Primary aldosteronism (PA) is a highly prevalent but underdiagnosed cause of hypertension, characterised by renin-independent aldosterone production. PA is associated with a higher incidence of cardiovascular and kidney complications, independent of blood pressure. Although mineralocorticoid receptor antagonists (MRAs) are the standard treatment when surgical adrenalectomy is not clinically indicated or possible, response is typically monitored using indirect clinical markers such as blood pressure and potassium. Emerging evidence suggests that achieving renin unsuppression may result in better outcomes, yet this hypothesis has not been tested in a randomised controlled trial. The objective of this trial is to evaluate whether a renin-guided MRA titration strategy improves biochemical efficacy compared with standard titration in patients with PA.

This is a multicentre, open-label, pragmatic randomised controlled trial in four academic centres in Canada. 58 adults with confirmed PA, suppressed renin at baseline, and an indication for long-term MRA therapy will be enrolled. Key exclusion criteria include prior MRA use, estimated glomerular filtration rate 4.8 mmol/L and pregnancy. The primary endpoint is the proportion of participants with unsuppressed renin at 12 months. Secondary outcomes include blood pressure, left ventricular mass, kidney function, MRA dose, quality of life and various safety outcomes. Participants will be randomised 1:1 to a renin-guided titration strategy or standard care. In the intervention arm, MRAs will be titrated to achieve unsuppressed renin (>10 ng/L, >15 mIU/L or >1.0 ng/mL/hour). The control arm follows usual clinical practice, without serial renin measurements during dose titration. All participants will be followed for 12 months, with visits at 1, 3, 6, 9 and 12 months. Analysis will follow the intention-to-treat principle and use Fisher’s exact test for proportions, mixed-effects models for continuous outcomes and Kaplan-Meier estimates for time-to-event data. The trial is powered to detect a 42% absolute difference in the primary outcome (40% in the control groups vs 82% in the experimental group; alpha 0.05, 80% power, 15% loss to follow-up). This trial will be the first to prospectively assess the biochemical efficacy of a renin-guided MRA titration strategy in PA. If successful, the next phase will be to assess the efficacy of this strategy on important surrogate outcomes and patient-reported outcome measures.

This study was approved by the Research and Ethics Board of the Centre intégré universitaire de santé et de services sociaux du Nord-de-l’Île-de-Montréal (project number 2024-2727). All the participating sites have received the ethics approval. The findings will be disseminated through national and international presentations and peer-reviewed publications.

NCT06108427.

The Veterans Health Administration (VA) integrated mental and physical health services to better detect and treat depression. Primary care nurses conduct screening annually. Clinicians, including Primary Care Mental Health Integration (PCMHI) specialists, follow-up as needed for treatment. Depression detection and management processes are complex, involve multilevel stakeholders, and are subject to significant disruption from COVID-19 and from the resulting expansion of telehealth, aiming to preserve care access. This study aimed to examine whether the COVID-19 pandemic worsened depression-related care quality and/or patient outcomes (eg, suicide).

Given hypothesised care disruption (lowered care quality) during COVID-19, we will first assess the VA population’s trajectory from a new positive depression (and suicide risk) screen to appropriate treatment (ie, medication, therapy) in the Fiscal Year 2019–2323. We will also examine the changing mix of virtual and in-person depression care delivered. Second, we will use interrupted time series analyses to explore the extent to which psychiatric emergency visits and hospitalisations may be mitigated by clinician detection of depression. As well as compare mental health-related mortality rates between patients detected and not detected to have depression. Subanalyses will reveal where (eg, clinics with low PCMHI access) and for whom (eg, minorities) detection does not systematically occur, and downstream negative sequelae, to guide future intervention. Finally, we will interview 40 veterans, half of whom were detected and half not detected to have depression and 40 VA primary care and PCMHI providers about changes brought on by the pandemic and the expansion of virtual care across three VA facilities. In addition to contextualising disrupted care findings, qualitative data will help identify best practices on patient-to-provider and provider-to-provider interactions in hybrid in-person/telehealth depression care models.

Ethics approval was granted by the VA Greater Los Angeles Healthcare System Institutional Review Board. Alongside journal publications, dissemination activities include briefings to our policy and operational partners, and presentations to clinical, research and policy-oriented audiences.

On 1 January 2023, Ontario expanded pharmacists’ scope of practice, allowing them to prescribe medications for 13 minor ailments, including antibiotics for uncomplicated urinary tract infections (UTIs) and Lyme disease (LD) prophylaxis. This study evaluates pharmacist billing claims and pharmacist and physician antibiotic-prescribing rates before and after policy implementation.

An interrupted time series analysis measuring changes in prescribing trends post-implementation.

This retrospective study analysed visit claims and antibiotic prescribing for UTIs and LD prophylaxis before policy implementation (2022) and after (2023–2024) in Ontario.

Data from Ontarians

Prescribing rates were standardised per 1000 inhabitants, stratified by provider type, patient age and sex, and antibiotic type.

In 2023 and 2024, pharmacists submitted over 1.47 million minor ailment claims, with UTIs making up 34.2% and LD prophylaxis making up 2.6% of total claims. UTI claims were primarily for women aged 25–64, and LD prophylaxis peaked in spring and fall. Pharmacist prescribing of eligible urinary drugs in females increased by 33.3 per 1000 person-years (95% CI 30.8 to 36.6) while physician prescribing decreased by 23.3 (95% CI –32.2 to –15.3), leading to a modest net increase of 10.1 (95% CI 0.0 to 18.7). Pharmacist prescribing of doxycycline was offset by decreased physician prescribing, resulting in no change (0.0, 95% CI –1.0 to 0.9). Pharmacist prescribing for other antibiotics was low over the study timeframe, while physician prescribing increased, which was driven by increased prescribing of penicillins and macrolides.

There was a clear increase in pharmacist prescribing for eligible drugs in the eligible population post-policy implementation. Pharmacists in Ontario appear to be prescribing within policy limits for uncomplicated UTIs and LD prophylaxis.

Neutropenic fever (NF) has a crude mortality rate of 3–18%. International guidelines recommend that all patients with NF receive ultrabroad-spectrum antibiotics (UBSAs) within 1 hour of emergency department (ED) registration. However, over 70% patients presenting to hospital with suspected NF (sNF) cannot access absolute neutrophil count (ANC) result within 1 hour, do not have NF and do not require UBSAs. In ED and hospitalised patients with sNF, we hypothesise that the ASTERIC protocol effectively and safely reduces the use of UBSAs compared with standard care alone.

This pragmatic, parallel, multicentre, type 1, hybrid effectiveness-implementation, stepped-wedge, before-and-after, cluster randomised controlled trial aims to evaluate whether antibiotic prescribing can be safely reduced through implementing a multifaceted antibiotic stewardship intervention (ASTERIC) in adult patients with sNF presenting to EDs. The sNF was defined as a fever with a single oral temperature of ≥38.3°C (101°F) within 24 hours before ED registration or a temperature of ≥38.0°C (100.4°F) sustained over a 1-hour period, following last chemotherapy or targeted therapy within 6 weeks for any solid tumour, or in any period following therapies against leucaemia, lymphoma, myelodysplastic syndrome, aplastic anaemia, multiple myeloma or recipient of HSCT. The study will involve eight hospitals in Hong Kong with variable baseline practice. We will include 704 adult patients (352 patients in pre-implementation and post-implementation periods, respectively) with sNF (tympanic temperature ≥38.3°C) and 48 staff participants (6 staff participants in each hospital). Healthcare professionals will receive a multifaceted stewardship intervention consisting of risk assessment tools, fast-track ANCs, a decision tool for patient management and antibiotic use, supported by an educational package and staff interaction programmes (ASTERIC protocol). Patients’ blood ANC, and cancer therapy and chronic illness therapy scores will be measured. The RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) and Proctor conceptual frameworks will be followed for evaluation of implementation. The main outcome measures are the mean total dose of UBSAs prescribed in 7 days and serious adverse events at 30 days. Data analysis will incorporate intention-to-treat, per-protocol and as-treated analyses for service outcomes (effectiveness, safety, quality of life assessments and cost-effectiveness) and mixed methods for implementation outcomes, informed by the Theoretical Domains Framework. We expect that the study results will inform health policy with improvement in hospital services in treating stable sNF, evidenced by improved safe antibiotic stewardship, early antibiotic de-escalation and reduced costs and length of stay.

The institutional review boards of all study sites approved this study. This study will establish the ASTERIC protocol safely improves antibiotic stewardship and clinical management in adult patients with sNF. We will disseminate the findings through peer-reviewed publications, conference presentations and educational activities. All patients with sNF will be influenced by the new protocol which is agreed at hospital level. Randomisation is at hospital level, not patient level. Patient consent is sought for follow-up and data access, not for treatment. Staff consent is sought for interviewing.

NCT06794320.

Infant feeding practices in the first 2 years of life are linked to long-term weight trajectories. Despite the importance of obesity prevention interventions, there are no randomised controlled trials (RCTs) evaluating early childhood education and care (ECEC) and primary caregiver-targeted interventions on child weight and feeding outcomes.

To assess the efficacy of an 18-month digital health intervention (Tiny Bites) delivered to ECEC services and primary caregivers of children aged 4 to ≤12 months on child age-adjusted and sex-adjusted body mass index-for-age z-score (zBMI) relative to usual care control in the Hunter New England (HNE) region of New South Wales, Australia.

This type 1 hybrid cluster RCT will include up to 60 ECEC services and 540 children/caregiver dyads. The intervention supports ECEC services and caregivers to deliver recommended responsive feeding practices to infants. ECEC services will receive access to an online assessment platform, training and resources, and implementation support. Primary caregivers will receive text messages, monthly e-newsletters, online links and direct communication from ECEC services. We will assess the impact on child zBMI at 18-month follow-up. Secondary outcomes include duration of consuming any breastmilk, child diet and caregiver responsive feeding practices. We will also assess ECEC policy and practice implementation related to targeted feeding practices, programme cost effectiveness, adverse effects and engagement with the programme (ECECs and caregivers). For the primary outcome, between-group differences will be assessed for paired data using two-level hierarchical linear regression models.

Ethics approval has been provided by HNE Human Research Ethics Committee (HREC) (2023/ETH01158), Deakin University (2024-202) and University of Newcastle HREC (R-2024-0039). Trial results will be submitted for publication in peer-reviewed journals, presented at scientific conferences locally and internationally and to relevant practice stakeholders.

ACTRN12624000576527.

Inequities in health status exist in New Zealand across the rural–urban spectrum. In parallel, rural–urban differences in health service utilisation vary by service type. Despite the New Zealand public health system being based on principles of universal access, equity and fairness, levels of health expenditure on rural and urban populations are not well understood. The purpose of the study is to undertake a rural–urban analysis of public health system expenditure, based on individual-level service utilisation and national pricing of health service events.

Individual-level service utilisation and pricing will be collated from national collection databases for all eligible users of publicly funded services. The analysis will include calendar years 2017–2024. Descriptive analysis and a two-part generalised linear regression model will be used to identify if rural–urban differences in expenditure exist, and what the association of rurality is with expenditure (if any). The model will also be used to identify geographic regions with expenditure levels that vary from those predicted using regression model weights. As the specific statistical approach will be determined by data attributes, this protocol outlines the intended approach to construct the analytical model.

Ethics approval was obtained from the University of Otago Human Research Ethics Committee (HD23/052). Māori consultation has been undertaken with the Ngāi Tahu Research Consultation Committee and will continue throughout the research process.

Healthcare workers (HCWs) report overwhelming demands and experience crisis levels of burnout and unique challenges that further impair their mental health. Promotion of mental health among HCWs using information and communication technology (ICT) has received little empirical research attention and interventions for improving mental health resilience in HCWs are not well established.

Scoping review to map existing evidence and identify gaps for future research regarding the main barriers and facilitators of the acceptance of ICT-based interventions for improving resilience and mental health among HCWs working in all healthcare settings.

This protocol was developed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews guidelines. A comprehensive bibliographic search will be conducted between October 2024 and October 2025 in Pubmed, Web of Science, PsycINFO, Scopus, Cochrane Library and CINAHL Ultimate (MedicLatina, Psychology and Behavioural Sciences Collection), with the assistance of a qualified research librarian, to retrieve studies describing data on the main barriers and facilitators to the acceptance of ICT-based interventions for improving resilience and mental health among HCWs working in healthcare settings. There will be no restrictions based on date of publication or language. Inclusion and exclusion criteria will be defined for each element of the PICO(D) framework, and both quantitative and qualitative data will be extracted. Quality will be assessed using the mixed methods assessment tool. Two independent investigators will perform the eligibility assessment and data extraction, and any disagreements will be resolved by a third reviewer. The main results will be narratively synthesised and analysed.

Since secondary data will be analysed, no ethical approval is required. The results will be disseminated through publications subject to peer review.

https://doi.org/10.17605/OSF.IO/5R36Q.

To assess predictors of timely transition to adult diabetes care among individuals diagnosed with type 1 diabetes during childhood and adolescence. We hypothesised that older age at the last paediatric visit and urban residency would be predictors of timely transition.

Retrospective cohort study using healthcare administrative data in a jurisdiction with a universal healthcare system.

2045 adolescents and young adults diagnosed with type 1 diabetes between the ages of 0.5 and 18 years.

We ascertained age at the last paediatric diabetes visit (LPDV), age at the first adult diabetes visit (FADV) and transition duration, defined as the time between LPDV and FADV. Timely transition was defined as a transition duration of

Only 31.3% of individuals saw an adult provider within 1 year of their LPDV. Each 1-year increase in the age at LPDV was associated with increased odds of timely transition (adjusted OR 1.82, 95% CI 1.71 to 1.93, p0.05).

Older age at the LPDV and urban residency are associated with increased odds of timely transition. Interventions should be developed to help keep adolescents engaged in paediatric care until an older age before referring them to adult diabetes care. Limitations of this study include unmeasured confounding and limited generalisability to non-universal healthcare systems.

Various psychological, cognitive, behavioural, medication and neurostimulation treatments can improve the outcomes of people with depressive and anxiety disorders. However, in usual practice, there is large variability in treatment delivery and treatments are poorly characterised. The effectiveness and quality of mental health services in the community are not accurately monitored and are poorly understood. At present, healthcare organisations, payers and policy makers know little about the quality of care they support. Similarly, patients and families have limited information on quality to guide choice of provider or organisation. It will be necessary to implement monitoring of treatment quality so that treatment and outcomes can be improved. This study develops, tests and validates a new, transdiagnostic outcome-focused mental health quality measure. This measure is based on routine, regular patient reports of their symptoms. It is designed to be aggregated at the provider, clinic, organisation or plan level; inform choice of provider; and be used to improve routine delivery of services and quality of care among patients with common psychiatric disorders.

The project analyses existing data with responses to a wide variety of items that are known to assess depression or anxiety and empirically selects symptom items for a transdiagnostic outcome-focused quality measure. The project informs risk adjustment and benchmarking of the quality measure by studying how patient, provider and practice factors, including health-related social needs, baseline symptom severity and diagnoses, affect outcomes. Drawing on these, the project specifies an outcome-focused quality measure that includes risk adjustment and benchmarks for improvement; and studies, at practices nationally, its feasibility and psychometric properties, the effect of treatment characteristics on the quality of care, and the effect of quality on health-related quality of life.

Results will be published. The quality measure is designed to be broadly relevant across community settings and populations and to be submitted for endorsement by regulatory and governing bodies.