Development and initial validation of a consumer questionnaire to predict the presence of ear disease

Samantha J. Kleindienst*, David A. Zapala, Donald W. Nielsen, James W Griffith, Dania Rishiq, Larry Lundy, Sumitrajit Dhar

*Corresponding author for this work

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)983-989
Number of pages7
JournalJAMA Otolaryngology - Head and Neck Surgery
Volume143
Issue number10
DOIs
StatePublished - Oct 1 2017

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Ear Diseases
Hearing Loss
Hearing Aids
Noise
Hearing
Audiology
Sensitivity and Specificity
Health Services Accessibility
Otolaryngology
Expert Testimony
United States Food and Drug Administration
ROC Curve
Ear
Surveys and Questionnaires
Research Design
Logistic Models
Interviews
Control Groups
Population

ASJC Scopus subject areas

  • Surgery
  • Otorhinolaryngology

Cite this

Kleindienst, Samantha J. ; Zapala, David A. ; Nielsen, Donald W. ; Griffith, James W ; Rishiq, Dania ; Lundy, Larry ; Dhar, Sumitrajit. / Development and initial validation of a consumer questionnaire to predict the presence of ear disease. In: JAMA Otolaryngology - Head and Neck Surgery. 2017 ; Vol. 143, No. 10. pp. 983-989.
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abstract = "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.",
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Development and initial validation of a consumer questionnaire to predict the presence of ear disease. / Kleindienst, Samantha J.; Zapala, David A.; Nielsen, Donald W.; Griffith, James W; Rishiq, Dania; Lundy, Larry; Dhar, Sumitrajit.

In: JAMA Otolaryngology - Head and Neck Surgery, Vol. 143, No. 10, 01.10.2017, p. 983-989.

Research output: Contribution to journalArticle

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AU - Kleindienst, Samantha J.

AU - Zapala, David A.

AU - Nielsen, Donald W.

AU - Griffith, James W

AU - Rishiq, Dania

AU - Lundy, Larry

AU - Dhar, Sumitrajit

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N2 - 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.

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