Unilateral vocal fold paralysis (UVFP) is a debilitating condition with major health and quality of life implications. It is caused by injury to the recurrent laryngeal nerve and is iatrogenic in 50% of cases, most commonly from thyroidectomy or anterior cervical disc fusion surgeries. Rates of these procedures have increased several fold in the last few decades, which when combined with other surgical, traumatic, and other etiologies puts a correspondingly increased proportion of patients at risk for this condition. The quality of life consequences for patients with UVFP-associated voice disturbances are worse than those with asthma, acute coronary syndrome and depression. From a health perspective, 60% of UVFP patients suffer from dysphagia (23% among these have aspiration), and 75% have breathing difficulties. The basic tenet of treatment is to recapitulate the laryngeal sphincter to permit vocal fold closure thereby improving voice and swallowing, reducing aspiration risk, and normalizing respiration. Treatment algorithms vary widely based on timing and type of intervention. However, significant practice variation exists with advocates of each touting their advantages;however, no standard measure exists to compare their relative effectiveness at relieving symptoms related to all domains of laryngeal function (e.g. voice, swallowing, breathing). Lack of a standard composite measure of UVFP-attributable disability is a barrier to quantifying patient disability, tracking symptom improvement, and comparing treatment effectiveness. To date, objective measures (e.g. acoustics) have not consistently correlated with symptomatic improvement. Therefore, patient reported outcome measures (PROM) assessing quality of life and disability are arguably most relevant and should be used to optimize our treatment algorithms. No PROM currently evaluates all aspects of laryngeal function;instead their scope is limited to voice or swallowing, and none assess laryngeal- associated respiratory dysfunction. Such deficiencies in clinically applicable measures have limited our ability to comprehensively assess patient response to interventions aimed at treating UVFP. This proposal describes a career development plan that will enable me to develop expertise in outcome measure development methodology, systematic reviews and meta-analysis, and surgical comparative effectiveness research techniques. The research specific aims are: a) to systematically review the literature on PROMs related to voice, swallowing, and breathing, evaluating their construct and analyzing adequacy of psychometric development;b) to rigorously develop a PROM to assess UVFP-attributable disability using classical test theory principles and to perform principal component analysis to determine its latent dimension structure and scoring;and c) validate the PROM by: performing confirmatory factor analysis and assessing test-retest reliability, alternate administration/form reliability, concurrent criterion-related validity, and construct validity including longitudinal responsiveness to time and intervention. The career development plan integrates: a) advanced coursework and individualized mentor-directed instruction in outcome measure development methodology, systematic review/meta-analysis, and surgical comparative effectiveness techniques, b) participation in local/national seminars and conferences to advance expertise in qualitative and quantitative aspects in development of PROMs in addition to conduct of systematic reviews/meta-analysis and surgical trials, c) a multidisciplinary mentored research experience, and d) a highly supportive research environment. This environment includes the Center for Surgical Quality and Outcomes Research, an AHRQ-funded Evidence-based Practice Center, a NIH-funded Clinical Translation Science Award, a top-ranked Peabody School of Education, a Masters in Public Health program, and the state-of-the- art Bill Wilkerson Center for Otolaryngology and Communication Sciences. Overall, this career development award will advance my career in comparative effectiveness research by providing education in outcome measure development methodology and will yield a rigorously developed and psychometrically valid PROM that comprehensively assesses UVFP-attributable disability. Importantly, this award provides critical support to seamlessly transition toward future independently funded studies that use the newly created PROM to compare UVFP interventions, track recovery, prognosticate, and better tailor management algorithms to minimize UVFP-attributable disability.

Public Health Relevance

Unilateral vocal fold paralysis (UVFP) is one of the most debilitating laryngeal disorders with significant quality of life and health consequences. Wide variation in treatment and management algorithms for UVFP attests to the relatively poor comparative effectiveness research in this field, which is perpetuated by lack of standardized and comprehensive outcome measure that can accurately assess health and quality of life consequences of associated laryngeal dysfunction. The candidate's aim is to rigorously develop and psychometrically validate an innovative patient reported outcome measuring UVFP-attributable disability that can be used in future clinical trials comparing UVFP interventions.

National Institute of Health (NIH)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Mentored Patient-Oriented Research Career Development Award (K23)
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Communication Disorders Review Committee (CDRC)
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Sklare, Dan
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Vanderbilt University Medical Center
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Francis, David O; Hall, Eric; Dang, Jennifer H et al. (2015) Outcomes of serial dilation for high-grade radiation-related esophageal strictures in head and neck cancer patients. Laryngoscope 125:856-62
Ates, Fehmi; Francis, David O; Vaezi, Michael F (2014) Refractory gastroesophageal reflux disease: advances and treatment. Expert Rev Gastroenterol Hepatol 8:657-67
Francis, David O; Pearce, Elizabeth C; Ni, Shenghua et al. (2014) Epidemiology of vocal fold paralyses after total thyroidectomy for well-differentiated thyroid cancer in a Medicare population. Otolaryngol Head Neck Surg 150:548-57
Francis, David O; McKiever, Monique E; Garrett, C Gaelyn et al. (2014) Assessment of patient experience with unilateral vocal fold immobility: a preliminary study. J Voice 28:636-43
Daniero, James J; Garrett, C Gaelyn; Francis, David O (2014) Framework Surgery for Treatment of Unilateral Vocal Fold Paralysis. Curr Otorhinolaryngol Rep 2:119-130