【摘要】：目的:認(rèn)真依據(jù)美國食品及藥物管理局(FDA)規(guī)定的患者報告臨床結(jié)局(patient reported outcomes,PRO)量表制作原則及流程,從患者的角度著手,編制并考核量表,制定出符合我省胃癌患者身體狀況療效評價的PRO量表。方法:依據(jù)國際PRO量表制作的流程,通過查閱大量文獻(xiàn)、對患者進(jìn)行訪談,并閱讀國內(nèi)外相關(guān)量表,獲取關(guān)于胃癌患者的主要信息,形成概念框架及條目池。再對患者進(jìn)行認(rèn)知測試,咨詢相關(guān)領(lǐng)域?qū)＜?對條目池進(jìn)行進(jìn)一步修改,形成量表初稿。用量表初稿在山西省八所不同等級醫(yī)院進(jìn)行小規(guī)模預(yù)調(diào)查,量表回收后,使用經(jīng)典測量理論及項目反應(yīng)理論共7種方法進(jìn)行第一次條目篩選,形成初量表。然后用初量表在同以上相同的八所醫(yī)院進(jìn)行較大規(guī)模的正式調(diào)查,并用相同的方法對條目進(jìn)行第二次篩選,最后形成終量表。再對終量表進(jìn)行考核,分別從信度、效度及可行性三個方面來考核。結(jié)果:最終編制出適合我省胃癌患者的PRO量表,含有57個條目、4個領(lǐng)域、13個維度。其中生理領(lǐng)域有23個條目,包括腹部癥狀、全身癥狀、身體狀態(tài)及獨立性4個維度;心理領(lǐng)域有15個條目,包括焦慮、抑郁與悲觀3個維度;社會領(lǐng)域7個條目,包括社會適應(yīng)和社會支持2個維度;治療領(lǐng)域12個條目,包括有效性、滿意度、依從性及藥物副作用4個維度。并對量表的信度、效度與可行性進(jìn)行了考核。信度分析:總量表的克朗巴赫α系數(shù)為0.946。效度分析:結(jié)構(gòu)效度結(jié)果表明量表中大多維度的測量基本滿足專業(yè)上的預(yù)想結(jié)構(gòu)�？尚行苑治�:進(jìn)行大規(guī)模抽樣調(diào)查的胃癌患者,量表總接受率為93.40%,總完成率為96.16%,完成一份問卷的時間為15分鐘左右。結(jié)論:本課題研制的基于胃癌患者報告臨床結(jié)局評價量表具有較好的信度、效度和可行性,可以作為胃癌患者臨床療效評價研究的工具之一。
[Abstract]:Objective: according to the principle and procedure of the (patient reported outcomers pro) scale for reporting the clinical outcome of patients according to the requirements of the Food and Drug Administration of the United States (FDA), to compile and evaluate the quantity table from the patient's point of view. Pro scale was developed to evaluate the curative effect of gastric cancer patients in our province. Methods: according to the process of making the international pro scale, the patients were interviewed by consulting a large number of literatures, and the main information about gastric cancer patients was obtained by reading the relevant scales at home and abroad, and the conceptual framework and item pool were formed. Then the patients were tested by cognitive test, consulting experts in related fields, and the item pool was further revised to form the first draft of the scale. The first draft of the scale was carried out in eight hospitals of different grades in Shanxi Province. After the scale was recovered, the first item was screened by the classical measurement theory and the item reaction theory, and the initial scale was formed. Then a large scale formal investigation was carried out in the same eight hospitals with the initial scale, and the items were screened for a second time with the same method, finally the final scale was formed. Finally, the final scale is evaluated from three aspects: reliability, validity and feasibility. Results: pro scale for gastric cancer patients in our province was developed, including 57 items, 4 fields and 13 dimensions. There are 23 items in the physiological field, including abdominal symptoms, systemic symptoms, physical state and independence, 15 items in the psychological field, including anxiety, depression and pessimism, 7 items in the social field, It includes two dimensions of social adaptation and social support, and 12 items in the field of treatment, including 4 dimensions of effectiveness, satisfaction, compliance and side effects of drugs. The reliability, validity and feasibility of the scale were evaluated. Reliability analysis: the Cronbach 偽 coefficient of the total table was 0.946. Validity analysis: the results of structural validity showed that most of the dimensions measured in the scale basically met the expected professional structure. Feasibility analysis: the total acceptance rate of the scale was 93.400.The total completion rate was 96.160.The time to complete a questionnaire was about 15 minutes. Conclusion: the clinical outcome evaluation scale based on the report of gastric cancer patients has good reliability, validity and feasibility, and can be used as one of the tools to evaluate the clinical efficacy of gastric cancer patients.
【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】：2016
【分類號】：R735.2

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