Diagnostic Precision and Accuracy Using the TEED and O'Neill Clinical Grading Systems
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|ClinicalTrials.gov Identifier: NCT04726306|
Recruitment Status : Enrolling by invitation
First Posted : January 27, 2021
Last Update Posted : February 9, 2023
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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.
There are two alternative 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 has been found to have limitations among clinicians. The OGS is an alternative grading system with less classification categories than the Teed utilizes. The OGS system is tied directly to treatment decision making, specific to the respective grading level.
This study will utilize a sample of clinical examiners/observers 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 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.
Ho: There is no difference in diagnostic precision and accuracy when grading otic barotrauma between examiners/observers using either the TEED or OGS grading systems.
Ha: There is a difference in diagnostic precision and accuracy when grading otic barotrauma between examiners/observers using either the TEED or OGS grading systems.
|Condition or disease||Intervention/treatment|
|Otic Barotrauma Pressure Injury Ear Injury Barotitis Barotrauma||Diagnostic Test: Otic Barotrauma Grading System|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
|Actual Study Start Date :||February 1, 2023|
|Estimated Primary Completion Date :||May 31, 2023|
|Estimated Study Completion Date :||August 30, 2023|
- Diagnostic Test: Otic Barotrauma Grading System
Otic Barotrauma Grading System Placards for TEED Score and the OGS grading system.
- 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
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- Hyperbaric Nurses
- Nurse Practitioners
1-Refusal to participate upon invitation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04726306
|United States, New York|
|Sleepy Hollow, New York, United States, 10591|
|Principal Investigator:||Owen J O'Neill, MD, MPH||Phelps Hospital Northwell Health|
|Responsible Party:||Owen J O'Neill, MD, MPH, Medical Director, Northwell Health|
|Other Study ID Numbers:||
|First Posted:||January 27, 2021 Key Record Dates|
|Last Update Posted:||February 9, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||In Progress|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Wounds and Injuries