Evidence map›Paper›PMID 27612460›Full record

ArticleDrug safety2016

Vaccine Case-Population: A New Method for Vaccine Safety Surveillance.

Hélène Théophile, Nicholas Moore, Philip Robinson, Bernard Bégaud, Antoine Pariente

Abstract readComparative Study
PubMed Publisher
In one paragraph

Article in Drug safety, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Hélène ThéophileDépartement de Pharmacologie médicale, Centre Régional de Pharmacovigilance, CHU Bordeaux, Hôpital Pellegrin-Bât. 1A Zone Nord, 33076, Bordeaux Cedex, France. helene.theophile@u-bordeaux.fr.
Nicholas MooreDépartement de Pharmacologie médicale, Centre Régional de Pharmacovigilance, CHU Bordeaux, Hôpital Pellegrin-Bât. 1A Zone Nord, 33076, Bordeaux Cedex, France.
Philip RobinsonCIC Bordeaux CIC1401, Bordeaux, France.
Bernard BégaudDépartement de Pharmacologie médicale, Centre Régional de Pharmacovigilance, CHU Bordeaux, Hôpital Pellegrin-Bât. 1A Zone Nord, 33076, Bordeaux Cedex, France.
Antoine ParienteDépartement de Pharmacologie médicale, Centre Régional de Pharmacovigilance, CHU Bordeaux, Hôpital Pellegrin-Bât. 1A Zone Nord, 33076, Bordeaux Cedex, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionThe case-population approach compares exposure among cases to that of their source population. By using aggregated data to estimate the denominator, this approach can provide a real-time estimate of an association that could be particularly valuable to explore urgent vaccine safety concerns and to generate signals during a vaccine campaign.

objectiveOur objective was to present the vaccine case-population method, a method derived from the case-population approach and adapted for vaccine safety surveillance, and to test it using several published examples.

methodsFor the vaccine case-population method, exposure in the population is estimated from the sum of at-risk periods using the number of vaccinated individuals, or data of vaccine sales, and the at-risk period considered for the vaccine-event pair. The vaccine case-population method was applied to data from published case-control studies retrieved from the MEDLINE database and having quantified risks associated with vaccines. Odds ratios derived from the vaccine case-population method were compared with those from published case-control studies.

resultsA total of 20 vaccine-event pairs were retrieved in which the vaccine case-population method could be applied. For all identified vaccine-event pairs, when a significant association was found using the vaccine case-population method, a significant association was also found in the corresponding case-control study. Conversely, when no association was found by the vaccine case-population method, no association was found in the corresponding case-control study.

conclusionThese results suggest that the vaccine case-population method can produce coherent conclusions and may be used in the future for prospective investigation of urgent vaccine safety concerns or for the prospective generation of vaccine safety signals. This method could also be used to identify selection bias from cases excluded from the case-control study.

Indexed as

Adverse Drug Reaction Reporting SystemsCase-Control StudiesDatabases, FactualHumansPopulation SurveillancePredictive Value of TestsVaccinesVaccines

Identifiers

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Registered trials

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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.