Spinal cord injury (SCI) affects over 18 000 individuals annually, leading to significant motor and autonomic dysfunctions that reduce quality of life (QoL). Epidural spinal cord stimulation (eSCS) has shown potential in restoring function in chronic individuals with SCI. However, research on cervical and autonomic dysfunction-related SCI remains limited. This study will assess the safety and efficacy of eSCS in improving autonomic and volitional functions, as well as truncal stability, bowel, bladder and sexual function, and overall QoL.

The study is a phase I/II trial in which participants will serve as their own controls. The Abbott Eterna epidural stimulator system will be implanted, and assessments will occur every 3 months. The study will be conducted over a period of 4 years. A total of 36 participants will be enrolled and followed for 1 year.

Bayesian optimisation will be used to determine the most effective stimulation settings, with 15 settings programmed at the end of each visit.

Food and Drug Administration and University of Minnesota Institutional Review Board approvals have been secured for the study. Interim reports will be made available through peer-reviewed journals, conference presentations and clinical network reporting.

CE-STAND (Cervical Epidural STimulation After Neurological Damage) seeks to advance SCI treatment by expanding eSCS applications in chronic cervical SCI, improving patient outcomes and reducing healthcare costs. Future studies could consider a larger sample size, long-term safety, matched-control and randomisation.

NCT06410001

To evaluate the feasibility of conducting a full-scale randomised controlled trial to assess the clinical and cost-effectiveness of the MAINTAIN intervention, designed to support recovery and independence following a fall among people living with dementia.

Pilot cluster randomised controlled trial (c-RCT).

Community-based healthcare services across six UK sites representing primary and secondary care settings.

31 participant-carer dyads were recruited. Eligibility criteria included a diagnosis of dementia and a recent fall. Exclusion criteria included severe comorbidity precluding participation. The consent rate was 84%, and retention at follow-up was 81%.

The MAINTAIN intervention comprised tailored, home-based therapy sessions delivered by trained professionals, focusing on functional recovery, confidence and re-engagement in daily activities, compared with usual care. The intervention was delivered over 12 weeks with booster sessions up to week 24, with the full trial period lasting 28 weeks.

Feasibility outcomes included recruitment and retention rates, intervention adherence and data completeness for outcome and economic measures. Exploratory outcomes assessed functional performance and quality of life. Feasibility outcomes were assessed at baseline, 12 weeks and 28 weeks.

Recruitment occurred over an 8-month period (September 2023–April 2024) across six UK sites. Most intervention participants (89%) attended at least 60% of planned sessions. Completion rates for outcome and economic data were high, indicating strong acceptability and feasibility of both the intervention and trial procedures.

The pilot c-RCT demonstrated that recruitment, retention and intervention delivery were feasible and well accepted. Findings support progression to a definitive trial to evaluate the effectiveness and cost-effectiveness of the MAINTAIN intervention.

ISRCTN16413728 (International Standard Randomised Controlled Trial Number registry).

This research aims to explore the factors that hinder professionals in delivering integrated care for children under 5 in temporary accommodation (TA) and understand their experiences of collaboration during the pandemic to inform recommendations.

Semistructured qualitative interviews.

England, UK.

45 professionals working across health, housing, education and non-profit sectors in England. Purposive and snowball sampling was employed to recruit a representation of key professionals across England. Those not eligible to take part in the study included people who did not work with families and/or children in TA settings.

To explore cross-sector learnings that are applicable to improving integrated care and to tailor recommendations to the needs of families and children under 5 experiencing homelessness in the UK today.

This study highlights the complex, multilevel barriers that professionals face when delivering integrated care to children under 5 in TA. Findings are organised using a framework that distinguishes between practice-level, organisational and systemic challenges. From siloed working practices and limited training to staffing shortages and restrictive data-sharing policies, these challenges collectively hinder service continuity and collaboration.

Although this project was conducted during the COVID-19 pandemic, the challenges identified reflect deeper, long-standing issues in service delivery. As services continue to recover and prepare for future crises, these insights remain highly relevant and can inform more resilient, integrated recovery plans to support children in TA beyond the pandemic context. Addressing these barriers, through improved collaboration, training and data-sharing, is key to strengthening care for this vulnerable population.

Shoulder osteoarthritis most commonly affects older adults, causing pain, reduced function and quality of life. Total shoulder replacements (TSRs) are indicated once other non-surgical options no longer provide adequate pain relief. Two main types of TSRs are widely used: anatomic TSR (aTSR) and reverse TSR (rTSR). It is not clear whether one TSR type provides better short- or long-term outcomes for patients, and which, if either, is more cost-effective for the National Health Service (NHS).

RAPSODI-UK is a multi-centre, pragmatic, two-parallel arm, superiority randomised controlled trial comparing the clinical- and cost-effectiveness of aTSR versus rTSR for adults aged 60+ with a primary diagnosis of osteoarthritis, an intact rotator cuff and bone stock suitable for TSR. Participants in both arms of the trial will receive usual post-operative rehabilitation. We aim to recruit 430 participants from approximately 28 NHS sites across the UK. The primary outcome is the Shoulder Pain and Disability Index (SPADI) at 2 years post-randomisation. Outcomes will be collected at 3, 6, 12, 18 and 24 months after randomisation. Secondary outcomes include the pain and function subscales of the SPADI, the Oxford Shoulder Score, health-related quality of life (EQ-5D-5L), complications, range of movement and strength, revisions and mortality. The between-group difference in the primary outcome will be derived from a constrained longitudinal data analysis model. We will also undertake a full health economic evaluation and conduct qualitative interviews to explore perceptions of acceptability of the two types of TSR and experiences of recovery with a sample of participants.

Ethics committee approval for this trial was obtained (London - Queen Square Research Ethics Committee, Rec Reference 22/LO/0617) on 4 October 2022. The results of the main trial will be submitted for publication in a peer-reviewed journal and using other professional and media outlets.

ISRCTN12216466.

In middle-income to high-income countries, temporary accommodation (TA), regardless of type, is considered a form of homelessness. Families with young children living in these countries, in these circumstances, often become disconnected from friends, family and services (such as health and welfare support). The additional impact of pandemic restrictions on parents with children under 5 already living in TA had the potential to be considerable. However, this remains an area of limited research. To address this, this study explored the experiences of parents with children under 5, who lived in TA during the pandemic.

The research adopted a qualitative descriptive approach, using semi-structured telephone interviews with 41 families, to explore parents’ experiences of living in TA during the pandemic, with a child under 5. Interviews considered a broad range of factors such as housing quality, access to healthcare and education and the environment. Interviews were audio-recorded, transcribed verbatim and then analysed using a thematic analysis approach.

Parent interviews identified that living in TA with a child under 5 during the pandemic impacted their access to services such as healthcare and ability to gather resources, while also affecting their mental health and general well-being. These parent experiences were detailed in three themes, including: (1) effect of restrictions on access, which included healthcare, environment and basic necessities; (2) impact on parents, which included mental health, physical and social impacts and (3) supports, including support services and networks.

The challenges conveyed by COVID-19 restrictions, on those already parenting a young child while living in TA, caused concerning health impacts for those affected, while also having potential developmental side effects on their children. This indicates the urgent need for targeted interventions and policies to support vulnerable families in TA, ensuring their well-being during crises and beyond.

This study aimed to investigate the factors influencing health-related quality of life (HRQoL) in patients undergoing haemodialysis, focusing on the association between HRQoL dimensions and sociodemographic variables, clinical parameters, mental health status and biochemical indicators.

A multicentre cross-sectional study conducted over 30 months.

The study was carried out in secondary care centres across multiple locations in the Community of Extremadura, Spain.

A total of 150 patients undergoing haemodialysis were recruited between March 2022 and September 2023. Inclusion criteria required patients to be diagnosed with chronic kidney disease (CKD) and undergoing haemodialysis. Patients unable to provide informed consent or with severe cognitive impairment were excluded.

HRQoL was assessed using the Kidney Disease Quality of Life 36-item Short Form scale. Mental health parameters, specifically anxiety and depression, were evaluated using the Hospital Anxiety and Depression Scale. Biochemical markers such as haemoglobin and haematocrit levels, as well as sociodemographic and clinical data, were analysed for their influence on HRQoL.

Symptoms of anxiety and depression were prevalent among patients undergoing haemodialysis. Anxiety had the greatest negative effect on HRQoL, being significantly associated with lower scores in the mental component summary (MCS) (β = –2.06; 95% CI –2.78 to –1.33; R² = 0.106; p

Depression and anxiety, along with older age, were identified as key factors negatively affecting HRQoL of patients undergoing haemodialysis. Management of mental health, alongside optimisation of clinical care to minimise complications, could enhance the HRQoL in this patient population. Further research is recommended to develop targeted interventions addressing anxiety and other modifiable factors influencing HRQoL in haemodialysis patients.

Studies suggest that extreme heat events can have negative effects on mental health. However, characterisation of these effects in urban communities remains limited, and few studies have investigated the potential modifying effects of demographic, clinical and environmental characteristics. The aim of this study is to address this knowledge gap and quantify the impacts of extreme heat on mental health, health service use and mental well-being in vulnerable urban populations.

In this multidisciplinary project, we will assess mental health outcomes in different populations by bringing together two distinct datasets: electronic health record (EHR) data on mental health service users and data from general public participants of Urban Mind, a citizen science project. We will use EHRs from the South London and Maudsley NHS Foundation Trust (SLaM) and the North London NHS Foundation Trust (NLFT), from six boroughs which collectively cover more than 1.8 million residents in Greater London, to capture mental health service use and mortality among people with existing diagnoses of mental illness across 2008–2023. We will use smartphone-based ecological momentary assessment data from Urban Mind to measure mental well-being in the general population (2018–2023). These datasets will be linked to high-resolution spatiotemporal data on temperature, fine and coarse particulate matter (PM_2.5, PM₁₀), nitrogen dioxide (NO₂), Normalised Difference Vegetation Index (NDVI) and density of large mature tree canopy. We will employ novel quasi-experimental designs, including case time series and case-crossover analysis, to examine the impact of extreme heat on mental health and explore effect modification by sociodemographic, clinical and environmental factors, including air pollution and types of green space coverage. We will also develop a microsimulation model combined with the InVEST urban cooling model to assess and forecast the mental health and social care impacts of extreme heat events and the mitigation of these impacts by different green space coverage and pollution-reduction policies. With a core team composed of researchers, community organisations, industry partners and specialist policy experts, this project will consider lived experience, benefit from broad stakeholder engagement and address gaps in policy and practice.

Each component of this project has been approved by the relevant ethics committee (ref RESCM-22/23-6905 for Urban Mind, LRS/DP-23/24-41409 for the co-development of a screening tool, 23/SC/0257 for the SLaM EHRs, and 24/EE/0178 for the NLFT EHRs). Our dissemination plan includes peer-reviewed scientific articles, policy briefs, a practical guide on fostering ecological and human resilience at the neighbourhood level, and a technical guide for planting and improving the growing conditions of large canopy trees.

Opioid use disorder (OUD) is a chronic and severe psychiatric condition defined by a level of opioid use which significantly impairs interpersonal and social functioning. In the biopsychosocial model of addiction, research has shown that psychiatric, sociological and neurobiological factors individually affect OUD severity. However, how these factors interact in the determination of OUD severity remains poorly understood.

The Epigenetic Bonds of Opioid Use Profiles are a multidisciplinary project whose primary objective is to characterise psychiatric and social factors of OUD in a large cohort of patients. The secondary objectives are, first, to correlate psychosocial severity with blood-derived epigenetic biomarkers to provide a deeper understanding of determinants of OUD and, second, to examine over a 2 year follow-up the correlation between the evolution of OUD and psychosocial severity with epigenetic biomarkers at inclusion. An additional objective is to analyse the impact of drug consumption rooms on access to care for most severely affected patients with OUD. In total, 300 opioid users will be recruited at supervised injection sites in Strasbourg and Paris and at addiction care centres in Strasbourg and Lyon to explore four psychiatric (substance use disorders beyond opioids, depression, anxiety, post-traumatic stress disorder) and five social (social support and status, traumatic experiences, housing, imprisonment, access to care) factors. Opioid users will be followed for 24 months and reassessed for psychosocial factors at 3, 6, 12, 18 and 24 months. Opioid consumption will be measured in all subjects using questionnaires, complemented by toxicological screenings (mass spectrometry). Finally, DNA methylation and gene expression will be characterised in capillary blood using next-generation sequencing. Mixed models will be used to model the primary and secondary outcomes.

This ongoing study was approved by the French Ethics Committee ‘Sud Méditerranée III’ of University Hospital of Nîmes (approval 2023–2024, protocol IDRCB number 2022-A02477-36) and authorised by the French Data Protection Authority (authorisation decision DR-2023–277 in December 2023). Results will be presented in international and national conferences and published in peer-reviewed international journals.

NCT06021548.

Current guideline-recommended antibiotic treatment durations for ventilator-associated pneumonia (VAP) are largely standardised, with limited consideration of individual patient characteristics, pathogens or clinical context. This one-size-fits-all approach risks both overtreatment—promoting antimicrobial resistance and adverse drug events—as well as undertreatment, increasing the likelihood of pneumonia recurrence and sepsis-related complications. There is a critical need for VAP-specific biomarkers to enable individualised treatment strategies. The Ventilator-associated pneumonia Biomarker Evaluation (VIBE) study aims to identify a dynamic alveolar biomarker signature associated with treatment response, with the goal of informing personalised antibiotic duration in future clinical trials.

VIBE is a prospective, observational, case-cohort study of 125 adult patients with VAP in Michigan Medicine University Hospital intensive care units. Study subjects will undergo non-bronchoscopic bronchoalveolar lavage on the day of VAP diagnosis (Day 1) and then on Days 3 and 5. Alveolar biomarkers (quantitative respiratory culture bioburden, alveolar neutrophil percentage and pathogen genomic load assessed via BioFire FilmArray polymerase chain reaction) will be assessed. An expert panel of intensivists, blinded to biomarker data, will adjudicate each patient’s Day 10 outcome as VAP clinical cure (control) or treatment failure (case). Absolute biomarker levels and mean-fold changes in biomarker levels will be compared between groups. Data will be used to derive a composite temporal alveolar biomarker signature predictive of VAP treatment failure.

Ethical approval was obtained from the University of Michigan Institutional Review Board (IRB #HUM00251780). Informed consent will be obtained from all study participants or their legally authorised representatives. Findings will be disseminated through peer-reviewed publications, conferences and feedback into clinical guidelines committees.

To estimate the direction and magnitude of socioeconomic inequalities in outcome, experience and care among adults consulting for a musculoskeletal pain condition.

Multicentre, prospective observational cohort with repeated measures at three waves (baseline, 3 months and 6 months after index consultation).

30 general practices in North Staffordshire and Stoke-on-Trent, England.

1875 consecutive, eligible, consenting patients, aged 18 years and over, presenting with a relevant SNOMED CT-coded musculoskeletal pain condition between September 2021 and July 2022.

Standard care.

Primary outcome was patient-reported pain and function using the Musculoskeletal Health Questionnaire (MSK-HQ score, 0–56). Secondary outcomes were patient experience (overall dissatisfaction with consultation experience, dichotomised) and an indicator of care received (opioid prescription within 14 days of index consultation). Using multilevel models, we examined inequalities in primary and secondary outcomes by area deprivation (Index of Multiple Deprivation derived from patient residential postcode), before and after adjusting for sociodemographic and survey administration variables, clinical case-mix and selected practice-level covariates.

Compared with patients from the least deprived neighbourhoods, patients from the most deprived neighbourhoods had significantly poorer MSK-HQ scores at baseline (mean 22.6 (SD 10.4) vs 27.6 (10.1)). At 6 months, the inequality gap in MSK-HQ score widened (difference in mean score after adjustment for all covariates: 1.94; 95% CI: –0.70 to 4.58). Opioid prescription was more common for patients living in the most deprived neighbourhoods (30% vs 19%; fully adjusted OR: 0.69; 95% CI: 0.44 to 1.08). Only 6% of patients overall reported being dissatisfied with their consultation. Analysis of multiply imputed data produced a similar pattern of findings to complete-case analysis.

Substantial inequalities in the chronicity, severity and complexity of musculoskeletal pain problems are already present at the time of accessing care. Inequalities in pain and function do not reduce after accessing care and may even widen slightly.

ISRCTN18132064; Results.