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首页> 外文期刊>Prevention science: the official journal of the Society for Prevention Research >Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes
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Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes

机译:除了主要终点范式之外:艾滋病毒行为干预试验中的干预效果试验,具有许多相关结果

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摘要

Behavioral interventions are increasingly based on holistic approaches to health with an understanding that health-related behaviors are linked. A motivating example is provided by the Philani study, an intervention trial conducted to improve the health of South African mothers and their children. Inter-related health problems around maternal alcohol use, malnutrition, and HIV were addressed; multiple endpoints were targeted. The traditional hypothesis testing paradigm that tests significance on one primary outcome did not suffice. Past multiple endpoint studies have utilized a sign test on the number of estimated differences between treatment and control that favor the intervention. However, in order to preserve type 1 error, one must account for correlations among the outcomes. We propose an alternative approach that counts the number of significant treatment-control differences. Monte Carlo simulation is used to adjust for correlation, providing updated critical values and p values. Our method is implemented through an R package and applied to the Philani data to test the intervention's overall effect.
机译:行为干预越来越多地基于健康的整体方法,并理解与健康相关的行为是相互关联的。Philani研究提供了一个令人振奋的例子,这是一项旨在改善南非母亲及其子女健康的干预试验。解决了与产妇饮酒、营养不良和艾滋病毒相关的健康问题;针对多个终点。传统的假设检验范式对一个主要结果进行显著性检验是不够的。过去的多终点研究对治疗组和对照组之间有利于干预的估计差异的数量进行了符号检验。然而,为了保留1型错误,必须考虑结果之间的相关性。我们提出了一种计算显著治疗控制差异数量的替代方法。蒙特卡罗模拟用于调整相关性,提供更新的临界值和p值。我们的方法通过R软件包实现,并应用于Philani数据,以测试干预的总体效果。

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