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

Assessment of an App Based on Artificial Intelligence for Purulent Acute Otitis Media (AOM) Diagnosis in a a Pediatric Emergency Department

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

Study Overview

• Status: Completed
• Conditions: Otitis Media, Suppurative
• Intervention / Treatment: Other: AOM diagnosis with app; Other: AOM diagnosis without app

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nice, France
    • Hôpitaux Pédiatrique de Nice CHU Lenval

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AOM diagnosis with app	Other: AOM diagnosis with app; the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone
Other: AOM diagnosis without app	Other: AOM diagnosis without app; the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
diagnosis of purulent Acute Otitis Media (AOM) made by junior physicians using the i-Nside application associated with Smartscope®	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).	at inclusion
diagnosis of purulent Acute Otitis Media (AOM) made by senior physicians using a standard otoscope	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)	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of misdiagnoses of purulent Acute Otitis Media (AOM) with and without the use of the application	a misdiagnosis is measured by a discordant diagnosis of the juniors compared to the seniors considered as the Gold Standard for the AOM diagnosis	at inclusion
collection risk factors for a discrepancy in the diagnosis of purulent AOM	collection data of age of patients,pain requiring analgesia, period of the day of diagnosis (morning, afternoon,night)	at inclusion
satisfaction of junior physicians regarding the use of the app	a questionnaire will be given at the end of the study. The questions relate to the use of the application and its perceived usefulness by practitioners. Satisfaction will be assessed by a Lickert scale	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Fondation Lenval

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): March 16, 2023

Study Registration Dates

• First Submitted: February 2, 2021
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Otorhinolaryngologic Diseases; Ear Diseases; Suppuration; Otitis; Otitis Media; Otitis Media, Suppurative
• Other Study ID Numbers: 20-HPNCL-07

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No