IgG4-related disease is a chronic fibroinflammatory disease with multiorgan involvement. Glucocorticoids and/or immunosuppressants as well as rituximab are both first-line treatments in remission induction therapy. However, relapse is common during the maintenance period, particularly in patients with re-elevation of serum IgG4 level. This study aims to evaluate whether adding mycophenolate mofetil (MMF) during the maintenance phase for such patients can reduce the risk of disease flare.

This study is a multicentre, randomised, double-blind, placebo-controlled study. A total of 108 eligible patients with re-elevation of serum IgG4 level during maintenance therapy will be included in this study and randomised in a 1:1 ratio to receive add-on MMF 0.5 g one time per day or placebo for 52 weeks. The primary outcome is the proportion of patients experiencing relapse at week 52. Secondary outcomes include time-to-relapse, changes in disease activity and serum IgG4 level, stratified relapse rate according to the elevation level of IgG4. Analyses will follow the intention-to-treat principle.

The study has been approved by the Ethics Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences (approval no. K3231). Written informed consent will be obtained from all participants before enrolment. Findings will be disseminated through peer-reviewed journals and conference presentations.

NCT05974683.

Single-arm trials (SATs) with objective performance criteria (OPCs) or performance goals (PGs) are increasingly used for regulatory approval of medical devices and other interventions. However, the comparability of study design characteristics between SAT and their external comparator sources remains unclear. This scoping review aimed to evaluate the comparability of study design characteristics between SATs and their matched OPC/PG sources.

Scoping review.

PubMed, Embase, the Cochrane Library and four Chinese databases—China National Knowledge Infrastructure, Wanfang Data, CQVIP and SinoMed—were searched from inception to 30 April 2026.

We included SATs that used one or more OPCs or PGs as external comparators to evaluate safety and/or effectiveness endpoints and reported specific numerical values of OPCs or PGs.

Two reviewers independently screened the retrieved records and extracted data using a standardised form. For each included SAT, we retrieved the cited OPC/PG sources and extracted study design characteristics data (age, sex, health conditions, outcome definitions and measurement time points) for comparison. Age and sex were compared using summary t-tests and ² tests; health conditions were assessed by two clinicians based on eligibility criteria and baseline characteristics. Results were stratified by OPC versus PG.

A total of 1243 records were identified, and 133 SATs were included. Most studies used PGs (84, 63.2%); 34 (25.6%) claimed to use OPCs, and 15 (11.3%) could not be classified. Of the 60 age comparisons available from 41 studies, 30 showed statistically significant differences; of the 82 sex comparisons available from 59 studies, 60 showed significant differences. Health conditions, outcome definitions and time points were assessed descriptively in a subset of studies, and discrepancies were also observed.

Suboptimal comparability of study design characteristics was observed between SATs and their OPC/PG sources, which might influence the treatment effect estimates. Greater attention to the comparability of study design characteristics in SATs with OPC/PGs may improve the validity of evidence.

This study aimed to examine whether lifestyle risk factors were associated with reporting any presenteeism and among primary care physicians (PCPs) who reported presenteeism, with the degree of productivity impairment.

Cross-sectional study.

Primary healthcare institutions across all 31 provincial-level administrative regions of mainland China.

PCPs were eligible if they were aged ≥18 years, had worked in a primary healthcare institution for at least 1 year and provided written informed consent. Participants were recruited using multistage sampling with convenience sampling at the area, institution and physician levels. Of the 1500 questionnaires distributed, 1214 were returned, yielding a response rate of 80.9%. Following data quality screening, 338 questionnaires were excluded, leaving 876 physicians for analysis.

Presenteeism was assessed using the Work Productivity and Activity Impairment Questionnaire: General Health version. Lifestyle risk factors (irregular diet, insufficient leisure-time physical activity (LTPA), poor sleep quality, smoking and drinking) were assessed using a structured questionnaire.

Among the 876 PCPs included in the analysis, 417 (47.6%) reported presenteeism. Insufficient LTPA and poor sleep quality were associated with higher odds of reporting presenteeism (adjusted OR (aOR) 1.65, 95% CI 1.20 to 2.28; and aOR 1.59, 95% CI 1.12 to 2.26, respectively). Among PCPs reporting presenteeism, poor sleep quality was associated with a 3.85-percentage-point higher presenteeism score (average marginal effect 3.85, 95% CI 0.32 to 7.38). Smoking was associated overall with the degree of presenteeism (p=0.003), with category-specific estimates differing in direction. No clear associations were observed for irregular diet or drinking.

Poor sleep quality was associated with both the presence and degree of presenteeism, whereas insufficient LTPA was associated primarily with its presence. Sleep quality and LTPA may warrant further investigation as potentially modifiable factors associated with presenteeism among PCPs.

The optimal timing for direct oral anticoagulants (DOACs) initiation after acute ischaemic stroke in patients with atrial fibrillation (AF) remains unclear, particularly in those undergoing endovascular thrombectomy (EVT), who are at higher risk of both haemorrhagic transformation and early embolic recurrence. Patients undergoing thrombectomy have been under-represented in previous randomised trials, resulting in limited evidence for guiding management in this high-risk population. The TIMERS trial aims to evaluate the efficacy and safety of early versus delayed initiation of DOACs therapy after EVT in patients with large vessel occlusion stroke and AF.

This is a multicentre, prospective, randomised, open-label trial with a blinded outcome assessment. In total, 438 patients with acute ischaemic stroke and AF treated with EVT will be enrolled in this study. Patients will be randomised in a 1:1 ratio within 72 hours after stroke onset to early initiation (≤4 days) or delayed initiation (5–14 days). The primary outcome is a composite of recurrent ischaemic stroke, symptomatic intracranial haemorrhage or all-cause death within 90 days. Secondary outcomes include individual components of the primary endpoint, venous thromboembolism, systemic embolism, myocardial infarction, functional outcome (modified Rankin Scale), health-related quality of life (EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L)) and major extracranial bleeding events.

The study is approved by the Ethics Committee of Xuanwu Hospital of Capital Medical University, the ethics approval document number is (2025)259-001. The trial findings will be disseminated through peer-reviewed publications and presentations at scientific conferences.

NCT07139301.

Intravenous thrombolysis is the standard early treatment for acute ischaemic stroke (AIS), yet a substantial proportion of patients, particularly those with mild disabling deficits, do not achieve favourable functional recovery. Tenecteplase (TNK), a fibrin-specific thrombolytic agent administered as a single bolus, and butylphthalide (NBP), a multi-mechanism neuroprotective agent, have each shown benefit in AIS. However, whether their combination confers additional benefit in mild disabling AIS remains unknown. This trial aims to determine whether adding NBP to TNK improves functional outcomes in patients with mild disabling ischaemic stroke treated within 4.5 hours of symptom onset.

BENEFIT-2 is a prospective, multicentre, randomised, double-blind, active-controlled trial. Eligible patients will be randomised 1:1 to receive either TNK plus NBP (combination group) or TNK plus placebo (control group) via block randomisation. The intervention comprises intravenous NBP 25 mg/100 mL two times per day for 7 days, followed by oral NBP 0.2 g three times per day up to day 14, with matching placebos for the control group. Key eligibility criteria include age 18–80 years, symptom onset within 4.5 hours, baseline National Institutes of Health Stroke Scale (NIHSS) score 2–5 with persistent unilateral weakness or speech impairment, and prestroke modified Rankin Scale (mRS) score 0 or 1. The primary outcome is the proportion of patients achieving mRS 0–1 at 90 days (allowable window ±7 days). Secondary endpoints include change in NIHSS, stroke recurrence, major vascular events, quality of life measured by EQ-5D and penumbral salvage on imaging. Safety endpoints comprise symptomatic intracranial haemorrhage, vascular death, all-cause mortality and other adverse events within 90 days. The primary analysis will follow the intention-to-treat principle.

Ethics approval has been obtained from the Independent Ethics Committee of Xiangya Hospital (No. 2026020399), Central South University. Results will be published in peer-reviewed journals and presented at academic conferences.

NCT07369999

Dietary modification is an important strategy for the prevention of type 2 diabetes, with fibre intake recognised as a key factor in promoting metabolic health. Resistant starch (RS), a type of fermentable dietary fibre, has emerged as a promising therapeutic approach due to its association with weight loss, enhanced insulin sensitivity and improved glucose metabolism. As nutritional research progresses, the focus has shifted from individual nutrients to overall dietary patterns. Based on this concept, this study aims to investigate the metabolic effects of a dietary pattern that optimises carbohydrate structure by increasing RS intake and reducing rapidly digestible carbohydrate in adults with pre-diabetes.

This is a multicentre, randomised, parallel-controlled clinical trial, which will enrol 250 adults diagnosed with pre-diabetes. Eligible participants will undergo randomisation to receive either a guideline-based conventional diet or an optimised carbohydrate diet (OCD). In the OCD intervention, daily RS intake will be increased to approximately 40 g, with fibre intake rising to 20–40 g per 1000 kcal. At the same time, the intake of rapidly digestible starch and free sugars will be reduced. The intervention will last for 6 months, followed by a 3-month post-intervention follow-up period. The primary outcome is the change in postprandial glycaemic response, assessed using the incremental area under the curve (iAUC) for plasma glucose during the oral glucose tolerance test (OGTT). Secondary outcomes include the proportion of participants achieving remission to normoglycaemia or progressing to type 2 diabetes, changes in other glucose- and lipid-related metabolic parameters and changes in lifestyle-related behavioural factors. Exploratory outcomes will include changes in appetite-related hormones, circulating cytokines, immune function and multi-omics profiles.

This study was approved by the Ethics Committee of Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (Approval No. 2025-122; Protocol V.1.0, 20250811) and the Ethics Committee of Shenzhen Center for Chronic Disease Control (Approval No. SZCCC-2024-011-01-PJ) and registered in the Chinese Clinical Trial Registry. Findings from this study will be disseminated in peer-reviewed journal publications.

ChiCTR2500113583.

Inadequately managed postoperative pain remains a significant clinical challenge, often leading to delayed mobilisation and increased complications. While intravenous patient-controlled analgesia (PCA) is a mainstay of treatment, conventional fixed-rate basal infusion modes may not align with the fluctuating biphasic nature of postoperative pain. This often results in either insufficient analgesia or unnecessary opioid overexposure. Advanced network-integrated PCA pumps now allow for ‘variable-rate feedback infusion,’ which dynamically adjusts the background rate based on real-time patient demand. This study aims to determine whether a variable-rate feedback infusion mode reduces total cumulative opioid consumption at 48 hours postoperatively while providing non-inferior analgesic efficacy compared with a fixed-rate basal infusion mode.

This is a multicentre, randomised, double-blind, controlled trial to be conducted at three hospitals in China. A total of 1170 patients (aged 18–65 years, American Society of Anaesthesiologists I-III) undergoing elective mixed surgery under general anaesthesia, including thoracic, abdominal, spinal, orthopaedic and cranial procedures performed using either minimally invasive or open approaches, will be recruited and randomised in a 1:1 ratio to either the fixed-rate basal infusion group or the variable-rate feedback infusion group. Both groups will receive a standardised PCA solution of sufentanil. In the variable-rate feedback infusion group, the background infusion rate will automatically increase by 0.5 mL/hour on demand boluses during lockout intervals and decrease by 0.5 mL/hour after 1 hour of inactivity. The primary outcome is the total cumulative opioid consumption at 48 hours postoperatively, including sufentanil delivered via PCA and opioid-equivalent rescue analgesics. Key secondary outcomes include resting and movement pain scores, cumulative PCA volume consumption, number and dosage of additional rescue analgesia and postoperative quality of recovery. Exploratory outcomes include sleep quality, sedation and agitation levels, and the degree of nausea and vomiting, patient’s satisfaction with PCA. These outcomes are assessed at predefined postoperative time points.

The study has been approved by the Institutional Review Board of Beijing Tiantan Hospital (KY2025-387-02) and the Affiliated Hospital of Youjiang Medical University for Nationalities (YYFY-LL-2026-006), and the Second Affiliated Hospital of Hainan Medical University (2026-K140-01). The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. Written informed consent will be obtained from all participants before enrolment. Findings from this study will be disseminated through peer-reviewed journals and at scientific conferences. A summary of the findings will also be made available to participants on request.

NCT07361822.

Diabetic neuropathy is one of the most common and disabling complications of diabetes mellitus. Current management strategies are largely limited to glycaemic control and symptomatic relief, and few therapies have demonstrated definitive disease-modifying effects. Sodium-glucose cotransporter 2 (SGLT2) inhibitors have shown multiple metabolic and vascular benefits. However, the efficacy and safety of SGLT2 inhibitors as adjunctive therapy for diabetic neuropathy have not yet been systematically evaluated. This protocol aims to describe the methodology for a systematic review and meta-analysis that will comprehensively assess the therapeutic value of SGLT2 inhibitors in diabetic neuropathy.

A systematic search will be conducted in PubMed, Embase, Cochrane Library and Web of Science, as well as in clinical trial registries including the WHO International Clinical Trials Registry Platform and ClinicalTrials.gov, from database inception to 31 May 2026. Eligible studies will include randomised controlled trials evaluating SGLT2 inhibitors in combination with conventional therapy in patients with diabetic neuropathy. Two reviewers will independently perform study selection, data extraction and methodological quality assessment. Extracted data will include study characteristics, participant demographics, intervention details, outcome measures and adverse events. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool. Quantitative synthesis will be conducted using meta-analytic methods, with the choice of statistical model determined by the degree of heterogeneity, as assessed by Cochran’s Q test and the I² statistic. Where appropriate, meta-regression, subgroup analyses, sensitivity analyses and trial sequential analysis will be performed. Publication bias will be assessed using funnel plots and Egger’s regression test, and the certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.

Ethical approval is not required because this study will involve only the analysis of published data. The findings will be disseminated through publication in a peer-reviewed journal.

CRD420261389933.

Diabetic cardiomyopathy (DCM) is an important contributor to heart failure and death in patients with diabetes. Current management strategies mainly focus on glycaemic control and symptomatic treatment with limited disease-specific therapeutic options available. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) have demonstrated promising cardioprotective effects beyond glucose lowering; however, their efficacy and safety in DCM remain unclear. Therefore, this protocol describes the methods for a systematic review and meta-analysis to evaluate the efficacy and safety of GLP-1RAs in patients with DCM.

A systematic search will be conducted in PubMed (National Library of Medicine), Embase (Elsevier), the Cochrane Library (Wiley) and Web of Science (Clarivate Analytics), along with clinical trial registries and other relevant sources, up to 31 December 2026. All randomised controlled trials investigating GLP-1RAs for the treatment of DCM will be included. The primary outcomes will be cardiac function parameters, including left ventricular ejection fraction and left ventricular fractional shortening, while secondary outcomes will include metabolic indicators such as glycaemic and lipid profiles, biochemical markers such as oxidative stress-related indices and safety outcomes. Study selection and data extraction will be performed independently by two reviewers and risk of bias will be evaluated using version 2 of the Cochrane Risk of Bias tool. Statistical analyses will be performed using Stata V.16.0. Pooled effect sizes will be calculated using mean differences for continuous outcomes and risk ratios for dichotomous outcomes, with fixed-effect or random-effect models applied as appropriate. Meta-regression, subgroup and sensitivity analyses will be conducted to investigate the sources of heterogeneity. Publication bias will be assessed using funnel plots and Egger’s test, and the certainty of the evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

Ethical approval is not required because this protocol relies exclusively on secondary analysis of previously published randomised trial data. The review findings will be disseminated through peer-reviewed journal publication.

CRD420261360886.

The passive mast cell activation test (pMAT) is a novel in vitro assay designed to complement existing tools like the skin test (ST) and basophil activation test (BAT) for allergen identification. This study aimed to validate the diagnostic accuracy of pMAT specifically for neuromuscular blocking agent (NMBA)-induced perioperative anaphylaxis (POA).

A diagnostic accuracy study.

A tertiary hospital in Beijing, China.

44 patients with suspected POA were enrolled. Participants were stratified into groups based on ST and/or BAT. The NMBA-allergic group comprised 15 patients with confirmed NMBA allergy while the non-NMBA-allergic group consisted of 29 individuals without NMBA allergy.

All participants underwent pMAT testing for relevant NMBA.

The diagnostic performance of pMAT for NMBA was assessed by measuring sensitivity, specificity, likelihood ratios and the Youden index. An exploratory analysis evaluated its performance in diagnosing antibiotic-induced allergies within the same population.

For NMBA allergy, pMAT demonstrated high diagnostic accuracy (90.9%; 95% CI 77.4% to 97.1%) with excellent sensitivity (93.3%; 95% CI 66.0% to 99.7%) and specificity (89.7%; 95% CI 71.5% to 97.3%). This was reflected in a high positive likelihood ratio (9.05; 95% CI 3.06 to 26.57), a low negative likelihood ratio (0.07; 95% CI 0.01 to 0.50), a Youden index of 0.83 and a Cohen’s kappa of 0.804 (indicating substantial agreement with the reference standard). In contrast, pMAT showed reduced performance for antibiotic allergy, with an accuracy of 79.5% (95% CI 64.3% to 89.7%), sensitivity of 66.7% (95% CI 30.9% to 91.0%), specificity of 82.9% (95% CI 65.7% to 92.8%) and a kappa of 0.378 (fair agreement).

pMAT demonstrated high diagnostic accuracy for NMBA allergy, filling critical gaps in current POA diagnostic workflow. Its robust performance supports its clinical utility as a complementary tool alongside ST and BAT.

ChiCTR2400084268.

Lung cancer is the leading cause of cancer-related death worldwide, with substantial variations in incidence, stage at diagnosis and outcomes across regions. High-quality, standardised diagnosis and treatment are essential to improving survival and quality of life. Multidisciplinary care (MDC) is a cornerstone of cancer care; however, its implementation faces barriers such as limited resources, uneven policy support and inequitable access to specialised care, particularly in low- and middle-income countries. To date, no global scoping review has systematically mapped lung cancer MDC—covering implementation models, facilitators, barriers, policy frameworks, technology integration and evidence gaps. This review seeks to fill that gap and inform the optimisation of MDC models.

The Joanna Briggs Institute methodological framework, underpinned by the framework of Arksey and O’Malley and enhanced by Levac and colleagues, will be used for this scoping review. Results will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-analyses Extension for Scoping Reviews (PRISMA-ScR). We will perform a comprehensive search of six electronic databases (PubMed, CINAHL, Scopus, CNKI, VIP and WanFang) and grey literature sources (ClinicalTrials.gov). In addition, we will screen the reference lists of included studies for further relevant publications. Two review authors will independently conduct the screening and data extraction processes; discrepancies will be resolved through consensus or discussion with a third review author. Findings will be presented graphically and tabularly, together with a narrative description.

We will collect all data from published and grey literature, meaning ethical approval is not necessary. To disseminate our findings, we plan to use diverse means, such as publishing in peer-reviewed journals and presenting at academic conferences.

https://doi.org/10.17605/OSF.IO/MVSPH.

Fibromyalgia (FM) is a prevalent chronic pain condition that significantly impairs quality of life. The current treatments for FM still have some disadvantages and limitations. Pregabalin, a standard pharmacological treatment, provides relief for some patients but is associated with dose-dependent adverse events (AEs) and incomplete efficacy, highlighting a significant unmet clinical need. Mirogabalin, as a novel α2 ligand similar to pregabalin but with distinct binding properties, has shown a favourable safety profile and potential analgesic effects in preclinical studies and trials for other neuropathic pain conditions. However, data on its efficacy in FM are limited and no studies have directly compared mirogabalin with pregabalin in an Asian FM population.

This is a prospective, multicentre, randomised, open-label, blinded endpoint trial to compare the efficacy and safety of mirogabalin versus pregabalin for the management of pain and other core symptoms in adult patients with FM. This study will be conducted at the Department of Pain Management, Beijing Tiantan Hospital, the First Affiliated Hospital of Nanchang University, Chongqing University Three Gorges Hospital, the First Affiliated Hospital of Army Medical University and the Affiliated Hospital of Yanbian University. Patients aged over 18 years, diagnosed with FM according to the 2016 Revisions to the 2010/2011 FM diagnostic criteria, will be enrolled. 674 qualified patients experiencing moderate-to-severe FM will be randomly assigned to either the pregabalin group or the mirogabalin group in a 1:1 ratio. Treatment will involve individualised dose titration based on treatment response and tolerability. All participants will be followed for a duration of 12 weeks. The primary outcome will be the proportion of patients achieving a pain reduction of at least 50% at 12 weeks. Secondary endpoints will include the average pain intensity, the worst pain intensity, the Revised FM Impact Questionnaire, the Brief Pain Inventory severity and interference subscales, the Short-Form 36 Health Survey, the Medical Outcomes Study Sleep Scale, the Beck Depression Inventory-II, AEs throughout the study. An open-label administration is selected to reflect real-world clinical practice and to allow individualised dose titration according to tolerability and response, while blinded endpoint assessment is implemented to minimise evaluation bias and preserve methodological rigour.

This study was approved by the Institutional Review Board of Beijing Tiantan Hospital, Capital Medical University (KY2025-217-03), the First Affiliated Hospital of Nanchang University (IIT (2026) Clinical Ethics Review no. 676), Chongqing University Three Gorges Hospital (2026 Scientific Ethics Review no. 41), the Affiliated Hospital of Yanbian University (Yan Medical Ethics no. 20260275) and the First Affiliated Hospital of Army Medical University (AIIT2026081KX). All participants will provide written informed consent prior to enrolment. This study will be conducted in accordance with the Declaration of Helsinki. Findings from this study will be disseminated through peer-reviewed journals and at scientific conferences.

NCT07157852.

Chronic kidney disease (CKD) is frequently accompanied by nutritional imbalance, inflammation and metabolic disturbance. Single-marker assessment may not capture the multidimensional nutritional heterogeneity of CKD. This protocol aims to derive nutritional phenotypes in adults with CKD and examine their cross-sectional associations with prevalent anaemia and metabolic abnormalities.

This single-centre study comprises an electronic health record (EHR)-based retrospective baseline cross-sectional cohort and a prospective continuous-enrolment baseline extension for standardised measurements. Retrospective records will be deterministically linked at the person level across the hospital information system, laboratory information system and dialysis system using a shared hospital patient identifier. Adults aged 18 years or older with CKD confirmed using Kidney Disease: Improving Global Outcomes (KDIGO)-based criteria will be included. The common-core phenotype will be derived from body mass index, serum albumin, ferritin and 25(OH)D. Haemoglobin, lipid measures, glycated haemoglobin and fasting plasma glucose will be used only for outcome ascertainment and descriptive characterisation, not for latent phenotype derivation. C reactive protein and/or the NLR will be examined as complementary inflammation-related variables in covariate, effect-modification and sensitivity analyses. Waist circumference and standardised body-composition measures will inform a prospective subcohort specific extended phenotype framework. Bayesian latent class/profile models will identify phenotypes, and Bayesian regression models will estimate their associations with prevalent anaemia, dyslipidaemia and prevalent diabetes or diabetes-level hyperglycaemia while propagating phenotype-classification uncertainty. Missing data will be handled according to variable role. Pooled cross-phase analyses will be restricted to the common-core variable framework, with extended phenotyping limited to the prospective subcohort.

The study was approved by the Ethics Committee of Cangzhou Central Hospital (approval No. 2025–286-02). The retrospective component will use de-identified EHR data under an approved waiver of individual informed consent, whereas written informed consent will be obtained for the prospective component. Findings will be disseminated through peer-reviewed publications and academic conferences.

Open Science Framework: 10.17605/OSF.IO/FZ65E.

Sinonasal carcinomas are rare malignancies with an overall poor prognosis. These tumours arise in close proximity to vital structures, critical organs and cranial nerves involved in essential sensory and endocrine functions. Although multimodal treatment strategies combining surgery and radiotherapy (RT) are required to maximise the chances of cure while sparing surrounding tissues and reducing the risk of recurrence, they are associated with substantial cumulative morbidity. Building on high conformality and steep gradients of modern dose-painting RT, multidisciplinarity can be exploited on technical inter-disciplinary aspects. In particular, minimally morbid endoscopic endonasal multi-block surgery (EES), together with accurate histosurgical mapping, can be leveraged to individualise target tumour subvolumes delineation by risk level to avoid unnecessarily large irradiation and reduce the morbidity of RT while maintaining or improving local tumour control.

We designed a randomised multicentre phase II study to assess whether EES-based histosurgical mapping delineation and optimisation using a dose-painting approach can reduce treatment-related toxicity compared with standard intensity-modulated RT using conventional delineation in sinonasal carcinomas. The primary endpoint is the proportion of patients free from severe clinically significant radiation-induced toxicity involving the nasal mucosa, eyes, auditory system, endocrine system and/or brain within 3 months following RT completion. Secondary objectives include assessing the proportion of patients free from severe toxicities at 12 months, tumour control, quality of life, tolerance profile, RT plan quality and the association of histoclinical characteristics and radiomic features with toxicities. To ensure tumour control and avoid quality biases on toxicity outcomes, multidisciplinary volume delineation with the surgeon, as well as prospective individual case review (ICR) of the first 2 cases for each centre and both technique arms, and retrospective ICR for all cases, will be conducted.

Eligible patients will be 1:1 randomised between dose-painting based on histosurgical mapping (experimental arm) or standard delineation/optimisation (control arm), with stratification according to RT modality (photons or protons). We plan to enrol 52 patients. RT will start no earlier than 4 weeks and no later than 8 weeks after surgery, and will be delivered over a 7-week period. Patients will be followed-up for 18 months after completion of RT. We hypothesise that dose-painting RT, which relies on extensive interdisciplinary optimisation, will enable a selective de-escalation of irradiated volumes, which should translate into lower treatment-related toxicities.

Ethical approval was obtained from the Comité de Protection des Personnes Nord-Ouest IV (N°ID-RCB: 2022-A02011-42; cppnordouestiv@univ-lille.fr) on 12 April 2023, and authorisation from the National Agency for Medical and Health Products Safety on 15 May 2023. The most recent amendment (V2) was approved on 25 January 2024. Written informed consent will be obtained from all participants. Final trial results will be published in peer-reviewed journals and adhere to International Committee of Medical Journal Editors guidelines.

NCT05943119.

To explore the association between serum 25-hydroxyvitamin D (25-OH-D) levels and mild cognitive impairment (MCI) and further analyse the association between serum 25-OH-D levels and different dimensions of cognitive function.

Cross-sectional study.

Tianjin, China.

A total of 866 participants aged 65 and above were enrolled in this study.

MCI was diagnosed based on the revised Petersen diagnostic criteria. Cognitive function was assessed by the Wechsler Adult Intelligence Scale Revised in China.

The prevalence of MCI was 12.0%. Higher serum 25-OH-D levels were significantly associated with lower odds of MCI, as well as with MCI across all subgroups (p

Higher serum 25-OH-D levels were significantly associated with lower odds of MCI. Furthermore, serum 25-OH-D levels were significantly and positively associated with different dimensions of cognitive function, specifically FIQ, VIQ, information, similarity and vocabulary. There was no statistically significant interaction observed between serum 25-OH-D levels and age, gender or education level.

HER2-expressing advanced urothelial cancer is associated with poor prognosis and substantial treatment burden, and the economic value of emerging combination therapies remains uncertain. This study aimed to evaluate whether disitamab vedotin combined with toripalimab is more cost-effective than chemotherapy for patients with HER2-expressing advanced urothelial cancer from the perspective of the Chinese healthcare system.

Based on the RC48-C016 trial (NCT05302284), a partitioned survival model was developed to simulate lifetime health outcomes and economic costs. Data were obtained from the RC48-C016 trial and other publicly available published literature.

Patients with HER2-expressing advanced or metastatic urothelial carcinoma in China were included in this study. They were assigned to receive either disitamab vedotin plus toripalimab or chemotherapy based on the treatment arms defined in the RC48-C016 trial.

Economic value was assessed using quality-adjusted life years (QALYs) and the incremental cost-effectiveness ratio (ICER). Model robustness was evaluated through deterministic sensitivity analysis and probabilistic sensitivity analysis.

The base-case analysis showed that disitamab vedotin plus toripalimab resulted in an incremental cost of US$16 101.81 and an incremental QALY gain of 0.28, corresponding to an ICER of US$56 889.17 per QALY gained. This value exceeded China’s willingness-to-pay threshold of US$38 224 per QALY. Probabilistic sensitivity analysis showed that, at this threshold, disitamab vedotin plus toripalimab had a 38.5% probability of being cost-effective. These findings suggest that disitamab vedotin plus toripalimab is unlikely to be cost-effective under current pricing.

The cost-effectiveness analysis indicated that disitamab vedotin plus toripalimab is not a cost-effective treatment option for patients with HER2-expressing advanced urothelial cancer in China.

Kashin–Beck disease (KBD) is a chronic, endemic osteoarthropathy that imposed a heavy financial burden on patients and their households. This study aimed to measure the incidence of catastrophic health expenditure (CHE), and compare its differences between KBD-suffered households with and without access to the Free Surgery Policy in China.

A cross-sectional survey was conducted between 2023 and 2024 in Shaanxi Province of China.

The study was carried out in four KBD-endemic counties (Linyou, Qishan, Huanglong and Yongshou) of Shaanxi Province, China.

A two-stage probability sampling method was used to select 709 households having at least one patient diagnosed with KBD. Households were divided into policy recipients and non-recipients.

The primary outcome was incidence of CHE, defined as out-of-pocket health expenditures accounting for 40% or more of a household’s capacity to pay.

The overall incidence of CHE was 38.93% among KBD households. A statistically significant difference in CHE incidence was observed between policy recipients and non-recipients, with the former presenting a lower incidence (35.35% vs 45.04%, p=0.011). After coarsened exact matching, the odds of CHE in policy-recipient households were 0.651 times that of non-recipient households (p

KBD households experience high CHE incidence. Policy-recipient households demonstrate a lower incidence of CHE compared with non-recipient households, with the comparative advantage of the Free Surgery Policy being more pronounced in low-income and middle-income groups. These comparative findings provide empirical support for healthcare providers and policymakers to consider expanding the coverage of the policy and optimising its reimbursement process, thereby mitigating CHE incidence in their households.

Post-traumatic stress symptoms (PTSS) are prevalent among children with cancer and their families. Although family-based interventions such as the Surviving Cancer Competently Intervention Programme (SCCIP) are effective, their reliance on mental health specialists limits scalability, highlighting the need for nurse-led approaches. This trial aims to evaluate the efficacy of SCCIP-N, a nurse-led family-based psychosocial intervention, in reducing PTSS among families of paediatric cancer patients in China.

This multicentre randomised controlled trial will enrol 110 families across Hunan and Xinjiang. Participants will be randomly assigned (1:1) to the intervention group or an active control group, stratifying randomisation by study site. The study employs a hybrid outcome assessment strategy that integrates validated psychosocial measures with objective physiological monitoring. Assessments occur at baseline (T₀), 1 week (T₁), 4 weeks (T₂) and 8 weeks (T₃) postintervention. The primary outcome is PTSS in children and caregivers. Secondary outcomes include post-traumatic growth, post-traumatic cognitions, anxiety, depression, family management, family hardiness, quality of life, sleep quality and objective physiological measures collected from primary caregivers. Wearable devices will continuously record these physiological measures, including total sleep time, sleep score, heart rate and resting heart rate. A process evaluation will apply the Reach, Effectiveness, Adoption, Implementation and Maintenance framework. Data will be analysed according to intention-to-treat principles using linear mixed-effects models. Recruitment of participants began on 20 December 2025, and the study is expected to be completed by 20 December 2026.

The study was approved by the Ethics Review Committee of Xiangya School of Nursing, Central South University (approval number: E2025172) and the Medical Ethics Committee of Central South University (approval number: CSUMEC-E2025011). Written informed consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations.

ChiCTR2500114338.

Healthcare settings are high-risk environments for the transmission of respiratory viruses. Effective strategies to prevent hospital-acquired influenza, particularly post-exposure prophylaxis for close contacts (CCs), are urgently needed. This study aims to assess the effectiveness of baloxavir marboxil (baloxavir) and oseltamivir in preventing influenza virus infection among CCs who have been exposed to confirmed influenza cases and are unable to be immediately isolated in the hospital ward.

This multicentre, randomised, open-label, parallel-controlled trial involves hospitalised patients with laboratory-confirmed influenza (index patients) and their CCs. CCs will be randomised into three groups: baloxavir marboxil, oseltamivir or placebo. Baloxavir (40 mg or 80 mg for ≥80 kg) will be administered as a single dose on day 1, while oseltamivir (75 mg) will be given once a day for 5 days. CCs will be monitored for influenza-like symptoms, with respiratory samples collected for rapid antigen test or reverse-transcription PCR testing at baseline, day 5±1 and day 10±1 or earlier if symptoms develop. The primary outcome is the 5-day incidence of clinical influenza, defined as laboratory-confirmed infection with concurrent fever and at least one respiratory symptom. Secondary outcomes will include the 5-day incidence of laboratory-confirmed influenza, the 10-day incidence of clinical influenza and the percentage of CCs infected with resistance-associated treatment-emergent influenza variants.

The study has been approved by the Clinical Research Ethics Committee of China-Japan Friendship Hospital (2024-KY-401). The results of the study will be submitted for publication in a peer-reviewed journal with online accessibility. The full protocol, de-identified participant data and statistical code will be openly available in a public repository within 12 months after trial completion.

NCT06762587.