Assessment of an App Based on Artificial Intelligence for Purulent AOM Diagnosis in a Pediatric Department (OMA-IA)

Fondation Lenval

Status: Completed

Conditions: Otitis Media, Suppurative

Treatments: Other: AOM diagnosis without app; Other: AOM diagnosis with app

Study type: Interventional

Funder types: Other

Identifiers

NCT04752891

20-HPNCL-07

Details and patient eligibility

About

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

Full description

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

Enrollment: 203 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

A sign (s) of vital distress Trans-tympanic drains

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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203 participants in 2 patient groups

AOM diagnosis with app

Experimental group

Treatment:

Other: AOM diagnosis with app

AOM diagnosis without app

Other group

Treatment:

Other: AOM diagnosis without app