Evidence map›Paper›PMID 37853843›Full record

ArticleClinical pharmacology and therapeutics2024

High-Dose vs. Standard-Dose Influenza Vaccine and Cardiopulmonary Hospitalization or Mortality: Emulating the INVESTED Trial Using Insurance Claims Data.

Mehdi NajafZadeh, HoJin Shin, Sebastian Schneeweiss, Shirley V Wang, Scott D Solomon, Orly Vardeny, Elisabetta Patorno

Open access · bronzeAbstract read
In one paragraph

Article in Clinical pharmacology and therapeutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed, 2 pooled it
0.7field-weighted citation impact, top 27% of its field
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

4 citing papers in PubMed, 2 syntheses or guidelines pooled it, 2 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Review
  4. 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

7 authors at 2 institutions in 2 countries.

Mehdi NajafZadeh *Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
HoJin Shin *Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0002-2032-6134
Sebastian SchneeweissDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0003-2575-467X
Shirley V WangDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.ORCID 0000-0001-7761-7090
Scott D SolomonDepartment of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Orly VardenyDepartment of Medicine, University of Minnesota, Minneapolis, Minnesota, USA.
Elisabetta PatornoDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
Brigham and Women's Hospital · USUniversity of Minnesota · US

Funding

Randomized Cardiovascular Trials Duplicated Using Prospective Longitudinal Insurance Claims: Applying Techniques of Epidemiology (RCT DUPLICATE)R01HL141505 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI SCHNEEWEISS, SEBASTIAN G., WANG, SHIRLEY · 2019 to 2023
$3.6M
New approaches to safety monitoring of novel systemic treatments for atopic dermatitis in clinical practice and underrepresented populationsR01AR080194 · NIAMS · BRIGHAM AND WOMEN'S HOSPITAL · PI Sebastian G. Schneeweiss · 2022 to 2026
$3.3M
Generalizing data from randomized trials to predict long-term treatment outcomes in older populationsR01AG060163 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI WANG, SHIRLEY · 2018 to 2022
$2.5M
Understanding effectiveness of new drugs in older adults shortly after market entryR01AG053302 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI WANG, SHIRLEY · 2018 to 2021
$2.0M
Novel Approaches to Monitor the Safety and Effectiveness of Newly Marketed Diabetes Medications in Older Adults Considering Frailty and MultimorbidityK08AG055670 · NIA · BRIGHAM AND WOMEN'S HOSPITAL · PI PATORNO, ELISABETTA · 2018 to 2021
$661k
FDA HHS U01 FD007213NHLBI NIH HHS R01 HL141505NIAMS NIH HHS R01 AR080194NIA NIH HHS K08 AG055670NIA NIH HHS R01 AG053302NIA NIH HHS R01 AG060163
6 · The paper itself

Abstract

The INVESTED trial did not show benefits of high-dose (HD) vaccine vs. standard-dose (SD) for a primary composite outcome of cardiopulmonary hospitalization or all-cause mortality (hazard ratio (HR) = 1.05, 95% confidence interval (CI) = 0.96-1.15) and its components (all-cause mortality HR = 1.01, 95% CI = 0.84-1.21, cardiopulmonary hospitalization HR = 1.05, 95% CI = 0.96-1.16) during three influenza seasons (2016-2019) among participants with recent myocardial infarction or hospitalization for heart failure (HHF). We emulated INVESTED using Medicare claims data to assess whether the real-world evidence (RWE) study reached similar conclusions. We identified 1:1 propensity score (PS)-matched trial-eligible Medicare beneficiaries aged > 65 years and with prior HHF who received an HD or SD vaccine for the 2016-2019 seasons. We also re-analyzed the INVESTED trial data restricting to participants > 65 years with prior HHF to align eligibility criteria more closely with the RWE study. We compared HRs from the trial and RWE study for the main outcomes. Among 53,393 pairs of PS-matched Medicare beneficiaries, the HD vaccine group showed lower risk of the primary composite outcome (HR = 0.96, 95% CI = 0.95-0.98) and all-cause mortality (HR = 0.93, 95% CI = 0.91-0.95), and similar risk of cardiopulmonary hospitalization (HR = 0.98, 95% CI = 0.96-1.00), compared with SD. The RWE and trial results were closely concordant after the trial population was limited to participants > 65 years with prior HHF: trial-based results for the primary composite outcome (HR = 1.02, 95% CI = 0.89-1.17), all-cause mortality (HR = 0.92, 95% CI = 0.72-1.16), and cardiopulmonary hospitalization (HR = 1.02, 95% CI = 0.88-1.18). Although similar to the main trial results, the RWE was closer to the results from trial participants with aligned eligibility criteria. This study affirms the importance of considering different distributions of baseline patient characteristics when comparing trial findings to RWE.

Indexed as

Heart FailureInfluenza VaccinesAgedHospitalizationHumansMedicareUnited StatesInfluenza Vaccines

Identifiers

PMID37853843
PMCPMC12787785
OpenAlexW4387765296

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.