Mobile Otoscopy - Efficacy of Residents to Diagnose Acute Otitis Media Using a Smartphone Otoscope Attachment
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Cellscope; Traditional otoscope
Intervention type(s): Device; Device
Intervention description(s): The CellScope Oto, is a portable video-otoscope that allows residents and staff to share diagnostic-quality images; Use of a regular otoscope
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic