Evaluation of an augmented reality-assisted system for standardizing spirometry (AR-SPIRO trial): Protocol for three-stage system development, agreement validation, and pragmatic implementation.

OBJECTIVE: Spirometry, the gold-standard diagnostic tool for chronic obstructive pulmonary disease, is limited in primary care due to shortages of qualified technicians and inconsistent testing quality. Evidence for augmented reality (AR)-assisted spirometry remains limited. This three-stage study aims to evaluate the task performance, operational efficiency, cost-effectiveness, and usability of an AR-assisted spirometry system, AR-SPIRO. METHODS: The pre-evaluation stage included system development, technical verification, and usability testing. In Phase 1, a single-center randomized crossover agreement validation and usability evaluation study will compare the quality of spirometry between the AR-assisted and senior technician-led modes using weighted Kappa coefficients. In Phase 2, a multi-center, open-label, pragmatic, randomized implementation evaluation will be conducted at 14 primary care institutions. High-risk participants will be randomly assigned to AR-assisted or technician-led guidance. AR-SPIRO integrates a portable spirometer, a mobile terminal for real-time flow data processing, and AR glasses for synchronized visual-auditory feedback. RESULTS: The AR-SPIRO system has been developed, and technical verification and preliminary usability testing have been completed. The study protocol has been finalized, and the Phase 1 agreement validation and Phase 2 pragmatic implementation evaluation are planned according to the predefined protocol. CONCLUSION: AR-SPIRO is expected to provide standardized spirometry guidance in primary care. This trial will provide evidence for the usability and implementation value of AR-SPIRO in resource-limited settings.