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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.
 Previous Article | Next Article 
Submitted July 11, 2008
Accepted October 28, 2008
Standardization of terminology, definitions and
outcome criteria in immune thrombocytopenic purpura
(ITP) of adults and children: Report from an
International Working Group
Francesco Rodeghiero*, Roberto Stasi, Terry Gernsheimer, Marc Michel, Drew Provan, Donald M. Arnold, James B. Bussel, Douglas B. Cines, Beng H. Chong, Nichola Cooper, Bertrand Godeau, Klaus Lechner, Maria Gabriella Mazzucconi, Robert McMillan, Miguel A. Sanz, Paul Imbach, Victor Blanchette, Thomas Kuhne, Marco Ruggeri, and James N. George
Department of Hematology, San Bortolo Hospital, Vicenza, Italy
Department of Medical Sciences, Ospedale "Regina Apostolorum", Albano Laziale, Italy
Puget Sound Blood Center, University of Washington School of Medicine, Washington, WA, United States
Service de Medecine Interne, AP-HP, Hopital Henri Mondor, Universite Paris 12, Faculte de Medecine, Creteil, France
Department of Haematology, Bart's & The London School of Medicine and Dentistry, London, United Kingdom
Department of Medicine and Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada
Weill Cornell Medical College, Cornell University, New York, NY, United States
Department of Pathology and Laboratory Medicine, University of Pennsylvania School of Medicine, Philadelphia, PA, United States
Department of Hematology, St George Hospital, SEALS, and Department of Medicine, St George Clinical School, University of New South Wales, Sidney, NSW, Australia
Molecular Immunology Unit, Institute of Child Health, London, United Kingdom
Department of Internal Medicine I, Division Haematology and Haemostaseology, Medical University of Vienna, Vienna, Austria
Department of Cellular Biotechnology and Hematology, La Sapienza University, Roma, Italy
Scripps Research Institute, La Jolla, CA, United States
Hematology Service, Hospital Universitario La Fe, Valencia, Spain
Pediatric Oncology/Hematology, University Children's Hospital Basel, Basel, Switzerland
Division of Hematology/Oncology, The Hospital for Sick Children, Department of Pediatrics, University of Toronto, Toronto, Canada
Hematology-Oncology Section, College of Medicine, Department of Biostatistics and Epidemiology, College of Public Health, University of Oklahoma Health Sciences Center, Oklahoma City, OK, United States
* Corresponding author; email: rodeghiero{at}hemato.ven.it.
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 utilized 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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