论文标题
在临床试验中定义，识别和传达估计的单个世界干预图
Single-World Intervention Graphs for Defining, Identifying, and Communicating Estimands in Clinical Trials
论文作者
论文摘要
试图用普通语言阐明临床试验的目标估计和估计目标时，经常会出现混乱。我们旨在通过使用称为单个世界干预图（SWIG）的因果图来纠正这种混乱，以提供可以有效传达给跨学科利益相关者的估算和估算的视觉表示。这些图不仅显示估计值，而且还说明了因果估计值可以通过介绍治疗，事件间事件和临床结果之间的图形关系来识别的假设。为了证明其在药物研究中的有用性，我们介绍了ICH E9（R1）附录中指定的各种互动事件策略的SWIG的例子，以及来自现实世界中慢性疼痛的现实世界临床试验的例子。乳胶代码生成所显示的所有swigs均可提供本文。我们主张临床试验者在研究阶段的估计和讨论中采用了SWIG的使用。
Confusion often arises when attempting to articulate target estimand(s) of a clinical trial in plain language. We aim to rectify this confusion by using a type of causal graph called the Single-World Intervention Graph (SWIG) to provide a visual representation of the estimand that can be effectively communicated to interdisciplinary stakeholders. These graphs not only display estimands, but also illustrate the assumptions under which a causal estimand is identifiable by presenting the graphical relationships between the treatment, intercurrent events, and clinical outcomes. To demonstrate its usefulness in pharmaceutical research, we present examples of SWIGs for various intercurrent event strategies specified in the ICH E9(R1) addendum, as well as an example from a real-world clinical trial for chronic pain. Latex code to generate all the SWIGs shown is this paper is made available. We advocate clinical trialists adopt the use of SWIGs in their estimand discussions during the planning stages of their studies.
