gms | German Medical Science

20. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin e. V.

Deutsches Netzwerk Evidenzbasierte Medizin e. V.

21. - 23.03.2019, Berlin

The Wearable Cardioverter-Defibrillator (WCD) for the prevention of sudden cardiac death in patients at risk: a systematic review of the clinical effectiveness and safety

Meeting Abstract

  • Gregor Goetz - Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Österreich
  • Massimiliano Orso - National Agency for Regional Health Services (AGENAS), Italien
  • Michal Stanak - Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Österreich
  • Emilio Chiarolla - National Agency for Regional Health Services (AGENAS), Italien
  • Claudia Wild - Ludwig Boltzmann Institute for Health Technology Assessment (LBI-HTA), Österreich
  • Tom Jefferson - National Agency for Regional Health Services (AGENAS), Italien

EbM und Digitale Transformation in der Medizin. 20. Jahrestagung des Deutschen Netzwerks Evidenzbasierte Medizin. Berlin, 21.-23.03.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. Doc19ebmP-EG01-09

doi: 10.3205/19ebm044, urn:nbn:de:0183-19ebm0442

Veröffentlicht: 20. März 2019

© 2019 Goetz et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background/research question: The evidence regarding the wearable cardioverter defibrillator was assessed in 2016 by the LBI-HTA within a EUnetHTA project and by the Spanish Avalia-t in 2018 as an update assessment. Both reports highlighted the lack of sound scientific evidence and concluded that results from randomised controlled trials (RCTs) are necessary to prove the (comparative) effectiveness and safety of the device in a solid manner.

Due to ongoing research in the field of the WCD and new results from a previously conducted RCT, there is a need for another assessment of the most recent evidence on the use of the WCD.

This project aims at synthesising the current available evidence on the clinical effectiveness and safety of the WCD to be used for preventing sudden cardiac deaths in patients at risk.

Methods: Relevant studies were identified through a systematic literature search in three databases [Cochrane (CENTRAL), Embase, PubMed]. In addition, a hand-search was conducted and manufacturers were contacted for further information.

The EUnetHTA Core Model® was applied as the methodological framework. Two review authors (MO, GG) screened the abstracts independently and evaluated their eligibility to be included in the assessment. In case of disagreement, a third researcher was consulted (TJ). The critical appraisal (=risk of bias assessment) was conducted by two researchers (GG, MO) using the EUnetHTA® Guidelines. For RCTs, the Cochrane risk of bias tool was applied, while the Institute of Health Economics (IHE) checklist was utilised to assess the risk of bias for observational studies. Data of the included studies was then extracted systematically by one researcher (MO) and verified by another researcher (GG). The strength of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.

For the evidence synthesis, a qualitative approach was selected. Because only one RCT was retrieved, it is impossible to perform inferential statistical analysis.

Preliminary or expected results, outlook: To date (October 2018), the evidence synthesis is still ongoing. However, one recent RCT was included that will allow evidence-based conclusions on the comparative effectiveness and safety of the device.