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Activity Number:
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376
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Type:
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Contributed
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Date/Time:
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Wednesday, August 1, 2007 : 8:30 AM to 10:20 AM
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Sponsor:
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Biometrics Section
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| Abstract - #308785 |
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Title:
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Analysis of Binary and Continuous Outcomes in Neonatal Clinical Trials with Twin Births
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Author(s):
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Michele Shaffer*+ and Kristi L. Watterberg and Allen Kunselman
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Companies:
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The Pennsylvania State University and University of New Mexico and The Pennsylvania State University
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Address:
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600 Centerview Drive, College of Medicine, Hershey, PA, 17033,
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Keywords:
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Correlated data ; mixed-effects models ; generalized estimating equations
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Abstract:
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In neonatal trials of pre-term or low-birth-weight infants twins may represent 10-20% of the study sample. Mixed-effects models and generalized estimating equations are common approaches for handling correlated binary or continuous data. However, the operating characteristics of these methods for mixes of correlated and independent data are not well established. Simulation studies are conducted to compare mixed-effects models and generalized estimating equations to linear regression for continuous outcomes and logistic regression for binary outcomes to estimate the treatment effect in two-armed clinical trials. Additionally, the ability to estimate the magnitude of within-birth correlation for twins is examined for the correlated data methods. Data from the National Institute of Child Health & Human Development Neonatal Research Network are used for illustration.
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