Protocol for: mixed methods study on diversity of children with cochlear implants and their families engaging with the BEARS (Both Ears) virtual reality training games: improving clinical trial diversity and scale-up inclusiveness

Introduction We are currently working on the BEARS (Both Ears) virtual reality (VR) Randomised Controlled Trial. We are recruiting 272 deaf children and young people who use bilateral (both ears) cochlear implants (CI) to examine if using the BEARS VR games helps their hearing in background noise and ultimately their quality of life. Clinical trial participants should be representative of the population with the health condition, although this is rarely achieved in practice as people from ethnic minorities or those from more deprived areas may face barriers to participation. Study Design Mixed methods design Objectives Use a literature review and collection of data from cochlear implant centres to establish the sociodemographic characteristics of deaf children aged 8 to 16 years with bilateral cochlear implants in the United Kingdom (UK). a. Establish the sociodemographic characteristics of the families recruited to the BEARS clinical trial in the first six months, and compare with the age-matched population of deaf children with bilateral cochlear implants in the UK. b. Analyse the BEARS clinical trial pre-screening diversity data. c. Implement an established recruitment intervention method in a workshop to explore and optimise recruitment number and diversity. d. Compare the final six months of recruitment data diversity with the initial six months. Use interviews and focus groups to collect qualitative data from children and their families who chose not to take part in BEARS, clinicians, and family representatives (e.g. teachers) to explore barriers and facilitators to families taking part in BEARS. Amend the BEARS scale-up plan based on new learning. Methods Literature and scoping reviews, quantitative analysis of BEARS recruitment data, in-depth interviews, paired interviews, focus groups Sample size Qualitative sample: 10-15 children aged 8-16 with bilateral CI, 10-15 parents/carers of children with bilateral CI, 10-12 clinicians and 10-12 family representatives. Significance This work will evaluate how diverse the BEARS clinical trial recruitment is and whether it is representative of the UK population of children with bilateral cochlear implants. We will investigate recruitment barriers and implement measures to try to improve recruitment diversity.