Elena Pizzo

Cost-Utility Analysis of Mechanical Thrombectomy Using Stent Retrievers in Acute Ischemic Stroke

Background and Purpose— Recently, 5 randomized controlled trials demonstrated the benefit of endovascular therapy compared with intravenous tissue-type plasminogen activator in acute stroke. Economic evidence evaluating stent retrievers is limited. We compared the cost-effectiveness of intravenous tissue-type plasminogen activator alone versus mechanical thrombectomy and intravenous tissue-type plasminogen activator as a bridging therapy in eligible patients in the UK National Health Service. Methods— A model-based cost-utility analysis was performed using a lifetime horizon. A Markov model was constructed and populated with probabilities, outcomes, and cost data from published sources, including 1-way and probabilistic sensitivity analysis. Results— Mechanical thrombectomy was more expensive than intravenous tissue-type plasminogen activator, but it improved quality-adjusted life expectancy. The incremental cost per (quality-adjusted life year) gained of mechanical thrombectomy over a 20 year period was

Gallstone ileus treated with non-surgical conservative methods: a case report

11 651 (£7061). The probabilistic sensitivity analysis demonstrated that thrombectomy had a 100% probability of being cost-effective at the minimum willingness to pay for a quality-adjusted life year commonly used in United Kingdom. Conclusions— Although the upfront costs of thrombectomy are high, the potential quality-adjusted life year gains mean this intervention is cost-effective. This is an important factor for consideration in deciding whether to commission this intervention.

The cost of local, multi-professional obstetric emergencies training.

IntroductionThe preoperative diagnosis of gallstone ileus is challenging due to the variability of its presentation, often resulting in late diagnosis. Controversy remains regarding the management of gallstone ileus; surgery is the standard treatment, but also less invasive approaches have proven to be successful. We present an unusual case of gallstone ileus and its conservative treatment.Case presentationWe describe the case of a 49-year-old Caucasian woman with a bowel sub-occlusion, treated conservatively. The imaging technique (plain abdominal X-ray and computed tomography scan) led to a diagnosis of gallstones ileus. A surgical intervention was not performed. Instead, she underwent extracorporeal shock-wave lithotripsy to fragment the stones, mechanical intestinal dilatation for ileocolic stenosis and endoscopic removal of the gallstone. The presence of an apricot shell contributed to the bowel occlusion and was removed. The intervention was successful and without complications.ConclusionsGiven the variability of the gallstone ileus presentation, surgery could not be the only treatment for our patient. In our case report, we show that colonoscopy could be a non-invasive approach that allows for diagnosis and treatment at the same time. The available data do not show a higher rate of recurrent biliary disease in cases where this method has been used, therefore in select patients, a conservative treatment could be an effective solution.

Mixed methods evaluation of the Getting it Right First Time programme - improvements to NHS orthopaedic care in England: study protocol

We aim to outline the annual cost of setting up and running a standard, local, multi‐professional obstetric emergencies training course, PROMPT (PRactical Obstetric Multi‐Professional Training), at Southmead Hospital, Bristol, UK – a unit caring for approximately 6500 births per year.

The Age of BLood Evaluation (ABLE) randomised controlled trial: description of the UK-funded arm of the international trial, the UK cost-utility analysis and secondary analyses exploring factors associated with health-related quality of life and health-care costs during the 12-month follow-up.

BackgroundOrthopaedic procedures, such as total hip replacement and total knee replacement, are among the commonest surgical procedures in England. The Getting it Right First Time project (GIRFT) aims to deliver improvements in quality and reductions in the cost of NHS orthopaedic care across the country. We will examine whether the planned changes have delivered improvements in the quality of care and patient outcomes. We will also study the processes involved in developing and implementing changes to care, and professional and organisational factors influencing these processes. In doing so, we will identify lessons to guide future improvement work in other services.Methods/designWe will evaluate the implementation of the GIRFT programme, and its impact on outcomes and cost, using a mixed methods design. Qualitative methods will be used to understand the programme theory underlying the approach and study the effect of the intervention on practice, using a case study approach. This will include an analysis of the central GIRFT programme and local provider responses. Data will be collected via semi-structured interviews, non-participant observation, and documentary analysis. Quantitative methods will be used to examine ‘what works and at what cost?’ We will also conduct focus groups with patients and members of the public to explore their perceptions of the GIRFT programme. The research will draw on theories of adoption, diffusion, and sustainability of innovation; its characteristics; and contextual factors at provider-level that influence implementation.DiscussionWe will identify generalisable lessons to inform the organisation and delivery of future improvement programmes, to optimise their implementation and impact, both within the UK and internationally. Potential challenges involved in conducting the evaluation include the phased implementation of the intervention in different provider organisations; the inclusion of both retrospective and prospective components; and the effects of ongoing organisational turbulence in the English NHS. However, these issues reflect the realities of service change and its evaluation.

Impact and experiences of delayed discharge: A mixed-studies systematic review

BACKGROUNDnAt present, red blood cells (RBCs) are stored for up to 42 days prior to transfusion. The relative effectiveness and safety of different RBC storage times prior to transfusion is uncertain.nnnOBJECTIVEnTo assess the clinical effectiveness and cost-effectiveness of transfusing fresher RBCs (stored for ≤u20097 days) compared with current standard-aged RBCs in critically ill patients requiring blood transfusions.nnnDESIGNnThe international Age of BLood Evaluation (ABLE) trial was a multicentre, randomised, blinded trial undertaken in Canada, the UK, the Netherlands and France. The UK trial was funded to contribute patients to the international trial and undertake a UK-specific health economic evaluation.nnnSETTINGnTwenty intensive care units (ICUs) in the UK, as part of 64 international centres.nnnPARTICIPANTSnCritically ill patients aged ≥u200918 years (≥u200916 years in Scotland) expected to require mechanical ventilation for ≥u200948 hours and requiring a first RBC transfusion during the first 7 days in the ICU.nnnINTERVENTIONSnAll decisions to transfuse RBCs were made by clinicians. One patient group received exclusively fresh RBCs stored for ≤u20097 days whenever transfusion was required from randomisation until hospital discharge. The other group received standard-issue RBCs throughout their hospital stay.nnnMAIN OUTCOME MEASURESnThe primary outcome was 90-day mortality. Secondary outcomes included development of organ dysfunction, new thrombosis, infections and transfusion reactions. The primary economic evaluation was a cost-utility analysis.nnnRESULTSnThe international trial took place between March 2009 and October 2014 (UK recruitment took place between January 2012 and October 2014). In total, 1211 patients were assigned to receive fresh blood and 1219 patients to receive standard-aged blood. RBCs were stored for a mean of 6.1 days [standard deviation (SD) ±u20094.9 days] in the group allocated to receive fresh blood and 22.0 days (SDu2009±u20098.4 days) in the group allocated to receive standard-aged blood. Patients received a mean of 4.3u2009RBC units (SDu2009±u20095.2u2009RBC units) and 4.3u2009RBC units (SDu2009±u20095.5u2009RBC units) in the groups receiving fresh blood and standard-aged blood, respectively. At 90 days, 37.0% of patients in the group allocated to receive fresh blood and 35.3% of patients in the group allocated to receive standard-aged blood had died {absolute risk difference 1.7% [95% confidence interval (CI) -2.1% to 5.5%]}. There were no between-group differences in any secondary outcomes. The UK cohort comprised 359 patients randomised and followed up for 12 months for the cost-utility analysis. UK patients had similar characteristics and outcomes to the international cohort. Mean total costs per patient were £32,346 (95% CI £29,306 to £35,385) in the group allocated to receive fresh blood and £33,353 (95% CI £29,729 to £36,978) in the group allocated to receive standard-aged blood. Approximately 85% of the total costs were incurred during the index hospital admission. There were no significant cost differences between the two groups [mean incremental costs for those receiving fresh vs. standard-aged blood: -£231 (95% CI -£4876 to £4415)], nor were there significant differences in outcomes (mean difference in quality-adjusted life-years -0.010, 95% CI -0.078 to 0.057).nnnLIMITATIONSnAdverse effects from the exclusive use of older RBCs compared with standard or fresh RBCs cannot be excluded.nnnCONCLUSIONSnThe use of RBCs aged ≤u20097 days confers no clinical or economic benefit in critically ill patients compared with standard-aged RBCs.nnnFUTURE WORKnFuture studies should address the safety of RBCs near the end of the current permitted storage age.nnnTRIAL REGISTRATIONnCurrent Controlled Trials ISRCTN44878718.nnnFUNDINGnThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 62. See the NIHR Journals Library website for further project information. The international ABLE trial was also supported by peer-reviewed grants from the Canadian Institutes of Health Research (177453), Fonds de Recherche du Québec - Santé (24460), the French Ministry of Health Programme Hospitalier de Recherche Clinique (12.07, 2011) and by funding from Établissement Français du Sang and Sanquin Blood Supply.

Does use of point-of-care testing improve cost-effectiveness of the NHS Health Check programme in the primary care setting? A cost-minimisation analysis

The impact of delayed discharge on patients, health‐care staff and hospital costs has been incompletely characterized.

Effectiveness and acceptability of myo-inositol nutritional supplement in the prevention of gestational diabetes (EMmY): a protocol for a randomised, placebo-controlled, double-blind pilot trial

Objective To determine if use of point of care testing (POCT) is less costly than laboratory testing to the National Health Service (NHS) in delivering the NHS Health Check (NHSHC) programme in the primary care setting. Design Observational study and theoretical mathematical model with microcosting approach. Setting We collected data on NHSHC delivered at nine general practices (seven using POCT; two not using POCT). Participants We recruited nine general practices offering NHSHC and a pathology services laboratory in the same area. Methods We conducted mathematical modelling with permutations in the following fields: provider type (healthcare assistant or nurse), type of test performed (total cholesterol with either lab fasting glucose or HbA1c), cost of consumables and variable uptake rates, including rate of non-response to invite letter and rate of missed [did not attend (DNA)] appointments. We calculated total expected cost (TEC) per 100 invites, number of NHSHC conducted per 100 invites and costs for completed NHSHC for laboratory and POCT-based pathways. A univariate and probabilistic sensitivity analysis was conducted to account for uncertainty in the input parameters. Main outcome measures We collected data on cost, volume and type of pathology services performed at seven general practices using POCT and a pathology services laboratory. We collected data on response to the NHSHC invitation letter and DNA rates from two general practices. Results TEC of using POCT to deliver a routine NHSHC is lower than the laboratory-led pathway with savings of £29 per 100 invited patients up the point of cardiovascular disease risk score presentation. Use of POCT can deliver NHSHC in one sitting, whereas the laboratory pathway offers patients several opportunities to DNA appointment. Conclusions TEC of using POCT to deliver an NHSHC in the primary care setting is lower than the laboratory-led pathway. Using POCT minimises DNA rates associated with laboratory testing and enables completion of NHSHC in one sitting.

Impact of interventions to prevent diabetes in England: a simulation model

Introduction Gestational diabetes increases maternal and offspring complications in pregnancy and cardiovascular complications in the long term. The nutritional supplement myo-inositol may prevent gestational diabetes; however, further evaluation is required, especially in multiethnic high-risk mothers. Our pilot trial on myo-inositol to prevent gestational diabetes will evaluate trial processes, assess acceptability to mothers and obtain preliminary estimates of effect and cost data prior to a large full-scale trial. Methods and analysis EMmY is a multicentre, placebo-controlled, double-blind, pilot, randomised trial, with qualitative evaluation. We will recruit pregnant women at 12–15+6 weeks’ gestation, with gestational diabetes risk factors, from five maternity units in England between 2018 and 2019. We will randomise 200 women to take either 2u2009g of myo-inositol powder (intervention) or placebo, twice daily until delivery. We will assess rates of recruitment, randomisation, adherence to intervention and follow-up. Gestational diabetes will be diagnosed at 24–28 weeks as per the National Institute for Health and Care Excellence (NICE) criteria (fasting plasma glucose: ≥5.6u2009mmol/L and 2-hour plasma glucose: ≥7.8u2009mmol/L). We will assess the effects of myo-inositol on glycaemic indices at 28 weeks and on other maternal, fetal and neonatal outcomes at postnatal discharge. Qualitative evaluation will explore the acceptability of the trial and the intervention among women and healthcare professionals. Cost data and health-related quality of life measures will be captured. We will summarise feasibility outcomes using standard methods for proportions and other descriptive statistics, and where appropriate, report point estimates of effect sizes (eg, mean differences and relative risks) and associated 95% CIs. Ethics and dissemination Ethical approval was obtained through the London Queen Square Research Ethics Committee (17/LO/1741). Study findings will be submitted for publication in peer-reviewed journals. Newsletters will be made available to participants, healthcare professionals and members of Katie’s Team (a patient and public advisory group) to disseminate. Trial registration number ISRCTN48872100. Protocol version and date Version 4.0, 15 January 2018.

Response to "Telling the whole story about simulation-based education"

Abstract Background Prevention of type 2 diabetes is a priority for England driven by the diabetes epidemic. Cost-effective, lifestyle interventions aimed at delaying or preventing the onset of diabetes in individuals at high risk represent the cornerstone of the National Diabetes Prevention Programme (NDPP). Pharmacological interventions (eg, metformin) are also recommended in national clinical guidelines. The UK Government proposes to introduce a sugar tax, a population-wide intervention that can contribute to lowering the prevalence of diabetes. We aimed to model the effect of these three interventions on prevention of diabetes. Methods We developed Markov models estimating the number of diabetic cases prevented in 20 years time by three interventions (NDPP, metformin, and a sugar tax) that represent current practice or proposed policy in England. The models assumptions and inputs were retrieved from the grey and published literature (searched on EMBASE, Medline, and National Health Service Economic Evaluation Database, published in English at any time) and were validated in two expert workshops. For each intervention, we developed different scenarios to reflect uncertainty in the inputs and ran sensitivity analyses. Findings For an average English local health economy with a population of 300u2008000, in 20 years time the number of cases of diabetes is projected to increase from 22u2008000 to 30u2008000. The NDPP is estimated to prevent about 30 cases of diabetes; metformin, if prescribed to half of those at high risk, about 200 cases; and a sugar tax about 600 cases. Interpretation Lifestyle interventions, such as the NDPP, though cost-effective, have negligible impact on the diabetes epidemic because of their limited scale, poor uptake, and declining adherence by participants over time. Metformin and a sugar tax could have a greater impact but together would only prevent about 10% of new cases. We argue for a diabetes prevention strategy based on three components: first, and most effective, national population-based interventions irrespective of individual risk of diabetes (eg, a sugar tax); second, pharmacological treatments for those at high risk who accept, tolerate, and are willing to comply with the medication; and third, locally implemented lifestyle interventions designed to achieve higher rates of uptake and adherence. Funding National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care North Thames at Barts Health NHS Trust (CDP, EP), London School of Economics and Political Science (GB, MJK).