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.