Objectives To develop a core outcome set (COS) for oropharyngeal dysphagia (swallowing disorder) interventions in Parkinson’s disease by agreeing core outcomes and definitions, outcome measurement instruments (OMIs) and time points of measurement for these core outcomes.
Design International online Delphi survey and consensus meetings.
Participants Individuals living with oropharyngeal dysphagia and Parkinson’s disease, family members and caregivers, healthcare professionals and researchers in the field of oropharyngeal dysphagia and Parkinson’s disease.
Methods A long list of outcomes was generated previously through scoping reviews, online surveys and focus groups with key stakeholders. Building on this, an international three-round online Delphi survey was conducted where participants rated the importance of outcomes. In subsequent online consensus meetings, core outcomes, their definitions, OMIs and time points of measurement were agreed on.
Results 90 participants from 21 countries completed all three rounds of the Delphi survey. Of these, 35 participated in a consensus meeting. Six outcomes were agreed as the core outcomes: ‘penetration/aspiration’, ‘aspiration pneumonia’, ‘choking’, ‘oropharyngeal dysphagia severity’, ‘swallowing related quality of life’ and ‘post swallow pharyngeal residue’.
Conclusions The use of a COS in future oropharyngeal dysphagia intervention studies in Parkinson’s disease will facilitate comparative effectiveness research and ensure that outcomes are relevant to all key stakeholders. This should help improve the evidence base for oropharyngeal dysphagia interventions in Parkinson’s disease.
Registration The study was registered prospectively with the Core Outcome Measures in Effectiveness Trials Database on 24 September 2021 (www.comet-initiative.org, registration number: 1942).
Principal Investigator:
Julia Hirschwald, PhD Candidate, Clinical Speech and Language Studies, Trinity College Dublin
Supervisory Team:
Margaret Walshe, Associate Professor, Clinical Speech and Language Studies, Trinity College Dublin
Disease Category: Rehabilitation
Disease Name: Dysphagia, Parkinson's disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Patient/ support group representatives
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- COS for practice
- Recommendations for outcome measures (measurement/how)
- Consensus conference
- Delphi process
- Focus group(s)
- Literature review
Established COS development methodology will be employed. There are 5 key deliverables:
1) A study protocol will be published and ethical approval for the study will be obtained.
2) A preliminary list of existing outcomes for OD in PD including the previous outcome definitions used, and their measurement methods and a further list of outcomes important to people with PD and OD and carers will be developed. Lists will be generated through a scoping review, published personal accounts, surveys and international focus groups of people with PD and carers.
3) The COS-DiP for people with OD and key stakeholders using the lists generated above will be defined. This consensus will be reached with other international stakeholders using specific survey methodology and specialist software (DelphiManager).
4) Consensus on how and when to measure the COS-DiP, following the same methodology as above, will be achieved.
5) The COS-DiP will be disseminated to ensure adoption in research.