We conducted a feasibility study to evaluate the feasibility of recruiting patients to examine the effect of near vision glasses in young infants at risk of cerebral visual impairment.

A three-arm, parallel-group, open-label randomised feasibility trial.

Tertiary neonatal intensive care in London, UK.

We included babies born before 29 weeks of gestation or at full term with hypoxic ischaemic encephalopathy. Babies who needed ongoing inpatient care, with established eye anomalies or with very high refractive errors at baseline (±8.00D) were not included. Infants with retinopathy of prematurity were not excluded.

At 8 weeks corrected age, we allocated 18 infants to wear glasses (+3.00D over full cycloplegic refraction) immediately (intervention 1), 18 to wear the same glasses at 16 weeks (intervention 2) and 19 infants were allocated to standard treatment (no glasses).

Recruitment and retention of study participants (primary), compliance wearing glasses, preferential-looking visual acuity (with glasses) and visual function as determined using A Test Battery of Child Development for Examining Functional Vision at 3-month and 6-month age post-term.

Of 70 eligible families, 55 consented and 34 attended baseline assessments, and 28 completed the study. Non-attendance was due mainly to prolonged inpatient stay, infant health and scheduling conflicts. Glasses were worn for similar periods in each group (Intervention 1: median 2 hours/day (95% CI 1 hour to 4 hours); Intervention 2: median 2 hours/day (95% CI 1.5 hours to 3 hours)). Visual acuity improved from baseline to 6 months. Mean (SE) LogMAR (Minimum Angle of Resolution) improvements were standard care: 0.47 (0.45); intervention 1: 0.66 (0.44); intervention 2: 0.37 (0.36). Among the 29 very preterm infants, there were similar findings: standard care: 0.35 (0.35); Intervention 1: 0.67 (0.47); Intervention 2: 0.34 (0.40). As a functional measure, object permanence was present at the following rates by randomised arm: standard care: 29%; whereas intervention 1: 56%; and intervention 2: 44% (OR intervention 1 vs standard care: 3.13 (95% CI 0.38 to 25.57), ie, not statistically significant).

We demonstrate feasibility for a definitive RCT (randomized controlled trial) with good recruitment and retention and observed potential benefits for vision and development following the dispensing of glasses at 8 weeks post-term age compared with untreated controls. We identified methodological modifications to further improve recruitment processes for a future larger study.

ISRCTN14646770; NCT05048550.

A significant proportion of adults in England and Wales report experiencing childhood trauma, which is often associated with poor health and negative social outcomes including a significant increase in the risk of poor mental health outcomes in adulthood. This proposed scoping review adopts a broad definition of childhood trauma and applies both a salutogenic framework and ecological systems theory to explore how protective factors at five ecological levels can support mental well-being. The review will also examine how protective factors vary across different population groups and contexts.

The scoping review will follow the Joanna Briggs Institute (JBI) protocol for scoping reviews. The databases that will be searched are Embase, PubMed, Web of Science, PsycINFO, CINAHL and Medline. Studies will be included if they include protective factors and involve adults aged 18 and over who have experienced childhood trauma, whether self-identified, retrospectively self-reported or measured using a validated instrument. Studies will be excluded if they focus on participants under the age of 18.

All search results will be uploaded to Covidence, duplicates removed, and titles/abstracts screened by at least two reviewers based on inclusion criteria. Full texts of potentially relevant sources will be imported into EndNote 21. Reasons for exclusions will be documented and disagreements resolved through discussion or a third reviewer. The full process will be reported using a Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram. Data will be extracted by at least two reviewers using a tool developed by the team based on the JBI guidance. A best-fit framework analysis will be used, using a matrix developed by the researchers including the four salutogenic domains and the five levels of the ecological framework.

Formal ethical approval is not necessary for this scoping review as it does not involve the collection of primary data. The outcomes of this study will be disseminated through peer-reviewed journal articles, conference/seminar presentations, and developed into resources for stakeholders and collaborators.

Open Science Framework (DOI 10.17605/OSF.IO/CJRUY).

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

A single NHS hospital in the UK.

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

Immunotherapy with anti-programmed cell death protein 1 (anti-PD-1) inhibitors has revolutionised the treatment of many solid tumours, however, only 30–40% of patients will have a lasting clinical response. Tumour-derived extracellular vesicles (EVs) have been implicated in the spread of solid tumours and resistance to these agents. A lectin-affinity plasmapheresis device called the Hemopurifier (HP) has been developed and shown to remove EVs in vitro and in patients. We hypothesise that the treatment of patients who are not improving on a regimen that includes an anti-PD-1 agent will be safe, decrease EV concentrations and improve antitumour T cell activity.

This safety, feasibility and dose-finding study is designed in a 3+3 safety study design with three treatment cohorts. Participants who are determined not to be responding to a regimen that includes an anti-PD-1 agent will be assigned to receive either one, two or three (HP) treatments over a 1-week period prior to their next scheduled dose of anti-PD-1 antibody. Advancement from one cohort to the next will be determined by a Data and Safety Monitoring Board. Data collection will include adverse events, safety labs, EV concentrations and T cell measurements, repeat imaging and survival status.

The primary outcome of the study will be the safety of the HP in this population, with additional endpoints to include the kinetics of EV removal and rebound following HP treatment, in addition to the effects on T cell numbers and activity.

The clinical protocol and amendment to the study protocol have been approved by the Central Adelaide Local Health Network Human Research Ethics Committee for Royal Adelaide Hospital (reference number 2024/HRE00031) and the Bellberry Human Research Ethics Committee for Pindara Private Hospital and Genesis Care/Royal North Shore Hospital (reference number 2024-06-724-A-6). The Therapeutic Goods Administration has been notified. The clinical trial is listed on the Australian New Zealand Clinical Trials Registry. Informed Consent is obtained from all participants prior to any protocol procedures being performed. Results of the main trial and each of the secondary endpoints will be submitted for publication in a peer-reviewed journal.

Australia New Zealand registration number ACTRN12624000732583.

Sleep impairments are prevalent among individuals recovering from substance use disorders (SUDs) and are associated with poorer treatment outcomes and increased relapse risk. Physical activity (PA) is known to enhance sleep in general populations, but its day-to-day effects on sleep during SUD recovery remain underexplored, especially across different recovery stages.

In this observational n-of-1 study, we aim to examine within-person associations between daily PA and sleep quality in three groups of individuals at varying stages of substance use recovery (early treatment, continuing care and long-term recovery). A substudy will validate the agreement between two wearable sleep-monitoring devices. A total of 90 participants (30 per recovery group) from Western Australia will complete daily ecological momentary assessments and wear the SENS Motion sensor and/or Withings Sleep Analyzer over a 30-day period. Outcomes include device-derived sleep and PA measures, self-reported affect, craving, well-being and recovery outcomes. Multilevel models will explore within-person and between-person associations. This study will generate individualised evidence on associations between PA and sleep to inform tailored SUD care. It will also assess the feasibility of using wearable sleep monitors in real-world SUD recovery settings. Results may support the future development of just-in-time adaptive intervention procedures.

The study was approved by the Human Research Ethics Committee of Curtin University (HRE2025-0379). Findings will be shared through peer-reviewed publications and conference presentations, with lay summaries provided to treatment facilities and interested participants to support translation into community and service settings.

ACTRN12625000835448.

In Canada, many families want to breastfeed, but there are several common challenges they may encounter. Currently, 91% of Canadian families initiate breastfeeding after giving birth, yet only 38% of babies are breastfed exclusively to 6 months. In 1991, the Breastfeeding Committee for Canada (BCC) was established to implement the World Health Organization’s Ten-Step Baby-Friendly Hospital Initiative, a series of evidence-based in-hospital practices to support families to breastfeed. Then, in recognition of the need to support breastfeeding beyond the hospital setting, the BCC expanded the Baby-Friendly Initiative (BFI) to apply the Ten Steps to both hospitals and community health settings. However, uptake of the BFI Ten Steps in community settings has been low and methodology on how to optimise implementation of the Ten Steps in community is not well developed. Therefore, the objective of this project is to develop and evaluate a quality improvement collaborative with 25 community health services from across Canada to learn how to best support the implementation of the BFI Ten Steps in community, with the ultimate goal of improving breastfeeding outcomes.

This protocol describes the activities of the Community Baby-Friendly Initiative Collaborative (CBFI-C) and the methods used to evaluate its effectiveness. We will use the Institute for Healthcare Information Breakthrough Series (IHI-BTS) model, a proven quality improvement model that has been widely used in clinical settings, but is not yet widely used in community settings. The IHI-BTS combines three virtual learning sessions with action cycles that allow the participating sites time to test and track small practice changes. Sites will be asked to track care indicator and breastfeeding outcome data, engage in monthly webinars, receive coaching from trained mentors, participate in focus groups and participate in a final summative workshop. We will use a multi-site case study approach, combining aggregate care indicator data and qualitative data from webinars, focus groups and workshops to evaluate how the CBFI-C model supports community sites in the process of implementing the BFI Ten Steps.

Ethics approval for this evaluation was obtained from the CHIPER Health Research Ethics Board (Number HS26947-H2025:157)). The results of the CBFI-C evaluation will be shared in a report, peer-reviewed publications and presentations to government and academic audiences. The findings will inform effective quality improvement strategies to enhance uptake of the BFI in community health settings.

To determine the use, frequency and factors linked to the use of any electronic point of care resources (ePOC resources) used by early-career general practitioners (GPs in training, otherwise known as GP residents or registrars) during consultations; and the frequency, and factors linked to the use of evidence-based clinical summaries.

Cross-sectional analysis of data collected as part of the Registrar Clinical Encounters in Training (ReCEnT) project from 2018 to 2022. Every 6 months, GP trainees record 60 consecutive consultations, including information about their use of resources.

Australian training general practices.

3024 GP trainees in community-based vocational training.

The primary outcome was the use of ePOC resources, and the secondary outcome was the use of evidence-based ePOC summaries.

A total of 3024 GP trainees accessed electronic resources during patient encounters for 67 651/628 855 (10.8%) of diagnoses/problems. Use of ePOC resources increased 4% per year over the study period. Therapeutic Guidelines was accessed most often (27 435/79 536, 34.7% of all ePOC use) followed by Australian Medicines Handbook (7507, 9.4%) and HealthPathways (6965, 8.7%). Various factors were associated with increased use of ePOC resources, including increasing patient age, diagnosis/problem type, increasing years of experience prior to GP training and stage of training. GP trainees rarely accessed dedicated evidence-based clinical summaries.

Australian GP trainees use a range of resources to answer their clinical questions, mostly from Therapeutic Guidelines and prescribing compendiums, but also system specific resources that are free to access.

Crohn’s disease (CD) and ulcerative colitis (UC) are chronic, inflammatory bowel diseases (IBDs) of unknown origin, affecting the gastrointestinal tract and often causing extraintestinal symptoms. Conventional treatments (eg, glucocorticosteroids, immunomodulators) and targeted advanced treatments, including anti-TNFα, antibodies to p40 subunit of IL-12/23, antibodies to p19 subunit of IL-23, anti-α4β7 integrin, Janus kinase inhibitors (JAKis) and sphingosine-1-phosphate receptor (S1PR) modulators, do not achieve sustained responses for all patients, leaving significant unmet therapeutic needs.

This prospective, multi-centre observational study will follow a cohort of 240 patients across multiple study centres within NHS trusts in the UK who are initiating or switching biologics, specifically anti-TNFα and anti-α4β7 integrin for UC, and anti-TNFα, antibodies to p40 subunit of IL-12/2 and JAKi for CD. Through comprehensive profiling of immunological, transcriptional, microbiome, genetic and proteomic markers at baseline, week 12, and week 52, this study aims to uncover non-invasive biomarkers that predict response to these drug classes, ultimately advancing personalised medicine in IBD.

Ethical approval for the Nottingham/AstraZeneca study was granted by the West of Scotland Research Ethics Committee. Recruitment began in December 2022 and is currently ongoing at 10 NHS Trust sites across the UK. Study findings will be disseminated by publication in peer-reviewed journals and presentations at relevant national and international conferences.

To understand healthcare professionals’ views on current physiotherapy service provision in children with congenital heart disease (CHD), how physiotherapy could be better used post-cardiac surgery and perceived barriers to service expansion.

Cross-sectional survey using a one-off self-completed online questionnaire, with open and closed questions, in June–August 2024.

Each of the 12 level 1 paediatric cardiac surgical centres in the UK National Health Service and Children’s Health Ireland.

Healthcare professionals providing clinical care to children undergoing cardiac surgery.

80 responses were obtained, with at least one response from each centre. Healthcare professionals conduct motor, developmental and functional evaluations across all age groups, with referrals to physiotherapy primarily based on physical examination (39, 87%). They expressed dissatisfaction with community physiotherapy services (64, 81%) compared with inpatient services (29, 36%), although they indicated that expanding services would positively impact patients and families. There is a lack of consensus regarding intervention frequency, duration and which patient groups should be prioritised. Respondents identified a lack of funding as the primary barrier to service expansion (76, 95%). Reported barriers for families included volume of medical appointments (69, 86%), transportation (66, 83%) and finances (62, 78%).

Healthcare professionals appreciate the positive impact physiotherapy can have on post-surgical management of children with CHD. The importance of expanding services was emphasised. However, to effectively support clinical practice, it is crucial to understand which patient groups should be prioritised and at what stage, as well as determining the optimal amount of physiotherapy that positively impacts patient outcomes.

Frequency of general practitioners’ (GPs’) antibiotic prescribing for acute, self-limiting respiratory tract infections (aRTIs) is high. The practice environment and culture influence the clinical behaviour, including prescribing behaviour, of GP specialist vocational trainees (registrars). We aimed to assess inter-practice variability in registrars’ antibiotic prescribing.

This was a cross-sectional analysis from the Registrar Clinical Encounters in Training (ReCEnT) cohort study, from 2010 to 2020.

ReCEnT documents registrars’ clinical experiences and behaviours. Before 2016, 5 of 17 Australian training regions participated in ReCEnT. From 2016, three of nine regions (~40% of Australian registrars) participated.

3210 registrars (response rate 91.8%) from 1286 training practices contributed to the analysis.

The outcomes were prescription of an antibiotic for new diagnoses of (1) all aRTIs and (2) acute bronchitis diagnoses specifically. Prescribing percentages were calculated at the training practice level. Intraclass correlation coefficients (ICCs) were used to measure the ratio of interpractice variation to total variance. Median ORs (MORs) were also estimated to quantify interpractice variability.

Practice-level antibiotic prescribing percentages ranged from 0% to 100% for both aRTIs and acute bronchitis diagnoses in the primary analysis. ICCs for aRTI prescribing were 0.08 (unadjusted) and 0.02 (adjusted). For acute bronchitis, ICCs were 0.10 (unadjusted) and 0.05 (adjusted). MORs were 1.66 (unadjusted) and 1.32 (adjusted) for aRTIs. MORs for acute bronchitis were 1.80 (unadjusted) and 1.53 (adjusted). This indicates a marked variation in the odds of a patient receiving antibiotics for an aRTI if randomly attending different practices.

There was considerable interpractice variation in registrars’ antibiotic prescribing frequencies. Further research is required to examine the factors accounting for this variation and to develop practice-level interventions to reduce antibiotic prescribing in high-prescribing practices.

Urban green and blue space (UGBS) interventions, such as the development of an urban greenway, have the potential to provide public health benefits and multiple co-benefits in the realms of the environment, economy and society. This paper presents the protocol for a 5-year follow-up evaluation of the public health benefits and co-benefits of an urban greenway in Belfast, UK.

The natural experiment evaluation uses a range of systems-oriented and mixed-method approaches. First, using group model building methods, we codeveloped a causal loop diagram with stakeholders to inform the evaluation framework. We will use other systems methods including viable systems modelling and soft systems methodology to understand the context of the system (ie, the intervention) and the stakeholders involved in the development, implementation and maintenance phases. The effectiveness evaluation includes a repeat cross-sectional household survey with a random sample of 1200 local residents (adults aged ≥16 years old) who live within 1 mile of the greenway. The survey is complemented with administrative data from the National Health Service. For the household survey, outcomes include physical activity, mental well-being, quality of life, social capital, perceptions of environment and biodiversity. From the administrative data, outcomes include prescription medications for a range of non-communicable diseases such as cardiovascular disease, type II diabetes mellitus, chronic respiratory and mental health conditions. We also investigate changes in infectious disease rates, including COVID-19, and maternal and child health outcomes such as birth weight and gestational diabetes. A range of economic evaluation methods, including a cost-effectiveness analysis and social return on investment (SROI), will be employed. Findings from the household survey and administrative data analysis will be further explored in focus groups with a subsample of those who complete the household survey and the local community to explore possible mechanistic pathways and other impacts beyond those measured. Process evaluation methods include intercept surveys and direct observation of the number and type of greenway visitors using the Systems for Observing Play and Recreation in Communities tool. Finally, we will use methods such as weight of evidence, simulation and group model building, each embedding participatory engagement with stakeholders to help us interpret, triangulate and synthesise the findings.

To our knowledge, this is one of the first natural experiments with a 5-year follow-up evaluation of an UGBS intervention. The findings will help inform future policy and practice on UGBS interventions intended to bring a range of public health benefits and co-benefits. Ethics approval was obtained from the Medicine, Health and Life Sciences Research Ethics Committee prior to the commencement of the study. All participants in the household survey and focus group workshops will provide written informed consent before taking part in the study. Findings will be reported to (1) participants and stakeholders; (2) funding bodies supporting the research; (3) local, regional and national governments to inform policy; (4) presented at local, national and international conferences and (5) disseminated by peer-review publications.