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Loneliness and social isolation at the emergency department: a scoping review protocol

Por: Chan · W. L. · Gao · Z. · Chuxi · A. L. · Rainer · T. · Tang · W. W. C. · Wing · Y. S. S. · Lederman · Z.
Introduction

Loneliness and social isolation are critical public health issues linked to significant adverse health outcomes and increased healthcare utilisation, including visits to the emergency department (ED). The ED often serves as a primary societal safety net, providing care for vulnerable populations who may be disproportionately affected by these conditions. In fact, loneliness and social isolation might be the underlying reasons they presented to the ED in the first place either consciously or not. For such individuals, the ED encounter may represent a rare point of human contact, yet the stressful and depersonalising nature of the ED environment may paradoxically exacerbate their sense of isolation. Furthermore, ED staff may lack the training and awareness of the scope of the problem to properly screen for loneliness and address it. Yet, the compounded impact of the ED experience on lonely or socially isolated patients and the relationship between loneliness and healthcare utilisation remains poorly understood. This paper presents a protocol for a scoping review designed to systematically map the existing evidence on the experiences of these patients and the perspectives of the clinicians who care for them.

Methods and analysis

This scoping review will be conducted following the Arksey and O’Malley methodological framework in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR). The findings will be reported according to the Extension to the PRISMA Statement for Reporting Literature Searches in Systematic Reviews (PRISMA-S; see ). A comprehensive search will be performed across five electronic databases (PubMed, Embase, Scopus, Web of Science, CNKI) and grey literature sources. Studies published in English or Chinese that address loneliness or social isolation in the ED context, from the perspective of adult or paediatric patients or clinical staff, will be included. A novel, artificial intelligence (AI)-assisted screening process will be utilised for initial relevance assessment, followed by full manual screening and data extraction by two independent reviewers to ensure rigour and mitigate bias. Findings will be synthesised using a narrative approach and thematic analysis to identify key concepts, themes and existing gaps in the literature.

Ethics and dissemination

As this study synthesises data from previously published literature, it does not require formal ethical approval. The findings will be disseminated through a manuscript submitted to a peer-reviewed, open-access journal. The aim is to provide an evidence-based roadmap to guide future research, inform policy and support the development of interventions designed to improve care and outcomes for this vulnerable population within the acute care setting.

Registration number

The review has been registered at Open Science Framework, DOI 10.17605/OSF.IO/MBVSR.

A scoping review of computational models of the diabetic foot

by Yufeng Li, Athia Haron, Chaofan Lin, Yuan Tang, Andrew Weightman, Glen Cooper

The prevalence of diabetes is expected to be 650 million people by 2030, and diabetic foot ulceration (DFU) is one of its most severe complications. It poses a significant challenge to global health and brings substantial social and economic burdens. Although many studies have explored the mechanisms of DFU development, they are still not fully understood. Due to the high cost of the experimental research, many recent studies have employed the computational modelling approaches to simulate the effects of diabetes on foot tissues from mechanical, thermal, fluid, and cellular perspectives. This study aims to provide a comprehensive review of computational modelling approaches used to investigate various factors influencing DFU, discuss current knowledge gaps and limitations, and outline future research directions. A systematic search was conducted in Web of Science, Scopus, and PubMed databases, identifying a total of N = 1631 records up to March 2025, 31 of which studies met the inclusion criteria and were analysed in this study. Results showed that DFU-related computational models can be categorized into five types: mechanical stress models, thermal models, vascular and nerve system models, multiphysics models, and cellular-based models. These models explore the formation mechanisms of DFU from different perspectives, including biomechanics, temperature, fluid dynamics, HHμm neural signalling, and cellular responses. However, except for mechanical stress models, the other approaches remain in the early stages of development, and the single physics modelling strategies are unable to provide understanding on the coupled processes with the foot and their effect on DFU. Future research should further develop modelling approaches and couple these together to develop comprehensive understanding of DFU pathogenesis.

Identifying social determinants of health subgroups and their associations with health outcomes in a prospective US adult COVID-19 cohort: an analysis of the INSPIRE registry

Por: Burrola-Mendez · Y. · Lin · E. · Parrish · C. · Hsu · C. · Hill · M. J. · Gottlieb · M. · Rising · K. L. · Wisk · L. E. · Gentile · N. L. · Geyer · R. E. · Weinstein · R. A. · Santangelo · M. · Gatling · K. · Dyal · J. W. · Elmore · J. G. · Rodriguez · R. M. · Watts · P. · Chen · J. · Diao
Objective

To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

Design

Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

Setting

Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).

Participants

Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).

Outcome measures

Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.

Results

LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (2 p

Conclusions

In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.

Trial registration number

NCT04610515.

Prevalence and psychosocial correlates of depression, anxiety and stress among caregivers of children with childhood-onset systemic lupus erythematosus in China: a cross-sectional study

Por: He · Y. · Xu · T. · Zhou · X. · Chai · X. · Tan · X. · Li · L. · Peng · J. · Pan · T. · Zeng · Y. · Tang · J. · Ho · K. Y. · Wen · H. · Sun · M.
Objectives

To investigate the prevalence of depression, anxiety and stress among primary caregivers of children with childhood-onset systemic lupus erythematosus (cSLE) in China and to explore their psychosocial correlates based on the stress process model.

Design

A cross-sectional study.

Setting

3 tertiary public hospitals in Hunan Province, China.

Participants

242 primary caregivers were invited, and 211 completed the study (87.2% response rate). Convenience sampling was used. Eligible participants were unpaid adult caregivers (aged ≥18 years) of children (aged 1 month. Exclusion criteria included inability to complete questionnaires independently, cognitive impairment due to major physical or mental disorders and current participation in other psychological interventions.

Primary and secondary outcome measures

Primary outcomes (depression, anxiety and stress) were measured using the Depression Anxiety and Stress Scale-21. Correlates included threat/challenge appraisal, coping style and perceived social support.

Results

Among 211 caregivers (mean age 40.55±8.22 years; 77.3% female), 31.8% reported depression, 27.0% anxiety and 24.2% stress. Higher threat appraisal was consistently associated with depression (regression coefficients (B) =1.012, p

Conclusions

Caregivers of children with cSLE face substantial psychological distress, with threat perception and negative coping as key modifiable correlates. Interventions to reshape cognitive appraisal and promote adaptive coping, alongside expanded health insurance coverage and optimised caregiving role distribution, are needed to alleviate caregiver burden.

Investigating haemodynamic changes during vaginal delivery in low-risk pregnant women and the association between haemodynamic and adverse pregnancy outcomes: an ambispective cohort study protocol

Por: Chen · C. · Guo · D. · Zhou · T. · Xu · W. · Yang · Y. · Tang · Z. · Zhang · H. · Wang · L. · Yu · X.
Introduction

The progressive adaptation of the maternal cardiovascular system throughout pregnancy is essential to maintaining adequate uteroplacental circulation and meeting maternal physiological demands. In recent years, maternal haemodynamic parameters have gained attention as useful indicators for screening and managing pregnancy, particularly for identifying women at high risk for complications and predicting adverse pregnancy outcomes. The aim of this study is to assess the trajectory of haemodynamic parameters during labour, establish reference ranges for different stages of labour and explore the association between haemodynamics and adverse pregnancy outcomes.

Methods and analysis

This is an ambispective observational cohort study conducted in a tertiary hospital in Chongqing, China. A total of 2800 pregnant women will be enrolled. After hospital admission and providing written informed consent, participants will complete a demographic questionnaire. Data collection will include maternal baseline characteristics, haemodynamic parameters at multiple stages of labour and maternal and newborn outcomes. These data will allow comprehensive analysis of haemodynamic changes during labour in women undergoing vaginal delivery.

Ethics and dissemination

This study has been approved by the Research Ethics Committee of the First Affiliated Hospital of Chongqing Medical University (ethics approval number: 2024–406-01). Participation is voluntary and initiated only after obtaining written informed consent. The findings will be disseminated through presentations at national and international conferences and through publications in peer-reviewed scientific journals.

Trial registration number

ChiCTR2500097643.

Diagnostic Accuracy of Pressure Injury Risk Assessment Tools for Critically Ill Patients: A Systematic Review and Network Meta‐Analysis

ABSTRACT

Aims and Objectives

To systematically evaluate and compare the diagnostic accuracy of pressure injury risk assessment tools in critically ill adult patients through a network meta-analysis.

Design

Systematic review and network meta-analysis.

Methods

A comprehensive literature search was conducted across PubMed, Embase, Web of Science, and the Cochrane Library from inception to November 2025. Studies reporting the sensitivity and specificity of the Braden, Waterlow, Norton, Cubbin & Jackson, COMHON, and machine learning-based tools in ICU patients were included. A Bayesian network meta-analysis was performed to estimate pooled sensitivity, specificity, diagnostic odds ratio, and summary receiver operating characteristic curve. The methodological quality of the included studies was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 tool.

Results

51 studies involving 30,246 patients were included. The Cubbin & Jackson scale demonstrated relatively higher diagnostic accuracy in the network meta-analysis (e.g., sensitivity 0.81, specificity 0.71), although direct pooled estimates showed a different trade-off (sensitivity 0.90, specificity 0.73). According to the results from network meta-analysis, the pooled diagnostic odds ratio and the summary receiver operating characteristic curve (SORC) for Cubbin & Jackson was 11.64 and 0.74 respectively, but with wide credible intervals, indicating substantial uncertainty. Machine learning-based model and the COMHON scale also exhibited balanced performance, although estimates for COMHON were based on only three studies and should be interpreted cautiously. Substantial heterogeneity was observed across studies.

Conclusions

The Cubbin & Jackson scale may offer relatively better diagnostic accuracy for pressure injury risk assessment in critically ill adults compared with generic scales, possibly due to its inclusion of ICU-specific clinical indicators. However, indirect comparisons and wide uncertainty limit definitive conclusions. These findings support the use of context-specific assessment tools in the ICU, but head-to-head studies are needed to confirm any single tool as the most accurate.

Development and validation of three risk prediction models for clinical deterioration of patients after craniotomy: a retrospective cohort study in China

Por: Xu · L. · Luo · Z. · Xu · H. · Tang · Y. · Wang · L. · Peng · L.
Objectives

This study aimed to identify a deterioration prediction tool for patients after craniotomy.

Design

A retrospective cohort study.

Setting

Three large tertiary hospitals in Hunan Province, China.

Participants

Between January 2018 and March 2020, 1576 patients who underwent craniotomy at three tertiary hospitals in Hunan Province were selected and randomly allocated to either the training or validation sets at a 7:3 ratio. Comprehensive demographic and disease-specific data were collected. Logistic regression, Bayes classification and back propagation neural network were used to construct the models. The Technique for Order Preference by Similarity to an Ideal Solution method was used to evaluate the efficiency of the models.

Results

The performance of all three models was commendable. In both the training and validation datasets, the back propagation neural network model demonstrated the highest efficiency, achieving a sensitivity of 77.1%, specificity of 91.7%, correctness of 86.8%, positive predictive value of 82.3% and negative predictive value of 88.9%. Conversely, the Bayes classifier exhibited the lowest predictive efficiency among the models evaluated.

Conclusions

We developed three models to predict clinical deterioration in patients following craniotomy. Among these, the back propagation neural network model demonstrated superior predictive performance. This model serves as a valuable reference for clinical nurses, aiding them in identifying high-risk patients who may deteriorate post-craniotomy.

Efficacy of artificial intelligence-based digital therapeutics versus traditional Schroth exercises for adolescent idiopathic scoliosis: protocol for a randomised controlled trial

Por: Ma · R. · Huang · Z. · Zhu · X. · Ma · X. · Cheng · W. · Tang · D. · Liu · J. · Shu · L.
Introduction

Adolescent idiopathic scoliosis (AIS) requires long-term conservative management to prevent curve progression. While physiotherapeutic scoliosis-specific exercises, specifically the Schroth method, are considered the gold standard for conservative treatment, their clinical efficacy is often limited by accessibility barriers, high costs and suboptimal treatment adherence. This study aims to evaluate the efficacy of a novel artificial intelligence (AI)-based digital therapeutic system, which uses computer vision for remote, personalised posture analysis and adaptive exercise prescription compared with traditional outpatient Schroth therapy.

Methods and analysis

This parallel-group randomised controlled trial will be conducted at Guangzhou Women and Children’s Medical Center (Guangzhou, China). 300 adolescents aged 10–18 years with AIS who present with a Cobb angle between 10° and 30° and a Risser sign of 0–2 will be recruited and randomised in a 1:1 ratio into an intervention group and a control group. The intervention group will use a smartphone application to capture standardised bi-weekly images. These images will be processed by an AI algorithm to classify curve patterns and assign personalised exercise modules with adaptive dosing ranging from maintenance to high-intensity levels. The control group will receive standard outpatient Schroth care. The primary outcome is the absolute change in the major curve Cobb angle from baseline to 6 months. Secondary outcomes include the angle of trunk rotation, trunk appearance perception, Scoliosis Research Society-22 Revised (SRS-22r) quality-of-life scores and adherence rates. Statistical analysis will follow the intention-to-treat principle using linear mixed models to account for repeated measures.

Ethics and dissemination

Ethical approval has been obtained from the Medical Ethics Committee of Guangzhou Women and Children’s Medical Center (Guangzhou, China) (approval no. [2025]497A01). Written informed assent and consent will be obtained from participants and their legal guardians respectively. Results will be disseminated through peer-reviewed journals and international conferences.

Trial registration number

ClinicalTrials.gov, NCT07341633.

Safety and efficacy of esketamine versus remifentanil as adjuncts to propofol sedation in children undergoing haematologic-oncologic procedures in China: a single-centre, randomised, controlled, crossover trial protocol

Por: Xu · S. · Yang · Y.-F. · Gao · J.-M. · Chen · X. · Tang · Z. · Ji · F.-H. · Peng · K. · Wang · Q.
Introduction

Adequate sedation is essential for paediatric patients undergoing invasive haematologic-oncologic procedures. The combination of propofol and remifentanil is commonly used yet is associated with respiratory depression. Esketamine has anaesthetic, analgesic and sympathomimetic properties and is known to cause less respiratory depression than other sedatives. This study aims to assess esketamine versus remifentanil in combination with propofol for invasive haematological-oncological procedures for paediatric patients.

Methods and analysis

This prospective, randomised, double-blind, two-period crossover trial will include 80 paediatric patients aged 6–12 years, with American Society of Anesthesiologists Physical Status II to III, who are scheduled to undergo repeated invasive procedures including bone marrow aspirates and lumbar punctures under sedation. Participants will be randomised to two sequences: AB or BA. In sequence AB, children will receive propofol (3 mg/kg) and esketamine (0.5 mg/kg) in period 1 and propofol (3 mg/kg) and remifentanil (1 µg/kg) in period 2. In sequence BA, the order is reversed. The primary endpoint of this trial is the incidence of desaturation events, defined as SpO2

Ethics and dissemination

The trial was approved by the Ethics Committee of the Children’s Hospital of Soochow University (Approval No. 2025008). The results of this trial will be submitted for peer review and publication in a scientific journal.

Trial registration number

ChiCTR2500098533.

Study of remimazolam besylate for general anaesthesia and population pharmacokinetics-pharmacodynamics in elderly, hepatic or renal-insufficient patients: a protocol for a multicentre randomised controlled trial in China

Por: Tang · M. · Zhu · M. · Chen · G. · Zhu · T. · Yin · Q.
Background

Remimazolam, an ultra-short-acting benzodiazepine, is characterised by rapid onset and recovery, metabolism independent of hepatic or renal function and haemostability. Despite the above pharmacokinetic (PK) advantages and potential benefits for renal- or hepatic-insufficient patients and the elderly patients, the effects and population pharmacokinetics–pharmacodynamics (popPK/PD) of remimazolam for general anaesthesia in elderly, hepatic or renal insufficient patients from large, randomised controlled trials remain unknown.

Methods and analysis

This is a randomised controlled single-blind multicentre study. Patients undergoing selective surgeries (eg, abdominal, orthopaedic or urologic procedures) will be screened and randomised into the elderly (age ≥65 years), hepatic insufficiency (Child-Pugh class B or C) or renal insufficiency (estimated glomerular filtration rate

Ethics and dissemination

This study was approved by the Ethics Committee of West China Hospital, Sichuan University, on 30 August 2024, and registered at the Chinese Clinical Trial Registry. The findings of this study will be disseminated through presentations at relevant conferences and published in peer-reviewed journals.

Trial registration number

ChiCTR2400089033.

Efficacy of sound therapy on tinnitus in idiopathic sudden sensorineural hearing loss: a systematic review and meta-analysis protocol

Por: Ren · Q. · Luo · H. · Li · J. · Yuan · H. · Hu · Y. · Tang · H. · Tian · L.
Introduction

Tinnitus is a highly prevalent and distressing symptom in patients with idiopathic sudden sensorineural hearing loss (ISSNHL). While international clinical guidelines primarily focus on hearing recovery through pharmacological interventions, effective treatment for tinnitus remains limited. Sound therapy, such as masking and retraining therapy, has emerged as a promising treatment. This systematic review aims to evaluate the efficacy and safety of sound therapy for the alleviation of tinnitus in adult patients with ISSNHL.

Methods and analysis

Researchers will independently conduct searches for randomised controlled trials in the following databases: PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, WHO International Clinical Trials Registry Platform (ICTRP), CNKI and Wanfang Data. The literature search is scheduled for March 2026 without language restrictions. The review will include studies involving adult patients (18 years or older) diagnosed with ISSNHL with tinnitus symptoms who underwent sound therapy (including Tinnitus Masking Therapy, Tinnitus Retraining Therapy or music therapy) with standard drug therapy, placebo or any other non-acoustic interventions compared with the same treatment alone. Researchers will independently screen studies, extract data and assess the risk of bias using the Cochrane Risk of Bias 2 tool. Data analyses will be performed using RevMan V.10.0.2 and Stata V.18.0 software. The certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethics and dissemination

This study relies on the analysis of secondary data from previously published trials; therefore, ethical approval from a research ethics committee is not required. The results of this systematic review will be disseminated through publication in a peer-reviewed scientific journal.

PROSPERO registration number

CRD420261294173.

Pilates during pregnancy for maternal musculoskeletal pain and discomfort: a systematic review and meta-analysis

Por: Song · C. · Shen · Y. · Tang · X. · Li · Z. · Li · X. · Zhang · X. · Xiang · Y. · Ma · J. · Tian · X. · Li · H. · Li · F. · Li · H.
Objectives

The predominant concern during pregnancy is musculoskeletal pain, often accompanied by additional discomforts such as anxiety and insomnia. Pilates, as a low-impact mind-body exercise, may be beneficial in managing musculoskeletal pain and associated symptoms in adults. This systematic review and meta-analysis aimed to synthesise the evidence on the effectiveness of Pilates for alleviating musculoskeletal pain and other discomforts during pregnancy.

Design

Systematic review and meta-analysis.

Data sources

PubMed, Scopus, TRIP Medical Database, Web of Science and the Cochrane Central Register of Controlled Trials (CENTRAL) were searched from inception to 14 January 2026.

Eligibility criteria

Randomised controlled trials and prospective non-randomised controlled studies that compared Pilates with other prenatal care modalities for improving musculoskeletal pain and discomfort were eligible.

Data extraction and synthesis

Two researchers independently extracted data using standardised forms with subsequent cross-verification. Risk of bias was assessed using the Cochrane Risk of Bias V.2.0 tool. Meta-analyses were performed using random-effects models. The certainty of evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

Results

13 studies were included in the systematic review, of which 10 contributed data to the meta-analysis. Primary outcomes were pain intensity and disability level. Pain intensity was assessed using Visual Analogue Scale (range 0–10). Moderate-certainty evidence demonstrated that Pilates significantly reduced musculoskeletal pain during pregnancy (mean differences (MD)=–2.59, 95% CI –4.19 to –1.00; I²=91%, p=0.001). Low-certainty evidence suggested that Pilates reduced pregnancy-related disability (standardised mean differences (SMD)=–1.82, 95% CI –2.99 to –0.66; I² = 93%, p=0.002). Secondary outcomes comprised sleep quality and psychological status. Multivariate meta-analysis showed significant improvements in psychological status (SMD=–0.86, 95% CI –1.31 to –0.42; ²=0.4, I²=86%, p=0.0005) but did not yield statistically significant improvements in sleep quality (MD=–1.93, 95% CI –4.70 to 0.84; I²=93%, p=0.17). Both secondary outcomes were supported by very low-certainty evidence. Risk of bias assessment rated three studies as high risk, three as unclear risk and seven as low risk. Formal assessment of publication bias was not feasible owing to the limited number of studies (fewer than 10 per outcome).

Conclusion

This meta-analysis demonstrates that, compared with standard care, structured prenatal Pilates significantly alleviates musculoskeletal pain and disability while also enhancing psychological status.

PROSPERO registration number

CRD42024628027.

Insights Into Self‐Care of Feet When Living With Diabetes: A Phenomenological Hermeneutic Interview Study

ABSTRACT

Aim

To describe how persons with diabetes experience learning about self-care, with a particular focus on foot self-care.

Methods

Narrative, semi-structured interviews were conducted with persons diagnosed with Type 1 or Type 2 diabetes. Participants were recruited through an advertisement in a diabetes association magazine and through convenience and snowball sampling. Eleven participants aged 53–87 were interviewed between December 2024 and April 2025. Interviews were audio-recorded, transcribed verbatim and analysed using a phenomenological hermeneutic approach.

Results

Learning about foot self-care emerged as a gradual, lived process shaped by bodily experiences, social relationships and access to support. Three themes were identified: the social landscape of self-care, the being of the feet and taking knowledge into your own hands. Learning was influenced by encounters with healthcare professionals, informal support from relatives and personal experiences over time. Bodily symptoms acted as driving forces for learning and self-care actions. Understanding why self-care mattered was essential for motivation, while seeking and evaluating knowledge became a strategy for control and participation in care.

Conclusion

Learning about foot self-care among persons with diabetes is an embodied, relational and ongoing process. That develops through interaction among lived bodily experiences, social support and personal responsibility rather than through information alone.

Implications for the Profession and/or Patient Care

Healthcare professionals must integrate persons' experience-based knowledge and support dialogue, reflection and shared learning to strengthen foot self-care practices.

Impact

The study addressed the limited understanding of how persons with diabetes learn foot self-care. The results showed that learning is shaped by lived experience, relationships and meaning-making. The findings are relevant for persons with diabetes and healthcare professionals involved in diabetes care.

Reporting Method

The study adhered to the COREQ criteria.

Patient or Public Contribution

No patient or public contribution.

Impact of the POPulation Medicine Multimorbidity Intervention in Xishui County (POPMIX) on people at high risk for COPD who smoke: protocol for the POPMIX-Smoking cluster randomised controlled trial

Por: Chen · S. · Huang · K. · Zheng · Z. · Liu · Y. · Zhang · S. · Chen · W. · Tang · X. · Cao · Z. · Tang · L. · Tong · X. · Zhao · J. · He · L. · Jiao · L. · Wang · Y. · Zhao · T. · Luo · Y. · Lai · Q. · Lyu · X. · Dou · R. · Chen · Q. · Bunker · A. · Vollmer · S. · Geldsetzer · P. · Jamison · D. · Bär
Introduction

Tobacco use is a major contributor to the burden of chronic obstructive pulmonary disease (COPD) and other non-communicable diseases in China. People at high risk for COPD who smoke, particularly those with pre-existing chronic conditions, often remain underserved by conventional smoking cessation programmes. Population medicine offers a promising framework for proactively identifying high-burden diseases, managing multimorbidity and prioritising interventions for vulnerable populations.

Methods and analysis

This protocol describes a stratified, two-arm cluster randomised controlled trial (Population Medicine Multimorbidity Intervention in Xishui County-Smoking) being conducted in Xishui County, a rural area of Guizhou Province, China. A total of 26 townships were stratified by population size and randomly assigned in a 1:1 ratio to receive either a multicomponent intervention or usual care. Eligible participants were individuals aged 35 years or older who smoked and were at high risk for COPD as identified by the COPD Screening Questionnaire. The intervention package integrates multiple components, including a digital smoking cessation programme, digital mental health support, community-based spirometry, tailored chronic disease management, health education and a performance-linked ‘pay-for-population’ scheme that aligns healthcare worker reimbursement with population health outcomes. Primary outcomes are smoking amount and nicotine dependence and secondary outcomes include COPD-related health outcomes, hypertension, diabetes, health risk behaviours, quality of life, healthcare utilisation and productivity loss. Follow-up occurs at 3, 6 and 12 months.

Ethics and dissemination

Ethical approval has been granted by the Peking Union Medical College Ethics Committee (CAMS&PUMC-IEC-2024-042). Informed consent was obtained from all participants prior to enrolment. Results will be shared through peer-reviewed publication and (inter)national conference presentations.

Trial registration number

NCT06458205.

Real-world changes in lipid-lowering therapy use and LDL-C goal attainment in high and very high cardiovascular risk patients in the UK: a secondary analysis of the European SANTORINI study 1-year follow-up

Por: Connolly · D. · Fuat · A. · McCormack · T. · Mcnally · D. · Garstang · J. · Ryan · J. · Reed · A. · Robinson · D. · Catapano · A. L. · Ray · K. K.
Objectives

This real-world study investigated the changes of lipid lowering therapy (LLT) usage in patients with high or very high cardiovascular (CV) risk in the UK and the group of all other European countries in the SANTORINI study up to 1 year from baseline and the impact this treatment had on the attainment of low-density lipoprotein cholesterol (LDL-C) risk-adjusted goals set by the National Institute for Health and Care Excellence (NICE) and those in the 2019 European Society of Cardiology (ESC)/European Atherosclerosis Society (EAS) dyslipidaemia guidelines.

Design

Secondary analysis of the SANTORINI dataset (an international, prospective, observational, non-interventional study (NCT04271280)).

Setting

Primary and secondary care centres in the UK and the group of other European countries (Austria, Belgium, Denmark, Finland, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, Sweden and Switzerland).

Participants

663 UK patients with high and very high CV risk were included in this analysis and 8502 from the group of other European countries. Of these, 380 UK patients and 6830 from the group of other European countries had LDL-C information available at baseline and 1-year follow-up.

Primary outcome measures

The primary objectives were to describe patients’ lipid management, LDL-C levels at 1-year follow-up and their attainment of 2023 NICE (≤2.0 mmol/L) and 2019 ESC/EAS LDL-C 2019 guideline-recommended LDL-C goals (

Results

Over the course of 1-year follow-up, the overall proportion of UK patients on no LLT reduced from 20.4% at baseline to 7.1%, similar to that observed in the group of other European countries (baseline–20.9%, 1 year–3.0%). The proportion of UK patients receiving LLT monotherapy increased from 74.8% at baseline to 84.9%, higher at both time points than that observed for the group of other European countries (baseline: 52.0%, 1 year: 55.0%). The use of any combination therapy increased slightly from baseline to 1 year in the UK overall cohort (4.9% vs 7.1%) and overall in the group of all other European countries, the cohort increased from baseline (27.1%) to 1 year (40.2%). Overall, mean (SD) LDL-C levels in the UK were 2.5 (1.2) mmol/L at baseline and 2.1 (1.0) mmol/L at 1 year and for the group of other European countries were 2.4 (1.2) mmol/L at baseline and 2.0 (0.9) mmol/L at 1 year. The overall proportions of UK patients achieving the UK NICE treatment goal and ESC/EAS 2019 guidelines at baseline versus 1-year follow-up were 40.3% vs 52.6% and 22.9% vs 32.9%, respectively; 21.1% and 30.9% of patients in the group of other European countries achieved the ESC/EAS 2019 guidelines at baseline and 1-year follow-up, respectively.

Conclusions

In this UK-focused analysis of the SANTORINI study, use of LLT increased modestly over 1 year, accompanied by a reduction in average LDL-C levels. However, mean LDL-C remained above the NICE goal, and attainment of both NICE and ESC/EAS LDL-C thresholds remained suboptimal. The findings highlight continued opportunities to optimise lipid management in UK clinical practice, including the potential for broader use of combination therapies.

Effects of nurse-led shared decision-making on low-dose CT uptake and screening outcomes in high-risk populations: a systematic review and meta-analysis

Por: Tang · X. · Cao · T. · He · W. · Ma · L. · Li · W. · Tao · W.
Objectives

To evaluate the effects of nurse-led shared decision-making (SDM) on lung cancer screening outcomes, including low-dose CT (LDCT) uptake, benign findings, early cancer detection and willingness to participate among high-risk populations.

Design

Systematic review and meta-analysis.

Data sources

PubMed, Medline via OvidSP, Cochrane Central Register of Controlled Trials, EMBASE via OvidSP, Web of Science, Scopus, grey literature databases and clinical trial registries were searched from inception to March 2025.

Eligibility criteria

Studies evaluating nurse-led SDM interventions in high-risk lung cancer populations, reporting outcomes including LDCT uptake rates, screening results (Lung-RADS (Lung Imaging Reporting and Data System) classifications), early-stage cancer detection or willingness to participate. Randomised controlled trials, quasi-experimental studies and observational studies were included.

Data extraction and synthesis

Two reviewers independently extracted data and assessed risk of bias using the Risk of Bias in Non-randomised Studies of Interventions (for non-randomised studies) and Cochrane Risk of Bias 2.0 (for randomised controlled trials). Meta-analyses were conducted using random-effects models. Meta-regression explored sources of heterogeneity.

Results

13 studies (n=13 608 participants) were included, comprising 10 single-arm studies and three comparative studies. In single-arm studies without control groups, nurse-led SDM programmes achieved a pooled LDCT uptake rate of 98% (95% CI 28% to 100%; I²=99%), and willingness to participate was 68% (95% CI 24% to 93%; I²=98%). In comparative studies, nurse-led SDM showed no significant difference in LDCT uptake compared with usual care (RR 1.00, 95% CI 0.99 to 1.02; I²=0%), suggesting non-inferiority rather than superiority. Among individuals who completed screening, 81% (95% CI 77% to 85%) had benign or low-risk findings (Lung-RADS [Lung Imaging Reporting and Data System] I/II), and 2% (95% CI 1% to 3%) were diagnosed with early-stage lung cancer, rates consistent with benchmark screening trials. Meta-regression identified female sex as positively associated with uptake (β=0.54, p

Conclusions

Comparative evidence suggests that nurse-led SDM achieves equivalent LDCT uptake to standard care approaches, indicating feasibility as an alternative service delivery model. However, the predominance of single-arm studies, high heterogeneity and moderate-to-serious risk of bias limit causal inference. High uptake rates in single-arm studies likely reflect selection bias rather than intervention effectiveness. Current evidence supports the feasibility but not the superiority of nurse-led SDM. Well-designed randomised controlled trials are needed to establish comparative effectiveness and cost-effectiveness before recommending widespread integration of nurse-led SDM into lung cancer screening programmes.

Trial registration number

PROSPERO CRD420251033595. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=1033595.

Global burden, trends and projections analysis of interstitial lung disease and pulmonary sarcoidosis in elderly adults (aged 55+ Years) based on GBD 2021

by Zhilan Huang, Tingyi Xie, Mingwen Tang, Zhuni Chen, Dan Jia, Anqi Su, Zhujin Jin, Tuliang Liang, Wei Xie

Background

Pulmonary fibrosis is a severe chronic lung disease whose prevalence has been rising in recent years, representing one of the major respiratory health challenges globally in the 21st century. The burden of this disease on the elderly population is garnering growing attention, particularly as the global population ages. The Global Burden of Disease (GBD) study has provided valuable insights; however, systematic analyses focused on this condition remain limited. To date, few studies have specifically examined interstitial lung disease and pulmonary sarcoidosis among individuals aged 55 years and older. This study aims to conduct a comprehensive analysis of burden trends from 1990 to 2021 for those aged 55 and above and to project future trends up to 2035.

Methods

Our approach utilizes the estimation of four broad component measures: incidence, prevalence, death and Disability-Adjusted Life Years (DALYs), using data on ILD&PS from the Global Burden of Disease (GBD) 2021 database. Joinpoint regression models were applied to calculate the average annual percentage change (AAPC) in order to analyze temporal trends in disease burden and to identify years with significant trend shifts. Analyses were further stratified by age, sex, region, country, and Sociodemographic Index (SDI). Additionally, a Bayesian age-period-cohort (BAPC) model was used to project future disease burden trends.

Results

Between 1990 and 2021, significant increases were observed in incidence, DALYs, and death rates for ILD&PS (AAPC incidence = 1.09, 95% CI: 1.04 to 1.15; AAPC DALYs = 1.10, 95% CI: 0.97 to 1.23; AAPC death = 1.65, 95% CI: 1.47 to 1.83). In 2021, the total number of incident cases reached 284,887 (95% UI 248,300–328,800), with the highest incidence rates observed in Andean Latin America. Across age- and sex-specific analyses, global burden trends were similar, though males consistently exhibited higher rates than females. The oldest age group (95 + years) had the highest incidence and DALYs rates among all age strata. Furthermore, incidence rates increased most markedly in high-SDI regions, showing a strong positive correlation between SDI and incidence. Bayesian age–period–cohort (BAPC) analyses indicated that while prevalence rates are projected to decline slightly, incidence rates are expected to continue rising. Both males and females showed a dip then rise in prevalence trends, but the increase was more pronounced among females. In 2035, the highest number of incident cases is projected to occur in the 65–69 age group, whereas the highest incidence rate is predicted in the 95 + age group.

Conclusions

A concerning upward trend in incidence, DALYs, and deaths related to ILD&PS was observed in the global population aged 55 years and older, particularly among females. To our knowledge, this is the first study to comprehensively analyze the burden of ILD&PS in this age group from 1990 to 2021. Our findings on epidemiological trends and their variations across geography, SDI, age, and sex can inform policy-makers in designing targeted strategies to mitigate the anticipated rise in disease burden.

A systematic review protocol: Efficacy and safety of nitrous oxide in analgesia in burn patients with dressing change

by Weifeng Wang, Xianli Meng, Yan Zhao, Wei Gong, Xiaochen Jiang, Wenjuan Cao, Xueling Qiu, Chenxi Sun, Fan Sun, Yuchen Wang, Lu Tang

Background

To alleviate pain in burn patients during dressing changes, it is necessary to identify an effective analgesic method. Conventional opioid analgesics have many limitations. Nitrous oxide is a fast-acting, safe and reversible inhaled analgesic gas. This systematic review will evaluate the effectiveness and safety of nitrous oxide in the treatment of pain during dressing changes in burn patients.

Method

The protocol was developed according to the PRISMA-P checklist and registered on PROSPERO (CRD42024550197). A systematic search will be performed in the following databases: PubMed, EMBASE, Web of Science, Cochrane Library to identify clinical trials comparing nitrous oxide inhalation with standard care in pain management during dressing changes in burn wounds. The search of all databases will be conducted on October 15, 2025.Our search scope will include studies published between each database creation and search date.Two researchers will independently screen studies, extract data, and evaluate study quality using the Risk of Bias2 tool. Primary outcomes will include pain, anxiety, side effects, among others.R statistical software (version 4.3.1) and R studio will be used to perform meta-analyses.Effect size will be expressed by 95% confidence interval (Cl) of weighted mean difference (MD) and risk ratio (RR). Subgroup analyses and sensitivity analyses will be performed to explore sources of heterogeneity and assess the robustness of the results.Publication bias will be assessed using funnel plot and Egger test. We will use the Grading of Recommendation, Evaluation, Development and Evaluation (GRADE) to assess the quality of the evidence.

Discussion

Operative pain has always been a difficult problem for burn patients. This study will evaluate the analgesic effect of nitrous oxide on dressing change in burn patients through comprehensive search and rigorous methods, and provide evidence support for clinical decision-making.

Sucralose inhibited cell survival through the activation of ER stress in human endothelial progenitor cells

by Chia-Ying Li, Hung-Yu Lin, En-Pei Isabel Chiang, Hung-Chang Hung, Feng-Yao Tang

Sucralose, a widely utilized non-caloric sweetener, is frequently added to food and beverage products as a sugar substitute aimed at lowering energy consumption and reducing obesity-related health risks. However, epidemiological studies have indicated a possible association between high intake of sucralose and increased prevalence of coronary artery disease (CAD). Prior research has demonstrated that diminished levels of circulating human endothelial progenitor cells (hEPCs) are linked to a higher risk of CAD. Although sucralose is broadly consumed, its direct biological impact on hEPCs has not been comprehensively characterized. In this study, we investigated the cellular effects of sucralose on hEPCs using a variety of in vitro techniques, including assays for viability, migration, capillary-like tube formation, lactate dehydrogenase (LDH) release-cytotoxicity assay, and protein expression profiling by Western blotting. Our results revealed that increased concentrations of sucralose significantly impaired hEPCs viability, motility, and neovasculogenic function, accompanied by increased expression of markers associated with apoptosis, inflammasome activation, and pyroptosis. Mechanistic analysis further demonstrated that sucralose strongly activated endoplasmic reticulum (ER) stress/PERK pathways in these cells. Inhibition of ER stress via 4-phenylbutyric acid (4-PBA) substantially attenuated sucralose-induced cell death and reduced the expression of pyroptosis-related proteins and inflammasome markers. Taken together, these findings suggest that sucralose disrupts hEPCs function in part by triggering ER stress, which promotes both apoptotic and pyroptotic cell death programs.

mHealth-based Healthy Lifestyle Promotion (MYLIFE) for metabolic syndrome risk reduction in Chinese employed adults: protocol for a cluster-randomised controlled trial

Por: Yu · B. · Tang · Q. · Hu · Y. · Zuo · H. · Yang · B. · Pan · J. · Jia · P. · Reinhardt · J. · Yang · S.
Introduction

Metabolic syndrome (MetS) poses a significant public health challenge among employed adults. Lifestyle modifications have been shown to be effective in preventing the onset and progression of MetS in employed adults, and the widespread adoption of mobile and wearable technologies introduces an appealing approach to mHealth lifestyle interventions. When widely implementing smartphone-based interventions for employed adults, enhancing equitable access and promoting wearable device use for those with MetS is a more cost-effective way to reduce health disparities, particularly in resource-limited settings. However, relevant evidence is currently lacking.

Objective

This study aims to design an mHealth-based Healthy Lifestyle Promotion (MYLIFE) trial, a three-arm randomised controlled trial (RCT), to evaluate the effectiveness of a smartphone-based lifestyle intervention and a combined smartphone-based lifestyle intervention with intensive intervention for MetS individuals using wearable devices, in reducing MetS risk among employed adults.

Methods and analysis

This is a three-arm, parallel, single-blind, cluster RCT with a 12-week intervention and a total follow-up of 1 year. The trial will recruit 120 workplaces from the Chinese Cohort of Working Adults in a 1:1:1 ratio to either a control group or one of two intervention groups. Within these workplaces, a total of at least 348 eligible participants will be enrolled. The regular mHealth group will receive smartphone-based intervention. The intensive mHealth group will receive smartphone-based intervention for all participants, and an additional wearable device-intensive intervention for those with MetS. The primary outcome is the Chinese MetS Z score at 12 weeks. Secondary outcomes include MetS Z score, prevalence of MetS, specific MetS components, questionnaire-based indicators, and clinical outcomes at 12 weeks and 1 years. The main analysis will follow the intention-to-treat principle, using mixed-effects models to assess between-group differences in outcomes.

Ethics and dissemination

The protocol has been approved by the Ethics Committee of the West China School of Public Health and the West China Fourth Hospital, Sichuan University (Gwll2025024). The findings will be published in peer-reviewed journals and presented at scientific conferences.

Trial registration number

ChiCTR2500101904.

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