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Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition
Test negative studies have been used extensively for the estimation of COVID-19 vaccine effectiveness (VE). Such studies are able to estimate VE against medically-attended illness under certain assumptions. Selection bias may be present if the probability of participation is associated with vaccinat...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
American Journal Experts
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10187407/ https://www.ncbi.nlm.nih.gov/pubmed/37205486 http://dx.doi.org/10.21203/rs.3.rs-2689147/v1 |
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author | Sullivan, Sheena Khvorov, Arseniy Huang, Xiaotong Wang, Can Ainslie, Kylie Nealon, Joshua Yang, Bingyi Cowling, Benjamin Tsang, Tim |
author_facet | Sullivan, Sheena Khvorov, Arseniy Huang, Xiaotong Wang, Can Ainslie, Kylie Nealon, Joshua Yang, Bingyi Cowling, Benjamin Tsang, Tim |
author_sort | Sullivan, Sheena |
collection | PubMed |
description | Test negative studies have been used extensively for the estimation of COVID-19 vaccine effectiveness (VE). Such studies are able to estimate VE against medically-attended illness under certain assumptions. Selection bias may be present if the probability of participation is associated with vaccination or COVID-19, but this can be mitigated through use of a clinical case definition to screen patients for eligibility, which increases the likelihood that cases and non-cases come from the same source population. We examined the extent to which this type of bias could harm COVID-19 VE through systematic review and simulation. A systematic review of test-negative studies was re-analysed to identify studies ignoring the need for clinical criteria. Studies using a clinical case definition had a lower pooled VE estimate compared with studies that did not. Simulations varied the probability of selection by case and vaccination status. Positive bias away from the null (i.e., inflated VE consistent with the systematic review) was observed when there was a higher proportion of healthy, vaccinated non-cases, which may occur if a dataset contains many results from asymptomatic screening in settings where vaccination coverage is high. We provide an html tool for researchers to explore site-specific sources of selection bias in their own studies. We recommend all group consider the potential for selection bias in their vaccine effectiveness studies, particularly when using administrative data. |
format | Online Article Text |
id | pubmed-10187407 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | American Journal Experts |
record_format | MEDLINE/PubMed |
spelling | pubmed-101874072023-05-17 Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition Sullivan, Sheena Khvorov, Arseniy Huang, Xiaotong Wang, Can Ainslie, Kylie Nealon, Joshua Yang, Bingyi Cowling, Benjamin Tsang, Tim Res Sq Article Test negative studies have been used extensively for the estimation of COVID-19 vaccine effectiveness (VE). Such studies are able to estimate VE against medically-attended illness under certain assumptions. Selection bias may be present if the probability of participation is associated with vaccination or COVID-19, but this can be mitigated through use of a clinical case definition to screen patients for eligibility, which increases the likelihood that cases and non-cases come from the same source population. We examined the extent to which this type of bias could harm COVID-19 VE through systematic review and simulation. A systematic review of test-negative studies was re-analysed to identify studies ignoring the need for clinical criteria. Studies using a clinical case definition had a lower pooled VE estimate compared with studies that did not. Simulations varied the probability of selection by case and vaccination status. Positive bias away from the null (i.e., inflated VE consistent with the systematic review) was observed when there was a higher proportion of healthy, vaccinated non-cases, which may occur if a dataset contains many results from asymptomatic screening in settings where vaccination coverage is high. We provide an html tool for researchers to explore site-specific sources of selection bias in their own studies. We recommend all group consider the potential for selection bias in their vaccine effectiveness studies, particularly when using administrative data. American Journal Experts 2023-05-04 /pmc/articles/PMC10187407/ /pubmed/37205486 http://dx.doi.org/10.21203/rs.3.rs-2689147/v1 Text en https://creativecommons.org/licenses/by/4.0/This work is licensed under a Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0/) , which allows reusers to distribute, remix, adapt, and build upon the material in any medium or format, so long as attribution is given to the creator. The license allows for commercial use. |
spellingShingle | Article Sullivan, Sheena Khvorov, Arseniy Huang, Xiaotong Wang, Can Ainslie, Kylie Nealon, Joshua Yang, Bingyi Cowling, Benjamin Tsang, Tim Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
title | Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
title_full | Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
title_fullStr | Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
title_full_unstemmed | Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
title_short | Revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
title_sort | revisiting assumptions in test-negative studies for estimating vaccine effectiveness: the need for a clinical case definition |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10187407/ https://www.ncbi.nlm.nih.gov/pubmed/37205486 http://dx.doi.org/10.21203/rs.3.rs-2689147/v1 |
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