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Scientific Evidence in Health Technology Assessment. Reports: An In-Depth Analysis of European Assessments on High-Risk Medical Devices.
Autor | Olberg B, Fuchs S,
Panteli D, Perleth M, Busse
R |
Journal | Value
in Health, December 2017, Volume 20, Issue 10, Pages 1420-1426,
DOI: dx.doi.org/10.1016/j.jval.2017.05.011
[1] |
Abstract
The aim of this study was to examine the scientific evidence
on clinical effectiveness and safety used in health technology
assessments (HTAs) of high-risk medical devices (MDs) in
Europe.
We applied a systematic approach to identify European
institutions involved in HTA and to select reports assessing MDs
considered high-risk according to the definition in the new German
health care regulation §137h. Reports published between 2010 and 2015
were considered in our subsequent analysis. We used a structured tool
based on widely accepted methodologic principles from Drummond’s
framework to extract key information on the clinical evidence
considered in the reports.
Out of 1376 identified reports, 93 were eligible for analysis.
All reports based their assessment primarily on direct evidence, in
most cases (68%) identified through an independent systematic
literature search. In more than half the identified studies considered
in the reports, clinical evidence for demonstration of effectiveness
and safety was of moderate or low quality. Even when systematic
reviews and randomized controlled trials were available for
assessment, most studies showed an unclear or high risk of
bias.
This study confirms that the quality of scientific evidence
used in HTA of high-risk MDs is low and therefore the use of evidence
needs improvement. The European Commission recently updated the
regulation on MDs but mainly focused on the safety of materials and
the CE (Conformité Européene [European Conformity]) mark. Our
results show that additional changes are necessary, specifically with
regard to the marketing authorization process of MDs, with stricter
quality requirements based on methodologically robust trials, possibly
in combination with other evidence sources.
Keywords: Europe, health technology
assessment, medical devices, scientific evidence
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