Statistical Validation of Traditional Chinese Diagnostic Procedures
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Chin-Fu Hsioo Division of Biostatistics and Bioinformatics. Institute of Population Health Science, National Health Research Institutes. Zhunan, Taiwan Hsiao-Hui Tsou Division of Biostalislics and Bioinformatics. National Health Research Institutes. Zhunan. Taiwan Annpey Pong Schering Plough, New jersey Jon-poi Liu Division of Biostalistics and Bioinformatics, National Health Research Institutes. Zhunan. Taiwan; Division of Biometry, Department of Agronomy, National Taiwan University, Taipei. Taiwan Chien-Hsiumg Lin Department of Acupuncture and Moxibustion. Center for Traditional Chinese Medicine, Chang Gung Memorial Hospital. Taoyuan Hsien. Taiwan You-Jhy Chong Stroke Center and Department of Neurolo&v, Chang Gung Memorial Hospital. and College of Medicine. Chang Gung University, Taoyuan, Taiwan Shein-Chrng Chow Department of Biostatistics and Bioinformatics. Duke University School of Medicine. Durham. North Carolina; Statistics Department. National Cheng-Kung University, Tainan, Taiwan Key Words Validity; Reliability; Calibration; Validation Correspondence Address Shein-Chung Chow. PhD. Department of Biostatistics and Bioinformatics. Duke University School of Medicine. 2400 Pratt St.. Room 031 I Terrace Level. Durham. NC 27705.
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Statistical Validation of Traditional Chinese Diagnostic Procedures 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 thepharmaceutical 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
INTRODUCTION In recent years, the search for new medicines for treating life-threatening diseases such as cancer has become the center of attention in pharmaceutical research and development. As a result, many pharmaceutical companies have begun to focus on the modernization of traditional Chinese medicine (TCM). Modernization of TCM is based on scientific evaluations of its efficacy and safety in terms of well-established clinical endpoints for a Western indication through clinical trials on humans. However, it should be recognized that there are fundamental differences in the scientific evaluation of the efficacy and safety of TCM as compared to a typical Western medicine (WM) even though they are for the same indication (1,2).For example, most WMs contain a single active ingredient, while most TCMs consist of a mixture of components or constituents, which may or may not be active pharmacologically. In addition, the traditional Chinese diagnostic procedure (CDP) for a TCM is quite different from that of a WM. Typically, the CDP consists of four major categories, namely, inspection, auscultation and olfaction, interrogati
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