An Integrated Target Study and Target Trial Framework to Evaluate Intervention Effects on Disparities

Abstract: We present a novel framework -- the integrated Target Study + Target Trial (TS+TT) -- to evaluate the effects of interventions on disparities. This framework combines the ethical clarity of the Target Study, which balances allowable covariates across social groups to define meaningful disparity measures, with the causal rigor of the Target Trial, which emulates randomized trials to estimate intervention effects. TS+TT achieves two forms of balance: (1) stratified sampling ensures that allowable covariates are balanced across social groups to enable an ethically interpretable disparity contrast; (2) intervention-randomization within social groups balances both allowable and non-allowable covariates across intervention arms within each group to support unconfounded estimation of intervention effects on disparity. We describe the key components of protocol specification and its emulation and demonstrate the approach using electronic medical record data to evaluate how hypothetical interventions on pulse oximeter racial bias affect disparities in treatment receipt in clinical care. We also extend semiparametric G-computation for time-to-event outcomes in continuous time to accommodate continuous, stochastic interventions, allowing counterfactual estimation of disparities in time-to-treatment. More broadly, the framework accommodates a wide range of intervention and outcome types. The TS+TT framework offers a versatile and policy-relevant tool for generating ethically aligned causal evidence to help eliminate disparities and avoid unintentionally exacerbating disparities.