16 research outputs found

    Healthcare costs for metastatic castrationā€‘resistant prostate cancer patients treated with abiraterone or enzalutamide

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    Objective: The aim was to assess the real-world healthcare resource use and direct medical costs for metastatic castration-resistant prostate cancer (mCRPC) patients treated with abiraterone or enzalutamide, in whom chemotherapy is not yet indicated (pre-chemotherapy) or who had previously received docetaxel-based chemotherapy (post-chemotherapy), before commencing these medicines. Methods: A retrospective cost analysis of mCRPC patients who commenced abiraterone or enzalutamide between 2012 and 2015 was conducted. Routinely collected datasets from the largest health board in Scotland and the UK, Greater Glasgow and Clyde, were linked. They contained information on patient demographics, diagnosis, outpatient consultations, hospital admissions, treatments (abiraterone and enzalutamide), and supportive medicines. Unit costs were obtained from the Scottish Health Service Costs, Personal Social Services Research Unit, and British National Formulary. Generalised linear model-based regression was used to estimate total mean direct costs, and two-part models were used to estimate separate cost components. All models were adjusted for propensity score and key variables. Sensitivity analysis was conducted to explore the impact of hypothetical patient access scheme discounts. Results: Estimated total mean direct medical costs of treating mCRPC patients were similar, albeit with wide and overlapping confidence intervals. Across both treatments, patients who received abiraterone or enzalutamide in a pre-chemotherapy setting incurred the highest total mean direct medical costs. However, post-chemotherapy patients were associated with higher outpatient clinic visits, inpatient hospital admissions, and supportive medicines. Regarding relative contribution to the total mean direct medical cost, the treatment costs were the main contributor, followed by inpatient admissions, outpatient clinic visits, and supportive medicines. Conclusion: The total mean direct medical costs were similar for abiraterone and enzalutamide patients. The costs were not driven by the choice of treatment regimen, but treatment setting (pre-chemotherapy or post-chemotherapy indications) and related healthcare resource utilisation. Future studies should focus on economic evaluations, such as cost-effectiveness analyses, using real-world data

    Economic evaluation of culprit lesion only PCI vs. immediate multivessel PCI in acute myocardial infarction complicated by cardiogenic shock: the CULPRIT-SHOCK trial.

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    BACKGROUND: The CULPRIT-SHOCK trial compared two treatment strategies for patients with acute myocardial infarction and multivessel coronary artery disease complicated by cardiogenic shock: (a) culprit vessel only percutaneous coronary intervention (CO-PCI), with additional staged revascularisation if indicated, and (b) immediate multivessel PCI (MV-PCI). METHODS: A German societal and national health service perspective was considered for three different analyses. The cost utility analysis (CUA) estimated costs and quality adjusted life years (QALYs) based on a pre-trial decision analytic model taking a lifelong time horizon. In addition, a within trial CUA estimated QALYs and costs for 1 year. Finally, the cost effectiveness analysis (CEA) used the composite primary outcome, mortality and renal failure at 30-day follow-up, and the within trial costs. Econometric and survival analysis on the trial data was used for the estimation of the model parameters. Subgroup analysis was performed following an economic protocol. RESULTS: The lifelong CUA showed an incremental cost effectiveness ratio (ICER), CO-PCI vs. MV-PCI, of ā‚¬7010 per QALY and a probability of CO-PCI being the most cost-effective strategyā€‰>ā€‰64% at a ā‚¬30,000 threshold. The ICER for the within trial CUA was ā‚¬14,600 and the incremental cost per case of death/renal failure avoided at 30-day follow-up was ā‚¬9010. Cost-effectiveness improved with patient age and for those without diabetes. CONCLUSIONS: The estimates of cost-effectiveness for CO-PCI vs. MV-PCI have been shown to change depending on the time horizon and type of economic evaluation performed. The results favoured a long-term horizon analysis for avoiding underestimation of QALY gains from the CO-PCI arm

    Cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study: a protocol.

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    IntroductionThe aim of the cervical ripening at home or in-hospital-prospective cohort study and process evaluation (CHOICE) study is to compare home versus in-hospital cervical ripening to determine whether home cervical ripening is safe (for the primary outcome of neonatal unit (NNU) admission), acceptable to women and cost-effective from the perspective of both women and the National Health Service (NHS).Methods and analysisWe will perform a prospective multicentre observational cohort study with an internal pilot phase. We will obtain data from electronic health records from at least 14 maternity units offering only in-hospital cervical ripening and 12 offering dinoprostone home cervical ripening. We will also conduct a cost-effectiveness analysis and a mixed methods study to evaluate processes and women/partner experiences. Our primary sample size is 8533 women with singleton pregnancies undergoing induction of labour (IOL) at 39+0 weeks' gestation or more. To achieve this and contextualise our findings, we will collect data relating to a cohort of approximately 41ā€‰000 women undergoing IOL after 37 weeks. We will use mixed effects logistic regression for the non-inferiority comparison of NNU admission and propensity score matched adjustment to control for treatment indication bias. The economic analysis will be undertaken from the perspective of the NHS and Personal Social Services (PSS) and the pregnant woman. It will include a within-study cost-effectiveness analysis and a lifetime cost-utility analysis to account for any long-term impacts of the cervical ripening strategies. Outcomes will be reported as incremental cost per NNU admission avoided and incremental cost per quality adjusted life year gained.Research ethics approval and disseminationCHOICE has been funded and approved by the National Institute of Healthcare Research Health Technology and Assessment, and the results will be disseminated via publication in peer-reviewed journals.Trial registration numberISRCTN32652461

    Following the Science? Comparison of methodological and reporting quality of covid-19 and other research from the first wave of the pandemic

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    Background: Following the initial identification of the 2019 coronavirus disease (covid-19), the subsequent months saw substantial increases in published biomedical research. Concerns have been raised in both scientific and lay press around the quality of some of this research. We assessed clinical research from major clinical journals, comparing methodological and reporting quality of covid-19 papers published in the first wave (here defined as December 2019 to May 2020 inclusive) of the viral pandemic with non-covid papers published at the same time. Methods: We reviewed research publications (print and online) from The BMJ, Journal of the American Medical Association (JAMA), The Lancet, and New England Journal of Medicine, from first publication of a covid-19 research paper (February 2020) to May 2020 inclusive. Paired reviewers were randomly allocated to extract data on methodological quality (risk of bias) and reporting quality (adherence to reporting guidance) from each paper using validated assessment tools. A random 10% of papers were assessed by a third, independent rater. Overall methodological quality for each paper was rated high, low or unclear. Reporting quality was described as percentage of total items reported. Results: From 168 research papers, 165 were eligible, including 54 (33%) papers with a covid-19 focus. For methodological quality, 18 (33%) covid-19 papers and 83 (73%) non-covid papers were rated as low risk of bias, OR 6.32 (95%CI 2.85 to 14.00). The difference in quality was maintained after adjusting for publication date, results, funding, study design, journal and raters (OR 6.09 (95%CI 2.09 to 17.72)). For reporting quality, adherence to reporting guidelines was poorer for covid-19 papers, mean percentage of total items reported 72% (95%CI:66 to 77) for covid-19 papers and 84% (95%CI:81 to 87) for non-covid. Conclusions: Across various measures, we have demonstrated that covid-19 research from the first wave of the pandemic was potentially of lower quality than contemporaneous non-covid research. While some differences may be an inevitable consequence of conducting research during a viral pandemic, poor reporting should not be accepted

    Cost utility analysis of the FEMME trial reports uterine artery embolization as not cost-effective over myomectomy

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    Understanding the effectiveness and underlying mechanisms of lifestyle modification interventions in adults with learning disabilities: Protocol for a mixed-methods systematic review

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    Background: Adults with learning disabilities have an increased disposition to unhealthy lifestyle behaviours which often occur simultaneously. Existing studies focus on complex interventions targeting unhealthy diet, physical inactivity, sedentary behaviour, smoking, and alcohol use to reduce health risks experienced. It is essential to understand how well these interventions work, what works, for whom, in what context and why. This study aims to investigate the effectiveness and underlying mechanisms of lifestyle modification interventions for adults with learning disabilities. Methods: This is a mixed-methods systematic review consisting of a network meta-analysis (NMA) and realist synthesis. Electronic databases (ASSIA, CINAHL, EMBASE, MEDLINE, and PsycINFO) will be searched from inception to 14 January 2021 with no language restriction. Additionally, trial registries, grey literature databases and references lists will be searched. Studies related to lifestyle modification interventions on the adult population (>18 years) with learning disabilities will be eligible for inclusion. Two independent researchers will screen studies, extract data and assess its quality and risk of bias using the Cochrane Collaborationā€™s Risk of Bias Assessment Tool (RoB Version 2) and ROBINS-I. The strength of the body of evidence will be assessed based on the GRADE approach. The NMA will incorporate results from RCTs and quasi-experimental studies to estimate the effectiveness of various lifestyle interventions. Where appropriate, a component NMA (CNMA) will be used to estimate effectiveness. The realist synthesis will complement and explain the findings of NMA and CNMA by including additional qualitative and mixed-methods studies. Studies will be included based on their relevance to the programme theory and the rigour of their methods, as determined by quality appraisal tools appropriate to the study design. Results from both syntheses will be incorporated into a logic model
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