消化性溃疡PRO量表的研制与评价

发布时间：2018-04-29 19:11

本文选题：消化性溃疡 + 患者报告临床结局（PRO）　；参考：《山西医科大学》2014年硕士论文

【摘要】：研究目的：按照美国食品及药物管理局（FDA）规定的患者报告临床结局（patient,report outcomes, PRO）量表制作原则及流程，从患者的角度编制及测评量表，制定出适合我国西医消化性溃疡患者健康状况疗效评价的PRO量表，进一步完善慢性消化系统疾病PRO量表评价体系。研究方法：量表的研制过程按照国际PRO测量工具的研制规范及流程，通过文献查阅、访谈患者和咨询相关专家，收集和提取有关消化性溃疡疾病的重要信息，形成理论框架和条目池。结合专家及患者对条目的建议，对各条目进行增减修改，形成初始量表。在山西省选取八所不同等级的医疗机构进行预调查，通过运用经典测量理论和项目反应理论相结合的方法进行条目筛选和维度调整，形成初量表。用初量表在以上八所不同等级的医疗机构进行大规模的正式调查，量表回收后运用相同的方法对量表条目进行筛选，形成终选量表。最终对终选量表进行信度、效度、公平性及可行性的考核，并对性别可能产生的量表差异进行项目功能差异分析。研究结果：编制出包含54个条目、4个领域、11个维度的“消化性溃疡PRO量表”。其中生理领域17个条目，包括躯体症状和身体状态2个维度；心理领域16个条目，包括工作压力、焦虑、抑郁和恐惧4个维度；社会领域9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，包括依从性、有效性和满意度3个维度。对量表的信度、效度、公平性和可行性进行考核。信度分析：总量表的克朗巴赫系数为0.761。效度分析：结构效度结果说明量表中多维度的测量满足专业上的预想结构。公平性分析：项目功能差异检测结果提示，社会支持（SUP）维度的嵌套模型存在不显著的DIF。可行性分析：抽样调查消化性溃疡患者，量表总接受率为92.76%，总完成率为94.47%，作答时间均小于15分钟。研究结论：本课题研制的基于消化性溃疡患者报告临床结局评价量表具有较好的信度、效度、公平性和可行性，可以作为消化性溃疡疾病临床疗效评价研究的工具。
[Abstract]:Objective: according to the principle and process of making the patient report clinical outcome (patient, report outcomes, PRO) set up by the United States Food and Drug Administration (FDA), from the point of view of patients and evaluation scale, a PRO scale suitable for the evaluation of health status of patients with peptic ulcer in China is formulated, and the chronic digestion is further perfected. System disease PRO scale evaluation system.
Research methods: the development process of the scale is based on the standard and process of the development of international PRO measurement tools. Through literature review, interview patients and consulting related experts, the important information about peptic ulcer disease is collected and extracted, and the theoretical framework and entry pool are formed. The initial survey was made in eight different levels of medical institutions in Shanxi province. Through the combination of the classical measurement theory and the project response theory, the entry screening and dimension adjustment were used to form the initial scale. The initial scale was conducted on a large scale in the eight different levels of medical institutions. After the table recovery, the same method was used to screen the items of the scale, and the final selection scale was formed. Finally, the reliability, validity, fairness and feasibility of the final selection scale were evaluated, and the difference of the project function difference was analyzed.
Results: a "peptic ulcer PRO scale" consisting of 54 items, 4 fields and 11 dimensions, including 17 entries in the physiological field, including 2 dimensions of physical symptoms and body states, 16 items in the psychological field, including 4 dimensions of work stress, anxiety, depression and fear, and 9 items in the social field, including social adaptation and society. It will support 2 dimensions; 12 items in the treatment field include 3 dimensions: compliance, effectiveness and satisfaction.
Assessment of the reliability, validity, fairness and feasibility of the scale. Reliability analysis: the Krone Bach coefficient of the aggregate table is 0.761. validity analysis: the measurement of multi dimension in the structural validity result statement satisfies the preconceived structure of the professional. The fairness analysis: the result of the project functional difference detection results, the nesting of the social support (SUP) dimension There was no significant DIF. feasibility analysis in the model: a sampling survey of patients with peptic ulcers, the total acceptance rate of the scale was 92.76%, the total completion rate was 94.47%, and the answer time was less than 15 minutes.
Conclusion: the clinical outcome assessment scale based on peptic ulcer patients has good reliability, validity, fairness and feasibility, which can be used as a tool for the evaluation of clinical efficacy of peptic ulcer disease.

【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2014
【分类号】：R573.1

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