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Determining reference ranges and sample sizes in parallel-group studies.

Gwowen Shieh1

  • 1Department of Management Science, National Yang Ming Chiao Tung University, Hsinchu, Taiwan.

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|November 30, 2022
PubMed
Summary
This summary is machine-generated.

This study introduces new methods for determining reference ranges in parallel-group studies, addressing sample size and precision for better atypical measurement identification.

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Area of Science:

  • Statistics
  • Biostatistics
  • Clinical Research Methodology

Background:

  • Reference ranges identify typical measurement distributions, flagging atypical results for investigation.
  • Existing methods primarily focus on one- and paired-sample designs.
  • Methodological gaps exist for reference ranges in parallel-group studies, particularly for limits and sample sizes.

Purpose of the Study:

  • To develop comprehensive one- and two-sided reference ranges for parallel-group studies.
  • To address sample size determination for precise reference ranges.
  • To provide practical tools for applying these statistical methods.

Main Methods:

  • Developed a complete collection of one- and two-sided reference ranges for parallel-group studies assuming variance homogeneity.
  • Investigated sample size determination using expected half-width and assurance probability.
  • Created computer programs for efficient calculation and analysis.

Main Results:

  • Proposed sample size criteria that explicitly incorporate desired interval width for precise estimation.
  • Validated the proposed reference range and sample size procedures through theoretical and empirical assessments.
  • Demonstrated application with a real-world example of drug formulation comparison.

Conclusions:

  • The developed reference range and sample size procedures are effective for parallel-group studies.
  • The provided computational tools facilitate practical application in clinical research.
  • This work enhances the statistical assessment of measurement differences in comparative studies.