Diagnostic Precision and Accuracy Using the Teed Scoring System Versus the O'Neill Grading System

Part of paid clinical trials in Sleepy Hollow, New York.

Sponsor
Northwell Health
Study ID
NCT04726306
Status
Enrolling By Invitation

Conditions

  • Barotitis
  • Barotrauma
  • Ear Injury
  • Otic Barotrauma
  • Pressure Injury

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Otic Barotrauma Grading System — DIAGNOSTIC_TEST
    Otic Barotrauma Grading System Placards for TEED Score and the OGS grading system.

Study Details

This validation study investigates the diagnostic precision and accuracy when grading otic barotrauma using two alternative gradings systems including the TEED and the OGS grading systems. Background There are two grading systems used to grade otic barotrauma. They include the Teed Score (TEED) and the O'Neill Grading System (OGS). Teed has been utilized more extensively but among physicians has been found to have limitations. The OGS is an alternative grading system with less classification categories than what the Teed classification system utilizes. The OGS system is tied directly to treatment decision making, specific to the respective grading level. Methods This study will utilize a sample of clinical examiners who will independently grade 120 digital color photos of actual patient tympanic membranes with and without evidence of eustachian tube dysfunction and middle ear barotrauma including variable stages or grades of otic barotrauma. They will use the TEED chart as a reference in selecting the appropriate TEED score for each of the photos. Simultaneously they will also utilize the OGS chart as a reference in selecting the appropriate OGS grade for each of the photos. The grading will be conducted by physicians, nurses, and technicians. This will allow for comparisons at varying provider levels. The comparisons will be made using the kappa statistics across the disciplines. This will allow comparison between observed agreement, and expected agreement due to chance for all reviewers. Research Hypothesis Ho: There is no difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems. Ha: There is a difference in diagnostic precision and accuracy when grading otic barotrauma between clinical examiners using either the TEED or OGS grading systems.

Key Dates

Start date
Feb 1, 2023
Status verified
Jun 2026
Primary completion
Dec 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Teed Score [ Time Frame: 3 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Phelps Hospital Northwell HealthSleepy HollowNew York10591-

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