• Yoga Outcomes Get Assessed in Cystic Fibrosis (YOGA-CF): protocol of a multicentre interventional randomised controlled clinical trial-investigating effects of a 12-week yoga intervention for adults with cystic fibrosis.
    3 weeks ago
    Yoga is an emerging exercise choice for people with cystic fibrosis (CF), but evidence of its effect in this population is scarce, with a recent systematic review advocating for further research. Yoga Outcomes Get Assessed in CF (YOGA-CF) is a real-world multicentre randomised controlled trial (RCT) investigating a bespoke CF-specific online 12-week yoga intervention, vers usual care, to determine effectiveness for adults with CF.

    A multicentre RCT of adults with CF across the UK. Participants are randomised to usual care or a 12-week online bespoke yoga programme with an expectation of two classes completed weekly. Assessments of lung function, 1 min sit-to-stand, the Cystic Fibrosis Questionnaire-Revised (CFQ-R) and other trial questionnaires are completed preintervention and postintervention (0 and 12 weeks) and after 12 weeks of follow-up (week 24). The primary outcome is the difference in respiratory-related quality of life measured using the CFQ-R before and after yoga/control. Sample size was calculated based on detecting a minimally clinically important difference of 4 for the CFQ-R respiratory domain, with power of 80% and 5% significance level (total target, n=314).

    Ethics approval gained from the South Yorkshire and Humber Research Ethics Committee (REC) (reference: 23/YH/0270, project ID 303898). Dissemination to involve direct participant feedback and lay webinar, scientific conference presentation and publication in a peer-reviewed journal.

    NCT06120465.
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  • Role of the general medical registrar in performing out-of-hours pleural procedures: a UK national survey of trainee and trainer perspectives.
    3 weeks ago
    UK General Internal Medicine (GIM) registrars are traditionally expected to be able to perform pleural procedures out-of-hours (OOH) if required. Pleural exposure for GIM registrars has declined, with procedures increasingly performed by specialists in-hours. Pleural procedures can cause significant harm. We explored the role of the GIM registrar in performing OOH pleural procedures, with particular focus on competence and confidence.

    An anonymous survey was distributed to GIM registrars and respiratory consultants across the UK.

    Responses were received from 391 non-respiratory GIM registrars and 93 respiratory consultants. 37% of registrars reported being 'signed-off' as independent in chest drain insertion for pneumothorax. 69% had not done a pleural procedure for at least a year. Regarding perceived confidence for OOH chest drain insertion for pneumothorax, 42% reported no confidence to perform the procedure even if directly supervised, with only 11% feeling confident to proceed unsupervised. Consultants rated the pleural competence of an average non-respiratory GIM registrar; only 4% felt they could perform the procedure unsupervised. Common themes in the free text included anxiety surrounding pleural procedures, patient safety concerns, insufficient available training opportunities to maintain competency and differing opinions on the evolving role of the medical registrar and who should be expected to perform OOH pleural procedures.

    The majority of UK GIM registrars are neither confident nor perceived by trainers as competent to independently perform OOH chest drain insertion. This has implications for patient safety and service delivery, informing broader discussions regarding GIM training, curriculum and the need to establish local OOH pleural pathways.
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  • Association between metabolic score for visceral fat and adverse outcomes in chronic obstructive pulmonary disease.
    3 weeks ago
    The metabolic score of visceral fat (METS-VF) is linked to chronic obstructive pulmonary disease (COPD) incidence, while its association with mortality and adverse outcomes in patients with COPD remains unclear.

    We analysed 7246 participants with COPD from the UK Biobank and 869 from US National Health and Nutrition Examination Survey (US NHANES) (1999-2018). METS-VF was categorised into quartiles. In UK Biobank, outcomes included all-cause, cardiovascular disease (CVD), COPD-specific mortality, pulmonary heart disease (PHD), pulmonary embolism (PE) and heart failure (HF); in NHANES, only all-cause and CVD mortality were evaluated. UK Biobank analyses used Cox models, restricted cubic splines, Kaplan-Meier curves, time-dependent receiver operating characteristic (ROC) curves and mediation analysis (C reactive protein (CRP), white blood cell count (WBC), platelet count (PLT)). NHANES served as an external validation cohort using survey-weighted Cox models, subgroup and sensitivity analyses and time-dependent ROC for the two mortality outcomes.

    In UK Biobank, restricted cubic splines identified non-linear associations of METS-VF with all-cause and CVD mortality, with a common inflection point at 7.03, and linear associations with secondary outcomes. Compared with the lowest quartile, the highest METS-VF quartile showed significantly higher risks of all-cause mortality (HR 1.467), CVD mortality (HR 3.000), COPD-specific mortality (HR 1.952), PHD (HR 3.505), PE (HR 2.301) and HF (HR 2.567). Similar positive associations were observed in NHANES, where the highest METS-VF quartile remained significantly associated with all-cause mortality (HR 3.337) and CVD mortality (HR 3.011). Time-dependent ROC analyses demonstrated modest but stable discrimination across follow-up in both cohorts. Mediation analyses showed that CRP and WBC partially mediated the associations of METS-VF with mortality and cardiopulmonary outcomes, whereas PLT did not exhibit significant mediation effects.

    Elevated METS-VF is consistently associated with increased long-term risks of mortality and cardiopulmonary complications in COPD across independent discovery and validation cohorts. METS-VF may serve as a practical prognostic biomarker for risk stratification in the clinical management of COPD.
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  • Singing for lung health following completion of pulmonary rehabilitation: feasibility of a randomised controlled trial.
    3 weeks ago
    Pulmonary rehabilitation (PR) is a highly effective intervention for people with chronic respiratory disease; however, it is not known how best to sustain its benefits. Clinical trials are needed to establish if participation in singing for lung health (SLH) groups following PR will improve health-related quality of life, healthcare utilisation and exercise capacity compared with usual care. A feasibility study would help to guide development of these trials.

    In a multicentre, mixed-methods randomised controlled feasibility trial, PR participants at four sites were prescreened at baseline assessment. An SLH taster session was included routinely as part of the PR programmes. Eligible PR completers were invited to take part in the trial and randomised to usual care or a 12-week SLH course. Feasibility outcomes included recruitment rate, intervention compliance (at least 8/12 sessions) and health economic analysis. Interviews with participants and study personnel were undertaken and thematic analysis of the results was completed.

    Between October 2022 and November 2023, 1311 patients were assessed to start PR, 838 completed. Of those completing, 243 were ineligible to take part (predominantly due to vaccination status and excluded diagnoses for PR referral), and 531 declined. 64 people (33 female, mean (SD) age 69 (12), 41 ethnically white, 33 with chronic obstructive pulmonary disease, 16 with asthma, 9 with interstitial lung disease, 6 with bronchiectasis) were recruited, with 30 (93.8%) SLH and 29 (90.6%) controls completing the study. 20 (62.5%) of the SLH group completed at least 8/12 SLH sessions. There was enthusiasm for a definitive trial from participants, clinicians and singing group leaders' perspectives, based on positive experiences of trial involvement. Improvements to recruitment strategy, intervention structure, outcome measures and staffing were suggested.

    A definitive randomised controlled trial of SLH post-PR appears feasible, with acceptable uptake and completion rates.

    ISRCTN11056049.
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  • Validation of plasma soluble receptor of advanced glycation end-products and angiopoietin-2 in paediatric acute respiratory distress syndrome.
    3 weeks ago
    Paediatric acute respiratory distress syndrome (PARDS) is a heterogeneous condition and identifying a specific biomarker remains a challenge. We aimed to validate the association of plasma soluble receptor for advanced glycation end-products (sRAGE) and angiopoietin-2 (Ang-2) with PARDS diagnosis, and its prognostic performance.

    This prospective observational study included children with PARDS and non-PARDS critical illness. Plasma sRAGE and Ang-2 levels were measured using enzyme-linked immunosorbent assays. Comparisons were made between PARDS versus non-PARDS critical illness and survivors versus non-survivors. Multivariable logistic regression was used to determine the association between biomarkers and intensive care unit (ICU) mortality after adjusting for age and the Pediatric Index of Mortality 3 score.

    93 and 117 patients with PARDS and non-PARDS critical illness, respectively, were included in this study. Plasma sRAGE was higher in PARDS versus non-PARDS critical illness (2981 (1027 to 6198) vs 1575 (864 to 2994) pg/mL; p=0.002) and in non-survivors vs survivors (5323 (1647 to 8261) vs 1601 (864 to 3572); p<0.001). Plasma Ang-2 was elevated in non-survivors versus survivors (3054 (1760 to 6808) vs 1748 (845 to 3868); p=0.002), though there was no difference between PARDS and non-PARDS groups. In the multivariable model, sRAGE demonstrated an independent association with PARDS diagnosis (adjusted OR (aOR) 1.01 95% CI 1.01 to 1.02; p=0.003) and ICU mortality (aOR 1.02 (95% CI 1.01 to 1.03); p<0.001), whereas there was no association observed with Ang-2.

    Within an ICU cohort, only sRAGE demonstrated an association with the diagnosis of PARDS and ICU mortality, which remained after controlling for confounders.
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  • Previous tuberculosis modifies spirometry outcomes among small-scale gemstone miners in Tanzania: a cross-sectional, clinic-based study.
    3 weeks ago
    Small-scale miners are known to experience high silica exposures, associated with high rates of silicosis and Tuberculosis (TB). TB has been shown to worsen underlying impairment of lung function in miners. We describe the spirometry outcomes, according to previous TB status, among a large cohort of small-scale miners attending a screening centre.

    We collected cross-sectional spirometry and clinical data from consecutive miners and ex-miners, with negative Xpert TB results, attending a screening clinic in Northern Tanzania, between February 2018 and December 2020. Spirometry values assessed using the ATS/ERS 2019 quality criteria and compared with GLI 2022 global (GLIgl) reference values. We used multiple linear regression to model excess Forced Expiratory Volume in 1 s (FEV1) and Forced Vital Capacity (FVC) loss using an a priori interaction between duration of work and previous TB.

    Of 542 participants with spirometry results, 80 (15%) reported previous TB. At least moderate (z-score ≤-2.5) FEV1 reductions were present in 51% of participants with previous TB and 18% of those without previous TB. For FVC, respective values were 34% and 10%. A miner with TB and 10 years of work was modelled to have lost 1405 (95% CI 1134 to 1676) mls of FEV1 and 1342 (95% CI 1042 to 1641) mls of FVC compared with GLIgl reference values. For miners without previous TB, the corresponding excess FEV1 and FVC losses were 693 (95% CI 581 to 804) mls and 624 (95% CI 504 to 743) mls, respectively.

    Unmeasured silicosis may partially explain some of the observed effect of previous TB. However, this does not change our observation of a clinically significant burden of abnormal spirometry in a clinic-based population of small-scale miners. Reducing silica exposures and preventing TB are key to improving lung health in miners.
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  • Prognostic Impact of Radiologic and Pathologic Features on the Development of Progressive Pulmonary Fibrosis in Patients With Interstitial Lung Disease Other Than Idiopathic Pulmonary Fibrosis.
    3 weeks ago
    To evaluate the prognostic impact of radiologic and pathologic features in patients with interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF), and to identify the factors associated with the development of progressive pulmonary fibrosis (PPF) and survival.

    This study retrospectively enrolled 75 patients diagnosed with ILD other than IPF who underwent surgical lung biopsy between January 2004 and December 2020. Three chest radiologists independently reviewed the CT features and extent of fibrosis on preoperative and follow-up CT scans. Two pathologists reviewed the histopathological features, including the presence of interstitial pneumonia. The time to PPF and overall survival were estimated using the Kaplan-Meier method. The associations of CT and pathological features with PPF and all-cause mortality were examined using standard Cox regression and time-dependent Cox models, respectively.

    A total of 75 non-IPF ILD patients (mean age ± standard deviations 56.4 ± 13.2 years; range, 40-88 years) were enrolled. The median follow-up duration was 75.3 months (range, 7.8-189.8 months). Traction bronchiectasis on CT (adjusted hazard ratio [HR], 6.40; P = 0.003) and body mass index (adjusted HR per 1-kg/m² increase, 0.82; P = 0.002) were found to be significantly associated with PPF in multivariable analysis. Radiological progression (adjusted HR, 18.44; P < 0.001), symptomatic progression (adjusted HR, 4.19; P = 0.011), and age (adjusted HR for 1-year increase, 1.12; P < 0.001) were significantly associated with death.

    Traction bronchiectasis on CT was a significant predictor of PPF, while radiologic and symptomatic progression and older age were associated with poorer survival in patients with ILD other than IPF. These findings indicate that careful radiological evaluation and symptom monitoring may help to predict disease progression and outcomes in patients with non-IPF ILD.
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  • Cocreating Principles for Digital Health Equity: Cross-Sectional, Qualitative Study for Participatory Human-Centered Design in Catalonia.
    3 weeks ago
    Digital health technologies promise to democratize health care access yet often exacerbate existing inequalities when developed through traditional top-down approaches that prioritize technology implementation and exclude end users from design processes. The COVID-19 pandemic accelerated digital transformation while simultaneously exposing how technology can both bridge and widen gaps in health care access. Understanding how to systematically integrate equity considerations into digital health transformation across entire health systems has become increasingly urgent.

    This study aims to cocreate actionable design principles for equitable digital health transformation through a large-scale participatory human-centered design (PHCD) process involving diverse stakeholders across Catalonia's health care ecosystem (northeast Spain), with the aim of establishing guidelines for information systems that support a person-centered, integrated, and longitudinal care delivery model.

    We conducted a qualitative PHCD research study involving 265 participants representing diverse stakeholder groups: citizens and informal caregivers (n=106), health care professionals (n=83), health care managers and leaders (n=50), and experts representing various domains of digital health innovation (n=26). Through two sequential rounds of participation between June 2024 and April 2025, we used design thinking methodologies and cocreation tools in 24 sessions across Catalan geography and 7 topic-specific expert sessions. Data collection used innovative visual tools, including journey mapping, care model animations, future scenario storyboarding, and facilitated ideation techniques. Analysis followed an inductive-deductive approach combining affinity mapping, thematic synthesis, and participant validation to transform stakeholder proposals into actionable design principles.

    Participants identified critical barriers to digital health equity, including digital literacy gaps, fragmented information systems, a lack of user involvement in design, and insufficient consideration of vulnerable populations' needs. The cocreation process yielded 10 fundamental principles: (1) the person and their care circle at the center, (2) health for everyone, everywhere, (3) tools for more compassionate care, (4) a better professional experience, (5) an active role of the population, (6) personalized and proactive care, (7) systematic use of data for decision-making, (8) integrated quality data working for health, (9) an information system that builds trust, and (10) collaboration as a driver of innovation.

    This study shows how large-scale, rigorously conducted PHCD can uncover and address equity barriers in health information systems. Beyond producing 10 actionable design principles, it highlights how engaging diverse stakeholders can turn complex inequities into practical guidance for equitable digital transformation. The resulting principles provide a framework for creating person-centered systems that are robust, inclusive, and accessible to all, while underscoring the need for enduring partnerships among public institutions, researchers, design experts, and communities as a foundation for sustainable and equitable digital health innovation.
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  • Attitudes Toward Video Consultations From the Perspective of Physicians and Psychotherapists in German Outpatient Care After the COVID-19 Pandemic: Survey Study.
    3 weeks ago
    Although video consultations (VCs) are permitted in German outpatient care and have seen a notable rise during the COVID-19 pandemic, their use still does not seem to have become established in Germany.

    This survey aims to evaluate the attitudes of physicians and psychotherapists with regard to the use of VC after the COVID-19 pandemic, in particular in the context of types of treatment and suitable medical fields.

    A standardized questionnaire was sent out to all 34,095 physicians and psychotherapists in 4 German regions. The analysis consisted of both descriptive and inferential statistics. Subgroup analysis included gender, age groups, community size of practice location, VC experience, type and ownership of practice, and area of medical care. Binary logistic regression was conducted to determine whether physicians' and psychotherapists' individual factors, organizational factors, or area of medical care were associated with at least monthly VC provision or interest in VC provision.

    The response rate was 17.9%, including a total of 5930 participants in the analysis. About 40% (2216/5863) of the physicians and psychotherapists surveyed stated that they offer VC at least once a month. In the area of medical care, the odds ratio (OR) of at least monthly VC provision in psychotherapeutic care was about 8.2 (95% CI 7.4-1.64; P<.001) compared to primary care, whereas in specialist care, the odds for monthly VC provision were approximately 50% lower than in primary care (OR 0.5, 95% CI 0.43-0.59; P<.001). Further, female participants have higher odds to provide VC at least once a month (OR 1.163, 95% CI 1.01-1.34; P=.03). The odds for monthly VC provision in older age groups are approximately 60% higher than in the <40 years old age group (OR 0.41, 95% CI 0.32-0.52; P<.001). Around 80% (4347/5442) of the participants expressed interest in VC use. The most common occasions for which treatment by VC was reported to be suitable were discussing test results (1422/1896, 75.0%), taking the patient's medical history (1195/2147, 55.7%), issuing prescriptions for drugs and remedies (793/1204, 65.9%), and the issuing of incapacity certificates for work (677/1042, 65.0%).

    There has been an increase in the self-reported uptake of VC among physicians and psychotherapists compared to prepandemic levels, although this remains at a relatively low level in primary and specialist care. A significant proportion of doctors and psychotherapists have expressed an interest in using VC after the pandemic period. However, this self-reported use is not yet reflected in actual usage data, suggesting the need for further investigation into the underlying factors influencing the gap and identifying potential enablers. Further, these self-assessments by service providers on suitable types of treatment and suitable medical fields can inform political decision-making.
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  • The association between rural/urban residence status and patient-reported outcomes in individuals with Chronic Obstructive Pulmonary Disease (COPD): Protocol for a systematic review and meta-analysis.
    3 weeks ago
    Rural residency is associated with a disproportionate burden of chronic obstructive pulmonary disease (COPD) and poorer COPD health outcomes. While increasing focus has been placed on the influence of rural/urban residence on clinical outcomes, little is known about the impact of rural versus urban residency status on patient-reported outcome measures (PROMs) in individuals with COPD, despite the use of PROMs to tailor interventions and treatments to individual patient needs.

    The objective of this review is to synthesize evidence of a relation between rural/urban residency status and PROMs in individuals with COPD.

    Beginning May 2025, we will search EBSCO, Elsevier, Cochrane Library, PubMed, and relevant websites to identify research published between January 1, 2012, and November 1, 2024. Two reviewers will independently screen titles, abstracts, and full texts, with a third reviewer to resolve any discrepancies. All data sources and selection management will be fulfilled and housed in the Covidence systematic review software. The primary outcome of this review is the association between rural/urban residency and PROMs in individuals with COPD. If appropriate, a meta-analysis will be conducted. Sub-group analysis will be performed by sex. Sensitivity analysis will be performed by excluding studies with "low quality" based on risk of bias assessment.

    This study is exempt from institutional review as it will be a secondary analysis of published data. Results of this study are expected by September 2025 and will be disseminated in a relevant peer-reviewed journal.

    Prospero registration number: CRD42024627343.
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