Risk screening for pre-eclampsia relies on accurate gestational age assessment, but routine access to ultrasound-based gestational dating remains challenging in many low- and middle-income countries. As part of the formative work for the ‘Preventing pre-eclampsia: Evaluating AspiRin Low-dose regimens following risk Screening’ (PEARLS) platform, we aim to validate and implement an artificial intelligence (AI)-based algorithm for estimation of gestational age, using blind sweeps done with a handheld ultrasound device. This study protocol outlines the accuracy cohort for AI-based gestational age estimation in participating facilities in Ghana, Kenya and South Africa.

This multicountry prospective cohort study will recruit 969 pregnant women at 13 health facilities across Kenya, Ghana and South Africa. The eligible population is pregnant women presenting for antenatal visits from 11⁺⁰ to 13⁺⁶ weeks’ gestation. Eligible women will have a gestational age assessment by a trained sonographer using fetal biometry (reference standard), followed by gestational age estimation conducted by a trained midwife using the AI-based Intelligent Ultrasound ScanNav FetalCheck system (experimental). Both conventional and AI-based gestational age scans will be conducted with the General Electric VScan Air platform. Women will return for a second visit between 14⁺⁰ and 27⁺⁶ weeks’ gestation (week of visit is randomly selected) for an assessment with both conventional and AI-based ultrasound. The primary objective is to determine the accuracy and precision of gestational age estimation using an AI ultrasound system in first and second trimesters, as compared with gestational age estimation using crown-rump length measurement by conventional ultrasound in first trimester (11⁺⁰ to 13⁺⁶ weeks’).

This study has received or sought ethics approval from the following entities: Australia: University of Melbourne, Office of Research Ethics and Integrity (Reference Number: 2024–28489-49438-3) and the Alfred Hospital Ethics Committee (Reference: Project 727/23); Ghana: Ghana Health Service Ethics Review Committee (GHS-ERC Number 002/01/24); Kenya: Kenyatta National Hospital, University of Nairobi ERC (Ref: KNH-ERC/01/MISC/20); South Africa: University of Cape Town, Faculty of Health Science, Human Research Ethics Committee (HREC Ref: 138/2024). Key findings will be disseminated to research teams to inform future scale-up of AI-based pregnancy dating and pre-eclampsia risk screening. Findings from this pilot work will be published in peer-reviewed open-access journals, conferences and meetings to maximise reach of our findings.

Chronic pain is a leading public health problem, impacting over 1.5 billion people worldwide. Standard-of-care includes pharmaceutical medication, surgery and physical therapy, yet many patients experience continued symptoms. Investigation into lifestyle-based approaches such as dietary interventions has increased in recent years, including intermittent fasting, due to known impacts on inflammation and neurotransmitters.

This systematic review and meta-analysis will be conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The literature search will include the PubMed/MEDLINE, Embase (Ovid), Web of Science (Core Collection) and LILACS (VHL) databases. The Google Scholar, ClinicalTrials.gov, PROSPERO, Open Science Forum and MedRXiv platforms will also be searched. Randomised, controlled trials investigating the impact of intermittent fasting interventions in adult humans with any chronic pain condition will be included. The primary outcomes will be self-reported pain or function and the secondary outcome will be rescue medication use. Study screening, data extraction and risk of bias assessment will be conducted independently in duplicate. The Cochrane Risk of Bias-2 tool will be used to assess bias at the study level, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) guidelines will be used to assess bias at the outcome level. The meta-analysis will use random effects, with heterogeneity assessed using the I² statistic. For studies that report rescue medication use, we will analyse the impact of intermittent fasting on pain or function, adjusting for rescue medication use, using established methods. Subgroup and sensitivity analyses will be conducted to explore heterogeneity.

As this project involves analysis of publicly available data, no ethical oversight was or is required. The results of this review will be disseminated by publication in a peer-reviewed journal.

CRD #420261395061.

To describe antibacterial consumption (ABC) in four paediatric inpatient facilities in Sri Lanka in 2023.

Descriptive cross-sectional study, adapted from the WHO Global Antimicrobial Resistance and Use Surveillance System methodology.

Paediatric inpatient facilities in two tertiary and two secondary care government hospitals located across three provinces.

Data on antibacterials for systemic use, J01 in the Anatomical Therapeutic Chemical (ATC) classification issued to these paediatric inpatient facilities in 2023 by their respective hospital pharmacies.

(1) ABC at ATC third and fifth levels expressed as defined daily doses (DDDs)/100 admissions, (2) ABC as per WHO ‘Access, Watch and Reserve’ category, (3) choice of antibacterials within a class, (4) DU 75% for oral and parenteral dosage forms, (5) quality indicators such as amoxicillin index and broad:narrow spectrum ratio.

In 2023, total antibacterial (J01) consumption across the four paediatric inpatient facilities was 94.49 DDDs/100 admissions. Together, non-penicillin beta-lactams, penicillins and macrolides/lincosamides/streptogramins accounted for 90–98%. Co-amoxiclav was the most consumed antibacterial, and six agents (co-amoxiclav, cefotaxime, clarithromycin, azithromycin, cefuroxime and meropenem) collectively accounted for 70–90%. Aminoglycosides, tetracyclines, sulfonamides and trimethoprim, and quinolones contributed minimally. Access and Watch group antibacterials accounted for 34 and 65%. Quality indicators demonstrated disproportionately higher use of broad-spectrum and Watch group antibacterials.

High use of broad-spectrum and Watch-group antibacterials was observed across the four paediatric inpatient facilities. The findings highlight targets for antibacterial stewardship programmes and demonstrate the feasibility of ABC surveillance in Sri Lanka.

During pregnancy, physiological and psychological factors influence eating behaviour and food preferences. Food cravings are common in pregnancy and contribute to excessive gestational weight gain (GWG). Excessive GWG is present across all body mass index (BMI) categories and is associated with adverse outcomes. Outside of pregnancy, highly palatable food cues activate brain regions involved in reward and attention, which may influence eating behaviour and behavioural responses. However, brain and behavioural responses to food cues across pregnancy, and their association with psychological and metabolic factors, remain poorly understood. This study aims to investigate spatiotemporal brain responses to visual food cues across individuals with different BMI categories and their associations with behavioural, psychological and metabolic outcomes during pregnancy.

This is a prospective observational cohort study conducted at the Lausanne University Hospital, Switzerland. 94 pregnant individuals (47 healthy normal weight and 47 with overweight/obesity) will be assessed at 12–16 and 31–36 weeks of gestational age from November 2024 to September 2026. Data collected for the primary outcomes include electroencephalography-based brain responses to validated visual food cues varying in fat and carbohydrate content, behavioural responses to the same cues using a gamified smartphone Go/NoGo task. Secondary validated outcomes include heart rate variability (Actiheart), body composition (InBody S10), glycated haemoglobin (Afinion), cardiorespiratory fitness (The Chester step test), snack intake, eating behaviour (Intuitive Eating Scale-2, Three-Factor Eating Questionnaire-Revised), food cravings (Food Craving Questionnaire-state), mood and depressive symptoms (Edinburgh Postnatal Depression Scale). Statistical analyses include group comparisons, longitudinal analyses and regression models adjusted for potential sociodemographic/medical confounders.

All participants will provide written informed consent. The Human Research Ethics Committee of the Canton de Vaud approved the study protocol (CER-VD 2023-01462). Findings will be disseminated through peer-reviewed publications, (inter)national conferences and shared with healthcare professionals and stakeholders to inform strategies for improving maternal health.

Anastomotic leak is a major complication after anterior resection for rectal cancer, with reported rates of 10–15%. Recent evidence implicates the gut microbiome, where specific bacteria colonise the anastomotic site and secrete collagenase that weakens healing tissue. Preclinical studies demonstrate that tranexamic acid can inhibit this process when delivered rectally into the bowel lumen. This protocol outlines a feasibility trial of rectally administered tranexamic acid delivered via rectal catheter to the anastomotic site after anterior resection, accompanied by embedded microbiome and qualitative substudies.

This is an open-label, single-centre, randomised controlled feasibility trial. 45 patients undergoing anterior resection for rectal or sigmoid cancer will be randomised 2:1 to receive tranexamic acid or sterile water, administered intraoperatively and on postoperative days 1–3 via a rectal catheter. Feasibility outcomes include assessment of recruitment, intervention adherence, protocol compliance and safety. Exploratory clinical outcomes include anastomotic leak and other postoperative complications. A mandatory microbiome substudy will characterise changes in microbial composition and bacterial collagenase activity, providing mechanistic insight into treatment response. An optional qualitative substudy will explore acceptability of the intervention from the perspectives of patients and healthcare professionals.

The protocol was approved by the North West Liverpool Central Research Ethics Committee and the Medicines and Healthcare products Regulatory Agency on 30 October 2024 (24/NW/0254). Recruitment commenced on 7 January 2025 following receipt of site-specific approvals. Feasibility, mechanistic and qualitative findings will be disseminated through peer-reviewed publications, academic conferences and stakeholder engagement activities. The results will inform progression to a definitive phase III trial and shape key elements of study design.

ISRCTN13727659.

The diagnostic and therapeutic landscape for high-risk localised prostate cancer and synchronous metastatic hormone-sensitive prostate cancer (mHSPC) is rapidly evolving, driven by advances in imaging, risk stratification and systemic therapies, including the advent of precision medicine. High-quality real-world data integrating clinical, imaging, molecular, quality-of-life information and outcome data remain scarce. The PROspective Prostate Cancer Infrastructure (ProPCI) is a nationwide, multicentre observational cohort designed to collect comprehensive longitudinal data and biomaterials to support real-world evidence generation, facilitate biomarker discovery and enable future cohort multiple randomised controlled trials (cmRCTs).

ProPCI includes adult men with high-risk localised prostate cancer or synchronous mHSPC across hospitals in the Netherlands. Clinical data are extracted from electronic health records using a standardised protocol and linked to national registries and healthcare use datasets. Patient-reported outcome measures are collected at baseline and regular intervals using validated instruments. Serial blood samples are biobanked for circulating tumour DNA and other molecular analyses. Outcomes include diagnostic and treatment patterns, Prostate-specific antigen kinetics, time to castration-resistant prostate cancer, radiological and clinical progression, health-related quality of life trajectories and healthcare use, including expenditure and exploratory biomarker associations. Statistical methods include descriptive analyses, time-to-event models, mixed-effects models and biomarker-outcome correlates.

Ethical approval has been obtained from the Committee on Research Involving Human Subjects (CMO) of Radboudumc. Written informed consent will be obtained from every participating patient and covers: (1) extraction and linkage of clinical, imaging, pathology and registry data, (2) future contact for potential cmRCT participation; and optional components (3) quality-of-life questionnaires, (4) collection of additional blood samples and (5) use of biomaterials for genomic testing. Results will be disseminated through peer-reviewed publications.

NCT07560748.

This study assessed the feasibility of both the delivery and evaluation of ‘enhanced’ (behaviourally informed) text message reminders containing links to existing co-designed resources supporting decision-making for people with severe mental illness (SMI) regarding attendance of cervical screening.

A pilot randomised controlled trial (RCT).

13 General Practice (GP) practices in London were recruited.

GP practices identified people with SMI aged 24–64 years who were overdue cervical screening. Target sample size was 120 participants (60 per arm) based on existing guidance for pilot trials.

In March 2025, participants were randomised (1:1) to receive either the enhanced (intervention) or the standard (control) SMS reminder.

18 weeks later, feasibility outcomes were collected (primary outcomes) and data analysis for a definitive RCT was rehearsed (secondary outcome).

Of the 150 participants across 13 GP practices that were randomised (n=75 per arm), 132 (88%) texts delivered (intervention n=64/75 (85%), control n=68/75 (91%)). 10 practices (76.9%) provided follow-up data for 102 participants (intervention n=50, control n=52). Five participants (intervention n=4, control n=1) attended screening within the trial period. Participant survey response rate was low (9/132 (7%), intervention n=5, control n=4). Both SMS messages were low cost, with the intervention SMS a 50% higher cost to deliver (7.5p vs 5p per SMS). Primary feasibility measures of recruitment rate of GP practices (27%), retention of GP practices (77%) and participants (100%), SMS delivery (88%) and data completeness (64%) indicated viability, although survey response rate (7%) did not.

Achieving adequate recruitment and retention, data completeness and comparable groups is viable with some amendments, although an alternative method is required to assess fidelity. Behaviourally informed SMS reminders are feasible to deliver to people with SMI, although it is uncertain if the extra resources are accessed and used. With changes to data collection, a definitive trial could be feasible. Given the low observed cervical screening attendance, additional intervention is needed for this group.

ISRCTN12558681.

This study examined social determinants and structural barriers to lung cancer outcomes in Kern and Fresno counties, California, and co-developed a multilevel intervention strategy informed by community perspectives.

Engaging stakeholders through group model building (GMB) to elicit their knowledge to build a system dynamics (SD) simulation model for intervention strategy design.

We identified and trained four community members from two community-based organisations in Central Valley, California, to help recruit GMB participants. 14 community members representing patient advocacy organisations, cancer survivors, clinicians, caregivers, public health professionals, medical interpreters, housing, agriculture, sanitation, healthcare payer organisations and local policymaking sectors were recruited.

The GMB protocol consisted of two in-person and four virtual workshops from 22 August to 11 November 2024. The SD simulation model was built with iSee System’s Stella Architect SD modelling software (V.4.0).

The 181 variables suggested by the GMB workshop participants were categorised into 3 themes and 13 subthemes, which shaped the system boundary and model structure. 7 of the 16 intervention scenarios tested showed a cumulative reduction in the at-risk population and increases in screening, diagnoses, treatment and cancer-free survival. Participants selected a multilevel strategy focused on expanding public health and insurance education and advocating for air pollution-related screening within existing protocols.

Community engagement is essential for understanding lung cancer disparities and designing practical multilevel interventions. Scenario testing enables informed planning to improve long-term population health outcomes.

Type 2 diabetes (T2DM) and cognitive impairment are common long-term chronic conditions affecting older people in hospital. Cognitive impairment can complicate glucose monitoring and lead to diabetes-related emergencies in T2DM. Traditionally, point of care test measurements of capillary blood glucose are conducted in-hospital for T2DM while continuous glucose monitoring (CGM) is not widely used.

To understand the feasibility, acceptability and tolerability of using CGM in older inpatients with T2DM and cognitive impairment.

32 older people (mean age=78.7±6.7 years) with comorbid T2DM and cognitive impairment (Abbreviated Mini-Mental Test ≤8/10 and Mini-Addenbrooke’s Cognitive Examination ≤22/30) were recruited within a tertiary care hospital in the UK. All participants were naive to CGM and were asked to wear blinded Dexcom G7 sensors for up to 10 days. Participants were asked about feasibility, acceptability and tolerability questions at the point of sensor removal.

29 participants (96%) reported no pain during CGM fitting. All participants (100%) agreed that they did not notice wearing the sensor, and it did not affect their day-to-day hospital activities. All participants (100%) found it ‘very easy’ or ‘easy’ to have the sensor fitted and wearing it for 10 days, with 27 participants (90%) finding CGM convenient. 17 participants (57%) reported favourable perceptions of the subcutaneous sensor sensation.

CGM use in older inpatients with T2DM and cognitive impairment is highly feasible and acceptable for patients. Future studies and trials are now needed to evaluate the clinical use of CGM for glucose monitoring in hospitalised or community-dwelling older individuals with T2DM and cognitive impairment.

This study aimed to explore and synthesise interpreters’ perspectives on the provision of sexual and reproductive health (SRH) care to Eritrean and Somali migrant women in Switzerland, and to identify and analyse the professional and ethical challenges they encounter in this context.

An exploratory qualitative study from a social constructionist perspective. The interviews were recorded, transcribed, categorised and analysed through thematic analysis.

The study was conducted in the canton of Basel-Stadt, northwestern Switzerland. We have purposively selected 10 Eritrean and Somali intercultural interpreters serving as crucial intermediaries in assisting immigrant women to access SRH services.

Our analysis of the interpreters’ perspectives revealed three key thematic areas that they identified as central challenges for their Eritrean and Somali immigrant women: (1) perceived limited health literacy among patients, (2) sociocultural barriers that interpreters observed hindering patient provider communication and (3) structural difficulties that interpreters reported their patients faced in navigating the Swiss healthcare system. These challenges have now persisted for a long time, and research findings and recommendations do not appear to have changed practices. For example, while abortion services are fully covered by Swiss health insurance, contraceptive methods often require out-of-pocket payments. This financial disparity may discourage appropriate use of SRH services among immigrant women. The lack of culturally competent care and the limited availability of funding for intercultural interpreters were among important bottlenecks identified.

This study explored interpreters’ perspectives on the provision of SRH care to Eritrean and Somali immigrant women in Switzerland. Despite the outstanding Swiss healthcare system, a majority of Eritrean and Somali refugee women struggle to benefit from SRH services due to limited health literacy, language barriers and challenges in navigating the Swiss healthcare system. Partnerships and integration of community entities, such as the Swisso-Kalmo association for Somali women and different Eritrean communities, could contribute via facilitating entry points for access to SRH healthcare.

Life expectancy for people with type 1 diabetes has increased due to improved treatment of diabetes and its comorbidities, allowing many to reach old age. Still, we lack knowledge of how individuals with type 1 diabetes age. On one hand, those who reach older age can be considered survivors, but on the other hand their long-standing diabetes might still exhibit negative impacts on their health and functional ability. Healthy ageing is the WHO’s priority for this decade. The focus has shifted from chronological age to functional ability, which reflects the ability of individuals to perform meaningful activities. Functional ability is shaped by intrinsic capacity, the environment and their interaction. Intrinsic capacity encompasses five main domains: cognition, vitality, sensory function, locomotion and psychological domain. This observational study aims to assess how this vulnerable group of individuals with type 1 diabetes age and to identify factors that contribute to their healthy ageing, intrinsic capacity and its domains.

The FinnDiane LifeOne Study is a prospective observational cohort study. We aim to recruit a minimum of 300 individuals with type 1 diabetes from the FinnDiane Study, aged >65 and a minimum of 100 matched controls without insulin-dependent diabetes. The cohort will be comprehensively characterised, including clinical assessment, laboratory tests, questionnaires and a geriatric assessment of different aspects of functioning ability, with 5 years intervals. We will compare the individuals with type 1 diabetes to their matched controls. For those with type 1 diabetes, we will further assess which factors from the FinnDiane baseline and trajectories during follow-up predict healthy ageing in above 65-year-olds.

The LifeOne Study protocol is approved by the Ethics Committee of HUS Helsinki University Hospital (HUS/4387/2023) and the study adheres to the Declaration of Helsinki. Written informed consent is obtained from each participant. Findings will be published in international peer-reviewed journals with an open access choice.

NCT07289204.

Floods and heatwaves are becoming more frequent and intense and can disrupt routine maternal and child health (MCH) services. Previous reviews have not systematically examined how context and mechanisms may shape adaptation outcomes. This realist-informed systematic review examines how, why and under what conditions interventions support access to, utilisation of and continuity of routine MCH services during flood and heat events.

The search strategy was developed by integrating terms from 17 related reviews, refined with the author team and checked by an experienced London School of Hygiene & Tropical Medicine librarian. The initial database search was conducted on 16 May 2025 and the search was updated on 30 April 2026. Eight databases were searched: Web of Science, Ovid MEDLINE, EMBASE, Global Health, EconLit, GreenFILE, CINAHL and ProQuest Environmental Science & Public Policy. Records published between January 2000 and April 2026 were eligible. Search results were imported into EndNote and deduplicated. Title-and-abstract screening and full-text assessment were conducted independently by two reviewers for the initial search and are ongoing for the updated search, with ASReview being used to prioritise records during title-and-abstract screening. Data extraction across the full review evidence base remains ongoing using a structured template covering study context, intervention characteristics, mechanisms, outcomes, costs and implementation conditions. Study settings will be classified by country income group, health system context and Köppen–Geiger climate zone to compare evidence across settings and, where appropriate, to identify possible climate analogues for exploratory, context-specific assessment. Climate-zone similarity will not be used to infer intervention transferability or future effectiveness. The synthesis will be guided by the WHO Climate-Resilient Health Systems framework, Meadows’ leverage-points framework and realist-informed C–M–O reasoning. Interventions will be grouped to identify where they operate within the health system and which health system components and vulnerabilities they address. Findings will be reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance.

Ethical approval is not required because the review uses published literature and does not involve human participants. The findings will be disseminated through a peer-reviewed systematic review publication. They will inform the design, improvement and scaling of interventions intended to maintain routine MCH services and strengthen health system resilience to floods and heatwaves across diverse settings.

The review was not prospectively registered with PROSPERO.

Studies have shown promising results using bone graft as a carrier for local administration of antibiotics to reduce the risk of prosthetic joint infection (PJI). The objective of this clinical trial is to determine if tobramycin and vancomycin-impregnated bone graft is safe and effective in reducing the rate of PJI after total hip arthroplasty (THA).

This study is an international, randomised, double-blinded, placebo-controlled clinical drug trial. Patients scheduled for THA (n=1100) requiring bone grafting (excluding revisions due to an ongoing infection) are randomised in a 1:1 ratio to prophylactic treatment with tobramycin and vancomycin or placebo-impregnated bone graft.

The primary outcome is the time to reoperation due to infection or diagnosis of PJI, expressed as a relative risk difference between the two groups. A risk reduction of at least 50% is considered clinically relevant. Secondary outcomes are time to and reason for reoperation and implant revision, type of micro-organism and antibiotic susceptibility pattern within 2 and 5 years after surgery. Safety outcomes are the number of adverse events and revision rate due to aseptic loosening. The primary analysis will be performed using proportional hazard models.

The study has been approved under the Clinical Trial Regulation No 536/2014 (EU CT; 2024-510921-25-00). Results will be published in open-access peer-reviewed journals and disseminated to patient organisations and the media, and de-identified individual participant data will be curated and shared on reasonable request in accordance with the Findability, Accessibility, Interoperability and Reuse principles, subject to the laws and regulations governing data protection in each participating country.

NCT05169229.

Whiplash-associated disorders (WADs) are the most common and costly consequence of road traffic injury (RTI). Providing early and effective treatment is a healthcare priority; however, current guideline-based care which focuses on education and physiotherapy-led exercise does not routinely address the psychosocial effects of trauma, and access to early integrated treatment is limited. This study aims to evaluate the feasibility of delivering and evaluating recovery, information, support and empowerment (RISE), a co-designed short message service-based intervention integrating psychosocial and exercise/activity support for individuals with acute whiplash injury who are at risk of poor recovery in a randomised feasibility trial. Secondary aims are to explore preliminary changes in candidate clinical outcomes and opportunities for intervention personalisation and future implementation.

This mixed-methods randomised controlled feasibility trial with a nested process evaluation will recruit 50 participants (>18 years) with WAD grade II/III who are identified at medium to high risk of poor recovery and within 12 weeks of RTI from Queensland emergency departments and the community. Participants will be randomised in a 1:1 ratio to receive either the RISE intervention (tailored, daily messaging+optional brief clinician support session/s) or an active control (general health-related text messages plus access to an online resource, My Whiplash Navigator). Feasibility outcomes, including recruitment and retention rates, data collection (including wearable-derived and economic data) and intervention uptake will be descriptively summarised and evaluated against pre-defined traffic light progression criteria. Acceptability will be examined using validated questionnaires and purpose-built items, qualitative interviews with intervention participants and focus groups with patients, clinicians and funders. Secondary aims will be addressed through preliminary estimates of between-group differences in patient-reported outcomes with 95% CIs and exploratory analysis of multimodal data (eg, wearable-derived physiological data, intervention engagement metrics) using a large language model where possible to inform future personalisation and implementation planning.

This trial is approved by the Townsville Hospital Human Research Ethics Committee (HREC/QTHS/121395) and ratified by the Human Research Ethics Committee at The University of Queensland, which is the study sponsor (2025/HE002491). Results will be published in peer-reviewed journals and presented at conferences and professional meetings.

ACTRN12626000506392; date registered: 23 April 2026; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=390706&isReview=true

To (1) systematically identify tools developed to assess and address the support needs of informal carers in palliative or end-of-life care and (2) examine the extent to which socially stratifying sample characteristics have been reported following tool use.

A systematic scoping review was conducted.

Medline, CINAHL, PsycINFO, ASSIA, ProQuest Central and Web of Science databases were searched from inception to May 2024 and again in May 2025. Primary studies using any methodology reporting the development and/or use of tools to assess informal carer support needs in end-of-life care were included. Consistent with scoping review methodology, we did not conduct a quality appraisal of included studies. We extracted tool characteristics, frequency of use and sample characteristics according to PROGRESS+.

A total of 74 articles were included. From these, 24 unique tools were identified. Nine tools were used in ≥2 articles, while 15 were used only once. The most commonly used tools were the Carer Support Needs Assessment Tool (35 articles), the Family Inventory of Needs (6 articles), the Carer Alert Thermometer (5 articles) and the Spiritual Needs Inventory (4 articles). There was limited evaluation of tools beyond psychometric validation. There were substantial gaps in equity-informed caregiver sample reporting. While gender, age and country of participants were commonly reported, most other PROGRESS+characteristics were inconsistently or minimally reported.

While numerous tools exist to assess and address informal caregiver support needs, there is considerable variation in tool uptake, evaluation and the extent to which tools consider equity factors. There is a need for equity-informed tool development and clearer conceptualisation of caregiver needs, alongside efforts to evaluate tool implementation, impact and sustainability in palliative care settings.

The COVID-19 pandemic had profound effects on mental health worldwide. Within Canada, the province of Québec experienced high increases in mental health distress and implemented particularly strict public health measures. These unique characteristics motivate the examination of the local experience of the COVID-19 pandemic. This study aimed to examine changes in incidence rates of diagnosed anxiety and depressive disorders in Québec, Canada before and after the COVID-19 pandemic.

Analyses drew on administrative health records from the Québec Integrated Chronic Disease Surveillance System from January 2010 to March 2022 (147 months).

The setting for analyses was the province of Québec, Canada.

The analytical sample covered January 2010 to March 2022 (147 months) for all individuals aged 15 years and older (men and women) eligible for the Québec public health insurance plan.

Interrupted time series methods were used to estimate counterfactual trends of monthly incidence rates of diagnosed anxiety and depressive disorders under conditions with and without the impact of the COVID-19 pandemic. Analyses adjusted for local public health policies, including the enactment of the Cannabis Act (2018) and major provincial health system reforms (2015). As we drew on count data, we used generalised linear modelling techniques with Poisson distribution to estimate predicted and counterfactual incidence rates of diagnosed anxiety and depressive disorders over time. We report regression results as the incidence rate ratio (IRR) with 95% CIs.

Following the onset of the COVID-19 pandemic, monthly incidence rates of diagnosed anxiety disorders were 4.9% higher (IRR: 1.049, 95% CI 0.955 to 1.153), but there was insufficient evidence of a statistically significant change; there was a statistically significant increase in the slope by 1% (IRR: 1.010, 95% CI 1.00 to 1.018). For diagnosed depressive disorders, monthly incidence rates were rather 3.6% lower (IRR: 0.965; 95% CI 0.904 to 1.030), although not statistically significant; there was a statistically significant increase in the slope by 1.4% (IRR: 1.014; 95% CI 1.008 to 1.020). Results from the counterfactual trends suggest that incidence rates of diagnosed anxiety disorders would have been lower (observed rates are higher), while incidence rates of depressive disorders would have been higher (observed rates are lower) had the COVID-19 pandemic not occurred.

Findings encourage further consideration of the indirect consequences of public health crises and related responses on population mental health. They also highlight the need to examine dynamics in local jurisdictions and support reflection on policy investments in mental health protection and promotion.

Distressing sensory experiences (DSEs) are commonly reported by children and young people accessing Child and Adolescent Mental Health Services (CAMHS) in the UK. Despite their prevalence, evidence-based tailored interventions for this population are scarce. The ChUSE trial aims to address this gap by evaluating the feasibility and acceptability of a novel brief talking therapy for children aged 8–16 years and an accompanying parent coaching programme.

A single-blind, two-arm randomised controlled feasibility trial will be conducted across three National Health Service trusts in Greater Manchester, UK. Sixty young people under the care of CAMHS experiencing DSEs and their parents/caregivers will be randomised 1:1 to receive either treatment as usual (TAU) or TAU plus the ChUSE intervention. The intervention involves four child therapy sessions and three optional parent sessions. Primary feasibility outcomes include recruitment and retention rates, treatment adherence and intervention safety. Secondary objectives assess the feasibility of data collection procedures and gather qualitative insights into trial acceptability and the influence of the intervention on young people’s well-being.

The ChUSE Trial has received ethical approval through the Health Research Authority following review by the West Midlands – South Birmingham Research Ethics Committee specialising in paediatric research (ID 327343). The feasibility trial addresses a significant clinical gap in CAMHS provision and will also capture information as to current TAU practices, contributing novel data to guide future service provision as TAU is currently understood to be heterogeneous. The information gathered through this trial will inform the design of a definitive trial evaluating the clinical effectiveness and cost-consequences of an early, age-appropriate intervention for DSEs. Findings and translational outputs will be shared through scientific and public forums to reach a variety of audiences.

ISRCTN12245618.

Mailed smoking and vaping cessation support provided through the Which Way? Quit Pack programme has demonstrated acceptability and preliminary effectiveness in delivering culturally grounded support. However, there is no evidence of the effectiveness of mailed cessation programmes for Aboriginal and Torres Strait Islander people when implemented on a national scale. Building on previous work, this study aims to evaluate both the implementation effectiveness and cost-effectiveness analysis of the Which Way? Quit Pack mailed smoking and vaping cessation intervention for Aboriginal and Torres Strait Islander people.

A national single-group hybrid type 2 effectiveness-implementation study with 2000 Aboriginal and/or Torres Strait Islander people who use cigarettes and/or e-cigarettes (vapes) daily, want to quit and are aged ≥18 years. Participants will receive access to a culturally tailored mailed quit pack that includes up to a 12-week supply of nicotine replacement therapy, phone-based behavioural counselling and access to an online support forum. Cessation outcomes including 7-day point prevalence abstinence, prolonged abstinence and quit rates will be evaluated at 3, 6 and 12 months. An intention-to-treat approach will be used for cessation outcomes, with participants lost to follow-up classified as smokers or vapers. Exploratory logistic regression analyses will examine factors associated with quitting, and causal machine learning methods will be used to explore variation in intervention effectiveness across participant subgroups. The Reach-Effectiveness-Adoption-Implementation-Maintenance framework will guide evaluation of implementation and effectiveness outcomes. Analysis measures include cessation and quit attempt rates, number of participants recruited, representativeness and intervention uptake. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) will guide the cost-effectiveness analysis.

This study is governed by Aboriginal and Torres Strait Islander leadership and community-controlled partnerships and is conducted in line with Indigenous data sovereignty and Indigenous research ethics principles. The study has also received approval from the following human research ethics committees: Aboriginal Health & Medical Research Council of NSW (2493/25), Aboriginal Health Committee South Australia (04-25-1209), the Western Australian Aboriginal Health (HREC1474), the Victorian Aboriginal Community Controlled Health Organisation (2025/HREC0061) and the University of Newcastle Human Research (H-2025-0311). Findings will be disseminated in forms determined, governed and endorsed by Aboriginal and Torres Strait Islander people and communities through the project Governance, including peer-reviewed publications, policy briefs, community-led knowledge translation activities and presentations at local, national and international conferences.

ACTRN12626000459325.