Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations

BACKGROUND: The lack of standardization of clinical diagnostic criteria, classification and severity scores of chronic graft-versus-host disease led the National Institutes of Health to propose consensus criteria for the purpose of clinical trials. METHODS: Here we describe a one-day workshop model...

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Main Authors: Rita de Cássia Barbosa da Silva Tavares, Márcia de Matos Silva, Luis Fernando da Silva Bouzas, Maria Cláudia Rodrigues, Afonso Celso Vigorito, Vaneusa Funke, Marcos Mauad, Maria Elvira Pizzigatti Correa, Clarissa Vasconcellos de Souza, Elenaide Nunes, Alessandra Ferrari, Ariana Paixão, Talita Martins, Érika Pallottino, Mary Evelyn Dantas Flowers
Format: Article
Language:English
Published: Elsevier 2011-10-01
Series:Revista Brasileira de Hematologia e Hemoterapia
Subjects:
Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842011000500012
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author Rita de Cássia Barbosa da Silva Tavares
Márcia de Matos Silva
Luis Fernando da Silva Bouzas
Maria Cláudia Rodrigues
Afonso Celso Vigorito
Vaneusa Funke
Marcos Mauad
Maria Elvira Pizzigatti Correa
Clarissa Vasconcellos de Souza
Elenaide Nunes
Alessandra Ferrari
Ariana Paixão
Talita Martins
Érika Pallottino
Mary Evelyn Dantas Flowers
author_facet Rita de Cássia Barbosa da Silva Tavares
Márcia de Matos Silva
Luis Fernando da Silva Bouzas
Maria Cláudia Rodrigues
Afonso Celso Vigorito
Vaneusa Funke
Marcos Mauad
Maria Elvira Pizzigatti Correa
Clarissa Vasconcellos de Souza
Elenaide Nunes
Alessandra Ferrari
Ariana Paixão
Talita Martins
Érika Pallottino
Mary Evelyn Dantas Flowers
author_sort Rita de Cássia Barbosa da Silva Tavares
collection DOAJ
description BACKGROUND: The lack of standardization of clinical diagnostic criteria, classification and severity scores of chronic graft-versus-host disease led the National Institutes of Health to propose consensus criteria for the purpose of clinical trials. METHODS: Here we describe a one-day workshop model conducted by the Chronic Graft-versus-Host Disease Brazil-Seattle Consortium Study Group to train investigators interested in participating in multicenter clinical trials in Brazil. Workshop participants included eight transplant physicians, one dermatologist, two dentists, three physical therapists and one psychologist from five institutions. Workshop participants evaluated nine patients with varying degrees of severity of mucocutaneous lesions and other manifestations of the disease followed by a training session to review and discuss the issues encountered with the evaluation and scoring of patients and in the methods used to evaluate grip strength and the 2-minute walk test. RESULTS: Most participants had difficulties in rating the percentage of each type of mucocutaneous lesion and thought 20 minutes was insufficient to evaluate and record the scores of each patient using the National Institutes of Health criteria and other cutaneous assessments. Several specific areas of difficulties encountered by the evaluators were: 1) determining the percentage of erythema in movable and non-movable sclerosis, 2) whether to score all cutaneous findings in a particular area or just the dominant lesion; 3) clarification of the definition of poikiloderma in chronic graft-versus-host disease; 4) discrepant interpretation of the mouth score and 5) clarification on the methodology used for the evaluation of grip strength and the 2-minute walk tests. CONCLUSIONS: Results of this workshop support the need to train investigators participating in clinical trials on chronic graft-versus-host disease.
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spelling doaj.art-a14c5b6243964c6789e4d136163744482022-12-22T02:58:59ZengElsevierRevista Brasileira de Hematologia e Hemoterapia1516-84841806-08702011-10-0133535836610.5581/1516-8484.20110099Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendationsRita de Cássia Barbosa da Silva TavaresMárcia de Matos SilvaLuis Fernando da Silva BouzasMaria Cláudia RodriguesAfonso Celso VigoritoVaneusa FunkeMarcos MauadMaria Elvira Pizzigatti CorreaClarissa Vasconcellos de SouzaElenaide NunesAlessandra FerrariAriana PaixãoTalita MartinsÉrika PallottinoMary Evelyn Dantas FlowersBACKGROUND: The lack of standardization of clinical diagnostic criteria, classification and severity scores of chronic graft-versus-host disease led the National Institutes of Health to propose consensus criteria for the purpose of clinical trials. METHODS: Here we describe a one-day workshop model conducted by the Chronic Graft-versus-Host Disease Brazil-Seattle Consortium Study Group to train investigators interested in participating in multicenter clinical trials in Brazil. Workshop participants included eight transplant physicians, one dermatologist, two dentists, three physical therapists and one psychologist from five institutions. Workshop participants evaluated nine patients with varying degrees of severity of mucocutaneous lesions and other manifestations of the disease followed by a training session to review and discuss the issues encountered with the evaluation and scoring of patients and in the methods used to evaluate grip strength and the 2-minute walk test. RESULTS: Most participants had difficulties in rating the percentage of each type of mucocutaneous lesion and thought 20 minutes was insufficient to evaluate and record the scores of each patient using the National Institutes of Health criteria and other cutaneous assessments. Several specific areas of difficulties encountered by the evaluators were: 1) determining the percentage of erythema in movable and non-movable sclerosis, 2) whether to score all cutaneous findings in a particular area or just the dominant lesion; 3) clarification of the definition of poikiloderma in chronic graft-versus-host disease; 4) discrepant interpretation of the mouth score and 5) clarification on the methodology used for the evaluation of grip strength and the 2-minute walk tests. CONCLUSIONS: Results of this workshop support the need to train investigators participating in clinical trials on chronic graft-versus-host disease.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842011000500012Graft vs. host diseaseGraft vs. host diseaseHematopoietic stem cell transplantationTraining
spellingShingle Rita de Cássia Barbosa da Silva Tavares
Márcia de Matos Silva
Luis Fernando da Silva Bouzas
Maria Cláudia Rodrigues
Afonso Celso Vigorito
Vaneusa Funke
Marcos Mauad
Maria Elvira Pizzigatti Correa
Clarissa Vasconcellos de Souza
Elenaide Nunes
Alessandra Ferrari
Ariana Paixão
Talita Martins
Érika Pallottino
Mary Evelyn Dantas Flowers
Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations
Revista Brasileira de Hematologia e Hemoterapia
Graft vs. host disease
Graft vs. host disease
Hematopoietic stem cell transplantation
Training
title Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations
title_full Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations
title_fullStr Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations
title_full_unstemmed Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations
title_short Brazilian workshop model to train investigators in chronic graft-versus-host disease clinical trials according to the 2005-2006 National Institutes of Health recommendations
title_sort brazilian workshop model to train investigators in chronic graft versus host disease clinical trials according to the 2005 2006 national institutes of health recommendations
topic Graft vs. host disease
Graft vs. host disease
Hematopoietic stem cell transplantation
Training
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1516-84842011000500012
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