A Roadmap to inform development, validation and approval of digital mobility outcomes: The Mobilise-D approach

Rochester, Lynn; Mazzà, Claudia; Mueller, Arne; Caulfield, Brian; McCarthy, Marie; Becker, Clemens; Miller, Ram; Piraino, Paolo; Viceconti, Marco; Dartee, Wilhelmus; García Aymerich, Judith; Aydemir, Aida A.; Vereijken, Beatrix; Arnera, Valdo; Ammour, Nadir; Jackson, Michael; Hache, Tilo; Roubenoff, Ronenn

A Roadmap to inform development, validation and approval of digital mobility outcomes: The Mobilise-D approach

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dc.contributor.author Rochester, Lynn
dc.contributor.author Mazzà, Claudia
dc.contributor.author Mueller, Arne
dc.contributor.author Caulfield, Brian
dc.contributor.author McCarthy, Marie
dc.contributor.author Becker, Clemens
dc.contributor.author Miller, Ram
dc.contributor.author Piraino, Paolo
dc.contributor.author Viceconti, Marco
dc.contributor.author Dartee, Wilhelmus
dc.contributor.author García Aymerich, Judith
dc.contributor.author Aydemir, Aida A.
dc.contributor.author Vereijken, Beatrix
dc.contributor.author Arnera, Valdo
dc.contributor.author Ammour, Nadir
dc.contributor.author Jackson, Michael
dc.contributor.author Hache, Tilo
dc.contributor.author Roubenoff, Ronenn
dc.date.accessioned 2022-05-03T05:51:39Z
dc.date.available 2022-05-03T05:51:39Z
dc.date.issued 2020
dc.description.abstract Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.
dc.description.sponsorship The MOBILISE-D project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No. 820820. 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).
dc.format.mimetype application/pdf
dc.identifier.citation Rochester L, Mazzà C, Mueller A, Caulfield B, McCarthy M, Becker C, Miller R, Piraino P, Viceconti M, Dartee WP, Garcia-Aymerich J, Aydemir AA, Vereijken B, Arnera V, Ammour N, Jackson M, Hache T, Roubenoff R. A Roadmap to inform development, validation and approval of digital mobility outcomes: The Mobilise-D approach. Digit Biomark. 2020 Nov 26;4(Suppl 1):13-27. DOI: 10.1159/000512513
dc.identifier.doi http://dx.doi.org/10.1159/000512513
dc.identifier.issn 2504-110X
dc.identifier.uri http://hdl.handle.net/10230/52959
dc.language.iso eng
dc.publisher Karger (S. Karger AG)
dc.relation.ispartof Digit Biomark. 2020 Nov 26;4(Suppl 1):13-27
dc.relation.projectID info:eu-repo/grantAgreement/EC/H2020/820820
dc.rights © 2020 The Author(s). This article is licensed under the Creative Commons Attribution-NonCommercial 4.0 Interna-tional License (CC BY-NC) (http://www.karger.com/Services/OpenAccessLicense). Usage and distribution for commercial purposes requires written permission.
dc.rights.accessRights info:eu-repo/semantics/openAccess
dc.rights.uri https://creativecommons.org/licenses/by-nc/4.0/
dc.subject.keyword Body-worn devices
dc.subject.keyword Digital mobility outcomes
dc.subject.keyword Remote monitoring
dc.title A Roadmap to inform development, validation and approval of digital mobility outcomes: The Mobilise-D approach
dc.type info:eu-repo/semantics/article
dc.type.version info:eu-repo/semantics/publishedVersion

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