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Sample size calculation for agreement between two raters with binary endpoints using exact tests.

Guogen Shan1

  • 1Department of Environmental and Occupational Health, Epidemiology and Biostatistics Program, School of Community Health Sciences, University of Nevada Las Vegas, Las Vegas, NV, USA.

Statistical Methods in Medical Research
|November 19, 2016
PubMed
Summary
This summary is machine-generated.

New exact methods improve sample size calculations for two-rater agreement studies. These approaches offer better type I error control than traditional asymptotic methods, ensuring more reliable results in clinical trials.

Keywords:
Agreement testexact testkappa coefficientsample sizeunconditional test

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Area of Science:

  • Biostatistics
  • Clinical Trial Design
  • Statistical Methods

Background:

  • Traditional sample size calculations for inter-rater agreement rely on asymptotic methods.
  • Asymptotic approaches may offer unreliable sample sizes due to poor type I error control.

Purpose of the Study:

  • To introduce novel exact sample size calculation methods for two-rater agreement studies with binary endpoints.
  • To enhance the reliability of sample size determination by controlling the type I error rate.

Main Methods:

  • Proposed two exact sample size calculation approaches: one based on maximization, and another on estimation and maximization.
  • Evaluated the power of the two exact approaches.

Main Results:

  • The exact approach based on estimation and maximization demonstrated superior power compared to the maximization-based approach.
  • The proposed exact methods provide better type I error control.

Conclusions:

  • Exact sample size calculation methods, particularly the estimation and maximization approach, are recommended for two-rater agreement studies.
  • These methods ensure more accurate and reliable sample sizes, crucial for clinical trial validity.