The IMPROVE trial: study protocol for a pragmatic cluster randomised controlled trial to assess the effectiveness of using lay health workers to improve uptake and completion of pulmonary rehabilitation in patients with chronic obstructive pulmonary disease.

BACKGROUND: Pulmonary rehabilitation (PR) is a programme of exercise and education and the most effective treatment for the symptoms and disability associated with chronic obstructive pulmonary disease. However, the benefits of PR are limited by poor uptake and completion. This trial will determine whether using trained volunteer lay health workers, called "PR buddies," improves uptake and completion of PR and is cost-effective. This trial protocol outlines the methods for evaluating effectiveness, cost-effectiveness, and acceptability. METHODS: The IMPROVE trial is a pragmatic, open, cluster randomised controlled trial planned in 38 PR services across England and Wales. PR services will be randomised to either intervention arm-offering support from PR buddies to patients with chronic obstructive pulmonary disease-or to usual care as the control arm. PR staff in trial sites randomised to the intervention arm will receive training in recruiting and training PR buddies. They will deliver training to volunteers, recruited from among people who have recently completed PR in their service. The 3-day PR-buddy training programme covers communication skills, confidentiality, boundaries of the PR-buddy role and behaviour change techniques to help patients overcome obstacles to attending PR. An internal pilot will test the implementation of the trial in eight sites (four intervention sites and four in control arm). The primary outcome of the trial is the uptake and completion of PR. A process evaluation will investigate the acceptability of the intervention to patients, PR staff and the volunteer PR buddies, and intervention fidelity. We will also conduct a cost-effectiveness analysis. DISCUSSION: Improving outcomes for chronic obstructive pulmonary disease and access to PR are priorities for the UK National Health Service (NHS) in its long-term plan. The trial hypothesis is that volunteer PR buddies, who are recruited and trained by local PR teams, are an effective and cost-effective way to improve the uptake and completion rates of PR. The trial is pragmatic, since it will test whether the intervention can be incorporated into NHS PR services. Information obtained in this trial may be used to influence policy on the use of PR buddies in PR and other similar services in the NHS. TRIAL REGISTRATION: ISRCTN12658458. Registered on 23/01/2023.

Patterns of cigarette and e-cigarette use among UK adolescents: a latent class analysis of the Millennium Cohort Study.

BACKGROUND: Patterning of cigarette and e-cigarette use among young people remains poorly characterized. We aimed to describe these patterns in the UK Millennium Cohort Study at age 14 and 17 years. METHODS: Data on cigarette and e-cigarette use come from 9731 adolescents. Latent class analysis assigned participants to membership of classes of product use and multinomial logistic regression analyses assessed differences in the likelihood of belonging to classes by sociodemographic (age, gender, ethnicity, household income, maternal education and country of residence) and smoking-related social factors (caregiver tobacco use, caregiver e-cigarette use and peer smoking). RESULTS: We identified four classes of use: 45.8% of adolescents 'continued to abstain' from cigarettes or e-cigarettes; 21.3% 'experimented' (used once or in the past but not currently) with cigarettes and/or e-cigarettes by age 17 but were not current users; 19.0% were 'late adopters', characterized by low levels of use at age 14 but high levels of experimentation and current use at age 17; and 13.9% were 'early adopters', characterized by high levels of experimentation and current use at ages 14 and 17. At age 17, 70.4% of 'early adopters' smoked cigarettes regularly plus an additional 27.3% experimented with cigarettes. Corresponding percentages for e-cigarettes were 37.9% and 58.9%. Tobacco and e-cigarette use by caregivers, and cigarette use by peers, were associated with being both 'late adopters' and 'early adopters'. CONCLUSIONS: Approximately one in seven adolescents in the UK are 'early adopters' of nicotine products. This highlights the need to develop and implement effective policies to prevent nicotine use uptake.

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.

Music and dance in respiratory disease management in Uganda: a qualitative study of patient and healthcare professional perspectives.

INTRODUCTION: Music and dance are increasingly used as adjunctive arts-in-health interventions in high-income settings, with a growing body of research suggesting biopsychosocial benefits. Such low-cost, low-resource interventions may have application in low-resource settings such as Uganda. However, research on perceptions of patients and healthcare professionals regarding such approaches is lacking. METHODS: We delivered sample sessions of music and dance for chronic respiratory disease (CRD) to patients and healthcare professionals. Seven participants took part in one singing and dance sample session. One patient completed only the dance session. We then conducted an exploratory qualitative study using thematic analysis of semistructured interviews with healthcare professionals and patients regarding (1) the role of music and dance in Ugandan life and (2) the perceived acceptability and feasibility of using music and dance in CRD management in Uganda. RESULTS: We interviewed 19 participants, made up of 11 patients with long-term respiratory conditions and 8 healthcare professionals, who were selected by purposeful convenience sampling. Four key themes were identified from interview analysis: music and dance (1) were central components of daily life; (2) had an established role supporting health and well-being; and (3) had strong therapeutic potential in respiratory disease management. The fourth theme was (4) the importance of modulating demographic considerations of culture, religion and age. CONCLUSION: Music and dance are central to life in Uganda, with established roles supporting health and well-being. These roles could be built on in the development of music and dance interventions as adjuncts to established components of CRD disease management like pulmonary rehabilitation. Through consideration of key contextual factors and codevelopment and adaptation of interventions, such approaches are likely to be well received.

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).

Eligibility for Lung Volume Reduction Surgery in Patients With COPD Identified in a UK Primary Care Setting.

BACKGROUND: Although lung volume reduction surgery (LVRS) improves survival in appropriately selected patients with COPD, few procedures are performed. The National Institute for Health and Care Excellence has recommended a more systematic approach to identifying potential candidates. We investigated LVRS referrals from a UK primary care population and aimed to establish an accurate estimate of eligible patients and determine a strategy for identifying potential candidates systematically. METHODS: Clinical Practice Research Datalink GOLD (a primary care database) and the linked Hospital Episode Statistics inpatient and Diagnostic Imaging Dataset were used. Patients with COPD who had undergone LVRS, patients who met basic eligibility criteria for further screening for LVRS, and patients meeting a more stringent eligibility criteria were identified from April 2012 to September 2015. Thoracic CT scan, pulmonary rehabilitation status, referral to respiratory outpatient clinics, and acute exacerbation of COPD requiring hospitalization were compared between actual LVRS recipients and potentially eligible patients. RESULTS: Among the 73,697 patients with COPD included, 36 (0.05%) received LVRS, 5,984 (8.1%) met basic eligibility criteria, and 159 (0.2%) met more stringent eligibility criteria. LVRS recipients were younger (mean age ± SD, 64 ± 9.2 years) than the stringently eligible patients (mean age ± SD, 69 ± 8.9 years; P = .01). Few patients meeting stringent eligibility criteria (6.9%) had a CT scan of the thorax in the preceding 3 years or had been referred for assessment in secondary care. CONCLUSIONS: A substantial unmet need exists among patients with COPD who could potentially benefit from a lung volume reduction procedure but who are not being investigated or referred to consider this possibility.

Cigarette Smoking: An Assessment of Tobacco's Global Environmental Footprint Across Its Entire Supply Chain.

While the health effects of cigarette smoking are well recognized and documented, the environmental impacts of tobacco are less appreciated and often overlooked. Here, we evaluate tobacco's global footprint across its entire supply chain, looking at resource needs, waste, and emissions of the full cradle-to-grave life cycle of cigarettes. The cultivation of 32.4 Mt of green tobacco used for the production of 6.48 Mt of dry tobacco in the six trillion cigarettes manufactured worldwide in 2014, were shown to contribute almost 84 Mt CO2 equiv emissions to climate change-approximately 0.2% of the global total, 490 000 tonnes 1,4-dichlorobenzene equiv to ecosystem ecotoxicity levels, and over 22 billion m3 and 21 Mt oil equiv to water and fossil fuel depletion, respectively. A typical cigarette was shown to have a water footprint of 3.7 L, a climate change contribution of 14 g CO2 equiv, and a fossil fuel depletion contribution of 3.5 g oil equiv. Tobacco competes with essential commodities for resources and places significant pressures on the health of our planet and its most vulnerable inhabitants. Increased awareness, as well as better monitoring and assessment of the environmental issues associated with tobacco, should support the current efforts to reduce global tobacco use as an important element of sustainable development.

Singing for Lung Health: a qualitative assessment of a British Lung Foundation programme for group leaders.

INTRODUCTION: Singing for Lung Health (SLH) groups are an increasingly popular intervention for people with respiratory disease. There are limited data as to how these groups should be developed and run. We aimed to evaluate the experience of singing leaders both to assess the training provided by the British Lung Foundation (BLF) and to provide information to guide future development of programmes. METHODS: A convenience sample of 15 leaders who had received BLF SLH training participated in the BLF service evaluation. Fifteen singing groups were observed, and singing leader interviews and questionnaires were collected. Inductive themes from the qualitative data were the primary outcome. The content of observed singing groups was also rated against the training leaders had received. RESULTS: Singing leaders valued the BLF training but felt that a significant level of expertise is required before joining. Singing leaders often found setting up groups challenging and some found clinician support beneficial. There were important technical aspects of running a lung health group including issues around content, for example, choice of repertoire to suit breathing pattern, and delivery, for example, pace, rhythm and management of group dynamics. Leaders said that group participants reported physical health improvements such as reduced breathlessness on activity. The content and delivery of singing classes observed displayed a good level of fidelity, suggesting that SLH training is effective. CONCLUSION: The experience of the leaders highlights the requirements, support and technical skills needed to run SLH groups, which have features distinct from generic community singing groups.

Use and abuse of statistics in tobacco industry-funded research on standardised packaging.

In this commentary we consider the validity of tobacco industry-funded research on the effects of standardised packaging in Australia. As the first country to introduce standardised packs, Australia is closely watched, and Philip Morris International has recently funded two studies into the impact of the measure on smoking prevalence. Both of these papers are flawed in conception as well as design but have nonetheless been widely publicised as cautionary tales against standardised pack legislation. Specifically, we focus on the low statistical significance of the analytical methods used and the assumption that standardised packaging should have an immediate large impact on smoking prevalence.

The COPD Assessment Test (CAT): short- and medium-term response to pulmonary rehabilitation.

BACKGROUND: The COPD Assessment Test (CAT) is a recently introduced instrument to assess health-related quality of life in COPD. We aimed to evaluate the longitudinal change in CAT following Pulmonary Rehabilitation (PR), and test the relationship between CAT and CRQ-Self Report (SR) over time. We hypothesised that the CAT would show similar responsiveness to PR as the CRQ-SR both in the short and medium-term. METHODS: 118 COPD patients completed an eight-week outpatient multidisciplinary PR programme. CAT, CRQ-SR and the incremental shuttle walk (ISW) were measured prior to starting PR (T1), completion of PR (T2) and 6 months after completion of PR (T3). RESULTS: There was a significant improvement in CAT, CRQ-SR and ISW immediately following PR (p < 0.001). Although there was decline between T2 and T3, CAT, CRQ-SR and ISW remained significantly better at T3 compared with T1 (ANOVA p < 0.001). Both between T1-T2 and between T2-T3, change in CAT correlated significantly with change in CRQ (both r = -0.44 and p < 0.001). The slope of the relationship between CAT change and CRQ-SR change at T1-T2 and T2-T3 was not significantly different (ANCOVA: intercept p = 0.79, interaction effect p = 0.95). CONCLUSIONS: In COPD, the CAT score is immediately responsive to PR and remains improved at 6 months. There is no significant difference in the short and medium term changes in the CAT and CRQ-SR following PR. We propose that for most clinical indications for assessing health-related quality of life in COPD, the CAT is a robust and practical alternative to longer-established instruments such as the CRQ-SR.