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.