Abstract
INTRODUCTION: The translation of traditional Chinese medicine (TCM), which is experience-based, into evidence-based frameworks of Western medicine poses significant challenges due to differences in conceptualization, diagnosis, and evaluation methodologies. A critical need exists to bridge these disparities to enhance the integration of TCM into modern medical practices. METHODS: This study proposes a novel statistical methodology, leveraging confidence interval-based mapping, to calibrate subjective TCM diagnostic outcomes (eg, instruments or questionnaires) with objective Western clinical endpoints (eg, analytical test results). A quantitative mapping formula was developed to determine TCM diagnostic cutoff values based on the concept of confidence intervals, aligning them with Western clinical standards. The methodology was rigorously evaluated using clinical trial simulations. RESULTS: Simulation results demonstrated that the proposed method enhances the accuracy and consistency of diagnostic calibration. Furthermore, it effectively addresses potential misclassification issues, thereby improving the reliability of aligning TCM diagnostic outcomes with Western clinical endpoints. DISCUSSION: The findings underscore the potential of this methodology to refine the calibration process between TCM and Western medicine. This approach provides a pathway for integrating TCM into evidence-based practices, contributing to the modernization of traditional medical systems.