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. TRIAL REGISTRATION: ISRCTN12051706.

Reporting of data on participant ethnicity and socioeconomic status in high-impact medical journals: a targeted literature review.

OBJECTIVES: To assess the frequency of reporting of ethnicity (or 'race') and socioeconomic status (SES) indicators in high-impact journals. DESIGN: Targeted literature review. DATA SOURCES: The 10 highest ranked general medical journals using Google scholar h5 index. ELIGIBILITY CRITERIA: Inclusion criteria were, human research, reporting participant level data. Exclusion criteria were non-research article, animal/other non-human participant/subject or no participant characteristics reported. DATA EXTRACTION AND SYNTHESIS: Working backwards from 19 April 2021 in each journal, two independent reviewers selected the 10 most recent articles meeting inclusion/exclusion criteria, to create a sample of 100 articles. Data on the frequency of reporting of ethnicity (or 'race') and SES indicators were extracted and presented using descriptive statistics. RESULTS: Of 100 research articles included, 35 reported ethnicity and 13 SES. By contrast, 99 reported age, and 97 reported sex or gender. Among the articles not reporting ethnicity, only 3 (5%) highlighted this as a limitation, and only 6 (7%) where SES data were missing. Median number of articles reporting ethnicity per journal was 2.5/10 (range 0 to 9). Only two journals explicitly requested reporting of ethnicity (or race), and one requested SES. CONCLUSIONS: The majority of research published in high-impact medical journals does not include data on the ethnicity and SES of participants, and this omission is rarely acknowledged as a limitation. This situation persists despite the well-established importance of this issue and International Committee of Medical Journal Editors recommendations to include relevant demographic variables to ensure representative samples. Standardised explicit minimum standards are required.

Immediate smoking cessation support versus usual care in smokers attending a targeted lung health check: the QuLIT trial.

OBJECTIVES: Lung cancer screening programmes offer an opportunity to address tobacco dependence in current smokers. The effectiveness of different approaches to smoking cessation in this context has not yet been established. We investigated if immediate smoking cessation support, including pharmacotherapy, offered as part of a lung cancer screening programme, increases quit rates compared to usual care (Very Brief Advice to quit and signposting to smoking cessation services). MATERIALS AND METHODS: We conducted a single-blind randomised controlled trial of current smokers aged 55-75 years attending a Targeted Lung Health Check. On randomly allocated days smokers received either (1) immediate support from a trained smoking cessation counsellor with appropriate pharmacotherapy or (2) usual care. The primary outcome was self-reported quit rate at 3 months. We performed thematic analysis of participant interview responses. RESULTS: Of 412 people attending between January and March 2020, 115 (27.9%) were current smokers; 46% female, mean (SD) 62.4 (5.3) years. Follow-up data were available for 84 smokers. At 3 months, quit rates in the intervention group were higher 14/48 (29.2%) vs 4/36 (11%) (χ2 3.98, p=0.04). Participant interviews revealed four smoking-cessation related themes: (1) stress and anxiety, (2) impact of the COVID-19 pandemic, (3) CT scans influencing desire to quit and (4) individual beliefs about stopping smoking. CONCLUSION: The provision of immediate smoking cessation support is associated with a substantial increase in quit rates at 3 months. Further research is needed to investigate longer-term outcomes and to refine future service delivery. TRIAL REGISTRATION NUMBER: ISRCTN12455871.

Physiological demands of singing for lung health compared with treadmill walking.

INTRODUCTION: Participating in singing is considered to have a range of social and psychological benefits. However, the physiological demands of singing and its intensity as a physical activity are not well understood. METHODS: We compared cardiorespiratory parameters while completing components of Singing for Lung Health sessions, with treadmill walking at differing speeds (2, 4 and 6 km/hour). RESULTS: Eight healthy adults were included, none of whom reported regular participation in formal singing activities. Singing induced acute physiological responses that were consistent with moderate intensity activity (metabolic equivalents: median 4.12, IQR 2.72-4.78), with oxygen consumption, heart rate and volume per breath above those seen walking at 4 km/hour. Minute ventilation was higher during singing (median 22.42 L/min, IQR 16.83-30.54) than at rest (11 L/min, 9-13), lower than 6 km/hour walking (30.35 L/min, 26.94-41.11), but not statistically different from 2 km/hour (18.77 L/min, 16.89-21.35) or 4 km/hour (23.27 L/min, 20.09-26.37) walking. CONCLUSIONS: Our findings suggest the acute metabolic demands of singing are comparable with walking at a moderately brisk pace, hence, physical effects may contribute to the health and well-being benefits attributed to singing participation. However, if physical training benefits result remains uncertain. Further research including different singing styles, singers and physical performance impacts when used as a training modality is encouraged. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov registry (NCT04121351).