全球心力衰竭流行病学与关键试验的招生:一个巨大的不匹配
Guillaume Baudry1,2, Guowei Li3, Ruoting Wang3
1Université de Lorraine, INSERM, Centre d'Investigation Clinique Plurithématique 1433, Inserm U1116, CHRU de Nancy and F-CRIN INI-CRCT, Nancy, France.
European journal of heart failure
|May 28, 2025
概括
在关键心力衰竭 (HF) 临床试验中的地理代表性是倾斜的. 试验过度代表欧洲和北美,而亚洲和非洲则严重不足,影响了指南的适用性.
科学领域:
- 心脏病学 心脏病学
- 临床试验 临床试验
- 健康 公平 卫生 公平
背景情况:
- 国际临床实践指南依赖于随机临床试验 (RCT) 来告知患者护理.
- 在关键的RCT中充分的地理代表性至关重要,以确保指南在不同人群中的适用性.
- 心力衰竭 (HF) 是一个全球性的健康负担,不成比例地影响某些地区.
研究的目的:
- 评估国际指导方针形成的关键第3阶段高频电流RCT的地理代表性.
- 将HF病例的分布与参与者在关键HF试验中的地理入学情况进行比较.
- 评估两个衡量地理代表性的指标:代表性指数 (RI) 和参与者与流行率 (PPR).
主要方法:
- 2021年全球HF流行数据来自全球疾病负担数据集.
- 使用RI (区域试验地点与疾病分布) 和PPR (区域参与者与疾病分布) 评估了关键HFRCT的地理代表性.
- 分析重点是影响国际高频指南的第三阶段RCT.
主要成果:
- 2021年,亚洲占全球HF负担的50%,其次是欧洲 (18%),非洲 (14%),北美 (10%),中南美洲 (8%).
- 欧洲 (RI: 2.41,PPR: 2.69) 和北美 (RI: 3.25,PPR: 2.58) 在关键HF试验中过度代表.
- 亚洲 (RI:0.26,PPR:0.22) 和非洲 (RI:0.14,PPR:0.05) 显著代表性不足,而中美洲和南美洲 (RI:1.29,PPR:1.59) 代表性充足.
结论:
- 关键高频RCT主要从欧洲和北美产生证据,导致非洲和亚洲的代表性严重不足.
- 无论是RI还是PPR,都表明区域参与者招生和区域内的试验地点数量之间存在强烈的相关性.
- 在试验设计过程中,RI指标为试验规划提供了优势,可以进行主动调整,以提高试验设计过程中的区域代表性.
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