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

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)

Support and Assessment for Fall Emergency Referrals (SAFER 1): Cluster Randomised Trial of Computerised Clinical Decision Support for Paramedics

Objective: To evaluate effectiveness, safety and cost-effectiveness of Computerised Clinical Decision Support (CCDS) for paramedics attending older people who fall. Design: Cluster trial randomised by paramedic; modelling. Setting: 13 ambulance stations in two UK emergency ambulance services. Participants: 42 of 409 eligible paramedics, who attended 779 older patients for a reported fall. Interventions: Intervention paramedics received CCDS on Tablet computers to guide patient care. Control paramedics provided care as usual. One service had already installed electronic data capture. Main Outcome Measures: Effectiveness: patients referred to falls service, patient reported quality of life and satisfaction, processes of care. Safety: Further emergency contacts or death within one month. Cost-Effectiveness Costs and quality of life. We used findings from published Community Falls Prevention Trial to model cost-effectiveness. Results: 17 intervention paramedics used CCDS for 54 (12.4%) of 436 participants. They referred 42 (9.6%) to falls services, compared with 17 (5.0%) of 343 participants seen by 19 control paramedics [Odds ratio (OR) 2.04, 95% CI 1.12 to 3.72]. No adverse events were related to the intervention. Non-significant differences between groups included: subsequent emergency contacts (34.6% versus 29.1%; OR 1.27, 95% CI 0.93 to 1.72); quality of life (mean SF12 differences: MCS −0.74, 95% CI −2.83 to +1.28; PCS −0.13, 95% CI −1.65 to +1.39) and non-conveyance (42.0% versus 36.7%; OR 1.13, 95% CI 0.84 to 1.52). However ambulance job cycle time was 8.9 minutes longer for intervention patients (95% CI 2.3 to 15.3). Average net cost of implementing CCDS was £208 per patient with existing electronic data capture, and £308 without. Modelling estimated cost per quality-adjusted life-year at £15,000 with existing electronic data capture; and £22,200 without. Conclusions: Intervention paramedics referred twice as many participants to falls services with no difference in safety. CCDS is potentially cost-effective, especially with existing electronic data capture

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement–the Mobilise-D study protocol

Background The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. Methods/design The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson’s Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. Discussion The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility

Older fallers attended to by an ambulance but not transported to hospital: A vulnerable population at high risk of future falls

Abstract Objective : This prospective cohort study describes older non‐transported fallers seen by the Ambulance Service of New South Wales (ASNSW), quantifies the level of risk and identifies predictors of future falls and ambulance use. Methods : Participants were 262 people aged 70 years or older with a fall‐related ASNSW attendance who were not transported to an emergency department. They completed a questionnaire about health, medical and physical factors previously associated with falling. Falls were monitored for six months after ambulance attendance with monthly fall calendars. Results : Participants had a high prevalence of chronic medical conditions, functional limitations and past falls. During follow‐up, 145 participants (58%) experienced 488 falls. Significant predictors of falls during follow‐up were three or more falls in the past year, being unable to walk more than 10 minutes without resting, and requiring assistance for personal‐care activities of daily living (ADLs). Sixty‐two participants (25%) required repeat, fall‐related ambulance attendance during the study. Predictors of repeat ambulance use were: 3+ falls in past year, requiring assistance for personal‐care ADLs and having disabling pain in past month. Conclusions : Older, non‐transported fallers seen by the ASNSW are a vulnerable population with high rates of chronic health conditions. Implications : Onward referral for preventive interventions may reduce future falls and ambulance service calls

Reaction Time and Postural Sway Modify the Effect of Executive Function on Risk of Falls in Older People with Mild to Moderate Cognitive Impairment

Objectives To explore the relationship between cognitive performance and falls in older people with mild to moderate cognitive impairment (CI) by investigating the mediational effects of medical, medication, neuropsychological, and physiological factors. Design Secondary analysis, prospective cohort study. Setting Community and low-level care. Participants 177 older people (aged 82 ± 7 years) with mild to moderate CI (MMSE 11–23; ACE-R < 83). Measurements Global cognition and six neuropsychological domains (memory, language, visuospatial, processing speed, executive function [EF], and affect) were assessed. Participants also underwent sensorimotor and balance assessments. Falls were recorded prospectively for 12 months. Results The EF domain was most strongly associated with multiple falls (relative risk [RR]: 1.50, 95% CI: 1.18–1.91). Global cognition was not associated with falls (RR: 1.09, 95% CI: 0.92–1.30). Additional analyses showed that participants with poorer EF (median cutpoint) were more likely to be taking centrally acting medications and were less physically active. They also had significantly worse vision, reaction time, knee extension strength, balance (postural sway, controlled leaning balance), and higher physiological fall risk scores. Participants with poorer EF were 1.5 times (RR: 1.50, 95% CI: 1.03–2.18) more likely to have multiple falls. Mediational analyses demonstrated that reaction time and postural sway reduced the relative risk of EF on multiple falls by 31% (RR: 1.19, 95% CI: 0.81–1.74). Conclusions Within this sample of older people with mild to moderate CI, poorer EF increased the risk of multiple falls. This relationship was mediated by reaction time and postural sway,suggesting cognitively impaired older people with poorer EF may benefit from fall prevention programs targeting these mediating factors

Inaccurate judgement of reach is associated with slow reaction time, poor balance, impaired executive function and predicts prospective falls in older people with cognitive impairment

Background: Awareness of physical ability may impact fall risk during everyday tasks. Therefore, we investigated perceived reach (PR; estimation of furthest reach distance), maximal reach (MR) and reach judgement error (RJE), and their relationships with neuropsychological and physical performance, and falls in older people with cognitive impairment (CI). Methods: Prospective cohort study of 110 (mean age = 82 ± 7 years; female = 52%) older people with mild-moderate CI (MMSE 11–23; Addenbrooke's Cognitive Examination-Revised (ACE-R) < 83). PR, MR and detailed neuropsychological and physical assessments were assessed at baseline. Participants were divided into tertiles based on their absolute RJE. Falls were recorded prospectively over 12 months with the assistance of carers. Results: The populations mean MR was 79 ± 10 cm and PR was 75 ± 13 cm, indicating participants tended to underestimate their reach ability. The large RJE tertile performed significantly poorer in measures of global cognition (ACE-R; OR 0.54 95%CI 0.31–0.95) and executive function (Trail Making Test B; OR 1.84 95%CI 1.00–3.36) and had increased concern about falling (Falls Efficacy Scale-International; OR 2.01 95% CI 1.06–3.79) compared to the minimal RJE tertile. The moderate and large RJE tertile groups had significantly slower hand reaction time and larger postural sway on foam compared to the minimal RJE tertile. Each 1% increase in RJE increased the risk of falls by 2% (RR 1.02 95%CI 1.01–1.03). This relationship withstood adjustment for other fall risk factors (sway on foam, Trail Making Test B and ACE-R). Conclusions: Inaccurate reach judgement predicts future falls and is associated with poorer global cognitive performance and executive function, increased concern about falling, slower reaction time and poorer balance. Our results offer insight into the disparity between actual and perceived physical capabilities in people with CI, and how this impacts their risk of falling

Intervention to prevent further falls in older people who call an ambulance as a result of a fall: A protocol for the iPREFER randomised controlled trial

Background: An increasing number of falls result in an emergency call and the subsequent dispatch of paramedics. In the absence of physical injury, abnormal physiological parameters or change in usual functional status, it could be argued that routine conveyance by ambulance to the Emergency Department (ED) is not the most effective or efficient use of resources. Further, it is likely that non-conveyed older fallers have the potential to benefit from timely access to fall risk assessment and intervention. The aim of this randomised controlled trial is to evaluate the effect of a timely and tailored falls assessment and management intervention on the number of subsequent falls and fall-related injuries for non-conveyed older fallers. Methods. Community dwelling people aged 65 years or older who are not conveyed to the ED following a fall will be eligible to be visited at home by a research physiotherapist. Consenting participants will receive individualised intervention strategies based on risk factors identified at baseline. All pre-test measures will be assessed prior to randomisation. Post-test measures will be undertaken by a researcher blinded to group allocation 6 months post-baseline. Participants in the intervention group will receive individualised pro-active fall prevention strategies from the clinical researcher to ensure that risk factors are addressed adequately and interventions carried out. The primary outcome measure will be the number of falls recorded by a falls diary over a 12 month period. Secondary outcome measures assessed six months after baseline will include the subsequent use of medical and emergency services and uptake of recommendations. Data will be analysed using the intention-to-treat principle. Discussion. As there is currently little evidence regarding the effectiveness or feasibility of alternate models of care following ambulance non-conveyance of older fallers, there is a need to explore assessment and intervention programs to help reduce subsequent falls, related injuries and subsequent use of health care services. By linking existing services rather than setting up new services, this pragmatic trial aims to utilise the health care system in an efficient and timely manner. Trial registration. Australian New Zealand Clinical Trials Registry: ACTRN 12611000503921. © 2013 Mikolaizak et al.; licensee BioMed Central Ltd

Slow gait speed is associated with executive function decline in older people with mild to moderate dementia: A one year longitudinal study

Objectives This study aimed to document change in neuropsychological, physical and functional performance over one year and to investigate the relationship between baseline gait speed and cognitive decline in this period in older people with dementia. Methods One hundred and seventy-seven older people with dementia (Mini-Mental State Examination 11–23; Addenbrooke's Cognitive Examination-Revised <83) residing in the community or low level care facility completed baseline neuropsychological, physical and functional assessments. Of these, 134 participants agreed to reassessment of the above measures one year later. Results Overall, many neuropsychological, physical and functional performance measures declined significantly over the one year study period. Baseline gait speed was significantly associated with decline in verbal fluency (B(109) = 2.893, p = 0.046), specifically phonemic/letter fluency (B(109) = 2.812, p = 0.004) while controlling for age, education, dementia drug use and baseline cognitive performance. There was also a trend for an association between baseline gait speed and decline in clock drawing performance (B(107) = 0.601, p = 0.071). Conclusions Older people with mild to moderate dementia demonstrate significant decline in neuropsychological, physical and functional performance over one year. Baseline gait speed is associated with decline in executive function over one year, suggesting shared pathways/pathology between gait and cognition