“基于慢性阻塞性肺病患者报告的临床结局评价量表”的编制与评价

发布时间：2018-07-11 09:56

本文选题：慢性阻塞性肺病（COPD） + 患者报告的临床结局量表（PRO）　；参考：《山西医科大学》2012年硕士论文

【摘要】：研究目的：根据美国食品及药物管理局（FDA）规定的PRO量表制作原则与流程，从患者角度编制基于慢性阻塞性肺病患者报告的临床结局评价量表（PRO量表），通过预调查以及大样本的临床正式调查，修订量表，并对其计量心理学特征做出评价。研究方法：遵循国际量表研制的流程规范，以慢性阻塞性肺病的理论知识为基础，通过文献查阅以及患者访谈、借鉴国内外相关量表形成量表域结构及条目池，之后由多位各领域专家对条目池进行修改，做小范围调查进行语言调试，形成初量表。通过预调查对条目进行初步筛选和调整，形成正式量表。于医院及社区展开现场调查获得样本，评价终量表的信度、效度、反应度等各指标，经过调整，形成终量表。研究结果：1．形成基于慢性阻塞性肺病患者报告的临床结局评价量表。量表由生理领域、心理领域、社会领域、治疗领域4个一级维度组成，其中生理领域包括特异性症状、全身症状、独立性3个方面；心理领域包括焦虑、抑郁2个方面；社会领域包括疾病认知、疾病对社会活动的影响、社会支持度3个方面；治疗领域包括依从性、药物副作用、满意度3个方面，共11个二级维度。量表包含52个条目。2．对395例有效数据进行分析。结果显示该量表评价慢性阻塞性肺病患者具有较好的信度、效度、反应度及临床可行性。分半信度系数：生理领域0.762，心理领域0.865，社会领域0.755，治疗领域0.862，整个量表0.757。克朗巴赫系数：生理领域0.888，，心理领域0.898，社会领域0.704，治疗领域0.696，整个量表0.923。研究结论：根据FDA的规定，我们研制出基于慢性阻塞性肺病患者报告的临床结局评价量表。将经典测量方法和项目反应理论结合对量表进行评价。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,可以作为慢性阻塞性肺病临床疗效评价研究的工具。
[Abstract]:Objective: according to the principle and procedure of the pro scale made by the Food and Drug Administration (FDA), The clinical outcome evaluation scale (pro) based on the report of patients with chronic obstructive pulmonary disease (COPD) was compiled from the patient's point of view. The scale was revised by pre-investigation and a large sample of clinical formal investigation, and the characteristics of econometric psychology were evaluated. Methods: according to the procedure of international scale development, based on the theoretical knowledge of chronic obstructive pulmonary disease (COPD), through literature review and patient interviews, the scale domain structure and item pool were formed by referring to the relevant scales at home and abroad. After that, a number of experts in various fields modify the item pool, do a small survey to debug the language, and form a preliminary scale. Through preliminary screening and adjustment of items through pre-investigation, a formal scale was formed. Field investigation was carried out in hospitals and communities to obtain samples and evaluate the reliability, validity and response of the final scale, which were adjusted to form the final scale. Results: 1. A clinical outcome evaluation scale based on COPD patient reports was developed. The scale consists of four dimensions: physiological field, psychological field, social field and therapeutic field, in which the physiological field includes three aspects: specific symptom, systemic symptom, independence, anxiety and depression. The social domain includes disease cognition, the influence of disease on social activities, social support degree, and the treatment field includes compliance, side effects of drugs and satisfaction, which are 11 second-order dimensions. The data of 395 cases were analyzed. The results showed that the scale had good reliability, validity, response and clinical feasibility in evaluating patients with chronic obstructive pulmonary disease (COPD). Split-half reliability coefficient: physiological field 0.762, psychological field 0.865, social field 0.755, treatment field 0.862. the whole scale 0.757. Cronbach coefficient: physiological field 0.888, psychological field 0.898, social field 0.704, therapeutic field 0.696, whole scale 0.923. Conclusion: in accordance with FDA guidelines, we developed a clinical outcome evaluation scale based on chronic obstructive pulmonary disease (COPD) reports. The classical measurement method and item response theory were combined to evaluate the scale. The results showed that the scale had good reliability, validity, response and clinical feasibility, and could be used as a tool to evaluate the clinical efficacy of chronic obstructive pulmonary disease (COPD).
【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】：R563.9

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