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  • BACKGROUND: Health Technology Assessment is an established term, while technology means prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained (www.inahta.org) or, in other words, interventions that may be used to promote health, to prevent, diagnose or treat acute or chronic disease, or for rehabilitation (http://htaglossary.net). Although the term technology suggests a link to engineering, HTA is not much utilized to medical devices. Out of 812 contributions accepted to the HTAi 2012 Annual Meeting in Bilbao, only 39 (4.8 %) dealt primarily with medical devices. Similar figures can be obtained generally. The objective of this paper is to articulate reasons of this situation, discuss related problems, and to recommend solutions. METHODS AND CONCLUSIONS: Medical devices can be divided to those applied to a single patient (usually therapeutically), and those used repeatedly (often for diagnostic purposes or in surgery). While the former group allows assessment of clinical outcomes similarly as in drugs, the situation is much more complex in the latter group. These are usually expensive technologies requiring also the perspective of the hospital or region as a whole. Thus, the main goal of HTA studies is not maximization of cost-effectiveness ratio, but a decision about procurement and/or incorporation of the device. The clinical benefit is not expressed in terms of quality of life, but in the rate of diagnostic yield, and in the measure it makes the therapy shorter and/or more patient-friendly. An important issue is also the moral lifetime of the device; rapid upgrades pressurize the researchers into assessing devices immediately, without much experience, and in a shorter time, which does not allow for extended clinical experiments. The paper studies these issues in depth, and recommends utilization of appropriate methods.
  • BACKGROUND: Health Technology Assessment is an established term, while technology means prevention and rehabilitation, vaccines, pharmaceuticals and devices, medical and surgical procedures, and the systems within which health is protected and maintained (www.inahta.org) or, in other words, interventions that may be used to promote health, to prevent, diagnose or treat acute or chronic disease, or for rehabilitation (http://htaglossary.net). Although the term technology suggests a link to engineering, HTA is not much utilized to medical devices. Out of 812 contributions accepted to the HTAi 2012 Annual Meeting in Bilbao, only 39 (4.8 %) dealt primarily with medical devices. Similar figures can be obtained generally. The objective of this paper is to articulate reasons of this situation, discuss related problems, and to recommend solutions. METHODS AND CONCLUSIONS: Medical devices can be divided to those applied to a single patient (usually therapeutically), and those used repeatedly (often for diagnostic purposes or in surgery). While the former group allows assessment of clinical outcomes similarly as in drugs, the situation is much more complex in the latter group. These are usually expensive technologies requiring also the perspective of the hospital or region as a whole. Thus, the main goal of HTA studies is not maximization of cost-effectiveness ratio, but a decision about procurement and/or incorporation of the device. The clinical benefit is not expressed in terms of quality of life, but in the rate of diagnostic yield, and in the measure it makes the therapy shorter and/or more patient-friendly. An important issue is also the moral lifetime of the device; rapid upgrades pressurize the researchers into assessing devices immediately, without much experience, and in a shorter time, which does not allow for extended clinical experiments. The paper studies these issues in depth, and recommends utilization of appropriate methods. (en)
Title
  • Health technology assessment applied to medical devices
  • Health technology assessment applied to medical devices (en)
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  • Health technology assessment applied to medical devices
  • Health technology assessment applied to medical devices (en)
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  • RIV/68407700:21460/13:00205723!RIV14-MZ0-21460___
http://linked.open...avai/riv/aktivita
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  • P(NT11532), P(NT14473)
http://linked.open...vai/riv/dodaniDat
http://linked.open...aciTvurceVysledku
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  • 77129
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  • RIV/68407700:21460/13:00205723
http://linked.open...riv/jazykVysledku
http://linked.open.../riv/klicovaSlova
  • HTA; medical devices (en)
http://linked.open.../riv/klicoveSlovo
http://linked.open...ontrolniKodProRIV
  • [D1D0196C72BE]
http://linked.open...in/vavai/riv/obor
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http://linked.open...vavai/riv/projekt
http://linked.open...UplatneniVysledku
http://linked.open...iv/tvurceVysledku
  • Rogalewicz, Vladimír
  • Juřičková, Ivana
  • Mezerová, Veronika
http://localhost/t...ganizacniJednotka
  • 21460
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