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

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).

SUBMITTER: Polhemus AM

PROVIDER: S-EPMC7371223 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

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

Polhemus Ashley Marie AM Bergquist Ronny R Bosch de Basea Magda M Brittain Gavin G Buttery Sara Catherine SC Chynkiamis Nikolaos N Dalla Costa Gloria G Delgado Ortiz Laura L Demeyer Heleen H Emmert Kirsten K Garcia Aymerich Judith J Gassner Heiko H Hansen Clint C Hopkinson Nicholas N Klucken Jochen J Kluge Felix F Koch Sarah S Leocani Letizia L Maetzler Walter W Micó-Amigo M Encarna ME Mikolaizak A Stefanie AS Piraino Paolo P Salis Francesca F Schlenstedt Christian C Schwickert Lars L Scott Kirsty K Sharrack Basil B Taraldsen Kristin K Troosters Thierry T Vereijken Beatrix B Vogiatzis Ioannis I Yarnall Alison A Mazza Claudia C Becker Clemens C Rochester Lynn L Puhan Milo Alan MA Frei Anja A

BMJ open 20200719 7

<h4>Introduction</h4>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 ...[more]

PMID: 32690539

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Project description:IntroductionTuning of lower-limb (LL) robotic prosthesis control is necessary to provide personalised assistance to each human wearer during walking. Prostheses wearers' adaptation processes are subjective and the efficiency largely depends on one's mental processes. Therefore, beyond physical motor performance, prosthesis personalisation should consider the wearer's preference and cognitive performance during walking. As a first step, it is necessary to examine the current measures of cognitive performance when a wearer walks with an LL prosthesis, identify the gaps and methodological considerations, and explore additional measures in a walking setting. In this protocol, we outlined a scoping review that will systematically summarise and evaluate the measures of cognitive performance during walking with and without LL prosthesis.Methods and analysisThe review process will be guided and documented by CADIMA, an open-access online data management portal for evidence synthesis. Keyword searches will be conducted in seven databases (Web of Science, MEDLINE, BIOSIS, SciELO Citation Index, ProQuest, CINAHL and PsycINFO) up to 2020 supplemented with grey literature searches. Retrieved records will be screened by at least two independent reviewers on the title-and-abstract level and then the full-text level. Selected studies will be evaluated for reporting bias. Data on sample characteristics, type of cognitive function, characteristics of cognitive measures, task prioritisation, experimental design and walking setting will be extracted.Ethics and disseminationThis scoping review will evaluate the measures used in previously published studies thus does not require ethical approval. The results will contribute to the advancement of prosthesis tuning processes by reviewing the application status of cognitive measures during walking with and without prosthesis and laying the foundation for developing needed measures for cognitive assessment during walking. The results will be disseminated through conferences and journals.

Project description:INTRODUCTION:Food environments are the interface through which people interact with the broader food system. They are a key determinant of healthy and sustainable diets. The widespread use of digital technology in late modernity and the shift towards a digital society have posed new challenges for nutrition and health, with a concomitant surge in research on social media, digital health promotion interventions, and more recently, increasing interest in digital food marketing. While the literature is abundant on studies linking food, nutrition and digital technology, the effort to conceptualise and describe the digital food environment is new. This scoping review aims to support the development of a definition of the digital food environment and characterise it, along with key thematic research trends on this topic and potential consequences for nutrition and health. METHODS AND ANALYSIS:The planned scoping review will be supported by the methodological framework proposed by Arksey and O'Malley and further developed by Levac et al. Development and reporting will follow the Preferred Reporting Items for Systematic Reviews and MetaAnalyses-Extension for Scoping Reviews (PRISMA-ScR) checklist and guidelines. The development of the search strategy was guided by the food environment conceptual framework developed by Turner et al. Four databases will be searched: MEDLINE, EMBASE, Scopus and Web of Science. Citation searching will be applied to identify additional studies, through checking of reference lists of primary studies and reviews. Studies in English, published from the year 2000 onwards, will be included. No geographical or population limits will be applied. Data will be extracted and analysed using a standardised charting tool. ETHICS AND DISSEMINATION:No ethical approval is required for this study. The results will be submitted to an international peer-reviewed journal and scientific conferences. They will be disseminated through digital science communication platforms, including academic social media, to amplify its reach and usefulness.

Project description:BackgroundFrail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits.MethodsWe will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps.ConclusionIf changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints.Trial registrationThe randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.

Project description:IntroductionMeasures of health-related quality-of-life (HRQoL) are increasingly important for evaluating healthcare interventions and treatments, understanding the burden of disease, identifying health inequities, allocating health resources and for use in epidemiological studies. Although many HRQoL measures developed for use in adult populations are robust, they are not necessarily designed, or appropriate, to measure HRQoL for children/youth. Furthermore, the appropriateness of HRQoL measures for use with Indigenous child/youth populations has not been closely examined. The aims of this scoping review are to (1) identify and describe empirical studies using HRQoL measures among children/youth (aged 8-17 years) from Indigenous populations within the Pacific Rim, (2) summarise the study designs and modes of HRQoL measure administration, (3) describe the key dimensions of the identified HRQoL measures used among Indigenous populations, including specifically among Māori and (4) map the HRQoL measure dimensions to commonly used Māori models of health.Methods and analysisThe scoping review framework developed by Arksey and O'Malley and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews guidelines will be followed for best practice and reporting. An iterative search of peer-reviewed published empirical research reporting the use of child/youth HRQoL measures among Indigenous populations will be conducted. This literature will be identified across the following five databases: Ovid (Medline), PubMed, Scopus, Web of Science and CINHAL. The search will be restricted to papers published in English between January 1990 and June 2020. Two reviewers will independently review the papers in two stages. A third reviewer will resolve any discrepancies that arise. A data charting form will be completed using data extracted from each paper.Ethics and disseminationEthical approval was not required for this scoping review. Dissemination will include publication of the scoping review in a peer-reviewed journal. This scoping review will inform a larger research project (HRC 20/166).

Project description:IntroductionThe notion of compassion and compassionate care is playing an increasingly important role in health professional education and in the delivery of high-quality healthcare. Digital contexts, however, are not considered in the conceptualisation of compassionate care, nor is there guidance on how compassionate care is to be exercised while using digital health technologies. The widespread diffusion of digital health technologies provides new contexts for compassionate care, with both opportunities for new forms and instantiations of compassion as well as new challenges. How compassion is both understood and enacted within this evolving, digital realm has not been synthesised.Methods and analysisThis scoping review protocol follows Arksey and O'Malley's methodology to examine dimensions of compassionate professional practice when digital technologies are integrated into clinical care. Relevant peer-reviewed literature will be identified using a search strategy developed by medical librarians, which applies to six databases of medical, computer and information systems disciplines. Eligibility of articles will be determined using the two-stage screening process consisting of (1) title and abstract scan, and (2) full-text review. Screening, abstracting and charting will be conducted by two independent reviewers, with a third reviewer available for resolution when consensus is not achieved. In order to look at the range of current research in this area, extracted data will be thematically analysed and validated by content experts. Descriptive statistics will be calculated where necessary.Ethics and disseminationResearch ethics approval and consent to participate is not required for this scoping review. The results of the review will inform resource development and strategy for Associated Medical Services (AMS) Healthcare, a Canadian charitable organisation at the forefront of advancing research and leadership development in health and humanities, as part of the AMS Phoenix Project: A Call to Caring, particularly for digital professionalism frameworks so that they are inclusive of a compassion competency.

Dataset Information

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

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

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