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

NCT04726306 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2024-10-24

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Otic Barotrauma Grading System

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

Sponsors & Collaborators

  • Northwell Health

    lead OTHER

Principal Investigators

  • David Dayya, DO, PhD, MPH · Phelps Hospital Northwell Health

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04726306 on ClinicalTrials.gov