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Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study

BACKGROUND & OBJECTIVES: Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pande...

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Autores principales: Dodd, Caitlin N., de Ridder, Maria, Huang, Wan-Ting, Weibel, Daniel, Giner-Soriano, Maria, Perez-Vilar, Silvia, Diez-Domingo, Javier, Svenson, Lawrence W., Mahmud, Salahddin M., Carleton, Bruce, Naus, Monika, Kwong, Jeffrey C., Murray, Brian J., Arnheim-Dahlstrom, Lisen, Pedersen, Lars, Morros, Rosa, Puertas, Francisco Javier, Black, Steven, Sturkenboom, Miriam
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192586/
https://www.ncbi.nlm.nih.gov/pubmed/30332477
http://dx.doi.org/10.1371/journal.pone.0204799
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author Dodd, Caitlin N.
de Ridder, Maria
Huang, Wan-Ting
Weibel, Daniel
Giner-Soriano, Maria
Perez-Vilar, Silvia
Diez-Domingo, Javier
Svenson, Lawrence W.
Mahmud, Salahddin M.
Carleton, Bruce
Naus, Monika
Kwong, Jeffrey C.
Murray, Brian J.
Arnheim-Dahlstrom, Lisen
Pedersen, Lars
Morros, Rosa
Puertas, Francisco Javier
Black, Steven
Sturkenboom, Miriam
author_facet Dodd, Caitlin N.
de Ridder, Maria
Huang, Wan-Ting
Weibel, Daniel
Giner-Soriano, Maria
Perez-Vilar, Silvia
Diez-Domingo, Javier
Svenson, Lawrence W.
Mahmud, Salahddin M.
Carleton, Bruce
Naus, Monika
Kwong, Jeffrey C.
Murray, Brian J.
Arnheim-Dahlstrom, Lisen
Pedersen, Lars
Morros, Rosa
Puertas, Francisco Javier
Black, Steven
Sturkenboom, Miriam
author_sort Dodd, Caitlin N.
collection PubMed
description BACKGROUND & OBJECTIVES: Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage. METHODS: We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals. RESULTS: Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis. CONCLUSIONS: Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as signal-generating methods and drawing conclusions regarding individual-level risk should be avoided.
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spelling pubmed-61925862018-11-05 Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study Dodd, Caitlin N. de Ridder, Maria Huang, Wan-Ting Weibel, Daniel Giner-Soriano, Maria Perez-Vilar, Silvia Diez-Domingo, Javier Svenson, Lawrence W. Mahmud, Salahddin M. Carleton, Bruce Naus, Monika Kwong, Jeffrey C. Murray, Brian J. Arnheim-Dahlstrom, Lisen Pedersen, Lars Morros, Rosa Puertas, Francisco Javier Black, Steven Sturkenboom, Miriam PLoS One Research Article BACKGROUND & OBJECTIVES: Vaccine safety signals require investigation, which may be done rapidly at the population level using ecological studies, before embarking on hypothesis-testing studies. Incidence rates were used to assess a signal of narcolepsy following AS03-adjuvanted monovalent pandemic H1N1 (pH1N1) influenza vaccination among children and adolescents in Sweden and Finland in 2010. We explored the utility of ecological data to assess incidence of narcolepsy following exposure to pandemic H1N1 virus or vaccination in 10 sites that used different vaccines, adjuvants, and had varying vaccine coverage. METHODS: We calculated incidence rates of diagnosed narcolepsy for periods defined by influenza virus circulation and vaccination campaign dates, and used Poisson regression to estimate incidence rate ratios (IRRs) comparing the periods during which wild-type virus circulated and after the start of vaccination campaigns vs. the period prior to pH1N1 virus circulation. We used electronic health care data from Sweden, Denmark, the United Kingdom, Canada (3 provinces), Taiwan, Netherlands, and Spain (2 regions) from 2003 to 2013. We investigated interactions between age group and adjuvant in European sites and conducted a simulation study to investigate how vaccine coverage, age, and the interval from onset to diagnosis may impact the ability to detect safety signals. RESULTS: Incidence rates of narcolepsy varied by age, continent, and period. Only in Taiwan and Sweden were significant time-period-by-age-group interactions observed. Associations were found for children in Taiwan (following pH1N1 virus circulation) and Sweden (following vaccination). Simulations showed that the individual-level relative risk of narcolepsy was underestimated using ecological methods comparing post- vs. pre-vaccination periods; this effect was attenuated with higher vaccine coverage and a shorter interval from disease onset to diagnosis. CONCLUSIONS: Ecological methods can be useful for vaccine safety assessment but the results are influenced by diagnostic delay and vaccine coverage. Because ecological methods assess risk at the population level, these methods should be treated as signal-generating methods and drawing conclusions regarding individual-level risk should be avoided. Public Library of Science 2018-10-17 /pmc/articles/PMC6192586/ /pubmed/30332477 http://dx.doi.org/10.1371/journal.pone.0204799 Text en © 2018 Dodd et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
spellingShingle Research Article
Dodd, Caitlin N.
de Ridder, Maria
Huang, Wan-Ting
Weibel, Daniel
Giner-Soriano, Maria
Perez-Vilar, Silvia
Diez-Domingo, Javier
Svenson, Lawrence W.
Mahmud, Salahddin M.
Carleton, Bruce
Naus, Monika
Kwong, Jeffrey C.
Murray, Brian J.
Arnheim-Dahlstrom, Lisen
Pedersen, Lars
Morros, Rosa
Puertas, Francisco Javier
Black, Steven
Sturkenboom, Miriam
Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
title Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
title_full Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
title_fullStr Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
title_full_unstemmed Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
title_short Incidence rates of narcolepsy diagnoses in Taiwan, Canada, and Europe: The use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the SOMNIA study
title_sort incidence rates of narcolepsy diagnoses in taiwan, canada, and europe: the use of statistical simulation to evaluate methods for the rapid assessment of potential safety issues on a population level in the somnia study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6192586/
https://www.ncbi.nlm.nih.gov/pubmed/30332477
http://dx.doi.org/10.1371/journal.pone.0204799
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