Aim: To develop a core outcome set (COS) and their linked measurement instrument for assessment and evaluation of any research or clinical program of non-invasive brain computer interface (BCI) use for children with complex physical disabilities.
ContributorsA Hilderley, S Pot, A Kirton, J Andersen, T Chau, N Ruest, D Rowley, D Comaduran Marquez, E Kinney-Lang, HL Carlson, A Barnfather, L Mumford, S Van Damme, M Rizaey, N Nagy, S Mercury, M Tolensky.
Disease Category: Child health, Developmental, psychosocial, & learning problems
Disease Name: Neurodevelopmental Disability
Age Range: 0 - 25
Sex: Either
Nature of Intervention: Other
- Clinical experts
- Families
- Researchers
- Service providers
- COS for clinical trials or clinical research
- COS for practice
- Consensus meeting
- Nominal group technique (NGT)
Method: Experts will be recruited from three Canadian pediatric BCI programs that are members of BCI-CAN, with representation from clinical, engineering, research, and lived-experience perspectives. A three-phase COS development process will be used, with the six F-words for Child Development serving as outcome domains.
Phase 1: Outcome identification. Potential outcomes within each F-word domain will be identified through small-group discussions during a virtual expert meeting.
Phase 2: Outcome prioritization. Experts will discuss the importance of identified outcomes within each F-word during a virtual meeting, followed by a survey to rank outcomes within each domain. The top 2–3 outcomes from each F-word will then be included in a separate survey, in which experts will select essential outcomes. Consensus will be defined as =80% agreement. A second voting round will be conducted if consensus is not reached.
Phase 3: Recommendations for outcome measurement. Experts will develop recommendations for selecting and/or developing outcome measures during a virtual meeting. The research team will conduct a literature review to identify high-quality measurement instruments aligned with these recommendations. Where no adequate measure exists, this will be reported. For outcomes with suitable measures, experts will select one measure per outcome through a final consensus survey. Measures reaching =80% agreement will be recommended.