Determining the threshold time in restricted mean survival time analysis for two group comparisons with applications in clinical and epidemiology studies.

The restricted mean survival time (RMST) analysis has been used extensively in clinical research involving time-to-event endpoints. The threshold time up to which the restricted mean survival is calculated has a critical impact on the analysis results. However, identifying an optimal threshold time...

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Published in:American Journal of Epidemiology Vol. 195; no. 1; pp. 32 - 40
Main Authors: Han, Gang, Schell, Michael J, Smith, Matthew Lee, Hopkins, Laura, Liu, Yushi, Carroll, Raymond J, Ory, Marcia G
Format: research tables/charts Journal Article
Published: Oxford University Press / USA Jan2026
Online Access:View this record in EBSCOhost
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      dt: Jan2026
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      pub: Oxford University Press / USA
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        190773788
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        atl: Determining the threshold time in restricted mean survival time analysis for two group comparisons with applications in clinical and epidemiology studies.
      aug:
        au:
          Han, Gang
          Schell, Michael J
          Smith, Matthew Lee
          Hopkins, Laura
          Liu, Yushi
          Carroll, Raymond J
          Ory, Marcia G
        affil: Center for Community Health and Aging, Texas A&M University, College Station, TX, United StatesDepartment of Epidemiology and Biostatistics, School of Public Health, Texas A&M University, College Station, TX, United States
      sug:
        subj:
          Survival Analysis
          Data Analysis, Statistical Methods
          Models, Statistical
          Treatment Outcomes
          Comparative Studies
          Time
          Human
          Female
          Male
          Sample Size Determination
          Algorithms
          Performance Measurement Systems
          Simulations
          Docetaxel
          Carcinoma, Non-Small-Cell Lung
          Antibodies, Monoclonal
          Programmed Cell Death Ligand 1
          Tumor Markers, Biological
          Activities of Daily Living
          Dementia Patients
          Progression-Free Survival
          Kaplan-Meier Estimator
          Data Analysis Software
          Descriptive Statistics
          Funding Source
          Female
          Male
      ab: The restricted mean survival time (RMST) analysis has been used extensively in clinical research involving time-to-event endpoints. The threshold time up to which the restricted mean survival is calculated has a critical impact on the analysis results. However, identifying an optimal threshold time for treatment comparison, which corresponds to the greatest restricted mean lifetime difference between groups, remains unclear in practice, and no analytical method has been developed on this topic. We present a novel method for determining the threshold time in the RMST analysis to compare two groups. Simulation studies indicate that this method leads to high statistical power and controlled type I error rate compared with existing methods. The proposed method is illustrated in two applications: (1) a clinical oncology study for non–small-cell lung cancer treatments comparison given a programmed death-ligand 1 biomarker measurement, and (2) a gerontology study of instrumental activities for care recipients with dementia.
      pubtype: Academic Journal
      doctype:
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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