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Blood, 12 March 2009, Vol. 113, No. 11, pp. 2386-2393.
Prepublished online as a Blood First Edition Paper on November 12, 2008; DOI 10.1182/blood-2008-07-162503.
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PERSPECTIVE
Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group
Francesco Rodeghiero1,
Roberto Stasi2,
Terry Gernsheimer3,
Marc Michel4,
Drew Provan5,
Donald M. Arnold6,
James B. Bussel7,
Douglas B. Cines8,
Beng H. Chong9,
Nichola Cooper10,
Bertrand Godeau4,
Klaus Lechner11,
Maria Gabriella Mazzucconi12,
Robert McMillan13,
Miguel A. Sanz14,
Paul Imbach15,
Victor Blanchette16,
Thomas Kühne15,
Marco Ruggeri1, and
James N. George17
1 Department of Hematology, San Bortolo Hospital, Vicenza, Italy;
2 Department of Medical Sciences, Ospedale Regina Apostolorum, Albano Laziale, Italy;
3 Puget Sound Blood Center, University of Washington School of Medicine, Seattle;
4 Université Paris 12, Faculté de Medecine, Assistance Publique-Hôpitaux de Paris (AP-HP), Hopital Henri Mondor, Service de Medecine Interne, Créteil, France;
5 Department of Haematology, Barts and The London School of Medicine and Dentistry, London, United Kingdom;
6 Department of Medicine, Michael G. DeGroote School of Medicine, McMaster University, Hamilton, ON;
7 Weill Cornell Medical College of Cornell University, New York, NY;
8 Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Philadelphia;
9 Department of Hematology, St George Hospital, South Eastern Area Laboratory Service, and Department of Medicine, St George Clinical School, University of New South Wales, Sydney, Australia;
10 Molecular Immunology Unit, Institute of Child Health, London, United Kingdom;
11 Department of Internal Medicine I, Division of Haematology and Haemostaseology, Medical University of Vienna, Vienna, Austria;
12 Department of Cellular Biotechnology and Hematology, La Sapienza University, Rome, Italy;
13 Scripps Research Institute, La Jolla, CA;
14 Hematology Service, Hospital Universitario La Fe, Valencia, Spain;
15 Pediatric Oncology/Hematology, University Children's Hospital Basel, Basel, Switzerland;
16 Division of Hematology/Oncology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, ON; and
17 Hematology-Oncology Section, College of Medicine, Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City
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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