A Retrospective Estimate of Ear Disease Detection Using the “Red Flags” in a Clinical Sample

Objectives: The purpose of this study was to evaluate the specificity and sensitivity of two red flag protocols in detecting ear diseases associated with changes in hearing. Design: The presence of red-flag symptoms was determined in a chart review of 307 adult patients from the Mayo Clinic Florida Departments of Otorhinolaryngology and Audiology. Participants formed a convenience sample recruited for a separate study. Neurotologist diagnosis was the criterion for comparisons. Results: Of the 251 patient files retained for analysis, 191 had one or more targeted diseases and 60 had age- or noise-related hearing loss. Food and Drug Administration red flags sensitivity was 91% (confidence interval [CI], 86 to 95%) and specificity was 72% (CI, 59 to 83%). American Academy of Otolaryngology-Head and Neck Surgery red flags sensitivity was 98% (CI, 95 to 99%) and specificity was 20% (CI, 11 to 32%). Conclusions: Stakeholders must determine which diseases are meaningful contraindications for hearing aid use and whether these red-flag protocols have acceptable levels of sensitivity and specificity. As direct-to-consumer models of hearing devices increase, a disease detection method that does not require provider intercession would be useful. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and text of this article on the journal's Web site (www.ear-hearing.com). ACKNOWLEDGMENTS: All authors contributed equally to this work. N.A.M.K. and D.A.Z. provided analyses. S.K.R. reviewed analyses and provided critical interpretation. D.A.Z., L.L., and S.K.R. contributed to data collection. S.K.R., R.A., and D.A.Z. pulled and deidentified data for analysis. N.A.M.K. wrote the initial draft of this work. All authors reviewed, edited, and approved the final paper. This research was supported by the National Institutes of Health/National Institute of Deafness and Other Communication Disorders (R21/33 DC013115; S.D. and D.A.Z.) and the Knowles Hearing Center at Northwestern University (S.D., D.A.Z., and D.W.N.). The authors declare no conflicts of interest. Address for correspondence: Niall A. M. Klyn, Roxelyn and Richard Pepper Department of Communication Sciences and Disorders, Northwestern University, 2240 Campus Dr, Evanston, IL 60208, USA. E-mail: niall.klyn@northwestern.edu Received July 6, 2017; accepted January 7, 2018. Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.

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