哮喘患者报告临床结局量表的研制与评价

发布时间：2018-05-08 23:07

本文选题：哮喘 + 患者报告临床结局(PRO)　；参考：《山西医科大学》2012年硕士论文

【摘要】：研究目的：本文旨在研制可行性高，信度、效度、反应度均较好的哮喘患者报告临床结局量表(哮喘PRO量表)，该量表可以用于新药临床试验或临床疗效评价。研究方法：按照美国食品及药品管理局(FDA)规定的PRO量表制作原则与流程，结合哮喘的理论知识和临床特点，通过大量查阅文献、借鉴国内外相关量表及访谈病人形成量表域结构及条目池，，咨询多位多专业专家，对条目池进行修改，形成含有72个条目的初量表。通过多所医院和社区开展现场调查获得样本，先进行预调查，收集哮喘病人108例，健康人50例，结合经典测量理论和现代测量理论---项目反应理论，进行条目初步筛选，并初步检验量表的反应度和可行性，形成含有67个条目的正式调查量表。正式调查收集哮喘病人366例，健康人100例，采用上述统计方法继续筛选条目，形成含有60个条目的终量表。并对终量表的信度、效度、反应度等指标进行评价。研究结果：1．设计形成哮喘患者报告临床结局量表。量表分为生理领域、心理领域、社会领域、治疗领域4个一级维度，其中生理领域包括躯体症状、生理机能2个方面；心理领域包括焦虑、敌对、恐怖、偏执、抑郁5个方面；社会领域包括社会活动、社会支持2个方面；治疗领域包括依从性、药物评价、满意度3个方面，共12个二级维度。量表包含60个条目。 2．正式调查对466例有效数据进行分析。结果显示该量表具有较好的信度、效度、反应度及临床可行性。分半信度系数：生理领域0.913，心理领域0.950，社会领域0.846，治疗领域0.894，整个量表0.958。克朗巴赫α系数：生理领域0.902，心理领域0.913，社会领域0.702，治疗领域0.810，整个量表0.919。验证性因子分析显示量表的构念效度良好。哮喘患者与健康人在每个方面的测评结果比较，各方面分量表及总量表得分差异均有统计学意义。调查表的回收率、有效率都达95%以上，患者一般在20分钟内完成量表，表明该量表有较高的可行性。研究结论：根据FDA的规定，我们研制出哮喘患者报告临床结局量表。综合采用经典测量方法和项目反应理论对其进行评价。结果表明：该量表具有较好的信度、效度、反应度和临床可行性,可以作为哮喘临床疗效评价研究的工具。
[Abstract]:Objective: to develop a clinical outcome report scale (PRO) for asthma patients with high feasibility, reliability, validity and response, which can be used in clinical trials of new drugs or evaluation of clinical efficacy. Methods: according to the principles and procedures of PRO scale made by the Food and Drug Administration (FDA), combined with the theoretical knowledge and clinical characteristics of asthma, a large number of literatures were consulted. Referring to the relevant scales at home and abroad and interviewing patients to form the scale domain structure and item pool, consulting a number of multi-professional experts to modify the entry pool, forming a preliminary scale containing 72 items. Samples were obtained through field investigation in many hospitals and communities. First, 108 asthmatic patients and 50 healthy people were collected. Combined with classical measurement theory and modern measurement theory-item reaction theory, the items were preliminarily screened. The reactivity and feasibility of the scale were preliminarily tested to form a formal investigation scale with 67 items. 366 asthmatic patients and 100 healthy persons were collected. The above statistical method was used to continue to screen the items and to form a final scale containing 60 items. The reliability, validity and response of the final scale were evaluated. The result of the study was: 1. A clinical outcome scale for reporting asthma patients was designed. The scale is divided into four dimensions: physical field, psychological field, social field, therapeutic field, including physical symptoms, physiological function, anxiety, hostility, phobia, paranoid ideation, depression, anxiety, hostility, phobia, paranoid ideation and depression. The social field includes social activities and social support, while the treatment field includes compliance, drug evaluation and satisfaction. The scale contains 60 items. 2. 466 valid data were analyzed. The results showed that the scale had good reliability, validity, response and clinical feasibility. Split-half reliability coefficient: physiological domain 0.913, psychological field 0.950, social field 0.846, treatment field 0.894, the whole scale 0.958. Cronbach 伪 coefficient: physiological field 0.902, psychological field 0.913, social field 0.702, therapeutic field 0.810, the whole scale 0.919. Confirmatory factor analysis showed that the structural validity of the scale was good. There were significant differences in the scores of component tables and total tables between asthmatic patients and healthy subjects in each aspect. The recovery rate of the questionnaire and the effective rate were over 95%. The patients generally completed the scale within 20 minutes, which indicated that the scale was feasible. Conclusion: according to FDA, we developed the report clinical outcome scale for asthma patients. The classical measurement method and item response theory are used to evaluate it. The results showed that the scale had good reliability, validity, response and clinical feasibility, and could be used as a tool for evaluating the clinical efficacy of asthma.
【学位授予单位】：山西医科大学
【学位级别】：硕士
【学位授予年份】：2012
【分类号】：R562.25

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