Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes

Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral... 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. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Prevention Science Springer Journals

Beyond the Primary Endpoint Paradigm: A Test of Intervention Effect in HIV Behavioral Intervention Trials with Numerous Correlated Outcomes

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Publisher
Springer US
Copyright
Copyright © 2017 by Society for Prevention Research
Subject
Medicine & Public Health; Public Health; Health Psychology; Child and School Psychology
ISSN
1389-4986
eISSN
1573-6695
D.O.I.
10.1007/s11121-017-0788-y
Publisher site
See Article on Publisher Site

Abstract

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.

Journal

Prevention ScienceSpringer Journals

Published: Apr 22, 2017

References

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