在扩散性皮肤系统性硬化症中,医生评估和复合反应指数之间的协议
Boyang Zheng1, Mianbo Wang2, Kerry McKenna2
1McGill University, Jewish General Hospital, Montreal, Quebec, Canada.
Arthritis care & research
|April 25, 2024
概括
扩散性皮肤系统性硬化症 (CRISS) 的综合反应指数显示与临床试验中的医生评估有很大一致. 这证实了CRISS作为扩散皮肤SSc患者改善的可靠结果指标.
科学领域:
- 类风湿病学 类风湿病学
- 临床试验 临床试验
- 系统性硬化症研究研究
背景情况:
- 扩散性皮肤全身性硬化症 (SSc) 是一种复杂且高度可变的自身免疫性疾病.
- 分散皮肤SSc的复合反应指数 (CRISS) 是临床试验的临时1年结果指标.
- 需要对CRISS进行进一步的验证,以确认其在评估治疗疗效方面的可靠性.
研究的目的:
- 通过将其改进标准与专家医生评估进行比较,验证分散皮肤SSc (CRISS) 的复合反应指数.
- 评估CRISS截止分数和医生确定的结果之间的一致性在患有分散皮肤SSc.的患者中.
主要方法:
- 分析了100名扩散皮肤SSc患者 (50名通过CRISS得到改善,50名没有得到改善) 的患者个人资料,疾病持续时间<5年.
- 三位专家医生独立评估每个患者在基线和1年后的疾病状况.
- 使用卡帕统计数据计算了医生多数意见和0.6.6的CRISS截止值之间的一致性.
主要成果:
- 在CRISS和医生多数意见 (κ = 0.76) 之间发现了实质性的一致性.
- 个人医生对CRISS的同意也很大 (κ = 0.70).
- 虽然所有的CRISS非增强剂被医生认为没有改善,12种CRISS增强剂被医生归类为没有改善.
结论:
- 0.6的CRISS截止值显示了与医生评估评估扩散皮肤SSc.改善的实质性一致.
- 克里斯 (CRISS) 是一种验证的临床试验结果指标,用于扩散皮肤SSc的临床试验.
- 与CRISS相比,医生评估发现改善的患者较少,这表明灵敏度的潜在差异.
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