Thrombosis with thrombocytopenia syndrome (TTS) and vaccine-induced immune thrombocytopenia and thrombosis (VITT): Brighton Collaboration case definitions and guidelines for data collection, analysis, and presentation of immunisation safety data
This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials a...
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| Veröffentlicht in: | Vaccine 2024-03, Vol.42 (7), p.1799-1811 |
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| container_title | Vaccine |
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| creator | Schönborn, Linda Pavord, Sue Chen, Vivien Mun Yee Pai, Menaka Gwarzo, Dalha Haliru Buttery, Jim Munoz, Flor M. Tran, Huyen Greinacher, Andreas Law, Barbara |
| description | This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. They are not intended to guide clinical management.
The case definitions were developed by a group of subject matter and Brighton Collaboration process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Safety Platform for Evaluation of vACcines (SPEAC).
The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity. |
| doi_str_mv | 10.1016/j.vaccine.2024.01.045 |
| format | Article |
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The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity.</description><identifier>ISSN: 0264-410X</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2024.01.045</identifier><identifier>PMID: 38302339</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adenoviruses ; Adverse events ; Antibodies ; Case definition ; Clinical trials ; Collaboration ; Cooperation ; COVID-19 vaccines ; Data analysis ; Data collection ; Disease ; Feedback ; Guidelines ; Hematology ; Idiopathic thrombocytopenic purpura ; Immunization ; Pathogenesis ; Pathophysiology ; Pharmacovigilance ; Questionnaires ; Safety ; Thrombocytopenia ; Thrombocytopenia with thrombosis syndrome ; Thromboembolism ; Thrombosis ; TTS ; Vaccination ; Vaccine-induced immune thrombocytopenia and thrombosis ; Vaccines ; VITT ; Working groups</subject><ispartof>Vaccine, 2024-03, Vol.42 (7), p.1799-1811</ispartof><rights>2024 The Author(s)</rights><rights>Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.</rights><rights>2024. The Author(s)</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c440t-131c28b8d07c8390bd49bfd9e452e79c1473759fe9d58bab881c8e8a3bf1ff063</citedby><cites>FETCH-LOGICAL-c440t-131c28b8d07c8390bd49bfd9e452e79c1473759fe9d58bab881c8e8a3bf1ff063</cites><orcidid>0000-0002-0840-5614 ; 0000-0002-6660-9949 ; 0000-0001-9905-2035 ; 0000-0003-1989-959X ; 0000-0002-6053-689X ; 0000-0002-0457-7689</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/2956165282?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3548,27922,27923,45993,64383,64385,64387,72239</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/38302339$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Schönborn, Linda</creatorcontrib><creatorcontrib>Pavord, Sue</creatorcontrib><creatorcontrib>Chen, Vivien Mun Yee</creatorcontrib><creatorcontrib>Pai, Menaka</creatorcontrib><creatorcontrib>Gwarzo, Dalha Haliru</creatorcontrib><creatorcontrib>Buttery, Jim</creatorcontrib><creatorcontrib>Munoz, Flor M.</creatorcontrib><creatorcontrib>Tran, Huyen</creatorcontrib><creatorcontrib>Greinacher, Andreas</creatorcontrib><creatorcontrib>Law, Barbara</creatorcontrib><title>Thrombosis with thrombocytopenia syndrome (TTS) and vaccine-induced immune thrombocytopenia and thrombosis (VITT): Brighton Collaboration case definitions and guidelines for data collection, analysis, and presentation of immunisation safety data</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. They are not intended to guide clinical management.
The case definitions were developed by a group of subject matter and Brighton Collaboration process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Safety Platform for Evaluation of vACcines (SPEAC).
The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity.</description><subject>Adenoviruses</subject><subject>Adverse events</subject><subject>Antibodies</subject><subject>Case definition</subject><subject>Clinical trials</subject><subject>Collaboration</subject><subject>Cooperation</subject><subject>COVID-19 vaccines</subject><subject>Data analysis</subject><subject>Data collection</subject><subject>Disease</subject><subject>Feedback</subject><subject>Guidelines</subject><subject>Hematology</subject><subject>Idiopathic thrombocytopenic purpura</subject><subject>Immunization</subject><subject>Pathogenesis</subject><subject>Pathophysiology</subject><subject>Pharmacovigilance</subject><subject>Questionnaires</subject><subject>Safety</subject><subject>Thrombocytopenia</subject><subject>Thrombocytopenia with thrombosis 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definitions and guidelines for data collection, analysis, and presentation of immunisation safety data</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2024-03-07</date><risdate>2024</risdate><volume>42</volume><issue>7</issue><spage>1799</spage><epage>1811</epage><pages>1799-1811</pages><issn>0264-410X</issn><eissn>1873-2518</eissn><abstract>This is a revision of the online November 2021 Brighton thrombosis with thrombocytopenia syndrome (TTS) case definition and a new Brighton Collaboration case definition for vaccine-induced immune thrombocytopenia and thrombosis (VITT). These case definitions are intended for use in clinical trials and post-licensure pharmacovigilance activities to facilitate safety data comparability across multiple settings. They are not intended to guide clinical management.
The case definitions were developed by a group of subject matter and Brighton Collaboration process experts as part of the Coalition for Epidemic Preparedness Innovations (CEPI)-funded Safety Platform for Evaluation of vACcines (SPEAC).
The case definitions, each with defined levels of diagnostic certainty, are based on relevant published evidence and expert consensus and are accompanied by specific guidelines for TTS and VITT data collection and analysis. The document underwent peer review by a reference group of vaccine safety stakeholders and haematology experts to ensure case definition useability, applicability and scientific integrity.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>38302339</pmid><doi>10.1016/j.vaccine.2024.01.045</doi><tpages>13</tpages><orcidid>https://orcid.org/0000-0002-0840-5614</orcidid><orcidid>https://orcid.org/0000-0002-6660-9949</orcidid><orcidid>https://orcid.org/0000-0001-9905-2035</orcidid><orcidid>https://orcid.org/0000-0003-1989-959X</orcidid><orcidid>https://orcid.org/0000-0002-6053-689X</orcidid><orcidid>https://orcid.org/0000-0002-0457-7689</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Vaccine, 2024-03, Vol.42 (7), p.1799-1811 |
| issn | 0264-410X 1873-2518 |
| language | eng |
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| source | ScienceDirect Journals (5 years ago - present); ProQuest Central UK/Ireland |
| subjects | Adenoviruses Adverse events Antibodies Case definition Clinical trials Collaboration Cooperation COVID-19 vaccines Data analysis Data collection Disease Feedback Guidelines Hematology Idiopathic thrombocytopenic purpura Immunization Pathogenesis Pathophysiology Pharmacovigilance Questionnaires Safety Thrombocytopenia Thrombocytopenia with thrombosis syndrome Thromboembolism Thrombosis TTS Vaccination Vaccine-induced immune thrombocytopenia and thrombosis Vaccines VITT Working groups |
| title | Thrombosis with thrombocytopenia syndrome (TTS) and vaccine-induced immune thrombocytopenia and thrombosis (VITT): Brighton Collaboration case definitions and guidelines for data collection, analysis, and presentation of immunisation safety data |
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