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Ayer — Abril 21st 2026Interdisciplinares

Risk of severe cardiovascular events and incidence rate of cardiopulmonary events among patients with COPD in China: a retrospective cohort study

Por: Liu · Z. · Cheang · I. · Chen · Y. · Zhang · M. · Shen · P. · Li · W. · Hou · D. · Lin · H. · Zhan · S. · Sun · F. · Song · Y. · Li · X.
Objectives

To examine the risk of severe cardiovascular (CV) events in patients with chronic obstructive pulmonary disease (COPD) across different time periods following COPD exacerbations and the incidence rate of cardiopulmonary events in a real-world setting in China.

Design

Retrospective cohort study.

Setting

Regional electronic health records database from Yinzhou District of Ningbo City, China.

Participants

A total of 14 713 patients aged ≥40 years with a first COPD diagnosis between 1 January 2014 and 1 March 2022.

Primary and secondary outcome measures

The risk of severe CV events (ie, hospitalisation and a primary or secondary discharge code for acute coronary syndrome, heart failure decompensation, cerebral ischaemia, arrhythmia and CV-related death) during different exposed time periods following a COPD exacerbation, the incidence rate of overall cardiopulmonary events (ie, severe exacerbation of COPD, all-cause mortality, inpatient CV events, inpatient ischaemic stroke and inpatient tachyarrhythmia/atrial fibrillation) and the incidence rate stratified by COPD exacerbation history.

Results

We included a total of 14 713 patients. During a median (IQR) follow-up of 2.8 (4.0) years, 20.1% experienced severe CV events. Compared with the unexposed period, the risk of severe CV events was the highest in the first 10 days following a COPD exacerbation (adjusted HR 10.00, 95% CI 8.16 to 12.25). The risk of severe CV events decreased over time but remained significantly elevated up to 90 days post exacerbation. We found that 32.7% of COPD patients experienced cardiopulmonary events, with a crude incidence rate of 9.38 (95% CI 9.09 to 9.69) per 100 person-years.

Conclusion

This study is the largest retrospective cohort study investigating CV and cardiopulmonary events among patients with COPD in China. Our findings highlight an elevated risk of CV events closer to the time of COPD exacerbations and show that nearly one-third of COPD patients experience cardiopulmonary events.

Core outcome set for Traditional Chinese Medicine treatment of adult allergic rhinitis: study protocol

Por: Xu · Y. · Jiang · J. · Zhu · H. · Sun · Y. · Jin · X.
Introduction

Allergic rhinitis (AR) is a highly prevalent condition worldwide and imposes a substantial public health burden on adults. Although Traditional Chinese Medicine (TCM) therapies have shown potential therapeutic benefits in AR management, the lack of a standardised outcome evaluation framework limits evidence comparability and synthesis. Current studies commonly exhibit inconsistent outcome selection, heterogeneous measurement instruments and unclear assessment time points, reducing the applicability of findings to evidence-based practice and guideline development. Moreover, existing AR-related core outcome set (COS) studies generally target a broad population, with limited focus on adults (aged 18–75 years) and insufficient involvement of patients and other stakeholders. Therefore, this study aims to establish a standardised COS for clinical research in adult allergic rhinitis (COS-AR), with clearly defined outcomes, measurement instruments and recommended assessment time points. This COS-AR will provide a framework for outcome selection and measurement in clinical studies of TCM for adult AR.

Methods and analysis

The development of COS-AR will be conducted in four sequential phases: (1) A comprehensive review of randomised controlled trials and clinical trial registry entries related to adult AR from major domestic and international databases published between 1 January 2019 and 31 August 2025 will be performed. This phase will involve the systematic categorisation of all reported outcomes, including their definitions, measurement instruments and assessment time points. (2) An online survey will be administered to both clinicians and patients involved in AR management to identify outcomes considered most important by these stakeholders. (3) A modified Delphi process, consisting of two to three rounds of online surveys, will be conducted with over 100 key stakeholders to establish a COS. (4) One or two online consensus meetings will be convened with a representative group of 20–30 key stakeholders to reach final consensus on the outcomes, their definitions, measurement instruments and recommended assessment time points to be included in the COS-AR.

Ethics and dissemination

All activities conducted in this study have received ethical approval from the Medical Ethics Committee of Zhejiang Hospital (Ethics Approval Number: 2023 (9K)-X4). Written informed consent will be obtained from all participants prior to participation. The research findings will be disseminated through peer-reviewed publications and relevant academic and professional conferences.

Trial registration number

China Clinical Trial Core Outcome Sets Research Centre (ChiCOS). Available at: https://www.chicos.org.cn/cos/1788748723768049665 (accessed 29 December 2025)

Analysis of risk factors for primary non-central malposition of peripherally inserted central catheter tip in neonates with different diseases admitted to neonatal surgical department: a case-control study

Por: Mai · J. · Ruan · J. · Zhang · Y. · Xiao · Z. · Zhong · X. · Dai · K. · Jiang · X.
Objectives

To investigate the risk factors for primary non-central malposition of peripherally inserted central catheter (PICC) tip in neonates admitted to the neonatal surgical department, compare the malposition rates across different insertion sites in disease types, and explore whether different diseases affect PICC tip malposition.

Design

A retrospective case–control study conducted in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement.

Setting

A 3A women’s and children’s hospital in South China (Guangdong Province).

Participants

A total of 558 neonates aged ≤28 days who underwent PICC insertion between January 2019 and November 2024 were enrolled. Neonates with congenital circulatory system malformations, incomplete clinical data and death or treatment withdrawal before tip positioning were excluded.

Outcome measures

The primary outcome was the incidence of primary non-central PICC tip malposition confirmed by X-ray or ultrasound within 24 h after insertion. Secondary outcomes included comparison of primary non-central PICC tip malposition rates across different insertion sites and comparison of primary PICC tip malposition rates by insertion sites across different disease groups.

Results

558 neonates were included in this study, including 460 cases with PICC tip in place and 98 with PICC tip malposition. In binary logistic regression analysis, the PICC insertion site was considered an independent risk factor (OR 2.908, 95% CI 1.748, 4.840, p

Conclusion

Medical staff can choose appropriate upper or lower limb veins for PICC insertion without worrying about the impact of abdominal diseases or thoracic diseases on non-central PICC tip malposition. PICC insertion via the head and neck veins should be performed with caution in neonates, as these sites carry a high risk of primary non-central tip malposition compared with other insertion sites.

AnteayerInterdisciplinares

Development and real-world cohort validation of a meta-analysis-derived simplified scoring model for cardiac resynchronisation therapy response: a study protocol

Por: Liu · X. · Wang · Y. · Wei · M. · Tuerhong · Z. · Lu · Y.
Background

Cardiac resynchronisation therapy (CRT) is a cornerstone device-based treatment for patients with heart failure with ventricular dyssynchrony. However, approximately 30–40% of recipients fail to achieve clinical response. Despite extensive research, validated prediction tools grounded in high-level evidence and readily applicable in clinical practice remain lacking. This study protocol describes the development and real-world validation of a simplified clinical scoring model for CRT response derived from systematic review and meta-analysis.

Methods and analysis

This study will develop a CRT response prediction model via meta-analysis and preliminarily validates it in a single-centre retrospective cohort. Initially, systematic searches of multiple databases up to 31 January 2026 and meta-analysis will synthesise effect estimates for candidate predictors, creating an evidence-based foundation that conceptually functions as a ‘training dataset’. Predictor selection and prioritisation will be guided by study frequency, effect magnitude and clinical accessibility, with factor weights derived directly from pooled random-effects meta-analytic estimates. Log relative risks will be converted to integer scores to establish a series of nested prediction models. Model performance will then be comprehensively assessed in an independent ‘validation dataset’ comprising a single-centre cohort from Xinjiang Medical University, evaluating discrimination (area under the receiver operating characteristic curve), calibration (calibration plots and Hosmer-Lemeshow test) and clinical utility (decision curve analysis). The final scoring system will be identified through comparative model evaluation guided by parsimony principles.

Ethics and dissemination

This meta-analysis exclusively uses published, de-identified data and therefore does not require ethical approval. The validation cohort employs retrospectively anonymised patient data in strict adherence to the ethical principles of the Declaration of Helsinki. The study protocol has been approved by the Institutional Review Board of the First Affiliated Hospital of Xinjiang Medical University (Approval No.: K202403-48-2503A-Y1). As this constitutes a retrospective analysis of existing data, individual informed consent will be waived. Comprehensive measures to protect participant privacy and ensure data integrity will be implemented throughout all research procedures. The findings will be presented at academic gatherings or published in scholarly, peer-reviewed journals.

PROSPERO registration number

CRD42024572313

Comparison of the effects of eHealth-delivered sedentary breaks versus physical activity promotion interventions on sedentary time: protocol for a systematic review and meta-analysis

Por: Chen · S. · Nie · X. · Giovannucci · E. · Yang · L.
Introduction

Prolonged sedentary behaviour (SB) is an independent risk factor for adverse health outcomes, with current WHO guidelines emphasising both increased physical activity (PA) and reduced sitting time. While electronic health (eHealth) interventions offer scalable solutions, the comparative effectiveness of two dominant strategies: sedentary break interventions (frequent interruptions of sitting) versus PA promotion (structured activity sessions) remains unclear. This systematic review and meta-analysis protocol aims to compare the effectiveness of interventions targeting breaks in SB versus increased PA in reducing sedentary time through meta-analysis of randomised controlled trials (RCTs) comparing either intervention to a control condition, while exploring key moderating factors including participant characteristics, intervention type, duration, eHealth delivery mode, theoretical basis, use of behaviour change techniques (BCTs), PA intensity and SB frequency.

Methods and analysis

This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines. A comprehensive search will be conducted in PubMed, Embase, Web of Science and the Cochrane Library from inception to 31 July 2025, with language restrictions limited to English and Chinese publications. RCTs comparing eHealth-delivered interventions promoting sedentary breaks with those increasing PA in adults will be included. The primary outcome is sedentary time (objectively measured or self-reported), and secondary outcomes include health outcomes such as cardiometabolic markers, fatigue and well-being. Two reviewers (SC and XN) will independently screen studies, extract data and assess risk of bias using validated tools. Meta-analyses will be performed if sufficient homogeneous data are available, comparing changes in sedentary time. Subgroup analyses will explore effects by participant characteristics including gender (male vs female), age groups (3 to

Ethics and dissemination

Ethical approval is not required as this study involves secondary analysis of published data. Findings will be disseminated through peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD420251042994.

Indocyanine green fluorescence for intraoperative detection of liver tumours in minimally invasive surgery: protocol for the LIVERGREEN phase IV multicentre clinical trial

Por: Huerta · M. · Lopez-Ben · S. · Llado · L. · Sanchez-Cabus · S. · Mils · K. · Molina · V. · Dopazo · C. · Vidal · L. · Dalmau · M. · Caralt · M. · Roson · N. · Merino · X. · Armario · D. · Salcedo · M. T. · Pellino · G. · Sapisochin · G. · Gomez-Gavara · C. · LIVERGREEN Collaborative Grou
Introduction

Liver tumours are a leading cause of global morbidity and mortality. Current diagnostic tools, including computed tomography (CT), magnetic resonance imaging (MRI) and intraoperative ultrasound (IOUS), have limitations in detecting liver neoplasms. Indocyanine green (ICG) has emerged as a promising tool for improving liver tumour detection. This study aims to assess the impact of preoperative ICG on intraoperative tumour detection in minimally invasive surgery and develop a machine-learning algorithm to enhance tumour detection using ICG fluorescence.

Methods and analysis

This prospective, multicentre, phase IV clinical trial adheres to Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines. Patients with liver tumours eligible for minimally invasive surgery and a preoperative imaging test will be included. ICG will be administered intravenously 24 hours before surgery. Intraoperative procedures will include IOUS, ICG mapping and photographic documentation. Patients will be followed for 90 days to assess tumour progression, morbidity and mortality. The photographic analysis will enable the development of an artificial intelligence algorithm using machine learning and neural networks to identify lesions based on ICG fluorescence. The estimated sample size is 173 patients and the trial is predicted to accrue in 3 years.

Ethics and dissemination

The trial will be conducted in accordance with the Declaration of Helsinki and the Spanish Agency of Medicines and Medical Devices (AEMPS) guidelines. Approved by the local institutional Ethics Committee and the AEMPS, the results will be shared with the scientific community through publications and conferences.

EudraCT number

2023–5 08 316-27-00.

Trial registration number

NCT06398028.

Protocol version

V.12, 18 March 2025

Adjuvant short-course radiotherapy combined with chemotherapy and a PD-1 inhibitor for resected mucosal melanoma: study protocol for a single-arm, prospective, phase II trial

Por: Lv · J. · Shen · L. · Jiang · X. · Wu · R. · Zhou · S. · Zhang · Z. · Wan · J. · Xia · L. · Liu · F. · Liu · X. · Chen · Y. · Wang · Y. · Zhang · Z. · Xu · Y.
Introduction

Mucosal melanoma (MM) carries a high risk of postoperative relapse and poorer survival than cutaneous disease. Prospective data from China support adjuvant temozolomide–cisplatin (TMZ/DDP) in resected MM, while radiotherapy (RT) may augment antitumour immunity and synergise with programmed death 1 (PD-1) inhibitor. We therefore designed an adjuvant regimen combining short-course RT (SCRT) with chemotherapy and PD-1 inhibitor after curative-intent resection.

Methods and analysis

This investigator-initiated, single-arm, prospective, phase II study at Fudan University Shanghai Cancer Centre enrols adults (≥18 years) with histologically confirmed MM after R0/R1 resection, Eastern Cooperative Oncology Group (ECOG) performance status 0–1 and M0 disease. Patients receive six 3-week cycles of systemic therapy: pucotenlimab 200 mg IV on day 1; TMZ 200 mg/m² orally on days 1–5 and DDP 25 mg/m² IV on days 1–3. (SCRT; 25 Gy in five fractions) is delivered after the first two cycles of systemic therapy, followed by four additional cycles of systemic therapy without RT. The primary endpoint is 1-year recurrence-free survival (RFS). Secondary endpoints include locoregional RFS, distant metastasis-free survival, overall survival and safety (CTCAE V.5.0). The planned sample size is 47 (44 evaluable), providing 80% power (one-sided α of 0.10) to detect an improvement in 1-year RFS from 55% to 70%. Time-to-event endpoints will be estimated using Kaplan–Meier methods with 95% CIs.

Ethics and dissemination

The protocol was approved by the Ethics Committee of Fudan University Shanghai Cancer Centre (approval number: 2407300-5), and all participants will provide written informed consent. Findings will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

ChiCTR2400093001.

Mapping the landscape of concept analysis in nursing and auditing reporting completeness: a scoping review protocol

Por: Ge · J. · Yang · J. · Feng · Y. · Fan · T. · Ding · X. · Zhou · H. · Peng · S.
Introduction

Concept analysis is widely used in nursing to clarify key concepts, support theory development and improve conceptual consistency in research and practice. Although concept analysis studies have increased substantially, concerns remain regarding methodological heterogeneity and incomplete reporting. Based on preliminary scoping of the literature, no dedicated scoping review has yet mapped the broad landscape of concept analysis studies in nursing while also examining reporting completeness. This protocol describes a scoping review that will characterise methodological trends, identify recurrent reporting omissions and generate an evidence map to support future methodological work in this field.

Methods and analysis

This scoping review will follow established scoping review guidance and will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Guided by the Population-Concept-Context framework, we will search major English-language and Chinese-language databases for nursing-related concept analysis studies. All concept analysis approaches will be considered eligible, provided the study explicitly reports analysing a nursing-related phenomenon. Two reviewers will independently screen records, assess full texts and chart data using a standardised extraction form. In parallel, reporting completeness will be examined using an author-developed, evidence-informed audit checklist. Findings will be synthesised using descriptive statistics and qualitative thematic analysis.

Ethics and dissemination

Ethical approval is not required because this review will synthesise data from publicly available sources. Findings will be disseminated through peer-reviewed publication and conference presentation. The review is expected to provide a structured overview of current concept analysis practices in nursing and to identify priority areas for improving reporting transparency in future methodological work.

Comparing the effectiveness and safety of different surgical procedures for haemorrhoids: a protocol for systematic evaluation and network meta-analysis of randomised controlled trials

Por: Li · X. · Cheng · Y. · Zhi · C. · Liu · N. · Wang · X. · Zheng · L.
Introduction

Haemorrhoidal disease affects 25–40% of adults worldwide and constitutes a primary reason for outpatient colorectal consultations. Surgical management is essential for grade III–IV or treatment-refractory cases. Numerous procedures have emerged, including Milligan-Morgan open haemorrhoidectomy, Ferguson closed haemorrhoidectomy, stapled haemorrhoidopexy, Doppler-guided haemorrhoidal artery ligation, transanal haemorrhoidal dearterialisation and laser haemorrhoidoplasty. However, randomised controlled trials and conventional meta-analyses report conflicting results on efficacy, postoperative pain, recurrence rates and complications such as bleeding, stenosis and incontinence. Although network meta-analyses exist, an updated synthesis is needed because outcomes and follow-up vary across trials. This protocol aims to determine the most effective and safest haemorrhoid interventions (office-based and operative) through systematic review and network meta-analysis, providing evidence-based guidance for clinical practice and guideline development.

Methods and analysis

The Cochrane Library, Web of Science, MEDLINE, Embase, China National Knowledge Infrastructure, VIP, SinoMed and Wanfang databases will be searched from inception to January 2025, limited to English or Chinese publications. Randomised controlled trials evaluating haemorrhoid interventions/procedures for haemorrhoidal disease will be included, with outcomes encompassing cure rate, recurrence, complications, postoperative pain, wound-healing time, anal function and operative duration. Risk of bias will be assessed using RoB 2. Pairwise meta-analyses will be conducted in RevMan; network meta-analysis will employ Bayesian frameworks in GeMTC or R, incorporating consistency evaluation, node-splitting and surface under the cumulative ranking curve for treatment ranking. Subgroup analyses (haemorrhoid grade, follow-up duration), sensitivity analyses and publication bias assessments will be performed. Evidence certainty will be graded using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach and the Confidence in Network Meta-Analysis (CINeMA) framework.

Ethics and dissemination

As only published data will be used, ethical approval is not required. Results will be disseminated via peer-reviewed publication and conference presentations.

PROSPERO registration number

CRD420251053697.

Seasonal and temporal trends in leading causes of hospitalisation among older adults in Hong Kong: a retrospective study across community and institutional care settings

Por: Qian · X. X. · Chau · P. H. · Lai · E. T. C. · Wong · G. L.-H. · Woo · J.
Objectives

With an ageing population, understanding leading causes of hospitalisation in older adults is critical for care strategies. These leading causes may vary across residential settings and by seasonal patterns. This study examines the temporal trends of leading causes of hospitalisation among older adults in community-dwelling and nursing home settings, specifically comparing patterns during winter and summer seasons.

Design, setting, participants and main outcome measures

A retrospective analysis of electronic medical records from Hong Kong public hospitals (2012–2018) was conducted for three million adults aged ≥65. Age-standardised and sex-standardised monthly hospitalisation rates and average annual percentage change (AAPC, representing the average yearly percentage change in rates) were examined for leading causes during summer and winter across settings.

Results

Among community-dwelling individuals, the top five causes in 2018 were symptoms, signs and abnormalities not classified elsewhere (NEC), neoplasms, genitourinary, circulatory and respiratory diseases in winter, with digestive diseases replacing respiratory diseases in summer. Symptoms, signs and abnormalities NEC (AAPC: 2.7% (95% CI 1.8% to 3.6%) in winter; 3.4% (2.8% to 4.0%) in summer), neoplasms (2.4% (1.4% to 3.4%) in winter; 2.5% (1.6% to 3.4%) in summer), genitourinary (2.5% (2.1% to 2.9%) in winter; 2.4% (1.8% to 3.0%) in summer) and digestive diseases (2.5% (1.6% to 3.3%) in winter; 2.6% (1.7% to 3.5%) in summer) increased, while circulatory diseases decreased in winter. In nursing home residents, the top five causes in 2018 were respiratory diseases, symptoms, signs and abnormalities NEC, genitourinary, circulatory and digestive diseases in winter and summer. Symptoms, signs and abnormalities NEC increased (2.9% (0.9% to 5.0%) in winter; 2.9% (0.8% to 5.1%) in summer), while circulatory diseases declined across seasons. Genitourinary diseases remained stable across seasons, whereas digestive diseases declined in winter.

Conclusions

In Hong Kong’s ageing population, seasonal and temporal shifts in hospitalisation causes were observed. Symptoms, signs and abnormalities NEC emerged as the top two causes across settings, highlighting challenges for primary care and hospital management and need for enhanced prevention and care strategies.

Effectiveness of Balint group interventions for physician burnout: a systematic review and meta-analysis protocol

Por: Li · J. · Jiang · H. · He · X. · Xi · W. · Zhu · R. · Chen · S. · Zhang · X. · Nie · D. · Zeng · X. · Zou · C.
Introduction

Physician burnout is a global crisis compromising healthcare sustainability and patient safety. Balint groups, a structured case-based discussion intervention focusing on the doctor-patient relationship, are increasingly used to mitigate this distress. However, existing evidence regarding their efficacy remains fragmented. This systematic review and meta-analysis aims to evaluate the effectiveness of Balint groups in reducing physician burnout and improving secondary psychological outcomes, while also assessing implementation characteristics.

Methods and analysis

We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials, Web of Science, CINAHL, PsycINFO and major Chinese databases (China National Knowledge Infrastructure, Wanfang Data and SinoMed) from inception to 31 May 2026, supplemented by grey literature and trial registries. The formal search has not yet commenced and is planned to begin on protocol publication. We will include both randomised controlled trials (RCTs) and non-randomised studies of interventions (non-randomised trials (NRTs), including non-controlled before-after studies) that evaluate Balint groups for practising physicians. The primary outcome is the change in burnout severity, with priority given to the emotional exhaustion subscale of the Maslach Burnout Inventory; however, data from other validated tools, such as the Oldenburg Burnout Inventory, will also be extracted and synthesised if reported. Secondary outcomes include stress and anxiety as psychological comorbidities closely associated with burnout, and job satisfaction, adherence and medical errors as its downstream occupational consequences. Two reviewers will independently screen studies, extract data and assess risk of bias using the Cochrane RoB 2.0 tool for RCTs and the Effective Public Health Practice Project tool for NRTs. Data synthesis will be conducted separately for RCTs (between-group effects) and NRTs (within-group effects) using random-effects models. Heterogeneity will be explored via subgroup analyses (eg, career stage) and, where data permit, meta-regression. The certainty of evidence will be assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethics and dissemination

Ethical approval is not required as this study synthesises primary data from published research. Findings will be disseminated through a peer-reviewed journal publication and conference presentations to inform interventions for physician well-being.

PROSPERO registration number

CRD420251142526.

Effects of modified site for radial artery cannulation on the stability of arterial blood pressure monitoring in patients undergoing elective surgery (MoSRAC): protocol for a randomised controlled trial

Por: Yang · X. · Liang · H.-M. · Huang · Y.-B. · Li · S. · Chen · Y. · Luo · T.-F. · Wang · W. · Li · J. · Zhao · Y.-Y. · Jin · Y. · Wang · F. · Yao · Y.-C. · Jin · S.-Q. · Zheng · Z.-N.
Introduction

Invasive arterial blood pressure monitoring is critical for perioperative and critically ill patients, yet traditional radial artery cannulation near the wrist joint is prone to catheter dysfunction (eg, kinking, occlusion) due to positional changes, compromising accuracy and patient safety. This trial hypothesises that modifying the cannulation site to 1.5–2.5 cm proximal to the radial styloid process may enhance catheter stability.

Methods and analysis

This is a prospective, parallel-group, randomised, controlled, analyst-blinded trial. A total of 486 participants (243 per group) will be enrolled at the Sixth Affiliated Hospital, Sun Yat-sen University. Eligible patients (18–75 years, American Society of Anesthesiologists physical status I–III, requiring elective surgery with radial artery cannulation) will be randomised 1:1 to the modified group (1.5–2.5 cm proximal to the radial styloid process) or the conventional group (traditional site). The primary outcome is the incidence of arterial catheter dysfunction (defined by criteria such as blood sampling difficulty, position-dependent waveform or improved waveform post-square wave test). Secondary outcomes include frequency of catheter dysfunction, damping abnormality rate, first-puncture success rate, number of arterial punctures, arterial cannulation time, complication incidence and blood pressure measurement differences.

Ethics and dissemination

This study protocol (V.4.0) was approved by the Ethics Committee of the Sixth Affiliated Hospital of Sun Yat-sen University in Guangzhou, China on 2 September 2025. The first participant was recruited on 15 September 2025, with an estimated completion date of 31 December 2025. Informed consent will be obtained from all participants. Findings will be published in peer-reviewed journals.

Trial registration number

NCT06566456.

Influencing factors and sex differences of life satisfaction in patients with chronic kidney disease: a national cross-sectional study in China

Por: Shen · K. · Ji · X. · Zhang · Y. · Cheng · Y. · Xian · X.
Objectives

The purpose of this study was to investigate the factors influencing life satisfaction in patients with chronic kidney disease and to explore any sex differences. Thus, this provides a theoretical basis for improving the life satisfaction status of middle-aged and elderly patients with chronic kidney disease, as well as formulating prevention, treatment and intervention strategies.

Design

Based on the health ecology model, 22 potential influencing factors were identified at five levels. Subsequent analyses examined whether they impacted the life satisfaction of patients with chronic kidney disease and had varying effects on different sexes.

Participants

A total of 1422 patients with chronic kidney disease were included from the 2018 China Health and Retirement Longitudinal Study.

Primary and secondary outcome measures

The 2 test and multivariate logistic regression model were used to analyse the influencing factors of life satisfaction in patients with chronic kidney disease and their sex differences. Sensitivity analyses additionally supported the robustness of the results.

Results

Age, self-rated health, depressive symptoms, marital satisfaction, satisfaction with children, activities of daily living and pension were all significant influencing factors of life satisfaction in patients with chronic kidney disease (p

Conclusions

This study reveals that a combination of factors affects life satisfaction in patients with chronic kidney disease. Therefore, targeted prevention and intervention strategies should be carried out, with specific focus on females, individuals with poor self-rated health and those experiencing depressive symptoms from a multidimensional perspective.

Health outcomes and reinfection among COVID-19 survivors 4 years after hospital discharge in Wuhan, China: a cohort study

Por: Dai · Y. · Luo · H. · Liu · X. · Hu · B. M. · Wang · M. · Cheng · L. X. · Luo · Y. · Ma · X.-y. · Cao · G. · Mao · Q. · Li · L.
Objectives

To evaluate health outcomes and identify risk factors for reinfection and persistent symptoms among COVID-19 survivors 4 years after hospital discharge.

Design

Longitudinal cohort study.

Setting

Two hospitals in Wuhan, China.

Participants

1076 COVID-19 survivors discharged from hospital.

Outcome measures

Self-reported symptom questionnaire, Chronic Obstructive Pulmonary Disease Assessment Test, Hospital Anxiety and Depression Scale and Checklist Individual Strength (CIS) fatigue subscale. Long covid was defined according to WHO criteria.

Results

Median age was 58 years and 50.2% were male. Reinfection during December 2022–April 2023 occurred in 36.1%; 21 developed pneumonia and 14 required hospitalisation. At least 12 months after reinfection, 12.1% reported sequelae compared with 46.9% after the initial infection. At 4 years, 16.7% reported long covid symptoms, commonly fatigue, chest tightness, cough and dyspnoea. In multivariable analysis, risk factors for abnormal fatigue (CIS ≥27) included age (OR 1.020, 95% CI 1.007 to 1.034; p=0.003), reinfection (OR 2.393, 95% CI 1.708 to 3.352; p

Conclusions

At 4 years post discharge, symptom burden was lower than at earlier follow-up time points for most survivors. Reinfection and older age were associated with persistent symptoms.

Efficacy and Safety of preoperative Controlling Heart Rate in Patients with Acute Type A Aortic Dissection (ESCORT): protocol for a randomised controlled trial

Por: Liu · G. · Wang · D. · Yang · Y. · Zhang · T. · Xie · B. · Hu · J. · Wei · X. · Chen · J. · Yuan · S. · Yu · C.
Introduction

Aortic dissection (AD) is a life-threatening cardiovascular emergency with a high mortality rate, and acute Stanford Type A AD is the most dangerous form, often requiring surgical intervention. Factors contributing to the progression of AD include increased heart rate, blood pressure and the rate of ventricular contraction (dP/dt). While heart rate control is a cornerstone of preoperative management for AD per existing guidelines, the recommended target (eg, ≤60 bpm in American Heart Association 2010) is consensus-driven (Level C) and thus not grounded in high-level evidence. The ESCORT (Efficacy and Safety of preoperative Controlling heart Rate in patients with acute Type A aortic dissection) trial is designed to address this critical gap by providing high-level evidence from a randomised controlled trial to define the optimal preoperative heart rate target.

Methods and analysis

The study is a multicentre, single-blind, RCT involving adult patients diagnosed with acute (Stanford Type A) AD, scheduled for aortic arch prosthetic vascular replacement and elephant trunk stent implantation surgery. 680 patients will be randomised into two groups: low heart rate target group (55–65 beats per minute) and standard heart rate target group (75–85 beats per minute). The intervention involves protocol-directed medication to achieve the target heart rates, with esmolol as the primary recommended agent. The primary outcome measure is the rate of major adverse cardiovascular event within 30 days after surgery, and secondary outcomes include various clinical, economic and biochemical measures.

Discussion

The ESCORT study is the large-scale RCT to investigate the optimal preoperative heart rate control in patients with acute type A AD. The results of this study have the potential to fill the evidence gap in current clinical guidelines and provide evidence-based support for clinical management. The findings may influence the standard of care by either endorsing lower heart rate targets or providing alternative guidance for managing heart rate in this high-risk patient population. The study’s results will be disseminated through publications and presentations at both national and international conferences, ensuring that the results are accessible to the medical community and relevant patient organisations.

Ethics and dissemination

This study, including the study protocol (version 1.3, 3 December 2022), was approved by the Ethics Committee of Fuwai Hospital, CAMS and PUMC (approval number: 2022-1886). Additional approvals were obtained from the ethics committees of participating subcentres (approval numbers are listed in the main text). The findings will be disseminated through publications in peer-reviewed journals and presentations at scientific conferences.

Trial registration number

ChiCTR2300067811.

Facilitators and challenges in the practice of skin-to-skin contact after birth: a scoping review protocol

Por: Wu · Y. · Huang · Y. · Xiao · X. · Huang · C.
Introduction

Neonatal survival continues to pose a global health challenge. Skin-to-skin contact (SSC) has been shown to significantly reduce neonatal mortality and offer numerous benefits for both mothers and newborns. However, its implementation varies widely across healthcare settings and is often hindered by practical barriers. This scoping review aims to systematically explore the facilitators and challenges associated with implementing SSC after birth and to synthesise relevant evidence to guide clinical practice.

Methods and analysis

This scoping review will follow the Joanna Briggs Institute methodological framework for scoping studies. A comprehensive search will be conducted across seven electronic databases and grey literature sources. Two review authors will independently perform the screening of studies and data extraction in parallel. Discrepancies will be resolved through consensus or consultation with a third author. A data extraction form will be developed based on key themes related to SSC implementations. The extracted data will be qualitatively analysed and presented in diagrammatic, tabular and narrative summary forms, in line with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses: Extension for Scoping Reviews reporting guidelines.

Ethics and dissemination

All data to be used in this study will be derived from previously published studies, thus rendering the need for ethical approval and informed consent superfluous

Registration

This protocol has been registered in Open Science Framework (https://doi.org/10.17605/OSF.IO/CWPK4).

Impact of a clinical pharmacist-led stewardship programme on antibiotic utilisation and clinical outcomes in thoracic surgery: a retrospective interrupted time-series study at a tertiary hospital in China

Por: Wu · G. · Guo · F. · He · Y. · Lu · J. · Liu · D. · Yin · X.
Objectives

This study aims to assess the impact of clinical pharmacist-led antimicrobial stewardship on antibiotic use and postoperative pulmonary infection in a surgical department.

Design

Retrospective and cross-sectional.

Setting

A tertiary hospital in Wuhan, China.

Participants

A total of 9157 patients who underwent video-assisted thoracoscopic lung surgery (VATLS) were included (4949 and 4208 pre-implementation and post-implementation).

Methods

An interrupted time-series design with segmented regression analysis was employed to evaluate changes in antibiotic use intensity (defined daily dose/100 bed-days), antibiotic spectrum coverage (scores/100 bed-days) and postoperative pulmonary infection rate before and after implementation of the stewardship programme. Between-group comparisons of antibiotic use rates and treatment duration were performed using 2 test, Fisher’s exact test, t-test or Mann-Whitney U test, as appropriate.

Outcome measures

Antibiotic use intensity (defined daily dose/100 bed-days), antibiotic spectrum coverage (scores/100 bed-days), postoperative pulmonary infection rates, the proportion and the duration of antibiotic use.

Results

Following implementation, antibiotic use intensity decreased immediately by 96.65 defined daily doses/100 bed-days (95% CI –122.56 to –70.74; p

Conclusion

Clinical pharmacist-led antimicrobial stewardship can reduce the antibiotic use intensity among patients undergoing VATLS in thoracic surgery, decrease the use of broad-spectrum antibiotics and shorten the duration of antibiotic therapy.

Analysis of risk factors and development of a predictive nomogram for chronic postsurgical pain after hip arthroplasty: a study protocol in a Chinese tertiary hospital

Por: Ni · R. · Gao · Z. · Jiang · Z. · Hao · X. · Zhang · M. · Lu · D. · Wu · Z. · Huang · P.
Introduction

Chronic postsurgical pain (CPSP) after hip arthroplasty is a major complication that affects patients’ long-term quality of life. However, reliable tools for the individualised prediction of CPSP risk after hip arthroplasty are lacking. This study aims to develop and validate a nomogram model to predict CPSP risk in patients undergoing hip arthroplasty.

Methods and analysis

This prospective observational cohort study will consecutively recruit 300 patients undergoing primary hip arthroplasty at the Department of Orthopaedics and Joints, Nanping First Hospital Affiliated with Fujian Medical University. The primary outcome is CPSP assessed at 3 months postoperatively (Visual Analogue Scale score ≥4). Candidate predictor variables have been identified based on literature review and clinical expertise, and include demographics, comorbidities, preoperative pain, psychological status and surgical and perioperative management. The dataset will be randomly split into development and internal validation sets in a 7:3 ratio. We will employ Least Absolute Shrinkage and Selection Operator regression to select variables and will use multivariable logistic regression to build the final prediction model. Internal validation will be performed using bootstrap resampling (1000 repetitions). The model’s discrimination, calibration and clinical utility will be assessed using the C-statistic (area under the curve), calibration plots and decision curve analysis, respectively. The final model will be presented as a nomogram.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of Nanping First Hospital (Approval No: NPSY202412034). All participants will provide written informed consent. The results will be submitted for publication in a peer-reviewed academic journal.

Trial registration number

ChiCTR2500107193; https://www.chictr.org.cn/showproj.html?proj=282634.

Effects of transcutaneous auricular vagus nerve stimulation on perioperative anxiety in patients undergoing laparoscopic colorectal cancer surgery: a study protocol for a double-blind, prospective, single-centre, randomised controlled trial

Por: Zhou · Y. · Sang · S. · Yuan · M. · Zhu · X. · Wu · M. · Halisa · P. · Gu · L. · Zhang · M.
Background

Perioperative anxiety, characterised by tension, worry or fear from preoperative to postoperative phases, is prevalent among patients with colorectal tumour. It exacerbates intraoperative haemodynamic instability, postoperative pain and delirium and prolongs hospital stay, underscoring the need for effective management. Transcutaneous auricular vagus nerve stimulation (TaVNS) represents a promising non-invasive intervention for anxiety alleviation. This study aims to evaluate the efficacy of TaVNS in reducing perioperative anxiety in patients with colorectal tumour, thereby providing evidence for its clinical application.

Methods and analysis

This randomised, prospective, double-blind, single-centre controlled trial will enrol 120 patients undergoing laparoscopic surgery for colorectal tumours. These patients will be randomly assigned to either the TaVNS group (n=60) or the control group (n=60). Both groups will receive corresponding stimulation for half an hour on the day before surgery and after extubation postoperatively. For the primary outcome measure, differences in anxiety scores will be assessed using the Hospital Anxiety and Depression Scale (HADS) on postoperative days 1–3 and 3 months postoperatively in patients with laparoscopic colorectal tumours. For the secondary outcome measures, the incidence of postoperative delirium, pain scores, Richards–Campbell sleep questionnaire scores and the occurrence of various postoperative adverse reactions will be compared.

Ethics and dissemination

This study has received approval from the Ethics Committee of Jiangsu Cancer Hospital on 28 September 2025 (Approval number KY-2025-149). The research findings will be published in international peer-reviewed academic journals and presented at academic conferences.

Trial registration number

ChiCTR2500112808.

LED red light for atrophy and microcirculation in pathologic myopia (RAMP): study design and protocol for a multicentre randomised controlled trial

Por: Zhang · J. · Yu · J. · Wang · X. · Sun · T. · Zou · Y.-l. · Zou · H. · Xu · Y.
Introduction

Pathologic myopia (PM) is a leading cause of irreversible blindness worldwide, yet effective therapeutic interventions remain limited. Although repeated low-level red light (RLRL) therapy has demonstrated significant efficacy in controlling myopia progression among children, its application in patients with PM remains unexplored. This study aims to evaluate the regulatory effects of RLRL on choroidal vascular density and thickness in patients with PM and verify its safety and efficacy in delaying the progression of fundus atrophic lesions.

Methods and analysis

This is a prospective, randomised, controlled trial enrolling 158 patients with PM aged 18–55 years. Participants will be randomised (1:1) to an intervention group or a control group. The intervention group will receive light-emitting diode–based RLRL therapy (wavelength, 660 nm; power density, 65 mW/cm²) administered two times daily for 3 min per session, 5 days per week, over a 12-month period. The control group will receive a sham treatment (power density, 5 mW/cm²) following an identical schedule. The primary outcome measure is the change in choroidal vascular density and choroidal vessel volume index at 12 months.

Ethics and dissemination

This study has been approved by the Ethics Review Committee of Shanghai Eye Disease Prevention and Treatment Centre (EC-20250506-04). This study will be conducted in adherence to the approved protocol, Good Clinical Practice and the Declaration of Helsinki. The study results will be submitted to a peer-reviewed journal and presented at both local and international congresses.

Trial registration number

NCT07312214

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