Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review
Sarah Koch,
Milo Alan Puhan,
Anja Frei,
Kristin Taraldsen,
A Stefanie Mikolaizak,
Clemens Becker,
Ronny Bergquist,
Beatrix Vereijken,
Lynn Rochester,
Basil Sharrack,
Claudia Mazza,
Ashley Marie Polhemus,
Magda Bosch de Basea,
Gavin Brittain,
Sara Catherine Buttery,
Gloria dalla Costa,
Laura Delgado Ortiz,
Heleen Demeyer,
Kirsten Emmert,
Heiko Gassner,
Nicholas Hopkinson,
Jochen Klucken,
Felix Kluge,
Letizia Leocani,
Paolo Piraino,
Christian Schlenstedt,
Thierry Troosters,
Ioannis Vogiatzis
Affiliations
Sarah Koch
Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain
Milo Alan Puhan
Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
Anja Frei
Epidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland
Kristin Taraldsen
7 Oslo Metropolitan University, Oslo, Norway
A Stefanie Mikolaizak
Department of Clinical Gerontology, Robert-Bosch-Krankenhaus GmbH, Stuttgart, Germany
Clemens Becker
Unit of Digital Geriatric Medicine, Heidelberg University Hospital, Heidelberg, Germany
Ronny Bergquist
Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, Norway
Beatrix Vereijken
Department of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, Norway
Lynn Rochester
NIHR Newcastle Biomedical Research Centre, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK
Basil Sharrack
Neurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
Claudia Mazza
Department of Mechanical Engineering and INSIGNEO, The University of Sheffield, Sheffield, Sheffield, UK
Ashley Marie Polhemus
Epidemiology, Biostatistics, and Prevention Institute, University of Zürich, Zürich, Switzerland
Magda Bosch de Basea
Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain
Gavin Brittain
Neuroscience Institute, The University of Sheffield, Sheffield, UK
Sara Catherine Buttery
National Heart and Lung Institute, Imperial College London, London, UK
Gloria dalla Costa
Department of Neurology, San Raffaele Hospital, Milan, Italy
Laura Delgado Ortiz
Barcelona Institute for Global Health (ISGlobal), Barcelona, Spain
Heleen Demeyer
8 Department of Respiratory Diseases, University Hospital Leuven, Leuven, Belgium
Kirsten Emmert
Department of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Schleswig-Holstein, Germany
Heiko Gassner
6 Department of Molecular Neurology, Erlangen University Hospital, Erlangen, Germany
Nicholas Hopkinson
reader in respiratory medicine
Jochen Klucken
9 Department of Molecular Neurology, Friedrich-Alexander University Erlangen, Nürnberg, Germany
Felix Kluge
7 Machine Learning and Data Analytics Lab, Department of Computer Science, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
Letizia Leocani
Experimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE) Scientific Institute San Raffaele and University Vita-Salute San Raffaele, Milan, Italy
Paolo Piraino
Department of Research & Early Development Statistics, Bayer AG, Berlin, Germany
Christian Schlenstedt
Department of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Schleswig-Holstein, Germany
Thierry Troosters
Department of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, Belgium
Ioannis Vogiatzis
Sport, Exercise & Rehabilitation, University of Northumbria at Newcastle, Newcastle upon Tyne, UK
Introduction Advances in wearable sensor technology now enable frequent, objective monitoring of real-world walking. Walking-related digital mobility outcomes (DMOs), such as real-world walking speed, have the potential to be more sensitive to mobility changes than traditional clinical assessments. However, it is not yet clear which DMOs are most suitable for formal validation. In this review, we will explore the evidence on discriminant ability, construct validity, prognostic value and responsiveness of walking-related DMOs in four disease areas: Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and proximal femoral fracture.Methods and analysis Arksey and O’Malley’s methodological framework for scoping reviews will guide study conduct. We will search seven databases (Medline, CINAHL, Scopus, Web of Science, EMBASE, IEEE Digital Library and Cochrane Library) and grey literature for studies which (1) measure differences in DMOs between healthy and pathological walking, (2) assess relationships between DMOs and traditional clinical measures, (3) assess the prognostic value of DMOs and (4) use DMOs as endpoints in interventional clinical trials. Two reviewers will screen each abstract and full-text manuscript according to predefined eligibility criteria. We will then chart extracted data, map the literature, perform a narrative synthesis and identify gaps.Ethics and dissemination As this review is limited to publicly available materials, it does not require ethical approval. This work is part of Mobilise-D, an Innovative Medicines Initiative Joint Undertaking which aims to deliver, validate and obtain regulatory approval for DMOs. Results will be shared with the scientific community and general public in cooperation with the Mobilise-D communication team.Registration Study materials and updates will be made available through the Center for Open Science’s OSFRegistry (https://osf.io/k7395).
