Current status of clinical outcome measures in inclusion body myositis: a systematised review.

OBJECTIVES: Sporadic inclusion body myositis (IBM) is a debilitating idiopathic inflammatory myopathy (IIM) which affects hand function, ambulation, and swallowing. There is no approved pharmacological therapy for IBM, and there is a lack of suitable outcome measure to assess the effect of an intervention. The IBM scientific interest group under IMACS reviewed the previously used outcome measures in IBM clinical studies to lay the path for developing a core set of outcome measures in IBM. METHODS: In this systematised review, we have extracted all outcome measures reported in IBM clinical studies to determine what measures were being used and to assess the need for optimising outcome measures in IBM. RESULTS: We found 13 observational studies, 17 open-label clinical trials, and 15 randomised control trials (RCTs) in IBM. Six-minute walk distance, IBM-functional rating scale (IBM-FRS), quantitative muscle testing, manual muscle testing, maximal voluntary isometric contraction testing, and thigh muscle volume measured by MRI were used as primary outcome measures. Twelve different outcome measures of motor function were used in IBM clinical trials. IBM-FRS was the most used measure of functionality. Swallowing function was reported as a secondary outcome measure in only 3 RCTs. CONCLUSIONS: There are inconsistencies in using outcome measures in clinical studies in IBM. The core set measures developed by the IMACS group for other IIMs are not directly applicable to IBM. As a result, there is an unmet need for an IBM-specific core set of measures to facilitate the evaluation of new potential therapeutics for IBM.

New horizons in understanding oral health and swallowing function within the context of frailty.

Frailty is a complex and multidimensional condition wherein declines in physiologic reserve and function place individuals in a state of heightened vulnerability and decreased resiliency. There has been growing interest in both research and clinical settings to understand how to best define, assess and characterise frailty in older adults. To this end, various models and clinical assessment tools have been used to define and measure frailty. While differences exist among these models and tools, a common unifying theme is a focus on physical function and activity. Notably absent across many available conceptual models and clinical tools are items directly related to oral and swallowing function. This is an important oversight as widespread changes to both oral and swallowing function are evident in older adults. Indeed, emerging evidence suggests many of the functional domains affected in frail older adults, such as nutrition and sarcopenia, have cyclical relationships with impairments in oral (oral hypofunction) and swallowing function (dysphagia) as well. The increasing appreciation for the interrelationships among oral hypofunction, dysphagia and frailty provides an opportunity for refinement of frailty assessment and characterisation in older adults to incorporate metrics specific to oral and swallowing function.

Measuring change in inclusion body myositis: clinical assessments versus imaging.

Sporadic inclusion body myositis (sIBM) is a heterogeneous progressive inflammatory muscle disease impacting skeletal muscles in the head, neck, and limbs. Use of valid, reliable, sensitive, and standardised clinical and paraclinical outcome assessments (COA) are critical to inform both proactive clinical care and clinical trial design. Here we review clinical and imaging methods used to quantify muscle strength, size, or function in sIBM, and discuss their application to clinical practice and use in clinical trials. Considerations for future work to validate measures in this population are also discussed.

Pilot Study of Quantitative Methods for Differentiating Pharyngeal Swallowing Mechanics by Dysphagia Etiology.

Quantitative analysis of modified barium swallow (MBS) imaging is useful to determine the impact of various disease states on pharyngeal swallowing mechanics. In this retrospective proof of concept study, kinematic analysis and computational analysis of swallowing mechanics (CASM) were used to demonstrate how these methods differentiate swallowing dysfunction by dysphagia etiology. Ten subjects were randomly selected from four cohorts of dysphagic patients including COPD, head and neck cancer (HNC), motor neuron disease, and stroke. Each subject was age- and gender-matched with healthy, non-dysphagic controls. MBS videos of 5 ml thin and 5 ml thick bolus trials from each subject were used. A MATLAB tracker tool was adapted and updated to collect and compile data for each video (n = 160). For kinematic measurements, a MANOVA was performed with post-hoc analyses to determine group differences. For CASM measurements, a morphometric canonical variate analysis with post hoc analysis was performed to determine group differences. Kinematic analyses indicated statistically significant differences between HNC cohort and controls in distance measurements for hyolaryngeal approximation (p = .001), laryngeal elevation (p = 0.0001), pharyngeal shortening (p = 0.0002), and stage transition duration timing (p = 0.002). Timing differences were noted between the stroke cohort and controls for pharyngeal transit time (p = 0.007). Multivariate morphometric canonical variate analysis showed significant differences between etiology groups (p < 0.0001) with eigenvectors indicating differing patterns of swallowing mechanics. This study demonstrated that swallowing mechanics among cohorts of dysphagic patients can be differentiated using kinematics and CASM, providing different but complementary quantitative methods for investigating the impact of various disease states on swallowing function.

Obstructive sleep apnea syndrome (OSAS) and swallowing function-a systematic review.

OBJECTIVES: The purpose of this systematic review was to summarize and qualitatively analyze published evidence elucidating the prevalence of dysphagia and detail alterations in swallowing function in patients with OSAS. METHODS: Computerized literature searches were performed from four search engines. The studies were selected based on the inclusion and exclusion criteria. The studies were screened using Covidence (Cochrane tool) and followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement standards (PRISMA-2009). A total 2645 studies were initially retrieved, of which a total of 17 studies met inclusion criteria. Two reviewers, blinded to each other, evaluated level and strength of evidence using the Oxford Centre for Evidence-based Medicine Levels of Evidence and QualSyst, respectively. RESULTS: Dysphagia prevalence ranged from 16 to 78% among the eligible studies. Studies varied in operational definitions defining swallowing dysfunction (dysphagia) and method used to assess swallowing function. Approximately 70% of eligible studies demonstrated strong methodological quality. The majority of studies (n = 11; 65%) reported pharyngeal swallowing impairments in patients with OSAS, including delayed initiation of pharyngeal swallow and penetration/aspiration. CONCLUSION: This systematic review describes swallowing function in patients with OSAS. However, due to the variability in defining OSAS and dysphagia, in the assessment method used to determine dysphagia, and heterogeneity of study designs, true prevalence is difficult to determine. Clinicians involved in the management of OSAS patients should employ validated assessment measures to determine if swallow dysfunction is present.

Provisional best practices guidelines for the evaluation of bulbar dysfunction in amyotrophic lateral sclerosis.

INTRODUCTION: Universally established comprehensive clinical bulbar scales objectively assessing disease progression in amyotrophic lateral sclerosis (ALS) are currently lacking. The goal of this working group project is to design a best practice set of provisional bulbar ALS guidelines, available for immediate implementation within all ALS clinics. METHODS: ALS specialists across multiple related disciplines participated in a series of clinical bulbar symposia, intending to identify and summarize the currently accepted best practices for the assessment and management of bulbar dysfunction in ALS Results: Summary group recommendations for individual speech, Augmentative and Alternative Communication (AAC), and swallowing sections were achieved, focusing on the optimal proposed level of care within each domain. DISCUSSION: We have identified specific clinical recommendations for each of the 3 domains of bulbar functioning, available for incorporation within all ALS clinics. Future directions will be to establish a formal set of bulbar guidelines through a methodological and evidence-based approach. Muscle Nerve 59:531-531, 2019.

A Clinician's Guide to Critically Appraising Randomized Controlled Trials in the Field of Speech-Language Pathology.

PURPOSE: When considering original research articles, randomized controlled trials (RCTs) provide the highest level of research evidence. Given this, RCTS are often used by clinicians performing evidence-based practice to determine the most effective intervention for a specific patient or patient population. Although RCTs represent a high level of research evidence, it is important for clinicians to critically appraise RCTs to determine the validity of the study methods deployed, the statistical and clinical significance of treatment effects, and whether or not the results generalize to a particular patient, patient population, and/or clinical setting. Therefore, this tutorial will provide clinicians with an overview of what an RCT is, the various types of RCTs, when RCTs are appropriate to conduct and/or use to inform clinical practice, and the advantages and limitations of RCTs. Additionally, this tutorial will provide clinicians with practical tools to employ when reading an RCT, including checklists with questions, definitions of important terminology frequently used in RCTs, and demonstrations of how to critically appraise RCTs using literature examples from the speech-language pathology literature. CONCLUSIONS: Learning how to interpret and apply the results from RCTs to inform clinical practice for purposes of improving patient care is a critical evidence-based practice skill for clinicians to develop. This tutorial will assist clinicians in the field of speech-language pathology by furthering their fundamental knowledge of RCTs and by providing them with pragmatic tools to critically appraise RCTs to inform their clinical practice.

Aspiration Screening in Motor Neuron Disease: Preliminary Results From Utilization of the Yale Swallow Protocol.

Purpose Dysphagia is a common symptom experienced by patients with motor neuron disease (MND). The Yale Swallow Protocol (YSP) is a validated screening instrument for identifying patients at risk for aspiration. The purpose of this exploratory cross-sectional, multicenter study was to investigate how the YSP results in identifying aspiration risk in patients with MND in comparison with aspiration observed during a videofluoroscopic swallow study (VFSS). Method Participants referred for VFSS as part of clinical management were recruited from four specialized MND clinics. All participants were administered the YSP immediately prior to the VFSS by a speech-language pathologist, with results recorded as pass or fail. Aspiration on VFSS was determined using the Penetration-Aspiration Scale (scores 6-8). A 2 × 2 contingency table was constructed to compare results of YSP with those on VFSS. Results Thirty-one patients with MND (13 males, 18 females; M age = 64 ± 12 years) referred for VFSS participated in this study. Of the 22 patients who failed the YSP, interrupted drinking was the most frequent reason (65%). Compared to the VFSS, the YSP yielded a sensitivity of 80%, a specificity of 33%, positive predictive value of 36%, and negative predictive value of 78%. Conclusions The YSP is a simple tool and easy to utilize and has a high sensitivity in identifying aspiration risk in amyotrophic lateral sclerosis. A future investigation with a larger sample size is needed to better investigate the utility of YSP as a screening tool for this population.

Factors Influencing Initiation of Pharyngeal Swallow in Healthy Adults.

Purpose The purpose of this study was to investigate factors influencing the initiation of pharyngeal swallow (IPS) in healthy, nondysphagic adults. Method A total of 195 healthy participants ranging in age from 21 to 89 years participated in a modified barium swallow study. IPS was quantified using the Modified Barium Swallow Impairment Profile standardized scoring system across nine swallowing tasks observed in the lateral viewing plane for each participant. Results Large variability for bolus head location at time of hyoid burst (IPS) was observed within this healthy cohort, ranging from the ramus of the mandible to the pyriform sinuses. Significant effects of bolus volume, viscosity, sex, and race were also observed. Conclusion Study findings indicate that IPS is variable in healthy adults and influenced by volume, viscosity, sex, and race. Thus, variability in IPS may be considered typical in otherwise nondysphagic adults. The clinical significance of high Modified Barium Swallow Impairment Profile IPS scores in dysphagic patients, therefore, must be considered within the context of other swallowing impairments. Supplemental Material https://doi.org/10.23641/asha.12735935.

Aging Effects on Eating Assessment Tool-10 (EAT-10) Total Scores in Healthy, Community-Dwelling Adults.

The purpose of this study was to examine how aging and sex impacted scores on the Eating Assessment Tool-10 in a large sample of healthy, non-dysphagic adults. Differences in Eating Assessment Tool-10 total normal (< 3) and abnormal (≥ 3) scores were examined across four age categories (21-39 years, 40-59 years, 60-79 years, 80 years and older) and between sexes. The mean (± SD) Eating Assessment Tool-10 total score for this healthy cohort of 167 individuals was 0.6 (± 1.6), with the majority of participants (75%) earning a score of zero. No significant differences were found in Eating Assessment Tool-10 total scores across age categories (p = .53) or between sexes (p = .79). Post-hoc analyses further explored relationships between Eating Assessment Tool-10 total scores and swallow performance measures as observed during videofluoroscopy. All participants (n = 15) scoring 3 and greater on the Eating Assessment Tool-10 passed an aspiration screen (i.e., 3-ounce water swallow challenge). Nine participants scoring less than 3 and failing the aspiration screen were not observed to have airway invasion as measured by the Penetration-Aspiration Scale during videofluoroscopy. A significant relationship was not observed between Eating Assessment Tool-10 total scores and highest Penetration-Aspiration Scale score. Eating Assessment Tool-10 total scores reported in the current study for patients with gastroesophageal reflux disease were significantly lower (p < .001) than total scores reported in the Eating Assessment Tool-10 validation study by Belafsky et al. (2008). In summary, aging or sex effects did not appear to impact self-report of dysphagia-related symptoms as measured by the Eating Assessment Tool-10. The Eating Assessment Tool-10, therefore, may not demonstrate the sensitivity needed to capture sub-clinical changes of the aging swallowing mechanism.

L'objectif de cette étude était d'examiner l'impact du vieillissement et du sexe sur les scores du Eating Assessment Tool-10, et ce, auprès d'un grand échantillon d'adultes en santé qui n'ont pas de dysphagie. Les scores totaux normaux (< 3) et anormaux (≥ 3) obtenus à l'Eating Assessment Tool-10 ont été examinés au sein de quatre catégories d'âge (21­39 ans, 40­59 ans, 60­79 ans, 80 ans et plus), ainsi qu'en fonction du sexe. La moyenne (± ÉT) des scores totaux était de 0,6 (± 1,6) pour cette cohorte de 167 individus en santé et une majorité d'entre eux (75%) ont obtenu un score de zéro. Aucune différence significative n'a été trouvée entre les catégories d'âge (p = 0,53) ou en fonction du sexe (p = 0,79). Des analyses post-hoc ont exploré plus en détail la relation entre les scores totaux du Eating Assessment Tool-10 et des mesures de performance de la déglutition recueillies lors d'une vidéofluoroscopie. Aucune aspiration n'a été dépistée (à l'aide d'une épreuve demandant d'avaler 3 onces d'eau) chez les 15 participants ayant obtenu un score égal ou plus grand que 3 à l'Eating Assessment Tool-10. Des aspirations ont été dépistées (à l'aide d'une épreuve demandant d'avaler 3 onces d'eau) chez neuf des participants ayant obtenu un score inférieur à 3 à l'Eating Assessment Tool-10. Néanmoins, aucun matériel n'est entré dans leurs voies respiratoires, si l'on se fie aux résultats obtenus avec la Penetration-Aspiration Scale lors de la vidéofluoroscopie. Aucune relation significative n'a été observée entre les scores totaux obtenus à l'Eating Assessment Tool-10 et les scores plus élevés obtenus à la Penetration-Aspiration Scale. Les scores totaux obtenus à l'Eating Assessment Tool-10 par les patients de la présente étude ayant du reflux gastro-oesophagien étaient significativement inférieurs (p < 0,001) à ceux obtenus dans l'étude de validation de Belafsky et al. (2008). En résumé, l'âge et le sexe ne semblent pas influencer les symptômes de dysphagie rapportés par les patients et mesurés par l'Eating Assessment Tool-10. Par conséquent, l'Eating Assessment Tool-10 ne semble pas avoir la sensibilité nécessaire pour identifier les changements subcliniques se produisant en cours de vieillissement au niveau du mécanisme de la déglutition.