验证了新型乙酸性食道炎影响调查问卷
Eilish McCann1, Mirna Chehade2, Jonathan M Spergel3
1Regeneron Pharmaceuticals, Tarrytown, NY, USA. eilish.mccann@regeneron.com.
Journal of patient-reported outcomes
|November 27, 2023
概括
乙性食道炎影响问卷 (EoE-IQ) 是衡量乙性食道炎 (EoE) 患者健康相关生活质量的可靠工具. 0.6分的得分降低表明EoE患者的临床上有意义的改善.
科学领域:
- 胃肠病学 胃肠病学
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 性食道炎 (EoE) 显著影响与健康相关的生活质量 (HRQOL).
- 性食管炎影响问卷 (EoE-IQ) 是一种新的患者报告结果 (PRO) 测量方法,旨在评估EoE患者的HRQOL.
- 评估EoE-IQ的测量特性对于其临床实用性至关重要.
研究的目的:
- 评估EoE-IQ的测量特性,包括可靠性,有效性和检测变化的能力.
- 为EoE-IQ分数建立一个临床上有意义的变化值.
主要方法:
- 利用了dupilumab的第三阶段,随机,安慰剂对照试验 (NCT03633617) 的数据.
- 评估了可靠性,构造有效性,已知组有效性,以及使用基线和24周数据对239名患有EoE的成人和青少年的变化反应.
- 确定了EoE-IQ平均得分的临床重要差异最小值.
主要成果:
- EoE-IQ表现出可接受的可靠性 (ICC 0.75-0.81) 和构造有效性 (与其他PRO有中等到强烈的相关性).
- 实际上,EoE-IQ对具有不同EoE严重程度的患者群体进行了有效的歧视.
- 在EoE-IQ平均得分下降≥0.6分被认为具有临床意义.
结论:
- "EoE-IQ"是一个有效可靠的PRO衡量标准,用于评估成人和青少年EoE患者的HRQOL影响.
- 确定的最小临床重要差异为解释治疗对HRQOL的影响提供了基准.
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