试验中的并发症与社区之间的相关性:个体级参与者数据元分析
Jamie Crowther1, Elaine W Butterly1, Laurie J Hannigan2,3,4
1School of Health and Wellbeing, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.
Journal of multimorbidity and comorbidity
|November 13, 2023
概括
临床试验中的并发症模式在很大程度上反映了社区中的情况,即使在试验中并发症较少. 这表明,试验数据可以为现实世界并发症研究提供信息.
科学领域:
- 临床流行病学临床流行病学
- 生物统计学 生物统计学
- 医疗保健服务研究 医疗服务研究
背景情况:
- 在随机对照试验 (RCT) 中,并发症的代表性较低.
- 目前尚不清楚试验中的并发症模式是否反映了一般人群中的并发症模式.
研究的目的:
- 为了比较临床试验和社区数据之间的并发症模式.
- 评估在试验中观察到的并发症相关性的概括性.
主要方法:
- 分析了来自83个RCT (54,688名参与者) 的个人参与者数据和社区数据 (860,177人).
- 在使用并发性药物时发现了并发性疾病.
- 贝叶斯的多变量探针模型被用来估计六种最常见的共同疾病之间的对对应关系,调整年龄和性别.
主要成果:
- 试验和社区之间的并发症相关性在很大程度上是相似的 (68%相似,在社区中21%更强,在试验中10%更强).
- 虽然该社区共患病的患病率较高,但它们之间的相关性强度和方向与试验数据有相当大的重叠.
- 具体的相关性模式有所不同,试验显示更多的零相关性,社区显示更多的积极相关性.
结论:
- 同病相关性在临床试验和社区环境之间通常是一致的.
- 这些发现支持使用临床试验数据来报告相关疾病特异性发现,但对患病率差异有警告.
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