Cargando…

The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings

Background: The test-negative design (TND) to evaluate influenza vaccine effectiveness is based on patients seeking care for acute respiratory infection, with those who test positive for influenza as cases and the test-negatives serving as controls. This design has not been validated for the inpatie...

Descripción completa

Detalles Bibliográficos
Autores principales: Foppa, Ivo M, Ferdinands, Jill M, Chaves, Sandra S, Haber, Michael J, Reynolds, Sue B, Flannery, Brendan, Fry, Alicia M
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5025336/
https://www.ncbi.nlm.nih.gov/pubmed/26979985
http://dx.doi.org/10.1093/ije/dyw022
_version_ 1782453938859016192
author Foppa, Ivo M
Ferdinands, Jill M
Chaves, Sandra S
Haber, Michael J
Reynolds, Sue B
Flannery, Brendan
Fry, Alicia M
author_facet Foppa, Ivo M
Ferdinands, Jill M
Chaves, Sandra S
Haber, Michael J
Reynolds, Sue B
Flannery, Brendan
Fry, Alicia M
author_sort Foppa, Ivo M
collection PubMed
description Background: The test-negative design (TND) to evaluate influenza vaccine effectiveness is based on patients seeking care for acute respiratory infection, with those who test positive for influenza as cases and the test-negatives serving as controls. This design has not been validated for the inpatient setting where selection bias might be different from an outpatient setting. Methods: We derived mathematical expressions for vaccine effectiveness (VE) against laboratory-confirmed influenza hospitalizations and used numerical simulations to verify theoretical results exploring expected biases under various scenarios. We explored meaningful interpretations of VE estimates from inpatient TND studies. Results: VE estimates from inpatient TND studies capture the vaccine-mediated protection of the source population against laboratory-confirmed influenza hospitalizations. If vaccination does not modify disease severity, these estimates are equivalent to VE against influenza virus infection. If chronic cardiopulmonary individuals are enrolled because of non-infectious exacerbation, biased VE estimates (too high) will result. If chronic cardiopulmonary disease status is adjusted for accurately, the VE estimates will be unbiased. If chronic cardiopulmonary illness cannot be adequately be characterized, excluding these individuals may provide unbiased VE estimates. Conclusions: The inpatient TND offers logistic advantages and can provide valid estimates of influenza VE. If highly vaccinated patients with respiratory exacerbation of chronic cardiopulmonary conditions are eligible for study inclusion, biased VE estimates will result unless this group is well characterized and the analysis can adequately adjust for it. Otherwise, such groups of subjects should be excluded from the analysis.
format Online
Article
Text
id pubmed-5025336
institution National Center for Biotechnology Information
language English
publishDate 2016
publisher Oxford University Press
record_format MEDLINE/PubMed
spelling pubmed-50253362017-05-24 The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings Foppa, Ivo M Ferdinands, Jill M Chaves, Sandra S Haber, Michael J Reynolds, Sue B Flannery, Brendan Fry, Alicia M Int J Epidemiol Methodological Insights Background: The test-negative design (TND) to evaluate influenza vaccine effectiveness is based on patients seeking care for acute respiratory infection, with those who test positive for influenza as cases and the test-negatives serving as controls. This design has not been validated for the inpatient setting where selection bias might be different from an outpatient setting. Methods: We derived mathematical expressions for vaccine effectiveness (VE) against laboratory-confirmed influenza hospitalizations and used numerical simulations to verify theoretical results exploring expected biases under various scenarios. We explored meaningful interpretations of VE estimates from inpatient TND studies. Results: VE estimates from inpatient TND studies capture the vaccine-mediated protection of the source population against laboratory-confirmed influenza hospitalizations. If vaccination does not modify disease severity, these estimates are equivalent to VE against influenza virus infection. If chronic cardiopulmonary individuals are enrolled because of non-infectious exacerbation, biased VE estimates (too high) will result. If chronic cardiopulmonary disease status is adjusted for accurately, the VE estimates will be unbiased. If chronic cardiopulmonary illness cannot be adequately be characterized, excluding these individuals may provide unbiased VE estimates. Conclusions: The inpatient TND offers logistic advantages and can provide valid estimates of influenza VE. If highly vaccinated patients with respiratory exacerbation of chronic cardiopulmonary conditions are eligible for study inclusion, biased VE estimates will result unless this group is well characterized and the analysis can adequately adjust for it. Otherwise, such groups of subjects should be excluded from the analysis. Oxford University Press 2016-12 2016-03-15 /pmc/articles/PMC5025336/ /pubmed/26979985 http://dx.doi.org/10.1093/ije/dyw022 Text en © The Author 2016. Published by Oxford University Press on behalf of the International Epidemiological Association. http://creativecommons.org/licenses/by-nc/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com
spellingShingle Methodological Insights
Foppa, Ivo M
Ferdinands, Jill M
Chaves, Sandra S
Haber, Michael J
Reynolds, Sue B
Flannery, Brendan
Fry, Alicia M
The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
title The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
title_full The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
title_fullStr The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
title_full_unstemmed The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
title_short The case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
title_sort case test-negative design for studies of the effectiveness of influenza vaccine in inpatient settings
topic Methodological Insights
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5025336/
https://www.ncbi.nlm.nih.gov/pubmed/26979985
http://dx.doi.org/10.1093/ije/dyw022
work_keys_str_mv AT foppaivom thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT ferdinandsjillm thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT chavessandras thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT habermichaelj thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT reynoldssueb thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT flannerybrendan thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT fryaliciam thecasetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT foppaivom casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT ferdinandsjillm casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT chavessandras casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT habermichaelj casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT reynoldssueb casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT flannerybrendan casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings
AT fryaliciam casetestnegativedesignforstudiesoftheeffectivenessofinfluenzavaccineininpatientsettings