Cargando…
Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA
OBJECTIVES: External validity, or generalisability, is the measure of how well results from a study pertain to individuals in the target population. We assessed generalisability, with respect to socioeconomic status, of estimates from a matched case–control study of 13-valent pneumococcal conjugate...
Autores principales: | , , , , , , , , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2017
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724195/ https://www.ncbi.nlm.nih.gov/pubmed/28851801 http://dx.doi.org/10.1136/bmjopen-2017-017715 |
_version_ | 1783285317408653312 |
---|---|
author | Link-Gelles, Ruth Westreich, Daniel Aiello, Allison E Shang, Nong Weber, David J Rosen, Jennifer B Motala, Tasneem Mascola, Laurene Eason, Jeffery Scherzinger, Karen Holtzman, Corinne Reingold, Arthur L Barnes, Meghan Petit, Susan Farley, Monica M Harrison, Lee H Zansky, Shelley Thomas, Ann Schaffner, William McGee, Lesley Whitney, Cynthia G Moore, Matthew R |
author_facet | Link-Gelles, Ruth Westreich, Daniel Aiello, Allison E Shang, Nong Weber, David J Rosen, Jennifer B Motala, Tasneem Mascola, Laurene Eason, Jeffery Scherzinger, Karen Holtzman, Corinne Reingold, Arthur L Barnes, Meghan Petit, Susan Farley, Monica M Harrison, Lee H Zansky, Shelley Thomas, Ann Schaffner, William McGee, Lesley Whitney, Cynthia G Moore, Matthew R |
author_sort | Link-Gelles, Ruth |
collection | PubMed |
description | OBJECTIVES: External validity, or generalisability, is the measure of how well results from a study pertain to individuals in the target population. We assessed generalisability, with respect to socioeconomic status, of estimates from a matched case–control study of 13-valent pneumococcal conjugate vaccine effectiveness for the prevention of invasive pneumococcal disease in children in the USA. DESIGN: Matched case–control study. SETTING: Thirteen active surveillance sites for invasive pneumococcal disease in the USA. PARTICIPANTS: Cases were identified from active surveillance and controls were age and zip code matched. OUTCOME MEASURES: Socioeconomic status was assessed at the individual level via parent interview (for enrolled individuals only) and birth certificate data (for both enrolled and unenrolled individuals) and at the neighbourhood level by geocoding to the census tract (for both enrolled and unenrolled individuals). Prediction models were used to determine if socioeconomic status was associated with enrolment. RESULTS: We enrolled 54.6% of 1211 eligible cases and found a trend toward enrolled cases being more affluent than unenrolled cases. Enrolled cases were slightly more likely to have private insurance at birth (p=0.08) and have mothers with at least some college education (p<0.01). Enrolled cases also tended to come from more affluent census tracts. Despite these differences, our best predictive model for enrolment yielded a concordance statistic of only 0.703, indicating mediocre predictive value. Variables retained in the final model were assessed for effect measure modification, and none were found to be significant modifiers of vaccine effectiveness. CONCLUSIONS: We conclude that although enrolled cases are somewhat more affluent than unenrolled cases, our estimates are externally valid with respect to socioeconomic status. Our analysis provides evidence that this study design can yield valid estimates and the assessing generalisability of observational data is feasible, even when unenrolled individuals cannot be contacted. |
format | Online Article Text |
id | pubmed-5724195 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-57241952017-12-19 Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA Link-Gelles, Ruth Westreich, Daniel Aiello, Allison E Shang, Nong Weber, David J Rosen, Jennifer B Motala, Tasneem Mascola, Laurene Eason, Jeffery Scherzinger, Karen Holtzman, Corinne Reingold, Arthur L Barnes, Meghan Petit, Susan Farley, Monica M Harrison, Lee H Zansky, Shelley Thomas, Ann Schaffner, William McGee, Lesley Whitney, Cynthia G Moore, Matthew R BMJ Open Epidemiology OBJECTIVES: External validity, or generalisability, is the measure of how well results from a study pertain to individuals in the target population. We assessed generalisability, with respect to socioeconomic status, of estimates from a matched case–control study of 13-valent pneumococcal conjugate vaccine effectiveness for the prevention of invasive pneumococcal disease in children in the USA. DESIGN: Matched case–control study. SETTING: Thirteen active surveillance sites for invasive pneumococcal disease in the USA. PARTICIPANTS: Cases were identified from active surveillance and controls were age and zip code matched. OUTCOME MEASURES: Socioeconomic status was assessed at the individual level via parent interview (for enrolled individuals only) and birth certificate data (for both enrolled and unenrolled individuals) and at the neighbourhood level by geocoding to the census tract (for both enrolled and unenrolled individuals). Prediction models were used to determine if socioeconomic status was associated with enrolment. RESULTS: We enrolled 54.6% of 1211 eligible cases and found a trend toward enrolled cases being more affluent than unenrolled cases. Enrolled cases were slightly more likely to have private insurance at birth (p=0.08) and have mothers with at least some college education (p<0.01). Enrolled cases also tended to come from more affluent census tracts. Despite these differences, our best predictive model for enrolment yielded a concordance statistic of only 0.703, indicating mediocre predictive value. Variables retained in the final model were assessed for effect measure modification, and none were found to be significant modifiers of vaccine effectiveness. CONCLUSIONS: We conclude that although enrolled cases are somewhat more affluent than unenrolled cases, our estimates are externally valid with respect to socioeconomic status. Our analysis provides evidence that this study design can yield valid estimates and the assessing generalisability of observational data is feasible, even when unenrolled individuals cannot be contacted. BMJ Publishing Group 2017-08-28 /pmc/articles/PMC5724195/ /pubmed/28851801 http://dx.doi.org/10.1136/bmjopen-2017-017715 Text en © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ |
spellingShingle | Epidemiology Link-Gelles, Ruth Westreich, Daniel Aiello, Allison E Shang, Nong Weber, David J Rosen, Jennifer B Motala, Tasneem Mascola, Laurene Eason, Jeffery Scherzinger, Karen Holtzman, Corinne Reingold, Arthur L Barnes, Meghan Petit, Susan Farley, Monica M Harrison, Lee H Zansky, Shelley Thomas, Ann Schaffner, William McGee, Lesley Whitney, Cynthia G Moore, Matthew R Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA |
title | Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA |
title_full | Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA |
title_fullStr | Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA |
title_full_unstemmed | Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA |
title_short | Generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the USA |
title_sort | generalisability of vaccine effectiveness estimates: an analysis of cases included in a postlicensure evaluation of 13-valent pneumococcal conjugate vaccine in the usa |
topic | Epidemiology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5724195/ https://www.ncbi.nlm.nih.gov/pubmed/28851801 http://dx.doi.org/10.1136/bmjopen-2017-017715 |
work_keys_str_mv | AT linkgellesruth generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT westreichdaniel generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT aielloallisone generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT shangnong generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT weberdavidj generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT rosenjenniferb generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT motalatasneem generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT mascolalaurene generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT easonjeffery generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT scherzingerkaren generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT holtzmancorinne generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT reingoldarthurl generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT barnesmeghan generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT petitsusan generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT farleymonicam generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT harrisonleeh generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT zanskyshelley generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT thomasann generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT schaffnerwilliam generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT mcgeelesley generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT whitneycynthiag generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa AT moorematthewr generalisabilityofvaccineeffectivenessestimatesananalysisofcasesincludedinapostlicensureevaluationof13valentpneumococcalconjugatevaccineintheusa |