The Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and research

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dc.contributor.authorMagro, Elsa
dc.contributor.authorGentric, Jean-Christophe
dc.contributor.authorBatista, André Lima
dc.contributor.authorKotowski, Marc
dc.contributor.authorChaalala, Chiraz
dc.contributor.authorRoberge, David
dc.contributor.authorWeill, Alain
dc.contributor.authorStapf, Christian
dc.contributor.authorRoy, Daniel
dc.contributor.authorBojanowski, Michel W
dc.contributor.authorDarsaut, Tim E
dc.contributor.authorKlink, Ruby
dc.contributor.authorRaymond, Jean
dc.date.accessioned2023-05-16T20:47:06Z
dc.date.available2023-05-16T20:47:06Z
dc.date.issued2018-06
dc.description.resumoOBJECTIVE 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).pt_BR
dc.identifier.citationMAGRO, 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.jns162751pt_BR
dc.identifier.doi10.3171/2017.2.JNS162751
dc.identifier.urihttps://repositorio.ufrn.br/handle/123456789/52440
dc.languagept_BRpt_BR
dc.publisherJournal of neurosurgerypt_BR
dc.subjectAVM = arteriovenous malformationpt_BR
dc.subjectCHUM = Centre Hospitalier de l’Université de Montréalpt_BR
dc.subjectRCT = randomized care trialpt_BR
dc.subjectTOBAS = Treatment of Brain AVMs Studypt_BR
dc.subjectbAVM = brain AVMpt_BR
dc.subjectbrain arteriovenous malformationpt_BR
dc.subjectcare trialpt_BR
dc.subjectmRS = modified Rankin Scalept_BR
dc.subjectrandomized trialpt_BR
dc.subjectruptured AVMpt_BR
dc.subjectunruptured AVMpt_BR
dc.subjectvascular disorderspt_BR
dc.titleThe Treatment of Brain AVMs Study (TOBAS): an all-inclusive framework to integrate clinical care and researchpt_BR
dc.typearticlept_BR

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