Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 203
- 试验地点
- 1
- 主要终点
- diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
研究概览
简要总结
Otitis media (OM) is one of the most common childhood infections and is a major cause of morbidity in children and results as being the first cause of antibiotic prescription among children in developed countries . An artificial intelligence-based tool could help physicians refine their diagnosis
详细描述
Ear infections in children are very common, particularly acute otitis media (AOM) which represents the first reason for visiting physicians and for antibiotic prescription in children in developed countries. However, the diagnosis is not easy because of the narrowness of the ear canal, the discomfort of the child during the otoscopic exam. Moreover, the accuracy of the AOM diagnosis depends on the subjectivity of the physician mostly. This can result in an misdiagnosis and inappropriate treatment with, as a result, the emergence of multi-resistant germ.
Artificial intelligence (AI) in medicine is booming and has already proven its worth in terms of prevention, monitoring and diagnosis. I-Nside, an app based on Artificial Intelligence is able to make automatic diagnosis of many ear pathologies, after capturing picture of any eardrum using an otoendoscope fixed on a connected smartphone (SmartScope®).
Therefore, the investigators aim to assess the accuracy of AOM diagnosis the existing app, by comparing the inter-rater agreement between the diagnosis made by a senior physician using a traditional otoscope (considered as "gold standard" ) and the one made by a junior physician using the app
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child under 18 years Presenting signs that may suggest acute otitis media (fever, earache, purulent otorrhea) For which the informed written consent of, at least, one of the two parents or the holder of parental authority has been obtained
排除标准
- •A sign (s) of vital distress Trans-tympanic drains
结局指标
主要结局
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®
时间窗: at inclusion
diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle).
diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope
时间窗: at inclusion
diagnosis of purulent AOM is made on an inflammatory aspect of the eardrum with retrotympanic effusion, exteriorized (otorrhea) or not (opacity, effacement of reliefs or bulging, disappearance of the light triangle)
次要结局
- rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application(at inclusion)
- satisfaction of junior physicians regarding the use of the app(through study completion, an average of 1 year)
- collection risk factors for a discrepancy in the diagnosis of purulent AOM(at inclusion)