Department of Medical Statistics, London School of Hygiene & Tropical Medicine, London, UK.
MRC Biostatistics Unit, University of Cambridge, Institute of Public Health, Forvie Site, Robinson Way, Cambridge, UK.
Biom J. 2021 Oct;63(7):1526-1541. doi: 10.1002/bimj.202000040. Epub 2021 May 13.
Observational longitudinal data on treatments and covariates are increasingly used to investigate treatment effects, but are often subject to time-dependent confounding. Marginal structural models (MSMs), estimated using inverse probability of treatment weighting or the g-formula, are popular for handling this problem. With increasing development of advanced causal inference methods, it is important to be able to assess their performance in different scenarios to guide their application. Simulation studies are a key tool for this, but their use to evaluate causal inference methods has been limited. This paper focuses on the use of simulations for evaluations involving MSMs in studies with a time-to-event outcome. In a simulation, it is important to be able to generate the data in such a way that the correct forms of any models to be fitted to those data are known. However, this is not straightforward in the longitudinal setting because it is natural for data to be generated in a sequential conditional manner, whereas MSMs involve fitting marginal rather than conditional hazard models. We provide general results that enable the form of the correctly specified MSM to be derived based on a conditional data generating procedure, and show how the results can be applied when the conditional hazard model is an Aalen additive hazard or Cox model. Using conditional additive hazard models is advantageous because they imply additive MSMs that can be fitted using standard software. We describe and illustrate a simulation algorithm. Our results will help researchers to effectively evaluate causal inference methods via simulation.
观察性纵向数据越来越多地用于研究治疗效果,但通常受到时间依赖性混杂的影响。使用逆概率治疗加权或 g 公式估计的边缘结构模型 (MSM) 是处理此问题的常用方法。随着先进因果推理方法的不断发展,能够评估它们在不同情况下的性能以指导其应用非常重要。模拟研究是一种关键工具,但它们在评估因果推理方法方面的应用一直受到限制。本文重点介绍了在具有事件时间结局的研究中使用模拟来评估 MSM 的方法。在模拟中,能够以能够生成要拟合那些数据的任何模型的正确形式的方式生成数据非常重要。然而,在纵向设置中,这并不简单,因为数据以顺序条件方式生成是很自然的,而 MSM 涉及拟合边缘而不是条件风险模型。我们提供了一般结果,使能够基于条件数据生成过程推导出正确指定的 MSM 的形式,并展示了当条件风险模型是 Aalen 加法风险或 Cox 模型时如何应用这些结果。使用条件加法风险模型是有利的,因为它们意味着可以使用标准软件拟合加法 MSM。我们描述并说明了一种模拟算法。我们的结果将帮助研究人员通过模拟有效地评估因果推理方法。