In recent years, the modernization of traditional Chinese medicine (TCM) for treatment of patients with critical and life-threatening diseases has attracted much attention in the pharmaceutical industry. The modernization of TCM is based on a scientific 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 instrument, some validation performance characteristics such as validity, reliability, and ruggedness are considered. In this article, a design for validation of a standard quantitative instrument that is commonly employed for diagnosis of a patient's functions and activities, performance, signs and symptoms of disease, and disease status and severity based on Chinese diagnostic practice is proposed. Methods for statistical validation of the standard instrument are derived. A numerical example is given to illustrate the proposed methods for validation of Chinese diagnostic procedures.
