RADIATE - Radial Dysplasia Assessment, Treatment and Aetiology: Protocol for the development of a core outcome set using a Delphi survey

Background: Radial dysplasia (RD) is a disfiguring, potentially disabling congenital upper limb anomaly. Multiple surgical techniques are in current use, with little agreement on the optimal treatment approach. At present, no core outcome set exists specifically for radial dysplasia, and the literature is dominated by retrospective case series. A recent systematic review by this group demonstrated significant heterogeneity in both which outcomes are measured, and how they are measured.
Methods: The RADIATE study will conduct a three-round online Delphi process, involving adult radial dysplasia patients, the parents of children with radial dysplasia, hand surgeons and hand therapists. The initial list of outcomes is drawn from our recent systematic review and will be supplemented by suggestions from the stakeholder groups. Following the Delphi process, outcomes which meet the ‘consensus in’ definition will be ratified at a final consensus meeting. We will then follow the COSMIN guidelines to select outcome measurement instruments; where appropriate, these will overlap with the outcome measures specified in the forthcoming ICHOM congenital upper limb anomalies standard set.
Discussion: The Radial Dysplasia Assessment, Treatment and Aetiology (RADIATE) study aims to address the uncertainty in the treatment of radial dysplasia, and to begin to answer the question “what is the most appropriate treatment of the forearm and hand for children with radial dysplasia?” by establishing a core outcome set.

Trial registration: COMET initiative study 902, registered May 2016 http://www.comet-initiative.org/studies/details/902