Osteoporosis (OP) is a systemic skeletal disorder that increases fragility and susceptibility to fractures. Despite the availability of teriparatide for the treatment of patients with acute fractures with better efficacy, its long-term daily injection and high cost limit its broader use among a wider patient population, especially for those living in low- and middle-income countries. This study aims to evaluate the efficacy of a novel sequential treatment with teriparatide daily for 6 months followed by denosumab every 6 months for another 18 months, in comparison with denosumab monotherapy every 6 months for 24 months, in reducing the risk of fractures in patients with newly diagnosed osteoporotic fractures. The study will also explore the possible difference between two sequential treatments (shifting to denosumab treatment at 6 or 12 months) in their effect on increasing bone mineral density (BMD).

This study is designed as a multicentre, open-label, randomised controlled trial among 2478 patients with newly diagnosed osteoporotic fractures from 58 hospitals across China. Participants will be randomly assigned in a 10:10:1 ratio to three treatment groups: 24 months of denosumab monotherapy, early sequential treatment (teriparatide for 6 months followed by denosumab for 18 months) and late sequential treatment (teriparatide for 12 months followed by denosumab for 12 months). The primary outcome is the incidence of vertebral fractures over 24 months of treatment. Secondary outcomes include changes in BMD at the lumbar spine, total hip and femoral neck, changes in bone turnover markers (β-carboxy-terminal telopeptide of type 1 collagen and procollagen type 1 N-terminal propeptide), treatment adherence and cost-effectiveness. Follow-up assessments are scheduled at 3, 6, 9, 12, 18 and 24 months post-randomisation for primary and secondary outcomes, and biannually afterwards for the primary outcome.

The study protocol has been registered on ClinicalTrials.gov and has received ethical approval from the Peking Union Medical College Hospital Medical Science Research Ethics Committee (1-22PJ939). The findings will be disseminated through peer-reviewed scientific journals.

NCT05866029.

Peritoneal dialysis (PD) is a widely used renal replacement therapy for chronic kidney disease patients, yet malnutrition remains a common complication linked to poor outcomes. Nearly 40% of PD patients in China are malnourished, with serum albumin levels below 35 g/L. Amino acid-based peritoneal dialysis solutions (AA-PDS), which replace glucose with amino acids as the osmotic agent, have been used globally for decades to improve nutrition and reduce peritoneal damage, but they were introduced to mainland China only in 2022. This study aims to evaluate the efficacy and safety of AA-PDS in improving nutritional status and clinical outcomes among malnourished PD patients in mainland China, providing a potential new therapeutic option for this population.

This multicentre, open-label, prospective, parallel-controlled study will enrol patients with end-stage kidney disease who were stable on PD for more than 3 months. A total of 500 eligible patients will be divided into the intervention group undergoing PD once every morning using 2.0 L of amino acid (15) PD solution and the control group using conventional PD solution (lactate) in a 4:1 ratio based on their willingness and clinical needs. Our primary outcome is serum albumin, while other nutritional indicators, including serum prealbumin, serum transferrin, total cholesterol, triglycerides, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol and ultrafiltration volumes are considered secondary outcomes. Information such as demographics, clinical and biochemical characteristics, examination indicators, anthropometry measurements and Subjective Global Assessment scores will be collected at baseline, 1 month, 3 month and 6 month follow-up. Statistical analysis will be conducted using SAS V.9.4 or higher versions. All statistical tests are conducted through the two-tailed test, and a p value≤0.05 will be considered statistically significant. The description of quantitative indicators will be used in calculating the number of cases, mean, SD, median and IQR method. The classification indicators will be used to describe the number of cases and percentages (frequency and frequency rate).

This multicentre study obtained ethical approval from the lead ethics committee at the First Affiliated Hospital of Zhejiang Chinese Medical University (approval no.: 2024-KLS-379-02). Additionally, each participating site provided local ethical approval or a formal waiver, as required by their institutional policies. The results will be reported in a peer-reviewed journal and a relevant academic conference.

ChiCTR2400090896.

Acute pain following pulmonary surgery can affect the recovery process of patients. The use of intrathecal morphine (ITM) injections offers a long-lasting analgesic effect, but its clinical application remains controversial. This study aims to investigate the impact of combining bupivacaine with ITM injections on the quality of postoperative recovery in patients who have undergone pulmonary surgery.

This multicentre, randomised, double-blind, controlled trial will enrol 254 patients undergoing elective lung surgery, who will be randomly assigned in a 1:1 ratio to either group IT (receiving an intrathecal injection of 3 mg bupivacaine and 0.25 mg morphine before general anaesthesia induction) or the control group (C group). The primary outcome includes postoperative recovery quality on day 1 (quality of recovery, QoR-15), with secondary outcomes encompassing postoperative recovery quality on days 2 and 3 (QoR-15), pain scores within 72 hours postoperatively, analgesic rescue, intraoperative haemodynamic parameters, opioid consumption, postoperative adverse reactions, recovery metrics, complications, chronic pain incidence and sleep quality.

The results will be disseminated through peer-reviewed publications. This study protocol (V.2.0, 30 October 2024) involves human participants and has been approved by the Ethics Committee of Affiliated Hospital of Yangzhou University (number 2024-08-02-2), Taicang Hospital Affiliated to Soochow University (number 2025 SR-041) and Yichang Central People’s Hospital (number 2024-513-02). Each individual who agrees to participate in the research will provide written informed consent after the objectives and procedures of this study are explained to them.

ChiCTR2400092935. Registered on 26 November 2024.

The diversity of treatment options for diabetic retinopathy (DR) and the high uncertainty about the benefits and risks of different treatment modalities necessitate shared decision-making between patients and healthcare professionals. However, little is known about the involvement of individuals with DR in treatment decision-making in China. This study aims to gain insight into the current status and factors associated with involvement in treatment decision-making in patients with DR. Furthermore, we will explore the experiences and perceptions of patients with DR regarding their involvement in treatment decision-making.

We will conduct a mixed-method study using an explanatory sequential design. In the quantitative research (n=350), participants’ actual decision-making roles, sociodemographic data, disease-related data, health literacy, need for involvement in decision-making, decision-making self-efficacy, social support and ophthalmologist facilitation of patient involvement will be investigated to analyse the current state of patient involvement in treatment decision-making and the factors influencing it. Descriptive statistics, one-way analysis of variance and multinomial logistic regression will be performed. During this period, individual semistructured interviews will be conducted with a subset of these participants to understand the perceptions and experiences of people with DR regarding their involvement in treatment decision-making, and thematic analysis will be used to analyse the interview data. Finally, the joint display will be used to integrate quantitative and qualitative data.

Ethical approval for this study has been obtained from the Ethical Review Committee for Human Trials of Shanghai General Hospital, China (number: 2024–098). Written informed consent will be obtained from all participants after they have been fully informed about the study, prior to any data collection. The study’s findings will be disseminated through peer-reviewed publications and conference reports.

ChiCTR2400087906.

Postoperative acute pain following video-assisted thoracoscopic surgery (VATS) impedes patient rehabilitation. While multimodal analgesia effectively mitigates postoperative acute pain and facilitates the postoperative rehabilitation process, the efficacy of preventive precision multimodal analgesia (PPMA) remains uncertain. This study designs a PPMA strategy targeting incisional pain, inflammatory pain and visceral pain in VATS. It aims to investigate the impact of the PPMA strategy on the postoperative acute pain process and rehabilitation outcomes.

This multicentre, single-blinded, randomised controlled trial will enrol adult patients scheduled for elective thoracoscopic lobectomy or segmentectomy. A total of 1372 participants will be recruited and randomly allocated in a 1:1 ratio to either the preventive precision multimodal analgesia group (PPMA Group) or the conventional multimodal analgesia group (CMA Group). Patients in the PPMA Group will receive a regimen consisting of local anaesthetic infiltration of surgical incision (for incisional pain), intravenous injection of oxycodone (for visceral pain) and parecoxib sodium (for inflammatory pain) before surgery initiation. Patients in the CMA Group will receive the same regimen after specimen isolation. This trial will be conducted across 13 medical centres in China from 2023 to 2026. The primary outcome is the duration of postoperative acute pain. Secondary outcomes include postoperative analgesic consumption, postoperative pain scores, intraoperative haemodynamic parameters and the Indexes of Consciousness (IoC₁ and IoC₂), as well as intraoperative arterial blood gas and ventilation parameters, intraoperative dosages of general anaesthesia, inflammatory markers at predefined time points, postoperative rehabilitation process and perioperative adverse events and complications.

This study has been approved by the Ethics Committee of Xuanwu Hospital, Capital Medical University (Linyanshen[2023]-NO.012-003-Revised Vision 1). The results will be published in a peer-reviewed journal.

Chinese Clinical Trial Registry (ChiCTR2300072176).

The optimal maternal age at childbirth has been a topic of bourgeoning literature, with earlier ages offering physiological benefits for maternal recovery. In contrast, later ages to give birth may provide psychological advantages due to greater emotional maturity. This study investigates the impact of maternal age at childbirth on children’s internalising problems and explores the mediating roles of housing instability and family support in this relationship.

Cross-sectional study; mediation analysis of the 2022 National Survey of Children’s Health (NSCH) data.

Response in the 2022 NSCH in the USA.

This study is based on the 2022 NSCH, collecting a total of 54 103 completed surveys from randomly selected households across the USA. In this study, after excluding participants due to missing values in critical variables, 48 073 participants were included in the final analysis.

Our findings are consistent with the hypothesis that increasing maternal age at childbirth is associated with lower children’s internalising problems. Analysis suggested this association operates directly and is indirectly linked to child outcomes through lower levels of housing instability and higher levels of family support. However, a distinct indirect effect emerged: increased maternal age was also associated with reduced family support, which was in turn linked to more internalising problems. The results illuminate potential mechanisms linking maternal age at childbirth to children’s internalising problems and underscore the importance of stable housing and family support in mitigating risk factors for children’s emotional well-being.

We found an association between advanced maternal age and fewer internalising problems in children. This relationship appears to operate directly and indirectly via a sequential pathway: higher maternal age correlates with lower housing instability, which in turn is associated with increased family support, ultimately correlating with improved child mental health outcomes.

To develop and validate a mortality-risk prediction model for patients with advanced splenomegaly-subtype schistosomiasis, enabling accurate prognosis assessment and informed resource allocation.

Retrospective, population-based cohort study using clinical data from a single-centre registry.

Endemic regions of Hubei Province, China.

The study includes 628 patients with advanced splenomegaly-subtype schistosomiasis from the Hubei Provincial Advanced Schistosomiasis Registry between September 2014 and January 2015. The splenomegaly subtype is defined as splenomegaly extending below the umbilical line or with a transverse diameter exceeding the mid-abdominal line. We divided the study population into two cohorts. The derivation cohort included 452 patients selected from several counties within the registry. These patients had a confirmed diagnosis of advanced splenomegaly-subtype schistosomiasis. Only those with complete data were retained. The external validation cohort comprised 176 patients from geographically distinct counties in the same registry, and the same inclusion and exclusion criteria were applied. 10-fold cross-validation was employed to evaluate the model’s generalisation on the derivation cohort.

6-year all-cause mortality was the outcome measure. Baseline variables, included age, serum aspartate aminotransferase, albumin, splenectomy history and frequency of ascites ≥5 episodes were analysed using Cox proportional hazards regression. Model performance was assessed via C-statistics, net reclassification improvement (NRI) and integrated discrimination improvement (IDI).

Five predictors were integrated into the mortality risk model. The C-statistic for predicting 6-year mortality was 0.79 (95% CI 0.74 to 0.83) in the derivation cohort, with robust validation in the external validation cohort (0.78, 95% CI 0.70 to 0.86). Simplified models using subsets of predictors showed slight reductions in discrimination (NRI and IDI). Patients with a frequency of ascites ≥5 episodes had significantly lower survival rates and should be given special attention in clinical practice.

The validated prediction model identifies high-risk patients using accessible clinical variables. The approach may optimise prognostication and prioritisation of healthcare resources for advanced schistosomiasis. The model’s performance remains to be confirmed in a prospectively enrolled cohort.

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

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

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

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

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

Atrial fibrillation (AF), with a prevalence of 1–2%, is the most common cardiac arrhythmia. AF is associated with a fivefold increased risk of cardioembolic events; approximately 20% of all strokes are caused by AF. Pulmonary vein isolation (PVI) has become the first-line treatment for AF. However, PVI cannot eliminate the residual stroke risk. Current guidelines recommend that anticoagulation be continued in this specific group of patients, regardless of the presence or absence of AF. In this large AF population post-PVI, who are considered to be in an earlier stage of AF, it is unknown whether left atrial appendage closure (LAAC) offers an alternative to direct oral anticoagulant (DOAC) therapy.

The trial will be a prospective, randomised, multicentre non-inferiority study comparing two treatment strategies in AF patients after atrial ablation. Patients will be randomly assigned to either percutaneous LAAC (group A) or DOAC treatment (group B) in a 1:1 ratio; both sequential and concomitant planned ablation with or without LAAC are accepted. Randomisation will be conducted using web-based randomisation software. A total of 1012 participants (506 patients per group) will be enrolled. The primary effectiveness measure will be the occurrence of any of the specified events within 24 months after randomisation: stroke/transient ischaemic attack/systemic thromboembolism, cerebral haemorrhage, other major haemorrhages (Bleeding Academic Research Consortium ≥2), cardiovascular mortality and all-cause mortality.

The study was approved by the Ethical Review Board of Shanghai Chest Hospital, China (KS(Y)20287). Written informed consent will be obtained from all participants. The trial will follow the Declaration of Helsinki and Good Clinical Practice. Confidentiality will be maintained with anonymised, securely stored data. Findings will be disseminated through peer-reviewed publications and conferences.

ChiCTR2000036538.

Ultrasound guidance improves the success rate and efficiency of radial arterial catheterisation (RAC). However, the procedure remains more challenging in obese patients, in whom excess subcutaneous tissue can impair anatomical visualisation. Additionally, frequent head shifts between the procedural site and ultrasound screen usually increase procedural complexity, prolong the procedural time and adversely affect both patient comfort and clinician performance. Smart glasses that project real-time ultrasound images directly into the clinician’s field of view offer a potential solution. The study aimed to evaluate whether the use of smart glasses improves the efficiency of ultrasound-guided RAC in obese patients.

In this prospective, single-centre, randomised controlled trial, a total of 176 eligible obese patients (body mass index ≥30 kg/m²) requiring RAC for perioperative monitoring will be enrolled. Participants will be randomly assigned in a 1:1 ratio to either the control group, receiving conventional ultrasound-guided RAC, or the smart-glasses group, undergoing ultrasound-guided RAC with real-time image display and needle-tracking assistance via smart glasses. The primary outcome is the first-attempt success rate. Secondary outcomes include the second-attempt success rate, time to successful catheterisation within the first and second attempts, overall procedural time, overall number of arterial catheterisation attempts; ultrasound scanning time, number of probe repositionings and needle redirections; incidence of RAC-related complications, and satisfaction scores of both patients and clinicians. Statistical analyses will be performed using Statistical Package for the Social Sciences (SPSS) and GraphPad Prism.

This study will be conducted in accordance with the principles of the Declaration of Helsinki. Written informed consent will be obtained from all participants before enrolment. The study protocol has been reviewed and approved by the Medical Research Ethics Committee of the Second Affiliated Hospital of Anhui Medical University. This study has been prospectively registered at Chinese Clinical Trial Registry. Study results will be disseminated through presentations at scientific conferences and publication in peer-reviewed scientific journals.

ChiCTR2500108023.

To investigate the impact of residual refraction within ±1.0 dioptre (D) on uncorrected distance visual acuity (UDVA) in pseudophakic eyes.

Cross-sectional study.

This study was based on retrospectively collected electronic refraction records from a tertiary care academic ophthalmology centre in southern China between May 2022 and July 2025.

Patients aged ≥40 years who underwent uneventful phacoemulsification cataract surgery with in-the-bag monofocal intraocular lens implantation and achieved a postoperative corrected distance visual acuity (CDVA) of ≤0.1 logarithm of the minimum angle of resolution were enrolled. They were stratified by astigmatism subtypes: minimal astigmatism (

Postoperative evaluation (≥1 month) included spherical equivalent (SE) refraction, UDVA and CDVA. UDVA was compared across eyes with SE intervals of 0.50 D within ±1.0 D. ORs were calculated to assess the relative risk of failing to achieve a UDVA of 0.1 or better for postoperative SE within ±1.0 D, using 0.00 D as the reference.

The study included 1333 eyes from 1333 patients (mean (SD) age, 66.1 (8.96) years; 532 male (39.9%)). Overall, and particularly in the minimal astigmatism (

The impact of refractive errors (≤1.0 D) on UDVA was associated with the magnitude and type of astigmatism. Residual astigmatism of ≥0.50 D exerted a significant negative effect on UDVA. A plano SE (0 D) was optimal for minimum and WTR astigmatism, whereas slight hyperopia yielded superior UDVA in ATR and oblique astigmatism.

High costs of screening and diagnostic tests remain a major barrier to timely tuberculosis (TB) identification in resource-limited settings. Evidence on the cost-effectiveness of scalable screening algorithms is limited. Start4All is a research project aimed at developing and evaluating algorithmic approaches to TB screening and diagnosis, with the goal of optimising technical and allocative efficiency when expanding diagnostic coverage to primary healthcare and community settings.

Five screening and diagnostic tests will be evaluated: a capillary blood-based assay (C-reactive protein (CRP)), sputum-based rapid molecular tests (PCR; individual and pooled Xpert MTB/RIF Ultra assay (Xpert Ultra, Cepheid®, California, USA)), a lateral-flow urine-based test for lipoarabinomannan (LF-LAM), and digital chest X-rays with artificial intelligence-based computer-aided detection (CXR-CAD). A microbiological reference standard of positive culture using the mycobacteria growth indicator tube will be used to confirm TB disease.

We will compare the cost and effectiveness of concurrent and sequential positive serial combinations (screening algorithms) of CRP, CXR-CAD, LF-LAM, individual and pooled Xpert Ultra. Diagnostic performance will be estimated using sensitivity, specificity, predictive values and proportions of positive results, with Bayesian inference used to derive these estimates. The analysis will include adults (15 years and older) only and will be stratified by HIV status and level of care, including facility and community-based case finding. Effectiveness will be assessed based on the number of people with TB detected. Cost analysis will be conducted from the provider perspective, incorporating commodity and implementation costs. A decision tree model will be developed to assess the cost per number of persons with confirmed TB detected across all countries. Probabilistic sensitivity analysis will be conducted to account for uncertainty in model parameters, incorporating willingness-to-pay and willingness-to-accept thresholds.

WHO ethical review committee approval ERC.0003921. Data will be available on reasonable request to the principal investigator of the consortium.

NCT05845112.

To describe the structured process of threshold optimisation for a commercially available multiclass chest X-ray (CXR) deep learning model, to evaluate its diagnostic performance across different operating thresholds, and to estimate its potential operational impact within an artificial intelligence (AI)-enabled triage workflow in a primary care setting.

Retrospective diagnostic performance evaluation with threshold-based analysis.

Primary care radiography services in Singapore, using data derived from two primary care clinics and a tertiary hospital.

A total of 816 adult frontal chest radiographs were included (multiethnic Asian, 464 males, 352 females; mean age 60.8 years). Images were selected to represent the spectrum of findings often encountered in primary care. Exclusion criteria included paediatric studies, lateral or oblique radiographs, and findings not supported by the AI model (eg, bony abnormalities and medical devices).

Primary outcome measures were sensitivity, specificity, and negative and positive predictive value (NPV and PPV). Secondary outcomes included estimated potential operational improvement, which is calculated by dividing the number of true negatives by the total number of CXRs.

At the default threshold of 0.15, the AI model achieved a sensitivity of 87.3% (95% CI 83.9% to 90.4%) and an NPV of 87.0% (95% CI 83.6% to 90.2%). Lowering the threshold to 0.10 increased sensitivity to 93.2% (95% CI 90.7% to 95.5%) and NPV to 91.3% (95% CI 88.2% to 94.3%), with specificity of 71.7% (95% CI 67.3% to 76.1%). These trade-offs were considered acceptable for a safety-focused co-triage workflow prioritising minimisation of false negatives.

Threshold optimisation is critical for adapting AI models to context-specific clinical workflows. Our study shows that adjusting the operating threshold enabled prioritisation of sensitivity and NPV, supporting safe AI-assisted triage in primary care. This is a deeply collaborative process that must involve radiology and clinical teams: selecting appropriate thresholds aligned with clinical objectives for safe and effective implementation. Future work will assess real-world operational impact and user acceptance following prospective deployment.

To qualitatively explore the lived experiences and perceptions of patients with chronic obstructive pulmonary disease (COPD) using the harmonica as a therapeutic intervention.

A qualitative study.

The study was conducted at a tertiary hospital in Guangzhou, China.

Patients with COPD who had participated in supervised harmonica playing for at least 12 weeks. (clinical trial registration: NCT05995847).

The study focused on patients’ experiences, including perceived facilitators, barriers and needs regarding the intervention.

We interviewed 19 patients with COPD between September and December 2024, with interviews lasting an average of 54 min (range: 36–77 min). Five primary themes were identified. Participants reported better physical functioning, including better breathing control, enhanced functional capacity and improved sleep quality. Psychological well-being improved with increased relaxation, emotional improvement and mental engagement. Patients also experienced increased social engagement and role shift, such as expanded social connections, family support and restored family roles. Harmonica playing promoted enhanced self-reliance and personal development, with increased self-management confidence, mastery of the harmonica and encouragement for lifelong learning. Barriers and challenges included physical limitations, breathing difficulties, adherence issues and concerns about the sustainability of long-term benefits.

Our study indicates that harmonica playing could improve physical health, psychological well-being, social participation and self-reliance, although barriers persist. Tailored programmes could enhance benefits and adherence, and future research should evaluate durability within comprehensive COPD care.

NCT05995847.

Childhood and adolescence are critical developmental periods marked by increasing physical inactivity, stress and mental health problems. TABATA training, a supramaximal form of high-intensity interval training, has been increasingly promoted as a time-efficient approach to improving health. However, evidence on its specific effects in children and adolescents remains limited, fragmented and not systematically synthesised. The objective of this review is to determine whether TABATA training improves physical fitness and mental health outcomes in children and adolescents aged 6–18 years.

We will perform a systematic review of experimental studies in the following databases: PubMed, Scopus, Cochrane Library and Web of Science. The initial literature search was conducted in May 2025, and the systematic review is expected to be completed by March 2026. Eligible studies will include multisession Tabata interventions defined as repeated 20 s high-intensity bouts with 10 s rest intervals, typically performed for 7–8 cycles per set, with or without multiple sets. Outcomes will include physical fitness indicators and mental health indicators. Study selection and data extraction will follow the Population, Intervention, Comparison, Outcomes, Study design framework and Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The risk of bias will be assessed using the Cochrane Risk of Bias 2 tool for randomised trials and Risk Of Bias In Non-randomised Studies - of Interventions for non-randomised studies. When sufficient data are available, quantitative synthesis will be conducted using a three-level random-effects meta-analytic model to account for dependency among effect sizes and anticipated clinical and methodological heterogeneity across studies. Effect sizes for continuous outcomes will be calculated as standardised mean differences. Sensitivity analyses will be performed, and publication bias will be assessed using funnel plots when an adequate number of studies is available. Statistical analyses will be performed using R and Review Manager (RevMan) V.5.4, where appropriate.

The results of the systematic review will be disseminated via publication in a peer-reviewed journal and presented at a relevant conference. As we will not use individual patient data, ethical approval is not required.

CRD42025632986.

Norepinephrine (NE) and phenylephrine (PE) are routinely administered vasopressors used to maintain haemodynamic stability during caesarean section. Emerging evidence suggests that sustained infusion of these agents may disrupt maternal blood glucose regulation. This randomised controlled trial aims to compare the effects of NE and PE infusion on changes in postpartum blood glucose levels, insulin concentrations and insulin resistance in women after caesarean delivery.

In this double-blind, randomised trial, 100 eligible parturients will receive prophylactic intravenous infusion of either NE or PE at a rate of 30 mL/hour immediately after subarachnoid anaesthesia, continuing until the end of surgery. The primary outcome is the difference between maternal preoperative and immediate postoperative blood glucose levels. Secondary outcomes include immediate and 6-hour postoperative insulin levels, as well as Homeostasis Model Assessment of Insulin Resistance.

The Institutional Ethics Committee of Xuancheng People’s Hospital approved the trial protocol (ID: 2025-yjky022-02). Findings will be published in an appropriate journal, and original data will be made available in November 2029 via the ResMan primary data-sharing platform of the China Clinical Trial Registry (http://www.medresman.org.cn).

ChiCTR2500107683.

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

This was a single-centre retrospective diagnostic study.

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

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

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

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

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

NCT06762184.

To investigate the impact of sleep duration on glucose homeostasis in individuals with gestational diabetes mellitus (GDM).

Cross-sectional observational study.

Secondary-level maternity care at two centres in Ningbo, China.

A total of 381 women with GDM were included (median age 30.6 years (IQR 28.2–33.1); median gestational age 26.0 weeks (IQR 25.0–27.0)). All participants underwent 2 weeks of continuous glucose monitoring (CGM), and nocturnal sleep duration was assessed using a structured questionnaire.

CGM-derived summary metrics were analysed using multivariable linear regression, and 24-hour glucose trajectories were evaluated using functional data analysis (FDA).

Long sleep duration (>9 hours/day) was associated with higher mean glucose, time above range, coefficient of variation, the pregnancy-specific glucose risk index and lower time in range (β values were 2.41 mg/dL, 1.84%, 1.04%, 1.88% and –1.85%, respectively; all pβ: mean glucose 1.29 mg/dL, time above range 0.89%, coefficient of variation 0.45%, pregnancy-specific glucose risk index 0.91%; all pβ=–0.87%; p9 hours/day) had elevated glucose by 2.1–5.8 mg/dL from 10:55 to 00:45, lasting for 13.8 hours.

In GDM, long sleep duration was associated with less favourable glucose patterns, suggesting possible windows of greater vulnerability in glucose regulation. These findings indicate that sleep behaviours may represent an important behavioural characteristic relevant to clinical glucose management in pregnancy and warrant further investigation.

The Osseointegration Group of Australia Accelerated Protocol-3 (OGAAP-3) presents the latest iteration of a structured, prospective, clinical-based protocol for single-stage osseointegration surgery in lower limb amputees. Building on the foundational work of OGAAP-1 and OGAAP-2, this protocol incorporates a decade of institutional experience and over 1000 cases using the Osseointegrated Prosthetic Limb system. OGAAP-3 introduces stratified rehabilitation categories—immediate, standard, slow and delayed loading—based on intraoperative findings, residual limb characteristics and patient-specific physiological factors. The surgical approach remains a single-stage procedure, with modifications described for transfemoral and transtibial levels, including primary amputation with simultaneous implant placement. The aim is to enhance safety, optimise functional outcomes and broaden access to osseointegration.

OGAAP-3 is a prospective registry-based protocol enrolling approximately 50 patients annually at the Osseointegration Group of Australia and affiliated centres, with data collection ongoing since mid-2023 and planned until 2027. Eligibility criteria include adults (aged 18 years or over) with unilateral or bilateral transfemoral or transtibial amputations, as well as primary amputees undergoing concurrent osseointegration. All patients receive osseointegrated implants which are press-fitted into the residual bone. Functional and quality-of-life outcome measures are recorded preoperatively and at defined postoperative follow-up intervals up to 2 years. Postoperative adverse events are also recorded. The preoperative and postoperative values will be compared for each outcome measure, and the outcomes of the OGAAP-3 procedure will be compared with the results of the OGAAP-1 and OGAAP-2 protocol.

This study has received ethics approval by Macquarie University, Sydney, Australia. The study outcomes will be disseminated by publications in peer-reviewed academic journals and presentations at relevant clinical and orthopaedic conferences with final outcome analyses planned following completion of 2-year follow-up in 2027.

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.