Evidence map›Paper›PMID 33875441›Full record

ArticleBMJ open2021

Effectiveness of HPV vaccine by age at vaccination and number of doses: protocol for a population-based matched case-control study.

Carlos R Oliveira, Anette Michelle Ortiz, Sangini S Sheth, Eugene D Shapiro, Linda M Niccolai

Open access · goldAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.3field-weighted citation impact, top 42% 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, 3 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Review
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

5 authors at 1 institution in 1 country.

Carlos R OliveiraPediatrics, Yale University School of Medicine, New Haven, Connecticut, USA carlos.oliveira@yale.edu.
Anette Michelle OrtizPediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.ORCID 0000-0002-7609-5689
Sangini S ShethObstetrics, Gynecology, & Reproductive Sciences, Yale School of Medicine, New Haven, Connecticut, USA.
Eugene D ShapiroPediatrics, Yale University School of Medicine, New Haven, Connecticut, USA.
Linda M NiccolaiEpidemiology of Microbial Diseases, Yale University School of Public Health, New Haven, Connecticut, USA.
Yale University · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Yale University Clinical and Translational Science Award ProgramUL1TR000142 · NCATS · YALE UNIVERSITY · PI SHERWIN, ROBERT S · 2012 to 2015
$31.8M
Institutional Career Development CoreKL2TR001862 · NCATS · YALE UNIVERSITY · PI CANTLEY, LLOYD G, EDELMAN, E. JENNIFER · 2016 to 2025
$12.2M
Effectiveness of HPV Vaccine by Age at Immunization as Used in Clinical PracticeR01AI123204 · NIAID · YALE UNIVERSITY · PI NICCOLAI, LINDA M · 2017 to 2020
$1.8M
Implementation of Inpatient Postpartum Human Papillomavirus ImmunizationK07CA230234 · NCI · YALE UNIVERSITY · PI SHETH, SANGINI S. · 2018 to 2021
$680k
NCATS NIH HHS KL2 TR001862NCATS NIH HHS UL1 TR000142NCATS NIH HHS UL1 TR001863NCI NIH HHS K07 CA230234NIAID NIH HHS R01 AI123204
6 · The paper itself

Abstract

introductionIn 2006, the first human papillomavirus (HPV) vaccine was approved by the Food and Drug Administration in the USA based on pre-licensure clinical trials that found it to be highly efficacious at preventing persistent infection and precancerous, high-grade cervical lesions (HGCLs) caused by viral types the vaccine protects against. However, the real-world effectiveness of HPV vaccines as used in clinical practice may be quite different from the efficacy found in pre-licensure clinical trials. More than 10 years have passed since the introduction of the vaccine programme. It is critical to determine if the full benefits of HPV are being realised in real-world settings. METHODS AND ANALYSIS: The objectives of this study were to estimate the effectiveness of HPV vaccines as used in real-world clinical settings and to determine the degree to which the vaccine's effectiveness varies based on age at the time of immunisation and the number of doses received. The study will be a population-based, matched case-control study. Cases will be women with newly diagnosed HGCL associated with HPV types 16 and 18. Matched controls will be women with a normal Pap test result, matched individually to cases in a 2:1 ratio by age, a practice and date of testing. Medical records will be reviewed to determine dates of receipt of the HPV vaccine for all participants. We will use multivariate conditional logistic regression to control for potential confounders. ETHICS AND DISSEMINATION: This protocol presents minimal risk to the subjects. This protocol has received approval from the Institutional Review Board of Yale University (HIC: 1502015308), and a Health Insurance Portability and Accountability Act (HIPAA) Waiver of Authorisation has been granted to allow investigators to recruit subjects for the study. Findings will be disseminated through peer-reviewed, open-access scientific journals and conference presentations.

Indexed as

Papillomavirus InfectionsPapillomavirus VaccinesUterine Cervical NeoplasmsCase-Control StudiesFemaleHumansVaccinationPapillomavirus Vaccinesepidemiologygynaecological oncologypublic health

Identifiers

PMID33875441
PMCPMC8057558
OpenAlexW3153139018

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.