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Kuan Jiang

Publications and source records attributed to Kuan Jiang.

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Improve Sensitivity Analysis Synthesizing Randomized Clinical Trials With Limited Overlap

Randomized clinical trials are the gold standard when estimating the average treatment effect. However, they are usually not a random sample from the real-world population because of the inclusion/exclusion rules. Meanwhile, observational studies typically consist of representative samples from the real-world population. However, due to unmeasured confounding, sensitivity analysis is often used to estimate bounds for the average treatment effect without relying on stringent assumptions of other existing methods. This article introduces a synthesis estimator that improves sensitivity analysis in observational studies by incorporating randomized clinical trial data, even when overlap in covariate distribution is limited due to inclusion/exclusion criteria. We show that the proposed estimator will give a tighter bound when a "separability" condition holds for the sensitivity parameter. Theoretical proofs and simulations show that this method provides a tighter bound than the sensitivity analysis using only observational study. We apply this method to combine an observational study on drug effectiveness with a partially overlapping RCT dataset, yielding improved average treatment effect bounds.

stat.ME

A Practical Analysis Procedure on Generalizing Comparative Effectiveness in the Randomized Clinical Trial to the Real-world Trialeligible Population

When evaluating the effectiveness of a drug, a Randomized Controlled Trial (RCT) is often considered the gold standard due to its perfect randomization. While RCT assures strong internal validity, its restricted external validity poses challenges in extending treatment effects to the broader real-world population due to possible heterogeneity in covariates. In this paper, we introduce a procedure to generalize the RCT findings to the real-world trial-eligible population based on the adaption of existing statistical methods. We utilized the augmented inversed probability of sampling weighting (AIPSW) estimator for the estimation and omitted variable bias framework to assess the robustness of the estimate against the assumption violation caused by potentially unmeasured confounders. We analyzed an RCT comparing the effectiveness of lowering hypertension between Songling Xuemaikang Capsule (SXC), a traditional Chinese medicine (TCM), and Losartan as an illustration. The generalization results indicated that although SXC is less effective in lowering blood pressure than Losartan on week 2, week 4, and week 6, there is no statistically significant difference among the trial-eligible population at week 8, and the generalization is robust against potential unmeasured confounders.

stat.AP