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The Senior Management Committee were asked to reinstate their commitment to PDRs and share why they believe they are important.
Exploring the long-term utility of remotely monitored FeNO suppression testing in severe asthma.
BACKGROUND: Confirmation of optimal inhaled corticosteroid use is essential before initiating biologic therapy. FeNO suppression testing (FeNOSuppT) is a proven phenotyping technique, however its long-term effect on clinical outcomes remains unclear. OBJECTIVES: To assess the real-world feasibility of delivering FeNOSuppT alongside digital inhaler monitoring, and to examine its effect on biologic initiation and clinical outcomes. METHODS: Prospective cohort study within seven UK severe asthma centres. Patients received a sensor-enabled ICS/LABA inhaler during an initial appointment between July 2020 and June 2022. A positive FeNOSuppT was defined as >42% FeNO reduction at short-term follow-up (typically 1-3 months post-baseline). Biologic initiation and clinical outcomes were compared at short-term and long-term (typically 12 months post-baseline) follow-up. RESULTS: Of 353 included patients, 257 (72.8%) completed the FeNOSuppT and 140 (54.5%) were positive. A positive FeNOSuppT was associated with greater improvements in short-term FEV1% (8.6% vs. -0.3, p<0.001) and ACQ6 (0.7 vs. 0.3, p=0.001) compared to a negative test. Of 168 patients eligible for biologics who completed the FeNOSuppT, those with a positive result initiated biologics less often (48.2% vs. 65.2%, p=0.035). Despite this, there was a greater improvement in FEV1 (11.0% vs. 2.3%, p=0.016), and a similar reduction in both asthma symptoms (ACQ6: 0.7 vs. 0.8, p=0.623) and exacerbations (66.7% vs. 66.7%, p=0.349) at long-term follow-up when compared to those with a negative FeNOSuppT. CONCLUSIONS: Delivering FeNOSuppT aligned with digital monitoring is feasible within routine care. A positive FeNOSuppT was associated with lower rates of biologic initiation, with similar clinical outcomes.
Recognition and management of acute functional decline in older people living in care homes: a qualitative interview study with UK care home staff.
BACKGROUND: Older people living in care homes who experience acute functional decline pose a diagnostic challenge to GPs. AIM: We aimed to explore beliefs, practices and experiences of UK care home staff who first recognise and respond to acute functional decline, including in the context of the COVID-19 pandemic. DESIGN & SETTING: Qualitative interview study with 25 UK care home staff. METHOD: Semi- structured interviews were conducted over the phone between January 2021 and April 2022. Thematic analysis was facilitated by NVivo software. RESULTS: Care home staff recognised acute functional decline as subtle changes from normal, which required knowing a resident well. However, it could be difficult to differentiate between an 'off day' and a more significant deviation, particularly for residents with a variable baseline. Acute functional decline caused anxiety to care home staff, in part due the uncertainty about illness trajectory and outcome. They commonly considered UTI a likely underlying cause. Some participants described a watch and wait approach or trying simple interventions, whilst others preferred escalating directly to outside clinical support. Triggers for escalation included perceived severity of illness, gut feeling or failure to respond to initial supportive management. CONCLUSION: This study has highlighted the complexities around the identification and management of a care home resident experiencing acute functional decline. There was variation in interpretation and responding to these episodes within the care home. More work is needed to understand the physiology and risk profiles of acute functional decline, as well as any relationship to UTI.
Variations in the Use of Faecal Immunochemical Testing (FIT) in Primary Care in England: A Population-Based Cohort of 531,735 FITs from 495,121 Patients Between 2019 and 2023.
BACKGROUND/OBJECTIVES: Faecal Immunochemical Testing (FIT) is recommended for patients presenting to primary care with symptoms suggestive of colorectal cancer. This study quantified variations in use across England. METHODS: Retrospective cohort of English patients (≥18 years) with a FIT result reported in routinely collected primary care records, 2019-2023. Rates of FIT testing by age, sex, year and region were adjusted using Poisson regression. Multivariate logistic regression compared the effect of factors on the proportion of results exceeding the recommended referral threshold (10µgHb/g). RESULTS: Between 01/01/2019 and 05/06/2023 there were 531,735 FIT results among 495,121 patients. Rates of testing increased from 0.69 per thousand person-years in 2019 (95% CI 0.68-0.71) to 27.70 in 2023 (95% CI 27.56-27.85). There were large variations in testing between regions, with rates >3-fold higher in the Northeast than the West Midlands: 17.05 (95% CI 16.87-17.23) versus 4.72 (95% CI 4.67-4.76) per thousand person-years. About 20.4% of FIT results were ≥10µgHb/g. Despite increased testing, this did not change over time. The proportion of FIT ≥10µgHb/g was lower in regions with higher rates of testing, from 16.7% (Southwest) to 25.3% (Southeast; rates of testing 14.62 and 8.00 per thousand person-years respectively). This difference in proportion of FIT ≥10µgHb/g persisted after adjusting for year, sex and age (OR 0.57, 95% CI 0.55-0.58). CONCLUSION: Rapid increases in FIT testing in primary care show large, persistent variations between English regions, which correlate with the proportion of results meeting the criteria for onward referral. Differences in the population tested and FIT's implementation between regions are likely to explain these variations.
Inclusion of under-served groups in trials: an audit at a UK primary care clinical trials unit.
BACKGROUND: Clinical trials need to include patients who are representative of the population who may receive the tested interventions in the future. The importance of inclusivity is recognised by ethical and funding bodies and has public support. Appropriate inclusion is required to provide equitable evidence-based healthcare and to comply with ethical principles for research. However, there is little information about the inclusivity of most under-served groups in UK clinical trials. METHODS: This audit assesses the inclusion of under-served groups in trials run by the Oxford Primary Care Clinical Trials Unit (PC-CTU). We included trials with ethical approval between 2017 and 2023. We checked protocols, patient-facing information and selected data collection tools for information on the under-served groups in the INCLUDE guidance and protected characteristics in the UK Equality Act 2010, to identify explicit exclusions and data collection. RESULTS: We included 19 trials. They were in a variety of clinical conditions, testing different types of interventions, both Clinical Trial of an Investigational Medicinal Product (CTIMP) and non-CTIMP. Most were non-commercially funded. We reviewed 21 protocols, 29 Patient Information Sheets/Leaflets and 40 data collection tools. Common exclusions were based on age (19), sex or gender (11), language (8), capacity to consent (14), pregnancy (11), multiple health conditions (10) and severity of illness (17). Trials most often collected data on age (19), sex or gender (15), ethnicity (16), education (11), address (13), mental health conditions (6), who gave consent (19), addiction (6), multiple health conditions (10), severity of illness (17), smoking status (12) and obesity (13). CONCLUSIONS: Often, exclusions were due to the focusing of the trial for a specific group, such as older people, women, or people being treated for a specific severity of condition. However, many explicit exclusions may not have been essential, may have reduced the inclusivity of the trials and might limit the applicability of the trial's findings to people to whom the tested interventions might be relevant. These include the exclusion of people aged under 18, people without English language fluency and people without capacity to consent. All trials could have collected more informative data on under-served group status.
Planetary health for health systems: A scoping review and content analysis of frameworks
Planetary health movements have advanced substantially within the last ten years with new frameworks and models being considered within health systems in varied contexts. Despite advancements, there continues to be an overall lack of accessible and regional- or field-specific planetary health frameworks to inform health systems. We therefore set out to conduct a scoping review to identify current planetary health-related frameworks that have been developed for health systems. We systematically searched the following electronic databases up to November 2023: Medline, CAB Abstracts, and Scopus; and carried out manual searches in Overton, Policy Commons, Google, and Google Scholar. We engaged a two-stage article review process, then used content analysis to identify the different domains. We identified six overarching categories within the planetary health-related frameworks including: 1) health system and environmental impacts; 2) vision, advocacy, leadership, and communication elements; 3) key structural components for environmentally sustainable health systems; 4) climate resiliency and environmental sustainability of healthcare facilities and systems; 5) climate-resilient and sustainable technologies and infrastructure; and 6) evaluation and accountability mechanisms. Regional, national, and international governments, funding agencies, and organizations are called to support greater research and implementation work around planetary health-informed health systems change while considering existing frameworks. Better inclusion of all facets of planetary health (e.g., biodiversity), as well as key acknowledgement and work with other knowledge systems (e.g., Indigenous Peoples and their knowledge systems) are needed to ensure planetary health-related frameworks are grounded in what we are trying to protect—the planet itself.
An intensive weight loss programme with behavioural support for people with type 2 diabetes at risk of eating disorders in England (ARIADNE): a randomised, controlled, non-inferiority trial
Background: There are concerns that low-energy total diet replacement (TDR) programmes could trigger eating disorders, given their focus on weight and rigid dietary rules. We aimed to assess the effect of a TDR programme on eating disorder symptoms in people living with overweight or obesity and type 2 diabetes at high risk of developing an eating disorder. Methods: In this randomised, controlled, non-inferiority trial, participants with type 2 diabetes, overweight, and eating disorder symptoms across England were randomly assigned (1:1) to a low-energy TDR programme with formula products and behavioural support delivered remotely, or usual care. In brief, the intervention comprised 12 weeks of low-energy TDR in a nutritionally complete package of soups, shakes, and bars. After the 12 weeks, the intervention continued with stepped food reintroduction (around 8 weeks) based on a low-energy, nutrient-rich diet, followed by weight maintenance advice (around 4 weeks), personalised to an individual participant's circumstances and preferences. Participants allocated to the control group received usual care for their diabetes. The primary outcome was the change in eating disorder symptoms using the Eating Disorders Examination Questionnaire (EDE-Q) global score at 6 months (programme end). Safety was determined by the incidence of cases with high suspicion of a new eating disorder. The primary outcome analysis had an upper non-inferiority margin for EDE-Q of +1 SD (0·72). People with lived experience were involved throughout the trial and provided input on study conceptualisation, protocol development, delivery of the intervention, and intervention materials. The study was registered with ClinicalTrials.gov, NCT05744232. Findings: Between March 8, 2023, and Sept 12, 2023, 56 participants were randomly assigned to the intervention group (28 participants) or control group (28 participants). Participants had a mean age of 49·9 years (SD 8·1). 35 (63%) of 56 participants were women, 20 (36%) were men, and one (2%) was non-binary. 54 (96%) of participants were White and two (4%) were Asian. Participants had a mean BMI of 39·6 kg/m2 (SD 7·8) and a mean EDE-Q global score of 3·3 (0·4). 49 (88%) of 56 participants provided outcome data at 6 months and 45 (80%) at 1 year. At completion of the programme at 6 months, the mean weight loss was –13·9 kg (SD 11·2) in the intervention group and –3·7 kg (7·9) in the control group, with a between-group difference of –10·2 kg (95% CI –14·2 to –6·2). The between-group difference in the EDE-Q score was –0·8 points (–1·4 to –0·3) at 6 months, indicating non-inferiority. At 12 months, weight change was not different between groups, but non-inferiority and superiority in EDE-Q remained. No participants were suspected of having developed an eating disorder. 13 adverse events were documented, of which one, a cholecystectomy, was serious. Interpretation: Participation in a supported TDR programme did not worsen eating disorder symptoms in people with overweight or obesity and type 2 diabetes at high risk of developing an eating disorder. We found no evidence these programmes cause harm and a suggestion of benefit on eating disorder symptoms, independent of weight loss. Funding: Novo Nordisk UK Research Foundation.
Routine testing for group B streptococcus in pregnancy: protocol for a UK cluster randomised trial (GBS3).
INTRODUCTION: It is unclear whether routine testing of women for group B streptococcus (GBS) colonisation either in late pregnancy or during labour reduces early-onset neonatal sepsis, compared with a risk factor-based strategy. METHODS AND ANALYSIS: Cluster randomised trial. SITES AND PARTICIPANTS: 320 000 women from up to 80 hospital maternity units. STRATEGIES: Sites will be randomised 1:1 to a routine testing strategy or the risk factor-based strategy, using a web-based minimisation algorithm. A second-level randomisation allocates routine testing sites to either antenatal enriched culture medium testing or intrapartum rapid testing. Intrapartum antibiotic prophylaxis will be offered if a test is positive for GBS, or if a maternal risk factor for early-onset GBS infection in her baby is identified before or during labour. Economic and acceptability evaluations will be embedded within the trial design. OUTCOMES: The primary outcome is all-cause early (<7 days of birth) neonatal sepsis, defined as either a positive blood/cerebrospinal fluid culture, early neonatal death from infection or a negative/unknown culture status with ≥3 agreed clinical signs or symptoms, who receive intravenous antibiotics ≥5 days. All women giving birth ≥24 weeks' gestation, regardless of mode of birth, and all her babies will be included in the dataset. Cost-effectiveness will be expressed in terms of incremental cost per case of early neonatal sepsis avoided and incremental cost per quality-adjusted life-year associated with each strategy. ETHICS AND DISSEMINATION: The trial received a favourable opinion from Derby Research Ethics Committee on 16 September 2019 (19/EM/0253). The allocated testing strategy will be adopted as standard clinical practice by the site. Women in the routine testing sites will give verbal consent for the test. The trial will use routinely collected data retrieved from National Health Service databases, supplemented with limited participant-level collection of process outcomes. Individual written consent will not be sought. The trial results, and parallel economic, qualitative, implementation and methodological results, will be published in the journal Health Technology Assessment. TRIAL REGISTRATION NUMBER: ISRCTN49639731.
Educating healthcare students in the Sustainable Development Goals: from translational science to translational humanities.
Healthcare courses typically approach Sustainable Development Goals (SDGs) education from a 'translational science' perspective. Students are taught about 'evidence-based' interventions, which are developed through scientific research (hence, assumed to be politically neutral), implemented with 'fidelity' (ie, in a standardised way in diverse contexts) and then 'rolled out'. Progress is measured using standardised indicators. We argue for a shift to 'translational humanities', in which students are supported to engage critically with the cultural and political dynamics and epistemic uncertainties underpinning the setting of SDG targets, the development and implementation of programmes, and the measurement of success. Translational humanities seeks to surface alternative framings and measures of success, especially by giving voice to marginalised and ignored communities. This radical approach, informed by political philosophy, recognises that conflict among stakeholders and the uncertainty it generates are inevitable and can be a productive force (eg, if surfaced and used to inform multifaceted debate and values-driven action).Whereas a translational science approach to SDG education emphasises objectivity, technical precision and (the pursuit of) certainty, a translational humanities approach seeks to foster human and interpretive qualities such as reflection, critical thinking, commitment to human rights and fairness, appreciation of complexity, epistemic humility and flexibility, willingness to examine problems from multiple angles, the capacity to adapt, and tolerance of uncertainty. In a worked example of how this can be achieved, we introduce the 'critical datathon'-a group exercise in which students engage deeply with case studies of SDGs, examine the assumptions and interests behind conventional solutions, and navigate diverse implementation contexts.
Retrospective analysis of the global antibiotic residues that exceed the predicted no effect concentration for antimicrobial resistance in various environmental matrices.
BackgroundAntimicrobial resistance (AMR) is a growing public health concern. Recent research has suggested that interactions between pathogens and antibiotic residues in various environmental matrices promote the development and spread of AMR in the environment. The levels of antibiotic residues in the aquatic environment have been analysed globally. Recently, Predicted No Effect Environmental Concentration (PNEC) values for many antibiotics have been suggested, based on their estimated minimal selective concentrations for selected bacterial species. The PNEC values can serve as a guide on the maximum levels of antibiotic residues in an environmental matrix, below which resistance is unlikely to develop.AimWe aimed to determine which of the antibiotics, considered as "priority antibiotics" by the World Health Organisation (WHO), most frequently exceeded their PNEC values in the global aquatic environment.MethodsWe obtained data from the German Environment Agency pharmaceutical database on means, medians or single values of 12 antibiotic types in five different environmental matrices [municipal wastewater treatment plant effluent, industrial wastewater effluent, hospital wastewater effluent, surface water, and drinking water] across 47 countries. We compared the mean levels of the 12 antibiotics in each environmental matrix to their suggested PNEC values to determine which antibiotic types exceeded PNEC and were most likely to select for resistance. We also determined which environmental matrices and countries had the highest burden of antibiotic residues.ResultsOur study revealed that 7.9% of all analyses of antibiotic residues performed in the environmental matrices globally exceeded PNEC. Ciprofloxacin and clarithromycin had the greatest proportion (>30%) of residues exceeding PNEC. Hospital wastewater and industrial wastewater had the highest burden of antibiotic residues exceeding PNEC. No antibiotics exceeded PNEC in drinking water.ConclusionWhile most environmental monitoring studies have focused on municipal wastewater treatment plants, the limited number of studies on hospital wastewater and industrial wastewater revealed that a large number of antibiotic residues coming from these sources exceeded their PNEC values. Our study highlights the importance of implementing on-site treatment systems that aim to destroy antibiotics prior to discharging wastewater to surface waters. Attention needs to be focused on the role that environmental matrices, particularly our wastewater sites, play in promoting antibiotic resistance. Novel treatment technologies need to be developed and implemented to increase the removal efficiencies of treatment plants and from antibiotic manufacturing, and decrease the discharge of antibiotic residues into aquatic environments.
A Sustainable Future in Digital Health: Leveraging Environmentally Friendly Architectural Tactics for Sustainable Data Processing
The rapid growth of big data in healthcare necessitates optimising data processing to reduce its environmental impact. This paper proposes a pilot architectural framework to evaluate the sustainability of a Big Healthcare Data (BHD) system using Microservices Architecture (MSA). The goal is to enhance MSA's architectural tactics by incorporating environmentally friendly metrics into healthcare systems. This is achieved by adopting energy and carbon efficiency models, alongside exploring innovative architectural strategies. The framework, based on recent research, manipulates cloud-native system architecture by using a controller to adjust microservice deployment through real-time monitoring and modelling. This approach demonstrates how sustainability-driven metrics can be applied at different abstraction levels to estimate environmental impact from multiple perspectives.
Sociodemographic Profile of People with Diagnosed Pancreatic Cancer in the UK: Retrospective Sentinel Network Cohort Study
Pancreatic cancer is a devasting disease which is an increasing cause of cancer mortality. The aim of this study was to characterise, using descriptive statistics, the sociodemographic, risk and clinical characteristics of who develops pancreatic cancer. This retrospective cohort study examined data from one of the largest UK primary care databases, from January 1st 2006 to August 31st 2020. A total of 573 primary care practices contributed data. There were 9,267 people diagnosed with pancreatic cancer. The median age at diagnosis was 73 years (IQR 16) and 49.8% (4,616) of people were female. Nearly a third (30.2%, 2,798) of people had diabetes, and 85.8% (2,400) of the people with diabetes received the diabetes diagnosis before pancreatic cancer. For people for whom ethnicity was recorded 94.4% (5,979) were white. Under half of people with BMI recorded (41.9%, 571) were overweight or obese at pancreatic cancer diagnosis and 5.9% (80) were underweight. In addition, 12.6% (1,168) of participants were active smokers and 1.4% (130) exceeded recommended limits of alcohol. Improved characterisation of the sociodemographic, risk and clinical characteristics of who develops pancreatic cancer highlights the opportunity for machine learning and other technologies to flag people at high risk of this cancer.