Aims: The aims of this study were to develop and validate an instrument for the measurement of health-related quality of life (HRQoL) based on Traditional Chinese Medicine (TCM) perspective. Methods: Six groups (scales) of questions, five questions for each scale, were developed from literature review and professional consultation: general health, and health of major five aspects according to TCM theory (heart, liver, spleen, lung, and kidney) to measure the HRQoL of each aspect. One hundred and thirty-six patients (age 49±15 years) visiting the TCM clinic of a medical center in northern Taiwan were interviewed. Health conditions of the five aspects for each patient were rated by a TCM physician. A telephone interview was conducted 1 week later as a retest. Test–retest reliability (intraclass correlation coefficient, ICCR), internal consistency (Cronbach’s a coefficient), and the ability to differentiate the health conditions of the patients for of each scale were assessed. Results: Five of the test–retest reliability and internal consistency coefficients of the six scales were fair to good (0.43–0.75 and 0.51–0.75, respectively), except that of spleen. Both the test–retest reliability and internal consistency coefficients for the liver scale for male were higher than the counterpart for female. The scores of spleen, lung and kidney scales were significantly different in patients with different health conditions of the same aspect. Conclusions: Most scales in the questionnaire had fair to good test–retest reliability and internal consistency. Scores in three scales could differentiate patients’health conditions.
