FreshRSS

🔒
☐ ☆ ✇ BMJ Open

Assessing the utility of fractional excretion of urea in distinguishing intrinsic and prerenal acute kidney injury in hospitalised patients: a systematic review and meta-analysis

Por: Pan · H.-C. · Jiang · Z.-H. · Chen · H.-Y. · Liu · J.-H. · Chen · Y.-W. · Peng · K.-Y. · Wu · V.-C. · Hsiao · C.-C. — Enero 14th 2026 at 15:37
Objective

Acute kidney injury (AKI) is a significant challenge in hospital settings, and accurately differentiating between intrinsic and prerenal AKI is crucial for effective management. The fractional excretion of urea (FEUN) has been proposed as a potential biomarker for this purpose, offering an alternative to traditional markers such as fractional excretion of sodium. This study aimed to assess the diagnostic accuracy of FEUN for differentiating intrinsic from prerenal AKI in hospitalised patients.

Designs

We conducted a systematic review and bivariate random effects meta-analysis of diagnostic accuracy studies. The study followed the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Data sources

PubMed, Embase and Cochrane databases were searched from inception to 1 November 2023.

Eligibility criteria for selecting studies

We included observational studies that focused on patient with AKI and reported FEUN data sufficient to reconstruct a complete 2x2 contingency table (true positives, true negatives, false positives and false negatives) for evaluating its diagnostic accuracy.

Data extraction and synthesis

Two reviewers extracted data, assessed risk of bias with Quality Assessment of Diagnostic Accuracy Studies-2 and graded certainty of evidence using the GRADE approach. Pooled sensitivity, specificity, positive and negative likelihood ratios, and the area under the summary receiver operating characteristic curve (SROC) were calculated; heterogeneity was measured with I². A prespecified subgroup restricted to patients receiving diuretics served as a sensitivity analysis.

Results

12 studies involving 1240 patients were included, with an overall occurrence rate of intrinsic AKI of 38.8%. FEUN had a pooled sensitivity of 0.74 (95% CI 0.60 to 0.84) and specificity of 0.78 (95% CI 0.66 to 0.87), with positive predictive value and negative predictive value of 0.76 (95% CI 0.68 to 0.83) and 0.74 (95% CI 0.66 to 0.81), respectively. The SROC curve showed a pooled diagnostic accuracy of 0.83. Heterogeneity was substantial (I²>90%) for sensitivity and specificity. In a diuretic-only subgroup (six studies) specificity rose to0.87 and heterogeneity declined (I²=56%). Overall certainty of evidence was low owing to inconsistency.

Conclusions

FEUN is a biomarker with moderate diagnostic accuracy for differentiating between intrinsic and prerenal AKI in hospitalised patients. Its application could enhance AKI management; however, the high heterogeneity observed in our study highlights the need for further research to evaluate its utility across diverse patient populations and clinical settings.

PROSPERO registration number

CRD42024496083.

☐ ☆ ✇ BMJ Open

Does CMR improve aetiological sub-phenotyping beyond echocardiography in patients with elevated LV filling pressure? A prospective registry study (PREFER-CMR)

Por: Bana · A. · Li · R. · Mehmood · Z. · Rogers · C. · Grafton-Clarke · C. · Bali · T. · Hall · D. · Jamil · M. · Ramachenderam · L. · Dudhiya · U. · Spohr · H. · Underwood · V. · Girling · R. · Kasmai · B. · Nair · S. · Matthews · G. · Garg · P. — Enero 14th 2026 at 15:37
Objectives

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Design

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

Setting

A single NHS hospital in the UK.

Main outcome measures

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

Results

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

Conclusions

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

☐ ☆ ✇ BMJ Open

Neurofilament light chain as a potential biomarker of perioperative neurocognitive disorders: a systematic review and meta-analysis

Por: Chen · F. · Wu · Z.-X. · Chen · Q. · Zuo · D.-K. · Ye · X.-M. · Li · H. — Enero 14th 2026 at 15:37
Objectives

Although neurofilament light chain (NfL) is used as a biomarker of neurodegenerative decline, its application in surgery- and anaesthesia-induced acute cognitive dysfunction remains uncertain. We aimed to synthesise existing evidence to evaluate the potential of NfL as a biomarker for perioperative neurocognitive disorder (PND).

Design

Systematic review and meta-analysis.

Data sources

PubMed, EMBASE, MEDLINE, the Cochrane Library and the Cochrane Central Register of Clinical Trials were systematically searched up to March 2024.

Eligibility criteria

Observational studies—including cohort, case-control and cross-sectional designs—were included if they reported cerebrospinal fluid (CSF) or blood NfL levels in individuals with and without PND.

Data extraction and synthesis

Three independent reviewers assessed each article. Quality scoring was conducted, and the extracted data were analysed using STATA. Risk of bias was evaluated using the Newcastle–Ottawa Scale. Meta-analytical model selection was guided by the I2 statistic, with I2≤40% indicating low heterogeneity and the use of a fixed-effect model; random-effects models were used when this threshold was exceeded.

Results

Within-group analyses showed significant postoperative increases in blood NfL levels in both the postoperative delirium (POD) group (standardised mean difference (SMD) = 0.49; 95% CI 0.34 to 0.64) and the no-POD group (SMD=0.67, 95% CI 0.53 to 0.81). Between-group comparisons revealed significantly higher preoperative CSF NfL levels in the POD group (SMD=0.27, 95% CI 0.07 to 0.47). Both preoperative and postoperative blood NfL levels were also significantly elevated in the POD group (SMD=0.53, 95% CI 0.40 to 0.66, and SMD=0.58, 95% CI 0.43 to 0.73, respectively).

Conclusions

This meta-analysis suggests that NfL may be a potential biomarker for POD. Further research is needed to clarify the association between CSF and blood NfL levels and other forms of PND.

PROSPERO registration number

CRD42024516907.

☐ ☆ ✇ BMJ Open

UNIversity students LIFEstyle behaviours and Mental health cohort (UNILIFE-M): study protocol of a multicentre, prospective cohort study

Por: Schuch · F. B. · Waclawoscky · A. · Tornquist · D. · Oyeyemi · A. L. · Sadarangani · K. P. · Takano · K. · Teychenne · M. · Balanza-Martinez · V. · ONeil · A. · Romain · A. J. · McGrath · A. · Alselmi · A. · Andrade-Lima · A. · Zanetti · A. C. G. · Trompetero-Gonzalez · A.-C. · Heiss — Enero 12th 2026 at 15:08
Introduction

Students enrolling in higher education often adopt lifestyles linked to worse mental health, potentially contributing to the peak age onset of mental health problems in early adulthood. However, extensive research is limited by focusing on single lifestyle behaviours, including single time points, within limited cultural contexts, and focusing on a limited set of mental health symptoms.

Methods and analysis

The UNIversity students’ LIFEstyle behaviours and Mental health cohort (UNILIFE-M) is a prospective worldwide cohort study aiming to investigate the associations between students’ lifestyle behaviours and mental health symptoms during their college years. The UNILIFE-M will gather self-reported data through an online survey on mental health symptoms (ie, depression, anxiety, mania, sleep problems, substance abuse, inattention/hyperactivity and obsessive/compulsive thoughts/behaviours) and lifestyle behaviours (ie, diet, physical activity, substance use, stress management, social support, restorative sleep, environment and sedentary behaviour) over 3.5 years. Participants of 69 universities from 28 countries (300 per site) will be assessed at university admission in the 2023 and/or the 2024 academic year and followed up for 1, 2 and 3.5 years.

Ethics and dissemination

The study was first approved at a national level in Brazil (CAE:63025822.8.1001.5346). Study sites outside Brazil obtained additional ethics approval from their institutions using the main approval. Results from the UNILIFE-M cohort will be disseminated through scientific publications, presentations at scientific meetings, press releases, the general media and social media.

☐ ☆ ✇ BMJ Open

Telehealth-delivered exercise and nutrition intervention to improve outcomes in patients with early stage non-small cell lung cancer: protocol for the multicentre STARLighT phase II (neoadjuvant) and phase III (adjuvant) trial

Por: Avancini · A. · Giannarelli · D. · Ugel · S. · Mafficini · A. · Fiorini · P. · Scaglione · I. · Adamoli · G. · Borsati · A. · Belluomini · L. · Eccher · S. · Trestini · I. · Tregnago · D. · Sposito · M. · Insolda · J. · Schena · F. · Scarpa · A. · Derosa · L. · Milella · M. · Novello · S. — Enero 12th 2026 at 15:08
Introduction

In early stage non-small cell lung cancer (NSCLC), recurrence is frequent despite surgery and systemic treatments. Observational studies suggest that physical exercise and nutrition could improve outcomes, such as survival and treatment tolerance; however, solid evidence is lacking. The STARLighT trial aims to assess the effects of a telehealth-delivered combined exercise and nutrition intervention on clinical, biological and patient-reported outcomes in early stage NSCLC.

Methods and analysis

STARLighT is a multicentre master protocol study conducted in Italy, comprising two cohorts of patients affected by early stage NSCLC (stages IB–IIIA) epidermal growth factor receptor and anaplastic lymphoma kinase wild type. Cohort A will include 46 patients with resectable NSCLC receiving neoadjuvant treatment and will exploit a single-arm phase II design. Cohort B will enrol 268 patients undergoing adjuvant treatment (including as a part of a perioperative strategy) and proposes a randomised controlled phase III design. Patients in Cohort A and those allocated to the interventional arm in Cohort B will receive a tailored telehealth-delivered exercise and nutritional intervention. The control group will receive the usual care plus educational material. For cohort A, two coprimary endpoints are set: pathological complete response and quality of life, whereas the primary endpoint for cohort B is 2-year disease-free survival. Secondary and exploratory endpoints include a series of clinical (eg, overall survival and safety), biological (immune–inflammatory markers, gut microbiota and transcriptomics) and patient-reported outcomes (eg, sleep habits, physical activity, anxiety and depression and distress) evaluations.

Ethics and dissemination

The study is approved by the Ethics Committee of the University of Verona (Prot. No. 33979) and registered on ClinicalTrials.gov (NCT07042724). Findings will be disseminated through peer-reviewed journals, scientific meetings, public forums and guideline updates.

Trial registration number

Clinicaltrial.gov: NCT07042724.

☐ ☆ ✇ BMJ Open

CapeOX (capecitabine and oxaliplatin) combined with sintilimab and bevacizumab biosimilar (IBI305) for first-line treatment of advanced gastric or oesophagogastric junction adenocarcinoma: study protocol for a single-arm, phase Ib/II trial

Por: Dai · R. · Zhang · P. · Cheng · M. · Bi · F. · Zhou · J. · Liu · M. — Enero 9th 2026 at 14:17
Background

A combination of chemotherapy and immune checkpoint inhibitor therapy has been demonstrated to be effective as a first-line treatment of gastric or gastro-oesophageal junction (G/GEJ) cancer. The conventional treatment strategy for patients with advanced/metastatic human epidermal growth factor receptor 2-negative G/GEJ cancer is recommended. However, the response rate and enhancements in survival are still significantly insufficient. The present study will investigate the efficacy and safety of incorporating a bevacizumab biosimilar IBI305 into chemotherapy and immunotherapy as a first-line treatment for advanced or metastatic G/GEJ cancer.

Methods and analysis

This single-arm, open-label, prospective phase Ib/II clinical study will involve 57 participants. In phase Ib of the trial, patients with advanced or metastatic G/GEJ cancer will receive capecitabine and oxaliplatin (CapeOX) together with sintilimab (200 mg intravenously every 3 weeks) and IBI305 (7.5, 10 or 15 mg/kg intravenously every 3 weeks) in a 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs) within 6 weeks of treatment initiation. In phase II, the patients will receive CapeOX combined with sintilimab and IBI305 at the recommended phase II dose. The primary objectives will be to assess DLTs (phase Ib) and the objective response rate (phase II). The secondary objectives will include progression-free survival, overall survival, disease control rate, duration of response, adverse effects, quality of life and safety.

Ethics and dissemination

The trial protocol was approved by the Ethics Committee of West China Hospital and ClinicalTrials. The final results will be published in a peer-reviewed journal upon completion of the study.

Trial registration number

NCT05640609.

☐ ☆ ✇ BMJ Open

Chinese neuroimmunological disease (NIDBase) cohort study: cohort profile

Por: Zhang · M. · Han · J. · Xia · J. · Lin · M. · Chen · T. · Ruan · S. · Wang · Q. · Men · Y. · Gao · R. · Zheng · H. · Li · J. · Qi · Y. · Chen · S. · Wang · Y. · Tang · Y. · Li · D. · Yang · X. · Qiu · Z. · Liu · Z. · Dong · H. · Zhao · Y. · Hao · J. — Enero 8th 2026 at 13:18
Purpose

The Chinese neuroimmunological disease database (NIDBase) cohort was established to explore genetic and environmental risk factors, clinical features, multi-omics data and prognostic biomarkers. The aim is to enhance our understanding of central nervous system (CNS) demyelinating diseases. Additionally, the establishment of this cohort will address the critical issue of the lack of comprehensive genetic data and biological samples for precision diagnosis and treatment research related to neuroimmunological diseases in China.

Participants

56 hospitals in various regions of China were selected to participate in this study. The patients diagnosed with CNS demyelinating diseases were recruited, including clinically isolated syndrome (CIS), multiple sclerosis (MS), neuromyelitis optica spectrum disease (NMOSD), myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune glial fibrillary acidic protein astrocytopathy (GFAP-A).

Finding to date

At the time of patient enrolment, the clinical information is designated as baseline data. The collected baseline data include demographic information, disease history, clinical features of each demyelinating event, treatment records, standardised scales, questionnaire assessments and laboratory test results. Furthermore, biological samples, MRI and high-density electroencephalography (hd-EEG) data will be collected at baseline. All patients will be followed up at 3 months and 6 months and annually thereafter. As of December 2024, 3866 patients with CNS demyelinating diseases have been enrolled, including 84 CIS, 282 MOGAD, 1405 MS and 2095 NMOSD. Our findings indicate that CNS demyelinating diseases, particularly NMOSD, are more prevalent in women in China, with significant age differences observed among NMOSD patients compared with those with CIS, MS and MOGAD.

Future plans

In future, all patients in our cohort will be followed up at 3 months and 6 months and then annually. By the end of December 2024, the database has been locked and is now being processed and analysed, while our data continue to be updated and expanded for further analysis. Both prospective and retrospective observations will be included in this study. Subsequent publications will emerge from this multicentre cohort, encompassing genomics, clinical cohort studies, hd-EEG biomarkers, imaging-based radiomics and electrical stimulation therapies.

Trail registration number

NCT06443333.

☐ ☆ ✇ BMJ Open

Sex-specific machine learning models for carotid plaque prediction in individuals with fatty liver disease: a cross-sectional study

Por: Cheng · Y. · Yang · J. · Zheng · H. · Yin · H. · Yin · D. · Wang · H. · Wang · Y. — Enero 8th 2026 at 13:18
Introduction

Early detection of carotid plaque prevents stroke and myocardial infarction. Individuals with fatty liver might be at an increased risk of developing carotid plaque, yet limited access to carotid artery ultrasound underscores the need for predictive models.

Aims

We aimed to construct six predictive models for males and females separately to predict carotid plaque among individuals with fatty liver disease.

Design

A cross-sectional study.

Data sources

We included 8361 participants aged ≥40 years (4871 males; 3490 females) with fatty liver who underwent at least one health check-up between 1 January 2020 and 31 December 2023.

Methods

The sex-stratified dataset was randomly divided into 70% training and 30% internal testing datasets. With 24 potential predictors, we applied four machine learning (ML) algorithms and two conventional logistic regression (LR) models: stepwise LR and LR based on ML-selected features (LR-ML) to develop sex-specific carotid plaque prediction models. The performances were evaluated by area under the receiver operating characteristic curve (AUC), sensitivity, specificity, precision, F1-score, accuracy, calibration curve and decision curve analysis.

Main outcome measures

Carotid plaque was determined when the local carotid intima-media thickness was ≥1.5 mm in any of the arterial segments.

Results

Four predictors (age, hypertension, total bilirubin, total cholesterol and white blood cell count) in males and three (age, systolic blood pressure and fasting blood glucose) in females were identified by consensus across the four ML algorithms and subsequently used to construct LR models. Among all 4 ML and two LR models, the gradient boosting machine model demonstrated the best overall performance in males (AUC=0.773, 95% CI 0.749 to 0.797), while the LR-ML model was optimal in females (AUC=0.817, 95% CI 0.791 to 0.843). Calibration and decision curve analyses further demonstrated satisfactory agreement and higher net benefit across sexes. Risk stratification identified distinct low-, intermediate- and high-risk groups with progressively higher observed prevalence of carotid plaque (20.25%, 48.58% and 69.41% in males; 15.28%, 50.89% and 66.56% in females).

Conclusion

Our findings highlight significant sex differences in practical carotid plaque prediction, providing crucial insights for public health implications in the early identification and risk assessment of carotid plaque among individuals with fatty liver.

☐ ☆ ✇ BMJ Open

Association between age-specific preconception thyroid-stimulating hormone (TSH) and birth weight: a retrospective study

Por: Bai · X. · Zhou · Z. · Guo · X. · Yang · H. · Du · H. · Zhu · H. · Chen · S. · Pan · H. — Enero 7th 2026 at 04:50
Objective

Maternal thyroid function affects fetal birth weight and age is an important factor in regulating thyroid function. Thus, we aimed to explore the association between age-specific preconception thyroid-stimulating hormone (TSH) and birth weight.

Design

Cohort study.

Participants

A total of 97 755 preconception Chinese women aged 20–39 years old from the National Free Preconception Checkups Project were included.

Setting

Participants were divided into four age groups: 20–25 years, 25–29 years, 30–34 years and 35–39 years. The preconception TSH levels within 6 months before pregnancy and fetal birth weight, including large for gestational age (LGA), small for gestational age (SGA) and appropriate for gestational age (AGA), were collected and analysed using restricted cubic spline regression. Logistic regression investigated the relationship between various TSH groups and birth weight.

Results

(1) Preconception TSH levels differed among four age groups; (2) in the 20-24 years group, preconception TSH was associated with the incidence of LGA and AGA (p2.12 mIU/L) TSH were associated with a higher risk of LGA and lower incidence of AGA in 20–24 years.

Conclusion

Preconception TSH exhibited a significant association with LGA and AGA in the 20–24 years age group, but not in the 25–39 years age group. Young preconception women should not neglect paying attention to their thyroid function, associated with the risk of LGA.

☐ ☆ ✇ BMJ Open

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

Por: Cheng · Z. · Xu · L. · Lu · Z. · Wang · H. · Song · T. · Cui · Y. — Enero 7th 2026 at 04:50
Introduction

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

Methods and analysis

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

Ethics and dissemination

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

Trial registration number

ChiCTR2300069996.

☐ ☆ ✇ BMJ Open

Burden and characteristics of revision total hip arthroplasty in China: a national study based on hospitalised cases

Por: Feng · H. · Wang · Y. · Xie · D. · Long · H. · Chen · H. · Xiao · Y. · Yang · T. — Enero 7th 2026 at 04:50
Objective

This study aimed to investigate the burden and characteristics of revision total hip arthroplasty (THA) in China.

Design

A national retrospective study was conducted based on the Hospital Quality Monitoring System (HQMS) in China. Patients who underwent revision total hip arthroplasty (THA) between 2013 and 2018 were included. Revision burden was calculated as the ratio of revision procedures to the total number of THA procedures. Demographic and hospital characteristics, hospitalisation charges, clinical indications and patient migration patterns related to revision THA were analysed.

Setting

Tertiary hospitals across China.

Participants

A total of 13 029 revision THA cases from HQMS.

Primary outcome measures

Revision burden, indications for revision, hospitalisation charges, hospital level, patient migration and their trend.

Results

During the study period, 13 029 revision THA cases were identified. The revision burden showed an increasing trend from 2013 to 2018 (4.5% to 5.4%; p for trend=0.002). The hospitalisation charges continued to increase between 2013 and 2016 and decreased over the next 2 years. The leading indications for revision THA were prosthesis loosening (44.0%), prosthesis dysfunction (13.7%) and fracture (10.7%). More than 60% of patients were hospitalised in provincial hospitals, but this proportion gradually decreased over time. 14.8% of patients were hospitalised in a hospital outside the province of their residence. Shanghai and Beijing were the most preferred migration destinations, with 63.5% and 52.0% of patients from outside provinces, respectively.

Conclusions

This study provided epidemiological data on revision THA in China based on a national database. During the study period, there was an increasing trend in the revision burden, and hospitalisation costs shifted from an annual increase to a decrease. China exhibits distinct characteristics regarding indications for revision THA. Additionally, significant regional disparities in revision THA were evident, leading to a considerable phenomenon of migration.

☐ ☆ ✇ BMJ Open

Impact of patient empowerment on continuity of care needs in patients with stable COPD: the mediating role of eHealth literacy in a cross-sectional study from China

Por: Chen · C. · Feng · J. · Cai · B. · Qian · Y. — Enero 5th 2026 at 12:39
Objective

To explore the relationships among continuity of care needs, patient empowerment and eHealth literacy in patients with stable chronic obstructive pulmonary disease (COPD), and to further identify the potential mediating role of eHealth literacy.

Design

Cross-sectional study.

Setting

A tertiary care hospital (Level 3A, the highest level in the Chinese hospital classification system) in Shanghai, China.

Participants

The study participants consisted of 219 patients with stable COPD who visited or underwent follow-up at the outpatient clinic between December 2023 and May 2024.

Outcome measures

The Continuity of Care Needs Questionnaire, COPD Patient Empowerment Evaluation Scale and eHealth Literacy Scale (eHEALS) were used to assess 219 patients with stable COPD. Univariate analysis, Pearson correlation analysis and mediation analysis were performed.

Results

The mean Continuity of Care Needs score was 24.17 (SD=2.74), with medication guidance needs being the highest-scoring domain. The COPD Patient Empowerment score was 84.37 (SD=11.58), and the eHEALS score was 23.37 (SD=6.06). Pearson correlation analysis showed that continuity of care needs were negatively correlated with patient empowerment (r=–0.930, 95% CI –0.946 to –0.910) and eHealth literacy (r=–0.976, 95% CI –0.982 to –0.969), while patient empowerment was positively correlated with eHealth literacy (r=0.919, 95% CI 0.895 to 0.937) (all p

Conclusions

Patients with stable COPD demonstrated high continuity of care needs, with eHealth literacy partially mediating the relationship between patient empowerment and continuity of care needs. Healthcare providers should consider patients’ eHealth literacy to enhance patient empowerment and develop personalised continuity of care strategies.

☐ ☆ ✇ BMJ Open

Association between pneumoconiosis and cataract risk: a nationwide retrospective cohort study in Taiwan

Por: Cheng · J.-S. · Lin · Y.-S. · Lin · C.-L. · Hsia · N.-Y. · Shen · T.-C. · Cho · D.-Y. — Diciembre 31st 2025 at 18:10
Objectives

To investigate whether pneumoconiosis increases the risk of cataract.

Design

Nationwide population-based retrospective cohort study.

Setting

Taiwan’s National Health Insurance database, which covers >99% of the population.

Participants

The study included 19 841 adults newly diagnosed with pneumoconiosis between 2001 and 2020 and 79 364 age-matched and sex-matched individuals without pneumoconiosis. Participants with a prior history of cataract were excluded.

Outcome measures

The primary outcome was incident cataract identified through International Classification of Diseases diagnostic codes. Subgroup analyses were performed to evaluate cataract risk across different strata of age, sex and comorbidity. In addition, among patients with pneumoconiosis, we conducted a secondary analysis evaluating the association between systemic corticosteroid use and cataract development.

Results

During follow-up, the incidence of cataract was significantly higher in the pneumoconiosis cohort (38.9 vs 35.3 per 1000 person-years). Patients with pneumoconiosis had an increased risk of cataract after adjustment for age, sex and comorbidities (adjusted HR (aHR)=1.22, 95% CI 1.18 to 1.26). Elevated risks were observed in both men (aHR=1.22, 95% CI 1.18 to 1.26) and women (aHR=1.20, 95% CI 1.13 to 1.29). All age groups showed increased risks, with the highest estimate observed among patients aged ≥75 years (aHR=1.24, 95% CI 1.19 to 1.30). Subgroup analyses showed an increased risk in patients with pneumoconiosis who had no comorbidities (aHR=1.12, 95% CI 1.07 to 1.18). In a secondary analysis, systemic corticosteroid exposure was not significantly associated with cataract development (adjusted OR=0.65, 95% CI 0.39 to 1.09).

Conclusions

Pneumoconiosis is associated with an increased risk of cataract. Routine ophthalmologic surveillance should be considered in pneumoconiosis management.

☐ ☆ ✇ BMJ Open

Efficacy and safety of adjuvant short-course immune checkpoint inhibitors following TACE combined with MWA in patients with BCLC A-B hepatocellular carcinoma: a single-arm, prospective, phase II study protocol

Por: Fang · Y. · Zhang · M. · Chen · J. · Han · Z. · Piao · X. · Zhang · S. — Diciembre 30th 2025 at 15:31
Background

Patients with early-stage to intermediate-stage hepatocellular carcinoma (HCC) face a high risk of recurrence after transarterial chemoembolisation (TACE) plus microwave ablation (MWA), often resulting in early relapse and poor prognosis. Adjuvant immunotherapy may reduce this risk by eliminating residual disease and enhancing antitumour immunity, thereby lowering recurrence and improving outcomes. However, evidence supporting adjuvant immunotherapy alone after curative locoregional therapy remains limited. This study evaluates the efficacy and safety of short-course adjuvant Tislelizumab in patients with Barcelona Clinic Liver Cancer(BCLC)stage A–B HCC treated with TACE plus MWA.

Method and analysis

This prospective, single-arm, phase II trial will enrol 30 patients with BCLC stage A–B HCC who have received TACE plus MWA. Eligibility requires complete response confirmed by modified Response Evaluation Criteria in Solid Tumors(mRECIST) on imaging 1 week after treatment. All patients will receive tislelizumab (200 mg every 3 weeks) for 6 months. Follow-up will continue until recurrence, death or study completion. The primary endpoint is investigator-assessed recurrence-free survival. Secondary endpoints include local tumour progression, intrahepatic distant recurrence, time to extrahepatic disease, overall survival and adverse events.

Ethics and dissemination

Our study was approved by the Medical Research Ethics Committee of the Yanbian University Hospital (No. 20250006). The findings of this study will be submitted for publication in peer-reviewed journals and will also be presented at multiple international conferences on interventional radiology and oncology.

Trial registration number

ChiCTR2500110080.

☐ ☆ ✇ BMJ Open

Efficacy of Tuina in patients with knee osteoarthritis: study protocol for a randomised controlled trial

Por: Zhang · J. · Xue · B. · Wei · Y. · Shi · M. · Luo · Y. · Chen · W. · Wang · Q. · Xi · X. · Hu · Z. — Diciembre 30th 2025 at 15:31
Background

Tuina demonstrates clinical therapeutic efficacy in the treatment of knee osteoarthritis (KOA). However, due to the paucity of high-quality and credible evidence-based medical evidence, there is no unified consensus on the treatment of KOA with Tuina in the current medical guidelines. Therefore, we will conduct a two-arm parallel group design and a randomised controlled trial to evaluate the efficacy of Tuina for treating KOA and the effect of Tuina on various muscles of the knee joint.

Methods and analysis

A total of 84 participants from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine will be recruited. The participants will be randomly assigned to the Tuina group or the Infrared group in a 1:1 ratio. Participants in the Tuina group will receive manual therapy and infrared therapy, while the infrared group will receive infrared therapy exclusively. Both groups will undergo treatment twice per week during the 4-week treatment period and will be followed up at months 3 and 6 post-treatment period. All participants will receive healthcare education (encompassing knee joint exercise and protection) throughout the study duration. The primary outcome measure is the Lysholm score, which assesses the overall function of the knee joint. Secondary outcomes comprise Visual Analogue Scale, muscle tone and pressure pain threshold. All outcomes will be assessed and analysed by researchers blinded to the treatment allocation. Statistical analyses will adhere to the intention-to-treat principle.

Ethics and dissemination

This trial protocol has been approved by the Ethics Committee of Ruijin Hospital (project number 2024-38). Written informed consent from study participants will be obtained prior to enrolment. The findings will be disseminated through peer-reviewed journals.

Trial registration number

ITMCTR2024000469.

☐ ☆ ✇ BMJ Open

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

Por: Zhan · Z. · Xie · T. · Zhao · T. · Zhang · X. · Zhang · S. · Wang · M. · Xu · Q. · Cheng · Y. · Liu · Y. · Yang · S. · Cui · F. — Diciembre 30th 2025 at 15:31
Objective

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

Design and setting

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

Participants

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

Methods

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

Results

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

Conclusion

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

☐ ☆ ✇ BMJ Open

Adjunctive Tongxinluo capsule for patients with acute coronary syndromes undergoing percutaneous coronary intervention: a GRADE-assessed systematic review and meta-analysis of randomised controlled trials

Por: Liang · S.-B. · Wang · Y.-F. · Li · Y.-F. · Chen · W.-J. · Zhu · Y.-S. · Hua · Z. · Zheng · H.-M. · Niu · Z.-C. · Robinson · N. · Liu · J.-P. · Li · Y.-L. — Diciembre 30th 2025 at 15:31
Background

Tongxinluo capsule (TXL) is widely used in China as an adjunctive therapy for patients with acute coronary syndromes (ACS) who underwent percutaneous coronary intervention (PCI), collectively referred to as ACS-PCI. However, current evidence on its therapeutic effects and safety remains limited and insufficiently synthesised. This review aims to evaluate the therapeutic effects and safety of adding TXL to Western medical therapy (WM) in this population.

Methods

A systematic literature search was performed in PubMed, the Cochrane Library, CNKI, VIP and Wanfang from inception to August 2024; a rapid supplemental search was conducted up to November 2025, without language restrictions, to identify randomised controlled trials (RCTs) evaluating the therapeutic effects and safety of adding TXL to WM in patients with ACS-PCI. Dichotomous outcomes were summarised using risk ratios (RRs) with 95% CIs; absolute risk reductions (ARRs) were estimated as risk differences, and corresponding numbers needed to treat (NNTs) were calculated. Continuous outcomes were summarised using mean differences (MDs) with 95% CIs. All meta-analyses were performed using a random-effects model. The included studies generally had limitations in methodological quality, heterogeneity across analyses was low to moderate and the potential for publication bias could not be excluded. The evidence certainty for each outcome was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach.

Results

Eighteen RCTs involving 1800 participants were included. Low-certainty evidence indicated that adding TXL to WM may reduce the risks of restenosis (RR=0.30, 95% CI 0.10 to 0.91; ARR=0.056, NNT=18), revascularisation (RR=0.28, 95% CI 0.10 to 0.80; ARR=0.069, NNT=15), myocardial infarction (RR=0.44, 95% CI 0.20 to 0.98; ARR=0.033, NNT=31), angina (RR=0.32, 95% CI 0.17 to 0.61; ARR=0.076, NNT=14) and other cardiovascular events (RR=0.41, 95% CI 0.24 to 0.71; ARR=0.075, NNT=14). It also improved Seattle Angina Questionnaire scores (MD=8.82, 95% CI 6.58 to 11.05) and quality of life (qualitative synthesis). However, no statistically significant reductions were observed for sudden cardiac death (RR=0.39, 95% CI 0.12 to 1.27; ARR=0.022, NNT=45), or non-cardiovascular adverse events (RR=0.67, 95% CI 0.32 to 1.40; ARR=0.043, NNT=24) when TXL was added to WM.

Conclusion

Current evidence suggests that adjunctive TXL may reduce key cardiovascular events and improve symptoms and quality of life in patients with ACS-PCI, without increasing the risk of non-cardiovascular adverse events. However, all findings are based on low-certainty evidence. These results provide preliminary support for the use of TXL as an adjunctive therapy, but high-quality, multicentre RCTs are needed to confirm these effects and inform clinical guidelines.

PROSPERO registration number

CRD42024509453.

☐ ☆ ✇ BMJ Open

Effects of different folic acid supplementation doses on subsequent pregnancy outcomes in women with a history of pregnancy loss: study protocol for a multicentre randomised controlled trial

Por: Liu · C. · Cai · Z. · Du · L. · Fang · Z. · Yang · H. · Wu · H. · Li · Q. · Yan · A. · Chen · L. · An · R. · He · Q. · Zhang · X. · Ren · Y. · Wang · F. — Diciembre 30th 2025 at 05:33
Introduction

Folic acid is crucial for fetal development, particularly during early pregnancy. Studies suggest that high folic acid intake (≥800 µg/day) may be associated with a reduced risk of miscarriage. However, the impact of an 800 µg dose on pregnancy outcomes in women with prior pregnancy loss currently remains unclear.

Methods and analysis

We will conduct a multi-centre randomised controlled study comparing 800 µg and 400 µg in women with previous pregnancy loss. The primary outcome is live birth. Secondary outcomes include early pregnancy loss, ongoing pregnancy at 24 gestation weeks, homocysteine (Hcy) reduction, maternal and perinatal outcomes. We plan to recruit 1116 women (558 women per group). Data analysis will follow the intention-to-treat principle and per-protocol. Subgroup analysis will be conducted based on Hcy levels, previous pregnancy losses and body mass index.

Trial registration number

ChiCTR2500100255.

☐ ☆ ✇ BMJ Open

Building a library of acute traumatic spinal cord injury images across Canada: a retrospective cohort study protocol

Por: Rotem-Kohavi · N. · Humphreys · S. · Noonan · V. K. · Cheng · C. L. · Guay-Paquet · M. · Bouthillier · M. · Valosek · J. · Karthik · E. N. · Lichtenstein · E. · Guenther · N. · Ost · K. · Attabib · N. · Hardisty · M. · Badhiwala · J. · Larouche · J. · Pahuta · M. · Christie · S. · Fehlin — Diciembre 25th 2025 at 12:35
Introduction

MRI is increasingly recognised as a valuable tool for assessing prognosis and predicting outcomes following traumatic spinal cord injury (SCI). Several potential MRI biomarkers have been identified, but efforts are still needed to improve the accuracy and feasibility of these biomarkers in clinical practice. This study aims to build a national Canadian SCI imaging repository for storing and analysing imaging data for SCI, with the goal of improving SCI MRI biomarkers to predict outcomes and inform clinical management.

Method and analysis

As a substudy of the Rick Hansen SCI Registry (RHSCIR), this retrospective multisite study includes individuals who sustained a traumatic cervical SCI between 2015 and 2021, were previously enrolled in RHSCIR, and had MRI scans acquired within 72 hours of injury and before any surgical intervention. Individuals with a penetrating trauma and/or with any prior spine surgery are excluded. The study principal investigator and research associates, experienced with data curation and with the standardised format and specifications of the Brain Imaging Data Structure standard, guide the site’s curator on the steps to perform image deidentification and curation to create standardised datasets across all sites. These datasets are transferred to a Digital Research Alliance of Canada (‘the Alliance’) server designated for this project and concatenated to form the national Canadian SCI imaging repository (Neurogitea). We are using a semiautomated processing pipeline to quantify lesion morphology, together with additional imaging measures that are manually extracted from the images (for instance, the relative maximal spinal cord compression and the maximum canal compromise). Through linkage to RHSCIR clinical and epidemiological data already available on eligible participants, regression analysis is planned to predict neurological outcomes at discharge, including the American Spinal Injury Association Impairment Scale grade, upper and lower extremity motor and sensory scores.

Ethics and dissemination

This protocol has been submitted by the participating sites to obtain ethics and institutional approvals prior to the study initiation at each site. All 12 sites across Canada have now obtained ethics and institutional approvals. Study results will be disseminated at local, national and international conferences and by journal publications.

☐ ☆ ✇ BMJ Open

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

Por: Liu · Y. · Cui · S. · Zhang · Y. · Song · Z. · Luo · Z. · Chen · Z. · Gao · Q. · Wang · J. — Diciembre 25th 2025 at 05:45
Introduction

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

Methods and analysis

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

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

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

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

Ethics and dissemination

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

PROSPERO registration number

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

❌