患者报告的异常性肺纤维化结果尺度:在中国的开发和验证
Yang Xie1,2, Peng Zhang1,3, Jiaming Ren1,3
1Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, China.
已经开发出一种新的患者报告的异常性肺纤维化 (IPF-PRO) 结果表. 这种18项尺度表现出强大的可靠性和有效性,使其适用于IPF的临床试验.
科学领域:
- 肺部医学 肺部医学
- 临床试验方法论 临床试验方法论
- 患者报告的结果
背景情况:
- 异形性肺纤维化 (IPF) 需要对临床试验进行可靠的结果测量.
- 现有的措施可能无法完全捕捉IPF患者的体验.
研究的目的:
- 开发和验证异形性肺纤维化患者报告结果 (IPF-PRO) 尺度.
- 为IPF临床试验建立一个科学合理的措施.
主要方法:
- 文献审查,专家/患者采访和小组讨论为规模发展提供了信息.
- 经典的测试理论和项目响应理论 (IRT) 通过实地调查指导项目选择.
- 一个正式的调查评估了最终的18项IPF-PRO的测量特性.
主要成果:
- IPF-PRO包括四个领域的18个项目:生理学,心理学,环境和满意度.
- 证实了卓越的可靠性 (克朗巴赫的α = 0.917,概括系数 = 0.931) 和有效性 (内容,结构,标准,区分).
- 该尺度显示了高响应率 (100%) 和完成率 (100%),完成时间中位数为7分钟.
结论:
- 18项IPF-PRO是可靠和有效的患者报告结果指标.
- IPF-PRO适合用于调查异常性肺纤维化症的临床试验.
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