Statistical considerations for repeatability and reproducibility of quantitative imaging biomarkers.

Quantitative imaging biomarkers (QIBs) are increasingly used in clinical studies. Because many QIBs are derived through multiple steps in image data acquisition and data analysis, QIB measurements can produce large variabilities, posing a significant challenge in translating QIBs into clinical trials, and ultimately, clinical practice. Both repeatability and reproducibility constitute the reliability of a QIB measurement. In this article, we review the statistical aspects of repeatability and reproducibility of QIB measurements by introducing methods and metrics for assessments of QIB repeatability and reproducibility and illustrating the impact of QIB measurement error on sample size and statistical power calculations, as well as predictive performance with a QIB as a predictive biomarker.