Defining novel pharyngeal pressure metrics to predict dysphagia treatment outcomes and clinical prognosis using high-resolution manometry

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Oropharyngeal dysphagia, or difficulty swallowing, is a devastating condition that affects physiological and psychosocial functioning in 1 in 25 adults. In 2016, speech-language pathologists working in the VA completed more than 102,905 evaluation and 77,786 treatment procedures for oropharyngeal dysphagia. This highlights not only the incidence of suspected dysphagia in the Veteran population but also the substantial need for dysphagia management with appropriate outcomes tracking. Many dysphagia treatments exist, but our ability to adequately measure treatment outcomes is limited. Pharyngeal high-resolution manometry (pHRM) directly measures swallowing pressures, providing an objective measurement of physiology that characterizes the basic mechanisms of swallowing. pHRM is well-poised to measure outcomes of dysphagia treatments due to its direct, objective, and reproducible measures of swallowing function. We propose that adding pHRM to standard assessments will help address three current issues: 1) lack of objective measures to accurately monitor treatment effects; 2) uncertainty of how physiological measures relate to patient-reported outcome measures; and 3) absence of prognostic algorithms that predict treatment effects. This proposed project will address our central hypotheses that objective swallowing measures (including pHRM) will reveal treatment- mediated swallowing changes, will align with outcome measures, and will be able to predict who will benefit from treatment. This multi-center prospective study will follow a cohort of Veterans with dysphagia (n=150) for 8 weeks as they undergo clinically guided oropharyngeal exercises with oropharyngeal strengthening as the primary goal. Veterans with dysphagia will be assessed at three time points: baseline, 4 weeks after treatment initiation, and 8 weeks after treatment initiation. A non-dysphagic Veteran control group (n=50) will also undergo data collection at parallel time points, without completion of a treatment paradigm. We will then compare patients to non-dysphagic controls using pHRM, videofluoroscopy, diet assessment, functional reserve tests, and patient- reported outcome measures. We aim to 1) quantify change in pHRM measures of swallowing function resulting from dysphagia treatment; 2) determine which combination of standard of care and/or pHRM-based metrics best track with outcome measures; and 3) develop multimodal prognostic algorithms that predict treatment success. This research will establish a precise outcome measurement paradigm suitable for dysphagia clinical care and research, thus improving clinical confidence and paving the way for a personalized medicine approach for dysphagia rehabilitation in Veterans.