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Test equality between two binary screening tests with a confirmatory procedure restricted on screen positives.

Kung-Jong Lui1, Kuang-Chao Chang

  • 1a Department of Mathematics and Statistics, College of Sciences , San Diego State University , San Diego , California , USA.

Journal of Biopharmaceutical Statistics
|May 20, 2014
PubMed
Summary

This study introduces new statistical methods for comparing two screening tests when confirmatory tests are only given to screen positives. It provides formulas for sample size calculations and validates these methods with simulations and real-world data.

Keywords:
PowerSample size determinationSensitivitySpecificityTest equalityType I error

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Area of Science:

  • Biostatistics
  • Medical Screening
  • Diagnostic Test Evaluation

Background:

  • Confirmatory procedures are often ethically limited to screen-positive subjects in accuracy studies.
  • Comparing sensitivity and specificity between two binary screening tests presents unique statistical challenges under such conditions.

Purpose of the Study:

  • To develop and evaluate statistical methods for simultaneously testing the equality of sensitivity and specificity between two binary screening tests.
  • To derive a sample size calculation formula for ensuring adequate statistical power in such comparative studies.
  • To illustrate the practical application of these methods using real-world screening test data.

Main Methods:

  • Development of four asymptotic and one exact statistical test procedures.
  • Derivation of a sample size formula based on desired power and significance level.
  • Monte Carlo simulations to assess the performance of the proposed tests and sample size formula.
  • Application to a study comparing prostate-specific antigen (PSA) and digital rectal examination (DRE) tests.

Main Results:

  • The study presents novel statistical procedures for comparative screening test accuracy analysis.
  • Validated sample size calculation formulas are provided for study design.
  • Simulation results demonstrate the performance of the developed tests and the accuracy of the sample size formulas across various scenarios.
  • The methods are illustrated using a practical example from a study on Black men.

Conclusions:

  • The developed statistical methods and sample size formulas are effective for comparing binary screening tests when confirmatory procedures are selectively applied.
  • These tools enhance the rigor of diagnostic accuracy research, particularly in ethically constrained study designs.
  • The findings offer practical guidance for researchers designing and analyzing studies on screening test performance.