专家对下一代健康指南的观点:如何将RWE整合到EBM中
Stefano Del Giacco1, Giorgio Walter Canonica2, Ioana Agache3
1Department of Medical Sciences and Public Health, University of Cagliari, Monserrato, Cagliari, Italy.
Pragmatic and observational research
|September 18, 2025
概括
将现实世界的证据 (RWE) 整合到基于证据的医学 (EBM) 中,可以改善医疗保健决策. 这次研讨会的重点是为在呼吸道疾病研究中制定高质量的RWE建议.
科学领域:
- 医疗保健服务研究 医疗服务研究
- 临床流行病学临床流行病学
- 药物经济学 药物经济学
背景情况:
- 基于证据的医学 (EBM) 依赖于对证据的严格评估,包括临床试验和现实世界的证据 (RWE).
- RWE提供了对治疗有效性和安全性的见解,补充了随机对照试验 (RCT) 的数据.
- 临床试验数据的缺口需要将RWE整合到全面的医疗保健决策中.
研究的目的:
- 为产生高质量的RWE制定建议.
- 引导将RWE纳入用于医疗保健决策的证据综合.
- 专注于RWE和EBM在呼吸道疾病中的应用.
主要方法:
- 在第二届EAACI/REG研讨会上进行讨论和达成共识.
- 确定将RWE整合到EBM中的关键主题.
- 专注于制定行动计划,共享研究结果并建立质量基准.
主要成果:
- 承认需要一个行动计划来传播关于RWE整合的发现.
- 强调仔细考虑将非随机干预研究 (NRSI) 与RCT一起纳入.
- 强调患者协作,教育倡议和标准化数据质量基准的重要性.
结论:
- 涉及患者,临床医生和监管机构的协作方法对于RWE有意义的整合至关重要.
- 为确保RWE的有效性和准确性,对注册表的标准化协议和质量标准至关重要.
- 制定术语词典和设定质量值将提高EBM中RWE的理解和可靠性.
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