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A disproportionality analysis of FDA adverse event reporting system (FAERS) events for filgotinib

by Yinli Shi, Shuang Guan, Sicun Wang, Muzhi Li, Yanan Yu, Jun Liu, Weibin Yang, Zhong Wang

Background

Although filgotinib, a selective Janus kinase 1 inhibitor, has been increasingly applied in the treatment of inflammatory diseases, its comprehensive safety profile remains insufficiently characterized. Using data from the FAERS database covering Q1 2014 to Q2 2024, this study attempts to analyze adverse event signals linked to filgotinib and provide guidance for the safe and sensible clinical usage of filgotinib.

Methods

From Q1 2014 to Q2 2024, information on adverse drug events (ADEs) associated with filgotinib was gathered. The reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS) were among the signal detection methods that were employed for analysis following data normalization.

Results

Filgotinib was shown to be the main suspected medication in ADE reports, exposing 103 preferred terms (PTs) in 17 system organ classes (SOCs). Infections, gastrointestinal disorders, and musculoskeletal and connective tissue disorders were the most commonly reported adverse effects. Additionally, atrial fibrillation, alopecia, elevated serum creatinine, blood creatinine increased, pulmonary embolism, epididymitis, respiratory failure, and osteopenia were identified as potential disproportionate reporting signals for filgotinib, although these were not listed in the official drug label. Notable significant signals included large intestine erosion (ROR 2186.05, 95%CI(ROR): 1015.94–4703.86, PRR 2176.18, 95%CI(PRR): 1014.64–4667.42), mesenteric arterial occlusion (ROR 1832.17, 95%CI(ROR): 897.68–3739.48, PRR 1822.71, 95%CI(PRR): 896.17–3707.20), repetitive strain injury (ROR 1149.27, 95%CI(ROR): 363.16–3637.01, PRR 1147.05, 95%CI(PRR): 363.24–3622.15), oligoarthritis (ROR 755.02, 95%CI(ROR): 310.74–1834.54, PRR 752.59, 95%CI(PRR): 310.60–1823.51), and periostitis (ROR 676.03, 95%CI(ROR): 319.36–1431.06, PRR 672.98, 95%CI(PRR): 318.97–1419.87). The subgroup analysis identified obvious sex and age-specific trends in filgotinib-related adverse reactions, emphasizing a higher risk of renal disorders in females, a preponderance of gastrointestinal events in males, and age-dependent trends involving mesenteric occlusion, increased serum creatinine, and immunoglobulin reduction.

Conclusion

While filgotinib demonstrates therapeutic efficacy, it is associated with a range of potential adverse events, underscoring the need for vigilant clinical monitoring. Particular attention should be given to gastrointestinal, cardiovascular, respiratory, and metabolic complications.

Development and Preliminary Application of a KAP Scale for Nursing Assistants in Pain Care for Older Adults With Dementia

ABSTRACT

Aim

This study aimed to develop and preliminarily validate the KAP scale for pain management in older adults with dementia among nursing assistants.

Design

A cross-sectional study.

Methods

An initial item pool was constructed through literature reviews, semi-structured interviews and team discussions. Items were screened and optimised through two rounds of Delphi expert consultations, a pilot survey and item analysis, yielding a draft version of the scale. Psychometric evaluation was conducted to refine the scale into its final form.

Results

The final KAP scale developed in this study comprised 31 items. The scale exhibited good content validity, with item-level content validity index (I-CVI) values ranging from 0.83 to 1.00. Exploratory factor analysis revealed that the scale extracted five factors, which accounted for 65.732% of the cumulative variance, and all items demonstrated rotated factor loadings > 0.5, indicating good construct validity. The Cronbach's α coefficients for the knowledge, attitudes and practices dimensions were 0.877, 0.915 and 0.935, respectively, and the split-half reliability coefficients were 0.909, 0.886 and 0.864.

Conclusion

The KAP scale for pain care in older adults with dementia developed in this study possesses good reliability and validity and can be used to assess the knowledge, attitudes and behavioural levels of nursing assistants in pain care.

Implications for the Profession and/or Patient Care

This study developed and psychometrically validated a KAP scale specifically designed to assess pain care for older adults with dementia among nursing assistants. Clinical managers can utilise this tool to systematically identify deficiencies in staff members' knowledge, attitudes or practices, thereby providing scientific evidence for the development of targeted pain care training programs and pain management strategies. This contributes to enhancing nursing assistants' pain care competence, ultimately alleviating the pain burden of older adults with dementia and improving their quality of life.

Reporting Method

The STROBE checklist was used as a guideline.

Patient or Public Contribution

No patient or public involvement.

Study protocol for evaluating delayed antibiotic prescribing to promote rational antibiotic use in primary healthcare institutions in China: a pragmatic, multicentre, open-label, clustered-randomised controlled trial

Por: Chen · S. · Ko · W. · Li · W. · Xiao · R. · Du · F. · Zhang · J. · Wu · S. · Zheng · B. · Zhu · N. J. · Ahmad · R. · Little · P. · Guan · X. · Shi · L. · Wushouer · H.
Introduction

Delayed antibiotic prescribing (DAP) has demonstrated efficacy in reducing inappropriate antibiotic use for uncomplicated respiratory tract infections (uRTIs) in primary care across high-income countries. However, evidence regarding its effectiveness in low-income and middle-income countries remains limited. This cluster-randomised controlled trial (cRCT) aims to evaluate the effectiveness of DAP for optimising antibiotic use in primary healthcare institutions (PHIs) in China.

Methods and analysis

We designed a pragmatic, multicentre, open-label, three-arm cRCT in adult patients with uRTIs. The study will involve 12 PHIs in Korla City of China. Participating institutions will be randomised at a 1:1:1 ratio to three parallel arms: (1) DAP-intervention arm, (2) Immediate antibiotic prescribing comparator arm and (3) Usual care (observational arm). The primary outcome is symptom duration. Secondary outcomes include symptom severity, antibiotic use, adverse events, patient satisfaction and patient belief regarding antibiotic efficacy.

Ethics and dissemination

Ethics committee approval of this study was obtained from Peking University Institution Review Board (IRB00001052-24169). The findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

Trial registration number

ChiCTR2500097330.

Perfluorinated chemicals and adolescent respiratory health: Epidemiological evidence and mechanistic insights

by Xinfeng Xu, Xinyao Jiang, Meng Zou, Jinyan Hui, Guang Huang, Qian Wu

Perfluorinated compounds (PFCs) are persistent environmental pollutants with near-universal human exposure, yet their respiratory health impacts during adolescence remain insufficiently explored. This investigation evaluated single and combined effects of serum PFCs on pulmonary function and respiratory morbidity in a nationally representative adolescent cohort (n = 976, ages 12–19 years) utilizing 2007–2012 NHANES data. Advanced analytical approaches including multivariable regression, mixture modeling (BKMR and WQS), and mediation analysis were employed to assess associations with spirometric parameters (FEV1, FVC, FEV1/FVC) and respiratory symptoms while examining inflammatory and oxidative stress pathways. Computational approaches integrating network toxicology and molecular docking identified key protein targets. Analytical results demonstrated significant associations between specific PFC congeners (PFOA, PFHS, PFOS) and pulmonary function measures, with age-stratified effects observed for wheezing symptoms. Mixture analyses revealed PFOA as the predominant contributor to observed respiratory effects, partially mediated through oxidative stress pathways (6.8–8.2% mediation). Molecular investigations identified critical signaling nodes (INS, AKT1, TP53, TNF, IL6, ALB and PPARγ) potentially linking PFC exposure to respiratory outcomes. These findings provide mechanistic insights into PFC-induced pulmonary effects during adolescence, highlighting the need for continued investigation of these environmentally persistent compounds’ impact on developing respiratory systems. The integrated epidemiological-computational approach demonstrates the utility of combining population-level data with mechanistic modeling to elucidate environmental health effects.

Epidemiological impact of three major respiratory coronavirus epidemics on influenza transmission: a multicountry analysis using surveillance data and mathematical modelling

Por: Qu · H. · Li · K. · Rui · J. · Chen · Q. · Li · T. · Guo · X. · Guan · X. · Chen · T.
Background

With the acceleration of globalisation and the increasing frequency of international exchanges, the risk of cross-border transmission of emerging respiratory infectious diseases (ERIDs) has significantly increased. Since the year 2002, epidemics of SARS, Middle East respiratory syndrome (MERS) and COVID-19 have exemplified this trend. These epidemics have impacted the prevalence and transmission of traditional respiratory infectious diseases (RIDs), such as influenza, which share similar transmission routes and control measures. To better explore the impact of ERIDs epidemics on influenza, our study quantitatively evaluates the epidemiological changes in influenza during three representative emerging respiratory coronavirus epidemics: SARS, MERS and COVID-19.

Methods

Using Global Influenza Surveillance and Response System data, we examined influenza trends across different periods and regions affected by the three coronavirus epidemics. The impact of the epidemic on influenza was revealed by comparing and analysing the reported positive cases (RPCs) of influenza during the pre-epidemic and epidemics, and during the three postpandemic periods. Based on the Susceptible-Exposed-Infected-Asymptomatic-Recovered (SEIAR) compartmental model, the time-varying effective reproduction number () over time was calculated, and the Farrington surveillance algorithm was used to calculate the RPCs in the absence of an epidemic to analyse the characteristics of influenza transmissibility during the epidemics of the three respiratory coronavirus changes.

Results

There was a significant decline in the RPCs of influenza and transmissibility. The suppressive effect of the COVID-19 epidemic on influenza prevalence was the most pronounced. During the COVID-19 epidemic, the RPCs of the three major influenza subtypes showed the largest decrease compared with historical predictions, with reduction rates of –53.30% for A(H1N1), –57.50% for A(H3N2) and –48.56% for influenza B (p0.05). During the MERS epidemic, the RPCs of A(H1N1) and A(H3N2) decreased by 28.75% and 17.62%, respectively, although influenza B partially rebounded in the later stages, resulting in a relatively smaller overall impact.

Conclusions

The COVID-19 epidemic demonstrated the most pronounced suppressive effect on influenza prevalence. The impact of SARS was secondary, while MERS had the least effect. Among different influenza subtypes, A(H3N2) and influenza B exhibited greater declines compared with A(H1N1). The decrease in RPCs during coronavirus epidemics highlighted the importance of non-pharmaceutical interventions (NPIs), demonstrating the broad applicability and high efficacy of comprehensive control strategies for RIDs. Furthermore, when NPIs are lifted during the later stages of coronavirus epidemics, attention should be paid to the potential rebound of traditional respiratory diseases such as influenza.

Natural history of coronary atherosclerosis based on multimodal imaging and physiological fusion techniques: study protocol and rationale for the NASCENT study

Por: Jiang · Y. · Sun · Z. · Yu · B. · Liu · W. · Gao · H. · Li · J. · Jin · Z. · Yu · H. · Zheng · B. · Guan · C. · Zhang · H. · Zhang · Y. · Gao · L. · Cui · C. · Song · Y. · Xu · J. · Dou · K. · Yang · W. · Qian · J. · Wu · Y. · Song · L.
Introduction

Patients with acute myocardial infarction (AMI) and multivessel disease are at elevated risk of recurrent events. Radial wall strain (RWS), a novel indicator derived from angiography, has emerged as a potentially useful adjunct to optical coherence tomography (OCT) for assessing plaque vulnerability. The NASCENT trial is a prospective, multicentre cohort study designed to assess the natural history of coronary plaque in this high-risk AMI population and investigate the predictive value of angiography-based RWS for lesion progression, compared with OCT-assessed vulnerable plaque.

Methods and analysis

Following successful culprit lesion revascularisation for AMI patients with multivessel disease, we assessed eligible non-culprit lesions (30%–80% diameter stenosis) in non-flow-limiting, non-infarct-related arteries (Murray law-based quantitative flow ratio >0.80) using OCT and offline RWS analysis. The primary endpoint is lesion progression at 1 year, defined as a ≥20% increase in diameter stenosis percentage measured by quantitative coronary angiography. Between April 2024 and April 2025, 131 patients were enrolled. The 1-year angiographic and OCT follow-ups will be completed by May 2026. Clinical follow-ups are planned at 1 month, 6 months, 1 year and annually up to 3 years. As the first prospective trial comparing angiography-based RWS with OCT for predicting lesion progression in the AMI population, this study may provide crucial evidence for RWS as a valuable tool for risk stratification and clinical decision-making.

Ethics and dissemination

The protocol has been approved by the Institutional Review Board and Ethics Committee (Fuwai Hospital Approval No. 2023-2039) and will be conducted in accordance with the Declaration of Helsinki. Informed consent was obtained from all participants. The study results will undergo peer-reviewed publication.

Trial registration number

NCT06040073.

The prognostic value of the direct bilirubin to albumin ratio in critically ill patients with cirrhosis: Insights from MIMIC-IV database

by XingYi Yang, GuangDong Wang, Zhang Min, LiHong Lv, Ji Yang

Background

Patients with severe cirrhosis are at a higher risk of mortality. This study aimed to investigate the association between the direct bilirubin-to-albumin ratio (DBAR) and 28-day mortality in critically ill cirrhotic patients using data from the publicly available MIMIC-IV database.

Methods

This study explores DBAR’s relationship with 28-day mortality in severe cirrhosis patients. We first conducted univariate and multivariate analyses to identify independent risk factors. Then, we used Kaplan-Meier (KM) survival analysis to assess DBAR’s link with survival time and created KM curves. DBAR’s predictive accuracy was evaluated using Receiver Operating Characteristic (ROC) analysis, and the relationship was examined using restricted cubic spline modeling and subgroup analyses.

Result

This study enrolled 509 cirrhotic patients with in-hospital and ICU mortality rates of 22.3% and 14.3%, respectively. Univariate and multivariate analyses revealed a significant association between DBAR and 28-day mortality risk, with a hazard ratio of 1.16 (95% CI: 1.10–1.24, p  Conclusion

The DBAR scoring system offers an efficient and user-friendly approach for assessing prognosis in critically ill cirrhotic patients.

Prophylactic biological mesh reinforcement during ileostomy closure surgery evaluated by the image-based deep learning model for the prevention of stoma-site incisional hernia: phase II study protocol for a single-centre, prospective, randomised controlle

Por: Liu · Z. · Dong · Z. · Zhang · Y. · Guan · Y. · Bai · L. · Gu · J. · Ni · B. · Zhang · H.-y. · Aimaiti · M. · Wang · S. · Yue · B. · Xia · X. · Zhang · Z.
Background

Prophylactic ileostomy plays a critical role in the radical resection of low rectal cancer, but the incidence of stoma site incisional hernia (SSIH) after stoma closure remains high. No study has been reported in which radiomics has been used to predict SSIH. The primary aim of this study is to evaluate the safety and efficacy of biological mesh in preventing incisional hernia in patients with high-risk incisional hernia factors, as identified by image-based deep learning model, undergoing ileostomy closure surgery.

Methods and analysis

40 patients who need to undergo ileostomy closure and have been identified with high risk factors for SSIH by image-based deep learning model will be selected for this study. Patients will be randomly assigned equally to the prophylactic biological mesh placement group and the control group, and outcomes will be tracked via clinic review at 1 month, 3 months, 6 months and 12 months postoperatively. The outcome measures are the rate of postoperative incisional hernia, local pain, incisional infection, seroma and so on. This study demonstrates that prophylactic placement of biological mesh with ileostomy closure reduces the incidence of SSIH. Furthermore, it validates the feasibility of image-based deep learning models in predicting postoperative complications and identifying high-risk SSIH patients.

Ethics and dissemination

Informed consent has been obtained from all subjects. This protocol has been approved by the Ethics Committee of Renji Hospital, Shanghai Jiao Tong University School of Medicine (KY2022-087-B). The findings will be disseminated through peer-reviewed manuscripts, reports and presentations.

Trial registration number

ChiCTR2200064995. Registration date: October 2022. Registration authority: Chinese Clinical Trial Registry.

Association between blood pressure and metabolic dysfunction-associated fatty liver disease among adults without hypertension: a cross-sectional analysis of the National Health and Nutrition Examination Survey 2017-2018

Por: Wu · S. · Chen · N. · Wu · M. · Wang · Y. · Huang · Z. · Zhang · J. · Li · J. · Xu · D. · Guan · L. · Ge · J.
Objective

High blood pressure (BP) is one of the optional components of metabolic dysfunction-associated fatty liver disease (MAFLD). However, whether subclinical elevations in BP are related to MAFLD even in the absence of hypertension remains unclear. We investigated the association between BP and MAFLD among adults without hypertension.

Design and setting

A nationwide, multicentre and cross-sectional study of the National Health and Nutrition Examination Survey (NHANES).

Participants

2022 US adults without hypertension were recruited in the 2017–2018 cycle of the NHANES.

Exposure

Systolic BP (SBP) and diastolic BP (DBP).

Outcome measures

MAFLD was defined by the novel consensus of diagnostic criteria in 2020.

Results

MAFLD is common among US adults even at the ‘normal’ BP ranges, with a prevalence of 38.8%. We observed a positive, linear relationship between SBP and MAFLD down to 90 mm Hg, and between DBP and MAFLD down to 50 mm Hg. The MAFLD risk was elevated significantly with increasing SBP level (per 10 mm Hg increase: adjusted OR, 1.59 (95% CI, 1.21 to 2.09)) in the range of 90–129 mm Hg. The relationship between DBP and MAFLD was not evident (per 10 mm Hg increase: adjusted OR, 1.42 (95% CI, 0.96 to 2.21)) in the range of 50–79 mm Hg. Similar findings were identified in the sensitivity analyses.

Conclusions

In a population without hypertension, SBP is significantly associated with MAFLD, indicating potential early intervention to prevent MAFLD.

A blueprint of synergistic effect in Crataegus pinnatifida and obesity-related gut microbiota against obesity via systems biology concept

by Jinghui Xie, Haofang Guan, Maohui Liu, Weijun Ding

Background

Current obesity treatments include behavioral interventions, pharmacotherapy and surgery. Recently, the combination of ‘medicinal food’ products such as the plant Crataegus pinnatifida and its interaction with the gut microbiota has shown promise as an alternative therapeutic strategy to treat obesity.

Methods

We obtained secondary metabolites (SMs) of obesity-related gut microbiota and Crataegus pinnatifida from gutMGene database and NAPSS database. bioinformatics analysis was used to elucidate key target and signaling pathways, whereas molecular docking (MD), molecular dynamics simulation and quantum chemical calculations identified crucial SMs involved in these pathways. The toxicity and physicochemical properties of these SMs were also assessed.

Results

Phosphoinositide-3-kinase regulatory subunit 1 (PIK3R1), a key mediator in the phosphoinositide 3-kinase (PI3K)/ Protein Kinase B (Akt) pathway that is crucial for regulating insulin signaling and adipogenesis, emerged as the central hub within the PPI network. Strong binders to PIK3R1 were predicted to be quercetin, kaempferol and naringenin chalcone, suggesting their potential as therapeutic agents to treat obesity.

Conclusion

The synergistic combination of Crataegus pinnatifida and the obesity-related gut microbiota holds promise as a novel therapeutic strategy for obesity by targeting PIK3R1 and modulating the PI3K/Akt signaling pathway. Further experimental validation is necessary to confirm these findings.

Relationship between anion gap and 28-day all-cause mortality in patients with acute pulmonary edema: A retrospective analysis of the MIMIC-IV database

by Ping Guo, Yuwen Liu, Xiaomi Huang, Yanfang Zeng, Zhonglan Cai, Guang Tu

Background

Acute pulmonary edema is a severe clinical condition with high mortality. The anion gap, reflecting metabolic acid-base disturbances, is often elevated in critically ill patients. However, its relationship with outcomes in acute pulmonary edema remains unclear.

Objective

To explore the association between admission anion gap levels and 28-day all-cause mortality in patients with acute pulmonary edema.

Methods

This retrospective cohort study utilized data from the MIMIC-IV database (2008–2019) and included adult patients with acute pulmonary edema. Patients were categorized into quartiles based on anion gap levels. Cox regression models analyzed the relationship between anion gap and mortality, with restricted cubic spline (RCS) curves, Kaplan-Meier analysis, and subgroup analyses.

Results

A total of 1094 patients were included. Univariate Cox regression showed a positive correlation between anion gap levels and 28-day mortality (HR = 1.13, 95%CI: 1.09–1.17, P P P  Conclusion

Admission anion gap levels predict 28-day all-cause mortality in acute pulmonary edema patients, particularly in younger patients and those without renal disease. Clinically, anion gap monitoring should be emphasized, and individualized prognostic and treatment strategies should be developed with factors like age and renal status to improve outcomes.

The Mediation of AI Trust on AI Uncertainties and AI Competence Among Nurses: A Cross‐Sectional Study

ABSTRACT

Aim

This study aimed to validate the mediating role of nurses' AI trust in the relationship between AI uncertainties and AI competence.

Design

A cross-sectional study.

Methods

A purposive sample of 550 registered nurses with at least 1 year of clinical experience from three tertiary and two secondary hospitals in Jinan and Hangzhou, China, was used. Data were collected using structured questionnaires assessing AI uncertainty, trust and competence. Demographic data included gender, age, education level, years of clinical experience, professional title and hospital level. Mediation analysis.

Results

Most nurses were from tertiary hospitals (88.9%), held a bachelor's degree (87.6%), and had over 6 years of experience. The mediating role of AI trust between AI uncertainties and AI competence is validated. AI uncertainties affected AI trust (B = 0.39, p < 0.0001), explaining 10% of the variance. AI uncertainties and AI trust affected AI competence (B = 0.25 and 0.67, p < 0.0001), explaining 63% of the variation. AI trust's total effect was 0.51, comprising direct and indirect effects of 0.25 and 0.26, respectively.

Conclusion

Hospitals can reduce uncertainty through an AI-transparent decision-making process, providing clinical examples of AI and training nurses to use AI, thereby increasing trust. Second, AI systems should be designed to consider nurses' psychological safety needs. Hospital administrators utilise optimised AI technology training and promotional techniques to mitigate nurses' resistance to AI and enhance their positive perceptions of AI competence through trust-building mechanisms.

Implications for the Profession and/or Patient Care

Impact: Enhancing nurses' AI trust can reduce uncertainty and improve their competence in clinical use. Strategies such as transparency, explainability and training programmes are crucial for improving AI implementation in healthcare.

No Patient or Public Contribution

This study focused solely on clinical nurses and did not include patients or the public.

Reporting Method

The study adhered to STROBE guidelines.

Combined application of BNLF2b antibody with VCA-IgA, Rta-IgG, and Zta-IgA in nasopharyngeal carcinoma screening in the Guangxi region

by Ruilan Lin, Ru Qin, Yunlong Zhang, Yao Guan, Boheng Wu, Shangyang Li, Shenhong Qu, Yulin Yuan

Background

This study aims to assess the diagnostic value of the Epstein-Barr virus (EBV) BNLF2b antibody(P85-Ab), alone or in combination with VCA-IgA, Rta-IgG, and Zta-IgA antibodies, in the context of nasopharyngeal carcinoma (NPC).

Methods

The study included 100 NPC patients and 100 healthy controls. Chemiluminescent microparticle immunoassay was utilized to measure P85-Ab levels in the serum samples of both NPC patients and healthy controls. Additionally, the ELISA method was employed to detect serum levels of VCA-IgA, Rta-IgG, and Zta-IgA antibodies. The study analyzed the roles of serum P85-Ab in conjunction with VCA-IgA, Rta-IgG, and Zta-IgA antibodies in the diagnosis of NPC.

Results

Serum levels of P85-Ab, VCA-IgA, Rta-IgG, and Zta-IgA antibodies in NPC patients were significantly higher than those in the normal control group (P  Conclusion

The combined detection of P85-Ab with VCA-IgA, Rta-IgG, and Zta-IgA antibodies demonstrates high diagnostic value for nasopharyngeal carcinoma. Serum P85-Ab may serve as a potential marker for the diagnosis of NPC.

Superior vena cava isolation added to pulmonary vein isolation enhances outcomes in paroxysmal atrial fibrillation: a meta-analysis with trial sequential analysis

Por: Guan · W. · Liu · J. · Li · X. · Chen · K. · Yao · Y.
Objectives

To evaluate the efficacy and safety of adding Superior Vena Cava Isolation (SVCI) to Pulmonary Vein Isolation (PVI) in patients with drug-refractory paroxysmal atrial fibrillation (PAF).

Design

Systematic review and meta-analysis of randomised controlled trials (RCTs) using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach, supplemented with Trial Sequential Analysis (TSA) to assess evidence sufficiency.

Data sources

We searched PubMed, EMBASE, the Cochrane Library (CENTRAL) and Web of Science for relevant studies published up to 13 July 2025.

Eligibility criteria

We included prospective RCTs comparing SVCI+PVI versus PVI alone in adults with drug-refractory PAF, with at least 3 months of follow-up and reporting on atrial fibrillation (AF) recurrence and procedural complications. Case reports, reviews, observational studies, editorials, expert opinions and non-RCT studies were excluded.

Data extraction and synthesis

Two independent reviewers used standardised methods to search, screen and code included studies. Risk of bias was assessed using the Cochrane Collaboration and Evidence Project tools. A meta-analysis was conducted using random effects models, and TSA was conducted to evaluate the conclusiveness of evidence. Findings were summarised in GRADE evidence profiles and synthesised qualitatively.

Results

Three RCTs involving 332 patients were included. The addition of SVCI to PVI significantly reduced AF recurrence compared with PVI alone (Risk Ratio 0.54, 95% CI 0.32 to 0.91, p=0.02; I² = 0%, P_heterogeneity=0.79) at a mean 12-month follow-up. TSA confirmed that the current evidence is sufficient. There were no significant differences in procedural complications between groups (Risk Difference 0.00, 95% CI –0.04 to 0.03, p=0.99; I² = 0%, P_heterogeneity=0.96).

Conclusions

Adding SVCI to PVI for PAF ablation significantly reduces AF recurrence without increasing procedural risks. TSA confirms the robustness of the findings, supporting the potential integration of SVCI into routine clinical practice for PAF.

Mitigating Nurse Turnover in Urban China: Income Inequality and Nurse–Patient Relationships as Moderators of Occupational Stress

ABSTRACT

Aim

This study examined the moderating effects of income inequality and nurse–patient relationships on the association between occupational stress and nurse turnover intentions in large urban hospitals in China, providing evidence for developing targeted retention strategies.

Design

A cross-sectional study.

Methods

Data from 13,298 nurses in 46 hospitals in Xi'an, China (October–December 2023) were analysed using hierarchical regression to assess associations between occupational stress, organisational and professional turnover intentions and the moderating roles of the expected income achievement rate (calculated as [actual/expected income] × 100%) and nurse–patient relationship quality.

Results

Eighty-three percent of nurses reported moderate-to-severe occupational stress. Compared to nurses experiencing mild stress, those with moderate/severe stress demonstrated significantly higher organisational and professional turnover intentions. After adjusting for covariates, significant interaction effects were observed. Higher expected income achievement rate showed a modest but significant moderating effect, associated with reduced turnover intentions. While the nurse–patient relationship also moderated this relationship, its protective effect was attenuated under conditions of severe stress. Despite small effect sizes, the consistent patterns and theoretical coherence of these interactions warrant further investigation.

Conclusion

Occupational stress significantly predicts nurse turnover intentions in urban Chinese hospitals, with income inequality and nurse–patient relationship quality serving as modifiable moderating factors. Interventions should integrate equitable compensation, nurse–patient relationship enhancement programmes and stress management initiatives.

Impact

This study demonstrates that equitable income consistently buffers the effects of occupational stress on nurse turnover, while nurse–patient relationships show stress-level-dependent moderation. By implementing region-specific compensation benchmarks and structured communication training, healthcare policymakers can effectively address economic security and relational care quality in workforce stabilisation.

Reporting Method

The study has been reported following the STROBE guidelines.

Patient or Public Contribution

No patient or public contribution.

Development and validation of a dynamic prediction model for single-dose methotrexate treatment success in tubal ectopic pregnancy: a multicentre cohort study in Chinese hospitals

Por: Hu · Y. · Zhang · W. · Yao · Z. · Deng · L. · Guan · Q. · Wang · X.
Introduction

Tubal ectopic pregnancy (TEP) frequently presents as a gynaecological emergency, often necessitating prompt medical intervention. Although methotrexate therapy offers the advantage of being non-invasive, it still poses the risk of tubal rupture and consequent haemorrhage, which may require emergency surgery. The major challenges encountered in practice are the lack of reliable methods to anticipate the likelihood of failure of single-dose methotrexate therapy and identify associated risk factors and thereby preclude unnecessary medical procedures. Effective counselling, therefore, remains a pivotal step in clinical management. This study is aimed at developing a predictive model to assess response to single-dose methotrexate therapy in cases of TEP by employing a dynamic prediction model approach based on the clinical data of a large cohort.

Methods and analysis

This multicentre study will encompass 100 and 900 participants for the prospective and retrospective cohorts with TEP, respectively. Between 2010 and 2024, eligible patients who are diagnosed with TEP and opt for single-dose methotrexate therapy will be recruited as part of a retrospective cohort, from three participating hospitals in Zhejiang province, China. The comprehensive medical and obstetric histories of the patients will be collected, along with their clinical data, including the results of serological tests following the initial consultation. The control group will comprise patients who achieve uneventful, complete resolution of TEP, as evidenced by serum human chorionic gonadotropin level of

Ethics and dissemination

Ethical approval for data collection has been obtained from the Ethics Committee of the First Affiliated Hospital of Zhejiang Chinese Medical University (No. 2024-KLS-346–02), Hangzhou First People’s Hospital (No. ZN-20240627-0219-01), Anji Hospital of Chinese Medicine (No. 2025年第5号), Qingyuan Hospital of Chinese Medicine (No. (2024)伦审第(9)号) and Beilun Hospital of Chinese Medicine (No. 2024年伦审第12号). Additionally, written informed consent will be obtained from all participants and they will retain the right to withdraw from the study at any stage. The findings of this study will be disseminated through publication in a peer-reviewed journal.

Trial registration number

ChiCTR2400085829.

Associations between clinical benefits of cancer drugs and incremental quality-adjusted life years used in reimbursement decisions in Australia, Canada, England and China: an observational study

Por: Chen · J. · Han · K. · Zhang · Y. · Zhu · D. · Han · S. · Shi · L. · Xie · F. · Guan · X.
Objectives

To investigate the association between incremental quality-adjusted life years (QALYs) predicted in economic evaluations and clinical benefits assessed by the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS), examining how accurately predicted QALYs reflect actual clinical outcomes in cancer drug reimbursement decisions.

Design

Cross-sectional observational study.

Setting

Health technology assessment (HTA) documents from Australia, Canada and England, supplemented by published economic evaluations from China. Economic evaluation data were collected from database inception to 31 December 2023.

Participants

A total of 240 economic evaluation documents were identified from Australia (n=61), Canada (n=114) and England (n=65), along with 106 published studies from China, all focused on solid tumour cancer drugs with publicly available ESMO-MCBS scores. Documents were included based on completeness and consistency of data sources; those that were incomplete or relied on external controls were excluded.

Primary and secondary outcome measures

The primary outcomes were the incremental QALYs from manufacturer submissions and HTA agency reevaluations. Secondary outcomes included associations stratified by data maturity, country, treatment setting and reimbursement recommendations.

Results

Incremental QALYs showed a moderate positive correlation with ESMO-MCBS scores (Spearman’s =0.42, 95% CI: 0.31 to 0.53). All country-specific correlations were statistically significant: England (=0.53), Australia (=0.37), Canada (=0.39) and China (=0.49), all p70% events observed) demonstrated the strongest association (OR=1.53, 95% CI: 1.10 to 2.13). Among countries, England exhibited the highest association (OR=1.42, 95% CI: 1.15 to 1.74), followed by China (OR=1.30, 95% CI: 1.04 to 1.62), Australia (OR=1.28, 95% CI: 1.01 to 1.63), and Canada (OR=1.15, 95% CI: 1.05 to 1.26).

Conclusions

This study highlights a moderate alignment between incremental QALYs derived from economic evaluations and clinical benefit scores, emphasising the importance of rigorous reassessment, mature survival data and independent validation processes. Future research should explore strategies for enhancing data maturity and incorporating independent review mechanisms to strengthen healthcare decision-making globally.

Effectiveness of Interventions for Reducing Interruptions During Medication Administration: A Systematic Review

ABSTRACT

Background

Medication errors, particularly during administration, are a major threat to patient safety, with interruptions being a key contributor. Nurses are the most affected by these disruptions, and various interventions have been proposed to reduce interruptions.

Aims

This review evaluates the effectiveness of preventive and responsive interventions aimed at reducing interruptions during medication administration.

Methods

A systematic search of multiple databases identified 14 eligible studies on interventions targeting nurse interruptions. The review includes randomized controlled trials and quasi-experimental studies, focusing on interruption and medication error rates. Significant heterogeneity prevented meta-analysis.

Results

Preventive strategies, like no-interruption vests and awareness campaigns, may reduce interruptions from external sources, but nurse-to-nurse interruptions remained common. Responsive strategies showed limited success in reducing interruptions but improved nurses' ability to manage them. The impact on medication errors was inconclusive.

Linking Evidence to Action

Preventive strategies help reduce interruptions, but more targeted interventions are needed for nurse-to-nurse disruptions. A combined approach of preventive and responsive strategies can enhance medication safety.

Facilitators and barriers to implementing a social franchising model of delivering eye care services in rural China: a qualitative study using the updated Consolidated Framework for Implementation Research

Por: Dong · X. · Guan · H. · Liu · W. · Zhao · J. · Wang · H. · Shi · Y. · Ma · X.
Objectives

To identify the barriers and facilitators to implementing the social franchising model ‘Smart Focus’ for delivering eye care services to children in rural China, using the updated Consolidated Framework for Implementation Research (CFIR 2.0) as a theoretical basis to evaluate implementation performance drivers and propose strategies for effective scaling and sustainability.

Design

This qualitative study involved semi-structured interviews with key stakeholders from both the supply side and demand side. Interview guide development, coding, analysis and reporting of findings were thoroughly informed by the CFIR 2.0.

Setting

Smart Focus operated in 23 poverty-designated counties across four western provinces in China, collaborating with local public hospitals, private optical shops and third-party non-governmental organisations.

Participants

Key informants included two Smart Focus project managers, six representatives from local education and health bureaus and ten vision centre employees and franchise operators.

Results

Key facilitators of implementation included a robust evidence base, high trialability and adaptability of the innovation, relative advantages over competitors, standardised resources and effective training programmes. Major barriers included challenges in cross-departmental collaboration, underestimated variable costs, competition from private providers, high employee turnover due to inadequate incentives and the lack of feedback mechanisms for contextual adaptation.

Conclusions

This study highlights critical barriers and facilitators to implementing social franchising models for eye care in low-resource settings. While Smart Focus demonstrated success in scalability, achieving sustainability requires addressing financial constraints, staff retention and adaptive feedback mechanisms. The findings provide a context-specific framework for scaling health innovations in low- and middle-income countries, offering valuable lessons for bridging the gap between social and business objectives in hybrid models.

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