Translation in different diagnostic procedures---traditional Chinese medicine and Western medicine

Recently, 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. However, there exist essential differences in the evaluation of the efficacy and safety of a TCM as compared with a typical Western medicine (WM), even though they are for the same indication. Therefore, the modernization of a TCM should be based on a scientific evaluation of the safety and effectiveness of the TCM in terms of well-established quantitative criteria. We propose a study design to study the calibration and validation of the Chinese diagnostic procedure for evaluation of a TCM, with respect to a well-established clinical endpoint for evaluation of a WM. 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 to be commonly employed for diagnosis of patient function/activity, performance, disease signs and symptoms, and disease status and severity based on Chinese diagnostic practice is proposed. Methods for statistical validation of the standard instrument are derived. More specifically, for validation of the TCM diagnostic instrument, we consider the following validation performance characteristics (parameters): validity (or accuracy), reliability (or precision), and ruggedness (interrater variability). A numerical example is given to illustrate the proposed methods for validation of the Chinese diagnostic procedure.