The role of assignment in defining and identifying causal effects in randomized trials
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随机试验中分配对因果效应定义与识别的作用
- 研究问题
- 随机试验中的依方案效应是否等于治疗策略本身的效应，何时即使分配随机化，识别仍需要保留分配信息？
- 方法与思路
- 作者通过一个因果结构例子比较两类效应及其观测数据识别泛函，并讨论缺少分配信息时所需的额外排除与混杂限制。
- 材料陈述的贡献
- 摘要指出两类效应及识别泛函可以不同，随机分配不自动消除分配信息的重要性，并强调明确分配角色对试验解释的影响。
- 阅读关注点
- 应核对两类效应对应的具体干预定义、分配影响结局的路径、效应相等的条件，以及缺少分配信息时额外假设的形式。
- 阅读边界
- 这是 arXiv 预印本，同行评审与期刊接收未经核实；摘要给出概念性例子，未完整列出识别条件，不能推广为所有试验均不可识别。
原文摘要
In randomized trials, the per-protocol effect, that is, the effect of being assigned a treatment strategy and receiving treatment according to the assigned strategy, is sometimes thought to reflect the effect of the treatment strategy itself, without intervention on assignment. Here, we argue by example that this is not necessarily the case. We examine a causal structure for a randomized trial where these two causal estimands -- the per-protocol effect and the effect of the treatment strategy -- are not equal, and where their corresponding identifying observed data functionals are not the same, but both require information on assignment for identification. Our example highlights the conceptual difference between the per-protocol effect and the effect of the treatment strategy, the conditions under which these causal estimands are equal, and suggests that in some cases their identification requires information on assignment, even when assignment is randomized. Furthermore, both per-protocol effects and effects of treatment may be unidentifiable without information on treatment assignment, unless one makes additional assumptions -- informally, that assignment does not affect the outcome except through treatment (i.e., an exclusion-restriction assumption), and that assignment is not a confounder of the treatment-outcome association conditional on other variables in the analysis. Our analyses suggest a need to more clearly define the role of assignment when specifying causal effects of interest in randomized trials, which has implications for identification, analysis methods, and the interpretation of trial results.