Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation

Autor: Braden J. Manns, Brenda R. Hemmelgarn, John S. Gill, Michelle A. Josephson, Klemens Budde, Lionel Rostaing, Wim Van Biesen, Bénédicte Sautenet, Germaine Wong, Allison Tong, Wolfgang C. Winkelmayer, Nicole Evangelidis, Jonathan C. Craig, Lorna Marson, Anthony N. Warrens, Sally Crowe, Tess Harris, Timothy L. Pruett, Martin Howell, Peter P. Reese, David C. Wheeler, Peter Tugwell, David Rosenbloom, Jeremy R. Chapman
Přispěvatelé: Department of Nephrology [Berlin, Germany], Charité - UniversitätsMedizin = Charité - University Hospital [Berlin], Service de Néphrologie - Hypertension Artérielle Dialyse - Transplantation, CHU Toulouse [Toulouse]-Hôpital de Rangueil, CHU Toulouse [Toulouse], Imperial College London, Ciliopathy Alliance, University of Ottawa [Ottawa], Renal Division, Ghent, Ghent University Hospital, Centre Hospitalier Régional Universitaire de Tours (CHRU TOURS), Université Francois Rabelais [Tours], MethodS in Patients-centered outcomes and HEalth ResEarch (SPHERE), Université de Tours-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques, Université de Nantes (UN)-Université de Nantes (UN), Centre Hospitalier Régional Universitaire de Tours (CHRU Tours), Université de Tours (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR des Sciences Pharmaceutiques et Biologiques
Jazyk: angličtina
Rok vydání: 2016
Předmět:
Zdroj: Transplantation Direct
Transplantation Direct, 2016, 2 (6), pp.e79. ⟨10.1097/TXD.0000000000000593⟩
TRANSPLANTATION DIRECT
2016, ' Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation ', Transplantation Direct, vol. 2, no. 6 . https://doi.org/10.1097/TXD.0000000000000593
ISSN: 2373-8731
DOI: 10.1097/TXD.0000000000000593⟩
Popis: Background: While advances in treatment have dramatically improved short-term graft survival and acute rejection in kidney transplant recipients, long-term graft outcomes have not substantially improved. Transplant recipients also have a considerably increased risk of cancer, cardiovasculardisease, diabetes, and infection, which all contribute to appreciable morbidity and premature mortality. Many trials in kidney transplantation are short-term, frequently use un-validated surrogate endpoints, outcomes of uncertain relevance to patients and clinicians, and do not consistently measure and report key outcomes like death, graft loss, graft function, and adverse effects of therapy. This diminishes the value of trials in supporting treatment decisions that require individual-level multiple trade-offs between graft survival and the risk of side effects, adverse events, and mortality. The StandardizedOutcomes in Nephrology –Transplantation (SONG-Tx) initiative aims to develop a core outcome set for trials in kidney transplantation that is based on the shared priorities of all stakeholders.Methods: This will include a systematic review to identify outcomes reported in randomized trials, a Delphi survey with an international multi-stakeholder panel (patients, caregivers, clinicians, researchers, policy makers, members from industry) to develop a consensus-based prioritized list of outcome domains, and a consensus workshop to review and finalize the core outcome set for trials in kidney transplantation.Conclusions: Developing and implementing a core outcome set to be reported, at a minimum, in all kidney transplantation trials will improve the transparency, quality and relevance of research; to enable kidney transplant recipients and their clinicians to make better informed treatment decisions for improved patient outcomes.
Databáze: OpenAIRE
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