心血管疾病患者在重症监护随机对照试验中的代表性不足和排除
Tariq N Ali1, Alyssa A Grimshaw2, Alexander Thomas1
1Section of Cardiovascular Medicine, Yale School of Medicine, New Haven, CT 06517, USA.
European heart journal. Acute cardiovascular care
|February 14, 2025
概括
患有心血管疾病 (CVD) 的患者经常被排除在重症监护随机对照试验 (RCT) 中. 这种代表性不足限制了重症监护研究结果对这个复杂的患者群体的适用性.
科学领域:
- 关键护理医学 关键护理医学
- 心血管疾病研究研究
- 临床试验设计 临床试验设计
背景情况:
- 心脏重症监护室 (ICU) 管理着越来越多的患有复杂,非心脏相关疾病的患者.
- 患有心血管疾病 (CVD) 的患者在重症监护随机对照试验 (RCT) 中往往代表不足.
研究的目的:
- 在重症监护试验中量化心脏病并发症代表性的程度.
- 确定影响这些试验中心脏病患者排除和代表性不足的因素.
主要方法:
- 从2007年至2019年对重症监护,内科和心血管疾病的高影响因素期刊进行系统搜索.
- 在成年人ICU环境中包括未来的RCT,至少有50名参与者.
- 两位独立审稿人对研究特征,心血管疾病患病率和心血管疾病排除标准的提取.
- 多变量后勤回归用于识别排斥和代表性的预测因素.
主要成果:
- 对412个符合条件的RCT的分析显示,32.0%包括特定的CVD排除标准.
- 心力衰竭 (29.5%) 和缺血性心脏病 (26.5%) 是最常见的排除.
- 只有36.4%的RCT报告了任何心血管疾病史,心血管疾病的平均患病率为15.7%.
结论:
- 并发性心血管疾病是经常被排除在重症监护RCT之外的原因.
- 在重症监护试验中心血管疾病患者的代表性不足限制了研究结果的概括性.
- 需要制定战略,以改善将复杂心血管患者纳入临床研究的情况.
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