Do implementation interventions improve evidence-based care in acute stroke settings? A Cochrane Review summary with commentary.

BACKGROUND: Evidence on acute stroke management is continuously growing. Stroke units are often associated with better access to high-level evidence-based practices, but even there, recommendations can be inconsistently delivered to patients with stroke. Implementation interventions are strategies designed to improve the application of evidence-based care. OBJECTIVE: To provide a commentary on the Cochrane Review by Lynch et al. on the effects of implementation interventions on adherence to evidence-based recommendations by health professionals working in acute stroke units. METHODS: A systematic search was performed in CENTRAL, MEDLINE, Embase, and other databases. The search was also performed in grey literature databases, trial registries, systematic reviews and primary studies, as well as in the reference list of identified studies. RESULTS: The review included seven cluster-randomized trials (with 42,489 participants). Studies compared the implementation of strategies composed of different parts (multifaceted) to no intervention, or a multifaceted strategy vs another intervention. These strategies were aimed at changing and improving the delivery of care in the hospital. It included health professional participants, such as nurses, physicians and allied health professionals. The authors concluded that there was uncertainty whether implementation strategies compared with no intervention have any effect on patients receiving evidence-based care during their stroke unit admission. Implementation interventions compared to no intervention probably have little or no effect on the risk of patients dying or being disabled or dependent, and probably do not change patients' hospital length of stay. CONCLUSION: Due to the very low certainty of evidence, there is uncertainty whether a multifaceted implementation intervention, compared to no intervention, can improve adherence to evidence-based recommendations in acute stroke settings.

Introduction to target trial emulation in rehabilitation: a systematic approach to emulate a randomized controlled trial using observational data.

Rehabilitation providers and policymakers need valid evidence to make informed decisions about the healthcare needs of the population. Whenever possible, these decisions should be informed by randomized controlled trials (RCTs). However, there are circumstances when evidence needs to be generated rapidly, or when RCTs are not ethical or feasible. These situations apply to studying the effects of complex interventions, including rehabilitation as defined by Cochrane Rehabilitation. Therefore, we explore using the target trial emulation framework by Hernán and colleagues to obtain valid estimates of the causal effects of rehabilitation when RCTs cannot be conducted. Target trial emulation is a framework guiding the design and analysis of non-randomized comparative effectiveness studies using observational data, by emulating a hypothetical RCT. In the context of rehabilitation, we outline steps for applying the target trial emulation framework using real world data, highlighting methodological considerations, limitations, potential mitigating strategies, and causal inference and counterfactual theory as foundational principles to estimating causal effects. Overall, we aim to strengthen methodological approaches used to estimate causal effects of rehabilitation when RCTs cannot be conducted.

Correction to: "Dysphagia, dysphonia and olfactory disease: a map of Cochrane evidence relevant to rehabilitation for people with post-COVID-19 condition".

This article was published in volume 58, issue 6 of publishing year 2022, with a mistake in Table II. The correct Table II is the one included in this erratum.

Validity and reliability of the Italian translation of the Yale Pharyngeal Residue Severity Rating Scale.

Objective: In the dysphagic patient, pharyngeal residues (PR) are associated with aspiration and poor quality of life. The assessment of PR using validated scales during flexible endoscopic evaluation of swallowing (FEES) is crucial for rehabilitation. This study aims to validate and test the reliability of the Italian version of the Yale Pharyngeal Residue Severity Rating Scale (IT-YPRSRS). The effects of training and experience in FEES on the scale were also determined. Methods: The original YPRSRS was translated into Italian according to standardised guidelines. Thirty FEES images were selected after consensus and proposed to 22 naive raters who were asked to assess the severity of PR in each image. Raters were divided into two subgroups by years of experience at FEES, and randomly by training. Construct validity, inter-rater, and intra-rater reliability were assessed by kappa statistics. Results: IT-YPRSRS showed substantial to almost perfect agreement (kappa > 0.75) in validity and reliability for both the overall sample (660 ratings), and valleculae/pyriform sinus sites (330 ratings each). No significant differences emerged between groups considering years of experience, and variable differences were observed by training. Conclusions: The IT-YPRSRS demonstrated excellent validity and reliability in identifying location and severity of PR.

An intensive neurorehabilitation programme with sEMG biofeedback to improve swallowing in idiopathic Parkinson's disease (IPD): A feasibility study.

BACKGROUND: Studies suggest swallow intervention programmes that incorporate visual biofeedback and motor programming principles can improve swallowing and quality of life for people with idiopathic Parkinson's disease (IPD) and dysphagia. Few studies have examined outcomes using instrumentation. AIMS: Using fibreoptic endoscopic examination of swallowing (FEES), this study examines the effectiveness of a neurorehabilitation intervention involving biofeedback via surface electromyography (sEMG) to improve swallowing in people with IPD, and to explore the feasibility of the intervention approach. METHODS & PROCEDURES: We recruited 12 participants with IPD and dysphagia. A total of 10 completed the study. Intervention was delivered for 1 h per day, 5 days per week, for 4 weeks (20 h). Swallowing tasks using sEMG biofeedback incorporated principles of motor learning and neuroplasticity. Instrumental and non-instrumental assessment, including quality-of-life measures carried out at four different time points (two pre-treatment and two post-treatment). The final assessment was at 3 months post-intervention. OUTCOME & RESULTS: Statistically significant improvement (p < 0.05) in oral intake methods (95% confidence interval (CI) = 4.70-5.50) and in pharyngeal residue from saliva (95% CI = 2.14-3.15) and solids (95% CI = 2.4-3.5) post-intervention were confirmed using FEES with improvements at 3 months. The intervention protocol was well tolerated. Participants reported positive change in saliva control and duration of mealtimes as well as unanticipated improvements in voice and cognitive attention. CONCLUSIONS & IMPLICATIONS: An intensive neurorehabilitation with biofeedback shows positive effects in improving swallow function in IPD. This protocol is feasible with amendments to inform a larger clinical trial. WHAT THIS PAPER ADDS: What is already known on the subject Biofeedback has positive effects on increasing swallowing function and quality of life in people with IPD and dysphagia. sEMG is the most common method used to deliver swallowing biofeedback in this population. The quality of the evidence on the intervention, based on findings from a recent systematic review, is low. Included studies in this review were heterogeneous in terms of type and frequency of biofeedback, study design and outcome measures. The majority of outcome measures were subjective and higher quality studies to examine the efficacy of biofeedback using sEMG are needed. What this study adds Recognizing the limitations of earlier studies, this within-subject feasibility study examined the efficacy and effectiveness of an intensive biofeedback intervention using sEMG in a sample of people with dysphagia and IPD. Valid and reliable outcome measures were used and repeated after a 3-month period. The feasibility of the methodological approach was also tested and a qualitative component was included in the study. Positive findings were evident. Qualitative information added new perspectives and provided direction for new outcomes to be included in future studies. This study helps to inform further research trials as well as clinical practice. Clinical implications of this study This intensive intervention using principles of neuroplasticity and motor programming with sEMG biofeedback led not only to positive swallowing outcomes but also to unexpected benefits such as improved voice production and general attention skills. No adverse events were reported. Improvement in function was retained at 3 months post-intervention. Despite the small sample size, participants described the benefits of the treatment, and enjoyed sEMG biofeedback tasks, especially using an sEMG game mode. This suggests that intensive biofeedback not only improved swallowing but also was acceptable to these participants. This intensive protocol has merit and is worth considering further in clinical practice.

Dysphagia, dysphonia and olfactory disease: a map of Cochrane evidence relevant to rehabilitation for people with post COVID-19 condition.

INTRODUCTION: Currently, no evidence exists on specific treatments for post COVID-19 condition (PCC). However, rehabilitation interventions that proved effective for similar symptoms in other health conditions could be applied to people with PCC. With this overview of systematic reviews with mapping, we aimed to describe the Cochrane evidence on rehabilitation interventions proposed for dysphagia, dysphonia and olfactory dysfunction in different health conditions that can be relevant for PCC. EVIDENCE ACQUISITION: We searched the last five years' Cochrane Systematic Review (CSRs) using the terms "dysphagia," "swallowing disorder," "dysphonia," "voice disorder," "olfactory dysfunction," "smell changes" and "rehabilitation" in the Cochrane Library. We extracted and summarized the available evidence using a map. We grouped the included CSRs for health conditions and interventions, indicating the effect and the quality of evidence. EVIDENCE SYNTHESIS: We found 170 CSRs published between 2016 and 2021 and 1 was included. It provided data on dysphagia in acute and subacute stroke. Interventions included were acupuncture, neuromuscular electrical stimulation, transcranial magnetic stimulation and behavioral interventions, and swallowing therapy, with very low- to moderate-quality evidence. We did not find any CSR on dysphonia and olfactory disease. CONCLUSIONS: These results are the first step of indirect evidence able to generate helpful hypotheses for clinical practice and future research. They served as the basis for the three recommendations on treatments for these PCC symptoms published in the current WHO Guidelines for clinical practice.

The neurogenic dysphagia management via telemedicine: a systematic review.

INTRODUCTION: Telerehabilitation is the provision of rehabilitation remotely through Information and Communication Technologies (ICT). Recently, there has been an increase of interest in its application thanks to increasing a new technology. The aim of this systematic review was to examine the evidence of the literature regarding the management of neurogenic dysphagia via telerehabilitation, compared to face-to-face rehabilitation treatment. The secondary aim was to create recommendations on telerehabilitation sessions for patients diagnosed with neurogenic dysphagia. EVIDENCE ACQUISITION: The databases were: Medline, Embase, CINAHL, Scopus. A total of 235 records emerged from bibliographic research, manual search of full text and from gray literature, published until January 2021. Two blinded authors carried out titles and abstract screening and followed by full-text analysis. Sixteen articles were included in the systematic review and assessed through critical appraisal tools. EVIDENCE SYNTHESIS: The research shows that the majority of the studies on neurogenic dysphagia involved the Clinical Swallow Examination via telerehabilitation, compared with the in-person modality. Significant levels of agreement and high satisfaction from clinicians and patients are reported to support the use of telerehabilitation. Based on the results of this systematic review and qualitative analysis, the authors developed practical recommendations for the management of telerehabilitation sessions for patients with neurogenic dysphagia. CONCLUSIONS: Despite the presence of barriers, telerehabilitation allowed healthcare provision and increasing access to care and services with specialized professionals, remote rehabilitation can be a valid resource during the health emergency due to COVID-19.

Biofeedback as an Adjunctive Treatment for Post-stroke Dysphagia: A Pilot-Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Post-stroke dysphagia affects almost half of the survivors and severely influences quality of life, thus becoming swallowing rehabilitation of paramount importance. However, there is little adequate evidence on which the best rehabilitative strategy can be. Surface electromyography (sEMG) allows for recording swallowing muscles' activity and provides real time visual feedback, as a biofeedback adjunctive technique to improve treatment outcome. This study aimed to analyze the effectiveness of biofeedback rehabilitation of swallowing through sEMG compared to standard techniques, in post-stroke dysphagia. METHODS: A pilot-randomized controlled trial included 17 patients diagnosed with post-stroke dysphagia. Nine underwent sEMG-biofeedback rehabilitation; seven controls were submitted to control treatment, one dropout. The primary outcome was the functional oral intake scale (FOIS), secondary outcomes was pharyngeal clearance and safe swallowing, assessed through fiberoptic endoscopic evaluation of swallowing (FEES). RESULTS: FOIS improved in all patients, regardless of treatment. sEMG-biofeedback rehabilitation led to improvements of the pharyngeal clearance and swallowing safety. The rehabilitative effects appeared stable at 2-months follow-up. CONCLUSIONS: The application of biofeedback based on sEMG in post-stroke dysphagia patients resulted in an effective rehabilitative technique, in particular for pharyngeal clearance improvements and safe swallowing, thus reducing the risk of aspiration and malnutrition.

Interventions Involving Biofeedback to Improve Swallowing in People With Parkinson Disease and Dysphagia: A Systematic Review.

OBJECTIVES: To examine the effectiveness of biofeedback used in the treatment of adults with Parkinson disease (PD) and dysphagia, define the factors associated with biofeedback treatment outcomes, and inform a theory to guide the implementation of biofeedback in future dysphagia interventions. DATA SOURCES: A systematic review using a narrative synthesis approach of all published and unpublished studies were sought with no date or language restrictions. Ten electronic databases (EMBASE, PubMed, CINAHL, Web of Science, Scopus, Science Direct, AMED, The Cochrane Database of Systematic Reviews, ProQuest Dissertations and Theses A & I, Google Scholar) were searched from inception to April 2019. This search was updated in January 2020. The methodological quality of included studies was assessed using Downs and Black checklist. STUDY SELECTION: Four studies were included. The methodological quality of the included studies was low with a high risk of bias. Data were analyzed narratively and descriptively. Despite the heterogeneity of the included studies, the findings suggest that interventions incorporating visual biofeedback may have positive effects on swallowing-related quality of life. CONCLUSIONS: Based on these preliminary findings, we provide directions for further research and clinical interventions that incorporate an augmentative biofeedback component of swallowing interventions in people with PD. Future studies should be rigorously designed and set appropriate biofeedback treatment in terms of types, schedules, and timing.

The assessment of the peak of reflex cough in subjects with acquired brain injury and tracheostomy and healthy controls.

INTRODUCTION: There is no standard procedure to evaluated the peak of reflex cough flow (PCF-reflex) in the literature, which is important assessment in subjects with acquired brain injury and tracheostomy cannula. The present study aims to investigate the PCF of the reflex cough in a broad sample of healthy controls and, furthermore, the presence and the strength of voluntary and reflex cough in subjects with ABI with tracheostomy cannula. MATERIALS AND METHODS: We recruited 147 participants including the healthy subjects (n = 105) and acquired brain injury subjects (n = 43), who underwent respiratory assessment: the Tidal Volume, Forced Vital Capacity, PCF of voluntary cough (PCF-voluntary) and PCF-reflex (using a spirometer connected with a nebulizer by a bidirectional). RESULTS: The PCF-reflex of controls and subjects was significant lower than the PCF-voluntary (P < 0.01). The PCF-voluntary was not assessed in 26 (60.5 %) subjects due to severe cognitive deficit. In subjects without cognitive deficits (n = 17; 39.5 %), it was significantly lower than in healthy controls (p < 0.01). In contrast, the PCF-reflex was completed in all subjects and it was not significantly different from healthy controls. Furthermore, the strength of the PCF-reflex decreased with increasing inhalation numbers of nebulised air. CONCLUSION: Reflex cough behaviour differs largely from voluntary cough and the PCF results reflect this great discrepancy. PCF-reflex could be useful parameter for assessing the airway protection whereas PCF-voluntary for measuring airway clearance.

Cross-Cultural Validation of the Italian Version of the Functional Oral Intake Scale.

Outcome measures and scales translated into other languages according to conventions are important for international clinical research in dysphagia. Typically, assessments and scales are translated locally without cultural adaptation and validation. The Functional Oral Intake Scale (FOIS) is widely used in dysphagia research and clinical practice in English-speaking countries. Nevertheless, it is not available in Italian. The aim of this study was to translate the FOIS into Italian and validate it, allowing the FOIS to be available to speech-language pathologists (SLPs) and clinicians working with individuals with dysphagia in Italy. The FOIS was translated following 5 stages of cross-cultural adaptations. This involved (1) translation from English to Italian, (2) synthesis and solution of discrepancies between translators, (3) back-translation from Italian to English, (4) expert revisions, and (5) pretesting. To validate the translated scale, 10 SLPs were recruited from 3 different facilities across Italy. A questionnaire containing similar information to the FOIS and the Italian version of the FOIS (FOIS-It) was completed by SLPs for 227 people with dysphagia; the correlation was high (intraclass correlation coefficient [ICC] = 0.99). Interrater reliability, calculated for 2 blinded SLPs completing scales for 30 patients, was excellent (ICC = 0.99). In conclusion, the FOIS-It is now available for use in clinical practice and research studies in Italy.

The Test of Masticating and Swallowing Solids (TOMASS): reliability, validity and international normative data.

BACKGROUND: Clinical swallowing assessment is largely limited to qualitative assessment of behavioural observations. There are limited quantitative data that can be compared with a healthy population for identification of impairment. The Test of Masticating and Swallowing Solids (TOMASS) was developed as a quantitative assessment of solid bolus ingestion. AIMS: This research programme investigated test development indices and established normative data for the TOMASS to support translation to clinical dysphagia assessment. METHODS & PROCEDURES: A total of 228 healthy adults (ages 20-80+ years) stratified by age and sex participated in one or more of four consecutive studies evaluating test-retest and interrater reliability and validity to instrumental assessment. For each study the test required participants to ingest a commercially available cracker with instructions to 'eat this as quickly as is comfortably possible'. Further averaged measures were derived including the number of masticatory cycles and swallows per bite, and time per bite, masticatory cycle and swallow. Initial analyses identified significant differences on salient measures between two commercially available crackers that are nearly identical in shape, size and ingredients, suggesting the need for separate normative samples for specific regional products. Additional analyses on a single cracker identified that the TOMASS was sensitive at detecting changes in performance based on age and sex. Test-retest reliability across days and interrater reliability between clinicians was high, as was validation of observational measures to instrumental correlates of the same behaviours. Therefore, normative data are provided for the TOMASS from a minimum of 80 healthy controls, stratified by age and sex, for each of seven commercially available crackers from broad regions worldwide. OUTCOMES & RESULTS: Analyses on a single cracker identified Arnott's Salada, and that TOMASS measures were sensitive for detecting changes in performance based on age and sex. Interrater and test-retest reliability across days were high, as was validation of observational measures to instrumental correlates of the same behaviours. Significant differences were identified between two commercially available crackers, nearly identical in shape, size and ingredients, thus normative samples for specific regional products were required. Normative data were then acquired for the TOMASS from a minimum of 80 healthy controls, stratified by age and sex, for each of seven commercially available crackers from broad regions worldwide. CONCLUSIONS & IMPLICATIONS: The TOMASS is presented as a valid, reliable and broadly normed clinical assessment of solid bolus ingestion. Clinical application may help identify dysphagic patients at bedside and provide a non-invasive, but sensitive, measure of functional change in swallowing.

Clinical Criteria for Tracheostomy Decannulation in Subjects with Acquired Brain Injury.

BACKGROUND: Patients with acquired brain injury (ABI) often require long periods of having a tracheostomy tube for airway protection and prolonged mechanical ventilation. It has been recognized that fast and safe decannulation improves outcomes and facilitates the recovery process. Nevertheless, few studies have provided evidence for decannulation criteria, despite the high prevalence of ABI subjects with tracheostomies. The aim of our study was to assess which clinical parameters are the best predictors for decannulation in subjects with ABI. METHODS: In this cross-sectional study, we recruited 74 consecutive ABI subjects (mean age 51.52 ± 16.76) with tracheostomy tubes. First, the subjects underwent the original decannulation assessment for cannula removal. Second, they underwent our experimental decannulation protocol. The experimental protocol included: voluntary cough (cough peak flow ≥160 L/min), reflex cough, tracheostomy tube capping (≥72 h), swallowing instrumental assessment (penetration aspiration scale ≤5), blue dye test, number of trachea suctions, endoscopic assessment of airway patency (lumen diameter ≥50%), saturation (SpO2 >95%), and level of consciousness evaluation (Glasgow coma scale ≥8). The reference standard was clinical removal of the tracheostomy tube within 48 h. RESULTS: Parameters showing the highest values of sensitivity and specificity, respectively, were tracheostomy tube capping (80%, 100%), endoscopy assessment of airway patency (100%, 30%), swallowing instrumental assessment (85%, 96%), and the blue dye test (65%, 85%). All these were combined in a clinical cluster parameter, which had higher sensitivity (100%) and specificity (82%). CONCLUSION: These results suggest that the best clinical prediction rule for decannulation in acquired brain injury subjects is a combination of the following assessments: (1) tracheostomy tube capping, (2) endoscopic assessment of patency of airways, (3) swallowing instrumental assessment, and (4) blue dye test.

Efficacy of botulinum toxin type-A and swallowing treatment for oropharyngeal dysphagia recovery in a patient with lateral medullary syndrome.

BACKGROUND: Wallenberg's syndrome (WS) is known as posterior inferior cerebellar artery syndrome. Dysphagia has been reported from 51% to 94% of the patients, ranging from mild to severe. CASE REPORT: We reported a case of a patient (male; 52 years) with WS. MRI showed an intense hypodense area in the dorsolateral part of the ponto-medullary junction. The clinical signs were severe dysphagia, fed by PEG (FOIS 1; PAS 7), sialorrhea, trismus and ataxia. CLINICAL REHABILITATION IMPACT: Dysphagia was treated by botulinum toxin type-A (BoNT-A), which was injected into the parotid and submandibular salivary glands, temporalis and masseter muscles, cricopharyngeal muscle associated with specific swallowing exercise and food trails. The 3-months follow-up showed significant saliva reduction and improvement of swallowing to from PEG feeding to consistent oral intake of food (FOIS 3, PAS 5). The treatment with BoNT-A combined with swallowing rehabilitation was fundamental in order to restore the swallowing functions.

Persistent cortical deafness: a voxel-based morphometry and tractography study.

OBJECTIVE: In cortical deafness, no auditory signals can be perceived by the cortex despite normal peripheral hearing. Cortical deafness rarely persists, but generally evolves into other cortical auditory syndromes. In this report, we describe a patient showing a stable and persisting pattern of cortical deafness 16 months after two major ischemic strokes. METHODS: Voxel based morphometric evidence from high resolution three-dimensional MRI and data from tractography are reported for the first time, to our knowledge, in this syndrome in addition to behavioral and electrophysiological findings. RESULTS: The most remarkable findings came from the tractography data, where an asymmetric pattern was found showing severe damage of connections within the anterior right hemisphere, in regions subserving self-awareness. Frontal asymmetry, although detectable by the morphometric analysis, was less informative than that detected in the tractography data. CONCLUSION: The evidence from this case study suggests that damage to the neural systems involved in awareness may play an important role in the emergence of cortical deafness and its persistence.

Compounds in different aphasia categories: a study on picture naming.

This study investigated the production of compounds in Italian-speaking patients affected by different aphasia categories (i.e., Broca's, Wernicke's, and anomic aphasia) in a confrontation naming task. Questions of theoretical interest concerning the processing of compounds within the framework of the "lemma theory" as well as the role of morphological productivity in compound processing are addressed. Results indicate that all persons with aphasia retain knowledge of the morphological status of words, even when they fail to retrieve the corresponding phonological form (the "compound effect"). A difference was found among aphasia categories in the type of errors produced (omission vs. substitution) and in the position (first or second) of these errors within the compound words. In Broca's aphasia, the first component is omitted more frequently than the second one, but only in verb-noun compounds. Anomic and Wernicke's aphasia, unlike in Broca's aphasia, seem to retain sensitivity to morphological productivity.