Adverse pregnancy and perinatal outcomes (APPOs), including pre-term birth, pre-eclampsia and gestational diabetes, can result in maternal and neonatal morbidity and mortality, parental anxiety and increased healthcare costs. A better understanding of the causes of APPOs is essential to inform lifestyle and pharmaceutical interventions for their prevention and management. Given the difficulty of undertaking randomised controlled trials in pregnant women, triangulating evidence from across methods with different sources of bias may improve causal inference for APPOs. The purpose of the Mendelian randomisation in pregnancy (MR-PREG) collaboration is to support such triangulation using genetic (eg, Mendelian randomisation (MR)) and non-genetic (eg, partner negative controls) approaches to investigate the causal effects of maternal exposures on a comprehensive set of APPOs.

The MR-PREG collaboration includes individual participant data from three birth cohorts (two from the UK and one from Norway) and UK Biobank, as well as summary data from FinnGen and publicly available genome-wide association studies (GWAS). Data have been harmonised across studies and currently include information on up to 35 APPOs in up to 707 797 women.

The main aims of MR-PREG are to strengthen the evidence base for (1) prevention, by advancing understanding of maternal lifestyle factors on APPOs, (2) the role of pre-conceptional health, by improving understanding of the effect of maternal pre-existing conditions on APPOs, and (3) treatments, by evaluating the efficacy and safety of existing medications used for pre-existing conditions, and by identifying and testing novel or repurposed therapies for APPOs. To date, our published work has mainly addressed aims 1 and 3. Examples include triangulation of evidence from MR, conventional multivariable regression and paternal negative control, showing that higher maternal body mass index increases the risk of multiple APPOs, as well as the identification of maternal circulating metabolites and proteins that may influence birth weight.

Future priorities include increasing diversity within the MR-PREG collaboration by expanding representation of participants from non-European ancestries. We are also integrating molecular data, including circulating protein levels and placental transcriptomics, to better characterise the molecular mechanisms underlying APPOs. Additionally, we are using whole-exome and whole-genome sequencing to identify novel causal genes and to inform the prioritisation of candidate therapeutic targets for APPOs.

Geriatric patients often face issues related to polypharmacy and adverse drug events. Re-evaluating prescribed medications and considering deprescribing is critical. Medication discrepancies (MDs) during care transitions can compromise patient safety, as over 60% of medication errors occur at these points. This study aimed to assess the magnitude of MDs and their contributing factors through the medication reconciliation (MedRec) process among geriatric patients in emergency departments of comprehensive specialised hospitals in northwest Ethiopia, as well as to determine the acceptance of pharmaceutical interventions.

In this multicentre prospective observational study, the best possible medication history (BPMH) was obtained within 24 hours of emergency department admission from at least two sources. A comparison of the BPMH list with medication orders from treating physicians revealed discrepancies. Data were analysed using STATA V.17.0, using multivariable logistic regression to assess variable associations.

Adult emergency departments of comprehensive specialised hospitals in northwest Ethiopia.

Overall, 384 geriatric patients with chronic conditions and current medication use who visited the adult emergency department of the hospital from 10 January 2025 to 30 March 2025 were involved in this study.

Magnitude and types of MDs, acceptance of pharmacist interventions, and factors associated with MDs.

In total, 384 patients with chronic diseases visiting the hospital emergency department were recruited in the present study. Out of 384 patients involved in the study, 218 (56.77%) had encountered at least one MD. Omission error 190 (45.24%) was the most common type of MD, followed by wrong dose 82 (19.50%). Among 420 interventions, 80.48% of the total cases were accepted. Number of previous/home medications (≥5 medicines; adjusted OR (AOR)=3.12; 95% CI 1.190 to 8.151), older age (≥75 years; AOR=1.62; 95% CI 1.054 to 2.495), and number of comorbidities (≥3; AOR=1.65; 95% CI 1.066 to 2.546) were associated factors with MDs.

This study revealed a high prevalence of MDs in the emergency department. Polypharmacy, comorbidities and older age were factors associated with MDs. The study findings show the need for a clinical pharmacist-led MedRec implementation to enhance patient safety.

There are approximately 700 000 autistic people in the UK, and autism is increasingly being diagnosed in adulthood. Diagnosis on its own does not provide adequate information to plan post-diagnostic support for autistic people, and clinicians often plan support without the use of validated standardised tools which may exacerbate inequities in care. This study will evaluate a novel strengths and needs assessment, based on the WHO’s International Classification of Functioning, Disability and Health CoreSet for Autism, for use in adult diagnostic services immediately on receipt of an autism diagnosis. Potential issues, including the length of the assessment, timing of delivery and selection bias, will be explored as part of the trial process evaluation.

A two-arm, multisite, randomised pilot trial design will be used to evaluate the ICF CoreSets for Autism Strengths and Needs Assessment in three diagnostic services in England. A total of 72 newly diagnosed autistic adults will be recruited across the three sites over a 6-month period and randomised into an assessment group (strengths and needs assessment plus standard care) and a treatment as usual group (standard care only). The assessment group will receive a summary report of their strengths and needs on completion of the assessment. Both groups will complete measures of mental health and quality of life at baseline and 3 months follow-up (Patient Health Questionnaire-9, Generalised Anxiety Disorder questionnaire-7, Recovering Quality of Life questionnaire-10, EuroQoL-5D). Acceptability and feasibility will be measured for the strengths and needs assessment and for trial procedures using standardised measures, progression criteria and qualitative data from clinician focus groups and interviews with a subsample of autistic participants. The study design and procedures are being co-produced with an autistic advisor/patient and public involvement lead and with a steering group of autistic adults.

This study was reviewed by the East Midlands—Nottingham 2 Research Ethics Committee and was given Health Research Authority approval on 18 March 2025 (REC reference:25/EM/0041). The results will be disseminated via reports to the funder (NIHR), a peer-reviewed journal paper and academic conferences. We will email a summary report of findings to study participants and will invite participants to an information dissemination event at the end of the study. Links to reports and a lay summary will be provided on the research group’s website: https://sharl.sites.sheffield.ac.uk/home

ISRCTN10283350.

Common mental health outcomes among children in conflict with the law in correctional facilities in Africa are an under-researched area with significant public health implications. This review will synthesise available and accessible evidence on the prevalence and associated factors of common mental health outcomes among children in conflict with the law in Africa.

Comprehensive electronic searches will date from 01 January 2015 to 31 December 2025 and will be conducted in PubMed, Sabinet, Scopus, EBSCOhost, Web of Science and PsycINFO. Articles will be screened using defined inclusion and exclusion criteria and assessed for eligibility by three independent reviewers. Discrepancies will be reviewed by a ninth reviewer. The selection process of included articles will be reported by using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses will be used. The Mixed Methods Appraisal Tool will assess study quality, and data will be synthesised using meta-analysis or a narrative synthesis approach, depending on heterogeneity levels.

This study will not require ethical approval from an institutional review board, as it does not entail the direct collection of data from children in conflict with the law, nor does it pose any risk to their privacy. Once finalised, the full review report will be submitted for publication in a peer-reviewed journal. The key findings will also be shared at both local and international conferences, highlighting common mental health outcomes among children in conflict with the law.

CRD420251011484.

Stroke is one of the top causes of disability in Malaysia, yet caregivers have limited access to structured, culturally tailored education to support poststroke care.

To develop and validate the CaknaStrok Education Package (CEP), a blended learning intervention comprising a printed guidebook and a trilingual mobile health application for informal stroke caregivers in Malaysia.

Methodological study involving the development and validation of a caregiver education programme guided by the Analyse, Design, Develop, Implement, Evaluate (ADDIE) instructional design framework.

Development and validation were conducted in Malaysia between January 2022 and December 2023. Both experts and caregivers were recruited from two tertiary hospitals on the East Coast of Malaysia, with caregivers identified from inpatient wards and outpatient clinics at these hospitals.

Content validation involved 10 multidisciplinary experts. Face validation involved 14 informal stroke caregivers who met eligibility criteria, and all completed the study.

CEP was developed based on prior needs assessment and expert input. Content validation was undertaken using the Content Validity Index (CVI) and face validation using the Face Validity Index (FVI), both assessed on a four-point Likert scale. Qualitative feedback was also obtained from the participants.

CEP consists of six modules delivered via a printed guidebook and a trilingual app with videos, assessment tools and local resources. Experts rated the content highly valid (Scale-level (S)-CVI/the average method (Ave): 0.97–0.99 across domains). Caregivers reported strong acceptability (S-FVI/Ave: 0.95–0.99). Qualitative feedback from experts and caregivers informed refinements to content clarity, usability and presentation, including improved navigation, consistent language use and enhanced visual design. Suggestions requiring substantial structural changes were documented for future iterations.

The CEP shows strong content and face validity as a blended caregiver education tool. By combining printed and digital formats, CEP addresses cultural and access challenges and provides a scalable model for stroke caregiver education in Malaysia. Further pilot or feasibility studies are warranted to evaluate usability, engagement and implementation in real-world settings prior to effectiveness evaluation.

The mental health impacts of COVID-19 on frontline healthcare workers have been reported globally; however, there is limited evidence from low-income countries such as Ethiopia. We reviewed the literature to understand how COVID-19 impacted the mental health of frontline healthcare workers, including the associated risk and protective factors.

A scoping review of peer-reviewed research was conducted between 2020–2025 to explore the mental health and well-being of frontline healthcare workers in Ethiopia during COVID-19. The process adhered to the guidelines for data extraction outlined in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Our search identified 35 studies, of which 29 studies were included in the final synthesis.

Three online databases, PubMed, Web of Science and PsycInfo, were systematically searched for data.

Studies were considered for inclusion in the review if they focused on mental health conditions and psychosocial well-being among healthcare workers during COVID-19 in Ethiopia. Studies were only included if published in English and excluded if they were conference abstracts, case studies, reviews, commentaries, contained incomplete data or lacked variables of interest.

Data extraction was conducted manually by two reviewers by using a data extraction sheet created in Excel.

Most frontline healthcare workers experienced symptoms of insomnia, psychological distress, stress, anxiety, post-traumatic stress disorder and depression during COVID-19. Female frontline healthcare workers, nurses, midwives and laboratory technicians reported higher rates of adverse mental health outcomes. Our results found that being married, living together with a spouse and having a high educational level were risk factors for adverse mental health outcomes.

The mental health and well-being of frontline healthcare workers is at risk during a global health crisis; however, there is a limited understanding of how to protect the mental health of frontline healthcare workers in low-income countries, such as Ethiopia, at such a critical time. Additional research is needed to better inform mental health preparedness interventions for frontline healthcare workers in these contexts, particularly given predictions of another pandemic occurring within the next decade.

Perinatal depression poses substantial risks to both mothers and their offspring. Given its chronic and recurrent nature, developing effective prevention strategies is crucial. Internet-based cognitive–behavioural therapy (iCBT) has shown promise. However, the efficacy of specific CBT skills and the influence of individual differences remain unclear.

This protocol describes two harmonised multicentre, open-label, six-arm randomised controlled trials. Across both trials, a total of 2400 pregnant women between 10 and 20 weeks of gestation will be enrolled. After completing psychoeducation (PE), participants will be randomised to either the control condition (PE only) or one of five CBT programmes: behavioural activation (BA), assertion training, BA+cognitive restructuring, BA + problem solving or BA + behaviour therapy for insomnia. The objectives of the study are: (1) to ascertain that the iCBT approach is effective in perinatal depression, (2) to identify active CBT skills for perinatal women and (3) to examine interactions between these CBT skills and individuals’ baseline characteristics to find personalised and optimised therapy for individual women. The primary outcome is the point prevalence of depression at 1 month postpartum, defined as scoring of 9 or higher on the Edinburgh Postnatal Depression Scale.

The study has been approved by the Kyoto University Graduate School of Medicine Ethics Committee (C1710) and Nagoya City University Certified Review Board (2024A007). Anonymised study results will be presented at conferences and published by the investigators in peer-reviewed journals.

jRCTs042240162 (hospital-based, on-site trial) and jRCT1050250074 (nationwide online trial).

Non-communicable diseases are the leading causes of premature mortality worldwide. Both genetic predispositions and environmental exposures affect disease risk. While biobanks have increased understanding of genetic predictors of these diseases, environmental influences are expected to have a greater impact on disease development. Individuals also create their own environments and lifestyles based on genetically regulated preferences, leading to gene–environment interactions that require large datasets to study. Finnish biobanks typically lack sufficient lifestyle and environmental data, which limits their use. We present a protocol for a biobank-recall study (BioRecall) to collect data on lifestyle and environmental exposures and combine these findings with genotypes, biological samples and clinical outcomes.

All previously genotyped donors from the Central Finland Biobank who have been diagnosed with type 2 diabetes and have consented to recall will be invited to participate in the pilot study. The preliminary feasibility assessment reveals that there are 1580 suitable candidates. Participants will complete an electronic questionnaire on a secure online platform. The questionnaire includes validated questions on lifestyles, anthropometrics, weight loss history, health, symptoms, work characteristics, emotional states and residential environments. Postcode information will facilitate the addition of spatial environmental data. Genotype and related clinical data will be provided in the study in accordance with the Finnish Biobank Act and combined with questionnaire data.

The Human Sciences Ethics Committee of the University of Jyväskylä delivered a favourable statement regarding the study protocol (1671/13.00.04.00/2023). Central Finland Biobank approved the research plan (no: BB24-0333-A01). The data collected will be returned to the Central Finland Biobank for research purposes with the participants’ consent. Permission for data usage can then be applied through standard protocols of the Fingenious service (https://site.fingenious.fi/en/). If successful, the study will be expanded to other donors and Finnish biobanks.

This systematic review aims to synthesise current evidence on gut microbiome profiles among children with sickle cell disease (SCD), assess the influence of analgesic and antibiotic use, and explore the contributions of environmental factors on their gut microbiota diversity. Through identification of consistent microbial patterns and gaps in the existing literature, this review will provide vital insight into potential microbiome-targeted strategies for improving health outcomes in paediatric SCD care.

Studies describing the gut microbiota among paediatric SCD human subjects (

Ethical approval will not be required as this is a systematic review of published data. The findings will be disseminated through publications in peer-reviewed journals and presentations at relevant scientific conferences.

CRD420251102736.

To assess health-related quality of life (HRQoL), treatment satisfaction and associated factors among older adults with acute heart failure in Northwest Ethiopia.

Prospective, multicentre observational study.

Three tertiary hospitals in Northwest Ethiopia provide secondary and tertiary care services.

A total of 422 patients aged ≥60 years with a confirmed diagnosis of acute heart failure were consecutively enrolled between December 2024 and April 2025. Patients with unstable psychiatric conditions or advanced kidney disease were excluded.

HRQoL was assessed using the WHO Quality of Life – Brief Version questionnaire, and treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM). Multiple linear regression identified factors associated with HRQoL and treatment satisfaction.

95% of participants reported moderate HRQoL, and 3% reported poor HRQoL. Weight loss was positively associated with HRQoL (β=1.52; 95% CI 0.04 to 3.07; p=0.021), whereas asthma was negatively associated with HRQoL (β = –3.28; 95% CI 6.94 to 0.37; p=0.001). Regarding treatment satisfaction, 65% of patients were moderately satisfied, with notable concerns regarding medication safety and overall experience. Rural residents reported lower satisfaction than urban residents (β = –0.20; 95% CI 0.34 to 0.05; p=0.007). Patients with New York Heart Association (NYHA) class III had higher satisfaction (β=0.25; 95% CI 0.05 to 0.45; p=0.016). Effective hypertension management was linked to increased satisfaction (β=0.20; 95% CI 0.02 to 0.37; p=0.026), whereas coronary heart disease was associated with lower satisfaction (β = –0.40; 95% CI 0.64 to 0.88; p=0.012).

Among older adults with heart failure in Northwest Ethiopia, 98% reported moderate to low HRQoL. Asthma and polypharmacy negatively affected HRQoL, whereas weight loss was positively associated with HRQoL. An NYHA class III status and well-managed hypertension improved treatment satisfaction, whereas rural residency and coronary heart disease were associated with lower satisfaction. These findings underscore the need for targeted interventions to enhance outcomes and QoL in this vulnerable population.

Nigeria has the highest number of maternal deaths globally, and maternal peripartum sepsis is one of the leading causes of maternal mortality. A single oral dose of azithromycin (AZM; 2 g) is safe and effectively reduces 33%–60% of maternal sepsis during planned vaginal birth in low- and middle-income countries (LMICs). However, the clinical and cost-effectiveness of oral AZM during vaginal birth in Nigeria remains unknown in the context of poor antimicrobial stewardship practices, significant antimicrobial resistance and healthcare financing. Evidence is also lacking on the standard care for the prevention of maternal sepsis among pregnant women undergoing vaginal births in Nigeria. The AZIN-V trial is a hybrid type 2 effectiveness-implementation trial to determine the safety, clinical and cost-effectiveness of intrapartum oral AZM versus usual care in the prevention of peripartum maternal sepsis. The trial will also examine the impact of implementation strategies in enhancing adherence to the oral AZM protocol during planned vaginal births and identify effective strategies to improve adherence (fidelity) to the protocol in real-world LMIC settings.

This is a multicentre hybrid type 2 trial conducted in six Nigerian states: Ebonyi, Edo, Gombe, Kano, Kwara and Lagos. The study aims to simultaneously test the clinical and cost-effectiveness of AZM (clinical trial) and the impact of implementation strategies (implementation research) in Nigeria’s unique healthcare context. The clinical trial is a two-arm, cluster-randomised controlled trial conducted across 48 health facilities, randomly assigned (1:1) to either intrapartum administration of oral AZM (intervention group) or usual care—the current routine practice (control group). A total of 5040 study participants (2520 in each group) will be enrolled in the clinical trial. The implementation trial is a two-arm cluster non-randomised controlled trial conducted in 12 health facilities (1:1) allocated to either a bottom-up approach using the Plan-Do-Study-Act cycle or a usual top-down approach with a one-time training workshop and distribution of clinical guidelines, with both arms administering oral AZM during vaginal birth while assessing fidelity (primary outcome).

For the clinical trial, data will be analysed using intention-to-treat statistical methods. The cost-effectiveness outcome will be analysed using the Incremental Cost-Effectiveness Ratio. Implementation outcomes will be analysed using descriptive statistics and a thematic approach.

This study has been approved by the National Health Research Ethics Committee, Nigeria (NHREC/01/01/2007-30/09/2024), the ethics committees of the participating health institutions (Lagos University Teaching Hospital Research Ethics Committee: ADM/DSCST/HREC/APP/6325; University of Ilorin Teaching Hospital Health Research Ethics Committee: ERC/PAN/2025/03/0581; University of Benin Teaching Hospital Health Research Ethics Committee: ADM/E22/A/VOL. VII/483117141; Aminu Kano Teaching Hospital Research Ethics Committee: AKTH/MAC/SUB/12 A/P-3/VI/2509 and Irrua Specialist Teaching Hospital Research Ethics Committee: ISTH/HREC/20241507/605), the Ministries of Health of the six states and the National Agency for Food and Drug Administration and Control. Written informed consent will be obtained from all eligible study participants before enrolment. Results will be shared with communities and policy stakeholders and through peer-reviewed journals and will be presented at conferences.

ISRCTN16415327.

The management of active patients with symptomatic knee osteoarthritis (KnOA) who are too young for total knee arthroplasty poses a specific challenge to clinicians. Research studies show that improving quadriceps muscle strength improves pain and function; however, aspects of the disease render it difficult for patients to achieve and maintain improvements. Recombinant human growth hormone (rHGH) is shown to increase the magnitude and duration of muscle growth when combined with exercise treatment in adult populations. Hence, rHGH combined with physical therapy may provide meaningful benefits in the treatment of KnOA.

This is a single-centre, double-blind, randomised trial to pilot a future Phase III trial from 2025 to 2028. Participants are aged 18–60 with clinical and radiographic evidence of isolated degenerative arthritis of the knee (patellofemoral or tibiofemoral). The investigational product is rHGH (Saizen (somatropin of rDNA origin, EMD Serono)) and a saline placebo. Participants will deliver the solution via subcutaneous injection area once per day at a dose of 0.5 mg HGH per body surface area (0.5 mg/m²) for 6 weeks, alongside participation in a lower limb strengthening programme developed by rehabilitation specialists. 17 participants will be recruited into each study arm.

The primary outcomes are feasibility (compliance with the study drug regimen for the 6-week administration period and enrolment rate) and safety (the proportion of minor and major adverse events between groups). The primary endpoint for these outcomes will be at 6 weeks. The secondary outcomes are knee extension strength, knee flexion strength, radiographic arthritis progression, thigh muscle circumference, MRI-measured quadriceps muscle volume and patient-reported outcome measures (Knee Osteoarthritis Outcome Score (KOOS), SF-20 and Tegner). The primary endpoint for these outcomes will be at 12 weeks, and the final endpoint will be 24 months, where final radiographic (X-ray) assessment will take place.

The primary outcome of compliance will be a calculation of mean compliance between groups, which can be analysed as a t-test after the treatment period. A two-sample, two-sided t-test will compare the clinical (secondary) outcome of greatest interest: knee extension strength at baseline versus week 6 compared between treatment groups. Other secondary outcomes will be compared using a simple linear mixed-effects model. The ² test will be used to determine whether the number of participants who made meaningful changes was different between groups. The null hypotheses are that the rHGH and placebo groups will have no difference in compliance rates, safety events, knee extension strength at 12 weeks and arthritis grade progression at 24 months.

This study has been approved by the Sunnybrook Research Institute Research and Ethics Board (#6427) and received a no-objection letter from Health Canada Clinical Trials. The primary sponsor is the Sunnybrook Centre for Clinical Trial Studies (CCTS). The findings of this study will be published in a peer-reviewed journal and presented at orthopaedic conferences.

NCT07036003.

To examine the associations between food-related behaviours and nutrient intake on nutritional status among clients undergoing Community-Based Treatment and Rehabilitation (CBTaR) in Kelantan, Malaysia.

Cross-sectional analytical study.

Seven CBTaR centres (n=7) across the state of Kelantan, Malaysia.

A total of 393 adult clients (aged 18 years and above) enrolled in CBTaR programmes between June and December 2022 were selected through stratified random sampling.

The primary outcome was nutritional status, assessed using body mass index. Secondary outcomes included nutrient intake (macronutrients and micronutrients) and food-related behaviours (emotional eating, external eating, restrained eating and food addiction), measured through Bahasa Malaysia validated questionnaires and 24-hour dietary recalls. All variables were introduced into the structural equation modelling to examine the associations among these variables and their association with nutritional status.

The results revealed that food-related behaviour was significantly associated with the nutrient intake (β=–0.524, p≤0.001). Additionally, the drug use profile significantly determined the food-related behaviour (β=–0.129, p=0.006) and nutritional status (β=–0.134, p=0.007). Nutrient intake was found to be a significant predictor of nutritional status (β=–0.213, p≤0.001). Sociodemographic and drug use profiles were significantly correlated with nutritional outcomes through behavioural and dietary associations. Importance-performance map analysis identified nutrient intake as the most impactful variable, highlighting the need for urgent intervention (R²=0.272).

This study highlights that nutrient intake is a significant predictor associated with food-related behaviours on nutritional status among individuals with substance use disorder. Integrating nutrition counselling and behavioural interventions into CBTaR services may improve recovery and long-term health outcomes.

This study aims to identify factors associated with early antenatal care (ANC) initiation using a survival analysis approach applied to nationally representative data.

This study used a cross-sectional design based on data from the nationally representative 2022 Bangladesh Demographic and Health Survey. The survey was conducted at the community level across all administrative divisions of Bangladesh. A total of 5128 ever-married women aged 15–49 years who had a live birth within 5 years prior to the survey were included in the analysis. Women with missing or incomplete information regarding the timing of their first ANC visit were excluded from the study.

The primary outcome was early initiation of ANC, defined as the first ANC contact within the first trimester.

The study applied survival analysis methods, including Kaplan-Meier survival curves, log-rank tests and an Accelerated Failure Time model, to assess the determinants of early ANC initiation.

Only 37.9% (95% CI 36.0% to 39.9%) of women in Bangladesh initiated ANC within the first trimester. Early ANC initiation was associated with higher maternal age, education, skilled employment, wealthier households, media exposure, higher decision-making autonomy, higher husband’s education and urban residence. Women who reported that distance to a health facility was not a big problem had initiated ANC earlier than those who considered distance a major barrier. Regional disparities were also evident, with women from Barishal, Chattogram, Rajshahi, Khulna and Rangpur accessing ANC later than those in Dhaka.

Persistent inequalities in early ANC initiation highlight the need for targeted policies to reduce financial barriers, improve healthcare accessibility and strengthen awareness campaigns to ensure equitable maternal healthcare in Bangladesh.

Implementation of low-intensity, evidence-based psychological interventions can help meet the mental health and psychosocial needs of people with cancer, especially in low-resource settings where there is a dearth of mental health specialists. In this study, we will conduct a feasibility randomised controlled trial (RCT) of the stress management intervention Self-Help Plus, which has been translated and adapted to Vietnamese, vSH+, among people newly diagnosed with breast or gynaecological cancer in Viet Nam.

At six participating hospitals, individuals diagnosed with breast or gynaecologic cancer within the past year will be recruited, consented and randomised into either enhanced usual care (EUC) or EUC plus the vSH+ intervention, which consists of four sessions each lasting approximately 75 min. Quantitative surveys will be administered at three time points: enrolment/baseline (T0), after 6 weeks (T1) and after 4 months (T2). A qualitative evaluation component, which will include in-depth interviews with patients, implementers and healthcare staff and managers, as well as focus group discussions with caregivers, will assess the acceptability and feasibility of the vSH+ intervention.

Ethical reviews for the study were obtained from Boston University, Hanoi University of Public Health (HUPH) and all the participating hospital sites. On completion of data collection and analyses, the research team will prepare and submit abstracts to scientific conferences as well as manuscripts to peer-reviewed journals. We will also conduct dissemination events to report the trial results to relevant stakeholders.

NCT06398067.

To evaluate the accuracy of the arterial oxygen partial pressure/inspired oxygen fraction (PaO₂/FiO₂) ratio in predicting mortality among acute respiratory distress syndrome (ARDS) patients in Vietnam.

A retrospective observational study.

A central hospital in Vietnam.

Adult patients diagnosed with ARDS based on the Berlin definition and admitted to Bach Mai Hospital between August 2015 and August 2023. ARDS severity was converted from descriptive categories to the Berlin score, ranging from 1 (PaO₂/FiO₂>300 mm Hg) to 4 (PaO₂/FiO₂≤100 mm Hg).

All-cause hospital mortality.

Of 345 patients, 67.5% were male, and the median age was 55.0 years (IQR: 39.0–66.0). Hospital mortality was 61.2% (211/345). On the first day of admission, the PaO₂/FiO₂ ratio (areas under the receiver operating characteristic curves (AUROC): 0.585 (95% CI 0.522 to 0.649)) showed limited predictive ability for hospital mortality. Incorporating the PaO₂/FiO₂ ratio into the Berlin score did not substantially improve accuracy (AUROC: 0.578 (95% CI 0.516 to 0.641)). Both measures were less accurate than Sequential Organ Failure Assessment (SOFA) (AUROC: 0.650 (95% CI 0.590 to 0.711)), Acute Physiology and Chronic Health Evaluation II (APACHE II) (AUROC: 0.685 (95% CI 0.628 to 0.742)) and Confusion, Urea >7 mmol/L (20 mg/dL), Respiratory rate ≥30 breaths/min, Blood pressure (systolic 2/FiO₂ values (adjusted OR, AOR: 0.988 (95% CI 0.979 to 0.996)) were independently associated with lower mortality risk, while higher Berlin (AOR: 2.477 (95% CI 1.190 to 5.156)), SOFA (AOR: 1.278 (95% CI 1.102 to 1.482)), APACHE II (AOR: 1.236 (95% CI 1.108 to 1.379)) and CURB-65 (AOR: 7.142 (95% CI 2.581 to 19.763)) scores were associated with increased mortality risk.

In this study of ARDS patients in Vietnam, the PaO₂/FiO₂ ratio demonstrated limited discriminatory ability for hospital mortality, and incorporating it into the Berlin score did not meaningfully improve performance. While less accurate than SOFA, APACHE II and CURB-65 scores, the PaO₂/FiO₂ ratio and Berlin score remained independently associated with mortality risk. These findings should be interpreted cautiously, given the retrospective design, single-centre setting and potential selection bias; further validation in larger, multicentre studies is warranted.

Cardiovascular diseases (CVDs) are the leading cause of death worldwide, making the development of self-management strategies crucial for preventing complications and improving clinical outcomes. This process involves symptom monitoring, treatment adherence, emotional management and a healthy lifestyle, among others. Reliable instruments are necessary to measure self-management, requiring robust psychometric properties. In this way, this COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN)-based systematic review aims to assess the quality of specific self-management instruments for adults with CVDs.

This systematic review will follow the COSMIN and be reported according to the Preferred Reporting Items for Systematic Review and Meta-analysis Protocol. Searches will be conducted in seven databases: MEDLINE, Web of Science, Scopus, PsycINFO, EMBASE and CINAHL. Additionally, a manual search will be performed on PROQOLID, PROMIS and The Medical Outcome Trust websites. Studies on the development and validation of patient-reported instruments measuring specific self-management for individuals with CVDs will be included, without language or date restrictions. The search will be performed in November 2025, with the final version of the review expected to be completed in October 2026. Data extraction will follow COSMIN recommendations. The Modified Grading of Recommendations, Assessment, Development and Evaluation approach will be used to determine the quality of evidence. Instruments will be categorised according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer involved in case of discrepancies. Additionally, the content of the instruments will be analysed and linked to the International Classification of Functioning, Disability and Health, following international recommendations.

This study does not require ethics committee approval as it is a review of published data. The review results will be disseminated through peer-reviewed journal publications and presentations at scientific conferences.

CRD42024605969.

Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

The study is approved by the local ethical review board (‘Medisch Ethische Toetsing Commissie Isala Zwolle’). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

NCT04780971.

Rapid identification of high-risk and low-risk patients presenting to the emergency department (ED) influences clinical management and can help optimise patient outcomes as well as resource allocation. This study aims to externally validate the Risk Stratification in the Emergency Department in Acutely Ill Older Patients (RISE UP) score in adult patients in the ED with suspected infection. Furthermore, generalisability was assessed by comparing the discriminatory ability of the RISE UP with the quick Sequential Organ Failure Assessment (qSOFA) as well as the Modified Early Warning Score (MEWS) and National Early Warning Score (NEWS).

Retrospective cohort study.

Single-centre study in the ED of a tertiary, university-affiliated hospital.

Adult patients with suspected infection presenting at the ED for internal medicine from 2016 to 2022.

The primary outcome was all-cause 30-day mortality. Secondary outcomes were all-cause 14-day mortality, 7-day mortality and intensive care unit (ICU) admission.

Prognostic performance was evaluated using discrimination (area under the receiver operating characteristic curve (AUC)) and a calibration plot.

Of the included 5038 ED visits, there was a 30-day mortality of 7.1%. Discrimination of RISE UP for 30-day mortality was good (AUC 0.809; 95% CI 0.786 to 0.832) and significantly higher than that for the other risk scores: qSOFA (AUC 0.675; 95% CI 0.644 to 0.707), MEWS (AUC 0.688; 95% CI 0.658 to 0.718) and NEWS (AUC 0.725; 95% CI 0.696 to 0.754) (p

The RISE UP score outperformed the qSOFA, MEWS and NEWS in predicting 30-day mortality. It is generalisable to an adult infection-specific cohort and may facilitate distinction between high-risk and low-risk patients in the ED, particularly to rule out poor outcomes.

The highest childhood mortality rates are observed from external causes of death. Our study aims to investigate the trends in deaths from external causes among children aged 0–14 years between 2000 and 2022, comparing the pre-pandemic (2000–2019) and the COVID-19 pandemic (2020–2022) periods.

This is a population-based retrospective cohort study.

From the ‘Dissemination Database’ of the Hungarian Central Statistical Office, we collected the monthly and annual mortality of all external causes (International Classification of Diseases, 10th Revision: V01–Y89) and the two most common external causes (traffic accidents and drownings) for the period 2000–2022.

Children aged under 15 years, and the relevant population, were available from this database by gender, 5-year age group and region.

The trends were characterised by the incidence rate ratio (IRR) and its 95% CI.

During the study period, 1813 deaths (1142 boys and 671 girls) occurred. There was a significant decreasing trend in all external-cause mortality (IRR=0.94; 95% CI 0.93 to 0.95; p

There is a significant decreasing annual trend in childhood external-cause mortality in Hungary. Mortality from drowning was significantly higher around our larger natural water bodies in the summer months, while mortality from traffic accidents was the highest in the HU33.