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Enrolling by invitationNCT04726306OGSUpdated Jun 10, 2026

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

An observational study in Otic Barotrauma, Pressure Injury and Ear Injury, sponsored by Northwell Health. Enrolling by invitation at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-06-10.

Sponsored by Northwell Health · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
30
Sex
All
01

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.

Read the 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

A background search using PubMed without any restrictions on study type, date, language, country of origin, was carried out and no validation studies of either the TEED or the OGS grading system could be found. No studies comparing either of the two systems for consistency or uniformity of diagnoses were discovered or available for retrieval.

Specific Aims

The goal of this study is to determine if using either the OGS or TEED will provide consistent and uniform results in grading barotrauma. The study will determine if the OGS and TEED can be used by all clinical examiners including those seeing patients for suspected barotrauma in the community setting including medical professionals who routinely see patients undergoing clinical hyperbaric oxygen treatments (hyperbaric physicians, nurses, and technologists), in order to determine if (1) both systems yield consistent results regardless of the system used for grading barotrauma and (2) whether there will there be consistent results among the various professionals (physicians vs nurses vs. CHT's) performing the otoscopic evaluation.

Study Question and Research Hypothesis

Is there a difference in precision and accuracy when scoring and grading ETD and MEB in patients between clinical staff members based on the type of scoring/grading system used?

Ho: There is no difference in precision or accuracy when grading ETD and MEB between examiners using either the TEED or the OGS grading systems.

Ha: There is a difference in precision and accuracy when grading ETD and MEB between examiners using either the TEED or the OGS grading system.

Ho: There is no difference in diagnostic precision and accuracy when grading ETD and MEB based on training level of examiners using either the TEED or the OGS grading system.

Ha: There is no difference in diagnostic precision and accuracy when grading ETD and MEB based on training level of examiners using either the TEED or the OGS grading system.

Methods

Inclusion criteria

All patients photographed between March of 2013 and June of 2019 that developed symptoms undergoing hyperbaric oxygen therapy were selected and deidentified. This involved retrieving all documented photographic images of ETD and MEB to score/grade the degree of otic barotrauma. These patients all had baseline photographs taken of the external ear canal and tympanic membrane as part of the pre-treatment standardized protocol in our department. Baseline photographs (normal) are included in the retrieved images. The photographs were initially screened and any images that were blurry to the degree that rendered scoring/grading impossible were excluded. Images considered interpretable despite blurring or partial obstruction due to cerumen or hair were included. This was done to maximize the use of photos that reflect the varying quality of images encountered in everyday clinical treatment conditions using otoscopy. The candidate physicians, hyperbaric nurses, nurse practitioners, and physician assistants will not be limited to any specialty, however at the technician level the study was limited to those working in the hyperbaric medicine setting.

Sample size

The participants will review and independently grade a total of 120 otoscopic photos of tympanic membranes taken between March 2013 through June 2019. The photos include normal and abnormal images representing tympanic membranes with all levels of Eustachian tube dysfunction or middle ear barotrauma following hyperbaric pressurization that required a hold due to patient subjective ear symptoms.

The photo images were taken from actual hyperbaric patients seen at our facility with the exception of 10 photos. The 10 photographs included from outside sources were necessary to ensure inclusion of all stages of otic barotrauma including severe stages.

All participants in the study will be provided with instructions regarding the study both verbally and in writing. The study participants grading and scoring the ETD/MEB photos will have various levels of professional clinical training and will include physicians, nurses, and technologists.

Participants will use the modified TEED placard commonly used in hyperbaric centers as a reference in selecting the appropriate TEED score for each of the photos. Simultaneously, they will utilize the OGS placard as a reference in selecting the appropriate OGS grade for each of the photos.

The TEED will be used without the benefit of a baseline photo, which was not required when this system was developed in 1944 and subsequently modified. The OGS system will be used initially without the use of a baseline photo, this is similar to the intended use of the TEED. The OGS system will subsequently be graded separately with the benefit of a comparison baseline photo in accordance with the intended use in hyperbaric treatment centers where baseline photos can be readily obtained. Baseline photos could potentially be obtained in other settings beyond hyperbaric clinical settings e.g. pilots, navy divers, etc.

Data Analysis

There will be three levels of comparison of precision and accuracy in using these two scales. The first comparison will evaluate the consistency displayed using each grading system (TEED and OGS) independently without the knowledge of the baseline status of the tympanic membrane prior to trauma. The second level of comparison will evaluate both grading systems for precision and accuracy as compared to each other. The third level of comparison will have the reviewers compare a baseline photo of the patient's tympanic membrane taken prior to hyperbaric treatment and pressurization to the post treatment traumatic photo and provide an OGS grade as the OGS was intended to be used in hyperbaric patients or in other settings where an available baseline photo may be available.

The analysis will include the use of a kappa statistic for comparison between observed agreement and expected agreement for each of the scoring/grading systems comparing clinical examiners reviewing the images (5). The Fleiss kappa statistic will be used for comparison since 3 or more clinical examiners observers will score and grade the photo images (6).

A comparison of the kappa statistics with respect to scoring/grading system used, and level of training will be analyzed.

Ethical Considerations

The study uses de-identified archived photos of external ear canals and tympanic membranes. A protocol was submitted to the IRB and approved prior to the conduct of this study.

Funding Sources

None

02

Conditions studied

  • Otic Barotrauma
  • Pressure Injury
  • Ear Injury
  • Barotitis
  • Barotrauma
03

In context

Pressure Ulcer

545 studies on the registry are indexed under Pressure Ulcer; 129 are open to participants now.

This study's planned enrollment of 30 is below the median of 138 across 110 observational studies indexed under Pressure Ulcer.

Browse Pressure Ulcer studies →

Lead sponsor

Northwell Health is the lead sponsor of 475 studies on the registry; 107 are open to participants now.

Of its 45 completed or terminated interventional studies of FDA-regulated products, 23 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Physicians
  2. Hyperbaric Nurses
  3. Nurse Practitioners
  4. HyperbaricTechnicians
  5. Physician Assistants

Exclusion criteria

Exclusion Criteria:

1-Refusal to participate upon invitation.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testOtic Barotrauma Grading System

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

06

What researchers measure

Primary outcomes

  1. Teed Score

    Grade score by Healthcare provider, Teed Grade 0 - 5

    Time frame: 3 months

  2. O'Neill Grading System (OGS)

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

    Time frame: 3 months

07

Study locations

1 site
  • Phelps Hospital Northwell Health
    Sleepy Hollow, New York 10591, United States
08

References and documents

Publications

  • 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.
  • 2. Edmonds C, Bennett M, Lippman J, Mitchell SJ. Ear Barotrauma. Ch. 7, Pgs. 86 - 87. Diving and Subaquatic Medicine 5th ed.
  • MACFIE DD. E.N.T PROBLEMS OF DIVING. Med Serv J Can. 1964 Dec;20:845-61. No abstract available. PubMed 14235646 ↗
  • 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. PubMed 26152108 ↗
  • McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb). 2012;22(3):276-82. PubMed 23092060 ↗
  • 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. PubMed 26095449 ↗

Individual participant data

Plan to share: Undecided — In Progress

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Feb 2023 (actual). Primary completion is estimated for Dec 2026, 46 months after the start.

Of 49 observational studies under Pressure Ulcer, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 141. This study's planned 46 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 22, 2021
First posted
Jan 27, 2021
StartActual
Feb 1, 2023
Primary completionEst.
Dec 31, 2026
CompletionEst.
Mar 31, 2027
Last update
Jun 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04726306
Lead sponsor
Northwell Health
Responsible party
Sponsor
First posted
Jan 27, 2021
Start date
Feb 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Mar 31, 2027 (estimated)
Last update
Jun 10, 2026

Study contacts

David Dayya, DO, PhD, MPH
principal investigator · Phelps Hospital Northwell Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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