Identification of important outcomes for surgical and brace treatment of adolescent idiopathic scoliosis

Aims: High-quality clinical trials in adolescent idiopathic scoliosis (AIS) are needed to guide decision-making but progress is hindered by suboptimal selection of outcome measures. Identifying meaningful outcomes for consistent measurement across clinical trials and routine practice is critical. However, there is currently no understanding of which treatment outcome domains are considered important by adolescents, their parents, and healthcare professionals (HCPs). This study is the first to address this gap internationally. Methods: This study represents the first stage of core outcome set (COS) development, following gold-standard guidance. A cross-sectional qualitative interview study with 40 participants (adolescents with AIS, their parents, and HCPs) was conducted. Semi-structured interviews were analyzed to identify and categorize important AIS treatment outcomes. Analytical rigour was ensured through coder agreement and stakeholder consultation. Results: A total of 91 important outcome domains were identified; 53 outcome domains applying to both bracing and surgery, with 15 additional outcome domains for bracing only, and 23 additional outcome domains for surgery only. Of the 91 outcome domains, more than three-quarters (71/91, 78%) related to life impact, with smaller proportions relating to physiological/clinical outcomes (13/91, 14%), resource use (4/91, 4%), and adverse events (1/91, 1%). Conclusion: The current study highlights treatment outcomes considered important by adolescents with AIS, their parents, and HCPs. These findings will inform outcome selection in clinical trials and routine practice, as well as facilitating an ongoing programme of research to develop a COS for evaluating treatment of AIS.