To characterise patient and medication-related patterns observed in drug-related pressure ulcers (DRPUs) and provide descriptive findings that may support future consensus-building.

Multicentre retrospective observational study.

20 hospitals across Japan participated in the study with hospital pharmacists specialised in PU care.

A total of 1113 hospitalised patients with existing PUs were included and classified into three groups (definite, probable and no-possibility of DRPUs) based on predefined criteria.

The primary outcome was the description of medication-related characteristics observed in each DRPU classification group, including polypharmacy, initiation of new medications and dose adjustments. Secondary outcomes included differences in ulcer characteristics and functional status across DRPU categories.

The definite group (n=128, 11.5%) showed a significantly higher prevalence of polypharmacy (83.6% vs 71.1% in the no-possibility group, p

Medication-related characteristics such as polypharmacy, initiation of new medications, dose modifications and use of antipsychotics were more frequently observed in the definite DRPU group. These descriptive findings may help characterise the clinical patterns of DRPUs and may inform future hypothesis generation.

This study compared the reliability of two metabolic cart systems, Vyntus CPX and Vmax Encore 29N, to measure whole-body energy metabolism by indirect calorimetry (IC) in individuals with type 2 diabetes (T2D).

Randomised, prospective, crossover study.

Single-centre study conducted in the clinical research centre of the German Diabetes Study (GDS).

Five participants (3 men, 2 women, mean age 49±6 years, body mass index (BMI) 32.62±4.2 kg/m²) with T2D completed the study protocol. Eligibility requires existing participation in GDS and availability for four consecutive study days.

Participants underwent four IC measurements per day on four consecutive days, totalling 16 measurements per device. On each study day, two measurements with both devices, Vyntus CPX and Vmax Encore 29N, were performed in randomised order. Postcalorimetric gas calibration with normalisation was applied after each measurement.

Reliability of respiratory quotient (RQ) and resting energy expenditure (REE), as assessed from the coefficient of variation (CV) and 95% CIs.

Device comparison showed minor differences in CV (95% CI) for carbon dioxide production (VCO₂) (3.5% vs 5.3%; 95% CI –8.2% to 8.0%), oxygen consumption (VO₂) (3.4% vs 5.7%; 95% CI –9.3% to 8.2%), RQ (3.6% vs 2.3%; 95% CI –3.5% to 3.7%) and REE (3.1% vs 5.6%; 95% CI –8.4% to 7.8%). Postcalorimetric calibration did not consistently affect RQ or REE. 

Vyntus CPX provides reliable IC measurements comparable to Vmax Encore 29N and may serve as a suitable replacement in clinical settings.

ClinicalTrials.gov identifier: NCT01055093.

To determine whether hormonal contraceptives are associated with subsequent risks of suicidal behaviour and depression among women of reproductive age.

Nationwide register-based study.

Swedish national population using health and death registers. Nationwide registries provided individual-level information about the use of hormonal contraception, suicidal behaviour, depression and potential confounders.

All women in Sweden from 1 January 2006 to 31 December 2013.

Suicidal behaviour events or registered deaths due to suicide were identified through the National Patient Register and Cause of Death Register, respectively. Clinical diagnoses of depression were obtained from the patient register. Cox regression models were used to estimate HRs with 95% CIs of suicidal behaviour and depression in women using hormonal contraceptives.

We followed more than two million women for a median of 6.8 years (12.4 million person-years in total). No increased risk was observed among women using oral contraceptives or non-oral combined oestrogen/progestin formulations. Non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour using both population-based (HR=1.17, 95% CI 1.13 to 1.21) and within-individual (HR=1.16, 95% CI 1.11 to 1.21) analyses. Age-stratified analyses revealed that during late adolescence (age 15–18), use of oral contraceptives or non-oral combined formulations was associated with an increased risk of suicidal behaviour (range of HRs: 1.09–1.35), an effect that was not observed in adulthood. In contrast, non-oral progestin-only contraceptives were associated with an increased risk of suicidal behaviour during both late adolescence and adulthood.

We found no overall increased risk of suicidal behaviour among women using oral contraceptives or non-oral combined formulations. However, the observed increased risk associated with hormonal contraceptive use during adolescence, as well as with non-oral progestin-only contraception—particularly gonane-containing formulations—across the entire reproductive window warrants attention and further investigation.

To describe screening programmes for early chronic kidney disease (CKD) in the USA and other English-speaking countries (Canada, Australia and UK) involving patients with diabetes or hypertension, in addition to high-risk racial or ethnic groups.

Systematic literature review.

Embase and MEDLINE (both via Ovid) between 1 January 2018 and 17 October 2023.

CKD screening programmes in patients with diabetes and/or hypertension in the targeted countries were included.

Publications meeting the review objectives and prespecified population, intervention, comparator, outcome and eligible study design types were identified. Full-text publications were assessed for quality by two independent reviewers. For randomised controlled trials, quality/risk of bias (ROB) was assessed using version 2 of the Cochrane ROB tool for randomised trials; for observational longitudinal or prospective studies and non-randomised trials, quality/ROB was assessed using the Newcastle-Ottawa Scale.

Of 5542 records identified from database searches, 21 studies were included. Of these, the majority (13 studies) screened patients with diabetes and/or hypertension. Screening programmes were described in 16 studies; the remaining 5 reported CKD prevalence. Of 30 643 162 pooled participants, 6 413 466 (weighted mean: 21%) received complete screening for CKD (ie, evaluation of albumin-to-creatinine ratio plus estimated glomerular filtration rate). The weighted mean prevalences of any type of CKD testing in patients with diabetes or hypertension were 33% and 12%, respectively. For the pooled population of 24 608 indigenous persons or underserved communities, the weighted mean prevalence of CKD screening was 91%. Weighted mean prevalences for any type of CKD testing were 22% (n=30 705 837) in primary care and 93% (n=26 640) in community outreach settings. Follow-up testing was infrequent or not reported in most studies.

These findings indicate a low prevalence of CKD screening of high-risk patients, particularly in primary care. Contrary to Kidney Disease: Improving Global Outcomes (KDIGO) guidelines, most high-risk patients studied received incomplete screening. Lack of adherence to KDIGO guidelines on CKD screening may result in delays in CKD diagnosis and missed opportunities for therapy.

CRD42023492433.

There is a pressing need for effective interventions that can support healthcare workers and caregivers in the challenging yet crucial task of disclosing the HIV status to infected children and adolescents. Previously, we developed and tested a successful disclosure intervention called Sankofa in Ghana. In an ongoing 5-year follow-up study, Sankofa 2, we aim to build on the successful Sankofa trial by testing the intervention on a larger scale.

This study is a pragmatic, stepped-wedge cluster randomised trial.

It is being conducted in 12 HIV paediatric clinics in Ghana to examine the effectiveness, health benefits, cost and implementation of the Sankofa intervention. Caregiver–child dyads (n=700) will be enrolled. Evaluation of effectiveness, health benefits, cost and implementation of the Paediatric HIV disclosure intervention, Sankofa 2, is posed to offer valuable insights for scale-up and sustainability.

Ethical clearance has been obtained from the Ghana Health Service Ethics Review Committee, the University of Ghana Ethical and Protocol Review Committee, the Committee on Human Research Publication and Ethics of the Kwame Nkrumah University of Science and Technology, the Johns Hopkins Medicine Institutional Review Board and the Yale School of Medicine Human Investigation Committee. The clinical trial was registered on ClinicalTrials.gov on 5 March 2021. All caregiver participants are required to provide written informed consent and the children assent before enrolment. If either the child or caregiver says no to the study, the dyad is not eligible for the study. No study-related procedures are performed until consent is obtained. The results of the trial will be added on ClinicalTrials.gov, published in peer-reviewed journals and presented at international conferences.

NCT04791865.

The McMaster Monitoring My Mobility (MacM3) study aims to understand trajectories of mobility decline in later life using multisensor wearable technology. To our knowledge, MacM3 is the first major cohort to combine accelerometry and a Global Positioning System (GPS) to track real-world mobility in community-dwelling older adults.

Between May 2022 and May 2024, MacM3 recruited 1555 community-dwelling older adults (mean age 73.9 years, SD=5.5) from Hamilton and Toronto, Ontario. Of the cohort, 68.4% were female, 62.4% married/partnered, 75.3% had post-secondary education and 62.9% had≥3 comorbidities. Most were Canadian born (69.4%) and white/Caucasian (88.0%), with greater ethnocultural diversity observed at the Toronto site.

At baseline, 56.7% of participants reported no mobility limitations, 15.9% had preclinical limitations and 27.4% had minor mobility limitations. Mean gait speed for the total sample was 1.23 m/s, with a mean Timed Up and Go time of 9.4 s and a 5x sit-to-stand time of 13.0 s. A total of 1301 participants had valid wrist-worn device data, and 1008 participants who agreed to wear the thigh-worn device had valid data (≥7 days with ≥10 hours of wear per day). Step count data (n=1008) revealed a mean of 8437 steps per day (SD=2943), with 5073 steps in the lowest quartile and 12 303 steps in the highest.

Ongoing work aims to develop predictive models of mobility decline by integrating wearable, clinical and environmental data. Pipeline enhancements will enable GPS/inertial measurement unit fusion to explore mobility-environment interactions and support ageing-in-place tools.

The transition from hospital to home can be challenging for parents of premature infants due to a lack of education on specific care. This may lead to both higher readmission rates and healthcare costs. Telehealth interventions can improve the quality of care specific to premature and critically ill newborns. This protocol outlines the WELCOME study and evaluates its feasibility and effectiveness of this approach.

This two-centre randomised control trial (RCT) will assign 240 families with premature and critically ill newborns to an intervention or control group. The study has a parallel group design and an exploratory framework. The control group will receive standard postdischarge care. The intervention group will additionally receive scheduled video consultations, digital assessments and 24/7 access to educational resources. Primary outcomes will focus on 30-day readmission and emergency care use. Secondary outcomes will include child development and parental health. The intervention is expected to be feasible, with high acceptance and minimal drop-out. It will aim to improve parents’ self-efficacy and health literacy. If successful, insights from this multimethod telehealth study will inform standard care.

Results will be published in anonymised and summarised form in international and national journals and symposia. The study received ethical approval from the Ethics Committee of the Ludwig-Maximilians-University Munich (No. 25-0028) and was registered in the German Clinical Trials Register on 6 March 2025 (DRKS00034422).

DRKS00034422.

Improving outcomes from sepsis in children is a WHO Global Health Priority, yet mortality from sepsis remains high, particularly in low- and middle-income countries (LMICs). This database from children with community-acquired childhood sepsis in LMICs and some high-income countries will allow analysis of the burden of disease, including incidence, severity and outcomes. Understanding these aspects of sepsis care is fundamental for the design and conduct of future international interventional trials to improve childhood sepsis outcomes.

This multicountry retrospective observational study will include children up to 18 years of age presenting to emergency departments with suspected sepsis, defined as admission to hospital for treatment with intravenous antibiotics plus (1) a provisional diagnosis of sepsis and/or (2) treatment for suspected sepsis (operationalised as the administration of one or more fluid bolus to treat impaired perfusion or vasoactive infusion). Presenting characteristics, management and outcomes will be collected. These will include vital signs, serum biomarkers, intravenous fluid administration for the first 24 hours of hospitalisation, organ support therapies delivered, antimicrobial use, microbiological diagnoses, hospital and intensive care unit length of stay, and mortality censored at hospital discharge or 30 days from enrolment (whichever occurs first).

Central ethics approval was received from the Royal Children’s Hospital of Melbourne, Australia Human Research Ethics Committee (HREC/100648/RCHM-2023). Each international site will be required to obtain local Institutional Research Ethics Board approval. The findings will be disseminated in peer-reviewed journals, at academic conferences and through lay media. A cleaned study database and individual site-level data will be made available to site investigators upon completion of the study.

This study was registered with the Australian and New Zealand Clinical Trials Registry on 23 January 2024 prior to commencement of recruitment (ACTRN12624000052538).

To evaluate the associations between depressive symptoms, HIV vulnerability factors and oral pre-exposure prophylaxis (PrEP) use and adherence among adolescent girls and young women (AGYW) in Kenya.

Cross-sectional observational study.

Research site in Kisumu, Kenya.

300 AGYW aged 19–24 years (median age 21 years, IQR 20–22), attending follow-up visits in a randomised controlled trial of the efficacy of a single-dose HPV vaccine.

Participants responded to questionnaires assessing their depressive symptoms (Patient Health Questionnaire-9), HIV vulnerability and PrEP use and adherence.

Moderate to severe depressive symptoms were reported by 14.3% (95% CI 10.5% to 18.8%). Factors associated with increased prevalence of depressive symptoms included medium HIV risk perception (adjusted prevalence ratio (aPR) 2.25; 95% CI 1.20 to 4.26) and engaging in transactional sex (aPR 2.51; 95% CI 1.15 to 5.48). The rate of oral PrEP use was 19.3% (n=58, 95% CI 15.0% to 24.0%), with 43.0% reporting adherence (≥5 doses in the past week). Depressive symptoms were not significantly associated with PrEP use (aPR 0.94; 95% CI 0.52 to 1.70).

The high prevalence of depressive symptoms among AGYW highlights the importance of integrating mental health screening into HIV prevention services, particularly for individuals with higher HIV risk perception and those engaging in transactional sex.

Preoperative biliary drainage (PBD) is often required for patients with pancreatic cancer accompanied by biliary obstruction to ensure the safe administration of neoadjuvant chemotherapy or to manage cholangitis and jaundice. Although endoscopic retrograde cholangiopancreatography (ERCP) is the standard approach for PBD, it carries a significant risk of post-ERCP pancreatitis. Endoscopic ultrasound-guided biliary drainage (EUS-BD), particularly via hepaticogastrostomy (EUS-HGS), offers a promising alternative that avoids papillary manipulation. However, the clinical utility of EUS-BD as primary drainage for PBD remains unclear due to a lack of prospective studies. This multicentre prospective trial aims to evaluate the safety and efficacy of EUS-HGS as primary drainage for PBD in patients with resectable or borderline resectable pancreatic cancer.

This multicentre prospective study involves seven institutions in Japan. Eligible patients will undergo EUS-HGS using a 7Fr plastic stent. The primary endpoint is clinical success, defined by improvements in bilirubin or liver enzyme levels within 14 days postprocedure. Secondary endpoints include technical success rate, adverse event incidence, stent patency and surgical outcomes. A total of 30 patients will be enrolled, considering an expected clinical success rate of 90% and a 10% dropout allowance.

This study has been approved by the National Cancer Center Institutional Review Board (Research No. 2024-084). The results of this study will be reported at an international conference and published in an international peer-reviewed journal.

UMIN ID: 000055173.

Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.

The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature

This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.

Japan Registry of Clinical Trials (jRCT1012240051).

Oral HIV pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention for HIV prevention, but its access and utilisation are challenging, especially in high-burden settings such as Kenya. For potential PrEP users, long delays and repeated consultations with several providers are obstacles to both PrEP uptake and continuation. The One-Stop PrEP Care project aims to promote the use of PrEP among clients in the health system and enhance client satisfaction by reducing the waiting time.

We are conducting a 1:1 cluster-randomised trial to evaluate whether One-Stop PrEP Care achieves equivalent or better PrEP outcomes compared with the standard of care model in 12 high-volume HIV clinics in Kisumu County, Kenya. In the One-Stop model, all core PrEP components, including HIV risk evaluation, HIV testing and PrEP dispensing, are provided by one provider in a single consultation room. Programme data from ≥2400 new PrEP clients will be abstracted for 12 months each to obtain primary endpoints of PrEP initiation and continuation. Adherence will be assessed via blood drug level testing. A nested cohort of up to 300 PrEP clients will be enrolled and followed every 3 months to provide in-depth data on individual HIV prevention behaviour, risk perception and how they align PrEP use with perceived risk. We will also evaluate programme costs.

Ethical approval was obtained from the University of Washington Institutional Review Board (IRB) on 8 July 2022 (IRB ID: STUDY00015873) and the Kenya Medical Research Institute Scientific and Ethics Review Unit (SERU) with a letter dated 4 May 2023 (Ref: 4697). Project findings will be shared with stakeholders, including the Ministry of Health, County health officials and participants. Results will be disseminated through manuscripts, policy briefs and health meetings.

Plans for communicating important protocol modifications include timely notifications to all study team members and training on the changes, and updates to relevant stakeholders, including the two IRBs, through protocol amendment submissions.

V. 2.0 dated 21 May 2024.

NCT03194308.

Temperature control is a fundamental intervention for neuroprotection following resuscitation from cardiac arrest. However, evidence regarding the efficacy of hypothermia in post-cardiac arrest syndrome (PCAS) remains unclear. Retrospective studies suggest that the clinical effectiveness of hypothermia may depend on the severity of PCAS. The R-CAST OHCA trial aims to compare the efficacy of hypothermia versus normothermia in improving 30-day neurological outcomes in patients with moderately severe PCAS following out-of-hospital cardiac arrest.

The multicentre, single-blind, parallel-group, superiority, randomised controlled trial (RCT) is conducted with the participation of 35 emergency and critical care centres and/or intensive care units at academic and non-academic hospitals. The study enrols moderately severe PCAS patients, defined as those with a revised post-Cardiac Arrest Syndrome for induced Therapeutic Hypothermia score of 5.5–15.5. A target number of 380 participants will be enrolled. Participants are randomised to undergo either hypothermia or normothermia within 3 hours after return of spontaneous circulation. Patients in the hypothermia group are cooled and maintained at 34°C until 28 hours post-randomisation, followed by rewarming to 37°C at a rate of 0.25°C/hour. Patients in the normothermia group are maintained at normothermia (36.5°C–37.7°C). Total periods of intervention, including the cooling, maintenance and rewarming phases, will occur 40 hours after randomisation. Other treatments for PCAS can be determined by the treating physicians. The primary outcome is a favourable neurological outcome, defined as Cerebral Performance Category 1 or 2 at 30 days after randomisation and compared using an intention-to-treat analysis.

This study has been approved by the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee (approval number: R2201-001). Written informed consent is obtained from all participants or their authorised surrogates. Results will be disseminated via publications and presentations.

jRCT1062220035.

To estimate type 2 diabetes incidence trends by sex and socioeconomic position (SEP) and evaluate trends in SEP-related inequalities in incidence.

Ecological study using ambulatory claims data and regression-based modelling.

All 401 counties in Germany, covering the entire country.

All individuals with statutory health insurance (~85% of the population). Incident cases of type 2 diabetes were identified annually from 2014 to 2019 using the International Statistical Classification of Diseases and Related Health Problems, 10th revision codes.

Incident type 2 diabetes at the county level, adjusted for age and modelled using a mixed negative binomial regression. SEP was measured using the German Index of Socioeconomic Deprivation, and a random intercept accounted for county-level heterogeneity.

The incidence of type 2 diabetes decreased between 2014 and 2017 and plateaued thereafter. Trends were similar between sexes and deprivation levels. The greatest difference was observed between high and low deprivation, with an incidence rate ratio of 1.20 (95% CI: 1.14 to 1.27) among men and 1.21 (95% CI: 1.14 to 1.27) among women in 2014.

There was a positive trend in the decline in age-adjusted type 2 diabetes incidence between 2014 and 2019. However, social inequality persisted with deprived groups at higher risk of type 2 diabetes. The level of inequality was comparable between men and women. Continued monitoring is essential to assess whether these short-term trends persist over time.

Pre-eclampsia causes significant maternal and perinatal morbidity and mortality. It also causes changes in the cardiovascular, endothelial and metabolic systems, from which women may not fully recover after delivery. This study examined the association between the time of onset of pre-eclampsia and the risk for cardiovascular disease (using glucose tolerance, lipid profile and blood pressure) and renal function at 6 weeks post partum.

A prospective cohort study.

Lagos University Teaching Hospital, Idi-Araba, Mother and Child Centre, Gbaja, Surulere and Lagos Island Maternity Hospital, Lagos, Nigeria.

44 women with pre-eclampsia were studied and data on their sociodemographic characteristics, gestational age at diagnosis and blood pressure were collected on admission. They were followed up through delivery till 6 weeks post partum, when blood pressure check, 75 g oral glucose tolerance test, fasting lipid profile and serum creatinine were done.

The exposure was pre-eclampsia. The outcomes were cardiovascular disease risk markers, viz persistent hypertension, glucose intolerance and dyslipidaemia, and renal function at 6 weeks post partum in women who had pre-eclampsia.

Data were analysed using Stata V.16.1. Mann Whitney-U test was used to compare medians and Fisher's exact test was used to compare the categorical variables.

Of the women studied, 13 (29.5%) had early onset pre-eclampsia and 31 (70.5%) had late onset pre-eclampsia. Mean gestational age at diagnosis was 30.8±1.57 weeks in women with early-onset pre-eclampsia and 35.6±1.26 weeks in women with late-onset pre-eclampsia (p

The prevalence of persistent hypertension at 6 weeks post partum is high in women with pre-eclampsia. Serum triglyceride concentration was significantly higher in early onset compared with late onset pre-eclampsia; subsequent studies powered to determine the full cardiovascular risk and how long to follow postnatal women up will be beneficial.