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Pregestational diabetes is one of the most frequent medical conditions in pregnancy. Nutrition insecurity is a non-medical, health-related social need and affects glycaemic management and pregnancy outcomes for women with both type 1 and type 2 pregestational diabetes. Collaborative healthcare-community partnerships to enhance food access, facilitate culinary medicine, diabetes self-management education and support (DSMES) and address unmet social needs for pregnant women with pregestational diabetes remain to be evaluated.
In a two-arm randomised controlled trial, we will examine the combined effects of a tripartite NOURISH intervention ((1) produce home delivery, (2) culinary medicine with DSMES and (3) community health worker-led social needs assessment and support) versus the current standard of diabetes and prenatal care. We will recruit and enrol 174 pregnant women (87 NOURISH, 87 standard care) ≤22+6 weeks of gestation with pregestational diabetes, inadequate glycaemic management (haemoglobin A1c≥6.5%) and self-reported risk of food insecurity from a diabetes and prenatal care programme at a tertiary care academic health system located in the USA. We will measure the primary outcome of glycaemic management by delivery (haemoglobin A1c
The Institutional Review Board at The Ohio State University approved this study (IRB: STUDY20260307; date: 23 April 2026). We plan to submit results of the trial for publication in peer-reviewed journals and presentations at international scientific meetings.
The co-use of nicotine/tobacco products and cannabis among young adults is prevalent, yet little is known regarding the treatment impact of co-use and the underlying relationship between substances. No prospective treatment studies to date have evaluated the impact of cannabis use on nicotine cessation specifically among young adults, with an emphasis on dual-use substance patterns predicting outcomes. The overall goal of this protocol is to characterise the relationship between nicotine and cannabis and evaluate how patterns of co-use are associated with nicotine cessation outcomes through a behavioural economics framework to examine how cannabis co-use may be associated with nicotine cessation. This study protocol describes an ongoing, prospective nicotine cessation trial being conducted among young adults who co-use nicotine (vaping and/or cigarettes) and cannabis products to: (1) evaluate the association between behavioural economically derived measures of substance substitutability on end of treatment (EOT) nicotine abstinence, (2) examine whether changes in nicotine use are associated with changes in cannabis demand and use and (3) assess reciprocal prospective relationships between patterns of nicotine and cannabis use during treatment.
This is a fully remote, prospective, 12-week nicotine cessation trial among young adults (ages 18–25; target N=350) across the USA who co-use nicotine and cannabis. Eligible participants vape nicotine and/or smoke cigarettes regularly (20+ days in the past 30) and use cannabis on 10+ out of the past 30 days. Participants receive comprehensive nicotine cessation treatment, which includes digital contingency management to reinforce nicotine abstinence, brief counselling and SMS-text based cessation support whereas cannabis use is monitored but not treated. Biochemical verification (through oral fluid samples) and self-reports (mobile daily diaries) of substance use are collected longitudinally. Study enrolment began in May 2024 and is expected to conclude in September 2027.
Aim 1 (primary outcome) analyses will evaluate whether baseline behavioural economic indices of nicotine–cannabis substitutability predict EOT nicotine abstinence using logistic regression models. Aim 2 (exploratory outcome) analyses will use generalised linear mixed-effects models to examine within-person associations between changes in nicotine use (abstinence, reduction in use, nicotine withdrawal) and cannabis demand and use over time, and whether these associations are moderated by time-varying substitutability. Cross-lagged panel models will be used for Aim 3 (exploratory outcome) to assess reciprocal prospective relationships between nicotine and cannabis use during treatment.
This study has received Institutional Review Board approval from the Medical University of South Carolina (reference ID: Pro00131124). All participants provide informed consent prior to study procedures. Findings will be disseminated through peer-reviewed publications, conference presentations and data sharing in accordance with National Institutes of Health and institutional guidelines. The manuscript reports protocol components according to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist.
Wounds are one of the most common causes of emergency department visits. Their care often involves stitches, a potentially painful and stressful procedure. Pain and stress management is usually based on local anaesthesia, which is not always optimal. Medical hypnosis may offer a non-pharmacological alternative. Heart rate variability is a pain-free, easy-to-use and objective biomarker of stress. This study aims to assess the benefit of hypnosis on stress and pain during stitching using a randomised controlled trial.
This is a single-centre, randomised controlled trial in an emergency department in Clermont-Ferrand. Patients consulting for suturable wounds will be randomised into two groups: with or without medical hypnosis. Measurements will include questionnaires, heart rate variability, physical activity levels and blood biomarkers. The primary outcome is heart rate variability during the procedure. Data will be analysed with intention-to-treat and per-protocol approaches, with p
The study has received approval from the Ethics Committee Sud-Méditerranée III, France, and is registered on ClinicalTrials.gov. Written informed consent will be obtained from all participants. Results will be published in a peer-reviewed journal.
To explore the experience of participants using the Neurofenix (Naples, Florida, USA) platform for hospital and home-based upper limb rehabilitation in acute and subacute stroke, and to report acceptability of trial and data collection processes in a feasibility randomised controlled trial (Rehabilitation using virtual gaming for Hospital and hOMe-Based therapy for the Upper limb in acute and subacute Stroke (RHOMBUS II)). The trial investigated safety, feasibility and acceptability of the platform, a non-immersive virtual reality (VR) tool, to facilitate upper limb rehabilitation following stroke. The intervention group (n=16) received usual care plus the platform for 7 weeks. The control group (n=8) received usual care only.
A qualitative descriptive approach using semi-structured interviews. Interviews were audio-recorded, transcribed verbatim, and analysed using the Framework Method. The Theoretical Framework of Acceptability informed the development of the topic guide and the analysis.
Homes of participants and an inpatient stroke rehabilitation unit, London, UK.
A purposive sample of 11 adults (≥18 years) was recruited from the trial intervention group, 35–89 years of age, ranging from mild to severe upper limb impairment and representing varying levels of engagement with the Neurofenix platform. Additionally three participants were recruited from the trial control group.
Six themes were developed: (1) trial enrolment, indicated that participants enrolled in the study due to hope and for distraction; (2) affective attitude, described feelings associated with the platform, such as the subthemes ‘enjoyment of the games’ but also ‘frustration’, often caused by Wi-Fi connection issues; (3) barriers and facilitators, explored environmental factors such as having a suitable space to use the platform, usability factors such as comfort and the need for support from others; (4) perceived effectiveness of the intervention, described an overall belief that the platform had beneficial effects on both upper limb and cognitive function; (5) self-efficacy, showed how confidence with the platform grew with time and the value placed on performance tracking and routine; (6) trial processes, indicated that assessment burden was manageable and potential allocation to the control group was not a deterrent to trial enrolment.
This study demonstrated the overall acceptability of the platform and offers valuable insights to guide the further development of rehabilitation technologies. This study also adds to the limited literature on the user experience of VR technologies early post-stroke.
To explore the facilitators and barriers to staff providing psychologically safe care in inpatient mental healthcare when restrictive practices are used.
Qualitative descriptive interview study.
Twenty semi-structured interviews were conducted with staff with experience working in inpatient mental healthcare in England. Analysis included principles of framework analysis, informed by the Theoretical Domains Framework.
Access to resources and a safe environment for both patients and staff were recognised as important (environmental context and resources) but access was impacted by competing organisational priorities and expectations (beliefs about capabilities). Participants recognised knowledge gaps in themselves and their colleagues (knowledge). Being able to confidently make decisions about risk was seen as central to the staff role (social/professional role and identity). Collaboration between staff is needed to make positive change and progression towards psychologically safe care (social influences). Empathy and compassion were driving factors in participants trying to use psychologically informed alternatives, but burnout hindered this (emotions).
Ensuring that staff feel supported in their role to implement psychosocial informed alternatives to restrictive practices, as well as providing safe environments for both patients and staff, could support the integration of psychologically safe care on inpatient mental health wards.
Key facilitators and barriers to staff providing psychologically safe care are identified to support practice and improvements to patient care.
Consolidated criteria for reporting qualitative studies (COREQ).
Former patients and members of the public were involved in the conceptualisation of key concepts and design of this study.
Deep brain stimulation (DBS) for dystonia is effective but programming optimisation can take months. Local field potentials (LFPs) recorded by the Medtronic Percept device may provide biomarkers to guide stimulation. This study will prospectively evaluate whether chronic LFP profiles correlate with clinical outcomes and can inform DBS programming strategies.
LFP-DYT is a single-centre, multi-phase observational study at Newcastle upon Tyne National Health Service (NHS) Foundation Trust. An internal pilot (Cohort 1) will refine recording workflows, followed by Cohort 2 (traditional programming with LFP recordings) and Cohort 3 (LFP-informed programming). 20–25 adults with primary dystonia undergoing globus pallidus internus DBS will be recruited. The study combines chronic LFP sensing with neurophysiology (electromyography, electroencephalography), motor inhibition testing (stop-signal reaction time), patient-reported outcomes and wearable sensor monitoring (STAT-ON) to provide a comprehensive multi-modal assessment framework. Primary outcome: reproducibility of alpha–theta frequency LFP peaks and concordance with optimal stimulation site. Secondary outcomes include stimulation and medication effects on LFP profiles, clinical improvement (Toronto Western Spasmodic Torticollis Rating Scale-2 (TWSTRS-2), Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS)) and beta-band activity as a marker of stimulation-related bradykinesia. Analyses will be descriptive and exploratory. Feasibility outcomes, including recruitment rates, retention and data completeness, will inform design and power calculations for future multi-centre trials.
The study has NHS Research Ethics Committee approval from the East Midlands—Derby Research Ethics Committee (REC reference: 24/EM/0246; IRAS ID: 337426). All participants will provide informed consent. Data will be pseudonymised and stored on secure NHS servers. Results will be disseminated via peer-reviewed publications, conferences and participant summaries. De-identified data and analysis code will be available on reasonable request.
Burn injuries constitute a significant health concern, requiring immediate first aid to mitigate further tissue damage and complications. Most countries worldwide recommend application of 20 min of cool running water (20CRW) within 3 hours of the burn as the cornerstone in burn first aid management. Despite its widespread acceptance and proven benefits in reducing the severity of burns and subsequent interventions, concerns regarding the risk of hypothermia following this intervention persist, representing at least a perceived barrier to the delivery of 20CRW. When it does occur, hypothermia in patients with burns has been associated with higher mortality rates, even after controlling for burn injury severity. Developing an understanding of the incidence of post-burn hypothermia following 20CRW, with a specific focus on potential predictive and/or causative factors, is quintessential.
A retrospective cohort study of all adult and paediatric patients with thermal burn injuries presenting to one of 11 participating Australian or New Zealand hospitals between 1 January 2024 and 31 December 2024 will be conducted. The primary outcome is the incidence of hypothermia in patients with burns following their arrival at the emergency department (ED). Secondary outcomes include influence of burn first aid cooling, risk factors influencing hypothermia, impact of hypothermia on clinical patient outcomes and incidence of hypothermia in patients with burns in non-ED settings.
Ethical approval was granted by the Children’s Health Queensland Human Research Ethics Committee (CHQHREC; HREC Ref No: HREC/25/QCHQ/114285) as well as Health and Disability Ethics Committees, New Zealand (HDEC; Ref No: 2026 EXP 23892). The study findings will be formally disseminated through peer-reviewed journals and conference presentations.
by Lauren H. Baker, Terun Desai, Jonathan Sinclair, Amy V. Wells
ObjectivesTo monitor sleep patterns of elite swimmers and explore sleep as a potential risk factor for upper respiratory symptoms (URS) alongside salivary Immunoglobulin A (IgA) in elite swimmers, over an 8-month competitive season.
DesignSecondary analysis of an 8-month longitudinal study in elite international swimmers leading into either the Commonwealth Games 2018 or Swim Cup Eindhoven.
MethodsFourteen elite swimmers (age ± SD = 19.9 ± 0.8 years, height = 178.9 ± 6.3 cm, and mass = 75.0 ± 7.7 kg) were recruited. Self-reported sleep quality, URS data and salivary IgA was obtained weekly on a standardised day. Quantitative sleep parameters were measured using wrist-worn actigraphy four times for two-week bouts; during low, moderate, high training loads and once leading into competition.
ResultsSwimmers waking fatigued was positively associated with frequency (p Conclusions
Perceived fatigue on waking was significantly associated with both frequency and severity of URS, and inversely associated with mucosal immunity (salivary IgA), providing novel insight into the relationship between sleep, fatigue and illness in this cohort. Although causality cannot be established, the high prevalence of inadequate sleep shown in elite swimmers highlights the importance of individual sleep monitoring to support recovery and inform strategies aimed at illness prevention.
by Melissa M. Baker, Lyonel Nerolin Doffou Assalé, David Doledec, Romance Dissieka, Ahmenan Claude Liliane Konan, Agnes Helen Epse Assagou Mobio, Koffi Landry Kouadio, Oka René Kouamé, Ama Emilienne Yao, Hubert Zirimwabagabo
BackgroundWhile recent data on vitamin A deficiency (VAD) prevalence is lacking, the 2004 Côte d’Ivoire Nutrition and Mortality Survey reported that 26.7% of children aged 6–59 months were affected by VAD, and approximately 60% were at risk. Since 2016, the government has transitioned from mass campaigns to routine vitamin A supplementation (VAS) delivery integrated into health services. However, evidence on the cost-effectiveness of the routine distribution approaches is limited. This study evaluated the cost, coverage, and cost-effectiveness of three routine VAS delivery strategies across two health districts in northern Côte d’Ivoire.
MethodsA mixed-methods study evaluated three routine VAS delivery strategies – routine-fixed, advanced community-based, and catch-up – across two health districts, Ferkessédougou and Niakaramadougou, in northern Côte d’Ivoire. The quantitative cost data were collected via a structured tool covering six cost categories: planning, procurement, training, social mobilization, distribution, and supervision. VAS coverage was assessed through a post-event coverage survey (PECS) via a two-stage cluster sampling methodology. A cost-effectiveness analysis determined the cost per child supplemented, the cost per DALY averted, and a sensitivity analysis tested the robustness of the findings under different cost scenarios.
ResultsThe total program cost for July-December 2023 was 25.5 million FCFA, with personnel costs comprising over 70% of expenditures. In Ferkessédougou, the routine advanced community-based strategy was the most cost-effective, at 458 FCFA per child in rural areas (versus 596 FCFA for the routine-fixed facility-based approach in the same area). In Niakaramadougou, the December catch-up was more cost-effective in rural areas (606 FCFA per child) than the routine-fixed approach (714 FCFA). Across both districts combined, the routine-fixed strategy averaged roughly 651 FCFA per child supplemented, and the cost per DALY averted ranged from 30,093 FCFA (advanced strategy in Ferkessédougou) to 89,550 FCFA (catch-up Jul 2023 in Niakaramadougou) – all below Côte d’Ivoire’s cost-effectiveness threshold (0.5 x GDP per capita; approximately USD 1,265).
ConclusionAll three strategies were cost-effective, though the advanced community-based strategy achieved the best balance of reach and efficiency. Scaling advanced strategies within health system constraints may enhance sustainability and coverage in low-resource settings.
Delirium, a common, serious and often preventable complication in older hospitalised adults, contributes to significant health and social care costs. Carers are uniquely positioned to identify early signs and support delirium prevention. The Prevention & Early Delirium Identification Carer Toolkit (PREDICT), a novel model of care designed to educate carers about delirium management and prevention strategies, enables them to actively participate in the care and recovery of their person. Developed through a comprehensive literature review, a co-designed eDelphi and pilot study, PREDICT demonstrated acceptability and feasibility.
To evaluate the effectiveness, implementation and cost-benefit of a PREDICT in hospital settings.
A stepped-wedge cluster randomised controlled trial (SW-cRCT), consisting of a cohort study, healthcare service evaluation, and process evaluation. The study will assess carer and staff knowledge of delirium, carer care giving stress, health service outcomes (e.g., incidence, length of stay, readmissions) and cost-benefit.
PREDICT is a scalable, person-centred approach that supports both patients and carers, with the potential to embed best-practice delirium management into routine healthcare.
This study was developed in consultation with older adults, carers and healthcare staff. Two consumer representatives joined the project steering committee and contributed to shaping the research question, refining the study protocol and selecting outcome measures relevant to families and healthcare staff. Carers were involved in reviewing participant information sheets and the PREDICT website, providing feedback to ensure clarity and accessibility. Results will be shared with participants and the wider community through plain-language summaries and public presentations.
Australian and New Zealand Clinical trial: ACTRN12625000705482 registered on the 3rd of July 2025
Geographical isolation compounds limited access to healthcare services and skilled workforce for the provision of rural aged care. Residents have complex chronic disease management and end-of-life care needs. An undersupply of general medical practitioners due to retirement, attrition or unfilled training places in Australia has impacted recruitment to rural areas. Nurse practitioners have been identified as a potential solution.
To describe and explore the inner (local and organisational) and outer (wider health system) contexts of healthcare, from the perspective of care staff and residents' families. This, in turn, aims to inform the planned implementation of a nurse practitioner model, in several aged care facilities, operating within rural and remote settings, in Queensland Australia.
A convergent mixed methods design.
Qualitative data were collected, in 2022–2023, using semistructured interviews with staff focusing on role, knowledge development, workplace culture and care relationships with local community. Resident's family's perspectives were obtained as a secondary analysis of organisational feedback data. Quantitative data were collected from direct care workers using the Alberta Context Tool for Long-Term Care. Data were analysed according to type and integrated.
Relational care for residents and families is highly valued but provision of quality is challenging where time-poor staff are perceived to be doing the best they can. Scarce local healthcare services make it difficult to meet resident healthcare needs. Despite the supportive organisational culture, evolving policy requirements have impacted already difficult staff recruitment in rural settings.
Identifying contextual needs of organisations in readiness for change highlights geographical and sectoral nuances influencing any future implementation. As government policy changes to improve the older adult care sector, rural and remote facilities are forced to increasingly adapt.
Context-specific needs extend far beyond a nurse practitioner providing additional expertise in care provision.
What problem did the study address? Nurse practitioners have been successfully implemented into residential aged care facilities in metropolitan and major regional centres but translating this role into rural and remote Australia requires being cognisant of the needs, unique challenges and context of this setting.
What were the main findings? In an organisational culture of support, the importance of staff providing relational care and having connection with older adult residents and families was a central driver. It was challenging for staff to meet complex care requirements in the absence of local healthcare options and support. Time pressures, from inadequate staffing and changing structural aged care sector, force the prioritising of care requirements.
Where and on whom will the research have an impact? Older adults, policy makers and aged care providers will benefit from understanding the context of rural and remote settings, particularly in identifying potential solutions when there are gaps in primary and secondary healthcare.
The GRAMMS checklist was followed in reporting of this study.
Two lived experience consumers were involved as research team members. One was involved during the development and submission of the funding application and another during project activities including data collection and analysis and the development of publications.
To explore the social context of violence for hospital-based and community nurses from different ethnic groups, the types of violence experienced or witnessed both in and outside the workplace, and its impact on mental and physical health.
Cross-sectional, qualitative study using semi-structured interviews.
Semi-structured interviews were conducted online with 12 hospital-based and community nurses recruited from London, England, between May and August 2021. Data were analysed using reflexive thematic analysis.
The sample comprised seven hospital nurses and five community nurses. Four themes were identified: (i) the social context in which nurses from different ethnic groups are exposed to community violence; (ii) types of workplace violence experienced or witnessed by hospital-based and community nurses from different ethnic groups; (iii) perceptions of the factors contributing to workplace violence; (iv) impacts of violence on mental and physical health outcomes. Using the social ecological framework and sociological theory of stress, these findings informed a conceptual stress process model of violence exposure for nurses.
Nurses from different ethnic groups are exposed to violence both in and outside the workplace which negatively affects their mental and physical health. Effective violence prevention requires a multi-factorial approach that addresses the social and institutional factors contributing to violence, shifting the focus from individual measures to systemic organisational changes.
The NHS workforce is currently more diverse than ever, and healthcare leaders must improve access to mental health and well-being resources for staff affected by workplace violence, particularly for those who hold multiple social identities at the intersection of ethnicity, gender and age. Prioritising this support is essential not only to safeguard against negative health outcomes but also to improve the recruitment and retention of healthcare professionals.
No patient or public contribution.
Paramount to patient safety is the ability for nurses to make clinical decisions free from human error. Yet, the dynamic clinical environment in which nurses work is characterized by uncertainty, urgency, and high consequence, necessitating that nurses make quick and critical decisions. The aim of this study was to examine the influence of human and environmental factors on the decision to administer among new graduate nurses in response to alert generation during bar code–assisted medication administration. The design for this study was a descriptive, longitudinal, observational cohort design using EHR audit log and administrative data. The study was set at a large, urban medical center in the United States and included 132 new graduate nurses who worked on adult, inpatient units. Research variables included human and environmental factors. Data analysis included descriptive and inferential analyses. This study found that participants continued with administration of a medication in 90.75% of alert encounters. When considering the response to an alert, residency cohort, alert category, and previous exposure variables were associated with the decision to proceed with administration. It is important to continue to study factors that influence nurses' decision-making, particularly during the process of medication administration, to improve patient safety and outcomes. The aim of this study was to describe medication administration and alert patterns among a cohort of new graduate nurses over the first year of practice. Medical errors related to clinical decision-making, including medication administration errors, may occur more frequently among new graduate nurses. To better understand nursing workflow and documentation workload in today's clinical environment, it is important to understand patterns of medication administration and alert generation during barcode-assisted medication administration. Study objectives were addressed through a descriptive, longitudinal, observational cohort design using secondary data analysis. Set in a large, urban medical center in the United States, the study sample included 132 new graduate nurses who worked on adult, inpatient units and administered medication using barcode-assisted medication administration. Data were collected through electronic health record and administration sources. New graduate nurses in the sample experienced a total of 587 879 alert and medication administration encounters, administering 772 unique medications to 17 388 unique patients. Nurses experienced an average medication workload of 28.09 medications per shift, 3.98% of which were associated with alerts, over their first year of practice. In addition to high volume of medication administration, new graduate nurses administer many different types of medications and are exposed to numerous alerts while using barcode-assisted medication administration. 
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