Designing a Trial of Bilateral Cochlear Implantation in Adults

Launched by NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST · Sep 13, 2017

Keywords

ClinConnect Summary

The study design comprises focus groups, online surveys, a trial design workshop, a manufacturer's forum, and a care pathway working group.

Focus groups Two focus groups will be conducted to explore issues around the acceptability of the two-arm trial recommended by NICE. The recruitment strategy will target both individuals who have been referred for a cochlear implant but have yet to receive one and also existing users of a cochlear implant. The focus groups will explore issues such as acceptance of randomisation, how to minimise the burden associated with participating, potential barrie...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • All participants will be 18 years or older at the time consent is obtained.
• • Patients who participate in the focus groups and/or online survey must have received a cochlear implant on the NHS in the UK or must be currently being assessed for eligibility to receive a unilateral cochlear implantation by an NHS service provider.
• • Clinicians who participate in the trial design workshop and/or the online survey must be employed by a provider of NHS cochlear implantation services in the UK and be a clinically-trained professional who delivers one or more aspects of the cochlear implantation care pathway.
• • Representatives from manufacturers who attend the industry forum must be employed by a manufacturer of cochlear implants and hold a role that includes responsibility for developing, co-ordinating, or managing research activity sponsored and/or funded by the manufacturer.
• • Clinicians who participate in the care pathway working group must be employed by a provider of NHS cochlear implantation services in the UK and have a head of service or co-ordinator role in their cochlear implant service or have been delegated responsibility to contribute on behalf of a head of service / co-ordinator.
• Exclusion Criteria:
• • • None.