Standardization of criteria for adolescent idiopathic scoliosis brace studies: SRS Committee on Bracing and Nonoperative Management

Study Design. Literature review. Objective. To establish consistent parameters for future adolescent idiopathic scoliosis bracing studies so that valid and reliable comparisons can be made. Summary of Background Data. Current bracing literature lacks consistency for both inclusion criteria and the definitions of brace effectiveness. Methods. A total of 32 brace treatment studies and the current bracing in adolescent idiopathic scoliosis proposal were analyzed to: (1) determine inclusion criteria that will best identify those patients most at risk for progression, (2) determine the most appropriate definitions for bracing effectiveness, and (3) identify additional variables that would provide valuable information. Results. Early brace studies lacked clarity in their inclusion criteria. In more recent studies, inclusion criteria have narrowed considerably to include primarily those patients most at risk for curve progression who may benefit from the use of a brace. Brace effectiveness was usually defined by various degrees of curve progression at maturity. Less frequently, it was defined by the resultant curve magnitude at maturity, whether or not surgical intervention was needed, or if there was change to another brace. Conclusions. Optimal inclusion criteria for future adolescent idiopathic scoliosis brace studies consist of: age is 10 years or older when brace is prescribed, Risser 0-2, primary curve angles 25°-40°, no prior treatment, and, if female, either premenarchal or less than 1 year postmenarchal. Assessment of brace effectiveness should include: (1) the percentage of patients who have ≤5° curve progression and the percentage of patients who have ≥6° progression at maturity, (2) the percentage of patients with curves exceeding 45° at maturity and the percentage who have had surgery recommended/undertaken, and (3) 2-year follow-up beyond maturity to determine the percentage of patients who subsequently undergo surgery. All patients, regardless of subjective reports on compliance, should be included in the results (intent to treat). Every study should provide results stratified by curve type and size grouping.