Free-living monitoring of ambulatory activity after treatments for lower extremity musculoskeletal cancers using an accelerometer-based wearable - a new paradigm to outcome assessment in musculoskeletal oncology?

PURPOSE: Ambulatory activity (walking) is affected after sarcoma surgery yet is not routinely assessed. Small inexpensive accelerometers could bridge the gap. Study objectives investigated, whether in patients with lower extremity musculoskeletal tumours: (A) it was feasible to conduct ambulatory activity assessments in patient's homes using an accelerometer-based wearable (AX3, Axivity). (B) AX3 assessments produced clinically useful data, distinguished tumour sub-groups and related to existing measures. METHODS: In a prospective cross-sectional pilot, 34 patients with musculoskeletal tumours in the femur/thigh (19), pelvis/hip (3), tibia/leg (9), or ankle/foot (3) participated. Twenty-seven had limb-sparing surgery and seven amputation. Patients were assessed using a thigh-worn monitor. Summary measures of volume (total steps/day, total ambulatory bouts/day, mean bout length), pattern (alpha), and variability (S2) of ambulatory activity were derived. RESULTS: AX3 was well-tolerated and feasible to use. Outcomes compared to literature but did not distinguish tumour sub-groups. Alpha negatively correlated with disability (walking outside (r=-418, p = 0.042*), social life (r=-0.512, p = 0.010*)). Disability negatively predicted alpha (unstandardised co-efficient= -0.001, R2=0.186, p = 0.039*). CONCLUSIONS: A wearable can assess novel attributes of walking; volume, pattern, and variability after sarcoma surgery. Such outcomes provide valuable information about people's physical performance in their homes, which can guide rehabilitation. Implications for rehabilitationRoutine capture of ambulatory activity by sarcoma services in peoples' homes can provide important information about individuals "actual" physical activity levels and limitations after sarcoma surgery to inform personalised rehabilitation and care needs, including timely referral for support.Routine remote ambulatory monitoring about out of hospital activity can support personalised care for patients, including identifying high risk patients who need rapid intervention and care closer to home.Use of routine remote ambulatory monitoring could enhance delivery of evidence-based care closer to peoples' homes without disrupting their daily routine and therefore reducing patient and carer burden.Collection of data close to home using questionnaires and objective community assessment could be more cost effective and comprehensive than in-hospital assessment and could reduce the need for hospital attendance, which is of importance to vulnerable patients, particularly during the Covid-19 pandemic.

Auditory rhythmical cueing to improve gait in community-dwelling stroke survivors (ACTIVATE): a pilot randomised controlled trial.

BACKGROUND: Gait impairment limiting mobility and restricting activities is common after stroke. Auditory rhythmical cueing (ARC) uses a metronome beat delivered during exercise to train stepping and early work reports gait improvements. This study aimed to establish the feasibility of a full scale multicentre randomised controlled trial to evaluate an ARC gait and balance training programme for use by stroke survivors in the home and outdoors. METHODS: A parallel-group observer-blind pilot randomised controlled trial was conducted. Adults within 2 years of stroke with a gait-related mobility impairment were recruited from four NHS stroke services and randomised to an ARC gait and balance training programme (intervention) or the training programme without ARC (control). Both programmes consisted of 3x30 min sessions per week for 6 weeks undertaken at home/nearby outdoor community. One session per week was supervised and the remainder self-managed. Gait and balance performance assessments were undertaken at baseline, 6 and 10 weeks. Key trial outcomes included recruitment and retention rates, programme adherence, assessment data completeness and safety. RESULTS: Between November 2018 and February 2020, 59 participants were randomised (intervention n=30, control n=29), mean recruitment rate 4/month. At baseline, 6 weeks and 10 weeks, research assessments were conducted for 59/59 (100%), 47/59 (80%) and 42/59 (71%) participants, respectively. Missing assessments were largely due to discontinuation of data collection from mid-March 2020 because of the UK COVID-19 pandemic lockdown. The proportion of participants with complete data for each individual performance assessment ranged from 100% at baseline to 68% at 10 weeks. In the intervention group, 433/540 (80%) total programme exercise sessions were undertaken, in the control group, 390/522 (75%). Falls were reported by five participants in the intervention group, six in the control group. Three serious adverse events occurred, all unrelated to the study. CONCLUSION: We believe that a definitive multicentre RCT to evaluate the ARC gait and balance training programme is feasible. Recruitment, programme adherence and safety were all acceptable. Although we consider that the retention rate and assessment data completeness were not sufficient for a future trial, this was largely due to the UK COVID-19 pandemic lockdown. TRIAL REGISTRATION: ISRCTN, ISRCTN10874601 , Registered on 05/03/2018.

Body-Worn Sensors for Remote Monitoring of Parkinson's Disease Motor Symptoms: Vision, State of the Art, and Challenges Ahead.

The increasing prevalence of neurodegenerative conditions such as Parkinson's disease (PD) and related mobility issues places a serious burden on healthcare systems. The COVID-19 pandemic has reinforced the urgent need for better tools to manage chronic conditions remotely, as regular access to clinics may be problematic. Digital health technology in the form of remote monitoring with body-worn sensors offers significant opportunities for transforming research and revolutionizing the clinical management of PD. Significant efforts are being invested in the development and validation of digital outcomes to support diagnosis and track motor and mobility impairments "off-line". Imagine being able to remotely assess your patient, understand how well they are functioning, evaluate the impact of any recent medication/intervention, and identify the need for urgent follow-up before overt, irreparable change takes place? This could offer new pragmatic solutions for personalized care and clinical research. So the question remains: how close are we to achieving this? Here, we describe the state-of-the-art based on representative papers published between 2017 and 2020. We focus on remote (i.e., real-world, daily-living) monitoring of PD using body-worn sensors (e.g., accelerometers, inertial measurement units) for assessing motor symptoms and their complications. Despite the tremendous potential, existing challenges exist (e.g., validity, regulatory) that are preventing the widespread clinical adoption of body-worn sensors as a digital outcome. We propose a roadmap with clear recommendations for addressing these challenges and future directions to bring us closer to the implementation and widespread adoption of this important way of improving the clinical care, evaluation, and monitoring of PD.

A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach.

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.

Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project.

OBJECTIVE: To provide guidance to researchers, funders, regulators and study delivery teams to ensure that research on COVID-19 is inclusive, particularly of groups disproportionately affected by COVID-19 and who may have been historically under-served by research. SUMMARY OF KEY POINTS: Groups who are disproportionately affected by COVID-19 include (but are not limited to) older people, people with multiple long-term conditions, people with disabilities, people from Black, Asian and Ethnic minority groups, people living with obesity, people who are socioeconomically deprived and people living in care homes. All these groups are under-served by clinical research, and there is an urgent need to rectify this if COVID-19 research is to deliver relevant evidence for these groups who are most in need. We provide a framework and checklists for addressing key issues when designing and delivering inclusive COVID-19 research, based on the National Institute for Health Research INnovations in CLinical trial design and delivery for the UnDEr-served project roadmap. Strong community engagement, codevelopment and prioritisation of research questions and interventions are essential. Under-served groups should be represented on funding panels and ethics committees, who should insist on the removal of barriers to participation. Exclusion criteria should be kept to a minimum; intervention delivery and outcome measurement should be simple, flexible and tailored to the needs of different groups, and local advice on the best way to reach and engage with under-served communities should be taken by study delivery teams. Data on characteristics that allow identification of under-served groups must be collected, analyses should include these data to enable subgroup comparisons and results should be shared with under-served groups at an early stage. CONCLUSION: Inclusive COVID-19 research is a necessity, not a luxury, if research is to benefit all the communities it seeks to serve. It requires close engagement with under-served groups and attention to aspects of study topic, design, delivery, analysis and dissemination across the research life cycle.

Research with older people in a world with COVID-19: identification of current and future priorities, challenges and opportunities.

Older people are disproportionately affected by the COVID-19 pandemic, which has had a profound impact on research as well as clinical service delivery. This commentary identifies key challenges and opportunities in continuing to conduct research with and for older people, both during and after the current pandemic. It shares opinions from responders to an international survey, a range of academic authors and opinions from specialist societies. Priorities in COVID-19 research include its specific presentation in older people, consequences for physical, cognitive and psychological health, treatments and vaccines, rehabilitation, supporting care homes more effectively, the impact of social distancing, lockdown policies and system reconfiguration to provide best health and social care for older people. COVID-19 research needs to be inclusive, particularly involving older people living with frailty, cognitive impairment or multimorbidity, and those living in care homes. Non-COVID-19 related research for older people remains of critical importance and must not be neglected in the rush to study the pandemic. Profound changes are required in the way that we design and deliver research for older people in a world where movement and face-to-face contact are restricted, but we also highlight new opportunities such as the ability to collaborate more widely and to design and deliver research efficiently at scale and speed.