Document Detail


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:  MEDLINE    
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.
Authors:
Stanley Xu; Simon J Hambidge; David L McClure; Matthew F Daley; Jason M Glanz
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Publication Detail:
Type:  Journal Article; Research Support, N.I.H., Extramural; Research Support, U.S. Gov't, P.H.S.     Date:  2013-01-10
Journal Detail:
Title:  Statistics in medicine     Volume:  32     ISSN:  1097-0258     ISO Abbreviation:  Stat Med     Publication Date:  2013 Aug 
Date Detail:
Created Date:  2013-07-12     Completed Date:  2014-02-24     Revised Date:  2014-09-02    
Medline Journal Info:
Nlm Unique ID:  8215016     Medline TA:  Stat Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  3290-9     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 John Wiley & Sons, Ltd.
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MeSH Terms
Descriptor/Qualifier:
Adolescent
Adverse Drug Reaction Reporting Systems / standards*
Age Factors
Child
Child, Preschool
Computer Simulation
Humans
Incidence
Infant
Measles-Mumps-Rubella Vaccine / adverse effects
Models, Statistical*
Risk Assessment / methods*
Seasons
Thrombocytopenia / etiology
Time Factors
Vaccines / adverse effects*
Grant Support
ID/Acronym/Agency:
200-2002-00732//PHS HHS; UL1 RR025780/RR/NCRR NIH HHS; UL1 RR025780/RR/NCRR NIH HHS; UL1 TR001082/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Measles-Mumps-Rubella Vaccine; 0/Vaccines
Comments/Corrections

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