title: Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).
abstract: METHODS
  Descriptive.
  
  
  OBJECTIVE
  To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).
  
  
  BACKGROUND
  Bracing has remained the standard of care for the nonoperative treatment of adolescent idiopathic scoliosis since the introduction of the Milwaukee brace in the late 1940s, but it has never been subjected to a rigorous evaluation of either its efficacy or its effectiveness. The BrAIST was designed to address the primary question: Do braces (specifically a thoracolumbosacral orthosis) lower the risk of curve progression to a surgical threshold (≥50°) in patients with adolescent idiopathic scoliosis relative to watchful waiting alone?
  
  
  METHODS
  The authors describe the rationale for BrAIST, including the limitations of the current literature evaluating bracing for adolescent idiopathic scoliosis. Second, the authors describe the preliminary work, including the preparation of the National Institutes of Health clinical trials planning grant. Finally, the authors describe the trial design in detail.
  
  
  RESULTS
  BrAIST was conducted in 25 sites in North America. Subjects were treated either with a thoracolumbosacral orthosis or watchful waiting and followed every 6 months until they reached skeletal maturity or the surgical threshold of 50° Cobb angle.
  
  
  CONCLUSIONS
  Clinical decision making will be improved by translation of the BrAIST results into evidence-based prognosis and estimates of how the prognosis, specifically the risk of progressing to surgery, may be altered by the use of bracing.
  
  
  METHODS
  N/A.
authors.affiliation: *Department of Orthopaedics and Rehabilitation, University of Iowa, Iowa City, IA †Department of Surgery, The Hospital for Sick Children, Toronto, Ontario, Canada, and the Division of Orthopedic Surgery, University of Toronto, Toronto, Ontario, Canada; and ‡Department of Orthopaedic Surgery, Washington University School of Medicine and St. Louis Shriners Hospital for Children, St. Louis, MO.
authors.forename: Stuart L
authors.initials: SL
authors.lastname: Weinstein
authors.forename: Lori A
authors.initials: LA
authors.lastname: Dolan
authors.forename: James G
authors.initials: JG
authors.lastname: Wright
authors.forename: Matthew B
authors.initials: MB
authors.lastname: Dobbs
mesh_terms: D000293:Adolescent; D001915:Braces; D002170:Canada; D002648:Child; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016014:Linear Models; D016015:Logistic Models; D008297:Male; D011859:Radiography; D012107:Research Design; D012600:Scoliosis / Q000000981:diagnostic imaging* / Q000628:therapy*; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014481:United States; D057832:Watchful Waiting
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