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

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, cardiovascular
disease, 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 Standardized
Outcomes 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.