Utilization of the Community Engagement Studio model to facilitate participatory design of a multicenter randomized controlled trial of the efficacy of scoliosis specific exercise rehabilitation

IntroductionEngaging individuals with lived experience enhances the rigor and real-world relevance of clinical research. In adolescent idiopathic scoliosis (AIS), where non-surgical evidence remains limited, involving patients and caregivers informs design, recruitment, and retention for future trials. MethodsUsing the Community Engagement (CE) Studio model, we conducted a 1.5-hour virtual session with children aged 10-16 years with AIS and their caregivers residing in North America. Participants (no spinal surgery; with/without brace) were recruited through engagement databases, advocacy organizations, and social media. A trained facilitator led structured discussions. Responses were thematically synthesized, including summaries related to recruitment, retention, study protocol, meaningful outcomes and treatment success. Participants received compensation and a follow-up Qualtrics survey. The CE Studio, based on the Vanderbilt model is advisory, and IRB- exempt. ResultsOf 81 respondents, 31 were eligible and 18 participated (nine girls, nine caregivers) representing seven ethnicities across nine U.S. states. All participants valued the proposed multicenter RCT on scoliosis exercise rehabilitation and expressed willingness to enroll; 78% would accept randomization to either the active or 6-month waitlist control arm. Reported barriers included limited access to physiotherapy (43%), physician skepticism (57%), and bracing preference (43%). The most bothersome symptoms were pain (50%) and brace discomfort (17%). Prioritized outcomes included preventing curve progression, avoiding surgery, pain reduction, and improved appearance. ConclusionsParticipants expressed strong willingness to enroll, emphasizing pain, progression, and access to care as key barriers. Improved communication with providers about non-surgical options was viewed as essential to support shared decision-making.