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

ABSTRACT Purpose The 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, knowled...

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Veröffentlicht in:Pharmacoepidemiology and drug safety 2024-12, Vol.33 (12), p.e70057-n/a
Hauptverfasser: van Vliet, Ella, Lipovec, Nanča Čebron, van der Goot, Marloes, Abtahi, Shahab, Ribeiro ‐Vaz, Inês, Poplavska, Elita, Dermiki‐Gkana, Foteini, Oikonomou, Chara, Deligianni, Elena, Kontogiorgis, Christos, Silva, Ana Marta, Ferreira, Paula Barão Sousa, Kos, Mitja, Almarsdóttir, Anna Birna, Jacobsen, Ramune, Buhl, Caroline, Bruijn, Adrie, Hegger, Ingrid, Alves, Teresa Leonardo
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container_issue 12
container_start_page e70057
container_title Pharmacoepidemiology and drug safety
container_volume 33
creator van Vliet, Ella
Lipovec, Nanča Čebron
van der Goot, Marloes
Abtahi, Shahab
Ribeiro ‐Vaz, Inês
Poplavska, Elita
Dermiki‐Gkana, Foteini
Oikonomou, Chara
Deligianni, Elena
Kontogiorgis, Christos
Silva, Ana Marta
Ferreira, Paula Barão Sousa
Kos, Mitja
Almarsdóttir, Anna Birna
Jacobsen, Ramune
Buhl, Caroline
Bruijn, Adrie
Hegger, Ingrid
Alves, Teresa Leonardo
description ABSTRACT Purpose The 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). Methods Web‐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. Results We 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. Conclusions Awareness 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.
doi_str_mv 10.1002/pds.70057
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This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP). Methods Web‐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. Results We 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. Conclusions Awareness 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.</description><identifier>ISSN: 1053-8569</identifier><identifier>ISSN: 1099-1557</identifier><identifier>EISSN: 1099-1557</identifier><identifier>DOI: 10.1002/pds.70057</identifier><identifier>PMID: 39586738</identifier><language>eng</language><publisher>Chichester, UK: John Wiley &amp; Sons, Inc</publisher><subject>Adenovirus Vaccines - administration &amp; dosage ; Adenoviruses ; Adult ; Communication ; COVID-19 ; COVID-19 - epidemiology ; COVID-19 - prevention &amp; control ; COVID-19 vaccines ; COVID-19 Vaccines - administration &amp; dosage ; Cross-Sectional Studies ; Europe - epidemiology ; Female ; Health care ; Health Knowledge, Attitudes, Practice ; Health Personnel - statistics &amp; numerical data ; healthcare professionals ; Humans ; Immunization ; Male ; Medical personnel ; Middle Aged ; Original ; Professionals ; regulatory actions ; risk communication ; SARS‐CoV‐2 adenovirus vector vaccines ; Surveys and Questionnaires ; Thrombocytopenia ; Thrombocytopenia - epidemiology ; Thrombosis ; Thrombosis - epidemiology ; Thrombosis - etiology ; Thrombosis - prevention &amp; control ; thrombosis with thrombocytopenia syndrome ; Vaccines</subject><ispartof>Pharmacoepidemiology and drug safety, 2024-12, Vol.33 (12), p.e70057-n/a</ispartof><rights>2024 The Author(s). published by John Wiley &amp; Sons Ltd.</rights><rights>2024 The Author(s). 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This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP). Methods Web‐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. Results We 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. Conclusions Awareness 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.</description><subject>Adenovirus Vaccines - administration &amp; dosage</subject><subject>Adenoviruses</subject><subject>Adult</subject><subject>Communication</subject><subject>COVID-19</subject><subject>COVID-19 - epidemiology</subject><subject>COVID-19 - prevention &amp; control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - administration &amp; dosage</subject><subject>Cross-Sectional Studies</subject><subject>Europe - epidemiology</subject><subject>Female</subject><subject>Health care</subject><subject>Health Knowledge, Attitudes, Practice</subject><subject>Health Personnel - statistics &amp; numerical data</subject><subject>healthcare professionals</subject><subject>Humans</subject><subject>Immunization</subject><subject>Male</subject><subject>Medical personnel</subject><subject>Middle Aged</subject><subject>Original</subject><subject>Professionals</subject><subject>regulatory actions</subject><subject>risk communication</subject><subject>SARS‐CoV‐2 adenovirus vector vaccines</subject><subject>Surveys and Questionnaires</subject><subject>Thrombocytopenia</subject><subject>Thrombocytopenia - epidemiology</subject><subject>Thrombosis</subject><subject>Thrombosis - epidemiology</subject><subject>Thrombosis - etiology</subject><subject>Thrombosis - prevention &amp; 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Poplavska, Elita ; Dermiki‐Gkana, Foteini ; Oikonomou, Chara ; Deligianni, Elena ; Kontogiorgis, Christos ; Silva, Ana Marta ; Ferreira, Paula Barão Sousa ; Kos, Mitja ; Almarsdóttir, Anna Birna ; Jacobsen, Ramune ; Buhl, Caroline ; Bruijn, Adrie ; Hegger, Ingrid ; Alves, Teresa Leonardo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3347-a4bb0382eb86b3b031f836ba3ae6a1923ba87de297821253428f3f773ac0aac13</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adenovirus Vaccines - administration &amp; dosage</topic><topic>Adenoviruses</topic><topic>Adult</topic><topic>Communication</topic><topic>COVID-19</topic><topic>COVID-19 - epidemiology</topic><topic>COVID-19 - prevention &amp; control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - administration &amp; dosage</topic><topic>Cross-Sectional Studies</topic><topic>Europe - epidemiology</topic><topic>Female</topic><topic>Health care</topic><topic>Health Knowledge, Attitudes, Practice</topic><topic>Health Personnel - statistics &amp; numerical data</topic><topic>healthcare professionals</topic><topic>Humans</topic><topic>Immunization</topic><topic>Male</topic><topic>Medical personnel</topic><topic>Middle Aged</topic><topic>Original</topic><topic>Professionals</topic><topic>regulatory actions</topic><topic>risk communication</topic><topic>SARS‐CoV‐2 adenovirus vector vaccines</topic><topic>Surveys and Questionnaires</topic><topic>Thrombocytopenia</topic><topic>Thrombocytopenia - epidemiology</topic><topic>Thrombosis</topic><topic>Thrombosis - epidemiology</topic><topic>Thrombosis - etiology</topic><topic>Thrombosis - prevention &amp; control</topic><topic>thrombosis with thrombocytopenia syndrome</topic><topic>Vaccines</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>van Vliet, Ella</creatorcontrib><creatorcontrib>Lipovec, Nanča Čebron</creatorcontrib><creatorcontrib>van der Goot, Marloes</creatorcontrib><creatorcontrib>Abtahi, Shahab</creatorcontrib><creatorcontrib>Ribeiro ‐Vaz, Inês</creatorcontrib><creatorcontrib>Poplavska, Elita</creatorcontrib><creatorcontrib>Dermiki‐Gkana, Foteini</creatorcontrib><creatorcontrib>Oikonomou, Chara</creatorcontrib><creatorcontrib>Deligianni, Elena</creatorcontrib><creatorcontrib>Kontogiorgis, Christos</creatorcontrib><creatorcontrib>Silva, Ana Marta</creatorcontrib><creatorcontrib>Ferreira, Paula Barão Sousa</creatorcontrib><creatorcontrib>Kos, Mitja</creatorcontrib><creatorcontrib>Almarsdóttir, Anna Birna</creatorcontrib><creatorcontrib>Jacobsen, Ramune</creatorcontrib><creatorcontrib>Buhl, Caroline</creatorcontrib><creatorcontrib>Bruijn, Adrie</creatorcontrib><creatorcontrib>Hegger, Ingrid</creatorcontrib><creatorcontrib>Alves, Teresa Leonardo</creatorcontrib><collection>Wiley-Blackwell Open Access Collection</collection><collection>Wiley Free Archive</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health &amp; 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This study aimed to evaluate the impact of these actions on awareness, knowledge and implementation in practises of healthcare professionals (HCP). Methods Web‐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. Results We 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. Conclusions Awareness 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.</abstract><cop>Chichester, UK</cop><pub>John Wiley &amp; Sons, Inc</pub><pmid>39586738</pmid><doi>10.1002/pds.70057</doi><tpages>14</tpages><orcidid>https://orcid.org/0000-0002-8142-9807</orcidid><orcidid>https://orcid.org/0000-0001-6226-5491</orcidid><orcidid>https://orcid.org/0000-0003-0482-5563</orcidid><orcidid>https://orcid.org/0000-0001-7835-8246</orcidid><orcidid>https://orcid.org/0000-0002-3442-8158</orcidid><orcidid>https://orcid.org/0000-0001-5712-1338</orcidid><oa>free_for_read</oa></addata></record>
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1099-1557
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subjects Adenovirus Vaccines - administration & dosage
Adenoviruses
Adult
Communication
COVID-19
COVID-19 - epidemiology
COVID-19 - prevention & control
COVID-19 vaccines
COVID-19 Vaccines - administration & dosage
Cross-Sectional Studies
Europe - epidemiology
Female
Health care
Health Knowledge, Attitudes, Practice
Health Personnel - statistics & numerical data
healthcare professionals
Humans
Immunization
Male
Medical personnel
Middle Aged
Original
Professionals
regulatory actions
risk communication
SARS‐CoV‐2 adenovirus vector vaccines
Surveys and Questionnaires
Thrombocytopenia
Thrombocytopenia - epidemiology
Thrombosis
Thrombosis - epidemiology
Thrombosis - etiology
Thrombosis - prevention & control
thrombosis with thrombocytopenia syndrome
Vaccines
title Impact of Regulatory Risk Communication on Thrombosis With Thrombocytopenia Syndrome for COVID‐19 Adenovirus Vector Vaccines on European Healthcare Professionals
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