| Objective:On the basis of summarizing predecessors'experience, the study drew upon patient reported outcomes(PRO) used in the evaluation of the clinical effectiveness of Heart Diseases in Traditional Chinese Medicine(TCM), from the angle of patients, according to the regulation of U.S. food and drug administration (FDA) in working out the principle and procedure of PRO scale seek to make the standards not only practical and usable,but also valid, reliable and responsive. This PRO scale provided an objective and standardized measuring tool for clinical efficacy of Heart Diseases in TCM.Contents and Methods:Patients with Chronic Heart Disease are observed following the regulations of the international development program, referring to the PRO concept and combining with the characteristics of Chinese culture. In holistic conception of TCM, relative equilibrium of yin-yang is included in three aspects:unity of body and spirit (Physical field), unity of human and society(Society field and independent field), and the seven human emotions(psychological field). First, according to the discourse of theoretical Connotation of heart controlling blood circulation in TCM, the theoretical framework of Heart Diseases in TCM is formed. Second, the items pool, modified for different ages and classifications of diseases by experts in Heart diseases, can be summarized from consulting documents, inquiring patients and clinical feature of heart diseases. After surveying culture adaptability in10subjects with high school degree, this items pool is modified again. After confirming items pool,346subjects who came from the first affiliated hospital of Guangzhou University of Chinese medicine are divided into different groups in terms of diagnoses of TCM, age and gender in the study.46healthy subjects are investigated by PRO scale of Heart Diseases in TCM to screen out53+1items and form the official PRO scale of Heart Diseases in TCM, through the discrete trend analysis, factor analysis, Cronbach's alpha, stepwise regression analysis, the internal consistency analysis, expert important grade and so on. Finally, the science of PRO questionaires of Heart Diseases in TCM is evaluate from three aspects:Reliability including Crowns Bach coefficient and split-half reliability; Validity covering content validity, construct validity employing confirmatory factor analysis and discriminated validity adopting T-test to distinguishing the patients from healthy people. responsibility proving the structural model of PRO questionaires.Result:1. The PRO scale of Heart Diseases in TCM (heart governing blood and vessels) was completed. Physical domain is separated into eight domains, four main domains which are chest tightness and chest pain, palpitation, vertigo, and shortness of breath, and four other domains such as sprites and fatigue, complexion, sleeping, urine and stool; the seven human emotions (psychological field) have the positive feelings and the negative feelings; Social field relate to personal relationships, social support level, medical treatment and the ability to adjust to the world. Independent field always refers to three aspects:ability of daily living, dependence on drug, and capacity of work and learning;There are altogether53+1items in this questionaire.2. After analyzing346valid data, the results show that Crowns Bach coefficient, split-half reliability are above0.8in four main aspects of the PRO questionaire; By confirmatory factor analysis analyzing score in Physical field, psychological field, Model for chi-square value of the structure of PRO questionaire is0, P=1; Goodness of Fit Index equal to0.97; RMSEA equal to0.000, which show imitative effect of the structure is excellent; The difference in total score and every field between health people and patients express that the degree of response is well; Questionnaire have a modest response time, a the high rate of recovery and been easily understandable:Analyzing item response theory model established, Parapsychology index is1,which is mean model factors have a high imitation degree.Conclusion:In accordance with FDA regulations,the PRO scale used in clinic efficacy on Heart Diseases in TCM is assessed by Classic measurement method and item response theory, the results demonstrate that the PRO scale can be a tool to evaluate clinical efficacy on Heart Diseases in TCM on account of good reliability,validity,reaction degree and clinical feasibility. |
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