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NCT04726306

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

Sponsor: Northwell Health

View on ClinicalTrials.gov

Summary

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.

Official title: A Comparative Analysis of Diagnostic Precision and Accuracy Using the TEED and OGS Clinical Grading Systems for Symptomatic Eustachian Tube Dysfunction and Middle Ear Barotrauma: A Validation Study

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2023-02-01

Completion Date

2025-03-31

Last Updated

2024-10-24

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Otic Barotrauma Grading System

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

Locations (1)

Phelps Hospital Northwell Health

Sleepy Hollow, New York, United States