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Testing the construct validity of real-world digital mobility outcomes in multiple sclerosis

Gavin BrittainUniversity of SheffieldMichael LongSchool of Computer Science, The University of Sheffield, Sheffield, UKEllen BuckleyUniversity of SheffieldClemens BeckerRobert Bosch Gesellschaft für Medizinische Forschung, Stuttgart, GermanyJoren BuekersBarcelona Institute for Global HealthMartí De Las HerasISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, SpainClaudia ArmengolCentro de Investigación Biomédica en Red de Epidemiología y Salud PúblicaSarah KochISGlobal, Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain; Department of Sport, Exercise and Health, University of Basel, Basel, SwitzerlandJulia BraunEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, SwitzerlandBrian CaufieldInsight – Centre for Data Analytics, University College Dublin, Dublin, Ireland; UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, IrelandGiancarlo ComiDepartment of Neurorehabilitation Sciences, Casa di Cura IGEA, Milano, ItalyGloria Dalla CostaUniversita San Raffaele, Milan, Italy; Harvard T.H. Chan School of Public Health, Harvard University, Boston, MA, USAAnja FreiEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, SwitzerlandHeiko GassnerDepartment of Molecular Neurology, University Hospital Erlangen, Erlangen, Germany; Fraunhofer Institute for Integrated Circuits IIS, Erlangen, GermanyAnisoara IonescuEPFL, Lausanne, SwitzerlandLetizia LeocaniSan Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milano, ItalyLynn RochesterTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle Biomedical Research Centre (BRC), National Institute for Health and Care Research (NIHR), Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKVeit RothhammerDepartment of Neurology, University Hospital Erlangen, Erlangen, GermanyDavid SingletonInsight – Centre for Data Analytics, University College Dublin, Dublin, Ireland; UCD School of Public Health, Physiotherapy and Sports Science, University College Dublin, Dublin, IrelandKlarissa Hanja StürnerUniversity of LübeckDavid PalingNIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UKKrishnan Padmakumari Sivaraman NairUniversity of SheffieldArshad MajidSheffield Institute for Translational Neuroscience (SITraN), School of Medicine and Population Health, The University of Sheffield, Sheffield, UK; NIHR Sheffield Biomedical Research Centre, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield, UKGiampaolo BrichettoAISM Rehabilitation Service of Liguria, Genoa, ItalyBeatrix VereijkenDepartment of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, NorwayVita LanfranchiSchool of Computer Science, The University of Sheffield, Sheffield, UKCarl-Philipp JansenUniversity Hospital HeidelbergLou SutcliffeTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle Biomedical Research Centre (BRC), National Institute for Health and Care Research (NIHR), Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKSilvia Del DinTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle Biomedical Research Centre (BRC), National Institute for Health and Care Research (NIHR), Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKIsabel NeatrourTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK; Newcastle Biomedical Research Centre (BRC), National Institute for Health and Care Research (NIHR), Newcastle University and The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UKAndrea CereattiDepartment of Electronics and Telecommunications, Polytechnic University of Turin, Turin, UKWalter MaetzlerDepartment of Neurology, University Hospital Schleswig-Holstein and Kiel University, Kiel, GermanyClint HansenUniversity of LübeckDaniel RooksTranslational Medicine, Biomedical Research, Novartis AG, Cambridge, MA, USABasil SharrackUniversity of SheffieldJudith Garcia-AymerichBarcelona Institute for Global Health

2026en

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BACKGROUND: Wearable devices can measure real-world mobility and generate metrics known as digital mobility outcomes (DMOs). For people with multiple sclerosis (pwMS), these DMOs have not been clinically validated. This study aimed to evaluate the construct (convergent, divergent, and known groups) validity of a comprehensive panel of 24 DMOs in pwMS. 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.

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DOI: 10.1177/13524585261464537

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