Development of a core outcome set for paediatric upper limb spasticity; a structured review protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

Background Upper limb spasticity is a common condition in paediatric patients, often resulting from neurological disorders such as cerebral palsy, traumatic brain injury, or stroke. There are currently no standardised outcome measures to assess progress after interventions for upper limb spasticity in children. Wide variation in currently reported outcomes makes comparison of treatments difficult. This study aims to identify outcome measures that have previously been reported in studies evaluating the management of upper limb spasticity in children and to facilitate the development of a consensus core outcome set (COS) suitable for use in all future studies of upper limb spasticity in children.

Methods/design This study will include a systematic review of the academic literature to identify a list of outcome measures that have previously been reported. The list of outcome measures will be used in a consensus setting exercise with focus groups of key stakeholders to identify key outcomes. A Delphi process to include two rounds will then be used to define the most important outcomes to all stakeholders forming the COS.

Discussion Core outcomes represent the minimum expected data reported for a specific condition and will improve the quality of future studies, reducing bias, allowing easier comparison and enhancing opportunities for larger meta-analysis and more meaningful future research.