title: Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in Kidney Transplantation.
abstract: BACKGROUND
  Although 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, cardiovascular disease, diabetes, and infection, which all contribute to appreciable morbidity and premature mortality. Many trials in kidney transplantation are short-term, frequently use unvalidated 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 tradeoffs between graft survival and the risk of side effects, adverse events, and mortality. The Standardized Outcomes in Nephrology-Transplantation 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 multistakeholder 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.
authors: Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
authors: Allison
authors: A
authors: Tong
authors: Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.
authors: Klemens
authors: K
authors: Budde
authors: Division of Nephrology, University of British Columbia, Vancouver, Canada.
authors: John
authors: J
authors: Gill
authors: Department of Medicine, The University of Chicago, Chicago, IL.
authors: Michelle A
authors: MA
authors: Josephson
authors: Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.
authors: Lorna
authors: L
authors: Marson
authors: Department of Surgery, University of Minnesota, Minneapolis, MN.
authors: Timothy L
authors: TL
authors: Pruett
authors: Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.
authors: Peter P
authors: PP
authors: Reese
authors: ESRD Network 18, Los Angeles, CA.
authors: David
authors: D
authors: Rosenbloom
authors: Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.
authors: Lionel
authors: L
authors: Rostaing
authors: School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
authors: Anthony N
authors: AN
authors: Warrens
authors: Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.
authors: Germaine
authors: G
authors: Wong
authors: Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
authors: Jonathan C
authors: JC
authors: Craig
authors: Crowe Associates Ltd, Oxford, United Kingdom.
authors: Sally
authors: S
authors: Crowe
authors: PKD International, London, United Kingdom.
authors: Tess
authors: T
authors: Harris
authors: Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.
authors: Brenda
authors: B
authors: Hemmelgarn
authors: Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.
authors: Braden
authors: B
authors: Manns
authors: Department of Medicine, University of Ottawa, Ottawa, Canada.
authors: Peter
authors: P
authors: Tugwell
authors: Renal Division, Ghent University Hospital, Ghent, Belgium.
authors: Wim
authors: W
authors: Van Biesen
authors: Centre for Nephrology, University College London, London, United Kingdom.
authors: David C
authors: DC
authors: Wheeler
authors: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
authors: Wolfgang C
authors: WC
authors: Winkelmayer
authors: Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
authors: Nicole
authors: N
authors: Evangelidis
authors: Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.; Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.
authors: Benedicte
authors: B
authors: Sautenet
authors: Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
authors: Martin
authors: M
authors: Howell
authors: Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.
authors: Jeremy R
authors: JR
authors: Chapman