Diagnosing acute otitis media using a smartphone otoscope; a randomized controlled trial.

BACKGROUND: The CellScope Oto® is a smartphone otoscope attachment allowing physicians to share diagnostic-quality images of the ears. Our primary objective was to evaluate the residents' accuracy in diagnosing acute otitis media in children using the CellScope Oto® attachment compared to traditional otoscope.

METHODS: A randomized crossover controlled trial was performed at a single, tertiary care, pediatric emergency department. Participants were a convenience sample of preschool children, consulting for fever and respiratory symptoms. All children were evaluated by two residents randomized to use the CellScope Oto® smartphone device or a traditional otoscope. The primary outcome was the diagnostic accuracy of residents in ear evaluation compared to pediatric otolaryngologist's using binocular microscopy. Secondary outcomes included the need for a second ear exam by the treating physician and parental preference.

RESULTS: Between August 2015 and June 2016, 90 residents examined 100 patients. Six patients were excluded, leaving 94 children evaluated twice. Diagnostic accuracies were 0.69 (95% CI: 0.52 to 0.75) for the residents using a traditional otoscope and 0.74 (95% CI: 0.68 to 0.80) for those using the CellScope Oto® for an absolute difference of 0.06 (95% CI: -0.03 to 0.15). The emergency physicians reported no need for a control exam in 49/91 (54%) situations. Finally, 44 (47%) families preferred the CellScope Oto®, 26 (28%) the traditional otoscope and 23 (25%) had no preference.

CONCLUSIONS: Residents using the CellScope Oto® had accuracies as good as those using the traditional otoscope to evaluate the ears of young children at risk of acute otitis media. www.clinicaltrials.gov: Identifier NCT02521597.