Constructing external comparator groups via transportability in mean or in effect measure
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通过均值或效应尺度可迁移性构造外部对照组
- 研究问题
- 将试验与外部数据结合以比较不同人群中研究的治疗时，潜在结果均值可迁移性和效应尺度可迁移性分别如何支持识别？
- 方法与思路
- 作者区分两种识别策略，在单次处理和非生存时间结果设定下提出增广加权估计量，分析渐近性质，并以模拟和试验数据展示。
- 材料陈述的贡献
- 摘要提出半参数有效的增广加权估计量，讨论模型误设及部分辅助模型较慢收敛下的性质，并应用于银屑病生物制剂比较。
- 阅读关注点
- 应核对两种可迁移性假设的差异、共同第三种治疗的作用、目标人群定义，以及稳健性成立所需的模型组合和收敛条件。
- 阅读边界
- 这是 arXiv 预印本，同行评审和期刊接收均未核实。摘要未列出完整识别与稳健性条件，结论不能直接扩展到时变处理或生存结果。
原文摘要
Learning about causal effects in target populations and their subsets may be facilitated by combining information from multiple sources. One major class of study designs that combine information involves appending an index study with data from an external comparator, which may facilitate head-to-head comparisons of treatments initially studied in different populations. We delineate external comparator analyses under two distinct, but related, identification strategies. The first strategy relies on exchangeability (transportability) of potential outcome means, which uses information only on the treatments that are to be compared. The second strategy relies on transportability in effect measure, requiring additional use of information on a third treatment common to the populations that have been combined. In a time-fixed setting with a point treatment and non-failure time outcome, we examine identification and estimation under a basic setup where information from an index trial is combined with a second, and external to the index trial, data source. We propose estimators for identifying observed data functionals, with a particular focus on semiparametric efficient augmented weighting estimators that incorporate models for the probability of trial participation, the probability of treatment, and conditional outcome means. We derive the asymptotic properties of these augmented weighting estimators -- including robustness to model misspecification and slower rates of convergence for some nuisance function models -- and use simulation to compare their finite sample performance to estimators based only on outcome modeling or weighting. Last, we provide a practical demonstration of the proposed methods by combining the ACCEPT and PHOENIX 1 randomized trials to evaluate the effect of various biologic agents on plaque psoriasis, a chronic inflammatory disorder.