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Miguel A. Hernán

Publications and source records attributed to Miguel A. Hernán.

23 records · Page 2Linked to original sources
arXiv2019

Generalizing causal inferences from randomized trials: counterfactual and graphical identification

When engagement with a randomized trial is driven by factors that affect the outcome or when trial engagement directly affects the outcome independent of treatment, the average treatment effect among trial participants is unlikely to generalize to a target population. In this paper, we use counterfactual and graphical causal models to examine under what conditions we can generalize causal inferences from a randomized trial to the target population of trial-eligible individuals. We offer an interpretation of generalizability analyses using the notion of a hypothetical intervention to "scale-up" trial engagement to the target population. We consider the interpretation of generalizability analyses when trial engagement does or does not directly affect the outcome, highlight connections with censoring in longitudinal studies, and discuss identification of the distribution of counterfactual outcomes via g-formula computation and inverse probability weighting. Last, we show how the methods can be extended to address time-varying treatments, non-adherence, and censoring.

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arXiv2019

Sensitivity analysis using bias functions for studies extending inferences from a randomized trial to a target population

Extending (generalizing or transporting) causal inferences from a randomized trial to a target population requires ``generalizability'' or ``transportability'' assumptions, which state that randomized and non-randomized individuals are exchangeable conditional on baseline covariates. These assumptions are made on the basis of background knowledge, which is often uncertain or controversial, and need to be subjected to sensitivity analysis. We present simple methods for sensitivity analyses that do not require detailed background knowledge about specific unknown or unmeasured determinants of the outcome or modifiers of the treatment effect. Instead, our methods directly parameterize violations of the assumptions using bias functions. We show how the methods can be applied to non-nested trial designs, where the trial data are combined with a separately obtained sample of non-randomized individuals, as well as to nested trial designs, where a clinical trial is embedded within a cohort sampled from the target population. We illustrate the methods using data from a clinical trial comparing treatments for chronic hepatitis C infection.

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arXiv2019

Study designs for extending causal inferences from a randomized trial to a target population

We examine study designs for extending (generalizing or transporting) causal inferences from a randomized trial to a target population. Specifically, we consider nested trial designs, where randomized individuals are nested within a sample from the target population, and non-nested trial designs, including composite dataset designs, where a randomized trial is combined with a separately obtained sample of non-randomized individuals from the target population. We show that the causal quantities that can be identified in each study design depend on what is known about the probability of sampling non-randomized individuals. For each study design, we examine identification of potential outcome means via the g-formula and inverse probability weighting. Last, we explore the implications of the sampling properties underlying the designs for the identification and estimation of the probability of trial participation.

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arXiv2019

Data science is science's second chance to get causal inference right: A classification of data science tasks

Causal inference from observational data is the goal of many data analyses in the health and social sciences. However, academic statistics has often frowned upon data analyses with a causal objective. The introduction of the term "data science" provides a historic opportunity to redefine data analysis in such a way that it naturally accommodates causal inference from observational data. Like others before, we organize the scientific contributions of data science into three classes of tasks: Description, prediction, and counterfactual prediction (which includes causal inference). An explicit classification of data science tasks is necessary to discuss the data, assumptions, and analytics required to successfully accomplish each task. We argue that a failure to adequately describe the role of subject-matter expert knowledge in data analysis is a source of widespread misunderstandings about data science. Specifically, causal analyses typically require not only good data and algorithms, but also domain expert knowledge. We discuss the implications for the use of data science to guide decision-making in the real world and to train data scientists.

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