Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 25, Issue 5, Pages 1100-1113Publisher
TAYLOR & FRANCIS INC
DOI: 10.1080/10543406.2014.971167
Keywords
Negative binomial; Overdispersion; Power and sample size; Quasi-Poisson regression; Recurrent events
Categories
Ask authors/readers for more resources
A sample size formula is derived for negative binomial regression for the analysis of recurrent events, in which subjects can have unequal follow-up time. We obtain sharp lower and upper bounds on the required size, which is easy to compute. The upper bound is generally only slightly larger than the required size, and hence can be used to approximate the sample size. The lower and upper size bounds can be decomposed into two terms. The first term relies on the mean number of events in each group, and the second term depends on two factors that measure, respectively, the extent of between-subject variability in event rates, and follow-up time. Simulation studies are conducted to assess the performance of the proposed method. An application of our formulae to a multiple sclerosis trial is provided.
Authors
I am an author on this paper
Click your name to claim this paper and add it to your profile.
Reviews
Recommended
No Data Available