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Xianghua Luo

Publications and source records attributed to Xianghua Luo.

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Nonparametric Estimation of Event-Free Survival for Data with Left-Truncated Death and Intermittently Assessed Nonfatal Events

In certain clinical settings, patients diagnosed with a disease of interest are at risk for death as well as a serious nonfatal event, and interest lies in event-free survival (EFS), a composite endpoint defined as the time from disease onset until the earlier of the nonfatal event and death. Component-wise censoring of EFS arises when each component is subject to a different censoring mechanism. For example, the nonfatal event may be interval censored between assessments, and death is right-censored. Further, in studies where individuals enroll after disease onset (including prevalent cohort studies), EFS is left truncated. Methods to estimate EFS probability with left-truncated and right-censored data are available in the literature, but they cannot handle component-wise censoring. We propose a kernel smoothing method to non-parametrically estimate EFS in this setting. Our method can also estimate and test for differences in the restricted mean event-free survival time, and can leverage two types of supplemental data that may be available: data from participants followed for death only (not followed for the nonfatal event), and incident cohort data, which arises when there is no delay between disease onset and study enrollment. We assess the proposed method using simulations and demonstrate the method using data from the Atherosclerosis Risk in Communities (ARIC) Study to estimate dementia-free survival probability following a myocardial infarction.

stat.ME

Restricted Win Probability with Bayesian Estimation for Implementing the Estimand Framework in Clinical Trials With a Time-to-Event Outcome

We propose a restricted win probability estimand for comparing treatments in a randomized trial with a time-to-event outcome. We also propose Bayesian estimators for this summary measure as well as the unrestricted win probability. Bayesian estimation is scalable and facilitates seamless handling of censoring mechanisms as compared to related non-parametric pairwise approaches like win ratios. Unlike the log-rank test, these measures effectuate the estimand framework as they reflect a clearly defined population quantity related to the probability of a later event time with the potential restriction that event times exceeding a pre-specified time are deemed equivalent. We compare efficacy with established methods using computer simulation and apply the proposed approach to 304 reconstructed datasets from oncology trials. We show that the proposed approach has more power than the log-rank test in early treatment difference scenarios, and at least as much power as the win ratio in all scenarios considered. We also find that the proposed approach's statistical significance is concordant with the log-rank test for the vast majority of the oncology datasets examined. The proposed approach offers an interpretable, efficient alternative for trials with time-to-event outcomes that aligns with the estimand framework.

stat.ME