Adolescent Idiopathic Scoliosis Trial Research Articles

Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST): Development and Validation of a Prognostic Model in Untreated Adolescent Idiopathic Scoliosis Using the Simplified Skeletal Maturity System

Study DesignPrognostic study and validation using prospective clinical trial data. ObjectiveTo derive and validate a model predicting curve progression to ≥45° before skeletal maturity in untreated patients with adolescent idiopathic scoliosis (AIS). Summary of Background DataStudies have linked the natural history of AIS with characteristics such as sex, skeletal maturity, curve magnitude, and pattern. The Simplified Skeletal Maturity Scoring System may be of particular prognostic utility for the study of curve progression. The reliability of the system has been addressed; however, its value as a prognostic marker for the outcomes of AIS has not. The BrAIST trial followed a sample of untreated AIS patients from enrollment to skeletal maturity, providing a rare source of prospective data for prognostic modeling. MethodsThe development sample included 115 untreated BrAIST participants. Logistic regression was used to predict curve progression to ≥45° (or surgery) before skeletal maturity. Predictors included the Cobb angle, age, sex, curve type, triradiate cartilage, and skeletal maturity stage (SMS). Internal and external validity was evaluated using jackknifed samples of the BrAIST data set and an independent cohort (n = 152). Indices of discrimination and calibration were estimated. A risk classification was created and the accuracy evaluated via the positive (PPV) and negative predictive values (NPV). ResultsThe final model included the SMS, Cobb angle, and curve type. The model demonstrated strong discrimination (c-statistics 0.89–0.91) and calibration in all data sets. The classification system resulted in PPVs of 0.71–0.72 and NPVs of 0.85–0.93. ConclusionsThis study provides the first rigorously validated model predicting a short-term outcome of untreated AIS. The resultant estimates can serve two important functions: 1) setting benchmarks for comparative effectiveness studies and 2) most importantly, providing clinicians and families with individual risk estimates to guide treatment decisions. Level of EvidenceLevel 1, prognostic.

Brace Treatment for Adolescent Idiopathic Scoliosis.

In the past, numerous non-operative treatments for adolescent idiopathic scoliosis (AIS), including exercise, physical therapy, electrical stimulation, and brace treatment, have been tried to delay or prevent the curve progression. Of these, brace treatment is the only option that is widely accepted and has demonstrated the efficacy to alter the natural history of AIS. Recently, the importance of brace treatment for AIS has been increasing since the efficacy was objectively established by the BrAIST (Bracing in Adolescent Idiopathic Scoliosis Trial) study in 2013. This editorial article summarizes the current status of brace treatment in patients with AIS and discusses future prospects on the basis of our clinical experiences.

The Effect of the Risser Stage on Bracing Outcome in Adolescent Idiopathic Scoliosis.

To determine the influence of the Risser sign on the need for surgery in children wearing orthoses for the treatment of adolescent idiopathic scoliosis (AIS), data on compliance with brace wear were collected and analyzed. One hundred and sixty-eight patients were prospectively enrolled at the time that brace wear had been prescribed and were followed until the cessation of bracing or the need for surgery. Inclusion criteria were a curve magnitude between 25° and 45°; a Risser stage of 0, 1, or 2; and, if female, <1 year post menarche at the time of brace prescription. Compliance was measured using thermal monitors. The prevalence of surgery, or progression to a curve magnitude of ≥50°, was 44.2% for patients at Risser stage 0 (n = 120), 6.9% for patients at Risser stage 1 (n = 29), and 0% for patients at Risser stage 2 (n = 19). Brace wear averaged 11.3, 13.4, and 14.2 hours per day for the Risser stage-0, 1, and 2 groups, respectively. While the groups had no difference in initial curve magnitude (p = 0.11), more patients at Risser stage 0 had progression to surgery than did patients at Risser stage 1 or stage 2 despite bracing (p < 0.0001). Twenty-six (41.9%) of 62 Risser stage-0 patients who wore braces ≥12.9 hours per day had progression to surgery. Ten patients at Risser stage 0 with closed triradiate cartilage wore braces ≥18 hours per day, and none underwent surgery. In comparison, 7 of 10 patients at Risser stage 0 with open triradiate cartilage and similar daily brace wear underwent surgery. Of 9 patients at Risser stage 0 with open triradiate cartilage who wore braces ≥12.9 hours daily for curves measuring <30°, 7 had a nonsurgical outcome. Patients at Risser stage 0 are at risk for surgery despite brace wear. In these patients, 12.9 hours of daily wear-the number of hours linked with a successful outcome in the BRAIST (Bracing in Adolescent Idiopathic Scoliosis Trial)-did not prevent surgery. Patients with open triradiate cartilage were at highest risk, especially those with curves of ≥30°. Risser stage-0 patients should be prescribed a minimum of 18 hours of brace wear. Bracing should be initiated for curves of <30° in patients at Risser stage 0, especially those with open triradiate cartilage. Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Adolescent Idiopathic Scoliosis: Immaturity Predicts Progression, but Is More Brace Wear Time Beneficial? Commentary on an article by Lori A. Karol, MD, et al.: "The Effect of the Risser Stage on Bracing Outcome in Adolescent Idiopathic Scoliosis".

The study by Karol et al. evaluated the relationship between the Risser stage and bracing outcome for adolescent idiopathic scoliosis (AIS). Previous studies, including the important Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST), have generally described combined results for patients at Risser stages 0, 1, and 21. However, Karol et al. evaluated each stage of maturity independently. Brace wear time was also measured objectively with a thermal monitor in each brace. One hundred and sixty-eight patients were followed from the time of brace delivery until cessation of bracing or surgical intervention. This provided a large cohort of patients at Risser stage 0 for subgroup analysis. One limitation of the study, as noted by the authors, is that some of the subgroups became small, but several useful observations were identified by this study. The rate of progression to a curve magnitude requiring surgery was 44.2% for patients at Risser stage 0, 6.9% for patients at Risser stage 1, and 0% for patients at Risser stage 2. This confirms the importance of growth velocity in scoliosis progression. These findings also call into question all studies that have combined patients at Risser stages 0, 1, and …

Nonsurgical Management of Adolescent Idiopathic Scoliosis.

Pediatric patient visits for spinal deformity are common. Most of these visits are for nonsurgical management of scoliosis, with approximately 600,000 visits for adolescent idiopathic scoliosis (AIS) annually. Appropriate management of scoliotic curves that do not meet surgical indication parameters is essential. Renewed enthusiasm for nonsurgical management of AIS (eg, bracing, physical therapy) exists in part because of the results of the Bracing in Adolescent Idiopathic Scoliosis Trial, which is the only randomized controlled trial available on the use of bracing for AIS. Bracing is appropriate for idiopathic curves between 20° and 40°, with successful control of these curves reported in >70% of patients. Patient adherence to the prescribed duration of wear is essential to maximize the effectiveness of the brace. The choice of brace type must be individualized according to the deformity and the patient's personality as well as the practice setting and brace availability.

Body Image and Quality of Life and Brace Wear Adherence in Females With Adolescent Idiopathic Scoliosis.

Background:Clinical evidence regarding the ability of braces to decrease the risk of curve progression to surgical threshold in patients with adolescent idiopathic scoliosis (AIS) continues to strengthen. Unfortunately, there is still a great deal of uncertainty regarding the impact of brace wear on psychosocial well-being or the impact of psychological well-being on brace wear adherence. The purpose of this study is to evaluate psychosocial well-being, in particular body image and quality of life (QOL), and brace wear adherence in female AIS patients undergoing brace treatment.Methods:The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) was a multicenter, controlled trial using randomized and preference assignments into an observation or brace treatment group. BrAIST patients were skeletally immature adolescents diagnosed with AIS having moderate curve sizes (20 to 40 degrees). Patients in the bracing group were instructed to wear a thoracolumbosacral orthosis, at least 18 h/d. Scores on the Spinal Appearance Questionnaire and the PedsQL4.0 Generic Scales from 167 female BrAIST patients who were randomized to brace treatment (n=58) and patients who chose brace treatment (n=109) were analyzed.Results:At baseline and at 12 months, no differences were found between the least-adherent brace wear group (<6 h/d) and most-adherent brace wear group (≥12 h/d) patients in terms of major curve, body image, and QOL. In the most-adherent group, poorer body image scores were significantly correlated with poorer QOL scores at baseline, at 6 months, and at 12 months but not at 18 months. In general, body image scores and QOL scores were not significantly correlated in the least-adherent group. When comparing patients that had a ≥6 degree increase of their major curve between baseline and 12 months to patients that did not, there were no significant differences in body image or QOL scores.Conclusions:For females adolescents with AIS, body image and QOL do not have a significant impact on brace wear adherence and are subsequently not significantly impacted by brace wear.Level of Evidence:Level II—therapeutic (prospective comparative study).

Body Image and Quality-of-Life in Untreated Versus Brace-Treated Females With Adolescent Idiopathic Scoliosis.

Study Design.The Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST) included skeletally immature high-risk patients with adolescent idiopathic scoliosis (AIS) with moderate curve sizes (20°– 40°). BrAIST was a multicenter, controlled trial using both randomized and preference treatment arms into either an observation group or a brace treatment group.Objective.The aim of this study was to analyze and compare body image and quality-of-life (QOL) in female AIS patients who were observed or treated with a brace.Summary of Background Data.Brace treatment is an effective means for controlling progressive scoliosis and preventing the need for surgery, but there is no consensus regarding the effect of brace treatment on body image or on QOL in adolescents with AIS.Methods.Data from female BrAIST patients in the randomized (n = 132) or preference (n = 187) arms and were observed (n = 120) or brace treated (n = 199) were analyzed. Patients completed the Spinal Appearance Questionnaire (SAQ) and the Pediatric Quality of Life Inventory (PedsQOL) 4.0 Generic Scales at baseline and 6 month follow-up visits up to 2 years. Items on the SAQ measured three body image constructs (self, ideal, and overall). The PedsQOL measured health, activities, feelings, social factors, and school.Results.. In general, there were no significant differences within or between study arms or treatments regarding body image or QOL through 2 years of follow-up. Poorer body image was significantly correlated with poorer QOL during the first 2 years of follow-up regardless of study arm or treatment. Patients who crossed-over to a different treatment and patients with largest Cobb angles ≥ 40 degrees had significantly poorer body image, in particular self-body image, compared with those that did not.Conclusion.This study does not support findings from previous research indicating that wearing a brace has a negative impact on or is negatively impacted by body image or QOL.Level of Evidence: 2

Compliance Counseling Improves Outcomes of Bracing for Patients with Idiopathic Scoliosis. Commentary on an article by Lori A. Karol, MD, et al.: "Effect of Compliance Counseling on Brace Use and Success in Patients with Adolescent Idiopathic Scoliosis".

Until recently, five fundamental questions regarding the orthotic treatment of idiopathic scoliosis have eluded a clear answer: 1. Does bracing prevent the progression of scoliosis? 2. If so, in which patients? 3. What type of brace works best? 4. How many hours per day must the brace be worn in order to be effective? 5. Why do some patients have successful control of their curves while others do not? The first question was addressed in 1995 by a prospective controlled multicenter study sponsored by the Scoliosis Research Society, which showed that only 27% of patients treated with a brace had curve progression versus 63% in a control group1. Subsequently, another well-designed and executed prospective controlled multicenter study, the Bracing in Adolescent Idiopathic Scoliosis Trial (BRAIST)2, confirmed that bracing is effective in controlling the progression of scoliosis. Nevertheless, in that study, brace treatment was (once again) unsuccessful in 27% of patients. It is appropriate to ask why the curve progressed in 27% of the patients despite bracing …

Design of the Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST).

Descriptive. To describe the design and development of Bracing in Adolescent Idiopathic Scoliosis Trial (BrAIST). 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? 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. 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. 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. N/A.

Evaluation of TLSOS in the bracing in adolescent idiopathic scoliosis trial (BrAIST)

Background The success of TLSOs in reducing the risk of curve progression varies widely across published reports. This variation has been linked to patient risk factors such as initial Cobb angle and maturity, and time in brace. Percentage correction has also been associated with outcomes. [1-3] However, no reports have examined characteristics of individual braces, and how these characteristics influence percentage correction, compliance, and eventual outcome.

To BrAIST or not to BrAIST: decisions and characteristics of 1131 patients eligible for the Bracing in Adolescent Idiopathic Scoliosis Trial

Background BrAIST is a partially-randomized trial comparing the outcomes of bracing and observation in children with adolescent idiopathic scoliosis. The purpose of this study is to evaluate 1) whether the BrAIST sample is representative of the target population and 2) whether the treatment arms are equivalent. We addressed these questions by comparing baseline demographic, radiographic and psychosocial characteristics between the groups.

Does orthopaedics need randomized controlled trials?

Does orthopaedics need randomized controlled trials?

BrAIST: planning and current status of Bracing in Adolescent Idiopathic Scoliosis Trial

The randomized controlled trial has emerged as the gold standard for all clinical research. The combination of randomized assignment to groups, use of strict inclusion and exclusion criteria, standardized protocols and ad hoc power analysis serve to rule out many threats to the internal validity of research results. Thus, it is the most powerful methodology available to researchers investigating the relative effectiveness of treatments. To date, there have been only 2 randomized studies examining the effectiveness of bracing for adolescent idiopathic scoliosis. The purpose of this presentation is to discuss the planning and the current status of the Bracing in Adolescent Scoliosis Trial (BrAIST). This five-year, > $5 million project includes 27 healthcare centers, and is funded by the United States National Institutes of Health, the Canadian Institute of Health Research, and the Shriners Hospitals. Additionally, 3 institutions, including the Chinese University of Hong Kong, are participating using internal funding. The protocol randomizes children with AIS who are at high risk for curve progression to treatment with a thoracolumbosacral orthosis or to clinical monitoring. The study is currently in its second year of recruitment. BrAIST incorporates several innovations never used in a single study to date: 1) randomization, 2) objective brace dose monitoring, 3) standardized, objective radiographic measurement, 4) comprehensive radiographic, clinical, and psychosocial testing, 5) diversity of participating sites and 6) ad hoc determination of effect size, based on the risk/benefit considerations of potential patients. Issues to be discussed include • Ethics - rationale for the ethics of an observation arm • Protocol development and implementation - endpoints, measures, quality assurance • Recruitment and randomization - expectations and actuality • Bracing quality control - independent review of in-brace films • Patient/family decision-making - impact of information and being offered a choice • Brace compliance monitoring - reliability/validity of temperature as proxy for dose