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Evaluation of an augmented reality-assisted system for standardizing spirometry (AR-SPIRO trial): Protocol for
Tianqi Peng1,2, DanJing Hu1, Hanling Zhou1,3
1National Center for Respiratory Medicine, State Key Laboratory of Respiratory Health and Multi-Morbidity, National Office for Chronic Respiratory Disease Prevention and Control, National Clinical Research Center for Respiratory Diseases, Institute of Respiratory Medicine, Chinese Academy of Medical Sciences, Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, China-Japan Friendship Hospital, Beijing, China.
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.