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

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Title: Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review
Authors: Polhemus, AM
Bergquist, R
Bosch de Basea, M
Brittain, G
Buttery, SC
Chynkiamis, N
Dalla Costa, G
Delgado Ortiz, L
Demeyer, H
Emmert, K
Garcia Aymerich, J
Gassner, H
Hansen, C
Hopkinson, N
Klucken, J
Kluge, F
Koch, S
Leocani, L
Maetzler, W
Micó-Amigo, ME
Mikolaizak, AS
Piraino, P
Salis, F
Schlenstedt, C
Schwickert, L
Scott, K
Sharrack, B
Taraldsen, K
Troosters, T
Vereijken, B
Vogiatzis, I
Yarnall, A
Mazza, C
Becker, C
Rochester, L
Puhan, MA
Frei, A
Item Type: Journal Article
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).
Issue Date: 19-Jul-2020
Date of Acceptance: 18-May-2020
URI: http://hdl.handle.net/10044/1/80913
DOI: 10.1136/bmjopen-2020-038704
ISSN: 2044-6055
Publisher: BMJ
Start Page: 1
End Page: 10
Journal / Book Title: BMJ Open
Volume: 10
Issue: 7
Copyright Statement: © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/ 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/.
Sponsor/Funder: Commission of the European Communities
Funder's Grant Number: 820820
Keywords: 1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status: Published
Open Access location: https://bmjopen.bmj.com/content/10/7/e038704
Online Publication Date: 2020-07-19
Appears in Collections:National Heart and Lung Institute

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