In experimental and observational studies, there is often interest in understanding the potential mechanism by which an intervention program improves the final outcome. Causal mediation analyses have been developed for this purpose but are primarily restricted to the case of perfect treatment compliance, with a few exceptions that require exclusion restriction. In this article, we establish a semiparametric framework for assessing causal mediation in the presence of treatment noncompliance without exclusion restriction. We propose a set of assumptions to identify the natural mediation effects for the entire study population and further, for the principal natural mediation effects within subpopulations characterized by the potential compliance behaviour. We derive the efficient influence functions for the principal natural mediation effect estimands, which motivate a set of multiply robust estimators for inference. The semiparametric efficiency theory for the identified estimands is derived, based on which a multiply robust estimator is proposed. The multiply robust estimators remain consistent to the their respective estimands under four types of misspecification of the working models and is quadruply robust. We further describe a nonparametric extension of the proposed estimators by incorporating machine learners to estimate the nuisance parameters. A sensitivity analysis framework has been developed for address key identification assumptions-principal ignorability and ignorability of mediator. We demonstrate the proposed methods via simulations and applications to a real data example.
翻译:在实验和观察研究中,通常感兴趣的是理解干预方案如何改善最终结果的潜在机制。因果中介分析被开发出来以达到这个目的,但主要限制于完美的治疗遵从性情况下,除了一些需要排除限制的例外情况。在本文中,我们建立了在没有排除限制的情况下评估治疗遵从性下因果中介的半参数框架。我们提出了一组假设来确定整个研究人群以及在由潜在遵从性行为特征的子群中的主要自然中介效应。我们导出了主要自然中介效应估计的有效影响函数,从而激发了一组用于推断的多元稳健估计器。基于确定的估计量的半参数效率理论被导出,据此提出了多元稳健估计量。在工作模型的四种错误规范下,多元稳健估计器仍保持一致性,是四倍稳健的。我们还描述了将机器学习者纳入其中以估计无关参数的非参数扩展方法。我们已开发了一个敏感性分析框架,以解决主要可忽略性和中介者可忽略性的关键识别假设。我们通过模拟和对实际数据例子的应用来展示所提出的方法。