RADIATE: developing a core outcome set for Radial Dysplasia.
Research type
Research Study
Full title
RADIATE: developing a core outcome set for Radial Dysplasia.
IRAS ID
221850
Contact name
Malcolm Logan
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
www.comet-initiative.org/studies/details/902, COMET registry reference number
Duration of Study in the UK
0 years, 4 months, 2 days
Research summary
Radial dysplasia is a limb anomaly affecting about 1:7,000 children born. Affected children typically have a missing or very small thumb and radius (one of the forearm bones), and abnormal muscles on the thumb side of the forearm. A number of treatment approaches are used worldwide, but there is no consensus on the most important outcomes of treatment. This makes it difficult to compare or combine results from different studies, and increases the risk of outcome reporting bias (where multiple outcomes are measured, but only 'significant' findings reported).
This study will use a systematic search of the scientific literature on radial dysplasia to identify outcomes which have been measured in previous studies. We will then ask English-speaking key stakeholders from four groups (radial dysplasia patients aged 16 or over, families with children aged under 16 with radial dysplasia, children's hand surgeons and children's hand therapists) to suggest any other outcomes they feel are important, and to rate the relative importance of each outcome from 1 (least important) to 9 (most important) in a three round online 'Delphi survey'. In rounds 2 and 3, stakeholders will be given the average stakeholder score in the previous round for each outcome, then asked to re-score them. After round 3, outcomes scored as 7-9 by 70% or more participants, and 1-3 by <15% participants, will be included in the core outcome set.
All participants will then be invited to a meeting (in person or via conference call) to ratify the core outcome set, and discuss how each included outcome should be measured. The final outcome set will be published in an open-access journal, for use by clinicians and researchers.
REC name
London - Queen Square Research Ethics Committee
REC reference
18/LO/1561
Date of REC Opinion
11 Sep 2018
REC opinion
Further Information Favourable Opinion