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A retrospective audit of patients with a radiological finding of moderate or severe emphysema. Should we perform spirometry as part of the targeted lung health check?Low dose computer tomography (LDCT) performed in high risk patients in Targeted Lung Health Check programme commonly reports on incidental findings. An audit of patients has found the largest cohort with incidental findings is those with radiological findings of Emphysema. Should we routinely be offering spirometry to this patient group?
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A retrospective audit of patients with a radiological finding of moderate or severe emphysema. Should we perform spirometry as part of the targeted lung health check?Low dose computed tomography (LDCT), screening for lung cancer is being implemented in some European countries. The targeted lung health checks (TLHC) programme is a new and ground-breaking flagship programme of work in England which will contribute to the ambition of the NHS Long Term Plan to improve early diagnosis and survival for those diagnosed with cancer (NHSE, 2022). The Mansfield and Ashfield TLHC commenced in March 2021 and was part of phase one of the NHSE (National Health Service England) pilot programme. Participants invited for the TLHC are those who are, at the date of the first low dose CT scan, aged between 55 and 74 years, 364 days of age, are registered with a GP practice and have ever smoked. Those who are eligible will be assessed to calculate their individual risk of developing lung cancer within the next 5 years using a pre-defined algorithm that automatically calculates both Prostate, Lung, Colorectal and Ovarian (PLCO) (Hocking et al, 2010) risk prediction model and the Liverpool Lung project (LLP) (Cassidy et al, 2008). All identified high risk patients i.e., a risk threshold of ≥1.51% threshold for PLCO and/or ≥2.5 for LLPv2 algorithms, then go on to a face-to-face appointment with trained TLHC nurses to confirm their risk assessment and where it is proven high risk, a low dose computer tomography (LDCT). Incidental findings are detected frequently following a LDCT and have the potential to benefit or harm the participant, and their management adds costs (Morgan et al, 2017). Localised audit of the patients has found the largest cohort of patients with incidental findings within our programme was those with radiological findings of Emphysema. The question is should we routinely be offering spirometry to this patient group either as part of the TLHC programme or making recommendations to primary care to perform one and are there any benefits to the patient?
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Management of Paediatric Chronic Insomnia in Primary CareBehavioural insomnia, a form of chronic insomnia, is highly prevalent in children. Persisting sleep problems can have multiple impacts on the child and family. Behavioural/sleep hygiene interventions are effective management strategies, and primary care provides the potential for early management and prevention. This thesis explores the management of chronic insomnia in children within primary care. A systematic review explored the evidence-base for primary care practitioners’ (PCP) knowledge, beliefs/attitudes, and practice. A systematic narrative synthesis of 26 studies found that PCPs are aware of the impacts of chronic insomnia, perceive management to be within their role, and endorse behavioural management strategies, but have varied knowledge and confidence for management. However, the methodological quality of the studies varied, and they were from limited primary care settings and countries (usually UK health visitors or US paediatricians). Higher quality UK research for both GPs and health visitors was lacking. A qualitative study analysed posts in online discussion forums to explore parental concerns about children’s sleep problems, awareness of management resources, and perception of management within primary care. Results from 93 discussion threads across two forums suggested that: parents have multiple and varied concerns relating to their children’s sleep; that parents often turn to one another online for emotional and practical support; and use resources online, non-PCPs (such as private sleep consultants) and books. It is uncertain how many of these resources are evidence-based. Parents posted about primary care less frequently but had mixed experiences of and attitudes towards health visitors, and limited experiences with GPs. A mixed-methods study (surveys and qualitative interviews) of UK practicing PCPs was conducted to explore their knowledge, training, beliefs and practice for insomnia management in children up to the age of five. Survey findings (n=355, mainly GPs) suggested that PCPs perceive negative impacts of chronic insomnia on children and their families and believe that it should be addressed in healthcare. However, insomnia is infrequently discussed in consultations, PCPs have varied knowledge and confidence regarding management, and limited training and knowledge of resources. Interview findings (n=21) echoed the survey findings, providing greater depth and insight. Health visitors had greater training opportunities and were perceived to be more suited to in-depth management, whereas the general practitioner’s role was perceived as excluding the presence of other conditions, brief advice and signposting to health visitors and other resources. GPs were interested in undertaking brief training. Further health visitor research and support, Increased discussions of insomnia in primary care consultations, improved access to GP training, and greater awareness of available resources has the potential to improve paediatric chronic insomnia management in primary care.
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Community seroprevalence of SARS-CoV-2 in children and adolescents in England, 2019-2021Objective: To understand community seroprevalence of SARS-CoV-2 in children and adolescents. This is vital to understanding the susceptibility of this cohort to COVID-19 and to inform public health policy for disease control such as immunisation. Design: We conducted a community-based cross-sectional seroprevalence study in participants aged 0-18 years old recruiting from seven regions in England between October 2019 and June 2021 and collecting extensive demographic and symptom data. Serum samples were tested for antibodies against SARS-CoV-2 spike and nucleocapsid proteins using Roche assays processed at UK Health Security Agency laboratories. Prevalence estimates were calculated for six time periods and were standardised by age group, ethnicity and National Health Service region. Results: Post-first wave (June-August 2020), the (anti-spike IgG) adjusted seroprevalence was 5.2%, varying from 0.9% (participants 10-14 years old) to 9.5% (participants 5-9 years old). By April-June 2021, this had increased to 19.9%, varying from 13.9% (participants 0-4 years old) to 32.7% (participants 15-18 years old). Minority ethnic groups had higher risk of SARS-CoV-2 seropositivity than white participants (OR 1.4, 95% CI 1.0 to 2.0), after adjusting for sex, age, region, time period, deprivation and urban/rural geography. In children <10 years, there were no symptoms or symptom clusters that reliably predicted seropositivity. Overall, 48% of seropositive participants with complete questionnaire data recalled no symptoms between February 2020 and their study visit. Conclusions: Approximately one-third of participants aged 15-18 years old had evidence of antibodies against SARS-CoV-2 prior to the introduction of widespread vaccination. These data demonstrate that ethnic background is independently associated with risk of SARS-CoV-2 infection in children.
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Immediate oral versus immediate topical versus delayed oral antibiotics for children with acute otitis media with discharge: the REST three-arm non-inferiority electronic platform-supported RCTBackground: Acute otitis media is a painful infection of the middle ear that is commonly seen in children. In some children, the eardrum spontaneously bursts, discharging visible pus (otorrhoea) into the outer ear. Objective: To compare the clinical effectiveness of immediate topical antibiotics or delayed oral antibiotics with the clinical effectiveness of immediate oral antibiotics in reducing symptom duration in children presenting to primary care with acute otitis media with discharge and the economic impact of the alternative strategies. Design: This was a pragmatic, three-arm, individually randomised (stratified by age < 2 vs. ≥ 2 years), non-inferiority, open-label trial, with economic and qualitative evaluations, supported by a health-record-integrated electronic trial platform [TRANSFoRm (Translational Research and Patient Safety in Europe)] with an internal pilot. Setting: A total of 44 English general practices. Participants: Children aged ≥ 12 months and < 16 years whose parents (or carers) were seeking medical care for unilateral otorrhoea (ear discharge) following recent-onset (≤ 7 days) acute otitis media. Interventions: (1) Immediate ciprofloxacin (0.3%) solution, four drops given three times daily for 7 days, or (2) delayed 'dose-by-age' amoxicillin suspension given three times daily (clarithromycin twice daily if the child was penicillin allergic) for 7 days, with structured delaying advice. All parents were given standardised information regarding symptom management (paracetamol/ibuprofen/fluids) and advice to complete the course. Comparator: Immediate 'dose-by-age' oral amoxicillin given three times daily (or clarithromycin given twice daily) for 7 days. Parents received standardised symptom management advice along with advice to complete the course. Main outcome measure: Time from randomisation to the first day on which all symptoms (pain, fever, being unwell, sleep disturbance, otorrhoea and episodes of distress/crying) were rated 'no' or 'very slight' problem (without need for analgesia). Methods: Participants were recruited from routine primary care appointments. The planned sample size was 399 children. Follow-up used parent-completed validated symptom diaries. Results: Delays in software deployment and configuration led to small recruitment numbers and trial closure at the end of the internal pilot. Twenty-two children (median age 5 years; 62% boys) were randomised: five, seven and 10 to immediate oral, delayed oral and immediate topical antibiotics, respectively. All children received prescriptions as randomised. Seven (32%) children fully adhered to the treatment as allocated. Symptom duration data were available for 17 (77%) children. The median (interquartile range) number of days until symptom resolution in the immediate oral, delayed oral and immediate topical antibiotic arms was 6 (4-9), 4 (3-7) and 4 (3-6), respectively. Comparative analyses were not conducted because of small numbers. There were no serious adverse events and six reports of new or worsening symptoms. Qualitative clinician interviews showed that the trial question was important. When the platform functioned as intended, it was liked. However, staff reported malfunctioning software for long periods, resulting in missed recruitment opportunities. Troubleshooting the software placed significant burdens on staff. Limitations: The over-riding weakness was the failure to recruit enough children. Conclusions: We were unable to answer the main research question because of a failure to reach the required sample size. Our experience of running an electronic platform-supported trial in primary care has highlighted challenges from which we have drawn recommendations for the National Institute for Health Research (NIHR) and the research community. These should be considered before such a platform is used again.
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Designing a primary care pharmacist-led review for people treated with opioids for persistent pain: a multi-method qualitative studyBackground: Opioids are frequently prescribed for persistent non-cancer pain despite limited evidence of long-term effectiveness and risk of harm. Evidence-based interventions to address inappropriate opioid prescribing are lacking. Aim: To explore perspectives of people living with persistent pain to understand barriers and facilitators in reducing opioids in the context of a pharmacist-led primary care review, and identify review components and features for optimal delivery. Design & setting: Primary care multi-method qualitative study. Method: Adults with experience of persistent pain and taking opioids participated in semi-structured interviews (n=15, 73% female) and an online discussion forum (n=31). The Theoretical Domains Framework (TDF) provided a framework for data collection and thematic analysis, involving deductive analysis to TDF domains, inductive analysis within-domains to generate subthemes, and subtheme comparison to form across-domain overarching themes. The behaviour change technique taxonomy v.1 and motivational behaviour change technique classification system were used to systematically map themes to behaviour change techniques to identify potential review components and delivery features. Results: 32 facilitator and barrier subthemes for patients reducing opioids were identified across 13 TDF domains. These combined into six overarching themes: learning to live with pain, opioid reduction expectations, assuming a medical model, pharmacist-delivered reviews, pharmacist-patient relationship and patient engagement. Subthemes mapped to 21 unique behaviour change techniques, yielding 17 components and five delivery features for the proposed PROMPPT review. Conclusion: This study generated theoretically-informed evidence for design of a practice pharmacist-led PROMPPT review. Future research will test the feasibility and acceptability of the PROMPPT review and pharmacist training.
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Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility studyDepression is the leading cause of disability globally and has serious consequences for the individual, their family and for society. Effective, accessible and affordable treatments are urgently needed. In-person group-based mindfulness-based interventions are an effective treatment for depression, but are not widely available and can be costly. Clinician supported use of mindfulness self-help resources such as mindfulness smartphone applications could widen access at a reduced cost, but there are key feasibility questions that need answering. This is a mixed-methods feasibility study of a blended intervention involving the mindfulness smartphone app Headspace alongside six clinician support sessions with mental health treatment seeking adults experiencing moderate to moderately severe symptoms of depression. In line with recommendations for feasibility studies, we examine whether: (1) it is possible to recruit participants to this novel intervention, (2) participants engage with the intervention, (3) participants and clinicians find the intervention acceptable, and (4) pre-post outcomes on measures of depression (primary outcome), anxiety, wellbeing, mindfulness, self-compassion, rumination and worry indicate effectiveness. Findings show that recruitment is feasible with 54 participants enrolled in the intervention within a 6-month window. In terms of engagement, 44.4% completed at least 80% of recommended Headspace sessions and 72.2% of participants attended at least three clinician support sessions. Clinician-supported Headspace was deemed acceptable by participants and clinicians. Pre-post effect sizes were statistically significant and in the small-medium or medium-large range on all outcomes, with an effect size of d = 0.69 (95% CI: 0.34-1.04) for the primary outcome of depression symptom severity. The number of Headspace sessions engaged with was associated with greater reduction in depression symptom severity. Findings suggest that a blended intervention combining Headspace with clinician support has potential as a first-line treatment for moderate/moderately severe depression, but findings are too preliminary to recommend the intervention outside of a research trial. Important caveats are noted including the need for future research to examine predictors of engagement with Headspace sessions so that engagement can be enhanced, to measure the longer term effects of such interventions and to better understand the potential for lasting negative effects of the intervention so that these can be minimised.
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Implementing Germ Defence digital behaviour change intervention via all primary care practices in England to reduce respiratory infections during the COVID-19 pandemic: an efficient cluster randomised controlled trial using the OpenSAFELY platformBackground: Germ Defence ( www.germdefence.org ) is an evidence-based interactive website that promotes behaviour change for infection control within households. To maximise the potential of Germ Defence to effectively reduce the spread of COVID-19, the intervention needed to be implemented at scale rapidly. Methods: With NHS England approval, we conducted an efficient two-arm (1:1 ratio) cluster randomised controlled trial (RCT) to examine the effectiveness of randomising implementation of Germ Defence via general practitioner (GP) practices across England, UK, compared with usual care to disseminate Germ Defence to patients. GP practices randomised to the intervention arm (n = 3292) were emailed and asked to disseminate Germ Defence to all adult patients via mobile phone text, email or social media. Usual care arm GP practices (n = 3287) maintained standard management for the 4-month trial period and then asked to share Germ Defence with their adult patients. The primary outcome was the rate of GP presentations for respiratory tract infections (RTI) per patient. Secondary outcomes comprised rates of acute RTIs, confirmed COVID-19 diagnoses and suspected COVID-19 diagnoses, COVID-19 symptoms, gastrointestinal infection diagnoses, antibiotic usage and hospital admissions. The impact of the intervention on outcome rates was assessed using negative binomial regression modelling within the OpenSAFELY platform. The uptake of the intervention by GP practice and by patients was measured via website analytics. Results: Germ Defence was used 310,731 times. The average website satisfaction score was 7.52 (0-10 not at all to very satisfied, N = 9933). There was no evidence of a difference in the rate of RTIs between intervention and control practices (rate ratio (RR) 1.01, 95% CI 0.96, 1.06, p = 0.70). This was similar to all other eight health outcomes. Patient engagement within intervention arm practices ranged from 0 to 48% of a practice list. Conclusions: While the RCT did not demonstrate a difference in health outcomes, we demonstrated that rapid large-scale implementation of a digital behavioural intervention is possible and can be evaluated with a novel efficient prospective RCT methodology analysing routinely collected patient data entirely within a trusted research environment.
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Mapping and characterising electronic palliative care coordination systems and their intended impact: A national survey of end-of-life care commissionersObjectives: In England, Electronic Palliative Care Coordination Systems (EPaCCS) were introduced in 2008 to support care coordination and delivery in accordance with patient preferences. Despite policy supporting their implementation, there has been a lack of rigorous evaluation of EPaCCS and it is not clear how they have been translated into practice. This study sought to examine the current national implementation of EPaCCS, including their intended impact on patient and service outcomes, and barriers and facilitators for implementation. Methods: We conducted a national cross-sectional online survey of end-of-life care commissioning leads for Clinical Commissioning Groups (CCGs) in England. We enquired about the current implementation status of EPaCCS, their role in information sharing and intended impact, and requested routine patient-level data relating to EPaCCS. Results: Out of 135 CCGs, 85 (63.0%) responded, with 57 (67.1%) having operational EPaCCS. Use of EPaCCS were confined to healthcare providers with most systems (67%) not supporting information sharing with care homes and social care providers. Most systems (68%) sought to facilitate goal concordant care, although there was inconsonance between intended impacts and monitoring measures used. Common challenges to implementation included healthcare professionals' limited engagement. Only one-third of patients had an EPaCCS record at death with limited recording of patient preferences. Conclusions: Critical gaps exist in engagement with EPaCCS and their ability to facilitate information sharing across care providers. The limited alignment between stated goals of EPaCCS and their monitoring impedes efforts to understand which characteristics of systems can best support care delivery.
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Uptake of self-management education programmes for people with type 2 diabetes in primary care through the embedding package: a cluster randomised control trial and ethnographic studyBackground: Self-management education programmes are cost-effective in helping people with type 2 diabetes manage their diabetes, but referral and attendance rates are low. This study reports on the effectiveness of the Embedding Package, a programme designed to increase type 2 diabetes self-management programme attendance in primary care. Methods: Using a cluster randomised design, 66 practices were randomised to: (1) a wait-list group that provided usual care for nine months before receiving the Embedding Package for nine months, or (2) an immediate group that received the Embedding Package for 18 months. 'Embedders' supported practices and self-management programme providers to embed programme referral into routine practice, and an online 'toolkit' contained embedding support resources. Patient-level HbA1c (primary outcome), programme referral and attendance data, and clinical data from 92,977 patients with type 2 diabetes were collected at baseline (months - 3-0), step one (months 1-9), step 2 (months 10-18), and 12 months post-intervention. An integrated ethnographic study including observations, interviews, and document analysis was conducted using interpretive thematic analysis and Normalisation Process Theory. Results: No significant difference was found in HbA1c between intervention and control conditions (adjusted mean difference [95% confidence interval]: -0.10 [-0.38, 0.18] mmol/mol; -0.01 [-0.03, 0.02] %). Statistically but not clinically significantly lower levels of HbA1c were found in people of ethnic minority groups compared with non-ethnic minority groups during the intervention condition (-0.64 [-1.08, -0.20] mmol/mol; -0.06% [-0.10, -0.02], p = 0.004), but not greater self-management programme attendance. Twelve months post-intervention data showed statistically but not clinically significantly lower HbA1c (-0.56 [95% confidence interval: -0.71, -0.42] mmol/mol; -0.05 [-0.06, -0.04] %; p < 0.001), and higher self-management programme attendance (adjusted odds ratio: 1.13; 95% confidence interval: 1.02, 1.25; p = 0.017) during intervention conditions. Themes identified through the ethnographic study included challenges for Embedders in making and sustaining contact with practices and providers, and around practices' interactions with the toolkit. Conclusions: Barriers to implementing the Embedding Package may have compromised its effectiveness. Statistically but not clinically significantly improved HbA1c among ethnic minority groups and in longer-term follow-up suggest that future research exploring methods of embedding diabetes self-management programmes into routine care is warranted.
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A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivorsBackground: Many cancer survivors following primary treatment have prolonged poor quality of life. Aim: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. Design: Pragmatic parallel open randomised trial. Setting: UK general practices. Methods: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. Results: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. Conclusion: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.
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A Community and Hospital cAre Bundle to improve the medical treatment of severe cLaudIcation and critical limb iSchaemia (CHABLIS)Background: Patients with peripheral artery disease (PAD) often do not receive optimal best medical therapy (BMT). Through interaction with patients and healthcare-professionals (HCPs) we developed the LEaflet Gp letter Structured checklist (LEGS) complex clinical intervention to support HCPs in providing guideline-compliant PAD BMT. Methods: This was a prospective multicentre study assessing the feasibility and fidelity of delivering the LEGS intervention in primary and secondary care over six months. Intervention fidelity was scored based on the proportion of intervention components used correctly at discharge, 30 days, and six months. Results: Overall, 129 individuals were screened and 120 took part (33% female, 74% with chronic limb threatening ischaemia; 93% recruitment rate). Of those, 118 (98% retention rate) completed follow-up. Mean intervention fidelity score at discharge (primary outcome measure) was 63% [95% Confidence Interval (CI): 39-68%, SD: 5%], exceeding the success criteria set at 60% by a panel of HCPs and patients. This, however, declined to 51% at six months. Eight patients (6.7%) died (all cardiovascular deaths), four (3.3%) had a major lower limb amputation, 12 (10%) had a cardiovascular event, and 13 (11%) were admitted due to limb ischaemia at six months. Incomplete lipid therapy prescriptions and LEGS intervention documents not received by primary care CHPs were the most common reasons for not complying with the LEGS intervention. Conclusions: The LEGS intervention can be delivered in PAD care pathways across different hospitals, primary, and community healthcare settings with acceptable fidelity, to streamline and improve PAD BMT short- and medium-term.
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Nottinghamshire GP Phoenix Programme trainee transition scheme: an innovative education programme supporting GP trainees transition to independent practiceIt is well-established that GP trainees do not feel confident when transitioning to independent practice. In 2019, the Nottinghamshire GP Phoenix Programme Trainee Transition Scheme (TTS) was established to improve this transition and encourage local retention of newly qualified GPs. The TTS has been evaluated by surveying a total of 344 trainees from August 2022 to August 2023 using an electronic Google Form. Two-thirds of the trainees surveyed felt the mix of TTS-led non-clinical topics and trainee-led clinical topics taught during their locality time were useful for their learning. 72% felt that the TTS would influence their decision to remain working locally after qualification. Based on these positive findings, it is proposed that the TTS should be adopted in other areas to improve both transition and retention of newly qualified GPs.
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Thinking ahead about medical treatments in advanced illness: a qualitative study of barriers and enablers in end-of-life care planning with patients and families from ethnically diverse backgroundsBackground: This study explored whether or not, and how, terminally ill patients from ethnically diverse backgrounds and their family caregivers think ahead about deterioration and dying, and explored their engagement with health-care professionals in end-of-life care planning. Objective: The aim was to address the question, what are the barriers to and enablers of ethnically diverse patients, family caregivers and health-care professionals engaging in end-of-life care planning? Design: This was a qualitative study comprising 18 longitudinal patient-centred case studies, interviews with 19 bereaved family caregivers and 50 public and professional stakeholder responses to the findings. Setting: The study was set in Nottinghamshire and Leicestershire in the UK. Results: Key barriers - the predominant stance of patients was to live with hope, considering the future only in terms of practical matters (wills and funerals), rather than the business of dying. For some, planning ahead was counter to their faith. Health-care professionals seemed to feature little in people's lives. Some participants indicated a lack of trust and experienced a disjointed system, devoid of due regard for them. However, religious and cultural mores were of great importance to many, and there were anxieties about how the system valued and enabled these. Family duty and community expectations were foregrounded in some accounts and concern about being in the (un)care of strangers was common. Key enablers - effective communication with trusted individuals, which enables patients to feel known and that their faith, family and community life are valued. Health-care professionals getting to 'know' the person is key. Stakeholder responses highlighted the need for development of Health-care professionals' confidence, skills and training, Using stories based on the study findings was seen as an effective way to support this. A number of behavioural change techniques were also identified. Limitations: It was attempted to include a broad ethnic diversity in the sample, but the authors acknowledge that not all groups could be included. Conclusions: What constitutes good end-of-life care is influenced by the intersectionality of diverse factors, including beliefs and culture. All people desire personalised, compassionate and holistic end-of-life care, and the current frameworks for good palliative care support this. However, health-care professionals need additional skills to navigate complex, sensitive communication and enquire about aspects of people's lives that may be unfamiliar. The challenge for health-care professionals and services is the delivery of holistic care and the range of skills that are required to do this.
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Cohort Profile: Virus Watch-understanding community incidence, symptom profiles and transmission of COVID-19 in relation to population movement and behaviour• Virus Watch is a national community cohort study of COVID-19 in households in England and Wales, established in June 2020. The study aims to provide evidence on which public health approaches are most effective in reducing transmission, and to investigate community incidence, symptoms and transmission of COVID-19 in relation to population movement and behaviours. • In all, 28 527 households and 58 628 participants of age (0–98 years, mean age 48), were recruited between June 2020 and March 2022. • Data collected include demographics and details of occupation, comorbidities, medications and infection-prevention behaviours. Households are followed up weekly with illness surveys capturing symptoms and their severity, activities in the week prior to symptom onset and any COVID-19 test results. Additional occasional surveys capture household finance, employment, mental health, access to health care, vaccination uptake, activities and contacts. Data have been linked to Hospital Episode Statistics (HES), inpatient and critical care episodes, outpatient visits, emergency care contacts, mortality, virology testing and vaccination data held by National Health Service (NHS) Digital. • Nested within Virus Watch are a serology and Polymerase Chain Reaction (PCR) cohort study (n ¼ 12 877) and a vaccine evaluation study (n ¼ 19 555). • Study data are deposited in the Office of National Statistics (ONS) Secure Research Service (SRS). Survey data are available under restricted access upon request to ONS SRS.
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Randomised, placebo-controlled trial and meta-analysis show benefit of ondansetron for irritable bowel syndrome with diarrhoea: The TRITON trialBackground: Ondansetron may be beneficial in irritable bowel syndrome with diarrhoea (IBS-D). Aim: To conduct a 12-week parallel group, randomised, double-blind, placebo-controlled trial of ondansetron 4 mg o.d. (titrated up to 8 mg t.d.s.) in 400 IBS-D patients. Primary endpoint: % responders using the Food and Drug Administration (FDA) composite endpoint. Secondary and mechanistic endpoints included stool consistency (Bristol Stool Form Scale) and whole gut transit time (WGTT). After literature review, results were pooled with other placebo-controlled trials in a meta-analysis to estimate relative risks (RR), 95% confidence intervals (CIs) and number needed to treat (NNT). Results: Eighty patients were randomised. On intention-to-treat analysis, 15/37 (40.5%; 95% CI 24.7%-56.4%) met the primary endpoint on ondansetron versus 12/43 (27.9%; 95% CI 14.5%-41.3%) on placebo (p = 0.19). Ondansetron improved stool consistency compared with placebo (adjusted mean difference - 0.7; 95% CI -1.0 to-0.3, p < 0.001). Ondansetron increased WGTT between baseline and week 12 (mean (SD) difference 3.8 (9.1) hours, versus placebo -2.2 (10.3) hours, p = 0.01). Meta-analysis of 327 patients from this, and two similar trials, demonstrated ondansetron was superior to placebo for the FDA composite endpoint (RR of symptoms not responding = 0.86; 95% CI 0.75-0.98, NNT = 9) and stool response (RR = 0.65; 95% CI 0.52-0.82, NNT = 5), but not abdominal pain response (RR = 0.95; 95% CI 0.74-1.20). Conclusions: Although small numbers meant the primary endpoint was not met in this trial, when pooled with other similar trials meta-analysis suggests ondansetron improves stool consistency and reduces days with loose stool and urgency. Trial registration - http://www.isrctn.com/ISRCTN17508514.
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Multi-faceted intervention to improve management of antibiotics for children presenting to primary care with acute cough and respiratory tract infection (CHICO): efficient cluster randomised controlled trialObjective: To assess whether an easy-to-use multifaceted intervention for children presenting to primary care with respiratory tract infections would reduce antibiotic dispensing, without increasing hospital admissions for respiratory tract infection. Design: Two arm randomised controlled trial clustered by general practice, using routine outcome data, with qualitative and economic evaluations. Setting: English primary care practices using the EMIS electronic medical record system. Participants: Children aged 0-9 years presenting with respiratory tract infection at 294 general practices, before and during the covid-19 pandemic. Intervention: Elicitation of parental concerns during consultation; a clinician focused prognostic algorithm to identify children at very low, normal, or elevated 30 day risk of hospital admission accompanied by antibiotic prescribing guidance; and a leaflet for carers including safety netting advice. Main outcome measures: Rate of dispensed amoxicillin and macrolide antibiotics (superiority comparison) and hospital admissions for respiratory tract infection (non-inferiority comparison) for children aged 0-9 years over 12 months (same age practice list size as denominator). Results: Of 310 practices needed, 294 (95%) were randomised (144 intervention and 150 controls) representing 5% of all registered 0-9 year olds in England. Of these, 12 (4%) subsequently withdrew (six owing to the pandemic). Median intervention use per practice was 70 (by a median of 9 clinicians). No evidence was found that antibiotic dispensing differed between intervention practices (155 (95% confidence interval 138 to 174) items/year/1000 children) and control practices (157 (140 to 176) items/year/1000 children) (rate ratio 1.011, 95% confidence interval 0.992 to 1.029; P=0.25). Pre-specified subgroup analyses suggested reduced dispensing in intervention practices with fewer prescribing nurses, in single site (compared with multisite) practices, and in practices located in areas of lower socioeconomic deprivation, which may warrant future investigation. Pre-specified sensitivity analysis suggested reduced dispensing among older children in the intervention arm (P=0.03). A post hoc sensitivity analysis suggested less dispensing in intervention practices before the pandemic (rate ratio 0.967, 0.946 to 0.989; P=0.003). The rate of hospital admission for respiratory tract infections in the intervention practices (13 (95% confidence interval 10 to 18) admissions/1000 children) was non-inferior compared with control practices (15 (12 to 20) admissions/1000 children) (rate ratio 0.952, 0.905 to 1.003). Conclusions: This multifaceted antibiotic stewardship intervention for children with respiratory tract infections did not reduce overall antibiotic dispensing or increase respiratory tract infection related hospital admissions. Evidence suggested that in some subgroups and situations (for example, under non-pandemic conditions) the intervention slightly reduced prescribing rates but not in a clinically relevant way.
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Effectiveness and cost-effectiveness of behavioural support for prolonged abstinence for smokers wishing to reduce but not quit: Randomised controlled trial of physical activity assisted reduction of smoking (TARS)Aims: For smokers unmotivated to quit, we assessed the effectiveness and cost-effectiveness of behavioural support to reduce smoking and increase physical activity on prolonged abstinence and related outcomes. Design: A multi-centred pragmatic two-arm parallel randomised controlled trial. Setting: Primary care and the community across four United Kingdom sites. Participants: Nine hundred and fifteen adult smokers (55% female, 85% White), recruited via primary and secondary care and the community, who wished to reduce their smoking but not quit. Interventions: Participants were randomised to support as usual (SAU) (n = 458) versus multi-component community-based behavioural support (n = 457), involving up to eight weekly person-centred face-to-face or phone sessions with additional 6-week support for those wishing to quit. Measurements: Ideally, cessation follows smoking reduction so the primary pre-defined outcome was biochemically verified 6-month prolonged abstinence (from 3-9 months, with a secondary endpoint also considering abstinence between 9 and 15 months). Secondary outcomes included biochemically verified 12-month prolonged abstinence and point prevalent biochemically verified and self-reported abstinence, quit attempts, number of cigarettes smoked, pharmacological aids used, SF12, EQ-5D and moderate-to-vigorous physical activity (MVPA) at 3 and 9 months. Intervention costs were assessed for a cost-effectiveness analysis. Findings: Assuming missing data at follow-up implied continued smoking, nine (2.0%) intervention participants and four (0.9%) SAU participants achieved the primary outcome (adjusted odds ratio, 2.30; 95% confidence interval [CI] = 0.70-7.56, P = 0.169). At 3 and 9 months, the proportions self-reporting reducing cigarettes smoked from baseline by ≥50%, for intervention versus SAU, were 18.9% versus 10.5% (P = 0.009) and 14.4% versus 10% (P = 0.044), respectively. Mean difference in weekly MVPA at 3 months was 81.6 minutes in favour of the intervention group (95% CI = 28.75, 134.47: P = 0.003), but there was no significant difference at 9 months (23.70, 95% CI = -33.07, 80.47: P = 0.143). Changes in MVPA did not mediate changes in smoking outcomes. The intervention cost was £239.18 per person, with no evidence of cost-effectiveness. Conclusions: For United Kingdom smokers wanting to reduce but not quit smoking, behavioural support to reduce smoking and increase physical activity improved some short-term smoking cessation and reduction outcomes and moderate-to-vigorous physical activity, but had no long-term effects on smoking cessation or physical activity.
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Scaling-up a pharmacist-led information technology intervention (PINCER) to reduce hazardous prescribing in general practices: Multiple interrupted time series studyBackground: We previously reported on a randomised trial demonstrating the effectiveness and cost-effectiveness of a pharmacist-led information technology intervention (PINCER). We sought to investigate whether PINCER was effective in reducing hazardous prescribing when rolled out at scale in UK general practices. Methods and findings: We used a multiple interrupted time series design whereby successive groups of general practices received the PINCER intervention between September 2015 and April 2017. We used 11 prescribing safety indicators to identify potentially hazardous prescribing and collected data over a maximum of 16 quarterly time periods. The primary outcome was a composite of all the indicators; a composite for indicators associated with gastrointestinal (GI) bleeding was also reported, along with 11 individual indicators of hazardous prescribing. Data were analysed using logistic mixed models for the quarterly event numbers with the appropriate denominator, and calendar time included as a covariate. PINCER was implemented in 370 (94.1%) of 393 general practices covering a population of almost 3 million patients in the East Midlands region of England; data were successfully extracted from 343 (92.7%) of these practices. For the primary composite outcome, the PINCER intervention was associated with a decrease in the rate of hazardous prescribing of 16.7% (adjusted odds ratio (aOR) 0.83, 95% confidence interval (CI) 0.80 to 0.86) at 6 months and 15.3% (aOR 0.85, 95% CI 0.80 to 0.90) at 12 months postintervention. The unadjusted rate of hazardous prescribing reduced from 26.4% (22,503 patients in the numerator/853,631 patients in the denominator) to 20.1% (11,901 patients in the numerator/591,364 patients in the denominator) at 6 months and 19.1% (3,868 patients in the numerator/201,992 patients in the denominator). The greatest reduction in hazardous prescribing associated with the intervention was observed for the indicators associated with GI bleeding; for the GI composite indicator, there was a decrease of 23.9% at both 6 months (aOR 0.76, 95% CI 0.73 to 0.80) and 12 months (aOR 0.76, 95% CI 0.70 to 0.82) postintervention. The unadjusted rate of hazardous prescribing reduced from 31.4 (16,185 patients in the numerator/515,879 patients in the denominator) to 21.2% (7,607 patients in the numerator/358,349 patients in the denominator) at 6 months and 19.5% (2,369 patients in the numerator/121,534 patients in the denominator). We adjusted for calendar time and practice, but since this was an observational study, the findings may have been influenced by unknown confounding factors or behavioural changes unrelated to the PINCER intervention. Data were also not collected for all practices at 6 months and 12 months postintervention. Conclusions: The PINCER intervention, when rolled out at scale in routine clinical practice, was associated with a reduction in hazardous prescribing by 17% and 15% at 6 and 12 months postintervention. The greatest reductions in hazardous prescribing were for indicators associated with risk of GI bleeding. These findings support the wider national rollout of PINCER in England.
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What Should Be Considered When Assessing Hyperacusis? A Qualitative Analysis of Problems Reported by Hyperacusis PatientsHyperacusis (decreased sound tolerance) is a prevalent complaint. Yet, to date, no research has qualitatively evaluated the types of problems experienced by adults with hyperacusis. Our service evaluation aims to determine the hyperacusis-related problem domains reported by patients and the degree to which these domains were reported together. Retrospective analysis was conducted on an anonymised clinical dataset from 306 patients who attended a UK tinnitus and hyperacusis treatment centre between 1994 and 2017. Conventional content analysis was used to categorise responses to the question 'Why is hyperacusis a problem?' into domains which were then subjected to a cluster analysis. Twenty-five problem domains were identified, of which 12 were further classified into three overarching categories. 'Fear', 'Reduced quality of life' and 'Physical reaction to sound' were most frequently reported problems. Cluster analysis revealed that 'Sleep difficulties' and 'Despondency', were commonly reported together. Adults with hyperacusis face many challenges in their everyday lives. The nature of these problems indicates the need to develop complex interventions and assessments to aid management of hyperacusis. Current hyperacusis questionnaires may be useful in identifying some problem domains, but further assessment thorough patient interviews is required to fully explore all potential problems and make informed decisions about treatment.