| Background:The patient reported outcome scale is the patient’s self-assessment.It is not affected by the doctor or the interference of others, and it is from the patient’s own subjective feeling.The PRO scale reflects the patient’s subjective feeling, can make up for the curative effect which is not reflected from the objective index, it also can supplement disease curative effect evaluation method. Especially with the development of modern social economy and science and technology, the modern medical pattern has been changed, the purpose of medicine is in the transition from treating diseases to safeguard health. Along with the transition of the above several aspects, the PRO scale research which can be able to reflect the subjective feeling and guarantee the health of patients would be taken by wide attention both at home and abroad.In recent years, with the development of the domestic medical enterprise, perfecting the guidelines of the scale, the scale used in domestic is not confined to the translation of foreign scale, but made the scale suited to the characteristics of the Chinese medical and used for clinical curative effect evaluation of disease in each system, including heart, digestive, tumor, lung, gynecology, cerebrovascular, orthopedic and endocrine diseases, but there are still some problems with the scale. Now the scale is only made for a system or a kind of disease, not a universal. We should begin from the characteristics of the Chinese medicine "syndrome"to develop the PRO scale which is in line with the characteristics of traditional Chinese medicine. According to the thought of "homotherapy for heteropathy " of traditional Chinese medicine, the same syndromes may exist in different diseases, therefore syndrome’s PRO scale can be widely used for diseases in each system, but not limited to one or a kind of disease. But from the perspective of the domestic PRO scale, there is only one scale used for syndrome curative effect evaluation-the spleen Qi deficiency syndrome PRO scale which is eatablished by jian-dong Lin. Therefore, to formulate the PRO scale which conforms to the characteristics of traditional Chinese medicine and has universality, we should pay attention to the development of syndrome’s PRO scale.This study is based on the project which is called" State Administration of Traditional Chinese Medicine Special National Public Welfare Industry the Research of the Syndrome type of Chinese new drug’s Curative effect evaluation (NO.201207009)". On the premise of team project requirements and group discussion, in this paper we study a part of clinical efficacy evaluation of the stagnation of Qi and blood stasis syndrome-the eatablishment of PRO scale of traditional Chinese medicine of the stagnation of Qi and blood stasis syndrome.Objective:1.To establish the PRO scale of traditional Chinese medicine of qi and blood.2.To test the scientificity of the PRO scale of traditional Chinese medicine of qi and blood.Methods:1. The establishment of the PRO scaleThe establishment ofstructure model of PRO scale:On the basis of PRO concept, international scales, qi and blood syndrome differentiation theory, theory of medical, holism of body and spirit and heaven corresponding theory, we build a structure model of PRO scale of traditional Chinese medicine in Stagnation of qi and blood.The establishment of primary PRO scale:Then the scaleentries were established by the methods of retrospective review, literaturesstudy, reference to the international scale and the questionnaire and screened and modified preliminarily by a small sample, pre-survey and group interviews.The establishment offinal PRO scale:According to the entries of thePRO primary scale and the actual situation of the hospital, we determined to collect 338clinical cases,then the entries of PRO scale of traditional Chinese medicine of qi and bloodwere screened and modified by many kinds of statistical methods such the distribution of entry method, discrete tendency method, factor analysis and expert consultation method and so or Eventually the final PRO scale of traditional Chinese medicine of qi and blood was established.2.The scientific assessment of the scaleThe assessment of the feasibility:According to the entries of thePRO final scale and the actual situation of the hospital, we determined to collect clinical caseshe during the second round of clinical investigation.The recovery rate and acceptance of the PRO scale are the basis of feasibility of the PRO scale.The assessment of the reliablity:Thereliability of PRO scale of traditional Chinese medicine inStagnation of qi and bloodwere tested by using the methods of crowns Bach coefficient.The assessment of the validity:Thevalidity of PRO scale of traditional Chinese medicine in Stagnation of qi and blood were tested by using the methods ofhe factor analysis method and the spearman correlation coefficient method.The assessment of the degree of differentiation:Thedegree of differentiationof PRO scale of traditional Chinese medicine in Stagnation of qi and blood were tested by using the methods of independent sample T test with 213 cases of patients with stagnation of qi and blood and 100 cases of patients with no stagnation of qi and blood.Results:1. The PRO scaleThe structural model:The structural model of PRO scale of traditional Chinese medicine of qi and blood includes 4 domins, such asphysiological domain,psychological domain,social domain and independent domain. Then it extends to eight aspects such as symptoms and qi stagnation syndrome and blood stasis symptoms, the psychological positive feelings and negative feelings, life skills and the ability to work to learn, social environment and social relations.The primary PRO scale:The primary PRO scale which includes 61 entries including of 41 entries in physiological domain,11 entries in psychological domain,1 entry in social domain and 8 entries in independent domain.The final PRO scale:The final PRO scale which includes 37 entries including of 22 entries in physiological domain,9entries in psychological domain,1 entry in social domain and 5 entries in independent domain.2.The scientific assessment resultsFeasibility:Through the first round clinical investigation,220 scales were sent out and 213 scales were recycled, so the recovery rate and acceptance of the PRO scale are 96.8%, show that PRO scale of traditional Chinese medicine in Stagnation of qi and blood has high clinical feasibility.Relibility:To calculate the scale’s split-half reliability and consistency reliability, we used crowns Bach coefficient method.And then we got that Crowns Bach coefficient of physiological domain, psychological domain, and the total scale was 0.716, and the GuttmanSplit-half was 0.666 and they were also not less than 0.5.So the PRO scale of traditional Chinese medicine in Stagnation of qi and blood has good consistency and credibility.Validity:Through the factor analysis method, the common factors of this scale can explain 64.70% of the variable show that the PRO scale of traditional Chinese medicine in Stagnation of qi and blood has good structure validity. Through the spearman correlation coefficient method, besides independence field, the left entries and the correlation domain’scoefficient are all more than 0.2 and P are less than 0.01, which show that the entries and the correlation domain’s has significant correlation.So the PRO scale of traditional Chinese medicine in Stagnation of qi and blood has good content validity.Degree of differentiation:Based on 213 cases of patients with stagnation of qi and blood and 100 cases of patients with no stagnation of qi and blood, we used an independent sample T test to get that the physiological field, psychological field, independence, social fields and total P values are less than 0.01, so the difference was statistically significant, thus we can say that the PRO scale of traditional Chinese medicine in Stagnation of qi and blood has a good degree of differentiation.Conclusion:1.The PRO scale of traditional Chinese medicine in Stagnation of qi and blood includes 37 entries and through the scientific evaluate.2.The scientific assessment results are that the PRO scale of traditional Chinese medicine in Stagnation of qi and blood has good feasibility, reliability, validity and degree of differentiation.
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