Construction of a traditional Chinese medicine syndrome-specific outcome measure: the Kidney Deficiency Syndrome Questionnaire (KDSQ).

BACKGROUND: Development of Traditional Chinese Medicine (TCM) syndrome-specific outcome measures is needed for the evaluation of TCM syndrome-specific therapies. We constructed a Kidney Deficiency Syndrome Questionnaire (KDSQ) for the evaluation of the common TCM syndromes Kidney-Yin Deficiency Syndrome (KDS-Yin) and Kidney-Yang Deficiency Syndrome (KDS-Yang) in middle-aged women with menopausal symptoms. METHODS: KDS-Yin and KDS-Yang were traditionally defined by expert opinion were validated by exploratory factor analysis (EFA) and structural equation modeling (SEM). Content validity was tested by EFA on a sample of 236 women from a seminar and SEM on another sample of 321 women from a postal survey. Other psychometric properties were tested on 292 women from the seminar at baseline and two systematically selected sub-samples: 54 who reported no changes in discomforts 11-12 days after the baseline and 31 who reported changes in discomforts 67-74 days after the baseline. All participants completed the KDSQ, the Greene Climacteric Scale and the standard 12-item Short Form Health Survey. RESULTS: The EFA and SEM established the measurement models of KDS-Yin and KDS-Yang supporting content validity of the KDSQ. Internal consistency was good (Cronbach's Alpha >0.70). Construct validity was supported by theoretically-derived levels of correlation with the established external measures. Test-retest reliability was strong (ICC(agreement): KDS-Yin, 0.94; KDS-Yang, 0.93). The KDSQ was responsive to changes over time as tested by effect size and longitudinal validity. CONCLUSIONS: The KDSQ was a valid and reliable measure for KDS-Yin and KDS-Yang in Hong Kong Chinese middle-aged women with menopausal symptoms.

An evidence-based validation of traditional Chinese medicine syndromes.

OBJECTIVES: A standard description regarding the diagnosis of traditional Chinese medicine (TCM) syndromes based on validated evidence is needed for education, practice and evaluation of TCM syndrome-specific treatments. We studied whether an evidence-based four-step approach proposed for the validation of TCM syndromes could validate Kidney-Yin deficiency syndrome (KDS-Yin) and Kidney-Yang deficiency syndrome (KDS-Yang) in middle-aged women with menopausal symptoms. METHODS: TCM classic and contemporary literature were reviewed for the symptoms and the domain changes of KDS-Yin and KDS-Yang. Factor analysis was used to explore whether these symptoms could be grouped according to their mutual relationships in a sample of women. Latent tree models were constructed based on the factor loadings and justifiability by the theory, and were tested by structural equation modelling on another sample of women. RESULTS: The symptoms and domain changes were reviewed from the TCM literature. Exploratory factor analysis (EFA) identified symptom patterns on a sample of 236 women. Based on the findings and the TCM literature, latent tree models of KDS-Yin and KDS-Yang, showing their domain changes and domain symptoms, were constructed and could be confirmed by structural equation modelling on a sample of 323 women. CONCLUSION: KDS-Yin and KDS-Yang in middle-aged women with menopausal symptoms were validated and the four-step approach may be used to validate TCM syndromes.