分析带有二级干预措施的随机试验中的直接效应：在艾滋病预防试验中的应用
Analyzing Direct Effects in Randomized Trials with Secondary Interventions: An Application to HIV Prevention Trials.
作者信息
Rosenblum Michael, Jewell Nicholas P, van der Laan Mark, Shiboski Steve, van der Straten Ariane, Padian Nancy
机构信息
University of California, Berkeley, USA.
出版信息
J R Stat Soc Ser A Stat Soc. 2009 Apr;172(2):443-465. doi: 10.1111/j.1467-985X.2009.00585.x.
The Methods for Improving Reproductive Health in Africa (MIRA) trial is a recently completed randomized trial that investigated the effect of diaphragm and lubricant gel use in reducing HIV infection among susceptible women. 5,045 women were randomly assigned to either the active treatment arm or not. Additionally, all subjects in both arms received intensive condom counselling and provision, the "gold standard" HIV prevention barrier method. There was much lower reported condom use in the intervention arm than in the control arm, making it difficult to answer important public health questions based solely on the intention-to-treat analysis. We adapt an analysis technique from causal inference to estimate the "direct effects" of assignment to the diaphragm arm, adjusting for condom use in an appropriate sense. Issues raised in the MIRA trial apply to other trials of HIV prevention methods, some of which are currently being conducted or designed.
非洲改善生殖健康方法（MIRA）试验是一项近期完成的随机试验，该试验研究了使用子宫帽和润滑剂凝胶在降低易感女性感染艾滋病毒方面的效果。5045名女性被随机分配至积极治疗组或非积极治疗组。此外，两组的所有受试者均接受了强化的避孕套咨询与发放，这是预防艾滋病毒的“黄金标准”屏障方法。据报告，干预组的避孕套使用率远低于对照组，这使得仅基于意向性分析难以回答重要的公共卫生问题。我们采用因果推断中的一种分析技术来估计分配至子宫帽组的“直接效应”，并在适当意义上对避孕套使用情况进行调整。MIRA试验中提出的问题适用于其他艾滋病毒预防方法试验，其中一些试验目前正在进行或正在设计中。
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