Economic Analysis Of Evicel® Compared With Standard Of Care For Dural Closure In Elective Cranial Surgery: A United Kingdom Hospital Perspective

ObjectiveThe dural sealant patch (DSP) is designed for watertight dural closure after cranial surgery. The goal of this study is to assess, for the first time, safety and performance of the DSP as a means of reducing cerebrospinal fluid (CSF) leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.DesignFirst in human, open-label, single-arm, multicentre study with 360-day (12 months) follow-up.SettingThree large tertiary reference neurosurgical centres, two in the Netherlands and one in Switzerland.ParticipantsForty patients undergoing elective cranial neurosurgical procedures, stratified into 34 supratentorial and six infratentorial trepanations.InterventionEach patient received one DSP after cranial surgery and closure of the dura mater with sutures.Outcome measuresPrimary composite endpoint was occurrence of one of the following events: postoperative percutaneous CSF leakage, intraoperative leakage at 20 cm H2O positive end-expiratory pressure or postoperative wound infection. Overall success was defined as achieving the primary endpoint in no more than two patients. Secondary endpoints were device-related serious adverse events or adverse events (AEs), pseudomeningocele and thickness of dura+DSP. Additional endpoints were reoperation in 30 days and user satisfaction.ResultsNo patients met the primary endpoint. No device-related (serious) AEs were observed. There were two incidences of self-limiting pseudomeningocele as confirmed on MRI. Thickness of dura and DSP were (mean±SD) 3.5 mm±2.0 at day 7 and 2.1 mm±1.2 at day 90. No patients were reoperated within 30 days. Users reported a satisfactory design and intuitive application.ConclusionsDSP, later officially named Liqoseal, is a safe and potentially efficacious device for reducing CSF leakage after intracranial surgery, with favourable clinical handling characteristics. A randomised controlled trial is needed to assess Liqoseal efficacy against the best current practice for reducing postoperative CSF leakage.Trial registration numberNCT03566602.

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Economic Analysis of Accident Law: A New Liability Rule that Induces Socially Optimal Behaviour in Case of Limited Information

Review of Law & Economics ◽

10.1515/rle-2019-0049 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Astha Srivastava ◽

Ankur Srivastava

Keyword(s):

Nash Equilibrium ◽

Economic Analysis ◽

Standard Of Care ◽

Limited Information ◽

Liability Rule ◽

Rule Based ◽

Liability Rules ◽

Levels Of Care ◽

Unique Nash Equilibrium ◽

Optimal Behaviour

AbstractIn accident law, we seek a liability rule that will induce both the parties to adopt socially optimal levels of precaution. Economic analysis, however, shows that none of the commonly used liability rules induce both parties to adopt optimal levels, if courts have access only to ‘Limited Information’ on. In such a case, it has also been established (K. (2006). Efficiency of liability rules: a reconsideration. J. Int. Trade Econ. Dev. 15: 359–373) that no liability rule based on cost justified untaken precaution as a standard of care can be efficient. In this paper, we describe a two-step liability rule: the rule of negligence with the defence of relative negligence. We prove that this rule has a unique Nash equilibrium at socially optimal levels of care for the non-cooperative game, and therefore induces both parties to adopt socially optimal behaviour even in case of limited information.

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Neonatologie – Ausschließliche Ernährung mit humaner Milch: Rechnet sich das?

Gesundheitsökonomie & Qualitätsmanagement ◽

10.1055/a-1337-8561 ◽

2021 ◽

Vol 26 (01) ◽

pp. 15-15

Keyword(s):

High Risk ◽

Economic Analysis ◽

Human Milk ◽

Canadian Hospital ◽

Hospital Perspective

van Katwyk S et al. Economic Analysis of Exclusive Human Milk Diets for High-Risk Neonates, a Canadian Hospital Perspective. Breastfeed Med 2020; 15 (6): 377–386. DOI: 10.1089/bfm.2019.0273 Frühgeborene profitieren hinsichtlich einer Vielzahl potenzieller Komplikationen, beispielsweise der nekrotisierenden Enterokolitis, der Retinopathie, der Sepsis sowie der bronchopulmonalen Dysplasie, von einer ausschließlichen Ernährung mit humaner Milch, bei welcher die Milch der eigenen Mutter bzw. Donormilch mit aus pasteurisierter Spendermilch gewonnenem Fortifier angereichert wird. Ist dieses Vorgehen auch unter Kostenaspekten vertretbar?

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[177Lu]Lu-DOTA-TATE Versus Standard of Care in Adult Patients With Gastro-Enteropancreatic Neuroendocrine Tumours (GEP-NETS): A Cost-Consequence Analysis From an Italian Hospital Perspective

10.21203/rs.3.rs-455958/v1 ◽

2021 ◽

Author(s):

Francesca Spada ◽

Davide Campana ◽

Giuseppe Lamberti ◽

Riccardo Laudicella ◽

Renato Dellamano ◽

...

Keyword(s):

Clinical Outcomes ◽

Neuroendocrine Tumours ◽

Treatment Options ◽

Treatment Decision ◽

Progression Free Survival ◽

Standard Of Care ◽

Somatostatin Analogues ◽

Adult Patients ◽

Hospital Perspective ◽

Cost Consequence

Abstract Purpose To assess and compare clinical outcomes and costs, to the Italian healthcare system, of three therapeutic options approved in the management of adult patients with gastro-enteropancreatic neuroendocrine tumours (GEP-NETs). Methods We compared the efficacy, safety and costs of [177Lu]Lu-DOTA-TATE, everolimus (both originator and generic products) and sunitinib in patients with advanced GEP-NETs (NET G1 and G2) that had progressed following treatment with somatostatin analogues (SSAs). A cost-consequence model was developed and validated by a panel of clinical experts from three NET reference centres in Italy. The clinical outcomes included in the model were median progression-free survival and the incidence of grade 3 or 4 adverse events (AEs), as reported in pivotal clinical trials. The costs for acquisition and administration of each treatment, and of managing AEs, were calculated from the perspective of the Italian national health service. Treatment costs per progression-free month were calculated separately for patients with NETs of pancreatic (PanNETs; all three treatments) and gastrointestinal (GI-NETs; [177Lu]Lu-DOTA-TATE and everolimus only) origin. Results In patients with PanNETs, total costs per progression-free month were €2989 for [177Lu]Lu-DOTA-TATE, €4975 for originator everolimus, €3472 for generic everolimus, and €5337 for sunitinib. In patients with GI-NETs, total costs per progression-free month were €3189 for [177Lu]Lu-DOTA-TATE, €4990 for originator everolimus, and €3483 for generic everolimus. Conclusions [177Lu]Lu-DOTA-TATE was associated with lower costs per progression-free month versus relevant treatment options in patients with GI-NETs or PanNETs (NET G1–G2; progressed following SSA treatment), although acquisition and administration costs are higher. These findings provide further economic arguments in the overall context of treatment decision making.

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Study protocol: optimising newborn nutrition during and after neonatal therapeutic hypothermia in the United Kingdom: observational study of routinely collected data using propensity matching

BMJ Open ◽

10.1136/bmjopen-2018-026739 ◽

2018 ◽

Vol 8 (10) ◽

pp. e026739 ◽

Cited By ~ 2

Author(s):

Cheryl Battersby ◽

Nick Longford ◽

Mehali Patel ◽

Ella Selby ◽

Shalini Ojha ◽

...

Keyword(s):

United Kingdom ◽

Therapeutic Hypothermia ◽

Late Onset ◽

Standard Of Care ◽

Blood Stream ◽

Research Database ◽

Population Database ◽

Scientific Publications ◽

Link Type ◽

The United Kingdom

IntroductionTherapeutic hypothermia is standard of care for infants born ≥36 weeks gestation with hypoxic ischaemic encephalopathy (HIE); consensus on optimum nutrition during therapeutic hypothermia is lacking. This results in variation in enteral feeding and parenteral nutrition (PN) for these infants. In this study, we aim to determine the optimum enteral nutrition and PN strategy for newborns with HIE during therapeutic hypothermia.Methods and analysisWe will undertake a retrospective cohort study using routinely recorded electronic patient data held on the United Kingdom (UK) National Neonatal Research Database (NNRD). We will extract data from infants born ≥36 weeks gestational age between 1 January 2008 and 31 December 2016, who received therapeutic hypothermia for at least 72 hours or died during therapeutic hypothermia, in neonatal units in England, Wales and Scotland. We will form matched groups in order to perform two comparisons examining: (1) the risk of NEC between infants enterally fed and infants not enterally fed, during therapeutic hypothermia; (2) the risk of late-onset blood stream infections between infants who received intravenous dextrose without any PN and infants who received PN, during therapeutic hypothermia. The following secondary outcomes will also be examined: survival, length of stay, breast feeding at discharge, hypoglycaemia, time to full enteral feeds and growth. Comparison groups will be matched on demographic, maternal, infant and organisational factors using propensity score matching.Ethics and disseminationIn this study, we will use deidentifed data held in the NNRD, an established national population database; parents can opt out of their baby’s data being held in the NNRD. This study holds study-specific Research Ethics Committee approval (East Midlands Leicester Central, 17/EM/0307). These results will help inform optimum nutritional management in infants with HIE receiving therapeutic hypothermia; results will be disseminated through conferences, scientific publications and parent-centred information produced in partnership with parents.Trial registration numberNCT03278847; pre-results,ISRCTN47404296; pre-results.

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