A Consensus Statement for the Management and Rehabilitation of Communication and Swallowing Function in the ICU: A Global Response to COVID-19.

OBJECTIVE: To identify core practices for workforce management of communication and swallowing functions in coronavirus disease 2019 (COVID-19) positive patients within the intensive care unit (ICU). DESIGN: A modified Delphi methodology was used, with 3 electronic voting rounds. AGREE II and an adapted COVID-19 survey framework from physiotherapy were used to develop survey statements. Sixty-six statements pertaining to workforce planning and management of communication and swallowing function in the ICU were included. SETTING: Electronic modified Delphi process. PARTICIPANTS: Speech-language pathologists (SLPs) (N=35) from 6 continents representing 12 countries. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: The main outcome was consensus agreement, defined a priori as ≥70% of participants with a mean Likert score ≥7.0 (11-point scale: 0=strongly disagree, 10=strongly agree). Prioritization rank order of statements in a fourth round was also conducted. RESULTS: SLPs with a median of 15 years of ICU experience, working primarily in clinical (54%), academic (29%), or managerial positions (17%), completed all voting rounds. After the third round, 64 statements (97%) met criteria. Rank ordering identified issues of high importance. CONCLUSIONS: A set of global consensus statements to facilitate planning and delivery of rehabilitative care for patients admitted to the ICU during the COVID-19 pandemic were agreed by an international expert SLP group. Statements focused on considerations for workforce preparation, resourcing and training, and the management of communication and swallowing functions. These statements support and provide direction for all members of the rehabilitation team to use for patients admitted to the ICU during a global pandemic.

Development of a Core Outcome Set for Dysphagia Interventions in Parkinson's disease (COS-DIP): study protocol.

INTRODUCTION: Current clinical trials on swallowing disorders (dysphagia) in Parkinson's disease (PD) apply a high variety of outcomes and different outcome measures making comparative effectiveness research challenging. Furthermore, views of patients and dysphagia clinicians when selecting trial outcomes have not been considered in the past, thus study results may have little importance to them. This study aims to develop an agreed standardised Core Outcome Set for Dysphagia Interventions in Parkinson's disease (COS-DIP), systematically measured and reported as a minimum for all clinical trials. It will also comprise guidance on outcome definitions, outcome measures and time points of measurement. METHODS AND ANALYSIS: The COS-DIP development will comprise five stages following established methodology: (1) a recent scoping review on all applied outcomes, their definitions, methods and time points of measurement in clinical trials in dysphagia in PD, (2) online surveys and focus groups with clinicians, patients, caregivers and family members to identify outcomes that are important to them, (3) an identified list of outcomes based on results of stage 1 and 2, (4) three round online Delphi survey with up to 200 key stakeholders to determine core outcomes and (5) two online consensus meetings with up to 40 representative key stakeholders to agree on all outcomes, definitions, methods and time points of measurement in the final COS-DIP. ETHICS AND DISSEMINATION: Full ethical approval was obtained from the Research Ethics Committee, School of Linguistic, Speech and Communication Sciences, Trinity College Dublin, on 15 May 2023 (HT27). Dissemination of the COS-DIP will be enhanced through presentations at (inter-) national conferences and through peer-reviewed, open access publications of related manuscripts. Lay and professional information sheets and infographics will be circulated through relevant patient and professional organisations and networks. TRIAL REGISTRATION NUMBER: The COS-DIP study was registered prospectively with the Core Outcome Measures in Effectiveness Trials (COMET) database on 24 September 2021 (www.comet-initiative.org/Studies/Details/1942).

Swallowing outcomes in dysphagia interventions in Parkinson's disease: a scoping review.

OBJECTIVES: To identify all outcomes, their definitions, outcome measurement instruments (OMIs), timepoints and frequency of measurement applied in clinical trials in oropharyngeal dysphagia (OD) interventions in Parkinson's disease (PD). This scoping review is the first stage of a larger project establishing a core outcome set for dysphagia interventions in Parkinson's disease (COS-DIP). DESIGN: Scoping review. METHODS: Six electronic databases and one trial registry were searched without language restrictions until March 2022. Bibliography lists of included studies were also reviewed. Study screening and data extraction were conducted independently by two reviewers using Covidence. The scoping review protocol is registered and published (http://hdl.handle.net/2262/97652). RESULTS: 19 studies with 134 outcomes were included. Trial outcomes were mapped to a recommended taxonomy for COSs and merged. 39 outcomes were identified. The most frequently measured were general swallowing-related outcomes, global quality-of-life outcomes and swallowing-related perceived health status outcomes. The applied outcomes, their definitions, OMIs, timepoints and frequency of measurement showed a high variability across all studies. CONCLUSIONS: The high variability of outcomes emphasises the need for an agreed standardised COS. This will inform clinical trial design in OD in PD, increase the quality of OD trials in PD and facilitate synthesising and comparing study results to reach conclusion on the safety and effectiveness of OD interventions in PD. It will not prevent or restrict researchers from examining other outcomes. TRIAL REGISTRATION NUMBER: The COS-DIP study, including the scoping review, was registered prospectively with the Core Outcome Measures in Effectiveness Trials Database on 24 September 2021 (www.comet-initiative.org, registration number: 1942).

Prevalence of swallow, communication, voice and cognitive compromise following hospitalisation for COVID-19: the PHOSP-COVID analysis.

OBJECTIVE: Identify prevalence of self-reported swallow, communication, voice and cognitive compromise following hospitalisation for COVID-19. DESIGN: Multicentre prospective observational cohort study using questionnaire data at visit 1 (2-7 months post discharge) and visit 2 (10-14 months post discharge) from hospitalised patients in the UK. Lasso logistic regression analysis was undertaken to identify associations. SETTING: 64 UK acute hospital Trusts. PARTICIPANTS: Adults aged >18 years, discharged from an admissions unit or ward at a UK hospital with COVID-19. MAIN OUTCOME MEASURES: Self-reported swallow, communication, voice and cognitive compromise. RESULTS: Compromised swallowing post intensive care unit (post-ICU) admission was reported in 20% (188/955); 60% with swallow problems received invasive mechanical ventilation and were more likely to have undergone proning (p=0.039). Voice problems were reported in 34% (319/946) post-ICU admission who were more likely to have received invasive (p<0.001) or non-invasive ventilation (p=0.001) and to have been proned (p<0.001). Communication compromise was reported in 23% (527/2275) univariable analysis identified associations with younger age (p<0.001), female sex (p<0.001), social deprivation (p<0.001) and being a healthcare worker (p=0.010). Cognitive issues were reported by 70% (1598/2275), consistent at both visits, at visit 1 respondents were more likely to have higher baseline comorbidities and at visit 2 were associated with greater social deprivation (p<0.001). CONCLUSION: Swallow, communication, voice and cognitive problems were prevalent post hospitalisation for COVID-19, alongside whole system compromise including reduced mobility and overall health scores. Research and testing of rehabilitation interventions are required at pace to explore these issues.

Interventions for oropharyngeal dysphagia in acute and critical care: a systematic review and meta-analysis.

PURPOSE: To determine the effectiveness of dysphagia interventions compared to standard care in improving oral intake and reducing aspiration for adults in acute and critical care. METHODS: We searched electronic literature for randomised and quasi-randomised trials and bibliography lists of included studies to March 2020. Study screening, data extraction, risk of bias and quality assessments were conducted independently by two reviewers. Meta-analysis used fixed effects modelling. The systematic review protocol is registered and published. RESULTS: We identified 22 studies (19 stroke, 2 intensive care stroke and 1 general intensive care) testing 9 interventions and representing 1700 patients. Swallowing treatment showed no evidence of a difference in the time to return to oral intake (n = 33, MD (days) - 4.5, 95% CI - 10.6 to 1.6, 1 study, P = 0.15) (very low certainty) or in aspiration following treatment (n = 113, RR 0.79, 95% CI 0.44 to 1.45, 4 studies, I2 = 0%, P = 0.45) (low certainty). Swallowing treatment showed evidence of a reduced risk of pneumonia (n = 719, RR 0.71, 95% CI 0.56 to 0.89, 8 studies, I2 = 15%, P = 0.004) (low certainty) but no evidence of a difference in swallowing quality of life scores (n = 239, MD - 11.38, 95% CI - 23.83 to 1.08, I 2 = 78%, P = 0.07) (very low certainty). CONCLUSION: There is limited evidence for the effectiveness of swallowing treatments in the acute and critical care setting. Clinical trials consistently measuring patient-centred outcomes are needed.

Interventions for oropharyngeal dysphagia in acute and critical care: a protocol for a systematic review and meta-analysis.

BACKGROUND: Oropharyngeal dysphagia or swallowing difficulties are common in acute care and critical care, affecting 47% of hospitalised frail elderly, 50% of acute stroke patients and approximately 62% of critically ill patients who have been intubated and mechanically ventilated for prolonged periods. Complications of dysphagia include aspiration leading to chest infection and pneumonia, malnutrition, increased length of hospital stay and re-admission to hospital. To date, most dysphagia interventions in acute care have been tested with acute stroke populations. While intervention studies in critical care have been emerging since 2015, they are limited and so there is much to learn about the type, the delivery and the intensity of treatments in this setting to inform future clinical trials. The aim of this systematic review is to summarise the evidence regarding the relationship between dysphagia interventions and clinically important patient outcomes in acute and critical care settings. METHODS: We will search MEDLINE, EMBASE, CENTRAL, Web of Science, CINAHL and clinical trial registries from inception to the present. We will include studies conducted with adults in acute care settings such as acute hospital wards or units or intensive care units and critical care settings. Studies will be restricted to randomised controlled trials and quasi-randomised controlled trials comparing a new dysphagia intervention with usual care or another intervention. The main outcomes that will be collected include length of time taken to return to oral intake, change in incidence of aspiration and pneumonia, nutritional status, length of hospital stay and quality of life. Key intervention components such as delivery, intensity, acceptability, fidelity and adverse events associated with such interventions will be collected to inform future clinical trials. Two independent reviewers will assess articles for eligibility, data extraction and quality appraisal. A meta-analysis will be conducted as appropriate. DISCUSSION: No systematic review has attempted to summarise the evidence for oropharyngeal dysphagia interventions in acute and critical care. Results of the proposed systematic review will inform practice and the design of future clinical trials. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD 42018116849 (http://www.crd.york.ac.uk/PROSPERO/).