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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.
PLoS One. 2018; 13(10):e0204799.Plos

Abstract

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.

Authors+Show Affiliations

Erasmus Medical Center, Rotterdam, The Netherlands. Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.Erasmus Medical Center, Rotterdam, The Netherlands.Taiwan Centers for Disease Control, Taipei, Taiwan.Erasmus Medical Center, Rotterdam, The Netherlands.Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.Erasmus Medical Center, Rotterdam, The Netherlands. Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat (FISABIO), Vaccine Research, Valencia, Spain.University of Alberta, Division of Preventative Medicine, Alberta, Canada.University of Manitoba, Rady Faculty of Health Sciences, Winnipeg, Manitoba, Canada.University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada.University of British Columbia, Faculty of Medicine, Vancouver, British Columbia, Canada.Institute for Clinical Evaluative Sciences, Toronto, Ontario, Canada. Public Health Ontario, Toronto, Ontario, Canada. Department of Family & Community Medicine, University of Toronto, Toronto, Ontario, Canada. Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada. University Health Network, Toronto, Ontario, Canada.Division of Neurology, Department of Medicine, Sunnybrook Health Sciences Centre, Toronto, Canada.Karolinska Institut, Department of Medical Epidemiology and Biostatistics, Stockholm, Sweden.Aarhus University, Department of Clinical Epidemiology, Aarhus, Denmark.Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain. Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Barcelona, Spain.Sleep Unit, Neurophysiology Department, La Ribera University Hospital, Valencia, Spain. Physiology Department, University of Valencia, Valencia, Spain.Cincinnati Children's Hospital, Center for Global Health, Cincinnati, Ohio, United States of America.Julius Center Global Health, University Medical Center Utrecht, Utrecht, The Netherlands.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

30332477

Citation

Dodd, Caitlin N., et al. "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." PloS One, vol. 13, no. 10, 2018, pp. e0204799.
Dodd CN, de Ridder M, Huang WT, et al. 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. PLoS One. 2018;13(10):e0204799.
Dodd, C. N., de Ridder, M., Huang, W. T., Weibel, D., Giner-Soriano, M., Perez-Vilar, S., Diez-Domingo, J., Svenson, L. W., Mahmud, S. M., Carleton, B., Naus, M., Kwong, J. C., Murray, B. J., Arnheim-Dahlstrom, L., Pedersen, L., Morros, R., Puertas, F. J., Black, S., & Sturkenboom, M. (2018). 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. PloS One, 13(10), e0204799. https://doi.org/10.1371/journal.pone.0204799
Dodd CN, et al. 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. PLoS One. 2018;13(10):e0204799. PubMed PMID: 30332477.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Dodd,Caitlin N, AU - de Ridder,Maria, AU - Huang,Wan-Ting, AU - Weibel,Daniel, AU - Giner-Soriano,Maria, AU - Perez-Vilar,Silvia, AU - Diez-Domingo,Javier, AU - Svenson,Lawrence W, AU - Mahmud,Salahddin M, AU - Carleton,Bruce, AU - Naus,Monika, AU - Kwong,Jeffrey C, AU - Murray,Brian J, AU - Arnheim-Dahlstrom,Lisen, AU - Pedersen,Lars, AU - Morros,Rosa, AU - Puertas,Francisco Javier, AU - Black,Steven, AU - Sturkenboom,Miriam, Y1 - 2018/10/17/ PY - 2017/05/16/received PY - 2018/09/07/accepted PY - 2018/10/18/entrez PY - 2018/10/18/pubmed PY - 2019/3/15/medline SP - e0204799 EP - e0204799 JF - PloS one JO - PLoS One VL - 13 IS - 10 N2 - 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. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/30332477/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_ L2 - https://dx.plos.org/10.1371/journal.pone.0204799 DB - PRIME DP - Unbound Medicine ER -