Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions
Patient-reported outcomes (PROs) that assess individuals’ perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interv...
| Asıl Yazarlar: | , , , , , , , , , |
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| Materyal Türü: | Journal article |
| Dil: | English |
| Baskı/Yayın Bilgisi: |
Frontiers Media
2022
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| _version_ | 1826307956346454016 |
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| author | Tong, A Oberbauer, R Bellini, MI Budde, K Caskey, FJ Dobbels, F Pengel, L Rostaing, L Schneeberger, S Naesens, M |
| author_facet | Tong, A Oberbauer, R Bellini, MI Budde, K Caskey, FJ Dobbels, F Pengel, L Rostaing, L Schneeberger, S Naesens, M |
| author_sort | Tong, A |
| collection | OXFORD |
| description | Patient-reported outcomes (PROs) that assess individuals’ perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient’s perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020. |
| first_indexed | 2024-03-07T07:10:56Z |
| format | Journal article |
| id | oxford-uuid:7ea67464-bb3f-47d4-9744-68614e2fb2d9 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:10:56Z |
| publishDate | 2022 |
| publisher | Frontiers Media |
| record_format | dspace |
| spelling | oxford-uuid:7ea67464-bb3f-47d4-9744-68614e2fb2d92022-06-29T09:32:26ZPatient-reported outcomes as endpoints in clinical trials of kidney transplantation interventionsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:7ea67464-bb3f-47d4-9744-68614e2fb2d9EnglishSymplectic ElementsFrontiers Media2022Tong, AOberbauer, RBellini, MIBudde, KCaskey, FJDobbels, FPengel, LRostaing, LSchneeberger, SNaesens, MPatient-reported outcomes (PROs) that assess individuals’ perceptions of life participation, medication adherence, disease symptoms, and therapy side effects are extremely relevant in the context of kidney transplantation. All PROs are potentially suitable as primary or secondary endpoints in interventional trials that aim to improve outcomes for transplant recipients. Using PRO measures (PROMs) in clinical trials facilitates assessment of the patient’s perspective of their health, but few measures have been developed and evaluated in kidney transplant recipients; robust methodologies, which use validated instruments and established frameworks for reporting, are essential. Establishing a core PROM for life participation in kidney transplant recipients is a critically important need, which is being developed and validated by the Standardized Outcomes in Nephrology (SONG)-Tx Initiative. Measures involving electronic medication packaging and smart technologies are gaining traction for monitoring adherence, and could provide more robust information than questionnaires, interviews, and scales. This article summarizes information on PROs and PROMs that was included in a Broad Scientific Advice request on clinical trial design and endpoints in kidney transplantation. This request was submitted to the European Medicines Agency (EMA) by the European Society for Organ Transplantation in 2016. Following modifications, the EMA provided its recommendations in late 2020. |
| spellingShingle | Tong, A Oberbauer, R Bellini, MI Budde, K Caskey, FJ Dobbels, F Pengel, L Rostaing, L Schneeberger, S Naesens, M Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
| title | Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
| title_full | Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
| title_fullStr | Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
| title_full_unstemmed | Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
| title_short | Patient-reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
| title_sort | patient reported outcomes as endpoints in clinical trials of kidney transplantation interventions |
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