| A scan statistic for identifying optimal risk windows in vaccine safety studies using self-controlled case series design. | |
| | |
MedLine Citation:
|
PMID: 23303643 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
|
In the examination of the association between vaccines and rare adverse events after vaccination in postlicensure observational studies, it is challenging to define appropriate risk windows because prelicensure RCTs provide little insight on the timing of specific adverse events. Past vaccine safety studies have often used prespecified risk windows based on prior publications, biological understanding of the vaccine, and expert opinion. Recently, a data-driven approach was developed to identify appropriate risk windows for vaccine safety studies that use the self-controlled case series design. This approach employs both the maximum incidence rate ratio and the linear relation between the estimated incidence rate ratio and the inverse of average person time at risk, given a specified risk window. In this paper, we present a scan statistic that can identify appropriate risk windows in vaccine safety studies using the self-controlled case series design while taking into account the dependence of time intervals within an individual and while adjusting for time-varying covariates such as age and seasonality. This approach uses the maximum likelihood ratio test based on fixed-effects models, which has been used for analyzing data from self-controlled case series design in addition to conditional Poisson models. Copyright © 2013 John Wiley & Sons, Ltd. |
| | |
Authors:
|
Stanley Xu; Simon J Hambidge; David L McClure; Matthew F Daley; Jason M Glanz |
Related Documents
:
|
3546683 - Comparison of the gonadal response of wild and laboratory field voles (microtus agresti... 1342213 - Effect of medium- and long-chain triglycerides on human neutrophil migration. 20307593 - A new subunit vaccine based on nucleoprotein nanoparticles confers partial clinical and... |
Publication Detail:
|
Type: JOURNAL ARTICLE Date: 2013-1-10 |
Journal Detail:
|
Title: Statistics in medicine Volume: - ISSN: 1097-0258 ISO Abbreviation: Stat Med Publication Date: 2013 Jan |
Date Detail:
|
Created Date: 2013-1-10 Completed Date: - Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8215016 Medline TA: Stat Med Country: - |
Other Details:
|
Languages: ENG Pagination: - Citation Subset: - |
Copyright Information:
|
Copyright © 2013 John Wiley & Sons, Ltd. |
Affiliation:
|
The Institute for Health Research, Kaiser Permanente Colorado, Denver, CO, U.S.A. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Fast gas chromatography combined with a high-speed triple quadrupole mass spectrometer for the analy...
Next Document: External characteristics of unsteady spray atomization from a nasal spray device.