在现实世界的证据研究中确定克罗恩病的多重结果集:来自Delphi电子调查的结果
Paula Leão Moreira1, Axel Dignass2, Maria Manuela Estevinho3,4
1Department of Clinical Pharmacology, Unidade Local de Saúde São João, Porto, Portugal.
Journal of Crohn's & colitis
|November 9, 2025
概括
这项研究确定了克罗恩病现实世界证据研究的关键结果. 标准化结果选择提高了克罗恩病 (CD) 研究的一致性.
科学领域:
- 胃肠病学 胃肠病学
- 临床研究方法论 临床研究方法论
- 炎症性肠病 (IBD) 是一种炎症性肠病.
背景情况:
- 随机对照试验 (RCT) 提供了高质量的证据,但往往缺乏现实世界的概括性.
- 现实世界证据 (RWE) 研究解决了这一差距,但设计和结果异质性限制了克罗恩病 (CD) 的标准化.
研究的目的:
- 建立一个标准化的框架,在克罗恩病 (CD) 的现实世界证据 (RWE) 研究中选择最相关的结果.
主要方法:
- 一个由炎症性肠病 (IBD) 专家组成的国际小组使用了两轮的Delphi电子调查和RAND/UCLA适当性方法.
- 专家评估了八个领域的结果,包括疾病活性,患者报告的结果和安全性.
- 使用不同意指数 (DI) 确定协议,加权评分优先考虑关键结果.
主要成果:
- 在两轮德尔菲会议中,高专家达成共识,没有分歧 (DI < 1).
- 排名第一的结局包括或,内镜缓解,无皮质类固醇临床缓解,疾病进展和结肠直肠癌.
- 前四个结合的结果占专家选择的57.8%,突出显示了它们对CD RWE研究的重要性.
结论:
- 这项由专家驱动的Delphi研究成功开发了一种标准化框架,用于克罗恩氏病RWE研究中的结果选择.
- 拟议的框架提高了CD中未来的真实世界研究的一致性和可比性.
- 实施这一框架将提高现实世界的证据在管理克罗恩病的质量和实用性.
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