Introduction/Background: Swallowing function is often not preserved in as many as 50% of patients after receiving RT as part of their curative treatment for HNC. Dysphagia is of high relevance to various stakeholders: patients, their family caregivers, their clinical providers, as well as payer groups and policy makers. These stakeholders have different perspectives on the health impact of dysphagia – patients’ prioritize issues of depression/anxiety whereas clinicians prioritize pneumonia/malnutrition. Payers and policy makers prioritize reducing tube feeding duration and minimizing unnecessary rehospitalizations. As part of the investigators’ preparation for a large, international pragmatic RCT comparing the real world effectiveness of different swallowing interventions, it was critical to ascertain a set of outcomes relevant to all stakeholders by which to compare the benefits of these interventions.
Methods: Through a formal stakeholder engagement process, a descriptive qualitative design utilizing a staged iterative multi-focus group approach was mobilized to elicit recommendations on outcomes to measure effectiveness of dysphagia interventions. Four stakeholder groups were organized in both Canada and in United States including patients/caregivers, allied clinicians (i.e., speech language pathologists, nurses, dieticians. social workers), medical clinicians (i.e., surgeon, radiation and medical oncologists, general practitioners) and policy makers (representatives of advocacy groups as well as experts who make decisions regarding high level healthcare resource allocation). Sessions included open dialogue and priority setting exercises led by expert facilitators with the aim of achieving consensus on relevant outcomes to all concerned. Subsequent to these homogeneous group sessions, volunteer representatives from each stakeholder group met together as an interdisciplinary Stakeholder Advisory Board (SAB) to arrive at an overall set of recommendations regarding outcomes.
Results: In total, 16 patients and caregivers, 18 allied clinicians, 13 medical clinicians and 16 policy makers engaged in two parallel processes: one in the United States and one in Canada. All groups identified a lengthy list of potential outcomes meaningful from their own perspectives. The participants in the subsequent SAB meetings in Canada (n=12) and US (n=14) attended either live or via video conference. The SAB members reviewed all outcomes recommended by their peers in the context of the primary and secondary outcomes previously planned by the trial investigators. SAB members considered the extent of survey burden, and discussed additional recommendations for secondary outcomes and potential confounders. The consensus-building discussions resulted in a comprehensive list of specific outcomes addressing swallowing-related physiology, function, quality of life, mental health, health burden and health system variables. These SAB meetings in both Canada and the US discussed the importance of each outcome, a process that further generated additional specific measures. Stakeholder feedback regarding the sessions offered insight into the success of the engagement approaches.
Conclusion: It is possible to achieve consensus regarding a common set of meaningful outcomes for dysphagia interventions from a cross-section of stakeholders representing varying perspectives given appropriate engagement strategies. The engagement approach was well received resulting in a high degree of investment and commitment by the stakeholders to participate in this and future research efforts.