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Ayer — Marzo 4th 2026BMJ Open

Comparative effectiveness and safety of digital health delivery models for pulmonary rehabilitation in patients with chronic obstructive pulmonary disease: a protocol for systematic review and network meta-analysis of randomised controlled trials

Por: Xu · L. · Chen · X. · Yang · C. · Feng · M. · Wu · Y.
Introduction

Chronic obstructive pulmonary disease (COPD) affects approximately 480 million individuals globally and is projected to reach 600 million by 2050, representing a substantial burden on healthcare systems and patient quality of life. Pulmonary rehabilitation is a cornerstone intervention for COPD management, delivering clinically meaningful improvements in exercise capacity, health-related quality of life and dyspnoea. Despite strong guideline recommendations and established efficacy, only 2%–4% of eligible patients with COPD access traditional centre-based pulmonary rehabilitation due to geographical barriers, transportation difficulties, scheduling conflicts and limited healthcare resources. Digital health technologies offer promising alternatives to overcome these access barriers while potentially maintaining therapeutic benefits. Various digital delivery models have emerged, including video-based telerehabilitation, virtual reality platforms, mobile health applications and web-based programmes. However, their comparative effectiveness remains unclear, limiting evidence-based clinical decision making. This systematic review and network meta-analysis will aim to compare and rank the effectiveness and safety of different digital health delivery models for pulmonary rehabilitation in patients with COPD, providing evidence to inform optimal intervention selection in clinical practice.

Methods and analysis

We will conduct a systematic review and Bayesian network meta-analysis following Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Network Meta-Analyses guidelines. Comprehensive searches will be performed across five electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL) from inception to January 2026, without language restrictions. Eligible studies will include randomised controlled trials comparing digital health delivery models for pulmonary rehabilitation in adults with COPD. Digital health interventions will be categorised into four distinct delivery models: video-based telerehabilitation, virtual reality rehabilitation, mobile health rehabilitation and web-based platform rehabilitation. Interventions combining multiple modalities will be categorised according to the predominant component based on intervention frequency, duration and primary therapeutic mechanism. Two independent reviewers will perform study selection, data extraction and risk of bias assessment using the Cochrane Risk of Bias 2 tool. The primary outcome will be change in 6 min walk distance. Key secondary outcomes will include disease-specific quality of life measures, dyspnoea severity, hospitalisation rates, exacerbation frequency, intervention adherence and adverse events. A Bayesian random-effects network meta-analysis will be conducted, calculating mean differences or ORs with 95% credible intervals. Treatment rankings will be estimated using surface under the cumulative ranking curve probabilities. Evidence certainty will be assessed using the Confidence in Network Meta-Analysis framework. Planned subgroup analyses will explore potential effect modifiers including disease severity, intervention duration, supervision mode and technological features.

Ethics and dissemination

As this systematic review will use data from previously published studies, formal ethical approval is not required. Findings will be disseminated through peer-reviewed publication, presentations at relevant scientific conferences and communication to healthcare providers, policymakers and patient advocacy organisations.

PROSPERO registration number

CRD420251268701.

Efficacy of perioperative intravenous lidocaine infusion on postoperative recovery and analgesia in patients undergoing video-assisted thoracoscopic surgery: study protocol for a randomised, double-blind, placebo-controlled trial

Por: Omindo · W. W. · Xiao · Z. · Wang · X. · Fu · L. · Wang · J. · Zhang · R. · Ping · W. · Zhou · B. · Zhang · N.
Introduction

Despite the minimally invasive nature of video-assisted thoracoscopic surgery (VATS), moderate-to-severe postoperative pain remains frequent and impairs recovery. Intravenous lidocaine possesses multimodal analgesic, antihyperalgesic and anti-inflammatory properties that may improve pain control and functional outcomes, but robust evidence in thoracic surgery is lacking. Moreover, its potential to attenuate neuropathic pain, a key component of chronic post-thoracic pain syndromes, has not been adequately investigated. This trial will determine whether continuous perioperative intravenous lidocaine infusion improves recovery, reduces acute pain intensity and prevents the development of neuropathic pain after VATS.

Methods and analysis

This single-centre, randomised, double-blind, placebo-controlled trial will enrol 84 adult patients undergoing elective VATS. Participants will be randomised (1:1) to receive either intravenous lidocaine (bolus 1 mg/kg at induction followed by continuous infusion at 1.5 mg/kg/hour intraoperatively and postoperatively for 24 hours) or matched normal saline postoperatively, with identical intraoperative management in both groups. The primary outcome is the incidence of moderate-to-severe movement-evoked pain at 24 hours postoperatively. Secondary outcomes include pain at 48 and 72 hours, opioid consumption, pulmonary complications, sleep quality, quality of recovery, neurocognitive outcomes and chronic neuropathic pain at 3 months. Analyses will follow the intention-to-treat principle.

Ethics and dissemination

The study protocol was approved by the Institutional Review Board of Tongji Hospital (Reference No. TJ-IRB202509102) and registered in the Chinese Clinical Trial Registry (ChiCTR2500111163). Written informed consent will be obtained from all participants. Results will be submitted to peer-reviewed journals and academic conferences.

Trial registration number

ChiCTR2500111163.

Cross-sectional observational study evaluating social brain health in HIV using a research domain criteria-based approach: a protocol

Por: Vance · D. E. · Brennan-Ing · M. · Lambert · C. C. · Hellemann · G. · Zeng · X. · Lee · J.
Introduction

Some people with HIV (PWH) experience brain changes that affect neurocognition, but little is known about how HIV impacts social cognition or related brain regions. Social cognition, the ability to perceive, understand and respond to social information, is important for maintaining relationships and quality of life. This article provides the protocol for the first comprehensive study examining social brain function in PWH and people without HIV (PWoH). With three aims, this study will: (1) examine neural circuits related to social cognition; (2) examine social cognitive performance across two social cognitive domains and (3) examine the role of social cognition in everyday social functioning.

Methods and analysis

Referred to as Social Brain Health Study in HIV Study, this cross-sectional study will enrol 105 PWH and 105 demographically matched PWoH aged 18–65 years. The study administers a comprehensive assessment battery across two visits within a 2-week period. Visit 1 includes behavioural measures of social cognition (Perceiving Social Cues and Understanding Others), neurocognition and social functioning (social network size and loneliness). Visit 2 involves functional MRI procedures with three social cognitive tasks designed to activate key brain regions (ie, fusiform face area, superior temporal gyrus, temporo-parietal junction, dorsal medial prefrontal cortex).

Ethics and dissemination

This study was funded by the National Institute of Mental Health (MH139613) and approved by the Institutional Review Board of the University of Alabama at Birmingham (IRB-300013394). Data collection is ongoing. The first results are expected to be submitted for publication in 2030. Findings of this study will be published in peer-reviewed journals and presented at local, national and international conferences as well as patient organisations such as AIDS service organisations and community talks.

ReFIT study (reversing frailty in transplantation): protocol for a longitudinal study to assess clinical and biomedical changes in frailty through kidney transplantation

Por: Payne · T. · Shaw · A. · Hanjani · L. S. · Homes · R. · Giddens · F. · Ravuri · H. G. · Yap · C. X. · Walsh · J. · Kumar · V. · Garton · F. C. · Rhee · H. · Huang · A. · Francis · R. S. · Reid · N. · McAdams-DeMarco · M. · Gordon · E. · Midwinter · M. · Hubbard · R.
Introduction

Losses of functional reserve across multiple physiological systems have been identified in frail patients, yet the exact aetiology of frailty remains unclear. Although strongly associated with chronological age, frailty often develops at a younger age in patients with organ failure. Frailty is prevalent in patients with kidney failure; however, individuals experience improvements in physical frailty measures following kidney transplantation. This makes younger patients with kidney failure a unique population for studying both the accelerated onset of frailty and its reversal. This research project aims to test the hypothesis that frailty secondary to organ failure and age-related frailty are associated with similar molecular and physiological measures.

Methods and analysis

This longitudinal study will recruit 150 patients in three groups. Group A (kidney transplant recipients aged ≥40 years; n=50) and Group B (patients aged ≥40 years active on the kidney transplant waitlist; n=50) will comprise younger adults with frailty from organ failure. Group C (adults aged ≥65 years (or ≥55 years for Aboriginal and Torres Strait Islander patients); n=50) will comprise older community dwellers. The primary outcome is the Frailty Index (FI). Secondary outcomes include the change in FI over time, and at baseline when considering various clinical metadata, immune parameters, kidney function and nutrition intake which will be measured at baseline and 12-month time points. Longitudinal changes in frailty will be analysed using linear mixed models with multiple testing corrections for false discovery rates.

Endocrine profiles and metabolomics, measures of immune function and microcirculatory dysfunction, will be measured by liquid chromatography-mass spectrometry and/or gas chromatography-mass spectrometry. The gut microbiome will be sequenced via shotgun metagenomics (Illumina NextSeq500, 150 bp paired-end, 3Gbp/sample). Circulating cell-free DNA/mitochondrial DNA will be quantified through droplet digital PCR. Microcirculation will be assessed via sublingual dark field videomicroscopy with glycocalyx markers measured by ELISA.

Ethics and dissemination

This study will be conducted with all stipulations of this protocol, and the conditions of the ethics committee approval. Ethical principles have their origin in the Declaration of Helsinki, all Australian and local regulations and in the spirit of the standard of Good Clinical Practice (as defined by the International Conference on Harmonisation). Organs/tissues will be sourced ethically and will not be sourced from executed prisoners or prisoners of conscience or other vulnerable groups.

Ethics approval was received by the Metro South Health Research Ethics Committee (HREC/2023/QMS/95392) and ratified by the University of Queensland.

Results will be disseminated through peer-reviewed publications, academic conferences, participant newsletters and health organisation collaboration.

AnteayerBMJ Open

Efficacy of sequential denosumab after teriparatide for 6 months compared with denosumab monotherapy in reducing risk of osteoporotic fractures in patients with new fractures: a multicentre randomised controlled trial (STAND study) protocol

Por: Chi · Y. · Zhu · Y. · Yuan · J. · Pang · Q. · Cui · L. · Jiang · Y. · Jiajue · R. · Liu · W. · Wang · O. · Li · M. · Xing · X. · Li · H. · Xie · G. · Wu · Y. · Xia · W.
Introduction

Osteoporosis (OP) is a systemic skeletal disorder that increases fragility and susceptibility to fractures. Despite the availability of teriparatide for the treatment of patients with acute fractures with better efficacy, its long-term daily injection and high cost limit its broader use among a wider patient population, especially for those living in low- and middle-income countries. This study aims to evaluate the efficacy of a novel sequential treatment with teriparatide daily for 6 months followed by denosumab every 6 months for another 18 months, in comparison with denosumab monotherapy every 6 months for 24 months, in reducing the risk of fractures in patients with newly diagnosed osteoporotic fractures. The study will also explore the possible difference between two sequential treatments (shifting to denosumab treatment at 6 or 12 months) in their effect on increasing bone mineral density (BMD).

Methods and analysis

This study is designed as a multicentre, open-label, randomised controlled trial among 2478 patients with newly diagnosed osteoporotic fractures from 58 hospitals across China. Participants will be randomly assigned in a 10:10:1 ratio to three treatment groups: 24 months of denosumab monotherapy, early sequential treatment (teriparatide for 6 months followed by denosumab for 18 months) and late sequential treatment (teriparatide for 12 months followed by denosumab for 12 months). The primary outcome is the incidence of vertebral fractures over 24 months of treatment. Secondary outcomes include changes in BMD at the lumbar spine, total hip and femoral neck, changes in bone turnover markers (β-carboxy-terminal telopeptide of type 1 collagen and procollagen type 1 N-terminal propeptide), treatment adherence and cost-effectiveness. Follow-up assessments are scheduled at 3, 6, 9, 12, 18 and 24 months post-randomisation for primary and secondary outcomes, and biannually afterwards for the primary outcome.

Ethics and dissemination

The study protocol has been registered on ClinicalTrials.gov and has received ethical approval from the Peking Union Medical College Hospital Medical Science Research Ethics Committee (1-22PJ939). The findings will be disseminated through peer-reviewed scientific journals.

Trial registration number

NCT05866029.

Multicentre, open-label, prospective, parallel-controlled study protocol evaluating the effects of amino acid peritoneal dialysis solution on nutritional status in Chinese peritoneal dialysis patients

Por: Zhou · J. · Jiang · W. · Zhang · X. · Shi · J. · Ai · L. · Xia · C. · Lin · F. · Xiang · X. · He · Q. · Chen · H. · Hu · S.
Introduction

Peritoneal dialysis (PD) is a widely used renal replacement therapy for chronic kidney disease patients, yet malnutrition remains a common complication linked to poor outcomes. Nearly 40% of PD patients in China are malnourished, with serum albumin levels below 35 g/L. Amino acid-based peritoneal dialysis solutions (AA-PDS), which replace glucose with amino acids as the osmotic agent, have been used globally for decades to improve nutrition and reduce peritoneal damage, but they were introduced to mainland China only in 2022. This study aims to evaluate the efficacy and safety of AA-PDS in improving nutritional status and clinical outcomes among malnourished PD patients in mainland China, providing a potential new therapeutic option for this population.

Methods and analysis

This multicentre, open-label, prospective, parallel-controlled study will enrol patients with end-stage kidney disease who were stable on PD for more than 3 months. A total of 500 eligible patients will be divided into the intervention group undergoing PD once every morning using 2.0 L of amino acid (15) PD solution and the control group using conventional PD solution (lactate) in a 4:1 ratio based on their willingness and clinical needs. Our primary outcome is serum albumin, while other nutritional indicators, including serum prealbumin, serum transferrin, total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and ultrafiltration volumes are considered secondary outcomes. Information such as demographics, clinical and biochemical characteristics, examination indicators, anthropometry measurements and Subjective Global Assessment scores will be collected at baseline, 1 month, 3 month and 6 month follow-up. Statistical analysis will be conducted using SAS V.9.4 or higher versions. All statistical tests are conducted through the two-tailed test, and a p value≤0.05 will be considered statistically significant. The description of quantitative indicators will be used in calculating the number of cases, mean, SD, median and IQR method. The classification indicators will be used to describe the number of cases and percentages (frequency and frequency rate).

Ethics and dissemination

This multicentre study obtained ethical approval from the lead ethics committee at the First Affiliated Hospital of Zhejiang Chinese Medical University (approval no.: 2024-KLS-379-02). Additionally, each participating site provided local ethical approval or a formal waiver, as required by their institutional policies. The results will be reported in a peer-reviewed journal and a relevant academic conference.

Trail registration number

ChiCTR2400090896.

Associations of oxidative balance score with mortality and cardiovascular events: cohort study from NHANES and UK Biobank

Por: Zhang · H. · Chen · S. · Bai · X. · Zhou · X. · Zhang · F. · Wang · X. · Chen · L. · Wang · X.
Objective

To investigate the associations of oxidative balance score (OBS) with all-cause mortality, cardiovascular mortality and cardiovascular disease (CVD) incidence in two large, population-based cohorts.

Design

Cohort study and cross-sectional study were used.

Setting

The US National Health and Nutrition Examination Survey (NHANES) and the UK Biobank.

Participants

A total of 33 566 adults from NHANES (1998–2018) and 55 760 adults from the UK Biobank were included.

Main outcome measures

All-cause mortality, cardiovascular mortality and CVD. Mortality outcomes were ascertained through national death registries. Prevalent CVD was identified in NHANES through questionnaire, and incident CVD events were identified in the UK Biobank using linked hospital admission and death registry data.

Results

Higher OBS was consistently associated with lower all-cause and cardiovascular mortality in both cohorts. In NHANES, participants in the highest OBS quartile (Q4) had a 39% lower risk of all-cause mortality (adjusted HR: 0.61, 95% CI 0.52 to 0.72) and a 45% lower risk of cardiovascular mortality (adjusted HR: 0.55, 95% CI 0.41 to 0.74) compared with those in Q1. Similarly, in the UK Biobank, Q4 was associated with an 18% lower risk of all-cause mortality (adjusted HR: 0.82, 95% CI 0.74 to 0.91) and a 41% lower risk of cardiovascular mortality (adjusted HR: 0.59, 95% CI 0.4 to 0.87). In NHANES, Q4 was associated with lower odds of prevalent CVD (adjusted OR: 0.56, 95% CI 0.46 to 0.67), whereas in the UK Biobank, Q4 was associated with a 19% lower risk of incident CVD during follow-up (adjusted HR: 0.81, 95% CI 0.74 to 0.9). Subgroup analyses in NHANES indicated heterogeneity by ethnicity and socioeconomic status, whereas associations in the UK Biobank followed an L-shaped pattern with a flattening of estimated risk at moderate OBS levels.

Conclusion

Higher OBS was associated with more favourable mortality and cardiovascular outcomes. These findings indicate that OBS is a composite indicator associated with cardiovascular health at the population level.

Effect of preventive precision multimodal analgesia (PPMA) on postoperative acute pain process and rehabilitation in adult patients undergoing thoracoscopic pulmonary resection: protocol for a prospective, multicentre, randomised controlled study

Por: Fan · Z. · Zhang · Y. · Lei · Q. · Ma · H. · Zhu · X. · Yao · L. · Li · L. · Zheng · H. · Jin · H. · Gao · J. · Ge · Y. · Lin · J. · Lv · J. · Wang · X. · Xiao · Z. · Xiao · W. · Wang · T.
Introduction

Postoperative acute pain following video-assisted thoracoscopic surgery (VATS) impedes patient rehabilitation. While multimodal analgesia effectively mitigates postoperative acute pain and facilitates the postoperative rehabilitation process, the efficacy of preventive precision multimodal analgesia (PPMA) remains uncertain. This study designs a PPMA strategy targeting incisional pain, inflammatory pain and visceral pain in VATS. It aims to investigate the impact of the PPMA strategy on the postoperative acute pain process and rehabilitation outcomes.

Method and analysis

This multicentre, single-blinded, randomised controlled trial will enrol adult patients scheduled for elective thoracoscopic lobectomy or segmentectomy. A total of 1372 participants will be recruited and randomly allocated in a 1:1 ratio to either the preventive precision multimodal analgesia group (PPMA Group) or the conventional multimodal analgesia group (CMA Group). Patients in the PPMA Group will receive a regimen consisting of local anaesthetic infiltration of surgical incision (for incisional pain), intravenous injection of oxycodone (for visceral pain) and parecoxib sodium (for inflammatory pain) before surgery initiation. Patients in the CMA Group will receive the same regimen after specimen isolation. This trial will be conducted across 13 medical centres in China from 2023 to 2026. The primary outcome is the duration of postoperative acute pain. Secondary outcomes include postoperative analgesic consumption, postoperative pain scores, intraoperative haemodynamic parameters and the Indexes of Consciousness (IoC1 and IoC2), as well as intraoperative arterial blood gas and ventilation parameters, intraoperative dosages of general anaesthesia, inflammatory markers at predefined time points, postoperative rehabilitation process and perioperative adverse events and complications.

Ethics and dissemination

This study has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University (Linyanshen[2023]-NO.012-003-Revised Vision 1). The results will be published in a peer-reviewed journal.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR2300072176).

Effect of preoperative liposomal bupivacaine single-injection pericapsular nerve group (PENG) block on lower extremity deep vein thrombosis in elderly patients with hip fractures: a randomised controlled, double-blind, prospective clinical study protocol

Por: Peng · H. · Wen · J. · Chen · M. · Jiang · Y. · Ou · J. · Wu · X.
Introduction

Deep vein thrombosis (DVT) of the lower limbs has a significantly higher incidence among elderly populations than that observed in other types of fractures, prolonged immobilisation and the systemic inflammatory response triggered by preoperative pain are the main risk factors. Liposomal bupivacaine (LB) single-injection pericapsular nerve group (PENG) block has demonstrated effective analgesia both before and after surgery, while preserving motor function in patients with hip fracture. Although regional nerve block is a well-established component of preoperative multimodal analgesia, its potential role and underlying mechanisms in the prevention of DVT in elderly patients with hip fracture remain largely unexplored.

Methods and analysis

This study will be conducted as a double-blind, randomised, sham-controlled, prospective clinical trial. On admission, a total of 132 participants will be randomly assigned using block randomisation to receive either treatment group (LB single-injection PENG block) or sham group (saline solution single-injection PENG block). The primary outcome was the incidence of DVT, while secondary outcomes included perioperative inflammatory and immune-related stress levels and functional-based pain scores.

Ethics and dissemination

This study protocol complies with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 guidelines and has been approved by the Ethics Committee of Shunde Hospital, Guangzhou University of Traditional Chinese Medicine (Approval No KY-2025005). The raw data are planned to be made publicly available on the ResMan raw data–sharing platform (IPD sharing platform) of the Chinese Clinical Trial Registry in December 2027 and can be accessed at http://www.medresman.org.cn.

Trial registration number

ChiCTR2500100799.

Association between maternal age at childbirth and childrens internalising problems in the USA: a cross-sectional mediation analysis of housing instability and family support using the 2022 National Survey of Childrens Health (NSCH)

Por: Li · M. M. · Li · D. M. · Ju · Q. R. · Zhao · Y. J. · Tuo · Z. T. · Zhang · X. S. · Liu · J.
Objectives

The optimal maternal age at childbirth has been a topic of bourgeoning literature, with earlier ages offering physiological benefits for maternal recovery. In contrast, later ages to give birth may provide psychological advantages due to greater emotional maturity. This study investigates the impact of maternal age at childbirth on children’s internalising problems and explores the mediating roles of housing instability and family support in this relationship.

Design

Cross-sectional study; mediation analysis of the 2022 National Survey of Children’s Health (NSCH) data.

Setting

Response in the 2022 NSCH in the USA.

Participants

This study is based on the 2022 NSCH, collecting a total of 54 103 completed surveys from randomly selected households across the USA. In this study, after excluding participants due to missing values in critical variables, 48 073 participants were included in the final analysis.

Results

Our findings are consistent with the hypothesis that increasing maternal age at childbirth is associated with lower children’s internalising problems. Analysis suggested this association operates directly and is indirectly linked to child outcomes through lower levels of housing instability and higher levels of family support. However, a distinct indirect effect emerged: increased maternal age was also associated with reduced family support, which was in turn linked to more internalising problems. The results illuminate potential mechanisms linking maternal age at childbirth to children’s internalising problems and underscore the importance of stable housing and family support in mitigating risk factors for children’s emotional well-being.

Conclusion

We found an association between advanced maternal age and fewer internalising problems in children. This relationship appears to operate directly and indirectly via a sequential pathway: higher maternal age correlates with lower housing instability, which in turn is associated with increased family support, ultimately correlating with improved child mental health outcomes.

Cross-cultural adaptation and psychometric testing of the Evidence-Based Practice Mentoring Scale in Chinese nurses

Por: Wang · M. · Sun · S. · Guo · M. · Qian · J. · Sun · Y. · Chen · M. · Yu · X.
Objectives

Mentoring has been identified as a promising strategy for implementing and sustaining evidence-based practice (EBP) in healthcare organisation. However, no appropriate tools were specifically developed or cross-culturally adapted into Chinese context to assess nurse’s perceived EBP mentoring, impeding comprehensive evaluation of the effects of mentoring intervention studies. This study aimed to cross-cultural adapt the Evidence-Based Practice Mentoring (EBPM) scale into Mainland China and evaluate its psychometric properties, including validity and reliability.

Design

A comprehensive translation and adaptation process was adopted to achieve the Chinese version of the EBPM (C-EBPM) scale. It consists of four steps: (1) trilateral translation procedure, (2) cognitive interview, (3) psychometric testing and (4) cross-time confirmatory factor analysis (CFA).

Setting

This study was conducted in four 3A-level hospitals located in Shaanxi and Zhejiang provinces, China, during two different data collection periods.

Participants

A total of 598 registered nurses participated in this study.

Results

After two rounds of the trilateral translation procedure, a 9-item version of the C-EBPM scale was generated. Ten registered nurses participated in cognitive interview understood the meaning of all items but the response options. All items had significant critical ratio values (t=15.866~20.584, p²/df=65.681/27 0.950, Tucker-Lewis Index=0.966 > 0.950, and standardised root mean square residual=0.026 0.70) and average variance extracted was 0.60 (>0.50).

Conclusions

The 9-item C-EBPM scale demonstrated robust reliability and validity and is suitable for assessing EBP mentoring among nurses.

Efficacy and neural mechanisms of a vibrotactile-enhanced, brain-controlled soft robotic glove for upper limb rehabilitation after stroke: a multicentre randomised controlled trial protocol

Por: Catherine Chan · K. L. · Yan · C. · Wang · X. · Huang · S. · Dai · W. · Luo · Y. · Cheng · Y. · Xu · B. · Zhang · W. · Shen · Y.
Introduction

Soft robotic gloves (SRGs) integrated with brain-computer interfaces (BCIs) have demonstrated potential in facilitating motor recovery after stroke by enabling active, intention-driven rehabilitation. Emerging evidence suggests that incorporating vibrotactile stimulation (VTS) into SRG-BCI systems may further enhance sensorimotor feedback. The objective of this study is to evaluate the therapeutic efficacy and underlying neural mechanisms of BCI-driven, intention-based glove activation compared with automated glove-assisted training, with VTS applied identically in both groups.

Methods and analysis

This multicentre, single-blind, randomised controlled trial will involve 48 post-stroke patients within 1 week to 3 months after stroke onset, with stratification by time since stroke during randomisation. Participants will be randomly assigned to either the BCI-SRG group (n=24) or SRG group (n=24). Both groups will receive identical VTS. Patients in the BCI-SRG group will actively initiate movements of the SRG through motor imagery, while those in the SRG group will receive automated glove-assisted training without BCI control. The intervention will be administered 5 days per week for 4 weeks. The primary outcome measure is the Fugl-Meyer Assessment of Upper Extremity. Secondary outcome measures include Wolf Motor Function Test, International Classification of Functioning, Disability and Health Generic Set, Barthel Index, Modified Ashworth Scale, Semmes-Weinstein Monofilament Test, as well as event-related spectral perturbation and event-related desynchronisation. All assessments will be conducted at both baseline and post-intervention.

Ethics and dissemination

Ethics approval of this study protocol has been obtained from the Ethics Committee of the First Affiliated Hospital with Nanjing Medical University (2025-SR-508). The findings will be disseminated through peer-reviewed journals, conference presentations and communication with scientific, professional and general public audiences.

Trial registration number

ChiCTR2500106951.

Unravelling antecedents and bidirectional impacts of nurse work rumination: a scoping review to enhance nurses well-being and improve nursing quality

Por: Hu · W. · Xie · X. · Xu · X. · Wei · S. · Zhu · L. · An · Y.
Background

Globally, work rumination is a common phenomenon related to nurse burnout. However, most existing studies focus on the single negative impacts of rumination, with less exploration of its dual effects and antecedents. Therefore, comprehensively exploring the effect of nurse work rumination and its influencing factors is crucial for enhancing the accuracy of nursing management.

Objectives

Identify the antecedents and dual effects of nurse work rumination to deepen understanding of this phenomenon and provide references for formulating interventions that enhance nurses’ well-being and improve the quality of nursing work.

Eligibility criteria

Included studies were original research articles focusing on work-related rumination of nurses in clinical settings. Excluded studies were those involving nurses without patient contact, rumination unrelated to work, studies not addressing the effects or influencing factors of rumination and non-Chinese or non-English language publications.

Sources of evidence

CINAHL, Cochrane, EMBASE, MEDLINE, Pubmed, Scopus, Web of Science, Sinomed, Wanfang, VIP and CNKI were searched to identify articles about nurse work rumination which were published up to January 2025.

Charting methods

A scoping review of the published articles of nurse work rumination was performed with the methodological process guided by the framework proposed by Arksey and O’Malley. A three-step coding procedure was used to synthesise the impacts and antecedents of nurse work rumination, which were subdivided into four categories individually based on the conservation of resources theory, the three-dimension theory of happiness and the distinctive features of the nursing profession.

Results

30 articles from 12 countries were included. The findings indicate that nurse work rumination has 28 kinds of impacts, including positive, negative and double-edged sword effects, in four aspects: nursing quality and safety (n=7), happiness (n=7), health (n=10) and relationship (n=4) from 29 articles. The findings also suggest that from 26 articles, work rumination will be influenced by 31 factors, which are based on conservation of resources theory classified into four categories: resource depletion (n=14), resource protection (n=4), consequences of resource depletion (n=5) and behaviour and cognition (n=8).

Conclusions

This scoping review constructs a conceptual framework of ‘antecedent factors-nurse work rumination-dual impacts’ by systematically synthesising 30 studies. Rooted in the conservation of resources theory, three-dimensional theory of happiness and nursing professional characteristics, the framework clarifies the classification logic and internal connections of 31 influencing factors and 28 bidirectional impacts. The positive effect of work rumination can promote nurses’ personal development by facilitating the problem-solving pondering. Nursing managers can leverage this integrated framework to design targeted intervention strategies, maximising the constructive effects of rumination while mitigating its adverse impacts. Classifying the factors affecting nurse work rumination according to the conservation of resources theory provides an important basis for exploring the influence mechanism of nurse work rumination. Future research should focus more on empirical studies on rumination to reduce nurses’ burnout and improve the quality of nursing work.

Left atrial appendage closure versus direct oral anticoagulants after pulmonary vein isolation for atrial fibrillation: protocol for a multicentre, prospective, randomised, non-inferiority trial (PROMOTE study)

Por: Shen · L. · Jiang · L. · Hao · Z. · Chu · H. · Wang · X. · Ning · Z. · Zhang · J. · Yang · B. · Xu · Y. · Fang · R. · Kong · L. · Zhang · X. · He · Q. · Zhang · Z. · Zhang · T. · Du · C. · Wu · Y. · Zhao · D. · Huang · H. · Ma · W. · Liang · Z. · Pan · X. · Wang · C. · Miao · Y. · Shen · L. · He · B.
Introduction

Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy.

Methods and analysis

The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality.

Ethics and dissemination

The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences.

Trial registration number

ChiCTR2000036538.

Construction of an emergency nursing-sensitive quality indicator system for patients with severe trauma: a modified Delphi study in the Chinese context

Por: Xie · L. · He · M. · Xing · N. · Feng · M. · Liu · X.
Objectives

The aim of the study was to develop a nursing-sensitive quality indicator system for emergency care of patients with severe trauma, providing a scientific measurement tool for evaluating the quality of emergency trauma nursing.

Design

A modified Delphi study.

Participants

Experts working in emergency surgery or trauma surgery departments were recruited. First, initial nursing-sensitive quality indicators were derived from an analysis and synthesis of existing evidence and semistructured interviews with 12 clinical experts. Subsequently, two-round expert consultations were conducted with 15 experts from various regions of China to refine and finalise the indicators. Finally, the analytic hierarchy process was used to determine the weights of each indicator.

Results

The valid response rates of questionnaires in the two rounds of expert consultation reached 88.89% and 93.75%, respectively, and the expert authority coefficients were 0.856 and 0.880. The experts ultimately reached a consensus, establishing a nursing-sensitive quality indicator system for emergency care of patients with severe trauma, comprising 3 first-level indicators, 11 second-level indicators and 49 third-level indicators.

Conclusions

This study provides a tool for the assessment of emergency nursing service quality for patients with severe trauma, establishing a scientific and effective nursing-sensitive quality indicator system to evaluate and improve the quality of nursing services provided by emergency nurses to patients with severe trauma.

Biobanking knowledge and donation willingness among musculoskeletal patients in England: a multisite cross-sectional study

Por: Boakye Serebour · T. · Kerasidou · A. · Gray · N. · Griffin · X. L. · Peach · C. · Singh · H. P. · Wheway · K. · Ambrosio · M. d. G. · Baldwin · M. · Snelling · S. J. B.
Objective

To date, few studies have investigated the factors associated with musculoskeletal patients’ willingness to donate biological samples and their knowledge regarding the use of such samples. We investigated the associations between these distinct knowledge factors, patients’ willingness to donate and socio-demographic factors.

Design

Cross-sectional survey.

Setting

Musculoskeletal outpatient clinics across four sites in England, representing varied demographic populations.

Participants

A total of 469 adult patients attending musculoskeletal appointments were recruited through convenience sampling.

Primary and secondary outcome measures

Ordinal regression models were employed to identify socio-demographic and clinical predictors of patients’ willingness to donate biological samples. Other outcome measures specifically in two areas of patient knowledge include: (1) knowledge of sample use and (2) knowledge of surgical waste tissue value and management.

Results

Only 37% of participants were aware of the term ‘biobank’. Despite this, participants showed a high level of knowledge regarding both biological sample use and surgical waste tissue management, although their understanding varied considerably by ethnicity and education. Participants with no formal education exhibited a lower level of knowledge in both areas related to sample use and surgical waste tissue management for biomedical research ((OR 0.30, 95% CI 0.14 to 0.61; p=0.001); (OR=0.29, 95% CI 0.16 to 0.52, p

Conclusions

Despite low awareness, musculoskeletal patients showed a high willingness to participate in biobanking. However, significant disparities by ethnicity and education persist. Targeted, inclusive engagement strategies are needed to address under-representation and foster informed, equitable participation of musculoskeletal patients in biomedical research.

Preventive effect of liraglutide on postoperative delirium in elderly patients undergoing cardiac surgery: protocol for a single-centre, randomised, double-blind, placebo-controlled trial

Por: Bai · S. · Wei · M. · Wu · Y. · Zhu · X. · Wang · Z. · Wang · Y. · Zhu · C. · Guan · Y. · Wang · D. · Liu · W.
Introduction

Postoperative delirium (POD) is a common and serious complication after cardiac surgery, particularly in elderly patients, and is associated with adverse short- and long-term outcomes. Effective preventive strategies remain limited. Liraglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated potential neuroprotective, anti-inflammatory and metabolic benefits, which may reduce the incidence of POD.

Methods and analysis

This is a single-centre, randomised, double-blind, placebo-controlled trial in elderly patients undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to receive liraglutide or placebo from the day before surgery until postoperative day 3. A total of 260 patients are planned to be enrolled in this study. The primary endpoint is the incidence of POD within 7 days, assessed using the Confusion Assessment Method (CAM) or CAM-intensive care unit. Secondary outcomes include delirium severity, neurocognitive and psychological function, cardiac function, clinical outcomes, major adverse cardiovascular events within 1 year and perioperative biomarker changes. Exploratory outcomes include functional MRI in selected subgroups and additional biomarker analyses.

Ethics and dissemination

The protocol has been approved by the Medical Ethics Committee of Nanjing Drum Tower Hospital. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

Trial registration number

ChiCTR2500106943.

Scoping review of AI-driven wearable technologies for rehabilitation and functional assessment in Parkinsons disease: a protocol

Por: Li · S. · Chen · S. · Yu · X. · Quan · M. · Deng · R.
Background

Parkinson’s disease (PD) is a common neurodegenerative disorder characterised by high prevalence and disability rates, severely impairing patients’ quality of life and imposing a substantial societal burden. Rehabilitation interventions are an essential component of PD management; however, conventional face-to-face rehabilitation is constrained by limited resources and poor adherence. In recent years, the integration of artificial intelligence (AI) with wearable technologies has offered new avenues for rehabilitation, enabling continuous monitoring, objective assessment and personalised feedback. Although relevant studies have emerged, most are limited by small sample sizes, short-term designs and a lack of comprehensive synthesis. This study aims to conduct a scoping review to summarise the current applications of AI-driven wearable technologies in PD rehabilitation and functional assessment, and to identify existing research gaps.

Methods and analysis

This review will follow the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines and employ the Joanna Briggs Institute three-step search strategy. After an initial pilot search, a comprehensive search strategy will be developed to systematically search 10 databases (CNKI, Wanfang Data Knowledge Service Platform, SinoMed, the Cochrane Library, PubMed, Web of Science, CINAHL, Scopus, Embase and the IEEE Xplore Digital Library). One researcher will independently perform data extraction, and another will independently verify the extracted data. Eligible studies will include original research articles, dissertations and conference papers published after 2020, involving PD patients and using AI-driven wearable devices for rehabilitation or functional assessment. Data will be synthesised narratively and presented using tables and figures.

Ethics and dissemination

This study involves only publicly available published data and therefore does not require ethical approval. Findings will be disseminated through peer-reviewed journal publications and presentations at academic conferences.

Effectiveness of self-abdominal massage on gastrointestinal function in postoperative ileus: a randomised controlled trial protocol

Por: Ma · Y. · Wang · H. · Liu · S. · Xu · Z. · Cao · Y. · Wang · G. · Liu · X. · Zhang · K. · Guo · G.
Introduction

Postoperative ileus (POI) is a common complication after colorectal surgery, characterised by impaired gastrointestinal motility leading to abdominal distension, delayed flatus and defecation, nausea and vomiting. Self-abdominal massage (SM) can promote bowel peristalsis, but its clinical efficacy on improving colorectal cancer patients with POI treated with an intestinal decompression tube remains to be further verified. Therefore, this study aims to evaluate the efficacy and safety of SM in improving gastrointestinal function in colorectal cancer patients with POI treated with an intestinal decompression tube.

Methods and analysis

This is a prospective, single-centre, randomised controlled, assessor-blinded and statistician-blinded trial. A total of 102 colorectal cancer patients with POI undergoing intestinal decompression tube placement will be recruited. Participants will be randomised in a 1:1:1 ratio to receive basic treatment (BT), BT plus SM (BT-SM) or BT plus simple physical stimulation (BT-SPS). The primary outcome is the time to first defecation after intestinal decompression tube placement. Secondary outcomes include time to first flatus, radiological evaluation, time to tolerability of semiliquid and solid foods, severity of nausea, vomiting, pain and abdominal distension, analgesic consumption, time to intestinal decompression tube removal, incidence of complications and adverse events after intestinal decompression tube placement. Outcome measures are collected at baseline, at 1, 2, 3 and 4 days after the end of the intervention. The primary time point will be 4 days postintervention.

Ethics and dissemination

This study has been approved by the ethical application of the Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine Ethics Committee (2025-K-49-01). All patients will be required to provide informed consent. Study results will be disseminated through publication in peer-reviewed journals and international conferences.

Trial registration number

ITMCTR2025001401.

Investigating the impact of residual refraction within {+/-}1.0 dioptre on uncorrected distance visual acuity in pseudophakic eyes: a cross-sectional study

Por: Li · D. · Zhang · J. · Jin · L. · Han · X. · Chen · L. · Liu · Y. · Cai · W. · Cao · Q.
Objectives

To investigate the impact of residual refraction within ±1.0 dioptre (D) on uncorrected distance visual acuity (UDVA) in pseudophakic eyes.

Design

Cross-sectional study.

Setting

This study was based on retrospectively collected electronic refraction records from a tertiary care academic ophthalmology centre in southern China between May 2022 and July 2025.

Participants

Patients aged ≥40 years who underwent uneventful phacoemulsification cataract surgery with in-the-bag monofocal intraocular lens implantation and achieved a postoperative corrected distance visual acuity (CDVA) of ≤0.1 logarithm of the minimum angle of resolution were enrolled. They were stratified by astigmatism subtypes: minimal astigmatism (

Outcomes measures

Postoperative evaluation (≥1 month) included spherical equivalent (SE) refraction, UDVA and CDVA. UDVA was compared across eyes with SE intervals of 0.50 D within ±1.0 D. ORs were calculated to assess the relative risk of failing to achieve a UDVA of 0.1 or better for postoperative SE within ±1.0 D, using 0.00 D as the reference.

Results

The study included 1333 eyes from 1333 patients (mean (SD) age, 66.1 (8.96) years; 532 male (39.9%)). Overall, and particularly in the minimal astigmatism (

Conclusions

The impact of refractive errors (≤1.0 D) on UDVA was associated with the magnitude and type of astigmatism. Residual astigmatism of ≥0.50 D exerted a significant negative effect on UDVA. A plano SE (0 D) was optimal for minimum and WTR astigmatism, whereas slight hyperopia yielded superior UDVA in ATR and oblique astigmatism.

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