慢性鼻炎与鼻息肉 (CRSwNP) 症状口头反应量表:用于成人CRSwNP的内容有效性测试
Tom Keeley1, Nina Gaw2, Waseem Ahmed3
1Patient Centered Outcomes, GSK, London, UK. tom.x.keeley@gsk.com.
Journal of patient-reported outcomes
|December 20, 2024
概括
慢性鼻炎与鼻息肉 (CRSwNP) 的口头反应量表 (VRSs) 有效捕捉患者报告的症状和生活质量. 一个类别的改善被确定为这些CRSwNP症状措施的有意义的变化.
科学领域:
- 临床研究是临床研究.
- 患者报告的结果.
- 医疗器械评估 医疗器械评估
背景情况:
- 对于CRSwNP症状,传统的视觉和数值尺度可能比口头描述器对患者差异化效果不那么好.
- 口头反应量表 (VRS) 为患者提供了一种潜在的更容易获取的方法,以便在临床试验中报告症状严重程度.
研究的目的:
- 评估五个口头响应量表 (VRSs) 的内容有效性,用于慢性鼻炎与鼻 (CRSwNP) 的症状严重程度.
- 探索CRSwNP.患者感知到的有意义变化的初步见解.
主要方法:
- 在美国,德国和中国,对24名被诊断患有中度至重度CRSwNP的成年人进行了定性,半结构化的采访.
- 面试涉及关于CRSwNP经验的概念提醒和认知汇报,以评估VRS理解和相关性.
- 应用了主题分析来对面试成绩单进行定性分析.
主要成果:
- 报告的最常见的CRSwNP症状是鼻腔阻塞,鼻水,喉粘液,嗅觉丧失和面部疼痛/压力.
- 参与者表现出对VRS指令,项目,召回期和响应选项的深刻理解.
- 五个VRS项目对大多数参与者来说都是相关的,一个类别的个人改善最常被认为是有意义的.
结论:
- 评估的CRSwNP症状VRS通过评估中度至严重CRSwNP患者的相关和烦人的症状来证明内容有效性.
- 初步见解表明,一个类别的改进可能代表有意义的变化,尽管需要进一步的定量验证.
- 心理测量评估是必要的,以确认这些VRSs对于CRSwNP临床试验终点的适当性.
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