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Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children : report from an international working group

Identifieur interne : 003157 ( PascalFrancis/Curation ); précédent : 003156; suivant : 003158

Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children : report from an international working group

Auteurs : Francesco Rodeghiero [Italie] ; Roberto Stasi [Italie] ; Terry Gernsheimer [États-Unis] ; Marc Michel [France] ; Drew Provan [Royaume-Uni] ; Donald M. Arnold [États-Unis] ; James B. Bussel [États-Unis] ; Douglas B. Cines [États-Unis] ; Beng H. Chong [Australie] ; Nichola Cooper [Royaume-Uni] ; Bertrand Godeau [France] ; Klaus Lechner [Autriche] ; Maria Gabriella Mazzucconi [Italie] ; Robert Mcmillan [États-Unis] ; Miguel A. Sanz [Espagne] ; Paul Imbach [Suisse] ; Victor Blanchette [États-Unis] ; Thomas Kühne [Suisse] ; Marco Ruggeri [Italie] ; James N. George [États-Unis]

Source :

RBID : Pascal:09-0185117

Descripteurs français

English descriptors

Abstract

Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.
pA  
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A11 03  1    @1 GERNSHEIMER (Terry)
A11 04  1    @1 MICHEL (Marc)
A11 05  1    @1 PROVAN (Drew)
A11 06  1    @1 ARNOLD (Donald M.)
A11 07  1    @1 BUSSEL (James B.)
A11 08  1    @1 CINES (Douglas B.)
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A11 16  1    @1 IMBACH (Paul)
A11 17  1    @1 BLANCHETTE (Victor)
A11 18  1    @1 KÜHNE (Thomas)
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A11 20  1    @1 GEORGE (James N.)
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A14 05      @1 Department of Haematology, Barts and The London School of Medicine and Dentistry @2 London @3 GBR @Z 5 aut.
A14 06      @1 Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University @2 Hamilton, ON @3 USA @Z 6 aut.
A14 07      @1 Weill Cornell Medical College of Cornell University @2 New York, NY @3 USA @Z 7 aut.
A14 08      @1 Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine @2 Philadelphia @3 USA @Z 8 aut.
A14 09      @1 Department of Hematology, St George Hospital, South Eastern Area Laboratory Service @3 AUS @Z 9 aut.
A14 10      @1 Department of Medicine, St George Clinical School, University of New South Wales @2 Sydney @3 AUS @Z 9 aut.
A14 11      @1 Molecular Immunology Unit, Institute of Child Health @2 London @3 GBR @Z 10 aut.
A14 12      @1 Department of Internal Medicine I, Division of Haematology and Haemostaseology, Medical University of Vienna @2 Vienna @3 AUT @Z 12 aut.
A14 13      @1 Department of Cellular Biotechnology and Hematology, La Sapienza University @2 Rome @3 ITA @Z 13 aut.
A14 14      @1 Scripps Research Institute @2 La Jolla, CA @3 USA @Z 14 aut.
A14 15      @1 Hematology Service, Hospital Universitario La Fe @2 Valencia @3 ESP @Z 15 aut.
A14 16      @1 Pediatric Oncology/Hematology, University Children's Hospital Basel @2 Basel @3 CHE @Z 16 aut. @Z 18 aut.
A14 17      @1 Division of Hematology/Oncology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto @2 Toronto, ON @3 USA @Z 17 aut.
A14 18      @1 Hematology-Oncology Section, College of Medicine, Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center @2 Oklahoma City @3 USA @Z 20 aut.
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C01 01    ENG  @0 Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.
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C07 02  X  SPA  @0 Hemopatía @5 37
N21       @1 138
N44 01      @1 OTO
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Pascal:09-0185117

Le document en format XML

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<term>Immune thrombocytopenic purpura</term>
<term>International</term>
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<div type="abstract" xml:lang="en">Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.</div>
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<s0>Hematología</s0>
<s5>12</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Thrombocyte</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Platelet</s0>
<s5>25</s5>
</fC03>
<fC03 i1="10" i2="X" l="SPA">
<s0>Trombocito</s0>
<s5>25</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Homme</s0>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Human</s0>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Hombre</s0>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Hémopathie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Hemopathy</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Hemopatía</s0>
<s5>37</s5>
</fC07>
<fN21>
<s1>138</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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