Statistical Validation of Traditional Chinese Medicine Diagnostic Procedure

Abstract

In recent years, the modernization of traditional Chinese medicines (TCM) for treatment of patients with critical and/or life-threatening diseases has attracted much attention in the pharmaceutical industry. The modernization of a TCM is based on a scientifically evaluation of the safety and effectiveness of the TCM in terms of some well-established quantitative instruments. As a result, statistical validation of such an instrument is essential to have an accurate and reliable clinical assessment of the performance of the TCM. Similar to the validation of a typical quality of life (QOL) instrument, some validation performance characteristics such as validity, reliability, ruggedness, and responsiveness are considered. In this article, a design for validation of a standard quantitative instrument that is commonly employed for diagnosis of patient's functions/activities, performances, signs and symptoms of the disease, and disease status and severity based on Chinese medical practice is proposed. Methods for statistical validation of the standard instrument are derived.