Development of a core outcome set (COS) for research studies about children with cerebral visual impairment plus profound and multiple learning disabilities (CVI+): A study Protocol

Background There is lack of evidence describing what outcomes are most important when testing interventions for children with cerebral visual impairment plus profound and multiple learning disabilities (CVI+). Traditional outcomes such as visual acuity are not useful in this group of children. This research aims to develop a core outcome set (COS) for children with CVI+ enabling the effectiveness of vision-related interventions, such as visual stimulation programmes, to be measured in a standardised manner within health research settings. Methods This mixed methods study will include a scoping review, interviews, focus groups, Delphi survey, and consensus meeting. The initial list of outcomes will be extracted from the literature via a scoping review. Parents/carers of children with CVI+ will be recruited to participate in an interview through NHS sites, social media, and charities. Inclusion criteria for CVI+ will be based on subtyping CVI to ensure that parents/carers of children with profound and multiple learning disabilities plus any suggestion or diagnosis of CVI are invited. Professionals and researchers who have at least 12 months’ experience of care for children with CVI + and/or one publication related to CVI will be invited to participate in a focus group via their professional networks. Following the interviews and focus group, parent/carer and professional stakeholders will be invited to participate in the Delphi survey, and consensus meeting. Outcome scoring, feedback methods, and procedure for determining inclusion/exclusion of outcomes for the Delphi survey and consensus meeting will be developed with the Patient and Public Involvement (PPI) group. Consensus for inclusion in the final list will be determined a priori. Discussion The core outcome set developed from this study will represent a minimum requirement for studies researching interventions for CVI+. It will enable standardisation of measurement of agreed and relevant outcomes so that future studies can be designed, compared and combined to bring quicker answers to families about what interventions work for CVI+.