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Abstract Details
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Activity Number:
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488
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Type:
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Invited
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Date/Time:
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Wednesday, August 3, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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IMS
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| Abstract - #300546 |
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Title:
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Performance of a Comparative New User Design for Drug Safety Signal Detection
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Author(s):
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Maurice Alan Brookhart*+
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Companies:
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The University of North Carolina at Chapel Hill
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Address:
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Department of Epidemiology, Chapel Hill, NC, 27514, USA
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Keywords:
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Abstract:
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We describe a general approach for detecting drug safety signals in large administrative databases based on a comparative new user design combined with propensity score (PS) methods to adjust for confounding by baseline covariates. We propose and empirically compare various drug safety signal detection assays based on different implementations of this general approach. The implementations vary in how the cohort is defined (cohort entry occurring at first use versus a run-in period); how the PS is specified (i.e., what covariates are included); whether the PS is truncated to eliminate non-overlap; and how follow-up and censoring are handled. We then discuss the performance of this approach across a range of known or strongly suspected drug-outcome relations or non-relations.
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