开发和外部验证一个内镜和组织学炎评估工具:大西洋炎指数
Rocio Sedano1, Christopher Ma2, Malcolm Hogan3
1Division of Gastroenterology, Department of Medicine, Western University, London, Ontario, Canada; Alimentiv Inc, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
概括
一个新的指数,大西洋炎指数 (API),被开发和验证,以准确测量炎疾病活动. 这种可靠和快速响应的工具结合了内镜和组织学发现,以更好地评估毛囊炎患者的治疗.
科学领域:
- 胃肠病学 胃肠病学
- 炎症性肠道疾病研究研究
- 临床试验方法论 临床试验方法论
背景情况:
- 目前用于测量囊炎活动的指数缺乏充分的验证.
- 需要一种可靠且快速响应的工具来评估炎疾病的活性.
研究的目的:
- 开发和外部验证一种用于测量囊炎疾病活性的新型指数.
- 将内镜和组织学发现整合到一个单一的,全面的索引中.
主要方法:
- 一个新的指数,大西洋炎指数 (API),是使用线性回归来开发的.
- 使用98名患者的数据,评估了API的可靠性 (类内相关系数) 和响应能力 (接收器操作特征曲线下的面积).
- 外部验证使用来自EARNEST vedolizumab试验的数据进行.
主要成果:
- 该API结合了克罗恩病的简单内镜评分和罗巴茨组织病理学指数.
- 该API表现出优异的内部评审者 (ICC,0.88) 和实质性的评审者之间的可靠性 (ICC,0.72).
- 该API显示出高响应性 (AUROC,0.95) 和优于现有的内镜指数.
结论:
- 大西洋口腔炎指数 (API) 的开发和验证代表了口腔炎疾病评估的重大进展.
- API提供了一个客观,可靠和响应的工具来评估治疗的有效性.
- 该指数可以在研究和临床环境中用于改善患者管理.
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