Sequential allocation to balance prognostic factors in a psychiatric clinical trial

Detalhes bibliográficos
Autor(a) principal: Fossaluza, Victor
Data de Publicação: 2009
Outros Autores: Diniz, Juliana Belo, Pereira, Basilio de Bragança, Miguel, Eurípedes Constantino, Pereira, Carlos Alberto de Bragança
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Clinics
Texto Completo: https://www.revistas.usp.br/clinics/article/view/18049
Resumo: OBJECTIVE: This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. METHOD: Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. RESULTS: We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment. CONCLUSION: Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602.
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spelling Sequential allocation to balance prognostic factors in a psychiatric clinical trial Clinical researchRandomizationAitchison's compositional distance OBJECTIVE: This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. METHOD: Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. RESULTS: We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment. CONCLUSION: Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602. Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo2009-06-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://www.revistas.usp.br/clinics/article/view/1804910.1590/S1807-59322009000600005Clinics; Vol. 64 No. 6 (2009); 511-518 Clinics; v. 64 n. 6 (2009); 511-518 Clinics; Vol. 64 Núm. 6 (2009); 511-518 1980-53221807-5932reponame:Clinicsinstname:Universidade de São Paulo (USP)instacron:USPenghttps://www.revistas.usp.br/clinics/article/view/18049/20114Fossaluza, VictorDiniz, Juliana BeloPereira, Basilio de BragançaMiguel, Eurípedes ConstantinoPereira, Carlos Alberto de Bragançainfo:eu-repo/semantics/openAccess2012-05-22T18:53:13Zoai:revistas.usp.br:article/18049Revistahttps://www.revistas.usp.br/clinicsPUBhttps://www.revistas.usp.br/clinics/oai||clinics@hc.fm.usp.br1980-53221807-5932opendoar:2012-05-22T18:53:13Clinics - Universidade de São Paulo (USP)false
dc.title.none.fl_str_mv Sequential allocation to balance prognostic factors in a psychiatric clinical trial
title Sequential allocation to balance prognostic factors in a psychiatric clinical trial
spellingShingle Sequential allocation to balance prognostic factors in a psychiatric clinical trial
Fossaluza, Victor
Clinical research
Randomization
Aitchison's compositional distance
title_short Sequential allocation to balance prognostic factors in a psychiatric clinical trial
title_full Sequential allocation to balance prognostic factors in a psychiatric clinical trial
title_fullStr Sequential allocation to balance prognostic factors in a psychiatric clinical trial
title_full_unstemmed Sequential allocation to balance prognostic factors in a psychiatric clinical trial
title_sort Sequential allocation to balance prognostic factors in a psychiatric clinical trial
author Fossaluza, Victor
author_facet Fossaluza, Victor
Diniz, Juliana Belo
Pereira, Basilio de Bragança
Miguel, Eurípedes Constantino
Pereira, Carlos Alberto de Bragança
author_role author
author2 Diniz, Juliana Belo
Pereira, Basilio de Bragança
Miguel, Eurípedes Constantino
Pereira, Carlos Alberto de Bragança
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Fossaluza, Victor
Diniz, Juliana Belo
Pereira, Basilio de Bragança
Miguel, Eurípedes Constantino
Pereira, Carlos Alberto de Bragança
dc.subject.por.fl_str_mv Clinical research
Randomization
Aitchison's compositional distance
topic Clinical research
Randomization
Aitchison's compositional distance
description OBJECTIVE: This paper aims to describe and discuss a minimization procedure specifically designed for a clinical trial that evaluates treatment efficacy for OCD patients. METHOD: Aitchison's compositional distance was used to calculate vectors for each possibility of allocation in a covariate adaptive method. Two different procedures were designed to allocate patients in small blocks or sequentially one-by-one. RESULTS: We present partial results of this allocation procedure as well as simulated data. In the clinical trial for which this procedure was developed, successful balancing between treatment arms was achieved. Separately, in an exploratory analysis, we found that if the arrival order of patients was altered, most patients were allocated to a different treatment arm than their original assignment. CONCLUSION: Our results show that the random arrival order of patients determine different assignments and therefore maintains the unpredictability of the allocation method. We conclude that our proposed procedure allows for the use of a large number of prognostic factors in a given allocation decision. Our method seems adequate for the design of the psychiatric trials used as models. Trial registrations are available at clinicaltrials.gov NCT00466609 and NCT00680602.
publishDate 2009
dc.date.none.fl_str_mv 2009-06-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://www.revistas.usp.br/clinics/article/view/18049
10.1590/S1807-59322009000600005
url https://www.revistas.usp.br/clinics/article/view/18049
identifier_str_mv 10.1590/S1807-59322009000600005
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv https://www.revistas.usp.br/clinics/article/view/18049/20114
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
publisher.none.fl_str_mv Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo
dc.source.none.fl_str_mv Clinics; Vol. 64 No. 6 (2009); 511-518
Clinics; v. 64 n. 6 (2009); 511-518
Clinics; Vol. 64 Núm. 6 (2009); 511-518
1980-5322
1807-5932
reponame:Clinics
instname:Universidade de São Paulo (USP)
instacron:USP
instname_str Universidade de São Paulo (USP)
instacron_str USP
institution USP
reponame_str Clinics
collection Clinics
repository.name.fl_str_mv Clinics - Universidade de São Paulo (USP)
repository.mail.fl_str_mv ||clinics@hc.fm.usp.br
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