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).

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.

Persistent Features of Laryngeal Injury Following Endotracheal Intubation: A Systematic Review.

This systematic review examined (i) prevalence, severity, and impact of persistent post-extubation laryngeal injury beyond hospital discharge and (ii) differences in persistent laryngeal injury between COVID-19 and non-COVID-19 populations. The review was completed following PRISMA-2020 guidelines. Four databases (PubMed, CINHAL complete, EMBASE, Web of Science) were searched (inception to March 2021). Screening, full text review and data extraction were completed by two reviewers. Primary outcomes were swallow, voice and cough and airway measures obtained after hospital discharge. Quality assessment was measured using Downs & Black Tool and Johanna Briggs Institute Checklist for Cohort Studies. Meta-analysis was not completed due to study heterogeneity. Six cohort studies were included. Total number of participants across the included studies was 436. ICU admission diagnoses included respiratory disease 46% (COVID-19 and non-COVID-19), sepsis 14%, non-sepsis-related organ dysfunction 9%, general medical 11%, general surgical 10%, trauma 2%, ENT 0.6% and other not specified by authors 7%. Outcomes were obtained between 2 and 60 months post hospital discharge. Assessment methods included endoscopic evaluation, clinician ratings and patient-reported outcomes. Persistent features of laryngeal injury identified were airway abnormalities (18.9-27%), dysphonia (13.2-60%) and dysphagia (23-33%). Persistent laryngeal injury was associated with ICU length of stay, respiratory diagnosis and tracheostomy. Study quality ranged from poor-good. This is the first systematic review to examine post-extubation laryngeal injury beyond hospital discharge. Significant gaps in the literature were identified. Given the impact on clinical and patient outcomes, large scale, well-designed research is needed to guide post-ICU service delivery.

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).