Journal of the Formosan Medical Association
Volume 107, Issue 12, Supplement , Pages S74-S85, December 2008

Translation in Different Diagnostic Procedures—Traditional Chinese Medicine and Western Medicine

  • Chin-Fu Hsiao

      Affiliations

    • Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taoyuan, Taiwan
    • Corresponding Author InformationCorrespondence to: Dr Chin-Fu Hsiao, Division of Biostatistics and Bioinformatics, National Health Research Institutes, 35 Keyan Road, Zhunan Town, Miaoli County 350, Taiwan
    • ,
  • Hsiao-Hui Tsou

      Affiliations

    • Division of Biostatistics and Bioinformatics, Institute of Population Health Sciences, National Health Research Institutes, Zhunan, Taoyuan, Taiwan
    • ,
  • Yuh-Jenn Wu

      Affiliations

    • Department of Applied Mathematics, Chung Yuan Christian University, Chung Li, Taoyuan, Taiwan
    • ,
  • Chien-Hsiung Lin

      Affiliations

    • Department of Acupuncture and Moxibustion, Center for Traditional Chinese Medicine, Taoyuan, Taiwan
    • ,
  • Yeu-Jhy Chang

      Affiliations

    • Stroke Center and Department of Neurology, Chang Gung Memorial Hospital and College of Medicine, Chang Gung University, Taoyuan, Taiwan

Received 25 July 2008; received in revised form 24 September 2008; accepted 9 October 2008.

Article Outline

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.

Key Words:  calibration , reliability , validation , validity

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PII: S0929-6646(09)60011-5

doi:10.1016/S0929-6646(09)60011-5

Journal of the Formosan Medical Association
Volume 107, Issue 12, Supplement , Pages S74-S85, December 2008

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