ArticleTrials2025
Development of a core outcome set for the assessment of spasticity in adults: a study protocol.
Article in Trials, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
Corrections and comments
- Erratum issued
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundMuscle 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.
methodsThis 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 registrationhttps://www.comet-initiative.org/Studies/Details/3345 . 31st January, 2025.
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