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Megestrol acetate versus dexamethasone to prevent nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer treated with oxaliplatin-based chemotherapy: study protocol of a multicentre, randomised, non-inferiority trial

Por: Luo · H. · Hu · Q. · Zeng · L. · Huang · Q. · Luo · Y. · Li · T. · Chen · P. · Yi · C. · Gou · H.
Introduction

Oxaliplatin is widely used in the treatment of gastric and gastro-oesophageal junction cancer. However, oxaliplatin-induced nausea and vomiting often complicate treatment and negatively affect patients’ quality of life. The current standard antiemetic regimen—dexamethasone (DEX) plus palonosetron—offers only limited efficacy, benefiting approximately 70% of patients, and is associated with steroid-related adverse effects, including insomnia and gastrointestinal bleeding. Consequently, there is a clear clinical need for effective DEX-free antiemetic regimens. This study aims to evaluate the efficacy and safety of megestrol acetate versus DEX in preventing oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer.

Method and analysis

This is an investigator-led, multicentre, randomised-controlled, open-label, phase III, non-inferiority trial. Chemotherapy-naïve patients scheduled to receive oxaliplatin-based chemotherapy are randomly (1:1) assigned to receive either megestrol acetate (megestrol acetate group) or DEX (DEX group) in combination with palonosetron. The primary endpoint is the complete response (CR; no vomiting and no rescue therapy) rate during the first 120 hours following the initiation of chemotherapy (0–120 hours). Secondary endpoints include the following indicators: CR rate in acute period (0–24 hours), CR rate in delayed period (24–120 hours), time to treatment failure, frequency of salvage medication use, nausea, anorexia, adverse events and quality of life.

The study will evaluate the efficacy and safety of megestrol acetate compared with DEX for prevention of oxaliplatin-induced nausea and vomiting in patients with gastric or gastro-oesophageal junction cancer. If proven effective, the results might inform future antiemetic strategies in the long term to (1) provide a novel DEX-free antiemetic treatment for prevention of moderate-emetogenic chemotherapy, (2) reduce DEX-related adverse effects and improve quality of life in patients with gastric or gastro-oesophageal junction cancer and (3) support the potential incorporation of megestrol acetate into standard antiemetic medications.

Ethics and dissemination

The study protocol is conducted in accordance with the Declaration of Helsinki and approved by the Certified Review Board of West China Hospital, Sichuan University (Ethics Approval No 1116/2023). The results of this study will be disseminated via presentations at national and international scientific conferences and publication in peer-reviewed journals.

Trial registration number

ChiCTR2300075943.

Effectiveness of Multifactorial and Exercise Programs in Preventing Falls Among Older Adults: A Systematic Review and Component Network Meta‐Analysis

ABSTRACT

Background

To compare the effectiveness of multifactorial and exercise programs in preventing falls among older adults, with a specific focus on evaluating the individual and combined contributions of their key intervention components.

Methods

This study was a systematic review and component network meta-analysis. PubMed, Embase, and Web of Science were searched from inception to February 2025 for randomized controlled trials, focusing on four primary outcomes: fallers, recurrent fallers, injurious fallers, and fractured fallers. Risk of bias was evaluated using the Cochrane tool, and additive component network meta-analysis compared intervention group and component efficacy.

Results

69 randomized controlled studies were included. In multifactorial interventions, traditional health education could increase fall risk (iRR: 1.10, 95% CI [1.03; 1.67]) and recurrent fall risk (iRR: 1.25, 95% CI [1.06; 1.48]). Medication management can increase recurrent fall risk (iRR: 1.35, 95% CI [1.09; 1.67]) and fracture risk (iRR: 2.11, 95% CI [1.48; 3.00]). Exercise (iRR: 1.24, 95% CI [1.01; 1.53]) increased fracture risk, and environment modification (iRR: 0.56, 95% CI [0.61; 0.79]) reduced it. The additive effect of risk assessment and advice, exercise, and environment modification reduced fall risk. In exercise programs, gait and balance (iRR: 0.58, 95% CI [0.36; 0.93]) can reduce recurrent fall risk. An intervention containing two components (gait and balance + strength and resistance) reduced the risk of falls and fall-related injuries.

Linking Evidence to Action

Environment modification reduced fracture risk, emphasizing the value of creating safe living spaces. The combination of risk assessment, advice, exercise, and environment modification reduced fall risk, suggesting a holistic approach may be effective in preventing falls. Traditional methods of health education and medication management are in urgent need of updating to synergize with other exercise components and enhance the effectiveness of fall prevention. Prospective clinical trials are needed to optimize combinations of exercise components, particularly integrating gait and balance training with strength and resistance exercises.

Trial Registration

The review was registered online in the International Prospective Register of Systematic Reviews (PROSPERO) under registration number (CRD42025643530)

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Liposomal bupivacaine versus standard ropivacaine for pain control in adults receiving continuous supraclavicular brachial plexus blocks for open elbow arthrolysis: study protocol for a randomised controlled non-inferiority clinical trial

Por: Luo · T. · Zheng · S. · Zhao · Y. · Yang · X. · Li · X. · Ji · Y. · Wang · Y. · Tang · H. · Xiao · R. · Zhang · W. · Li · T. · Wang · G. · Yuan · Y.
Introduction

Open elbow arthrolysis effectively treats post-traumatic elbow stiffness, but severe postoperative pain during early rehabilitation impedes recovery. Continuous brachial plexus blocks, though effective, face limitations such as catheter displacement and infection risks. Liposomal bupivacaine, an ultra-long-acting local anaesthetic, offers prolonged analgesia and may circumvent these challenges. This study aims to compare the analgesic efficacy of a single-dose liposomal bupivacaine supraclavicular block versus continuous ropivacaine infusion in patients undergoing open elbow arthrolysis.

Methods and analysis

This single-centre, randomised, double-blind, non-inferiority trial will enrol 72 adults (ASA I–III,the American Society of Anesthesiologists physical status classification for preoperative risk) scheduled for open elbow release surgery. Participants will be randomised (1:1) to receive either a single supraclavicular block with 10 mL liposomal bupivacaine plus 10 mL 0.5% ropivacaine followed by saline infusion (liposomal bupivacaine group) or continuous catheter infusion with 20 mL 0.5% ropivacaine followed by 0.2% ropivacaine infusion (control group). The primary outcome is the weighted area under the curve (AUC) of Numerical Rating Scale (NRS) pain scores during functional exercises within 72 hours postoperatively. Secondary outcomes include resting NRS scores, sleep quality (Pittsburgh Sleep Quality Index), rehabilitation metrics (range of motion, grip strength), recovery quality (Quality of Recovery -15) and long-term functional outcomes (Quick Disabilities of the Arm, Shoulder and Hand scores, Quick-DASH scores) at 2 weeks, 6 weeks and 12 weeks. Non-inferiority will be established if the upper 95% confidence limit of the AUC difference is ≤1.3. Statistical analyses will employ intention-to-treat principles with SPSS V.24.0.

Ethics and dissemination

Ethical approval was granted by Beijing Jishuitan Hospital Ethics Committee (K2025-213-00). The trial is registered with the Chinese Clinical Trial Registry (ChiCTR2500103911). Results will be disseminated via peer-reviewed journals, contributing evidence on liposomal bupivacaine’s role in perioperative analgesia and rehabilitation for elbow surgery.

Trial registration number

Chinese Clinical Trial Registry (ChiCTR ID provided on acceptance).

Cross-sectional study of respiratory virus infections in upper respiratory tract infection patients: post-COVID-19 pandemic trends in Sichuan, China

Por: Li · Y. · Yin · W. · Zhang · L. · Sun · M. · Yang · Q. · Ren · S. · Lin · X. · Liu · J. · Yang · J. · Zhu · S. · Li · W. · Luo · H. · Chen · X. · Xu · Y. · Zhang · G.
Objectives

Post-COVID-19 respiratory infection patterns require updated epidemiological data. To investigate the prevalence and infection patterns of upper respiratory tract infections (URTIs), a survey was conducted to assess the presence of influenza A (IFV A), influenza B (IFV B), respiratory syncytial virus (RSV), human rhinovirus (HRV), adenovirus (Adv), and SARS-CoV-2 among outpatients diagnosed with URTIs.

Design

A community-based cross-sectional study.

Setting

Three cities in Sichuan, China.

Participants

1174 outpatients diagnosed with URTIs from December 2023 to February 2024.

Methods

Oropharyngeal swabs were collected using sterile flocked swabs, preserved at 4°C and analysed within 24 hours. Viral nucleic acid was extracted automatically and detected via multiplex PCR-melting curve analysis.

Results

Results showed in positive detection rates varied significantly by age (p

Conclusions

This study reveals persistent influenza dominance and age-stratified co-infection risks and provides critical baseline data for optimising respiratory infectious disease control in the post-pandemic era.

The Impact of Game‐Based Teaching on Undergraduate Nursing Students' Learning Satisfaction, Clinical Thinking, Clinical Skills and Anxiety: A Systematic Review and Meta‐Analysis

ABSTRACT

Aim

To evaluate the impact of game-based teaching on undergraduate nursing students' learning satisfaction, clinical thinking, clinical skills, and anxiety.

Design

Systematic review and meta-analysis.

Data Sources

China National Knowledge Infrastructure, Wanfang, Weipu, SinoMed, CINAHL, PubMed, Web of Science, Cochrane Library, and Embase. Our systematic literature search was conducted up to 31 October 2024 and included all studies published before this date, with no restrictions on publication year.

Methods

The study quality was appraised using version 1 of the Cochrane risk-of-bias tool and the JBI Critical Appraisal Tools for Quasi-Experimental Studies. A meta-analysis was performed using STATA version 12.

Results

1712 undergraduate nursing students from 19 studies were included. Meta-analysis showed that game-based teaching improved undergraduate nursing students' learning satisfaction, critical thinking, clinical decision-making, and clinical skills. Game-based teaching did not significantly enhance undergraduate nursing students' problem-solving skills.

Conclusions

Our research findings indicated that game-based teaching had more significant potential to enhance undergraduate nursing students' learning satisfaction, critical thinking, clinical decision-making, and clinical skills. However, game-based teaching did not show a substantial advantage in improving problem-solving skills compared to other teaching methods. Limited studies of the effects of game-based teaching on clinical reasoning and anxiety in nursing students cannot be meta-analysed. Future studies could improve how game-based learning is designed to support undergraduate nursing students' development of these competencies.

Impact

This study explores the effects of game-based teaching in nursing education and finds that it promotes learning satisfaction, critical thinking, clinical decision-making, and clinical skills in undergraduate nursing students, while having no significant effect on problem-solving skills. Game-based teaching can be a functional pedagogical approach to guide nursing educators to improve learning outcomes for undergraduate nursing students.

Patient or Public Contribution

Inapplicable.

The Effect of Holistic and Humanistic Approach on Professional Pride in Nursing Care

ABSTRACT

Aim

This study examines the effect of nurses' holistic nursing competency levels and humanistic behaviour skills on their professional pride levels.

Design

The study was designed as a cross-sectional study.

Methods

The sample consisted of 224 nurses working in a city hospital. The data were collected using the Personal Information Form, the Holistic Nursing Competence Scale, the Humanistic Behaviour Skill Scale in Nursing Practices and the Pride in Nursing Profession Scale. Independent groups t-test, ANOVA, and regression analyses were applied to analyse the data.

Results

The mean ± standard deviation of the total score of the nurses participating in the study from the Holistic Nursing Competence Scale was 170.48 ± 42.41, the mean ± standard deviation of the total score from the Humanistic Behaviour in Nursing Practice Scale was 121.35 ± 20.81, and the mean ± standard deviation of the total score from the Pride in Nursing Profession Scale was 79.65 ± 22.80. A statistically significant positive relationship was found between the Holistic Nursing Competence Scale and the Humanistic Behaviour in Nursing Practice Scale. The results showed a statistically significant relationship between the Holistic Nursing Competence Scale, the Humanistic Behaviour in Nursing Practice Scale and the Pride in Nursing Profession Scale. In addition, it was determined that nurses' holistic and humanistic behaviour skills explained 12.2% of the change in professional pride. The holistic nursing competencies and professional pride levels of nurses who willingly chose the nursing profession and loved their profession were found to be statistically significantly higher (p < 0.05).

Conclusion

Nurses demonstrated above-average holistic and humanistic competencies, yet their professional pride remained below average. This indicates that professional pride may be shaped not only by individual skills but also by external factors such as working conditions and societal perceptions of the profession.

Implication for the Profession and/or Patient Care

These findings suggest that to increase professional pride among nurses, not only is the development of individual competencies insufficient, but also the improvement of workplace environments and greater societal appreciation of the profession are necessary. Without addressing systemic and societal challenges, the development of holistic and humanistic nursing competences may have a limited impact on professional satisfaction. On the other hand, nurses' provision of care services in line with holistic and humanistic principles positively affects their professional satisfaction and the quality of patient care, patient satisfaction, safety and general health outcomes.

Reporting Method

This study adhered to the STROBE criteria.

Influence of COVID-19 on postoperative prognosis and pain management

by Yue-Zi Hu, Zai-Long Qin, Wen Tang, Zhao-Lan Hu, Ru-Yi Luo

Background

The COVID-19 pandemic has significantly affected healthcare, particularly surgical care. Although short-term effects on surgical outcomes have been examined, understanding of long-term postoperative prognosis and pain management in COVID-19 patients remains limited. This knowledge gap is critical as the pandemic evolves and the need for optimized postoperative care becomes increasingly important.

Objective

The primary objective of this study was to evaluate the impact of COVID-19 infection on postoperative outcomes and pain management in surgical patients. We aimed to assess surgical mortality, complication rates, and postoperative pain levels in COVID-19-positive patients relative to a closely matched control group.

Methods

We conducted a retrospective cohort study of COVID-19 patients admitted to the ICU following surgery. Data were collected on baseline characteristics, postoperative complications, mortality and pain scores. Univariate and multivariate linear regression models were used to evaluate the impact of COVID-19 infection on postoperative pain. Stratified and interaction analyses were additionally performed to examine the robustness of these associations across subgroups.

Results

Mortality rates and the incidence of sepsis were significantly higher in the COVID-19 cohort. Patients with COVID-19 also experienced longer duration of mechanical ventilation in the ICU and prolonged ICU stays. In the fully adjusted multivariate linear regression model, COVID-19 infection was positively associated with higher postoperative visual analog scale pain scores (β = 1.51; 95% CI: 1.03–1.98; p  Conclusions

Surgical intervention in patients with COVID-19 was associated with higher mortality and sepsis rates, longer ICU stays, and increased postoperative pain scores. These findings highlight the need for continued research to optimize surgical care and improve patient outcomes in the evolving post-pandemic era.

Efficacy of transcutaneous electrical acupoint stimulation on early mobilisation in patients undergoing unilateral biportal endoscopic discectomy: a study protocol for a randomised controlled trial

Por: Luo · X. · Qi · Y. · Ma · Z. · Li · Y. · An · L.-X.
Background

Early mobilisation represents a core element of enhanced recovery after surgery (ERAS) and is recommended after minimally invasive spine surgery including unilateral biportal endoscopy (UBE). However, strategies to facilitate early mobilisation after UBE remain limited. Transcutaneous electrical acupoint stimulation (TEAS) may improve postoperative pain and recovery after spine surgery, but available evidence in UBE remains inconclusive.

Objective

To investigate whether perioperative TEAS enhances postoperative recovery after UBE.

Methods

This single-centre randomised controlled trial with blinded assessors will enrol 114 patients undergoing elective UBE discectomy. Participants will be randomly allocated (1:1) by simple randomisation to receive stimulation via self-adhesive electrodes, either single-session TEAS at Neiguan, Dazhui, Chengshan and Sanyinjiao initiated 30 min before surgery until the end of the procedure using a disperse–dense waveform (2/100 Hz) with individualised intensity (10–15 mA) or sham stimulation applied at four non-meridian, non-acupoint sites with brief initial stimulation followed by 0 mA output. Standardised general anaesthesia with bispectral index and analgesia nociception index monitoring will be provided following ERAS recommendations. The primary outcome is successful ambulation rate at 6 hour postoperatively; baseline pain, nausea, quality of recovery and functional status will be assessed using the Numerical Rating Scale, Visual Analogue Scale, Quality of Recovery-15 questionnaire, Oswestry Disability Index (ODI) and Japanese Orthopaedic Association (JOA) score at baseline before intervention while postoperative pain, nausea and vomiting, opioid consumption and Quality of recovery will be evaluated at 6, 24 and 48 hours after surgery, with ODI and JOA assessed during longer-term follow-up and surgery-related adverse events monitored postoperatively. Continuous outcomes will be analysed using parametric (repeated-measures analysis of variance) or non-parametric (Mann-Whitney U) tests, and categorical variables using ² or Fisher’s exact tests.

Ethical considerations and dissemination

This study was approved by the Ethics Committee of Beijing Friendship Hospital (No: 2024-P2-087-01) and registered with Chinese Clinical Trial Registry. Results will be published in peer-reviewed journals.

Trial registration number

ChiCTR2400083344.

Ozone exposure and semen quality in low-income men with unhealthy behaviours in Foshan, China: a case-control study

Por: Chen · W. · Zou · H. · Shui · H. · Luo · L. · Jiang · Y. · Wan · Z. · Yue · Q. · Li · Q. · Liu · W. · Liu · W.
Objective

To assess the association between ambient ozone (O3) exposure and semen quality among men with unhealthy behaviours and low income.

Design and setting

A case-control study was conducted from February 2024 to January 2025, in which male participants aged 18–45 years were recruited from Foshan, and following propensity score matching, a total of 820 participants were included in the final analysis.

Methods

The evaluated the association between O3 exposure during the 70–90 days, 10–14 days, 0–9 days and 0–90 days prior to semen collection and semen quality using stepwise conditional logistic regression analyses, and restricted cubic splines were incorporated into the models.

Results

O3 exposure during the 70–90 days and 0–90 days preceding semen sample collection was significantly associated with an increased risk of low semen quality, with ORs of 1.020 (95% CI 1.003 to 1.039) and 1.056 (95% CI 1.008 to 1.108), respectively. Additionally, O3 exposure during the 0–90-days period showed a significant positive association with abnormal sperm concentration. A non-linear relationship between O3 exposure and sperm concentration was also observed. Notably, O3 exposure during the 0–9 days before semen collection was inversely associated with the risk of low semen quality. Subgroup analyses across age, lifestyle factors and socioeconomic strata revealed no significant effect modifications.

Conclusion

This study found that O3 exposure during the 70–90 days and 0–90 days before sampling was associated with reduced semen quality in men with unhealthy behaviours and low income.

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

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

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

ChiCTR2500106951.

Prediction Models for Falls Risk Among Inpatients: A Systematic Review and Meta‐Analysis

ABSTRACT

Aim

To systematically review published studies on fall risk prediction models for inpatients.

Design

A systematic review and meta-analysis of prognostic model studies.

Data Sources

A literature search was carried out in Web of Science, the Cochrane Library, PubMed, Embase, CINAHL, SinoMed, VIP Database, CNKI and Wanfang Database. The search covered studies on risk prediction models for falls in inpatients from inception to March 9, 2024.

Methods

The research question was formulated using the PICOTS framework. Data extraction was performed following the Critical Appraisal and Data Extraction for Systematic Reviews of Prediction Modelling Studies (CHARMS). The quality of studies related to risk prediction models was evaluated with the Prediction Model Risk of Bias Assessment Tool (PROBAST). Meta-analysis was conducted using STATA 18.0 software.

Results

A total of 15 studies were included, with 13 eligible for meta-analysis. Only 2 of these 15 studies had external validation. The reported AUC values ranged from 0.681 to 0.900. The overall risk of bias was high, mainly attributed to inappropriate data sources and improper processing in the analysis domain. The pooled AUC from the meta-analysis was 0.799. After reviewing the predictors included in various models, FRIDs, fall history, age, gait, mental status, gender and incontinence were relatively common.

Conclusion

The fall risk prediction model for inpatients performs well overall, but it has a high risk of bias. Future development of risk prediction models should strictly adhere to the PROBAST, combine clinical reality, optimise study design and improve methodological quality.

Impact

This study provides medical professionals with a clear overview of constructing fall risk prediction models for inpatients. The fall-related predictors in these models help healthcare providers identify high-risk patients and implement preventive strategies. It also offers valuable insights for the development of future prediction models.

No Patient or Public Contribution

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

The Role Transition Journey of Spousal Caregivers of People Living With Dementia: A Meta‐Synthesis of Qualitative Studies

ABSTRACT

Aim

To explore the role transition journey of spousal caregivers of people living with dementia based on transition theory.

Design

A meta-synthesis.

Methods

This review employed a directed content analysis approach to systematically synthesise qualitative evidence. The findings were reported in accordance with the Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guidelines and the Joanna Briggs Institute (JBI) Manual for Evidence Synthesis.

Data Sources

A comprehensive search was conducted in eight electronic databases for studies published from the inception of each database to November 2024.

Results

This review ultimately included a total of 31 studies. Three themes were identified, including role stage, role transition properties and role transition conditions of spousal caregivers of people living with dementia. Role stage of spousal caregivers of people living with dementia encompassed seven sub-themes; role transition properties of spousal caregivers of people living with dementia included five sub-themes; role transition conditions of spousal caregivers of people living with dementia involved six sub-themes.

Conclusions

This review synthesises evidence to explore the role transition journey of spousal caregivers of people living with dementia. The role transition properties highlight the impact of critical points and events, as well as caregivers' awareness, engagement, change and difference and transition time span during their role transition journey. The role transition conditions emphasise that personal meanings, cultural beliefs and attitudes, socioeconomic status, preparation and knowledge, as well as community and society simultaneously influence the role transition journey of the caregivers.

Reporting Method

The Enhancing Transparency in Reporting the Synthesis of Qualitative Research (ENTREQ) guided the reporting of the study.

Patient or Public Contribution

No patient or public contribution.

Trial Registration

PROSPERO registration number: CRD 42024623402

Evaluation of a pharmacist-led patient-self-testing model for warfarin management in patients undergoing mechanical heart valve replacement in China: a multicentre, open-label, randomised, controlled trial

Por: Wang · C. · Luo · J. · Zhou · X. · Guo · Y. · Cao · W. · Zhang · D. · Song · L. · Tan · S.
Objectives

Patient self-testing (PST) for warfarin management is well-established in developed countries but remains underused in developing regions. This study compared the safety and effectiveness of PST with usual care (UC) in China.

Design

A multicentre, open-label, randomised, controlled trial.

Setting

A total of five centres participated in this study, including one provincial tertiary hospital, two municipal tertiary hospitals and two primary hospitals.

Participants

Patients undergoing mechanical heart valve (MHV) replacement at five centres were prospectively enrolled. Patients were trained and stratified according to time on warfarin at enrolment and were randomly assigned to the PST or UC group.

Interventions

The PST group used a point-of-care testing device for at-home international normalised ratio (INR) monitoring with pharmacist-guided warfarin dosing, while the UC group attended outpatient clinics for INR monitoring and dosing.

Primary and secondary outcome measures

The primary outcome was the difference in time in therapeutic range (TTR). The secondary outcomes were incidences of major bleeding, thromboembolism and all-cause deaths in 12 months.

Results

From March 2021 to March 2023, a total of 556 patients were enrolled, with a mean age of 47.5 years, 45.1% being male. 342 were newly initiating warfarin therapy, while 214 had been on warfarin for over 6 months. Baseline characteristics were similar between the PST and UC groups. The PST group showed significantly higher TTR (67.2% vs 55.1%, p

Conclusions

A pharmacist-led PST intervention with ongoing education and counselling led to improved TTR and clinical outcomes in patients with MHV in China.

Trial registration number

China Clinical Trial Registry (ChiCTR2000038984).

MetaMind: A multi-agent transformer-driven framework for automated network meta-analyses

by Achilleas Livieratos, Maria Kudela, Yuxi Zhao, All-shine Chen, Xin Luo, Junjing Lin, Di Zhang, Sai Dharmarajan, Sotirios Tsiodras, Vivek Rudrapatna, Margaret Gamalo

Background

Network meta-analysis (NMA) can compare several interventions at once by combining head-to-head and indirect trial evidence. However, identifying, extracting, and modelling these often takes months, delaying updates in many therapeutic areas.

Objective

To develop and validate MetaMind, an end-to-end, transformer-driven framework that automates NMA processes—including study retrieval, structured data extraction, and meta-analysis execution—while minimizing human input.

Methods

MetaMind integrates Promptriever, a fine-tuned retrieval model, to semantically retrieve high-impact clinical trials from PubMed; a multi-agent LLM architecture--Mixture of Agents (MoA)-- pipeline to extract PICO-structured (Population, Intervention, Comparison, Outcome) endpoints; and GPT-4o–generated Python and R scripts to perform Bayesian random-effects NMA and other NMA designs within a unified workflow. Validation was conducted by comparing MetaMind’s outputs against manually performed NMAs in ulcerative colitis (UC) and Crohn’s disease (CD).

Results

Promptriever outperformed baseline SentenceTransformer with higher similarity scores (0.7403 vs. 0.7049 for UC; 0.7142 vs. 0.7049 for CD) and narrower relevance ranges. Promptriever performance achieved 82.1% recall, 91.1% precision and an F1 score of 86.4% when compared to a previously published NMA. MetaMind achieved 100% accuracy on a limited set of remission endpoints regarding PICO (Population, Intervention, Comparator, Outcome) element extraction and produced comparative effect estimates and credible intervals closely matching manual analyses.

Conclusions

In our validation studies, MetaMind reduced the end-to-end NMA process to less than a week, compared with the several months typically needed for manual workflows, while preserving statistical rigor. This suggests its potential for future scaling of evidence synthesis to additional therapeutic areas.

IL-22 inhibits ferroptosis and attenuates ischemia-reperfusion-induced acute kidney injury: Association with activation of the P62-Keap1-Nrf2 signaling pathway

by Lin Zhang, Feng Luo, Yalin Chai, Lijie Sun, Xuan Wang, Le Yin, Congjuan Luo

Acute kidney injury (AKI) remains a major clinical challenge due to its high morbidity and mortality, with ischemia-reperfusion injury (IRI) as one of its primary causes. Severe IRI-associated AKI (IRI-AKI) can progress to irreversible renal failure, yet no effective therapies are currently available. Ferroptosis, an iron-dependent regulated cell death, has recently been implicated in the pathogenesis of IRI-AKI. Moreover, IL-22 may alleviate AKI by modulating the ferroptosis process through regulation of the P62-Keap1-Nrf2 signaling axis. In this study, we examined the protective role of the immune cytokine interleukin-22 (IL-22) in IRI-AKI and its mechanistic association with ferroptosis. Using a murine IRI model and an HK-2 cell hypoxia/reoxygenation system, we systematically assessed the impact of IL-22 treatment. IL-22 administration significantly enhanced renal function, reduced histological injury, and limited both reactive oxygen species accumulation and ferroptotic cell death. Further mechanistic studies demonstrated that IL-22 suppresses ferroptosis in vitro through an Nrf2-dependent mechanism and is associated with activation of the P62-Keap1-Nrf2 signaling pathway. These findings offer experimental evidence supporting IL-22 as a potential therapy for IRI-AKI and highlight ferroptosis modulation as a promising therapeutic strategy.

Symptom Clusters and Influencing Factors in Adult Patients With Haematological Malignancies During Chemotherapy: A Cross‐Sectional Study

ABSTRACT

Aims

To identify symptom clusters in haematological malignancy patients during chemotherapy and determine the factors associated with different symptom clusters.

Design

A cross-sectional study.

Method

Convenience sampling was used to investigate haematological malignancy patients hospitalised for chemotherapy at a tertiary teaching hospital in Chengdu, China, from January 2021 to December 2023. Participants completed the Chinese version of the Condensed Memorial Symptom Assessment Scale. Hierarchical cluster analysis was used to identify symptom clusters; univariate analyses and logistic regression analyses were used to determine their related factors. This study was reported following the STROBE checklist.

Results

A total of 600 participants were included in the study. We have identified the psychological, sleep, pain-fatigue, gastrointestinal-asthenia symptom clusters in haematological malignancy patients during chemotherapy. Binary logistic regression analysis indicated that being female and having lactate dehydrogenase levels of 220 IU/L or higher are associated with an increased risk for the psychological symptom cluster. The sleep symptom cluster is more likely to occur in females, those with a prognostic nutritional index < 45, lactate dehydrogenase ≥ 220 IU/L and platelet-to-lymphocyte ratio ≥ 107.85. Female, the prognostic nutritional index < 45 and age ≥ 60 years are correlated with the pain-fatigue symptom cluster. The gastrointestinal-asthenia symptom cluster is related to female, a diagnosis of acute leukaemia or lymphoma, lactate dehydrogenase ≥ 220 IU/L and prognostic nutritional index < 45.

Conclusion

Adult haematological malignancy patients undergoing chemotherapy experience multiple symptoms that can be further divided into four symptom clusters. The occurrence of symptom clusters is influenced by a combination of patient sociodemographic characteristics, disease conditions and biochemical indicators.

Relevance to Clinical Practice

The symptom burden is a major issue for haematological malignancy patients during chemotherapy. Health caregivers should focus on the connection between symptoms rather than individual symptoms when developing and providing interventions. Identifying the factors influencing symptom clusters in haematological malignancy patients should be the basis for accurate, efficient and cost-effective interventions.

Patient or Public Contribution

The patients completed the questionnaires during the data collection in this study.

Comparison of the predictive value of APACHE II, SOFA, SAPS II, GCS and GCS-P scores for in-hospital mortality in critically ill patients after craniotomy: a retrospective cohort study in a Chinese tertiary hospital

Por: Zhou · J. · Luo · X.-Y. · Li · H.-L. · Shi · G. Z. · Chen · G.-Q.
Objective

The purpose of this study was to evaluate the accuracy of different scoring systems, including the Acute Physiology and Chronic Health Evaluation (APACHE) II, the Simplified Acute Physiology Score (SAPS) II, the Sequential Organ Failure Assessment (SOFA) score, the Glasgow Coma Scale (GCS) and the Glasgow Coma Scale-Pupils (GCS-P), in predicting in-hospital mortality for critically ill patients after craniotomy.

Design

This was a single-centre retrospective diagnostic study.

Setting

The study was conducted in three intensive care units (70 beds) of a teaching hospital.

Participants

Adult patients who underwent craniotomy and stayed in the ICU for more than 24 hours were included. Pregnant or lactating women and patients enrolled in other clinical studies were excluded.

Outcome measures

Data on demographics, clinical characteristics and scoring systems (APACHE II, SOFA, SAPS II, GCS and GCS-P) were collected. Receiver operating characteristic (ROC) curves were used to assess the predictive accuracy of each scoring system.

Results

Among 1717 patients included, the in-hospital mortality rate was 6.8%. SAPS II (AUC = 0.822) and APACHE II (AUC = 0.819) demonstrated the highest predictive accuracy, followed by GCS-P (AUC = 0.812), GCS (AUC = 0.803) and SOFA (AUC = 0.762). SAPS II and APACHE II significantly outperformed SOFA, while no significant differences were observed among SAPS II, APACHE II, GCS and GCS-P. For patients with supratentorial lesions, APACHE II, SAPS II, GCS and GCS-P showed similar predictive accuracy, all superior to SOFA. For infratentorial lesions, SOFA outperformed GCS and GCS-P. Among patients with cerebrovascular diseases, SOFA had the lowest predictive accuracy, while GCS-P outperformed GCS.

Conclusions

APACHE II, SAPS II, GCS and GCS-P demonstrated comparable predictive accuracy for in-hospital mortality in critically ill post-craniotomy patients, with SOFA being less effective.

Trial registration number

NCT06762184.

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

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

Although caesarean section (CS) has been reported as one of the potential risk factors for postpartum depression (PPD), there is uncertainty about the association between repeat CS and the risk of developing PPD. We sought to explore whether repeat CS will further increase the risk of PPD compared with primary CS.

Design

Observational cohort study.

Setting

A tertiary maternity hospital in Shanghai, China.

Participants

571 women, aged 20 years and older, full-term parturients with singleton scheduled for elective primary or repeat CS were enrolled between December 2020 and September 2021.

Primary and secondary outcome measures

An increased risk of PPD was defined as the total scores of the Edinburgh Postnatal Depression Scale ≥11. The primary outcome was the risk of PPD at 6 weeks postpartum. Secondary outcomes included the risk of postpartum depressive symptoms at 48 hours after CS, pain situation at 48 hours after CS and 6 weeks postpartum.

Results

Among the 571 women included in the final analyses, PPD at 6 weeks postpartum occurred in 41 women (24.0%) in the repeat CS group (n=171) versus 93 (23.3%) in the primary CS group (n=400). After adjusting for the confounders, repeat CS was not associated with higher odds of PPD at 6 weeks postpartum (adjusted relative risk (aRR), 1.04 (95% CIs 0.73 to 1.45); adjusted risk difference (aRD), 0.03 (95% CI –0.32 to 0.37), p=0.84). Compared with primary CS, women with repeat CS were more likely to report significant uterine contraction pain (NRS ≥4) at 48 hours after CS (aRR, 1.51 (95% CI 1.23 to 2.03); aRD, 0.41 (95% CI 0.12 to 0.71), p

Conclusions

Repeat CS was not associated with the increased risk of PPD at 6 weeks postpartum in comparison to primary CS. But women undergoing elective repeat CS were more likely to suffer significant uterine contraction pain in early postoperative stage.

Refining Fall Risk Assessment Scale for Nursing Homes Among Older Adults With Cognitive Impairment: A Mokken Analysis

ABSTRACT

Aim

To refine fall risk assessment scale among older adults with cognitive impairment in nursing homes.

Design

A cross-sectional survey.

Methods

Mokken analysis was conducted to refine the assessment scale based on unidimensionality, local independence, monotonicity, dimensionality, and reliability. Data were gathered from cognitively impaired older adults in a nursing home from January to February 2023. Trained nursing assistants conducted face-to-face assessments and reviewed medical records to administer the scale.

Results

Emotion and State Dimension did not meet unidimensionality criteria (H = 0.14), particularly item Q9, which also violated local independence. Monotonicity analysis showed all items exhibited monotonic increases. After refinement at c = 0.3, the scale consists of nine items. With increasing c-values, the first seven items were ultimately retained to form the final version of the scale. Both optimised scales (9-item and 7-item) satisfied reliability requirements, with all coefficients (Cronbach's α, Guttman's lambda-2, Molenaar-Sijtsma, Latent Class Reliability Coefficient) ≥ 0.74.

Conclusions

The scale is suitable for assessing fall risk among older adults with cognitive impairment, with a unidimensional scale of the first seven items recommended for practical use. Future efforts should refine the scale by exploring additional risk factors, especially emotion-related ones.

Implications for the Profession and Patient Care

The refined 7-item scale provides nursing home staff with a practical, reliable tool for assessing fall risk in cognitively impaired older adults, enabling targeted prevention strategies to enhance safety and reduce injuries.

Impact

The refined 7-item scale provides nursing home staff with a reliable, practical, and scientifically validated tool specifically designed for assessing fall risk in older adults with cognitive impairment. Its simplicity enables efficient integration into routine clinical workflows, empowering caregivers to proactively identify risk factors and implement timely, targeted interventions. This approach directly enhances resident safety by translating assessment results into actionable prevention strategies within daily care practices.

Reporting Method

This study was reported in accordance with the STROBE guidelines.

Patient or Public Contribution

No Patient or Public Contribution.

Subsequent risk of non-keratinocyte skin cancers in adult cancer survivors: a SEER-based cohort study

Por: Jiayuan · L. · Luo · Z. · Guo · Z. · Chen · D. · Deng · G. · Xu · S. · Yao · L. · Sun · Y. · Zeng · F.
Objective

To characterise the risk of subsequent primary non-keratinocyte skin cancers (NKSCs) among adult-onset cancer survivors.

Design

Data analysis of this population-based cohort study was conducted from September to November 2024.

Setting

The data are based on 17 Surveillance, Epidemiology and End Results (SEER) registries from 2000 to 2021.

Participants

Survivors of first primary cancers diagnosed in individuals aged 20–84 years between 2000 and 2021, across 17 registries in the SEER Program

Primary and secondary outcome and measure

Primary outcomes were a statistically significant increase in the incidence of subsequent NKSCs. Standardised incidence rate (SIR) and excess risk analysis were used to evaluate the risk of subsequent NKSCs after different primary cancers.

Results

Among 5 691 336 survivors (51.3% male), 31 529 subsequent NKSCs were observed during a total follow-up of 36 440 569 person-years (mean, 6.4 years). The risk of subsequent NKSCs was increased after the first primary cancer (SIR, 1.12 (95% CI 1.10 to 1.13)). Across 35 first primary cancers, 19 showed a statistically significant rise in subsequent NKSC incidence. The highest SIR for subsequent NKSCs was observed after eye and orbit cancer (SIR, 2.96 (95% CI 2.55 to 3.41)), followed by cutaneous melanoma (SIR, 2.67 (95% CI 2.41 to 2.94)) and chronic lymphocytic leukaemia (SIR, 2.24 (95% CI 2.10 to 2.38)). Across NKSC types, cancer survivors were more likely to develop subsequent hemangiosarcoma (SIR, 2.66 (95% CI 2.31 to 3.05)), adenocarcinoma, not otherwise specified (SIR, 2.14 (95% CI 1.53 to 2.91)) and sebaceous adenocarcinoma (SIR, 1.70 (95% CI 1.57 to 1.83)). 10 specific first primary cancers demonstrated a consistently high risk of several specific NKSCs throughout the study period. Furthermore, the risk of subsequent NKSCs among cancer survivors was largely elevated following radiotherapy or chemotherapy (range, 13%–18%), especially for hemangiosarcoma.

Conclusions and relevance

Several types of primary cancers were strongly linked to an increased risk of subsequent NKSCs, underscoring the critical importance of implementing continuous surveillance and proactive prevention strategies to mitigate the risk of developing subsequent primary NKSCs among cancer survivors.

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