The role of single case experimental designs in evidence creation in rehabilitation.

Randomized controlled trials (RCTs) are considered the gold standard of evidence guiding intervention selection in rehabilitation. However, conduct of sufficiently powered RCTs in rehabilitation can be expensive, pose ethical and attrition concerns when participants are assigned to ineffective treatment as usual conditions, and are infeasible with low-incidence populations. Single-case experimental designs (SCEDs), including N-of-1 RCTs are causal inference studies for small numbers of participants and not necessarily one participant as the name implies. These designs are increasingly used to evaluate the effectiveness of rehabilitation interventions in diverse clinical settings and employ design features including but not limited to randomization and each participant serving as their own control. These and other internal validity enhancements can increase the confidence in study results coming from these designs. This manuscript discusses the expanded application of SCEDs in rehabilitation contexts to answer everyday clinical rehabilitation research questions with emphasis on strategies to use: 1) to maximize internal validity of this family of designs; 2) improve utility, effectiveness, and acceptability of these designs for rehabilitation end-users (clinicians, policymakers, and participants); 3) build evidence bases in areas of rehabilitation where RCTs are uncommonly used. Primary considerations for situating SCEDs within the continuum of experimental designs include increasing internal validity within designs, improving transparency in conduct and reporting of these studies, and increasing access to advanced research methods training for rehabilitation professionals.

Long-term impact of aerodigestive symptoms on adults with oesophageal cancer: A qualitative study.

PURPOSE: The impact of long-term aerodigestive symptoms following oesophageal cancer surgery is still not well understood. This study aimed to qualitatively understand the long-term impact of aerodigestive symptoms on quality of life in adults post-oesophagectomy. METHOD: Participants who received curative transhiatal/transthoracic surgery for oesophageal cancer in Ireland's National Oesophageal Cancer Centre were invited to attend semi-structured interviews. Surgery had to be completed at least 12 months prior. Reflexive thematic analysis was conducted. RESULT: Forty participants were interviewed individually face-to-face. Four key themes were identified: (a) isolation, reflecting the reported solitude experienced by oesophageal cancer survivors when attempting to manage their ongoing aerodigestive symptoms; (b) fear, including fear of choking and fear that dysphagia symptoms may indicate recurrence of oesophageal cancer; (c) altered work capacity, caused by ongoing aerodigestive symptoms; and (d) avoidance of social situations involving food, due to the pain, discomfort, and embarrassment caused by these symptoms. CONCLUSION: Oesophageal cancer treatment can be lifesaving, however, such medical interventions can result in distressing physiological aerodigestive symptoms throughout survivorship, which can significantly impact quality of life. Our findings indicate a need for greater community support to manage aerodigestive symptoms and reduce the impact these have on quality of life.

Dysphagia Prevalence in Progressive Supranuclear Palsy: A Systematic Review and Meta-Analysis.

The objective of this systematic review was to determine the prevalence of dysphagia and aspiration in people with progressive supranuclear palsy (PSP). A search of six electronic databases was performed from inception to April 2022. No context restrictions were set. All primary research comprising figures to derive a prevalence rate were included. Two independent reviewers screened search results. Data were extracted by one reviewer. Conflicts were resolved by discussion with a third reviewer. The quality of included studies was assessed using the JBI Checklist for Prevalence Studies. From 877 studies, 12 were eligible for inclusion. Dysphagia had to be confirmed using instrumental assessments, clinical swallowing evaluation, screening, and patient-reported outcome measures (PROM). A random-effects meta-analysis calculated a pooled dysphagia prevalence in 78-89% (95% CI [60.6, 89.1], [78.9, 95.0]). depending on the chosen assessment method, and a pooled aspiration prevalence of 23.5% (95% CI [14.5, 33.7]). The included studies were of moderate quality, with high risk of selection and coverage bias and low to moderate risk of measurement bias. Dysphagia is highly prevalent in a sample of participants with mostly moderately severe PSP. Aspiration occurs in a quarter of this sample and is likely to increase as the disease progresses. Given the low general prevalence of PSP, studies remain at high risk for selection bias. Prospective research should focus on the development of dysphagia in the course of PSP and its subcategories using instrumental assessment and consider all phases of swallowing. REGISTRATION: The protocol of this systematic review was registered on the International Prospective Register of Systematic Reviews (PROSPERO) in April 2021 (registration number: CRD42021245204).

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).

Nature, severity, and impact of chronic oropharyngeal dysphagia following curative resection for esophageal cancer: a cross-sectional study.

Chronic oropharyngeal dysphagia (COD) and aspiration after esophageal cancer surgery may have clinical significance; however, it is a rarely studied topic. In a prospective cross-sectional observational study we comprehensively evaluated the nature, severity, and impact of COD, its predictors, and the impact of the surgical approach and site of anastomosis. Forty participants were recruited via purposive sampling from the (Irish) National Center between November 2021 and August 2022. Swallow evaluations included videofluoroscopy [Dynamic Imaging Grade of Swallowing Toxicity v2 (DIGESTv2), MBS Impairment Profile, Penetration-Aspiration Scale)]. Functional Oral Intake Scale (FOIS) identified oral intake status. The patient reported outcome measures of swallowing, and Quality of Life (QL) included EAT-10 and MD Anderson Dysphagia Inventory (MDADI). Fourteen (35%) participants presented with COD on DIGESTv2 and 10% had uncleared penetration/aspiration. Avoidance or modification of diet on FOIS was observed in 17 (42.5%). FOIS was associated with pharyngeal dysphagia (OR = 4.05, P = 0.046). Median (range) EAT-10 and MDADI Composite results were 3(0-30) and 77.9(60-92.6), respectively. Aspiration rates significantly differed across surgical groups (P = 0.029); only patients undergoing transhiatal surgery aspirated. Survivors of esophageal cancer surgery may have COD that is undiagnosed, potentially impacting swallow-related QL. Given the small number of aspirators, further research is required to determine whether aspiration risk is associated with surgical approach. A FOIS score below 7 may be a clinically useful prompt for the MDT to refer for evaluation of COD following curative intent surgery. These data present findings that may guide preventive and rehabilitative strategies toward optimizing survivorship.

Underserved groups in dysphagia intervention trials in Parkinson's disease: A scoping review.

BACKGROUND: Underserved groups in Parkinson's disease (PD) intervention studies are well recognised. However, it remains unclear whether these exclusions apply to oropharyngeal dysphagia (OD) intervention studies in PD. The aim of this scoping review was to identify characteristics of included participants and underserved groups in intervention studies in OD in PD. METHODS: Six electronic databases and one trial registry were searched without language restrictions. Screening of studies and data extraction were independently conducted by four reviewers. RESULTS: Of the 26 studies included, none fully reported the participants' ethnicity. Where data was available, 70% of participants were male with a mean age of 68 years, mean PD duration of 7.26 years, median Hoehn and Yahr stage of 2.5, mild OD and mostly recruited from movement disorders clinics. Underserved groups were younger people (< 50 years), older people (≥ 80 years), women, non-white people, people with severe OD and PD, longer PD duration, other neurological conditions, cognitive impairment/dementia, and depression. CONCLUSIONS: Careful consideration of all characteristics of individuals with OD in PD is essential for improving the external validity of studies. This will enhance the generalisability of research findings to the broader PD population, ultimately strengthening the evidence base for OD interventions in PD.

The influence of bias in randomized controlled trials on rehabilitation intervention effect estimates: what we have learned from meta-epidemiological studies.

This study aimed to synthesize evidence from studies that addressed the influence of bias domains in randomized controlled trials on rehabilitation intervention effect estimates and discuss how these findings can maximize the trustworthiness of an RCT in rehabilitation. We screened studies about the influence of bias on rehabilitation intervention effect estimates published until June 2023. The characteristics and results of the included studies were categorized based on methodological characteristics and summarized narratively. We included seven studies with data on 227,806 RCT participants. Our findings showed that rehabilitation intervention effect estimates are likely exaggerated in trials with inadequate/unclear sequence generation and allocation concealment when using continuous outcomes. The influence of blinding was inconsistent and different from the rest of medical science, as meta-epidemiological studies showed overestimation, underestimation, or neutral associations for different types of blinding on rehabilitation treatment effect estimates. Still, it showed a more consistent pattern when looking at patient-reported outcomes. The impact of attrition bias and intention to treat has been analyzed only in two studies with inconsistent results. The risk of reporting bias seems to be associated with overestimation of treatment effects. Bias domains can influence rehabilitation treatment effects in different directions. The evidence is mixed and inconclusive due to the poor methodological quality of RCTs and the limited number and quality of studies looking at the influence of bias and treatment effects in rehabilitation. Further studies about the influence of bias in RCTs on rehabilitation intervention effect estimates are needed.

Conversation coaching in dementia: a feasibility study.

PURPOSE: Conversation abilities of people with dementia are impacted by cognitive-communication deficits. Communication interventions can improve quality of life by increasing positive interactions and well-being. This study evaluates the feasibility of a conversation coaching intervention for people with dementia and their communication partners. METHOD: A mixed-method design was used. Thirty-four people were recruited over 12 months; 17 people with dementia and 17 communication partners. Participants with dementia were aged between 62 and 79 years (8 females, 9 males) and the communication partners were aged 33-77 years (5 males, 12 females). This conversation coaching intervention involved two assessment sessions (pre and post intervention) and 6 weekly sessions, alternating between individual and group-based sessions. These were facilitated by two experienced speech and language therapists with a three-month follow-up period. Participants were assessed initially and three months following intervention using Profiling Communication Ability in Dementia (P-CAD), Goal Attainment Scaling, and Capability Index for Older people (ICECAP-O). RESULTS: Twenty-eight participants completed the conversation coaching intervention. P-CAD scores for people with dementia were maintained at three months for 71% (n = 10) showing no decline in function and 29% (n = 4) showed improvement. Using the Goal Attainment Scaling, all people with dementia and their communication partners reported that this conversation coaching intervention helped them achieve their individual communication goals. Ten (71%) people with dementia rated their well-being as higher on the ICE-CAP-O following intervention with 29% (n = 4) rating no change in well-being from initial assessment. Over three-quarters of communication partners, (79%: n = 11), reported an increased sense of well-being following intervention and 21% (n = 3) had no change in well-being. CONCLUSIONS: Preliminary outcomes including participant feedback indicate that this conversation coaching intervention is feasible for people with dementia. The communication function and well-being of people with dementia were either maintained or improved. Conversation coaching intervention is collaborative and enhances the retained communication abilities of people living with dementia.

Clinical predictors of early and late endoscopic recurrence following ileocolonic resection in Crohn's disease.

BACKGROUND AND AIM: Multiple factors are suggested to place Crohn's disease patients at risk of recurrence after ileocolic resection with conflicting associations. We aimed to identify clinical predictors of recurrence at first (early) and further (late) postoperative colonoscopy. METHODS: Crohn's disease patients undergoing ileocolic resection were prospectively recruited at six North American centers. Clinical data was collected and endoscopic recurrence was defined as Rutgeerts score ≥i2. A multivariable model was fitted to analyze variables independently associated with recurrence. RESULTS: A total of 365 patients undergoing 674 postoperative colonoscopies were included with a median age of 32 years, 189 (51.8%) were male and 37 (10.1%) non-Whites. Postoperatively, 133 (36.4%) used anti-TNF and 30 (8.2%) were smokers. At first colonoscopy, 109 (29.9%) had recurrence. Male gender (OR = 1.95, 95% CI 1.12 - 3.40), non-White ethnicity (OR = 2.48, 95% CI 1.09 - 5.63), longer interval between surgery and colonoscopy (OR = 1.09, 95% CI 1.002 - 1.18), and postoperative smoking (OR = 2.78, 95% CI 1.16 - 6.67) were associated with recurrence, while prophylactic anti-TNF reduced the risk (OR = 0.28, 95% CI 0.14 - 0.55). Postoperative anti-TNF prophylaxis had a protective effect on anti-TNF experienced patients but not on anti-TNF naïve patients. Among patients without recurrence at first colonoscopy, Rutgeerts score i1 was associated with subsequent recurrence (OR = 4.43, 95% CI 1.73 - 11.35). CONCLUSIONS: We identified independent clinical predictors of early and late Crohn's disease postoperative endoscopic recurrence. Clinical factors traditionally used for risk stratification failed to predict recurrence and need to be revised.

Oral stimulation for promoting oral feeding in preterm infants.

BACKGROUND: Preterm infants (< 37 weeks' post-menstrual age (PMA)) are often delayed in attaining oral feeding. Normal oral feeding is suggested as an important outcome for the timing of discharge from the hospital and can be an early indicator of neuromotor integrity and developmental outcomes. A range of oral stimulation interventions may help infants to develop sucking and oromotor co-ordination, promoting earlier oral feeding and earlier hospital discharge. This is an update of our 2016 review. OBJECTIVES: To determine the effectiveness of oral stimulation interventions for attainment of oral feeding in preterm infants born before 37 weeks' PMA. SEARCH METHODS: Searches were run in March 2022 of the following databases: CENTRAL via CRS Web; MEDLINE and Embase via Ovid. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-randomised trials. Searches were limited by date 2016 (the date of the search for the original review) forward. Note: Due to circumstances beyond our control (COVID and staffing shortages at the editorial base of Cochrane Neonatal), publication of this review, planned for mid 2021, was delayed. Thus, although searches were conducted in 2022 and results screened, potentially relevant studies found after September 2020 have been placed in the section, Awaiting Classification, and not incorporated into our analysis. SELECTION CRITERIA: Randomised and quasi-randomised controlled trials comparing a defined oral stimulation intervention with no intervention, standard care, sham treatment or non-oral intervention (e.g. body stroking protocols or gavage adjustment protocols) in preterm infants and reporting at least one of the specified outcomes. DATA COLLECTION AND ANALYSIS: Following the updated search, two review authors screened the titles and abstracts of studies and full-text copies when needed to identify trials for inclusion in the review. The primary outcomes of interest were time (days) to exclusive oral feeding, time (days) spent in NICU, total hospital stay (days), and duration (days) of parenteral nutrition. All review and support authors contributed to independent extraction of data and analysed assigned studies for risk of bias across the five domains of bias using the Cochrane Risk of Bias assessment tool. The GRADE system was used to rate the certainty of the evidence. Studies were divided into two groups for comparison: intervention versus standard care and intervention versus other non-oral or sham intervention. We performed meta-analysis using a fixed-effect model. MAIN RESULTS: We included 28 RCTs (1831 participants). Most trials had methodological weaknesses, particularly in relation to allocation concealment and masking of study personnel. Oral stimulation compared with standard care Following meta-analysis, it is uncertain whether oral stimulation reduces the time to transition to oral feeding compared with standard care (mean difference (MD) -4.07 days, 95% confidence interval (CI) -4.81 to -3.32 days, 6 studies, 292 infants; I2 =85%, very low-certainty evidence due to serious risk of bias and inconsistency). Time (days) spent in the neonatal intensive care unit (NICU) was not reported. It is uncertain whether oral stimulation reduces the duration of hospitalisation (MD -4.33, 95% CI -5.97 to -2.68 days, 5 studies, 249 infants; i2 =68%, very low-certainty evidence due to serious risk of bias and inconsistency). Duration (days) of parenteral nutrition was not reported. Oral stimulation compared with non-oral intervention Following meta-analysis, it is uncertain whether oral stimulation reduces the time to transition to exclusive oral feeding compared with a non-oral intervention (MD -7.17, 95% CI -8.04 to -6.29 days, 10 studies, 574 infants; I2 =80%, very low-certainty evidence due to serious risk of bias, inconsistency and precision). Time (days) spent in the NICU was not reported. Oral stimulation may reduce the duration of hospitalisation (MD -6.15, 95% CI -8.63 to -3.66 days, 10 studies, 591 infants; I2 =0%, low-certainty evidence due to serious risk of bias). Oral stimulation may have little or no effect on the duration (days) of parenteral nutrition exposure (MD -2.85, 95% CI -6.13 to 0.42, 3 studies, 268 infants; very low-certainty evidence due to serious risk of bias, inconsistency and imprecision). AUTHORS' CONCLUSIONS: There remains uncertainty about the effects of oral stimulation (versus either standard care or a non-oral intervention) on transition times to oral feeding, duration of intensive care stay, hospital stay, or exposure to parenteral nutrition for preterm infants. Although we identified 28 eligible trials in this review, only 18 provided data for meta-analyses. Methodological weaknesses, particularly in relation to allocation concealment and masking of study personnel and caregivers, inconsistency between trials in effect size estimates (heterogeneity), and imprecision of pooled estimates were the main reasons for assessing the evidence as low or very low certainty. More well-designed trials of oral stimulation interventions for preterm infants are warranted. Such trials should attempt to mask caregivers to treatment when possible, paying particular attention to blinding of outcome assessors. There are currently 32 ongoing trials. Outcome measures that reflect improvements in oral motor skill development as well as longer term outcome measures beyond six months of age need to be defined and used by researchers to capture the full impact of these interventions.

Reduced Serological Response to COVID-19 Booster Vaccine is Associated with Reduced B Cell Memory in Patients With Inflammatory Bowel Disease; VARIATION [VAriability in Response in IBD AgainsT SARS-COV-2 ImmunisatiON].

BACKGROUND AND AIMS: Patients with inflammatory bowel disease [IBD] have an attenuated response to initial COVID-19 vaccination. We sought to characterize the impact of IBD and its treatment on responses after the third vaccine against SARS-CoV-2. METHODS: This was a prospective multicentre observational study of patients with IBD [n = 202] and healthy controls [HC, n = 92]. Serological response to vaccination was assessed by quantification of anti-spike protein [SP] immunoglobulin [Ig]G levels [anti-SPIgG] and in vitro neutralization of binding to angiotensin-converting enzyme 2 [ACE2]. Peripheral blood B-cell phenotype populations were assessed by flow cytometry. SARS-CoV-2 antigen-specific B-cell responses were assessed in ex vivo culture. RESULTS: Median anti-SP IgG post-third vaccination in our IBD cohort was significantly lower than HCs [7862 vs 19 622 AU/mL, p < 0.001] as was ACE2 binding inhibition [p < 0.001]. IBD patients previously infected with COVID-19 [30%] had similar quantitative antibody response as HCs previously infected with COVID-19 [p = 0.12]. Lowest anti-SP IgG titres and neutralization were seen in IBD patients on anti-tumour necrosis factor [anti-TNF] agents, without prior COVID-19 infection, but all IBD patients show an attenuated vaccine response compared to HCs. Patients with IBD have reduced memory B-cell populations and attenuated B-cell responses to SARS-CoV-2 antigens if not previously infected with COVID-19 [p = 0.01]. Higher anti-TNF drug levels and zinc levels <65 ng/ml were associated with significantly lower serological responses. CONCLUSIONS: Patients with IBD have an attenuated response to three doses of SARS-CoV-2 vaccine. Physicians should consider patients with higher anti-TNF drug levels and/or zinc deficiency as potentially at higher risk of attenuated response to vaccination.

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.

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).

Perspectives on speech and language pathology practices and service provision in adult critical care settings in Ireland and international settings: A cross-sectional survey.

PURPOSE: Patients admitted to critical care (CC) are at risk of impaired swallowing and communication function. Speech-language pathologists (SLPs) play an important role in this context. In Ireland and internationally speech-language pathology CC guidelines are lacking, with possible variations in practice. To compare clinical practices in dysphagia, communication and tracheostomy management among SLPs working in adult CC units in Ireland and internationally, and explore their perspectives on training, skills and resources. METHOD: Participants were SLPs working in CC. An international online survey sought information on (i) SLP workforce demographics and staffing levels, (ii) current dysphagia and communication assessment and management practices, (iii) practices and perspectives on training, skills and resources. RESULT: 366 responses were received across 29 countries. 18.03% (66/366) of these respondents worked in Ireland. Findings showed similarities and differences in practices. Total CC SLP whole-time equivalent (WTE) at each staff grade was lower (mean difference: -0.21 to -0.65 WTE p <.001) than desired for optimal service delivery. Negative effects of under-staffing were reported. Recommendations that all tracheostomised patients receive SLP input was unmet in 66% (220/334) of services. CONCLUSION: SLP input in CC is limited in terms of dedicated posts, multidisciplinary team (MDT) involvement, consistent management approaches and training opportunities internationally. Implications of findings are discussed.

Patient Reported Outcome Measures in Dysphagia Research Following Stroke: A Scoping Review and Qualitative Analysis.

Patient reported outcome measures (PROMs) are commonly used to evaluate the impact of a health condition on quality of life (QOL). This study aimed to identify the range of PROMs that are currently in common use in clinical trials in dysphagia following stroke and to qualitatively analyse these PROMs by mapping the content to both the International Classification of Functioning and Disability Framework (ICF) and the Core Outcome Measures in Effectiveness Trials (COMET) Taxonomy for outcome classification. With consideration for the PRISMA-ScR checklist, a scoping review was conducted to identify commonly used PROMs in randomised controlled trials reported in persons with dysphagia stroke. A search of five databases was conducted. Studies were excluded if they included pediatric participants i.e. < 18 years of age, or if the text was not available in the English language. 110 papers met the inclusionary criteria. Twelve of these 110 papers included a dysphagia PROM. Two PROMs were identified as being in common use-the SWAL-QOL and the EAT-10. These two tools consisted of 47 items and 78 meaningful concepts, which were subsequently mapped to the ICF and the COMET Taxonomy. Mapping to the ICF showed that neither tool directly assessed the impact of 'Environmental Factors' on the experience of dysphagia. Mapping to the COMET Taxonomy showed that neither tool considered the impact of 'Role Functioning' on the person's experience of dysphagia. The development of a suitable and appropriate patient-reported assessment tool for use in those with dysphagia following stroke is warranted.

Prevalence, nature and trajectory of dysphagia postoesophageal cancer surgery: a prospective longitudinal study protocol.

INTRODUCTION: Dysphagia is a common problem following oesophagectomy, and is associated with aspiration pneumonia, malnutrition, weight loss, prolonged enteral feeding tube dependence, in addition to an extended in-hospital stay and compromised quality of life (QOL). To date, the prevalence, nature and trajectory of post-oesophagectomy dysphagia has not been systematically studied in a prospective longitudinal design. The study aims (1) to evaluate the prevalence, nature and trajectory of dysphagia for participants undergoing an oesophagectomy as part of curative treatment, (2) to determine the risk factors for, and post-operative complications of dysphagia in this population and (3) to examine the impact of oropharyngeal dysphagia on health-related QOL across time points. METHODS AND ANALYSIS: A videofluoroscopy will be completed and analysed on both post-operative day (POD) 4 or 5 and at 6-months post-surgery. Other swallow evaluations will be completed preoperatively, POD 4 or 5, 1-month and 6-month time points will include a swallowing screening test, tongue pressure measurement, cough reflex testing and an oral hygiene evaluation. Nutritional measurements will include the Functional Oral Intake Scale to measure feeding tube reliance, Malnutrition Screening Tool and the Strength, Assistance With Walking, Rise From a Chair, Climb Stairs and Falls questionnaire. The Reflux Symptom Index will be administered to investigate aerodigestive symptoms commonly experienced by adults post-oesophagectomy. Swallowing-related QOL outcome measures will be determined using the European Organisation for Research and Treatment of Cancer QLQ-18, MD Anderson Dysphagia Inventory and the Swallowing Quality of Life Questionnaire. ETHICS AND DISSEMINATION: Ethical approval has been granted by the Tallaght University Hospital/St. James' Hospital Research Ethics Committee (JREC), Dublin, Ireland (Ref. No. 2021-Jul-310). The study results will be published in peer-reviewed journals and presented at national and international scientific conferences.

Exercise-based dysphagia rehabilitation for adults with oesophageal cancer: a systematic review.

BACKGROUND: Dysphagia is prevalent in oesophageal cancer with significant clinical and psychosocial complications. The purpose of this study was i) to examine the impact of exercise-based dysphagia rehabilitation on clinical and quality of life outcomes in this population and ii) to identify key rehabilitation components that may inform future research in this area. METHODS: Randomised control trials (RCT), non-RCTs, cohort studies and case series were included. 10 databases (CINAHL Complete, MEDLINE, EMBASE, Web of Science, CENTRAL, and ProQuest Dissertations and Theses, OpenGrey, PROSPERO, RIAN and SpeechBITE), 3 clinical trial registries, and relevant conference abstracts were searched in November 2020. Two independent authors assessed articles for eligibility before completing data extraction, quality assessment using ROBINS-I and Downs and Black Checklist, followed by descriptive data analysis. The primary outcomes included oral intake, respiratory status and quality of life. All comparable outcomes were combined and discussed throughout the manuscript as primary and secondary outcomes. RESULTS: Three single centre non-randomised control studies involving 311 participants were included. A meta-analysis could not be completed due to study heterogeneity. SLT-led post-operative dysphagia intervention led to significantly earlier start to oral intake and reduced length of post-operative hospital stay. No studies found a reduction in aspiration pneumonia rates, and no studies included patient reported or quality of life outcomes. Of the reported secondary outcomes, swallow prehabilitation resulted in significantly improved swallow efficiency following oesophageal surgery compared to the control group, and rehabilitation following surgery resulted in significantly reduced vallecular and pyriform sinus residue. The three studies were found to have 'serious' to 'critical' risk of bias. CONCLUSIONS: This systematic review highlights a low-volume of low-quality evidence to support exercise-based dysphagia rehabilitation in adults undergoing surgery for oesophageal cancer. As dysphagia is a common symptom impacting quality of life throughout survivorship, findings will guide future research to determine if swallowing rehabilitation should be included in enhanced recovery after surgery (ERAS) programmes. This review is limited by the inclusion of non-randomised control trials and the reliance on Japanese interpretation which may have resulted in bias. The reviewed studies were all of weak design with limited data reported.

Dysphagia, Dysphonia, and Dysarthria Outcomes Among Adults Hospitalized With COVID-19 Across Ireland.

OBJECTIVE: To investigate the presence, degree, predictors, and trajectory of dysphagia, dysphonia, and dysarthria among adults hospitalized with COVID-19 across the Republic of Ireland (ROI) during the first wave of the pandemic. STUDY DESIGN: Prospective observational cohort study. METHODS: Adults with confirmed COVID-19 who were admitted into 14 participating acute hospitals across ROI and referred to speech and language therapy between March 1st and June 30th, 2020 were recruited. Outcomes obtained at initial SLT evaluation and at discharge were oral intake status (Functional Oral Intake Scale), perceptual voice quality (GRBAS), and global dysarthria rating (Dysarthria Severity Scale). RESULTS: Data from 315 adults were analyzed. At initial SLT assessment, 84% required modified oral diets, and 31% required tube feeding. There were high rates of dysphonia (42%) and dysarthria (23%). History of intubation (OR 19.959, 95% CI 6.272, 63.513; P = .000), COVID-19 neurological manifestations (OR 3.592, 95% CI 1.733, 7.445; P = .001), and age (OR 1.034; 95% CI 1.002, 1.066; P = .036) were predictive of oral intake status. History of intubation was predictive of voice quality (OR 4.250, 95% CI 1.838, 9.827; P = .001) and COVID-19 neurological manifestations were predictive of dysarthria (OR 2.275; 95% CI 1.162, 4.456; P = .017). At discharge, there were significant improvements in oral intake (Z = -7.971; P = .000), voice quality (Z = -5.971; P = .000), and dysarthria severity (Z = -2.619; P = .009), although need for modified oral intake (59%), dysphonia (23%), and dysarthria (14%) persisted. CONCLUSION: Dysphagia, dysphonia, and dysarthria were widespread among adults hospitalized with COVID-19 and they persisted for many at discharge. Prompt SLT evaluation is required to minimize complications. LEVEL OF EVIDENCE: 3 Laryngoscope, 132:1251-1259, 2022.

A Role for CXCR3 Ligands as Biomarkers of Post-Operative Crohn's Disease Recurrence.

BACKGROUND AND AIMS: Crohn's disease [CD] recurrence following ileocolic resection [ICR] is common. We sought to identify blood-based biomarkers associated with CD recurrence. METHODS: CD patients undergoing ICR were recruited across six centres. Serum samples were obtained at post-operative colonoscopy. A multiplex immunoassay was used to analyse 92 inflammation-related proteins [Olink Proteomics]. Bayesian analysis was used to identify proteins associated with increasing Rutgeerts score. Identified proteins were used in receiver operating characteristic [ROC] analysis to examine the ability to identify CD recurrence [Rutgeerts score ≥i2]. Existing single cell data were interrogated to further elucidate the role of the identified proteins. RESULTS: Data from 276 colonoscopies in 213 patients were available. Median time from surgery to first and second colonoscopy was 7 (interquartile range [IQR] 6-9) and 19 [IQR 16-23] months, respectively. Disease recurrence was evident at 60 [30%] first and 36 [49%] second colonoscopies. Of 14 proteins significantly associated with Rutgeerts score, the strongest signal was seen for CXCL9 and MMP1. Among patients on anti-tumour necrosis factor drugs, CXCL9 and CXCL11 were most strongly associated with Rutgeerts score. Both are CXCR3 ligands. Incorporation of identified proteins into ROC analysis improved the ability to identify disease recurrence as compared to C-reactive protein alone: area under the curve [AUC] 0.75 (95% confidence interval [CI]: 0.66-0.82] vs 0.64 [95% CI 0.56-0.72], p = 0.012. Single cell transcriptomic data provide evidence that innate immune cells are the primary source of the identified proteins. CONCLUSIONS: CXCR3 ligands are associated with CD recurrence following ICR. Incorporation of novel blood-based candidate biomarkers may aid in identification of CD recurrence.