Dysphagia Days as an Assessment of Clinical Treatment Outcome in Eosinophilic Esophagitis.

INTRODUCTION: The aim of this study was to evaluate Dysphagia Days as a measure of symptom improvement in patients with eosinophilic esophagitis from the HEROES study. METHODS: Dysphagia Days, defined as a yes answer to the following question: During any meal today, did food go down slowly or get stuck in your throat or chest? was assessed for cendakimab vs placebo. RESULTS: A statistically significant reduction in the mean number of Dysphagia Days experienced was observed with cendakimab 360 mg vs placebo at week 16 (-4.67 vs -1.83; P = 0.0115); an even greater improvement was observed in steroid-refractory patients vs placebo (-4.48 vs -0.04; P = 0.0079). DISCUSSION: Dysphagia Days represents a relevant clinical end point to capture dysphagia-related symptoms.

Development and validation of the INappropriate solid oral dosaGE form modification aSsessmenT (INGEST) Algorithm using data of patients with medication dysphagia from a neurology ward and nursing home in Singapore.

OBJECTIVES: This study aims to develop and validate a novel implicit tool to assist clinicians in resource-limited settings to promptly assess suitability for modification of solid oral dosage forms (SODFs) during medication prescribing, review and/or administration for patients with dysphagia. DESIGN: Literature review and a group discussion were conducted to elicit items for the construction of the INappropriate solid oral dosaGE form modification aSsessmenT (INGEST) algorithm. For its validation, inter-rater reliability among three independent users was evaluated. Accuracy of users' ratings was also evaluated against the screening results using the Don't Rush to Crush handbook. SETTING AND PARTICIPANTS: Three pharmacists were involved in the development and another three were involved in the validation of the INGEST algorithm using anonymised medication records of 50 patients in a nursing home and a hospital ward; only SODFs that were modified prior to administration were evaluated. RESULTS: Following literature review, considerations included by consensus in the INGEST algorithm were the presence of special coating or modified release characteristics of the SODF medications, hazardous nature and taste of the active ingredients, manufacturer's advice and use of tube feeding. Of the 381 SODF medications evaluated, 26 (6.8%) were identified by at least one pharmacist to be inappropriate for modification. Gwet's AC among the three pharmacists in identifying SODF medications inappropriate for modification was 0.75 (p<0.001, 95% CI 0.63 to 0.87), and 0.80 (p<0.001, 95% CI 0.71 to 0.89) in identifying SODF medications appropriate for modification, suggesting substantial inter-rater agreement. Overall accuracy of each pharmacist's ratings was high, ranging from 93.7% to 95.6%. CONCLUSIONS: The implicit INGEST algorithm has potential for use by clinicians in nursing home and hospital settings for determining suitability of SODF medications for modification. Further studies should be conducted to assess its external validity and utilisation in daily practice for improving clinical outcomes for patients with SODF dysphagia.

Dysphagia Risk in Patients Prescribed Rivastigmine: A Systematic Analysis of FDA Adverse Event Reporting System.

BACKGROUND: Dysphagia has been reported as an adverse event for patients receiving rivastigmine for Alzheimer's disease (AD) treatment. OBJECTIVE: The purpose of this study was to determine the association between dysphagia and the usage of rivastigmine by using the pharmacovigilance data from the FDA Adverse Event Reporting System (FAERS). METHODS: The risk of dysphagia in patients who took rivastigmine was compared with those of patients who took other medications. In addition, this study sought to determine if the dysphagia risk was influenced by sex, age, dosage, and medication routes of administration. RESULTS: When compared to patients prescribed donepezil, galantamine, or memantine, individuals prescribed rivastigmine were almost twice as likely to report dysphagia as an adverse event. The dysphagia risk in individuals prescribed rivastigmine is comparable to individuals prescribed penicillamine but significantly higher than clozapine, drugs of which have been previously shown to be associated with elevated dysphagia likelihood. Individuals older than 80 were 122% more likely to report having dysphagia after being prescribed rivastigmine than patients that were 50-70 years of age. Oral administration of rivastigmine was associated with approximately 2 times greater likelihood of reporting dysphagia relative to users of the transdermal patch. In addition, dysphagia showed higher association with pneumonia than other commonly reported adverse events. CONCLUSION: Patients prescribed rivastigmine were at greater risk of reporting dysphagia as an adverse event than patients prescribed many other medicines. This increase in dysphagia occurrence may be attributed to the dual inhibition of both acetylcholinesterase and butyrylcholinesterase.

A guide for the administration of oral antineoplastic in patients with swallowing disorders.

OBJECTIVE: To review the available literature on the administration of oral antineoplastic drugs in patients with swallowing disorders and  ystematize the information obtained. METHOD: Between September 2019 and April 2020, two hospital  harmacists drew up a list of the oral antineoplastic drugs available in  Spain, which was then distributed to three hospital pharmacists, each of  whom carried out a literature search and a review. An analysis was made  of the prescribing information and searches were performed in Pubmed, Micromedex, Uptodate, the Cancer Care Ontario website,  different pharmaceutical bulletins, feeding tube administration guidelines,  and tertiary information sources. Lastly, the pharmaceutical industry was  contacted. The group systematized the information obtained, after which a fourth hospital pharmacist and an independent physician reviewed the  work carried out. RESULTS: A total of 64 oral antineoplastic drugs were reviewed. Relevant information was obtained for 48 drugs, of which 44 were  amenable to administration to these patients (69% of the investigated  drugs). A systematization of the information found was carried out. Conclusions: Despite having found different methods for preparing and administering most of the oral antineoplastic drugs reviewed, the  information compiled was rather scarce and with a low level of evidence.  Further studies, based on pharmacokinetic and stability studies, are  necessary in this field as there is a sore need for oral liquid pharmaceutical forms or extemporaneous preparations allowing administration of oral  antineoplastic drugs to these patients.

Objetivo: Revisar la literatura disponible sobre la administración de  antineoplásicos orales en pacientes con trastornos de la deglución y  realizar una síntesis de la información hallada.Método: En el periodo septiembre 2019-junio 2020, tres farmacéuticos hospitalarios elaboraron una lista con los antineoplásicos  orales disponibles en España, la cual fue repartida, y cada cual llevó a  cabo la búsqueda y revisión bibliográfica de los medicamentos asignados.  Se revisaron las fichas técnicas y así como Pubmed, Micromedex,  Uptodate, la página web del Cancer Care Ontario, diferentes boletines  farmacéuticos, guías de administración por sonda y otras fuentes terciarias de información. En último lugar, se contactó con la industria farmacéutica. Posteriormente cada uno sintetizó la información que había  hallado y para concluir, un médico y un cuarto farmacéutico hospitalario  revisaron todo el trabajo llevado a cabo.Resultados: Se revisaron un total de 64 fármacos antineoplásicos orales. Se obtuvo información pertinente en el caso de 48, de los cuales 44  presentaban posibilidad de administración en estos pacientes (un 69% de  los fármacos investigados). Se realizó una síntesis de la información  hallada.Conclusiones: Pese a haber encontrado posibles métodos de preparación y administración para la mayoría de los antineoplásicos orales  revisados, se constata que la información es más bien escasa y con bajo  nivel  de evidencia. Es necesario seguir investigando en este campo, ya  que se precisan formas farmacéuticas líquidas, o preparaciones  extemporáneas, que en base a estudios farmacocinéticos y de estabilidad  permitan la administración de antineoplásicos orales en este grupo de  pacientes.

Comprehensive assessment of levodopa-carbidopa intestinal gel for Turkish advanced Parkinson's disease patients

Background/aim: Levodopa-carbidopa intestinal gel (LCIG) is an effective treatment modality in the management of advanced Parkinson's disease (PD) despite frequent adverse events and different rates of dropouts. Efficacy and safety data regarding Turkish patients on LCIG are limited. This study aims to report in detail the efficacy and adverse effect profile of LCIG among advanced PD patients from a Turkish center for movement disorders. Materials and methods: Twenty-two patients (50% male) who started receiving LCIG between December 2014 and March 2020 were recruited. The efficacy of LCIG was assessed with the Unified Parkinson's Disease Rating Scale (UPDRS III), Clinical Global Improvement (CGI) scale, and Quality of Life scale (PDQ8). Improvements in gait disorders and nonmotor features were also questioned. Adverse events (AE) were collated into 3 topics: related to percutaneous endoscopic gastrojejunostomy (PEG-J), device-related, and LCIG infusion-related. Results: Mean age and pre-LCIG disease duration were 66.7 (8.8) and 13.3 (8.0) years respectively. UPDRS III scores and H-Y scale assessments significantly improved. Better quality of life scores, clinical global improvements, and improvements in dysarthria, dysphagia, and gait were observed. None of our patients dropped out or died during a mean 17.5-month (12.3) period. Overall 20 (90.9%) patients experienced at least one AE. Twelve patients had PEG-J­related complications; three had acute abdomen. Eight (36.4%) patients had device-associated problems. Half of the patients required at least one additional endoscopic procedure and 7 had a device replaced. Mean body weight decreased from 69.5 to 62.5 kg and seven patients had newly onset PNP at a follow-up electromyography. Dyskinesia related to LCIG infusion was observed in 5 (22.7%) patients. There was no significant increase in hallucination among patients. Conclusion: LCIG is an efficient treatment modality in the management of Turkish patients with advanced Parkinson's disease. Although most of the patients had at least one AE, none of them dropped out. Patient selection, patient compliance, and collaborative management are important steps affecting the success of modality.

Dysphagia and pharmacotherapy in older adults.

PURPOSE OF REVIEW: The review summarizes current knowledge and recent findings about how to practically apply medication in patients with dysphagia and how swallowing function may be positively or negatively affected by drugs. RECENT FINDINGS: Oropharyngeal dysphagia is a major health problem in older persons and was recently classified as a geriatric syndrome. Although the knowledge about an effective diagnostic approach increased during the last years, comparatively little is known about how to effectively manage and treat dysphagia and hardly anything is implemented in clinical routine. Studies have shown a considerable lack of knowledge about the adequate modification of medication and demonstrated an increased rate of practical medication errors in patients with dysphagia. With regard to dysphagia therapy, two systematic reviews have identified neuroleptics as potentially harmful for swallowing function. The role of other candidates is controversial. Contrary to this, some pharmacological approaches may be future options for the treatment of dysphagia, with capsaicin currently being the most evaluated and potential one. SUMMARY: More professional training and advice about the adequate management of medication in dysphagic patients is necessary for all healthcare professionals. Large observational and interventional studies are needed to identify and confirm the influence of pharmacological substances on the swallowing function.

Conhecimento das equipes médicas e de enfermagem sobre o manejo de medicamentos orais no paciente adulto disfágico hospitalizado / Knowledge of the medical and nursing teams about the management of oral medications in hospitalized adult dysphagic patients

RESUMO Objetivo Descrever o conhecimento das equipes assistenciais sobre a disfagia e prescrição e administração de medicamentos orais em pacientes disfágicos adultos. Métodos Estudo transversal, realizado com médicos, enfermeiros e técnicos de enfermagem das unidades de internação e terapia intensiva em hospital universitário do Sul do Brasil. Participaram 102 profissionais, que responderam questionários adaptados e previamente testados para a pesquisa. As variáveis exploratórias foram: dados sociodemográficos; orientação acadêmica e profissional sobre disfagia; conhecimento sobre disfagia; fases da deglutição; sinais, sintomas e comorbidades associados à disfagia; manejo, prescrição e administração de medicações no paciente disfágico. Resultados Dos entrevistados, 93,5% dos médicos, 100% dos enfermeiros e 97,8% dos técnicos de enfermagem sabiam o que é disfagia. A maioria reconheceu o fonoaudiólogo como responsável pela reabilitação da deglutição, mas não identificou os sinais e sintomas da disfagia, sendo o engasgo na deglutição o mais reconhecido. Ao prescrever medicamentos, 58,1% dos médicos responderam que não cogitam vias alternativas (enteral ou endovenosa) para administração medicamentosa e 22,5%, que orientam a equipe de enfermagem sobre como administrar em pacientes disfágicos. A maioria dos enfermeiros e técnicos - 50,0% e 68,9% respectivamente -, informou que tritura o medicamento, misturando com água, e 65,4% e 46,7%, respectivamente, mencionaram que se sentem pouco preparados para administrar medicamentos em pacientes disfágicos. Conclusão O conhecimento das equipes assistenciais ainda é incipiente, quando relacionado ao cuidado do paciente adulto disfágico hospitalizado e ao uso de medicações por via oral. O compartilhamento de saberes, o investimento em educação permanente e a qualificação durante a formação destes profissionais é fundamental para melhorar o atendimento integral ao paciente.

ABSTRACT Purpose To describe the knowledge of healthcare teams about dysphagia, prescription, and administration of oral medications in dysphagic adult patients. Methods Cross-sectional study that included physicians, nurses, and nursing technicians from Hospitalization and Intensive Therapy Units of a university hospital in southern Brazil. A total of 102 professionals participated and answered an adapted and previously tested survey for this research. Exploratory variables were: sociodemographic data; academic and professional guidance on dysphagia; knowledge about dysphagia; phases of swallowing; signs, symptoms, and comorbidities associated with dysphagia; management, prescription, and administration of medications in the dysphagic patient. Results 93.5% of the physicians, 100% of the nurses, and 97.8% of the nursing technicians know what dysphagia is. Most recognize the speech therapist as being responsible for swallowing rehabilitation; however they do not identify the signs and symptoms of dysphagia; choking during swallow was the most recognized symptom. For prescription drugs, 58% of the physicians do not consider alternative routes (enteral or intravenous) for administration, and 22.5% advise the nursing staff on how to manage patients with dysphagia. Most nurses and nursing technicians, 50,0% and 68,9% respectively, crush the medicine and mix it with water; and 65,4% and 46,7%, respectively, feel unprepared to administer medications in patients with dysphagia. Conclusion The knowledge of healthcare teams is still incipient when it comes to the care of the hospitalized adult dysphagic patients and the use of oral medications. Knowledge sharing, investment in permanent education, and qualification during the education of these professionals is fundamental to improve the integral care to the patient.

Medicines administration for residents with dysphagia in care homes: A small scale observational study to improve practice.

BACKGROUND: In the UK, 69.5% of residents in care homes are exposed to one or more medication errors and 50% have some form of dysphagia. Hospital research identified that nurses frequently crush tablets to facilitate swallowing but this has not been explored in care homes. This project aimed to observe the administration of medicines to patients with dysphagia (PWD) and without in care homes. METHOD: A convenient sample of general practitioners in North Yorkshire invited care homes with nursing, to participate in the study. A pharmacist specialised in dysphagia observed nurses during drug rounds and compared these practices with national guidelines. Deviations were classified as types of medication administration errors (MAEs). RESULTS: Overall, 738 administrations were observed from 166 patients of which 38 patients (22.9%) had dysphagia. MAE rates were 57.3% and 30.8% for PWD and those without respectively (p<0.001). PWD were more likely to experience inappropriate prescribing (IP). Signs of aspiration were more frequently observed in PWD when IP occurred (p<0.001). CONCLUSION: Observation of medication administration practices by independent pharmacists may enable the identification of potentially dangerous practices and be used as a method of staff support. Unidentified signs of aspiration suggest that nurses require training in dysphagia and need to communicate its presence to the resident's GP. Further research should explore the design of an effective training for nurses.

Pediatric patients with dyspepsia have chronic symptoms, anxiety, and lower quality of life as adolescents and adults.

BACKGROUND & AIMS: Little is known about long-term health outcomes of children with dyspeptic symptoms. We studied the natural history of pediatric patients with dyspeptic symptoms, with and without histologic reflux, compared with healthy controls. METHODS: We performed a prospective study of consecutive new patients, ages 8-16 years, who underwent evaluation for dyspepsia, including upper endoscopy. Patients were assigned to groups with histologic evidence of reflux esophagitis (n = 50), or normal histology results (n = 53). Healthy children were followed up as controls (n = 143). Patients and controls were evaluated 5-15 years later. They provided self-reports on severity of dyspeptic symptoms, use of acid suppression, quality of life, anxiety, and depression. RESULTS: When the study began, the groups with histologic evidence of esophagitis and normal histologies did not differ in severity of dyspeptic symptoms, functional disability, or depression. After a mean 7.6-year follow-up period, each group had significantly lower quality-of-life scores and more severe dyspeptic symptoms and functional disability than controls, but did not differ significantly from each other; both groups were significantly more likely than controls to meet criteria for an anxiety disorder. At time of follow-up evaluation, use of acid-suppression medication was significantly greater in the group with histologic evidence for esophagitis, compared with patients who had normal histology findings when the study began. CONCLUSIONS: Among pediatric patients with dyspepsia evaluated by endoscopy and biopsy, those with histologic evidence for esophagitis or normal histology findings are at increased risk for chronic dyspeptic symptoms, anxiety disorder, and reduced quality of life in adolescence and young adulthood.

Controlling hypertension and hypotension immediately post stroke (CHHIPS)--a randomised controlled trial.

OBJECTIVES: To assess the effects of acute pressor and depressor blood pressure (BP) manipulation on 2-week death and dependency following acute stroke and investigate the safety and efficacy of such treatments. DESIGN: A multicentre, prospective, randomised, double-blind, placebo-controlled titrated-dose trial. SETTING: Five hospitals in England. PARTICIPANTS: Patients over 18 years admitted to hospital with a clinical diagnosis of suspected stroke and either (1) symptom onset < 36 hours and hypertension, defined as systolic BP (SBP) < 160 mmHg (depressor arm), or (2) symptom onset < 12 hours and hypotension, defined as SBP < or = 140 mmHg (pressor arm). INTERVENTIONS: Patients were allocated to either the pressor or the depressor arm depending on blood pressure at randomisation. The ratio of allocation to active intervention versus matched placebo was 2:1 for the depressor arm and 1:1 for the pressor arm. MAIN OUTCOME MEASURES: The primary end point was death and dependency at 2 weeks, with dependency defined as a modified Rankin score < 3. Secondary end points were the safety of acute pressor (0-12 hours post stroke) and depressor (0-36 hours post stroke) BP manipulation in stroke patients; whether effects of BP reduction are influenced by stroke type (ischaemic versus haemorrhagic); whether alternative routes for administration of antihypertensive therapy (including sublingual and intravenous) are effective in dysphagic stroke patients; whether effects of BP manipulation are influenced by the time to treatment; and the short- and medium-term cost-effectiveness of such therapy in the acute post-stroke period on subsequent disability or death. RESULTS: 180 patients were recruited over the 36-month trial period, 179 in the depressor arm and one in the pressor arm (who received placebo). No significant difference was found in death or dependency at 2 weeks between those receiving active depressor treatment with lisinopril or labetalol and those receiving placebo, although numbers recruited to the trial were lower than projected. Active treatment was not associated with an increase in early neurological deterioration despite significantly greater reductions in BP at 24 hours and 2 weeks with active therapy compared with placebo. Active treatment was generally well tolerated and treatment discontinuation rates were similar in active and placebo groups. Survival analysis showed that the active treatment group had a lower mortality at 3 months than the placebo group (p = 0.05). The pressor arm was closed early because of problems with recruitment, so no conclusions can be drawn regarding this therapy. CONCLUSIONS: Oral and sublingual lisinopril and oral and intravenous labetalol are effective BP-lowering agents in acute cerebral infarction and haemorrhage and do not increase the likelihood of early neurological deterioration. The study was not sufficiently powered to detect a difference in disability or death at 2 weeks. However, the 3-month difference in mortality in favour of active treatment is of interest, although care must be taken in interpretation of the results. Further work is needed to confirm this and to assess whether there are differences in the effectiveness of labetalol compared with lisinopril in terms of reducing death or dependency after acute stroke, and whether the introduction of treatment post stroke earlier than was achieved here would be of greater benefit.