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脾气虚证PRO量表概念框架的探讨
林建东1, 胡镜清2,3, 刘保延4
1.福建中医药大学, 福州 350001;2.河南中医学院, 郑州 450008;3.中国中医科学院广安门医院国家中医药管理局中医临床研究方法重点研究室, 北京 100053;4.中国中医科 学院, 北京 100700
摘要:
[目的] 构建脾气虚证患者报告结局(PRO)量表的概念框架为进一步发展量表条目、建立条目池和量表的研制奠定理论基础。[方法] 在中医传统理论的指导下,参照美国食品药品监督管理局(FDA)所规定的PRO量表的制作原则及流程,根据脾气虚证的临床特点,结合世界卫生组织(WHO)的健康概念、中医整体观念及脾脏的生理功能构建量表的概念框架。[结果] 量表分为生理、心理、独立性和社会4个领域,生理领域由脾虚症状、气虚症状、五脏相关3个方面组成;心理领域由消极感受、积极感受2个方面组成;独立性领域由日常生活能力、工作学习能力2个方面组成;社会领域由社会支持、社会关系2个方面组成。[结论] 通过对脾气虚证概论的操作及界定,初步探讨形成的4个领域9个方面能够较为全面地概括了脾气虚的内涵和外延。
关键词:  脾气虚证  疗效评价  PRO量表  概念框架
DOI:10.11656/j.issn.1672-1519.2013.05.08
分类号:
基金项目:国家中医药管理局中医药行业科研专项项目(201107006);北京市科技计划项目(Z11110207031101)
Research on conceptual framework of PRO scale in spleen Qi deficiency syndrome
LIN Jian-dong1, HU Jing-qing2,3, LIU Bao-yan4
1.Fujian University of TCM, Fuzhou 350001, China;2.Henan College of TCM, Zhengzhou 450008, China;3.The key research unit of TCM clinical research methods, Guanganmen Hospital, China Academy of Chinese Medical Science, Beijing 100053, China;4.China Academy of Chinese Medical Science, Beijing 100700, China
Abstract:
[Objective] To develop a conceptual framework of patient-reported outcomes (PRO) scale in spleen Qi deficiency syndrome for the further development of scale items, the establishment of the item pool and lay a theoretical foundation. [Methods] The work was performed under the guidance of traditional Chinese medicine (TCM) theory and the direction of psychometrics. The formation of the conceptual framework of PRO scale in spleen Qi deficiency syndrome is set up according to the clinical features of spleen Qi deficiency syndrome, the production principles and processes of PRO scale in United States Food and Drug Administration (FDA) and combined with the WHO concept of health, TCM holistic concept and physiological functions of the spleen. [Results] The scale is composed of four domains: physiology domain, psychology domain, independence domain and social domain. The physiology domain is composed of three facets, which are symptoms of spleen deficiency, symptoms of Qi deficiency and symptoms of the five viscera. The psychology domain is composed of negative feelings and positive feelings. The independence domain is composed of three faces of the activities of daily living and work learning ability. The social domain is composed of social support and social relations. [Conclusion] The four domains and nine fields that formed by preliminary study of defineing and explaining the conception of Spleen Qi Deficiency Syndrome generalize about the connotation and extension of it allsidely.
Key words:  spleen Qi deficiency syndrome  evaluation of the effect  PRO scale  conceptual framework
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