Recruitment of the multiple sclerosis cohort within the European Mobilise-D clinical validation study-lessons learnt, baseline demographics and clinical characteristics
Abstract
Background: Multiple sclerosis (MS) is a common cause of disability in working age adults. Current clinical assessments are inadequate at disability assessment or predicting clinically relevant outcomes. Loss of mobility is an important functional disability to people with MS. Mobilise-D aims to develop, validate, and implement a digital mobility solution which measures unsupervised mobility performance across several chronic conditions, including MS, using a single wearable device.
Methods: Six hundred two adults with MS, an Expanded Disability Status Scale (EDSS) score of 3.0-6.5, documented disability worsening over the previous 2 years and a 30-day freedom from relapses, were recruited across four European centres.
Results: Of 1416 invited, 602 participants (42%) were recruited. Primary recruitment sources were clinicians (42%) and local registries (42%). Among 616 who declined screening, the main reasons were a lack of interest (44%), the time commitment (25%) or the travel involved (13%). Participants had a mean age of 52 years; 64% were female, with a median EDSS score of 5.0. Of those, 56% had relapsing-remitting MS, 33% secondary progressive MS and 10% primary progressive MS. Falls occurred in 58% of participants in the 12 months prior to recruitment. Of those recruited, 556 (93%) participants had valid mobility data recorded.
Conclusions: The longitudinal collection of clinical and unsupervised mobility assessments will provide a comprehensive dataset, allowing for…
How strong is the evidence?
Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 602 participants or records.
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