Effects of Statistical Practices for Longitudinal Group Comparison of the Penetration-Aspiration Scale on Power and Effect Size Estimation: A Monte Carlo Simulation Study.

Multiple bolus trials are administered during clinical and research swallowing assessments to comprehensively capture an individual's swallowing function. Despite valuable information obtained from these boluses, it remains common practice to use a single bolus (e.g., the worst score) to describe the degree of dysfunction. Researchers also often collapse continuous or ordinal swallowing measures into categories, potentially exacerbating information loss. These practices may adversely affect statistical power to detect and estimate smaller, yet potentially meaningful, treatment effects. This study sought to examine the impact of aggregating and categorizing penetration-aspiration scale (PAS) scores on statistical power and effect size estimates. We used a Monte Carlo approach to simulate three hypothetical within-subject treatment studies in Parkinson's disease and head and neck cancer across a range of data characteristics (e.g., sample size, number of bolus trials, variability). Different statistical models (aggregated or multilevel) as well as various PAS reduction approaches (i.e., types of categorizations) were performed to examine their impact on power and the accuracy of effect size estimates. Across all scenarios, multilevel models demonstrated higher statistical power to detect group-level longitudinal change and more accurate estimates compared to aggregated (worst score) models. Categorizing PAS scores also reduced power and biased effect size estimates compared to an ordinal approach, though this depended on the type of categorization and baseline PAS distribution. Multilevel models should be considered as a more robust approach for the statistical analysis of multiple boluses administered in standardized swallowing protocols due to its high sensitivity and accuracy to compare group-level changes in swallowing function. Importantly, this finding appears to be consistent across patient populations with distinct pathophysiology (i.e., PD and HNC) and patterns of airway invasion. The decision to categorize a continuous or ordinal outcome should be grounded in the clinical or research question with recognition that scale reduction may negatively affect the quality of statistical inferences in certain scenarios.

Clinical Implementation of DIGEST as an Evidence-Based Practice Tool for Videofluoroscopy in Oncology: A Six-Year Single Institution Implementation Evaluation.

Clinical implementation of evidence-based practice (EBP) tools is a healthcare priority. The Dynamic Grade of Swallowing Toxicity (DIGEST) is an EBP tool developed in 2016 for videofluoroscopy in head and neck (H&N) oncology with clinical implementation as a goal. We sought to examine: (1) feasibility of clinical implementation of DIGEST in a national comprehensive cancer center, and (2) fidelity of DIGEST adoption in real-world practice. A retrospective implementation evaluation was conducted in accordance with the STARI framework. Electronic health record (EHR) databases were queried for all consecutive modified barium swallow (MBS) studies conducted at MD Anderson Cancer Center from 2016 to 2021. Implementation outcomes included: feasibility as measured by DIGEST reporting in EHR (as a marker of clinical use) and fidelity as measured by accuracy of DIGEST reporting relative to the decision-tree logic (penetration-aspiration scale [PAS], residue, and Safety [S] and Efficiency [E] grades). Contextual factors examined included year, setting, cancer type, MBS indication, and provider. 13,055 MBS were conducted by 29 providers in 7,842 unique patients across the lifespan in diverse oncology populations (69% M; age 1-96 years; 58% H&N cancer; 10% inpatient, 90% outpatient). DIGEST was reported in 12,137/13,088 exams over the 6-year implementation period representing 93% (95% CI: 93-94%) adoption in all exams and 99% (95% CI: 98-99%) of exams excluding the total laryngectomy population (n = 730). DIGEST reporting varied modestly by year, cancer type, and setting/provider (> 91% in all subgroups, p < 0.001). Accuracy of DIGEST reporting was high for overall DIGEST (incorrect SE profile 1.6%, 200/12,137), DIGEST-safety (incorrect PAS 0.4% 51/12,137) and DIGEST-efficiency (incorrect residue 1.2%, 148/12,137). Clinical implementation of DIGEST was feasible with high fidelity in a busy oncology practice across a large number of providers. Adoption of the tool across the lifespan in diverse cancer diagnoses may motivate validation beyond H&N oncology.

Telemedicine-enabled biofeedback electropalatography rehabilitation (TEBER): A pilot study for patients treated with surgery for oral cavity carcinoma.

BACKGROUND: To address the rehabilitative barriers to frequency and precision of care, we conducted a pilot study of a biofeedback electropalatography (EPG) device paired with telemedicine for patients who underwent primary surgery +/- adjuvant radiation for oral cavity carcinoma. We hypothesized that lingual optimization followed by telemedicine-enabled biofeedback electropalatography rehabilitation (TEBER) would further improve speech and swallowing outcomes after "standard-of-care" SOC rehabilitation. METHOD: Pilot prospective 8-week (TEBER) program following 8 weeks of (SOC) rehabilitation. RESULTS: Twenty-seven patients were included and 11 completed the protocol. When examining the benefit of TEBER independent of standard of care, "range-of-liquids" improved by +0.36 [95% CI, 0.02-0.70, p = 0.05] and "range-of-solids" improved by +0.73 [95% CI, 0.12-1.34, p = 0.03]. There was a positive trend toward better oral cavity obliteration; residual volume decreased by -1.2 [95% CI, -2.45 to 0.053, p = 0.06], and "nutritional-mode" increased by +0.55 [95% CI, -0.15 to 1.24, p = 0.08]. CONCLUSION: This pilot suggests that TEBER bolsters oral rehabilitation after 8 weeks of SOC lingual range of motion.

Revisiting Feeding Tube Utilization in Oropharynx Cancer: 6-Year Prospective Registry Analysis.

OBJECTIVE: Patients treated for oropharyngeal cancer (OPC) have historically demonstrated high feeding tube rates for decreased oral intake and malnutrition. We re-examined feeding tube practices in these patients. STUDY DESIGN: Retrospective analysis of prospective cohort from 2015 to 2021. SETTING: Single-institution NCI-Designated Comprehensive Cancer Center. METHODS: With IRB approval, patients with new oropharyngeal squamous cell cancer or (unknown primary with neck metastasis) were enrolled. Baseline swallowing was assessed via videofluoroscopy and Performance Status Scale for Head and Neck Cancer (PSSHN). G-tubes or nasogastric tubes (NGT) were placed for weight loss before, during, or after treatment. Prophylactic NGT were placed during transoral robotic surgery (TORS). Tube duration was censored at last disease-free follow-up. Multivariate regression was performed for G-tube placement (odds ratio [OR] [95% confidence interval [CI]) and removal (Cox hazard ratio, hazard ratio [HR] [95% CI]). RESULTS: Of 924 patients, most had stage I to II (81%), p16+ (89%), node-positive (88%) disease. Median follow-up was 2.6 years (interquartile range 1.5-3.9). Most (91%) received radiation/chemoradiation, and 16% received TORS. G-tube rate was 27% (5% after TORS). G-tube risk was increased with chemoradiation (OR 2.78 [1.87-4.22]) and decreased with TORS (OR 0.31 [0.15-0.57]) and PSSHN-Diet score ≥60 (OR 0.26 [0.15-0.45]). G-tube removal probability over time was lower for T3 to T4 tumors (HR 0.52 [0.38-0.71]) and higher for PSSHN-Diet score ≥60 (HR 1.65 [1.03-2.66]). CONCLUSIONS: In this modern cohort of patients treated for OPC, 27% received G-tubes-50% less than institutional rates 10 years ago. Patients with preserved baseline swallowing and/or those eligible for TORS may have lower G-tube risk and duration.

Tongue electrical impedance myography correlates with functional, neurophysiologic, and clinical outcome measures in long-term oropharyngeal cancer survivors with and without hypoglossal neuropathy: An exploratory study.

BACKGROUND: This pilot study analyzed correlations between tongue electrical impedance myography (EIM), standard tongue electromyography (EMG), and tongue functional measures in N = 4 long-term oropharyngeal cancer (OPC) survivors. METHODS: Patients were screened for a supportive care trial (NCT04151082). Hypoglossal nerve function was evaluated with genioglossus needle EMG, functional measures with the Iowa oral performance instrument (IOPI), and multi-frequency tissue composition with tongue EIM. RESULTS: Tongue EIM conductivity was higher for patients with EMG-confirmed cranial nerve XII neuropathy than those without (p = 0.005) and in patients with mild versus normal EMG reinnervation ratings (16 kHz EIM: p = 0.051). Tongue EIM correlated with IOPI strength measurements (e.g., anterior maximum isometric lingual strength: r2 = 0.62, p = 0.020). CONCLUSIONS: Tongue EIM measures related to tongue strength and the presence of XII neuropathy. Noninvasive tongue EIM may be a convenient adjunctive biomarker to assess tongue health in OPC survivors.

Glossectomy for the treatment of oral cavity carcinoma: Quantitative, functional and patient-reported quality of life outcomes differ by four glossectomy defects.

OBJECTIVE: The goal was to characterize four clinically distinct glossectomy defects to establish significant quantitative cut points using functional metrics, the MD Anderson Dysphagia Index (MDADI) and speech intelligibility. METHODS: Population included 101 patients treated with surgery, adjuvant radiation per NCCN guidelines, and ≥ 12 months follow-up. RESULTS: Defect groups: subtotal hemiglossectomy (1), hemiglossectomy (2), extended hemiglossectomy (3) and oral glossectomy (4) were compared: All outcomes supported a four defect model. Intergroup comparison of outcomes with subtotal hemiglossectomy as reference (p value): Tongue Protrusion <0.001,<0.001,<0.001; Elevation <0.001,<0.001,<0.001; Open Mouth Premaxillary Contact Elevation <0.001,<0.001,<0.001; Obliteration 0.6,<0.001,<0.001; Normalcy of Diet, <0.3,<0.001,<0.001; Nutritional Mode, <0.9,<0.8,<0.001; Range of Liquids, <0.4,<0.016,<0.02; Range of Solids, <0.5,<0.004,<0.001; Eating in Public, <0.2,<0.002,<0.03; Understandability of Speech, <0.9,<0.001,<0.001; Speaking in Public, <0.4,<0.03,<0.001; MDADI, <0.4,<0.005,<0.01; Single Word Intelligibility, <0.4,<0.1,<0.001; Sentence Intelligibility, <0.5,<0.08,<0.001; Words Per Minute Intelligibility, <0.6,<0.04,<0.001; Sentence Efficiency Ratio, <0.4,<0.03,<0.002. Proportion of patients by 4 defect groups who underwent: tissue transplantation, 51%,93.9%,100%,100%.Radiation,24%,67%,88%,80%.Between hemiglossectomy and extended hemiglossectomy, the defect extends into the contralateral floor of the mouth and/or the anterior tonsillar pillar; resection of these subunits limits tongue mobility with an impact on functional outcome and MDADI. Between extended hemiglossectomy and oral glossectomy, the defect extends to include the tip of the tongue and appears to impact functional outcome and MDADI. CONCLUSIONS: Subtotal hemiglossectomy, hemiglossectomy, extended glossectomy and oral glossectomy are associated with quantitative (elevation, protrusion, open mouth premaxillary contact and obliteration), qualitative (speech and swallowing) and MDADI differences, suggesting that these 4 ordinal defect groups are distinct.

Optimizing Function and Appearance After Head and Neck Reconstruction: Measurement and Intervention.

Approximately 50% of head and neck cancer (HNC) survivors are left with dysphagia as a result of treatment sequele, and 25% of survivors experience clinically significant body image distress (BID). Both dysphagia and BID adversely affect quality of life and should be tracked using validated clinician- and patient-reported outcome measures such as the Performance Status Scale for Head and Neck Cancer, MD Anderson Dysphagia Inventory, and Inventory to Measure and Assess imaGe disturbancE-Head & Neck (IMAGE-HN). Subjective and objective evaluation measures are critical to dysphagia workup and management. Building a renewed image after head and neck cancer treatment, a brief telemedicine-based cognitive behavioral therapy, has become the first evidence-based treatment for BID among HNC survivors.

Using Reference Values to Identify Profiles of Swallowing Impairment in a Case Series of Individuals With Traumatic Spinal Cord Injury.

PURPOSE: In this article, we illustrate use of a systematic approach to rating videofluoroscopic swallowing studies (VFSS), the Analysis of Swallowing Physiology: Events, Kinematics and Timing (ASPEKT) method. The method is applied to a clinical case series of individuals with a history of traumatic spinal cord injury (tSCI) requiring surgical intervention using a posterior approach. Previous studies suggest that swallowing is highly variable in this population given heterogeneity in mechanisms, location and extent of injury, and in surgical management approaches. METHOD: The case series involved 6 individuals who were at least 1 month postsurgery for management of tSCI. Participants completed a VFSS using a standardized bolus protocol. Each VFSS was blindly rated in duplicate using the ASPEKT method and compared with published reference values. RESULTS: The analysis revealed considerable heterogeneity across this clinical sample. Penetration-aspiration scale scores of 3 or higher were not observed in this cohort. Of note, patterns of impairment did emerge, suggesting there are some commonalities across profiles in this population, including the presence of residue associated with poor pharyngeal constriction, reduced upper esophageal opening diameter, and short upper esophageal sphincter opening duration. CONCLUSIONS: Although the participants in this clinical sample shared a history of tSCI requiring surgical intervention using a posterior approach, there was great heterogeneity in swallowing profile. Using a systematic method to identify atypical swallowing parameters can guide clinical decision making for determining rehabilitative targets and measuring swallowing outcomes.

Adhering to Eat and Exercise Status During Radiotherapy for Oropharyngeal Cancer for Prevention and Mitigation of Radiotherapy-Associated Dysphagia.

Importance: Previously published work reported independent benefit of maintenance of oral intake (eat) and swallowing exercise adherence (exercise) during radiotherapy (RT) on diet and functional outcomes. The current study seeks to validate the authors' previously published findings in a large contemporary cohort of patients with oropharynx cancer (OPC) and address limitations of the prior retrospective study using prospective, validated outcome measures. Objective: To examine the longitudinal association of oral intake and swallowing exercise using validated, clinician-graded and patient-reported outcomes. Design, Setting, and Participants: Secondary analysis of a prospective OPC registry including patients who underwent primary RT/chemoradiotherapy (CRT) or primary transoral robotic surgery plus RT/CRT for OPC at a single-institution comprehensive cancer center. Exposures: Adherence to speech pathology swallowing intervention during RT coded as (1) eat: oral intake at end of RT (nothing by mouth [NPO]; partial oral intake [PO], with feeding tube [FT] supplement; full PO); and (2) exercise: swallowing exercise adherence (nonadherent vs partial/full adherence). Main Outcomes and Measures: Feeding tube and diet (Performance Status Scale for Head and Neck Cancer) patient-reported swallowing-related quality of life (MD Anderson Dysphagia Inventory; MDADI) and clinician-graded dysphagia severity grade (videofluoroscopic Dynamic Imaging Grade of Swallowing Toxicity; DIGEST) were collected at baseline, 3 to 6 months, and 18 to 24 months post-RT. Results: A total of 595 patients (mean [SD] age, 65 [10] years; 532 [89%] male) who underwent primary RT (111 of 595 [19%]), CRT (434 of 595 [73%]), or primary transoral robotic surgery plus RT/CRT (50 of 595 [8%]) were included in this cohort study. At the end of RT, 55 (9%) patients were NPO, 115 (19%) were partial PO, 425 (71%) were full PO, and 340 (57%) reported exercise adherence. After multivariate adjustment, subacute return to solid diet and FT were independently associated with oral intake (odds ratio [OR], 2.0; 95% CI, 1.0-4.1; OR, 0.1; 95% CI, 0.0-0.2, respectively) and exercise (OR, 2.9; 95% CI, 1.9-4.5; OR, 0.3; 95% CI, 0.1-0.5, respectively). Subacute MDADI (ß = 6.5; 95% CI, 1.8-11.2), FT duration (days; ß = -123.4; 95% CI, -148.5 to -98.4), and less severe dysphagia per DIGEST (OR, 0.6; 95% CI, 0.3-1.0) were independently associated with oral intake, while exercise was independently associated with less severe laryngeal penetration/aspiration per DIGEST-safety (OR, 0.7; 95% CI, 0.4-1.0). DIGEST grade associations with oral intake were not preserved long-term; however, exercise was associated with a higher likelihood of solid diet intake and better swallow safety per DIGEST. Conclusions and Relevance: The findings of this cohort study extend the authors' previously published findings that oral intake and swallowing exercise during RT are associated with favorable functional outcomes, now demonstrated with broader domains of function using validated measures. Patterns of benefit differed in this study. Specifically, better subacute recovery of swallow-related quality of life and less severe dysphagia were found among patients who maintained oral intake independent of exercise adherence, and shorter FT utilization and better long-term diet and swallowing safety were found among those who exercised independent of oral intake.

Manual Therapy for Patients With Radiation-Associated Trismus After Head and Neck Cancer.

Importance: Trismus is highly prevalent in head and neck cancer (HNC) survivorship. Current standards for trismus treatment include various stretch-based exercise protocols as a primary and single treatment modality with limited evidence regarding the role of manual therapy (MT) for this indication. Objective: To assess the effect size and associations of response to MT to increase oral opening in the setting of radiation-associated trismus. Design, Setting, and Participants: This retrospective case series was conducted at the University of Texas MD Anderson Cancer Center between 2016 and March 2020 (before COVID-19 interruption) and included 49 disease-free survivors of HNC who were referred for treatment of radiation-associated trismus. Intervention: Intraoral MT (including or excluding external head and neck) targeting the muscles of mastication. Main Outcomes and Measures: Maximum interincisal opening (MIO) before and after the initial MT session compared with serial MT sessions. Covariates were examined to determine the association with response to MT for trismus. Results: A total of 49 survivors of HNC (13 women [27%]; 24 [49%] 64 years or younger; 25 [51%] 65 years or older; mean [range] of 6.6 [0-33] years postradiotherapy were included, 9 [18.4%] of whom underwent a single MT session; 40 [81.6%] who underwent multiple sessions [mean, 6; median (range), 3 (2-48)]). The MIO improved after a single session by a mean (SD) of 4.1 (1.9) mm (0.45 effect size) and after serial MT sessions by a mean (SD) of 6.4 (4.8) mm with an effect size of 0.7. No covariates were found to be clinically meaningfully associated with MIO improvement following MT. Conclusions and Relevance: The findings of this case series study suggest that MT improved MIO with a medium to large effect size in survivors of HNC with radiation-associated trismus. The results suggest that the largest increase in oral opening was achieved after the initial treatment and although gains were more modest, oral opening continued to improve with serial treatment. Covariates were not associated with MT response, suggesting that patients with clinical features often considered treatment refractory (eg, advanced disease, multiple lines of oncology treatment, ≥5 years posttreatment) may benefit from treatment with MT. Manual therapy may be a beneficial frontline or adjuvant treatment when combined with traditional stretching therapy. A clinically meaningful increase in oral opening has the potential to improve swallow function, speech, pain, and quality of life.

Refining measurement of swallowing safety in the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) criteria: Validation of DIGEST version 2.

BACKGROUND: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a validated method to grade the severity of pharyngeal swallowing impairment as a toxicity of cancer based on the degree and patterns of penetration/aspiration and pharyngeal residue over a standardly acquired radiographic modified barium swallow (MBS) study. Since its implementation in 2016, areas for the refinement of grading mild safety impairments have been identified by clinical and research users. The objective of this study was to assess the performance and validity of refined DIGESTsafety grading criteria (per DIGEST version 2 [DIGESTv2 ]). METHODS: Refined safety criteria were developed and vetted with clinical and research users. DIGESTv2 included 2 changes to the safety criteria. All MBSs with blinded DIGEST version 1 grading were sampled from a registry database (1331 patients underwent MBS over the period of December 2005 to July 2019). New criteria were applied to derive DIGESTsafety grading version 2. Measures of criterion validity, including the MD Anderson Dysphagia Inventory [MDADI] composite score, the Modified Barium Swallow Impairment Profile (MBSImP) pharyngeal total, the MBSImP hyolaryngeal components (items 8-11), and the Performance Status Scale for Head and Neck Cancer Patients [PSS-HN] diet, were correlated with DIGESTsafety and overall DIGEST grades from versions 1 and 2 and were compared pairwise between reassigned grades. RESULTS: With the application of version 2 safety criteria, 112 of 1331 examinations (8.4%) and 79 of 1331 examinations (5.9%) changed in their DIGESTsafety and overall grades, respectively. The safety and overall DIGEST grades (versions 1 and 2) significantly correlated with criterion measures, including the MBSImP pharyngeal total, laryngeal MBSImP parameters of interest, MDADI, and PSS-HN (P < .0001); correlations maintained a similar magnitude between versions 1 and 2. Forty-six upgraded examinations (reassigned from safety grade 1 per version 1 to grade 2 per version 2) performed similarly to other safety grade 2 examinations (version 1), and this was likewise true for 66 downgraded examinations (reassigned from safety grade 1 per version 1 to grade 0 per version 2). CONCLUSIONS: Refined criteria defining mild safety impairments with the DIGEST methodology changed grades in small numbers of examinations. DIGESTv2 criteria maintained criterion validity, demonstrated ordinality, and improved the performance of the method in these rare scenarios. LAY SUMMARY: Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) is a method developed and validated by the investigators in 2016 to grade the severity of pharyngeal swallowing dysfunction (dysphagia) with a decision tree or flowsheet to guide the clinician's review of a standard radiographic modified barium swallow study. This work reports on the validity of updated DIGEST criteria (version 2) that incorporate 2 modifications to the decision tree.

Swallowing After Primary TORS and Unilateral or Bilateral Radiation for Low- to Intermediate-Risk Tonsil Cancer.

OBJECTIVE: The primary course of treatment for patients with low- to intermediate-risk tonsil cancer has evolved with a shift toward primary transoral robotic surgery (TORS) or radiation therapy (RT). While favorable outcomes have been reported after deintensification via unilateral TORS or RT (uniRT), comparisons of functional outcomes between these treatments are lacking. We compared clinical outcomes (Dynamic Imaging Grade of Swallowing Toxicity [DIGEST] and feeding tube [FT]) and patient-reported swallowing outcomes (MD Anderson Dysphagia Inventory [MDADI]) based on primary treatment strategy: TORS, uniRT, or bilateral RT (biRT). STUDY DESIGN: Secondary analysis of prospective cohort. SETTING: Single institution. METHODS: The study sample comprised 135 patients with HPV/p16+ T1-T3, N0-2b (American Joint Committee on Cancer, seventh edition), N0-1 (eighth edition) squamous cell carcinoma of the tonsil were sampled from a prospective registry. Modified barium swallow studies graded per DIGEST, FT placement and duration, and MDADI were collected. RESULTS: Baseline DIGEST grade significantly differed among treatment groups, with higher dysphagia prevalence in the TORS group (34%) vs the biRT group (12%, P = .04). No significant group differences were found in DIGEST grade or dysphagia prevalence at subacute and longitudinal time points (P = .41). Mean MDADI scores were similar among groups at baseline (TORS, 92; uniRT, 93; biRT, 93; P = .90), subacute (TORS, 83; uniRT, 88; biRT, 82; P = .38) and late time points (TORS, 86; uniRT, 86; biRT, 87; P = .99). FT placement and duration significantly differed among primary treatment groups (FT [median days]: TORS, 89% [3]; uniRT, 8% [82]; biRT, 37% [104]; P < .001). CONCLUSION: While TORS and uniRT offer optimal functional outcomes related to dysphagia, results suggest that no measurable clinician-graded or patient-reported differences in swallow outcomes exist among these primary treatment strategies and biRT. Aside from baseline differences that drive treatment selection, differences in FT rate and duration by primary treatment strategy likely reflect diverse toxicities beyond dysphagia.

Determining the Impact of Thickened Liquids on Swallowing in Patients Undergoing Irradiation for Oropharynx Cancer.

The current standard for the treatment of oropharynx cancers is radiation therapy. However, patients are frequently left with dysphagia characterized by penetration-aspiration (impaired safety) and residue (impaired efficiency). Although thickened liquids are commonly used to manage dysphagia, we lack evidence to guide the modification of liquids for clinical benefit in the head and neck cancer population. The objective of this study was to assess the impact of slightly and mildly thick liquids on penetration-aspiration and residue in 12 patients with oropharyngeal cancer who displayed penetration-aspiration on thin liquid within 3 to 6 months after completion of radiotherapy. Significantly fewer instances of penetration-aspiration were seen with slightly and mildly thick liquids as compared with thin (P < .05). No differences were found across stimuli in the frequency of residue. Patients with oropharyngeal cancers who present with post-radiation therapy dysphagia involving penetration-aspiration on thin liquids may benefit from slightly and mildly thick liquids without risk of worse residue.

Dysphagia profiles after primary transoral robotic surgery or radiation for oropharyngeal cancer: A registry analysis.

OBJECTIVE: To describe the physiologic swallowing impairments (MBSImP™©) associated with safety/efficiency impairments (DIGESTsafety /DIGESTefficiency grades) at 3-6 months after transoral robotic surgery (TORS) or radiation therapy (RT). STUDY DESIGN: Secondary analysis of registry data. SETTING: Single, academic institution. METHODS: Two hundred and fifty-seven patients with HPV+ oropharynx cancer were stratified by primary treatment (75 TORS, 182 RT). Modified barium swallow studies were analyzed at baseline and 3-6 months using MBSImP scores and DIGESTsafety /DIGESTefficiency grades. DIGESTsafety /DIGESTefficiency grades and MBSImP were compared groupwise and associations between DIGESTsafety /DIGESTefficiency grades and MBSImP were explored by ordinal logistic regression. Exploratory analyses were stratified by multimodality treatment. RESULTS: Neither DIGESTsafety /DIGESTefficiency differed significantly between groups at baseline or 3-6 months. Laryngeal vestibule closure was impaired more frequently in the RT group (RT: 41% vs. TORS: 27%; p = 0.02) while the TORS group had significantly more pharyngeal contraction impairment (63%; p < 0.001) compared to RT at 3-6 months. CONCLUSION: The results suggest a focal injury associated with DIGESTsafety /DIGESTefficiency post-TORS in contrast to a low-level diffuse physiologic impairment associated with post-RT dysphagia.

Mechanisms of Impaired Swallowing on Thin Liquids Following Radiation Treatment for Oropharyngeal Cancer.

Purpose Dysphagia is one of the most debilitating chronic symptoms experienced by patients who undergo radiation treatment for head and neck cancer. Despite the high prevalence of dysphagia in patients with head and neck cancer, we lack understanding of the specific changes in swallowing physiology that arise in the short-term following radiation therapy and how these changes impact the key functions of swallowing safety and efficiency. This study sought to identify pathophysiological mechanisms underlying impairments in swallowing safety and efficiency on thin liquids following (chemo)radiation for oropharyngeal cancer. Method Videofluoroscopic swallowing studies were completed in 12 male patients within 6 months following completion of (chemo)radiation and in 12 healthy male controls. To compare swallowing function and physiology between groups, we analyzed three discrete sips of 20% w/v thin liquid barium per participant. The videofluoroscopic swallowing study recordings were rated for swallowing safety, efficiency, timing parameters, and pixel-based measures of structural area or movement. Results The oropharyngeal cancer cohort displayed significantly higher frequencies of penetration-aspiration, incomplete laryngeal vestibule closure, prolonged time-to-laryngeal vestibule closure, and poor pharyngeal constriction. Incomplete or delayed laryngeal vestibule closure was associated with airway invasion, while poor pharyngeal constriction was associated with pharyngeal residue. Conclusions This study highlights the primary mechanisms behind impaired safety and efficiency of the swallow in patients following (chemo)radiation for oropharyngeal cancer.

A Cross-Sectional, Quantitative Videofluoroscopic Analysis of Swallowing Physiology and Function in Individuals With Amyotrophic Lateral Sclerosis.

Purpose To date, research characterizing swallowing changes in individuals with amyotrophic lateral sclerosis (ALS) has primarily relied on subjective descriptions. Thus, the degree to which swallowing physiology is altered in ALS, and relationships between such alterations and swallow safety and/or efficiency are not well characterized. This study provides a quantitative representation of swallow physiology, safety, and efficiency in a sample of individuals with ALS, to estimate the degree of difference in comparison to published healthy reference data and identify parameters that pose risk to swallow safety and efficiency. Secondary analyses explored the therapeutic effect of thickened liquids on swallowing safety and efficiency. Method Nineteen adults with a diagnosis of probable-definite ALS (El-Escorial Criteria-Revised) underwent a videofluoroscopic swallowing study, involving up to 15 sips of barium liquid (20% w/v), ranging in thickness from thin to extremely thick. Blinded frame-by-frame videofluoroscopy analysis yielded the following measures: Penetration-Aspiration Scale, number of swallows per bolus, amount of pharyngeal residue, degree of laryngeal vestibule closure (LVC), time-to-LVC, duration of LVC (LVCdur), pharyngeal area at maximum constriction, diameter of upper esophageal sphincter opening, and duration of UES opening (UESOdur). Measures of swallow physiology obtained from thin liquid trials were compared against published healthy reference data using unpaired t tests, chi-squared tests, and Cohen's d effect sizes (adjusted p < .008). Preliminary relationships between parameters of swallowing physiology, safety, and efficiency were explored using nonparametric Cochrane's Q, Friedman's test, and generalized estimating equations (p < .05). Results Compared to healthy reference data, this sample of individuals with ALS displayed a higher proportion of swallows with partial or incomplete LVC (24% vs. < 1%), increased time-to-LVC (d = 1.09), reduced UESwidth (d = 0.59), enlarged pharyngeal area at maximum constriction, prolonged LVCdur (d = 0.64), and prolonged UESOdur (d = 1.34). Unsafe swallowing (i.e., PAS ≥ 3) occurred more frequently when LVC was partial/incomplete or time-to-LVC was prolonged. Pharyngeal residue was associated with larger pharyngeal areas at maximum constriction. Unsafe swallowing occurred less frequently with extremely thick liquids, compared to thin liquids. No significant differences in pharyngeal residue were observed based on liquid thickness. Conclusions Quantitative videofluoroscopic measurements revealed moderate-to-large differences in swallow physiology between this sample of individuals with ALS and healthy reference data. Increased time-to-LVC, noncomplete LVC, and enlarged pharyngeal area at maximum constriction were associated with impaired swallow safety or efficiency. Thickened liquids may mitigate the risk of acute episodes of aspiration in individuals with ALS. Further work is needed to corroborate these preliminary findings and explore how swallowing profiles evolve throughout disease progression.

Characterizing the Flow of Thickened Barium and Non-barium Liquid Recipes Using the IDDSI Flow Test.

The use of thickened liquids for dysphagia management has become wide-spread. Videofluoroscopy is commonly used to determine dysphagia severity and to evaluate the effectiveness of interventions, including texture modification, but this requires the use of radio-opaque contrast media. In order for the results of a videofluoroscopy to have validity with respect to confirming swallowing safety and efficiency on different liquid consistencies, it is important to understand the flow characteristics of the contrast media used and how the flow of these stimuli compares to the flow of liquids that are provided outside the assessment context. In this study, we explored the flow characteristics of 20% w/v barium and non-barium stimuli prepared using starch and gum thickeners to reach the slightly, mildly and moderately thick liquid categories defined by the International Dysphagia Diet Standardisation Initiative (IDDSI). Our goal was to identify recipes that would produce stimuli with stable flow properties over a 3 h time frame post mixing. Thickener concentration was titrated to achieve matching flow (i.e., IDDSI Flow Test results within a 1 ml range) across the four stimulus types (non-barium starch, non-barium gum, barium starch, barium gum) within each IDDSI level. The combination of barium and thickeners resulted in further thickening, particularly with starch-based thickening agents. A probe of the influence of refrigeration showed no difference in flow measures between chilled and room temperature stimuli over a 3-h time frame. Overall, recipes with stable flow over three hours were identified for all barium and non-barium liquids tested.

Thickened Liquids for Dysphagia Management: a Current Review of the Measurement of Liquid Flow.

PURPOSE OF REVIEW: The use of thickened liquids has become one of the most common management strategies for individuals with dysphagia. The purpose of this paper is to review methods that can be used to measure the flow characteristics of liquids used in dysphagia management. We describe the measurement of apparent viscosity, measures of extensional flow, slump tests (specifically the line-spread test and Bostwick consistometry), gravity flow tests, and subjective methods. RECENT FINDINGS: We discuss the relationship between different approaches to measuring flow, the 2002 American National Dysphagia Diet and the 2017 International Dysphagia Diet Standardisation Initiative (IDDSI) framework. A comparison of test results across four methods is provided. SUMMARY: A consistent approach is needed for the measurement of flow for thickened liquids used in dysphagia management. This review highlights differences that can be expected across different flow testing methodologies. Adherence to a common method and measurement definitions will promote patient safety and facilitate future research regarding the effectiveness of texture modification as an intervention for dysphagia.

A review of swallow timing in the elderly.

Many studies evaluate dysphagia in elderly patients and compare their swallowing to younger controls to assess the degree of swallowing impairment. Previous research suggests that changes should be expected in swallowing due to aging, and these changes need to be considered when performing swallowing assessments. A systematic review was conducted to elucidate the timing of swallowing in healthy. A comprehensive multiengine literature search was conducted to find articles studying swallowing in the healthy elderly, which yielded 22,852 articles of which 11 were judged to be relevant. Only articles using videofluoroscopy as an assessment method for swallowing timing were included. The articles underwent detailed review for study quality and data extraction. The eleven studies contained data for 32 different parameters, and 10 of the 11 studies compared elderly subjects to a younger group. Timing measures from the studies were compiled for analysis. In general, bolus transit times do not appear to change with age. Of note, elderly subjects tended to have a significantly delayed swallow response times and longer duration of upper esophageal sphincter opening. Results showed a large degree of variability across studies for each of the timing measures. Confidence intervals for timing in healthy older participants were computed across studies. Potential sources of variation were identified, including methodological, stimulus-related and participant-related sources. The results suggests that aging affects only a few very specific swallowing timing parameters, and many parameters appear to be unaffected by aging. Therefore, significant differences from a young reference sample should be interpreted as dysphagia rather than normal changes due to aging.