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.

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.

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

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.

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.

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.

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.

CRD42024496083.

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).

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

A single NHS hospital in the UK.

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.

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).

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.

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).

Systematic review and meta-analysis.

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

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.

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.

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).

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.

CRD42024516907.

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.

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.

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.

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.

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.

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.

Clinicaltrial.gov: NCT07042724.

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.

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.

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.

NCT05640609.

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.

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).

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.

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.

NCT06443333.

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.

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

A cross-sectional study.

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.

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.

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

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).

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.

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.

Cohort study.

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

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.

(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.

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.

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.

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.

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.

ChiCTR2300069996.

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

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.

Tertiary hospitals across China.

A total of 13 029 revision THA cases from HQMS.

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

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.

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.

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.

Cross-sectional study.

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

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.

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.

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

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.

To investigate whether pneumoconiosis increases the risk of cataract.

Nationwide population-based retrospective cohort study.

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

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.

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.

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).

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

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.

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.

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.

ChiCTR2500110080.

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.

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.

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.

ITMCTR2024000469.