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

Ashley Marie Polhemus, Ronny Bergquist, Magda Bosch De Basea, Gavin Brittain, Sara Catherine Buttery, Nikolaos Chynkiamis, Gloria Dalla Costa, Laura Delgado Ortiz, Heleen Demeyer, Kirsten Emmert, Judith Garcia Aymerich, Heiko Gassner, Clint Hansen, Nicholas Hopkinson, Jochen Klucken, Felix Kluge, Sarah Koch, Letizia Leocani, Walter Maetzler, Encarna Micó AmigoA Stefanie Mikolaizak, Paolo Piraino, Francesca Salis, Christian Schlenstedt, Lars Schwickert, Kirsty Scott, Basil Sharrack, Kristin Taraldsen, Thierry Troosters, Beatrix Vereijken, Ioannis Vogiatzis, Alison Yarnall, Claudia Mazza, Clemens Becker, Lynn Rochester, Milo Alan Puhan, Anja Frei

Research output: Contribution to journalReview articlepeer-review

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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).
Original languageEnglish
Article numbere038704
Number of pages10
JournalBMJ Open
Volume10
Issue number7
Early online date19 Jul 2020
DOIs
Publication statusPublished - Jul 2020

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