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

Tong, Allison MPH, PhD; Budde, Klemens MD; Gill, John MD, MSc; Josephson, Michelle A. MD; Marson, Lorna MBBS, FRCS, MD, FRCPEd; Pruett, Timothy L. MD (Hons); Reese, Peter P. MD, MSCE; Rosenbloom, David; Rostaing, Lionel MD, PhD; Warrens, Anthony N. BM, ChB, DM, PhD; Wong, Germaine MBBS, PhD; Craig, Jonathan C. BMChB, MMed, PhD; Crowe, Sally PG Dip; Harris, Tess; Hemmelgarn, Brenda MD, PhD; Manns, Braden MD, PhD; Tugwell, Peter MBBS, MRCP, LMCC, FRCPC; Van Biesen, Wim MD, PhD; Wheeler, David C. MD; Winkelmayer, Wolfgang C. MD, ScD; Evangelidis, Nicole BSocSc; Sautenet, Benedicte MD, PhD; Howell, Martin PhD; Chapman, Jeremy R. MD, FRCP; on behalf of the SONG-Tx Investigators

doi: 10.1097/TXD.0000000000000593
Study Protocol

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.

1 Sydney School of Public Health, The University of Sydney, Sydney, Australia.

2 Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.

3 Department of Nephrology, Charité-Universitätsmedizin, Berlin, Germany.

4 Division of Nephrology, University of British Columbia, Vancouver, Canada.

5 Department of Medicine, The University of Chicago, Chicago, IL.

6 Transplant Unit, University of Edinburgh, Edinburgh, United Kingdom.

7 Department of Surgery, University of Minnesota, Minneapolis, MN.

8 Renal Division, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA.

9 ESRD Network 18, Los Angeles, CA.

10 Department of Nephrology, Dialysis and Organ Transplantation, Centre Hospitalier Universitaire Rangueil, Toulouse, France.

11 School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.

12 Centre for Transplant and Renal Research, Westmead Hospital, Sydney, Australia.

13 Crowe Associates Ltd, Oxford, United Kingdom.

14PKD International, London, United Kingdom.

15 Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.

16 Department of Medicine, University of Ottawa, Ottawa, Canada.

17 Renal Division, Ghent University Hospital, Ghent, Belgium.

18 Centre for Nephrology, University College London, London, United Kingdom.

19 Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.

20 Department of Nephrology and Clinical Immunology, University Francois Rabelais, Tours, France.

Published online 19 May 2016.

Received 15 February 2016. Revision requested 6 April 2016.

Accepted 9 April 2016.

This project is supported by the National Health and Medical Research Council (NHMRC) Program Grant 1092597. AT is supported by the NHMRC Career Development Fellowship (1106716).

The authors declare no conflicts of interest.

A.T. contributed to the conception and design of the work, drafted the article and is the guarantor. K.B., J.G., M.A.J., L.M., T.L.P., P.P.R., D.R., L.R., A.W., G.W., J.C.C., S.C., T.S., B.H., B.M., P.T., W.V.B., D.W., W.C.W., N.E., B.S., M.H., and J.R.C. contributed to the conception and design of the work, revised the article for important intellectual content, and approved submission of the article.

Correspondence: Allison Tong, PhD, Centre for Kidney Research, The Children's Hospital at Westmead, Westmead NSW 2145, Australia. (allison.tong@sydney.edu.au).

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© 2016 The Authors. Published by Wolters Kluwer Health, Inc.