开发和验证一种新型的内镜活动评分用于评估克罗恩病 (EASE-CD),使用来自两个随机对照试验的数据
Christopher Ma1, Reena Khanna2, Bryan R Maguire3
1Division of Gastroenterology & Hepatology, Department of Medicine, Cumming School of Medicine, University of Calgary, Calgary, AL, Canada; Department of Community Health Sciences, University of Calgary, Calgary, AL, Canada; Alimentiv, London, ON, Canada.
一个新的内镜指数,EASE-CD,准确地测量克罗恩病的活动. 这种经过验证的工具可靠地评估的活性,改善了克罗恩病患者的内镜评估.
科学领域:
- 胃肠病学 胃肠病学
- 内镜检查的评估.
- 炎症性肠病是一种炎症性肠病.
背景情况:
- 目前对克罗恩病 (CD) 的内镜指数与临床活动的相关性有限,并存在可靠性问题.
- 需要一个经过验证的内镜指数,有明确的定义和可靠的值来评估CD活性.
研究的目的:
- 开发和验证一种新的内镜指数,用于测量克罗恩病中的光线疾病活性.
主要方法:
- 来自阿达利穆马布和瑞桑基祖马布试验的配对结肠直肠镜视频被中央阅读器评估.
- 候选内镜项目是根据评审者之间的可靠性 (ICC ≥0·41) 和响应性 (WinP ≥0·56) 进行选择的.
- 为内部验证建立了一个回归模型,并使用来自risankizumab试验的数据进行外部验证.
主要成果:
- 开发了新的评估CD的内镜活动评分 (EASE-CD),结合了的存在,大小,深度和受影响表面积的比例.
- EASE-CD表现出强大的内部验证 (调整r2=0·554) 和外部验证 (调整r2=0·565).
- 该指数显示了实质性的评价者间可靠性 (ICC 0·798) 和响应性 (WinP 0·769),减少了10个点,表明内镜反应具有82.4%的特异性.
结论:
- EASE-CD是一种新的,经过验证的,在克罗恩病中对内镜活动的持续测量方法.
- 该指数是可靠的,对治疗有反应,提供了更好的内镜评估.
- 与现有的指数相比,EASE-CD提供了更准确的疾病活动评估.
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