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Ayer — Marzo 4th 2026Interdisciplinares

Transcutaneous auricular vagus nerve stimulation for postoperative pain: a protocol for a systematic review and meta-analysis

Por: Lu · Y. · Lv · H. · Bian · Z. · Shen · Y. · Li · R. · Xia · Y. · Fang · J.-Q. · Wan · Y.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

PROSPERO registration number

CRD420251207651.

AnteayerInterdisciplinares

Exploring the drivers of price variation in orthopaedic radical bone tumor resection: A nationwide database study

by Devika A. Shenoy, William C. Cruz, Shamik Bhat, Katelyn Parsons, Aaron D. Therien, Kevin A. Wu, Christian A. Pean, William C. Eward

Background

Radical resection of bone tumors is a clinically effective but costly procedure. Despite the implementation of federal price transparency mandates, little is known about the nationwide variation in negotiated prices for these specialized oncologic surgeries. This study aimed to quantify the variation in negotiated rates for radical resection of the humerus and femur/knee and identify associated hospital, payor, and state-policy drivers.

Methods

This cross-sectional study analyzed hospital-negotiated payor rates from the Turquoise Health database for current procedural terminology (CPT) codes 24150 (humerus resection) and 27365 (femur/knee resection). Multivariate linear regression was used to determine the associations between hospital size and type, payor class, and state-level policies (Medicaid expansion, Certificate of Need [CoN] laws, All-Payer Claims Database [APCD] mandates, and Nurse Practitioner [NP] scope of practice) on negotiated payor rates.

Results

A total of 285,857 negotiated rates were analyzed. Significant price variation was observed across all factors. Large hospitals (>1000 beds) and Critical Access Hospitals (for femur/knee resection only) had significantly higher rates. CoN laws were associated with higher prices for both procedures (+$348.25 and +$667.98, respectively), as were APCD mandates for femur/knee resections (+$1231.24). Medicare Advantage plans paid inconsistently compared to commercial plans, paying more for humerus but substantially less for femur/knee resections.

Discussion

Negotiated prices for radical bone tumor resection are highly variable and influenced by a complex interplay of market dynamics, challenging the assumption that price transparency alone can standardize healthcare costs for specialized care.

Factors influencing patient involvement in treatment decision-making for diabetic retinopathy: a mixed methods study protocol

Por: Xu · L. · Zhang · H. · Shen · Y. · Pu · J. · Wu · Q. · Chen · L.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

ChiCTR2400087906.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

ChiCTR2500106951.

Association between endothelial activation and stress index and mortality in critically ill patients with atrial fibrillation: In MIMIC database: A Retrospective Cohort Study

by Peiling Zuo, Huanhuan Zhu, Chunying Sun, Xiaohan Ma, Sheng Chen, Rong Tang, Tong Wu, Ding Zhang, Xiao Tang, Wenquan Lv, Wenzhong Chen, Xiawei Wei, Encun Hou, Minsheng Wu, Minghe Jiang

Background

Evidence indicates that the Endothelial Activation and Stress Index (EASIX) is a predictor of mortality in endothelium-related conditions; however, its association with mortality risk in atrial fibrillation (AF) remains uncertain. Accordingly, this study examines the relationship between EASIX and mortality risk among patients with AF.

Methods

This retrospective analysis utilized data from the Medical Information Marketplace in Intensive Care IV (MIMIC-IV) database, which includes critically ill patients diagnosed with AF. To examine the association between EASIX scores and mortality, Kaplan–Meier survival analysis, Cox proportional hazards models, and restricted cubic spline regression were applied to evaluate the relationship between EASIX and all-cause mortality. Subgroup analyses were conducted to explore potential interactions with key patient characteristics, and sensitivity analyses were performed to further confirm the robustness of the results.

Results

A total of 3,193 patients were included in the analysis. KM survival analysis showed that elevated EASIX levels were associated with a higher risk of both in-hospital and ICU mortality. After adjusting for potential confounders, increased EASIX levels remained significantly associated with in-hospital mortality [HR, 1.09 (95% CI 1.03, 1.15), P = 0.0002] and ICU mortality [HR, 1.10 (95% CI 1.04, 1.17), P = 0.0002]. Stratified analyses revealed a significant interaction between sepsis, respiratory failure, and EASIX in relation to both in-hospital and ICU mortality. To evaluate the robustness of the findings, a sensitivity analysis was performed. After additionally adjusting for metoprolol and heparin as covariates, patients in the highest EASIX group continued to demonstrate the greatest mortality risk: the HR for in-hospital death was 2.08 (95% CI: 1.51–2.85), and the HR for ICU death was 1.83 (95% CI: 1.21–2.65).

Conclusion

Elevated EASIX levels correlate with higher mortality rates, underscoring its potential as an accessible tool for identifying high-risk patients and informing clinical decisions. However, further studies are needed to explore the underlying mechanisms and validate its applicability across diverse patient populations.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

ChiCTR2000036538.

Impact of syncope history on long-term physical activity in patients >=2 years after transcatheter aortic valve replacement: a single-centre cross-sectional study in China

Por: Shen · Z. · Zhu · Z. · Huang · C. · Zhou · D. · Lv · J. · Lin · Y. · Zhang · Y.
Objective

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.

Design

This was a cross-sectional study conducted using an on-site questionnaire.

Setting

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.

Participants

Patients who had undergone TAVR for 2 years or more were included in the study.

Primary and secondary outcome measures

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.

Result

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).

Conclusion

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.

Prevalence and risk factors of chronic kidney disease among Iranian adults with and without diabetes: a cross-sectional study using STEPS 2021 national survey

Por: Ataei · S. M.-N. · Almasi · G. · Kazemi · A. · Ahmadi · N. · Golestani · A. · Rashidi · M.-M. · Rezaei · N. · Azadnajafabad · S. · Rezaei · N. · Dilmaghani-Marand · A. · Ghasemi · E. · Farzi · Y. · Yoosefi · M. · Rezaee · K. · Foroutan Mehr · E. · Nasserinejad · M. · Haghshenas · R. · Al
Objectives

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.

Design

Population-based cross-sectional study.

Setting

Nationally representative survey across Iran (STEPS 2021).

Participants

17 607 adults aged ≥25 years with complete kidney function and albuminuria data, selected through systematic sampling with weighting to ensure national representativeness.

Primary and secondary outcome measures

CKD was defined as an estimated glomerular filtration rate (eGFR)

Results

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.

Conclusions

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.

Sleep disturbance and risk of incident incontinence in middle-aged and older Chinese adults: a 4-year national cohort study

Por: Shen · Y. · Zhang · W. · Gao · J. · Shao · S.
Objectives

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.

Design

A prospective cohort study based on a nationally representative survey.

Setting

Data were obtained from the China Health and Retirement Longitudinal Study, a national survey of middle-aged and elderly community-dwelling Chinese adults.

Participants

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.

Measures

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.

Results

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.

Conclusion

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.

Double Flap Tibial Transverse Transport Improves Microcirculation and Peripheral Nerve Function in Severe Diabetic Foot Ulcers

ABSTRACT

This retrospective study aimed to evaluate the clinical efficacy of double flap tibial transverse transport (dTTT) in the treatment of Wagner grade 3–4 diabetic foot ulcers (DFUs) and to assess its impact on peripheral nerve function in the affected limb. A total of 25 patients with DFUs who underwent dTTT at our institution were included. Baseline data were collected, and patients were systematically followed at 1, 3, 6 and 12 months postoperatively. Primary outcome measures included wound healing status, postoperative complications, microcirculatory indicators and nerve conduction parameters. All bone transport sites healed successfully, with no major complications observed except for one patient who died from COVID-19. At 12 months postoperatively, significant improvements were noted in foot skin temperature, transcutaneous oxygen partial pressure and the ankle-brachial index (all p < 0.001). Additionally, motor nerve conduction velocities of the posterior tibial and common peroneal nerves increased significantly (p < 0.001), and corresponding compound muscle action potential amplitudes rose to 4.91 ± 0.14 mV and 4.68 ± 0.29 mV, respectively (p < 0.001). These findings suggest that dTTT not only facilitates wound healing by improving local microcirculation but also enhances peripheral nerve function, offering a promising therapeutic approach for improving long-term outcomes and quality of life in patients with advanced DFUs.

Prophylactic norepinephrine versus phenylephrine infusion on postpartum blood glucose in women undergoing caesarean section: a randomised controlled trial protocol

Por: Zhang · K. · Cao · H. · Ji · H. · Yu · G. · Wu · L. · Shen · Q. · Qian · W. · Tao · W.
Introduction

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.

Methods analysis

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.

Ethics and dissemination

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).

Trial registration number

ChiCTR2500107683.

Association between repeat caesarean section and postpartum depression: an observational cohort study in Shanghai, China

Por: Lin · R. · Shuai · W. · Yu · Y. · Ma · R. · Zhou · X. · Luo · W. · Shen · F. · Xu · Z.
Objectives

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.

Design

Observational cohort study.

Setting

A tertiary maternity hospital in Shanghai, China.

Participants

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.

Primary and secondary outcome measures

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.

Results

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

Conclusions

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.

Measurement instruments for assessing support needs of dementia caregivers: a COSMIN-based systematic review protocol

Por: Xiang · C. · Shen · Y. · Zhuo · Y. · Zhao · X. · Qiao · B.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

PROSPERO registration number

CRD420251129741.

Implementing multi-component intervention to reduce antibiotic prescribing in primary care of rural China: a qualitative process evaluation of the trial

Por: Zhang · T. · Shen · X. · Chai · J. · Liu · R. · Wang · D. · Yardley · L. · Lambert · H. · Cabral · C.
Objectives

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.

Design

Qualitative process study nested in a randomised controlled trial, including observation and semi-structured interviews.

Setting

Primary healthcare in rural China.

Participants

27 health practitioners from township health centres assigned to the intervention arm.

Intervention

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.

Primary and secondary outcome measures

Not applicable.

Analysis

Data were analysed using thematic analysis.

Results

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.

Conclusions

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.

Trial registration number

ISRCTN30652037 (01/12/2020).

Clinical Study on Masquelet Membrane Induction Technique Combined With Free Skin Grafting for the Treatment of Chronic Refractory Wounds With Bone/Tendon Exposure in Aged Patients

ABSTRACT

The treatment of chronic wounds in the Aged is often difficult. Masquelet technique is used for the treatment of infected large segmental bone defects as it provides an adequate blood supply for bone and soft tissue reconstruction. In this study, a two-stage wound management strategy was used, consisting of covering the initial wound with bone cement and skin grafting under induced membranes. From September 2020 to September 2022, 20 Aged patients with chronic refractory wounds of the lower extremities with exposed bone or tendons were recruited in the Department of Wound Repair Surgery of the Second Affiliated Hospital of Wenzhou Medical University. Each patient was reconstructed according to a two-stage process. In the first stage, while treating the patient's underlying disease, several debridements were first performed on the wound; subsequently, the Masquelet technique was applied to seal the wound with antibiotic bone cement. Four to 6 weeks later, the second stage was initiated—after confirming the sufficient formation of wound induced membranes, the bone cement was removed, and free skin grafts were finally used to cover the chronic refractory wounds on the extremities. The area of the defects ranged from 4.5 × 3.0 cm to 15.0 × 6.0 cm, and all soft tissue defects were associated with tendon or bone exposure. After the surgery, patients attended regular outpatient visits and were followed up by telephone and video to observe the healing of the wounds and whether there were any complications in the donor site. The Lower Extremity Function Scale (LEFS) score was used to evaluate the functional recovery of the lower extremities. We found that all implants survived without necrosis or infection. All 20 cases were followed up regularly after surgery for 3 to 12 months, with a mean of 7.6 months. In the first stage, Induced Membranes induction was performed 1–4 times, with an average of (1.3 ± 0.7) times, and in the second stage, free skin grafting was performed on the induction membrane, and all 20 cases of skin grafting survived without necrosis or infection; the appearance and texture of the skin in the grafted area were satisfactory, and the postoperative LEFS score was (69.83 ± 10.82). Finally, our strategy for the management of chronic refractory wounds in the Aged can achieve satisfactory clinical results, reduce surgical risk, be simple and reliable, and be an effective addition to the repair modality.

Mental health and the knowledge and attitude towards insomnia among medical staff in China: a cross-sectional study

Por: Tang · T. · Zhang · N. · Qu · L. · Zhang · J. · Yang · D. · Shen · S. · Du · B. · Du · X. · Liu · N. · Cui · L.
Objectives

To assess Chinese medical staff’s knowledge and attitudes towards insomnia and explore their association with mental health status.

Design

A multicentre cross-sectional survey conducted across hospitals in China using convenience sampling.

Setting

Multiple hospitals across different regions of China; level of care primarily secondary.

Participants

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 and secondary outcome measures

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).

Results

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

Conclusions

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.

Single‐Center Epidemiological Analysis of Malignant Transformation With Skin Ulcers in Outpatients

ABSTRACT

Investigate the epidemiological characteristics of outpatients initially diagnosed with skin ulcers who were ultimately confirmed to have cutaneous malignant tumours, and provide a diagnostic and therapeutic basis for the occurrence of secondary diseases in chronic wounds. We conducted a retrospective study analysing clinical data from patients initially diagnosed with skin ulcers at our hospital between July 2021 and February 2025, and analysed the epidemiological characteristics of malignant transformation in these ulcer cases. Among 128 patients initially diagnosed with skin ulcers, 16 cases (12.5%) were confirmed with cutaneous malignancies. The malignant group had a significantly higher mean age (69.44 ± 11.30 years) compared to the non-malignant group (58.39 ± 17.88 years; t = 5.752, p = 0.01). The distribution of lesion sites differed significantly between the malignant and non-malignant groups (χ2 = 30.498, p < 0.01). In the malignant group, the head and neck (41.2%) and trunk & extremities (41.2%) were the predominant sites. The most common malignancy was squamous cell carcinoma (SCC). The trunk & extremities was the most frequent site (62.5%). The second was basal cell carcinoma, which mainly occurs in the head and neck (80.0%). The mean duration of ulceration was 4.5 years. The primary treatment modality was surgical excision (11 cases, 68.8%). Approximately one-seventh of skin ulcer cases were confirmed as cutaneous malignancies. This finding underscores the significance of skin ulcers as potential malignant lesions, highlighting the need for clinicians to maintain a high index of suspicion and promptly perform histopathological examinations to improve early detection rates of skin cancers.

Association between pneumoconiosis and cataract risk: a nationwide retrospective cohort study in Taiwan

Por: Cheng · J.-S. · Lin · Y.-S. · Lin · C.-L. · Hsia · N.-Y. · Shen · T.-C. · Cho · D.-Y.
Objectives

To investigate whether pneumoconiosis increases the risk of cataract.

Design

Nationwide population-based retrospective cohort study.

Setting

Taiwan’s National Health Insurance database, which covers >99% of the population.

Participants

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.

Outcome measures

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.

Results

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).

Conclusions

Pneumoconiosis is associated with an increased risk of cataract. Routine ophthalmologic surveillance should be considered in pneumoconiosis management.

Adaptation and evaluation of a digital dialectical behaviour therapy for youth at clinical high risk for psychosis: A protocol for a feasibility randomized controlled trial

by Thea Lynne Hedemann, Yun Lu, Sofia Campitelli, Lisa D. Hawke, Nelson Shen, Sarah Saperia, Brett D. M. Jones, Gillian Strudwick, Chelsey R. Wilks, Wei Wang, Marco Solmi, Michael Grossman, Muhammad Ishrat Husain, Nicole Kozloff, George Foussias, Muhammad Omair Husain

Background

Youth at clinical high risk (CHR) for psychosis often experience emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functional impairment. Dialectical behaviour therapy (DBT) is an evidence-based intervention that improves emotion regulation, clinical outcomes, and functioning across psychiatric populations. Digital adaptations (d-DBT) may enhance accessibility and engagement for CHR youth, but acceptability and potential benefits in this group are unknown.

Objective

To adapt d-DBT for CHR youth and evaluate the acceptability of delivering it to this population, as well as the feasibility of a larger-scale clinical trial.

Methods

This mixed-methods clinical trial has two phases. In Phase 1, d-DBT will be adapted for CHR youth in collaboration with a lived-experience youth advisory group. In Phase 2, an assessor-masked randomized controlled trial will compare d-DBT (n = 30) with treatment as usual (n = 30). The intervention consists of eight weekly modules, with primary outcomes assessing acceptability, usability, and trial feasibility. Secondary outcomes include changes in emotional dysregulation, psychiatric symptoms, substance use, suicidality, and functioning.

Conclusions

We anticipate that d-DBT will be acceptable to CHR youth and that conducting a larger trial will be feasible. Preliminary findings may demonstrate improvements in emotion regulation, psychiatric symptoms, suicidality, and functioning. Results will guide further refinement of the intervention and inform the design of a confirmatory clinical trial.

Trial registration

ClinicalTrials.gov #NCT06928935

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