炎症性肠道疾病的核心成果集:通过国际多利益相关者共识进程在临床实践中实施开发和建议
Liselotte Fierens1, Nicholas Carney2, Gottfried Novacek3
1Department of Chronic Diseases and Metabolism, KU Leuven, Leuven, Belgium.
Journal of Crohn's & colitis
|November 29, 2023
概括
通过使用修改的Delphi方法确定了炎症性肠病 (IBD) 的核心结局. 这种标准化的测量方法旨在改善IBD管理的护理和研究.
科学领域:
- 胃肠病学和临床研究
- 健康结果 测量 测量
- 患者报告的结果
背景情况:
- 标准化健康结果测量对于改善医疗服务和实现数据驱动学习系统至关重要.
- 卫生结果观测站 (H2O) 倡议旨在建立强大的数据系统,用于研究和二次数据使用.
- 利用现有知识,定义了炎症性肠病 (IBD) 的核心结果集 (COS).
研究的目的:
- 通过国际修改的Delphi方法,通过国际修改的Delphi方法来定义基于共识的炎症性肠病 (IBD) 的核心结果集 (COS).
- 建立炎症性肠病 (IBD) 的标准化测量方法,以支持临床实践和研究.
- 推特定的测量工具来收集IBD护理中患者报告的结果 (PRO).
主要方法:
- 一个国际修改的Delphi方法涉及136个利益相关者,包括来自20个国家的患者,医疗保健专业人员和监管机构.
- 利益相关者对90个变量进行了两次评分,分别以9分的重要性级别进行评分,反影响了后续的评分.
- 举行了共识会议,讨论结果,并包括满足特定共识标准的变量 (≥80%的协议或会议协议).
主要成果:
- 定义了IBD的最终核心结果集 (COS),包括18个案例组变量,3个生物标志物 (血红蛋白,C反应蛋白,便calprotectin) 和28个结果.
- 该组包括16个患者报告的结果 (PRO) 和一个患者报告的经验指标.
- 具体的问卷 (PRO-2,IBD-Control,PROMIS全球健康等等) 提供了更多信息. 建议用于收集疾病特异性和通用PROs.
结论:
- 对炎症性肠道疾病 (IBD) 定义了一个核心结果集 (COS),并提出了临床实践实施的建议.
- 最初的实施地点包括维也纳,柏林,巴塞罗那,卢温和鹿特丹,计划进行全球扩张.
- 该COS旨在赋予患者管理IBD护理的能力,并改善整体疾病管理.
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