Nesting a Target Study within a Target Trial: A Framework for Evaluating Intervention Effects on Disparities

TL;DR

The paper introduces a novel TS+TT framework that combines Target Study and Target Trial designs to ethically evaluate intervention effects on disparities, demonstrated through clinical care examples.

Contribution

It proposes a new framework integrating ethical assumptions and causal inference methods for disparity evaluation, extending semiparametric G-computation for continuous interventions.

Findings

Framework effectively evaluates hypothetical interventions on disparities.

Application to pulse oximeter bias demonstrates practical utility.

Extended G-computation estimates counterfactual disparities in time-to-event outcomes.

Abstract

We present a novel framework (TS+TT) to nest a Target Study (TS) within a Target Trial (TT) for evaluating the effects of interventions on disparities. The TS component grounds the measurement of disparity in ethical assumptions, based on the concept of allowability, and anchors it to an explicit population within calendar time. It specifies an enrollment plan of stratified sampling of eligible persons to yield a sample where social groups are distributionally similar on covariates deemed allowable for measuring disparity. Within this enrolled sample, the TT component specifies randomization of intervention strategies within each social group. Because social groups are similarly situated on allowable covariates at baseline, and because assigned intervention arms are exchangeable within social groups, TS+TT reflects a meaningful causal estimand for evaluating how interventions impact disparity. We describe the framework's key components, its emulation, and demonstrate its application to evaluate how hypothetical interventions on pulse oximeter bias affect disparities in treatment receipt in clinical care. We also extend semiparametric G-computation to accommodate continuous stochastic interventions and estimate counterfactual disparities in time-to-event outcomes. The TS+TT framework offers a versatile and policy-relevant approach for generating ethically informed causal evidence to reduce disparities and avoid exacerbating disparities.