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

NCT04726306 | Enrolling By Invitation

• 1 other identifier: 19-0868
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Teed Score

  Grade score by Healthcare provider, Teed Grade 0 - 5

  3 months

• O'Neill Grading System (OGS)

  Grade score by Healthcare provider. O'Neill Grade 0 - 2

  3 months

Interventions

Otic Barotrauma Grading System DIAGNOSTIC_TEST

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Sample of healthcare professionals invited to participate in grading of otic barotrauma.

You may qualify if:

• Physicians
• Hyperbaric Nurses
• Nurse Practitioners
• HyperbaricTechnicians
• Physician Assistants

You may not qualify if:

• Refusal to participate upon invitation.

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Phelps Hospital Northwell Health

Sleepy Hollow, New York, 10591, United States

Location

Related Publications (6)

• 1. Teed RW (Lieutenant Commander, USN). Factors Producing Obstruction of the Auditory Tube in Submarine Personnel. United States Navy Medical Bulletin, Washington: U.S. Govt. Print. Off. Vol. XLII, No. 2. February 1944, pgs. 293-306. Bureau of Medicine and Surgery, Navy Department, Washington, D.C.

  BACKGROUND

• 2. Edmonds C, Bennett M, Lippman J, Mitchell SJ. Ear Barotrauma. Ch. 7, Pgs. 86 - 87. Diving and Subaquatic Medicine 5th ed.

  BACKGROUND

• MACFIE DD. E.N.T PROBLEMS OF DIVING. Med Serv J Can. 1964 Dec;20:845-61. No abstract available.

  PMID: 14235646 BACKGROUND

• O'Neill OJ, Weitzner ED. The O'Neill grading system for evaluation of the tympanic membrane: A practical approach for clinical hyperbaric patients. Undersea Hyperb Med. 2015 May-Jun;42(3):265-71.

  PMID: 26152108 BACKGROUND

• McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb). 2012;22(3):276-82.

  PMID: 23092060 BACKGROUND

• Nelson KP, Edwards D. Measures of agreement between many raters for ordinal classifications. Stat Med. 2015 Oct 15;34(23):3116-32. doi: 10.1002/sim.6546. Epub 2015 Jun 21.

  PMID: 26095449 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer; Barotrauma

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• David Dayya, DO, PhD, MPH

  Phelps Hospital Northwell Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 27, 2021
• Study Start: February 1, 2023
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Locations

US (1)