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Statistical Methods for the Analysis of Case Series Data

Date

2014-08-14

Authors

Ling, Shen

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Abstract

This paper compares the three methods -conditional Poisson method, unconditional Poisson method and self-controlled case series (SCCS) method, based on the retrospective cohort study with full cohort and case series sampling designs, with particular emphasis on their assumptions, power, MSE, relative efficiency, and handling of confounding. The performance of the three methods is contrasted in a study investigating the causality between vaccination and rare adverse events seizures. And we extend these methods to random effect model.

Description

The thesis is motivated by a study investigating the causality between vaccination and seizures, or more general adverse events. The assumption is that seizure events occur according to a homogeneous Poisson process, and that the rate may change after vaccination. The observation period consists of a baseline or low risk interval, and a high risk interval after vaccination. Three methods for estimating the relative incidence rate are considered - an unconditional method with allows for different rates before and after vaccination, a conditional method which conditions on the total number of events in the two intervals, and the self-controlled case series (SCCS) method, which conditions on a subject having at least one event. The performance of the methods, with particular emphasis on their MSE, power, and efficiency, is considered, under both full cohort and case series sampling designs.

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