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A normalized quality of life approach for regulatory approval of medical devices

Year: 2024

Type: article

Abstract: Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of treatment on patients’ symptoms, function and quality of life. High-quality PRO data from trials can inform shared decisionmaking, regulatory and economic analyses and health policy. The heterogeneity between the patient groups and the associated differences in morbidity and quality of life can be taken into account by standardization to the general population. As a result, our study shows that despite the retrospective design with the corresponding level of evidence, mesh repair of a ventral hernia leads to an equivalent result compared to tissue hernia surgery.

Source: Current Directions in Biomedical Engineering

DOI: 10.1515/cdbme-2024-2104

Authors: Matthias Leuchter, Mark Philipp, Stefan Siewert, Clemens Schafmayer, Klaus-Peter Schmitz, Sebastian Kaule

Institutions: Institute for ImplantTechnology and Biomaterials, Universitätsmedizin Rostock

Language: English

Topic: Health Systems, Economic Evaluations, Quality of Life

Subfield: Economics and Econometrics

Field: Economics, Econometrics and Finance

Domain: Social Sciences

SDG: Good health and well-being

Open Access status: diamond

OpenAlex ID: W4405554733

FWCI:

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