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Cost-effectiveness of regular surveillance versus endoscopy at need for patients with Barrett's esophagus: economic evaluation alongside the BOSS randomized controlled trial.
INTRODUCTION: The Barrett's esophagus surveillance study (BOSS) was the first randomized study of surveillance. This study reports the costs and quality of life outcomes from the BOSS trial and models the outcomes and cost-effectiveness of surveillance beyond the follow up period of the BOSS study. This trial showed similar stages and rates of esophageal cancer in both arms, but the regular surveillance arm did identify more high-grade dysplasia after a median of 12.8 years follow up. METHODS: We used a decision tree model based on results from BOSS to conduct a cost-effectiveness analysis of costs and quality adjusted life years (QALYs). A Markov model was used to extrapolate costs and outcomes over a further 10 years after the trial had ended representing a 22.8 year time horizon. The proportion with high grade dysplasia and QALYs were derived from the randomized trial. RESULTS: The total costs associated with two yearly surveillance was $5,309 vs. $3,182 in the at need arm. Total QALY in the two-yearly endoscopy arm were 8.647 as compared to 8.629 in the at need arm. Compared with at need endoscopy, two-yearly surveillance costs $115,563/QALY gained. In the sensitivity analyses around assumptions on the proportion of high-grade dysplasia that is undetected in the at need endoscopy arm, surveillance had an incremental cost effectiveness ratio of $94,513/QALY for the best-case and $146,272/QALY for the worst-case scenario. CONCLUSION: BE surveillance every 2-3 years is unlikely to be a cost-effective strategy. Guidelines should take this into account when deciding surveillance intervals.
Clinical effectiveness of a child-specific dynamic stretching programme, compared to usual care, for ambulant children with spastic cerebral palsy (SPELL trial): a parallel group randomized controlled trial.
AIMS: Dynamic muscle stretching exercises are one of the interventions frequently prescribed by physiotherapists for children with cerebral palsy (CP). However, there is wide variability in the exercise regimes used and limited evidence of their effectiveness. The SPELL trial will assess the clinical effectiveness of an individually tailored dynamic stretching programme, compared to usual care for ambulant children with spastic CP. METHODS: We are conducting a multicentre, two-arm, parallel group, superiority randomized controlled trial. We will recruit children aged four to 11 years with a diagnosis of spastic CP (bilateral or unilateral) and Gross Motor Function Classification System (GMFCS) levels I to III who are able to comply with assessment procedures and exercise programme with or without support. Participants will be recruited from at least 12 UK NHS Trust physiotherapy and related services. Participants (n = 334) will be randomized (centralized computer-generated one:one allocation ratio) to either: 1) a dynamic stretching exercise programme, with six one-to-one physiotherapy sessions over 16 weeks; or 2) usual NHS care, with a single physiotherapy session and an assessment, and advice regarding self-management and exercise. CONCLUSION: The primary outcome is functional mobility measured using the child-/parent-reported Gait Outcomes Assessment List (GOAL) at six months. Secondary outcomes are: joint range of motion (Cerebral Palsy Integrated Pathway protocol) and motor function (timed up and go test) at six months; functional mobility (GOAL) at 12 months; independence (GOAL subdomain A); balance (GOAL subdomain A, B, D); pain and discomfort (GOAL subdomain C); health-related quality of life (youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)); educational attendance; exercise adherence; and additional physiotherapy treatment at six and 12 months. The primary analysis will be intention to treat.
Novel La1−xCaxMnO3 perovskite materials for chemical looping combustion applications
Novel customized lanthanum calcium manganese (LCM) perovskite structures were synthesized as candidate materials for chemical looping combustion (CLC) following the coprecipitation method and varying the Ca percentage (0, 30, 50, 70, 100 wt%). Their ability either to offer oxygen and thus oxidize CH4 during the fuel oxidation stage, and/or to reversibly receive oxygen during the solid oxidation stage was explored performing pulse reaction experiments in a lab scale, fixed-bed reactor at 1000°C. Their stability in multiple redox cycles was also further explored in a larger, fluid-bed reactor unit, where the stability of the optimum oxygen carrier material (OCM) sample was further investigated (up to 100 redox cycles). All materials were physicochemically characterized before and after their use (porosity characteristics by N2 adsorption-desorption isotherms, identification of crystalline phases by X-ray diffraction, morphological observation by scanning electron microscopy, investigation of the redox properties by H2-TPR, TPD-O2, and TPO), in an effort to track down any alterations in their textural and morphological characteristics, as a result of Ca doping and multiple reduction-oxidation cycles. All materials exhibited varying efficiency concerning their oxygen transfer capacity (OTC), their CH4 oxidation ability, their selectivity to CO2 and CO, and their stability in multiple reduction-oxidation cycles, a behavior depending on the Ca content and derived physicochemical properties. The reducibility and the oxygen adsorption capacity of the as synthesized LCM samples is enhanced with increasing Ca content with CaMnO3 (LCM100) presenting the best redox properties and suggested as the most promising OCM among the studied perovskites, reaching a maximum OTC of 7.73 wt% at 1000°C. Further evaluation of the CaMnO3 perovskite at lower temperatures (720°C, 820°C, and 920°C) showed great redox potential, while the spongy morphology and the reduction-oxidation ability of the sample was retained after multiple redox cycles.
Engineering the Catalytic Properties of HZSM5 by Cobalt Modification and Post-synthetic Hierarchical Porosity Development
Hierarchical zeolites have been identified as special catalytic materials with improved catalytic properties. In this study, hierarchical bifunctional ZSM5 based catalysts were prepared by desilication for controlled mesoporosity development and have been modified by Co doping. Their performance in the catalytic pyrolysis of oak in a lab scale reactor was evaluated. Desilicated counterparts were proven more active in deoxygenation of bio oil, while carbon deposition on the catalysts reduced compared to non-desilicated counterparts. Increased Lewis acidity favors decarboxylation reactions, while higher olefins as well as PAH content indicate easier diffusion within and from the porous network and interactions in the mesopores. The conversion of bulky lignin molecules (alkoxy phenols) is enhanced by the mesopores, while acidity is of secondary importance. Coke deposition inside the pores is more profound in the desilicated catalysts due to larger pore size. Carbon deposition on the catalysts is reduced in the following order: HZSM5 > Co/HZSM5 > Ds-HZSM5 > Co/Ds-HZSM5. GC–MS characterization of the CH2Cl2 soluble coke indicated that for the desilicated counterparts the main coke precursors are the bulky lignin molecules which are partially deoxygenated.
A review of the statistical analysis of randomised controlled trials conducted within OCTRU.
INTRODUCTION: Despite a proliferation of statistical methodologies and developments within randomised controlled trials (RCTs) in recent decades, it is unclear which approaches are being implemented in practice. Oxford Clinical Trials Research Unit (OCTRU) is a UK Clinical Research Collaboration (UKCRC) registered Clinical Trials Unit (CTU) that has been operational since 2013 based in the Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences at the University of Oxford. We performed a review of all published RCTs conducted within OCTRU, with particular emphasis on trial methodology, statistical study design and statistical analysis. METHODS: Studies were considered eligible if they were: RCTs conducted by OCTRU, have been completed and disseminated their primary results. Studies were ineligible if they were: a pilot or feasibility trial, a simulation study, a secondary analysis of an existing RCT, or a phase I trial. Phase II trials were considered if they were randomised. We performed double data extraction of all fields for all eligible trials. General trial information, such as primary disease area, main funding source, sample size, trial design and analysis information (e.g. number of study outcomes and analyses performed), were extracted and summarised. An analysis was defined as any time a statistical model was fit or a corresponding statistical test (e.g. χ2 test) and/or estimation of a parameter was performed. RESULTS: Of the 142 OCTRU studies registered & funded (as of June 2023), 70 were completed and written up and 27 were eligible at the time of this review. The rest were ongoing or found to be ineligible. Included studies were published between 2014 and 2023, the majority in the last 5 years (20/27, 74% published between 2020 and 2023). All trials were multi-centre, prospectively designed and referred to both a study protocol and sample size justification (usually a power calculation) in their published results. Most included studies had elements of what could be referred to as a 'standard' RCT; used a parallel group design (93%), powered with superiority question (26/27, 96%), had two randomised groups (23/27, 85%) or used an equal allocation ratio (25/27, 93%). The median sample size was 451 (interquartile range: 238-836). The median total number of analyses performed was 22 (Interquartile range: 14-30) with the most analyses performed within a single trial being 69. Eighty-one per cent (22/27) of trials had a primary outcome with either binary or continuous data. Linear mixed effects, linear regression or logistic regression was used as the primary analysis model in 74% of the 27 trials. All trials that included at least one analysis (26/27) featured at least one additional analysis on the primary outcome, the most popular additional analyses were on an alternative population (for example a per-protocol population), occurring in 20/27, 74% of all trials, or a subgroup (18/27, 67%)). CONCLUSIONS: This review summarises RCTs conducted by one academic UKCRC-registered CTU with a focus on the trial design and statistical analysis. We found most RCTs adopted what could be considered a 'standard' design, using appropriate, but not complex, analysis methods. Consideration of variation in practice across other groups, both academic and commercial, through a larger review would allow systematic exploration of methodological differences, less common study design usage, and would enable a fuller understanding of practice, outcomes, and methods used in different clinical areas and contexts.
The burden of hand trauma surgery on primary care in the United Kingdom: a nation-wide analysis of antibiotic and opioid prescriptions.
Although surgical site infection (SSI) risk after hand trauma surgery is around 5%, the severity of these infections is not known. The risk of superficial SSI in a cohort study was evaluated using NHS UK-wide primary care records (n = 641,223), using the Clinical Practice Research Datalink GOLD database. Within this cohort, a subcohort of those who had undergone a hand surgery operation for trauma were identified (n = 3,088). Antibiotic and analgesic prescriptions were analysed at 30 and 90 days postoperatively. By 30 days, 6.2% had been prescribed antibiotics appropriate for SSI, rising to 14.4% (CI [13.2 to 15.8]) by 90 days. By 30 days, 10% had been prescribed opioid analgaesia and by 90 days this had increased to 13.8%. Antibiotics prescriptions for SSI in primary care are substantially higher than the NICE estimate for SSI overall and the expected risk in hand trauma. The implications of this study are that many patients are receiving treatment for SSI in primary care and may be in more pain, for longer, than we expect. Further exploration of this is warranted and future research in hand trauma surgery should capture adverse events occurring outside of the hospital environment.Level of evidence: II.
Treatment choice for adult patients with moderate-to-severe asthma – The TAILOR study
BackgroundIn patients with uncontrolled asthma treated with medium dose (md) inhaled corticosteroid/long-acting beta2 agonist (ICS/LABA), The Global Initiative for Asthma (GINA) recommends to increase to high dose (hd) ICS/LABA or to start therapy consisting of md ICS/LABA+LAMA (long-acting muscarinic antagonist). Adding LAMA on top of hd ICS/LABA is not recommended for Step 4 asthma patients, yet it is used in the real world. Patient characteristics influencing treatment step-up are unknown.ObjectivesIdentify determinants of step-up option (hd ICS/LABA, md ICS/LABA+LAMA, hd ICS/LABA+LAMA) in patients with moderate to severe asthma.MethodsA retrospective cohort study using three primary care databases (IPCI, HSD, CPRD GOLD) and one prescription database (Aarhus) included asthma patients with step-up after≥3 months use of md ICS/LABA, from January 2010 to April 2020. Characteristics of patients were described and determinants of choice for md ICS/LABA+LAMA or high dose ICS/LABA were investigated.Results492 639 adults with asthma and≥1 year of database history were identified and 25 558 were eligible for analysis. 6126 patients stepped-up to md ICS/LABA+LAMA and 18 947 patients stepped-up to hd ICS/LABA. Determinants for step-up to md ICS/LABA+LAMA were higher age and presence of COPD whereas history of atopy lowered this choice. Other covariates were differentially associated with specific treatment step-up depending on the databases.ConclusionIn uncontrolled asthma patients on md ICS/LABA, treatment step-up with add-on LAMA was more likely than step-up to hd ICS/LABA in older patients, current smokers, with a history of asthma exacerbations and concomitant diagnosis of COPD.
Ethnic disparities in COVID-19 mortality and cardiovascular disease in England and Wales between 2020-2022
Previous studies reported higher COVID-19 mortality risk among certain ethnic groups, but data on ethnic disparities in COVID-19-related cardiovascular disease (CVD) were lacking. We estimated age-standardised incidence rates and adjusted hazard ratios for 28-day mortality and 30-day CVD for individual ethnicity groups from England and Wales, using linked health and administrative data. We studied 6-level census-based ethnicity group classification, 10-level classification (only for Wales), and 19-level classification as well as any ethnicity sub-groups comprising >1000 individuals each (only for England). COVID-19 28-day mortality and 30-day CVD risk was increased in most non-White ethnic groups in England and Asian population in Wales between 23rd January 2020 and 1st April 2022. English data show mortality decreased during the Omicron variant's dominance, whilst CVD risk [95% confidence interval] remained elevated for certain ethnic groups when compared to White populations (January-April 2022): by 120% [28-280%] in White and Asian men and 58% [32-90%] in Pakistan men, as compared to White British men; and by 75% [13-172%] in Bangladeshi women, 55% [19-102%] in Caribbean women, and 82% [31-153%] in Any Other Ethnic Group women, as compared to White British women. Ethnically diverse populations remained disproportionately affected by CVD throughout and beyond the COVID-19 pandemic.
Secular trends in heat related illness and excess sun exposure rates across climatic zones in the United States from 2017 to 2022.
Heat waves are a major public health challenge, yet the link between heat-related illness (HRI) and regional climate and geography is underexplored. We examined HRI and excess sun exposure incidence rates (IR) [95% confidence interval (CI) per 100,000 person-years], and their correlation with regional maximum temperatures across 9 US climatic zones 33,603,572 individuals were followed from 2017 to 2022. We observed 10,652 individuals with HRI diagnosis (median age: 49 years, 62.3% male). Seasonal peaks occurred during summer: highest overall IR (130.97 [119.93-142.75]) was recorded in July 2019, highest regional IR was reported in the South (186.04 [117.93-279.15]) during 2020. Strongest correlations between monthly maximum temperature and incidence of HRI were observed in the West (Pearson Correlation Coefficient (cor) = 0.854) and Southwest (cor = 0.832). In contrast, we observed 131,204 individuals with excess sun exposure (predominantly older adults [median age: 67 years], 52.3% female, 30% with history of cancer). Overall IR for sun exposure peaked in March 2021 (664.31 [644.84-684.21]) and lacked a consistent seasonal pattern. Sun exposure exhibited weaker correlations with regional temperatures, even in high-temperature regions like the West (cor = 0.305). These data indicate regional variations in HRI. With distinct at-risk groups for HRI and sun exposure, targeted regional interventions may be beneficial, such as heat safety protocols to reduce HRI risk and sun protection campaigns for older adults to mitigate sun exposure risk.
Development of the ECHOES national dataset: a resource for monitoring post-acute and long-term COVID-19 health outcomes in England.
INTRODUCTION: Electronic health records can be used to understand the diverse presentation of post-acute and long-term health outcomes following COVID-19 infection. In England, the UK Health Security Agency, in collaboration with the University of Oxford, has created the Evaluation of post-acute COVID-19 Health Outcomes (ECHOES) dataset to monitor how an initial SARS-CoV-2 infection episode is associated with changes in the risk of health outcomes that are recorded in routinely collected health data. METHODS: The ECHOES dataset is a national-level dataset combining national-level surveillance, administrative, and healthcare data. Entity resolution and data linkage methods are used to create a cohort of individuals who have tested positive and negative for SARS-CoV-2 in England throughout the COVID-19 pandemic, alongside information on a range of health outcomes, including diagnosed clinical conditions, mortality, and risk factor information. RESULTS: The dataset contains comprehensive COVID-19 testing data and demographic, socio-economic, and health-related information for 44 million individuals who tested for SARS-CoV-2 between March 2020 and April 2022, representing 15,720,286 individuals who tested positive and 42,351,016 individuals who tested negative. DISCUSSION: With the application of epidemiological and statistical methods, this dataset allows a range of clinical outcomes to be investigated, including pre-specified health conditions and mortality. Furthermore, understanding potential determinants of health outcomes can be gained, including pre-existing health conditions, acute disease characteristics, SARS-CoV-2 vaccination status, and genomic variants.