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Published on: April 12, 2021
Standardized Outcomes in Nephrology-Transplantation: A Global Initiative to Develop a Core Outcome Set for Trials in
Allison Tong1, Klemens Budde2, John Gill3
1Sydney School of Public Health, The University of Sydney, Sydney, Australia.; Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia.
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.
Insights
Developing a standardized core outcome set for kidney transplantation trials will improve research quality and patient outcomes. This ensures consistent reporting of vital results, aiding informed treatment decisions for transplant recipients.
Area of Science:
- Nephrology
- Transplantation Research
- Clinical Trial Methodology
Background:
- Short-term kidney transplant outcomes have improved, but long-term graft survival remains stagnant.
- Kidney transplant recipients face increased risks of cancer, cardiovascular disease, diabetes, and infection, contributing to morbidity and mortality.
- Current kidney transplant trials often lack standardized, patient-relevant outcome measures, hindering informed treatment decisions.
Purpose of the Study:
- To develop a consensus-based core outcome set for kidney transplantation trials.
- To enhance the transparency, quality, and relevance of research in kidney transplantation.
- To support better-informed treatment decisions for kidney transplant recipients.
Main Methods:
- Systematic review of outcomes reported in randomized kidney transplantation trials.
- International Delphi survey with a multistakeholder panel to prioritize outcome domains.
- Consensus workshop to finalize the core outcome set for clinical trials.
Main Results:
- Identification of key outcomes reported in existing literature.
- Development of a prioritized list of outcome domains through expert consensus.
- Establishment of a finalized core outcome set for kidney transplantation research.
Conclusions:
- A standardized core outcome set will improve the consistency and relevance of kidney transplantation research.
- Implementing this core outcome set will enhance transparency and quality in clinical trials.
- This initiative aims to empower kidney transplant recipients and clinicians with better data for improved patient outcomes.
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