Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review
| العنوان: | Walking-related digital mobility outcomes as clinical trial endpoint measures: protocol for a scoping review |
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| المؤلفون: | Ioannis Vogiatzis, Lynn Rochester, Christian Schlenstedt, Laura Delgado Ortiz, Gavin Brittain, Kirsten Emmert, M. Encarna Micó-Amigo, Letizia Leocani, Nicholas S Hopkinson, Sarah Koch, Magda Bosch de Basea, Clemens Becker, Clint Hansen, Basil Sharrack, Ashley Polhemus, Jochen Klucken, Alison J. Yarnall, Heleen Demeyer, Judith Garcia Aymerich, Thierry Troosters, Milo A. Puhan, Claudia Mazzà, Felix Kluge, Paolo Piraino, Anja Frei, Francesca Salis, Kristin Taraldsen, Ronny Bergquist, Kirsty Scott, Lars Schwickert, Walter Maetzler, Beatrix Vereijken, Gloria Dalla Costa, Sara Buttery, Heiko Gassner, A. Stefanie Mikolaizak, Nikolaos Chynkiamis |
| المساهمون: | Polhemus, A. M., Bergquist, R., Bosch De Basea, M., Brittain, G., Buttery, S. C., 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., Mico-Amigo, M. E., Mikolaizak, A. S., 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, M. A., Frei, A., Commission of the European Communities |
| المصدر: | BMJ Open BMJ Open, Vol 10, Iss 7 (2020) BASE-Bielefeld Academic Search Engine BMJ OPEN |
| بيانات النشر: | BMJ PUBLISHING GROUP, 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | MILD COGNITIVE IMPAIRMENT, lcsh:Medicine, Walking, Cochrane Library, multiple sclerosis, B800, 0302 clinical medicine, Medicine and Health Sciences, Medicine, 030212 general & internal medicine, General Medicine, Digital library, 3. Good health, PROGNOSTIC VALUE, VARIABILITY, Research Design, BALANCE, RELIABILITY, telemedicine, medicine.medical_specialty, Telemedicine, trauma surgery, MEDLINE, B100, CINAHL, 1117 Public Health and Health Services, Rehabilitation Medicine, orthopaedic & trauma surgery, 03 medical and health sciences, Humans, Medical physics, SPEED, Protocol (science), business.industry, geriatric medicine, GAIT-ANALYSIS, DISABILITY, lcsh:R, Construct validity, 1103 Clinical Sciences, C600, Clinical trial, PHYSICAL-ACTIVITY, orthopaedic &, chronic airways disease, PATIENT-REPORTED OUTCOMES, business, Parkinson-s disease, 030217 neurology & neurosurgery, 1199 Other Medical and Health Sciences |
| الوصف: | IntroductionAdvances 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 analysisArksey 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 disseminationAs 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. RegistrationStudy materials and updates will be made available through the Center for Open Science’s OSFRegistry (https://osf.io/k7395Test). This work was supported by the Mobilise-D project, that 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 program and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Content in this publication reflects the authors’ view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained herein. |
| وصف الملف: | Electronic; application/pdf |
| اللغة: | English |
| تدمد: | 2044-6055 0959-8138 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::b24f2b42d9d86053c8ee6138a6649150Test https://lirias.kuleuven.be/handle/123456789/657986Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....b24f2b42d9d86053c8ee6138a6649150 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20446055 09598138 |
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