Project name:

Development and Initial Validation of a Consumer Questionnaire to Predict the Presence of Ear Disease.

Project description:

Kleindienst SJ, Zapala DA, Nielsen DW, Griffith JW, Rishiq D, Lundy L, Dhar S.
Development and Initial Validation of a Consumer Questionnaire to Predict the
Presence of Ear Disease. JAMA Otolaryngol Head Neck Surg. 2017 Aug 3. doi:
10.1001/jamaoto.2017.1175. [Epub ahead of print] PubMed PMID: 28772310.

Importance: The already large population of individuals with age- or
noise-related hearing loss in the United States is increasing, yet hearing aids
remain largely inaccessible. The recent decision by the US Food and Drug
Administration to not enforce the medical examination prior to hearing aid
fitting highlights the need to reengineer consumer protections when increasing
accessibility. A self-administered tool to estimate ear disease risk would
provide disease surveillance without posing an unreasonable barrier to hearing
aid procurement.

Objective: To develop and validate a consumer questionnaire for the
self-assessment of risk for ear diseases associated with hearing loss.

Design, Setting, and Participants: The questionnaire was developed using
established methods including expert opinion to validate and create questions,
and cognitive interviews to ensure that questions were clear to respondents.
Exploratory structural equation modeling, logistic regression, and receiver
operating characteristic curve analysis were used to determine sensitivity and
specificity with blinded neurotologist opinion as the criterion for evaluation.
Patients 40 to 80 years old with ear or hearing complaints necessitating a
neurotologic examination and a control group of participants with a diagnosis of
age- or noise-related hearing loss participated at the Departments of
Otorhinolaryngology and Audiology of Mayo Clinic Florida.

Main Outcomes and Measures: Sensitivity and specificity of the prototype
questionnaire to identify individuals with targeted diseases.
Results: Of 307 participants (mean [SD] age, 62.9 [9.8] years; 148 [48%] female),
75% (n = 231) were enrolled with targeted disease(s) identified on neurotologic
assessment and 25% (n = 76) with age- or noise-related hearing loss. Participants
were randomly divided into a training sample (80% [n = 246; 185 with disease, 61
controls]) and a test sample (20% [n = 61; 46 with disease, 15 controls]). Using
a simple scoring method, a sensitivity of 94% (95% CI, 89%-97%) and specificity
of 61% (95% CI, 47%-73%) were established in the training sample. Applying this
cutoff to the test sample resulted in 85% (95% CI, 71%-93%) sensitivity and 47%
(95% CI, 22%-73%) specificity.

Conclusions and Relevance: This is the first self-assessment tool designed to
assess an individual’s risk for ear disease. Our preliminary results demonstrate
a high sensitivity to disease detection. A further validated and refined version
of this questionnaire may serve as an efficacious tool for improving access to
hearing health care while minimizing the risk for missed ear diseases.