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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：行为干预越来越基于健康的整体方法，了解与健康相关的行为相关联。菲尔迪研究提供了一个激励例子，进行了一个干预审判，以改善南非母亲及其子女的健康。母亲酒精使用的与相关的健康问题，营养不良和艾滋病病毒杂志进行了解决;针对多个端点。传统的假设检测范式，测试对一个主要结果的意义并不足够。过去的多个终点研究已经利用了对有利于干预的治疗和控制之间的估计差异的次数。但是，为了保留1型错误，必须考虑结果中的相关性。我们提出了一种替代方法，可以计算重大治疗控制差异的数量。 Monte Carlo仿真用于调整相关性，提供更新的临界值和P值。我们的方法是通过R包实现的，并应用于Philani数据以测试干预的整体效果。

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