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  本文選題：肝硬化 + 患者報告結(jié)局（PRO）��； 參考：《山西醫(yī)科大學(xué)》2014年碩士論文

【摘要】：研究目的：本研究嚴格遵循美國食品及藥物管理局（FDA）規(guī)定的基于患者報告結(jié)局（patientreport outcomes, PRO）量表的制作原則與流程，從患者角度出發(fā)，對量表條目進行編制、篩選及測評，制定出適合我國西醫(yī)肝硬化患者的PRO量表。并通過計算最小臨床意義變化值(minimal clinical important difference，MCID)解決PRO量表分值變化的臨床解釋問題，使該量表能廣泛應(yīng)用于臨床療效評價和新藥臨床試驗中。 研究方法：根據(jù)國際PRO量表的研制規(guī)范，通過查閱文獻、患者訪談及借鑒國內(nèi)外相關(guān)量表，收集和提取肝硬化患者的重要信息，形成概念框架，列出條目池。再經(jīng)過各個領(lǐng)域的專家和患者的認知測試對條目池進行修正，形成量表初稿。用此量表分別在山西省不同城市的八所不同等級的醫(yī)院進行小規(guī)模的預(yù)調(diào)查，采用經(jīng)典測量理論和項目反應(yīng)理論共7種方法對條目進行篩選并結(jié)合專業(yè)知識，剔除不符合要求的條目，形成初量表。利用初量表做大規(guī)模的正式調(diào)查，回收后運用與預(yù)調(diào)查相同的方法再次對條目進行篩選，形成終量表，并對其進行信度和效度分析。用終量表調(diào)查100例患者，計算輕微變化組與未改變組得分均值之差，即最小臨床意義變化值。 研究結(jié)果：1．編制出“肝硬化患者PRO評價量表”。量表共有50個條目，，4個領(lǐng)域，13個維度。分為生理、心理、社會、治療4個領(lǐng)域，其中生理領(lǐng)域包括腹部癥狀、皮膚癥狀、食欲睡眠、認知能力、獨立性5個維度；心理領(lǐng)域包括焦慮抑郁、自信心、疾病結(jié)局3個維度；社會領(lǐng)域包括社會支持、社會適應(yīng)2個維度；治療領(lǐng)域包括滿意度、依從性、藥物副作用3個維度；2．對終量表進行效度和信度分析。結(jié)果顯示總量表的克朗巴赫系數(shù)為0.921，結(jié)構(gòu)效度顯示各項模型擬合指標幾乎都達到了參考標準中的要求；3.我們最終確定肝硬化PRO評定量表生理領(lǐng)域、心理領(lǐng)域、社會領(lǐng)域和治療領(lǐng)域的最小臨床意義變化值分別為7.06、4.65、3.02和2.08。 研究結(jié)論：本研究研制的基于肝硬化患者報告的臨床結(jié)局評價量表具有較好的信度和效度，并且計算出了最小臨床意義變化值，解決了PRO量表分值變化的臨床解釋問題，充分說明本量表可以作為評價肝硬化疾病臨床療效的工具。
[Abstract]:Objective: the purpose of this study was to follow the principles and procedures of the patient reporting report outcomers (Pros) scale based on the FDAs prescribed by the Food and Drug Administration of the United States. From the patient's point of view, the items of the scale were compiled, screened and evaluated. To develop a suitable PRO scale for patients with liver cirrhosis in western medicine. The minimum clinical important difference value was calculated to solve the problem of clinical interpretation of the change of PRO scale, so that it could be widely used in clinical efficacy evaluation and clinical trials of new drugs. Methods: according to the development standard of international PRO scale, the important information of cirrhotic patients was collected and extracted by consulting literature, interviewing patients and referring to relevant scales at home and abroad to form a conceptual framework and list items pool. After the experts and patients in various fields of cognitive tests to amend the pool of items to form a preliminary draft of the scale. The scale was used to carry out small-scale pre-investigation in eight hospitals of different levels in different cities of Shanxi Province, and seven methods were used to screen items and combine professional knowledge with classical measurement theory and item response theory. Eliminate items that do not meet the requirements and form a preliminary scale. A large-scale formal investigation was made by using the initial scale, and the items were screened again with the same method as the pre-survey after recovery, and the final scale was formed, and the reliability and validity of the final scale were analyzed. A total of 100 patients were investigated with the final scale to calculate the difference of the mean score between the slight change group and the unaltered group, that is, the minimum clinical significance change value. The result of the study was: 1. The PRO evaluation scale for patients with liver cirrhosis was developed. The scale consists of 50 items, 4 domains and 13 dimensions. It is divided into four fields: physiology, psychology, society and treatment, including abdominal symptoms, skin symptoms, appetite and sleep, cognitive ability, independence, anxiety and depression, self-confidence, anxiety and depression, Three dimensions of disease outcome; two dimensions of social support and social adaptation; two dimensions of treatment, including satisfaction, compliance, drug side effects. 2. The validity and reliability of the final scale were analyzed. The results showed that the Krombach coefficient of the total table was 0.921, and the structural validity showed that almost all the model fitting indexes met the requirements of the reference standard. We finally determined the minimum clinical significance of the PRO scale for cirrhotic cirrhosis in the physiological, psychological, social and therapeutic fields, respectively, and the minimum clinical significance values were 7.06-4.65V3.02 and 2.08. Conclusion: the clinical outcome evaluation scale based on the report of cirrhotic patients has good reliability and validity, and the minimum clinical significance change value is calculated, and the clinical interpretation of the change of PRO scale score is solved. It is fully demonstrated that this scale can be used as a tool to evaluate the clinical efficacy of liver cirrhosis.
【學(xué)位授予單位】：山西醫(yī)科大學(xué)
【學(xué)位級別】：碩士
【學(xué)位授予年份】：2014
【分類號】：R575.2

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