Postoperative pain is common after surgery, with a high incidence and risk of becoming chronic. Current multimodal analgesia has drawbacks, including limited efficacy from single agents and opioid side effects and addiction risk. These issues have led to opioid-sparing multimodal analgesia. Transcutaneous auricular vagus nerve stimulation (taVNS) is non-invasive and convenient. Studies have shown it can reduce postoperative pain, improve mood and lower adverse events. However, taVNS lacks a comprehensive evaluation and standardised protocols, so further research is needed to provide reliable evidence.
This study strictly adheres to the guidelines of the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. To identify suitable randomised controlled trials (RCTs), eight credible databases will be searched, including four English databases (Web of Science, PubMed, Cochrane Central Register of Controlled Trials, EMBASE) and four Chinese databases (China National Knowledge Infrastructure, VIP Database for Chinese Technical Periodicals, Wanfang Database, Chinese Biomedical Literature Database). RevMan V.5.3 will be employed to integrate the retrieved data and conduct meta-analyses. The methodological quality of included RCTs will be evaluated using the Cochrane Risk of Bias Assessment 2.0 tool. Additionally, the Grading of Recommendations, Assessment, Development and Evaluation system will be applied to assess the strength and certainty of the evidence. We will also conduct publication bias analyses, sensitivity analyses and subgroup analyses.
No ethical review is required as no private or confidential patient data will be included. Results of this study will be disseminated through a peer-reviewed journal.
CRD420251207651.
The diversity of treatment options for diabetic retinopathy (DR) and the high uncertainty about the benefits and risks of different treatment modalities necessitate shared decision-making between patients and healthcare professionals. However, little is known about the involvement of individuals with DR in treatment decision-making in China. This study aims to gain insight into the current status and factors associated with involvement in treatment decision-making in patients with DR. Furthermore, we will explore the experiences and perceptions of patients with DR regarding their involvement in treatment decision-making.
We will conduct a mixed-method study using an explanatory sequential design. In the quantitative research (n=350), participants’ actual decision-making roles, sociodemographic data, disease-related data, health literacy, need for involvement in decision-making, decision-making self-efficacy, social support and ophthalmologist facilitation of patient involvement will be investigated to analyse the current state of patient involvement in treatment decision-making and the factors influencing it. Descriptive statistics, one-way analysis of variance and multinomial logistic regression will be performed. During this period, individual semistructured interviews will be conducted with a subset of these participants to understand the perceptions and experiences of people with DR regarding their involvement in treatment decision-making, and thematic analysis will be used to analyse the interview data. Finally, the joint display will be used to integrate quantitative and qualitative data.
Ethical approval for this study has been obtained from the Ethical Review Committee for Human Trials of Shanghai General Hospital, China (number: 2024–098). Written informed consent will be obtained from all participants after they have been fully informed about the study, prior to any data collection. The study’s findings will be disseminated through peer-reviewed publications and conference reports.
ChiCTR2400087906.
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.
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 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.
ChiCTR2500106951.
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.
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.
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.
ChiCTR2000036538.
To explore long-term physical activity (PA) among patients 2 years post-transcatheter aortic valve replacement (TAVR) and assess the impact of syncope history on post-TAVR activity.
This was a cross-sectional study conducted using an on-site questionnaire.
In this cross-sectional study, we used convenience sampling to recruit participants from the outpatient department at a tertiary hospital in Shanghai, China, between July 2023 and December 2023.
Patients who had undergone TAVR for 2 years or more were included in the study.
The self-reported PA levels were assessed using the validated Chinese version of the International Physical Activity Questionnaire-Short Form. Additionally, medical records of the patients were thoroughly reviewed to accurately document the history of syncope for everyone.
Via convenience sampling, we recruited 179 consecutive participants aged 60 years and older who underwent TAVR. Only 36.31% (65/179) of patients remained physically active ≥2 years post-TAVR, with 27.37% having a syncope history. After adjusting for potential confounders, a history of syncope was independently associated with significantly lower levels of long-term PA (adjusted OR 0.287, 95% CI 0.122 to 0.675). This negative association was particularly pronounced among men and individuals with a normal body mass index (BMI).
A history of syncope is a strong independent predictor of reduced PA in the long term after TAVR. These findings highlight that patients with a history of syncope, especially men and those with normal BMI, represent a high-risk subgroup warranting particular attention in post-TAVR care. Targeted assessment and rehabilitation strategies should be considered for this population, and further research is needed to elucidate the underlying mechanisms.
Chronic kidney disease (CKD) is a global health concern and a major long-term complication of diabetes, yet its burden remains understudied in regions with limited epidemiological data. This study aimed to evaluate the prevalence of CKD and its associated risk factors in the Iranian adult population, stratified by diabetes status.
Population-based cross-sectional study.
Nationally representative survey across Iran (STEPS 2021).
17 607 adults aged ≥25 years with complete kidney function and albuminuria data, selected through systematic sampling with weighting to ensure national representativeness.
CKD was defined as an estimated glomerular filtration rate (eGFR)
The national prevalence of CKD was 11.9% (95% CI 11.2% to 12.6%), with 9.1% (8.5% to 9.9%) among individuals without diabetes and 28.6% (26.2% to 31.1%) among those with diabetes. According to KDIGO classification, 88.1% (87.4% to 88.8%) were at low risk, 9.0% (8.4% to 9.6%) at moderate risk, 2.0% (1.6% to 2.4%) at high risk and 0.9% (0.7% to 1.1%) at very high risk. Albuminuria was more prevalent than low eGFR in both groups with (22.5% (20.4% to 24.8%) vs 10.3% (8.7% to 12.1%)) and without (5.7% (5.2% to 6.3%) vs 4.3% (3.8% to 4.8%)) diabetes. Diabetes was more strongly linked to albuminuria than low eGFR and was progressively associated with higher risk categories (adjusted ORs (aORs) 2.41 (2.03–2.86) for moderate, 2.63 (1.74–3.97) for high, 3.93 (2.56–6.07) for very high vs low-risk). CKD prevalence was highest in northwest Iran, increased significantly with age, with a stronger association observed for low eGFR than albuminuria, and was associated with hypertension (aOR 2.41 (2.07–2.82)), dyslipidaemia (1.60 (1.31–1.94)), obesity (1.94 (1.59–2.36)), ischaemic heart disease (1.53 (1.25–1.87)) and physical inactivity (1.40 (1.20–1.62)). Higher socioeconomic status and education were associated with lower odds of CKD.
CKD is a major burden, especially in individuals with diabetes, with regional and socioeconomic disparities. Addressing risk factors, integrating CKD into non-communicable disease surveillance and prioritising it in global health agendas, including the Sustainable Development Goals, are essential.
This study aimed to investigate the longitudinal association between sleep disturbance and the risk of new-onset incontinence in middle-aged and older Chinese adults and to explore whether chronic lung diseases mediate this relationship.
A prospective cohort study based on a nationally representative survey.
Data were obtained from the China Health and Retirement Longitudinal Study, a national survey of middle-aged and elderly community-dwelling Chinese adults.
A total of 7098 participants aged ≥50 years who were continent at baseline in 2011 and completed follow-up in 2015 were included in the analysis.
Sleep disturbance was assessed via self-report and categorised into good versus poor quality. Incident incontinence was defined as a new onset of difficulty in controlling urination or defecation. Multivariable logistic regression models were used to estimate the association between baseline sleep disturbance and incident incontinence, adjusting for sociodemographic, behavioural and health-related covariates. Mediation analysis was conducted to evaluate the indirect role of chronic lung disease in the sleep–incontinence pathway. Subgroup and interaction analyses assessed whether key demographic or health factors influenced the sleep–incontinence association.
Sleep disturbance at baseline was significantly associated with a higher risk of developing incontinence over 4 years (adjusted OR 1.34, p=0.040). This association remained robust across subgroups, particularly among participants aged ≥65 years, rural residents, those with higher education and those with chronic lung disease. Mediation analysis revealed that chronic lung disease partially mediated the relationship between sleep disturbance and incontinence, accounting for 7.59% of the total effect (indirect effect: 0.00104, 95% CI 0.00012 to 0.00170). Subgroup and interaction analyses confirmed the consistency of the findings across various demographic and health strata.
Sleep disturbance was associated with higher odds of incident incontinence among middle-aged and older Chinese adults. Chronic lung disease contributed modestly to this association. These findings underscore the potential importance of sleep health and comorbidity management in continence care for ageing populations.
Norepinephrine (NE) and phenylephrine (PE) are routinely administered vasopressors used to maintain haemodynamic stability during caesarean section. Emerging evidence suggests that sustained infusion of these agents may disrupt maternal blood glucose regulation. This randomised controlled trial aims to compare the effects of NE and PE infusion on changes in postpartum blood glucose levels, insulin concentrations and insulin resistance in women after caesarean delivery.
In this double-blind, randomised trial, 100 eligible parturients will receive prophylactic intravenous infusion of either NE or PE at a rate of 30 mL/hour immediately after subarachnoid anaesthesia, continuing until the end of surgery. The primary outcome is the difference between maternal preoperative and immediate postoperative blood glucose levels. Secondary outcomes include immediate and 6-hour postoperative insulin levels, as well as Homeostasis Model Assessment of Insulin Resistance.
The Institutional Ethics Committee of Xuancheng People’s Hospital approved the trial protocol (ID: 2025-yjky022-02). Findings will be published in an appropriate journal, and original data will be made available in November 2029 via the ResMan primary data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).
ChiCTR2500107683.
Although caesarean section (CS) has been reported as one of the potential risk factors for postpartum depression (PPD), there is uncertainty about the association between repeat CS and the risk of developing PPD. We sought to explore whether repeat CS will further increase the risk of PPD compared with primary CS.
Observational cohort study.
A tertiary maternity hospital in Shanghai, China.
571 women, aged 20 years and older, full-term parturients with singleton scheduled for elective primary or repeat CS were enrolled between December 2020 and September 2021.
An increased risk of PPD was defined as the total scores of the Edinburgh Postnatal Depression Scale ≥11. The primary outcome was the risk of PPD at 6 weeks postpartum. Secondary outcomes included the risk of postpartum depressive symptoms at 48 hours after CS, pain situation at 48 hours after CS and 6 weeks postpartum.
Among the 571 women included in the final analyses, PPD at 6 weeks postpartum occurred in 41 women (24.0%) in the repeat CS group (n=171) versus 93 (23.3%) in the primary CS group (n=400). After adjusting for the confounders, repeat CS was not associated with higher odds of PPD at 6 weeks postpartum (adjusted relative risk (aRR), 1.04 (95% CIs 0.73 to 1.45); adjusted risk difference (aRD), 0.03 (95% CI –0.32 to 0.37), p=0.84). Compared with primary CS, women with repeat CS were more likely to report significant uterine contraction pain (NRS ≥4) at 48 hours after CS (aRR, 1.51 (95% CI 1.23 to 2.03); aRD, 0.41 (95% CI 0.12 to 0.71), p
Repeat CS was not associated with the increased risk of PPD at 6 weeks postpartum in comparison to primary CS. But women undergoing elective repeat CS were more likely to suffer significant uterine contraction pain in early postoperative stage.
Supporting dementia caregivers is essential for improving patient outcomes and reducing caregiver burden, and it has become a core element of comprehensive dementia care. Accurate assessment of caregivers’ support needs is crucial for designing effective and targeted interventions. Although several instruments have been developed to assess these needs, there is limited evidence from systematic reviews regarding their measurement properties. Conducting a systematic review of the psychometric evidence for these instruments is therefore necessary to inform the selection and application of reliable tools in both research and practice. This review aims to identify and evaluate existing instruments for measuring support needs among dementia caregivers, summarise their psychometric properties and provide evidence-based recommendations for their use and future development.
This protocol follows the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols 2015 guidelines. A comprehensive search will be conducted in eight electronic databases from 1 August 2025 to 31 January 2026 to identify studies reporting the development or use of instruments measuring support needs among dementia caregivers. Two reviewers will independently perform literature screening, data extraction and methodological quality assessment, with disagreements resolved by discussion or consultation with a third reviewer. The measurement properties of the included instruments will be appraised in accordance with the Consensus-based Standards for the Selection of Health Measurement Instruments methodology.
Ethical approval is not required for this study as it will use data from previously published literature. The results of this systematic review will be disseminated through presentations at national and/or international conferences and publication in a peer-reviewed journal.
CRD420251129741.
The overuse of antibiotics for respiratory tract infections in primary healthcare in rural China is a particular challenge and is highly related to antibiotic resistance. Our research team designed a multi-component intervention focusing predominantly on health practitioners to reduce antibiotic prescriptions in rural communities of China. The effects of the intervention were evaluated through a randomised controlled trial. This study was conducted alongside the trial to develop a contextualised understanding of the implementation of the intervention and related influencing factors.
Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.
Primary healthcare in rural China.
27 health practitioners from township health centres assigned to the intervention arm.
A complex intervention to reduce antibiotic prescriptions in rural communities of China, which includes the following components: training for health practitioners, a public letter of commitment, patient leaflets, a decision support system and a peer support group.
Not applicable.
Data were analysed using thematic analysis.
The overall multi-component intervention was described as useful in reducing antibiotic prescribing, with a particularly high acceptance and use of patient leaflets and the public letter of commitment among health practitioners. There were mixed views on the decision support system and peer support group. Practitioners reported usability-related barriers to using the decision support system during consultations. Practitioners did not understand the role or benefits of the peer support group and found it difficult to initiate group discussions, due to the lack of any existing clinical team at the primary care level.
The multi-component intervention appears to be acceptable and useful in primary healthcare in rural China. Successful implementation requires a comprehensive understanding of the contextual characteristics of the setting. Interventions to reduce antibiotic prescribing in China in the future could consider wider stakeholders including patients, retail pharmacies and health authorities.
ISRCTN30652037 (01/12/2020).
To assess Chinese medical staff’s knowledge and attitudes towards insomnia and explore their association with mental health status.
A multicentre cross-sectional survey conducted across hospitals in China using convenience sampling.
Multiple hospitals across different regions of China; level of care primarily secondary.
A total of 654 medical staff enrolled from 23 hospitals between April and June 2023, with 420 (64.22%) nurses. Inclusion criteria encompassed hospital staff involved in patient care; exclusion criteria included those on leave or unwilling to participate. Data on sex and ethnicity were collected but not specified in the abstract.
Primary outcomes included insomnia knowledge and attitudes, assessed by a structured questionnaire. Secondary outcomes encompassed mental health status, measured via the Depression-Anxiety-Stress Scale (DASS)-21 (stress, anxiety and depression). The interactions between these variables were analysed using structural equation modelling (SEM).
Of the participants, 392 (59.94%) reported insomnia symptoms. The median scores for insomnia knowledge and attitudes were 16.0 (range 0–24) and 27.0 (range 7–35), respectively. The median DASS-21 score was 30.0; 189 (28.90%) experienced stress, 400 (61.16%) anxiety and 302 (46.18%) depression. SEM analysis indicated that night shift work (β=–0.101, p=0.024) and job satisfaction (β=–0.258, p
Medical staff showed limited understanding of insomnia and a high prevalence of stress, anxiety and depression. Targeted education, optimised shift scheduling and accessible mental health support are recommended to promote staff well-being and improve care quality. Nevertheless, the findings should be interpreted with caution because of the cross-sectional design and convenience sampling method.
To investigate whether pneumoconiosis increases the risk of cataract.
Nationwide population-based retrospective cohort study.
Taiwan’s National Health Insurance database, which covers >99% of the population.
The study included 19 841 adults newly diagnosed with pneumoconiosis between 2001 and 2020 and 79 364 age-matched and sex-matched individuals without pneumoconiosis. Participants with a prior history of cataract were excluded.
The primary outcome was incident cataract identified through International Classification of Diseases diagnostic codes. Subgroup analyses were performed to evaluate cataract risk across different strata of age, sex and comorbidity. In addition, among patients with pneumoconiosis, we conducted a secondary analysis evaluating the association between systemic corticosteroid use and cataract development.
During follow-up, the incidence of cataract was significantly higher in the pneumoconiosis cohort (38.9 vs 35.3 per 1000 person-years). Patients with pneumoconiosis had an increased risk of cataract after adjustment for age, sex and comorbidities (adjusted HR (aHR)=1.22, 95% CI 1.18 to 1.26). Elevated risks were observed in both men (aHR=1.22, 95% CI 1.18 to 1.26) and women (aHR=1.20, 95% CI 1.13 to 1.29). All age groups showed increased risks, with the highest estimate observed among patients aged ≥75 years (aHR=1.24, 95% CI 1.19 to 1.30). Subgroup analyses showed an increased risk in patients with pneumoconiosis who had no comorbidities (aHR=1.12, 95% CI 1.07 to 1.18). In a secondary analysis, systemic corticosteroid exposure was not significantly associated with cataract development (adjusted OR=0.65, 95% CI 0.39 to 1.09).
Pneumoconiosis is associated with an increased risk of cataract. Routine ophthalmologic surveillance should be considered in pneumoconiosis management.
To investigate, in a prospective cohort study, the association between cognitive impairment and cardiovascular disease (CVD), to quantify the extent to which uncontrolled risk factors mediate this association, and to explore whether the mediation effect varies across sex and age groups.
Prospective cohort study.
UK Biobank, a large population-based cohort study in the UK.
A total of 152 155 participants without prevalent CVD or dementia at baseline were included. The mean age was 56.3±8.2 years, and 44.0% were male.
Cardiovascular death and composite cardiovascular outcomes, assessed using Cox proportional-hazards models and mediation analyses.
During a median follow-up of 13.03–13.87 years, 1474 cardiovascular deaths and 21 518 composite cardiovascular outcomes were recorded. Participants with cognitive impairment (n=23 146; 15.2%) exhibited higher proportions of lifestyle, metabolic and psychological risks (p
Cognitive impairment is associated with increased risks of cardiovascular death and composite cardiovascular outcomes. Uncontrolled lifestyle, cardiometabolic and psychological risk factors partially mediate this association, highlighting the importance of comprehensive management to improve cardiovascular prognosis in this population.
Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.
DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6–18 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m2, and either a 24-hour urinary protein level of >0.2 g or a urinary protein-to-creatinine ratio (UPCR) of >0.2 mg/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.
This study has been approved by the Ethics Committee of the Children’s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.
To explore stakeholder perceptions on sugar-sweetened beverage (SSB) policies for Chinese children and adolescents and facilitators and challenges for policy implementation.
This study followed the sector governance analysis framework, which included three steps: context analysis, mapping stakeholders and stakeholder analysis. Context analysis comprised policy and literature reviews of existing domestic and international measures, complemented by expert consultation to clarify the policy context and identify relevant stakeholders. Guided by these insights, we mapped stakeholders for key informant interviews, in-depth interviews and focus group discussions to explore stakeholders’ perceptions of SSB policies. Qualitative data were collected and analysed through a thematic analysis approach.
Shanghai and Chongqing, China, July to August 2022.
37 stakeholders including policymakers, nutrition experts, industry and consumers (primary caregivers of children and adolescents aged 6–17 years).
Context and stakeholder analyses indicated rising SSB consumption among Chinese youth since 2000. Qualitative interviews reflected the absence of national policies due to inadequate policymaker awareness. Although policymakers and nutrition experts supported SSB policies, consumers were worried about their personal choices being affected and the industry feared innovation challenges and profit loss. Multiple stakeholders mentioned that a comprehensive national standard is lacking, which is needed to facilitate national policy roll-out. An initial focus on health education is suggested to raise awareness among policymakers and consumers to foster a supportive environment for SSB policy development.
Although SSB intake is rising among Chinese children, policymakers’ insufficient awareness and the lack of national standards hinder SSB policy development and implementation. Strategies that raise health knowledge and awareness among policymakers and consumers should be prioritised for now to assist future introduction of SSB standards and related policies.
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.
Spiritual well-being (SpWB) is a critical yet often underexplored component of holistic care for patients with advanced cancer. This study aimed to assess the SpWB and quality of life (QOL) levels and examine their correlation among patients receiving palliative care at a tertiary cancer centre in Kerala, India.
Institution-based cross-sectional observational study among patients with advanced cancer conducted between August 2023 and December 2024.
The outpatient department of a major tertiary-level, autonomous cancer centre under the Government of Kerala, India.
398 patients with advanced cancer aged 18 and above.
SpWB and QOL were measured using validated Malayalam versions of the Functional Assessment of Chronic Illness Therapy–Spiritual well-being Expanded Version and European Organisation for Research and Treatment of Cancer, Quality of Life Core 30 questionnaires, respectively. Data collection included patient self-reports or assistance by a medical social worker.
The median (IQR) age of participants was 59 (51–65) years; most were married (94.5%) and from an upper-lower socioeconomic background (55%). Hinduism was the predominant religion (67.1%). Almost all patients (99%) were aware of their diagnosis, but only 62.3% knew their prognosis. The median (IQR) SpWB score was 67.5 (57–76), significantly higher in females (p=0.02). The median (IQR) QOL score was 50 (41.7–66.7). SpWB was positively correlated with QOL (r=0.766, p
SpWB showed a strong positive correlation with QOL among patients with advanced cancer. Enhancing SpWB may play a pivotal role in improving overall QOL in palliative care settings.
Dexamethasone is commonly used to prevent postoperative nausea and vomiting (PONV). However, PONV is an unresolved complex problem; even with preoperative dexamethasone administration, 14.0%–26.3% of patients undergoing minimally invasive endoscopic procedures still experience PONV within 24 hours postoperatively. Compared with dexamethasone, dexamethasone palmitate has a long-lasting anti-inflammatory effect, two to five times that of traditional water-soluble dexamethasone, with fewer adverse events. This trial aims to assess the efficacy and safety of preoperative dexamethasone palmitate administration on postoperative PONV.
The INDEX trial is a multicentre, open-label, randomised, positive-controlled trial. A total of 588 patients will be recruited from three centres in China. Eligible patients are adults (aged 18–65 years) who undergo elective minimally invasive endoscopic surgery (laparoscopic or thoracoscopic surgery) under general anaesthesia. Eligible patients will be randomly assigned (1:1) to the dexamethasone palmitate or dexamethasone group. Patients in the dexamethasone palmitate group will receive intravenous injection of 8 mg of dexamethasone palmitate (containing 5 mg of dexamethasone), and those in the dexamethasone group will receive 5 mg of dexamethasone after anaesthesia induction and before surgical incision. The primary endpoint will be the incidence of PONV within the first 24 hours postoperatively. Secondary outcomes will include the incidence of PONV, postoperative nausea, postoperative vomiting, number of vomiting or retching episodes, severity of PONV, participant satisfaction, use of rescue antiemetic drugs and quality of postoperative recovery. The safety of participants will be monitored. A primary analysis will be conducted to evaluate between-group differences in the incidence of PONV in the intention-to-treat population and within the first 24 hours postoperatively. We will also perform a sensitivity analysis to evaluate the effect of missing values in the outcome parameters on the results. There is no plan to conduct an interim analysis.
Ethical approval was obtained from the Institutional Review Board of Beijing Tiantan Hospital Affiliated to Capital Medical University (KY 2025-041-02-01). The results will be disseminated in open-access publications and plain-language summaries.
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.