Health technology assessment of medical devices: What is different? An overview of three European projects

Zeitschrift fur Evidenz, Fortbildung und Qualitat im Gesundheitswesen

Volumn 109, Issue 4-5, 2015, Pages 309-318

  Schnell Inderst, Petra ^a   Mayer, Julia ^b   Lauterberg, Jörg ^c   Hunger, Theresa ^a   Arvandi, Marjan ^a   Conrads Frank, Annette ^a   Nachtnebel, Anna ^b   Wild, Claudia ^b   Siebert, Uwe ^a,d,e  

^a UNIVERSITY FOR HEALTH SCIENCES   (Austria)

^b LUDWIG BOLTZMANN INSTITUTE FOR LUNG VASCULAR RESEARCH   (Austria)

^c INSTITUTE FOR QUALITY AND EFFICIENCY IN HEALTH CARE IQWIG   (Germany)

^d HARVARD SCHOOL OF PUBLIC HEALTH   (United States)

^e MASSACHUSETTS GENERAL HOSPITAL   (United States)

Author keywords

comparative effectiveness research; equipment and supplies; international cooperation; Technology assessment, biomedical

Indexed keywords

BIOMEDICAL TECHNOLOGY ASSESSMENT; COOPERATION; DEVICES; EUROPE; HUMAN; INTERDISCIPLINARY COMMUNICATION; ORGANIZATION; PROCEDURES;

COOPERATIVE BEHAVIOR; DECISION MAKING, ORGANIZATIONAL; EQUIPMENT AND SUPPLIES; EUROPE; HUMANS; INTERDISCIPLINARY COMMUNICATION; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 84941261325     PISSN: 18659217     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.zefq.2015.06.011     Document Type: Article

References (36)

1. HAS Methodological Choices for the Clinical Development of Medical Devices 2013 Haute Autorité de Santé Saint-Denis La Plaine
2. R. Mears, R. Taylor, P. Littlejohns, and A. Dillon Review of International Health Technology Assessment (IHTA) 2000 National Institute for Clinical Excellence (NICE) London
3. HAS Methodological Choices for the Clinical Development of Medical Devices. 2013
4. NICE Medical Technologies Evaluation Programme. 2011
5. Elaborating Studies for the Assessment of Medical Care Equipment Ministry of Health of Brazil 2013
6. C. Sorenson, R. Tarricone, M. Siebert, and M. Drummond Applying health economics for policy decision making: do devices differ from drugs? Europace. 13 Suppl 2 2011 ii54 ii58 Epub 2011/04/29
7. M. Drummond, A. Griffin, and R. Tarricone Economic evaluation for devices and drugs-same or different? Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research. 12 4 2009 402 404 Epub 2009/01/14
8. R.S. Taylor, and C.P. Iglesias Assessing the clinical and cost-effectiveness of medical devices and drugs: are they that different? Value in health: the journal of the International Society for Pharmacoeconomics and Outcomes Research. 12 4 2009 404 406 Epub 2009/01/14
9. J.M. Schulenburg Graf v.d., T. Mittendorf, W. Kulp, and W. Greiner Health Technology Assessment (HTA) im Bereich der Medizinprodukte - gleiches Spiel mit gleichen Regeln? Gesundh ökon Qual manag. 14 3 2009 144 155
10. EUnetHTA Joint Action 2 Workpackage 8. HTA Core Model version 2.0 2013. Available from: http://www.corehta.info/BrowseModel.aspx.
11. FDA Design Considerations for Pivotal Clinical Investigations for Medical Devices Draft Guidance for Industry, Clinical Investigators, and Food and Drug Administration Staff. 2011
12. M.N. Wente [Barriers to clinical studies involving medical devices] Z Evid Fortbild Qual Gesundhwes. 106 5 2012 Epub 2012/07/24. Hurden bei Studien mit Medizinprodukten
13. M. Siebert, L.C. Clauss, M. Carlisle, B. Casteels, P. de Jong, M. Kreuzer, and et al. Health technology assessment for medical devices in Europe. What must be considered Int J Technol Assess Health Care. 18 3 2002 733 740 Epub 2002/10/24
14. J.A. Cook, C.R. Ramsay, and P. Fayers Statistical evaluation of learning curve effects in surgical trials Clin Trials. 1 5 2004 421 427 Epub 2005/11/11
15. G. Mowatt, D.J. Bower, J.A. Brebner, J.A. Cairns, A.M. Grant, and L. McKee When and how to assess fast-changing technologies: a comparative study of medical applications of four generic technologies Health Technol Assess. 1 14 1997 i vi 1-149. Epub 1997/01/01
16. H.C. Sox, and S. Greenfield Comparative effectiveness research: a report from the Institute of Medicine Annals of internal medicine. 151 3 2009 203 205
17. J.A. Cook, P. McCulloch, J.M. Blazeby, D.J. Beard, D. Marinac-Dabic, and A. Sedrakyan IDEAL framework for surgical innovation 3: randomised controlled trials in the assessment stage and evaluations in the long term study stage BMJ. 346 2013 f2820 Epub 2013/06/20
18. P.L. Ergina, J.S. Barkun, P. McCulloch, J.A. Cook, and D.G. Altman IDEAL framework for surgical innovation 2: observational studies in the exploration and assessment stages BMJ. 346 2013 f3011 Epub 2013/06/20
19. P. McCulloch, D.G. Altman, W.B. Campbell, D.R. Flum, P. Glasziou, J.C. Marshall, and et al. No surgical innovation without evaluation: the IDEAL recommendations Lancet. 374 9695 2009 1105 1112 Epub 2009/09/29
20. P. McCulloch, J.A. Cook, D.G. Altman, C. Heneghan, and M.K. Diener IDEAL framework for surgical innovation 1: the idea and development stages BMJ. 346 2013 f3012 Epub 2013/06/20
21. P. Bonangelino, T. Irony, S. Liang, X. Li, V. Mukhi, S. Ruan, and et al. Bayesian approaches in medical device clinical trials: a discussion with examples in the regulatory setting J Biopharm Stat. 21 5 2011 938 953 Epub 2011/08/13
22. A. Sedrakyan, D. Marinac-Dabic, S.L. Normand, A. Mushlin, and T. Gross A framework for evidence evaluation and methodological issues in implantable device studies Medical care. 48 6 Suppl 2010 S121 S128 Epub 2010/04/28
23. C.R. Ramsay, A.M. Grant, S.A. Wallace, P.H. Garthwaite, A.F. Monk, and I.T. Russell Statistical assessment of the learning curves of health technologies Health Technol Assess. 5 12 2001 1 79 Epub 2001/04/26
24. C.R. Ramsay, S.A. Wallace, P.H. Garthwaite, A.F. Monk, I.T. Russell, and A.M. Grant Assessing the learning curve effect in health technologies. Lessons from the nonclinical literature Int J Technol Assess Health Care. 18 1 2002 1 10 Epub 2002/05/04
25. R.J. Lilford, D.A. Braunholtz, R. Greenhalgh, and S.J. Edwards Trials and fast changing technologies: the case for tracker studies BMJ. 320 7226 2000 43 46 Epub 2000/01/05
26. M. Petticrew, L. Anderson, R. Elder, J. Grimshaw, D. Hopkins, R. Hahn, and et al. Complex interventions and their implications for systematic reviews: a pragmatic approach Journal of clinical epidemiology. 66 11 2013 1209 1214 Epub 2013/08/21
27. M. Petticrew, E. Rehfuess, J. Noyes, J.P. Higgins, A. Mayhew, T. Pantoja, and et al. Synthesizing evidence on complex interventions: how meta-analytical, qualitative, and mixed-method approaches can contribute Journal of clinical epidemiology. 66 11 2013 1230 1243 Epub 2013/08/21
28. T. Pigott, and S. Shepperd Identifying, documenting, and examining heterogeneity in systematic reviews of complex interventions Journal of clinical epidemiology. 66 11 2013 1244 1250 Epub 2013/08/21
29. P. Tugwell, J.A. Knottnerus, and L. Idzerda Complex interventions-how should systematic reviews of their impact differ from reviews of simple or complicated interventions? Journal of clinical epidemiology. 66 11 2013 1195 1196 Epub 2013/10/02
30. C. Stettler, S. Wandel, S. Allemann, A. Kastrati, M.C. Morice, A. Schomig, and et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis Lancet. 370 9591 2007 937 948 Epub 2007/09/18
31. T. Palmerini, G. Biondi-Zoccai, D. Della Riva, C. Stettler, D. Sangiorgi, F. D'Ascenzo, and et al. Stent thrombosis with drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis Lancet. 379 9824 2012 1393 1402 Epub 2012/03/27
32. NICE. Guide to the processes of technology appraisal. Available from: http://www.nice.org.uk/article/pmg19/chapter/2-selection-of-technologies.: 2014.
33. M. Eikermann, C. Gluud, M. Perleth, C. Wild, S. Sauerland, I. Gutierrez-Ibarluzea, and et al. Commentary: Europe needs a central, transparent, and evidence based regulation process for devices BMJ. 346 2013 f2771
34. L. Krüger, S. Evers, M. Hiligsmann, and C. Wild Divergent evidence requirements for authorisation and reimbursement of high-risk medical devices - the European situation Health Policy and Technology. 2014 10.1016/j.hlpt.2014.08.005
35. C. Wild, J. Erdös, and I. Zechmeister-Koss Contrasting clinical evidence for market authorisation of cardio-vascular devices in Europe and USA: A systematic analysis of 10 devices based on Austrian pre-reimbursement assessments BMC Cardiovascular Disorders. 2014 10.1186/1471-2261-14-154
36. F.B. Kristensen Development of European HTA: from Vision to EUnetHTA Michael. 2012 9