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Effects and safety of dapagliflozin in paediatric hereditary kidney disease: protocol for a multicentric, prospective, open and randomised crossover study (DAPA-PedHKD)

Por: Zhang · W. · Dou · Y. · Liu · J. · Liu · T. · Yan · W. · Shen · Q. · Xu · H. · Zhai · Y.
Introduction

Sodium-glucose cotransporter-2 inhibitors have demonstrated cardiorenal protective effects in adults with chronic kidney disease (CKD), but their efficacy and safety in paediatric CKD remain uncertain. Treatment for hereditary kidney disease in children is limited. This DAPA-PedHKD study aims to evaluate the effectiveness and safety of combining renin-angiotensin-aldosterone system inhibitors (RAASi) with dapagliflozin compare to RAASi alone in children with hereditary kidney disease accompanied by proteinuria.

Methods and analysis

DAPA-PedHKD is a multicentre, randomised, crossover, open-label clinical trial. Patients aged 6–18 years with hereditary kidney disease will be eligible. All patients must have received stable RAASi therapy for at least 4 weeks, with a baseline estimated glomerular filtration rate (eGFR) of ≥60 mL/min/1.73 m2, and either a 24-hour urinary protein level of >0.2 g or a urinary protein-to-creatinine ratio (UPCR) of >0.2 mg/mg. Participants will be randomised in a 1:1 ratio to receive either dapagliflozin in addition to standard RAASi therapy or RAASi therapy alone for 12 weeks. After a 4-week washout period with continued RAASi therapy, participants will crossover to the other treatment for another 12 weeks. Outcome assessments will be conducted at baseline and at weeks 2, 6, 12, 16, 18, 22 and 28. The primary outcome is the change in 24-hour urinary protein excretion from baseline to week 12. Secondary outcomes include changes in the UPCR, urinary albumin-to-creatinine ratio, serum albumin, eGFR, blood pressure and body weight from baseline to week 12. Neither participants nor investigators are blinded to treatment allocation, and placebo control is not used.

Ethics and dissemination

This study has been approved by the Ethics Committee of the Children’s Hospital of Fudan University and 11 local ethics committees. We will publish results in peer-reviewed journals and present at international conferences.

Trial registration number

NCT06890143.

Multilayer low-stretch bandage combined with conventional rehabilitation to promote functional recovery after knee surgery: study protocol for a prospective, single-blind, randomised controlled trial

Por: Han · X. · Cao · W. · Jin · W. · Hu · K. · Xu · R. · Sun · C.
Introduction

Patients undergoing anterior cruciate ligament reconstruction (ACLR) and patellar fracture frequently present with substantial pain, swelling and inflammation. These pathophysiological changes not only intensify postoperative pain but also compromise the intra-articular environment via mechanical compression and localised microcirculatory deficits, thereby impeding recovery. Conventional interventions for postoperative swelling, such as cryotherapy and physical agent modalities, are commonly applied yet exhibit limited efficacy. Multilayer low-stretch bandage (MLB), with its gradient compression properties, has recently demonstrated superior swelling control and functional restoration; however, existing research primarily assesses short-term outcomes and lacks a systematic analysis across the postoperative continuum—acute, subacute and chronic phases—as well as long-term follow-up. This study therefore employs a multi-temporal intervention design and extended follow-up to evaluate the effectiveness of MLB in managing swelling, modulating pain and enhancing long-term knee function and activities of daily living across different recovery stages. The findings aim to furnish high-level evidence for knee rehabilitation protocols, refine clinical practice and ultimately improve patient quality of life.

Methods and analysis

This prospective, single-blind, randomised controlled trial will enrol 36 patients following ACLR and patellar fracture. Participants will be allocated at a 1:1 ratio through computerised randomisation to either an experimental group receiving MLB plus conventional rehabilitation, or a control group receiving conventional rehabilitation alone. The study spans 12 weeks, with follow-up assessments scheduled at baseline (T0), 4 weeks (T1), 8 weeks (T2) and 12 weeks (T3). Outcome measures comprise the Hospital for Special Surgery (HSS) Knee Rating Score, affected limb oedema regression rate, Visual Analogue Scale (VAS) pain score, knee range of motion, quadriceps and hamstring muscle strength, centre of pressure (COP) displacement parameters, proprioceptive testing, the 36-Item Short Form Health Survey (SF-36) and the Holden Walking Function Classification. A subsequent 1-year follow-up will assess long-term efficacy and patient satisfaction, while adverse events are strictly monitored throughout the entire study period. Adherence to Consolidated Standards of Reporting Trials guidelines is maintained, and a single-blind design ensures that both participants and assessors remain unaware of group assignments. This trial aims to establish an evidence-based foundation for optimising postoperative rehabilitation in this patient population.

Ethics and dissemination

Ethical approval for the study was obtained from the Medical Ethics Committee of Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School (2025-0141-01). The results of the study will be published in a peer-reviewed medical journal.

Trial registration number

ClinicalTrials.gov chiCTR2500100566. Registration date is 10 April 2025.

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Buccal fat applied to transoral robotic lateral oropharyngectomy defects to lessen radical tonsillectomy pain (BOLT): a single-centre, phase II, parallel, randomised control trial study protocol

Por: Xie · M. · de Almeida · J. · Goldstein · D. · Martino · R. · Liu · Y. F. · Allen · B. · Xu · W. · Hueniken · K. · Yao · C. M.
Introduction

Transoral robotic surgery (TORS) is a minimally invasive technique for surgical removal of tumours of the tonsil and lateral oropharynx. Surgical defects after TORS lateral oropharyngectomy are traditionally left open to heal by secondary intention, resulting in significant postoperative pain and secondarily resulting in delayed swallowing and discharge. Although multimodal analgesia can improve postoperative pain control, no studies to date have assessed the impact of adjunct surgical interventions for reducing postoperative pain after TORS. Buccal fat rotation flap is a regional reconstruction option after TORS lateral oropharyngectomy and provides immediate coverage of the open surgical wound. However, the impact of buccal fat rotation flap reconstruction on postoperative pain and swallowing remains unclear. This trial aims to compare postoperative pain outcomes in patients who undergo TORS lateral oropharyngectomy with and without buccal fat rotation reconstruction.

Methods and analysis

This protocol outlines a single centre, parallel, unblinded, phase II, randomised control trial. Inclusion criteria include adult patient (≥18 years) undergoing TORS lateral oropharyngectomy for early to intermediate stage tonsillar squamous cell carcinoma (T1-2N0-1 p16+/–) or early to intermediate stage salivary gland tumours of the palatine tonsils. Exclusion criteria include a history of prior head and neck squamous cell carcinoma, prior head and neck radiotherapy, retropharyngeal lymphadenopathy, bilateral lymphadenopathy, need for bilateral neck dissection, baseline trismus, opioid use or drug addiction, need for open surgery (transcervical lateral oropharyngectomy), free tissue transfer, or alternative regional flap, and pregnancy. All patients are planned for a TORS lateral oropharyngectomy. The intervention group will have a buccal fat rotation flap reconstruction, and the control group will be allowed to heal via secondary intention. The allocation sequence will be created using a computer-generated random sequence with a permuted block strategy. The allocation sequence will be concealed until the time of assignment. The primary outcome is postoperative pain intensity during rest and swallowing using the visualised analogue scale. Secondary outcomes include postoperative complications, other adverse events, patient-reported speech and swallowing, opioid usage, length of hospital stay, feeding tube dependence and blood glucose levels. The trial has a target sample size of 40 patients. Statistical analysis of the primary outcome will be analysed in an intention to treat analysis using a linear mixed effects model.

Ethics and dissemination

The study was approved by the University Health Network Coordinated Approval Process for Clinical Research. Study number CAPCR ID: 24-5894. All participants will be required to provide written informed consent to participate. Findings will be presented at national conferences and published in medical journals.

Trial registration number

NCT06965738.

Metabolomic characteristics of aerobic and resistance exercise modes

Por: Junjie Kuang · Jie Ju · Xin Xu

by Junjie Kuang, Jie Ju, Xin Xu

Aerobic and resistance exercises are the two most common modes of physical activity. They may cause some functional changes such as elevation of VO2max and muscle mass. However, descriptions of changes in complex molecular network induced by exercise are often insufficiently comprehensive, limiting the exploration of some new indicators. We utilized a metabolomics analysis method based on Liquid chromatography-mass spectrometry (LC-MS) to investigate the metabolic characteristics of 10 healthy male college students at two time points before and after a single session of aerobic and resistance exercise. The analysis was conducted at both the metabolite and metabolic pathway levels. Notably, the concentrations of several amino acids including aspartic acid, glutamic acid, histidine and tryptophan exhibited significant changes following both modes of exercise. These findings offer a more comprehensive understanding of the molecular effects of acute exercise on the human body, contributing to evaluating post-exercise physiological states and screening for relevant metabolite indicators. Future research could employ multi-omics approaches to validate these results and explore the long-term impact of exercise on human metabolic profiles, linking specific metabolic pathways to functional outcomes.

A Late Pleistocene archaic human tooth from Gua Dagang (Trader’s Cave), Niah national park, Sarawak (Malaysia)

by Darren Curnoe, Mohammed S. Sauffi, Hsiao Mei Goh, Xue-feng Sun, Roshan Peiris

The rarity of Late Pleistocene hominin remains from Insular Southeast Asia (ISEA) has hampered our ability to understand a crucial episode of human evolutionary history, namely, the global dispersal of Homo sapiens from Africa. Moreover, recent discoveries indicate a surprising level of taxic diversity during this time with at least two species—H. floresiensis and H. luzonensis—endemic to the region when H. sapiens first arrived. A third hominin dubbed the ‘Denisovans’ is shown from DNA evidence to have interbred with the ancestors of contemporary Indigenous populations across ISEA, New Guinea and Australia. Yet, the Denisovans have not been identified from the fossil record of the area despite recent breakthroughs in this regard on mainland East Asia. New excavations by our team at the Trader’s Cave in the Niah National Park (‘Niah Caves’), northern Borneo, have yielded an isolated hominin upper central permanent incisor dated with Optically Stimulated Luminescence dating of sediments to about 52 − 55 thousand years ago. Specimen SMD-TC-AA210 has a massive crown absolutely and relative to its root size, the crown is wide (mesiodistally) and relatively short (labiolingually). Morphologically, it exhibits a very strong degree of labial convexity, pronounced shovelling, and the bulging basal eminence exhibits several upward finger-like projections. Labial enamel wrinking on the enamel-dentine junction is expressed as two large ridges exhibiting numerous spine-like projections, and the lingual extensions on the enamel surface of the basal eminence are expressed as six extensions. This combination of crown size and morphological traits is not normally found in H. sapiens and instead characterises archaic members of Homo such as H. erectus, H. neanderthalensis and Middle Pleistocene hominins sharing a clade with H. heidelbergensis. The Trader’s Cave tooth suggests that an archaic hominin population inhabited northern Borneo just prior to or coincident with the arrival of H. sapiens as documented at the nearby West Mouth of the Niah Great Cave.

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.

Exosomes from bone marrow mesenchymal stem cells protect melanocytes under vitiligo-related conditions through induction of NRF2/HO1 expression

by Xuecheng Sun, Bo Huang, Gaobo Ruan, Aie Xu

Background

Vitiligo, a chronic autoimmune disease linked to excess oxidative stress, can be temporarily improved. Bone marrow mesenchymal stem cells (BMSCs)-derived exosomes (BMSCs-Exos) have recently emerged as a promising novel therapeutic means for vitiligo.

Methods

Exosomes were isolated and characterized from BMSCs-conditioned medium. PIG3V cells and those transfected with NRF2 siRNA or negative control were cultured under normal conditions or exposure to hydrogen peroxide (H₂O₂) to induce oxidative stress, with addition of BMSCs-conditioned medium, conditioned medium from BMSCs pretreated with GW4869 (referred to as BMSCs-GW4869), or BMSCs-Exos. Cell viability, apoptosis, and oxidative stress parameters, including cellular glutathione (GSH)/oxidized glutathione (GSSG) ratio, superoxide dismutase (SOD), reactive oxygen species (ROS), and malondialdehyde (MDA), were assessed. The expression of Ki67, NRF2, HO1, BAC, and Bcl-2 was measured.

Results

BMSC-Exos significantly enhanced cell viability and reduced apoptosis and oxidative stress in H₂O₂-treated PIG3V cells. Simultaneously, BMSCs-Exos reversed H₂O₂-induced downregulation of Ki67, NRF2, HO1, and Bcl-2, and upregulation of BAX in PIG3V cells. Silencing NRF2 by siRNA in PIG3V cells prior to H2O2 treatment abolished the protective effect of BMSCs-Exos and decreased the HO1 expression.

Conclusions

BMSCs-Exos protect melanocytes from vitiliog-related oxidative stress by mitigating oxidative damage through induction of NRF2/HO1 expression.

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.

Ju-LiteMobileAtt: A lightweight attention network for efficient jujube defect classification

by Xiyuan Zhu, Hongtao Dang, Xiaoyuan Jin, Xun Li

Surface defect detection of organic jujubes is critical for quality assessment. However, conventional machine vision lacks adaptability to polymorphic defects, while deep learning methods face a trade-off—deep architectures are computationally intensive and unsuitable for edge deployment, whereas lightweight models struggle to represent subtle defects. To address this, we propose Ju-LiteMobileAtt, a high-precision lightweight network based on MobileNetV2, featuring two key innovations: First, the Efficient Residual Coordinate Attention Module (EfficientRCAM) integrates spatial encoding and channel interaction for multi-scale feature capture; Second, the Cascaded Residual Coordinate Attention Module (CascadedRCAM) refines features while preserving efficiency. Experiments on the Jujube12000 dataset show Ju-LiteMobileAtt improves accuracy by 1.72% over baseline while significantly reducing parameters, enabling effective real-time edge-based jujube defect detection.

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

ABSTRACT

Aim

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

Design

A cross-sectional study.

Methods

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

Results

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

Conclusion

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

Implications for the Profession and/or Patient Care

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

Reporting Method

The STROBE checklist was used as a guideline.

Patient or Public Contribution

No patient or public involvement.

Global trends in Alzheimer’s disease and other dementias: A comprehensive analysis of incidence, socio-demographic variations, and future projections

by Ruixue Qin, Huijuan Zhao, Hui Gao, He Liu

Background

Alzheimer’s disease and other dementias (ADRD) are significant global health concerns, with rising incidence rates and substantial social and economic implications due to population aging.

Methods

We investigated trends in ADRD incidence from 1992 to 2021 across age, sex, and socio-demographic index (SDI) regions, utilizing data from the Global Burden of Disease (GBD) 2021 platform. An age-period-cohort (APC) model was employed to analyze the effects of age, period, and birth cohort on ADRD incidence, and a Bayesian age-period-cohort (BAPC) model was used to predict future trends.

Results

Globally, the age-standardized incidence rates (ASIR) remained relatively steady. However, the total number of ADRD cases witnessed a remarkable 141.25% increase, with 9,837,056 cases (95% UI: 8,620,519–11,163,700) in 2021. High SDI regions exhibited higher ASIR, whereas high-middle SDI regions showed the greatest growth, particularly among females. The net drift of ADRD incidence ranged from 0.43% per year in China to −0.68% per year in Denmark. Age effect was consistent across SDI regions, increasing exponentially with age. The 60–64 age group experienced the fastest annual incidence growth. High-middle SDI regions faced unfavorable period and cohort effects.

Conclusion

Although progress in ADRD globally, significant regional and sex disparities persist. Strengthened surveillance and management of adults over 60 are urgently needed. Targeted public health policies and interventions are essential to address the escalating global dementia burden.

Annual U.S. healthcare expenditures attributable to cigar smoking between 2001 and 2018, overall and by payer

by Xin Xu, Ghada Homsi, Sherry T. Liu, Jennifer M. Gaber, Naa A. Inyang, Brian L. Rostron, Caryn F. Nagler, James Nonnemaker

Background

In 2022, 3.7% of U.S. adults currently smoked cigars. This study assesses cigar-smoking-attributable fractions in U.S. healthcare expenditures and associated annual healthcare expenditures overall and by payer, including publicly funded healthcare programs.

Methods

Data were obtained from the 2000, 2005, 2010, and 2015–2017 National Health Interview Survey linked with corresponding panels from the Medical Expenditure Panel Survey data through 2018. The final sample (n = 53,733) was restricted to adults aged 25 + . Estimates from four-part models and data from the Personal Health Care component of the 2001–2018 National Health Expenditures Accounts were combined to estimate fractions of and annual healthcare expenditures attributable to cigar smoking. All models controlled for sociodemographic characteristics and health-related behaviors.

Results

During 2001–2018, an estimated 1.8% (95% CI = 0.9%–3.4%) or $29.7 billion annually of U.S. healthcare expenditures could be attributed to cigar smoking. Most of this was funded by other third-party health insurance programs, a mix of private and public payers (e.g., Department of Veterans Affairs).

Conclusions

Cigar smoking creates a preventable financial burden on the U.S. healthcare system. Health consequences associated with cigar smoking may remain after successful quitting. The findings underscore the importance of preventing initiation of cigar smoking and providing evidence-based cessation methods to reduce the health and economic burden of cigar smoking.

Dysregulated serum chloride and clinical outcomes in critically ill adults: A systematic review and meta-analysis

by Xiaoliang Wan, Feiyao Deng, Xue Bai, Chenxi Xiang, Chuan Xu, Linxiao Qiu

Dysregulated serum chloride levels are prevalent in critically ill patients. However, their clinical impact remains unclear. This first systematic review and meta-analysis quantified the prevalence of hypochloremia and hyperchloremia, and their associations with mortality and acute kidney injury (AKI) in critically ill populations. We searched PubMed, Embase, Web of Science, and the Cochrane Library for studies reporting hyperchloremia prevalence or outcomes in adult ICU patients until August 2025. Statistical analyses were conducted using Stata v16.0, and study quality was assessed using the Newcastle-Ottawa Scale. 34 studies (n = 175,021 patients) were included. The aggregated prevalence of hyperchloremia was 34% (95% CI [26%−43%]) and hypochloremia was 14% (95% CI [1%−28%]). Meta-analysis demonstrated that both hyperchloremia and hypochloremia were significantly associated with increased mortality, conferring a 28% (OR = 1.28, 95% CI [1.08–1.52]) and 55% (OR = 1.55%, 95% CI [1.33–1.81]) elevated risk for mortality, respectively. Crucially, a dose-response analysis revealed a non-linear relationship between serum chloride levels and mortality, confirming that the risk is independently elevated at both extremes. Furthermore, hyperchloremia was linked to an increased risk of AKI (OR = 1.40, 95% CI [1.07–1.85]). These findings establish dysregulated serum chloride as a common and clinically significant biomarker, underscoring the necessity of monitoring and managing both high and low chloride levels in critically ill patients. Future large-scale studies are warranted to validate these results and elucidate the mechanistic pathways linking chloride dysregulation to such adverse outcomes.

Effects of peer-led or peer-supported physical activity interventions on health outcomes in community-dwelling older adults: a protocol for a systematic review and meta-analysis of randomised controlled trials

Por: Xue · D. · Peng · J. · Wei · L. · Cui · C. · Ye · Y. · Wang · Y.
Introduction

Physical activity (PA) has considerable benefits for older adults, yet they often face various barriers that hinder participation. Peer-led or peer-supported PA interventions represent a promising strategy to address barriers, such as cost and lack of motivation. Although existing reviews suggest that these interventions improve PA adherence, combining randomised controlled trials (RCTs) with other study designs may weaken their validity. Furthermore, their effects on PA levels and physical function are inconsistent, and their impacts on cognitive abilities, psychosocial well-being and social support, as well as the influence of peer characteristics and programme design, remain unexamined. This review aims to synthesise evidence regarding the effectiveness of peer-led or peer-supported PA interventions across multiple health outcomes and identify possible influencing factors.

Methods and analysis

The search will encompass six English and three Chinese databases, namely, PubMed, Web of Science, Embase, Cumulative Index to Nursing and Allied Literature, PsycINFO, CENTRAL, China National Knowledge Infrastructure, Wanfang Data and the Chinese Biomedical Literature Database. It will cover literature from inception to December 2025. Trial registries will be searched, and a manual search of relevant studies will also be conducted. RCTs that focus on community-dwelling older adults participating in peer-led or peer-supported PA interventions will be included. Outcomes include PA levels, physical function, cognitive function, psychosocial well-being, self-efficacy, social support, health-related quality of life (HRQoL) and programme adherence. Two reviewers will independently screen the literature, extract data and evaluate the risk of bias by using the Cochrane Risk of Bias Tool 2.0. Meta-analyses will be conducted for outcomes reported in at least two studies, and narrative analyses will be performed for others. Subgroup analyses, metaregression, sensitivity analyses and assessments of publication bias will be conducted as appropriate. The Grading of Recommendations, Assessment, Development and Evaluations approach will be used to assess the certainty of evidence.

Ethics and dissemination

Ethical approval is not required because only published data will be used. Results will be disseminated through peer-reviewed publications and conference presentations.

PROSPERO registration number

CRD420251112127.

Folate exposures and risk of colorectal cancer: an umbrella review of meta-analyses of observational studies and randomised controlled trials

Por: Li · T. · Yin · L. · Li · Y. · Huang · L. · Zhang · K. · Wang · H. · Xu · D. · Yan · J. · Huang · G.
Objectives

To systematically summarise and evaluate the existing evidence of the associations between diverse folate exposures and the risk of colorectal cancer (CRC), while identifying evidence quality.

Design

Umbrella review of meta-analyses.

Data sources

PubMed, Web of Science, Cochrane and Embase were searched from the database inception to March 2024, with an update to 12 October 2025.

Eligibility criteria

We included meta-analyses of randomised controlled trials or observational studies that investigated the associations between folate exposures and CRC or precancerous lesions (ie, adenoma and polyps).

Data extraction and synthesis

For each association, we recalculated the summary effect size with 95% CI using the DerSimonian and Laird random-effects model, heterogeneity (I² statistic), 95% prediction interval, small-study effect (Egger’s test) and excess significance bias (² test).

Results

This umbrella review included five meta-analyses describing 10 associations between folate exposures and CRC risk. In the general population, moderate-quality evidence supported an inverse association between total folate intake (from foods and supplements) and CRC risk (RR 0.84; 95% CI 0.80 to 0.90), while low-quality evidence suggested inverse associations of dietary folate intake (from foods alone) (RR 0.88; 95% CI 0.81 to 0.96) and folic acid supplement intake (RR 0.83; 95% CI 0.77 to 0.90) with CRC risk. Among patients with inflammatory bowel disease, low-quality evidence suggested an inverse association between folic acid supplement intake and CRC incidence (HR 0.71; 95% CI 0.53 to 0.96). Additionally, elevated circulating folate levels were observed to have a provoking effect on advanced-stage tumours (OR 1.95; 95% CI 1.18 to 3.22; Grading of Recommendations Assessment, Development and Evaluation (GRADE): very low). Sensitivity analysis revealed a potential increased risk of adenoma recurrence associated with folic acid supplement use among patients with a history of adenoma (RR 1.05; 95% CI 0.86 to 1.29; GRADE: high).

Conclusions

These findings suggest that consuming dietary folate and total folate intake may be beneficial in CRC primary prevention. Specifically, folic acid supplements may inhibit colorectal carcinogenesis in normal tissues while promoting cancer in the established neoplastic foci.

PROSPERO registration number

CRD42024537550.

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.

Knowledge, attitudes and practices towards dysphagia and its care among patients and caregivers: a multicentre cross-sectional study in Beijing and Shandong Province

Por: Zhu · M. · Jin · Z. · Gan · X. · Jia · J. · Xu · Y. · Sun · Z. · Song · S. · Wu · J. · Wang · C.
Objectives

This study aimed to investigate the knowledge, attitudes and practices (KAP) regarding dysphagia and its care among patients with dysphagia and their caregivers.

Design

A cross-sectional survey.

Setting

This multicentre cross-sectional study was conducted between May and September 2024. It was led by the China-Japan Friendship Hospital and involved multiple institutions, including nursing communities, nursing homes and community hospitals, located in both Beijing and Shandong Province.

Participants

Patients with clinically diagnosed dysphagia and their caregivers recruited from the China-Japan Friendship Hospital, nursing communities, nursing homes and community hospitals.

Primary and secondary outcome measures

Data were collected through a self-designed questionnaire encompassing sociodemographic characteristics and three dimensions of KAP. The primary outcome was the KAP scores. Secondary outcomes included the interaction between the three KAP dimensions.

Results

A total of 416 participants were included in the final analysis, of whom 317 (76.2%) were female. The mean scores for KAP were 12.02±8.12 (possible range: 0–24), 31.38±4.77 (possible range: 8–40) and 29.29±9.03 (possible range: 8–40), respectively. Correlation analysis indicated significant positive relationships between knowledge and attitudes (r=0.416, p=0.002), knowledge and practices (r=0.412, p

Conclusions

Patients with dysphagia and their caregivers demonstrated inadequate knowledge but generally positive attitudes and proactive practices towards dysphagia and its care. Adequate knowledge might be correlated with better attitudes and practices.

Global, regional and national burden and trends of sense organ diseases from 1990 to 2021: based on the Global Burden of Disease (GBD) study

Por: Zheng · M. · Yin · T. · Jiang · Z. · Li · X. · Fang · B. · Pan · M. · Xu · J. · Xu · Y. · Hendsun · H. · Xu · J. · Zhang · Y. · Kan · H. · Wang · X. · Chen · R. · Zheng · W. · Chen · A.
Objectives

Sense organ diseases (SODs) are among the leading causes of disability worldwide. They severely impact communication, mobility and quality of life, with rising prevalence and widening inequalities across populations. This study aims to provide an updated, comprehensive assessment of the global, regional and national burden and trends of SODs, and to inform strategies for prevention, treatment and health policy development.

Design

This is a population-based observational study using secondary data from the Global Burden of Disease (GBD) 2021 study. SODs, defined in the GBD framework as age-related and other hearing loss (AHL), blindness and vision loss (BVL), and other sensory impairments, were analysed in terms of prevalence and disability-adjusted life years (DALYs). We focused on SODs overall and conducted specific analyses for AHL and BVL, stratified by age, sex and sociodemographic index (SDI).

Setting

Global dataset covering 204 countries and territories across all regions and sociodemographic strata from 1990 to 2021.

Participants

This study covered the global population represented in the GBD 2021 dataset, using aggregated population-level estimates with no direct individual recruitment.

Interventions

Not applicable.

Primary and secondary outcome measures

Primary outcomes were prevalence (cases and age-standardised prevalence rates) and DALYs (number and age-standardised DALY rates). Secondary outcomes included age–period–cohort effects, decomposition of contributors (population growth, ageing and epidemiological change), inequality metrics and burden projections to 2030.

Results

Between 1990 and 2021, the global age-standardised rate (ASR) of DALYs for SODs increased from 884.07 to 912.8 per 100 000 population. The ASR of prevalence rose from 25 297.36 to 28 050.29 per 100 000. The disease burden increased across all age groups, with females experiencing a higher prevalence of SODs, and population growth and ageing as the leading contributors. AHL emerged as the predominant category of SODs. Socioeconomic disparities widened, with the slope index of inequality for DALYs rising from 128.82 in 1990 to 418.62 in 2021. In 2021, China reported the highest DALYs and case numbers. Predictive analysis showed a stable ASR of DALYs and prevalence, but a continued rise in cases through 2030, with COVID-19 further exacerbating the burden.

Conclusions

The global burden of SODs continues to rise, driven primarily by population ageing and growth, with widening disparities across sociodemographic levels. These findings emphasise the need for targeted prevention strategies, improved early detection and equitable access to sensory healthcare services. Monitoring the long-term impact of COVID-19 and demographic shifts remains a priority.

Trial registration number

Not applicable. This study is a secondary analysis of GBD data and is not linked to a clinical trial.

Quality of life in patients with chronic kidney disease in low- and middle-income countries: protocol for a systematic review and meta-analysis

Por: Muxunov · A. · Kalinina · D. · Gaipov · A. · Sarria-Santamera · A.
Introduction

Chronic kidney disease (CKD) affects over 850 million people globally, with nearly 80% residing in low- and middle-income countries (LMICs). Despite this high prevalence, there is limited understanding of health-related quality of life (HRQOL) among patients with CKD in these resource-constrained settings. This systematic review and meta-analysis aims to quantify HRQOL scores across CKD stages and treatment modalities in LMICs.

Methods and analysis

We will conduct a comprehensive search of electronic databases including PubMed, Medline, Scopus and Web of Science, for observational studies published from January 2000 onwards in English or Russian. Eligible studies will include adult patients (≥18 years) with CKD stages 1–5, those on dialysis or kidney transplant recipients in LMICs. Two independent reviewers will screen studies, extract data and assess methodological quality using the Joanna Briggs Institute critical appraisal checklist. We will perform random-effects meta-analyses to pool HRQOL scores, stratified by CKD treatment groups. Heterogeneity will be assessed using I² statistics, with subgroup analyses and meta-regression conducted to explore potential sources of heterogeneity. The primary outcome will be pooled estimates of HRQOL scores across different CKD stages and treatment modalities in LMICs. Secondary outcomes will include subgroup analyses by income classification, geographical region and CKD stage depending on the availability of the data.

Ethics and dissemination

Ethical approval is not required for this study. Results will be submitted to a peer-reviewed, open-access journal and presented at scientific conferences.

PROSPERO registration number

CRD420251016382.

Building a Delphi‐Informed Transitional Care Programme Guided by the Omaha System for Gynaecologic Oncology Patients

ABSTRACT

Objective

This study aimed to develop and validate a standardised transitional care programme for postoperative gynaecologic cancer patients utilising the Omaha system framework.

Methods

A preliminary transitional care programme was constructed through literature review, semi-structured interviews and multidisciplinary team discussions. The programme was refined via two rounds of Delphi expert consultations involving 17 oncology nursing specialists. Consensus criteria included expert authority coefficient (Cr), Kendall's W test and coefficient of variation (CV).

Results

The Delphi consultation demonstrated robust expert consensus, with high authority coefficients (Cr: 0.886 in Round 1; 0.906 in Round 2), exceptional participation rates (88.2% and 100% response rates across two rounds) and statistically significant concordance as evidenced by Kendall's W values (0.233–0.358 and 0.326–0.383; all p < 0.01). All coefficients of variation (CV) metrics fell within acceptable ranges (0.09–0.42 in the initial phase; 0.08–0.27 post-refinement).

Conclusion

The Omaha system-based transitional care programme exhibits strong expert consensus, scientific rigour and clinical applicability, providing a structured approach to improving postoperative recovery in gynaecologic cancer patients.

Relevance to Clinical Practice

This protocol standardises postoperative care transitions for gynaecologic oncology patients by integrating multidimensional assessments (physiological, psychosocial and health behaviour domains) and family-centred education. Clinicians can utilise its evidence-based framework to reduce preventable complications, enhance caregiver preparedness and improve continuity of care between hospital and home settings.

Patient or Public Contribution

Six postoperative gynaecologic cancer patients and eight family caregivers participated in semi-structured interviews to identify unmet transitional care needs. Their insights informed the design of intervention components, including self-management education and psychosocial support strategies. Patients reviewed draft materials for clarity and cultural appropriateness during Delphi Round 2.

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