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IntroductionParkinson’s disease (PD) is an incurable, progressive, neurodegenerative disorder. As PD advances and symptoms progress, patients become increasingly dependent on family and carers. Traditional cost-effectiveness analyses (CEA) only consider patient and payer-related outcomes, failing to acknowledge impacts on families, carers, and broader society. This novel Social Return on Investment (SROI) analysis aimed to evaluate the broader impact created by improving access to levodopa (LD) device-aided therapies (DATs) for people living with advanced PD (aPD) in Australia.MethodsA forecast SROI analysis over a three-year time horizon was conducted. People living with aPD and their families were recruited for qualitative interviews or a quantitative survey. Secondary research and clinical trial data was used to supplement the primary research. Outcomes were valued and assessed in a SROI value map in Microsoft Excel™. Financial proxies were assigned to each final outcome based on willingness-to-pay, economic valuation, and replacement value. Treatment cost inputs were sourced from Pharmaceutical Benefits Schedule (PBS) and Medicare Benefits Scheme (MBS) published prices.ResultsTwenty-four interviews were conducted, and 55 survey responses were received. For every $1 invested in access to LD-based DATs in Australia, an estimated $1.79 of social value is created. Over 3 years, it was estimated $277.16 million will be invested and $406.77 million of social return will be created. This value is shared between people living with aPD (27%), their partners (22%), children (36%), and the Australian Government (15%). Most of the value created is social and emotional in nature, including reduced worry, increased connection to family and friends, and increased hope for the future.DiscussionInvestment in LD-based DATs is expected to generate a positive social return. Over 50% of the value is created for the partners and children of people living with aPD. This value would not be captured in traditional CEA. The SROI methodology highlights the importance of investing in aPD treatment, capturing the social value created by improved access to LD-based DATs.

Abstract Physical mobility is essential to health, and patients often rate it as a high-priority clinical outcome. Digital mobility outcomes (DMOs), such as real-world gait speed or step count, show promise as clinical measures in many medical conditions. However, current research is nascent and fragmented by discipline. This scoping review maps existing evidence on the clinical utility of DMOs, identifying commonalities across traditional disciplinary divides. In November 2019, 11 databases were searched for records investigating the validity and responsiveness of 34 DMOs in four diverse medical conditions (Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease, hip fracture). Searches yielded 19,672 unique records. After screening, 855 records representing 775 studies were included and charted in systematic maps. Studies frequently investigated gait speed (70.4% of studies), step length (30.7%), cadence (21.4%), and daily step count (20.7%). They studied differences between healthy and pathological gait (36.4%), associations between DMOs and clinical measures (48.8%) or outcomes (4.3%), and responsiveness to interventions (26.8%). Gait speed, step length, cadence, step time and step count exhibited consistent evidence of validity and responsiveness in multiple conditions, although the evidence was inconsistent or lacking for other DMOs. If DMOs are to be adopted as mainstream tools, further work is needed to establish their predictive validity, responsiveness, and ecological validity. Cross-disciplinary efforts to align methodology and validate DMOs may facilitate their adoption into clinical practice.

Context Long-term adherence to physical activity (PA) interventions is challenging. The Lifestyle-integrated Functional Exercise programmes were adapted Lifestyle-integrated Functional Exercise (aLiFE) to include more challenging activities and a behavioural change framework, and then enhanced Lifestyle-integrated Functional Exercise (eLiFE) to be delivered using smartphones and smartwatches.Objectives To (1) compare adherence measures, (2) identify determinants of adherence and (3) assess the impact on outcome measures of a lifestyle-integrated programme.Design, setting and participants A multicentre, feasibility randomised controlled trial including participants aged 61–70 years conducted in three European cities.Interventions Six-month trainer-supported aLiFE or eLiFE compared with a control group, which received written PA advice.Outcome measures Self-reporting adherence per month using a single question and after 6-month intervention using the Exercise Adherence Rating Scale (EARS, score range 6–24). Treatment outcomes included function and disability scores (measured using the Late-Life Function and Disability Index) and sensor-derived physical behaviour complexity measure. Determinants of adherence (EARS score) were identified using linear multivariate analysis. Linear regression estimated the association of adherence on treatment outcome.Results We included 120 participants randomised to the intervention groups (aLiFE/eLiFE) (66.3±2.3 years, 53% women). The 106 participants reassessed after 6 months had a mean EARS score of 16.0±5.1. Better adherence was associated with lower number of medications taken, lower depression and lower risk of functional decline. We estimated adherence to significantly increase basic lower extremity function by 1.3 points (p

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. Trial registration ISRCTN12051706.

The European Commission Horizon 2020 project—PreventIT—evaluated two approaches to delivering Lifestyle-Integrated Functional Exercise (LiFE) programs for maintaining older adults' physical function: the paper-based adapted LiFE and mobile health device delivered enhanced LiFE. A self-reported method was used to measure users' monthly adherence over 12 months. This analysis aimed to explore young seniors' adherence patterns between enhanced LiFE and adapted LiFE groups. Results showed that adherence level decreased with time in both groups. The enhanced LiFE group had slightly higher adherence than the adapted LiFE group during most of the 12 months. However, the overall adherence levels were not significantly different during either intervention or follow-up periods. Monthly self-reported adherence measurement can help to understand users' adherence comprehensively. The comparable adherence levels between both groups indicate mobile health could be an alternative to delivering home-based physical activity for young seniors. However, this feasibility study was not powered to detect differences between groups. [ABSTRACT FROM AUTHOR]

Background: Behavioral change is the key to alter individuals' lifestyle from sedentary to active. The aim was to assess the feasibility of delivering a Lifestyle-integrated Functional Exercise programme and evaluate the delivery of the intervention by use of digital technology (eLiFE) to prevent functional decline in 61–70 year-old adults.Methods: This multicentre, feasibility randomized controlled trial was run in three countries (Norway, Germany, and the Netherlands). Out of 7,500 potential participants, 926 seniors (12%) were screened and 180 participants randomized to eLiFE (n = 61), aLiFE (n = 59), and control group (n = 60). eLiFE participants used an application on smartphones and smartwatches while aLiFE participants used traditional paper-based versions of the same lifestyle-integrated exercise intervention. Participants were followed for 12 months, with assessments at baseline, after a 6 month active trainer-supported intervention, and after a further 6 months of unsupervised continuation of the programme.Results: At 6 months, 87% of participants completed post-test, and 77% completed the final assessment at 12 months. Participants were willing to be part of the programme, with compliance and reported adherence relatively high. Despite small errors during start-up in the technological component, intervention delivery by use of technology appeared acceptable. No serious adverse events were related to the interventions. All groups improved regarding clinical outcomes over time, and complexity metrics show potential as outcome measure in young seniors.Conclusion: This feasibility RCT provides evidence that an ICT-based lifestyle-integrated exercise intervention, focusing on behavioral change, is feasible and safe for young seniors.Clinical Trial Registration:ClinicalTrials.gov, identifier: NCT03065088. Registered on 14 February 2017.

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).

Summary: Reproductive aging in female mammals is an irreversible process associated with declining oocyte quality, which is the rate-limiting factor to fertility. Here, we show that this loss of oocyte quality with age accompanies declining levels of the prominent metabolic cofactor nicotinamide adenine dinucleotide (NAD+). Treatment with the NAD+ metabolic precursor nicotinamide mononucleotide (NMN) rejuvenates oocyte quality in aged animals, leading to restoration in fertility, and this can be recapitulated by transgenic overexpression of the NAD+-dependent deacylase SIRT2, though deletion of this enzyme does not impair oocyte quality. These benefits of NMN extend to the developing embryo, where supplementation reverses the adverse effect of maternal age on developmental milestones. These findings suggest that late-life restoration of NAD+ levels represents an opportunity to rescue female reproductive function in mammals. : Declining oocyte quality is considered an irreversible feature of aging and is rate limiting for human fertility. Bertoldo et al. show that reversing an age-dependent decline in NAD(P)H restores oocyte quality, embryo development, and functional fertility in aged mice. These findings may be relevant to reproductive medicine. Keywords: oocyte, nicotinamide adenine dinucleotide (NAD+), nicotinamide mononucleotide (NMN), SIRT2, female fertility, infertility, reproductive aging, aging, embryo development, in vitro fertilization

Abstract Background With the growing number of young-older adults (baby-boomers), there is an increasing demand for assessment tools specific for this population, which are able to detect subtle balance and mobility deficits. Various balance and mobility tests already exist, but suffer from ceiling effects in higher functioning older adults. A reliable and valid challenging balance and mobility test is critical to determine a young-older adult’s balance and mobility performance and to timely initiate preventive interventions. The aim was to evaluate the concurrent validity, inter- and intrarater reliability, internal consistency, and ceiling effects of a challenging balance and mobility scale, the Community Balance and Mobility Scale (CBM), in young-older adults aged 60 to 70 years. Methods Fifty-one participants aged 66.4 ± 2.7 years (range, 60–70 years) were assessed with the CBM. The Fullerton Advanced Balance scale (FAB), 3-Meter Tandem Walk (3MTW), 8-level balance scale, Timed-Up-and-Go (TUG), and 7-m habitual gait speed were used to estimate concurrent validity, examined by Spearman correlation coefficient (ρ). Inter- and intrarater reliability were calculated as Intra-class-correlations (ICC), and internal consistency by Cronbach alpha and item-total correlations (ρ). Ceiling effects were determined by obtaining the percentage of participants reaching the highest possible score. Results The CBM significantly correlated with the FAB (ρ = 0.75; p

Abstract Background Physical activity is considered an effective measure to promote health in older people. There is evidence that the number of outdoor trips increases physical activity by increasing walking duration. The objective of this study was to analyse the relationship between daily time out-of-home and walking duration. Furthermore, predictors for walking duration and time out-of-home were evaluated. Methods Walking duration was measured prospectively over a 1 week period by a body-fixed sensor and the time out-of-home was assessed by a questionnaire at the same days. Seven thousand, two hundred and forty-three days from 1289 older people (mean age 75.4 years) with both sensor-based measures and completed questionnaires were included in the analyses. To account for several observation days per participant multilevel regression analyses were applied. Analyses were stratified according to the time out-of-home (more or less than 100 min/day). Results In the group with less than 100 min out-of-home, each additional minute out-of-home added 20 s to overall walking duration. If the time exceeded 100 min the additional increase of walking duration was only moderate or weak. Leaving the home once added 40 min of walking, the following trips 15 to 20 min. Increasing age, lower gait speed, comorbidities, low temperature, rain and specific week days (Sunday) decreased both the time out-of-home and walking duration. Other variables like gender (female), isolation or living with a spouse reduced the time out-of-home without affecting walking duration. Conclusions Being out-of-home increases daily walking duration. The association is strongest if the time out-of-home is 100 min or less.

Extensive test batteries are often needed to obtain a comprehensive picture of a person’s functional status. Many test batteries are not suitable for active and healthy adults due to ceiling effects, or require a lot of space, time, and training. The Community Balance and Mobility Scale (CBMS) is considered a gold standard for this population, but the test is complex, as well as time- and resource intensive. There is a strong need for a faster, yet sensitive and robust test of physical function in seniors. We sought to investigate whether an instrumented Timed Up and Go (iTUG) could predict the CBMS score in 60 outpatients and healthy community-dwelling seniors, where features of the iTUG were predictive, and how the prediction of CBMS with the iTUG compared to standard clinical tests. A partial least squares regression analysis was used to identify latent components explaining variation in CBMS total score. The model with iTUG features was able to predict the CBMS total score with an accuracy of 85.2% (84.9–85.5%), while standard clinical tests predicted 82.5% (82.2–82.8%) of the score. These findings suggest that a fast and easily administered iTUG could be used to predict CBMS score, providing a valuable tool for research and clinical care.

Assessment of physical performance by standard clinical tests such as the 30-sec Chair Stand (30CST) and the Timed Up and Go (TUG) may allow early detection of functional decline, even in high-functioning populations, and facilitate preventive interventions. Inertial sensors are emerging to obtain instrumented measures that can provide subtle details regarding the quality of the movement while performing such tests. We compared standard clinical with instrumented measures of physical performance in their ability to distinguish between high and very high functional status, stratified by the Late-Life Function and Disability Instrument (LLFDI). We assessed 160 participants from the PreventIT study (66.3 ± 2.4 years, 87 females, median LLFDI 72.31, range: 44.33–100) performing the 30CST and TUG while a smartphone was attached to their lower back. The number of 30CST repetitions and the stopwatch-based TUG duration were recorded. Instrumented features were computed from the smartphone embedded inertial sensors. Four logistic regression models were fitted and the Areas Under the Receiver Operating Curve (AUC) were calculated and compared using the DeLong test. Standard clinical and instrumented measures of 30CST both showed equal moderate discriminative ability of 0.68 (95%CI 0.60–0.76), p = 0.97. Similarly, for TUG: AUC was 0.68 (95%CI 0.60–0.77) and 0.65 (95%CI 0.56–0.73), respectively, p = 0.26. In conclusion, both clinical and instrumented measures, recorded through a smartphone, can discriminate early functional decline in healthy adults aged 61–70 years.

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.

Time spent out-of-home can increase physical activity (PA) levels. However, the association between the purpose for leaving home and the mode of transport on time out-of-home and PA are not straightforward. In a large sample of community-dwelling older adults (≥65 years), daily walking duration was measured prospectively over 1 week using body-fixed sensors and time-out-of-home questionnaires. Data from1,277 participants yielded 6,500 full days for analysis. The following statistically significant associations were seen: public transport use increased the time spent out-of-home by 88 min and daily walking duration by 16 min. Social contacts or the use of a car increased the time out-of-home, but decreased PA. Shopping or "going by foot" decreased the time spent out-of-home by 19 and 62 min, respectively, while both increased the daily walking duration by 5 min. The association between time out-of-home and PA (daily walking duration) is strongly dependent on the activity and mode of transport. [ABSTRACT FROM AUTHOR]

The emerging mHealth applications, incorporating wearable sensors, enables continuous monitoring of physical activity (PA). This study aimed at analyzing the relevance of a multivariate complexity metric in assessment of functional change in younger older adults. Thirty individuals (60–70 years old) participated in a 4-week home-based exercise intervention. The Community Balance and Mobility Scale (CBMS) was used for clinical assessment of the participants’ functional balance and mobility performance pre- and post- intervention. Accelerometers worn on the low back were used to register PA of one week before and in the third week of the intervention. Changes in conventional univariate PA metrics (percentage of walking and sedentary time, step counts, mean cadence) and complexity were compared to the change as measured by the CBMS. Statistical analyses (21 participants) showed significant rank correlation between the change as measured by complexity and CBMS (ρ = 0.47, p = 0.03). Smoothing the activity output improved the correlation (ρ = 0.58, p = 0.01). In contrast, change in univariate PA metrics did not show correlations. These findings demonstrate the high potential of the complexity metric being useful and more sensitive than conventional PA metrics for assessing functional changes in younger older adults.