Bolus Type Research Articles

Effect of Volitional Effort on Submental Surface Electromyographic Activity During Healthy Swallowing.

The effortful swallowing technique aims to compensate for or rehabilitate impaired swallowing by using maximal volitional effort to behaviorally modify aspects of swallowing physiology. Given that swallowing is a submaximal task, swallowing at submaximal levels has recently been suggested as a more task-specific therapeutic technique. The aim of this study was to investigate differences in muscle activity during minimum, regular, and maximum effort swallowing of different boluses and across different ages, with the goal of characterizing the task specificity of minimum effort and maximum effort swallowing. Forty-three healthy adults (22 female) representing four age groups (20-39, 40-59, 60-79, and 80 + years) participated in the study. They were verbally cued to swallow saliva and 5 mL water boluses using participant-determined minimum, regular, and maximum levels of effort, in randomized order. sEMG peak amplitude and duration of each swallow were measured. Linear mixed effects analyses demonstrated that compared to regular effort swallowing, maximum effort swallowing resulted in increased sEMG amplitude (p < .001) and prolonged duration (p < .001), while minimum effort swallowing resulted in decreased amplitude (p < .001) but no significant difference in duration (p = .06). These effects occurred regardless of age or bolus type. Differences in sEMG activity were smaller between regular and minimum effort swallowing than regular and maximum effort swallowing. Both increasing and decreasing volitional efforts during swallowing translate to significant modulation of muscle activity. However, regular swallowing is more similar to minimal effort swallowing. Results reinforce the concept of swallowing as a submaximal task, and provide insight into the development of sEMG biofeedback techniques for rehabilitation.

Evaluating 3D-printed Bolus Compared to Conventional Bolus Types Used in External Beam Radiation Therapy.

When treating superficial tumors with external beam radiation therapy, bolus is often used. Bolus increases surface dose, reduces dose to underlying tissue, and improves dose homogeneity. The conventional bolus types used clinically in practice have some disadvantages. The use of Three-Dimensional (3D) printing has the potential to create more effective boluses. CT data is used for dosimetric calculations for these treatments and often to manufacture the customized 3D-printed bolus. The aim of this review is to evaluate the published studies that have compared 3D-printed bolus against conventional bolus types. A systematic search of several databases and a further appraisal for relevance and eligibility resulted in the 14 articles used in this review. The 14 articles were analyzed based on their comparison of 3D-printed bolus and at least one conventional bolus type. The findings of this review indicated that 3D-printed bolus has a number of advantages. Compared to conventional bolus types, 3D-printed bolus was found to have equivalent or improved dosimetric measures, positional accuracy, fit, and uniformity. 3D-printed bolus was also found to benefit workflow efficiency through both time and cost effectiveness. However, factors such as patient comfort and staff perspectives need to be further explored to support the use of 3Dprinted bolus in routine practice.

Ultrasound: Validity of a Pocket-Sized System in the Assessment of Swallowing.

Adequate hyoid and laryngeal displacement facilitate safe and efficient swallowing. Although videofluoroscopy is commonly used for assessment of this biomechanical event, ultrasound provides benefits as a radiation-free modality for this purpose. This study investigated validity of a pocket-sized ultrasound system (Clarius™) in the assessment of hyoid and laryngeal excursion. Hyoid excursion and thyrohyoid approximation were concurrently assessed in 20 healthy adults using ultrasound and videofluoroscopy during saliva, liquid, and puree swallowing. Correlation analyses were performed to evaluate validity. There was a strong and moderate positive association between ultrasound and videofluoroscopic measurements of hyoid excursion during dry and liquid swallowing, respectively. No evidence for a significant association was found for ultrasound and videofluoroscopic measurements of hyoid excursion for puree swallowing and of thyrohyoid approximation for any bolus type. Further work towards improved validity is necessary prior to clinical transfer of the pocket-sized Clarius™ system in clinical swallowing assessment.

Residue Ratings on FEES: Trends for Clinical Application of Residue Measurement.

Considering that measurement is a critical part of diagnostic technique for evaluating swallowing dysfunction, there is a need for abetter foundational understanding of what influences residue measurement on flexible endoscopic evaluation of swallowing (FEES). This study investigated two factors and their potential influence on trends in residue ratings on FEES: (1) bolus consistency, and (2) residue severity levels on two different types of rating scales. Thirty-three clinicians were asked to rate their overall impressions of pharyngeal residue on 75 FEES videos representing a wide range of residue severities for thin liquid, applesauce, and cracker boluses. Ratings were made on both a visual analog scale (VAS) and a five-point ordinal scale in a randomized fashion across two sessions about two weeks apart. Statistical correlations were determined to assess the association between residue ratings and severity levels and bolus consistency. A total of 2475 VAS ratings and 2473 ordinal ratings were collected. Residue ratings were statistically different depending on severity level (p < 0.0001) and bolus consistency (p < 0.004). Raters appeared to avoid rating at the severe end of the scales, especially on visual analog scales. This study documented the relationship between clinician ratings of pharyngeal residue on FEES and various factors like severity and bolus type. Other findings, such as differences in ratings depending on the type of rating scale and halo effects on the VAS, are valuable for future scale development for understandingperceptual ratings of residue on FEES.

394 Esophageal Food Impaction - A Retrospective Chart Review

INTRODUCTION: Esophageal Food Impaction (EFI) is the third most common non-biliary emergency in gastroenterology with an estimated annual incidence rate of 13 episodes per 100,000 person-year and resulting in 1500 deaths per year. Patient’s presenting with food impaction often have underlying esophageal pathology. Esophageal dysmotility is one of them which can be seen in diabetics and 60% of these patients have manometric abnormalities which may be associated with increased risk of food impaction but limited studies have been done to evaluate these correlations. The possible risk factors and association with diabetes in EFI was evaluated in our study. METHODS: Retrospective chart review of 455 patients who presented to the Staten Island University Hospital with symptoms of food impaction from 1999 to 2017. A retrospective analysis was undertaken on relevant clinical data such as age, risk factors, type of bolus, location, administration of glucagon, endoscopic technique, complications, and outcome. RESULTS: Overall, 174 patients had endoscopically confirmed FI with males 102/174 (58%). Esophageal pathology found in endoscopy includes esophagitis in 58/174 (33%), stricture in 43/174 (24%), hiatal hernia in 29/174 (17%), Schatzki ring in 15/174 (9%), normal endoscopy in 32/174 (19%) (Figure 1). Diabetes was reported in 20/174 (11%) (Figure 2). Type of food was meat in 73/174 (41%). Location of EFI mainly in the lower one-third of the esophagus in 94/174 (61%). Endoscopic push technique was used in 95/174 (55%), pull technique in 83/174 (48%). Endoscopy was successful for the first time in 165/174 (96%) patients. Complications were reported in only 5/174 (3%) including perforation and tear. Glucagon was given to 74/174 (43%) and mean door to endoscopy time (time of presentation to the emergency department to endoscopy procedure) was 10 hours in patients received glucagon, 13 hours in patients who didn’t receive glucagon (Figure 3). CONCLUSION: EFI is more common in males. Esophageal stricture and hiatal hernia were the most common pathologies found in endoscopy. Esophagitis is found in 33% of patients but whether it is the culprit for FI or consequence of FI is not clear. Diabetes is associated with food impaction in only 11% of patients but more studies are needed to find out the true association. Administration of glucagon resulted in the decreased door to scope time. Endoscopy is a safe and effective method for food impaction and complications reported were minimal.

Use of fast-acting insulin aspart in insulin pump therapy in clinical practice.

Fast‐acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) containing the additional excipients niacinamide and L‐arginine. The improved pharmacological profile and greater early glucose‐lowering action of faster aspart compared with IAsp suggests that faster aspart may be advantageous for people with diabetes using continuous subcutaneous insulin infusion (CSII). The recent onset 5 trial was the first to evaluate the efficacy and safety of an ultra‐fast‐acting insulin in CSII therapy in a large number of participants with type 1 diabetes (T1D). Non‐inferiority of faster aspart to IAsp in terms of change from baseline in HbA1c was confirmed, with an estimated treatment difference (ETD) of 0.09% (95% CI, 0.01; 0.17; P < 0.001 for non‐inferiority [0.4% margin]). Faster aspart was superior to IAsp in terms of change from baseline in 1‐hour post‐prandial glucose (PPG) increment after a meal test (ETD [95% CI], −0.91 mmol/L [−1.43; −0.39]; P = 0.001), with statistically significant improvements also at 30 minutes and 2 hours. The overall rate of severe or blood glucose‐confirmed hypoglycaemia was not statistically significantly different between treatments, with an estimated rate ratio of 1.00 (95% CI, 0.85; 1.16). A numerical imbalance in severe hypoglycaemic episodes between faster aspart and IAsp was seen in the treatment (21 vs 7) and the 4‐week run‐in periods (4 vs 0). Experience from clinical practice indicates that all pump settings should be reviewed when initiating faster aspart with CSII, and that the use of continuous glucose monitoring or flash glucose monitoring, along with a good understanding of meal content and bolus type, may also facilitate optimal use. This review summarizes the available clinical evidence for faster aspart administered via CSII and highlights practical considerations based on clinical experience that may help healthcare providers and individuals with T1D successfully initiate and adjust faster aspart with CSII.

International standardisation of the test of masticating and swallowing solids in children

The Test of Masticating and Swallowing Solids (TOMASS) is a validated assessment tool measuring the efficiency of solid bolus intake by four quantitative parameters: discrete bites, masticatory cycles, swallows and time to ingest a single cracker. A normative database for adults (20-80+ years) has previously been established. The objective of this study was to investigate the applicability and reliability of the TOMASS in children and adolescents (TOMASS-C) and to establish the normative database for this younger population. We collected data from 638 participants (male: 311, female: 327) in five age groups (4-18years) with five different but very similar test crackers in four countries. Significant effects of bolus type (cracker), age group and gender on the TOMASS parameters were identified, requiring stratification of the TOMASS-C database by these variables. Intra-rater reliability was excellent (ICC>0.94) for all parameters; inter-rater reliability was moderate for "number of swallows" (ICC=0.54), good for "bites" (ICC=0.78) and "time" (ICC=0.82), and excellent for "masticatory cycles" (ICC=0.96). The "Test of Masticating and Swallowing Solids in Children (TOMASS-C)" was identified to be a reliable diagnostic tool for the comprehensive measurement of discrete oral stage components of solid bolus ingestion, standardised by a large normative database that covers age groups from preschoolers to young adults. While differences between gender groups were less pronounced than in the adult population, previous results relating to changes in masticatory and swallowing as a function of age are confirmed by our data.

Post-extubation Dysphagia: Does Timing of Evaluation Matter?

Swallowing evaluations are often delayed at least 24h following extubation with the assumption that swallow function improves over time. The purpose of this prospective cohort study was to determine if dysphagia, as measured by aspiration and need for diet modification, declines over the first 24-h post-extubation, whereby providing evidence-based evaluation guidelines for this population. Forty-nine patients completed FEES at 2-4h post-extubation and 24-26h post-extubation. We compared Penetration-Aspiration Scale scores and diet recommendation between time points. Multivariable logistic regression models were created to investigate associations between age, reason for admission, reason for intubation, and a history of COPD and outcomes of aspiration or silent aspiration at either FEES exam. Sixty-nine percent of participants safely swallowed at least one texture without aspiration at 2-4h post-extubation. Within participants, there was a significant decrease in penetration/aspiration at 24h and 79% showed improvement in airway protection on at least one bolus type, suggesting an improvement in swallow function over the first day following extubation. These findings suggest that although patients may be safe to begin a modified diet soon after extubation, delaying evaluation until 24-h post-extubation may allow for a less restricted diet.

Swallowing Kinematic Differences Across Frozen, Mixed, and Ultrathin Liquid Boluses in Healthy Adults: Age, Sex, and Normal Variability.

The aim of this study was to examine the effects of frozen and mixed-consistency boluses on the swallowing physiology of younger and older adults. We also aimed to quantify factors that lead to increased variability in swallowing outcomes (i.e., age, sex, bolus type). Forty-one healthy adults (18-85 years old) swallowed 5 blocks of 5 different boluses: 10-ml ultrathin liquid, a teaspoon of iced barium, a teaspoon of room-temperature pudding, a teaspoon of frozen pudding, and ultrathin barium with chocolate chips. All data were recorded with videofluoroscopy and underwent detailed timing kinematic measurements. Neither barium ice nor frozen pudding sped up swallow responses. Many healthy adults initiated swallowing with the bolus as deep as the pyriform sinuses. Swallowing temporal kinematics for ultrathin liquid consistencies are most different from all others tested, requiring the best possible physiological swallowing performance in younger and older healthy individuals (i.e., faster reaction times, longer durations) compared with other bolus types tested. In each measure, older adults had significantly longer durations compared with the younger adults. More variability in swallowing kinematics were seen with age and laryngeal vestibule kinematics. This study provides important contributions to the literature by clarifying normal variability within a wide range of swallowing behaviors and by providing normative data from which to compare disordered populations.

Metallic Nanoislands on Graphene for Monitoring Swallowing Activity in Head and Neck Cancer Patients.

There is a need to monitor patients with cancer of the head and neck postradiation therapy, as diminished swallowing activity can result in disuse atrophy and fibrosis of the swallowing muscles. This paper describes a flexible strain sensor comprising palladium nanoislands on single-layer graphene. These piezoresistive sensors were tested on 14 disease-free head and neck cancer patients with various levels of swallowing function: from nondysphagic to severely dysphagic. The patch-like devices detected differences in (1) the consistencies of food boluses when swallowed and (2) dysphagic and nondysphagic swallows. When surface electromyography (sEMG) is obtained simultaneously with strain data, it is also possible to differentiate swallowing vs nonswallowing events. The plots of resistance vs time are correlated to specific events recorded by video X-ray fluoroscopy. Finally, we developed a machine-learning algorithm to automate the identification of bolus type being swallowed by a healthy subject (86.4%. accuracy). The algorithm was also able to discriminate between swallows of the same bolus from either the healthy subject or a dysphagic patient (94.7% accuracy). Taken together, these results may lead to noninvasive and home-based systems for monitoring of swallowing function and improved quality of life.

Intrapatient study comparing 3D printed bolus versus standard vinyl gel sheet bolus for postmastectomy chest wall radiation therapy

PurposeThis patient study evaluated the use of 3-dimensional (3D) printed bolus for chest wall radiation therapy compared with standard sheet bolus with regard to accuracy of fit, surface dose measured in vivo, and efficiency of patient setup. By alternating bolus type over the course of therapy, each patient served as her own control. Methods and materialsFor 16 patients undergoing chest wall radiation therapy, a custom 5.0 mm thick bolus was designed based on the treatment planning computed tomography scan and 3D printed using polylactic acid. Cone beam computed tomography scanning was used to image and quantify the accuracy of fit of the 2 bolus types with regard to air gaps between the bolus and skin. As a quality assurance measure for the 3D printed bolus, optically stimulated luminescent dosimetry provided in vivo comparison of surface dose at 7 points on the chest wall. Durations of patient setup and image guidance were recorded and compared. ResultsIn 13 of 16 patients, the bolus was printed without user intervention, and the median print time was 12.6 hours. The accuracy of fit of the bolus to the chest wall was improved significantly relative to standard sheet bolus, with the frequency of air gaps 5 mm or greater reduced from 30% to 13% (P < .001) and maximum air gap dimension diminished from 0.5 ± 0.3 to 0.3 ± 0.3 mm on average. Surface dose was within 3% for both standard sheet and 3D printed bolus. On average, the use of 3D printed bolus reduced the setup time from 104 to 76 seconds. ConclusionsThis study demonstrates 3D printed bolus in postmastectomy radiation therapy improves fit of the bolus and reduces patient setup time marginally compared with standard vinyl gel sheet bolus. The time savings on patient setup must be weighed against the considerable time needed for the 3D printing process.

Novel Mealtime Duration Measures: Reliability and Preliminary Associations With Clinical Feeding and Swallowing Performance in Self-Feeding Children With Cerebral Palsy.

The purpose of this study is to examine (a) the reliability of newly developed measures of mealtime duration and (b) their relationship to clinical feeding/swallowing performance in children with spastic cerebral palsy (SCP). Seventeen self-feeding children (9 boys, 8 girls) with SCP (age range = 5;1 [years;months] to 17;6, Gross Motor Function Classification System range = I-IV) were assessed during mealtimes using the Dysphagia Disorder Survey (DDS; Sheppard, Hochman, & Baer, 2014). Children were divided into 2 groups, children with primarily unilateral or bilateral brain involvement. Duration measures included mealtime duration and total sip/bite duration for each bolus type (liquid and solid). Excellent intra- and inter-rater reliability for all duration measures was observed (intraclass correlation coefficient [ICC] = 1.00 and 0.955, respectively, for mealtime duration; ICC = 1.00 and 0.963, respectively, for solid/bite duration; ICC = 1.00 and 0.957, respectively, for liquid/sip duration). Positive correlations were found between total mealtime duration and DDS Part 1, rs = .514 [.045-.797], p = .035; Part 2, rs = .528 [.064-.804], p = .029; and total scores, rs = .665 [.271-.868], p = .004, and between total solid/bite duration and DDS Part 1, rs = .579 [.137-.828], p = .015; Part 2, rs = .620 [.199-.847], p = .007; and total scores, rs = .762 [.444-.909], p < .001. Children with unilateral brain involvement exhibited significantly lower DDS total (p = .049) and Part 2 scores (p = .026), indicating better feeding/swallowing performance/skills. They also had shorter mealtime duration (p = .019) and solid/bite duration (p = .025) compared with children with bilateral involvement. Our new mealtime duration measures are reliable and correlate with feeding/swallowing performance in a sample of self-feeding children with SCP. Therefore, they may be useful supplements to feeding/swallowing assessments for this population. https://doi.org/10.23641/asha.5715076.

Rethinking Residue: Determining the Perceptual Continuum of Residue on FEES to Enable Better Measurement.

The goal of this work was to better understand perceptual judgments of pharyngeal residue on flexible endoscopic evaluation of swallowing (FEES) and the influence of a visual analog scale (VAS) versus an ordinal scale on clinician ratings. The intent was to determine if perceptual judgments of residue were more accurately described by equal or unequal intervals. Thirty-three speech language pathologists rated pharyngeal residue from 75 FEES videos representing a wide range of residue severities for thin liquid, applesauce, and cracker boluses. Clinicians rated their impression of the overall residue amount in each video on a VAS and, in a different session, on a five-point ordinal scale. Residue ratings were made in two separate sessions separated by several weeks. Statistical correlations of the two rating methods were carried out and best-fit models were determined for each bolus type. A total of 2475 VAS ratings and 2473 ordinal ratings were collected. Residue ratings from both methods (VAS and ordinal) were strongly correlated for all bolus types. The best fit for the data was a quadratic model representing unequal intervals, which significantly improved the r 2 values for each bolus type (cracker r 2=0.98, applesauce r 2=0.99, thin liquid r 2=0.98, all p<0.0001). Perceptual ratings of pharyngeal residue demonstrated a statistical relationship consistent with unequal intervals. The present findings support the use of a VAS to rate residue on FEES, allowing for greater precision as compared to traditional ordinal rating scales. Perceptual judgments of pharyngeal residue reflected unequal intervals, an important concept that should be considered in future rating scales.

Within-Bolus Variability of the Penetration-Aspiration Scale Across Two Subsequent Swallows in Patients with Head and Neck Cancer

To compare two consecutive swallowing attempts to study if there is a difference in Rosenbek’s penetration-aspiration scale (PAS) scores between the first and second swallowing attempt of the same bolus type in videofluoroscopic examination of swallowing (VFS). Additional aims include reflecting on which bolus sizes and consistencies are the most relevant to include in further studies for head and neck cancer (HNC) patients. The VFS for 38 patients curatively treated for HNC was studied. All included patients showed swallowing difficulties (PAS ≥ 2). The examination protocol included two swallows each of six different boluses: 3, 5, 10, 20 ml thin, 5 ml mildly thick, and 3 ml of extremely thick liquid. All boluses were compared between the first and second swallowing attempt with regard to PAS scores. No statistically significant differences in PAS were found between the first and second swallow for any of the boluses in this study on group level. For 20 ml thin and 3 ml extremely thick liquid, there were low Intra-Class Correlations, indicating a low within-bolus agreement. The greatest within-bolus differences were found for 20 ml thin, 5 ml mildly thick and 3 ml extremely thick liquid, which demonstrated high intra-individual coefficient of variation (0.458–0.759). The data of this study show a high within-bolus variability of the PAS score between two subsequent swallows for all different consistencies. In order to assess swallowing safety, the highest PAS score for each bolus type is suggested for use in studies of HNC patients.

Fiberoptic Endoscopic Evaluation of Swallowing as possible index of ALS clinical development

Our purpose was to assess the relationship between the disease severity of Amyotrophic Lateral Sclerosis (ALS) and the main parameters of Fiberoptic Endoscopic Evaluation of Swallowing (FEES), indirectly hypothesizing for FEES a role as clinical indicator of the progression of ALS. We studied 220 patients (101 women, 119 men) with ALS; of these, 148 had spinal and 72 bulbar onset. They were analyzed according to the Amyotrophic Lateral Sclerosis Functioning Rating Scale (ALSFRS) and the b-ALSFRS subscale (bulbar scale). All subjects underwent FEES. Post-swallowing residue was classified into four classes (0-3); premature spillage and aspiration were considered either present or absent. An in-depth statistical analysis revealed a highly significant relationship between the FEES parameters studied and the severity of the disease assessed through ALSFRS and b-ALSFRS (p < 0.0001), no matter what bolus texture was used. Moreover, statistical analysis showed a highly significant association between the classes of severity in bulbar forms and all the FEES parameters, no matter what type of bolus was administered (p <0.0001), whereas a significant correlation in spinal forms only for post-swallowing residue with solid (p= 0.025) and semisolid (p= 0.034) boluses. FEES is a good indicator of the severity of dysphagia and of its progression in patients with ALS, as well as of the clinical progression of the disease.

Respiratory-swallowing coordination in normal subjects: Lung volume at swallowing initiation

This study was designed to investigate the significance of bolus types and volumes, delivery methods and swallowing instructions on lung volume at swallowing initiation in normal subjects in a single experiment using a multifactorial approach. Our broad range goal was to determine optimal lung volume range associated with swallowing initiation to provide training targets for dysphagic patients with disordered respiratory-swallow coordination. Our hypothesis was that swallows would be initiated within a limited range of quiet breathing lung volumes regardless of bolus volume, consistency or task. Results confirmed this hypothesis and revealed that swallows were initiated at mean lung volume=244ml. Cued swallows were initiated at lower quiet breathing volumes than un-cued swallows (cued=201ml; un-cued=367ml). Water boluses were initiated at slightly higher quiet breathing volumes than solids. Data suggest that swallows occur within a restricted range of lung volumes with variation due to instructions, bolus type and other experimental variables.

Dysphagia in Amyotrophic Lateral Sclerosis: Relationships between disease progression and Fiberoptic Endoscopic Evaluation of Swallowing.

Our aim was to evaluate the relationship between the disease severity of Amyotrophic Lateral Sclerosis (ALS) and the following parameters of Fiberoptic Endoscopic Evaluation of Swallowing (FEES): premature spillage, post-swallowing residue and aspiration. We studied 202 patients (95 women and 107 men) with ALS; of these, 136 had spinal and 66 had bulbar onset. They were analyzed according to the Amyotrophic Lateral Sclerosis Functioning Rating Scale (ALSFRS) and the b-ALSFRS subscale (bulbar scale). All subjects underwent FEES. Post-swallowing residue was classified into four classes (0-3); premature spillage and aspiration were considered either present or absent. Spearman's correlation test showed a highly significant correlation (p<0.0001) between the value of ALSFRS and b-ALSFRS and the FEES parameters as the following: disease severity and dysphagia severity are closely related, both in spinal and bulbar onset, no matter what bolus texture was used. Spearman's Rho was more significant for post-swallowing residue, ≤-0.500 with all three consistencies (p<0.0001) in spinal onset and -0.520 only with liquid bolus (p<0.0001) in bulbar onset. Independent T-Test revealed a significant difference (p<0.0001) between the mean ALSFRS and b-ALSFRS scores and the presence/absence of aspiration. For the premature spillage in spinal onset (ALSFRS), we found a statistically significant difference for all three bolus textures (p<0.0001). Analysis of variance for the post-swallowing residue in spinal onset (ALSFRS) revealed a statistically significant difference (p<0.0001) for most of the comparisons between groups for all three textures. For the premature spillage in bulbar onset (b-ALSFRS), we found a statistically significant difference for all three textures (p<0.0001). Analysis of variance for the post-swallowing residue in bulbar onset (b-ALSFRS) showed a statistically significant difference (p<0.0001) for most of the comparisons between groups for all three textures. Kruskal-Wallis test showed a highly significant association between the classes of severity in bulbar forms and all the FEES parameters, no matter what type of bolus was administered (p<0.0001), whereas a significant correlation in spinal forms only for post-swallowing residue with solid (p=0.026) and semisolid (p=0.031) boluses. There is a highly significant relationship as the following between the FEES parameters and the disease severity assessed via ALSFRS and b-ALSFRS: classes of greater severity entail a greater deterioration of FEES parameters. FEES can be considered a good indicator of the dysphagia severity and a useful test for the follow-up of dysphagia in patients with ALS, whether of spinal or bulbar onset.

Effects of Change in Tongue Pressure and Salivary Flow Rate on Swallow Efficiency Following Chemoradiation Treatment for Head and Neck Cancer.

Patients treated with chemoradiation for head and neck cancer frequently develop dysphagia. Tissue damage to the oral tongue causing weakness along with decreases in saliva production may contribute to dysphagia. Yet, effects of these variables on swallowing-related measures are unclear. The purpose of this study was (1) to determine effects of chemoradiation on tongue pressures, as a surrogate for strength, and salivary flow rates and (2) to elucidate relationships among tongue pressures, saliva production, and swallowing efficiency by bolus type. Twenty-one patients with head and neck cancer treated with chemoradiation were assessed before and after treatment and matched with 21 healthy control participants who did not receive chemoradiation. Each participant was given a questionnaire to rate dysphagia symptoms.Videofluoroscopic Evaluation of Swallowing (VFES) was used to determine swallowing efficiency; the Saxon test measured salivary flow rate; and the Iowa Oral Performance Instrument (IOPI) was used for oral tongue maximum and endurance measures. Results revealed significantly lower tongue endurance measures for patients post-treatment as compared to controls (p = .012). Salivary flow rates also were lower compared to pre-treatment (p = .000) and controls (p = .000). Simple linear regression analyses showed that change in salivary flow rate was predictive of change in swallow efficiency measures from pre- to post-treatment for 1mL thin liquid (p = .017), 3mL nectar-thick liquid (p = .026), and 3mL standard barium pudding (p = .011) boluses. Based on these findings, it appears that chemoradiation treatment affects tongue endurance and salivary flow rate, and these changes may impact swallow efficiency. These factors should be considered when planning treatment for dysphagia.

Initiation of Pharyngeal Response during Discrete Swallowing and Chew-swallowing in Healthy Subjects.

The aim of this study was to measure the initiation of pharyngeal swallowing during discrete swallowing and during chew-swallowing in younger and older healthy subjects and to determine the normal range of the stage transition duration (STD) for different food boluses. The correlations between STDs were investigated. Twenty-eight younger subjects (< 60 years old) and 25 older subjects (≥ 60 years old) were enrolled. While in the sitting position, the subjects swallowed 10 ml of thin liquid barium (LQ), 8 g of corned beef hash with barium (CB), 8 g of cookie with barium (CK), and a two-phase mixture of 4 g of corned beef hash with barium and 5 ml of thin liquid barium (MX). A videofluoroscopic examination of swallowing was performed at 30 frames/s in the lateral projection. The delay in pharyngeal swallowing (i.e., STD) was measured. The normal range (mean ± 2SD) of STDs for each bolus type was determined, and correlations were calculated to examine the relationship among STDs. The median STDs for LQ, CB, CK, and MX in all subjects were 0.0, 1.2, 2.4, and 1.9 s, respectively. The STDs were prolonged for CB, CK, and MX compared with LQ. Additionally, the median STD was longer for LQ, CB, and CK in older than in younger subjects. No significant correlations were found between STDs except for those between CB and CK. A delayed pharyngeal response is commonly observed during chew-swallowing. Liquids, solids, and two-phase mixtures exhibit independent timings of pharyngeal swallow initiation.

Insulin degludec: a new basal insulin analogue with an ultra-long duration of action. Safety and efficacy in Russian patients with diabetes

Aims. Insulin degludec (IDeg) is a novel insulin analogue that, following subcutaneous injection, forms soluble multihexamers, resulting in an ultra-long duration of action, which is two-fold longer than that of insulin glargine (IGlar). We present data from Russian cohorts of two multinational, open-label, treat-to-target phase 3 trials that investigated the efficacy and safety of IDeg and IGlar administered once daily.Materials and methods. The BEGIN Basal–Bolus Type 1 trial was a 52-week study comparing IDeg (n = 45) to IGlar (n = 16), both 100 U/mL, and in combination with insulin aspart in patients with type 1 diabetes (T1D). The BEGIN LOW VOLUME trial compared IDeg (200 U/mL; n = 27) to IGlar (100 U/mL; n = 28) over 26 weeks in insulin-naïve patients with type 2 diabetes (T2D) inadequately controlled with oral antidiabetic drugs. The primary outcome of both studies was the non-inferiority of IDeg to IGlar, as assessed by HbA1c level reduction at the trial end.Results. In patients with T1D, HbA1c level reductions at the trial end were 0.42% (IDeg) and 0.22% (IGlar). The rates of confirmed hypoglycaemia (plasma glucose level 3.1 mmol/L or severe) were lower in IDeg than in IGlar [17.83 vs. 22.87 events/patient/year exposure (PYE), respectively]. The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (2.24 vs. 4.77 events/PYE, respectively). Severe episodes occurred in 10% of patients in both treatment groups, with rates per PYE of 0.12 (IDeg) and 0.06 (IGlar). In patients with T2D, HbA1c levels decreased by 1.17% (IDeg) and 1.26% (IGlar) at the trial end. The rates of confirmed hypoglycaemia were comparable in IDeg and IGlar (0.52 vs. 0.44 events/PYE, respectively). The rates of nocturnal-confirmed hypoglycaemia were lower for IDeg than for IGlar (0.18 vs. 0.28 events/PYE, respectively). No severe episode occurred in either treatment group. In both studies, IDeg was well tolerated with no difference in safety between the two analogues investigated.Conclusions. In both T1D and T2D, IDeg provided similar glycaemic control to IGlar, with a lower risk of nocturnal hypoglycaemia.