Testing the construct validity of real-world digital mobility outcomes in multiple sclerosis.
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Brittain Gavin, Long Michael, Buckley Ellen, Becker Clemens, Buekers Joren, de Las Heras Martí, Armengol Claudia, Koch Sarah, Braun Julia, Caufield Brian, Comi Giancarlo, Dalla Costa Gloria, Frei Anja, Gassner Heiko, Ionescu Anisoara, Leocani Letizia, Rochester Lynn, Rothhammer Veit, Singleton David, Stuerner Klarissa Hanja, Paling David, Padmakumari Sivaraman Nair Krishnan, Majid Arshad, Brichetto Giampaolo, Vereijken Beatrix, Lanfranchi Vita, Jansen Carl-Philipp, Sutcliffe Lou, Del Din Silvia, Neatrour Isabel, Cereatti Andrea, Maetzler Walter, Hansen Clint, Rooks Daniel, Sharrack Basil, Garcia-Aymerich Judith
Аннотация
METHODS: PwMS were recruited to the Mobilise-D Clinical Validation Study, which involved 7-days of real-world mobility monitoring with a lower-back-worn wearable device. DMOs of walking amount, pattern, pace, rhythm, and variability domains were assessed. Convergent validity was evaluated against established clinical constructs (Expanded Disability Status Scale (EDSS), Timed 25-Foot Walk, Multiple sclerosis (MS) Walking Scale-12, and Patient-Determined Disease Steps) using a priori hypotheses. Divergent validity was tested against systolic blood pressure. Known-groups validity was assessed across three EDSS strata. An expert panel completed a standardised consensus process.
RESULTS: We included 556 participants: 65% women, mean (SD) age of 52.3 (10.7) years, and median (p25-p75) EDSS 5 (4-6). Convergent, divergent, and known-groups validity were supported for 19, 24, and 23 DMOs, respectively. Nineteen DMOs, covering all domains, reached consensus agreement.
CONCLUSION: This study confirms the construct validity of 19 DMOs across all walking domains in pwMS, supporting their use in clinical research and practice. www.isrctn.com/ISRCTN12051706.