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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.

Occurrence and nature of questionable research practices in the reporting of messages and conclusions in international scientific Health Services Research publications: a structured assessment of publications authored by researchers in the Netherlands

Por: Gerrits · R. G. · Jansen · T. · Mulyanto · J. · van den Berg · M. J. · Klazinga · N. S. · Kringos · D. S.
Objectives

Explore the occurrence and nature of questionable research practices (QRPs) in the reporting of messages and conclusions in international scientific Health Services Research (HSR) publications authored by researchers from HSR institutions in the Netherlands.

Design

In a joint effort to assure the overall quality of HSR publications in the Netherlands, 13 HSR institutions in the Netherlands participated in this study. Together with these institutions, we constructed and validated an assessment instrument covering 35 possible QRPs in the reporting of messages and conclusions. Two reviewers independently assessed a random sample of 116 HSR articles authored by researchers from these institutions published in international peer-reviewed scientific journals in 2016.

Setting

Netherlands, 2016.

Sample

116 international peer-reviewed HSR publications.

Main outcome measures

Median number of QRPs per publication, the percentage of publications with observed QRP frequencies, occurrence of specific QRPs and difference in total number of QRPs by methodological approach, type of research and study design.

Results

We identified a median of six QRPs per publication out of 35 possible QRPs. QRPs occurred most frequently in the reporting of implications for practice, recommendations for practice, contradictory evidence, study limitations and conclusions based on the results and in the context of the literature. We identified no differences in total number of QRPs in papers based on different methodological approach, type of research or study design.

Conclusions

Given the applied nature of HSR, both the severity of the identified QRPs, and the recommendations for policy and practice in HSR publications warrant discussion. We recommend that the HSR field further define and establish its own scientific norms in publication practices to improve scientific reporting and strengthen the impact of HSR. The results of our study can serve as an empirical basis for continuous critical reflection on the reporting of messages and conclusions.

Gut-directed hypnotherapy versus standard medical treatment for nausea in children with functional nausea or functional dyspepsia: protocol of a multicentre randomised trial

Por: Browne · P. D. · den Hollander · B. · Speksnijder · E. M. · van Wering · H. M. · Tjon a Ten · W. · George · E. K. · Groeneweg · M. · Bevers · N. · Wessels · M. M. S. · van den Berg · M. M. · Goede · J. · Teklenburg-Roord · S. T. A. · Frankenhuis · C. · Benninga · M. A. · Vlieger · A
Introduction

The treatment of chronic functional nausea or nausea due to functional dyspepsia in children is generally symptomatic. Moreover, these disorders pose a risk for worse psychosocial and health outcomes in children. Hypnotherapy (HT), by its ability to positively influence gastrointestinal and psychosocial functioning, may be an effective treatment for chronic nausea.

Methods and analysis

To test efficacy, this multicentre, parallel, randomised controlled, open label trial evaluates whether gut-directed HT is superior to standard medical treatment (SMT) for reducing nausea. The study will be conducted at eleven academic and non-academic hospitals across the Netherlands. A total of 100 children (8–18 years), fulfilling the Rome IV criteria for chronic idiopathic nausea or functional dyspepsia with prominent nausea, will be randomly allocated (1:1) to receive HT or SMT. Children allocated to the HT group will receive six sessions of HT during 3 months, while children allocated to the SMT group will receive six sessions of SMT+supportive therapy during the same period. The primary outcome will be the difference in the proportion of children with at least 50% reduction of nausea, compared with baseline at 12 months’ follow-up. Secondary outcomes include the changes in abdominal pain, dyspeptic symptoms, quality of life, anxiety, depression, school absences, parental absence of work, healthcare costs and adequate relief of symptoms, measured directly after treatment, 6 and 12 months’ follow-up. If HT proves effective for reducing nausea, it may become a new treatment strategy to treat children with chronic functional nausea or functional dyspepsia with prominent nausea.

Ethics and dissemination

Results of the study will be publicly disclosed to the public, without any restrictions, in peer-reviewed journal and international conferences. The study is approved by the Medical Research Ethics Committees United (MEC-U) in the Netherlands.

Trial registration number

NTR5814.

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