Responsiveness And The Item Response Theory Research Of The Health Status Scale Of Traditional Chinese Medicine In Different Diseases

Background and ObjectiveTraditional Chinese Medicine sets holistic concept and treatment based on syndrome differentiation as the main guiding ideology, which pay attention to diagnosis and treatment of the individual and their functional integral adjustment. The reason of Traditional Chinese Medicine for thousands of years lays on its objective clinical efficacy. However, the failure to establish a reasonable and scientific Chinese medicine curative effect evaluation standards systemmakes it hard for Traditional Chinese Medicine to develop and spread in the world.TCM-HSS is in accordance with international patient reported outcome index connotation and definition, as well as traditional Chinese medicine theory to develop into a universal scale, the scale preliminary study evaluation of its good reliability, validity and equivalence.The objective of this study is to examine the responsiveness of TCM-HSS by extend through the disease types and increase number of cases. The assessment on the scale of application of item response theory (IRT) was used to prove the TCM-HSS has good scientific and operability, can popularize application.Methods1. Through the application of TCM-HSS, we investigated to4disease subgroups (Coronary heart disease in30cases,41cases of rheumatoid arthritis, chronic obstructive pulmonary disease in29cases,31cases of chronic renal failure) with a total of131patients before and after treatment, to examines the reliability to change of the scale. 2. Application of item response theory to the China Health Status Scale examine the scale of different characteristics of the population equivalence.Result1. Responsiveness:Evaluate the ability of TCM-HSS to differentiate between healthy people and patients, the results indicated that there exist significant difference between them (P＜0.05); We used the scale in each subgroup to examine the resposiveness, and the results indicated that in the aspects of the physical all the patients before and after treatment was not statistically significant difference (P＞0.05);The urine aspects in coronary heart disease group and rheumatoid arthritis patients before and after treatment difference was statistically significant (P＞0.05);The aspects of pain and sleep in chronic obstructive pulmonary disease group was not statistically significant difference (P＞0.05); Chronic renal failure patients before and after treatment group, the quality of sleep not are statistically significant difference (P＞0.05);The rest aspects of the scale showed the all the patients before and after treatment changes in quality of life are statistically significant (P＜0.05); Scale score of all aspects before and after treatment between the differences were significant (P＜0.05); except for the physical aspects of the reaction degree lower between the remaining aspects of the ES value of0.24to0.48, the SRM value of0.37to0.83, the CR value is23-47%, with a highly responsiveness. China health status scale is more sensitive to reflect changes in patient outcomes compared with the SF-36. The scale has a good acceptance rate and completion rate, completion time is16minutes.2. The IRT analysis:different age analysis showed that all the items don’t exist the uniform DIF and non-uniform DIF, different gender group analysis showed that the item9、item10、item12、item21、item27exist uniform DIF, the rest items don’t exist uniform DIF and non-uniform DIF. The scale has good measurement of psychological characteristics.ConclusionTCM-HSS has a high responsiveness and it can be used for measuring the Traditional Chinese Medicine curative effect of different diseases.