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. 2016 May 19;2(6):e79.
doi: 10.1097/TXD.0000000000000593. eCollection 2016 Jun.

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

Allison Tong  1 , Klemens Budde  2 , John Gill  3 , Michelle A Josephson  4 , Lorna Marson  5 , Timothy L Pruett  6 , Peter P Reese  7 , David Rosenbloom  8 , Lionel Rostaing  9 , Anthony N Warrens  10 , Germaine Wong  11 , Jonathan C Craig  1 , Sally Crowe  12 , Tess Harris  13 , Brenda Hemmelgarn  14 , Braden Manns  14 , Peter Tugwell  15 , Wim Van Biesen  16 , David C Wheeler  17 , Wolfgang C Winkelmayer  18 , Nicole Evangelidis  1 , Benedicte Sautenet  19 , Martin Howell  1 , Jeremy R Chapman  20
Affiliations

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

Allison Tong et al. Transplant Direct. .

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.

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Conflict of interest statement

The authors declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Conceptual schema of core outcomes.
FIGURE 2
FIGURE 2
SONG-Tx process.
See this image and copyright information in PMC

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