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Questionable levels of evidence in new atrial fibrillation guidelines? / Hans Van Brabandt in European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology, 15(2013)3 ([11/01/2012])
[article] Questionable levels of evidence in new atrial fibrillation guidelines? [printed text] / Hans Van Brabandt , Author ; Mattias Neyt , Author ; Carl Devos , Author . - 2012 . - 461.
Languages : English (eng)
in European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology > 15(2013)3 [11/01/2012] . - 461
Descriptors: Classification
W 1 Serials. Periodicals
Indexation
2009-30 ; Atrial Fibrillation ; Female ; Humans ; Journal Article ; Male ; Peer Review ; R184Link for e-copy: http://dx.doi.org/10.1093/europace/eus393 Format of e-copy: PDF Require subscription Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3709 [article]Rapid Assessment: Cardiovasculaire Primaire Preventie in de Belgische Huisartspraktijk. / Chris De Laet / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2007)
Rapid Assessment: Cardiovasculaire Primaire Preventie in de Belgische Huisartspraktijk. [printed text] / Chris De Laet , Author ; Mattias Neyt , Author ; Hans Van Brabandt , Author ; Dirk Ramaekers, Author ; Domus Medica . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2007 . - vi, 80 p. : ill. ; 30 cm.. - (KCE Reports A. Good Clinical Practice (GCP); 52A) .
ISSN : D/200710.273/03 : 0 €
Studie nr : 2007-06
Languages : Dutch (dut) English (eng)
Descriptors: Classification
WG 120 Cardiovascular diseases (General or not elsewhere classified)
Indexation
2007-06 ; Cardiovascular diseases ; Costs and Cost Analysis ; Guidelines as Topic ; Primary Prevention ; R52Link for e-copy: https://doi.org/10.57598/R52A Format of e-copy: .PDF (1,55 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1390 Copies(0)
Status No copy Rapid Assessment: Prévention cardiovasculaire primaire dans la pratique du médecin généraliste en Belgique / Chris De Laet / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2007)
Rapid Assessment: Prévention cardiovasculaire primaire dans la pratique du médecin généraliste en Belgique [printed text] / Chris De Laet , Author ; Mattias Neyt , Author ; Hans Van Brabandt , Author ; Dirk Ramaekers, Author ; Domus Medica . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2007 . - vi, 80 p. : ill. ; 30 cm.. - (KCE Reports B. Good Clinical Practice (GCP); 52B) .
ISSN : D/2007/10.273/04
Studie nr : 2007-06
Languages : English (eng) French (fre)
Descriptors: Classification
WG 120 Cardiovascular diseases (General or not elsewhere classified)
Indexation
2007-06 ; Cardiovascular diseases ; Costs and Cost Analysis ; Guidelines as Topic ; Primary Prevention ; R52Link for e-copy: https://doi.org/10.57598/R52B Format of e-copy: .PDF (1,55 MB) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=1616 Copies(0)
Status No copy Recommandations belges pour les évaluations économiques et les analyses d’impact budgétaire / Irina Cleemput / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2012)
Recommandations belges pour les évaluations économiques et les analyses d’impact budgétaire : deuxième édition [printed text] / Irina Cleemput , Author ; Mattias Neyt , Author ; Stefaan Van de Sande , Author ; Nancy Thiry, Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2012 . - IX, 76 p. : ill. ; A4. - (KCE Reports B. Health Technology Assessment (HTA); 183B) .
ISSN : D/2012/10.273/53 : € 0,00
Etude n° 2011-44 HTA Pharma-Eco Evaluation Update
Languages : English (eng) French (fre)
Descriptors: Classification
QV 736 Drug industry. Economics of pharmacy. Advertising
Indexation
2011-44 ; Economics, Pharmaceutical ; Guidelines as Topic ; R183Abstract: En 2008, le Centre Fédéral d’Expertise des Soins de Santé (KCE) et l’INAMI ont développé des recommandations auxquelles doivent satisfaire les demandes de remboursement de certains médicaments (ceux de la classe 1). Le KCE a fait une mise à jour de ces recommandations et les a complétées en ajoutant des recommandations spécifiques à l’élaborations d’analyses de l’impact budgétaire. De plus, le champ d’application des recommandations a été élargi à l’ensemble des interventions médicales (c'est-à-dire les médicaments, les prothèses, les implants ou toute autre prestation médicale…). Le but des recommandations est de conduire à une plus grande transparence et une plus grande cohérence des évaluations économiques et des analyses de l’impact budgétaire qui accompagnent les demandes de remboursement. Ceci devrait aider l’INAMI dans son processus de décision. Contents note: SCIENTIFIC REPORT 8 -- 1 BACKGROUND 8 -- 2 OBJECTIVES 10 -- 3 METHODS10 -- 4 OVERVIEW OF THE BELGIAN GUIDELINES AND GENERAL REMARKS 12 -- 4.1 OVERVIEW OF THE BELGIAN GUIDELINES 12 -- 4.2 GENERAL REMARKS 13 -- 5 GUIDELINES FOR HEALTH ECONOMIC EVALUATIONS 15 -- 5.1 GUIDELINE 1: LITERATURE REVIEW 15 -- 5.2 GUIDELINE 2: PERSPECTIVE OF THE EVALUATION 17 -- 5.3 GUIDELINE 3: TARGET POPULATION 18 -- 5.4 GUIDELINE 4: COMPARATORS 19 -- 5.5 GUIDELINE 5: ANALYTIC TECHNIQUE 21 -- 5.5.1 Cost-effectiveness analysis 21 -- 5.5.2 Cost-utility analysis 22 -- 5.5.3 Cost-minimisation analysis 22 -- 5.5.4 Cost-benefit analysis 23 -- 5.6 GUIDELINE 6: STUDY DESIGN 23 -- 5.6.1 Trial-based economic evaluations 23 -- 5.6.2 Modelling 24 -- 5.7 GUIDELINE 7: CALCULATION OF COSTS 25 -- 5.7.1 Cost categories 25 -- 5.7.2 Measurement of resource use 26 -- 5.7.3 Valuation of resource use 26 -- 5.8 GUIDELINE 8: ESTIMATION AND VALUATION OF OUTCOMES 36 -- 5.8.1 Effectiveness evaluation in cost-effectiveness analysis 37 -- 5.8.2 Utility assessment in cost-utility analysis 37 -- 5.9 GUIDELINE 9: TIME HORIZON 39 -- 5.10 GUIDELINE 10: MODELLING 39 -- 5.10.1 Need for modelling 39 -- 5.10.2 Choice of the model design 40 -- 5.10.3 Precision of model structure and hypotheses 40 -- 5.10.4 Calibration, face validity and cross-validation of a model 41 -- 5.11 GUIDELINE 11: HANDLING UNCERTAINTY AND TESTING THE ROBUSTNESS OF THE RESULTS .. 42 -- 5.12 GUIDELINE 12: DISCOUNT RATE 43 -- 6 GUIDELINES FOR BUDGET IMPACT ANALYSES 44 -- 6.1 SIMILARITIES AND DIFFERENCES BETWEEN ECONOMIC EVALUATIONS AND BUDGET IMPACT -- ANALYSES 44 -- 6.2 GUIDELINE 13: PERSPECTIVE 45 -- 6.3 GUIDELINE 14: TARGET POPULATION 45 -- 6.4 GUIDELINE 15: COMPARATORS 46 -- 6.5 GUIDELINE 16: COSTS AND OUTCOMES 47 -- 6.6 GUIDELINE 17: TIME HORIZON 48 -- 6.7 GUIDELINE 18: MODELLING 48 -- 6.8 GUIDELINE 19: HANDLING UNCERTAINTY 49 -- 6.9 GUIDELINE 20: DISCOUNT RATE 49 -- 6.10 GUIDELINE 21: PRESENTING RESULTS 49 -- 7 DISCUSSION 50 -- 8 POLICY RECOMMENDATIONS 51 -- 9 REPORTING GUIDELINES 53 -- 9.1 EXECUTIVE SUMMARY 53 -- 9.2 INTRODUCTION 53 -- 9.3 OBJECTIVES 53 -- 9.4 LITERATURE REVIEW 53 -- 9.4.1 Clinical literature review 53 -- 9.4.2 Economic literature review 54 -- 9.5 BASIC ELEMENTS OF THE ECONOMIC EVALUATION 54 -- 9.5.1 Analytic technique 54 -- 9.5.2 Study design 54 -- 9.5.3 Methods used for valuation of costs 54 -- 9.5.4 Methods used for outcome assessment 54 -- 9.5.5 Method of analysis of the data 54 -- 9.5.6 Time horizon and discount rate54 -- 9.5.7 Sensitivity analysis 54 -- 9.6 RESEARCH METHODS 54 -- 9.6.1 Identification, measurement and valuation of costs 54 -- 9.6.2 Identification, measurement and valuation of health-related outcomes 55 -- 9.7 RESULTS 55 -- 9.7.1 Basic results 55 -- 9.7.2 Uncertainty analysis 55 -- 9.8 DISCUSSION 55 -- 9.9 CONCLUSION 55 -- 9.10 TRANSPARENCY OF FINANCIAL SUPPORT 55 -- 9.11 REFERENCES 56 -- 9.12 ADDENDA 56 -- 10 PRESENTATION OF A MODEL 56 -- 10.1 DATA 56 -- 10.2 RESULTS 56 -- 10.2.1 Reference case analysis 56 -- 10.2.2 Uncertainty analysis 56 -- 11 METHODOLOGICAL REFERENCES BY TOPIC 57 -- 11.1 COUNTRY-SPECIFIC GUIDELINES 57 -- 11.2 METHODS FOR ECONOMIC EVALUATIONS 57 -- 11.3 LITERATURE REVIEW 58 -- 11.4 STUDY DESIGN 58 -- 11.4.1 Trial-based economic evaluations 58 -- 11.4.2 Modelling 58 -- 11.5 CALCULATION OF COSTS 58 -- 11.5.1 Measurement of resource use 58 -- 11.5.2 Valuation of resource use 58 -- 11.6 HANDLING UNCERTAINTY 58 -- 11.6.1 Overview 58 -- 11.6.2 Confidence interval around the ICER 59 -- 11.7 INDIRECT COMPARISONS 59 -- 11.8 DISCOUNTING 59 -- 11.9 BUDGET IMPACT ANALYSES 59 -- APPENDICES 60 -- APPENDIX 1. CLASSIFICATION OF ECONOMIC STUDIES 60 -- APPENDIX 2. CHECKLIST FOR ASSESSING ECONOMIC EVALUATIONS 61 -- APPENDIX 3. DATA EXTRACTION SHEET FOR ECONOMIC EVALUATIONS 61 -- APPENDIX 4. TECHNICAL NOTES 62 -- APPENDIX 4.1. ASSESSMENT OF EXTERNAL VALIDITY 62 -- APPENDIX 4.2. OUTCOME VALUATION 63 -- APPENDIX 4.3. USE OF EXPERT PANELS 64 -- APPENDIX 4.4. HOSPITAL PER DIEM PRICES 64 -- APPENDIX 4.5. INDIRECT COMPARISONS 66 -- APPENDIX 5. THE COST-EFFECTIVENESS PLANE, COST-EFFECTIVENESS ACCEPTABILITY CURVE, AND EFFICIENCY FRONTIER 67 -- APPENDIX 6. LIST OF BELGIAN DATABASES FOR THE MEASUREMENT AND VALUATION OF RESOURCE USE 70 -- APPENDIX 7. FLEMISH EQ-5D INDEX VALUES 73 -- REFERENCES 74 Link for e-copy: http://doi.org/10.57598/R183B Format of e-copy: pdf (805 Kb) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=3021 Copies(0)
Status No copy Responsible use of high-risk medical devices / Imgard Vinck / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2018)
Responsible use of high-risk medical devices : the example of 3D printed medical devices [printed text] / Imgard Vinck , Author ; An Vijverman, Author ; Erik Vollebregt, Author ; Nils Broeckx, Author ; Karlien Wouters, Author ; Mariel Piët, Author ; Natalija Bacic, Author ; Joan Vlayen , Author ; Nancy Thiry, Author ; Mattias Neyt , Author . - Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre, 2018 . - 158 p. : ill., ; A4. - (KCE Reports. Health Technology Assessment (HTA); 297C) .
ISSN : D/2018/10.273/03 : € 0,00
Languages : English (eng)
Descriptors: Classification
W 82 Biomedical technology (General)
Indexation
2016-01 ; Device Approval ; Equipement and Supplies ; European Union ; Government Regulation ; Printing, Three-Dimensional ; R297Contents note: SCIENTIFIC REPORT 9 -- 1 BACKGROUND 9 -- 1.1 SCOPE AND RESEARCH QUESTIONS 11 -- 2 SOME TECHNICAL ASPECTS 12 -- 2.1 TECHNIQUES OF 3D PRINTING 12 -- 2.2 COMPONENT ELEMENTS 12 -- 2.3 PROCESS OF 3D PRINTING (MEDICAL) DEVICES 13 -- 3 SYSTEMATIC REVIEW OF THE MEDICAL LITERATURE 16 -- 3.1 RESEARCH QUESTION 16 -- 3.2 METHODOLOGY 16 -- 3.2.1 Literature search and study selection 16 -- 3.2.2 Quality appraisal and data extraction 17 -- 3.2.3 Statistical analysis 17 -- 3.2.4 GRADE 17 -- 3.3 RESULTS 18 -- 3.3.1 Overall yield of the search 18 -- 3.3.2 Custom-made implants 21 -- 3.3.3 Surgical guides 21 -- 3.3.4 Model for surgery planning 26 -- 3.3.5 Model for implant shaping 26 -- 4 SYSTEMATIC REVIEW OF THE ECONOMIC LITERATURE 27 -- 4.1 METHODS 27 -- 4.1.1 Inclusion and exclusion criteria 27 -- 4.1.2 Search strategy 27 -- 4.1.3 Selection procedure 28 -- 4.1.4 Data extraction 28 -- 4.2 OVERVIEW OF THE ECONOMIC LITERATURE 29 -- 4.2.1 Technical characteristics of the economic evaluations 29 -- 4.2.2 Medical and clinical characteristics of the economic evaluations 30 -- 4.2.3 Cost items 32 -- 4.2.4 Outcome measures 32 -- 4.2.5 Results of the economic evaluations 33 -- 4.3 DISCUSSION 36 -- 5 LEGAL PART 38 -- 5.1 RESEARCH QUESTIONS 38 -- 5.2 METHODOLOGY 39 -- 5.3 MAIN LEGAL TEXTS AND DEFINITIONS 40 -- 5.4 LEGAL QUALIFICATION (AND CLASSIFICATION) AND REQUIREMENTS FOR THE PLACING ON THE MARKET OF 3D PRINTING OF / 3D PRINTED MEDICAL DEVICES UNDER EU RULES 43 -- 5.4.1 Current regime: Medical Devices Directive & IVD Directive 45 -- 5.4.2 Future regime: Medical Devices Regulation & IVD Regulation 57 -- 5.5 LEGAL QUALIFICATION OF 3D PRINTING/3D PRINTED MEDICAL DEVICES IN BELGIUM 64 -- 5.5.1 Legal qualification 64 -- 5.5.2 Applicable requirements for the placing on the market 65 -- 5.5.3 Conclusion 68 -- 5.6 LIABILITY AND INSURANCE ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 69 -- 5.6.1 Liability and insurance issues associated with 3D printed medical devices in the EU 70 -- 5.6.2 Liability and insurance issues associated with 3D printed medical devices in Belgium 75 -- 5.6.3 Conclusion 85 -- 5.7 DATA PROTECTION ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 86 -- 5.7.1 EU 86 -- 5.7.2 Belgium 95 -- 5.7.3 Conclusion 98 -- 5.8 PATIENTS’ RIGHTS ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 98 -- 5.8.1 EU 99 -- 5.8.2 Belgium 101 -- 5.8.3 Conclusion 103 -- 5.9 TRACEABILITY ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 104 -- 5.9.1 EU 104 -- 5.9.2 Belgium 107 -- 5.9.3 Conclusion 111 -- 5.10 REIMBURSEMENT ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 112 -- 5.10.1 EU 112 -- 5.10.2 Belgium 113 -- 5.10.3 Conclusion 136 -- 5.11 INTELLECTUAL PROPERTY RIGHTS ISSUES ASSOCIATED WITH 3D PRINTED MEDICAL DEVICES 139 -- 5.11.1 EU 142 -- 5.11.2 Belgium 153 -- 5.11.3 Conclusion 154 -- REFERENCES 156 Link for e-copy: http://doi.org/10.57598/R297C Format of e-copy: PDF (2,24 Mb) Record link: https://kce.docressources.info/index.php?lvl=notice_display&id=4348 Responsible use of high-risk medical devices / Nancy Thiry / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2018)
PermalinkSafety of percutaneous aortic valve insertion / Hans Van Brabandt in BMC cardiovascular disorders, 9(2009)45 ([09/01/2009])
PermalinkSearch MEDLINE for Economic Evaluations / Mattias Neyt in Pharmacoeconomics, 31(2013)12 ([12/01/2013])
PermalinkSilicone adhesive multilayer foam dressings to prevent hospital-acquired pressure ulcers / Mattias Neyt / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2023)
PermalinkSteunharten bij de behandeling van terminaal hartfalen / Mattias Neyt / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2016)
PermalinkLa stimulation cardiaque chez les patients bradycardes en Belgique / Hans Van Brabandt / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2010)
PermalinkPermalinkTest prénatal non invasif (NIPT) pour la trisomie 21 / Frank Hulstaert / Brussels [Belgium] : KCE = Federaal Kenniscentrum voor de Gezondheidszorg = Centre Fédéral d'Expertise des Soins de Santé = Belgian Health Care Knowledge Centre (2014)
PermalinkThe cost-effectiveness of tiotropium for the treatment of chronic obstructive pulmonary disease (COPD) / Mattias Neyt in European Journal of Health Economics (The), 13(2012)4 ([08/01/2012])
PermalinkThe cost-utility of catheter ablation of atrial fibrillation / Mattias Neyt in BMC cardiovascular disorders, 13(2013)70 ([09/26/2013])
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