Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study

Detalhes bibliográficos
Autor(a) principal: Martin, Fabiola
Data de Publicação: 2015
Outros Autores: Inoue, Eisuke, Cortese, Irene C. M, Kruschewsky, Ramon de Almeida, Adonis, Adine, Grassi, Maria Fernanda Rios, Castro Filho, Bernardo Galvão, Jacobson, Steven, Yamano, Yoshihisa, Taylor, Graham P, Bland, Martin
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/13949
Resumo: University of York. Centre for Immunology and Infection. Department of Biology. Hull York Medical School, York, UK
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spelling Martin, FabiolaInoue, EisukeCortese, Irene C. MKruschewsky, Ramon de AlmeidaAdonis, AdineGrassi, Maria Fernanda RiosCastro Filho, Bernardo GalvãoJacobson, StevenYamano, YoshihisaTaylor, Graham PBland, Martin2016-04-20T17:22:15Z2016-04-20T17:22:15Z2015MARTIN, F. et al. Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study. Martin et al. Pilot and Feasibility Studies, v. 1, p. 35, 2015.2055-5784https://www.arca.fiocruz.br/handle/icict/1394910.1186/s40814-015-0031-1engBioMed CentralTimed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility studyinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversity of York. Centre for Immunology and Infection. Department of Biology. Hull York Medical School, York, UKNational Centre for Child Health and Development. National Medical Centre for Children and Mothers. Research Institute. Tokyo, JapanNational Institutes of Health. National Institute of Neurological Disorders and Stroke. Bethesda, USAFundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Bahian School of Medicine and Public Health. EBMSP. Salvador, BA, BrasilImperial College London. Department of Medicine. Section of Virology. London, UKFundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Bahian School of Medicine and Public Health. EBMSP. Salvador, BA, BrasilFundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil / Bahian School of Medicine and Public Health. EBMSP. Salvador, BA, BrasilNational Institutes of Health. National Institute of Neurological Disorders and Stroke. Bethesda, USAInstitute of Medical Science, St. Marianna University Graduate School of Medicine. Department of Rare Diseases Research. Kawasaki, Japan.National Institutes of Health. National Institute of Neurological Disorders and Stroke. Bethesda, USAUniversity of York. Department of Health Sciences. York, UKBackground: To advance the treatment of HTLV-1-associated myelopathy/tropical spastic paraparesis (HAM/TSP), randomised controlled therapeutic studies with appropriate and sensitive outcomes are reuired. One candidate outcome is the 10-metre walk test (10MWT), a patient-centred, simple and functional measure. To calculate sample size based on 10MWT as the primary outcome, variability within and between subjects must be known. Methods: Data on 10MWT from 76 patients with HAM/TSP were prospectively collected from four specialist centres in Brazil, Japan, USA and UK. Data, collected at two time points, 6 months apart, were log transformed and subjected to analysis of covariance. Results: Baseline mean (standard deviation = SD), median 10MWT were 23.5 (18.9), 16.3 s/10 m and at 6 months 24.9 (23.9), 16.4 s/10 m. The mean (SD) % increase in walk time was 5.74 % (28.2 %). After logarithmic transformation, the linear correlation between baseline and 24 weeks 10MWT was r = 0.938. Using these data, it was determined that a randomised controlled trial with 30 participants per group would have 90 % power to detect a 19 % decrease or a 23 % increase in 10MWT. Conclusions: The intra-patient variability of 10MWT is relatively small in HAM/TSP over 6 months. 10MWT is a feasible outcome measure for a clinical trial in HAM/TSP. To our knowledge, this is the first ever recommendation for the sample size required for trials in HAM/TSP patientsHTLVMyelopathyHAM/TSP10-metre walk testSample sizeClinical trialRare diseaseinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-82991https://www.arca.fiocruz.br/bitstream/icict/13949/1/license.txt5a560609d32a3863062d77ff32785d58MD51ORIGINALMartin F Timed walk as primary....pdfMartin F Timed walk as primary....pdfapplication/pdf563439https://www.arca.fiocruz.br/bitstream/icict/13949/2/Martin%20F%20Timed%20walk%20as%20primary....pdfe8101f872e309aeec0a8231eb7bce763MD52TEXTMartin F Timed walk as primary....pdf.txtMartin F Timed walk as primary....pdf.txtExtracted 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dc.title.pt_BR.fl_str_mv Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
title Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
spellingShingle Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
Martin, Fabiola
HTLV
Myelopathy
HAM/TSP
10-metre walk test
Sample size
Clinical trial
Rare disease
title_short Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
title_full Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
title_fullStr Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
title_full_unstemmed Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
title_sort Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study
author Martin, Fabiola
author_facet Martin, Fabiola
Inoue, Eisuke
Cortese, Irene C. M
Kruschewsky, Ramon de Almeida
Adonis, Adine
Grassi, Maria Fernanda Rios
Castro Filho, Bernardo Galvão
Jacobson, Steven
Yamano, Yoshihisa
Taylor, Graham P
Bland, Martin
author_role author
author2 Inoue, Eisuke
Cortese, Irene C. M
Kruschewsky, Ramon de Almeida
Adonis, Adine
Grassi, Maria Fernanda Rios
Castro Filho, Bernardo Galvão
Jacobson, Steven
Yamano, Yoshihisa
Taylor, Graham P
Bland, Martin
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Martin, Fabiola
Inoue, Eisuke
Cortese, Irene C. M
Kruschewsky, Ramon de Almeida
Adonis, Adine
Grassi, Maria Fernanda Rios
Castro Filho, Bernardo Galvão
Jacobson, Steven
Yamano, Yoshihisa
Taylor, Graham P
Bland, Martin
dc.subject.en.pt_BR.fl_str_mv HTLV
Myelopathy
HAM/TSP
10-metre walk test
Sample size
Clinical trial
Rare disease
topic HTLV
Myelopathy
HAM/TSP
10-metre walk test
Sample size
Clinical trial
Rare disease
description University of York. Centre for Immunology and Infection. Department of Biology. Hull York Medical School, York, UK
publishDate 2015
dc.date.issued.fl_str_mv 2015
dc.date.accessioned.fl_str_mv 2016-04-20T17:22:15Z
dc.date.available.fl_str_mv 2016-04-20T17:22:15Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv MARTIN, F. et al. Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study. Martin et al. Pilot and Feasibility Studies, v. 1, p. 35, 2015.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/13949
dc.identifier.issn.none.fl_str_mv 2055-5784
dc.identifier.doi.none.fl_str_mv 10.1186/s40814-015-0031-1
identifier_str_mv MARTIN, F. et al. Timed walk as primary outcome measure of treatment response in clinical trials for HTLV-1- associated myelopathy: a feasibility study. Martin et al. Pilot and Feasibility Studies, v. 1, p. 35, 2015.
2055-5784
10.1186/s40814-015-0031-1
url https://www.arca.fiocruz.br/handle/icict/13949
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
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instacron:FIOCRUZ
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