@article{d485ac3861ac4ddaa1257529d5b33bc4,
title = "Design of the bracing in adolescent idiopathic scoliosis trial (BrAIST)",
abstract = "Study Design. Descriptive. Objective. To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST). Summary of Background Data. 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. Conclusion. 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.",
keywords = "Adolescent idiopathic scoliosis, Bracing, Clinical trials, Natural history, Orthotics, Outcomes, Phase iii study",
author = "Weinstein, {Stuart L.} and Dolan, {Lori A.} and Wright, {James G.} and Dobbs, {Matthew B.}",
note = "Funding Information: From the * 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. Acknowledgment date: May 17, 2013. Revision date: July 22, 2013. Acceptance date: August 16, 2013. The device(s)/drug(s) that is/are the subject of this manuscript is/are exempt from FDA or corresponding national regulations. The project described was supported by Award Numbers R21AR049587 and R01AR052113 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (Weinstein SL, PI); the Shriners Hospitals for Children (#79125, Dobbs, MB, PI); the Canadian Institutes of Health Research (FRN-81050, Wright JG, PI); the University of Rochester (Sanders JO, PI); the Children{\textquoteright}s Mercy Hospitals & Clinics (Price NJ, PI); and the Children{\textquoteright}s Miracle Network (Weinstein SL, PI). Funding Information: *Site was original supported by internal funds; currently supported by the NIH. NIH indicates National Institutes of Health. Funding Information: Figure 1 is an overview of the major organizational components of BrAIST. The executive committee included the NIH principal investigator, the Clinical Trial director, the principal investigators of the Canadian Institute of Health Research and Shrine grants, the director of the Data Management Center (DMC), and a representative from the NIAMS. Three major work groups resided at the University of Iowa. The Clinical Trial director and the staff of the Clinical Coordinating Center (CCC) implemented the policies and procedures set by the PI and the executive committee and coordinated the activities of the DMC, the Radiographic Reading Center (RRC), and the clinical sites. Funding Information: Development of the science and infrastructure of the trial was supported by a Clinical Trial Planning Grant (R21-AR-49587) from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) of the National Institutes of Health (NIH). The BrAIST planning grant had 4 general goals: (1) appointing key personnel and creating the structural organization of the trial; (2) developing procedures for data management and safety monitoring; (3) developing materials, methods, and the data analysis plan; and (4) recruiting participating institutions. Beyond these goals, most resources during the planning grant phase were directed at demonstrating feasibility: establishing the ethics of randomization 70; estimating the willingness of adolescents and their parents to enroll into a randomized trial, and their preferences for treatment and their required benefit 71; and determining the reliability and validity of the brace wear monitoring system. 72 Funding from the NIH/NIAMS for the clinical trial was obtained in September 2006 (RO1-AR-O52113); support for central administration and clinical sites was also obtained through the Canadian Institute of Health Research and the Shriners Hospitals for Children.",
year = "2013",
month = oct,
day = "1",
doi = "10.1097/01.brs.0000435048.23726.3e",
language = "English",
volume = "38",
pages = "1832--1841",
journal = "Spine",
issn = "0362-2436",
number = "21",
}