This study aims to examine the longitudinal relationship between fear of disease recurrence and depressive symptoms in elderly patients who have experienced postoperative adjacent vertebral refractures, as well as in their spouses, using the actor-partner interdependence model (APIM) to assess both individual and mutual psychological influences.

A prospective longitudinal study in China.

A total of 230 osteoporotic vertebral compression fractures (OVCF) and their spouses were selected by convenience sampling method.

Simplified fear disease Progression Scale and 9-item Patient Health Questionnaire were used at admission (T1), before discharge (T2) and 1 month after discharge (T3), respectively. Equivalence test and cross-lagged analysis of APIM were used for statistical examination.

A total of 224 valid questionnaires were collected in this study, yielding an effective recovery rate of 97.31%. Across the measurement stages, both patients and their spouses exhibited a decreasing trend in scores for fear of disease recurrence and depressive symptoms. The subjective effect analysis revealed that, in elderly patients with postoperative adjacent vertebral refracture, fear of disease recurrence significantly and positively predicted depressive symptoms at the subsequent stage (T1->T2: β=0.18, T2->T3: β=0.17, pT2: β=0.16, T2->T3: β=0.17, pT2: β=0.21, T2->T3: β=0.20, pT2: β=0.20, pT3: β=0.18, pT2: β=0.21, T2->T3: β=0.20, pT2: β=0.17, T2->T3: β=0.16, all p

It is recommended that medical staff prioritise the assessment and management of fear of disease recurrence and depressive symptoms in elderly patients with OVCF and their spouses, and strategically leverage the mutual influence between them to minimise depressive symptom levels as much as possible.

Many patients receive oral anticoagulation for reduced stroke risk in atrial fibrillation or as treatment or prevention of venous thromboembolism. Oral factor Xa inhibitors (oral FXaI, eg, apixaban, edoxaban or rivaroxaban) are commonly prescribed for this indication. Dabigatran, an oral direct thrombin inhibitor, is similarly approved. In vitro and animal model evidence suggests that dabigatran also has direct effects on Staphylococcus aureus virulence and infection. Observational data have shown that dabigatran users are less likely to develop S. aureus bacteremia (SAB), and a small randomised controlled trial showed that dabigatran has anti-S. aureus effects when compared with low molecular weight heparins during bloodstream infection. We seek to answer whether dabigatran is superior to the oral FXaIs in achieving better SAB outcomes among patients who independently require oral anticoagulation. We report the intervention-specific protocol, embedded in an adaptive platform trial.

The S. aureus Network Adaptive Platform (SNAP) trial [NCT05137119] is a pragmatic, randomised, multicentre adaptive platform trial that compares different SAB therapies for 90-day mortality rates. For this intervention (‘Dabi-SNAP’), patients receiving therapy with an oral FXaI will be randomised to continue as usual or to change to dabigatran as of the next scheduled dose. All subjects will receive standard of care antibiotics and/or antibiotics allocated through other active domains in the platform. As the choice of anticoagulant may not demonstrate large differences in mortality, a ranked composite of death and adverse outcomes (Desirability of Outcome Ranking, or DOOR) was chosen as the primary outcome.

The study is conditionally approved by the research ethics board of the McGill University Health Centre: identifier 2025-10900. Trial results will be published open access in a peer-reviewed journal and presented at a global infectious disease conference. The trial is registered at clinicaltrials.gov with the identifier NCT06650501.

NCT0665050.

Women who develop gestational diabetes mellitus (GDM) have a 60% lifetime risk of developing type 2 diabetes mellitus (T2D), which is already elevated within the first decade following childbirth. Despite the impact of lifestyle interventions to reduce long-term T2D risk in women with previous GDM, successful implementation of lifestyle interventions remains a barrier. Metformin is recommended for adults at increased risk of developing T2D; however, there is limited evidence of tolerability in the early postpartum period. Glucagon-like peptide 1 receptor agonists (GLP-1 RA) are effective at improving glycaemic status and body weight. However, GLP-1 RA have not been evaluated in the postpartum population. Finally, physical activity monitors may support behaviour changes related to physical activity to reduce long-term risk of T2D but are yet to be studied following GDM.

This will be a multicentre, randomised, open-label interventional pilot study. Using a 2x2 factorial design, we will examine the feasibility and acceptability of a pharmacotherapy intervention and a physical activity intervention in women with previous GDM at increased risk of developing T2D. Participants will be recruited from tertiary referral hospitals in Australia and will be randomised to receive either metformin alone or in combination with a GLP-1 RA and subsequently randomised to either a physical activity intervention involving activity monitor use, or usual care for 6 months, followed by a 6-month follow-up period. Primary feasibility outcomes include the acceptability and safety of the metformin and GLP-1 RA as measured through pill and injection counts, acceptability questionnaire and adverse events.

This trial is registered with the Australian and New Zealand Clinical Trials Registry (Registration Number: ACTRN12624001253594). This trial has received ethics approval from the South Eastern Sydney Local Health District Human Research Ethics Committee (Approval Number: 2024/ETH00042, protocol version v1.1, 28/02/2025).

Australian and New Zealand Clinical Trials Registry, Registration Number: ACTRN12624001253594.

Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.

This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.

The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.

ChiCTR2400090542.

Hypertension and depression frequently co-occur, complicating patient management and worsening outcomes. This scoping review aims to systematically map non-pharmacological interventions for managing comorbid hypertension and depression, providing insights into current practices and guiding future research.

Following the Joanna Briggs Institute guidelines and Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews standards, a comprehensive search was conducted across multiple databases, including PUBMED, Embase, PsycINFO, CINAHL, Cochrane Library, Chinese Biomedical Literature Database and Chinese National Knowledge Infrastructure, covering the literature from January 2004 to December 2023. Studies were selected based on predefined inclusion criteria focusing on non-pharmacological or complex interventions. Data extraction was performed using the Template for Intervention Description and Replication checklist to ensure detailed and structured summaries of each intervention.

Fifteen quantitative studies were included, most of which were pilot randomised control trials, pre-post studies and with generally small sample sizes (20 to 2365). Interventions were categorised into integrated and coordinated care, behavioural and psychological interventions and physical and lifestyle interventions. Delivery methods varied, with most interventions being face-to-face, while a few used digital platforms such as mobile apps and telephone support. Disease-level and patient-level outcomes were mainly reported, while only three examined system-level outcomes. 13 of 15 included studies showed positive results in managing comorbidity. The variability in follow-up periods (ranging from 1 week to 12 months) and measurement instruments across studies limited the ability to draw consistent long-term conclusions.

This scoping review highlights the role of psychosocial and non-pharmacological interventions, particularly collaborative/integrated care and behavioural therapies, in managing comorbid hypertension and depression. These interventions consistently improve depressive symptoms, with mixed effects on blood pressure control. Further research is needed to standardise core outcomes and evaluate the long-term effectiveness and scalability of these interventions.

Ischaemic stroke, the most prevalent stroke subtype, imposes a significant long-term disease burden. However, patients with first-ever stroke exhibit substantial individual variability in poststroke health trajectories, manifesting heterogeneous clinical presentations. We therefore started with the overall health of patients in order to delineate heterogeneous clusters characterised by distinct demographic profiles, clinical features and behavioural determinants and elucidate shared longitudinal trajectories in the temporal development of adverse health outcomes.

We designed a multicentre, cross-sectional and longitudinal study focusing on patients with first-ever ischaemic stroke. We will employ patient self-reported outcomes and objective measurements to comprehensively evaluate patients’ health status from a multidimensional perspective. Following baseline assessments, participants will undergo follow-up evaluations at 1 month, 3 months and 6 months post inclusion. The primary objective is twofold: (1) to identify distinct patient clusters with heterogeneous multidimensional health profiles using the k-prototype clustering algorithm and (2) to characterise synergistic trajectories of core health attributes within the largest cluster through parallel process latent class growth modelling. By combining cross-sectional and longitudinal analyses, this phased study should elucidate static heterogeneity and dynamic recovery patterns following a first-ever ischaemic stroke.

The project conforms to the ethical principles enshrined in the Declaration of Helsinki (2013 amendment) and all local ethical guidelines. The ethics committee at the University of South China approved the study (approval no. 2024 NHHL023). The ethics committee of Gansu Provincial Hospital approved the study (approval no. 2025–023). The ethics committee of the Central Hospital of Shaoyang approved the study (approval no.KY-2025–12). The findings will be published and presented at conferences for widespread dissemination.

Trial registration number: ChiCTR2500098442

Diabetes distress (DD) constitutes a negative emotional experience for patients with diabetic retinopathy (DR), having a detrimental impact on their physical and mental health.

The aim of this study was to understand the current status and influencing factors of DD in patients with DR and to explore the relationship between self-efficacy, coping styles and DD.

A cross-sectional study.

The study was conducted at the Eye Hospital of Wenzhou Medical University, Zhejiang Province, China.

Patients diagnosed with DR.

The Diabetes Distress Scale was used to assess DD.

DD was present in more than half (53.07%) of patients with DR. There were significant differences in DD among patients with DR who reported different employment statuses, modes of residence and body mass index. Coping styles partially mediated the relationship between self-efficacy and DD, with the mediating effect accounting for 71% of the total effect.

Considering the high prevalence of DD among patients with DR, healthcare professionals should pay more attention to the psychological needs of patients with DR. Effective interventions could be used to promote self-efficacy and coping styles of patients with DR, leading to lower levels of DD.

Proximal humeral fractures are increasingly common, particularly among older people, whereas the prognosis of surgical treatments for these fractures remains substantially uncertain. In China, where the ageing population is rapidly growing, high-quality prospective data on surgical outcomes, complications and cost-effectiveness are lacking. To address this gap, we propose to initiate a prospective, multicentre cohort study on surgical treatment for proximal humeral fractures in China—Cohort of Acute Shoulder Trauma (CAST) study.

The CAST is a multicentre, prospective cohort study enrolling patients with acute proximal humeral fractures undergoing surgical treatments at eight hospitals in China between May 2024 and December 2029. Patients can receive any of the surgical treatment methods which include percutaneous Kirschner wire fixation, external fixation, open reduction and internal fixation using locking plates or intramedullary nails, suture anchors and shoulder arthroplasty. We will collect patient-reported outcome measures (Quick Disabilities of the Arm, Shoulder and Hand), Constant-Murley, American Shoulder and Elbow Surgeons, EuroQol 5-Dimension and Visual Analogue Scale), physical examination results, imaging assessments (based on X-rays, ultrasound, CT and MRI scans), laboratory tests (including inflammatory cytokines) and data on medical costs. We will follow patients at 1 day, and at 1 month, 3 months, 6 months, 12 months and 24 months postoperatively. The planned sample size is 1500 patients.

The study protocol has been approved by the Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University (Approval No. 2024-ky-104(K)). Written informed consent will be obtained from all participants. Findings from the CAST study will be disseminated through peer-reviewed journals and academic conferences.

ChiCTR2500109651.

Atrial fibrillation (AF) constitutes a growing public health challenge. Consequently, the exploration of modifiable risk factors is essential for advancing AF prevention and management. While obstructive sleep apnoea is established as a risk factor for AF recurrence following catheter ablation, and its treatment with continuous positive airway pressure therapy reduces recurrence rates, the influence of non-sleep apnoea-related sleep indicators remains unclear. This systematic review aims to elucidate the association between these non-sleep apnoea-related sleep indicators and AF recurrence to inform optimised management strategies.

A comprehensive search will be performed in databases, including PubMed, Embase, the Cochrane Library, Chinese National Knowledge Infrastructure, VIP Database and Wanfang Data, covering publications from database inception to 27 August 2024. Study selection will be performed independently by two reviewers using predefined eligibility criteria, with the screening process documented in a referred Reporting Items for Systematic Review and Meta-Analysis-compliant flow diagram. Data will be extracted using standardised forms and risk of bias of included studies will be assessed with the Risk Of Bias In Non-randomised Studies-of Interventions tool. Non-sleep apnoea-related sleep indicators, including sleep duration, sleep quality, sleep latency, sleep efficiency, REM (Rapid Eye Movement)/NREM (Non-Rapid Eye Movement), etc, serve as exposure factors. The primary outcome is defined as AF recurrence, whereas the secondary outcome comprises quality of life measures among AF patients. Should sufficient data be available, a meta-analysis will be performed using appropriate statistical methods; otherwise, a narrative synthesis will be conducted.

This study uses publicly available data, so ethical approval is not required. The findings will be disseminated through peer-reviewed journals and scholarly platforms to inform clinical practice and future research.

CRD42024607124.

Emergence agitation (EA), defined as acute postoperative restlessness after general anaesthesia, is a common complication in the post-anaesthesia care unit (PACU). The reported incidence of EA is nearly 30% in neurosurgical surgery, which bears tremendous risks for neurosurgical patients. Although current evidence suggests that remifentanil may reduce EA risk in non-cardiac settings, its preventive efficacy in patients undergoing intracranial surgery remains unclear.

In this single-centre, randomised, double-blind, parallel-group prospective clinical trial, patients scheduled for elective craniotomy will be screened to confirm their eligibility. After surgery under general anaesthesia, patients will be assigned to groups to receive either remifentanil or placebo infusion on admission to the PACU. The remifentanil group will be given remifentanil infusion at a dose of 0.1 µg/(kgxmin), whereas the control group will be given the same volume of normal saline. The primary outcome is the effect of remifentanil on EA incidence during the emergence period. Secondary outcomes include the following: time to regain consciousness, extubation time, total PACU duration, extubation comfort score measured by the modified Minogue Scale, postoperative pain intensity assessed using a Numerical Rating Scale, awakening quality and postoperative delirium assessed by alertness and orientation score, and a 3-Minute Diagnostic Interview for Confusion Assessment Method.

The study protocol (V.4.0, dated 14 August 2025, No. 2025–0954) has been approved by the Institutional Ethics Committee of the First Affiliated Hospital, Zhejiang University School of Medicine and complies with the Declaration of Helsinki and relevant regulations for research involving human participants. Findings will be disseminated through peer-reviewed publications and conference presentations.

ChiCTR2500096691.

Cervical cancer (CaCx) is a leading cause of cancer-related deaths among women in South Africa, often presenting at advanced stages and requiring chemoradiotherapy. In South Africa, the burden is disproportionately high among women living with HIV, with limited access to radiotherapy further compounding treatment challenges. Despite this documented disparity, limited data exist on patients in a South African context. This protocol describes the research methodology to assess patterns of care, treatment delays, interruptions and survival outcomes in patients with advanced CaCx, addressing an urgent need for local data in low-income and middle-income countries to provide evidence-based improvements in care.

The Cervical Cancer Cohort at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH-CCC), initiated in 2023, is a mixed retrospective and prospective single-centre study investigating the characteristics, challenges and outcomes of patients with advanced CaCx. It includes women aged ≥18 years with a histopathological diagnosis of stage IB3–IVA CaCx treated at CMJAH Radiation Oncology. The retrospective component covers data from September 2018 to August 2023. Data collection is complete and the team is currently conducting quality control. The prospective component began in October 2023 and aims to enrol participants over 2 years, with follow-up for up to 3 years. The study is ongoing, and an extension for continued enrolment beyond September 2025 is being sought. Participants provide baseline data on demographics, socioeconomic status, cultural influences and healthcare access, with updates every 3 months. When necessary, the next of kin provides follow-up information. The study aims to inform strategies to improve outcomes and reduce the CaCx burden in South Africa.

Ethics approval for this study was obtained from the Human Research Ethics Committee (Medical) at the University of the Witwatersrand in Johannesburg, South Africa, with an ethical clearance certificate (MM221001 MED22-09-085). The results will be widely distributed through presentations at national and international conferences and published in peer-reviewed open-access journals, ensuring wide access to the results.

Gastric cancer (GC) remains a leading cause of cancer-related mortality worldwide, with most Chinese patients diagnosed at a locally advanced stage. Neoadjuvant chemotherapy (NAC) is increasingly used to improve resectability and survival. Laparoscopy-assisted distal gastrectomy (LADG) provides short-term recovery benefits compared with open distal gastrectomy (ODG), but its safety and oncologic efficacy following NAC remain uncertain. This trial aims to determine whether LADG is non-inferior to ODG in terms of long-term survival outcomes in patients with locally advanced distal gastric cancer (LAGC) after NAC.

This is a multicentre, randomised, controlled, non-inferiority trial conducted at high-volume GC centres in China. Eligible patients (aged 18–75 years; cT3–4a, N0/+, M0) with histologically confirmed distal gastric adenocarcinoma who have completed standard NAC will be randomised 1:1 to LADG or ODG with D2 lymphadenectomy. Surgical quality will be standardised through operative manuals, intraoperative video recording and central auditing. The primary endpoint is 3-year disease-free survival. Secondary endpoints are 3- and 5-year overall survival. A total of 998 patients (499 per arm) will be enrolled, providing 80% power to test non-inferiority with an absolute 8% margin, accounting for 15% attrition. Analyses will follow the intention-to-treat principle, with Cox models used for survival comparisons and subgroup analyses according to nodal status, tumour size and pathological response.

This trial has been reviewed and approved by the Biomedical Ethics Committee of West China Hospital, Sichuan University (Approval No. 2025 (865), 16 July 2025). Written informed consent will be obtained from all participants. The results will be disseminated through peer-reviewed journals and international conferences, providing high-level evidence to guide the surgical management of LAGC after NAC.

Chinese Clinical Trial Registry, ChiCTR2500109677; registered on 23 September 2025. Protocol V.2.1, dated 29 June 2025.

Low back pain (LBP) is the leading contributor to disability globally. It has a substantial impact on the lives of those who experience it, and places considerable economic burden on healthcare systems. Despite these impacts, and the consistency of guideline recommendations, many individuals do not receive recommended LBP management. Structural barriers to accessing timely, evidence-based care, as well as public uncertainty about where to seek appropriate management, can influence the care individuals receive. Telephone and digitally based helplines assist to overcome many traditional barriers to accessing care and offer a scalable platform to improve the delivery of guideline recommended management for LBP. However, uptake of such services can be limited without targeted promotion and patient-centred design. This project aims to codesign, implement and evaluate an upgraded component of an existing Australian helpline service, tailored for people with back pain and supported by a media awareness campaign. This protocol outlines the codesign process, implementation and planned evaluation of the helpline.

This protocol uses three complementary frameworks—an iterative codesign process, the Practical Robust Implementation Sustainability Model, and the Reach, Effectiveness, Adoption, Implementation and Maintenance framework—to guide the codesign and development, implementation and evaluation of an upgraded helpline for people with LBP. The codesign process involves key stakeholders, including consumers and clinicians, to inform the development and implementation of both the upgraded helpline service and the media campaign to raise awareness and uptake of the helpline. Data sources will include a pre–post cohort of helpline service users, routinely collected service data (eg, monthly call rate) and health system data to evaluate the broader population level impact (eg, rates of emergency department presentations for LBP in the Australian region targeted by the media campaign). Implementation evaluation will include Reach, Effectiveness, Adoption, Implementation and Maintenance as well as internal and external environmental factors that influence the success of these outcome measures.

The project was approved by the University of Sydney’s Human Research Ethics Committee (HE001081). This project involves collaboration with consumers, clinicians and other stakeholders to interpret, translate and disseminate research findings to relevant audiences.

Microvascular obstruction (MVO) is a common complication following primary percutaneous coronary intervention (PPCI) for ST-segment elevation myocardial infarction (STEMI) and is strongly associated with adverse clinical outcomes. MVO is a dynamic, multifactorial process shaped by factors spanning the myocardial infarction–reperfusion continuum and by PPCI-related microcirculatory injury, which leaves current early risk stratification—often a static snapshot—with limited power to anticipate its evolution. Renalase, a cardioprotective enzyme, exhibits a post-reperfusion surge that parallels MVO development; periprocedural renalase release may likewise be driven by overlapping mechanisms along the ischaemia–reperfusion pathway. This hypothesis-generating observation supports evaluating the delta-Renalase (periprocedural change in serum renalase) as a candidate association-based biomarker. Accordingly, this study aims to assess whether delta-Renalase is independently associated with MVO in patients with STEMI after PPCI and to evaluate its incremental predictive value, without causal inference.

The Renalase and MicroVascular Obstruction Study (ReMVOS) is a prospective, single-centre, observational cohort study conducted at a nationally accredited chest pain centre in China. We will enrol 266 patients with consecutive STEMI with symptom onset within 12 hours who undergo PPCI. The exposure variable is delta-Renalase, calculated as the increase in serum renalase levels at 24 hours post-PPCI relative to the preprocedural baseline. The primary outcome is the presence of MVO, assessed by cardiovascular magnetic resonance (CMR) performed 2–5 days post-PPCI. Secondary outcomes include infarct size and peak global longitudinal strain quantified by CMR, major adverse cardiovascular events within 90 days and peak oxygen pulse from cardiopulmonary exercise testing (CPET) at the 90-day visit. The independent association and predictive value of delta-Renalase will be evaluated using a prespecified multivariable logistic regression model.

This protocol has been approved by the Ethics Committee of the Third Xiangya Hospital of Central South University (approval No. K24655). All patients will provide written informed consent prior to enrolment. The findings of this study will be disseminated through publications in peer-reviewed international medical journals and presentations at relevant academic conferences.

NCT06669520.

This study aimed to analyse the burden of myocarditis in the Western Pacific Region (WPR).

Data from the Global Burden of Disease (GBD) Study 2021, covering 31 countries in the WPR, were analysed.

Patients diagnosed with myocarditis.

Numbers and age-standardised rates (ASRs) of incidence, prevalence, mortality and disability-adjusted life years (DALYs), along with their average annual percentage changes (AAPCs), were included. The contributions of population growth, ageing and epidemiological changes to ASR changes were assessed. Additionally, the ASRs of four indicators are projected until 2035.

In 2021, GBD estimates for myocarditis were 375 241.19 incident cases, 15 307.52 deaths and 379 674.28 DALYs in the WPR. From 1990 to 2021, the incidence, prevalence and mortality increased by 53.58%, 67.88% and 67.16%, respectively, whereas DALYs decreased by 24.77%. ASRs declined across all metrics: incidence (17.68 to 16.70 per 100,000; AAPC = –0.18, 95% CI –0.19 to –0.18), mortality (0.82 to 0.64 per 100,000; AAPC = –0.78, 95% CI –0.83 to –0.72) and DALYs (35.69 to 19.36 per 100,000; AAPC = –1.97, 95% CI –2.02 to –1.89). Papua New Guinea exhibited the highest increases in incidence, prevalence, deaths and DALYs. Japan, Singapore, China and Kiribati had the highest age-standardised incidence rate (ASIR), prevalence rate (ASPR), mortality rate (ASMR) and DALY rate (ASDR), respectively. Individuals aged ≥65 years and infants had significantly higher ASIR, ASMR and ASDR. Males consistently demonstrated higher myocarditis ASRs than females in the WPR from 1990 to 2021. Ageing was identified as the primary driver of increased incidence and mortality. Projections indicate that the ASIR of myocarditis will remain stable through 2035.

The burden of myocarditis in the WPR exhibits substantial cross-country variation, with males, infants and the elderly disproportionately affected, underscoring the urgent need for context-specific management strategies tailored to high-risk populations and regional epidemiological profiles.