Evidence map›Paper›PMID 31675362›Full record

ArticlePloS one2019

Early signal detection of adverse events following influenza vaccination using proportional reporting ratio, Victoria, Australia.

Hazel J Clothier, Jock Lawrie, Melissa A Russell, Heath Kelly, Jim P Buttery

Open access · goldAbstract read
In one paragraph

Article in PloS one, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.1field-weighted citation impact, top 26% 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

6 citing papers in PubMed, 20 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

5 authors at 4 institutions in 1 country.

Hazel J ClothierMonash Centre for Health Research Implementation, Monash University, Clayton, Australia.ORCID 0000-0001-7594-0361
Jock LawrieMonash Centre for Health Research Implementation, Monash University, Clayton, Australia.
Melissa A RussellSchool of Population & Global Health, Melbourne University, Parkville, Victoria, Australia.
Heath KellySchool of Population Health, Australian National University, Canberra, Australia.
Jim P ButteryMonash Centre for Health Research Implementation, Monash University, Clayton, Australia.
The University of Melbourne · AUAustralian National University · AUHudson Institute of Medical Research · AUMurdoch Children's Research Institute · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionTimely adverse event following immunisation (AEFI) signal event detection is essential to minimise further vaccinees receiving unsafe vaccines. We explored the proportional reporting ratio (PRR) ability to detect two known signal events with influenza vaccines with the aim of providing a model for prospective routine signal detection and improving vaccine safety surveillance in Australia.

methodsPassive AEFI surveillance reports from 2008-2017 relating to influenza vaccines were accessed from the Australian SAEFVIC (Victoria) database. Proportional reporting ratios were calculated for two vaccine-event categories; fever and allergic AEFI. Signal detection sensitivity for two known signal events were determined using weekly data; cumulative data by individual year and; cumulative for all previous years. Signal event thresholds of PRR ≥2 and Chi-square ≥4 were applied.

resultsPRR provided sensitive signal detection when calculated cumulatively by individual year or by all previous years. Known signal events were detected 15 and 11 days earlier than traditional methods used at the time of the actual events.

conclusionUtilising a single jurisdiction's data, PRR improved vaccine pharmacovigilance and showed the potential to detect important safety signals much earlier than previously. It has potential to maximise immunisation safety in Australia. This study progresses the necessary work to establish national cohesion for passive surveillance signal detection and strengthen routine Australian vaccine pharmacovigilance.

Indexed as

Data Interpretation, StatisticalHumansInfluenza, HumanInfluenza VaccinesMaleModels, StatisticalPopulation SurveillanceRetrospective StudiesVictoriaInfluenza Vaccines

Identifiers

PMID31675362
PMCPMC6824574
OpenAlexW2989151273

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.