在COVID-19随机对照试验中的复合终点:系统性审查
Pedro Nascimento Martins1,2, Mateus Henrique Toledo Lourenço1, Gabriel Paz Souza Mota1
1Federal University of Juiz de Fora, Juiz de Fora, Brazil.
Clinical trials (London, England)
|October 11, 2024
概括
在COVID-19试验中,复合终点是常见的,特别是在严重病例中. 他们的估计往往低估了死亡率,这表明在评估治疗有效性的潜在偏见.
科学领域:
- 临床试验方法论 临床试验方法论
- 流行病学 流行病学
- 生物统计学 生物统计学
背景情况:
- 在临床试验中经常使用复合终点来增加统计能力和效率.
- 在2019年冠状病毒病 (COVID-19) 试验中复合终点的使用和影响需要彻底调查.
研究的目的:
- 在COVID-19随机试验中确定不同类型的复合终点 (顺序,二进制,数值) 的患病率.
- 通过使用复合终点与单个关键组件 (如死亡率) 相比,评估使用组合终点引入的潜在偏差.
主要方法:
- 对随机临床试验的Cochrane COVID-19研究注册表进行系统审查.
- 综合终点的流行,特征和偏差的评估.
- 通过将复合结果与最关键的组件 (死亡) 进行比较,计算可归因于复合结果指数的偏差.
主要成果:
- 在417项COVID-19试验中的152项 (36%) 中,复合终点是主要终点,在高影响期刊和严重疾病试验中更为常见.
- 顺序终点 (54%) 是最常见的,通常是二分化的. 在复合组中,死亡率占事件中位数的24%.
- 可归因于复合结果的偏差指数通常低于1,表明复合估计可能低估了关键组件的影响.
结论:
- 复合终点在COVID-19试验中普遍存在,特别是在严重病例中,可能是由于死亡等预期的竞争事件.
- 虽然顺序复合材料很常见,但由于二分化,它们的全部潜力往往无法实现.
- 复合结果估计可能低估了死亡效应,因此需要仔细考虑和进一步审查较新的复合终点类型.
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