Case-control vaccine effectiveness studies: Data collection, analysis and reporting results

Jennifer R. Verani, Abdullah Baqui, Claire V. Broome, Thomas Cherian, Cheryl Cohen, Jennifer L. Farrar, Daniel Feikin, Michelle J. Groome, Rana A. Hajjeh, Hope L. Johnson, Shabir A. Madhi, Kim Mulholland, Katherine L O'Brien, Umesh D. Parashar, Manish M. Patel, Laura C. Rodrigues, Mathuram Santosham, J. Anthony Scott, Peter G. Smith, Halvor SommerfeltJacqueline E. Tate, J. Chris Victor, Cynthia G. Whitney, Anita K. Zaidi, Elizabeth R. Zell

Research output: Contribution to journalArticle

Abstract

The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection, analysis and presentation of the data in order to best inform evidence-based vaccine policies.

Original languageEnglish (US)
JournalVaccine
DOIs
StateAccepted/In press - Dec 20 2016

Fingerprint

Research Design
Vaccines
vaccines
Vaccination
case-control studies
vaccination
Case-Control Studies
History
Research Personnel
primary contact
history
Licensure
Practice Guidelines
confidence interval
control methods
Immunization
immunization
methodology
Confidence Intervals

Keywords

  • Case-control studies
  • Evaluation studies
  • Vaccines

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Case-control vaccine effectiveness studies : Data collection, analysis and reporting results. / Verani, Jennifer R.; Baqui, Abdullah; Broome, Claire V.; Cherian, Thomas; Cohen, Cheryl; Farrar, Jennifer L.; Feikin, Daniel; Groome, Michelle J.; Hajjeh, Rana A.; Johnson, Hope L.; Madhi, Shabir A.; Mulholland, Kim; O'Brien, Katherine L; Parashar, Umesh D.; Patel, Manish M.; Rodrigues, Laura C.; Santosham, Mathuram; Scott, J. Anthony; Smith, Peter G.; Sommerfelt, Halvor; Tate, Jacqueline E.; Victor, J. Chris; Whitney, Cynthia G.; Zaidi, Anita K.; Zell, Elizabeth R.

In: Vaccine, 20.12.2016.

Research output: Contribution to journalArticle

Verani, JR, Baqui, A, Broome, CV, Cherian, T, Cohen, C, Farrar, JL, Feikin, D, Groome, MJ, Hajjeh, RA, Johnson, HL, Madhi, SA, Mulholland, K, O'Brien, KL, Parashar, UD, Patel, MM, Rodrigues, LC, Santosham, M, Scott, JA, Smith, PG, Sommerfelt, H, Tate, JE, Victor, JC, Whitney, CG, Zaidi, AK & Zell, ER 2016, 'Case-control vaccine effectiveness studies: Data collection, analysis and reporting results', Vaccine. https://doi.org/10.1016/j.vaccine.2017.04.035
Verani, Jennifer R. ; Baqui, Abdullah ; Broome, Claire V. ; Cherian, Thomas ; Cohen, Cheryl ; Farrar, Jennifer L. ; Feikin, Daniel ; Groome, Michelle J. ; Hajjeh, Rana A. ; Johnson, Hope L. ; Madhi, Shabir A. ; Mulholland, Kim ; O'Brien, Katherine L ; Parashar, Umesh D. ; Patel, Manish M. ; Rodrigues, Laura C. ; Santosham, Mathuram ; Scott, J. Anthony ; Smith, Peter G. ; Sommerfelt, Halvor ; Tate, Jacqueline E. ; Victor, J. Chris ; Whitney, Cynthia G. ; Zaidi, Anita K. ; Zell, Elizabeth R. / Case-control vaccine effectiveness studies : Data collection, analysis and reporting results. In: Vaccine. 2016.
@article{5442a011d16e438584b1cf62c6e88935,
title = "Case-control vaccine effectiveness studies: Data collection, analysis and reporting results",
abstract = "The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection, analysis and presentation of the data in order to best inform evidence-based vaccine policies.",
keywords = "Case-control studies, Evaluation studies, Vaccines",
author = "Verani, {Jennifer R.} and Abdullah Baqui and Broome, {Claire V.} and Thomas Cherian and Cheryl Cohen and Farrar, {Jennifer L.} and Daniel Feikin and Groome, {Michelle J.} and Hajjeh, {Rana A.} and Johnson, {Hope L.} and Madhi, {Shabir A.} and Kim Mulholland and O'Brien, {Katherine L} and Parashar, {Umesh D.} and Patel, {Manish M.} and Rodrigues, {Laura C.} and Mathuram Santosham and Scott, {J. Anthony} and Smith, {Peter G.} and Halvor Sommerfelt and Tate, {Jacqueline E.} and Victor, {J. Chris} and Whitney, {Cynthia G.} and Zaidi, {Anita K.} and Zell, {Elizabeth R.}",
year = "2016",
month = "12",
day = "20",
doi = "10.1016/j.vaccine.2017.04.035",
language = "English (US)",
journal = "Vaccine",
issn = "0264-410X",
publisher = "Elsevier BV",

}

TY - JOUR

T1 - Case-control vaccine effectiveness studies

T2 - Data collection, analysis and reporting results

AU - Verani, Jennifer R.

AU - Baqui, Abdullah

AU - Broome, Claire V.

AU - Cherian, Thomas

AU - Cohen, Cheryl

AU - Farrar, Jennifer L.

AU - Feikin, Daniel

AU - Groome, Michelle J.

AU - Hajjeh, Rana A.

AU - Johnson, Hope L.

AU - Madhi, Shabir A.

AU - Mulholland, Kim

AU - O'Brien, Katherine L

AU - Parashar, Umesh D.

AU - Patel, Manish M.

AU - Rodrigues, Laura C.

AU - Santosham, Mathuram

AU - Scott, J. Anthony

AU - Smith, Peter G.

AU - Sommerfelt, Halvor

AU - Tate, Jacqueline E.

AU - Victor, J. Chris

AU - Whitney, Cynthia G.

AU - Zaidi, Anita K.

AU - Zell, Elizabeth R.

PY - 2016/12/20

Y1 - 2016/12/20

N2 - The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection, analysis and presentation of the data in order to best inform evidence-based vaccine policies.

AB - The case-control methodology is frequently used to evaluate vaccine effectiveness post-licensure. The results of such studies provide important insight into the level of protection afforded by vaccines in a 'real world' context, and are commonly used to guide vaccine policy decisions. However, the potential for bias and confounding are important limitations to this method, and the results of a poorly conducted or incorrectly interpreted case-control study can mislead policies. In 2012, a group of experts met to review recent experience with case-control studies evaluating vaccine effectiveness; we summarize the recommendations of that group regarding best practices for data collection, analysis, and presentation of the results of case-control vaccine effectiveness studies. Vaccination status is the primary exposure of interest, but can be challenging to assess accurately and with minimal bias. Investigators should understand factors associated with vaccination as well as the availability of documented vaccination status in the study context; case-control studies may not be a valid method for evaluating vaccine effectiveness in settings where many children lack a documented immunization history. To avoid bias, it is essential to use the same methods and effort gathering vaccination data from cases and controls. Variables that may confound the association between illness and vaccination are also important to capture as completely as possible, and where relevant, adjust for in the analysis according to the analytic plan. In presenting results from case-control vaccine effectiveness studies, investigators should describe enrollment among eligible cases and controls as well as the proportion with no documented vaccine history. Emphasis should be placed on confidence intervals, rather than point estimates, of vaccine effectiveness. Case-control studies are a useful approach for evaluating vaccine effectiveness; however careful attention must be paid to the collection, analysis and presentation of the data in order to best inform evidence-based vaccine policies.

KW - Case-control studies

KW - Evaluation studies

KW - Vaccines

UR - http://www.scopus.com/inward/record.url?scp=85018773931&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85018773931&partnerID=8YFLogxK

U2 - 10.1016/j.vaccine.2017.04.035

DO - 10.1016/j.vaccine.2017.04.035

M3 - Article

C2 - 28442230

AN - SCOPUS:85018773931

JO - Vaccine

JF - Vaccine

SN - 0264-410X

ER -