Development And Evaluation Of The Health Status Scale Of Traditional Chinese Medicine (TCM-HSS)

Objective:Through the clinical investigation with large samples and multicentre, the reliability,and validity of the pre-questionnaire were tested.The health status scale of traditional Chinese medicine(TCM-HSS) is going to be used for evaluating the health status of the general population and quantify the clinical effects of TCM.Methods:On the basis of prof.Fengbin Liu's study,the TCM-HSS and SF-36 (Chinese version) were applied into the field test of 295 samples respectively including 201 patients and 94 healthy persons.By applying 7 kinds of statistical methods,including the coefficient of variation analysis,factor analysis,cluster analysis,stepwise regressive analysis,Cronbach'sαcoefficient analysis, discriminatory analysis and confirmatory factor analysis,the formal scale were composed of 32 plus 1 items.Then the reliability and validity of the formal scale were tested.Reliability included split-half reliability and internal consistency and validity included content validity,construct validity,discriminated validity and criteria validity.The differential item functioning of the items was analyzed with item response theory.Results:The health status scale of traditional Chinese medicine was mainly composed of 8 facets and 32 plus 1 items.The reliability was tested with Split-half method and the Cronbach's a coefficient method.The scale's split-half reliability coefficient was 0.8235.The scale's split-half reliability coefficient of the energy, diet,sedes,urine,sleep,body and emotion were 0.8240,0.7743,0.6706,0.5120, 0.7345,0.4208 and 0.7088.The scale's Cronbach'sαwas 0.9061,the Cronbach'sαof the energy,pain,diet,excrement,urine,sleep,body and emotion were 0.8246,0.9100, 0.7412,0.6049,0.4562,0.7583,0.4651 and 0.7310.Construct validity:The result of correlation analysis showed that each item was correlated to it's own facet with r＞0.5 except the 17^th and the 18^th item and each facet was correlated to the total with r＞0.5. The CFI of the energy,diet,body,emotion and facets and the total were 0.96,0.97, 0.97,0.96 and 0.98 and the NNFI were 0.95,0.93,0.90,0.89 and 0.98.The CFI of the sedes 1 and 2 were 0.98 and 0.94.The NNFI of the sedes 1 and 2 were 0.94 and 0.81.Healthy people and patients with total score and the scores were statistically significant differences(P＜0.05).Criteria validity:The scale and SF-36 scale had well correlation.The correlation coefficient between the total scores was -0.692 (P＜0.01).The TCM-HSS had good acceptance rate and finish rate,the median of the complete time was 10 minutes.The results of analyzing the differential item functioning of the items show that there was no DIF of items between the healthy persons and patients,no DIF of items between the gender groups except the 22^th item and no DIF of items between the age groups except the 4^th,the 9^th and the 10^th item.Conclusion:The scientific assessment had proved that the health status scale of traditional Chinese medieine had good reliability and validity and scale items had good equivalence and the result has enriched the PRO concept and enlarged the international scale system.