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Robust variance estimation for covariate-adjusted unconditional treatment effect in randomized clinical trials with binary outcomes

Ting Ye, Marlena S. Bannick, Yanyao Yi, Jun Shao

2023Statistical Theory and Related Fields13 citationsDOIOpen Access PDF

Abstract

To improve precision of estimation and power of testing hypothesis for an unconditional treatment effect in randomized clinical trials with binary outcomes, researchers and regulatory agencies recommend using g-computation as a reliable method of covariate adjustment. However, the practical application of g-computation is hindered by the lack of an explicit robust variance formula that can be used for different unconditional treatment effects of interest. To fill this gap, we provide explicit and robust variance estimators for g-computation estimators and demonstrate through simulations that the variance estimators can be reliably applied in practice.

Topics & Concepts

CovariateEstimatorVariance (accounting)ComputationEconometricsStatisticsEstimationBinary numberRandomized controlled trialRandomized experimentMathematicsTreatment effectComputer scienceMedicineAlgorithmEconomicsManagementAccountingArithmeticTraditional medicineSurgeryAdvanced Causal Inference TechniquesStatistical Methods in Clinical TrialsStatistical Methods and Inference