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Cost-effectiveness of selective digestive decontamination (SDD) versus selective oropharyngeal decontamination (SOD) in intensive care units with low levels of antimicrobial resistance: an individual patient data meta-analysis

Objective

To determine the cost-effectiveness of selective digestive decontamination (SDD) as compared to selective oropharyngeal decontamination (SOD) in intensive care units (ICUs) with low levels of antimicrobial resistance.

Design

Post-hoc analysis of a previously performed individual patient data meta-analysis of two cluster-randomised cross-over trials.

Setting

24 ICUs in the Netherlands.

Participants

12 952 ICU patients who were treated with ≥1 dose of SDD (n=6720) or SOD (n=6232).

Interventions

SDD versus SOD.

Primary and secondary outcome measures

The incremental cost-effectiveness ratio (ICER; ie, costs to prevent one in-hospital death) was calculated by comparing differences in direct healthcare costs and in-hospital mortality of patients treated with SDD versus SOD. A willingness-to-pay curve was plotted to reflect the probability of cost-effectiveness of SDD for a range of different values of maximum costs per prevented in-hospital death.

Results

The ICER resulting from the fixed-effect meta-analysis, adjusted for clustering and differences in baseline characteristics, showed that SDD significantly reduced in-hospital mortality (adjusted absolute risk reduction 0.0195, 95% CI 0.0050 to 0.0338) with no difference in costs (adjusted cost difference 62 in favour of SDD, 95% CI –1079 to 935). Thus, SDD yielded significantly lower in-hospital mortality and comparable costs as compared with SOD. At a willingness-to-pay value of 33 633 per one prevented in-hospital death, SDD had a probability of 90.0% to be cost-effective as compared with SOD.

Conclusion

In Dutch ICUs, SDD has a very high probability of cost-effectiveness as compared to SOD. These data support the implementation of SDD in settings with low levels of antimicrobial resistance.

SUGAR-DIP trial: oral medication strategy versus insulin for diabetes in pregnancy, study protocol for a multicentre, open-label, non-inferiority, randomised controlled trial

Por: de Wit · L. · Rademaker · D. · Voormolen · D. N. · Akerboom · B. M. C. · Kiewiet-Kemper · R. M. · Soeters · M. R. · Verwij-Didden · M. A. L. · Assouiki · F. · Schippers · D. H. · Vermeulen · M. A. R. · Kuppens · S. M. I. · Oosterwerff · M. M. · Zwart · J. J. · Diekman · M. J. M.
Introduction

In women with gestational diabetes mellitus (GDM) requiring pharmacotherapy, insulin was the established first-line treatment. More recently, oral glucose lowering drugs (OGLDs) have gained popularity as a patient-friendly, less expensive and safe alternative. Monotherapy with metformin or glibenclamide (glyburide) is incorporated in several international guidelines. In women who do not reach sufficient glucose control with OGLD monotherapy, usually insulin is added, either with or without continuation of OGLDs. No reliable data from clinical trials, however, are available on the effectiveness of a treatment strategy using all three agents, metformin, glibenclamide and insulin, in a stepwise approach, compared with insulin-only therapy for improving pregnancy outcomes. In this trial, we aim to assess the clinical effectiveness, cost-effectiveness and patient experience of a stepwise combined OGLD treatment protocol, compared with conventional insulin-based therapy for GDM.

Methods

The SUGAR-DIP trial is an open-label, multicentre randomised controlled non-inferiority trial. Participants are women with GDM who do not reach target glycaemic control with modification of diet, between 16 and 34 weeks of gestation. Participants will be randomised to either treatment with OGLDs, starting with metformin and supplemented as needed with glibenclamide, or randomised to treatment with insulin. In women who do not reach target glycaemic control with combined metformin and glibenclamide, glibenclamide will be substituted with insulin, while continuing metformin. The primary outcome will be the incidence of large-for-gestational-age infants (birth weight >90th percentile). Secondary outcome measures are maternal diabetes-related endpoints, obstetric complications, neonatal complications and cost-effectiveness analysis. Outcomes will be analysed according to the intention-to-treat principle.

Ethics and dissemination

The study protocol was approved by the Ethics Committee of the Utrecht University Medical Centre. Approval by the boards of management for all participating hospitals will be obtained. Trial results will be submitted for publication in peer-reviewed journals.

Trial registration number

NTR6134; Pre-results.

Transplantation of high-risk donor livers after resuscitation and viability assessment using a combined protocol of oxygenated hypothermic, rewarming and normothermic machine perfusion: study protocol for a prospective, single-arm study (DHOPE-COR-NMP tri

Por: de Vries · Y. · Berendsen · T. A. · Fujiyoshi · M. · van den Berg · A. P. · Blokzijl · H. · de Boer · M. T. · van der Heide · F. · de Kleine · R. H. J. · van Leeuwen · O. B. · Matton · A. P. M. · Werner · M. J. M. · Lisman · T. · de Meijer · V. E. · Porte · R.
Introduction

Extended criteria donor (ECD) livers are increasingly accepted for transplantation in an attempt to reduce the gap between the number of patients on the waiting list and the available number of donor livers. ECD livers; however, carry an increased risk of developing primary non-function (PNF), early allograft dysfunction (EAD) or post-transplant cholangiopathy. Ischaemia-reperfusion injury (IRI) plays an important role in the development of these complications. Machine perfusion reduces IRI and allows for reconditioning and subsequent evaluation of liver grafts. Single or dual hypothermic oxygenated machine perfusion (DHOPE) (4°C–12°C) decreases IRI by resuscitation of mitochondria. Controlled oxygenated rewarming (COR) may further reduce IRI by preventing sudden temperature shifts. Subsequent normothermic machine perfusion (NMP) (37°C) allows for ex situ viability assessment to facilitate the selection of ECD livers with a low risk of PNF, EAD or post-transplant cholangiopathy.

Methods and analysis

This prospective, single-arm study is designed to resuscitate and evaluate initially nationwide declined ECD livers. End-ischaemic DHOPE will be performed for the initial mitochondrial and graft resuscitation, followed by COR of the donor liver to a normothermic temperature. Subsequently, NMP will be continued to assess viability of the liver. Transplantation into eligible recipients will proceed if all predetermined viability criteria are met within the first 150 min of NMP. To facilitate machine perfusion at different temperatures, a perfusion solution containing a haemoglobin-based oxygen carrier will be used. With this protocol, we aim to transplant extra livers. The primary endpoint is graft survival at 3 months after transplantation.

Ethics and dissemination

This protocol was approved by the medical ethical committee of Groningen, METc2016.281 in August 2016 and registered in the Dutch Trial registration number

Trial registration number

NTR5972, NCT02584283.

An auditory brainstem implant for treatment of unilateral tinnitus: protocol for an interventional pilot study

Por: van den Berge · M. J. C. · van Dijk · M. J. M. C. · Metzemaekers · J. D. M. · Maat · B. · Free · R. H. · van Dijk · P.
Introduction

Tinnitus may have a very severe impact on the quality of life. Unfortunately, for many patients, a satisfactory treatment modality is lacking. The auditory brainstem implant (ABI) was originally indicated for hearing restoration in patients with non-functional cochlear nerves, for example, in neurofibromatosis type II. In analogy to a cochlear implant (CI), it has been demonstrated that an ABI may reduce tinnitus as a beneficial side effect. For tinnitus treatment, an ABI may have an advantage over a CI, as cochlear implantation can harm inner ear structures due to its invasiveness, while an ABI is presumed to not damage anatomical structures. This is the first study to implant an ABI to investigate its effect on intractable tinnitus.

Methods and analysis

In this pilot study, 10 adults having incapacitating unilateral intractable tinnitus and ipsilateral severe hearing loss will have an ABI implanted. The ABI is switched on 6 weeks after implantation, followed by several fitting sessions aimed at finding an optimal stimulation strategy. The primary outcome will be the change in Tinnitus Functioning Index. Secondary outcomes will be tinnitus burden and quality of life (using Tinnitus Handicap Inventory and Hospital Anxiety and Depression Scale questionnaires), tinnitus characteristics (using Visual Analogue Scale, a tinnitus analysis), safety, audiometric and vestibular function. The end point is set at 1 year after implantation. Follow-up will continue until 5 years after implantation.

Ethics and dissemination

The protocol was reviewed and approved by the Institutional Review Board of the University Medical Centre Groningen, The Netherlands (METc 2015/479). The trial is registered at www.clinicialtrials.gov and will be updated if amendments are made. Results of this study will be disseminated in peer-reviewed journals and at scientific conferences.

Trial registration number

NCT02630589.

Trial status

Inclusion of first patient in November 2017. Data collection is in progress. Trial is open for further inclusion. The trial ends at 5 years after inclusion of the last patient.

Discovery of biomarkers for the presence and progression of left ventricular diastolic dysfunction and HEart faiLure with Preserved ejection Fraction in patients at risk for cardiovascular disease: rationale and design of the HELPFul case-cohort study in

Por: Valstar · G. B. · Bots · S. H. · Groepenhoff · F. · Gohar · A. · Rutten · F. H. · Leiner · T. · Cramer · M. J. M. · Teske · A. J. · Suciadi · L. P. · Menken · R. · Pasterkamp · G. · Asselbergs · F. W. · Hofstra · L. · Bots · M. L. · den Ruijter · H. M.
Introduction

Left ventricular diastolic dysfunction (LVDD) is a common condition in both sexes that may deteriorate into heart failure (HF) with preserved ejection fraction (pEF), although this seems to happen more often in women than in men. Both LVDD and HFpEF often go unrecognised, necessitating the discovery of biomarkers that aid both the identification of individuals with LVDD at risk of developing HF and identification of individuals most likely to benefit from treatment.

Methods and analysis

HELPFul is an ongoing case-cohort study at a Dutch cardiology outpatient clinic enrolling patients aged 45 years and older without history of cardiovascular disease, who were referred by the general practitioner for cardiac evaluation. We included a random sample of patients and enriched the cohort with cases (defined as an E/e’ ≥8 measured with echocardiography). Information about medical history, cardiovascular risk factors, electrocardiography, echocardiography, exercise test performance, common carotid intima-media thickness measurement and standard cardiovascular biomarkers was obtained from the routine care data collected by the cardiology outpatient clinic. Study procedure consists of extensive venous blood collection for biobanking and additional standardised questionnaires. Follow-up will consist of standardised questionnaires by mail and linkage to regional and national registries. We will perform cardiac magnetic resonance imaging and coronary CT angiography in a subgroup of patients to investigate the extent of macrovascular and microvascular coronary disease.

Ethics and dissemination

The study protocol was approved by the Institutional Review Board of the University Medical Center Utrecht. Results will be disseminated through national and international conferences and in peer-reviewed journals in cardiovascular disease.

Trial registration

NTR6016;Pre-results.

Local prevalence of extended-spectrum beta-lactamase (ESBL) producing Enterobacteriaceae intestinal carriers at admission and co-expression of ESBL and OXA-48 carbapenemase in Klebsiella pneumoniae: a prevalence survey in a Spanish University Hospital

Por: Diaz-Agero Perez · C. · Lopez-Fresnena · N. · Rincon Carlavilla · A. L. · Hernandez Garcia · M. · Ruiz-Garbajosa · P. · Aranaz-Andres · J. M. · Maechler · F. · Gastmeier · P. · Bonten · M. J. M. · Canton · R.
Objective

To assess the prevalence of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae (ESBL-E) faecal carriers at admission in a University Hospital in Spain.

Design

Prevalence survey.

Setting

Pneumology, gastroenterology, urology and neurosurgery units at a university tertiary hospital in Madrid (Spain).

Participants

A total of 10 643 patients aged 18 and older admitted from March 2014 to April 2016 with a rectal swab taken at admission or as soon as possible within the first 48 hours.

Primary and secondary outcome measures

Prevalence of ESBL-E faecal carriers and prevalence of ESBL-E infections at admission.

Results

The prevalance of ESBL-E carriers at admission was 7.69% (CI 95% 7.18 to 8.19). Most of the isolates were Escherichia coli (77.51%), followed by Klebsiella pneumoniae (20.71%). Eighty-eight (10.41%) of ESBL-E were simultaneous ESBL and carbapenemase (CP) producers, 1.83% in the case of E. coli and 42.86% among K. pneumoniae isolates. Of the ESBL typed, 52.15% belonged to the cefotaximases (CTX-M-15) type and 91.38% of the CP were oxacillinase (OXA-48) type. Only 0.43% patients presented an active infection by ESBL-E at admission.

Conclusions

The prevalence found in our study is very similar to that found in literature. However, we found a high percentage of simultaneous ESBL and CP producers, particularly in K. pneumoniae. Despite the high prevalence of colonised patients, the ESBL-infection rate at admission was very low.

Application of speCtraL computed tomogrAphy to impRove specIficity of cardiac compuTed tomographY (CLARITY study): rationale and design

Por: van Hamersvelt · R. W. · Isgum · I. · de Jong · P. A. · Cramer · M. J. M. · Leenders · G. E. H. · Willemink · M. J. · Voskuil · M. · Leiner · T.
Introduction

Anatomic stenosis evaluation on coronary CT angiography (CCTA) lacks specificity in indicating the functional significance of a stenosis. Recent developments in CT techniques (including dual-layer spectral detector CT [SDCT] and static stress CT perfusion [CTP]) and image analyses (including fractional flow reserve [FFR] derived from CCTA images [FFRCT] and deep learning analysis [DL]) are potential strategies to increase the specificity of CCTA by combining both anatomical and functional information in one investigation. The aim of the current study is to assess the diagnostic performance of (combinations of) SDCT, CTP, FFRCT and DL for the identification of functionally significant coronary artery stenosis.

Methods and analysis

Seventy-five patients aged 18 years and older with stable angina and known coronary artery disease and scheduled to undergo clinically indicated invasive FFR will be enrolled. All subjects will undergo the following SDCT scans: coronary calcium scoring, static stress CTP, rest CCTA and if indicated (history of myocardial infarction) a delayed enhancement acquisition. Invasive FFR of ≤0.80, measured within 30 days after the SDCT scans, will be used as reference to indicate a functionally significant stenosis. The primary study endpoint is the diagnostic performance of SDCT (including CTP) for the identification of functionally significant coronary artery stenosis. Secondary study endpoint is the diagnostic performance of SDCT, CTP, FFRCT and DL separately and combined for the identification of functionally significant coronary artery stenosis.

Ethics and dissemination

Ethical approval was obtained. All subjects will provide written informed consent. Study findings will be disseminated through peer-reviewed conference presentations and journal publications.

Trial registration number

NCT03139006; Pre-results.

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