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We lead multidisciplinary applied research and training to rethink the way health care is delivered in general practice and across the community.
Socioeconomic inequality and access to emergency care: understanding the pathways to the emergency department in the UK
OBJECTIVE: To examine how socioeconomic deprivation influences referral pathways to emergency departments (EDs) and to assess how these pathways affect subsequent hospital outcomes. DESIGN: Retrospective observational study. SETTING: Emergency department of a large teaching hospital in the East of England, providing secondary and tertiary care. PARTICIPANTS: 482 787 ED attendances by patients aged 16 years and over, recorded between January 2019 and December 2023. Patients were assigned Index of Multiple Deprivation (IMD) deciles based on residential postcode. MAIN OUTCOME MEASURES: Referral source (general practitioner (GP), National Health Service (NHS) 111, ambulance, self-referral, other), total ED time, 4-hour breach, hospital admission and unplanned return within 72 hours. RESULTS: Substantial socioeconomic inequalities were observed in referral pathways. Patients from the most deprived areas were significantly less likely to be referred by a GP (4.7%) than those from the least deprived areas (14.7%) and more likely to arrive via ambulance (32% vs 24%). These differences persisted after adjusting for demographic, clinical and contextual variables. Ambulance referrals showed the longest ED stays, ranging from 347 to 351 min across IMD deciles (overall 95% CI 343 to 363) and the highest probability of 4-hour breaches (51%; 95% CI 50% to 53%). Self-referrals had the greatest rates of unplanned returns within 7 days (up to 7.1%; 95% CI 5.5% to 8.7%). In contrast, NHS 111 and GP referrals were associated with shorter stays, lower breach rates and fewer reattendances. Minimal variation in outcomes was observed across deprivation levels once referral source was accounted for. CONCLUSIONS: Inequalities in how patients access emergency care, particularly reduced GP and NHS 111 referrals among more deprived groups, appear to underpin disparities in ED outcomes. Referral source captures important clinical and system-level factors that influence patient experience and resource use. Interventions to improve equitable access to structured referral pathways, particularly in more deprived areas, may enhance both the efficiency and fairness of emergency care delivery. Further research using national data is needed to assess broader policy implications and economic costs associated with differential access.
Depictions of the GP crisis: thematic analysis of UK newspapers pre-general election.
BACKGROUND: In the six weeks between the announcement of the 2024 UK General Election (22 May) and election day (4 July), national newspapers published numerous articles depicting a "crisis" in general practice. These portrayals varied across publications and may have influenced public discourse and political pledges. AIM: To explore how UK national newspapers depicted access to general practice during the six weeks preceding the 2024 General Election. DESIGN & SETTING: Thematic analysis of UK national newspaper articles published in the pre-election period. METHOD: Articles were retrieved from the LexisNexis® Academic database using predefined search terms and inclusion/exclusion criteria. After screening, 194 articles were included and analysed thematically. Key themes identified were the crisis itself, regional disparities, access challenges for the elderly, consequences of poor access, and political promises. RESULTS: All newspapers articulated a "GP crisis", though with distinct emphases. Inequalities featured prominently, with coverage highlighting rural GP shortages and difficulties for elderly patients. Articles frequently linked poor access with adverse outcomes, such as delayed or missed diagnoses, as well as wider system pressures, including strain on emergency services. Coverage was overwhelmingly negative, and political promises mirrored the crisis narrative presented in the press. CONCLUSION: In the run-up to the 2024 General Election, UK print media consistently portrayed general practice as being in crisis, often through sensationalised accounts of waiting times and limited access. These framings likely shaped public perception and influenced election pledges. Editorial choices played a key role in constructing dominant narratives around general practice and health policy discourse.
Bugbears in the Waiting Room: Revisiting Arber and Sawyer's Classic Study of GP Reception Work Using Ethnography in Eight English General Practices
In 1985, Arber and Sawyer described the discretionary rationing power of general practice receptionists. Our paper revisits this territory. Much has changed in the intervening decades. Digitalisation has altered reception work. Increasing multimorbidity and rising chronic illness, combined with a dwindling workforce, restricted funding and systemic pressures on public services, have fuelled the ‘crisis’ in general practice. ‘Unacceptable’ delays in getting a general practitioner (GP) appointment are seen as evidence of this. Our focused ethnography in eight English NHS general practices highlights important shifts in receptionists' management of GP access. We observed waiting and reception areas, interviewed 70 staff and 74 patients and examined practice documents. Arber and Sawyer's dragon metaphor remains salient, but receptionists have new strategies of bureaucratic distancing and redirection to manage appointment requests. They are gatekeepers still and remain a target for hostility but mitigate this by using these strategies. Patients on a quest to obtain an appointment with a GP may still be thwarted and sometimes meet dragons at the desk, but they may more often find themselves allied with the receptionist. The barrier to getting a GP appointment has become the access system and its discorporate digital forms, rather than the receptionist or the GPs she protects.
Thinking through family: Narratives of care experienced lives
Understanding what 'family' means - and how best to support families - depends on challenging politicized assumptions that frame 'ordinary' families in comparison to an imagined problematic 'other'. Learning from the perspectives of people who were in care in childhood, this innovative book helps redefine the concept of family. Linking two longitudinal studies involving young adults in England, it reveals important new insights into the diverse and dynamic complexity of family lives, identities and practices in time - through childhood and beyond. Paving the way for future policy and practice, this book makes an important contribution to the theorization of family in the 21st century.
Exploring Elinor Ostrom's principles for collaborative group working within a user-led project: lessons from a collaboration between researchers and a user-led organisation
Background: Some research has been undertaken into the mechanisms that shape successful participatory approaches in the context of efforts to improve health and social care. However, greater attention needs to be directed to how partnerships between researchers and user-led organisations (ULOs) might best be formed, practiced, managed, and assessed. We explored whether political economist Elinor Ostrom’s Nobel prize winning analysis of common pool resource management—specifically eight principles to enhance collaborative group working as derived from her empirical research—could be usefully applied within a user-led project aiming to co-design new services to support more inclusive involvement of Disabled people in decision-making processes in policy and practice. Methods: Participant observation and participatory methods over a 16-month period comprising observational notes of online user-led meetings (26 h), online study team meetings (20 h), online Joint Interpretive Forum meetings (8 h), and semi-structured one-to-one interviews with project participants (44 h) at two time points (months 6 and 10). Results: Initially it proved difficult to establish working practices informed by Ostrom’s principles for collaborative group working within the user-led project. Several attempts were made to put a structure in place that met the needs of both the research study and the aims of the user-led project, but this was not straightforward. An important shift saw a move away from directly applying the principles to the working practices of the group and instead applying them to specific tasks the group were undertaking. This was a helpful realisation which enabled the principles to become—for most but not all participants—a useful facilitation device in the latter stages of the project. Eventually we applied the principles in a way that was useful and enabled collaboration between researchers and a ULO (albeit in unexpected ways). Conclusions: Our joint reflections emphasise the importance of being reflexive and responsive when seeking to apply theories of collaboration (the principles) within user-led work. At an early stage, it is important to agree shared definitions and understanding of what ‘user-led’ means in practice. It is crucial to actively adapt and translate the principles in ways that make them more accessible and applicable within groups where prior knowledge of their origins is both unlikely and unnecessary.
Recognition and justice? Conceptualizing support for women whose children are in care or adopted
This paper examines the views of mothers who have experienced (or are judged to be at risk of) recurrent removal of children into care or adoption. Drawing on their accounts of working with an intensive 18 month support program called Pause, we argue for the relevance of conceptualizing policy and practice with reference to Honneth’s theory of recognition and Fraser’s arguments about the need to address misrecognition through redistribution, attending to gendered political and economic injustice. The analysis draws on qualitative longitudinal interviews with 49 women, conducted as part of a national UK Department for Education (DfE)-funded evaluation of Pause. Each woman was interviewed up to four times over a period of up to 20 months, both during and after the Pause intervention. Case-based longitudinal analysis illuminates how stigma can obscure women’s rights and needs—including welfare entitlements and health, as well as rights to family life—and shows how support can act to enable both redistribution, advocating to ensure women’s rights in a context of diminishing public welfare, and recognition, challenging stigmatization through recognition of women’s motherhood, and of their rights to care, solidarity, respect and fun.
Non-prescribed spaces, creativity and narrative formation: a systems-based examination of a community art group exploring food poverty
This article describes a year-long participatory arts project carried out as part of a community–university partnership in the South of England. The research sought to examine the relationship between the ‘user-led’ ethos of the Brighton Unemployed Centre Families Project (BUCFP) and emergence within it of creatively working and self-managing groups, examining how an environment that did not adhere to a prescribed use of space might enable groups to make sense of their experiences. The research used ethnographic methods and a theoretical framework informed by systems theory, critical health psychology and narrative analysis to explore the group’s experiences of food poverty. The research demonstrates ways in which the group provided community members with a space in which to examine, define and make legitimate their experiences and how this can be thought of as an educational and community knowledge-building practice that has important implications, particularly for notions of well-being.
Protocol for a Group-Sequential Two-Stratum Multicenter Open-Label Randomized Clinical Trial of Respiratory Support in Infants with Acute Bronchiolitis: Breathing Assistance in Children with Bronchiolitis (BACHb)
Objectives: The Breathing Assistance in Children with bronchiolitis (BACHb) trial aims to evaluate the clinical and cost-effectiveness of high-flow nasal cannula (HFNC) therapy compared with humidified standard oxygen (HSO) in infants with moderate bronchiolitis, and HFNC with continuous positive airway pressure (CPAP) in severe bronchiolitis. Design: Pragmatic, group-sequential, two-stratum, multicenter, open-label randomized clinical trial. Setting: Fifty hospitals across England, Scotland, and Wales. Patients: Hospitalized infants younger than 12 months old with a clinical diagnosis of bronchiolitis, assessed at least twice 15 minutes apart to fulfill criteria for either severe bronchiolitis (one or more of: respiratory rate > 70 breaths/min, grunting, marked chest recession, recurrent short apneas) or moderate bronchiolitis (lack of response to low-flow oxygen, indicated by persistent hypoxemia and/or moderate respiratory distress). Interventions: "Moderate bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. HSO through a facemask or headbox at a flow rate up to 15 L/min. "Severe bronchiolitis stratum": HFNC at a flow rate of 2 L/kg/min vs. CPAP pressure set at 6-8 cm H2O. Measurements and Main Results: In each stratum, eligible infants will be randomly allocated on a 1:1 basis to the trial treatments using a web-based system by permuted block randomization, stratified by site of recruitment and age (< 6 wk and ≥ 6 wk). Due to the emergency nature of the treatments, written informed consent will be deferred. The primary outcome is time from randomization to hospital discharge within 30 days. Baseline clinical characteristics and hospital course, including details of respiratory support, and discharge and cost-effectiveness outcomes will be collected. The trial received Health Research Authority and Research Ethics Committee approval from the Yorkshire and The Humber-South Yorkshire Research Ethics Committee on August 3, 2023 (reference: 23/YH/0166). The trial registration is ISRCTN52937119. Conclusions: Trial findings will be disseminated in national and international conferences, in peer-reviewed journals and through social media.
Health economic aspects of childhood excess weight
Background: Over the past four decades, the prevalence of childhood excess weight has risen significantly globally and remains high in many countries. In England, the prevalence of excess weight among Year 6 children (10–11-year-olds) increased from 31.6% in 2006/07 to 36.6% in 2022/23. Despite the increasing public health burden, substantial uncertainty persists regarding key economic parameters and outcomes necessary to guide research and inform policy for the efficient allocation of resources that target childhood excess weight. Methods: This thesis presents a structured review of economic aspects of childhood excess weight as a foundation for further analyses. A systematic review of economic evaluations of interventions targeting childhood excess weight was conducted, followed by an analysis of data from the UK Millennium Cohort Study to estimate transitions in childhood weight status. Additionally, electronic health records extracted from the Clinical Practice Research Datalink (CPRD), linked with Hospital Episode Statistics (HES), were analysed to estimate direct healthcare costs attributable to childhood excess weight. Results: The systematic review found that early prevention strategies for childhood excess weight are generally cost-effective. Analysis of data from the Millennium Cohort Study indicated that children aged 3 to 7 years had a significantly higher probability of transitioning from overweight or obesity to a healthy weight compared to older children, with more than twice the annual likelihood of such transitions. These movements between weight status categories were also influenced by child, maternal, and sociodemographic factors. My analyses of CPRD-HES data revealed that children living with overweight and obesity incurred significantly higher direct healthcare costs than their peers with a healthy weight. In comparison to children with healthy weight, those living with overweight generated additional costs of £133.93 and £66.32, on average, in the year preceding and following a BMI measurement, respectively, while children with obesity incurred additional costs of £115.47 and £154.51, on average, during the same periods. The total annual healthcare cost attributable to childhood excess weight in England was estimated at £0.3 billion. Conclusions: This thesis identifies critical areas for future economic research, offering insights for researchers and policymakers. It underscores the significance of investing early in cost-effective interventions to address childhood excess weight. The evidence presented in this thesis can serve as data inputs for future economic evaluations in this field.
Childhood Transitions Between Weight Status Categories: Evidence from the UK Millennium Cohort Study
Background: Assessing the cost-effectiveness of interventions targeting childhood excess weight requires estimates of the hazards of transitioning between weight status categories. Current estimates are based on studies characterized by insufficient sample sizes, a lack of national representativeness, and untested assumptions. Objectives: We sought to (1) estimate transition probabilities and hazard ratios for transitioning between childhood weight status categories, (2) test the validity of the underlying assumption in the literature that transitions between childhood bodyweight categories are time-homogeneous, (3) account for complex sampling procedures when deriving nationally representative transition estimates, and (4) explore the impact of child, maternal, and sociodemographic characteristics. Methods: We applied a multistate transition modeling approach accounting for complex survey design to UK Millennium Cohort Study (MCS) data to predict transition probabilities and hazard ratios for weight status movements for children aged 3–17. Surveys were conducted at ages 3 (wave 2 in 2004), 5 (wave 3 in 2006), 7 (wave 4 in 2008), 11 (wave 5 in 2012), 14 (wave 6 in 2015), and 17 (wave 7 in 2018) years. We derived datasets that included repeated body mass index measurements across waves after excluding multiple births and children with missing or implausible bodyweight records. To account for the stratified cluster sample design of the MCS, we incorporated survey weights and jackknife replicates of survey weights. Using a validation dataset from the MCS, we tested the validity of our models. Finally, we estimated the relationships between state transitions and child, maternal, and sociodemographic factors. Results: The datasets for our primary analysis consisted of 10,399 children for waves 2–3, 10,729 for waves 3–4, 9685 for waves 4–5, 8593 for waves 5–6, and 7085 for waves 6–7. All datasets consisted of roughly equal splits of boys and girls. Under the assumption of time-heterogeneous transition rates (our base-case model), younger children (ages 3–5 and 5–7 years) had significantly higher annual transition probabilities of moving from healthy weight to overweight (0.033, 95% confidence interval [CI] 0.026–0.041, and 0.027, 95% CI 0.021–0.033, respectively) compared to older children (0.015, 95% CI 0.012–0.018, at ages 7–11; 0.018, 95% CI 0.013–0.023, at ages 11–14; and 0.018, 95% CI 0.013–0.025 at ages 14–17 years). However, the resolution of unhealthy weight was more strongly age-dependent than transitions from healthy weight to non-healthy weight states. Transition hazards differed by child, maternal, and sociodemographic factors. Conclusions: Our models generated estimates of bodyweight status transitions in a representative UK childhood population. Compared to our scenario models (i.e., time-homogeneous transition rates), our base-case model fits the observed data best, indicating a non-time-homogeneous pattern in transitions between bodyweight categories during childhood. Transition hazards varied significantly by age and across subpopulations, suggesting that conducting subgroup-specific cost-effectiveness analyses of childhood weight management interventions will optimize decision-making.
Health Economic Aspects of Childhood Excess Weight: A Structured Review
An economic perspective is crucial to understand the broad consequences of childhood excess weight (CEW). These can manifest in the form of elevated health care and societal costs, impaired health status, or inefficiencies in the allocation of resources targeted at its prevention, management, or treatment. Although existing systematic reviews provide summaries of distinct economic research strands covering CEW, they have a restricted focus that overlooks relevant evidence. The overarching aim of this structured review was to update and enhance recent key reviews of four strands of economic evidence in this area, namely, (1) economic costs associated with CEW, (2) health utilities associated with CEW, (3) economic evaluations of interventions targeting CEW, and (4) economic determinants and broader consequences of CEW. Our de novo searches identified six additional studies for the first research strand, five studies for the second, thirty‐one for the third, and two for the fourth. Most studies were conducted in a small number of high‐income countries. Our review highlights knowledge gaps across all the research strands. Evidence from this structured review can act as data input into future economic evaluations in this area and highlights areas where future economic research should be targeted.
Thoracoscopic surgical ablation versus catheter ablation as first-line treatment for long-standing persistent atrial fibrillation: the CASA-AF RCT
BackgroundStandalone thoracoscopic surgical ablation may be more effective than catheter ablation in patients with long-standing persistent atrial fibrillation.ObjectivesTo determine whether or not surgical ablation is clinically superior to catheter ablation as the first-line treatment strategy in long-standing persistent atrial fibrillation.DesignThis was a prospective, multicentre, randomised control trial.SettingFour NHS tertiary centres in England.ParticipantsAdults with long-standing persistent atrial fibrillation, who had European Heart Rhythm Association symptom scores > 2 and who were naive to previous catheter ablation or thoracic/cardiac surgery.InterventionsMinimally invasive thoracoscopic surgical ablation and conventional catheter ablation (control intervention).Main outcome measuresThe primary outcome was freedom from atrial fibrillation/tachycardia ≥ 30 seconds after a single procedure without antiarrhythmic drugs (class 1C/3) at 1 year, excluding a 3-month blanking period. The secondary outcomes include the intervention-related major complication rate; clinical success (≥ 75% reduction in arrhythmia burden); and changes in symptoms, quality of life and cost-effectiveness.MethodsPatients (n = 120) were randomised to surgical ablation (n = 60) or catheter ablation (n = 60). An implanted loop recorder provided continuous cardiac monitoring following ablation. Follow-up visits were at 3, 6, 9 and 12 months. Loop recorder data were reviewed monthly by a physiologist who was blinded to the randomisation outcome.ResultsThe study treatment was received by 55 patients in the surgical ablation arm and 60 patients in the catheter ablation arm; five patients withdrew from surgical ablation before treatment. Data from randomised and treated patients were analysed as per intention to treat. Patients had a mean age of 62.3 (standard deviation 9.6) years, were predominantly male (74%), had a mean left atrial diameter of 44.6 mm (standard deviation 6 mm) and were in continuous atrial fibrillation for 22 months (range 16–31 months). At 12 months, 26% of patients in the surgical ablation arm (14/54) and 28% of patients in the catheter ablation arm (17/60) were free from atrial arrhythmias after a single procedure without antiarrhythmic drugs (odds ratio 1.13, 95% confidence interval 0.46 to 2.83; p = 0.84). An arrhythmia burden reduction of ≥ 75% was seen in 36 out of 54 (67%) patients in the surgical ablation arm, compared with 46 out of 60 (77%) patients in the catheter ablation arm (odds ratio 1.64, 95% confidence interval 0.67 to 4.08; p = 0.3). Procedure-related serious complications within 30 days of the intervention occurred in 15% (8/55) of patients in the surgical ablation arm (including one death) compared with 10% (6/60) of patients in the catheter ablation arm (p = 0.46). Surgical ablation was associated with significantly higher costs (£23,221 vs. £18,186; p = 0.02) and fewer quality-adjusted life-years than catheter ablation (0.76 vs. 0.83; p = 0.02).LimitationsThis study was conducted in four highly specialised cardiology centres that have substantial experience in both treatment modalities; therefore, the results may not be widely generalisable. The study was not powered to detect small differences in efficacy.ConclusionsWe found no evidence to suggest that standalone thoracoscopic surgical ablation outcomes were superior to catheter ablation outcomes in achieving freedom from atrial arrhythmia after a single procedure without antiarrhythmic drugs. Moreover, surgical ablation is associated with a longer hospital stay, smaller improvements in quality of life and higher health-care costs than catheter ablation (standard care therapy).Future workEvaluation of the impact of ablation treatments on sinus rhythm maintenance and quality of life with extended follow-up to 3 years. Model-based economic analysis to estimate long-term benefits, harms and costs of surgical and catheter ablation compared with antiarrhythmic drug therapy in long-standing persistent atrial fibrillation patients.Trial registrationCurrent Controlled Trials ISRCTN18250790 and ClinicalTrials.gov NCT02755688.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. This study was supported by the UK Clinical Research Collaboration-registered King’s Clinical Trials Unit at King’s Health Partners, which is part funded by the NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust and King’s College London and the NIHR Evaluation, Trials and Studies Coordinating Centre. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 8, No. 18. See the NIHR Journals Library website for further project information.
A duodenal sleeve bypass device added to intensive medical therapy for obesity with type 2 diabetes: a RCT
BackgroundThe EndoBarrier® (GI Dynamics Inc., Boston, MA, USA) is an endoluminal duodenal–jejunal bypass liner developed for the treatment of patients with obesity and type 2 diabetes mellitus. Meta-analyses of its effects on glycaemia and weight have called for larger randomised controlled trials with longer follow-up.ObjectivesThe primary objective was to compare intensive medical therapy with a duodenal–jejunal bypass liner with intensive medical therapy without a duodenal–jejunal bypass liner, comparing effectiveness on the metabolic state as defined by the International Diabetes Federation as a glycated haemoglobin level reduction of ≥ 20%. The secondary objectives were to compare intensive medical therapy with a duodenal–jejunal bypass liner with intensive medical therapy without a duodenal–jejunal bypass liner, comparing effectiveness on the metabolic state as defined by the International Diabetes Federation as a glycated haemoglobin level of DesignA multicentre, open-label, randomised controlled trial.SettingImperial College Healthcare NHS Trust and University Hospital Southampton NHS Foundation Trust.ParticipantsPatients aged 18–65 years with a body mass index of 30–50 kg/m2 and with inadequately controlled type 2 diabetes mellitus who were on oral glucose-lowering medications.InterventionsParticipants were randomised equally to receive intensive medical therapy alongside a duodenal–jejunal bypass liner device (n = 85) or intensive medical therapy alone for 12 months (n = 85), and were followed up for a further 12 months.ResultsThere was no significant difference between groups in the percentage of patients achieving the glycaemic primary or secondary outcomes [primary outcome at 12 months: duodenal–jejunal bypass liner group 54.5% vs. control group 55.2% (odds ratio 0.93, 95% confidence interval 0.44 to 1.98; p = 0.85); primary outcome at 24 months: duodenal–jejunal bypass liner group 39.7% vs. control group 36.5% (odds ratio 1.13, 95% confidence interval 0.52 to 2.47; p = 0.75)]. Significantly more patients in the duodenal–jejunal bypass liner group than in the control group lost > 15% of their total body weight (duodenal–jejunal bypass liner group 24.2% vs. control group 3.7%; odds ratio 8.33, 95% confidence interval 1.78 to 39.0; p = 0.007) and achieved blood pressure targets (duodenal–jejunal bypass liner group 68.2% vs. control group 44.4%; odds ratio 2.57, 95% confidence interval 1.21 to 5.48; p = 0.014). These differences were observed at 12 months but not at 24 months. There were more adverse events in the duodenal–jejunal bypass liner group, including one liver abscess. The increase in peripheral insulin sensitivity was superior in the duodenal–jejunal bypass liner group. Spectroscopic analyses of plasma, urine and faeces revealed several distinct metabolic perturbations in the duodenal–jejunal bypass liner group but not in the control group. Brain reward responses to food cues were not different between groups. The number of mean quality-adjusted life-years gained was similar in both groups and the additional costs of the duodenal–jejunal bypass liner may outweigh the value of the health benefits by £2560 per patient treated.ConclusionsThe results show that the endoluminal duodenal–jejunal bypass liner was not superior to intensive medical therapy for glycaemic control and was associated with more adverse events. The duodenal–jejunal bypass liner was associated with significant weight loss and improvement in cardiometabolic parameters at 12 months but not at 24 months. Economic evaluation showed that the bypass liner was not cost-effective for glycaemic control or for weight loss.Trial registrationCurrent Controlled Trials ISRCTN30845205.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) Programme, a Medical Research Council (MRC) and National Institute for Health Research (NIHR) partnership. This will be published in full in Efficacy and Mechanism Evaluation; Vol. 7, No. 6. See the NIHR Journals Library website for further project information. This study was executed with the support of GI Dynamics Inc. and with the kind support of Nutricia Advanced Medical Nutrition for providing oral nutritional supplements.
Catheter ablation vs. thoracoscopic surgical ablation in long-standing persistent atrial fibrillation: CASA-AF randomized controlled trial
Aims : Long-standing persistent atrial fibrillation (LSPAF) is challenging to treat with suboptimal catheter ablation (CA) outcomes. Thoracoscopic surgical ablation (SA) has shown promising efficacy in atrial fibrillation (AF). This multicentre randomized controlled trial tested whether SA was superior to CA as the first interventional strategy in de novo LSPAF. Methods and results : We randomized 120 LSPAF patients to SA or CA. All patients underwent predetermined lesion sets and implantable loop recorder insertion. Primary outcome was single procedure freedom from AF/atrial tachycardia (AT) ≥30 s without anti-arrhythmic drugs at 12 months. Secondary outcomes included clinical success (≥75% reduction in AF/AT burden); procedure-related serious adverse events; changes in patients' symptoms and quality-of-life scores; and cost-effectiveness. At 12 months, freedom from AF/AT was recorded in 26% (14/54) of patients in SA vs. 28% (17/60) in the CA group [OR 1.128, 95% CI (0.46-2.83), P = 0.83]. Reduction in AF/AT burden ≥75% was recorded in 67% (36/54) vs. 77% (46/60) [OR 1.13, 95% CI (0.67-4.08), P = 0.3] in SA and CA groups, respectively. Procedure-related serious adverse events within 30 days of intervention were reported in 15% (8/55) of patients in SA vs. 10% (6/60) in CA, P = 0.46. One death was reported after SA. Improvements in AF symptoms were greater following CA. Over 12 months, SA was more expensive and provided fewer quality-adjusted life-years (QALYs) compared with CA (0.78 vs. 0.85, P = 0.02). Conclusion : Single procedure thoracoscopic SA is not superior to CA in treating LSPAF. Catheter ablation provided greater improvements in symptoms and accrued significantly more QALYs during follow-up than SA. Clinical Trial Registration: ISRCTN18250790 and ClinicalTrials.gov: NCT02755688
Engaging adolescents in changing behaviour (EACH-B): a study protocol for a cluster randomised controlled trial to improve dietary quality and physical activity
Background: Poor diet and lack of physical activity are strongly linked to non-communicable disease risk, but modifying them is challenging. There is increasing recognition that adolescence is an important time to intervene; habits formed during this period tend to last, and physical and psychological changes during adolescence make it an important time to help individuals form healthier habits. Improving adolescents’ health behaviours is important not only for their own health now and in adulthood, but also for the health of any future children. Building on LifeLab—an existing, purpose-built educational facility at the University of Southampton—we have developed a multi-component intervention for secondary school students called Engaging Adolescents in Changing Behaviour (EACH-B) that aims to motivate and support adolescents to eat better and be more physically active. Methods: A cluster randomised controlled trial is being conducted to evaluate the effectiveness of the EACH-B intervention. The primary outcomes of the intervention are self-reported dietary quality and objectively measured physical activity (PA) levels, both assessed at baseline and at 12-month follow-up. The EACH-B intervention consists of three linked elements: professional development for teachers including training in communication skills to support health behaviour change; the LifeLab educational module comprising in-school teaching of nine science lessons linked to the English National Curriculum and a practical day visit to the LifeLab facility; and a personalised digital intervention that involves social support and game features that promote eating better and being more active. Both the taught module and the LifeLab day are designed with a focus on the science behind the messages about positive health behaviours, such as diet and PA, for the adolescents now, in adulthood and their future offspring, with the aim of promoting personal plans for change. The EACH-B research trial aims to recruit approximately 2300 secondary school students aged 12–13 years from 50 schools (the clusters) from Hampshire and neighbouring counties. Participating schools will be randomised to either the control or intervention arm. The intervention will be run during two academic years, with continual recruitment of schools throughout the school year until the sample size is reached. The schools allocated to the control arm will receive normal schooling but will be offered the intervention after data collection for the trial is complete. An economic model will be developed to assess the cost-effectiveness of the EACH-B intervention compared with usual schooling. Discussion: Adolescents’ health needs are often ignored and they can be difficult to engage in behaviour change. Building a cheap, sustainable way of engaging them in making healthier choices will benefit their long-term health and that of their future children. Trial registration: ISRCTN 74109264. Registered on 30 August 2019. EACH-B is a cluster randomised controlled trial, funded by the National Institute for Health Research (RP-PG-0216-20004).
Fulvestrant for Untreated Hormone-Receptor Positive Locally Advanced or Metastatic Breast Cancer: An Evidence Review Group Perspective of a NICE Single Technology Appraisal
Clinical and cost-effectiveness evidence on fulvestrant for untreated hormone-receptor positive locally advanced or metastatic breast cancer was submitted to the single technology appraisal process of the National Institute for Health and Care Excellence by the manufacturer of fulvestrant. The Southampton Health Technology Assessments Centre was commissioned by the National Institute for Health and Care Excellence as an independent Evidence Review Group to critique the company’s submitted evidence. Fulvestrant was compared directly with anastrozole in two randomised controlled trials and was compared indirectly by means of a network meta-analysis with anastrozole, letrozole and tamoxifen. This article summarises the Evidence Review Group’s review of the company’s submission and summarises the guidance the National Institute for Health and Care Excellence Appraisal Committee issued in January 2018. The Evidence Review Group had several concerns, the most important of which related to the degree to which fulvestrant might confer a benefit in overall survival. This was because mature data were not available from the key phase III trial FALCON. The economic model was sensitive to changes in overall survival and the Evidence Review Group considered the incremental cost-effectiveness ratio was uncertain and likely to increase once mature results from FALCON become available. The National Institute for Health and Care Excellence Appraisal Committee concluded that fulvestrant could not be recommended for treating locally advanced or metastatic estrogen-receptor-positive breast cancer in postmenopausal women who have not received previous endocrine therapy.
Two interferon gamma release assays for predicting active tuberculosis: The UK PREDICT TB prognostic test study
Background: Despite a recent decline in the annual incidence of tuberculosis (TB) in the UK, rates remain higher than in most Western European countries. The detection and treatment of latent TB infection (LTBI) is an essential component of the UK TB control programme. Objectives: To assess the prognostic value and cost-effectiveness of the current two interferon gamma release assays (IGRAs) compared with the standard tuberculin skin test (TST) for predicting active TB among untreated individuals at increased risk of TB: (1) contacts of active TB cases and (2) new entrants to the UK from high-TB-burden countries. Design: A prospective cohort study and economic analysis. Participants and setting: Participants were recruited in TB clinics, general practices and community settings. Contacts of active TB cases and migrants who were born in high-TB-burden countries arriving in the UK were eligible to take part if they were aged ≥ 16 years. Main outcome measures: Outcomes include incidence rate ratios comparing the incidence of active TB in those participants with a positive test result and those with a negative test result for each assay, and combination of tests and the cost per quality-adjusted life-year (QALY) for each screening strategy. Results: A total of 10,045 participants were recruited between May 2010 and July 2015. Among 9610 evaluable participants, 97 (1.0%) developed active TB. For the primary analysis, all test data were available for 6380 participants, with 77 participants developing active TB. A positive result for TSTa (positive if induration is ≥ 5 mm) was a significantly poorer predictor of progression to active TB than a positive result for any of the other tests. Compared with TSTb [positive if induration is ≥ 6 mm without prior bacillus Calmette–Guérin (BCG) alone, T-SPOT®.TB (Oxford Immunotec Ltd, Oxford, UK), TSTa + T-SPOT.TB, TSTa + IGRA and the three combination strategies including TSTb were significantly superior predictors of progression. Compared with the T-SPOT.TB test alone, TSTa + T-SPOT.TB, TSTb + QuantiFERON® TB Gold In-Tube (QFT-GIT; QIAGEN GmbH, Hilden, Germany) and TSTb + IGRA were significantly superior predictors of progression and, compared with QFT-GIT alone, T-SPOT.TB, TSTa + T-SPOT.TB, TSTa + QFT-GIT, TSTa + IGRA, TSTb + T-SPOT.TB, TSTb + QFT-GIT and TSTb + IGRA were significantly superior predictors of progression. When evaluating the negative predictive performance of tests and strategies, negative results for TSTa + QFT-GIT were significantly poorer predictors of non-progression than negative results for TSTa, T-SPOT.TB and TSTa + IGRA. The most cost-effective LTBI testing strategies are the dual-testing strategies. The cost and QALY differences between the LTBI testing strategies were small; in particular, QFT-GIT, TSTb + T-SPOT.TB and TSTb + QFT-GIT had very similar incremental net benefit estimates. Conclusion: This study found modest differences between tests, or combinations of tests, in identifying individuals who would go on to develop active TB. However, a two-step approach that combined TSTb with an IGRA was the most cost-effective testing option. Implications for practice and future research: The two-step TSTb strategy, which stratified the TST by prior BCG vaccination followed by an IGRA, was the most cost-effective approach. The limited ability of current tests to predict who will progress limits the clinical utility of tests. The implications of these results for the NHS England/Public Health England national TB screening programme for migrants should be investigated.