Development of a core outcome set for the assessment of spasticity in adults: a study protocol.

Abstract

Background: Muscle spasticity is common in adult-onset neurological conditions such as stroke, traumatic brain injury, multiple sclerosis, and spinal cord injury. Although effective interventions exist, studies evaluating interventions to improve rehabilitation or management outcomes for those with spasticity are methodologically heterogeneous, making meta-analysis impossible. This paper reports a protocol to develop a spasticity core outcome set (COS) to standardise the reporting of clinical trials and enable better evidence synthesis in future studies. Further, a spasticity COS may facilitate better patient assessment, guide treatment planning and goal setting, and further support evaluation of treatment outcomes in clinical practice.

Methods: This protocol has been developed according to the Core Outcome Measures in Effectiveness Trial (COMET) initiative guidelines. It has been prospectively registered on the COMET website. Outcome measures for inclusion in the COS will be based on COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). The study will adhere to the minimum standards for the design of a COS study (Core Outcome Set-Standards for Development [COS-STAD]). This project involves four phases. Phase 1 involves semi-structured interviews of people with a lived experience of spasticity to determine important areas for outcome evaluation. Phase 2 is a Delphi survey with experts in spasticity, together with people with lived experience, to select the outcome domains for inclusion in the COS. Phase 3 consists of systematic reviews of the literature to identify outcome measures specific to each of the domains selected in phase 2 and their psychometric properties. Phase 4 is a second Delphi survey with the spasticity experts, conducted to obtain consensus on outcome measures included in the COS.

Discussion: This proposal represents the first spasticity COS to improve the consistency in outcome measurement selection and reporting in clinical trials to enable future meta-analyses and reduce research waste. It will also provide clinicians with a resource for documenting and reporting patient outcomes that can be used for benchmarking and optimising care.

Trial registration: https://www.comet-initiative.org/Studies/Details/3345 . 31st January, 2025.