Belgian Center for Evidence Based Medicine

Leuven, Belgium

Belgian Center for Evidence Based Medicine

Leuven, Belgium
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Van den Bruel A.,Belgian Health Care Knowledge Center | Van den Bruel A.,Catholic University of Leuven | Gailly J.,Belgian Health Care Knowledge Center | Gailly J.,Belgian Center for Evidence Based Medicine | Neyt M.,Belgian Health Care Knowledge Center
BMC Pulmonary Medicine | Year: 2010

Background: International guidelines recommend long-acting bronchodilators in patients who remain symptomatic despite adequate treatment with short-acting bronchodilators. The purpose of this study is to estimate the effect of tiotropium, a long-acting anticholinergic inhalant, on exacerbation and hospitalisation frequency.Methods: Electronic databases (Medline, Embase, INAHTA, CRD databases, and the Cochrane Library) were searched for randomised controlled trials, comparing tiotropium to placebo, or other bronchodilators. Outcomes were the exacerbation frequency and hospitalisation frequency. Data were pooled using the generic inverse variance method for continuous outcomes.Results: Nine studies reported comparisons with placebo (n = 8), ipratropium (short-acting anticholinergic inhalant, n = 1), and salmeterol (long-acting β2-agonist inhalant, n = 1). Only two studies reported adequate concealment of allocation. Tiotropium reduces the number of exacerbations per patient year by 0.31 (95% CI 0.46- 0.17) compared to placebo, and by 0.23 (95% CI 0.31- 0.15) compared to ipratropium. A significant difference in exacerbation frequency between tiotropium and salmeterol was found (-0.16; 95% CI -0.29 - -0.03) based on approximations of the results of one study.The number of hospitalisations is reduced by 0.04 (95% CI 0.08- 0.01) per patient year compared to placebo and by 0.06 (95% CI -0.09 - -0.03) per patient year compared to ipratropium.Conclusions: Statistically significant but clinically small effects were found for tiotropium compared to placebo and ipratropium. The comparison with salmeterol is significant for exacerbation frequency but not for hospitalisation frequency. Publication bias may be present. © 2010 Van den Bruel et al; licensee BioMed Central Ltd.


Van Nuland M.,Catholic University of Leuven | Hannes K.,Catholic University of Leuven | Cools F.,Belgian Center for Evidence Based Medicine | Goedhuys J.,Catholic University of Leuven
Cochrane Database of Systematic Reviews | Year: 2017

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: The aim of this systematic review is to assess the effects of educational interventions to improve the communication skills of General Practice trainees during clinical consultations. The review will examine the effects of these interventions primarily on patient-related outcomes such as satisfaction with care, patients' assessment of the quality of communication during the clinical consultation, patients' health care behaviour, including adherence to therapy and management plans, and health outcome measures such as blood pressure or glucose control. The review will also examine the effects of the interventions on trainee-related outcomes, such as trainee performance in real patient consultations, trainee competence, such as that measured by an Objective Structured Clinical Examination (OSCE), and trainee knowledge of communication skills. Furthermore, the review will examine whether different educational strategies yield different results across these outcomes. © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.


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.


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.


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.


Courtois I.,Hasselt University | Cools F.,Belgian Center for Evidence Based Medicine | Calsius J.,Hasselt University
Journal of Bodywork and Movement Therapies | Year: 2015

Objectives: Patients with long-lasting pain problems often complain of lack of confidence and trust in their body. Through physical experiences and reflections they can develop a more positive body- and self-experience. Body awareness has been suggested as an approach for treating patients with chronic pain and other psychosomatic conditions. The aim of this systematic review is to assess the effectiveness of body awareness interventions (BAI) in fibromyalgia (FM) and chronic fatigue syndrome (CFS). Methods: Two independent readers conducted a search on Medline, Cochrane Central, PsycINFO, Web of knowledge, PEDro and Cinahl for randomized controlled trials. Results: We identified and screened 7.107 records of which 29 articles met the inclusion criteria. Overall, there is evidence that BAI has positive effects on the Fibromyalgia Impact Questionnaire (FIQ) (MD -5.55; CI -8.71 to -2.40), pain (SMD -0.39, CI -0.75 to -0.02), depression (SMD -0.23, CI -0.39 to -0.06), anxiety (SMD -0.23, CI -0.44 to -0.02) and Health Related Quality of Life (HRQoL) (SMD 0.62, CI 0.35-0.90) when compared with control conditions. The overall heterogeneity is very strong for FIQ (I2 92%) and pain (I2 97%), which cannot be explained by differences in control condition or type of BAI (hands-on/hands-off). The overall heterogeneity for anxiety, depression and HRQoL ranges from low to moderate (I2 0%-37%). Conclusions: Body awareness seems to play an important role in anxiety, depression and HRQoL. Still, interpretations have to be done carefully since the lack of high quality studies. © 2014 Elsevier Ltd.


Cools F.,Belgian Center for Evidence Based Medicine | Offringa M.,Belgian Center for Evidence Based Medicine | Askie L.M.,Belgian Center for Evidence Based Medicine
The Cochrane database of systematic reviews | Year: 2015

BACKGROUND: Respiratory failure due to lung immaturity is a major cause of mortality in preterm infants. Although the use of intermittent positive pressure ventilation (IPPV) in neonates with respiratory failure saves lives, its use is associated with lung injury and chronic lung disease. A newer form of ventilation called high frequency oscillatory ventilation has been shown in experimental studies to result in less lung injury.OBJECTIVES: The objective of this review was to determine the effect of the elective use of high frequency oscillatory ventilation (HFOV) as compared to conventional ventilation (CV) on the incidence of chronic lung disease (CLD), mortality and other complications associated with prematurity and assisted ventilation in preterm infants who were mechanically ventilated for respiratory distress syndrome (RDS).SEARCH METHODS: Searches were made of the Oxford Database of Perinatal Trials, MEDLINE, EMBASE, previous reviews including cross references, abstracts, conference and symposia proceedings; and from expert informants and handsearching of journals by The Cochrane Collaboration, mainly in the English language. The search was updated in January 2009 and again in November 2014.SELECTION CRITERIA: Randomised controlled trials comparing HFOV and CV in preterm or low birth weight infants with pulmonary dysfunction, mainly due to RDS, who required assisted ventilation. Randomisation and commencement of treatment needed to be as soon as possible after the start of CV and usually in the first 12 hours of life.DATA COLLECTION AND ANALYSIS: The methodological quality of each trial was independently reviewed by the review authors. The standard effect measures were relative risk (RR) and risk difference (RD). From 1/RD the number needed to benefit (NNTB) to produce one outcome was calculated. For all measures of effect, 95% confidence intervals (CIs) were used. For interpretation of subgroup analyses, a P value for subgroup differences as well as the I(2) statistic for between-subgroup heterogeneity were calculated. Meta-analysis was performed using both a fixed-effect and a random-effects model. Where heterogeneity was over 50%, the random-effects model RR was also reported.MAIN RESULTS: Nineteen eligible studies involving 4096 infants were included. Meta-analysis comparing HFOV with CV revealed no evidence of effect on mortality at 28 to 30 days of age or at approximately term equivalent age. These results were consistent across studies and in subgroup analyses. The risk of CLD in survivors at term equivalent gestational age was significantly reduced with the use of HFOV but this effect was inconsistent across studies, even after the meta-analysis was restricted to studies that applied a high lung volume strategy with HFOV. Subgroup analysis by HFOV strategy showed a similar effect in trials with a more strict lung volume recruitment strategy, targeting a very low fraction of inspired oxygen (FiO2), and trials with a less strict lung volume recruitment strategy and with a somewhat higher or unspecified target FiO2. Subgroup analyses by age at randomisation, routine surfactant use or not, type of high frequency ventilator (oscillator versus flow interrupter), inspiratory to expiratory (I:E) ratio of high frequency ventilator (1:1 versus 1:2) and CV strategy (lung protective or not) could not sufficiently explain the heterogeneity. Pulmonary air leaks, defined as gross air leaks or pulmonary interstitial emphysema, occurred more frequently in the HFOV group, whereas the risk of severe retinopathy of prematurity was significantly reduced.Although in some studies an increased risk of severe grade intracranial haemorrhage and periventricular leukomalacia was found, the overall meta-analysis revealed no significant differences in effect between HFOV and CV. The short-term neurological morbidity with HFOV was only found in the subgroup of two trials not using a high volume strategy with HFOV. Most trials did not find a significant difference in long-term neurodevelopmental outcome, although one recent trial showed a significant reduction in the risk of cerebral palsy and poor mental development.AUTHORS' CONCLUSIONS: There is evidence that the use of elective HFOV compared with CV results in a small reduction in the risk of CLD, but the evidence is weakened by the inconsistency of this effect across trials. Probably many factors, both related to the intervention itself as well as to the individual patient, interact in complex ways. In addition, the benefit could be counteracted by an increased risk of acute air leak. Adverse effects on short-term neurological outcomes have been observed in some studies but these effects are not significant overall. Most trials reporting long-term outcome have not identified any difference.


Hannes K.,Belgian Center for Evidence Based Medicine | Hannes K.,Royal Adelaide Hospital | Pieters G.,Catholic University of Leuven | Goedhuys J.,Catholic University of Leuven | Aertgeerts B.,Catholic University of Leuven
Community Mental Health Journal | Year: 2010

This study aims to explore the obstacles to Evidence-Based Practice (EBP) experienced by Belgian Dutch-speaking psychiatrists. We used an inductive, qualitative research strategy. Thirty-nine psychiatrists participated in five focus groups organised between September 2004 and September 2006. Data-analysis was guided by a 'grounded theory approach'. Three major themes emerged from the data: (1) Characteristics of evidence, including the lack of (use of) evidence and the applicability of evidence; (2) Characteristics of other partners in mental health care, including government, patients and drug companies and (3) Discipline-related barriers, including the complexity of diagnoses, the importance of the therapeutic relationship and personal experience, and the different schools of thoughts. A problem tree was developed, linking all obstacles. Although context-specific, the problem tree can assist policy makers working in health care systems with similar characteristics in formulating objectives and developing strategies that facilitate EBP in the field of psychiatric care. © 2009 Springer Science+Business Media, LLC.


PubMed | University Hospitals Leuven, Health Science University, Center for Care Research and Consultancy, Population Studies in Oral Health and 2 more.
Type: Journal Article | Journal: Advances in nutrition (Bethesda, Md.) | Year: 2016

The present systematic review critically examines the available scientific literature on risk factors for malnutrition in the older population (aged 65 y). A systematic search was conducted in MEDLINE, reviewing reference lists from 2000 until March 2015. The 2499 papers identified were subjected to inclusion criteria that evaluated the study quality according to items from validated guidelines. Only papers that provided information on a variables effect on the development of malnutrition, which requires longitudinal data, were included. A total of 6 longitudinal studies met the inclusion criteria and were included in the systematic review. These studies reported the following significant risk factors for malnutrition: age (OR: 1.038; P = 0.045), frailty in institutionalized persons (: 0.22; P = 0.036), excessive polypharmacy (: -0.62; P = 0.001), general health decline including physical function (OR: 1.793; P = 0.008), Parkinson disease (OR: 2.450; P = 0.047), constipation (OR: 2.490; P = 0.015), poor (OR: 3.30; P value not given) or moderate (: -0.27; P = 0.016) self-reported health status, cognitive decline (OR: 1.844; P = 0.001), dementia (OR: 2.139; P = 0.001), eating dependencies (OR: 2.257; P = 0.001), loss of interest in life (: -0.58; P = 0.017), poor appetite (: -1.52; P = 0.000), basal oral dysphagia (OR: 2.72; P = 0.010), signs of impaired efficacy of swallowing (OR: 2.73; P = 0.015), and institutionalization (: -1.89; P < 0.001). These risk factors for malnutrition in older adults may be considered by health care professionals when developing new integrated assessment instruments to identify older adults risk of malnutrition and to support the development of preventive and treatment strategies.


Heselmans A.,Catholic University of Leuven | Aertgeerts B.,Catholic University of Leuven | Aertgeerts B.,Belgian Center for Evidence Based Medicine | Donceel P.,Catholic University of Leuven | And 4 more authors.
Journal of Medical Systems | Year: 2012

An electronic decision support system (the EBMeDS system) was integrated in one of the Electronic Medical Records (EMR) of Belgian family physicians (Feb 2010). User acceptance of the system is considered as a necessary condition for the effective implementation of any IT project. Facilitators, barriers and issues of non-acceptance need to be understood in view of a successful implementation and to minimize unexpected adoption behavior. Objectives of the study were the assessment of users' perceptions towards the recently implemented EBMeDS system, the investigation of user-interactions with the system and possible relationships between perceptions and use. A mixed evaluation approach was performed consisting of a qualitative and a quantitative analysis. The technology acceptance model of UTAUT was used as a structural model for the development of our questionnaire to identify factors that may account for acceptance and use of the EBMeDS system (seven-point Likert scales). A quantitative analysis of computer-recorded user interactions with the system was performed for an evaluation period of 3 months to assess the actual use of the system. Qualitative and quantitative analysis were linked to each other. Thirty-nine family physicians (12 %) completed the survey. The majority of respondents (66 %) had a positive attitude towards the system in general. Mean intention to keep using the system was high (5,91∈±∈1,33). Their perception of the ease of use of the system (mean 5, 04∈±∈1,41), usefulness (mean 4,69∈±∈1,35) and facilitating conditions (4,43∈±∈1,13) was in general positive. Only 0,35 % of reminders were requested on demand, the other 99,62 % of reminders displayed automatically. Detailed guidelines (long) were requested for 0,47 % of reminders automatically shown versus 16,17 % of reminders on request. The script behind the reminders was requested for 8,4 % of reminders automatically shown versus 13,6 % of reminders on request. The majority of respondents demonstrated a relatively high degree of acceptance towards the EBMeDS system. Although the majority of respondents was in general positive towards the ease of use of the system, usefulness and facilitating conditions, part of the statements gave rather mixed results and could be identified as important points of interest for future implementation initiatives and system improvements. It has to be stressed that our population consisted of a convenience sample of early adopters, willing to answer a questionnaire. The willingness to adopt the system depends on the willingness to use ICPC coding. As such, the quality of reminding partly depends on the quality of coding. There is a need to reach a larger population of physicians (including physicians who never used the system or stopped using the system) to validate the results of this survey. © 2012 Springer Science+Business Media, LLC.

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