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

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          Abstract

          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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          Author and article information

          Journal
          J. Neurosurg.
          Journal of neurosurgery
          Journal of Neurosurgery Publishing Group (JNSPG)
          1933-0693
          0022-3085
          Jun 2018
          : 128
          : 6
          Affiliations
          [1 ] Service de Neurochirurgie, CHU Cavale Blanche, INSERM UMR 1101 LaTIM, Brest.
          [2 ] Service de Radiologie, CHU Cavale Blanche, INSERM EA 3878 GETBO, Brest, France.
          [3 ] Department of Radiology, Service of Neuroradiology, Notre-Dame Hospital, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal.
          [4 ] Department of Surgery, Service of Neurosurgery.
          [5 ] Department of Radio-oncology, and.
          [6 ] Department of Neurosciences, Centre Hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec.
          [7 ] Department of Surgery, Division of Neurosurgery, University of Alberta Hospital, Mackenzie Health Sciences Centre, Edmonton, Alberta; and.
          [8 ] Interventional Neuroradiology Laboratory, Centre Hospitalier de l'Université de Montréal (CHUM) Research Centre, Montreal, Quebec, Canada.
          Article
          10.3171/2017.2.JNS162751
          28862547

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