摘要
目的：
本研究在总结前人经验的基础上,按照美国食品及药物管理局(FDA)规定的PRO量表制作原则与流程,从患者角度出发,编制出运用于中医心系疾病(心主血脉)临床疗效评价PRO量表,力求使该量表既简明扼要,具有较强的实用性及可操作性,又有一定的信度、效度和反应度,为中医心系疾病的临床疗效评价提供一个客观化、标准化的测量工具。
内容与方法：
遵循国际量表研制的程序规范,参照PRO的概念,结合中国文化特色并且根据中医对于心系疾病临床特点及内涵的理解,提出中医心系疾病PRO的目标人群是慢性心系疾病患者。根据中医的整体观,将阴平阳秘分为形神统一(包括生理性领域)、人与自然社会统一(社会领域及独立性领域)、七情(心理领域)三个方面,根据中医对于心主血脉的内涵的论述,构建中医心系疾病(心主血脉)的理论框架。通过查阅文献、访谈病人、临床心系疾病表现的总结形成条目池,再通过心系疾病专家修改针对不同的年龄、疾病分类,选取中学文化程度的患者10例进行文化适应性调查,经适应性调查后对部分条目的表达进行修改。之后,按照中医主要诊断、年龄、性别等进行分组,根据分组情况在广州中医药大学第一附属医院门诊、病房收集患者共346例,附近社区现场调查获得健康人样本46例,用中医心系疾病PRO量表进行调查,回收后的调查资料经离散趋势分析、相关系数法、判别分析法、因子分析、克朗巴赫系数法、专家重要性评分等统计分析筛选出53+1个指标组成正式量表。并且对量表进行科学性考核,主要包括信度考核、效度考核、区分度考核及项目反应理论。其中信度考核采用克朗巴赫系数及分半信度考核；效度考核包括内容效度及结构效度考核采用证实性因子分析、区分度考核采用健康人与中医心系疾病患者总分及各领域得分进行t检验,同时采用项目反应理论证实本量表的结构模型。
结果：
1.设计形成“中医心系疾病(心主血脉)PRO量表”。生理性领域胸闷痛、心悸、眩晕、气短四个主要维度,以及精神与疲倦、气色、睡眠、小便等其他维度合计8个方面；七情(心理领域)包括正面情感及负面情感；社会领域包括个人关系、社会支持程度、医疗、自然适应能力,并将独立性领域,包括日常生活能力、药物医疗的依赖、工作学习能力3个方面也归入社会领域范畴。量表总共包括53+1个条目。
2.对346例有效数据进行信度分析,结果显示该量表总体及各领域、生理领域四个主要方面的克朗巴赫系数及分半信度均在0.8以上；对该量表的生理领域、心理领域、社会领域得分开展证实性因子分析,得到整个模型的卡方值为0,P=1.00；拟合优度指数(CFI)等于0.97,RMSEA等于0.000,说明整个模型的拟合效果优；健康人与中医心系疾病患者总分及各领域得分差异均具有统计学意义,反应度好；问卷应答时间适中、回收率高、易于理解；建立项目反应理论模型进行分析,得到PSI指数均接近1,表示模型的拟合度较好。
结论：
根据FDA量表研制的程序规范,研制出运用于中医心系疾病(心主血脉)临床疗效评价PRO量表,综合采用经典测量方法和项目反应理论对其进行评价。结果表明：该量表具有较好的信度、效度、反应度和临床可行性,可以作为中医心系疾病(心主血脉)临床疗效评价的工具,但仍需要在运用中不断改进。
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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