Smartphone-enabled otoscopy: method evaluation in clinical practice

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

摘要 目的：评估智能手机辅助耳镜检查（smartphone-enabled otoscopy）与硬质耳内镜（rigid otoendoscopy）在鼓膜（tympanic membrane）及中耳疾病（middle ear diseases）诊断中的一致性。
方法：本研究为横断面研究（cross-sectional study），纳入2019年6月至12月于耳鼻咽喉科（otorhinolaryngology, ORL）普通门诊就诊的患者，对其耳镜检查资料进行分析。共纳入并记录存储83例患者分别通过智能手机设备与硬质内镜完成耳镜检查所得的图像，用于后续分析。首先由一名经验丰富的耳科医师对所有图像进行评估，为每张图像给出诊断结论（该结论被视为金标准）。评估完成后，将图像展示给一组二级评估者：一名经验丰富的耳鼻咽喉科医师、一名耳鼻咽喉科二年级住院医师以及一名全科医师，并针对每张图像发放调查问卷。
结果：所有评估者的智能手机设备耳镜检查图像与硬质耳内镜图像均显示出较高的诊断一致性，Kappa系数（Kappa coefficient）为0.97（p < 0.001）。智能手机设备的诊断灵敏度（sensitivity）为81.1%，诊断特异度（specificity）为71.1%；硬质耳内镜的诊断灵敏度为84.7%，诊断特异度为72.4%。图像分级为“2=良好”的占比最高，硬质耳内镜图像占34.9%，智能手机设备图像占31.6%。
结论：智能手机辅助耳镜检查与硬质耳内镜的诊断一致性较高，证明该设备在临床实践中应用具有可行性。
证据等级：3级