To investigate the correlation between the urinary albumin-to-creatinine ratio (UACR) and adverse cardiovascular outcomes in the Beijing community population.

Prospective cohort study.

Beijing, China, from May 2014 to December 2021.

Recruited from a survey conducted as part of an ongoing atherosclerosis cohort study in the communities of Gucheng and Pingguoyuan, Shijingshan District in Beijing, China. Excluded participants who already had a history of stroke or myocardial infarction at baseline. Finally, 3627 eligible participants were included in this analysis.

The participants were divided into three groups on the basis of baseline UACR: the normal group (UACR

The primary endpoint was a composite endpoint (major adverse cardiovascular event, MACE) of cardiovascular death, first acute myocardial infarction or first stroke, whereas secondary endpoints included cardiovascular death, first acute myocardial infarction, first stroke or all-cause death.

The study included 3627 participants. According to the multivariable Cox model, compared with those in the normal group, the risks of MACE (HR=1.47; 95% CI 1.06 to 2.06; p=0.023), cardiovascular death (HR=3.03; 95% CI 1.56 to 5.88; p=0.001) and all-cause mortality (HR=1.91; 95% CI 1.23 to 2.97; p=0.004) were significantly greater in the microalbuminuria group. The risk of MACE (HR=3.65; 95% CI 2.14 to 6.23; p

This study indicates that an elevated UACR is a significant risk factor for adverse cardiovascular outcomes within the community population. This association remains consistent in individuals with low-grade albuminuria.

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.

Artificial intelligence (AI) is rapidly evolving, offering an expanding suite of capabilities that go beyond the traditional focus on prediction and classification. Generative AI (GenAI) and agentic AI could create transformative practices to support real-world evidence (RWE) generation for health research by streamlining studies, accelerating insights and improving decision-making. However, there is no published overview available describing the range of applications in RWE generation. This review aims to describe where and how genAI and agentic AI are applied across the domains of healthcare research tasks for RWE generation. Additionally, to map applications by tasks and methods across the product lifecycle continuum, and to identify emerging gaps and opportunities.

This Living Scoping Review (LSR) will include studies reporting an application and/or evaluation of genAI or agentic AI applied to one or more RWE generation research tasks. Searches will be conducted in Embase, MEDLINE and additional sources (eg, grey literature). Citations will be independently screened by two human senior reviewers for a substantive training dataset and a commercially available screening algorithm (Robot Screener) will complete screening with a human reviewer. The LSR will include reports of studies (primary or reviews) describing and/or evaluating the application of any genAI model for RWE generation in healthcare, in English, published from 1 January 2025 to the date of search. Data will be extracted from all studies included in the LSR by one independent senior reviewer using a piloted template, with 10% quality check by a second senior reviewer. Descriptive statistics will be used to summarise the applications of genAI per RWE research task, and the results of genAI evaluations. Thematic analysis will be used to describe genAI application patterns, trends, gaps and opportunities. The LSR protocol and reports will be updated annually, and findings will be published on a publicly available website (eg, ISPE—the International Society for Pharmacoepidemiology).

Ethical approval is not required due to use of previously published data. Planned dissemination includes peer-reviewed publication, presentation and short summaries.

The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.

A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.

Secondary care NHS perinatal health services across multiple centres in England.

A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.

Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.

The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.

Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.

On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.

SRCTN18308962.

Hypertension represents a major public health challenge globally, with a rising prevalence in China. This study aims to explore the factors shaping blood pressure (BP) control among hypertensive patients managed in community health centres (CHCs), with a particular emphasis on the association with age.

This was a population-based, observational study that used healthcare records from CHC in Shenzhen, covering the period from 1 January 2000 to 8 October 2024. Univariate and multivariate logistic regression analyses were employed to assess the independent associations of various factors with BP control rate. Additionally, the study evaluated the relationship between age and BP control across six distinct age subgroups.

The study included 1 073 914 participants who met the eligibility criteria, with 955 415 (88.97%) patients achieving BP control. The median baseline age was 55.9 (IQR 18–109) years. Individuals aged 45 years and above demonstrated better BP control rates (46–55, OR 1.053, 95% CI 1.020 to 1.087; 56–65, OR 1.246, 95% CI 1.205 to 1.289; 66–75, OR 2.183, 95% CI 2.103 to 2.265; >75, OR 2.159, 95% CI 2.060 to 2.262). Among young adults aged 18–35 years, increasing age was consistently associated with poorer BP control across most subgroups. For the middle-aged groups (36–45 and 46–65 years), age had little impact on BP control. In the 66–75 years age range, older age was linked to better BP control in some groups.

The association between age and BP control varied across age groups. Hypertension management strategies should be tailored to address the unique needs of different age groups, geographical regions and targeted populations.

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 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.

The aim of the study was to develop a nursing-sensitive quality indicator system for emergency care of patients with severe trauma, providing a scientific measurement tool for evaluating the quality of emergency trauma nursing.

A modified Delphi study.

Experts working in emergency surgery or trauma surgery departments were recruited. First, initial nursing-sensitive quality indicators were derived from an analysis and synthesis of existing evidence and semistructured interviews with 12 clinical experts. Subsequently, two-round expert consultations were conducted with 15 experts from various regions of China to refine and finalise the indicators. Finally, the analytic hierarchy process was used to determine the weights of each indicator.

The valid response rates of questionnaires in the two rounds of expert consultation reached 88.89% and 93.75%, respectively, and the expert authority coefficients were 0.856 and 0.880. The experts ultimately reached a consensus, establishing a nursing-sensitive quality indicator system for emergency care of patients with severe trauma, comprising 3 first-level indicators, 11 second-level indicators and 49 third-level indicators.

This study provides a tool for the assessment of emergency nursing service quality for patients with severe trauma, establishing a scientific and effective nursing-sensitive quality indicator system to evaluate and improve the quality of nursing services provided by emergency nurses to patients with severe trauma.

Postoperative delirium (POD) is a common and serious complication after cardiac surgery, particularly in elderly patients, and is associated with adverse short- and long-term outcomes. Effective preventive strategies remain limited. Liraglutide, a glucagon-like peptide-1 receptor agonist, has demonstrated potential neuroprotective, anti-inflammatory and metabolic benefits, which may reduce the incidence of POD.

This is a single-centre, randomised, double-blind, placebo-controlled trial in elderly patients undergoing elective cardiac surgery. Participants will be randomised in a 1:1 ratio to receive liraglutide or placebo from the day before surgery until postoperative day 3. A total of 260 patients are planned to be enrolled in this study. The primary endpoint is the incidence of POD within 7 days, assessed using the Confusion Assessment Method (CAM) or CAM-intensive care unit. Secondary outcomes include delirium severity, neurocognitive and psychological function, cardiac function, clinical outcomes, major adverse cardiovascular events within 1 year and perioperative biomarker changes. Exploratory outcomes include functional MRI in selected subgroups and additional biomarker analyses.

The protocol has been approved by the Medical Ethics Committee of Nanjing Drum Tower Hospital. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed journals and academic conferences.

ChiCTR2500106943.

Transgender and gender-diverse individuals often face significant barriers to accessing gender-affirming care, such as hormones and/or surgery, leading to poorer mental health, lower quality of life, and higher rates of substance use and suicidal ideation. Vaginoplasty, the most commonly sought genital gender-affirming surgery (GGAS), is desired by over half of all trans women but has been performed in only a minority. This is due largely to limited surgeon availability and long wait times. Peer support has been shown to improve health outcomes and reduce stigma in marginalised populations, including trans communities, but has never been studied for efficacy during the perioperative period of GGAS. Building on priorities identified by multi-stakeholder engagement from the Transgender & Non-Binary Surgery Allied Research Collective, the Support for Transgender and Nonbinary Individuals Seeking Vaginoplasty (STRIVE) study aims to evaluate the efficacy of a centralised peer support and education intervention for patients seeking vaginoplasty, addressing a critical gap in perioperative care.

The STRIVE Study is a pragmatic, multi-site randomised controlled trial enrolling trans adults seeking full depth vaginoplasty. Participants are randomised to one of two arms; enhanced usual care, or a facilitated group intervention. The primary outcome is coping self-efficacy at 6 months, with a secondary outcome of surgical readiness. Primary analysis uses an intention-to-treat approach with linear mixed effects modelling, adjusting for selected baseline values and site. The feasibility evaluation data collected via qualitative interviews will be analysed thematically.

Approvals were granted by the primary site’s Institutional Review Board on 10 May 2024 (STUDY00026957). The trial was registered on 24 May 2024. Results will be published in open access journals and made available to community members in plain language formats.

NCT06436560.

Postoperative ileus (POI) is a common complication after colorectal surgery, characterised by impaired gastrointestinal motility leading to abdominal distension, delayed flatus and defecation, nausea and vomiting. Self-abdominal massage (SM) can promote bowel peristalsis, but its clinical efficacy on improving colorectal cancer patients with POI treated with an intestinal decompression tube remains to be further verified. Therefore, this study aims to evaluate the efficacy and safety of SM in improving gastrointestinal function in colorectal cancer patients with POI treated with an intestinal decompression tube.

This is a prospective, single-centre, randomised controlled, assessor-blinded and statistician-blinded trial. A total of 102 colorectal cancer patients with POI undergoing intestinal decompression tube placement will be recruited. Participants will be randomised in a 1:1:1 ratio to receive basic treatment (BT), BT plus SM (BT-SM) or BT plus simple physical stimulation (BT-SPS). The primary outcome is the time to first defecation after intestinal decompression tube placement. Secondary outcomes include time to first flatus, radiological evaluation, time to tolerability of semiliquid and solid foods, severity of nausea, vomiting, pain and abdominal distension, analgesic consumption, time to intestinal decompression tube removal, incidence of complications and adverse events after intestinal decompression tube placement. Outcome measures are collected at baseline, at 1, 2, 3 and 4 days after the end of the intervention. The primary time point will be 4 days postintervention.

This study has been approved by the ethical application of the Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine Ethics Committee (2025-K-49-01). All patients will be required to provide informed consent. Study results will be disseminated through publication in peer-reviewed journals and international conferences.

ITMCTR2025001401.

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.

Chronic non-specific low back pain (CNLBP) is a multifactorial disease involving physical dysfunction and psychological distress. Acupuncture and mindfulness-based stress reduction (MBSR) are two non-pharmacological therapies recommended by guidelines, which have been proven effective in improving the clinical symptoms of CNLBP. However, the efficacy of their combined use has yet to be explored. This study aims to explore whether the combination of acupuncture and MBSR would have different synergistic effects in patients with CNLBP compared with acupuncture or MBSR alone.

This protocol describes a randomised controlled trial with a 2x2 factorial design involving 120 CNLBP patients. Participants will be randomly allocated to four groups: (1) acupuncture, (2) MBSR, (3) acupuncture combined with MBSR, and (4) health education. The intervention period is 6 weeks. The outcome measurements will include the Visual Analogue Scale (VAS), Tactile Acuity Test, Short-form of McGill Pain Questionnairethe(SF-MPQ); Roland-Morris Functional Disability Questionnaire (RMDQ), Oswestry Disability Index(ODI), the Five Facet Mindfulness Questionnaire (FFMQ), the 21-item Depression Anxiety Stress Scales (DASS-21), the Regulatory Self-Efficacy Scale (RESE), the Beck Depression Inventory (BDI-II), the Beck Anxiety Inventory (BAI), the Fear-Avoidance Beliefs Questionnaire (FABQ) and the Pain Catastrophizing Scale (PCS);Pain Sensitivity Questionnaire(PSQ); Pittsburgh Sleep Quality Index(PSQI). All evaluations will be conducted at the baseline stage as well as 6 weeks and 4 months after the implementation of the intervention measures.

Ethics approval was obtained from the Ethics Committee of the Affiliated Rehabilitation Hospital of the Fujian University of Traditional Chinese Medicine (2024KY-041-04). The results of the study will be disseminated through peer-reviewed publications and at scientific conferences.

ITMCTR2025000764.

To assess whether transgender women who have sex with men (TGWSM) sampled in men who have sex with men (MSM) biobehavioural surveys in Ukraine experience different levels of sexual risk, stigma, HIV prevalence and engagement in the HIV care than cisgender MSM (CMSM).

Analysis of secondary data from three population-level cross-sectional surveys.

The analysis was conducted on data from three rounds of integrated biobehavioural surveys of MSM in 27 cities of Ukraine from 2013 to 2018.

Data from n=18 621 MSM with n=18 102 CMSM and n=503 TGWSM.

The primary outcomes were differences in sexual risk behaviours, HIV testing and treatment uptake, and the secondary outcomes were differences in lifetime experiences of stigma, coercive sex and physical assault (in the 2018 survey only) between CMSM and TGWSM.

Compared with CMSM, TGWSM were more likely to be clients of non-governmental organisations (adjusted OR, aOR: 1.39, 95% CI 1.15 to 1.67), engage in commercial sex (last month; aOR: 1.28, 95% CI 1.01 to 1.61), have group sex (aOR: 1.31, 95% CI 1.06 to 1.61), more long-term sex partners (last month; adjusted incidence rate ratio: 1.14, 95% CI 1.03 to 1.27), history of imprisonment (aOR: 1.51, 95% CI 1.00 to 2.31) and engage in chemsex (last month, aOR: 1.58, 95% CI 1.12 to 2.23). We found no difference in HIV prevalence (5.17% in TGWSM vs 5.43% in CMSM, p=0.065). In 2018, more TGWSM reported lifetime experience of stigma from family and friends (aOR: 3.58, 95% CI 2.54 to 5.04), general social stigma (aOR: 3.13, 95% CI 2.22 to 4.41), anticipated healthcare stigma (aOR: 3.63, 95% CI 2.53 to 5.16), physical assault (aOR: 2.73, 95% CI 1.85 to 4.03) and coercive sex (aOR: 3.01, 95% CI 1.99 to 4.55) than CMSM.

TGWSM in Ukraine may be at increased risk of HIV acquisition compared to CMSM due to many factors including elevated levels of stigma and violence. Services specifically tailored for transgender people are needed to help reduce these high-risk behaviours.

Dementia contributes to the disease burden worldwide, and people with hypertension or type 2 diabetes are at an elevated risk of developing dementia. It is essential to prevent or delay cognitive decline in people at high risk within the community. Our trials aim to evaluate the effects of adaptive cognitive training on community-dwelling older adults with hypertension or type 2 diabetes but no dementia.

Two multicentre, double-blind, randomised, placebo-controlled trials, named COgNitive Training in community-dwelling older adults at high risk for demENTia and with Hypertension (CONTENT-Hypertension) and COgNitive Training in community-dwelling older adults at high risk for demENTia and with Diabetes (CONTENT-Diabetes), will be conducted to investigate the effects of adaptive cognitive training on participants aged 60 years or above who have been diagnosed with hypertension or type 2 diabetes but no dementia. Each trial will enrol 120 participants. Participants will be recruited from the local community in Shijingshan and Haidian Districts, Beijing, and allocated to either the intervention or control group using a 1:1 ratio. The intervention group will engage in 12 weeks of adaptive cognitive training, while the control group will receive 12 weeks of placebo cognitive training. A 24-week follow-up assessment will be conducted for all participants to evaluate the persistence of the effects. The primary outcome is the 12-week change in Montreal Cognitive Assessment (MoCA) Basic scores from baseline to the end of the intervention (12 weeks). Secondary outcomes include 6-week and 24-week changes in the MoCA from baseline; 6-week, 12-week and 24-week changes in Trail Making Test-A&B (TMT-A, TMT-B), Digit Symbol Substitution Test, the WHO/University of California at Los Angeles Auditory Verbal Learning Test and Boston Naming Test scores of cognitive functions; 6-week and 12-week changes in Geriatric Depression Scale, Generalised Anxiety Disorder-7 (GAD-7), Pittsburgh Sleep Quality Index and 12-week change in blood pressure (CONTENT-Hypertension) or fasting blood glucose and glycated haemoglobin (CONTENT-Diabetes) from baseline.

This study will adhere to the ethical principles outlined in the Declaration of Helsinki and comply with international standards for Good Clinical Practice. All participants will sign the informed consent at baseline. This study has been approved by the Ethics Committee of Plastic Surgery Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College (approval numbers: 2023-139 and 2024-162). The findings of the trials will be disseminated through publications in peer-reviewed scientific journals and presented at academic conferences.

NCT06512922 and NCT06524388.