序，提供带有逐步说明的用户友好图形界面。
英文摘要：
Evaluating treatment effects in clinical trials with time-to-event outcomes is complicated by intercurrent events (ICEs), e.g., treatment discontinuation or competing events. While the ICH E9 (R1) addendum outlines five strategies to address these challenges, accessible software implementing these methods is limited. This article introduces the \pkg{tteICE} package for \proglang{R}, which implements five strategies to facilitate valid causal inference in the presence of ICEs. \pkg{tteICE} enables researchers to either nonparametrically or semiparametrically efficiently estimate potential cumulative incidence functions under both treatment and control conditions. The treatment effect is assessed by contrasting these functions, with statistical uncertainty quantified using pointwise confidence intervals and $p$-values. The package supports data from randomized controlled trials and observational studies, including settings with competing risks and semi-competing risks. To reduce barriers for applied researchers, \pkg{tteICE} features integrated plotting functions and an accompanying interactive Shiny application that provides a user-friendly graphical interface with step-by-step instructions.
