Evidence map›Paper›PMID 39586738›Full record

ArticlePharmacoepidemiology and drug safety2024

Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID-19 Adenovirus Vector Vaccines on European Healthcare Professionals.

Ella van Vliet, Nanča Čebron Lipovec, Marloes van der Goot, Shahab Abtahi, Inês Ribeiro-Vaz, Elita Poplavska, Foteini Dermiki-Gkana, Chara Oikonomou, Elena Deligianni, Christos Kontogiorgis and 9 more

Abstract read
In one paragraph

Article in Pharmacoepidemiology and drug safety, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

19 authors.

Ella van VlietMedical Technology Department, Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.ORCID 0000-0001-6226-5491
Nanča Čebron LipovecFaculty of Pharmacy, Department of Social Pharmacy, University of Ljubljana, Ljubljana, Slovenia.
Marloes van der GootMedical Technology Department, Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Shahab AbtahiDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.ORCID 0000-0003-0482-5563
Inês Ribeiro-VazMEDCIDS - Department of Community Medicine, Health Information and Decision, Faculty of Medicine of University of Porto, Porto, Portugal.ORCID 0000-0002-3442-8158
Elita PoplavskaFaculty of Pharmacy & Institute of Public Health, Riga Stradins University, Riga, Latvia.
Foteini Dermiki-GkanaLaboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences, Democritus University of Thrace, Alexandroupolis, Greece.
Chara OikonomouLaboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences, Democritus University of Thrace, Alexandroupolis, Greece.
Elena DeligianniLaboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences, Democritus University of Thrace, Alexandroupolis, Greece.
Christos KontogiorgisLaboratory of Hygiene and Environmental Protection, Faculty of Medicine, School of Health Sciences, Democritus University of Thrace, Alexandroupolis, Greece.ORCID 0000-0001-7835-8246
Ana Marta SilvaMEDCIDS - Department of Community Medicine, Health Information and Decision, Faculty of Medicine of University of Porto, Porto, Portugal.
Paula Barão Sousa FerreiraDepartment of Pharmacy, Pharmacological Sciences and Health Technologies, Faculty of Pharmacy of University of Lisbon, Lisbon, Portugal.ORCID 0000-0001-5712-1338
Mitja KosFaculty of Pharmacy, Department of Social Pharmacy, University of Ljubljana, Ljubljana, Slovenia.
Anna Birna AlmarsdóttirDepartment of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Ramune JacobsenDepartment of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.ORCID 0000-0002-8142-9807
Caroline BuhlDepartment of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
Adrie de BruijnMedical Technology Department, Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Ingrid HeggerMedicines Department, Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
Teresa Leonardo AlvesMedicines Department, Centre for Health Protection, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.

Funding

European Medicines Agency
6 · The paper itself

Abstract

purposeThe European Medicines Agency (EMA) issued regulatory actions and communications in 2021 on thrombosis with thrombocytopenia syndrome (TTS) associated with adenovirus vector vaccines Vaxzevria or Jcovden. This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP).

methodsWeb-based cross-sectional surveys were conducted on HCPs engaged in the vaccination, monitoring or counselling about the vaccines. We measured awareness and knowledge of the risk of TTS and their implementation of recommendations in practise. Descriptive and qualitative analyses were conducted. This study took place in Greece, Latvia, Netherlands, Portugal and Slovenia.

resultsWe surveyed 1659 HCPs. From these, 914 were included in the analysis. Most were aware about the reports of TTS associated with COVID-19 adenovirus vector vaccines, with countries reporting percentages between 85% and 97%. Mainstream media, health authorities and peers were the main sources of TTS risk information. Most HCPs were able to identify key symptoms from TTS but were less familiar with minor symptoms. Guidelines from health authorities on COVID-19 vaccination impacted on professional practise of 55%-77% of HCPs. The reported use of product information across countries was moderate, with some variations.

conclusionsAwareness about and knowledge of TTS risk from COVID-19 adenoviral vector vaccines were high among HCPs. HCPs reported a clear preference for national guidelines as source of risk information and the implementation of product information remained moderate across countries.

Indexed as

COVID-19 VaccinesHealth Knowledge, Attitudes, PracticeHealth PersonnelAdenovirus VaccinesAdultCommunicationCOVID-19Cross-Sectional StudiesEuropeFemaleHumansMaleMiddle AgedSurveys and QuestionnairesThrombocytopeniaThrombosisAdenovirus VaccinesCOVID-19 VaccinesCOVID‐19 vaccineshealthcare professionalsregulatory actionsrisk communicationSARS‐CoV‐2 adenovirus vector vaccinesthrombosis with thrombocytopenia syndrome

Identifiers

PMID39586738
PMCPMC11589195

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.