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The home of collaborative applied health and social care research in Oxford and the Thames Valley.
An intensive weight loss programme with behavioural support for people with type 2 diabetes at risk of eating disorders in England (ARIADNE): a randomised, controlled, non-inferiority trial.
BACKGROUND: There are concerns that low-energy total diet replacement (TDR) programmes could trigger eating disorders, given their focus on weight and rigid dietary rules. We aimed to assess the effect of a TDR programme on eating disorder symptoms in people living with overweight or obesity and type 2 diabetes at high risk of developing an eating disorder. METHODS: In this randomised, controlled, non-inferiority trial, participants with type 2 diabetes, overweight, and eating disorder symptoms across England were randomly assigned (1:1) to a low-energy TDR programme with formula products and behavioural support delivered remotely, or usual care. In brief, the intervention comprised 12 weeks of low-energy TDR in a nutritionally complete package of soups, shakes, and bars. After the 12 weeks, the intervention continued with stepped food reintroduction (around 8 weeks) based on a low-energy, nutrient-rich diet, followed by weight maintenance advice (around 4 weeks), personalised to an individual participant's circumstances and preferences. Participants allocated to the control group received usual care for their diabetes. The primary outcome was the change in eating disorder symptoms using the Eating Disorders Examination Questionnaire (EDE-Q) global score at 6 months (programme end). Safety was determined by the incidence of cases with high suspicion of a new eating disorder. The primary outcome analysis had an upper non-inferiority margin for EDE-Q of +1 SD (0·72). People with lived experience were involved throughout the trial and provided input on study conceptualisation, protocol development, delivery of the intervention, and intervention materials. The study was registered with ClinicalTrials.gov, NCT05744232. FINDINGS: Between March 8, 2023, and Sept 12, 2023, 56 participants were randomly assigned to the intervention group (28 participants) or control group (28 participants). Participants had a mean age of 49·9 years (SD 8·1). 35 (63%) of 56 participants were women, 20 (36%) were men, and one (2%) was non-binary. 54 (96%) of participants were White and two (4%) were Asian. Participants had a mean BMI of 39·6 kg/m2 (SD 7·8) and a mean EDE-Q global score of 3·3 (0·4). 49 (88%) of 56 participants provided outcome data at 6 months and 45 (80%) at 1 year. At completion of the programme at 6 months, the mean weight loss was -13·9 kg (SD 11·2) in the intervention group and -3·7 kg (7·9) in the control group, with a between-group difference of -10·2 kg (95% CI -14·2 to -6·2). The between-group difference in the EDE-Q score was -0·8 points (-1·4 to -0·3) at 6 months, indicating non-inferiority. At 12 months, weight change was not different between groups, but non-inferiority and superiority in EDE-Q remained. No participants were suspected of having developed an eating disorder. 13 adverse events were documented, of which one, a cholecystectomy, was serious. INTERPRETATION: Participation in a supported TDR programme did not worsen eating disorder symptoms in people with overweight or obesity and type 2 diabetes at high risk of developing an eating disorder. We found no evidence these programmes cause harm and a suggestion of benefit on eating disorder symptoms, independent of weight loss. FUNDING: Novo Nordisk UK Research Foundation.
GPs' perspectives on GLP-1RAs for obesity management: a qualitative study in England.
Background Effective treatments are needed for the increasing number of people living with obesity. General practitioners (GPs) are key in managing obesity within the NHS but report low confidence in available treatment options. Glucagon-like Peptide-1 receptor agonists (GLP-1RAs) have shown promise in weight management, but at the time of this study lacked commissioned primary care service pathways for this indication. Aim To explore the perspectives of NHS GPs in England on GLP-1RAs and their integration into primary care for weight management. Design and Setting Participants were GPs practising in England, recruited through purposive sampling to reflect diverse geographical and socioeconomic contexts. Method 25 semi-structured interviews, conducted April-July 2024, were thematically analysed. Results Participants generally held positive views about the implementation of GLP-1RAs for weight management in primary care, however this was joined by hesitations about resource limitations. Navigating consultations with patients asking for prescriptions, or support with private use, often posed difficulties. Concerns included that GLP-1RAs could detract from tackling the broader determinants of obesity. Participants also worried that the medications could be misused, ultimately becoming an overly simplistic solution for patients, practitioners, and the wider health system. Conclusion Our findings suggest that while GPs view GLP-1RA integration as a valuable therapeutic option for primary care obesity management, they have concerns about this being done well. To strengthen GP support for implementation, it is essential to recognise the need for adequate resources and ensure that GLP-1RAs are integrated into a holistic strategy for addressing obesity.
Severe Dietary Energy Restriction for Compensated Cirrhosis Due to Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomised Controlled Trial.
BACKGROUND: Compensated cirrhosis due to metabolic dysfunction-associated steatotic liver disease (CC-MASLD) increases morbidity and mortality risk but has no aetiology-specific treatment. We investigated the safety and efficacy signals of severe energy restriction. METHODS: In this randomised controlled trial, adults with CC-MASLD and obesity in a tertiary hepatology centre were randomised 2:1 to receive one-to-one remote dietetic support with a low-energy (880 kcal/day, 80 g protein/day) total diet replacement programme for 12 weeks and stepped food reintroduction for another 12 weeks or standard of care (SoC). Given the exploratory nature of the study, three pre-defined co-primary outcomes were used to assess safety and efficacy signals: severe increases in liver biochemistry, changes in iron-corrected T1, and changes in liver stiffness on magnetic resonance elastography. Changes in liver steatosis on magnetic resonance imaging, physical performance based on the physical performance test and liver frailty index, and changes in fat-free mass were secondary outcomes. Magnetic resonance outcomes were assessed blind. RESULTS: Between February 2022 and September 2023, 17 participants (36% female, median [IQR] age 58 [7.5] years) were randomised to SoC (n = 6) or intervention (n = 11). The trial stopped earlier than planned due to slow recruitment rate. 91% and 94% of participants completed the intervention and attended the 24-week follow-up, respectively. Compared with the SoC, the between-group weight change in the intervention was -11.9 kg (95% CI: -17.2, -6.6, p
Stakeholder understanding of social prescribing in England: a qualitative study in primary care.
BackgroundSocial prescribing (SP) seeks to support patients' wider needs by connecting them to non-medical community resources. Link workers (LWs) facilitate SP's delivery across the National Health Service (NHS) in England. As a concept, SP may be perceived in different ways by various stakeholders. This study set out to explore how SP is understood among healthcare professionals (HCPs), voluntary and community sector (VCS) representatives, LWs, and patients (Ps) in England.MethodsA secondary qualitative analysis was conducted using interview data from a realist evaluation on the implementation of LWs in primary care. Interview data from 106 participants (HCPs, VCS representatives, LWs, Ps), across seven sites in England, were analysed using reflexive thematic analysis.ResultsAnalysis resulted in 127 codes. These were clustered into the following themes: (1) the need for system optimisation, (2) SP as a tool for personal empowerment, (3) SP's broad and inclusive nature, (4) community engagement through LWs, and (5) a holistic approach to well-being. These themes highlight SP's potential as an integrated and empowering ecosystem; requiring effective collaboration and clearer communication among stakeholders to enhance understanding of its purpose, streamline referral processes, and align expectations for greater impact. Understanding of SP could be related to five broad questions around how, who, what, where, and why; the themes produced from the analysis aligned with these questions, each exploring different dimensions of SP. Through this, we developed the 5Ws Framework, which is outlined in the paper.ConclusionsSP is not a standalone intervention; it is a complex system that requires optimisation and balance across its elements. Its effectiveness as an integrated empowerment ecosystem depends on addressing all facets of the 5Ws-how, who, what, where, and why it operates-engaging the right stakeholders, clearly defining its scope, and implementing it appropriately. Policymakers and commissioners could use the 5Ws Framework to guide decision-making, align health system priorities, and ensure the effective integration of SP within primary care.
Intervention development and optimisation of a multi-component digital intervention for the monitoring and management of hypertensive pregnancy: the My Pregnancy Care Intervention.
BACKGROUND: Hypertensive disorders of pregnancy affect around 10% of pregnancies and remain a major cause of maternal and foetal morbidity and mortality. Trials have shown that self-monitoring blood pressure during pregnancy is safe, but self-monitoring alone does not improve blood pressure control or pregnancy outcomes. This study aimed to develop and optimise a multicomponent intervention to support blood pressure monitoring, hypertension management and urine testing within current care pathways. METHODS: Relevant literature, input from patient and public contributors (PPI) and stakeholder groups, and the researcher's previous experience were used to develop an initial intervention. Think-aloud interviews and focus groups with women from diverse backgrounds with lived experience of hypertension in pregnancy and healthcare professionals provided feedback on the intervention prototype (n = 29). The MRC Framework for Developing Complex Interventions guided the processes to optimise the intervention's acceptability and maximise engagement. A detailed tabulation of participants' views and logic models was produced using the COM-B model of Behaviour Change. RESULTS: The prototype intervention was acceptable and viable to both pregnant women with experience of hypertensive pregnancy and healthcare professionals. Emerging themes centred on how the intervention could be optimised within current National Health Service care pathways and the lives of pregnant women to support behaviour change. Key target behaviours to support the intervention included increasing understanding of blood pressure management, engagement with the intervention, monitoring blood pressure and urine and taking appropriate actions based on those readings. This informed the development of recommendations involving clear action timelines for women and evidence-based guidance to support decision-making by healthcare professionals. The findings were used to produce the multi-component My Pregnancy Care intervention, consisting of a smartphone application and an information leaflet to support blood pressure self-monitoring and proteinuria self-testing, self-management of antihypertensive medication and smartphone application use. CONCLUSIONS: This research provided comprehensive insight into the needs of pregnant women with hypertension and their healthcare teams regarding self-monitoring and management of blood pressure. This supported the development of a tailored multi-component digital intervention that addresses barriers to blood pressure self-management by being user-friendly, persuasive and acceptable. It is hoped that the intervention will support the monitoring and management process, collaboration between healthcare professionals and women, clinical action and improved clinical outcomes.
Using qualitative research and the person-based approach to coproduce an inclusive intervention for postpartum blood pressure self-management.
OBJECTIVE: To coproduce an inclusive intervention for blood pressure (BP) self-management post partum. DESIGN: Using the person-based approach, an intervention was coproduced in three phases. Phase 1 entailed intervention coproduction with a diverse patient and public involvement panel and stakeholders (clinical, academic, government and third sector-based). Phase 2 involved intervention optimisation through think-aloud interviews with former patients and clinicians. Phase 3 was user-testing followed by semistructured interviews with current patients and their clinicians. SETTING: Patients and clinicians from primary and secondary care drawn from Southern and Northern England. PARTICIPANTS: Seven former patients and 11 clinicians participated in think-aloud interviews to provide their views of intervention prototypes (phase 2). Additionally, 23 patients and 9 of their clinicians participated in semistructured interviews after using the intervention for 2 weeks (phase 3). INTERVENTION: An interactive patient app-My BP Care-and accompanying leaflet to support BP self-monitoring. These were linked to a clinician dashboard with alerts and an emailing system to facilitate appropriate titration of patient medication. RESULTS: The intervention was codeveloped following these guiding principles to ensure it was accessible and inclusive: easily comprehensible, motivating, simple and quick to use. Interview findings indicated that patient adherence to the intervention was promoted by the initial patient training conducted by the midwives, the enhanced clinical oversight they felt they received as a result of the intervention, the free BP monitor they received, reassurance they received of the medication safety for them and their baby, the intervention's simplicity and the motivating reminders they received. CONCLUSIONS: Through coproduction with a diverse group of patients and stakeholders, and optimisation through testing among further diverse patients and clinicians, we developed a multicomponent intervention that is accessible and engaging for diverse patients, compatible with prevailing clinical practice and adaptable to different clinical contexts.
Incidence and Outcomes of Intraductal Oncocytic Papillary Neoplasm-Derived Pancreatic Cancer Compared with Tubular and Colloid Intraductal Papillary Mucinous Neoplasm-Derived Pancreatic Cancer: An International Multicenter Retrospective Study.
BACKGROUND: Intraductal papillary mucinous neoplasm (IPMN)-derived pancreatic cancer was previously categorized into tubular, colloid, and oncocytic subtypes. Intraductal oncocytic papillary neoplasms (IOPN) has long been associated with superior prognosis/indolent behavior, however, there is discordant emerging evidence. This study aimed to investigate this conflicting literature. METHODS: Patients with resected IOPN-derived and IPMN-derived pancreatic cancer were identified from six international centers. Log-rank tests compared time to (TtR) and survival after (SAR) recurrence and five-year overall survival (OS). A multivariable mixed model was used to determine hazard ratios (HR) with confidence intervals (95%CI) for five-year survival. RESULTS: Of 879 patients, 20 (2%) had IOPN-derived pancreatic cancer. Most patients had T1 (55%) or N0 (70%) disease. IOPN and colloid IPMN-derived pancreatic cancers had similar recurrence rates (25% vs. 24%), while recurrence was more common in tubular IPMN-derived pancreatic cancer (42%, p
The effects of individual-level smoking cessation interventions by socioeconomic groups and their potential impact on inequalities in smoking
Supplementary information (table and figure) in Microsoft Excel that provide additional information to accompany the Cochrane review: The effects of individual-level smoking cessation interventions by socioeconomic groups and their potential impact on inequalities in smoking
Development and evaluation of prompts for a large language model to screen titles and abstracts in a living systematic review.
BACKGROUND: Living systematic reviews (LSRs) maintain an updated summary of evidence by incorporating newly published research. While they improve review currency, repeated screening and selection of new references make them labourious and difficult to maintain. Large language models (LLMs) show promise in assisting with screening and data extraction, but more work is needed to achieve the high accuracy required for evidence that informs clinical and policy decisions. OBJECTIVE: The study evaluated the effectiveness of an LLM (GPT-4o) in title and abstract screening compared with human reviewers. METHODS: Human decisions from an LSR on prodopaminergic interventions for anhedonia served as the reference standard. The baseline search results were divided into a development and a test set. Prompts guiding the LLM's eligibility assessments were refined using the development set and evaluated on the test set and two subsequent LSR updates. Consistency of the LLM outputs was also assessed. RESULTS: Prompt development required 1045 records. When applied to the remaining baseline 11 939 records and two updates, the refined prompts achieved 100% sensitivity for studies ultimately included in the review after full-text screening, though sensitivity for records included by humans at the title and abstract stage varied (58-100%) across updates. Simulated workload reductions of 65-85% were observed. Prompt decisions showed high consistency, with minimal false exclusions, satisfying established screening performance benchmarks for systematic reviews. CONCLUSIONS: Refined GPT-4o prompts demonstrated high sensitivity and moderate specificity while reducing human workload. This approach shows potential for integrating LLMs into systematic review workflows to enhance efficiency.
Brain network dynamics following induced acute stress: a neural marker of psychological vulnerability to real-life chronic stress.
BACKGROUND: Stress leads to neurobiological changes, and failure to regulate these can contribute to chronic psychiatric issues. Despite considerable research, the relationship between neural alterations in acute stress and coping with chronic stress is unclear. This longitudinal study examined whole-brain network dynamics following induced acute stress and their role in predicting chronic stress vulnerability. METHODS: Sixty military pre-deployment soldiers underwent a lab-induced stress task where subjective stress and resting-state functional magnetic resonance imaging were acquired repeatedly (before stress, after stress, and at recovery, 90 min later). Baseline depression and post-traumatic stress symptoms were assessed, and again a year later during military deployment. We used the Leading Eigenvector Dynamic Analysis framework to characterize changes in whole-brain dynamics over time. Time spent in each state was compared across acute stress conditions and correlated with psychological outcomes. RESULTS: Findings reveal significant changes at the network level from acute stress to recovery, where the frontoparietal and subcortical states decreased in dominance in favor of the default mode network, sensorimotor, and visual states. A significant normalization of the frontoparietal state activity was related to successful psychological recovery. Immediately after induced stress, a significant increase in the lifetimes of the frontoparietal state was associated with higher depression symptoms (r = 0.49, p
A qualitative analysis of young adults’ beliefs about bullying: exploring associations with social anxiety and post-traumatic stress
Background: Bullying can be associated with emotional and social difficulties, but not all individuals experience enduring negative effects. Objective: This study aimed to explore beliefs about bullying, self, and other people among young adults who were bullied that may be associated with ongoing anxiety and distress related to those experiences. Method: Semi-structured interviews with 20 people, aged 18–29 years, who had experienced bullying were analysed using thematic analysis. The sample was split, by current symptoms of social anxiety and post-traumatic stress related to bullying, into a lower symptoms group (n = 12) and a higher symptoms group (n = 8). Results: Participants reported multiple types of bullying, including online. Four superordinate themes were identified in negative beliefs related to bullying experiences: personal deficiency (i.e. victimization was due to own low value or undesirable traits), social threat (i.e. wariness of others due to their negative motives or traits), acceptance is fragile (i.e. being accepted by others is transient and requires effort), and minimizing (i.e. downplaying severity and impact of past experiences). These were evident in both groups but were more frequently endorsed in the higher symptoms group. Conclusion: Negative appraisals related to bullying can persist into young adulthood and may influence social interactions and mental health. Interventions targeting these beliefs could mitigate negative outcomes and bolster resilience among individuals affected by bullying. Further research should explore these themes to inform effective therapeutic strategies for young adults who have been bullied.
Evaluating a brief imagery-based intervention for adolescent depression: study protocol for a Phase IIB randomised control trial (INDIGO) in secondary schools.
BACKGROUND: There is an urgent need for psychological interventions that can target depression in late adolescence and prevent it from having lifelong implications. Schools have been identified as a promising setting to enhance access to interventions and offer support earlier. We have co-developed a novel intervention, IMAGINE, that targets key cognitive mechanisms implicated in depression across the lifespan. Depression has been associated with distressing negative mental images, a deficit in positive future images and overgeneral autobiographical memories. Interventions targeting these factors have shown clinical promise in adults. Here, we combine techniques targeting these cognitive processes into a novel, brief psychological intervention for adolescent depression. This Phase IIb randomised controlled trial will evaluate IMAGINE compared to an active psychological intervention. METHODS/DESIGN: One hundred sixty adolescents (aged 16-18) with high levels of depressive symptoms will be recruited from schools. Participants will be randomly allocated to IMAGINE or the active psychological control intervention, non-directive support (NDS). Assessment will take place at baseline, 8-, 16- and 24-week post randomisation. The primary objective is to establish whether IMAGINE reduces symptoms of depression, relative to NDS, at 8 weeks following randomisation. Secondary objectives include whether changes in depression are maintained at 16- and 24-week follow-up, the efficacy of IMAGINE on secondary clinical outcomes and key cognitive mechanisms and, finally, to assess outcomes around acceptability, safety and adherence. DISCUSSION: If IMAGINE is shown to be safe and clinically effective, an effectiveness-implementation hybrid RCT will be indicated. If rolled out as an intervention, IMAGINE would significantly extend the range of effective therapies available for adolescent depression. TRIAL REGISTRATION: ISRCTN, ISRCTN14015295. Registered 11 September 2023, https://doi.org/10.1186/ISRCTN14015295 .
The PRINCIPLE randomised controlled open label platform trial of hydroxychloroquine for treating COVID19 in community based patients at high risk.
Early on in the COVID-19 pandemic, we aimed to assess the effectiveness of hydroxychloroquine on reducing the need for hospital admission in patients in the community at higher risk of complications from COVID-19 syndromic illness (testing was largely unavailable at the time, hence not microbiologically confirmed SARS-CoV-2 infection), as part of the national open-label, multi-arm, prospective, adaptive platform, randomised clinical trial in community care in the United Kingdom (UK). People aged 65 and over, or aged 50 and over with comorbidities, and who had been unwell for up to 14 days with suspected COVID-19 were randomised to usual care with the addition of hydroxychloroquine, 200 mg twice a day for seven days, or usual care without hydroxychloroquine (control). Participants were recruited based on symptoms and approximately 5% had confirmed SARS-COV2 infection. The primary outcome while hydroxychloroquine was in the trial was hospital admission or death related to suspected COVID-19 infection within 28 days from randomisation. First recruitment was on April 2, 2020, and the hydroxychloroquine arm was suspended by the UK Medicines Regulator on May 22, 2020. 207 were randomised to hydroxychloroquine and 206 to usual care, and 190 and 194 contributed to the primary analysis results presented, respectively. There was no swab result available within 28 days of randomisation for 39% in both groups: 107 (54%) in the hydroxychloroquine group and 111 (55%) in the usual care group tested negative for SARS-Cov-2, and 13 (7%) and 11 (5%) tested positive. 13 participants, (seven (3·7%) in the usual care plus hydroxychloroquine and six (3.1%) in the usual care group were hospitalized (odds ratio 1·04 [95% BCI 0·36 to 3.00], probability of superiority 0·47). There was one serious adverse event, in the usual care group. More people receiving hydroxychloroquine reported nausea. We found no evidence from this treatment arm of the PRINCIPLE trial, stopped early and therefore under-powered for reasons external to the trial, that hydroxychloroquine reduced hospital admission or death in people with suspected, but mostly unconfirmed COVID-19.