Sequential allocation to balance prognostic factors in a psychiatric clinical trial
Autor(a) principal: | |
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Data de Publicação: | 2009 |
Outros Autores: | , , , |
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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Clinics |
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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 |
_version_ |
1800222754771828736 |