COSMYC: Core Outcome Set for Myopia trials in Children & Young People
Research type
Research Study
Full title
COSMYC+: Core Outcome Set and Study Design for clinical trials of Myopia treatments in Children and Young People
IRAS ID
344573
Contact name
Annegret Dahlmann-Noor
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2024/08/46 health research, Data Protection
Duration of Study in the UK
2 years, 2 months, 1 days
Research summary
This project aims to develop agreement about how to run a future clinical trial of treatments to slow down the worsening of short-sightedness in children. Stakeholders will include children with myopia (shortsightedness), parents, eyecare professionals and myopia researchers. We will use an established method, COMET (core outcome measures for effectiveness trials) methodology, to develop consensus.
This work will have three phases.
Phase I: We will establish a “long-list” of participant characteristics, interventions, outcomes and outcome measurement tools reported in previous trials. To identify gaps, we will invite children aged 5-15 years with myopia and their parents/caregivers, from ethnically diverse background, and including those with syndromes/disabilities associated with myopia, to take part in focus groups to identify additional items. In parallel, we will invite eye care professionals and myopia researchers to take part in semi-structured interviews on the same question.Phase II: After establishing the “long-list”, we will carry out a consensus exercise to agree on core outcomes and interventions that should be used in future clinical trials. For adult participants, i.e. parents/caregivers, optometrists and researchers, we will run online Delphi consensus with 2-3 rounds, with pre-defined consensus threshold. For children and young people (CYP), we will run focus groups to discuss which participant outcomes and interventions they consider most appropriate and relevant. During these meetings, we will use creative methods to facilitate ranking of items and reaching consensus on which items are “core”.
To discuss items which failed to reach consensus, we will invite stakeholder group representatives to attend a final consensus workshop. Participants can contribute to as many stages of the project as they like; we will replace withdrawing with newly enrolled participants.Phase III: We will repeat the same steps as for Phase II, but the aim is to agree on participant characteristics and which tests to use to measure the agreed outcomes.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/PR/1288
Date of REC Opinion
12 Nov 2024
REC opinion
Further Information Favourable Opinion