N/A
Completed N=197
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
Ear Infection · Pediatric Disease · Acute otitis media
Source: ClinicalTrials.gov NCT04296448 ↗
Enrolled (actual)
197
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic — 0.64; 0.75 concordance-statistic
Summary
The Cellscope is an iPhone-based otoscope that uses the iPhone camera and light source to capture HIPAA compliant images and video recordings of the external and middle ear structure. This technology allows multiple providers, at different levels of training, the ability to simultaneously exam a child's external and middle ear structures. The investigators hypothesize this device will result in improved concordance in trainee/supervisor exam findings, increase trainee confidence in exam findings, decreased antibiotic prescriptions, and fewer repeat exams by multiple providers. Thus, this study has the potential to improve physician training and examination confidence, decrease the unnecessary use of antibiotics, and improve the patient/caregiver experience in healthcare interactions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic |
0.64; 0.75 | — |
| SECONDARY Interrater Reliability as Assessed by a Kappa Statistic |
0.37; 0.67 | — |
| SECONDARY Number of Patients Who Receive Antibiotics |
21; 11 | — |
| SECONDARY Number of Participants Who Receive a Repeat Examination |
94; 25 | — |
Eligibility Criteria
Inclusion Criteria
- All trainees and supervisors
- All patients where otoscopy would traditionally be indicated, at the discretion of the clinical team
Exclusion Criteria
- None
Data sourced from ClinicalTrials.gov (NCT04296448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.