"SWALLOWING AND ASPIRATION: HOW TO EVALUATE AND TREAT SWALLOWING DISORDERS ASSOCIATED WITH ASPIRATION PNEUMONIA IN OLDER PERSONS".

BACKGROUND Aspiration pneumonia (AP) is the most severe complication of oropharyngeal dysphagia (OD). It is highly underdiagnosed and undertreated among older patients hospitalized with community-acquired pneumonia (CAP). Our aim is to review the state of the art in the diagnosis and treatment of swallowing disorders associated with AP. METHODOLOGY We performed a narrative review, including our experience with prior studies at Hospital de Mataró, on the diagnosis and treatment of AP. RESULTS AP refers to pneumonia occurring in patients with swallowing disorders, frequently coinciding with poor oral health and vulnerability. Its main risk factors include oropharyngeal aspiration, impaired health status, malnutrition, frailty, immune dysfunction and oral colonization by respiratory pathogens. Incidence is estimated at between 5%-15% of cases of CAP but it is highly underdiagnosed. Diagnostic criteria for AP have not been standardized but should include its main pathophysiological element, oropharyngeal aspiration. Recently, a clinical algorithm was proposed, based on the recommendations of the Japanese Respiratory Society (JRS), that includes aspiration risk factors and clinical evaluation of OD. To facilitate the task for healthcare professionals, new AI-based screening tools for OD combined with validated clinical methods such as the volume-viscosity swallowing test (V-VST) for the detection of AP are being validated. Prevention and treatment of AP require multimodal interventions aimed to cover the main risk factors: textural adaptation of fluids and diets to avoid oropharyngeal aspiration; nutritional support to avoid malnutrition; and oral hygiene to reduce oral bacterial load. CONCLUSIONS The diagnosis of AP must be based on standardized criteria providing evidence on the main etiological factor, oropharyngeal aspiration. Clinical algorithms are valid in the diagnosis of AP and the identification of its main risk factors. Combination of AI-based tools with V-VST can lead to massive screening of OD and save resources and improve efficiency in the detection AP.

High-resolution manometry with impedance for the study of pharyngeal motility and the upper esophageal sphincter: Keys for its use in the study of the pathophysiology of oropharyngeal dysphagia. / Manometría de alta resolución con impedancia para el estudio de la motilidad faríngea y del esfínter esofágico superior: claves para su utilización en el estudio de la fisiopatología de la disfagia orofaríngea.

Oropharyngeal dysphagia (OD) is a pathology with a high prevalence in different patient phenotypes. High-resolution pharyngoesophageal manometry (HRPM) with impedance (HRPM-I) has become in recent years a fundamental technique for better understanding the pathophysiology of pharynx and upper oesophageal sphincter (UES) dysfunctions in patients with OD. Various groups of experts have proposed a methodology for the practice of the HRPM-I and for the standardization of the different metrics for the study of pharyngeal motility and UES dysfunctions based on the quantification of 3main phenomena: relaxation of the UES, resistance to flow through the UES and propulsion of the bolo through the pharynx into the oesophagus. According to the alterations of these metrics, 3patterns of dysfunction are proposed that allow a specific therapeutic approach: (a) UES flow restriction with normal pharyngeal propulsión; (b) UES flow restriction with ineffective pharyngeal propulsion, and (c) ineffective pharyngeal contraction with normal relaxation of the UES. We present a practical review of the methodology and metrics used by the main working groups together with the description of the main patterns of dysfunction according to our experience to highlight the usefulness of the HRPM-I in the study of the pathophysiology and selection of a specific treatment in patients with OD.

Characterization of obstructive defecation from a structural and a functional perspective.

BACKGROUND/AIMS: Defecation disorders can occur as a consequence of functional or structural anorectal dysfunctions during voiding. The aims of this study is to assess the prevalence of structural (SDD) vs functional (FDD) defecation disorders among patients with clinical complaints of obstructive defecation (OD) and their relationship with patients' expulsive capacity. PATIENTS AND METHODS: Retrospective study of 588 patients with OD studied between 2012 and 2020 with evacuation defecography (ED), and anorectal manometry (ARM) in a subgroup of 294. RESULTS: 90.3% patients were women, age was 58.5±12.4 years. Most (83.7%) had SDD (43.7% rectocele, 45.3% prolapse, 19.3% enterocele, and 8.5% megarectum), all SDD being more prevalent in women except for megarectum. Functional assessments showed: (a) absence of rectification of anorectal angle in 51% of patients and poor pelvic descent in 31.6% at ED and (b) dyssynergic defecation in 89.9%, hypertonic IAS in 44%, and 33.3% rectal hyposensitivity, at ARM. Overall, 46.4% of patients were categorized as pure SDD, 37.3% a combination of SDD+FDD, and 16.3% as having pure FDD. Rectal emptying was impaired in 66.2% of SDD, 71.3% of FDD and in 78% of patients with both (p=0.017). CONCLUSIONS: There was a high prevalence of SDD in middle-aged women with complaints of OD. Incomplete rectal emptying was more prevalent in FDD than in SDD although FDD and SDD frequently coexist. We recommend a stepwise therapeutic approach always starting with therapy directed to improve FDD and relaxation of striated pelvic floor muscles.

Prevalence and risk factors of SARS-CoV-2 antibody responses among healthcare workers (June 2020-November 2021).

BACKGROUND: To assess SARS-CoV-2 seroprevalence in healthcare workers (HCW) with sampling in June and October 2020 and April and November 2021. METHODS: Observational and prospective study in 2455 HCW with serum sampling. Antibodies against SARS-CoV-2 nucleocapsid and occupational, social and health risk factors were assessed at each time point. RESULTS: Seropositivity for SARS-CoV-2 in HCW increased from 11.8% in June 2020 to 28.4% in November 2021. Of those with a positive test in June 2020, 92.1% remained with a positive test, 6.7% had an indeterminate test and 1.1% had a negative test in November 2021. Non-diagnosed carriers represented 28.6% in June 2020 and 14.6% in November 2021. Nurses and nursing assistants showed the highest prevalence of seropositivity. Close contact (at home or in the hospital) with Covid-19 cases without protection and working in the frontline were the main risk factors. A total of 88.8% HCW were vaccinated, all with a positive serological response in April 2021, but levels of antibodies decreased about 65%, and two vaccinated persons presented a negative serological test against spike protein in November 2021. Levels of spike antibodies were higher in those vaccinated with Moderna compared with Pfizer and the percentage of antibody reduction was higher with Pfizer vaccine. CONCLUSIONS: This study shows that seroprevalence of SARS-CoV-2 antibodies among HCW doubled that of the general population and that protection both at the workplace and in the socio-familial field was associated with a lower risk of infection, which stabilized after vaccination.

Brain and Pharyngeal Responses Associated with Pharmacological Treatments for Oropharyngeal Dysphagia in Older Patients.

Impaired pharyngo-laryngeal sensory function is a critical mechanism for oropharyngeal dysphagia (OD). Discovery of the TRP family in sensory nerves opens a window for new active treatments for OD. To summarize our experience of the action mechanism and therapeutic effects of pharyngeal sensory stimulation by TRPV1, TRPA1 and TRPM8 agonists in older patients with OD. Summary of our studies on location and expression of TRP in the human oropharynx and larynx, and clinical trials with acute and after 2 weeks of treatment with TRP agonists in older patients with OD. (1) TRP receptors are widely expressed in the human oropharynx and larynx: TRPV1 was localized in epithelial cells and TRPV1, TRPA1 and TRPM8 in sensory fibers mainly below the basal lamina. (2) Older people present a decline in pharyngeal sensory function, more severe in patients with OD associated with delayed swallow response, impaired airway protection and reduced spontaneous swallowing frequency. (3) Acute stimulation with TRP agonists improved the biomechanics and neurophysiology of swallowing in older patients with OD TRPV1 = TRPA1 > TRPM8. (4) After 2 weeks of treatment, TRPV1 agonists induced cortical changes that correlated with improvements in swallowing biomechanics. TRP agonists are well tolerated and do not induce any major adverse events. TRP receptors are widely expressed in the human oropharynx and larynx with specific patterns. Acute oropharyngeal sensory stimulation with TRP agonists improved neurophysiology, biomechanics of swallow response, and safety of swallowing. Subacute stimulation promotes brain plasticity further improving swallow function in older people with OD.

Spontaneous Swallowing Frequency in Post-Stroke Patients with and Without Oropharyngeal Dysphagia: An Observational Study.

Oropharyngeal dysphagia (OD) is a frequent complication after stroke (PSOD) that increases morbidity and mortality. Early detection of PSOD is essential to reduce morbidity and mortality in patients with acute stroke. In recent years, an association between reduced spontaneous swallowing frequency (SSF) and OD has been described. Likewise, the reduction of saliva substance P (SP) concentration has been associated with an increased risk of aspiration and a decrease in SSF. In this study we aimed to compare SSF, salivary SP concentration, hydration and nutritional status in post-stroke (PS) patients with and without OD. We included 45 acute PS patients (4.98 ± 2.80 days from stroke onset, 62.22% men, 71.78 ± 13.46 year). The Volume-Viscosity Swallowing Test (V-VST) was performed for clinical diagnosis of OD. SSF/minute was assessed through 10-min neurophysiological surface recordings including suprahyoid-electromyography and cricothyroid-accelerometry. Saliva samples were collected with a Salivette® to determine SP by ELISA. Hydration status was assessed by bioimpedance. Nutritional status was evaluated by Mini Nutritional Assessment Short Form (MNA-sf) and blood analysis. Twenty-seven PS patients (60%) had OD; 19 (40%), impaired safety of swallow. SSF was significantly reduced in PSOD, 0.23 ± 0.18 and PSOD with impaired safety, 0.22 ± 0.18 vs 0.48 ± 0.29 swallows/minute in PS without OD (PSnOD); (both p < 0.005). Nutritional risk was observed in 62.92% PSOD vs 11.11% PSnOD (p = 0.007) and visceral protein markers were also significantly reduced in PSOD (p < 0.05). Bioimpedance showed intracellular dehydration in 37.50% PSOD vs none in PSnOD. There were no differences for saliva SP concentrations. SSF is significantly reduced in PSOD in comparison with PSnOD. Acute PSOD patients present poor nutritional status, hydropenia, and high risk for respiratory complications.

A Systematic and Universal Artificial Intelligence Screening Method for Oropharyngeal Dysphagia: Improving Diagnosis Through Risk Management.

Oropharyngeal dysphagia (OD) is underdiagnosed and current screening is costly. We aimed: (a) to develop an expert system (ES) based on machine learning that calculates the risk of OD from the electronic health records (EHR) of all hospitalized older patients during admission, and (b) to implement the ES in a general hospital. In an observational, retrospective study, EHR and swallowing assessment using the volume-viscosity swallow test for OD were captured over 24 months in patients > 70 yr admitted to Mataró Hospital. We studied the predictive power for OD of 25,000 variables. ES was obtained using feature selection, the final prediction model was built with non-linear methods (Random Forest). The database included 2809 older patients (mean age 82.47 ± 9.33 yr), severely dependent (Barthel Index 47.68 ± 31.90), with multiple readmissions (4.06 ± 7.52); 75.76% had OD. The psychometrics of the ES built with a non-linear model were: Area under the ROC Curve of 0.840; sensitivity 0.940; specificity, 0.416; Positive Predictive Value 0.834; Negative Predictive Value 0.690; positive likelihood ratio (LH), 1.61 and negative LH, 0.146. The ES screens in 6 s all patients admitted to a 419-bed hospital, identifies patients at greater risk of OD, and shows the risk for OD in the clinician's workstation. It is currently in use at our institution. Our ES provides accurate, systematic and universal screening for OD in real time during hospital admission of older patients, allowing the most appropriate diagnostic and therapeutic strategies to be selected for each patient.

The Impact of Periventricular Leukoaraiosis in Post-stroke Oropharyngeal Dysphagia: A Swallowing Biomechanics and MRI-Based Study.

Oropharyngeal dysphagia is a highly prevalent post-stroke complication commonly associated with topographically specific gray-matter damage. In contrast, the role of damage to the extensive white matter brain network (leukoaraiosis) in post-stroke oropharyngeal dysphagia has not yet been clarified. We aim to assess the role of leukoaraiosis in post-stroke oropharyngeal dysphagia. We designed a cross-sectional study and retrospectively collected from our database patients with dysphagia affected by a recent stroke and on whom both a brain 1.5 T-MRI and a videofluoroscopy had been performed. Leukoaraiosis was assessed in brainstem and in cerebral regions (periventricular or deep) with Fazekas scale. Penetration-Aspiration-Scale and time to laryngeal vestibule closure and to upper esophageal sphincter opening were analyzed. Study population (n = 121; 57% men, 75.5 ± 9.4y) presented mostly supratentorial ischemic PACI-type strokes. Of the patients, 86% had unsafe swallows (PAS = 3.97 ± 2.04); 94.2% had cerebral leukoaraiosis (Fazekas = 3.36 ± 1.7) and 42.1% had brainstem-leukoaraiosis, hypertension being the main risk factor. We found both significant positive associations between degree of periventricular-leukoaraiosis and total-leukoaraiosis and presence of risk of aspirations (p = 0.016 and p = 0.023, respectively); and a correlation between periventricular-leukoaraiosis and PAS scale severity (r = 0.179, p = 0.049). No correlations/associations were found between stroke volume and dysphagia in this study. Our study supports a role for leukoaraiosis in the pathophysiology of dysphagia. Stroke is associated with chronic short-connection/circuit injury and damage to periventricular white matter long connections is a relevant neuro-pathophysiological mechanism contributing to impaired safety of swallow in post-stroke oropharyngeal dysphagia patients.

The Role of TRP Channels in Nicotinic Provoked Pain and Irritation from the Oral Cavity and Throat: Translating Animal Data to Humans.

Tobacco smoking-related diseases are estimated to kill more than 8 million people/year and most smokers are willing to stop smoking. The pharmacological approach to aid smoking cessation comprises nicotine replacement therapy (NRT) and inhibitors of the nicotinic acetylcholine receptor, which is activated by nicotine. Common side effects of oral NRT products include hiccoughs, gastrointestinal disturbances and, most notably, irritation, burning and pain in the mouth and throat, which are the most common reasons for premature discontinuation of NRT and termination of cessation efforts. Attempts to reduce the unwanted sensory side effects are warranted, and research discovering the most optimal masking procedures is urgently needed. This requires a firm mechanistic understanding of the neurobiology behind the activation of sensory nerves and their receptors by nicotine. The sensory nerves in the oral cavity and throat express the so-called transient receptor potential (TRP) channels, which are responsible for mediating the nicotine-evoked irritation, burning and pain sensations. Targeting the TRP channels is one way to modulate the unwanted sensory side effects. A variety of natural (Generally Recognized As Safe [GRAS]) compounds interact with the TRP channels, thus making them interesting candidates as safe additives to oral NRT products. The present narrative review will discuss (1) current evidence on how nicotine contributes to irritation, burning and pain in the oral cavity and throat, and (2) options to modulate these unwanted side-effects with the purpose of increasing adherence to NRT. Nicotine provokes irritation, burning and pain in the oral cavity and throat. Managing these side effects will ensure better compliance to oral NRT products and hence increase the success of smoking cessation. A specific class of sensory receptors (TRP channels) are involved in mediating nicotine's sensory side effects, making them to potential treatment targets. Many natural (Generally Recognized As Safe [GRAS]) compounds are potentially beneficial modulators of TRP channels.

Functional Constipation in Older Adults: Prevalence, Clinical Symptoms and Subtypes, Association with Frailty, and Impact on Quality of Life.

INTRODUCTION: Functional constipation (FC) is very prevalent in older adults, especially in women, but its relationship with frailty is not fully understood. The aims were to assess FC prevalence, clinical symptoms and subtypes, association with frailty, and impact on quality of life (QoL) in older people. METHODS: This epidemiological study included 384 individuals aged over 70 years recruited from the community, a hospital, and a nursing home and stratified into robust, pre-frail, and frail groups (Fried criteria). The following criteria were evaluated: frailty, FC (Rome III criteria), stool consistency (Bristol Stool Chart), comorbidities (Charlson), dependency (Barthel), QoL (EQ5D), and clinical and sociodemographic data. Defined by symptom aggregation were 2 main clinical subtypes as follows: slow colonic transit time (CTT) and functional defecation disorder (FDD). RESULTS: Mean age was 79.11 ± 6.43 years. Overall FC prevalence was 26.8%, higher in women (32.4% women vs. 21.8% men; p = 0.019) and highest in frail patients (41.7% frail vs. 33.9% pre-frail vs. 24.2% robust; p < 0.001). Straining and hard stools (Bristol 1-2) were the most prevalent symptoms (89.3 and 75.7%, respectively). Frailty and benzodiazepine intake were independently associated with FC. Patients with FC obtained poorer QoL scores in the EQ5D (perceived health 66.09 ± 17.8 FC patients vs. 56.4 ± 19.03 non-FC patients; p < 0.05). The FDD subtype became significantly more prevalent as frailty increased (6.5, 25.8, and 67.7% for robust, pre-frail, and frail patients, respectively); the slow CTT subtype was significantly more frequent in robust patients (38.5% robust vs. 30.5% pre-frail vs. 23.1% frail), p = 0.002. DISCUSSION/CONCLUSION: FC prevalence in older adults was high, especially in women, and was associated with frailty and poor QoL. Clinical subtypes as related to frailty phenotypes reflect specific pathophysiological aspects and should lead to more specific diagnoses and improved treatment.

Oropharyngeal Dysphagia in Older People is Associated with Reduced Pharyngeal Sensitivity and Low Substance P and CGRP Concentration in Saliva.

Substance P (SP) and Calcitonine gene-related peptide (CGRP) are released by sensory nerve fibers in the oropharynx. Patients with oropharyngeal dysphagia (OD) present reduced oropharyngeal sensitivity and low SP concentration in saliva. We aimed to assess the concentration of salivary SP and CGRP in healthy volunteers, and older people without and with OD, and the relationship with pharyngeal sensory threshold. We included 15 healthy volunteers, 14 healthy elderly and 14 elderly with OD. Swallow function was assessed by videofluoroscopy (VFS). Pharyngeal sensory threshold was assessed by intrapharyngeal electrical stimulation. Hydration and phase angle were assessed by bioimpedance. Saliva samples were collected with a Salivette® to determine SP and CGRP concentration by ELISA. Elderly patients with OD presented impaired safety of swallow (PAS 4.38 ± 0.77 p < 0.0001 vs. healthy volunteers = 1 and healthy elderly = 1.43 ± 0.51). Healthy elderly and elderly with OD presented a reduction in intracellular water and saliva volume (healthy elderly, 592.86 ± 327.79 µl, p = 0.0004; elderly with OD, 422.00 ± 343.01 µl, p = 0.0001 vs healthy volunteers, 1333.33 ± 615.91 µl, r = 0.6621, p < 0.0001). Elderly patients with OD presented an impairment in pharyngeal sensory threshold (10.80 ± 3.92 mA vs. healthy volunteers, 5.74 ± 2.57 mA; p = 0.007) and a reduction in salivary SP (129.34 pg/ml vs. healthy volunteers: 173.89 pg/ml; p = 0.2346) and CGRP levels (24.17 pg/ml vs. healthy volunteers: 508.18 pg/ml; p = 0.0058). There was a negative correlation between both SP and CGRP concentrations and pharyngeal sensory threshold (r = - 0.450, p = 0.024; r = - 0.4597, p = 0.036, respectively), but only SP identified elderly patients with OD with higher pharyngeal sensory threshold. Elderly patients with OD presented hydropenia and sarcopenia, reduced salivary SP and CGRP and impaired pharyngeal sensitivity. Our study suggests SP levels in saliva as a potential biomarker to monitor pharyngeal sensitivity in elderly patients with OD.

A Comparative Study on the Effect of Acute Pharyngeal Stimulation with TRP Agonists on the Biomechanics and Neurophysiology of Swallow Response in Patients with Oropharyngeal Dysphagia.

Fluid thickening is the main compensatory strategy for patients with oropharyngeal dysphagia (OD) associated with aging or neurological diseases, and there is still no pharmacological treatment. We aimed to compare the effects of increasing bolus viscosity with that of acute stimulation with TRPV1, TRPA1 or TRPM8 agonists on the biomechanics and neurophysiology of swallow response in patients with OD. We retrospectively analyzed seven studies from our laboratory on 329 patients with OD. The effect of increasing shear viscosity up to 3682 mPa·s was compared by videofluoroscopy and pharyngeal sensory evoked potentials (pSEP) with that of adding to the bolus: capsaicin (TRPV1, 150 µM/10 µM), piperine (TRPA1/V1, 1 mM/150 µM), menthol (TRPM8, 1 mM/10 mM), cinnamaldehyde-zinc (TRPA1, 100 ppm−70 mM), citral (TRPA1, 250 ppm) or citral-isopulegol (TRPA1-TRPM8, 250 ppm−200 ppm). Fluid thickening improved the safety of swallow by 80% (p < 0.0001) by delaying bolus velocity by 20.7 ± 7.0% and time to laryngeal vestibule closure (LVC) by 23.1 ± 3.7%. Capsaicin 150µM or piperine 1 mM significantly improved safety of swallow by 50% (p < 0.01) and 57.1% (p < 0.01) by speeding time to LVC by 27.6% (p < 0.001) and 19.5% (p < 0.01) and bolus velocity by 24.8% (p < 0.01) and 16.9% (p < 0.05), respectively. Cinnamaldehyde-zinc shortened the P2 latency of pSEPs by 11.0% (p < 0.01) and reduced N2-P2 amplitude by 35% (p < 0.01). In conclusion, TRPV1 and TRPV1/A1 agonists are optimal candidates to develop new pharmacological strategies to promote the recovery of brain and swallow function in patients with chronic OD.

Healthcare costs of post-stroke oropharyngeal dysphagia and its complications: malnutrition and respiratory infections.

BACKGROUND AND PURPOSE: The healthcare economic costs of post-stroke oropharyngeal dysphagia (OD) are not fully understood. The purpose of this study was to assess the acute, subacute and long-term costs related to post-stroke OD and its main complications (malnutrition and respiratory infections). METHODS: A cost of illness study of patients admitted to Mataró Hospital (Catalonia, Spain) from May 2010 to September 2014 with a stroke diagnosis was performed. OD, malnutrition and respiratory infections were assessed during hospitalization and follow-up (3 and 12 months). Hospitalization and long-term costs were measured from hospital and healthcare system perspectives. Multivariate linear regression analysis was performed to assess the independent effect of OD, malnutrition and respiratory infections on healthcare costs during hospitalization, and at 3 and 12 months' follow-up. RESULTS: In all, 395 patients were included of whom 178 had OD at admission. Patients with OD incurred major total in-hospital costs (€5357.67 ± €3391.62 vs. €3976.30 ± €1992.58, p < 0.0001), 3-month costs (€8242.0 ± €5376.0 vs. €5320.0 ± €4053.0, p < 0.0001) and 12-month costs (€11,617.58 ± €12,033.58 vs. €7242.78 ± €7402.55, p < 0.0001). OD was independently associated with a cost increase of €789.68 (p = 0.011) during hospitalization and of €873.5 (p = 0.084) at 3 months but not at 12 months. However, patients with OD who were at risk of malnutrition or malnourished and suffered respiratory infections incurred major mean costs compared with those patients without OD (€19,817.58 ± €13,724.83 vs. €7242.8 ± €7402.6, p < 0.0004) at 12 months' follow-up. CONCLUSION: Oropharyngeal dysphagia causes significant high economic costs during hospitalization that strongly and significantly increase with the development of malnutrition and respiratory infections at long-term follow-up.

ESSD Commentary on Dysphagia Management During COVID Pandemia.

Since the World Health Organization declared the COVID-19 pandemic a Global Public Health Emergency, experts in swallowing are seeking guidance on service delivery and clinical procedures. The European Society for Swallowing Disorders provides considerations to support experts in swallowing disorders in clinical practice. During the COVID-19 pandemic, assessment and treatment of patients with oropharyngeal dysphagia should be provided, while at the same time balancing risk of oropharyngeal complications with that of infection of patients and healthcare professionals involved in their management. Elective, non-urgent assessment may be temporarily postponed and patients are triaged to decide whether dysphagia assessment is necessary; instrumental assessment of swallowing is performed only if processing of the instruments can be guaranteed and clinical assessment has not provided enough diagnostic information for treatment prescription. Assessment and management of oropharyngeal dysphagia is a high-risk situation as it must be considered an aerosol-generating procedure. Personal protective equipment (PPE) should be used. Telepractice is encouraged and compensatory treatments are recommended.

European white paper: oropharyngeal dysphagia in head and neck cancer.

PURPOSE: To develop a European White Paper document on oropharyngeal dysphagia (OD) in head and neck cancer (HNC). There are wide variations in the management of OD associated with HNC across Europe. METHODS: Experts in the management of specific aspects of OD in HNC across Europe were delegated by their professional medical and multidisciplinary societies to contribute to this document. Evidence is based on systematic reviews, consensus-based position statements, and expert opinion. RESULTS: Twenty-four sections on HNC-specific OD topics. CONCLUSION: This European White Paper summarizes current best practice on management of OD in HNC, providing recommendations to support patients and health professionals. The body of literature and its level of evidence on diagnostics and treatment for OD in HNC remain poor. This is in the context of an expected increase in the prevalence of OD due to HNC in the near future. Contributing factors to increased prevalence include aging of our European population (including HNC patients) and an increase in human papillomavirus (HPV) related cancer, despite the introduction of HPV vaccination in various countries. We recommend timely implementation of OD screening in HNC patients while emphasizing the need for robust scientific research on the treatment of OD in HNC. Meanwhile, its management remains a challenge for European professional associations and policymakers.

A retrospective and prospective 12-month observational study of the socioeconomic burden of moderate to severe irritable bowel syndrome with constipation in Spain.

INTRODUCTION: The socioeconomic burden of irritable bowel syndrome with constipation (IBS-C) has never been formally assessed in Spain. PATIENTS AND METHODS: This 12-month (6-month retrospective and prospective periods) observational, multicentre study assessed the burden of moderate-to-severe IBS-C in Spain. Patients were included if they had been diagnosed with IBS-C (Rome III criteria) within the last 5 years and had moderate-to-severe IBS-C (IBS Symptom Severity Scale score [IBS-SSS] ≥175) at inclusion. The primary objective was to assess the direct cost to the Spanish healthcare system (HS). RESULTS: A total of 112 patients were included, 64 (57%) of which had severe IBS-C at inclusion. At baseline, 89 (80%) patients reported abdominal pain and distention. Patient quality of life (QoL), measured by the IBS-C QoL and EQ-5D instruments, was found to be impaired with a mean score of 59 and 57 (0-100, worst-best), respectively. Over the 6-month prospective period the mean IBS-C severity, measured using the IBS-SSS showed some improvement (315-234 [0-500, best-worst]). During the year, 89 (80%) patients used prescription drugs for IBS-C, with laxatives being the most frequently prescribed (n=70; 63%). The direct cost to the HS was €1067, and to the patient was €568 per year. The total direct cost for moderate-to-severe IBS-C was €1635. DISCUSSION: The majority of patients reported continuous IBS-C symptoms despite that 80% were taking medication to treat their IBS-C. Overall healthcare resource use and direct costs were asymmetric, with a small group of patients consuming the majority of resources.

Using Rasch Analysis to Evaluate the Reliability and Validity of the Swallowing Quality of Life Questionnaire: An Item Response Theory Approach.

The Swallowing Quality of Life questionnaire (SWAL-QOL) is widely used clinically and in research to evaluate quality of life related to swallowing difficulties. It has been described as a valid and reliable tool, but was developed and tested using classic test theory. This study describes the reliability and validity of the SWAL-QOL using item response theory (IRT; Rasch analysis). SWAL-QOL data were gathered from 507 participants at risk of oropharyngeal dysphagia (OD) across four European countries. OD was confirmed in 75.7% of participants via videofluoroscopy and/or fiberoptic endoscopic evaluation, or a clinical diagnosis based on meeting selected criteria. Patients with esophageal dysphagia were excluded. Data were analysed using Rasch analysis. Item and person reliability was good for all the items combined. However, person reliability was poor for 8 subscales and item reliability was poor for one subscale. Eight subscales exhibited poor person separation and two exhibited poor item separation. Overall item and person fit statistics were acceptable. However, at an individual item fit level results indicated unpredictable item responses for 28 items, and item redundancy for 10 items. The item-person dimensionality map confirmed these findings. Results from the overall Rasch model fit and Principal Component Analysis were suggestive of a second dimension. For all the items combined, none of the item categories were 'category', 'threshold' or 'step' disordered; however, all subscales demonstrated category disordered functioning. Findings suggest an urgent need to further investigate the underlying structure of the SWAL-QOL and its psychometric characteristics using IRT.

Pharyngeal Electrical Stimulation for Treatment of Dysphagia in Subacute Stroke: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Dysphagia is common after stroke, associated with increased death and dependency, and treatment options are limited. Pharyngeal electric stimulation (PES) is a novel treatment for poststroke dysphagia that has shown promise in 3 pilot randomized controlled trials. METHODS: We randomly assigned 162 patients with a recent ischemic or hemorrhagic stroke and dysphagia, defined as a penetration aspiration score (PAS) of ≥3 on video fluoroscopy, to PES or sham treatment given on 3 consecutive days. The primary outcome was swallowing safety, assessed using the PAS, at 2 weeks. Secondary outcomes included dysphagia severity, function, quality of life, and serious adverse events at 6 and 12 weeks. RESULTS: In randomized patients, the mean age was 74 years, male 58%, ischemic stroke 89%, and PAS 4.8. The mean treatment current was 14.8 (7.9) mA and duration 9.9 (1.2) minutes per session. On the basis of previous data, 45 patients (58.4%) randomized to PES seemed to receive suboptimal stimulation. The PAS at 2 weeks, adjusted for baseline, did not differ between the randomized groups: PES 3.7 (2.0) versus sham 3.6 (1.9), P=0.60. Similarly, the secondary outcomes did not differ, including clinical swallowing and functional outcome. No serious adverse device-related events occurred. CONCLUSIONS: In patients with subacute stroke and dysphagia, PES was safe but did not improve dysphagia. Undertreatment of patients receiving PES may have contributed to the neutral result. CLINICAL TRIAL REGISTRATION: URL: http://www.controlled-trials.com. Unique identifier: ISRCTN25681641.

Effect of Bolus Viscosity on the Safety and Efficacy of Swallowing and the Kinematics of the Swallow Response in Patients with Oropharyngeal Dysphagia: White Paper by the European Society for Swallowing Disorders (ESSD).

BACKGROUND: Fluid thickening is a well-established management strategy for oropharyngeal dysphagia (OD). However, the effects of thickening agents on the physiology of impaired swallow responses are not fully understood, and there is no agreement on the degree of bolus thickening. AIM: To review the literature and to produce a white paper of the European Society for Swallowing Disorders (ESSD) describing the evidence in the literature on the effect that bolus modification has upon the physiology, efficacy and safety of swallowing in adults with OD. METHODS: A systematic search was performed using the electronic Pubmed and Embase databases. Articles in English available up to July 2015 were considered. The inclusion criteria swallowing studies on adults over 18 years of age; healthy people or patients with oropharyngeal dysphagia; bolus modification; effects of bolus modification on swallow safety (penetration/aspiration) and efficacy; and/or physiology and original articles written in English. The exclusion criteria consisted of oesophageal dysphagia and conference abstracts or presentations. The quality of the selected papers and the level of research evidence were assessed by standard quality assessments. RESULTS: At the end of the selection process, 33 articles were considered. The quality of all included studies was assessed using systematic, reproducible, and quantitative tools (Kmet and NHMRC) concluding that all the selected articles reached a valid level of evidence. The literature search gathered data from various sources, ranging from double-blind randomised control trials to systematic reviews focused on changes occurring in swallowing physiology caused by thickened fluids. Main results suggest that increasing bolus viscosity (a) results in increased safety of swallowing, (b) also results in increased amounts of oral and/or pharyngeal residue which may result in post-swallow airway invasion, (c) impacts the physiology with increased lingual pressure patterns, no major changes in impaired airway protection mechanisms, and controversial effects on oral and pharyngeal transit time, hyoid displacements, onset of UOS opening and bolus velocity-with several articles suggesting the therapeutic effect of thickeners is also due to intrinsic bolus properties, (d) reduces palatability of thickened fluids and (e) correlates with increased risk of dehydration and decreased quality of life although the severity of dysphagia may be an confounding factor. CONCLUSIONS: The ESSD concludes that there is evidence for increasing viscosity to reduce the risk of airway invasion and that it is a valid management strategy for OD. However, new thickening agents should be developed to avoid the negative effects of increasing viscosity on residue, palatability, and treatment compliance. New randomised controlled trials should establish the optimal viscosity level for each phenotype of dysphagic patients and descriptors, terminology and viscosity measurements must be standardised. This white paper is the first step towards the development of a clinical guideline on bolus modification for patients with oropharyngeal dysphagia.

A Comparative Study Between Two Sensory Stimulation Strategies After Two Weeks Treatment on Older Patients with Oropharyngeal Dysphagia.

Oropharyngeal dysphagia (OD) is a prevalent geriatric syndrome. Treatment is based on compensatory strategies to avoid complications. New treatments based on sensory stimulation to promote the recovery of the swallowing function have proved effective in acute studies but prolonged treatment needs further research. Our aim was to evaluate and compare the effect of two, longer-term sensory treatment strategies on older patients with OD. 38 older patients (≥70 years) were studied with videofluoroscopy (pre/posttreatment) and randomized into two 10-day treatment groups: Group A-transient receptor potential vanilloid 1 (TRPV1) agonist (capsaicin 1 × 10(-5) M) and Group B-transcutaneous sensory electrical stimulation (TSES) (Intelect VitalStim, biphasic pulses, 300 µs, 80 Hz). Patients were analyzed for treatment response. Patients were old (80.47 ± 5.2 years), with comorbidities (3.11 ± 1.59 Charlson Index), polymedication (8.92 ± 3.31 drugs/patient), and mild functional impairment (86.84 ± 17.84 Barthel Index), and 28.9 % were at risk of malnutrition (MNA-sf). Overall, all patients had videofluoroscopic signs of impaired safety of swallow (ISS) with delayed oropharyngeal swallow response (OSR). After sensory stimulation, prevalence of ISS decreased to 68.42 % in both groups (P = 0.019). There were 68.42 % responders in Group A (TRPV1) and 42.11 % in Group B (TSES). Group A responders showed an improvement in the penetration-aspiration scale (PAS, 5.23 ± 2.04 to 3 ± 1.47; P = 0.002), and the same was true for those of Group B (4.63 ± 1.41 to 2.13 ± 0.64; P = 0.007). 10-day sensory stimulation with either therapy improved safety of swallow and OSR in older patients with OD, reducing the severity of OD in a significant subgroup of these patients.