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Real-world safety profile of novel anti-multidrug-resistant tuberculosis drugs: a disproportionality analysis based on the FAERS database

Por: Zhao · L. · Zeng · L. · Qian · Y. · Zhao · W. · Xie · R.
Objectives

Bedaquiline (BDQ), delamanid (DLM) and pretomanid (Pa) were widely used in recent years. This study aimed to analyse adverse drug event (ADE) reports associated with them based on the Food and Drug Administration Adverse Event Reporting System (FAERS) database, to explore the signals of ADEs and provide reference for clinical use.

Design

A retrospective pharmacovigilance study.

Setting

The FAERS database was extracted from 2015 to 2023, and the ADE reports about BDQ, DLM, and Pa were collected.

Main outcome measures

Data mining was carried out on relevant reports of BDQ, DLM, and Pa using the reporting odds ratio (ROR), proportional reporting ratio (PRR), medicines and healthcare products regulatory agency (MHRA) and the information component (IC).

Results

A total of 4010 ADE reports were included: 2477 for BDQ, 1360 for DLM and 173 for Pa. Combined with disproportionality analysis in different backgrounds, the salient risks of three target drugs varied. In the entire dataset, prolonged ECG QT (BDQ: ROR=42.57; DLM: ROR=28.00; Pa: ROR=20.45), hepatitis toxic (BDQ: ROR=28.65; DLM: ROR=21.42; Pa: ROR=90.67), bilirubin conjugated increased (BDQ: ROR=14.40; DLM: ROR=14.56; Pa: ROR=53.95), increased aspartate aminotransferase (BDQ: ROR=9.10; DLM: ROR=8.83; Pa: ROR=7.77), increased alanine aminotransferase (BDQ: ROR=5.68; DLM: ROR=5.54; Pa: ROR=8.92), drug-induced liver injury (BDQ: ROR=6.51; DLM: ROR=6.24; Pa: ROR=3.61) and anaemia (BDQ: ROR=6.54; DLM: ROR=5.75; Pa: ROR=4.83) remained common risks for them. However, in the other two contexts, only decreased haemoglobin (tuberculosis dataset: ROR=2.15; target dataset: ROR=1.03), which was more pronounced associated with DLM and prolonged ECG QT (tuberculosis dataset: ROR=2.46; target dataset: ROR=1.23), hepatotoxicity (tuberculosis dataset: ROR=1.74; target dataset: ROR=4.03) was more pronounced associated with BDQ, while other ADEs, like pancreatitis (tuberculosis dataset: ROR=4.54; target dataset: ROR=7.36), death (tuberculosis dataset: ROR=5.71; target dataset: ROR=2.47) and multiple organ dysfunction syndrome (tuberculosis dataset: ROR=1.46; target dataset: ROR=2.76), were worthy of attention associated with Pa apart from the common ADEs. The combination of linezolid (LZD) with the target drugs elevated risk signals for hepatotoxicity, haematologic toxicity and neurotoxicity. Subgroup analyses revealed that

Conclusion

Our study highlights the differences in common ADEs of BDQ, DLM and Pa, as well as the differences in these ADEs among genders and age groups, providing valuable insights for clinical application.

What is the postoperative prognosis of proximal humeral fractures in China? Protocol for a multicentre prospective cohort study (CAST)

Por: Wang · Q. · Chai · Y. · He · H. · Zhan · Z. · Ao · R. · Zeng · L. · Chen · Q. · Liu · Y. · Zhang · M. · Gu · Y. · Xiao · L. · Shen · L. · Chen · Y.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Study registration number

ChiCTR2500109651.

Acculturation and Self‐Care Behaviours Among First‐Generation Chinese Immigrants With Cardiovascular Disease: A Cross‐Sectional Study

ABSTRACT

Aims

With little known about the impact of acculturation on cardiovascular disease (CVD) self-care among immigrants, this study examined acculturation among Chinese immigrants and investigated its association with CVD self-care behaviours in this population.

Methods

A cross-sectional study was conducted, employing multiple acculturation indices and the Self-Care of Coronary Heart Disease Inventory to collect data from Chinese immigrants with CVD via Chinese Community Centres, social media and cardiac clinics. Descriptive statistics and multiple linear regression analyses were employed. The study adhered to the STROBE guidelines.

Results

Altogether 260 participants were recruited; 47.7% were female; the mean age was 71.8 years, the mean age at migration was 55.1 years and their mean duration of residence in Australia was 16.7 years; 41.2% could not speak English. Participants reported low acculturation levels via the Suinn Lew Asian Self-Identity Acculturation scale (mean score 1.8), but perceived high self-efficacy in coping with acculturation stressors relating to their health management (mean score 33.6). Their attitudes scored as slight agreement with Traditional Chinese Medicine (TCM) beliefs (mean score 3.4). Proxy acculturation measures revealed lower levels of acculturation associated with better CVD self-care behaviours. Higher perceived self-efficacy in coping with acculturation stress was linked with better CVD self-care maintenance and monitoring and better self-care management was observed among participants holding a stronger belief in TCM.

Conclusion

The acculturation of Chinese Australian immigrants contributed to the explanation of the variance in their CVD self-care behaviours.

Implication

Comprehensive assessment of acculturation in patients with culturally and linguistically diverse backgrounds can help nurses identify those likely to demonstrate poor CVD self-care behaviours, and culturally specific, individually tailored interventions may support improved self-care.

Patient or Public Contribution

Patients were involved as participants in this study for data collection.

Laparoscopic versus open distal gastrectomy with D2 lymphadenectomy following neoadjuvant chemotherapy for locally advanced gastric cancer (CLASS-03b): protocol for a multicentre, randomised, controlled, non-inferiority trial

Por: Liang · Y. · Chen · X. · Zhang · W. · Yang · K. · Wang · X. · Li · Z. · Li · G. · He · X. · Xu · Z. · Yan · S. · Liu · H. · Zang · L. · Zhao · G. · Wei · B. · Wang · G. · Tao · K. · Qian · K. · Ye · Z. · Zhang · B. · Wang · Q. · Zeng · Y. · Fan · Y. · Deng · Z. · Jing · C. · Zhou · J. · Deng · J. · Hu · W.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

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

Steerable versus Conventional flexible and navigable suction ureteral access sheath (FANS) flexible Ureteroscopy for Lower Pole stones Treatment: study protocol for a multicentre, randomised superiority trial (SCULPT trial)

Por: Yuen · S. K. K. · Liu · S. · Gauhar · V. · Mai · H. · He · W. · Hu · H. · Ke · C. · Dai · Y. · Shan · L. · Jiang · Y. · Yuan · J. · Cao · Z. · Zuo · L. · Yang · C. · Bai · B. · Bi · X. · Zhao · H. · Xi · M. · Ding · N. · Deng · S. · Tang · S. · Zeng · J. · Du · J. · Wu · W. · Ma · J. · Zhong · W. · Zhao
Introduction

Flexible ureteroscopy has advanced modern stone management; however, lower pole renal stones remain a challenge due to suboptimal ureteroscope deflection and navigation using conventional flexible and navigable suction ureteral access sheaths (FANS). The SCULPT trial is designed to assess whether the novel steerable FANS—which enables active controlled deflection—can improve the success rate of lower pole access during flexible ureteroscopy.

Methods and analysis

This multicentre, prospective, single-blinded, randomised controlled superiority trial will recruit 400 adult patients (aged 18–75 years) with solitary lower pole renal stones ≤2 cm diagnosed by CT from 20 high-volume urological centres in China. Participants will be randomised 1:1 to undergo flexible ureteroscopy with either steerable or conventional FANS. The primary outcome is the success rate of navigating into the lower pole calyx (defined as successful direct stone visualisation, laser lithotripsy and aspiration without adjunct use). Secondary outcomes include immediate and 1 month stone-free rates, operative time, complication profiles (graded by Clavien–Dindo), instrument damage rates, quality-of-life assessments and cost analysis. Statistical analysis will be performed using appropriate tests for continuous and categorical data, with their significance set by prespecified superiority margins.

Ethics and dissemination

The study protocol has been designed in accordance with the Declaration of Helsinki and ICH-GCP guidelines. Ethical approval was centrally granted by the Institutional Review Board of The First Affiliated Hospital of Guangzhou Medical University and adopted by all participating centres following local feasibility review. The trial results will be disseminated via peer-reviewed publication and presentation at international conferences.

Trial registration number

NCT06898216.

Association between periprocedural change in serum renalase and microvascular obstruction in patients with STEMI after primary percutaneous coronary intervention: protocol for the ReMVOS prospective cohort study

Por: Chen · Y. · Li · R. · Fu · R. · Zhao · L. · Sheng · Z. · Xu · K. · Liu · J. · Huang · W. · Wen · J. · Zeng · L. · Ou · Z. · Jiang · Z. · Liu · Y. · Wang · Y. · Jiang · W. · Li · X.
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

NCT06669520.

Association between latent tuberculosis infection and assisted reproductive outcomes: a systematic review and meta-analysis

Por: Sheng · Z. · Zeng · L. · Zhang · Y. · Chi · H. · Gai · X. · Sun · Y. · Li · R.
Objectives

Tuberculosis (TB) is a common cause of infertility in humans, especially in regions with high TB prevalence. However, the impact of latent TB infection (LTBI) on pregnancy outcomes following assisted reproduction in patients with infertility remains unclear. This systematic review and meta-analysis aimed to assess significant differences in pregnancy outcomes after assisted reproduction between infertile patients with and without LTBI.

Design

Systematic review and meta-analysis using the Grading of Recommendation, Assessment, Development and Evaluation approach.

Data sources

PubMed, Embase and Web of Science were searched from inception to 1 September 2025.

Eligibility criteria

Case–control or cohort studies comparing assisted reproduction outcomes between infertile patients with and without LTBI, diagnosed via tuberculin skin test or interferon-gamma release assay, were included. Outcomes of interest were clinical pregnancy rate, miscarriage rate and live birth rate.

Data extraction and synthesis

Two independent reviewers used standardised methods to search, screen and code included studies, extracted data and assessed study quality using the Newcastle-Ottawa Scale. Meta-analysis was performed using a fixed-effects model. Heterogeneity was evaluated with the I² statistic. Sensitivity analysis was performed using the leave-one-out method, and publication bias was assessed using funnel plots and Egger’s test.

Results

Four studies met the inclusion criteria for this meta-analysis. The included studies showed low heterogeneity for clinical pregnancy rate (I²=45.9%), miscarriage rate (I²=0%) and live birth rate (I²=8.9%). The miscarriage rate was significantly higher in the LTBI group than in the non-LTBI group (OR 1.14; 95% CI 1.00 to 1.31; p=0.049). No significant differences were observed between the two groups in terms of clinical pregnancy rate (OR 0.98; 95% CI 0.91 to 1.06; p=0.692) and live birth rate (OR 0.96; 95% CI 0.88 to 1.04; p=0.305). Sensitivity analysis confirmed the robustness of the miscarriage rate outcome. Publication bias was low for clinical pregnancy and miscarriage rates but potential bias was detected for live birth rate (Egger’s test p=0.029). The overall certainty of evidence was rated as low due to the observational nature of included studies and limited number of studies.

Conclusions

Infertile patients with LTBI might have a higher miscarriage rate after assisted reproduction compared with non-LTBI patients, although no differences were observed in clinical pregnancy or live birth rates. These results, particularly regarding miscarriage, should be interpreted with caution due to the limitations of the available evidence. Further high-quality studies are needed to strengthen the evidence base.

PROSPERO registration number

CRD42024605623.

Overall reporting quality of randomised controlled trials of acupuncture for low back pain reported after 2020: a systematic review

Por: Liu · J. · Lai · P. · Chen · X. · Jia · C. · He · J. · Xin · M. · Zhu · D. · Cheng · S. · Zeng · F.
Objective

To evaluate the reporting quality of recent randomised controlled trials (RCTs) of acupuncture for low back pain (LBP) and investigate associated factors.

Study design

A systematic review was conducted to identify and evaluate the reporting quality of RCTs of acupuncture for LBP reported after 2020. The Consolidated Standards of Reporting Trials (CONSORT), STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) and CONSORT-Outcomes statements were used to evaluate the reporting quality of the included studies. Regression analyses were performed on pre-specified study characteristics to explore factors associated with the reporting quality.

Data sources

Cochrane Library, PubMed, Web of Science, Embase, China National Knowledge Infrastructure (CNKI), Wan Fang, VIP Database and Chinese Biomedical Literature Database were systematically searched from January 2021 to January 2025.

Eligibility criteria

Only RCTs enrolling patients with LBP diagnosed according to the criteria of the North American Spine Society or other recognised clinical guidelines were included. The eligible interventions comprised manual acupuncture, electroacupuncture and other acupuncture-related therapies. Publication language was restricted to English and Chinese.

Data extraction and synthesis

Literature screening, data extraction and reporting quality assessment were independently conducted by two reviewers with professional training. Any discrepancies were resolved by a third reviewer.

Results

Fifty-seven RCTs were ultimately included, with a median overall quality score of 32 (range, 17–54). The CONSORT-based median quality score (QS) was 14 (range, 7–31). Among the 37 items comprised in the statement, 11 were sufficiently reported (reporting rate, >80%), whereas 19 were inadequately reported (reporting rate,

Conclusion

RCTs of acupuncture for LBP should focus more on reporting open science, key methodology, details of acupuncture and comprehensive outcome-related information. Authors and journals, especially those in China, need to strengthen their adherence to the CONSORT statement and its extensions to enhance the reporting quality of RCTs.

Maximising the potential of the National Compulsory Service Programme in rural China: a mixed methods study

Por: Li · H. · Guo · X. · Guo · Z. · Wang · P. · Chen · Y. · Shen · L. · Zeng · X. · He · Y. · Du · Y. · Liang · W. · Zhu · J.
Objectives

To alleviate the shortage of qualified physicians in rural areas, since 2010, the Chinese government has launched a National Compulsory Service Programme (NCSP) to enrol medical students for future work in township health centres (THCs) as general practitioners (GPs). The educational background of NCSP GPs is the best at THCs. This study aims to evaluate whether NCSP GPs have contributed to improving the quality of patient care at THCs and in what way.

Design

This is an explanatory sequential mixed methods study.

Setting

NCSP GPs are assigned to THCs in the rural areas of central and western China, where assistant physicians are permitted to practice independently as licensed physicians. The contribution of NCSP GPs was defined as the extent to which they were perceived to improve the quality of care at THCs. Job performance was defined as the aggregated value to the organisation of discrete behaviour episodes that an individual performs.

Participants

For the quantitative component, nine provinces were selected by using a stratified random sampling method based on NCSP admission numbers. A total of 2815 THC leaders completed the survey (response rate, 32%). For the qualitative component, 33 NCSP GPs were recruited for semi-structured interviews through purposive and snowball sampling method.

Outcome measures

The contribution of NCSP GPs to improvements in the quality of care at THCs was assessed as a key outcome measure.

Results

68% of THC leaders reported that NCSP GPs contributed considerably to improving the quality of care. The contribution of NCSP GPs was significantly and positively associated with the performance of NCSP GPs themselves (β=0.789, 95% CI 0.724 ~ 0.854) and THC remoteness (β=0.144, 95% CI 0.067 ~ 0.222), but negatively associated with the percentage of licensed physicians at the THC (β=–0.340, 95% CI –0.483 ~ –0.197) and with the turnover of NCSP GPs (β=–0.119, 95% CI –0.221 ~ –0.016). The percentage of licensed physicians has a mediating role between THC remoteness and the contribution of NCSP GPs. Interviews revealed that NCSP GPs contributed to the THC as individual clinicians, and a majority also contributed by influencing others or participating in THC management, such as by improving diagnosis and treatment performance of others, standardising patient care, teaching and training and implementing safety processes.

Conclusions

NCSP GPs have a positive impact on the quality of care at THCs. In addition to working as individual competent physicians, they can contribute to the THCs in many ways. Adjustments in NCSP curriculum design, more supportive measures and better allocation processes are recommended to maximise this programme’s potential.

The suffering experiences of patients with nasopharyngeal carcinoma in China: a qualitative study

Por: Song · S. · Liu · X. · Lu · Y. · Xiong · W. · Wang · D. · Wen · R. · Zeng · Y. · Zhang · Z. · Luo · Y.
Objectives

To explore the suffering experiences of patients with nasopharyngeal carcinoma (NPC) in China.

Design, setting and participants

This qualitative study employed a descriptive phenomenological approach. Data were collected through semistructured interviews and analysed using Colaizzi’s seven-step method. The study was conducted at a university-affiliated cancer centre in Southwest China. A total of 20 patients diagnosed with NPC were recruited through purposive sampling between January and April 2024.

Results

‘Disruption to reinvention’ emerged as a unifying thread that integrated three main themes (and nine subthemes): (1) beginning of suffering: plunged into a world of illness (denial and fear, significant concern and life in chaos); (2) struggle for adjustment: a rollercoaster experience (suffering trajectory, aggravating factors and alleviating factors) and (3) beyond suffering: living with illness (perceived benefits, new normal in life and personal growth).

Conclusions

The suffering experiences of patients with NPC represent a complex and dynamic process. People with NPC frequently experience multiple sufferings, disrupting their lives. Notably, most patients progressed from disruption to reinvention, reflecting the possibility that suffering can be transcended. The findings of this study can assist healthcare professionals in better identifying the suffering of patients and its influencing factors, allowing for the tailoring of interventions to alleviate their suffering.

Relationships Between Job Engagement and Self‐Efficacy, Perceived Organisational Support and Perceived Job Security for Newly Recruited Nurses: A Cross‐Sectional Study

ABSTRACT

Aims

To examine the relationships among perceived organisational support, perceived job security, self-efficacy and job engagement among newly recruited nurses and the mediating role of perceived job security and self-efficacy in the relationship between perceived organisational support and job engagement.

Design

Cross-sectional study.

Methods

This study employed a multicentre cross-sectional survey design and used the Perceived Job Security Scale, General Self-Efficacy Scale, Perceived Organisational Support Scale and Job Engagement Scale to survey 536 newly recruited nurses (from September 2023 to April 2024). Structural equation modelling was used to test the effects of perceived organisational support, perceived job security and self-efficacy on job engagement.

Results

In the study model, perceived organisational support, perceived job security and self-efficacy all directly affect job engagement among newly recruited nurses. Additionally, perceived organisational support can be used to predict job engagement through self-efficacy and perceived job security.

Conclusion

Perceived organisational support, job security and self-efficacy are positive predictors of job engagement among newly recruited nurses. Furthermore, perceived job security and self-efficacy mediate the relationship between perceived organisational support and job engagement.

Impact

Newly recruited nurses, as key agents in clinical nursing practice, play a crucial role in reducing nursing errors and improving work efficiency. The results of this study show that perceived organisational support, perceived job security and self-efficacy positively predict job engagement among newly recruited nurses. Clinical nursing managers and educators should assist newly recruited nurses in enhancing their perceived organisational support to foster job engagement by bolstering their perceived job security and self-efficacy.

Reporting Method

This study adhered to the STROBE guidelines.

Patient or Public Contributions

No patient or public contribution.

Predicting disease progression in people living with HIV using machine learning and a nomogram: a 10-year cohort study based in Xinjiang, China

Por: Mao · Q. · He · Q. · Ni · Y. · Ni · Z. · Zeng · C. · Wang · J. · He · X. · Feng · X. · Ni · M.
Objectives

Current prediction models for disease progression to AIDS in people living with HIV primarily rely on traditional statistical methods. This study aimed to develop and compare four machine learning models and to create a clinically applicable nomogram for identifying risk factors associated with AIDS progression.

Design

A retrospective cohort study conducted from January 2013 to December 2022.

Setting

Yining City, Xinjiang, China.

Participants

Newly diagnosed HIV-infected patients (aged 18–60 years) who received antiretroviral therapy and had not progressed to AIDS at baseline.

Primary outcome measures

Progression from HIV infection to AIDS, as defined by the Chinese Center for Disease Control and Prevention criteria.

Results

Among the 2305 patients included, 652 progressed to AIDS. The cohort was predominantly male, with a mean baseline CD4 cell count of 384 cells/μL. Four machine learning models—Support Vector Machine, Random Forest, Logistic Regression and Extreme Gradient Boosting (XGBoost)—were developed. The XGBoost model demonstrated the best predictive performance (area under the curve, AUC: 0.877). Univariate and multivariate analyses identified WHO clinical stages, CD4 cell count, HIV transmission route, platelet count and haemoglobin level as significant predictors. The developed nomogram achieved an AUC of 0.840. Its calibration curve, after bias correction, showed good agreement with the ideal curve, and decision curve analysis indicated potential clinical utility.

Conclusions

In this cohort, the XGBoost model showed superior performance for predicting AIDS progression. The proposed nomogram may serve as a practical tool to facilitate rapid risk assessment in similar clinical settings. These findings suggest that enhanced monitoring and regular follow-up might be beneficial for patients with low CD4 counts for timely intervention and to improve outcomes.

Death Anxiety Among Patients With Advanced Cancer: A Systematic Review and Meta‐Analysis

ABSTRACT

Aims

To identify and synthesise the levels of death anxiety and potential moderating factors in patients with advanced cancer.

Design

A systematic review and meta-analysis of observational studies.

Data Sources

A comprehensive search was conducted across 10 electronic databases, including PubMed, Cochrane, Embase, Web of Science, CINAHL, PsycINFO, Scopus, Chinese Biomedical, China National Knowledge Infrastructure, and WANFANG, covering publications in both English and Chinese from inception through June 18, 2025.

Review Methods

Two independent reviewers performed study selection, data extraction, and quality assessment. Meta-analyses were conducted using STATA 16 software. Predefined subgroup analyses and meta-regression were carried out to examine variations in death anxiety among advanced cancer patients based on participant characteristics, disease-related factors, and study-level variables.

Results

Twenty-one studies involving 4337 patients with advanced cancer met the inclusion criteria. These studies, published between 1978 and 2025, were conducted across five countries. Meta-analyses were performed separately for 16 studies using the original 15-item dichotomous Templer Death Anxiety Scale and 3 studies using an adapted five-point Likert version. Both analyses indicated high levels of death anxiety among patients. Differences in participant age, country, continent, and publication year contributed to the variation in findings.

Conclusion

Advanced cancer patients experience high levels of death anxiety, with age, country, continent, and publication year identified as key moderating factors. Targeting these factors through tailored interventions, promoting a supportive culture around death, and providing effective psychological training for patients can help reduce anxiety. These efforts aim to equip patients to understand and cope with the realities of death, ultimately improving their psychological well-being.

Impact

This review highlights the high levels of death anxiety in advanced cancer patients and identifies potential moderators. It underscores the need for targeted interventions to improve psychological care, particularly in end-of-life settings.

Patient or Public Contribution

No patient or public contribution.

Prospero Registration

The review was registered on PROSPERO (registration number: CRD420251033114).

Intervention effects of optimised carbohydrate diet in patients with type 2 diabetes: study protocol for a randomised controlled crossover trial

Por: LU · Y. · Zhang · R. · Yang · J. · Liu · D. · Wu · Q. · Long · X. · Cheng · D. · Guo · J. · Li · Q. · Zhang · Y. · Kang · P. · Wang · Q. · Gao · X. · Zeng · R. · Zhang · M. · Fang · Q. · Jia · W. · Ni · Y. · Li · H.
Introduction

Dietary intervention is fundamental for the management of type 2 diabetes (T2D), playing a crucial role in stabilising blood glucose levels and improving quality of life. As the major contributor to daily energy intake, the quality of carbohydrates can directly influence the glycaemic stability. Therefore, we aim to explore whether adjusting and optimising the composition of dietary carbohydrates, specifically starch, can provide multiple metabolic benefits for patients with T2D.

Methods and analysis

This multicentre randomised crossover clinical trial will include 150 participants with T2D. Participants will be assigned to either a conventional diet (CD) following the guidelines for T2D or an optimised carbohydrate diet (OCD) focused on increasing resistant starch intake to 40 g/day and decreasing rapidly digestible starch intake for 12 weeks. This will be followed by a 6-week wash-out period, after which participants will crossover to the alternate diet with equal energy and consistent energy proportion of the three macronutrients for another 12 weeks. The primary outcome is the difference in the change of postprandial glycaemia (changes in the average incremental area under the blood glucose curve (iAUC)) induced by OCD and CD interventions. Secondary outcomes include changes in other glucose and lipid metabolism-related parameters and cognitive function, as well as psychological, behavioural and physiological factors. Exploratory outcomes include changes in the iAUCs for each of the three meals, appetite-related hormone levels, degree of hepatic steatosis, serum cytokines, immune functions and multiomics parameters.

Ethics and dissemination

The protocol has received approval from the Ethics Committee of Shanghai Sixth People’s Hospital (Approval No. 2025–018; Protocol V.4.1, 20250112) and has been registered with the ClinicalTrials.gov Registry. The findings will be disseminated through peer-reviewed journal publications, conference presentations and media releases.

Trial registration number

NCT06936657.

BEdside ultraSound-guided ulTrafiltration for Acute Kidney Injury patients receiving CRRT: protocol for a randomised controlled trial (the BEST-AKI study)

Por: Liu · C. · Huang · Y. · Tang · X. · Wei · W. · Jin · L. · Zeng · X. · Fu · P. · Yin · W. · Zhao · Y. · Zhang · L.
Introduction

The mortality of critical acute kidney injury (AKI) patients requiring continuous renal replacement therapy (CRRT) is estimated to be as high as 50%. Fluid overload (FO) is a leading factor contributing to poor prognosis. CRRT, aimed at removing excessive water and toxins from the body, is an efficient method to address FO. However, accurate ultrafiltration is challenging because of the difficulty of quantifying fluid status, which usually relies on traditional examinations and clinicians’ perceptions. Both overultrafiltration and underultrafiltration are associated with adverse events. Critical care ultrasound (CCUS), introduced as a non-invasive tool, might be promising for assessing the volume status of AKI. However, there has been no solid evidence on the application of bedside CCUS in directing CRRT ultrafiltration among AKI patients. Therefore, in this randomised controlled trial (RCT), we aimed to investigate the efficacy and reliability of BEdside ultraSound-guided ultrafiltration (BEST) in comparison with conventional methods for AKI patients receiving CRRT.

Methods and analysis

This study is a single-centre, prospective, parallel-group, open-label RCT involving AKI patients who receive CRRT due to FO in the intensive care unit of a university-affiliated medical centre from September 2024. A total of 132 patients will be enrolled and randomly assigned to receive either bedside CCUS via an integrated score combining vascular, lung and cardiac ultrasonography or traditional methods to assess the volume status and guide CRRT ultrafiltration. The FO status will be quantified using a novel BEST score, where 1 point will be given if the inferior vena cava diameter >2.1 cm, 2 or more positive lung regions (B-line score >3) are identified under lung ultrasound, or E/e' >14 under echocardiography, with a total score of 3. The primary outcome is the rate of resuming euvolaemic status at the 72nd hour, on day 7 and at the end of CRRT. The secondary outcomes encompass the rates of FO correction, in-hospital events, renal outcomes, patient mortality and rehospitalisation.

Ethics and dissemination

The Institutional Review Board of West China Hospital, Sichuan University, granted ethical approval for this study (protocol version 2 dated 3 June 2024; Approval No. of the ethics committee: 2024-919). All participants or their legal representatives will sign the informed written consent. We intend to disseminate these findings to participants, medical practitioners, the public and other interested parties via conference presentations and publications without imposing any restrictions.

Trial registration number

ChiCTR2400087833.

The Relationship Between Chinese Nurses' Subjective Age and Career Satisfaction: The Mediating Role of Role Breadth Self‐Efficacy

ABSTRACT

Aim(s)

To assess career satisfaction among Chinese nurses, explore influencing factors, and examine the mediating role of role breadth self-efficacy (RBSE) in the relationship between subjective age and career satisfaction.

Design

A multi-centre, cross-sectional study.

Methods

Between June and October 2024, 2033 questionnaires were distributed to nurses across seven geographic regions in China, collecting data on demographics, subjective age, RBSE, and career satisfaction. Descriptive statistics, Pearson correlation analysis, multiple linear stepwise regression, and path analysis were used to identify determinants of career satisfaction and test the mediating effect of RBSE.

Results

The effective response rate was 97%. Chinese nurses reported moderate-to-high career satisfaction, younger subjective age relative to chronological age, and moderate RBSE levels. Multivariate linear regression analysis identified education level, work institution, salary, weekly working hours, subjective age, and RBSE as significant predictors of career satisfaction. Path analysis revealed a significant negative association between subjective age and career satisfaction (β = −0.23, p < 0.001), which was partially mediated by RBSE (indirect effect = −0.11, 95% CI: −0.18 to −0.05).

Conclusions

The career satisfaction of Chinese nurses is at a moderately high level; the influencing factors include the intensity of nursing work and salary levels. There is a certain difference between the subjective age and the chronological age of Chinese nurses. RBSE partly mediates the relationship between subjective age and career satisfaction.

Implications for the Profession and/or Patent Care

Valuing the breadth of nurses' roles, self-efficacy, and subjective age may help improve job satisfaction.

Impact

What problem did the study address?: This study elucidates the present level of career satisfaction among nurses in China and the variables affecting it. What were the main findings?: The subjective age of Chinese nurses influences career satisfaction, with RBSE partly mediating the connection between subjective age and career satisfaction. Where and on whom will the research have an impact?: This study presents novel variables of subjective age and RBSE in the investigation of factors influencing career satisfaction among Chinese nurses, offering new avenues for enhancing career satisfaction in this demographic in the future.

Reporting Method

We adhered to STROBE guidelines for cross-sectional research.

Patient or Public Contribution

This study did not include patient or public involvement in its design, conduct, or reporting.

Patients sense of gain experience and its influencing factors: a cross-sectional study in Foshan, China

Por: Xia · P. · Liang · B. · Zeng · Q. · Wang · L. · Zhai · L. · Li · M. · Chen · L. · Yang · H. · He · H. · Xu · X. · Gong · W.
Objectives

Patients’ sense of gain experience (PSGE) is the comprehensive feeling throughout the treatment process, which is a critical benchmark for evaluating comprehensive medical and health system reform in China. This study aims to assess the current status of PSGE in public hospitals and identify important associated factors, providing evidence-based recommendations for improving healthcare services.

Design

This was a cross-sectional study conducted from October to November 2023.

Setting

A total of 14 public hospitals in Foshan, Guangdong Province, China.

Participants

There were 3223 responses, including 1592 from outpatients and 1631 from inpatients.

Primary outcome measure

PSGE was assessed across five domains: time accessibility, service accessibility, cost affordability, patient participation and efficacy predictability. Participants were also asked to provide an overall rating of the PSGE.

Results

The overall score for PSGE was 4.47±0.53 (mean±SD), with service accessibility receiving the highest score (4.68±0.50) and affordability the lowest (4.17±0.86). Secondary hospitals scored an overall PSGE of 4.55±0.50, while tertiary hospitals scored 4.42±0.54. Key factors associated with PSGE were overall satisfaction (β=0.164, p

Conclusions

This study found that patients reported a positive PSGE with service accessibility but reported a less positive PSGE with cost affordability. A tier-based disparity was evident, with secondary hospitals outperforming tertiary hospitals in overall PSGE outcome. Stronger PSGE was positively associated with higher scores in overall satisfaction, treatment satisfaction, satisfaction with medical reforms, patient loyalty and hospital reputation. Demographic and institutional factors, such as hospital level, patient type and household registration, were associated with the PSGE. Efforts can be focused on enhancing clinicians’ willingness and competence in discussing treatment costs during clinical encounters. It is essential for policymakers to address disparities in healthcare experiences among patient groups across hospital tiers to advance equitable, patient-centred systems.

Patient-reported outcome measured by EQ-5D and influencing factors among patients of systemic lupus erythematosus in China: a multicentre cross-sectional study from CSTAR Registry

Por: Li · L. · Bai · W. · Yu · B. · Zou · K. · Wang · Y. · Zuo · K. · Wang · L. · Wu · C.-Y. · Zhao · J. · Zeng · X. · Wang · Y. · Li · M.
Objectives

Until now, there has still been a lack of sufficient evidence on patient-reported outcomes (PROs) measured by the EuroQol-5 Dimension (EQ-5D) in patients with systemic lupus erythematosus (SLE) in China. This study aims to comprehensively assess EQ-5D outcomes and influencing factors in Chinese patients with SLE.

Design

A multicentre, cross-sectional study based on the Chinese Systemic Lupus Erythematosus Treatment and Research Group registry.

Setting

101 hospitals across 27 provinces of China.

Participants

1336 patients with SLE.

Outcome measures

The information on EQ-5D was collected via an online questionnaire. Medical records were obtained from the Chinese Rheumatology Data Centre (CRDC). Clinical influencing factors related to the reported health problems were identified using multivariate logistic regression. Then, each health state was converted into a health utility score based on the Chinese 2014 tariff. Given the ceiling effects, Tobit regression models were used to analyse the factors influencing health utility scores.

Results

A total of 1336 patients with SLE were included. Of them, 626 patients (46.9%) reported health problems using EQ-5D. The proportions of patients reporting problems in mobility, self-care, usual activities, pain/discomfort and anxiety/depression were 12.80%, 5.24%, 14.90%, 27.47% and 30.46%, respectively. The mean utility score was 0.89 (SD: 0.15), and the mean Visual Analogue Scale (VAS) score was 76.80 (SD: 16.54). There was a statistically significant correlation (r=0.503, p

Conclusions

EQ-5D may be a useful, preference-based PRO measure for SLE and could potentially be integrated into routine clinical monitoring of patients with SLE and applied in economic evaluations in the future.

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.

Barriers and facilitators of implementing escape room in nursing education: a mixed-method systematic review protocol using an implementation framework

Por: Tan · X. · Cao · F. · Hua · N. · Zeng · Y. · Peng · J. · Pan · T. · Zhang · N. · Sun · M.
Introduction

Escape room (ER) methodology is recognised as an innovative pedagogical tool in nursing education, fostering an interactive environment that transforms students from passive observers into active participants. Current research on ER in educational contexts primarily emphasises their effectiveness and learner experiences, while neglecting the specific facilitators and barriers relevant to nursing education. This gap leads to a lack of essential frameworks for course design. Understanding these barriers and facilitators is crucial for the effective application of ERs in educational settings. Consequently, this review aims to identify factors associated with the implementation of ER in nursing education, using the Consolidated Framework for Implementation Research as a guiding framework.

Methods and analysis

The search will encompass six English databases and three Chinese databases from their inception to 1 October 2025: CINAHL, Embase, Education Resources Information Center, Scopus, Web of Science and MEDLINE, Wang Fang, China National Knowledge Infrastructure and the Chinese Biomedical Literature Database. Studies with qualitative, quantitative or mixed-methods designs will be included. Publications in English or Chinese will be considered from database inception. Two independent researchers will conduct screening and data extraction according to predefined criteria. A convergent integrated approach, including the transformation of quantitative results, will be employed, followed by thematic synthesis to analyse the findings. Discrepancies will be resolved through discussions with a third reviewer.

Ethics and dissemination

The ethical approval for this review is unnecessary due to the utilisation of secondary data. The outcomes are scheduled for publication in a peer-reviewed journal, with the aim of elucidating the facilitators and barriers linked to the integration of ER in nursing education.

PROSPERO registration number

CRD42024605953.

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