Unilateral vocal fold paralysis is a debilitating condition that is increasing in prevalence due to proliferation of surgeries that may manipulate the recurrent laryngeal nerve (e.g., thyroidectomy, anterior cervical spine surgery). It has substantial quality of life and health consequences related to dysphonia, dysphagia (with aspiration in some circumstances) and dyspnea. Optimizing management and treatment of this condition has been hindered by lack of a rigorously developed outcome that can measure the degree of disability and track improvement in comparative effectiveness trials. Objective physiological measures do not consistently correspond with patient-reported improvement in function. Therefore, functional recovery needs to be patient-centered; thus patient-reported outcome (PRO) measures are the ideal outcome for this purpose. Unfortunately, current PRO measures are psychometrically inadequate for this purpose. To fill this void, the proposed investigation will finalize the development and validate a unilateral vocal fold paralysis-specific PRO measure that assesses disability related to all aspects of laryngeal dysfunction. Leveraging extensive systematic review of currently available PRO measures and qualitative interviews with UVFP patients and clinicians who routinely treat this population. An item bank was created using patient input, translated into Spanish, and is actively being refined and winnowed based cognitive interviews with both English- and Spanish- speaking UVFP patients. The resultant items will comprise the novel PRO measure, which requires further development and validation. The present investigation creates an online interface that will allow the administration of the novel PRO measure to a diverse, nationwide sample of patients with UVFP in both English and Spanish. It will enable rigorous evaluation of the PRO measure's test-retest reliability, alternative form reliability (online and paper), construct validity, responsiveness to change, and will provide critical data to establish the minimal important difference in scores needed to perform power calculations. The deliverable from this research program will be a patient- centered outcome that can be seamlessly applied as the primary endpoint in planned clinical trials comparing current standard of care and novel treatments for UVFP to optimize care of patients.

Public Health Relevance

Patients with unilateral vocal fold paralysis have severe voice, swallowing and breathing problems. Current treatments are variably effective at treating this condition and, as such, patients are often permanently disabled. This research aims to develop a patient-centered outcome that can be used in needed for clinical trials to compare available and novel treatments for this condition in order to improve care of affected patients.

National Institute of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Exploratory/Developmental Grants (R21)
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Motor Function, Speech and Rehabilitation Study Section (MFSR)
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Shekim, Lana O
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University of Wisconsin Madison
Schools of Medicine
United States
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