A normalized quality of life approach for regulatory approval of medical devices
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 hetero...
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| Format: | Article |
| Language: | English |
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De Gruyter
2024-12-01
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| Series: | Current Directions in Biomedical Engineering |
| Subjects: | |
| Online Access: | https://doi.org/10.1515/cdbme-2024-2104 |
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| _version_ | 1846096856409440256 |
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| author | Leuchter Matthias Philipp Mark Siewert Stefan Schafmayer Clemens Schmitz Klaus-Peter Kaule Sebastian |
| author_facet | Leuchter Matthias Philipp Mark Siewert Stefan Schafmayer Clemens Schmitz Klaus-Peter Kaule Sebastian |
| author_sort | Leuchter Matthias |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-3ad73bfbb1b64ed28f0dbfd9b6af40be |
| institution | Kabale University |
| issn | 2364-5504 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | De Gruyter |
| record_format | Article |
| series | Current Directions in Biomedical Engineering |
| spelling | doaj-art-3ad73bfbb1b64ed28f0dbfd9b6af40be2025-01-02T05:56:33ZengDe GruyterCurrent Directions in Biomedical Engineering2364-55042024-12-0110442442710.1515/cdbme-2024-2104A normalized quality of life approach for regulatory approval of medical devicesLeuchter Matthias0Philipp Mark1Siewert Stefan2Schafmayer Clemens3Schmitz Klaus-Peter4Kaule Sebastian5Institute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyDepartment of Surgery,University Medical Center Rostock,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyDepartment of Surgery,University Medical Center Rostock,Rostock, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyInstitute for ImplantTechnology and Biomaterials e.V., Rostock-Warnemünde, GermanyPatient-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.https://doi.org/10.1515/cdbme-2024-2104patient-reported outcomesmedical device regulationregulatory affairs |
| spellingShingle | Leuchter Matthias Philipp Mark Siewert Stefan Schafmayer Clemens Schmitz Klaus-Peter Kaule Sebastian A normalized quality of life approach for regulatory approval of medical devices Current Directions in Biomedical Engineering patient-reported outcomes medical device regulation regulatory affairs |
| title | A normalized quality of life approach for regulatory approval of medical devices |
| title_full | A normalized quality of life approach for regulatory approval of medical devices |
| title_fullStr | A normalized quality of life approach for regulatory approval of medical devices |
| title_full_unstemmed | A normalized quality of life approach for regulatory approval of medical devices |
| title_short | A normalized quality of life approach for regulatory approval of medical devices |
| title_sort | normalized quality of life approach for regulatory approval of medical devices |
| topic | patient-reported outcomes medical device regulation regulatory affairs |
| url | https://doi.org/10.1515/cdbme-2024-2104 |
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