The target population for this study was patients with high-risk adolescent idiopathic scoliosis who met current indications for brace treatment: an age of 10 to 15 years, skeletal immaturity (defined as a Risser grade [a measure of the amount of ossification and eventual fusion of the iliac apophysis, on a scale of 0 to 5, with higher grades indicating greater skeletal maturity] of 0, 1, or 214 (link)), and a Cobb angle for the largest curve of 20 to 40 degrees.15 (link) To be eligible, patients could not have received previous treatment for adolescent idiopathic scoliosis (Table S2 in the Supplementary Appendix ). Eligibility was determined by the local investigators. Standard information about the trial was presented to eligible patients by means of an online education module.
Patients who declined participation in the study were registered as screened, and their age, sex, race and ethnic group, curve type,16 Cobb angle of the largest curve, and reason for declining were recorded in a Web-based enrollment system. Patients providing assent to randomization received a computer-generated assignment to bracing or observation, which was stratified according to curve type (single thoracic curve vs. all other curves); patients in the preference cohort chose bracing or observation. Written informed consent from the parent or guardian was required before any study procedures were initiated.
Patients who declined participation in the study were registered as screened, and their age, sex, race and ethnic group, curve type,16 Cobb angle of the largest curve, and reason for declining were recorded in a Web-based enrollment system. Patients providing assent to randomization received a computer-generated assignment to bracing or observation, which was stratified according to curve type (single thoracic curve vs. all other curves); patients in the preference cohort chose bracing or observation. Written informed consent from the parent or guardian was required before any study procedures were initiated.
