ABSTRACT
Abstract Objective: To assess the diagnostic agreement between smartphone-enabled otoscopy and rigid otoendoscopy in tympanic membrane and middle ear diseases. Methods: A cross-sectional study was carried out to analyze otoscopies in patients seen at a general otorhinolaryngology (ORL) outpatient clinic, from June to December 2019. Eighty-three images of patients obtained from otoscopies performed through a smartphone device and a rigid endoscope were included, recorded, and stored for further analysis. The images were first analyzed by an experienced otologist, who assigned his diagnostic impression (defined as the gold standard) on each of the images. After this analysis, the images were displayed to a group of secondary raters (an experienced otorhinolaryngologist, a second-year resident in ORL, and a general practitioner). A questionnaire was applied related to each image. Results: There was high agreement between the smartphone device and the otoendoscopy images for all professionals, with a Kappa coefficient of 0.97 (p < 0.001). The smartphone device showed a diagnostic sensitivity of 81.1% and a specificity of 71.1%. As for the otoendoscopy, it showed a sensitivity of 84.7% and a specificity of 72.4%. The image classification as "2 = Good" was the most frequent one, with 34.9% for otoendoscopy and 31.6% for the smartphone device. Conclusion: There was a high diagnostic agreement between smartphone device-guided otoscopy and the rigid otoendoscopy, demonstrating the feasibility of using this device in clinical practice. Level of Evidence: 3