Evidence map›Paper›PMID 39515195›Full record

ArticleVaccine2025

Assessment and mitigation of bias in influenza and COVID-19 vaccine effectiveness analyses - IVY Network, September 1, 2022-March 30, 2023.

Nathaniel M Lewis, Elizabeth J Harker, Aleda Leis, Yuwei Zhu, H Keipp Talbot, Carlos G Grijalva, Natasha Halasa, James D Chappell, Cassandra A Johnson, Todd W Rice and 38 more

Abstract readMulticenter Study
In one paragraph

Article in Vaccine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Article
  2. Article
  3. Influenza vaccine effectiveness against outpatient acute respiratory illness with laboratory-confirmed influenza, United States, 2024-25 season.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
    Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

48 authors.

Nathaniel M LewisInfluenza Division, National Center for Immunization and Respiratory Diseases, CDC, United States. Electronic address: pha6@cdc.gov.
Elizabeth J HarkerInfluenza Division, National Center for Immunization and Respiratory Diseases, CDC, United States.
Aleda LeisUniversity of Michigan, Ann Arbor, MI, United States.
Yuwei ZhuVanderbilt University Medical Center, Nashville, TN, United States.
H Keipp TalbotVanderbilt University Medical Center, Nashville, TN, United States.
Carlos G GrijalvaVanderbilt University Medical Center, Nashville, TN, United States.
Natasha HalasaVanderbilt University Medical Center, Nashville, TN, United States.
James D ChappellVanderbilt University Medical Center, Nashville, TN, United States.
Cassandra A JohnsonVanderbilt University Medical Center, Nashville, TN, United States.
Todd W RiceVanderbilt University Medical Center, Nashville, TN, United States.
Jonathan D CaseyVanderbilt University Medical Center, Nashville, TN, United States.
Adam S LauringUniversity of Michigan, Ann Arbor, MI, United States.
Manjusha GaglaniBaylor Scott & White Health, TX, United States; Baylor College of Medicine, Temple, TX, United States.
Shekhar GhamandeBaylor College of Medicine, Temple, TX, United States.
Cristie ColumbusBaylor College of Medicine, Temple, TX, United States; Texas A&M University College of Medicine, Dallas, TX, United States.
Jay S SteingrubBaystate Medical Center, Springfield, MA, United States.
Nathan I ShapiroBeth Israel Deaconess Medical Center, Boston, MA, United States.
Abhijit DuggalCleveland Clinic, Cleveland, OH, United States.
Jamie FelzerEmory University, Atlanta, GA, United States.
Matthew E PrekkerHennepin County Medical Center, Minneapolis, MN, United States.
Ithan D PeltanUniversity of Utah, Salt Lake City, UT, United States; Intermountain Medical Center, Murray, UT, United States.
Samuel M BrownUniversity of Utah, Salt Lake City, UT, United States; Intermountain Medical Center, Murray, UT, United States.
David N HagerJohns Hopkins University School of Medicine, Baltimore, MD, United States.
Michelle N GongMontefiore Medical Center, Albert Einstein College of Medicine, New York, NY, United States.
Amira MohamedMontefiore Medical Center, Albert Einstein College of Medicine, New York, NY, United States.
Matthew C ExlineThe Ohio State University, Columbus, OH, United States.
Akram KhanOregon Health & Science University, Portland, OR, United States.
Jennifer G WilsonStanford University School of Medicine, Stanford, CA, United States.
Jarrod MosierUniversity of Arizona, Tucson, AZ, United States.
Nida QadirRonald Reagan UCLA Medical Center, Los Angeles, CA, United States.
Steven Y ChangRonald Reagan UCLA Medical Center, Los Angeles, CA, United States.
Adit A GindeUniversity of Colorado School of Medicine, Aurora, CO, United States.
Nicholas M MohrUniversity of Iowa School of Medicine, Iowa City, IA, United States.
Christopher MallowUniversity of Miami School of Medicine, Miami, FL, United States.
Estelle S HarrisUniversity of Utah, Salt Lake City, UT, United States.
Nicholas J JohnsonUniversity of Washington, Seattle, WA, United States.
Vasisht SrinivasanUniversity of Washington, Seattle, WA, United States.
Kevin W GibbsWake Forest School of Medicine, Winston-Salem, NC, United States.
Jennie H KwonWashington University in St. Louis, St. Louis, MO, United States.
Ivana A VaughnHenry Ford Health, Detroit, MI, United States.
Mayur RameshHenry Ford Health, Detroit, MI, United States.
Basmah SafdarYale University School of Medicine, New Haven, CT, United States.
Jennifer DeCuirInfluenza Division, National Center for Immunization and Respiratory Diseases, CDC, United States.
Diya SurieDivision of COVID-19 and Other Respiratory Viral Diseases, CDC, United States.
Fatimah S DawoodDivision of COVID-19 and Other Respiratory Viral Diseases, CDC, United States.
Sascha EllingtonInfluenza Division, National Center for Immunization and Respiratory Diseases, CDC, United States.
Wesley H SelfVanderbilt University Medical Center, Nashville, TN, United States.
Emily T MartinUniversity of Michigan, Ann Arbor, MI, United States.

Funding

Measuring and Learning from Care Variation in SepsisR35GM151147 · NIGMS · IHC HEALTH SERVICES, INC. · PI Ithan Daniel Peltan · 2023 to 2026
$1.5M
CDC HHS 75D30122C14944CDC HHS 75D30122C15294NIGMS NIH HHS R35 GM151147
6 · The paper itself

Abstract

backgroundIn test-negative studies of vaccine effectiveness (VE), including patients with co-circulating, vaccine-preventable, respiratory pathogens in the control group for the pathogen of interest can introduce a downward bias on VE estimates.

methodsA multicenter sentinel surveillance network in the US prospectively enrolled adults hospitalized with acute respiratory illness from September 1, 2022-March 31, 2023. We evaluated bias in estimates of VE against influenza-associated and COVID-19-associated hospitalization based on: inclusion vs exclusion of patients with a co-circulating virus among VE controls; observance of VE against the co-circulating virus (rather than the virus of interest), unadjusted and adjusted for vaccination against the virus of interest; and observance of influenza or COVID-19 against a sham outcome of respiratory syncytial virus (RSV).

resultsOverall VE against influenza-associated hospitalizations was 6 percentage points lower when patients with COVID-19 were included in the control group, and overall VE against COVID-19-associated hospitalizations was 2 percentage points lower when patients with influenza were included in the control group. Analyses of VE against the co-circulating virus and against the sham outcome of RSV showed that downward bias was largely attributable the correlation of vaccination status across pathogens, but also potentially attributable to other sources of residual confounding in VE models.

conclusionExcluding cases of confounding respiratory pathogens from the control group in VE analysis for a pathogen of interest can reduce downward bias. This real-world analysis demonstrates that such exclusion is a helpful bias mitigation strategy, especially for measuring influenza VE, which included a high proportion of COVID-19 cases among controls.

Indexed as

BiasCOVID-19COVID-19 VaccinesHospitalizationInfluenza, HumanInfluenza VaccinesVaccine EfficacyAdultAgedFemaleHumansMaleMiddle AgedProspective StudiesSARS-CoV-2Sentinel SurveillanceCOVID-19 VaccinesInfluenza VaccinesBiasCOVID-19EstimationInfluenzaRSVVaccine effectiveness

Identifiers

PMID39515195
PMCPMC12229715

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.