Trial Outcomes & Findings for Evaluation of Cellphone Based Otoscopy in Pediatric Patients (NCT NCT04296448)

Results Overview

Concordance of trainee and supervisor utilizing the OMgrade scale, between traditional otoscope and cellscope. Concordance is determined by the concordance-statistic (0-1) in a logistic regression model. The closer the number is to 1 the higher the concordance.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

197 participants

Primary outcome timeframe

6 months

Results posted on

2021-08-26

Participant Flow

Participant milestones

Participant milestones
Measure	Traditional Otoscope Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.	Cellscope Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams. Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Overall Study STARTED	98	99
Overall Study COMPLETED	98	99
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sex was not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traditional Otoscope n=98 Participants Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.	Cellscope n=99 Participants Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams. Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.	Total n=197 Participants Total of all reporting groups
Age, Customized 21 years and younger	98 Participants n=98 Participants	99 Participants n=99 Participants	197 Participants n=197 Participants
Sex: Female, Male Female	—	—	0 Participants Sex was not collected from any participant.
Sex: Female, Male Male	—	—	0 Participants Sex was not collected from any participant.
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	98 Participants n=98 Participants	99 Participants n=99 Participants	197 Participants n=197 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 7 from the cell scope arm.

Concordance of trainee and supervisor utilizing the OMgrade scale, between traditional otoscope and cellscope. Concordance is determined by the concordance-statistic (0-1) in a logistic regression model. The closer the number is to 1 the higher the concordance.

Outcome measures

Outcome measures
Measure	Traditional Otoscope n=96 Participants Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.	Cellscope n=92 Participants Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams. Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Concordance of Trainee and Supervisor Utilizing the OMgrade Scale as Assessed by the Concordance-statistic	0.64 concordance-statistic Interval 0.57 to 0.7	0.75 concordance-statistic Interval 0.69 to 0.81

SECONDARY outcome

Timeframe: 6 months

Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 8 from the cell scope arm.

Kappa statistic (Fleiss' Kappa) of trainee and supervisor utilizing the OMgrade scale. The kappa statistic ranges from 0-1. The closer the number is to 1 the higher the agreement.

Outcome measures

Outcome measures
Measure	Traditional Otoscope n=96 Participants Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.	Cellscope n=91 Participants Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams. Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Interrater Reliability as Assessed by a Kappa Statistic	0.37 Fleiss' Kappa Interval 0.24 to 0.51	0.67 Fleiss' Kappa Interval 0.57 to 0.78

SECONDARY outcome

Timeframe: 6 months

Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 6 from the cell scope arm.

Number of patients who receive antibiotics between traditional otoscope and cellscope.

Outcome measures

Outcome measures
Measure	Traditional Otoscope n=96 Participants Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.	Cellscope n=93 Participants Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams. Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Number of Patients Who Receive Antibiotics	21 Participants	11 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 2 subjects were excluded from analysis due to incomplete surveys in the traditional otoscope arm, and 7 from the cell scope arm.

Number of participants who receive a repeat examination between traditional otoscope and cellscope.

Outcome measures

Outcome measures
Measure	Traditional Otoscope n=96 Participants Pediatric trainees use a traditional otoscope to evaluate pediatric patient ears. Trainees' supervisors will also evaluate patients with the traditional otoscope. The study evaluates concordance of the exams.	Cellscope n=92 Participants Pediatric trainees use a cellphone otoscope (Cellscope) to evaluate pediatric patient ears. Trainees' supervisors will evaluate patients remotely with the video on the cellphone otoscope. The study evaluates concordance of the exams. Cellscope: Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
Number of Participants Who Receive a Repeat Examination	94 Participants	25 Participants

Adverse Events

Traditional Otoscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cellscope

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Therese Canares

Johns Hopkins University Department o Peidaitrics Division of Pediatric Emergency Medicne

Phone: (410) 955-6146‬

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place