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Activity Number:
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279
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Type:
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Contributed
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Date/Time:
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Wednesday, August 14, 2002 : 8:30 AM to 10:20 AM
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Sponsor:
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Section on Statistics in Epidemiology*
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| Abstract - #300829 |
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Title:
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Estimation of the Intervention Effect in a Nonrandomized Study with a Mismeasured Binary Response
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Author(s):
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Hung-Mo Lin*+ and Robert Lyles and John Williamson and Allen Kunselman
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Affiliation(s):
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Pennsylvania State University and Rollins School of Public Health of Emory University and Centers for Disease Control and Prevention and Pennsylvania State University
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Address:
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600 Centerview Dr., Hershey, Pennsylvania, 17033, USA
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Keywords:
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Binary response ; Intervention effect ; Misclassification ; Regression effec ; Validation study
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Abstract:
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In nonrandomized clinical studies, the regression phenomenon can confound interpretation of the effectiveness of an intervention. The regression effect arises due to daily variation and/or misclassification of the biologic marker used in selection, as well as in the assessment of the intervention effect. Here we focus on analyzing the change-in-event probability resulting from the implementation of an intervention among a selected group when the event of interest is a binary response. The selection is such that an intervention will be introduced to a subject if his/her response at screening tested positive. We propose methods for estimating the intervention effect while adjusting for the regression effect. We extend this approach to estimation of the placebo effect, as well as the intervention effect in placebo-controlled studies. Analyses of two biomedical studies are used for illustration.
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