| ObjectiveAccording to the regulations of the FDA’s PRO questionnaire principles and process of research and development, from the angle of patients, developed for assessing shipment of hypertension disease clinical curative effect of traditional Chinese medicine PRO scale, to simple and clear, the scale has stronger practicability and feasibility, use a variety of statistical methods for inventory statistics, make it has good reliability and validity, the degree of differentiation and operability. For hypertension clinical efficacy evaluation of traditional Chinese medicine to provide an objective and standard measuring tool.Contents and MethodsFollow the relevant procedures and specifications of PRO questionnaire was developed according to the theory of traditional Chinese medicine knowledge of hypertension disease and the understanding connotation, combining with the characteristics of TCM culture, construct the theoretical system of TCM hypertension PRO questionnaire. According to the overall concept of traditional Chinese medicine, the Chinese medicine. the health concept of "Yin pingyang secret" broken down into three dimensions (realm and unified, heaven corresponding, seven emotions related) four areas (physical) and independence, social environment and psychological field. Patients through interviews and comprehensive use of literature and method is derived form the item pool, through issues group to analyze integrated entry, the entry deleted, determine the entry blanks, formed a preliminary scale, according to different age, gender, culture degree selected30cultural adaptability investigation for patients with high blood pressure, and then according to the result of cultural adaptability to investigate modified again for entry, then the clinical investigation. In guangzhou university of Chinese medicine the first affiliated medical outpatient and ward were169scale, in the nearby community recycling54healthy scale. Scale data of recycling discrete tendency method, crowns Bach coefficient method, factor analysis six kinds of methods such as statistical analysis, the final screen29item, form the formal scale. The formal scale feasibility, reliability, degree of differentiation, structure validity and scientific appraisal. Reliability assessment to crowns Bach coefficient method and reliability method, and a half validity appraisal content validity and structure validity, to distinguish the degree evaluation is the ability to distinguish between hypertensive patients and healthy people.Result1. Design form "the PRO scale of hypertension in TCM", the scale is divided into physiological, psychological and social environment. Physiological areas include dizziness, headache, chest tightness, chest pain, palpitation, insomnia, fatigue and common clinical symptoms; Psychological field contains positive and negative two kind of emotion; Social areas (including independence) contains support, social activities, economic pressure, live and work. Scale contains29entry altogether.2. Analysis of223cases of effective data, results show that the formal scale, strong clinical feasibility of the crowns Bach coefficient of scale:the scale of0.945,0.915physiological field, psychological field0.826, social environment field,0.859meter and a half reliability: the scale of0.893,0.843physiological field, psychological field,0.7480.880; social field Both scale for each entry can distinguish between healthy people and patients with high blood pressure. The questionnaire has good reliability and degree of differentiation.ConelusionAccording to the United States food and drug administration (FDA) scale development program specification, developed for assessing shipment of hypertension clinical efficacy evaluation of traditional Chinese medicine "hypertension PRO scale" of traditional Chinese medicine, integrated using the reliability, validity, and to distinguish the degree of scientific evaluation method, the results show that the scale feasibility is stronger, and has good reliability and validity, the degree of differentiation, can be used as a tool of hypertension clinical efficacy evaluation of traditional Chinese medicine. As the sample come from guangzhou, still need further mobile data across the country, the scale to further modify and perfect, make it can be used widely across the country. |
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