The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research
Autor(a) principal: | |
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Data de Publicação: | 2018 |
Outros Autores: | , , , , , , , , , , , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Repositório Institucional da UFRN |
Texto Completo: | https://repositorio.ufrn.br/handle/123456789/52440 |
Resumo: | OBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers. RESULTS All patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT). CONCLUSIONS Clinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers. Clinical trial registration no.: NCT02098252 (clinicaltrials.gov). |
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Magro, ElsaGentric, Jean-ChristopheBatista, André LimaKotowski, MarcChaalala, ChirazRoberge, DavidWeill, AlainStapf, ChristianRoy, DanielBojanowski, Michel WDarsaut, Tim EKlink, RubyRaymond, Jean2023-05-16T20:47:06Z2023-05-16T20:47:06Z2018-06MAGRO, Elsa; GENTRIC, Jean-Christophe; BATISTA, André Lima; KOTOWSKI, Marc; CHAALALA, Chiraz; ROBERGE, David; WEILL, Alain; STAPF, Christian; ROY, Daniel; BOJANOWSKI, Michel W.. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. Journal Of Neurosurgery, [S.L.], v. 128, n. 6, p. 1823-1829, jun. 2018. Journal of Neurosurgery Publishing Group (JNSPG). http://dx.doi.org/10.3171/2017.2.jns162751https://repositorio.ufrn.br/handle/123456789/5244010.3171/2017.2.JNS162751Journal of neurosurgeryAVM = arteriovenous malformationCHUM = Centre Hospitalier de l’Université de MontréalRCT = randomized care trialTOBAS = Treatment of Brain AVMs StudybAVM = brain AVMbrain arteriovenous malformationcare trialmRS = modified Rankin Scalerandomized trialruptured AVMunruptured AVMvascular disordersThe Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and researchinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleOBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers. RESULTS All patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT). CONCLUSIONS Clinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers. Clinical trial registration no.: NCT02098252 (clinicaltrials.gov).porreponame:Repositório Institucional da UFRNinstname:Universidade Federal do Rio Grande do Norte (UFRN)instacron:UFRNinfo:eu-repo/semantics/openAccessORIGINALTreatmentBrainAVMs_Batista_etal_2022.pdfTreatmentBrainAVMs_Batista_etal_2022.pdfapplication/pdf2172581https://repositorio.ufrn.br/bitstream/123456789/52440/1/TreatmentBrainAVMs_Batista_etal_2022.pdf9ee6699368d3da74f354426387f8bfdfMD51LICENSElicense.txtlicense.txttext/plain; charset=utf-81484https://repositorio.ufrn.br/bitstream/123456789/52440/2/license.txte9597aa2854d128fd968be5edc8a28d9MD52123456789/524402023-05-16 17:47:44.246oai:https://repositorio.ufrn.br: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Repositório de PublicaçõesPUBhttp://repositorio.ufrn.br/oai/opendoar:2023-05-16T20:47:44Repositório Institucional da UFRN - Universidade Federal do Rio Grande do Norte (UFRN)false |
dc.title.pt_BR.fl_str_mv |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
title |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
spellingShingle |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research Magro, Elsa AVM = arteriovenous malformation CHUM = Centre Hospitalier de l’Université de Montréal RCT = randomized care trial TOBAS = Treatment of Brain AVMs Study bAVM = brain AVM brain arteriovenous malformation care trial mRS = modified Rankin Scale randomized trial ruptured AVM unruptured AVM vascular disorders |
title_short |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
title_full |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
title_fullStr |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
title_full_unstemmed |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
title_sort |
The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research |
author |
Magro, Elsa |
author_facet |
Magro, Elsa Gentric, Jean-Christophe Batista, André Lima Kotowski, Marc Chaalala, Chiraz Roberge, David Weill, Alain Stapf, Christian Roy, Daniel Bojanowski, Michel W Darsaut, Tim E Klink, Ruby Raymond, Jean |
author_role |
author |
author2 |
Gentric, Jean-Christophe Batista, André Lima Kotowski, Marc Chaalala, Chiraz Roberge, David Weill, Alain Stapf, Christian Roy, Daniel Bojanowski, Michel W Darsaut, Tim E Klink, Ruby Raymond, Jean |
author2_role |
author author author author author author author author author author author author |
dc.contributor.author.fl_str_mv |
Magro, Elsa Gentric, Jean-Christophe Batista, André Lima Kotowski, Marc Chaalala, Chiraz Roberge, David Weill, Alain Stapf, Christian Roy, Daniel Bojanowski, Michel W Darsaut, Tim E Klink, Ruby Raymond, Jean |
dc.subject.por.fl_str_mv |
AVM = arteriovenous malformation CHUM = Centre Hospitalier de l’Université de Montréal RCT = randomized care trial TOBAS = Treatment of Brain AVMs Study bAVM = brain AVM brain arteriovenous malformation care trial mRS = modified Rankin Scale randomized trial ruptured AVM unruptured AVM vascular disorders |
topic |
AVM = arteriovenous malformation CHUM = Centre Hospitalier de l’Université de Montréal RCT = randomized care trial TOBAS = Treatment of Brain AVMs Study bAVM = brain AVM brain arteriovenous malformation care trial mRS = modified Rankin Scale randomized trial ruptured AVM unruptured AVM vascular disorders |
description |
OBJECTIVE The management of brain arteriovenous malformations (bAVMs) remains controversial. The Treatment of Brain AVMs Study (TOBAS) was designed to manage patients with bAVMs within a clinical research framework. The objective of this study was to study trial feasibility, recruitment rates, patient allocation to the various management groups, and compliance with treatment allocation. METHODS TOBAS combines two randomized care trials (RCTs) and a registry. Designed to be all-inclusive, the study offers randomized allocation of interventional versus conservative management to patients eligible for both options (first RCT), a second RCT testing the role of preembolization as an adjunct to surgery or radiotherapy, and a registry of patients managed using clinical judgment alone. The primary outcome of the first RCT is death from any cause or disabling stroke (modified Rankin Scale score > 2) at 10 years. A pilot phase was initiated at one center to test study feasibility, record the number and characteristics of patients enrolled in the RCTs, and estimate the frequency of crossovers. RESULTS All patients discussed at the multidisciplinary bAVM committee between June 2014 and June 2016 (n = 107) were recruited into the study; 46 in the randomized trials (23 in the first RCT with 21 unruptured bAVMs, 40 in the second RCT with 17 unruptured bAVMs, and 17 in both RCTs), and 61 patients in the registry. Three patients crossed over from surgery to observation (first RCT). CONCLUSIONS Clinical research was successfully integrated with normal practice using TOBAS. Recruitment rates in a single center are encouraging. Whether the trial will provide meaningful results depends on the recruitment of a sufficient number of participating centers. Clinical trial registration no.: NCT02098252 (clinicaltrials.gov). |
publishDate |
2018 |
dc.date.issued.fl_str_mv |
2018-06 |
dc.date.accessioned.fl_str_mv |
2023-05-16T20:47:06Z |
dc.date.available.fl_str_mv |
2023-05-16T20:47:06Z |
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 |
MAGRO, Elsa; GENTRIC, Jean-Christophe; BATISTA, André Lima; KOTOWSKI, Marc; CHAALALA, Chiraz; ROBERGE, David; WEILL, Alain; STAPF, Christian; ROY, Daniel; BOJANOWSKI, Michel W.. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. Journal Of Neurosurgery, [S.L.], v. 128, n. 6, p. 1823-1829, jun. 2018. Journal of Neurosurgery Publishing Group (JNSPG). http://dx.doi.org/10.3171/2017.2.jns162751 |
dc.identifier.uri.fl_str_mv |
https://repositorio.ufrn.br/handle/123456789/52440 |
dc.identifier.doi.none.fl_str_mv |
10.3171/2017.2.JNS162751 |
identifier_str_mv |
MAGRO, Elsa; GENTRIC, Jean-Christophe; BATISTA, André Lima; KOTOWSKI, Marc; CHAALALA, Chiraz; ROBERGE, David; WEILL, Alain; STAPF, Christian; ROY, Daniel; BOJANOWSKI, Michel W.. The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research. Journal Of Neurosurgery, [S.L.], v. 128, n. 6, p. 1823-1829, jun. 2018. Journal of Neurosurgery Publishing Group (JNSPG). http://dx.doi.org/10.3171/2017.2.jns162751 10.3171/2017.2.JNS162751 |
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https://repositorio.ufrn.br/handle/123456789/52440 |
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Journal of neurosurgery |
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Journal of neurosurgery |
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