A statistical framework for planning and analysing test-retest studies of repeatability.
Moritz Fabian Danzer1, Maria Eveslage1, Dennis Görlich1
1Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.
Statistical Methods in Medical Research
|February 1, 2024
Summary
Accurate measurement repeatability is crucial for assessing biomarkers. This study introduces a framework for sample size calculation in test-retest studies to ensure reliable biomarker assessment in longitudinal research.
Area of Science:
- Biomarker research
- Longitudinal study design
- Statistical methodology
Background:
- Quantitative biomarkers aid early assessment of treatment response and disease progression.
- Biomarker measurements have inherent random variability, potentially masking real changes.
- Assessing measurement repeatability is essential before longitudinal biomarker studies.
Purpose of the Study:
- To develop a comprehensive framework for sample size calculation in test-retest studies.
- To establish criteria for assessing the quality of biomarker assessment in longitudinal studies.
- To enable flexible sample size determination for test-retest studies.
Main Methods:
- Quantification of measurement repeatability using the repeatability coefficient from test-retest studies.
- Development of a novel framework for sample size calculation based on longitudinal assessment quality criteria.
- Application of the framework for retrospective assessment of existing test-retest studies.
Main Results:
- A flexible framework for sample size calculation in test-retest studies has been established.
- The framework links sample size to the desired quality of biomarker assessment in longitudinal studies.
- The proposed method allows for retrospective evaluation of prior test-retest study sample sizes.
Conclusions:
- The developed framework addresses the lack of guidelines for sample size calculation in test-retest studies.
- Accurate estimation of the repeatability coefficient is vital for reliable longitudinal biomarker assessment.
- This framework enhances the quality and reliability of quantitative biomarker utilization in clinical research.
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