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积极控制随机试验的解释:一个新的分析视角的案例,涉及到避免事件

David T Dunn^1,2, Oliver T Stirrup³, Sheena McCormack⁴

¹Institute for Global Health, University College London, London, UK. d.dunn@ucl.ac.uk.

BMC medical research methodology

|June 26, 2023

概括

主动对照试验对实验性治疗提出了解释挑战. 考虑避免的事件,而不仅仅是观察到的事件,对于准确的评估至关重要,特别是有效的控制.

科学领域:

临床试验方法论临床试验方法论
生物统计学生物统计学
流行病学流行病学

背景情况:

主动对照试验比较实验性治疗与既定治疗,当安慰剂不道德时.
时间到事件的结果通常使用速率比率或危险比率来分析.

研究的目的:

要突出解释问题与率比率在积极控制试验.
提出并举例说明"避免事件比率"以进行更全面的评估.

主要方法:

使用COVID-19疫苗和HIV暴露前预防试验的比率解释问题的分析.
引入了"避免事件比率"指标.
讨论估计避免事件比率 (反事实发生率或控制有效性) 所需的假设.

主要成果:

比率比率可以误导地表明有价值的实验性治疗的劣势,而对照疗法是非常有效的.
建议的避免事件比率提供了一个概念上有吸引力的解释:实验治疗与对照治疗避免的事件的比例.

结论:

准确解释活体对照试验需要考虑观察到的事件以及避免的事件.
尽管存在估计挑战,但避免事件比率为公共卫生决策提供了更合理的推断.
这一指标在艾滋病毒预防之外,也广泛适用于各种治疗试验.

关键词:

活动控制控制器.避免了避免了这是一个估计和估计.没有劣势的不劣势.相对的疗效相对的疗效

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