Randomized controlled feasibility trial of swallow strength and skill training with surface electromyographic biofeedback in acute stroke patients with dysphagia.

BACKGROUND & OBJECTIVES: Swallow strength and skill training with surface electromyography (sEMG) biofeedback may improve dysphagia but little is known about the feasibility and efficacy of this intervention in acute stroke. METHODS: We conducted a randomized controlled feasibility study in acute stroke patients with dysphagia. Participants were randomized to either usual care or usual care plus swallow strength and skill training with sEMG biofeedback. Primary outcomes were feasibility and acceptability. Secondary measures included swallowing and clinical outcomes, safety and swallow physiology. RESULTS: Twenty-seven patients (13 biofeedback, 14 control) with average age of 73.3 (SD 11.0) and National Institute of Health Stroke Scale (NIHSS) of 10.7 (5.1) were recruited 22.4 (9.5) days post stroke. About 84.6% of participants completed >80% of sessions; failed sessions were mainly due to participant availability, drowsiness or refusal. Sessions lasted for an average of 36.2 (7.4) min. Although 91.7% found the intervention comfortable with satisfactory administration time, frequency and time post stroke, 41.7% found it challenging. There were no treatment-related serious adverse events. The biofeedback group had a lower Dysphagia Severity Rating Scale (DSRS) score at 2 weeks compared to control (3.2 vs. 4.3), but the difference did not reach statistical significance. CONCLUSIONS: Swallow strength and skill training with sEMG biofeedback appears feasible and acceptable to acute stroke patients with dysphagia. Preliminary data suggests it is safe and further research refining the intervention and investigating treatment dose and efficacy is warranted.

Diagnostic accuracy of the Dysphagia Trained Nurse Assessment tool in acute stroke.

BACKGROUND AND PURPOSE: Comprehensive swallow screening assessments to identify dysphagia and make early eating and drinking recommendations can be used by trained nurses. This study aimed to validate the Dysphagia Trained Nurse Assessment (DTNAx) tool in acute stroke patients. METHODS: Participants with diagnosed stroke were prospectively and consecutively recruited from an acute stroke unit. Following a baseline DTNAx on admission, participants underwent a speech and language therapist (SLT) bedside assessment of swallowing (speech and language therapist assessment [SLTAx]), videofluoroscopy (VFS) and a further DTNAx by the same or a different nurse. RESULTS: Forty-seven participants were recruited, of whom 22 had dysphagia. Compared to SLTAx in the identification of dysphagia, DTNAx had a sensitivity of 96.9% (95% confidence interval [CI] 83.8-99.9) and specificity of 89.5% (95% CI 75.2-97.1). Compared to VFS in the identification of aspiration, DTNAx had a sensitivity of 77.8% (95% CI 40.0-97.2) and a specificity of 81.6% (95% CI 65.7-92.3). Over 81% of the diet and fluid recommendations made by the dysphagia trained nurses were in absolute agreement compared to SLTAx. Both DTNAx and SLTAx had low diagnostic accuracy compared to the VFS-based definition of dysphagia. CONCLUSIONS: Nurses trained in DTNAx showed good diagnostic accuracy in identifying dysphagia compared to SLTAx and in identifying aspiration compared to VFS. They made appropriate diet and fluid recommendations in line with SLTs in the early management of dysphagia.

Accuracy and clinical utility of comprehensive dysphagia screening assessments in acute stroke: A systematic review and meta-analysis.

INTRODUCTION: Nurses and other nonspecialists in dysphagia are often trained to screen swallowing poststroke. There are many basic tools that test water only, they are usually conservative, and patients that fail the test remain nil by mouth until a speech and language therapy assessment. More comprehensive tests also allow nonspecialists to recommend modified oral intake. Little is known about the accuracy, clinical utility and cost-effectiveness of these tests. METHODS: Following PRISMA guidelines, a systematic review was conducted to describe comprehensive swallowing tests that are available for use in acute stroke by nurses or other nonspecialists in dysphagia. A meta-analysis was performed to evaluate accuracy and the clinical utility of the tests was considered. Searches and analyses, conducted by two reviewers, included MEDLINE, Embase, trial registries and grey literature up to December 2018. Validated studies were assessed for quality and risk of bias using QUADAS-2. RESULTS: Twenty studies were included, describing five different tests, three of which had undergone validation. The tests varied in content, recommendations and use. There was no test superior in accuracy and clinical utility. Three studies validating the Gugging Swallow Screen provided sufficient data for meta-analysis, demonstrating high sensitivity; 96% (95% CI 0.90-0.99), but low specificity, 65% (95% CI 0.47-0.79), in line with many water swallow tests. Results should be interpreted with caution as study quality and applicability to the acute stroke population was poor. CONCLUSIONS: There is no comprehensive nurse dysphagia assessment tool that has robustly demonstrated good accuracy, clinical utility and cost-effectiveness in acute stroke. RELEVANCE TO CLINICAL PRACTICE: Nurses and other clinicians can develop competencies in screening swallowing and assessing for safe oral intake in those with poststroke dysphagia. It is important to use a validated assessment tool that demonstrates good accuracy, clinical utility and cost-effectiveness.

Does Therapy With Biofeedback Improve Swallowing in Adults With Dysphagia? A Systematic Review and Meta-Analysis.

OBJECTIVE: To describe and systematically review the current evidence on the effects of swallow therapy augmented by biofeedback in adults with dysphagia (PROSPERO 2016:CRD42016052942). DATA SOURCES: Two independent reviewers conducted searches that included MEDLINE, EMBASE, trial registries, and gray literature up to December 2016. STUDY SELECTION: Randomized controlled trials (RCTs) and non-RCTs were assessed, including for risk of bias and quality. DATA EXTRACTION: Data were extracted by 1 reviewer and verified by another on biofeedback type, measures of swallow function, physiology and clinical outcome, and analysed using Cochrane Review Manager (random effects models). Results are expressed as weighted mean difference (WMD) and odds ratio (OR). DATA SYNTHESIS: Of 675 articles, we included 23 studies (N=448 participants). Three main types of biofeedback were used: accelerometry, surface electromyography (sEMG), and tongue manometry. Exercises included saliva swallows, maneuvers, and strength exercises. Dose varied between 6 and 72 sessions for 20-60 minutes. Five controlled studies (stroke n=95; head and neck cancer n=33; mixed etiology n=10) were included in meta-analyses. Compared to control, biofeedback augmented dysphagia therapy significantly enhanced hyoid displacement (3 studies, WMD=0.22cm; 95% confidence interval [CI] [0.04, 0.40], P=.02) but there was no significant difference in functional oral intake (WMD=1.10; 95% CI [-1.69, 3.89], P=.44) or dependency on tube feeding (OR =3.19; 95% CI [0.16, 62.72], P=.45). Risk of bias was high and there was significant statistical heterogeneity between trials in measures of swallow function and number tube fed (I2 70%-94%). Several nonvalidated outcome measures were used. Subgroup analyses were not possible due to a paucity of studies. CONCLUSIONS: Dysphagia therapy augmented by biofeedback using sEMG and accelerometry enhances hyoid displacement but functional improvements in swallowing are not evident. However, data are extremely limited and further larger well-designed RCTs are warranted.

Swallowing therapy for dysphagia in acute and subacute stroke.

BACKGROUND: Dysphagia (swallowing problems), which is common after stroke, is associated with increased risk of death or dependency, occurrence of pneumonia, poor quality of life, and longer hospital stay. Treatments provided to improve dysphagia are aimed at accelerating recovery of swallowing function and reducing these risks. This is an update of the review first published in 1999 and updated in 2012. OBJECTIVES: To assess the effects of swallowing therapy on death or dependency among stroke survivors with dysphagia within six months of stroke onset. SEARCH METHODS: We searched the Cochrane Stroke Group Trials Register (26 June 2018), the Cochrane Central Register of Controlled Trials (CENTRAL; 2018, Issue 6) in the Cochrane Library (searched 26 June 2018), MEDLINE (26 June 2018), Embase (26 June 2018), the Cumulative Index to Nursing and Allied Health Literature (CINAHL) (26 June 2018), Web of Science Core Collection (26 June 2018), SpeechBITE (28 June 2016), ClinicalTrials.Gov (26 June 2018), and the World Health Organization International Clinical Trials Registry Platform (26 June 2018). We also searched Google Scholar (7 June 2018) and the reference lists of relevant trials and review articles. SELECTION CRITERIA: We sought to include randomised controlled trials (RCTs) of interventions for people with dysphagia and recent stroke (within six months). DATA COLLECTION AND ANALYSIS: Two review authors independently applied the inclusion criteria, extracted data, assessed risk of bias, used the GRADE approach to assess the quality of evidence, and resolved disagreements through discussion with the third review author (PB). We used random-effects models to calculate odds ratios (ORs), mean differences (MDs), and standardised mean differences (SMDs), and provided 95% confidence intervals (CIs) for each.The primary outcome was functional outcome, defined as death or dependency (or death or disability), at the end of the trial. Secondary outcomes were case fatality at the end of the trial, length of inpatient stay, proportion of participants with dysphagia at the end of the trial, swallowing ability, penetration aspiration score, or pneumonia, pharyngeal transit time, institutionalisation, and nutrition. MAIN RESULTS: We added 27 new studies (1777 participants) to this update to include a total of 41 trials (2660 participants).We assessed the efficacy of swallowing therapy overall and in subgroups by type of intervention: acupuncture (11 studies), behavioural interventions (nine studies), drug therapy (three studies), neuromuscular electrical stimulation (NMES; six studies), pharyngeal electrical stimulation (PES; four studies), physical stimulation (three studies), transcranial direct current stimulation (tDCS; two studies), and transcranial magnetic stimulation (TMS; nine studies).Swallowing therapy had no effect on the primary outcome (death or dependency/disability at the end of the trial) based on data from one trial (two data sets) (OR 1.05, 95% CI 0.63 to 1.75; 306 participants; 2 studies; I² = 0%; P = 0.86; moderate-quality evidence). Swallowing therapy had no effect on case fatality at the end of the trial (OR 1.00, 95% CI 0.66 to 1.52; 766 participants; 14 studies; I² = 6%; P = 0.99; moderate-quality evidence). Swallowing therapy probably reduced length of inpatient stay (MD -2.9, 95% CI -5.65 to -0.15; 577 participants; 8 studies; I² = 11%; P = 0.04; moderate-quality evidence). Researchers found no evidence of a subgroup effect based on testing for subgroup differences (P = 0.54). Swallowing therapy may have reduced the proportion of participants with dysphagia at the end of the trial (OR 0.42, 95% CI 0.32 to 0.55; 1487 participants; 23 studies; I² = 0%; P = 0.00001; low-quality evidence). Trial results show no evidence of a subgroup effect based on testing for subgroup differences (P = 0.91). Swallowing therapy may improve swallowing ability (SMD -0.66, 95% CI -1.01 to -0.32; 1173 participants; 26 studies; I² = 86%; P = 0.0002; very low-quality evidence). We found no evidence of a subgroup effect based on testing for subgroup differences (P = 0.09). We noted moderate to substantial heterogeneity between trials for these interventions. Swallowing therapy did not reduce the penetration aspiration score (i.e. it did not reduce radiological aspiration) (SMD -0.37, 95% CI -0.74 to -0.00; 303 participants; 11 studies; I² = 46%; P = 0.05; low-quality evidence). Swallowing therapy may reduce the incidence of chest infection or pneumonia (OR 0.36, 95% CI 0.16 to 0.78; 618 participants; 9 studies; I² = 59%; P = 0.009; very low-quality evidence). AUTHORS' CONCLUSIONS: Moderate- and low-quality evidence suggests that swallowing therapy did not have a significant effect on the outcomes of death or dependency/disability, case fatality at the end of the trial, or penetration aspiration score. However, swallowing therapy may have reduced length of hospital stay, dysphagia, and chest infections, and may have improved swallowing ability. However, these results are based on evidence of variable quality, involving a variety of interventions. Further high-quality trials are needed to test whether specific interventions are effective.

Reliability of the Penetration-Aspiration Scale and Temporal and Clearance Measures in Poststroke Dysphagia: Videofluoroscopic Analysis From the Swallowing Treatment using Electrical Pharyngeal Stimulation Trial.

PURPOSE: Information on reliability of outcome measures used to assess the effectiveness of interventions in dysphagia rehabilitation is lacking, particularly when used by different research groups. Here, we report on reliability of the penetration-aspiration scale (PAS) and temporal and clearance measures, determined using videofluoroscopy. METHOD: Secondary analysis used videofluoroscopies from the Swallowing Treatment using Electrical Pharyngeal Stimulation trial in subacute stroke. PAS scores (719 scores from 18 participants) were evaluated and compared to the original PAS scores from the trial. Five conditions were assessed, including reliability for every swallow and overall mean of the worst PAS score. Operational rules for assessing temporal and clearance measures were also developed using the same data, and reliability of these rules was assessed. Reliability of component-level and derivative-level scores was assessed using the intraclass correlation coefficient (ICC) and weighted kappa. RESULTS: Image quality was variable. Interrater reliability for the overall mean of the worst PAS score was excellent (ICC = .914, 95% confidence interval [CI] [.853, .951]) but moderate for every swallow in the bolus (ICC = .743, 95% CI [.708, .775]). Intrarater reliability for PAS was excellent (all conditions). Excellent reliability (both inter- and intrarater > .90) was seen for temporal measures of stage transition duration (ICC = .998, 95% CI [.993, .999] and ICC = .995, 95% CI [.987, .998], respectively) as well as initiation of laryngeal closure and pharyngeal transit time and all individual swallow events. Strong scores were obtained for some clearance measures; others were moderate or weak. CONCLUSIONS: Interrater reliability for PAS is acceptable but depends on how the PAS scores are handled in the analysis. Interrater reliability for most temporal measures was high, although some measures required additional training. No clearance measures had excellent reliability. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.19090088.

Effect of continuing versus stopping pre-stroke antihypertensive agents within 12 h on outcome after stroke: A subgroup analysis of the efficacy of nitric oxide in stroke (ENOS) trial.

BACKGROUND: It is not known whether to continue or temporarily stop existing antihypertensive drugs in patients with acute stroke. METHODS: We performed a prospective subgroup analysis of patients enrolled into the Efficacy of Nitric Oxide in Stroke (ENOS) trial who were randomised to continue vs stop prior antihypertensive therapy within 12 h of stroke onset. The primary outcome was functional outcome, assessed with the modified Rankin Scale at 90 days by observers blinded to treatment assignment, and analysed with ordinal logistic regression. FINDINGS: Of 4011 patients recruited into ENOS from 2001 to 2014, 2097 patients were randomised to continue vs stop prior antihypertensive treatment, and 384 (18.3%, continue 185, stop 199) were enrolled within 12 h of ictus: mean (SD) age 71.8 (11.8) years, female 193 (50.3%), ischaemic stroke 342 (89.1%) and total anterior circulation syndrome 114 (29.7%). As compared with stopping, continuing treatment within 12 h of onset lowered blood pressure by 15.5/9.6 mmHg (p<0.001/<0.001) by 7 days, shifted the modified Rankin Scale to a worse outcome by day 90, adjusted common odds ratio (OR) 1.46 (95% CI 1.01-2.11), and was associated with an increased death rate by day 90 (hazard ratio 2.17, 95% CI 1.24-3.79). Other outcomes (disability - Barthel Index, quality of life - EQ-visual analogue scale, cognition - telephone mini-mental state examination, and mood - Zung depression scale) were also worse with continuing treatment. INTERPRETATION: In this pre-specified subgroup analysis of the large ENOS trial, continuing prior antihypertensive therapy within 12 h of stroke onset in a predominantly ischaemic stroke population was unsafe with worse functional outcome, disability, cognition, mood, quality of life and increased death. Future studies assessing continuing or stopping prior antihypertensives in the context of thrombectomy are awaited.

Effects of Pharyngeal Electrical Stimulation on Swallow Timings, Clearance and Safety in Post-Stroke Dysphagia: Analysis from the Swallowing Treatment Using Electrical Pharyngeal Stimulation (STEPS) Trial.

Swallowing impairment (dysphagia) post-stroke results in poorer outcomes. Pharyngeal electrical stimulation (PES) is a potential treatment for post-stroke dysphagia. In a post hoc analysis, we investigated PES using videofluoroscopy swallow studies (VFSS) from the STEPS trial incorporating multiple measures of safety (penetration aspiration scale-PAS), speed and duration (timing), and efficiency (clearance), as opposed to the original trial which only measured PAS scores. 81 randomised participants (PES (N = 43) versus sham (N = 38)) were analysed at baseline and 2 weeks. Participants swallowed up to 6 × 5 ml and 1 × 50 ml of thin liquid barium at 40% w/v, images at ≥25 fps. Based on PAS, the 5 ml mode bolus (most frequently occurring PAS from 6 × 5 ml) and the worst 50 ml bolus were chosen for further analysis. Eight timing measures were performed, including stage transition duration (STD) and pharyngeal transit time (PTT). Clearance measures comprised oral and pharyngeal residue and swallows to clear. Comparisons of change of scoring outcomes between PES and sham were done at 2 weeks. Wilcoxon Signed Ranks Test was also used to evaluate longitudinal changes from both groups' combined results at two weeks. Between-group analysis showed no statistically significant differences. Issues with suboptimal image quality and frame rate acquisition affected final numbers. At two weeks, both groups demonstrated a significant improvement in most safety scores (PAS) and STD, possibly due to spontaneous recovery or a combination of spontaneous recovery and swallowing treatment and usual care. A nonsignificant trend for improvement was seen in other timing measures, including PTT. This study, which conducted additional measurements of kinematic and residue analysis on the STEPS data did not detect "missed" improvements in swallowing function that the PAS is not designed to measure. However, more studies with greater numbers are required.

Psychometric assessment and validation of the dysphagia severity rating scale in stroke patients.

Post stroke dysphagia (PSD) is common and associated with poor outcome. The Dysphagia Severity Rating Scale (DSRS), which grades how severe dysphagia is based on fluid and diet modification and supervision requirements for feeding, is used for clinical research but has limited published validation information. Multiple approaches were taken to validate the DSRS, including concurrent- and predictive criterion validity, internal consistency, inter- and intra-rater reliability and sensitivity to change. This was done using data from four studies involving pharyngeal electrical stimulation in acute stroke patients with dysphagia, an individual patient data meta-analysis and unpublished studies (NCT03499574, NCT03700853). In addition, consensual- and content validity and the Minimal Clinically Important Difference (MCID) were assessed using anonymous surveys sent to UK-based Speech and Language Therapists (SLTs). Scores for consensual validity were mostly moderate (62.5-78%) to high or excellent (89-100%) for most scenarios. All but two assessments of content validity were excellent. In concurrent criterion validity assessments, DSRS was most closely associated with measures of radiological aspiration (penetration aspiration scale, Spearman rank rs = 0.49, p < 0.001) and swallowing (functional oral intake scale, FOIS, rs = -0.96, p < 0.001); weaker but statistically significant associations were seen with impairment, disability and dependency. A similar pattern of relationships was seen for predictive criterion validity. Internal consistency (Cronbach's alpha) was either "good" or "excellent". Intra and inter-rater reliability were largely "excellent" (intraclass correlation >0.90). DSRS was sensitive to positive change during recovery (medians: 7, 4 and 1 at baseline and 2 and 13 weeks respectively) and in response to an intervention, pharyngeal electrical stimulation, in a published meta-analysis. The MCID was 1.0 and DSRS and FOIS scores may be estimated from each other. The DSRS appears to be a valid tool for grading the severity of swallowing impairment in patients with post stroke dysphagia and is appropriate for use in clinical research and clinical service delivery.

Pharyngeal electrical stimulation for neurogenic dysphagia following stroke, traumatic brain injury or other causes: Main results from the PHADER cohort study.

BACKGROUND: Neurogenic dysphagia is common and has no definitive treatment. We assessed whether pharyngeal electrical stimulation (PES) is associated with reduced dysphagia. METHODS: The PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia European Registry (PHADER) was a prospective single-arm observational cohort study. Participants were recruited with neurogenic dysphagia (comprising five groups - stroke not needing ventilation; stroke needing ventilation; ventilation acquired; traumatic brain injury; other neurological causes). PES was administered once daily for three days. The primary outcome was the validated dysphagia severity rating scale (DSRS, score best-worst 0-12) at 3 months. FINDINGS: Of 255 enrolled patients from 14 centres in Austria, Germany and UK, 10 failed screening. At baseline, mean (standard deviation) or median [interquartile range]: age 68 (14) years, male 71%, DSRS 11·4 (1·7), time from onset to treatment 32 [44] days; age, time and DSRS differed between diagnostic groups. Insertion of PES catheters was successfully inserted in 239/245 (98%) participants, and was typically easy taking 11·8 min. 9 participants withdrew before the end of treatment. DSRS improved significantly in all dysphagia groups, difference in means (95% confidence intervals, CI) from 0 to 3 months: stroke (n = 79) -6·7 (-7·8, -5·5), ventilated stroke (n = 98) -6·5 (-7·6, -5·5); ventilation acquired (n = 35) -6·6 (-8·4, -4·8); traumatic brain injury (n = 24) -4·5 (-6·6, -2·4). The results for DSRS were mirrored for instrumentally assessed penetration aspiration scale scores. DSRS improved in both supratentorial and infratentorial stroke, with no difference between them (p = 0·32). In previously ventilated participants with tracheotomy, DSRS improved more in participants who could be decannulated (n = 66) -7·5 (-8·6, -6·5) versus not decannulated (n = 33) -2·1 (-3·2, -1·0) (p<0·001). 74 serious adverse events (SAE) occurred in 60 participants with pneumonia (9·2%) the most frequent SAE. INTERPRETATION: In patients with neurogenic dysphagia, PES was safe and associated with reduced measures of dysphagia and penetration/aspiration. FUNDING: Phagenesis Ltd.