Evaluating R2Play, A Novel Multidomain Return-to-Play Assessment Tool for Concussion: Mixed Methods Feasibility and Face Validity Study.

Background: Return-to-play guidelines for concussion recommend a multimodal approach to assess recovery, symptoms, exertion tolerance, and cognition. However, existing assessments do not reflect the speed or complexity of multidomain skill integration in sport. We developed R2Play, a dynamic multidomain return-to-play assessment tool, and previously established proof of concept by demonstrating design objectives alignment. Objective: We aim to (1) assess the feasibility of R2Play according to usability, reliability, practicality, and safety; (2) examine physical exertion levels during R2Play as a preliminary marker of face validity; and (3) understand clinician and youth perspectives on the feasibility, face validity, potential value, and challenges associated with R2Play. Methods: A convergent parallel mixed methods design was used. Rehabilitation clinicians were paired with youth cleared to return-to-play postconcussion to complete R2Play together and provide feedback through semistructured interviews. Feasibility was assessed on predefined criteria for usability (clinician ratings on System Usability Scale), practicality (assessment duration), reliability (technical issues), and safety (adverse events). Face validity was evaluated with a target of youth achieving ≥80% of age-predicted maximal heart rate or rating of perceived exertion ≥7/10. Interviews explored perspectives on feasibility and face validity, analyzed using content analysis. Quantitative and qualitative results were merged via joint display to identify areas of convergence, divergence, and complementarity. Results: Participants included 10 youth (ages 13-20 y) with a history of concussion and 5 clinicians (n=2 physiotherapists, n=2 occupational therapists, and n=1 kinesiologist). Success criteria were met or approached for all feasibility domains. Clinician-rated usability was good-to-excellent (System Usability Scale=84.00±6.02), and youth reported that instructions were easy to learn. There were no catastrophic technical or user errors interrupting assessments. Configuration was completed in 5.74 (SD 1.09) minutes, and assessments took 26.50±6.02 minutes. There were no safety or symptom exacerbation incidents requiring assessment modification. R2Play elicited vigorous intensity physical exertion (peak heart rate=90.10±5.78% age-predicted maximal heart rate, peak rating of perceived exertion=5.50±1.72), with target exertion criteria met for 9/10 youth. Clinician and youth feedback confirmed that R2Play reflects elements of sport across physical, cognitive, and perceptual domains, making it a valuable tool for assessing readiness to return-to-play and informing rehabilitation planning for unresolved issues. Mixed methods meta-inferences provided enhanced insights regarding how to improve the usability, practicality, safety, and face validity of R2Play. Conclusions: Findings support the potential feasibility and face validity of R2Play, a multidomain assessment tool for youth with concussion, demonstrating excellent usability, vigorous physical exertion demands, and promising feedback regarding its potential to fill gaps in the return-to-play process among this initial sample from a single site. Future work is underway to establish the cross-site feasibility of R2Play and evaluate its content validity by establishing the physical, cognitive, and perceptual loading of assessment levels.