This study intended to investigate barriers to implementing evidence-based intrapartum care during vaginal births, from maternity care providers’ point of view.

A descriptive qualitative study was conducted using in-depth interviews, with data analysed through thematic analysis.

The labour room of a major tertiary care hospital in Central Sri Lanka.

Purposively selected 17 maternity care providers including doctors, nurse managers, nurse-midwives and midwives.

Three major themes and twelve sub-themes were generated: (1) barriers related to care providers (lack of human resources, negative attitudes of care providers, poor relationship among care providers, poor relationship between women and care providers, lack of knowledge on evidence-based practice in childbirth care); (2) barriers related to organisational environment (gaps in management, heavy workload, inadequate physical resources, insufficient in-service training and lack of availability/use of updated guidelines) and (3) barriers related to women’s birth preparedness (women’s limited knowledge on childbirth and intrapartum practices and women’s limited engagement during labour and childbirth). Many maternity care providers perceived that prevailing challenges to implement evidence-based childbirth care were one of the major reasons that impacted the quality of current childbirth care in the labour room.

The findings showed that an integrative approach may be essential to address the diverse barriers to the implementation of evidence-based intrapartum care. It is necessary to engage healthcare administrators, healthcare professionals and care recipients to enhance the quality of current childbirth care in the setting through the successful implementation of evidence-based care.

The current German treatment guideline for chronic ischaemic heart disease (IHD) recommends that general practitioners (GPs) deliver brief advice on physical activity (PA) to patients with IHD. Such advice consists of at least three elements (ie, 3As): (1) assessing the PA level, (2) advising on PA and (3) assisting with recommendations. This study examined the extent to which individuals with self-reported IHD in Germany reported the receipt of such advice.

Cross-sectional population-based face-to-face survey (from June 2023 to August 2024).

Households across Germany.

1004 individuals aged 35+ years with self-reported IHD and GP contact.

Primary outcome: self-reported proportions of receipt of GP-delivered PA advice according to the 3As. Main secondary outcome: associations between person characteristics and the likelihood of receiving PA advice.

Among individuals with self-reported IHD, 36.4% (95% CI 33.4% to 39.4%) received all 3As of PA advice, 42.1% (95% CI 39.1% to 45.2%) received one or two elements, 9.9% (95% CI 8.1% to 11.8%) received no advice at all and 3.8% (95% CI 2.7% to 5.1%) were advised to avoid PA (7.9% did not remember/refused to answer). Women (vs men) were more likely to receive no advice (OR=1.74, 95% CI 1.11% to 2.72%), while middle (vs younger) aged individuals (OR=0.46, 95% CI 0.22% to 0.99%), those with PA levels of 1–149 min/week (vs no PA; OR=0.16, 95% CI 0.08% to 0.31%) and of 150+ min/week (vs no PA; OR=0.13, 95% CI 0.07% to 0.23%) and those with higher (vs lower) education (OR=0.39, 95% CI 0.20% to 0.76%) were less likely to receive no advice. Individuals living in urban (vs rural) areas (OR=0.65, 95% CI 0.46% to 0.88%) and those with PA levels of 1–149 min/week (vs no PA; OR=0.59, 95% CI 0.37% to 0.95%) and of 150+ min/week (vs no PA; OR=0.55, 95% CI 0.36% to 0.84%) were less likely to receive only one or two (vs all) of the 3As. Of those who received at least one element of advice (n=788), 72.5% reported they were more active afterwards, with a higher proportion when all 3As (vs only some elements) were provided (86.8% vs 59.6%).

Only one-third of individuals with self-reported IHD in Germany received comprehensive PA advice. Specific person characteristics, such as female gender and lower education, were associated with lower proportions of received PA advice. Efforts are needed to improve GP-led PA guidance, particularly for underserved groups.

German Clinical Trials Register (DRKS00031304).

Antimicrobial resistance (AMR) is one of the most urgent global health threats, responsible for an estimated 4.95 million deaths annually, including 1.27 million directly linked to drug-resistant infections. Nigeria is particularly affected, ranking 19th globally in AMR-related mortality, with an estimated 64 500 attributable and 263 400 associated deaths in 2019. These estimates are likely conservative due to limited surveillance. Economically, AMR could cost Nigeria 5%–7% of its GDP by 2050.

Despite this burden, antibiotic misuse remains widespread, with 42% of adults and over 46% of children under 5 receiving antibiotics without prescriptions. At the primary healthcare (PHC) level, where most antibiotics are prescribed, challenges such as limited diagnostics, inconsistent prescription and poor access to digital tools hinder effective antimicrobial stewardship (AMS).

The primary objective of this study is to assess the knowledge, attitudes and practices regarding antimicrobial resistance (AMR) among PHC prescribers in Imo State, Nigeria. A secondary objective is to explore preliminary indicators of their digital readiness to inform future technological interventions for AMS.

A cross-sectional study using an online questionnaire.

PHC facilities across all 27 local government areas of Imo State, Nigeria.

A purposive sample of 547 facility-based public PHC prescribers included 84% of all facility Officers-in-Charge of health facilities in the state and 16% of other PHC workers who were involved in prescription.

The primary outcome measures were composite scores for knowledge (adequate/inadequate), attitude (positive/negative) and prescribing practice (good/poor), derived from a validated questionnaire. Secondary measures included sources of AMR information and indicators of digital readiness.

While 77.1% demonstrated adequate knowledge, only 32.7% exhibited positive attitudes and 88.5% reported poor prescribing practices. Attitude was the strongest predictor of good practice (OR=17.585, p

These findings underscore a critical gap between knowledge and practice, driven in part by limited access to digital decision-support tools. To address the documented gaps in tool access and training, strengthening digital inclusion through context-adapted e-learning, offline-compatible AMS tools and simplified digital antibiograms is a necessary implication for improving antibiotic stewardship and clinical outcomes at the PHC level.

Cannabis-based medicine may alleviate breathlessness. This study will investigate whether dronabinol, a synthetic form of ⁹-tetrahydrocannabinol (⁹-THC), reduces breathlessness in patients with severe and very severe chronic obstructive pulmonary disease (sCOPD) compared to placebo.

This single-centre, randomised, double-blinded, placebo-controlled, crossover trial will enrol 30 patients with sCOPD and persistent breathlessness despite optimal treatment. Patients will be recruited from a pulmonary outpatient clinic in Denmark over 24 months. Eligible patients (aged ≥18 years) will receive either dronabinol or placebo for 4 weeks, followed by a 2-week washout, before crossing over to the other treatment for 4 weeks. Exclusion criteria include ongoing infection, substance abuse and significant comorbidities. Primary outcome is breathing discomfort or unpleasantness measured using the 0–10 Numerical Rating Scale. Secondary outcomes include lung function (forced expiratory volume in one second), hair cortisol concentrations, functional tests, plasma THC blood concentrations and questionnaires assessing breathlessness, activity, quality of life, anxiety and depression. Continuous monitoring of vital signs, activity and sleep will be performed using a Garmin Venu 3 smartwatch. Data will be entered into electronic case report forms and monitored by the Good Clinical Practice (GCP) unit in Odense.

This will be the largest randomised, double-blinded, crossover trial to investigate dronabinol in patients with COPD and will provide new knowledge on the efficacy and safety.

Written informed consents will be obtained from study patients. The study has been approved by the Danish Medicines Agency (case number: 2023010659) and the medical research ethics committees (case number: 2301456). It is registered in the European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701). The trial follows the Declaration of Helsinki II and International Council for Harmonisation-GCP guidelines. Findings will be disseminated in peer-reviewed publications.

The European Union Clinical Trials Registry (2024-513593-22-00) and ClinicalTrials.gov (NCT06473701).

To assess the prevalence and associated factors of dietary practices among antenatal women in Colombo district, Sri Lanka.

This descriptive cross-sectional study examined dietary practices among antenatal mothers in four Medical Officer of Health areas in Colombo, Sri Lanka. A total of 422 participants were selected using stratified random sampling. Data were collected via a validated Food Frequency Questionnaire and analysed using SPSS V.26. Dietary diversity, food variety and animal-source food consumption were assessed. Poisson regression identified predictors of dietary practices, adjusting for socio-economic and pregnancy-related factors. The statistical significance was set at p

Of the 380 antenatal mothers (mean age: 30.72±3.96 years), most were married (98.2%) with 73.7% living in urban areas. Regarding dietary practices, 64.7% had high dietary diversity, while 35.3% had low diversity. Of the sample, 52.1% had a high food variety score and 64.7% had a high animal-source food score. More than half (64.7%) had appropriate dietary practices. Fruits, vitamin A-rich vegetables and rice were the most consumed foods. Key factors influencing dietary practices included age, religion, education, employment and geographical location.

This study highlights the prevalence and factors influencing dietary practices among antenatal mothers. Although the predominant mothers had fair dietary diversities, a considerable number were found to have poor dietary practices. Better dietary practices were associated with major educational attainment, formal employment status and selected residential areas, while younger age, low educational qualification and housewife status were associated with poorer nutrition. The findings indicate that there is an urgent need for interventions related to nutrition for specific vulnerable groups so that they can improve their maternal nutrition and produce better pregnancy outcomes through education and support programmes.

To compare the short- and long-term outcomes of patients with colorectal liver metastases (CRLM) who underwent portal vein embolisation followed by liver resection (PVEfLR) with those who underwent other treatment strategies.

Rapid review of the literature retrieved through a systematic search.

Electronic databases PubMed, Embase and Ovid MEDLINE were searched from 1 April 2014 to 31 December 2025.

Studies were included if they involved only patients with CRLM, applied PVEfLR and reported comparative outcomes against other interventions (eg, associating liver partition and portal vein ligation for staged hepatectomy (ALPPS), liver transplantation and portal vein ligation). Only randomised controlled trials, cohort and case–control studies published in English were included. Studies that included patients other than those with CRLM were excluded.

Two authors independently screened records, extracted data and assessed quality using the Newcastle-Ottawa Scale. Data were narratively synthesised and presented in summary tables.

14 studies (n=2,022 patients) were included. The overall median survival time for the PVEfLR group was similar to that of the ALPPS group but significantly lower than that of the liver transplantation group (19 vs 41 months, p=0.007). Postoperative complications were significantly lower for PVEfLR than for ALPPS (27% vs 65%, p

PVEfLR is an effective strategy for converting selected patients with initially unresectable CRLM to resectable status, achieving long-term survival comparable to other complex techniques such as ALPPS, although with a different perioperative risk profile. The choice of technique should be individualised based on the patient’s anatomy, disease burden and institutional expertise.

Cancer remains a growing public health challenge in India, impacting not only patients but also their caregivers, often family members who bear the emotional, physical and financial burdens of care. These family caregivers face overwhelming stress, anxiety and depression, particularly in rural areas with limited healthcare access. Cultural expectations often lead them to neglect their own well-being. Many are forced to reduce work or quit jobs, worsening financial strain. Despite their vital role, caregivers are largely overlooked in cancer care discourse. There is an urgent need for India-specific, empathetic research and policies that support caregiver health and recognise caregiving as a public health priority.

This study employs a sequential explanatory mixed-methods design to examine the association between caregiver burden and mental health status among informal caregivers of patients with cancer in central rural India. In the quantitative phase, a cross-sectional survey will be conducted using systematic random sampling. Data will be collected via a semistructured questionnaire and standardised tools: the Copenhagen Burnout Inventory to assess burnout levels, and the Depression, Anxiety and Stress Scale-21 to evaluate psychological distress. Statistical analysis will include descriptive statistics and regression analysis.

The qualitative phase will involve in-depth interviews with purposively selected caregivers to explore lived experiences, coping mechanisms and emotional challenges. Interviews will be transcribed and analysed using thematic content analysis. Integration of quantitative and qualitative findings will provide a comprehensive understanding of caregiver burden and mental health, reflecting both measurable patterns and the human experience of caregiving in a rural setting.

Ethical clearance for this study protocol was obtained from the Institutional Ethics Committee of Datta Meghe Institute of Medical Education and Research, Sawangi (Meghe), Wardha (Approval No. DMIHER(DU)/IEC/2025/436). Permission for data collection was further granted by both the institutional ethics committee and Acharya Vinoba Bhave Rural Hospital, Sawangi (Meghe), Wardha. The findings of this research will be disseminated through publications in peer-reviewed scientific journals and by engaging relevant stakeholders through appropriate channels of communication.

CTRI/2025/08/093357.

Gastrointestinal bleeding (GIB) is a common cause of hospitalisation and decompensation in the hospital, is routinely managed by a wide variety of subspecialties, and requires a host of both technical and non-technical skills (NTS). Simulation-based training (SBT) exercises are an excellent means of training physicians and other healthcare professionals in both technical skills and NTS and are frequently used to teach and assess management of high-stress situations such as cardiopulmonary resuscitation and trauma situations. The manner in which SBT is used to train other types of clinical situations—and at what frequency—is less clear. The extent to which such training programmes are evaluated is also not clear. Here, we intend to characterise the body of literature describing SBT programmes for bedside management of GIB. In doing so, we will gain valuable insight into the current state of SBT as it relates to training healthcare professionals to handle complicated clinical situations.

Our review will follow the six-stage framework outlined by Arksey and O’Malley while considering elaborations and guidance made by Levac et al and the Joanna Briggs Institute. The protocol and review will be created in alignment with the preferred reporting items for systematic reviews and meta-analyses—scoping review checklist and explanatory paper. Using a carefully constructed search strategy, the following databases will be queried from their inception through 31 December 2025: PubMed, Embase, Scopus, Web of Science and ERIC. Following the initial database query and two-step screening process, included articles will be systematically examined and will serve as our data source. Our efforts will ultimately answer the following research question: How is simulation-based training currently used to teach bedside management of GIB to physicians (residents, fellows and attending physicians), and how are these simulation-based training exercises studied and evaluated?

Ethical approval from the Institutional Review Board is not required for this study since all investigations are being carried out on previously published manuscripts. Final results will be compiled and submitted for publication once the study has been completed and all data has been charted/analysed.

To develop a machine learning (ML)-based risk prediction model for 1-year mortality in ST-elevation myocardial infarction (STEMI) patients undergoing primary or rescue percutaneous coronary intervention.

Patient data, including demographic, clinical, biochemical, imaging and procedural details, were extracted from electronic medical records. Data were split into training (80%) and test (20%) sets. Eight supervised learning algorithms were evaluated: least absolute shrinkage and selection operator, ridge, Elastic Net (EN, decision tree, support vector machine, random forest, AdaBoost and gradient boosting. Feature selection was performed sequentially with subsets of the top 5/10/15/20/25/30 features. Model hyperparameters were optimised using fivefold cross-validation with area under the curve (AUC) as the scoring metric.

Single, tertiary Australian centre.

We analysed data from 1863 consecutive STEMI patients treated at a tertiary Australian centre from July 2010 to December 2019.

The primary outcome was 1-year all-cause mortality.

The 1-year mortality rate was 13.6% (n=254) in our cohort. The EN model with five key features (parsimonious model) demonstrated superior performance, achieving an AUC of 0.821, which was comparable to the full 30-variable model (AUC 0.821). Advanced age, pre-hospital cardiac arrest and management with balloon angioplasty alone were identified as predictors of increased mortality risk, while family history of premature coronary disease and higher left ventricular ejection fraction were associated with improved survival. To facilitate clinical implementation, we developed a user-friendly web application for individualised risk assessment.

Our ML model accurately predicts 1-year mortality in STEMI patients using only five clinical variables. This tool offers improved accuracy and ease of use compared with existing risk stratification methods, potentially enhancing patient stratification and guiding treatment decisions in STEMI management.

To identify predictors of treatment changes and to evaluate the effectiveness and patient-reported outcomes (PROs) in patients with rheumatoid arthritis (RA) initiating tofacitinib in a real-world setting.

The non-interventional study ESCALATE-RA included 1518 patients with RA from Germany. RA treatment, including all changes in therapy, was documented for 24 months starting from the initial intake of tofacitinib.

All patients started with tofacitinib therapy, either as monotherapy or in combination with methotrexate (MTX).

The impact of several factors of interest on the number and timing of treatment changes was assessed as primary outcome using Cox proportional hazards models. Further outcomes were tofacitinib drug survival and the use of follow-up disease-modifying antirheumatic drugs after first treatment change. We also assessed the effectiveness, concomitant glucocorticoid (GC) use, PROs (such as functional ability, patient satisfaction, pain and quality of life) and safety. Analyses were based on observed data.

‘Lack of efficacy’ (HR 3.30) and ‘intolerance’ (HR 4.43) leading to termination of tofacitinib were key factors favouring therapy changes. Higher patient satisfaction was significantly associated with a reduced likelihood of treatment changes (HR 0.82). Increasing GC doses were associated with a higher probability of step-up/switch changes (HR 1.21). The estimated tofacitinib drug survival was 48% at the end of study. Proportions of patients achieving low disease activity (both Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI) 62%) and remission (SDAI 25%, CDAI 28%) increased from baseline under tofacitinib and were comparable between monotherapy and combination therapy with MTX. Mean concomitant GC dose decreased (2 mg/day). PROs indicated reduced pain and fatigue, while functional ability and quality of life improved. 63.9% of the patients experienced a treatment-emergent adverse event (AE), 8.8% a treatment-emergent AE of special interest and deaths occurred in 0.5%.

Key factors for therapy changes in patients with RA treated with tofacitinib were lack of efficacy and intolerance. Higher patient satisfaction was associated with a reduced probability of treatment changes, while increased GC doses led to a higher likelihood of step-ups/switches. Patients demonstrated a marked reduction in disease activity for up to 24 months, along with improvements in functional ability, pain and quality of life. Observed AEs were consistent with the known safety profile of tofacitinib.

NCT03387423.

To assess health service use between days 43 and 365 postdelivery, comparing individuals with and without severe maternal morbidity (SMM).

Population-based cohort study.

Linked datasets from Population Data BC in British Columbia, Canada, April 2013–March 2021.

Postpartum individuals aged >18 years with a hospital or home delivery, with/without SMM occurring from 20 weeks’ gestation through 42 days post partum. Ectopic pregnancies, missing identifiers and maternal deaths at delivery or within 42 days post partum were excluded.

The primary outcome was high health service use, defined as being in the 95th percentile for use of one or more of the following non-obstetric visits: emergency department, hospitalisations and outpatient visits to a primary care physician or specialist—each occurring between 43 and 365 days after delivery hospitalisation discharge. Secondary outcomes included being in the 95th percentile for each visit type. Log binomial regression assessed the rate and risk of high health service use in SMM compared with non-SMM pregnancies, adjusting for confounders.

The cohort included 261 287 deliveries (5575 (2.1%) with SMM). Those with >15 visits within 43–365 days postdelivery were classified as having high health service use. SMM-affected individuals were twice as likely to have high health service use (9.2% vs 4.3%; adjusted relative risk (aRR)=1.96, 95% CI 1.78 to 2.17). Individuals with non-hypertensive cardiovascular SMM had markedly higher health service use (21.4% vs 4.3%; aRR=5.18, 95% CI 3.28 to 8.16). There was heterogeneity in the association between SMM and high health service use among those without versus with previous comorbidities, without versus with high service use in the 2 years prior to delivery, and without vs with preterm birth.

Our study revealed high health service use after SMM. These findings can help guide the development of standardised postpartum care pathways.

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.

We performed a microsimulation analysis predicting the societal cost of antimicrobial resistance (AMR), which represents the potential cost savings if Ghana eliminates AMR.

This study combined bacterial resistance epidemiology and cost data from Ghana to perform a microsimulation analysis focusing on sociodemographic groups, predicting the potential societal cost savings should Ghana eliminate AMR. The nationally representative data were collected from 12 reference laboratories across Ghana’s three geographical belts between June 2021 and December 2023. Case definition was enterobacterial third-generation cephalosporin (3GC) resistant infections, methicillin-resistant Staphylococcus aureus (MRSA) and multidrug-resistant Mycobacterium tuberculosis. Using an adapted microsimulation framework, the simulation incorporated four integrated data modules: population demographics, infection epidemiology, healthcare resource use and expenditure and labour market characteristics. This approach allowed for the construction of synthetic individuals from national data sets and the projection of annual outcomes over a 7-year horizon. Costs were calculated from a societal perspective under a status quo scenario, assuming that admission rates, resistant infection probabilities and mortality rates remain the same. This analysis also considers a 2.1% annual population growth rate, a 5% discount rate for future costs and age-specific resistance risk profile. We stratified the outcome of interest by age groups, sex and wealth quintiles to account for distributional effects and reported the costs in purchasing power parity equivalent in international US dollars.

Ghana in West Africa.

A simulated population of AMR patients of all ages and sex.

Societal cost attributable to AMR in Ghana.

Assuming probabilities of all-cause hospital admissions of 0.102 for females and 0.093 for males, along with probabilities of AMR infections of 0.239 and 0.193, we predicted nearly 78 000 (95% CI 72 000 to 83 520) annual AMR infections and approximately 6300 (95% CI 3900 to 8638) attributable deaths. MRSA and 3GC-resistant infections made up 20.2% and 79.2% of the predicted annual infections, corresponding to an estimated mean societal cost of about US$435 million. In decreasing order of magnitude, the estimated mean annual cost of productivity loss due to AMR attributable mortality accounted for 40.6% of the mean annual societal cost, followed by the cost to healthcare providers (24.1%), direct medical cost to patients and caregivers (22.4%), productivity loss for surviving patients and caregivers (10.4%) and direct non-medical costs to patients and caregivers (2.6%). Resistant infections in children under 5 and adults over 60 years contributed 48.2% and 26.9% of the estimated annual societal cost, respectively. Except for the number of resistant infections, the estimated mean annual costs between wealth quintile groups were significantly different (p=0.03) due to differences in productivity costs between wealth quintile groups.

The study shows that the societal cost implications attributable to AMR are enormous, requiring a concerted effort by society to mitigate the development and spread of AMR organisms.

Depression and sub-diagnostic depressive syndromes are prevalent and associated with suffering and reduced life expectancy. Access to care is limited even in countries with developed healthcare systems. In this context, it is important to strengthen the self-management expertise of people suffering from depressive symptoms. Smartphones offer the possibilities for improved self-management based on long-term monitoring of symptoms.

The present multicentre randomised controlled trial (the Protecting mental health in times of change (MENTINA) trial) aims to evaluate whether (1) daily smartphone-based monitoring and automatic rule-based feedback+smartphone-based outcome evaluations versus (2) smartphone-based outcome evaluations alone will improve depressive symptoms and other clinically relevant outcomes in participants with current depressive symptoms and/or one or more prior depressive episodes during a 12-month trial period.

The MENTINA trial is a multicentre randomised controlled parallel-group trial conducted in Denmark, Germany and Spain. Participants with current depressive symptoms and/or one or more previous depressive episodes are invited to participate. The included participants will be randomised to (1) daily smartphone-based monitoring and automatic rule-based feedback+outcome evaluations via smartphone (intervention group) or (2) outcome evaluations via smartphone alone (control group). All participants can continue with ongoing treatment in case they receive it. The trial started in May 2025 and has currently included 115 participants. The outcomes are differences between the intervention group and the control group in (1) Patient Health Questionnaire 9-items (PHQ-9) measured every 14th day during the 12-month trial period (primary), (2) WHO Quality of Life-BREF, Generalised Anxiety Disorder-7, monthly change in PHQ-9, proportion of participants with ≥50% reduction in PHQ-9, remission rate defined as PHQ-9≤9 and ≥5-point improvement, PHQ-9 scores after 6 months, area under the curve for PHQ-9 over the 12 months trial period, subgroup analyses in PHQ-9 in participants with or without lifetime depression, Perceived Stress Scale, user-reported healthcare contacts, usability of the app and negative effects, number of depressive episodes+duration and depressive-free days based on PHQ-9. A total of 660 participants will be included in the MENTINA trial.

The MENTINA trial is funded by the European Union under Grant Agreement No. 101 080 651. Ethical approval and approval from Medical Agencies have been obtained from Denmark (CIV-25-02-051094), Germany (CIV-25-02-05109) and Spain (CIV-25-02-051094). The results will be published in peer-reviewed academic journals, presented at scientific meetings and disseminated to patients’ organisations and media outlets.

NCT06919133.

Version 6, January 2026.

Glucocorticoid therapy is prescribed for a variety of inflammatory conditions and is associated with severe adverse effects. A glucocorticoid withdrawal syndrome (GWS) may occur after prolonged glucocorticoid treatment—with or without biochemical glucocorticoid-induced adrenal insufficiency (GIAI). Previously, GWS was not considered an entity, probably due to the overlap between symptoms of GWS and GIAI. The Addison’s disease-specific quality of life questionnaire (AddiQoL-30) is a validated tool for quantifying symptoms of adrenal insufficiency resembling GWS. In the present study, we test the hypothesis that patients with a low AddiQoL-30 score and/or low cortisol response to a short Synacthen test (SST), after cessation of prednisolone treatment, may benefit from low-dose hydrocortisone therapy without increasing the risk of metabolic and cardiovascular disease during prolonged cortisol exposure.

REPLACE is a multi-centre, double-blinded, placebo-controlled randomised controlled trial in patients with polymyalgia rheumatica or giant cell arteritis after cessation of prednisolone treatment. Criteria for randomisation are an AddiQoL-30 score ≤85 and/or plasma cortisol response to SST, 30-min p-cortisol >100 and 85; and (2) patients with a SST-stimulated cortisol ≤100 nmol/L.

The study is conducted in accordance with the Declaration of Helsinki, registered at the Clinical Trials Information System (CTIS: 2024-513822-53-00) and Clinicaltrials.gov (NCT05193396), and publications will be in accordance with the recommendations of the International Committee of Medical Journal Editors. The trial is monitored by local independent Good Clinical Practice units and overseen by the Danish Data Protection Agency (journal no. 21/27119), the Regional Committees on Health Research Ethics for Southern Denmark (project ID: S-20210076), the Danish Patient Safety Authority and the Danish Medicines Agency.

NCT05193396.

Gastric cancer is the fifth most common cancer globally and the fourth leading cause of cancer-related mortality. While gender and sex differences in gastric cancer care are underexplored in Germany, international studies have revealed disparities in aspects such as histology, comorbidities, treatment approaches and survival outcomes. This study aims to explore gender/sex-specific variations in clinical management and their impact on mortality, complications and survival rates in gastric carcinoma patients in Germany. The findings may inform revisions to clinical guidelines and support the development of more personalised treatment strategies. This study aims to improve the quality of care for gastric cancer patients and promote more individualised, sex-sensitive medical practices.

This nationwide, retrospective cohort study will analyse data from the German Diagnosis-Related Groups statistic and regional clinical cancer registries from 2017 to 2021. The study will evaluate both datasets separately, providing a comprehensive view of sex differences in gastric cancer care. Primary outcomes include hospital mortality and survival rates, while secondary endpoints include surgical complications, treatment modalities and postoperative outcomes. The analysis will investigate whether sex influences tumour characteristics, access to treatment and therapy effectiveness. Statistical methods such as descriptive analysis, regression models and survival analysis will be applied to identify sex-related variations in diagnosis, treatment and outcomes.

This study uses anonymised secondary data; thus, ethics approval is not necessary. Findings will be submitted to a peer-reviewed journal, reported to the Innovation Fund of the Federal Joint Committee of Germany, and a patient leaflet for the involved self-help groups will be made.

NCT06902337.

Breast screening uptake remains low in parts of the UK, partly due to barriers including limited transport access. Offering free transport to screening appointments may help address this and improve uptake. This general practitioner (GP) cluster-randomised feasibility trial will assess whether offering free door-to-door transport alongside routine screening invitations increases attendance.

Eight general practices in Yorkshire will be randomised to either the intervention (routine invitation plus information about booking free door-to-door transport) or control (routine invitation only) group. Around 8000 women due for routine breast screening will be included. Primary feasibility outcomes include GP recruitment and randomisation, intervention fidelity, proportion of women from the 10% most deprived areas, acceptability and data transfer processes. Secondary outcomes include understanding travel behaviour, cost-effectiveness and screening uptake. Data will be collected from routine National Health Service (NHS) screening records, data linkage with NHS England, travel surveys and qualitative interviews exploring experiences and acceptability. Patient and public involvement is embedded throughout with members contributing to advisory and oversight roles.

The trial has received ethical approval from the London–Harrow Research Ethics Committee, Section 251 approval from the Confidentiality Advisory Group and other relevant regulatory bodies. The University of Hull is the study sponsor. Results will be disseminated through peer-reviewed journal publications, conference presentations and plain English summaries for participants and the public. Findings will inform the feasibility and design of a potential larger trial to improve breast screening uptake via transport support.

ISRCTN17087898.