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ATTUNE: A groundbreaking UK research programme combining art and science to address adverse childhood experiences. Discover how this initiative is revolutionising mental health support for young people across five regions.
Risk stratification of childhood infection using host markers of immune and endothelial activation in Asia (Spot Sepsis): a multi-country, prospective, cohort study.
BACKGROUND: Prognostic tools for febrile illnesses are urgently required in resource-constrained community contexts. Circulating immune and endothelial activation markers stratify risk in common childhood infections. We aimed to assess their use in children with febrile illness presenting from rural communities across Asia. METHODS: Spot Sepsis was a prospective cohort study across seven hospitals in Bangladesh, Cambodia, Indonesia, Laos, and Viet Nam that serve as a first point of contact with the formal health-care system for rural populations. Children were eligible if aged 1-59 months and presenting with a community-acquired acute febrile illness that had lasted no more than 14 days. Clinical parameters were recorded and biomarker concentrations measured at presentation. The primary outcome measure was severe febrile illness (death or receipt of organ support) within 2 days of enrolment. Weighted area under the receiver operating characteristic curves (AUC) were used to compare prognostic accuracy of endothelial activation markers (ANG-1, ANG-2, and soluble FLT-1), immune activation markers (CHI3L1, CRP, IP-10, IL-1ra, IL-6, IL-8, IL-10, PCT, soluble TNF-R1, soluble TREM1 [sTREM1], and soluble uPAR), WHO danger signs, the Liverpool quick Sequential Organ Failure Assessment (LqSOFA) score, and the systemic inflammatory response syndrome (SIRS) score. Prognostic accuracy of combining WHO danger signs and the best performing biomarker was analysed in a weighted logistic regression model. Weighted measures of classification were used to compare prognostic accuracies of WHO danger signs and the best performing biomarker and to determine the number of children needed to test (NNT) to identify one additional child who would progress to severe febrile illness. The study was prospectively registered on ClinicalTrials.gov, NCT04285021. FINDINGS: 3423 participants were recruited between March 5, 2020, and Nov 4, 2022, 18 (0·5%) of whom were lost to follow-up. 133 (3·9%) of 3405 participants developed severe febrile illness (22 deaths, 111 received organ support; weighted prevalence 0·34% [95% CI 0·28-0·41]). sTREM1 showed the highest prognostic accuracy to identify patients who would progress to severe febrile illness (AUC 0·86 [95% CI 0·82-0·90]), outperforming WHO danger signs (0·75 [0·71-0·80]; p<0·0001), LqSOFA (0·74 [0·69-0·78]; p<0·0001), and SIRS (0·63 [0·58-0·68]; p<0·0001). Combining WHO danger signs with sTREM1 (0·88 [95% CI 0·85-0·91]) did not improve accuracy in identifying progression to severe febrile illness over sTREM1 alone (p=0·24). Sensitivity for identifying progression to severe febrile illness was greater for sTREM1 (0·80 [95% CI 0·73-0·85]) than for WHO danger signs (0·72 [0·66-0·79]; NNT=3000), whereas specificities were comparable (0·81 [0·78-0·83] for sTREM1 vs 0·79 [0·76-0·82] for WHO danger signs). Discrimination of immune and endothelial activation markers was best for children who progressed to meet the outcome more than 48 h after enrolment (sTREM1: AUC 0·94 [95% CI 0·89-0·98]). INTERPRETATION: sTREM1 showed the best prognostic accuracy to discriminate children who would progress to severe febrile illness. In resource-constrained community settings, an sTREM1-based triage strategy might enhance early recognition of risk of poor outcomes in children presenting with febrile illness. FUNDING: Médecins Sans Frontières, Spain, and Wellcome. TRANSLATIONS: For the Arabic and French translations of the abstract see Supplementary Materials section.
Racialised experience of detention under the Mental Health Act: a photovoice investigation.
BACKGROUND: The rates of compulsory admission and treatment (CAT) are rising in mental health systems in the UK. Persistent disparities have been reported among migrants, and black and ethnic minorities in Europe and North America for decades. Lived experience data can provide novel insights to reduce coercive care. METHODS: We purposively sampled people within 2 years of receiving CAT, to maximise diversity by age, sex, ethnicity and different 'sections' of the Mental Health Act (England and Wales) from eight health systems in England. Using participatory photovoice workshops, we assembled images, captions and reflective narratives, which were transcribed and subjected to thematic and intersectional analyses. The interpretation privileged lived experiences of participants and peer researchers alongside the research team. Preventive insights informed a logic model to reduce CAT. RESULTS: Forty-eight ethnically diverse people contributed over 500 images and 30 hours of recorded narratives. A significant proportion of participants reported multimorbidity, adverse childhood experiences and carer roles. Their experiences indicated insufficient co-ordination to prevent CAT despite early help seeking; they were not taken seriously or believed when seeking help. Dismissive responses and even hostility from professionals and unnecessary police involvement were distressing, stigmatising and risked criminalisation. Participants wanted more (a) advocacy given in crisis, (b) trauma-informed therapeutic and creative support from inpatient into community settings, (c) family and carer involvement and (d) more information about how to negotiate care options, appeals, restriction and seclusion. Practitioners were felt to lack the essential skills to care for racialised and traumatised people subjected to CAT. CONCLUSIONS: We propose a lived experience logic model for the practice, policy and legislative solutions to reduce epistemic injustice, CAT and criminalising care.
Risk of repeat self-harm among individuals presenting to healthcare services: development and validation of a clinical risk assessment model (OxSET).
BACKGROUND: A self-harm episode is a major risk factor for repeat self-harm. Existing tools to assess and predict repeat self-harm have major methodological limitations, and few are externally validated. OBJECTIVE: To develop and validate a risk assessment model of repeat self-harm up to 6 months after an episode of non-fatal self-harm that resulted in an emergency visit to hospital or specialised care. METHODS: Using Swedish national registers, we identified 53 172 people aged≥10 years who self-harmed during 2008-2012. We allocated 37 523 individuals to development (2820 or 7.5% repeat self-harm incidents within 6 months) and 15 649 to geographic validation (1373 repeat episodes) samples, based on region of residence. In a temporal validation of people who self-harmed during 2018-2019, we identified 25 036 individuals (2886 repeat episodes). We fitted a multivariable accelerated failure time model to predict risk of repeat self-harm. FINDINGS: In the external validations (n=40 685), rates of repeat self-harm were 8.8%-11.5% over 6 months. The final model retained 17 factors. Calibration and discrimination were similar in both validation samples, with observed-to-expected ratio=1.15 (95% CI=1.09 to 1.21) and c-statistic=0.72 (95% CI=0.70 to 0.73) in the geographical validation. At 6 months and a 10% risk cut-off, sensitivity was 51.5% (95% CI=48.8% to 54.2%) and specificity was 80.7% (95% CI=80.1% to 81.4%) in geographic validation; corresponding values were 56.9% (95% CI=55.1% to 58.7%) and 76.0% (95% CI=75.5% to 76.6%) in temporal validation. Discrimination was slightly worse at the 1-month prediction horizon (c-statistics of 0.66-0.68). CONCLUSIONS: Using mostly routinely collected data, simple risk assessment models and tools can provide acceptable levels of accuracy for repeat of self-harm. CLINICAL IMPLICATIONS: This risk model (OXford SElf-harm repeat tool) may assist clinical decision-making.
Precision computerised cognitive behavioural therapy (cCBT) intervention for adolescents with depression (SPARX-UK): protocol for the process evaluation of a pilot randomised controlled feasibility trial.
INTRODUCTION: While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The 'SPARX-UK' study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an 'eCoach') vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation. METHODS AND ANALYSIS: The process evaluation will use a mixed-methods design following the UK Medical Research Council's 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention. ETHICS: Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149). DISSEMINATION: Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.
Is noxious stimulus-evoked electroencephalography response a reliable, valid, and interpretable outcome measure to assess analgesic efficacy in neonates? A systematic review and individual participant data (IPD) meta-analysis protocol.
BACKGROUND: There are several major challenges limiting our ability to test analgesic efficacy for treatment of neonatal pain, and progress in analgesic drug studies in neonates has stalled. One significant issue is the reliance of clinical pain assessments on traditional behavioural and vital signs-based measures and the exclusion of novel brain-based biomarkers. In this review protocol, we outline our strategy to assess the reliability, validity, and interpretability of an electroencephalography (EEG)-based response biomarker for assessment of acute somatic nociceptive pain in neonates. METHODS: To standardise EEG analysis and generate the outcome of interest, we will perform an individual participant data (IPD) meta-analysis using data from neonates aged 34-44-week postmenstrual age that have had EEG recorded during acute somatic nociceptive skin-breaking procedures. Relevant data from both published and grey literature will be identified by searching six databases (MEDLINE, Embase, CINAHL, Web of Science, Scopus, Google Scholar), two clinical trial registry platforms (ClinicalTrials.gov, WHO ICTRP), and by consulting expert opinion. We will assess availability bias, data accuracy, and data quality by cross-referencing provided data with data descriptions in the literature, identifying duplicates and nonsensical values, and extracting quality control metrics. Data will be synthesised via a two-stage IPD meta-analysis using a random effects modelling approach grouped by site. Reliability (inter- and intra-rater) outcomes will be measured as Gwet's AC1 coefficient. Validity (known-groups and known-stimuli) outcomes will be measured as EEG response magnitude differences between clinically meaningfully different stimuli. Interpretability will be addressed by providing normative values, in both original and standardised units. DISCUSSION: The purpose of this study is to establish the reliability, validity, and interpretability of a specific EEG-based response biomarker for assessing acute somatic nociceptive pain in neonates. It will provide an overview of available data and how EEG is being used globally to assess acute neonatal pain. If sufficient IPD are made available and the outcome is reliable, valid, and interpretable, this work will support the use of EEG-based outcome measures as primary endpoints in clinical trials assessing analgesic efficacy in neonates. SYSTEMATIC REVIEW REGISTRATION: The protocol was registered with PROSPERO on 14 July 2023: CRD42023444809.
Protocol for a Group-Sequential Two-Stratum Multicenter Open-Label Randomized Clinical Trial of Respiratory Support in Infants With Acute Bronchiolitis: Breathing Assistance in Children With Bronchiolitis (BACHb).
OBJECTIVES: The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis. DESIGN: Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial. SETTING: Fifty hospitals across England, Scotland, and Wales. PATIENTS: Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress). INTERVENTIONS: "Moderate bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. "Severe bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H2O. MEASUREMENTS AND MAIN RESULTS: In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). Due to the emergency nature of the treatments, written informed consent will be deferred. The primary outcome is time from randomization to hospital discharge within 30 days. Baseline clinical characteristics and hospital course, including details of respiratory support, and discharge and cost-effectiveness outcomes will be collected. The trial received Health Research Authority and Research Ethics Committee approval from the Yorkshire and The Humber-South Yorkshire Research Ethics Committee on August 3, 2023 (reference: 23/YH/0166). The trial registration is ISRCTN52937119. CONCLUSIONS: Trial findings will be disseminated in national and international conferences, in peer-reviewed journals and through social media.
Risk assessment tools used at the policing stage for health and crime outcomes: A systematic review and meta-analysis.
INTRODUCTION: Risk assessment tools are increasingly employed at the policing stage to consider health-related needs and predict crime outcomes such as repeat intimate partner violence (IPV). Decisions informed by these tools can influence health outcomes, disproportionately affecting certain groups and potentially exacerbating health inequalities. However, their predictive accuracy, quality, and reliability remain uncertain. METHODS: Following PRISMA guidelines, we conducted a systematic review of development/derivation and validation studies on risk assessment tools used at the policing stage to evaluate health and crime outcomes. RESULTS: We identified 29 studies with 256,125 participants, reporting performance measures for 28 different tools for a range of health related and crime outcomes. The most common assessment was risk of IPV (18 studies or 62 %), and three studies (10 %) considered other health-related outcomes. Pooled estimates for outcomes ranged from 0.64 to 0.73, representing poor to moderate performance. The tools for predicting IPV demonstrated the weakest performance with a pooled AUC of 0.64 (95 % CI: 0.62, 0.66). The reporting of other performance measures beyond the AUC, such as true and false positives and negatives, and calibration was inadequate. CONCLUSIONS: Current evidence for the routine use of existing risk assessment tools at the policing stage is limited. Some newer tools, developed with robust methodologies, show high predictive performance. Research should prioritize the development, validation, and implementation of these newer tools, particularly for outcomes with significant morbidity and mortality, such as IPV victimization. Implementing higher quality tools could reduce health inequalities by fostering more consistent decision-making and efficient resource allocation.
Storytelling as an approach to understand how cultural activities support the well-being in older people from global majority groups.
BACKGROUND: Social prescribing is increasingly used to support well-being through non-clinical, community-based interventions. However, there is limited understanding of how cultural activities can be tailored for older people from global majority groups. The TOUS study (Tailoring cultural Offers with and for diverse older Users of Social prescribing) explores how cultural offers can be adapted to meet the needs of these communities. AIM: This study aims to understand how storytelling can be used within a realist evaluation to explore the role of cultural activities in enhancing well-being among older adults from global majority groups. METHOD: Storytelling was used as a key method of data collection in two case studies. This approach involves four open-ended questions that allow participants to share experiences in their own words. Each transcript is condensed into a two-page narrative, approved by the participant, and used in collaborative discussions with stakeholders. This method aligns with the patient-centred ethos of social prescribing and complements realist evaluation by highlighting mechanisms of change and barriers to participation. RESULTS: Preliminary findings suggest cultural institutions can foster inclusion, connection, and identity among participants. Storytelling revealed the importance of culturally relevant, welcoming spaces and captured the nuanced experiences of individuals often overlooked in traditional research. CONCLUSION: Storytelling enriches realist evaluation by offering a participant-led, less extractive method of data collection. It bridges individual experiences with broader programme outcomes and provides a valuable approach for researchers aiming to centre voices from underrepresented communities in primary care research.
Routes to social prescribing outside National Health Service (NHS) structures: a systematic map.
OBJECTIVES: Social prescribing, linking to community-based interventions to support individuals' health and well-being, has become established across social medicine in the UK. Currently, most of the evidence and knowledge about how social prescribing pathways' function focuses on primary care, and we know less about how social prescribing operates outside of these structures. This review explored the evidence concerning non-health service delivered social prescribing with a view to developing guidance that would support social prescribing pathways that function outside of the health service framework. DESIGN: This paper reports a systematic mapping review of evidence concerning how community-based social prescribing pathways were delivered, exploring what these looked like, what needed to be in place for these to function, what outcomes were measured and how could non-health service pathways be supported to deliver these outcomes. The review searched database and grey sources and synthesised findings relating to how social prescribing pathways' function. SETTING: Community settings, outside of formal National Health Service (NHS) structures without statutory service input. PARTICIPANTS: All participants that experienced pathways were included; no limits were applied. INTERVENTIONS: Non-NHS social prescribing pathways that included the core components of social prescribing. MAIN OUTCOME MEASURES: Rich descriptions of functions of pathways. RESULTS: This mapping review included 17 studies. The synthesis indicated that NHS and non-NHS social prescribing pathways are intertwined and mutually reliant, such that it was neither sensible nor valuable to view them as separate. CONCLUSIONS: Our review provides further evidence for social prescribing as a concept, variable across all components, rather than a single, coherent model. While there exists a 'core' health service pathway, we suggest that further work should be done with those delivering services to understand the roles and functions that contribute but may not presently be funded.
A realist evaluation to explain and understand the role of paramedics in primary care.
BACKGROUND: In response to the unsustainable workload and workforce crises in primary care, paramedics (with their generalist clinical background acquired from ambulance service experience) are increasingly employed in primary care. However, the specific contribution paramedics can offer to the primary care workforce has not been distinctly outlined. We used realist approaches to understand the ways in which paramedics impact (or not) the primary care workforce. METHODS: A realist evaluation was undertaken, consisting of three independent but inter-related research studies: In WP1, a mixed-methods cross-sectional survey of paramedics in primary care in the UK was conducted to comprehend the existing practices of paramedics within the NHS. WP2 involved an analytic auto-netnography, where online conversations among paramedics in primary care were observed to understand paramedics' perceptions of their role. WP3 utilised focused observations and interviews to delve into the impact of paramedics on the primary care workforce. This comparative study collected data from sixty participants across fifteen sites in the UK, and twelve participants across three sites in a specific region in Canada, where Community Paramedicine is well established. RESULTS: The culmination of findings from each phase led to the development of a final programme theory, comprising of 50 context-mechanism-outcome configurations (CMOCs) encompassing three conceptual categories: Expectations associated with paramedics in primary care, the transition of paramedics into primary care roles, and the roles and responsibilities of paramedics in primary care. CONCLUSIONS: Our realist evaluation used a mixed-method approach to present empirical evidence of the role of paramedics in primary care. It offers insights into factors relating to their deployment, employment, and how they fit within the wider primary care team. Based on the evidence generated, we produced a series of practice implementation recommendations and highlighted areas for further research.
Using an analytic auto-netnographic approach to explore the perceptions of paramedics in primary care.
INTRODUCTION: Paramedics in the UK are moving from emergency ambulance services into primary care, where they are employed to boost the clinical workforce. Whereas there is emerging research that seeks to understand the contribution of paramedics to the primary care workforce, there is none regarding the perceptions paramedics have regarding their role in primary care. METHODS: An analytic auto-ethnography was undertaken, utilising a peripheral membership approach for online communities used by paramedics on Facebook, Reddit and Twitter (now X). Over a 3-month period (December 2021 to February 2022), the primary researcher reflected on the conversations, comments and opinions posted within these communities within a reflexive (immersion) journal, considering them against the context of her own experience. RESULTS: Paramedics in primary care, who are generally isolated due to their geographical isolation from each other, utilise online social spaces to foster a community of practice. These forums are used to discuss their clinical role, education and experiences, as well as to consider their place within the primary care workforce. CONCLUSION: This is the first application of this methodology within online social spaces utilised by UK paramedics. This article also presents novel use of a peripheral membership approach within an analytic auto-netnography in public online spaces for researcher-practitioners.
The Effect of Weight Loss Before In Vitro Fertilization on Reproductive Outcomes in Women With Obesity : A Systematic Review and Meta-analysis.
BACKGROUND: It is unclear whether weight loss before in vitro fertilization (IVF) improves reproductive outcomes in women with obesity. PURPOSE: To assess whether weight loss interventions before IVF improve reproductive outcomes. DATA SOURCES: Five electronic databases through 27 May 2025. STUDY SELECTION: Randomized controlled trials (RCTs) in women with obesity who were offered a weight loss intervention before planned IVF. DATA EXTRACTION: Dual independent screening, data extraction, and assessment of risk of bias (RoB) and certainty of evidence. Primary outcomes were pregnancy and live birth rates. Where appropriate, studies were pooled using random-effects meta-analyses. DATA SYNTHESIS: Twelve RCTs (1921 randomly assigned participants) were included, 7 of which had high RoB. There was moderate certainty that pre-IVF weight loss interventions were associated with an increase in total pregnancy rates (risk ratio [RR], 1.21 [95% CI, 1.02 to 1.44]; 11 studies) and pregnancies resulting from unassisted conception (RR, 1.47 [CI, 1.26 to 1.73]; 10 studies), whereas the effect on pregnancies resulting solely from IVF was uncertain. Weight loss interventions were not associated with pregnancy loss rates (RR, 1.05 [CI, 0.98 to 1.13]; 8 studies; moderate certainty), but their effect on live birth rates was unclear (RR, 1.15 [CI, 0.95 to 1.40]; 9 studies; very low certainty). LIMITATIONS: Studies were small, had high RoB, and often did not report important outcomes, such as live births. Substantial clinical and methodological heterogeneity was unexplained by exploratory analyses. CONCLUSION: Weight loss interventions before IVF appear to increase the chances of pregnancy, especially unassisted conceptions. However, studies were small, and heterogeneity made it difficult to determine the benefit of any particular intervention. PRIMARY FUNDING SOURCE: National Institute for Health and Care Research Applied Research Collaboration Oxford and Thames Valley. (PROSPERO: CRD42023441457).