Qualitative Evaluation of the STOEMP Network in Ghent : An Intersectoral Approach to Make Healthy and Sustainable Food Available to All

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Intratympanic gentamicin treatment for Ménière's disease: A randomized, double-blind, placebo-controlled trial on dose efficacy - results of a prematurely ended study

Background: Gentamicin is used as a therapeutic agent for Ménière's disease because of its vestibulotoxicity causing chemo-ablation of the vestibular sensory epithelia. Its use has increased in recent years. However, there is still no consensus about the dose regimen of gentamicin in the treatment of Ménière's disease. In this study two different dose regimen treatment protocols are compared in a placebo controlled study design. The primary objective is to quantify the treatment effect on dizziness, the secondary objective is hearing evaluation.Methods: We performed a randomized, double-blind, placebo-controlled study in adults with unilateral Ménière's disease according to the AAO-HNS guidelines resistant to conservative medication. Three groups received four injections, administered weekly (four intratympanic injections with 40 mg/mL gentamicin solution, two injections gentamicin solution and two injections of placebo in random order, or four injections with placebo). Outcome measures were the score on the Dizziness Handicap Inventory and pure tone audiometry (PTA). Intended follow-up was 2 years.Results: During follow-up one patient exceeded the accepted amount of hearing loss. Further, enrollment was very slow (until 12 months between two patients) and new insights showed an apparent benefit of intratympanic gentamicin treatment (ITG). Therefore we performed an unscheduled interim analysis which showed that PTA threshold shifts reached the stopping criteria in two more patients. Because of this, this study was ended. Of the three patients with the significant PTA threshold shift two were enrolled in the gentamicin group.Conclusion: No conclusions can be drawn concerning doses regimens. Now that new publications have shown that ITG treatment can be an effective and safe treatment, a placebo-controlled randomized controlled trial may not pass the ethical committee because of these recent reports in literature. Still, a dose regimen study (without placebo) on ITG treatment needs to be performed.Trial registration: This trial was registered in The University Medical Center Utrecht/ Gelre hospital Apeldoorn. Protocol ID: 07/343, EudraCT number 2006-005913-37

CeRebrUm and CardIac Protection with ALlopurinol in Neonates with Critical Congenital Heart Disease Requiring Cardiac Surgery with Cardiopulmonary Bypass (CRUCIAL):study protocol of a phase III, randomized, quadruple-blinded, placebo-controlled, Dutch multicenter trial

BACKGROUND: Neonates with critical congenital heart disease (CCHD) undergoing cardiac surgery with cardiopulmonary bypass (CPB) are at risk of brain injury that may result in adverse neurodevelopment. To date, no therapy is available to improve long-term neurodevelopmental outcomes of CCHD neonates. Allopurinol, a xanthine oxidase inhibitor, prevents the formation of reactive oxygen and nitrogen species, thereby limiting cell damage during reperfusion and reoxygenation to the brain and heart. Animal and neonatal studies suggest that allopurinol reduces hypoxic-ischemic brain injury and is cardioprotective and safe. This trial aims to test the hypothesis that allopurinol administration in CCHD neonates will result in a 20% reduction in moderate to severe ischemic and hemorrhagic brain injury. METHODS: This is a phase III, randomized, quadruple-blinded, placebo-controlled, multicenter trial. Neonates with a prenatal or postnatal CCHD diagnosis requiring cardiac surgery with CPB in the first 4 weeks after birth are eligible to participate. Allopurinol or mannitol-placebo will be administered intravenously in 2 doses early postnatally in neonates diagnosed antenatally and 3 doses perioperatively of 20 mg/kg each in all neonates. The primary outcome is a composite endpoint of moderate/severe ischemic or hemorrhagic brain injury on early postoperative MRI, being too unstable for postoperative MRI, or mortality within 1 month following CPB. A total of 236 patients (n = 188 with prenatal diagnosis) is required to demonstrate a reduction of the primary outcome incidence by 20% in the prenatal group and by 9% in the postnatal group (power 80%; overall type 1 error controlled at 5%, two-sided), including 1 interim analysis at n = 118 (n = 94 with prenatal diagnosis) with the option to stop early for efficacy. Secondary outcomes include preoperative and postoperative brain injury severity, white matter injury volume (MRI), and cardiac function (echocardiography); postnatal and postoperative seizure activity (aEEG) and regional cerebral oxygen saturation (NIRS); neurodevelopment at 3 months (general movements); motor, cognitive, and language development and quality of life at 24 months; and safety and cost-effectiveness of allopurinol. DISCUSSION: This trial will investigate whether allopurinol administered directly after birth and around cardiac surgery reduces moderate/severe ischemic and hemorrhagic brain injury and improves cardiac function and neurodevelopmental outcome in CCHD neonates. TRIAL REGISTRATION: EudraCT 2017-004596-31. Registered on November 14, 2017. ClinicalTrials.gov NCT04217421. Registered on January 3, 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06098-y

Creating triple-wins for health, equity and environmental sustainability: elements of good practice based on learning from the INHERIT case studies

This report draws out dimensions of good practice for building this triple-win, based on learning from the INHERIT project’s 15 case studies. In the context of the project, good practice refers to ways that support changing contexts and create conditions to enable behaviour change to reach the triple-win. This report summarises key information for consideration by governmental and non-governmental policy-makers and practitioners planning to work across sectors to achieve the triple-win through behaviour change at every level. INHERIT researchers have focused their evaluations of the 15 INHERIT case studies on implementation, intersectoral cooperation, impacts and cost benefits. The researchers have taken dimensions of good practice from INHERIT research to be those elements that appear to be promising or necessary in the contexts in which the INHERIT cases studies are implemented. The extent to which these elements of good practice can be generalised to other contexts merits consideration in developing future initiatives towards creating synergies across sectors. INHERIT researchers have drawn out lessons learned from information gathered in evaluations about triggers for the initiatives, key elements for implementation, success factors in intersectoral cooperation, what could have been done better, what should be done in the future, and the most important learnings from the evaluation of outcomes, costs and benefits

Transitions to food democracy through multilevel governance

status: publishe

Creating triple-wins for health, equity and environmental sustainability: elements of good practice based on learning from the INHERIT case studies

This report draws out dimensions of good practice for building this triple-win, based on learning from the INHERIT project’s 15 case studies. In the context of the project, good practice refers to ways that support changing contexts and create conditions to enable behaviour change to reach the triple-win. This report summarises key information for consideration by governmental and non-governmental policy-makers and practitioners planning to work across sectors to achieve the triple-win through behaviour change at every level. INHERIT researchers have focused their evaluations of the 15 INHERIT case studies on implementation, intersectoral cooperation, impacts and cost benefits. The researchers have taken dimensions of good practice from INHERIT research to be those elements that appear to be promising or necessary in the contexts in which the INHERIT cases studies are implemented. The extent to which these elements of good practice can be generalised to other contexts merits consideration in developing future initiatives towards creating synergies across sectors. INHERIT researchers have drawn out lessons learned from information gathered in evaluations about triggers for the initiatives, key elements for implementation, success factors in intersectoral cooperation, what could have been done better, what should be done in the future, and the most important learnings from the evaluation of outcomes, costs and benefits

Transfer and Implementation Process of a Good Practice in Workplace Health Promotion

The procedure developed by the European Joint Action CHRODIS PLUS (JAC+) to transfer and implement good practices from one setting to another was tested in the context of a workplace health promotion good practice identified in the Region of Lombardy (Italy) and transferred and implemented in two organisations in Andalusia (Spain). This article provides a detailed account on how the JAC+ implementation methodology, which included the use of the SQUIRE (Standards for QUality Improvement Reporting Excellence) guidelines, was applied. It offers a practical overview for the uptake of this methodology and of the good practice itself. The account of how this systematic and rigorous implementation reporting model was applied can be of value to those with an interest in workplace health and in the transfer of good practice and implementation sciences.This work arises from the Joint Action CHRODIS PLUS implementing good practices for chronic diseases, funded by the 3rd Health Programme (2014–2017) of the European Union. Grant Number 761307.Ye

Poultry Culling and Campylobacteriosis Reduction among Humans, the Netherlands

In the Netherlands in 2003, an outbreak of avian influenza in poultry resulted in extensive culling, especially of layer hens. Concurrently, human campylobacteriosis cases decreased, particularly in the culling area. These observations raise the hypothesis that Campylobacter spp. dissemination from poultry farms or slaughterhouses might contribute to human campylobacteriosis