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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Northwell Health
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Teed Score
Study Overview
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.
Detailed Description
Background
Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are the two most common complications of clinical hyperbaric oxygen treatment (HBO2T) though these disorders can present in other settings. There are currently two alternative systems used to grade otic barotrauma in patients: the Teed Score (TEED) and the O'Neill Grading System (OGS). The TEED is the most commonly used grading system originally described in 1944 and contains five grades based on a single physician examination (1). There have been modifications to the TEED over the years included six grades, hence the TEED as modified by Macfie and Edmonds is commonly known as the Modified TEED Scale (2, 3). The TEED is not specific for the evaluation and treatment of middle ear barotrauma in patients undergoing HBO2T, pilots or airline passengers, soldiers exposed to explosive ordinance, recreational scuba divers, individuals driving to altitude, swimming injuries due to free diving to depths without equalization, loud sound pressure injuries, but rather to submariners practicing submarine escape training (1).
Otoscopy is commonly performed on all patients who present with these complaints and to hyperbaric oxygen patients prior to treatment. Though it is often performed on patients having difficulty equalizing middle ear pressure during the compression and/or decompression phase of the hyperbaric treatments. Although the results from these otoscopic examinations are used to determine the diagnosis and proper course of treatment for the ETD or MEB, the TEED may not correlate with the consistency of diagnosis, the clinical approach to relieving symptoms, or the definitive course of treatment for the otic barotrauma (2,3).
The OGS is a simplified classification system of ETD and MEB limiting the evaluation to three grade levels as opposed to six levels using the modified TEED classification system(4).
Literature Review
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Hyperbaric Nurses
- •Nurse Practitioners
- •HyperbaricTechnicians
- •Physician Assistants
Exclusion Criteria
- •1-Refusal to participate upon invitation.
Outcomes
Primary Outcomes
Teed Score
Time Frame: 3 months
Grade score by Healthcare provider, Teed Grade 0 - 5
O'Neill Grading System (OGS)
Time Frame: 3 months
Grade score by Healthcare provider. O'Neill Grade 0 - 2
Secondary Outcomes
No secondary outcomes reported