估计皮肤疼痛数值评分表,睡眠数值评分表和皮肤病生活质量指数的有意义变化值在结患者中
S Stander1, B S Kim2, I Guillemin3
1University Clinic Münster, Münster, Germany.
概括
新的门有助于解释患者报告的prurigo nodularis (PN) 的结果. 这些发现有助于在临床试验和实践中了解PN相关的皮肤疼痛,睡眠质量和生活质量.
科学领域:
- 皮肤病学 皮肤病学
- 临床试验 临床试验
- 患者报告的结果
背景情况:
- 结 (PN) 引起显著的皮肤疼痛并影响生活质量.
- 患者报告结果 (PRO) 仪器,如皮肤疼痛-NRS,睡眠-NRS和DLQI对于评估治疗益处至关重要.
- 在PN患者中,对于这些PROs没有确立的解释指南.
研究的目的:
- 在PN中导出皮肤疼痛-NRS,睡眠-NRS和DLQI的患者内部 (响应者) 和组间改善值.
- 评估这些PRO仪器在PN患者中的测量特性.
主要方法:
- 使用了来自Dupilumab第3期研究 (PRIME和PRIME2) 的聚合的治疗意图数据.
- 应用了基于和分布的方法来确定解释值.
- 评估了PRO的可靠性,有效性和响应能力.
主要成果:
- 患者内部门:皮肤疼痛-NRS为4.0,睡眠-NRS为2.0,DLQI为9.0.
- 两组之间的值:皮肤疼痛-NRS为1.5,睡眠-NRS为1.0,DLQI为4.0.
- 这三种PRO均表现出足够到良好的心理测量特性.
结论:
- 确定的值有助于在PN临床试验和实践中解释PRO得分.
- 这些发现改善了对PN相关症状及其对患者生活的影响的理解和管理.
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