胃癌PRO量表的研制与评价

发布时间：2018-07-18 14:10

【摘要】：目的:认真依据美国食品及药物管理局(FDA)规定的患者报告临床结局(patient reported outcomes,PRO)量表制作原则及流程,从患者的角度着手,编制并考核量表,制定出符合我省胃癌患者身体状况疗效评价的PRO量表。方法:依据国际PRO量表制作的流程,通过查阅大量文献、对患者进行访谈,并阅读国内外相关量表,获取关于胃癌患者的主要信息,形成概念框架及条目池。再对患者进行认知测试,咨询相关领域专家,对条目池进行进一步修改,形成量表初稿。用量表初稿在山西省八所不同等级医院进行小规模预调查,量表回收后,使用经典测量理论及项目反应理论共7种方法进行第一次条目筛选,形成初量表。然后用初量表在同以上相同的八所医院进行较大规模的正式调查,并用相同的方法对条目进行第二次筛选,最后形成终量表。再对终量表进行考核,分别从信度、效度及可行性三个方面来考核。结果:最终编制出适合我省胃癌患者的PRO量表,含有57个条目、4个领域、13个维度。其中生理领域有23个条目,包括腹部症状、全身症状、身体状态及独立性4个维度;心理领域有15个条目,包括焦虑、抑郁与悲观3个维度;社会领域7个条目,包括社会适应和社会支持2个维度;治疗领域12个条目,包括有效性、满意度、依从性及药物副作用4个维度。并对量表的信度、效度与可行性进行了考核。信度分析:总量表的克朗巴赫α系数为0.946。效度分析:结构效度结果表明量表中大多维度的测量基本满足专业上的预想结构。可行性分析:进行大规模抽样调查的胃癌患者,量表总接受率为93.40%,总完成率为96.16%,完成一份问卷的时间为15分钟左右。结论:本课题研制的基于胃癌患者报告临床结局评价量表具有较好的信度、效度和可行性,可以作为胃癌患者临床疗效评价研究的工具之一。
[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 伪 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.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R735.2

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