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Sample size estimation for time-dependent receiver operating characteristic.

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  • 1Department of Preventive Medicine, Rush University Medical Center, Chicago, IL 60612, U.S.A.

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Summary
This summary is machine-generated.

This study introduces a method to calculate the necessary sample size for diagnostic accuracy studies using time-dependent ROC analysis. This ensures reliable estimation of a test

Keywords:
censoringparametric survival modelsample size estimationtime-dependent AUCtime-dependent ROCuniform accrual period

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Area of Science:

  • Biostatistics
  • Medical Diagnostics
  • Survival Analysis

Background:

  • Traditional ROC analysis uses contemporaneous reference standards, which is insufficient for time-dependent settings where outcomes occur in the future.
  • Censoring in survival data complicates diagnostic accuracy assessment, as the true event status may be unknown for some patients.

Purpose of the Study:

  • To determine the required sample size for studies evaluating diagnostic test accuracy using time-dependent ROC analysis.
  • To adapt existing estimators for time-dependent AUC to accommodate censored data and inform sample size calculations.

Main Methods:

  • Adapted a published time-dependent AUC estimator based on expected conditional survival functions.
  • Estimated sample size using approximations of survival functions and their variances under exponential parametric assumptions.
  • Considered various patient enrollment strategies.

Main Results:

  • The proposed method provides adequate sample size for estimating test accuracy to a prespecified precision.
  • A simulation study assessed the method's accuracy and robustness to deviations from parametric assumptions.
  • The method was applied to design a study on positron emission tomography for cervical cancer patients.

Conclusions:

  • The developed sample size calculation method is effective for time-dependent ROC analysis with censored data.
  • This approach enhances the design of diagnostic accuracy studies in survival settings.
  • Accurate sample size determination is crucial for reliable diagnostic test evaluation in clinical research.