Article
How evidence-based is our medicine? An investigation of the relationship between evidence and utilization of innovations in hospitals using the example of coronary bioresorbable scaffolds
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Authors
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Helene Eckhardt
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Susanne Felgner
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Tanja Rombey
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Marie Böcker
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Hanna Ermann
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Hendrikje Lantzsch
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Cornelia Henschke
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
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Dimitra Panteli
- Technische Universität Berlin, Fachgebiet Management im Gesundheitswesen, Berlin, Deutschland
| Published: | February 23, 2021 |
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Outline
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Background/research question: Even if newly approved medical devices (NMDs) may lead to better patient outcomes, sufficient evidence is often not available when first introduced into the market. However, German hospitals can use every approved technology in inpatient care, excepted those explicitly excluded by the German Federal Joint Committee (G-BA). Using the example of bioresorbable drug-eluting scaffolds (BRS), the study aims at investigating to what extent the utilization of NMDs in German hospitals correlates with the results of the available clinical evidence and with the participation in evidence generation.
Methods: A systematic literature search was conducted in May 2019 in four databases. Additionally, clinical trial registries, Health Technology Assessment (HTA)-databases and different sources of clinical guidelines and funding documentation were searched. Publications of evidence levels I-IV (as defined by the G-BA) published 2010-2017 were included in the analysis. Hospital cases were identified through respective procedure codes having been captured in claims data and hospital quality reports since 2013.
Results: We included 230 publications: 201 publications on primary studies, including 24 publications on 10 RCTs, 27 systematic reviews or meta-analyses (SR/MA) and two HTAs. Between 2013 and 2017, 23,586 cases were treated in 357 hospitals. The number of cases increased from 5,100 in 2013 to its maximum of 7,494 cases in 2014, and then dropped to 1,016 cases in 2017. The increase in the period 2013–2014 was accompanied by mostly small, non-controlled trials reporting mainly positive results of the use of BRS in coronary heart disease. The period 2015–2017 was characterized by the publication of an increasing number of RCTs, SR/MA and HTAs with unfavourable results for BRS. In 2017, negative results at 2-year follow-up in the AIDA RCT (1,845 patients) were published. Despite the decreasing use of BRS in German hospitals over the period 2015–2017, BRS was, contrary to expectations, not reserved for exclusive use in clinical trials, as each year about 40% of cases were treated outside a clinical trial.
Conclusion: Several insights can be derived from the results: 1) Reliable evidence was only available 5 years after the market launch; 2) Negative results became apparent at a longer follow-up (2–5 years); 3) there is a reason to assume an effect of the evidence on the use of BRS in German hospitals; 4) given the current regulation, a large number of hospitals seem not to react (promptly) to negative evidence.
Competing interests: None.
