中华生存质量量表PRO特性的研究与考核
发布时间：2018-09-07 21:34
【摘要】： 背景：近20年来，医学界对生存质量逐步予以重视，并初步形成了对生存质量的衡量、评价方法和指标体系。中华生存质量量表是以中国文化为背景，在中医基础理论指导下，按照研制健康相关生存质量量表的方法进行研制。近几十年来，国外开始关注患者的主观感觉在临床实践中的重要性，国内外医学专家在临床实践中越来越多地重视患者报告地结局指标(patient reported outcomes，PRO)。PRO(即患者报告的结局指标)量表，其中患者报告成果成为重点，主要突出患者的主观感受，患者为疗效提供其自己的意见，PRO测量病人健康状况的所有方面，并完全来自于病人。目前正在研制的用于中医临床疗效评价的PRO量表，它将有效的用于临床试验疗效评估。 目的：按照美国食品及药物管理局(FDA)所规定的PRO量表的制作原则及流程，把量表的测评建立在以患者的感受为中心，制定出中医健康状况疗效评价PRO量表，通过大样本、多中心的临床调查研究，修订并考察该量表的信度、效度；研制出中华PRO量表，并通过对中华生存质量量表与PRO量表的比较研究，考核中华生存量表的PRO特性。中华生存量表若具PRO特性则可更加广泛的用于临床疗效评价。 方法：根据PRO量表的制作原理，结合中医理论中健康的概念框架，通过询问病人形成条目。再通过专家组对形成的条目池的进行删除或修正条目，形成初始量表，再经专家评议，作重要性评分，修改后作小范围的预调查(语言调试)再行修改后形成初量表。控制疾病状态、年龄、性别等因素，从广州、番禺、珠海及郑州抽取100例健康人和200例病人，用中华生存量表和中华PRO初量表进行临床(现场)调查，回收后的中华PRO量表的临床调查资料经专家重要性评分分析、离散度分析、因子分析、逐步回归分析、判别分析和内部一致性分析等统计分析方法筛选出60个指标组成正式量表，再进行信度和效度考核。信度考核包括重测信度、分半信度和内部一致性。效度考核包括内容效度、维度相关性、用量表的各条目得分与量表总分作多元线性回归分析以及采用因子分析和证实性因子分析方法考核量表的结构效度。同时对中华量表进行重测信度，内部一致性、结构效度以及区分效度来考核这两个量表的相关性。 结果：中华PRO量表的分半系数形神统一领域为0.71；人与自然领域的分半系数为0.70；七情领域的分半系数为0.78。形神统一领域的Cronbach's a系数为0.73，人与自然领域和七情领域的Cronbach's a系数分别为0.74、0.82。用量表的各条目得分与量表总分作多元线性回归分析，，表明四个领域得分均对总分有贡献。采用证实性因子分析方法考核量表的结构效度。量表模型的拟合优度(CFI)为0.925，四个领域的亚结构的拟合优度指数分别为0.968、0.901、0.902、0.934。中华量表与中华PRO量表通过内在一致性及效度的比较即两者的克朗巴赫信度a系数均为0.77左右。 结论：信度分析表明，中华PRO量表具有较好的信度。量表即形神统一领域、社会领域具有区分健康人与病人的能力，表明PRO量表有较好的区分效度。从以上分析结果可见，此量表具有较好的效度。总的来看，七情领域的信度、效度的考核结果多数优于其它各领域。通过对中华生存量表和中华PRO量表的条目、方面、领域以及信度、效度进行比较分析，结果表明其相关性较高，说明中华生存量表也具有一定的PRO特性。
[Abstract]:BACKGROUND: In the past 20 years, the medical community has gradually attached importance to the quality of life, and initially formed a system of measurement, evaluation methods and indicators for the quality of life. Foreign countries began to pay attention to the importance of patients'subjective feelings in clinical practice. In clinical practice, more and more medical experts at home and abroad attach importance to the patient reported outcomes (PRO). PRO (the outcome indicators of patients' reports) scale, in which the results of patients'reports become the focus, mainly highlighting the subjective feelings of patients. Pro measures all aspects of a patient's health and comes entirely from the patient. The Pro scale for evaluating the clinical efficacy of traditional Chinese medicine (TCM) is currently being developed and will be effective in evaluating the efficacy of clinical trials.
OBJECTIVE: According to the principles and procedures of the Pro scale formulated by the Food and Drug Administration of the United States (FDA), the evaluation of the scale is based on the patient's feelings, and the Pro scale for evaluating the curative effect of traditional Chinese medicine (TCM) is developed. The PRO characteristics of the Chinese Survival Scale were assessed by comparing the Chinese Quality of Life Scale with the PRO Scale.
METHODS: According to the principle of PRO scale and the conceptual framework of health in TCM theory, the items were formed by inquiring patients, and then deleting or modifying the items in the item pool by expert group to form the initial scale, which was then evaluated by experts and scored by importance. After modification, a small-scale preliminary investigation (language debugging) was conducted and then repaired. A preliminary scale was developed. 100 healthy people and 200 patients were selected from Guangzhou, Panyu, Zhuhai and Zhengzhou for clinical (on-the-spot) investigation with the Chinese Survival Scale and the Chinese Pro preliminary scale. The collected clinical data of the Chinese Pro scale were analyzed by the experts'importance score and dispersion analysis. Factor analysis, stepwise regression analysis, discriminant analysis and internal consistency analysis were used to select 60 indicators to form a formal scale, and then the reliability and validity were assessed. Multivariate linear regression analysis and confirmatory factor analysis were used to evaluate the construct validity of the scale, and the reliability, internal consistency, construct validity and discriminant validity of the Chinese scale were tested.
Results: The split coefficient of Chinese PRO scale was 0.71 in the field of physique and spirit unity, 0.70 in the field of human and nature, 0.78 in the field of seven emotions, 0.73 in the field of physique and spirit unity, 0.74 in the field of human and nature and 0.82 in the field of seven emotions, respectively. The construct validity of the scale was assessed by confirmatory factor analysis. The CFI of the scale model was 0.925, and the sub-structure goodness of fit index of the four fields were 0.968, 0.901, 0.902 and 0.934, respectively. The comparison between internal consistency and validity is that the Krone Bach reliability a coefficients of both are about 0.77.
Conclusion: The reliability analysis shows that the Chinese PRO scale has good reliability. The scale is the field of unity of body and mind, and the social field has the ability to distinguish healthy people from patients. The results show that the PRO scale has good validity. By comparing the items, aspects, fields, reliability and validity of the Chinese Survival Scale and the Chinese Pro Scale, the results show that the Chinese Survival Scale also has some PRO characteristics.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2007
【分类号】：R395
本文编号：2229483
[Abstract]:BACKGROUND: In the past 20 years, the medical community has gradually attached importance to the quality of life, and initially formed a system of measurement, evaluation methods and indicators for the quality of life. Foreign countries began to pay attention to the importance of patients'subjective feelings in clinical practice. In clinical practice, more and more medical experts at home and abroad attach importance to the patient reported outcomes (PRO). PRO (the outcome indicators of patients' reports) scale, in which the results of patients'reports become the focus, mainly highlighting the subjective feelings of patients. Pro measures all aspects of a patient's health and comes entirely from the patient. The Pro scale for evaluating the clinical efficacy of traditional Chinese medicine (TCM) is currently being developed and will be effective in evaluating the efficacy of clinical trials.
OBJECTIVE: According to the principles and procedures of the Pro scale formulated by the Food and Drug Administration of the United States (FDA), the evaluation of the scale is based on the patient's feelings, and the Pro scale for evaluating the curative effect of traditional Chinese medicine (TCM) is developed. The PRO characteristics of the Chinese Survival Scale were assessed by comparing the Chinese Quality of Life Scale with the PRO Scale.
METHODS: According to the principle of PRO scale and the conceptual framework of health in TCM theory, the items were formed by inquiring patients, and then deleting or modifying the items in the item pool by expert group to form the initial scale, which was then evaluated by experts and scored by importance. After modification, a small-scale preliminary investigation (language debugging) was conducted and then repaired. A preliminary scale was developed. 100 healthy people and 200 patients were selected from Guangzhou, Panyu, Zhuhai and Zhengzhou for clinical (on-the-spot) investigation with the Chinese Survival Scale and the Chinese Pro preliminary scale. The collected clinical data of the Chinese Pro scale were analyzed by the experts'importance score and dispersion analysis. Factor analysis, stepwise regression analysis, discriminant analysis and internal consistency analysis were used to select 60 indicators to form a formal scale, and then the reliability and validity were assessed. Multivariate linear regression analysis and confirmatory factor analysis were used to evaluate the construct validity of the scale, and the reliability, internal consistency, construct validity and discriminant validity of the Chinese scale were tested.
Results: The split coefficient of Chinese PRO scale was 0.71 in the field of physique and spirit unity, 0.70 in the field of human and nature, 0.78 in the field of seven emotions, 0.73 in the field of physique and spirit unity, 0.74 in the field of human and nature and 0.82 in the field of seven emotions, respectively. The construct validity of the scale was assessed by confirmatory factor analysis. The CFI of the scale model was 0.925, and the sub-structure goodness of fit index of the four fields were 0.968, 0.901, 0.902 and 0.934, respectively. The comparison between internal consistency and validity is that the Krone Bach reliability a coefficients of both are about 0.77.
Conclusion: The reliability analysis shows that the Chinese PRO scale has good reliability. The scale is the field of unity of body and mind, and the social field has the ability to distinguish healthy people from patients. The results show that the PRO scale has good validity. By comparing the items, aspects, fields, reliability and validity of the Chinese Survival Scale and the Chinese Pro Scale, the results show that the Chinese Survival Scale also has some PRO characteristics.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2007
【分类号】：R395
【引证文献】
相关期刊论文 前1条
1 何庆勇;王阶;张允岭;王师菡;杨戈;;基于患者报告的临床结局评价量表的条目筛选方法[J];中华中医药杂志;2011年01期
相关博士学位论文 前2条
1 何庆勇;冠心病心绞痛病证结合疗效评价体系研究[D];北京中医药大学;2011年
2 李筱颖;胃痛PRO计算机自适应试验的初步构建研究[D];广州中医药大学;2011年
本文编号：2229483
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