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首页> 外文期刊>Chest: The Journal of Circulation, Respiration and Related Systems >A preliminary quality of life questionnaire-bronchiectasis: A patient-reported outcome measure for bronchiectasis
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A preliminary quality of life questionnaire-bronchiectasis: A patient-reported outcome measure for bronchiectasis

机译：生活质量初步调查表-支气管扩张：病人报告的支气管扩张结局指标

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BACKGROUND: The Quality of Life Questionnaire-Bronchiectasis (QOL-B) is the first diseasespecific, patient-reported outcome measure for patients with bronchiectasis. Content validity, cognitive testing, responsivity to open-label treatment, and psychometric analyses are presented. METHODS: Reviews of literature, existing measures, and physician input were used to generate the initial QOL-B. Modifications following preliminary cognitive testing (N 5 35 patients with bronchiectasis) generated version (V) 1.0. An open-ended patient interview study (N 5 28) provided additional information and was content analyzed to derive saturation matrices, which summarized all disease-related topics mentioned by each participant. This resulted in QOL-B V2.0. Psychometric analyses were carried out using results from an open-label phase 2 trial, in which 89 patients were enrolled and treated with aztreonam for inhalation solution. Responsivity to open-label treatment was observed. Additional analyses generated QOL-B V3.0, with 37 items on eight scales: respiratory symptoms; physical, role, emotional, and social functioning; vitality; health perceptions; and treatment burden. For each scale, scores are standardized on a 0-to-100-point scale; higher scores indicate better health-related quality of life. No total score is calculated. A final cognitive testing study (N 5 40) resulted in a minor change to one social functioning scale item (QOL-B V3.1). RESULTS: Content validity, cognitive testing, responsivity to open-label treatment, and initial psychometric analyses supported QOL-B items and structure. CONCLUSIONS: This interim QOL-B is a promising tool for evaluating the efficacy of new therapies for patients with bronchiectasis and for measuring symptoms, functioning, and quality of life in these patients on a routine basis. A final psychometric validation study is needed and is forthcoming. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT00805025; URL: www.clinicaltrials.gov
机译：背景：支气管扩张症患者生活质量调查表（QOL-B）是针对支气管扩张症患者的第一种疾病特异性，患者报告的结局指标。介绍了内容的有效性，认知测试，对开放标签治疗的反应性以及心理分析。方法：文献，现有措施和医师意见的回顾被用于产生初始QOL-B。初步认知测试（N 5 35支气管扩张患者）后的修改产生版本（V）1.0。一项开放式患者访谈研究（N 5 28）提供了更多信息，并对内容进行了分析以得出饱和度矩阵，该矩阵总结了每个参与者提到的所有与疾病相关的主题。这产生了QOL-B V2.0。使用开放标签的2期试验的结果进行了心理分析，该试验招募了89名患者，并用氨曲南吸入溶液治疗。观察到对开放标签处理的反应。附加分析生成了QOL-B V3.0，共有8个级别的37个项目：呼吸道症状;身体，角色，情感和社会功能;活力;健康观念;和治疗负担。对于每个量表，分数均以0到100分制为标准;分数越高表明与健康相关的生活质量越好。没有计算总分。一项最终的认知测验研究（N 5 40）对一个社交功能量表项目（QOL-B V3.1）进行了微小改动。结果：内容有效性，认知测试，对开放标签治疗的反应性以及初步的心理分析支持了QOL-B的项目和结构。结论：该中期QOL-B是评估新疗法对支气管扩张患者的疗效以及常规评估这些患者的症状，功能和生活质量的有前途的工具。需要进行最终的心理计量学验证研究，并且即将进行。试用注册：ClinicalTrials.gov;编号：NCT00805025;网址：www.clinicaltrials.gov

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