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Abstract Details

Activity Number: 281
Type: Topic Contributed
Date/Time: Tuesday, July 31, 2012 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract - #304380
Title: Comparison of Confidence Intervals and Operating Characteristics for Generalized Models of Standardized Incidence Rates
Author(s): John Evans*+ and Sarah Chiodi and Wen Ding and Vivek Pradhan
Companies: Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
Address: 68 Jackson Hill Rd., Gardner, MA, 01440, United States
Keywords: Recurrent events ; Generalized models ; Standardized incidence rates

Evans (2009) considered distribution of recurrent events as either Poisson or Negative Binomial, for 2 case studies, one involving a single device, and the other comparing two devices. Evans (2011) considered departures from these models' assumptions and compared goodness of fit of counts to these distributions with Generalized Poisson, Double Poisson, Zero-Inflated Poisson, Zero-Inflated Negative Binomial, Poisson Inverse Gaussian (PIG), Poisson Log Normal, and Generalized Negative Binomial. They computed CIs of mean counts of recurrent events, and CIs of standardized incidence rates (IR) per 100 patient years, to compare these models, and drew inferences from confidence intervals of mean count and IR differences for the 2-arm study. We will further compare models using simulated datasets from the 2 case studies to compute coverage, length, & location of the CIs. We will fit non-linear mixed models of correlated counts to allow event rate to vary with time. We will present simulation results to confirm the significant IR difference previously found with the best-fitting PIG model in the 2-arm study. We will perturb the means and variances to compute the type I & II errors.

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