Objective:Using the TCM concept of integrated wholeness as a guide, and following strictly the standard of scale production methodlogy, to develop a Yang Deficiency Syndrome Patient Reported Outcome Scale. This scale will form a good foundation for future quantitative diagnosis of Yang Deficiency Syndrome Patient Reported Outcome Scale, and as a reference tool for clinical diagnosis of yang deficiency syndrome and treatment efficacy evaluation by TCM practitioners.Methods:Collating the concepts of yang deficiency syndrome arid reviewing relevant literature, textbooks and diagnostic criteria; organizing the yang deficiency diseases and syndromes, syndrome elements, and symptoms through standardized process; understanding of yang deficiency disease, syndrome and disease distribution extracting 308 common symptoms to form a scale item pool; creating a basic theoretical framework based on TCM holistic concept and syndrome element distribution scale. The initial Yang Deficiency Syndrome Patient Reported Outcome Scale was reviewed through three rounds of expert consultation to item selection, translation and inductive design for each item’s dimension. One hundred case studies were collected for clinical pre-survey. The items were further refined through a combination of the limited range pre-test, difficulty degree analysis, and reaction degree analysis using correlation coefficient method to arrive at a revised version of the Yang Deficiency Syndrome Patient Reported Outcome Scale. Further analyses were performed through the collection of 302 cases of yang deficiency syndrome and 100 cases of qi deficiency syndrome, and using the split half reliability, Cronbach’s coefficient, factor analysis and non parametric test to evaluate the reliability and validity scale table.Results:1. The content of the Scale:a revised (version 2) Yang Deficiency Syndrome Patient Reported Outcome Scale, with 7 dimensions and 50 items, including common dimension with 6 items, kidney dimension with 18 items, spleen dimension with 13 items, stomach dimension with 6 items, heart dimension with 4 items, lung dimension with 7 items, and uterus dimension with 4 items.2. The examination of the Scale:the split half reliability of the whole scale was 0.918, except the reliability coefficient of gastric dimensions was a little bit lower, while the rest of the dimension of the split half reliability were greater than 0.7. The Cronbach’s coefficient of the whole scale and uterus dimensions were 0.827 and 0.82, both were greater than 0.8. The Cronbach’s coefficient of the common dimensions, renal dimensions, dimensions of spleen, stomach dimension, dimension of heart, lung dimensions were 0.762,0.782,0.784,0.661, 0.763,0.744 respectively, which between 0.6 and 0.8, showing the scale has the good internal consistency. Totally collected 302 cases of yang deficiency and 100 cases of qi deficiency syndrome patients, both has significant statistical difference (P< 0.01) in the whole scale score and the score of each dimension, indicating this scale can well distinguish the two groups of people between yang deficiency syndrome and qi deficiency syndrome. Factor analysis extracted 13common factors, explainning 69.126% information about the original variables of scale, the actual test results are barely consistent with theoretical assumptions.Conclusion:Yang Deficiency Syndrome Patient Reported Outcome Scale has the characteristics of TCM and scientific significance, which can reflect the entire state of yang deficiency patients, also can make a cross-sectional survey of different yang deficiency disease’s state, which has good innovation and practicality. It laid a good foundation for the establishment of the quantitative diagnosis to the Yang Deficiency Syndrome Patient Reported Outcome Scale. |