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Strens D.,Deloitte | Colle A.,Deloitte | Vrijens F.,Belgian Health Care Knowledge Center | Paulus D.,Belgian Health Care Knowledge Center | And 4 more authors.
European Journal of Preventive Cardiology | Year: 2013

Background: There are concerns in Europe regarding the service provision and accessibility of multidisciplinary cardiac rehabilitation (MDCR) in general, and particularly in ambulatory settings. This paper analyses the utilization of outpatient MDCR and its determinants after cardiac revascularization or valve surgery in Belgium. Methods: Claims rehabilitation data for all patients discharged in 2007 after a percutaneous cardiac intervention or cardiac surgery were available from the Belgian Common Sickness Funds Agency. Logistic regressions were performed to identify patients demographic and socioeconomic characteristics associated with the uptake of outpatient MDCR during the year following the hospital discharge. Results: A total of 29,021 patients were included. During the hospitalization for the cardiac procedure, 44% were offered inpatient MDCR. After discharge, only 15.6% followed at least one session of outpatient MDCR. The chance of attending outpatient MDCR was lower for female, disabled, and older patients, as well as unemployed patients. The absence of an authorized MDCR centre in the neighbourhood of the patient's residence decreased the chance of attending outpatient MDCR, while living in a neighbourhood with a high education and income level increased this probability. Conclusion: These results confirm the low rates of MDCR attendance found in a previous study performed by the European Association of Cardiovascular Prevention and Rehabilitation. The study shows specific patient groups that should be targeted in priority, i.e. women, elderly, unemployed patients, disabled persons, and patients with a low socioeconomic status. © The European Society of Cardiology 2012. Source

Picavet E.,Catholic University of Leuven | Cassiman D.,University Hospital Leuven | Aertgeerts B.,Catholic University of Leuven | Aertgeerts B.,Belgian Center for Evidence Based Medicine | Simoens S.,Catholic University of Leuven
Orphanet Journal of Rare Diseases | Year: 2013

Background: Rare diseases are defined as life-threatening or chronically debilitating diseases with a prevalence of 50 out of 100,000 individuals or less. Orphan medicinal products (OMPs) are intended for the treatment of rare diseases. The assessment of quality of evidence in small populations is often complex. Many generic tools are unfit. Therefore, the aim of this study was to develop and validate a new tool to assess the quality of OMPs' clinical evidence (COMPASS). Methods. Firstly, a draft version of the COMPASS tool, developed by the authors and consisting of three parts, was amended based on suggestions obtained in four rounds of expert consultation. Secondly, the tool was put through three rounds of validation. The data source was information provided on the Orphanet website and in European Public Assessment Report (EPAR) document of the European Medicines Agency. Results: The first pilot round revealed a high (92.2%) inter-rater agreement for part one of the tool. After further improvements, the final inter-rater agreement was 86.4% for part two (on methodological quality) and three (on quality of reporting) of the tool. The COMPASS tool does not attempt to score or rank the quality of clinical evidence, but rather to give an outline of various, key elements with respect to quality of clinical evidence of OMP studies. Conclusions: The COMPASS tool can be applied to assess the quality of evidence of an OMP based on information in the registration dossier, for example by local reimbursement agencies, pharmacists or clinicians. In that way, the tool can contribute to making reimbursement and/or treatment decisions increasingly more founded on the principles of evidence-based decision making. © 2013 Picavet et al.; licensee BioMed Central Ltd. Source

Houttekier D.,Vrije Universiteit Brussel | Cohen J.,Vrije Universiteit Brussel | Cools F.,Belgian Center for Evidence Based Medicine | Deliens L.,Vrije Universiteit Brussel
Cochrane Database of Systematic Reviews | Year: 2016

This is the protocol for a review and there is no abstract. The objectives are as follows: The objective is to examine whether end-of-life care involving advance care planning, as compared to end-of-life care without or with a less structured form of advance care planning, results in fewer hospital admissions or less use of treatments with a primary life-prolonging or curative intent near the end of life and fewer hospital deaths. © 2016 The Cochrane Collaboration. Source

Velkeniers B.,Vrije Universiteit Brussel | Van Meerhaeghe A.,GERHPAC | Poppe K.,Vrije Universiteit Brussel | Unuane D.,Vrije Universiteit Brussel | And 3 more authors.
Human Reproduction Update | Year: 2013

Background: Previous meta-analyses of observational data indicate that pregnant women with subclinical hypothyroidism have an increased risk of adverse pregnancy outcome. Potential benefits of levothyroxine (LT4) supplementation remain unclear, and no systematic review or meta-analysis of trial findings is available in a setting of assisted reproduction technologies (ART). Methods: Relevant trials published until August 2012 were identified by searching MEDLINE, EMBASE, Web of Knowledge, the Cochrane Controlled Trials Register databases and bibliographies of retrieved publications without language restrictions. Results: From 630 articles retrieved, we included three trials with data on 220 patients. One of these three trials stated 'live delivery' as outcome. LT4 treatment resulted in a significantly higher delivery rate, with a pooled relative risk (RR) of 2.76 (95% confidence limits 1.20-6.44; P = 0.018; I2 = 70%), a pooled absolute risk difference (ARD) of 36.3% (3.5-69.0%: P = 0.030) and a summary number needed to treat (NNT) of 3 (1-28) in favour of LT4 supplementation. LT4 treatment significantly lowered miscarriage rate with a pooled RR of 0.45 (0.24-0.82; P = 0.010; I2 = 26%), a pooled ARD of 231.3% (248.2 to 214.5%: P < 0.001) and a summary NNT of 3 (2-7) in favour of LT4 supplementation. LT4 treatment had no effect on clinical pregnancy (RR 1.75; 0.90-3.38; P = 0.098; I2 = 82%). In an ART setting, no data are available on the effects of LT4 supplementation on premature delivery, arterial hypertension, placental abruption or pre-eclampsia. Conclusions: Our meta-analyses provide evidence that LT4 supplementation should be recommended to improve clinical pregnancy outcome in women with subclinical hypothyroidism and/or thyroid autoimmunity undergoing ART. Further research is needed to determine pregnancy outcome after close monitoring of thyroid function to maintain thyroid-stimulating hormone and free T4 levels within the trimester-specific reference ranges for pregnancy. © The Author 2013. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. Source

Vinck I.,Belgian Healthcare Knowledge Center | Hulstaert F.,Belgian Healthcare Knowledge Center | Van Brabandt H.,Belgian Center for Evidence Based Medicine | Neyt M.,Belgian Healthcare Knowledge Center | Stordeur S.,Belgian Healthcare Knowledge Center
European Journal of Health Law | Year: 2011

The European Conformity (CE) marking grants early market introduction to innovative high risk medical devices based on safety and device performance only, without any requirement to demonstrate clinical efficacy or effectiveness. Hence healthcare providers, patients and payers are informed neither about the added clinical value compared to an existing medical device nor about the risks incurred by using such innovations. In addition there is a lack of coherence and uniformity of approach in the assessment of high risk medical devices. These gaps may put the health and safety of patients in danger. The European Commission, in concert with Competent Authorities, industry, Notified Bodies, and other stakeholders, is working on a "recast" of the directives regulating medical devices. This article identifies and discusses the critical points of the pre-market clinical evaluation of innovative high-risk medical devices in the European legal framework and compares it with the USA. © 2011 Martinus Nijhoff Publishers. Source

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