People in rural areas of Australia experience poorer health in almost every indicator compared with urban populations; however, rural communities have lower access to primary health, allied health and specialist healthcare. Timely access to care is compounded by persistent and widespread health workforce issues, including attracting and retaining staff.

Australian University Departments of Rural Health (UDRH) have been established to address the needs of rural populations with the goal of improving recruitment and retention of health professionals across rural and remote Australia. The work-integrated learning team within The University of Melbourne works with nursing and allied health university students on clinical placement to provide exposure to working in rural health, with a remit to build the capacity of the existing and future workforce. The service-learning model aims to provide reciprocal benefits to stakeholders through purposefully co-designed placements that respond to rural health needs by providing services to underserved communities and ensuring university students are exposed to real world, diverse practice settings.

The overarching aim of this project is to determine the impact of the SL programme for key stakeholders, predominately end users and those stakeholders involved in the delivery of the SL model. The key stakeholders are host site staff, allied health university students, allied health supervisors and the end users of the programme. End users are those individuals that have received allied health services through the programme, such as clients, residents and children.

This study will adopt a convergent mixed methods methodology underpinned by a RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance)/PRISM (Practical, Robust Implementation Sustainability Model) approach. Data collection will include document review, existing programme data review and primary data collection. This will involve conducting surveys and interviews with allied health university students, host organisations and allied health supervisors, and interviews with adult recipients of the service-learning programme. Art-based consultation will be conducted with school-aged children recipients of the service-learning programme. Analysis will be underpinned by the RE-AIM/PRISM framework to inform programme learnings and impact for key stakeholders.

This study has been approved by the University of Melbourne Human Research Ethics Committee (Project ID: 30409).

Findings will be published in a stakeholder project report and peer-review journals in the fields of rural health, implementation science and work integrated learning.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147

Excessive sedentary behaviour (SB) is highly prevalent among children and adolescents and young adults (AYAs) treated for cancer. Although SB is associated with adverse health outcomes in adults with cancer, little is known about SB in younger cancer patients and survivors. In this scoping review, we aim to summarise current literature on (1) the association between SB and clinical outcomes and (2) results of intervention trials to reduce SB, specifically in paediatric and AYA cancer patients and survivors.

The scoping review will follow the five stages described in the Arksey and O’Malley methodology framework. We will conduct a comprehensive search in five varied electronic databases (PubMed, Embase, Web of Science, CINAHL and SportDiscus) for original articles published in peer-reviewed journals since 1 January 2000, and search reference lists of identified articles and previous review articles. All original research article types will be considered (ie, cross-sectional, cohort, interventional trials). Two reviewers will independently screen all articles based on predetermined inclusion and exclusion criteria, including (1) more than half the sample at the time of study must have been children (0–14 years old) and/or adolescent and young adults (AYAs, 15–39-year old) who were being or had been previously treated for cancer and (2) reporting of SB. Data will be extracted as a descriptive and quantitative summary of each study’s key characteristics and results. Study-specific quality assessment will be performed using established tools. Results will be presented in evidence tables with an accompanying narrative summary.

Ethics approval is not required as only publicly available data will be analysed. Results will be published in a peer-reviewed journal and may be presented at a scientific conference.

The protocol is registered in Open Science Framework (https://osf.io/ua8z9).

To explore intensive care unit (ICU) clinicians’ experiences of withdrawing mechanical ventilation during end-of-life care.

An exploratory qualitative design was used, with data collected via semistructured, face-to-face online interviews and analysed using reflexive thematic analysis.

We recruited ICU clinicians from two hospitals within the West Midlands region of the UK.

Semistructured, face-to-face online interviews were used to explore experiences with limitation of life-sustaining treatments in ICU, decision-making and practices for withdrawing mechanical ventilation.

22 ICU clinicians were interviewed (Physiotherapist=1, Advanced Critical Care Practitioners=4, Physicians=9 and Nurses=8), of which 13 were women (59%). Four themes were developed. (1) Multilayered communication: effective communication was key in planning withdrawal and informing family members, with conflicts arising from cultural differences. (2) Considerations regarding the mode of withdrawing invasive mechanical ventilation: clinicians expressed differing preferences for the method of mechanical ventilation withdrawal. (3) Multiprofessional teamwork: collaborative teamwork was vital, with palliative care practitioners consulted during conflicts or challenging symptoms. (4) Clinicians’ feelings and impact: clinicians empathised with families and experienced psychological burden.

Physician preferences influence the withdrawal process, which is communicated within the multidisciplinary team. Clear protocols can help reduce ambiguity and support less experienced clinicians. Reflection on these practices may help mitigate burnout and compassion fatigue. Further research should examine the effects of physician demographics and patient cultural diversity on the withdrawal process.

While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The ‘SPARX-UK’ study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an ‘eCoach’) vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation.

The process evaluation will use a mixed-methods design following the UK Medical Research Council’s 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention.

Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149).

Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences.

ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.

A relationship between long-term metformin use and vitamin B12 deficiency has been long discussed in the literature. Nonetheless, prior to 2022, there was no official guidance. In June 2022, the Medicines and Healthcare products Regulatory Agency (MHRA) published advice, stating that low vitamin B12 is now considered to be a common side effect. It advises checking levels in patients with symptoms of B12 deficiency, as well as monitoring those at risk of B12 deficiency.

Despite efforts to promote evidence-based practice, there is still a gap in the translation of research findings into policies and clinical practice. The above research has been shared widely in the academic and specialist diabetes literature over a prolonged period. The purpose of the scoping review is to explore what evidence is available regarding clinicians’ awareness of the association between metformin use and vitamin B12 deficiency in patients with type 2 diabetes mellitus, how this evidence is implemented into frontline clinical practice and what screening processes are recommended or exist.

This is a protocol for a scoping review to be guided by the Joanna Briggs Institute (JBI) methodology for scoping reviews 20. The databases to be searched will include MEDLINE (accessed via PubMed), British Nursing Index, Google Scholar, Cochrane, Embase, Web of Science and Cumulative Index to Nursing and Allied Health Literature (CINAHL) (accessed via EBSCO), alongside searching for grey literature such as Electronic Theses Online Service (EThOS), DART European and Kings College London Research Portal. Titles and abstracts of articles will be reviewed by the authors. If articles are representative of the inclusion criteria, the articles will go through a full-text review by the authors. The results of the search and study inclusion/exclusion process will be reported and presented in a Preferred Reporting Items for Systematic Reviews and Meta-analyses flow diagram. Data will be extracted from papers, using the recommended JBI data extraction tool. The search will commence in August 2025, and the review is expected to be completed by November 2025.

The search will commence in August 2025, and the review is expected to be completed by November 2025.

As this is a scoping review protocol that did not involve any human participants, human data or human tissue, no ethical approval was required. Our dissemination strategy includes peer review publication, presentation at conferences and with relevant stakeholders.

Investigate the impact of a 10-week whole-food plant-based (WFPB) community programme on weight and type 2 diabetes up to 36 months postintervention.

Randomised waitlist-controlled trial.

Community-based General Practice clinic classified as ‘Very Low-Cost Access’ in Gisborne, the main city of the Tairāwhiti region of New Zealand.

Adults (n=56) aged 30–72 years, with obesity (Body Mass Index (BMI) ≥30) and glycated haemoglobin (HbA1c≥40 mmol/mol) in the last 6 months. Of the participants, 59% identified as Māori and 5% as Pasifika.

A 10-week programme consisting of 2 hours, two times per week sessions (40 hours total), involving skills-based learning and health education.

Primary measures were changes in weight, BMI and HbA1c. Secondary measures included changes in cholesterol, waist circumference, exercise levels, plant-based and non-plant-based dietary scores and association with Big Five Inventory personality traits. The primary endpoint was assessed at post-treatment (10 weeks), with follow-up at 6 and 36 months postintervention.

Differences between the intervention and waitlist control groups at 10 weeks were compared with independent samples t-tests. In intention-to-treat analyses, the intervention group demonstrated significantly greater weight loss of 3.3 kg (95% CI (0.8 to 5.7), pp values

This 10-week WFPB diet community intervention decreased weight, BMI, HbA1c and cholesterol. The intervention produced a weight loss of 5 kg post-treatment, with 3 kg weight loss sustained at 36 months.

This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (https://anzctr.org.au); ACTRN12617000541303, date of registration 07/04/2017.

‘Caring’ is a critical concept in nursing discourse and many theories about care in nursing have been developed and applied to a variety of settings. One example is Swanson’s caring theory, an empirically derived middle-range nursing theory that situates caring as a relational way of attending to others to whom we have a sense of commitment and responsibility, through the five specific...

To determine if carer administration of as-needed subcutaneous medication for common breakthrough symptoms in people dying at home is feasible and acceptable in the UK, and if it would be feasible to test this intervention in a future definitive randomised controlled trial.

We conducted a two-arm, parallel-group, individually randomised, open pilot trial of the intervention versus usual care, with a 1:1 allocation ratio, using convergent mixed methods.

Home-based care without 24/7 paid care provision, in three UK sites.

Participants were dyads of adult patients and carers: patients in the last weeks of their life who wished to die at home and lay carers who were willing to be trained to give subcutaneous medication. Strict risk assessment criteria needed to be met before the approach, including a known history of substance abuse or carer ability to be trained to competency.

Intervention-group carers received training by local nurses using a manualised training package.

Quantitative data were collected at baseline and 6–8 weeks post-bereavement and via carer diaries. Interviews with carers and healthcare professionals explored attitudes to, experiences of and preferences for giving subcutaneous medication and experience of trial processes. The main outcomes of interest were feasibility, acceptability, recruitment rates, attrition and selection of the most appropriate outcome measures.

The secondary outcome measure was time to symptom relief, calculated using data items from the carer diary, after the patient had died.

In total, 40 out of 101 eligible dyads were recruited (39.6%), which met the feasibility criterion of recruiting >30% of eligible dyads. The expected recruitment target (50 dyads) was not reached, as fewer than expected participants were identified. Although the overall retention rate was 55% (22/40), this was substantially unbalanced (30% (6/20) usual care and 80% (16/20) intervention). The feasibility criterion of >40% retention was, therefore, considered not met. A total of 12 carers (intervention, n=10; usual care, n=2) and 20 healthcare professionals were interviewed. The intervention was considered acceptable, feasible and safe in the small study population. The intervention group had a considerably shorter time to medication administration than the usual-care group (median time to administer medication in intervention=5 min, usual-care=105 min). Intervention group carers felt confident in administering medication. Healthcare professional support was sought by intervention group carers in 24 out of 147 (16.3%) medication administration entries. The context of the feasibility study was not ideal, as district nurses were overstretched, unfamiliar with research methods and possibly not in equipoise. A disparity in readiness to consider the intervention was demonstrated between carers, who were uniformly enthusiastic, and healthcare professionals who were not. Findings confirmed methodological and ethics issues pertaining to researching the last days of life care.

The success of a future definitive trial is uncertain because of equivocal results in the progression criteria, particularly poor recruitment overall and a low retention rate in the usual-care group. Future work regarding the intervention should include understanding the context of UK areas where this has been adopted, ascertaining wider public views and exploring healthcare professional views on burden and risk in the NHS context. There should be consideration of the need for national policy and the most appropriate quantitative outcome measures to use. This will help to ascertain if there are unanswered questions to be studied in a trial.

ISRCTN11211024.

Patients with chronic limb-threatening ischaemia (CLTI) are often prescribed clopidogrel in order to reduce their risk of major adverse limb and cardiovascular events. Clopidogrel is metabolised by the CYP2C19 enzyme and genetic variations in CYP2C19 are common. These variants can influence an individual’s ability to metabolise clopidogrel to its active metabolite. Few studies have investigated the relationship between patient genotype and outcomes in vascular surgery. This work aims to establish the relationship between patient genotype and outcomes after revascularisation in patients with CLTI who are prescribed clopidogrel. It will consider whether pharmacogenetics can be used to ensure patients are prescribed effective medications to optimise their outcomes.

This is an observational cohort study of patients undergoing lower limb surgical, endovascular or hybrid revascularisation for CLTI at Manchester University NHS Foundation Trust. Patients taking clopidogrel post-procedure, as well as those prescribed a non-clopidogrel based medication regimen, will be recruited prior to or shortly after revascularisation. Patients will undergo CYP2C19 genotyping and will be followed up using online records. The study has 90% power to detect 114 amputations with a target sample size of 483 participants. The primary outcomes are risk of amputation at 1 year and a composite endpoint for the risk of major adverse limb events (MALE) or death from any cause at 1 year. Secondary outcomes are risk of MALE at 1 year, risk of major adverse cardiovascular events (MACE) or death from any cause at 1 year, death within 30 days of revascularisation, minor re-interventions at 1 year, total number of re-interventions at 1 year and rate of systemic or gastrointestinal bleed at 1 year.

Risk of amputation, MALE and MACE will be analysed using Cox models. All remaining outcomes will be analysed using negative binomial models. Potential competing events for the risk of amputation will be investigated as part of a sensitivity analysis. Patients given a non-clopidogrel-based medication will be compared as an additional analysis.

Manchester University Research Ethics Committee approval obtained as part of the Implementing Pharmacogenetics to Improve Prescribing (IPTIP) trial process (IRAS 305751). The results of the study will be published in a peer-reviewed journal and presented at international conferences.

This work is a sub-protocol for the IPTIP study which is registered as ISRCTN14050335.

The enteric microbiota drives inflammation in Crohn’s disease. Yet, there are no placebo controlled trials evaluating the efficacy and safety of faecal microbiota transplantation (FMT) in inducing and maintaining remission in patients with active Crohn’s disease. The Microbial Restoration (MIRO) study aims to establish this evidence.

At two specialist inflammatory bowel disease centres, 120 enrolled patients will have a 3-week period of diet optimisation (removal of ultra-processed foods) together with a 7-day course of antibiotics (to facilitate subsequent FMT engraftment). Patients will then be stratified to upper gut (for disease proximal to the splenic flexure) or lower gut (distal to the splenic flexure) disease. Patients will then be randomised in a 2:1 ratio to receive anaerobically prepared stool or placebo for 8 weeks either by gastroscopy, or colonoscopy and enemas. Clinical response at 8 weeks (Crohn’s Disease Activity Index (CDAI) reduction ≥100 points or to 70) receive FMT for weeks 8–16.

Patients achieving clinical response from FMT after 8 or 16 weeks will be randomised in a 1:1 ratio to either a 44-week maintenance phase of FMT or placebo. Patients will receive FMT from one donor throughout the study.

The MIRO study will establish whether FMT is an effective and safe therapy to induce and maintain remission in patients with active Crohn’s disease.

Ethical approval has been received by the St Vincent’s Hospital Melbourne Human Research Ethics Committee (HREC-A 084/21). The results will be disseminated in peer-reviewed journals and presented at international conferences.

ClinicalTrials.gov: NCT04970446; Registered on 20 July 2021.