Development of a Core Outcome Set (COS) for children with cerebral visual impairment plus profound and multiple learning disabilities (CVI+).

Title: Development of a Core Outcome Set (COS) for children with cerebral visual impairment plus profound and multiple learning disabilities (CVI+).

Introduction: Children with cerebral visual impairment plus profound and multiple learning disabilities (CVI+) do not receive evdience-based interventions because there are no agreed outcomes or measures available on which to base intervention development.

This research will aim to extract what outcomes are currently measured in the literature, explore stakeholder views on what outcomes should be measured for children with CVI+, and develop a core outcome set.

The core outcome set will be specific to CVI+, with the scope to allow vision-related interventions, such as visual stimulation programmes, to be measured.

The core outcome set will be applied in a health research setting to measure the effect of vision-related interventions. Methods: Mixed methods including scoping review, interviews, focus groups, and Delphi survey. The protocol for this study will be published and referenced in any further reporting.

The initial list of outcomes will be extracted from the literature using content analysis via a scoping review, all outcomes extracted will be shared with stakeholders.

Parents/carers of children with CVI+ will be invited to participate, they will be recruited through NHS sites, social media, and charities.

Inclusion criteria for CVI+ will be based on subtyping of CVI to ensure that 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 via their professional networks. Interviews, focus groups, Delphi survey, and a consensus meeting will be used to develop the COS.

Outcome scoring, feedback methods, and procedure for determining inclusion/exclusion of outcomes will be developed with the PPI group for this study. Each outcome will be approved by 70% of people at the meetings to be included in the final list. Ethical approval will be sought via IRAS.

Timeline of work plans and related objectives: WP1: Create outcome list from literature (Complete by - February 2025) WP2 (a): Interviews with parents/carers (Complete by - February 2026) WP2 (b): Focus groups with professionals (Complete by February 2026) WP2 (c): Delphi Survey (Complete by August 2026) WP3: Consensus Meeting (Complete by February 2027) Dissemination: The results will be presented at academic conferences and published in peer reviewed journals to reach researchers.

To increase breadth of impact, the PPI groups will be involved in the dissemination process and write up of the results.

To reach the public/parents/carers the results will be published on a website/blog, vision and disability charities, and the parent-led electronic newsletter, Special Needs Jungle.

The research protocol and results will be published following the COS reporting guidelines, to enable maximum uptake of the COS.