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The home of collaborative applied health and social care research in Oxford and the Thames Valley.
Intervention design and adherence to Mediterranean diet in the Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat (CADIMED) randomized trial.
Effective interventions targeting modifiable cardiovascular disease (CVD) risk factors, such as diet, are urgently needed. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat study hypothesizes that eliminating red and processed meat in the context of a Mediterranean diet (MD) will significantly modify circulating low-density lipoprotein cholesterol concentration and the fatty acid profile compared to general CVD prevention advice. Here we describe the intervention design and summarize baseline dietary intakes (mean ± standard deviation) related to MD adherence and red/processed meat intakes in a sample of 81 participants. The Cardiovascular Risk Prevention with a Mediterranean Dietary Pattern Reduced in Saturated Fat study is a two-arm, 8-week parallel randomized controlled intervention trial involving a final sample of 156 adults (≥18 years) with dyslipidemia (not undergoing pharmacological treatment) recruited from healthcare and community settings in Granada (Spain). The primary outcome will assess changes in circulating low-density lipoprotein cholesterol and the fatty acid profile, whilst secondary outcomes will measure changes in CVD-related metabolites/biomarkers, gut microbiome, diet/lifestyle, and intervention feasibility/acceptability. Preliminary findings indicate low MD adherence (Mediterranean Diet Adherence Screener score 7.6 ± 1.9), and high consumption of red and processed meat (1.04 ± 0.90) servings/d). These results underscore the need for targeted dietary interventions to address the growing burden of dyslipidemia and CVD. If successful, this intervention holds potential for scalability and significant impact on public health, dietary guidelines, and advancements in nutrition science by improving MD adherence and reducing CVD risk factors in adults with dyslipidemia.
Improving usability of Electronic Health Records in a UK Mental Health setting: a feasibility study.
BACKGROUND: Electronic Health Records (EHRs) can help clinicians to plan, document and deliver care for patients in healthcare services. When used consistently, EHRs can advance patient safety and quality, and reduce clinician's workload. However, usability problems can make it difficult for clinicians to use EHRs effectively, which can negatively impact both healthcare professionals and patients. OBJECTIVE: To improve usability of EHRs within a mental health service in the UK. METHODS: This was a feasibility study conducted with two mental health teams. A mixed-methods approach was employed. Focus group discussions with clinicians identified existing usability problems in EHRs and changes were made to address these problems. Updated EHR assessment forms were evaluated by comparing the following measures pre and post changes: (1) usability testing to monitor time spent completing and duplicating patient information in EHRs, (2) clinician's experience of using EHRs, and (3) proportion of completed EHR assessment forms. RESULTS: Usability testing with clinicians (n = 3) showed that the time taken to complete EHR assessment forms and time spent duplicating patient information decreased. Clinician's experience of completing EHR assessment forms also significantly improved post changes compared to baseline (n = 71; p
Paramedic analgesia comparing ketamine and morphine in trauma (PACKMaN): a randomised, double-blind, phase 3 trial
Background: Paramedics frequently administer analgesic medications for pain following trauma. Morphine is the most commonly administered strong analgesic. However, it may not be the best option as it may lower blood pressure, depress respiration and there is a risk of dependency. Ketamine might be a better option due to speed of onset and favourable side-effect profile. We sought to compare clinical effectiveness of paramedic administered ketamine and morphine in patients with severe pain following trauma. Methods: PACKMaN was a double-blinded, randomised controlled, superiority trial, conducted in two regional ambulance services in the UK. Eligible patients were 16 years of age or over, had an acute injury, and articulated a pain score of 7 or greater on a 0–10 numeric rating score (NRS). We excluded pregnant patients, prisoners, those unable to articulate a pain score and anyone lacking capacity. The randomisation list prepared by the study programmer, utilised a permuted, unstratified, block randomisation system (variable size blocks) to achieve an overall ratio of 1:1 control (morphine): intervention (ketamine). Treatment packs were identical in appearance, apart from their unique sequential number. Individual participant randomisation occurred when the attending paramedic opened the treatment pack. The maximum available dose of morphine was 20 mg while the maximum available dose of ketamine was 30 mg. The treating paramedic administered the trial drug slowly, in regular small aliquots, via the intravenous (or intraosseous) route, titrating treatment until the patient reported adequate analgesia or requested that treatment stop due to undesired side effects. Timing of drug administration was not prespecified. The primary outcome was the Sum of Pain Intensity Difference (SPID) score on arrival to the hospital, calculated using patient reported NRS scores. Analysis was performed on an intention to treat basis. PACKMaN is registered with the International Clinical Trials Registry (ISRCTN14124474). Findings: PACKMaN recruited its first patient on 10/11/2021 and achieved its recruitment target on 16/05/2023. We randomised 449 participants: 219 (49%) received ketamine and 230 (51%) received morphine. The SPID score was 3.5 (SD 2.8) for ketamine and 3.4 (SD 3.0) for morphine. We found no significant difference in efficacy between drugs (adjusted mean difference 0.1, 95%CI −0.4 to 0.6, p = 0.74). There was no significant difference in the incidence of serious adverse events [4 (2%) ketamine; 8 (3%) morphine]. There were no treatment related deaths. Interpretation: Ketamine did not provide superior analgesia than morphine when used by paramedics to treat acute severe trauma pain. Unexpected adverse events occurred infrequently. Despite analgesia, many patients still experienced pain on arrival at hospital, highlighting the need for further research. Funding: PACKMaN was funded by the National Institute for Health and Care Research.
Investigating Person-Centred Care Planning in Care Homes Across England: An Exploratory Study of Practices and Contextual Factors.
AIMS: To report how person-centred care principles are applied to care planning and to explore the contextual factors affecting their implementation in older adult care homes in England. DESIGN: A combined framework analysis and quantitative content analysis study. METHODS: Using a semi-structured questionnaire, we interviewed 22 care home managers in England, exploring topics around care planning processes. Audio recordings were transcribed verbatim. Transcripts were analysed through a combined framework approach and content analysis. RESULTS: Most care home managers discussed person-centred care planning in terms of understanding residents' values and preferences and their engagement in decision-making. Factors facilitating person-centred planning implementation included accessible planning tools, supportive care home leadership, effective communication and collaborative partnerships. Inhibiting factors included regulatory and care practice misalignment, time constraints and adverse staffing conditions. CONCLUSION: Differences between care home practitioners' understanding and practice of person-centred care planning require further examination to improve understanding of the sector's complexity and to develop suitable care planning instruments. IMPLICATIONS FOR THE PROFESSION: Findings demonstrate a need for improved staff access to specialised person-centred care training and an opportunity for care home nursing practitioners to lead the co-development of digital person-centred care planning tools that reflect the reality of long-term care settings. IMPACT: Identifying factors influencing the implementation of holistic approaches to care planning makes clear the need for modernising long-term care policy and practice to adapt to the contemporary challenges of the care home sector. REPORTING METHOD: Study reporting was guided by the Standards for Reporting Qualitative Research. PATIENT OR PUBLIC CONTRIBUTION: Two public involvement advisors with lived experience of caring for a relative living in a care home contributed to the development of the interview guide, advised on care home engagement, guided the interpretation of the findings and commented on the drafted manuscript.
Patient-reported harm from NHS treatment or care, or the lack of access to care: a cross-sectional survey of general population prevalence, impact and responses.
OBJECTIVES: The aim of this article is to provide an estimate of the proportion of the general public reporting healthcare-related harm in Great Britain, its location, impact, responses post-harm and desired reactions from healthcare providers. DESIGN: We used a cross-sectional survey, using quota sampling. SETTING: This research was conducted in Great Britain. PARTICIPANTS: The survey had 10 064 participants (weighted analysis). RESULTS: In our survey 9.7% participants reported harm caused by the National Health Service (NHS) in the last 3 years through treatment or care (6.2%) or the lack of access to care (3.5%). The main location where the harm first occurred was hospitals. A total of 37.6% of participants reported a moderate impact and 44.8% a severe impact of harm. The most common response to harm was to share their experience with others (67.1%). Almost 60% sought professional advice and support, with 11.6% contacting the Patient Advice and Liaison Service (PALS). Only 17% submitted a formal complaint, and 2.1% made a claim for financial compensation. People wanted treatment or care to redress the harm (44.4%) and an explanation (34.8%). Two-thirds of those making a complaint felt it was not handled well and approximately half were satisfied with PALS. Experiences and responses differed according to sex and age (eg, women reported more harm). People with long-term illness or disability, those in lower social grades, and people in other disadvantaged groups reported higher rates and more severe impact of harm. CONCLUSIONS: We found that 9.7% of the British general population reported harm by the NHS, a higher rate than reported in two previous surveys. Our study used a broader and more inclusive definition of harm and was conducted during the COVID-19 pandemic, making comparison to previous surveys challenging. People responded to harm in different ways, such as sharing experiences with others and seeking professional advice and support. Mostly, people who were harmed wanted help to redress the harm or to gain access to the care needed. Low satisfaction with PALS and complaints services may reflect that these services do not always deliver the required support. There is a need to better understand the patient perspective following harm and for further consideration of what a person-centred approach to resolution and recovery might look like.
The therapeutic potential of exercise in post-traumatic stress disorder and its underlying mechanisms: A living systematic review of human and non-human studies.
BACKGROUND: Exercise for post-traumatic stress disorder (PTSD) is a potentially effective adjunct to psychotherapy. However, the biopsychosocial mechanisms of exercise are not well understood. This co-produced living systematic review synthesizes evidence from human and non-human studies. METHODS: We Included controlled human and non-human studies involving searches of multiple electronic databases (until 31.10.23). Records were screened, extracted, assessed for risk of bias, and reconciled by two independent reviewers. The primary outcome for human studies was PTSD symptom severity, while outcomes of interest for non-human studies included freezing behaviour, fear memory, fear generalization, startle response, and locomotion. Data were synthesised with random-effects meta-analysis. RESULTS: Eleven human studies met the eligibility criteria. Overall, exercise was not associated with symptom severity improvement compared to control (standardized mean difference [SMD] -0.08, 95% confidence interval [CI] -0.24 to 0.07; 8 studies, one at low risk of bias). High-intensity exercise reduced PTSD symptoms scores more than moderate-intensity exercise. There was insufficient data to examine the effects of exercise on functional impairment, PTSD symptom clusters, and PTSD remission. Only three studies, all at high risk of bias, examined mechanisms of exercise with inconclusive results. Exercise was associated with improvement in all behavioural outcomes, including locomotor activity (SMD 1.30, 95% CI 0.74 to 1.87, 14 studies), and changes in several neurobiological markers, including increase in brain-derived neurotrophic factor (SMD 1.79, 95% CI 0.56 to 3.01). CONCLUSIONS: While non-human studies provide compelling evidence for the beneficial effects of exercise, human trials do not. Evidence from non-human studies suggest that exercise might increase the levels of brain-derived neurotrophic factor, enhance cognitive appraisal, and improve perceived exertion. Overall, the paucity of data on the effectiveness of exercise in PTSD and mechanisms of action underscore the need for rigorous trials. REGISTRATION: The protocol was registered with PROSPERO (ID:453615; 22.08.2023).
Support for hospital doctors' workplace well-being in England: the Care Under Pressure 3 realist evaluation.
INTRODUCTION: The vital role of medical workforce well-being for improving patient experience and population health while assuring safety and reducing costs is recognised internationally. Yet the persistence of poor well-being outcomes suggests that current support initiatives are suboptimal. The aim of this research study was to work with, and learn from, diverse hospital settings to understand how to optimise strategies to improve doctors' well-being and reduce negative impacts on the workforce and patient care. METHODS: Realist evaluation consistent with the Realist And Meta-narrative Evidence Synthesis: Evolving Standards (RAMESES) II quality standards. Realist interviews (n=124) with doctors, well-being intervention implementers/practitioners and leaders in eight hospital settings (England) were analysed using realist logic. RESULTS: There were four key findings, underpinned by 21 context-mechanism-outcome configurations: (1) solutions needed to align with problems, to support doctor well-being and avoid harm to doctors; (2) doctors needed to be involved in creating solutions to their well-being problems; (3) doctors often did not know what support was available to help them with well-being problems and (4) there were physical and psychological barriers to accessing well-being support. DISCUSSION AND CONCLUSION: Doctors are mandated to 'first, do no harm' to their patients, and the same consideration should be extended to doctors themselves. Since doctors can be harmed by poorly designed or implemented well-being interventions, new approaches need careful planning and evaluation. Our research identified many ineffective or harmful interventions that could be stopped. The findings are likely transferable to other settings and countries, given the realist approach leading to principles and causal explanations.
Is “nature” a policy solution to mental health in schools?
The UK faces a growing youth mental health crisis (NHS, 2023; RCPsych 2025). Schools may play a key role in preventing these difficulties from worsening. The integration of nature-based programs (NbPs) into school settings has been proposed as a policy solution to address such mental health challenges but robust evidence is lacking (Lomax et al., 2024), particularly at the secondary school level. This Sprint utilised an implementation science framework to co-produce evidence on NbPs in secondary schools with stakeholders including policymakers from the Government’s Department for Education (DfE), young people, and educators. Using a range of methodologies we are evaluating effectiveness, amplifying stakeholder voices, and creating actionable, evidence-based education policy insights.
Developing a set of key principles for care planning within older adult care homes: study protocol for a modified Delphi survey.
BACKGROUND: Older adult care homes in England are required to develop care plans on behalf of each of their residents and to make these documents available to those who provide care. However, there is a lack of formal agreement around the key principles that should inform the development of care plans in care homes for older adults. Using a modified Delphi survey, we intend to generate consensus on a set of key principles that should inform the care planning process. METHODS AND ANALYSIS: A two-stage modified Delphi survey will be used to try to reach a consensus on a set of key principles to inform care planning within older adult care homes in England. An interdisciplinary panel of approximately 50 people with experience in care planning will be convened and invited to provide feedback on a set of key principles. We will use an iterative, quasi-anonymous, multistage approach with controlled feedback. In the first round, panellists will be asked to provide feedback on a draft document whose contents have been informed by a systematic scoping review and consultations with care home staff. The first round will be administered and subsequently analysed. The results from the first round will be fed back to the panel members and panellists will be asked to complete a second survey. In each round, panel members will use a 5-point unipolar scale to rate their agreement with the item. Consensus will be considered if ≥75% of participants rate an item as 4-5. ETHICS AND DISSEMINATION: This study to which this protocol relates has been granted ethical approval by the University of Kent's Division for the Study of Law, Society and Social Justice Research Committee Ethics Panel (reference: 1006) on 9 April 2024. The results of this project will be disseminated through conferences and one or more peer-reviewed journals. In a subsequent research phase, the research team plans to share the key principles document developed through this modified Delphi survey with care home residents and their families and friends. We plan to invite their feedback through a series of focus groups with a view to developing a related document for the family and friends of care home residents.