Development and validation of an instrument for the measurement of Health-Related Quality of Life Based on View of Traditional Chinese Medicine Perspective

[[abstract]]Objectives: The objectives of this study were to develop and validate an instrument for the measurement of health-related quality of life (HRQoL) based on view of Traditional Chinese Medicine (TCM). Design: Six domains of questions, five questions for each domain were developed about general health, and health of five major viscera according to TCM theory to measure the HRQoL. Settings: 149 patients participated in this study and all of them were interviewed in the TCM clinic of a medical center. Interventions: When interviewing, these patients’ health conditions of the five viscera were rated by a TCM physician without knowledge of the patient’s answers. A telephone interview was conducted one week later as a retest. Main outcome measures: Test-retest reliability (intraclass correlation coefficient, ICC), internal consistency (Cronbach’s alpha coefficient), and the ability to differentiate the health conditions in each domain of the patients were assessed. Results: The test-retest reliability coefficients of the six domains ranged from 0.46 for spleen to 0.69 for liver-male and kidney. The internal consistency coefficients of the six domains varied from 0.38 for spleen to 0.72 for heart. All scales except that of liver for females could significantly classify different health conditions (evidence of abnormality) assessed by TCM physicians. Ten factors were identified through factor analysis. Some items were found to be correlated with more than one domain. Most domains in the questionnaire had fair test-retest reliability and fair to good internal consistency, and could differentiate patients’ health conditions. The low internal consistency of the spleen scale and the inter-related scale structures needs further evaluation