【摘要】： 背景：近20年來，醫(yī)學界對生存質(zhì)量逐步予以重視，并初步形成了對生存質(zhì)量的衡量、評價方法和指標體系。中華生存質(zhì)量量表是以中國文化為背景，在中醫(yī)基礎(chǔ)理論指導下，按照研制健康相關(guān)生存質(zhì)量量表的方法進行研制。近幾十年來，國外開始關(guān)注患者的主觀感覺在臨床實踐中的重要性，國內(nèi)外醫(yī)學專家在臨床實踐中越來越多地重視患者報告地結(jié)局指標(patient reported outcomes，PRO)。PRO(即患者報告的結(jié)局指標)量表，其中患者報告成果成為重點，主要突出患者的主觀感受，患者為療效提供其自己的意見，PRO測量病人健康狀況的所有方面，并完全來自于病人。目前正在研制的用于中醫(yī)臨床療效評價的PRO量表，它將有效的用于臨床試驗療效評估。 目的：按照美國食品及藥物管理局(FDA)所規(guī)定的PRO量表的制作原則及流程，把量表的測評建立在以患者的感受為中心，制定出中醫(yī)健康狀況療效評價PRO量表，通過大樣本、多中心的臨床調(diào)查研究，修訂并考察該量表的信度、效度；研制出中華PRO量表，并通過對中華生存質(zhì)量量表與PRO量表的比較研究，考核中華生存量表的PRO特性。中華生存量表若具PRO特性則可更加廣泛的用于臨床療效評價。 方法：根據(jù)PRO量表的制作原理，結(jié)合中醫(yī)理論中健康的概念框架，通過詢問病人形成條目。再通過專家組對形成的條目池的進行刪除或修正條目，形成初始量表，再經(jīng)專家評議，作重要性評分，修改后作小范圍的預(yù)調(diào)查(語言調(diào)試)再行修改后形成初量表�？刂萍膊顟B(tài)、年齡、性別等因素，從廣州、番禺、珠海及鄭州抽取100例健康人和200例病人，用中華生存量表和中華PRO初量表進行臨床(現(xiàn)場)調(diào)查，回收后的中華PRO量表的臨床調(diào)查資料經(jīng)專家重要性評分分析、離散度分析、因子分析、逐步回歸分析、判別分析和內(nèi)部一致性分析等統(tǒng)計分析方法篩選出60個指標組成正式量表，再進行信度和效度考核。信度考核包括重測信度、分半信度和內(nèi)部一致性。效度考核包括內(nèi)容效度、維度相關(guān)性、用量表的各條目得分與量表總分作多元線性回歸分析以及采用因子分析和證實性因子分析方法考核量表的結(jié)構(gòu)效度。同時對中華量表進行重測信度，內(nèi)部一致性、結(jié)構(gòu)效度以及區(qū)分效度來考核這兩個量表的相關(guān)性。 結(jié)果：中華PRO量表的分半系數(shù)形神統(tǒng)一領(lǐng)域為0.71；人與自然領(lǐng)域的分半系數(shù)為0.70；七情領(lǐng)域的分半系數(shù)為0.78。形神統(tǒng)一領(lǐng)域的Cronbach's a系數(shù)為0.73，人與自然領(lǐng)域和七情領(lǐng)域的Cronbach's a系數(shù)分別為0.74、0.82。用量表的各條目得分與量表總分作多元線性回歸分析，，表明四個領(lǐng)域得分均對總分有貢獻。采用證實性因子分析方法考核量表的結(jié)構(gòu)效度。量表模型的擬合優(yōu)度(CFI)為0.925，四個領(lǐng)域的亞結(jié)構(gòu)的擬合優(yōu)度指數(shù)分別為0.968、0.901、0.902、0.934。中華量表與中華PRO量表通過內(nèi)在一致性及效度的比較即兩者的克朗巴赫信度a系數(shù)均為0.77左右。 結(jié)論：信度分析表明，中華PRO量表具有較好的信度。量表即形神統(tǒng)一領(lǐng)域、社會領(lǐng)域具有區(qū)分健康人與病人的能力，表明PRO量表有較好的區(qū)分效度。從以上分析結(jié)果可見，此量表具有較好的效度。總的來看，七情領(lǐng)域的信度、效度的考核結(jié)果多數(shù)優(yōu)于其它各領(lǐng)域。通過對中華生存量表和中華PRO量表的條目、方面、領(lǐng)域以及信度、效度進行比較分析，結(jié)果表明其相關(guān)性較高，說明中華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.
【學位授予單位】：廣州中醫(yī)藥大學
【學位級別】：碩士
【學位授予年份】：2007
【分類號】：R395

【引證文獻】

相關(guān)期刊論文 前1條

1 何慶勇;王階;張允嶺;王師菡;楊戈;;基于患者報告的臨床結(jié)局評價量表的條目篩選方法[J];中華中醫(yī)藥雜志;2011年01期

相關(guān)博士學位論文 前2條

1 何慶勇;冠心病心絞痛病證結(jié)合療效評價體系研究[D];北京中醫(yī)藥大學;2011年

2 李筱穎;胃痛PRO計算機自適應(yīng)試驗的初步構(gòu)建研究[D];廣州中醫(yī)藥大學;2011年

本文編號：2229483