Evidence map›Paper›PMID 26572776›Full record

ArticlePharmacoepidemiology and drug safety2016

Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System.

Weiling Katherine Yih, Martin Kulldorff, Sukhminder K Sandhu, Lauren Zichittella, Judith C Maro, David V Cole, Robert Jin, Alison Tse Kawai, Meghan A Baker, Chunfu Liu and 5 more

Open access · hybridAbstract readComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed
2.6field-weighted citation impact, top 10% 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

18 citing papers in PubMed, 30 citations in OpenAlex.

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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

15 authors at 6 institutions in 1 country.

Weiling Katherine YihDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Martin KulldorffDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Sukhminder K SandhuCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Lauren ZichittellaDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Judith C MaroDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
David V ColeDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Robert JinDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Alison Tse KawaiDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Meghan A BakerDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Chunfu LiuGovernment and Academic Research, HealthCore, Alexandria, VA, USA.
Cheryl N McMahill-WalravenAetna Data Science, Aetna, Blue Bell, PA, USA.
Mano S SelvanComprehensive Health Insights, Humana Inc., Louisville, KY, USA.
Richard PlattDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Michael D NguyenCenter for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA.
Grace M LeeDepartment of Population Medicine, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, MA, USA.
Harvard Pilgrim Health Care · USHarvard University · USCenter for Biologics Evaluation and Research · USAetna (United States) · USGovernment of the United States of America · USHumana (United States) · US

Funding

FDA HHS HHSF223200910006I
6 · The paper itself

Abstract

purposeTo develop the infrastructure to conduct timely active surveillance for safety of influenza vaccines and other medical countermeasures in the Sentinel System (formerly the Mini-Sentinel Pilot), a Food and Drug Administration-sponsored national surveillance system that typically relies on data that are mature, settled, and updated quarterly.

methodsThree Data Partners provided their earliest available ("fresh") cumulative claims data on influenza vaccination and health outcomes 3-4 times on a staggered basis during the 2013-2014 influenza season, collectively producing 10 data updates. We monitored anaphylaxis in the entire population using a cohort design and seizures in children ≤4 years of age using both a self-controlled risk interval design (primary) and a cohort design (secondary). After each data update, we conducted sequential analysis for inactivated (IIV) and live (LAIV) influenza vaccines using the Maximized Sequential Probability Ratio Test, adjusting for data-lag.

resultsMost of the 10 sequential analyses were conducted within 6 weeks of the last care-date in the cumulative dataset. A total of 6 682 336 doses of IIV and 782 125 doses of LAIV were captured. The primary analyses did not identify any statistical signals following IIV or LAIV. In secondary analysis, the risk of seizures was higher following concomitant IIV and PCV13 than historically after IIV in 6- to 23-month-olds (relative risk = 2.7), which requires further investigation.

conclusionsThe Sentinel System can implement a sequential analysis system that uses fresh data for medical product safety surveillance. Active surveillance using sequential analysis of fresh data holds promise for detecting clinically significant health risks early. Limitations of employing fresh data for surveillance include cost and the need for careful scrutiny of signals. © 2015 The Authors. Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.

Indexed as

AdolescentAdultAnaphylaxisChildChild, PreschoolCohort StudiesFemaleHumansInfantInfluenza, HumanInfluenza VaccinesMaleMiddle AgedPilot ProjectsProspective StudiesSeizuresInfluenza VaccinesVaccines, AttenuatedVaccines, Inactivatedepidemiologic monitoringinfluenza vaccinespharmacoepidemiologypostmarketing product surveillanceresearch designsequential analysisvaccine safety

Identifiers

PMID26572776
PMCPMC5019152
OpenAlexW2173591266

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.