Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review
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....
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BMJ Publishing Group
2020-07-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/7/e038704.full |
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| author | 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 |
| author_facet | 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 |
| author_sort | Sarah Koch |
| collection | DOAJ |
| description | 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). |
| format | Article |
| id | doaj-art-7587f202ed18452698f3a623dffbd7fe |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-07-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-7587f202ed18452698f3a623dffbd7fe2025-08-20T02:30:43ZengBMJ Publishing GroupBMJ Open2044-60552020-07-0110710.1136/bmjopen-2020-038704Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping reviewSarah Koch0Milo Alan Puhan1Anja Frei2Kristin Taraldsen3A Stefanie Mikolaizak4Clemens Becker5Ronny Bergquist6Beatrix Vereijken7Lynn Rochester8Basil Sharrack9Claudia Mazza10Ashley Marie Polhemus11Magda Bosch de Basea12Gavin Brittain13Sara Catherine Buttery14Gloria dalla Costa15Laura Delgado Ortiz16Heleen Demeyer17Kirsten Emmert18Heiko Gassner19Nicholas Hopkinson20Jochen Klucken21Felix Kluge22Letizia Leocani23Paolo Piraino24Christian Schlenstedt25Thierry Troosters26Ioannis Vogiatzis27Barcelona Institute for Global Health (ISGlobal), Barcelona, SpainEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, SwitzerlandEpidemiology, Biostatistics and Prevention Institute, University of Zurich, Zurich, Switzerland7 Oslo Metropolitan University, Oslo, NorwayDepartment of Clinical Gerontology, Robert-Bosch-Krankenhaus GmbH, Stuttgart, GermanyUnit of Digital Geriatric Medicine, Heidelberg University Hospital, Heidelberg, GermanyDepartment of Neuromedicine and Movement Science, Norwegian University of Science and Technology (NTNU), Trondheim, NorwayDepartment of Neuromedicine and Movement Science, Norwegian University of Science and Technology, Trondheim, NorwayNIHR Newcastle Biomedical Research Centre, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UKNeurosciences, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UKDepartment of Mechanical Engineering and INSIGNEO, The University of Sheffield, Sheffield, Sheffield, UKEpidemiology, Biostatistics, and Prevention Institute, University of Zürich, Zürich, SwitzerlandBarcelona Institute for Global Health (ISGlobal), Barcelona, SpainNeuroscience Institute, The University of Sheffield, Sheffield, UKNational Heart and Lung Institute, Imperial College London, London, UKDepartment of Neurology, San Raffaele Hospital, Milan, ItalyBarcelona Institute for Global Health (ISGlobal), Barcelona, Spain8 Department of Respiratory Diseases, University Hospital Leuven, Leuven, BelgiumDepartment of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Schleswig-Holstein, Germany6 Department of Molecular Neurology, Erlangen University Hospital, Erlangen, Germanyreader in respiratory medicine9 Department of Molecular Neurology, Friedrich-Alexander University Erlangen, Nürnberg, Germany7 Machine Learning and Data Analytics Lab, Department of Computer Science, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, GermanyExperimental Neurophysiology Unit, Institute of Experimental Neurology (INSPE) Scientific Institute San Raffaele and University Vita-Salute San Raffaele, Milan, ItalyDepartment of Research & Early Development Statistics, Bayer AG, Berlin, GermanyDepartment of Neurology, University Medical Center Schleswig-Holstein Campus Kiel, Kiel, Schleswig-Holstein, GermanyDepartment of Rehabilitation Sciences, Research Group for Rehabilitation in Internal Disorders, KU Leuven, Leuven, BelgiumSport, Exercise & Rehabilitation, University of Northumbria at Newcastle, Newcastle upon Tyne, UKIntroduction 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).https://bmjopen.bmj.com/content/10/7/e038704.full |
| spellingShingle | 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 Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review BMJ Open |
| title | Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review |
| title_full | Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review |
| title_fullStr | Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review |
| title_full_unstemmed | Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review |
| title_short | Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review |
| title_sort | walking related digital mobility outcomes as clinical trial endpoint measures protocol for a scoping review |
| url | https://bmjopen.bmj.com/content/10/7/e038704.full |
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