Overweight and obesity are a growing global public health problem. Eating behaviours of adults and children are largely influenced by the home food environment (HFE). The lack of access to nutritious food in homes contributes to unhealthy dietary habits and, consequently, overweight and obesity among adults and children, as well as chronic diseases associated with poor diets. The present systematic review aims to identify existing HFE and household food security interventions and to determine the effects of these interventions in improving the availability of healthy food in the home, household access to food, diet quality and nutritional status of adults.

This systematic review protocol was developed according to the Preferred Reporting Items for Systematic reviews and Meta-Analysis protocols guidelines. Electronic databases including PubMed, Web of Science, Scopus, Science Direct and CINAHL (EBSCOhost) will be searched for relevant articles using keywords and MeSH terms. Risk of bias will be assessed using the adapted Cochrane effective practice and organisation of Care risk of bias tool for studies with a separate control group and Risk of Bias in non-randomised studies of interventions. The overall strength of the evidence for each outcome will be assessed using the Grading of Recommendations Assessment, Development and Evaluation tool. Two reviewers will independently screen the identified records and assess the eligible full texts for inclusion. Any discrepancies will be resolved through consensus or consultation with a third reviewer. Where sufficient homogeneous data are available, subgroup analysis will be conducted to explore heterogeneity. A thematic synthesis will be performed for qualitative studies.

This study has a systematic review and meta-analysis design, which will assess published data and does not require ethical approval. Findings of the systematic review will be disseminated through peer-reviewed publications and conference presentations.

CRD420251030896.

Settings with insufficient human resources struggle to provide timely eye care services and information to the population. mHealth (mobile healthcare) is a promising solution; however, evidence on the effectiveness of interactive voice response (IVR) and real-time phone-based education remains scarce, despite their potential to be scalable and cost-effective. This study aims to implement the Virtual Baithak, an interactive mHealth platform, to improve eye-health literacy among older adults residing in rural India. The objectives are to (1) Develop and validate the Virtual Baithak for improving vision health and (2) Determine its effectiveness, feasibility and acceptability among the older adults.

This 3-armed, parallel, randomised controlled trial of 14 months duration will enrol 381 older adults (aged 60 years and above). Participants will be blinded and randomly (computer-generated) assigned to either of the three groups based on the intervention for eye-health education they receive: both IVR and group calls moderated by a healthcare professional, only IVR and usual care. The two intervention arms will receive the information weekly over a 3-month period through the Virtual Baithak platform, which will be designed for this study using a participatory research approach to develop the content. The primary study outcomes are digital health literacy and vision health knowledge scores, measured at baseline and 14 months. The secondary outcomes include m-health technology acceptance and usage practices. A mixed-method process evaluation will be conducted to assess the intervention feasibility and implementation, including in-depth interviews with participants. The qualitative data will be thematically analysed to explore factors that promote or restrain the implementation. The inferential statistical quantitative analysis will be performed using linear mixed models.

The study has been approved by the ‘Institute Ethics Committee,’ PGIMER, Chandigarh, India (PGI/IEC/2022/EIC000282 dated 18 February 2022). The results will be disseminated via presentations and/or publications at the national and international levels.

CTRI/2023/02/049383, dated 1 February 2023.

The research explored how individuals experience chronic pain within their everyday social contexts over a 12-month period. The study focused on the interplay between pain and social worlds, through analysis of experiences of social relationships included in engagement in meaningful activities such as hobbies and work.

Drawing on ethnographic approaches from social science, the study involved 295 research visits with 19 participants living with chronic pain (totalling approximately 418 hours of fieldwork) and 48 semistructured interviews (around 30 hours).

The study was carried out in South West England, UK.

19 participants were identified through the Avon Longitudinal Study of Parents, 12 women and 7 men, all identifying as white British, aged between 32 and 33 years.

The analysis identified three key themes: (1) Social connections and everyday fluctuations in chronic pain; and (2) the interplay between work, family roles and fluctuations in chronic pain; and (3) Social spiralling and fluctuations in chronic pain. The third theme builds on and combines the patterns identified in the first two themes, drawing together how changes in social connections and balancing of roles coalesce in the experience of fluctuation in chronic pain. Relationships, roles and how these were experienced varied across participants, but all of their descriptions indicated that the constant flux was understood, even if financial or other circumstances meant that people were unable to exert agency that would have proved beneficial. Across themes, interconnected social processes appear to shift and move together, amplifying their collective impact on the experience of chronic pain.

Fluctuations in chronic pain were complex, shaped by and entangled with social contexts that vary in meaningful ways. The findings suggest that to address chronic pain effectively, health and social care may need to move beyond individual-level solutions to consider the multiple, interacting layers of influence that shape and sustain the experience of chronic pain.

Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

NCT03963622.

The National Institute for Health and Care Research (NIHR) has 20 Biomedical Research Centres (BRCs) and 28 Clinical Research Facilities (CRFs) that work with NHS organisations and universities to translate cutting-edge research into new interventions. As mandated by NIHR, all BRCs/CRFs have an Equality, Diversity and Inclusion (EDI) strategy which details how they will implement EDI through their practices, research and organisational systems. This UK-based study aimed to conduct a pilot qualitative analysis of EDI strategies to compare all 20 NIHR BRCs/CRFs, identify common priorities and improve inclusion across research infrastructures. The analysis was presented at the first in-person seminar for NIHR EDI professionals (Birmingham, October 2024).

Qualitative content analysis of publicly available EDI strategy documents.

48 research infrastructures (20 BRCs and 28 CRFs).

EDI strategies were collated into NVivo and Microsoft Excel where inductive coding and content analysis was executed for objectives, action plans and success measures. Both quantitative and qualitative content analyses were conducted to analyse the prevalence of categories and similarities or differences between them. Logic models were developed to map the process of implementing EDI for each main category generated.

The most common main category across objectives was ‘Cultural change in workplaces’ for BRCs and ‘Leadership, governance and policy’ for CRFs. For action plans, codes for ‘Collaborations and Networks’ and ‘Research development and delivery’ were most prevalent for BRCs—for CRFs, it was ‘Workforce culture change’ and ‘Research development and delivery’. Success measures for both BRCs and CRFs most often related to ‘Summary reports, feedback, audits and monitoring’. Differences between BRCs and CRFs reflected their organisational roles and strategic maturity, with BRCs tending to have more comprehensive, measurable strategies.

This study provides the first systematic analysis of EDI strategies across all NIHR BRCs and CRFs, offering a comprehensive mapping of how EDI priorities are articulated and operationalised across objectives, action plans and success measures. While both infrastructures align with NIHR’s inclusion goals, BRCs generally showed more strategic maturity than CRFs. As the analysis was based solely on publicly available strategy documents, it could not determine the extent to which any strategy had been implemented in practice. Future research is needed to examine implementation and impact. The contribution of this work lies in demonstrating systematically and for the first time the ways in which EDI commitments are framed across NIHR infrastructures and their varying levels of depth and maturity. Our findings support the development of more measurable EDI frameworks and highlight opportunities to strengthen inclusion across NIHR-funded research infrastructures.

To determine the safety and efficacy of ruxolitinib (RUX) and fostamatinib (FOS) compared with standard of care (SOC) in patients requiring hospital admission for the treatment of COVID-19 pneumonia.

Adaptive multiarm, multistage, randomised, open-label trial (three arm, two stage).

Five hospitals in England between October 2020 and September 2022.

Hospitalised patients (≥18 years) with COVID-19 pneumonia defined by a modified WHO COVID-19 severity grade of 3 or 4.

Participants were randomly assigned 1:1:1 to receive RUX (10 mg two times per day for 7 days then 5 mg two times per day for 7 days), FOS (150 mg two times per day for 7 days then 100 mg two times per day for 7 days) or SOC.

Primary outcome was development of severe COVID-19 pneumonia (modified WHO severity grade≥5) within 14 days of randomisation. Secondary outcomes included mortality, invasive and non-invasive ventilation, venous thromboembolism, duration of hospital stay, readmissions, inflammatory markers and serious adverse events (SAEs).

At stage 1, 181 patients were randomised, with 4 assessed as ineligible post randomisation. FOS was stopped early for futility with 16 participants (27.6%, n=58) developing severe COVID-19 pneumonia compared with 15 (25.0%, n=60) in the SOC arm (adjusted odds ratio (aOR) compared with SOC: 1.12; 95% CI 0.49 to 2.58; p=0.608). RUX progressed to stage 2 but the trial was stopped early due to slow recruitment. At the final analysis, 10 participants (16.1%, n=62) developed severe COVID-19 pneumonia in the RUX arm compared with 15 (24.6%, n=61) in the SOC arm (aOR: 0.63; 95% CI 0.25 to 1.57; p=0.161). Four (7.4%) participants in the FOS arm, none in the RUX arm and three (5.5%) in the SOC arm died within 14 days of randomisation. Infections were the most frequently reported SAE and were numerically higher in the FOS (10, 17.2%) and RUX (10, 16.1%) arms compared with SOC (7, 11.5%). Two unexpected serious adverse reactions occurred in the RUX arm only.

We found no evidence that FOS was superior to SOC for the treatment of COVID-19 pneumonia in patients requiring hospital admission. Due to early stopping, the trial was underpowered to establish RUX’s effect in this population. Further study is needed.

NCT04581954; EUDRA-CT: https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001750-22/GB.

Significant advances in systemic therapy have improved survival for patients with advanced-stage non-small cell lung cancer (NSCLC). However, the present treatment strategies and dose-fractionation for high-dose palliative radiotherapy (RT) are based on trials from the 1990s, when RT planning was simple with less precise delivery. Contemporary lung RT uses 4D-CT, volumetric modulated arc radiotherapy, aided by online verification using cone beam CT, which enables greater accuracy and better target volume coverage, while reducing doses to normal organs at risk. The Shortened High-dose Palliative Radiotherapy for Lung Cancer study aims to evaluate the safety and feasibility of reducing the number of RT fractions and RT duration, using contemporary planning, verification and delivery techniques.

This single-arm, multicentre, phase-II study will test the shortened hypofractionated accelerated palliative RT regimen of 30 Gy in 6 alternate-day fractions, with strict normal tissue dose constraints. We aim to recruit 37 patients across 4 sites within the West Midlands. Quality assurance for the RT is supported by the Radiotherapy Trials Quality Assurance Group (RTTQA). Patients with locally advanced or metastatic NSCLC, who are candidates for high-dose palliative RT, before or after first-line systemic therapy, are eligible for recruitment. The primary objective of this study is to assess the safety of the proposed dose-fractionation. Secondary objectives include evaluating toxicity profiles, patient-reported outcome measures, time to progression, feasibility and the National Health Service cost-saving.

This study is conducted in accordance with the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines and all applicable regulatory frameworks, including, but not limited to, the UK policy framework for health and social care research, as well as the Health Research Authority and Health and Care Research Wales regulations. Approval for the study was granted on 18 April 2024 (IRAS project ID: 332998; REC reference: 24/WM/0032). The chief investigator is responsible for obtaining informed consent from participants. Any individual delegated this responsibility is thoroughly authorised, trained and competent to conduct the informed consent process. On completion of the trial, the results will be shared with participants in a plain language summary and will be submitted for publication in a peer-reviewed journal. If successful, this study will inform a phase III randomised controlled trial to assess efficacy. For updates on the study, visit the study web page (https://research.mededcoventry.org/About-Us/Meet-The-Team/TMU/Ship-Rt).

NCT06483308.

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

We aimed to determine whether UCLP-PRIMROSE (a care innovation to reduce physical health inequalities for people with severe mental illness) could be set up in the current UK National Health Service (NHS) context and identify the processes, barriers and facilitators to implementation.

We employed a convergent mixed methods approach, combining interviews, ethnographic site visits and the collection of meeting notes and uptake data for core model components. Interview transcripts were analysed using reflexive thematic analysis, and all qualitative data, including interview transcripts, were analysed using the Consolidated Framework for Implementation Research. Qualitative work and insights from implementation uptake frequencies were integrated using Normalisation Process Theory.

We evaluated implementation in Yorkshire and three London boroughs, mainly within general practices.

We conducted interviews with 39 staff members who were implementing and/or delivering UCLP-PRIMROSE.

UCLP-PRIMROSE is an integrated evidence-based care pathway developed to reduce cardiovascular disease risk and mental health relapse in people with severe mental illness.

Adaptation and delivery varied in completeness and consistency across 24 general practices and their wider care teams. Factors outside the implementation teams’ influence challenged the embedding of UCLP-PRIMROSE. Factors included the impact from the immaturity of NHS integrated care systems, unintended consequences of the incentivised NHS severe mental illness physical health check and limited capacity for implementing in a system facing resourcing challenges. Drivers of successful implementation included staff being aligned with the values of the UCLP-PRIMROSE model and system leaders acting as champions. Supportive foundational processes acted as facilitators: these included protected and prioritised time for reflection, learning and problem solving.

Implementation of UCLP-PRIMROSE was moderately successful in a relatively short period of time. At the end of the research, all teams wanted to sustain delivery. However, further pathway simplification and additional resources are required to spread UCLP-PRIMROSE beyond early pockets of good practice.

The commercial determinants of health (CDoH) are a rapidly growing field of research and global health priority. Despite being disproportionately affected, Indigenous Peoples’ voices and perspectives are conspicuously absent from CDoH research and policy. This article outlines the protocol for Addressing Commercial Health determinants: Indigenous Empowerment and Voices for Equity (ACHIEVE), an Aboriginal and Torres Strait Islander-led project in Australia.

ACHIEVE integrates four research streams, using a novel combination of methods. The first three streams will (i) conceptualise the CDoH using Indigenous yarning methodology, (ii) evaluate the effectiveness and cost-effectiveness of policies to reduce exposure to harmful marketing and (iii) assess the impacts of specific commercial entities on Aboriginal and Torres Strait Islander health using case studies. The final stream will consolidate findings from streams 1–3 and work with Aboriginal Community Controlled Health Organisations (ACCHOs) to co-create strategies for addressing the commercial determinants of Aboriginal and Torres Strait Islander health.

Ethical approval for streams 1–3 has been granted by Deakin University Human Research Ethics Committee. ACHIEVE is guided by a governance model that prioritises Indigenous data sovereignty, community and ACCHO partnerships, capacity building and knowledge translation. Findings will be shared with participants, ACCHOs and policymakers to maximise research impact.

Patient-reported experience measures (PREMs) are measures of patients’ perceptions of care they receive. PREMs are critical in developing and evaluating programmes that aim to improve patient healthcare experiences and quality of care (QoC) according to patient-defined needs. This review aims to map key domains of PREMs across distinct healthcare technical areas and life stages from globally available literature.

A scoping review adapting Arksey and O’Malley’s framework and Joanna Briggs Institute’s guidelines for the conduct of scoping reviews.

Google Scholar, PubMed, WHO, US Academy of Medicine and USAID Momentum.

PREMs literature from electronic repositories of grey and peer-reviewed publications, published in English historically up to September 2023.

Two lead reviewers with support from the technical working group co-created a review framework of healthcare technical areas, life stages and PREMs domains. We screened eligible articles, prioritising reviews except for technical areas with no reviews, where we then selected individual studies. We charted, analysed and synthesised data from 52 eligible articles.

PREMs literature has recently increased, especially in low-income and middle-income countries (LMICs), although studies in high-income countries (HICs) dominate in proportion (n=38; 73.1%). Out of 52 eligible articles, technical areas with most publications were sexual and reproductive health (n=21; 40.4%) and general outpatient care (n=11; 21.2%). Studies in adulthood (n=24; 46.2%) and from pregnancy and birth to postnatal (n=16; 30.8%) were most represented. PREMs studies reported mostly on communication and rapport (n=33; 63.5%) and respect and dignity (n=42; 80.8%) domains. Nearly a quarter (n=12; 23.1%) of the articles included only validated tools; the rest included a combination of validated and unvalidated measures. Of the tools relating to life stages of babies, younger children and older adults, the majority (n=17; 94.4%) included patient proxies.

PREMs, as an important component of QoC measurement, are increasing across several healthcare technical areas and life stages with commonalities and notable distinctions in measurement domains and tools. Evidence on PREMs largely comes from HICs. Evidence on critical, yet sometimes overlooked domains, highlights key QoC implementation gaps. The adaptation and utilisation of PREMs in programmes, especially in LMICs and under-represented technical areas, present opportunities to close the QoC disparities in those settings. Strategic, concerted efforts towards the harmonisation of PREMs tools across multiple life course stages and technical areas are critically needed in high-level quality improvement efforts.

To characterise long-term trajectory of recovery in individuals with long covid.

Prospective cohort.

Single-centre, specialist post-COVID service (London, UK).

Individuals aged ≥18 years with long covid (hospitalised and non-hospitalised) from April 2020 to March 2024.

Routine, prospectively collected data on symptoms, quality of life (including Fatigue Assessment Scale (FAS) and EuroQol 5 Dimensions (EQ-5D), return to work status and healthcare utilisation (investigations, outpatient and emergency attendances). The primary outcome was recovery by self-reported >75% of ‘best health’ (EQ-5D Visual Analogue Scale) and was assessed using Cox proportional hazards regression models over 4 years. Linked National Health Service England registry data provided secondary care healthcare utilisation and expenditure.

We included 3590 individuals (63.3% female, 73.5% non-hospitalised, median age 50.0 years, 71.9% with ≥2 doses of COVID-19 vaccination), who were followed up for a median of 136 (0–346) days since first assessment and 502 (251–825) days since symptom onset. At first assessment, 33.2% of employed individuals were unable to work. Dominant symptoms were fatigue (78.7%), breathlessness (68.1%) and brain fog (53.5%). 33.4% of individuals recovered to >75% of best health prior to clinic discharge (recovery occurred median 202 (94–468) days from symptom onset). Vaccinated individuals were more likely to recover faster (pre: HR 2.93 (2.00–4.28) and post: HR 1.34 (1.05–1.71) COVID-19 infection), whereas recovery hazard was inversely associated with FAS (HR 0.37 (0.33–0.42)), myalgia (HR 0.59 (0.45–0.76)) and dysautonomic symptoms (HR 0.46 (0.34–0.62)). There was high secondary care healthcare utilisation (both emergency and outpatient care). Annual inpatient and outpatient expenditure was significantly lower in hospitalised individuals while under the service. When compared with the prereferral period, emergency department attendances were reduced in non-hospitalised patients with long covid, but outpatient costs increased.

In the largest long covid cohort from a single specialist post-COVID service to date, only one-third of individuals under follow-up achieved satisfactory recovery. Fatigue severity and COVID-19 vaccination at presentation, even after initial COVID-19 infection, was associated with long covid recovery. Ongoing service provision for this and other post-viral conditions is necessary to support care, progress treatment options and provide capacity for future pandemic preparedness. Research and clinical services should emphasise these factors as the strongest predictors of non-recovery.

Effective prevention of maternal-fetal transmission of hepatitis B virus (HBV) in highly endemic settings depends on targeting vaccination efforts to key priority groups, including pregnant women. However, the extent of HBV vaccination and determinants of uptake in sub-Saharan Africa (SSA) have not been systematically examined. This systematic review aims to estimate HBV vaccination among pregnant women in SSA and identify the broader factors influencing uptake.

This review will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA) guidelines. A comprehensive literature search will be conducted in MEDLINE, Embase, Web of Science, Scopus, African Journals Online and Google Scholar in November 2025. We will include published observational studies that assess HBV vaccination among pregnant women in SSA countries from database inception to October 2025. A meta-analysis will be conducted using random-effects models to pool estimates of HBV vaccination and multivariable-adjusted ORs for vaccination-associated factors. Statistical heterogeneity will be assessed using the I² statistic.

Ethical approval is not required as this review will not involve primary data collection. Findings will be published in a peer-reviewed journal, presented at regional and international public health conferences, and, where applicable, shared with policymakers and health authorities in SSA.

This protocol is registered with the International Prospective Register of Systematic Reviews, registration number CRD420251120357.

MRI is increasingly recognised as a valuable tool for assessing prognosis and predicting outcomes following traumatic spinal cord injury (SCI). Several potential MRI biomarkers have been identified, but efforts are still needed to improve the accuracy and feasibility of these biomarkers in clinical practice. This study aims to build a national Canadian SCI imaging repository for storing and analysing imaging data for SCI, with the goal of improving SCI MRI biomarkers to predict outcomes and inform clinical management.

As a substudy of the Rick Hansen SCI Registry (RHSCIR), this retrospective multisite study includes individuals who sustained a traumatic cervical SCI between 2015 and 2021, were previously enrolled in RHSCIR, and had MRI scans acquired within 72 hours of injury and before any surgical intervention. Individuals with a penetrating trauma and/or with any prior spine surgery are excluded. The study principal investigator and research associates, experienced with data curation and with the standardised format and specifications of the Brain Imaging Data Structure standard, guide the site’s curator on the steps to perform image deidentification and curation to create standardised datasets across all sites. These datasets are transferred to a Digital Research Alliance of Canada (‘the Alliance’) server designated for this project and concatenated to form the national Canadian SCI imaging repository (Neurogitea). We are using a semiautomated processing pipeline to quantify lesion morphology, together with additional imaging measures that are manually extracted from the images (for instance, the relative maximal spinal cord compression and the maximum canal compromise). Through linkage to RHSCIR clinical and epidemiological data already available on eligible participants, regression analysis is planned to predict neurological outcomes at discharge, including the American Spinal Injury Association Impairment Scale grade, upper and lower extremity motor and sensory scores.

This protocol has been submitted by the participating sites to obtain ethics and institutional approvals prior to the study initiation at each site. All 12 sites across Canada have now obtained ethics and institutional approvals. Study results will be disseminated at local, national and international conferences and by journal publications.

Pain in patients with rheumatoid arthritis (RA) is an unmet clinical need. Targeting joint inflammation with disease-modifying antirheumatic drugs has not resulted in the anticipated reduction in pain for many patients. This can partly be explained by the concept of central sensitisation whereby spinal and supraspinal pathways have a lower threshold of activation, leading to increased perception of pain. Synovial stromal cells, such as fibroblasts, are also thought to play a role through peripheral sensitisation of nerves in the joint. Synovial fibroblasts are known to produce pro-algesic mediators such as interleukin 6 and nerve growth factor at the messenger RNA level. These pro-algesic mediators could activate sensory nerve fibres that send signals from the joint to the spinal cord, thereby driving persistent pain in RA. The purpose of this study is to evaluate which pro-algesic mediators are produced by lining versus sub-lining fibroblasts and whether the level of these mediators correlates with clinical measures of pain in patients with RA.

FiND-Pain RA is a multicentre observational study which will recruit 50 patients with seropositive RA who attend the rheumatology department of Guy’s and St Thomas’ Hospital, London, and the Nuffield Orthopaedic Centre, Oxford. Clinical examination, pain-focused patient-reported outcome measures, ultrasound examination and ultrasound-guided synovial biopsy of the knee will be performed. The levels of known and putative pro-algesic mediators will be measured in fibroblasts from the lining and sub-lining layer of the synovium. The location and spatial morphology of sensory nerve fibres and their proximity to lining and sub-lining fibroblasts will be characterised. The primary outcome will be to determine whether the knee pain scores of participants correlate with the level of leukaemia inhibitory factor, a novel putative pain-mediator expressed in sub-lining fibroblasts. The secondary outcomes will be to determine whether other pro-algesic mediators produced by lining or sub-lining fibroblasts correlate with clinical measures of pain and to assess the location and proximity of sensory nerve fibres to lining versus sub-lining fibroblasts.

The study is a sub-study of the PUMIA (Pain Phenotypes and their Underlying Mechanisms in Inflammatory Arthritis) study, which has been approved by the Bromley Research Ethics Committee (REC: 21/LO/0712). The findings of this study will be disseminated through open-access publications, as well as scientific and clinical conferences.

More knowledge and resources are required to strengthen ‘leadership and governance’ (L+G) as a central building block to further develop emergency care (EC) systems in low-income and middle-income countries (LMICs).

This scoping review aimed to examine and map the impact of individual, collective or institutional L+G on the development of EC systems (prehospital and facility-based) in LMICs.

English language publications from January 2005 to April 2024 that linked any L+G action with the development and capacity of everyday EC in LMICs, specifically excluding disaster responses.

Medline (Ovid), Embase (Ovid), CINAHL, Web of Science (Clarivate), Central (Cochrane Central Register of Controlled Trials), Global Health (Ovid) and select grey literature.

Data from all eligible papers were jointly extracted using a piloted tool developed from the literature and WHO’s EC Systems Framework. L+G descriptors included level (from clinical to national) and components (informed by Siddiqi et al’s LMIC health system ‘good governance’ framework and a synthesis of EC policy documents). Impact of L+G on EC systems and key lessons were extracted from each publication.

From an initial 9713 items, 129 papers were included for final analysis and divided by EC component: prehospital (n=35), facility-based (n=53) and ‘whole of EC system’ (n=41). Qualitative and descriptive papers were most common, and 72 out of a possible 131 LMICs were represented. Findings were heterogeneous across all building blocks of EC systems and for different components of leadership and/or governance. Cross-cutting L+G themes were identified that demonstrated consistent impact across all EC systems development: government recognition, vision and human rights framing; coalition-building for effective partnerships and trained, empowered EC clinicians demonstrating emotionally intelligent, transformational leadership.

Applying new models such as Theories of Change and Social Network Analysis concepts may assist to illuminate how effective L+G is attained, what are the essential components and how these influence EC systems for better patient-centred outcomes. Further understanding the role of L+G for EC systems has utility for future EC clinician leadership training and policy-maker awareness, to strengthen resilience of overall health systems against likely future shocks.

To explore the views and perspectives of British South Asian (BSA) women and Positive Health Programme (PHP) facilitators on the usefulness and experiences of the PHP intervention for managing postnatal depression (PND) in primary care settings.

Qualitative study with semi-structured interviews to explore perceptions of acceptability and implementation. A patient and public involvement group provided their insights and feedback on study topic guides, analysis and outcomes.

We sampled trial participants from the PHP intervention database to ensure variation in geographic setting, age, socioeconomic status and ethnicity. PHP facilitators involved in the trial were also invited to participate in an interview.

Interviews with study participants were conducted at participants’ homes, and community centres, or via phone. Interviews with PHP facilitators were conducted via phone or online. Interview recordings were transcribed verbatim and analysed using thematic analysis and subsequently the Theoretical Framework of Acceptability (TFA) was applied. Recruitment took place between February 2017 and March 2020.

Thirty interviews were conducted—19 trial participants and 11 PHP facilitators. The PHP intervention was viewed positively, with appreciation of its therapeutic content and components such as childcare and refreshments that facilitated engagement. Participants reported improved confidence and well-being and supported their needs. Participants understood the intervention’s purpose. Both intervention participants and facilitators noted strengthened self-efficacy.

Some participants experienced difficulties balancing childcare and attendance, implying a need for logistical assistance. Stigma about mental health in the BSA community was viewed as persistent, recommending future programmes efforts on strategies to reduce stigma and develop supportive environment.

This study demonstrates the possibility of PHP intervention being integrated into routine care by providing culturally tailored support for BSA women with PND, primarily through family engagement and facilitator support. Future research on scalability, alongside community engagement efforts, will strengthen its acceptability and broader applicability.

ISRCTN10697380.

Tobacco use is the most significant modifiable risk factor for adverse health outcomes, and early research indicates there are also significant harms associated with vaping. National targets aim to reduce smoking and vaping during pregnancy for Aboriginal and Torres Strait Islander people. While most Aboriginal and Torres Strait Islander people want to quit, cessation is frequently attempted without support, increasing the chance of relapse. Group-based smoking cessation programmes increase quit success by 50%–130% in the general population; however, they have never been evaluated in Aboriginal and/or Torres Strait Islander communities.

The Gulibaa study is an Indigenous-led and community-embedded project that will co-design, implement and evaluate a group-based model of care to support Aboriginal and Torres Strait Islander women to be smoke- and vape-free. Staff of Health Services in New South Wales, Australia, will receive training to deliver a face-to-face group-based smoking and vaping cessation intervention. Aboriginal and/or Torres Strait Islander people who identify as a woman or non-binary, are pregnant or of reproductive age (16 to 49 years), currently smoke or vape at least once per day and are willing to attend the programme are eligible to participate. Up to 500 participants will be recruited. A mixed method evaluation approach will be implemented guided by the RE-AIM framework. Outcomes will include intervention reach, intervention effectiveness (determined primarily by self-reported 7-day point prevalence abstinence at 6 months follow-up), acceptability and feasibility of the intervention, programme fidelity and maintenance and cost effectiveness.

Embedding culturally safe support to quit during pregnancy can result in improved outcomes for both mother and child and immediately improve intergenerational health and well-being. Ethics approval has been provided by the Aboriginal Health and Medical Research Council and the University of Newcastle. Study findings will be disseminated to Aboriginal and Torres Strait Islander communities in ways that are meaningful to them, as well as through Aboriginal health services, key national bodies, relevant state and federal government departments.

ACTRN12625001050448.

Falls are a critical problem for older people, including those from ethnically diverse communities, who are under-represented in research. The aim of this pilot trial is to evaluate (1) the implementability of a co-designed intervention developed to support the sustained uptake of tailored exercise to reduce falls (MOVE Together: Reduce Falls) and (2) the feasibility of conducting a randomised controlled trial (RCT) in older people from Italian, Arabic, Cantonese or Mandarin-speaking communities.

Investigator and assessor-blinded pilot two-arm parallel RCT. 60 older people at risk of falls from Italian, Arabic, Cantonese or Mandarin speaking communities will be recruited, with the option to enrol on their own or with another participant (dyad). Participants or dyads will be randomly assigned to the experimental or control arm. The experimental arm will receive MOVE Together: Reduce Falls, which provides up to 12 sessions with a physiotherapist over 12 months and supports participants to engage in individualised exercises. Both arms will receive educational resources in the participant’s preferred language. The primary outcome is implementability of the co-designed intervention, MOVE Together: Reduce Falls; operationalised as fidelity (>70% of intended sessions delivered), feasibility (> 95% of sessions delivered with no serious adverse events related or likely related to the intervention) and acceptability (>50% acceptability score). The secondary outcome is feasibility of the RCT protocol, which will be evaluated quantitatively (eg, recruitment and retention rates, completion of clinical outcome data including prospective collection of falls data for 12 months via falls calendars) and qualitatively (eg, barriers and enablers to data collection).

Ethical approval has been granted for this study (HREC/106010/MH-2024). Study findings will be published in peer-reviewed journals and presented at relevant conferences and community forums.

ACTRN12624000658516.

The Clinical Frailty Scale is an ordinal scale from 1 (very fit) to 9 (terminally ill) commonly used to assess frailty in older patients. It is simple for clinicians to apply and can help identify patients who may benefit from discussions around end-of-life care. We externally validated the Scale to assess its performance for predicting 90-day mortality in a cohort of admitted older patients who had screened positive for being at risk of nearing the end of life.

We used data from a randomised controlled trial assessing a tailored feedback loop for reducing non-beneficial care. Our study included patients aged 75 and above admitted between May 2020 and June 2021 from 3 Australian hospitals. We assessed whether the Scale could be used in a frail population to identify patients who were at risk of short-term mortality. Predictive performance was assessed using the c-statistic, smoothed calibration curves and decision curves. Models were tested for coefficient stability.

Our dataset contained 4639 patients and 956 deaths within 90 days. The Clinical Frailty Scale had a c-statistic of 0.62 (95% CI 0.60 to 0.64) or 0.63 (95% CI 0.61 to 0.65) by adding age and transforming the Scale using a cubic spline. Risks were underestimated without a non-linear transformation as scores of 8 and 9 had a higher risk that diverged from a linear association. The net benefit of using the tool was greatest between 5 and 8 on the Scale.

The utility of the Clinical Frailty Scale may be as a flag to encourage clinicians to become more comfortable with discussing ageing and death, rather than as a highly discriminating model to classify patients as high risk or low risk. Statistical uncertainty over mortality should not be a barrier to initiating end-of-life care discussions with frail older patients.