Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review

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• dc.contributor.author Polhemus, Ashley Marie
• dc.contributor.author Bosch de Basea i Gómez, Magda, 1982-
• dc.contributor.author Delgado Ortiz, Laura
• dc.contributor.author García Aymerich, Judith
• dc.contributor.author Koch, Sarah
• dc.contributor.author Frei, Anja
• dc.date.accessioned 2021-01-25T07:31:04Z
• dc.date.available 2021-01-25T07:31:04Z
• dc.date.issued 2020
• dc.description.abstract 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).
• dc.description.sponsorship The MOBILISE-D project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820 820. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). HD is a postdoctoral research fellow of the FWO-Flanders. JGA, MBdB, LDO and SK acknowledge support from the Spanish Ministry of Science, Innovation and Universities through the 'Centro de Excelencia Severo Ochoa 2019–2023' Programme (CEX2018-000806-S), and support from the Generalitat de Catalunya through the CERCA Programme.
• dc.format.mimetype application/pdf
• dc.identifier.citation Polhemus AM, Bergquist R, Bosch de Basea M, Brittain G, Buttery SC, Chynkiamis N et al. Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review. BMJ Open. 2020; 10(7):e038704. DOI: 10.1136/bmjopen-2020-038704
• dc.identifier.doi http://dx.doi.org/10.1136/bmjopen-2020-038704
• dc.identifier.issn 2044-6055
• dc.identifier.uri http://hdl.handle.net/10230/46260
• dc.language.iso eng
• dc.publisher BMJ Publishing Group
• dc.relation.ispartof BMJ Open. 2020; 10(7):e038704
• dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/820820
• dc.rights © Author(s) (or their employer(s)) 2020. This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
• dc.subject.keyword Parkinson-s disease
• dc.subject.keyword Chronic airways disease
• dc.subject.keyword Geriatric medicine
• dc.subject.keyword Multiple sclerosis
• dc.subject.keyword Orthopaedic & trauma surgery
• dc.subject.keyword Telemedicine
• dc.title Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion