Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment — MOTO  

Acute Otitis Media Clinical Trial

Official title: Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment: A Randomized Controlled Trials

Status Completed

Clinical Trial Summary

To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children presenting with respiratory symptoms using a smartphone otoscope attachment compared with a classic otoscope.

Clinical Trial Description

Background: Acute otitis media (AOM) is one of the most common diseases of childhood and a leading cause for health care consultations. While otoscope is the tool traditionally used to diagnose AOM, otoscopic diagnostic skills of both trainees and practitioners appear to be limited. Therefore, new diagnostic methods are continuously developed. One of those devices is a smartphone otoscope attachment called CellScope Oto, a portable video-otoscope that allows residents and staff to share diagnostic-quality images.

Objective: To evaluate the residents' efficacy in diagnosing acute otitis media among febrile children presenting with respiratory symptoms using a smartphone otoscope attachment compared with a classic otoscope.

Methods: This will be a randomized controlled trial evaluating accuracy of evaluation of ears of children visiting the emergency department (ED) for suspected AOM by residents using the CellScope Oto in comparison to a classic otoscope. It will be performed at a single pediatric ED in a tertiary care Hospital. Participants will be children between 1 and 5 years of age presenting with fever and respiratory symptoms. Baselines characteristics of participants will be assessed. Participating residents will be taught how to use the CellScope Oto and will practice with a few patients before being ready to participate in the study. Eligible patients will be recruited during weekdays. If the parents consent, patients will first be evaluated by a staff Pediatric Otolaryngologist using a binocular microscope (gold standard). They will then be evaluated by two participating residents, one using the intervention method and one using the control. Randomization will be used to decide which visualisation method will be used first. After all three exams have been performed, the residents, patients' parent and staff in charge will each be asked to answer a short questionnaire about final diagnosis and confidence in the performed exam, favourite method and the need for a control exam. These questionnaires will be reviewed by a reviewer blinded to the randomization. The primary outcome measure will be the accuracy of AOM diagnosis made by the residents compared with the diagnosis made by a staff Pediatric Otolaryngologist using a binocular microscope. A sample size of 100 participants evaluated twice would provide a power of 80% and an alpha value of 0,05 to demonstrate a difference of 15% in the rate of appropriate diagnosis of AOM by residents using a smartphone otoscope attachment compared with classic otoscope use.

Expected results: The investigators expect to demonstrate a 15% increase in the efficacy rate of AOM diagnosis by residents registered to a paediatrics-related program using a smartphone otoscope attachment compared with a classic otoscope. This device has the potential to change current AOM diagnostic practice and might, in turn, provide a reduced amount of prescriptions made every year for antibiotics. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media

• NCT number: NCT02521597
• Study type: Interventional
• Source: St. Justine's Hospital
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Completion date: June 2016