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Transcutaneous auricular vagus nerve stimulation for moderate to severe chronic prostatitis/chronic pelvic pain syndrome (TASC-P) in China: study protocol for a randomised controlled trial

Por: Wei · X. · Cui · J. · Zang · Z. · Pang · R. · Qi · L. · Wang · Y. · Wang · H.-B. · Wu · Y. · Qin · Z. · Wu · J.
Introduction

Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects around 35%–50% of men during their lifetime. The efficacy of current oral medication for CP/CPPS remains limited. Recent studies demonstrated that vagus nerve stimulation may improve chronic pelvic and abdominal pain. Accordingly, transcutaneous auricular vagus nerve stimulation (taVNS) might represent a promising, non-invasive therapeutic approach for the clinical management of CP/CPPS.

Methods and analysis

The trial of Transcutaneous Auricular vagus nerve Stimulation for moderate to severe Chronic Prostatitis/CPPS is a prospective, randomised, sham-controlled trial with a 1:1 allocation ratio. Participants will be assigned randomly to either the taVNS group or the sham-taVNS group. The intervention period will consist of a 4-week treatment (a total of 40 sessions), followed by an 8-week follow-up period. The primary outcome is the change from baseline in the National Institutes of Health Chronic Prostatitis Symptom Score Index total score at week 4. Secondary outcomes include the International Prostate Symptom Score Scale, European Quality of Life 5-Dimensions-5-Levels questionnaire, Self-Rating Anxiety Scale and Self-Rating Depression Scale. Safety assessments will be conducted throughout the entire study period.

Ethics and dissemination

This study protocol and informed consent documents were reviewed and approved by the Institutional Review Board of Guang’anmen Hospital, China Academy of Chinese Medical Sciences (approval number: 2023-250 KY). Written informed consent will be obtained from all participants and/or their legal guardians prior to trial participation. The findings will be disseminated through publication in a peer-reviewed journal and presentations at scientific conferences. The research data will be made available on reasonable request.

Trial registration number

NCT06287970.

Virtual Reality Simulation in Disaster Nursing Education and Training: A Scoping Review

ABSTRACT

Background

Disaster response presents significant challenges to the competence of nurses. Virtual reality simulation (VRS) offers innovative opportunities for nursing administrators and educators in the field of disaster nursing education and training.

Objective

This study aimed to explore the use and effectiveness of virtual reality simulations in disaster nursing education and training.

Methods

A scoping review was conducted using the Arksey and O'Malley framework, extended by Levac. The following databases were systematically searched from inception to August 30, 2024: PubMed, Embase, CINAHL, Web of Science, Cochrane Library, CNKI, Wanfang Database and CBM. Two researchers independently screened the identified articles and extracted relevant data. This scoping review was reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist.

Results

The review included thirteen studies published between 2013 and 2024. Of these, seven studies employed a quasi-experimental design, six utilised a randomised controlled trial (RCT) design and one study used a longitudinal experimental design. The disaster nursing education and training content covered six main areas: triage training, on-site first aid training, infectious disease prevention and control, disaster response skills training, emergency response training for nursing staff and post-disaster psychological recovery training. The reported outcomes primarily focused on Kirkpatrick's Level 1 (participant satisfaction with the training experience) and Level 2 (measuring the benefit to participants from the training).

Relevance to Clinical Practice

This scoping review identified the research progress and trends of virtual reality simulation technology in the process of cultivating disaster nursing talents at home and abroad and provides a reference for disaster nursing managers and educators to conduct disaster nursing training based on virtual reality simulation technology.

No Patient or Public Contribution

This is a review article based on a review of the literature, with no patient participation.

Dilemmas in the development of the general practitioner workforce in primary care: a qualitative study in Beijing, China

Por: Cui · Y. · Sun · T. · Tian · M. · Jia · N. · Wang · W. · Lu · X. · Zhang · W. · Lan · L. · Jin · G.
Background

The general practitioner workforce (GPWF) is an important factor influencing primary care capacity. Many countries face GP shortages and substantial challenges in workforce development. However, the factors and mechanisms shaping GPWF development remain insufficiently understood.

Purpose

To explore key challenges affecting GPWF development and their interrelationships in the primary care system of Beijing, China.

Methods

Between October and December 2024, directors and GPs from 18 community health centres were recruited using purposive sampling. Data were collected through a focus group discussion and in-depth interviews; thematic analysis was conducted in line with Merriam and Tisdell’s approach. A causal loop diagram (CLD) was then developed to identify and visualise dynamic relationships among factors influencing the GPWF development.

Results

The participants comprised 10 directors and 8 GPs from urban and suburban areas, with a predominance of women and those holding senior professional titles. Participants had diverse educational and professional backgrounds. Three major themes were identified: (1) rising demand for GP services, (2) supply challenges in the GPWF, and (3) challenges to GPs’ professional sustainability. Across these themes, 12 subthemes and 10 key variables were identified. The CLD reflected participants’ perceptions of how these variables interacted and illustrated potential reinforcing interactions among them.

Conclusion

The development of the GPWF in Beijing is constrained by multiple interrelated challenges. Addressing these challenges entails coordinated policy actions to strengthen workforce planning and training, enhance job attractiveness, improve the alignment between training and practice, and reinforce professional support and continuing professional development, thereby promoting the sustainability of the GPWF.

Identification and functional analysis of key miRNAs and target genes associated with failure of HBV mother-to-child transmission prevention

by Quan He, Xiong Zou, Chunyan Zheng, Jiawei Zhang, Jialing Li, Liping Hu, Ting Zeng, Zijuan Huang, Peipei Zeng, Jinli Wei, Haichen Cui, Yongjian Su, Hai Li

Background

Residual mother-to-child transmission (MTCT) of hepatitis B virus (HBV) remains a significant clinical challenge despite standard immunoprophylaxis. Identifying molecular markers is crucial for improved prevention and diagnosis.

Methods

We conducted a case-control study using the Guangxi Liuzhou HBV MTCT registry. Peripheral blood RNA sequencing (Illumina HiSeq) was performed on infants from HBsAg-positive mothers: cases (HBsAg-positive, n = 6) and controls (HBsAg-negative, n = 10). All infants receive HBIG and the first dose of hepatitis B vaccine within 24 hours after birth, followed by completion of the three-dose vaccination series. Differentially expressed miRNAs (DEMs; adj-p  1) were identified. Target genes were predicted (miRanda/RNAhybrid) and functionally analyzed (GO/KEGG enrichment, PPI network). HBV-associated target genes were identified by cross-referencing GeneCards/NCBI.

Results

RNA-seq identified 62 DEMs (19 upregulated, 43 downregulated). Target prediction yielded 5,014 genes. Functional enrichment highlighted key pathways and processes. PPI analysis pinpointed highly connected genes. Integration with HBV databases revealed 3 key target genes potentially modulated by 4 specific DEMs (hsa-miR-6747-3p, hsa-miR-4772-3p upregulated; hsa-miR-4676-5p, hsa-miR-485-5p downregulated).

Conclusion

This study identifies dysregulation of 4 key miRNAs and their association with 3 HBV-linked target genes as potential contributors to residual HBV MTCT. These findings provide novel insights into the molecular mechanisms underlying HBV MTCT and suggest potential targets for intervention.

Effect of evening dexmedetomidine nasal spray on postoperative sleep disturbance in patients undergoing laparoscopic cholecystectomy: protocol for a multicentre, prospective, randomised, double-blind, controlled trial

Por: Shi · W. · Zhu · S. · Xia · T. · Cui · Y. · Bo · J. · Gu · X.
Background

Postoperative sleep disturbance (PSD) is a common complication following laparoscopic cholecystectomy (LC). It is associated with delirium, cognitive decline and delayed recovery. Effective preventive strategies are currently lacking. Dexmedetomidine, a highly selective α2-adrenergic receptor agonist, offered in a nasal spray formulation with high bioavailability and convenient administration, may present a novel approach for PSD prevention.

Objectives

The primary objective is to evaluate the effect of evening dexmedetomidine nasal spray on the incidence of PSD on the first postoperative day in LC patients. Secondary objectives include assessing its impact on the quality of recovery, anxiety and depression and pain scores.

Methods and analysis

This is a multicentre, prospective, randomised, double-blind, controlled trial. At least 260 patients will be enrolled and randomly allocated in a 1:1 ratio to receive either dexmedetomidine (50 µg nasal spray) or saline placebo the night before and the night of surgery (between 20:00 and 22:00). The primary outcome is the incidence of PSD on postoperative day 1 defined as an Numerical Rating Scale (NRS) >6 or Athens Insomnia Scale >6 score, which will be compared between groups using the 2 or Fisher’s exact test on the full analysis set. Secondary outcomes include quality of recovery (Quality of Recovery-15 scale, QoR-15), anxiety and depression (Hospital Anxiety and Depression Scale, HADS), pain (NRS), postoperative nausea and vomiting and adverse events, analysed using t-tests, rank-sum tests or repeated-measures mixed-effects models as appropriate.

Ethics and dissemination

The study protocol has been approved by the Ethics Committee of the Affiliated Drum Tower Hospital of Nanjing University Medical School (Approval No.: 2025–0064-02) and registered with the Chinese Clinical Trial Registry. The findings of this study will be disseminated through various channels. Academic dissemination will include publication in peer-reviewed journals and presentations at national and international conferences.

Trial registration number

ChiCTR2500101205.

Ectopic expression of <i>Aspergillus flavus</i> uricase and URAT1 in therapeutic cells promotes intracellular degradation of uric acid in hyperuricemic mice

by Yuzhong Feng, Jiazhen Cui, Xuan Huang, Yupeng Li, Haolong Dong, Xianghua Xiong, Gang Liu, Qingyang Wang, Huipeng Chen

Uricase-based drugs excel at treating refractory hyperuricemia and tumor lysis syndrome by directly degrading uric acid but are limited by immunogenicity. Here, we engineered RAW264.7 macrophages with ectopic co-expression of Aspergillus flavus uricase and murine urate anion transporter 1 (URAT1), forming a “transport-degradation” system: URAT1 actively transports uric acid into cells for intracellular degradation. Recombinant lentiviral vectors carrying target genes were transfected into RAW264.7 cells, followed by puromycin screening. In vitro assays showed that the engineered macrophages nearly completely degraded uric acid (from 556.0 ± 37.0 μmol/L to 0.7 ± 0.6 μmol/L) at 72 h. URAT1 inhibition with benzbromarone abolished uric acid degradation in URAT1-expressing cells. In both acute dietary-induced and chronic genetic hyperuricemic mouse models, RAW-afUri-URAT1 exerted robust and sustained uric acid-lowering activity, maintaining serum uric acid at 77.14 ± 37.48 μmol/L on day 16 in yeast extract gavaged mice and normalizing serum uric acid to 76.2 ± 15.9 μmol/L in liver uricase conditional knockout mice, both significantly superior to the rebound levels observed in mice treated with Rasburicase (143.19 ± 38.21 μmol/L and 142.4 ± 17.4 μmol/L, respectively; P

Heart rate variability as a biomarker for autonomic recovery and maternal wellbeing following caesarean delivery: a scoping review protocol

Por: Zhang · Y. · Deng · L. · Xiong · Y. · Zeng · Q. · Cui · H. · Guo · S.
Introduction

Caesarean delivery accounts for more than 21% of all births worldwide, with rates exceeding 30% in several countries, yet objective physiological markers for monitoring postoperative maternal recovery remain scarce. Heart rate variability (HRV), a non-invasive index of autonomic nervous system integrity, has demonstrated prognostic value in general surgical populations. This scoping review will map the extent, range and nature of evidence on HRV monitoring in caesarean populations within a recovery-assessment framework.

Methods and analysis

The review follows a Population–Concept–Context framework. The primary population comprises women undergoing elective caesarean delivery, with emergency procedures analysed as a distinct subgroup. The concept covers any validated measurement of HRV parameters (time-domain, frequency-domain and non-linear indices). The context spans the perioperative-to-postpartum continuum, from preoperative baseline through 6 weeks after delivery. Adhering to the Joanna Briggs Institute methodology, we will employ a three-step search strategy across PubMed, Embase, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science. Two independent reviewers will screen records and extract data. Findings will be synthesised narratively and presented via temporal evidence mapping, an evidence gap map, and structured summary tables.

Ethics and dissemination

Formal ethics approval is not required because this review exclusively analyses published data. We will disseminate our findings through publication in a peer-reviewed journal and presentations at relevant academic conferences.

Experiences and Role Adaptation of Nursing PhDs in Hospital Settings: A Qualitative Study

ABSTRACT

Aims

To explore the experiences, perceptions, and role adaptation of nursing PhDs in hospital settings in China.

Design

A descriptive phenomenological qualitative study.

Methods

Individual in-depth interviews were conducted with eight female nursing PhD holders from eight tertiary hospitals across five provinces between November 2024 and February 2025. Data were concurrently collected and analysed using NVivo 11.0, guided by Colaizzi's seven-step analysis.

Results

Four main themes were identified: (1) Multidimensional motivations for choosing hospital work; (2) professional challenges; (3) perceived professional value and benefits; and (4) career expectations and developmental recommendations. Fifteen subthemes further detailed these dynamics.

Conclusion

This study offers a nuanced understanding of the career development of nursing PhDs within hospital settings. The findings reveal the complex interplay of factors influencing their decisions to enter clinical practice. Moreover, it underscores the dual challenges of role ambiguity and limited resources, while also illustrating the transformative potential of applying academic training to drive clinical innovation among nursing PhDs in hospital environments.

Implications for the Profession

These findings offer critical insights for hospital administrators and educational policymakers. By elucidating the career development challenges and opportunities for nursing PhDs, the study underscores the need for tailored talent management frameworks and targeted educational reforms. The findings have important implications for hospital settings in China and offer guidance for global strategies in talent management and clinical education reform, ultimately contributing to improved patient care and healthcare outcomes.

Reporting Method

Adhered to COREQ guidelines for qualitative research.

Patient or Public Involvement

None.

Latent profile analysis and influencing factors of engagement in medication safety among older adults with cardiometabolic multimorbidity: a cross-sectional study

Por: Liu · C. · Chen · J. · Jin · R. · Li · J. · Cui · M. · Wang · F. · Chen · L.
Objective

This study aims to explore the latent profiles and influencing factors of engagement in medication safety among elderly patients with cardiometabolic multimorbidity.

Design

A cross-sectional study.

Setting

The study was conducted at a class III hospital in Jiangsu, China.

Participants

The study included a sample of 316 older adult inpatients with cardiometabolic multimorbidity.

Outcome measures

Participants completed the Inpatients’ Involvement in Medication Safety Scale and the Multimorbidity Treatment Burden Questionnaire. Latent profile and multivariate regression analyses were used to identify subgroups and their associated factors.

Results

Latent profile analysis identified three distinct profiles: ‘passive participation’ (22.47%), ‘moderate participation’ (52.53%) and ‘active participation’ (25.0%). Multivariate logistic regression revealed that occupational status, marital status, medical payment method, daily medication type and treatment burden were significant independent factors distinguishing among these profiles (p

Conclusions

The study confirms significant heterogeneity in medication safety engagement among older adults with cardiometabolic multimorbidity. The identified profiles and their specific influencing factors provide a basis for clinicians to stratify patients and develop targeted interventions, particularly for the vulnerable ‘passive participation’ group, to improve medication safety outcomes.

Comprehensive post-marketing safety evaluation of atezolizumab: A disproportionality analysis based on individual case safety reports in the FAERS

by Yu Cui, Yuxuan Gao, Na Meng, Xiaojuan Li, Na Zhao, Lili Yu

Atezolizumab is a widely used immune checkpoint inhibitor (ICI) for cancer treatment, and postmarketing testing is important. This study aims to provide a reference for the safe and rational use of drugs in clinical practice by mining and analyzing the adverse event (AE) signals of atezolizumab on the basis of the FDA Adverse Event Reporting System (FAERS). This research extracted AE reports from the second quarter (Q2) of 2016 to Q2 of 2024 from the FAERS. AEs were standardized and classified on the basis of the System Organ Class (SOC) and Preferred Term (PT) from the Medical Dictionary for Regulatory Activities (MedDRA) version 23.0. This study utilized disproportionality analysis (DPA) for signal mining and analysis, including the reporting odds ratio (ROR) method, the Medicines and Healthcare Products Regulatory Agency (MHRA) method, and the Bayesian confidence propagation neural network (BCPNN) method. We obtained a total of 3,124 AE signals and identified 640 PTs and 21 SOCs for atezolizumab. The highest signal intensity was systemic immune activation (n = 15, ROR = 449.20, PRR = 449.07, IC = 8.06), and the most frequently reported AEs were death, pyrexia, infectious pneumonia, anaemia, and febrile neutropenia. The top 100 PTs in terms of signal intensity involved a total of 16 SOCs, including those associated with endocrine disorders; respiratory, thoracic and mediastinal disorders; and renal and urinary disorders. This study revealed that AEs in the endocrine, respiratory and urinary systems need to be monitored in clinical practice.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT05866029.

Transmission dynamics and control of tuberculosis in high-altitude regions: a modelling study in Xizang, China

Por: Li · M. · Zheng · R. · Guo · L. · Wu · Y. · Dong · J. · Jiang · H. · Song · D. · Cui · Z. · Li · C.
Objectives

To estimate tuberculosis (TB) incidence trends in the high-altitude Xizang, China, and to explore the key intervention strategies on achieving the WHO 2030 TB control target.

Design

We developed a susceptible–exposed–infectious–recovered transmission model using routinely reported TB surveillance data from 2004 to 2022. Scenario-based simulations were conducted to project future TB incidence under alternative intervention strategies. Model assumptions are as follows: (1) a stable population, (2) lifelong vaccine-induced immunity, (3) infectiousness of active TB cases, (4) relapse risk after recovery and (5) homogeneous mixing within the population.

Setting

Seven prefectures of Xizang Autonomous Region on the Tibetan Plateau, China.

Participants

An estimated population of approximately 3 million individuals residing in Xizang.

Interventions

We assessed the epidemiological impact of four interventions implemented independently: increasing vaccine efficacy rate, reducing transmission rates of susceptible individuals, decreasing progression rate from latent TB infection to active disease and reducing relapse rate among successfully treated patients, compared with continuation of current control measures.

Results

The estimated basic reproduction number (R0 ) for TB in Xizang was 0.39 (95% CI 0.21 to 0.71) in the absence of additional interventions, which was the highest among all regions of China. Model simulations indicated that all four evaluated interventions were each likely to reduce TB incidence, but only reducing the latent-to-active TB progression had a substantial effect. A 50% reduction in the progression rate was predicted to lower TB incidence from 66.56 (62.00–70.11) to 40.54 (37.15–43.77) cases per 100 000 population, meeting the WHO 2030 TB control target.

Conclusion

Targeted management of individuals with latent TB infection should be strengthened to substantially reduce TB transmission in high-altitude areas.

Concurrent Trajectories of Depressive Symptoms and Insomnia and Influencing Factors in Adolescents

ABSTRACT

Objective

To explore the concurrent trajectories of depressive symptoms and insomnia among adolescents and to analyse the individual, familial and social predictors of the concurrent trajectories.

Study Design

This study tracked depressive symptoms and insomnia in eight secondary schools annually from 2021 to 2023. We also collected data on individual, familial and social factors that may influence these conditions. Group-based multi-trajectory (GBMT) modelling was used to categorise adolescents into depressive–insomnia severity subgroups.

Result

This study included 2822 adolescents, who were categorised into four groups, including the no symptom group, mild symptom group, symptom relief group and symptom increase group. Compared with the no symptom group, predictors of the mild symptom group were gender (OR = 1.30), academic performance (OR = 1.57), subjective well-being (OR = 0.78), anxiety (OR = 1.14), economic status (OR = 1.23) and relationship with teachers (OR = 1.46). Predictors of the symptom relief group were personality (OR = 1.75), academic performance (OR = 2.28), subjective well-being (OR = 0.69) and anxiety (OR = 1.25). Predictors of the symptom-increasing group were personality (OR = 2.45), academic performance (OR = 1.96), subjective well-being (OR = 0.69), anxiety (OR = 1.20), maternal education level (OR = 1.58), family function (OR = 0.93), parental relationship (OR = 2.07) and relationship with teachers (OR = 1.54).

Conclusion

This study provided a comprehensive understanding of the concurrent trajectories of depressive symptoms and insomnia among adolescents, revealing distinct subgroups and identifying predictors across individual, familial and social levels.

Implications for Patient Care

This study emphasises the importance of a multi-faceted approach involving family, school and society to promote adolescent mental health and also highlights the need for conducting precise interventions according to adolescents' features.

Impact

The identification of four distinct symptom trajectories and their predictors advances the understanding of adolescent mental health development, informing precision prevention strategies.

Reporting Method

STROBE checklist.

Patient or Public Contribution

None.

Endocrine advantages of PD-1/PD-L1 therapy: Comparative analysis of FAERS-JADER

by Yuxuan Gao, Shiyao Jiang, Yu Cui, Yumeng Wang, Lili Yu

With the extensive clinical application of immune checkpoint inhibitors (ICIs), immune-related adverse events (irAEs) associated with these agents have increasingly garnered significant attention. Unlike other irAEs, endocrine irAEs are mostly irreversible, with variable and nonspecific symptoms, which poses challenges for clinicians in diagnosis. As a result, this study leveraged the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) and the Japanese Adverse Drug Event Report (JADER) pharmacovigilance databases to conduct an in-depth investigation into adverse events induced by PD-1/PD-L1 inhibitors, with a focus on irAEs induced by PD-1/PD-L1 inhibitors. This study pioneers the systematic cross-database validation of endocrine irAEs induced by PD-1/PD-L1 inhibitors. The integration of data from the JADER offers unique safety insights for Asian populations, bolsters global pharmacovigilance efforts, and uncovers regional variations in irAEs reporting. Notably, this study revealed a higher prevalence of endocrine irAEs among men aged over 50 years receiving PD-1/PD-L1 inhibitors. Both PD-1 and PD-L1 inhibitors are strongly associated with thyroid dysfunction, adrenal insufficiency, and pituitary inflammation. Additionally, it identifies several previously undocumented endocrine irAEs. This result unearthed safety signals hitherto unreported in drug inserts, underscoring the imperative for updating the safety labeling of PD-1/PD-L1 inhibitors with respect to endocrine irAEs. The emergence of off-label uses further underscores the need for additional clinical trials to assess their efficacy and safety.

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.

Midazolam oral solution for neonatal MRI: study protocol of a randomised controlled trial

Por: Cheng · Z. · Xu · L. · Lu · Z. · Wang · H. · Song · T. · Cui · Y.
Introduction

Current medications used for neonatal MRI sedation may lead to complications such as decreased oxygen saturation, apnoea and bradycardia. There has been no study investigating the application of midazolam oral solution in neonatal MRI examinations. Therefore, this study aims to observe the safety and efficacy of midazolam oral solution for sedation during neonatal MRI examinations, providing a reference for clinical application.

Methods and analysis

We designed a double-blind randomised controlled trial. A total of 140 neonates who underwent MRI are included. The neonates are randomly assigned into two groups of n=70 each to receive either midazolam oral solution or chloral hydrate oral solution. The primary outcome indicator of the study is the success rate of sedation as assessed by the University of Michigan Sedation Scale (UMSS). In addition, the time to a UMSS score of 2 or greater after drug administration, the number of sedation remedies, the behavioural scores of the children while taking the drug and the movement scores during the MRI performed are collected as secondary outcome indicators.

Ethics and dissemination

Ethical approval for the study was obtained from the Ethics Committee of the Chengdu Women’s and Children’s Central Hospital (Approval No. 2023 (18)–2). The study findings will be submitted for peer-reviewed publication in a scientific journal.

Trial registration number

ChiCTR2300069996.

Factors influencing participation of patients who had a stroke in rehabilitation shared decision-making: a qualitative meta-synthesis

Por: Zang · S. · Ye · M. · Qi · W. · Wu · Z. · He · M. · Lou · Q. · Cui · Z.
Objective

By adopting the shared decision-making (SDM) model, this study aims to improve treatment adherence and patients’ subjective initiative. It intends to systematically explore the barriers and facilitating conditions for patients who had a stroke to participate in rehabilitation SDM through the analysis and integration of qualitative research methods. The ultimate goal is to provide a basis for optimising the formulation of rehabilitation plans, enhancing the quality of nursing services and improving patients’ medical experience.

Methods

The following databases were searched, with only literatures published in English or Chinese included: Cochrane Library, PubMed, Embase, Scopus, Web of Science, CNKI (China National Knowledge Infrastructure), CBM (Chinese Biomedical Literature Database) and Wanfang Database. The search covered the period from the establishment of each database to 1 March 2025. The quality of the included literatures was evaluated using the Qualitative Research Quality Assessment Tool provided by the Joanna Briggs Institute in 2016, with a focus on factors affecting participation of patients who had a stroke in rehabilitation SDM.

Results

A total of 1502 articles were retrieved in the preliminary search, and 10 were finally included. From these included literatures, 31 findings were extracted. Similar results were categorised and grouped into 10 new categories, which were further integrated into 3 core integrated findings: (1) patient-related factors, including interference from negative emotions, the gap between rehabilitation expectations and reality, the impact of socio-demographic factors and self-efficacy with stage-specific autonomous needs; (2) family-related factors, including family support, the impact of patients’ sense of responsibility to their families on decision choices and trade-offs forced by economic burden; (3) healthcare provider and environmental factors, including paternalistic models undermining autonomy, insufficient information and difficulty in screening hindering decision-making and discontinuity in the rehabilitation system and lack of resources increasing decision-making burden.

Conclusion

Through the meta-synthesis of qualitative studies, this research shows that negative emotions and realistic gaps reduce patients’ participation in decision-making. While family support helps enhance patients’ confidence in decision-making, economic burden affects their decision choices. Additionally, one-way doctor–patient communication, insufficient information support and discontinuity in the rehabilitation service system increase patients’ decision-making burden.

Epidemiological characteristics of major respiratory infectious diseases in Baiyin, China, from 2014 to 2023: a descriptive epidemiological study

Por: Zhan · Z. · Xie · T. · Zhao · T. · Zhang · X. · Zhang · S. · Wang · M. · Xu · Q. · Cheng · Y. · Liu · Y. · Yang · S. · Cui · F.
Objective

To analyse temporal trends of respiratory infectious diseases (RIDs) in Baiyin City from 2014 to 2023, aiming to explore the epidemiological patterns of these diseases (tuberculosis, scarlet fever, pertussis, measles, influenza, mumps, varicella and rubella) and provide evidence for developing effective prevention and control strategies.

Design and setting

A descriptive epidemiological study was conducted to analyse the incidence of tuberculosis, scarlet fever, pertussis, measles, influenza, mumps, varicella and rubella in Baiyin City, China, from 2014 to 2023, using data from the national notifiable disease reporting system.

Participants

All reported cases of eight notifiable RIDs in Baiyin City between 2014 and 2023 were included in the analysis. Data were categorised by age and sex.

Methods

Joinpoint Regression Software was employed to estimate both the annual percentage change in incidence and the average annual percentage change, facilitating a phased comparison of incidence trends.

Results

Between 2014 and 2023, the annual incidence of major bacterial RIDs (tuberculosis, scarlet fever and pertussis) in Baiyin City fluctuated between 52.69 and 87.94 per 100 000 population, demonstrating an overall declining trend. Specifically, the annual decrease rates for the age groups of 0–14 years, 15–59 years and ≥60 years were 11.62% (95% CI –20.26% to –2.16%), 6.44% (95% CI –10.37% to –2.46%) and 5.15% (95% CI –9.12% to –1.07%), respectively. The annual incidence of major viral RIDs (measles, influenza, mumps, varicella and rubella) fluctuated between 111.70 per 100 000 and 541.12 per 100 000. No significant temporal trend was observed for major viral RIDs in Baiyin City. With the exception of pertussis, measles and rubella, the overall incidence rate was significantly higher in males than in females (p

Conclusion

From 2014 to 2023, the annual incidence of major bacterial RIDs in Baiyin City showed an overall decline, mainly due to a reduction in tuberculosis incidence, whereas the annual incidence of major viral RIDs fluctuated and rose sharply in 2023. The overall incidence of both major bacterial and viral RIDs was consistently higher in males, with major viral RIDs occurring predominantly in children aged 0–14 years and major bacterial RIDs being more common in older adults aged ≥60 years. Further efforts are needed to monitor the epidemiological patterns and develop strategies to reduce the incidence of major viral RIDs, particularly among children aged 0–14 years.

Best practices in methodological frameworks for evaluating procedure-based treatments in traditional, complementary and integrative medicine: a scoping review protocol

Por: Liu · Y. · Cui · S. · Zhang · Y. · Song · Z. · Luo · Z. · Chen · Z. · Gao · Q. · Wang · J.
Introduction

While numerous evidence-based studies have been conducted on procedure-based treatments (PBTs) in traditional, complementary and integrative medicine (TCIM) (eg, acupuncture, special diets, lifestyle modification, yoga, Tai ), high-quality research reports accepted by the academic community remain scarce. Key factors contributing to the low evidence quality in this field include researchers’ insufficient grasp of clinical research methodology concepts, inadequate study designs and lack of pilot studies. Scholars now widely recognise that establishing a robust evaluation framework for PBTs in TCIM is crucial for progressively refining research protocols and advancing clinical practice. Therefore, this scoping review aims to systematically map current evaluation methods for PBTs in TCIM, analyse their critical procedural components and lay the groundwork for developing a tailored evaluation framework.

Methods and analysis

Forty-three databases will be systematically searched using comprehensive search strategies. Two independent reviewers will screen potential literature and select eligible studies. Literature management will be performed using NoteExpress and Excel 2016, with a pre-designed standardised Excel sheet employed for data extraction.

This scoping review will include literature that provides multidimensional evaluation (eg, efficacy, safety and health economics) for PBTs in TCIM. This encompasses methodological guidelines, systematic protocols outlining evaluative structures, procedural steps and core components, as well as conceptual or theoretical frameworks describing phased evaluation processes. Screening and data extraction will be conducted independently by two researchers. Inter-rater agreement will be assessed using the Kappa statistic. Any discrepancies will be resolved through consultation with a senior reviewer or correspondence with original authors.

Data extraction will capture: general information, types and number of included primary studies, interventions assessed, evaluation dimensions, procedural workflows for evaluation, version iterations of evaluation frameworks, staging configurations for evaluation, framework development methods, as well as documented strengths and limitations of the frameworks.

Results will be structured following the Preferred Reporting Items for Systematic reviews and Meta-Analyses extension for Scoping Reviews checklist. Findings will be presented through tables, charts and figures, with narrative synthesis describing key outcomes.

Ethics and dissemination

No private information was issued in the entire process of the systematic review. Therefore, ethical approval is not required. Findings of the scoping review will be published in a peer-reviewed journal and/or disseminated through conference presentations.

PROSPERO registration number

The protocol has been archived in the Open Science Framework (Registration DOI: https://doi.org/10.17605/OSF.IO/92DRM).

Effect of qigong on sleep quality and hyperarousal in patients with chronic insomnia: a study protocol for a multi-centre randomised controlled trial

Por: Cui · J. · Han · H. · Yue · H. · Xie · C. · Ma · J. · Xie · F. · You · Y.-l. · Yao · F.
Introduction

Chronic insomnia is a pressing public health issue that significantly affects patients’ quality of life. In China, Prolong Life With Nine Turn-Method (PLWNT) Qigong exercise has long been used to improve sleep quality, yet evidence that supports its efficacy for chronic insomnia treatment remains lacking. The aim of this study is to evaluate the effectiveness and safety of the PLWNT qigong exercise for treating chronic insomnia and its relationship with hyperarousal.

Methods and analysis

This multi-centre randomised controlled trial will recruit 348 eligible patients from three hospitals in Shanghai. Participants will be randomly assigned to either the treatment group (PLWNT qigong exercise) or the control group (cognitive behavioural therapy). The treatment will occur once a week for 12 weeks, followed by an 8-week follow-up phase. The primary outcome is the change in the total Pittsburgh Sleep Quality Index (PSQI) score from baseline to week 12. The secondary outcomes are the scores on the Hyperarousal Scale (HAS), Insomnia Severity Index (ISI), Multidimensional Fatigue Inventory 20 (MFI-20), Hospital Anxiety and Depression (HADS), Medical Outcome Trust 36–Item Short Form Health Survey (SF–36) and Gastrointestinal Symptom Rating Scale (GSRS), gut microbiota, actigraphy, sleep diary, cortisol, adrenocorticotrophic hormone, corticotropin-releasing hormone, polysomnography and functional MRI. All adverse events during the trial will be promptly recorded and assessed. The PSQI, HAS, ISI, MFI-20, HADS, SF–36 and GSRS will be evaluated at baseline, 6 weeks post-treatment and 12 weeks post-treatment, as well as at the 4- week and 8- week follow-ups. Other outcomes will only be evaluated at baseline and 12 weeks post-treatment.

Ethics and dissemination

The trial has been approved by the Ethics Committee of the Shanghai Municipal Hospital of Traditional Chinese Medicine (2024SHL-KY-92–01). Written informed consent was obtained from all participants before their involvement in the trial. Results of this study will be published in peer-reviewed journals or at conferences.

Trial registration number

ITMCTR2024000534.

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