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Core Patient-Reported Outcomes for Trials in Nephrology.
Anastasia Hughes1, Nicole Scholes-Robertson1, Angela Ju1
1Sydney School of Public Health, University of Sydney, Sydney, Australia; Centre for Kidney Research, Children's Hospital at Westmead, Sydney, Australia.
Seminars in Nephrology
|September 17, 2024
Summary
Chronic kidney disease (CKD) trials often lack patient-relevant outcomes. The Standardized Outcomes in Nephrology (SONG) initiative developed core outcome sets, prioritizing patient-reported outcomes like fatigue and pain, to improve trial relevance.
Area of Science:
- Nephrology
- Clinical Trials
- Patient-Reported Outcomes
Background:
- Outcomes in chronic kidney disease (CKD) trials are highly variable and often use unvalidated surrogate endpoints.
- This variability and lack of patient-relevant outcomes diminish the value of trials for treatment decisions.
Purpose of the Study:
- To address the variability and lack of patient-centered outcomes in CKD trials.
- To introduce the concept and development of core outcome sets for kidney disease research.
- To highlight the importance and implementation of patient-reported outcomes (PROs) in clinical trials.
Main Methods:
- Development of core outcome sets through consensus among patients, caregivers, and health professionals.
- The Standardized Outcomes in Nephrology (SONG) initiative established seven core outcome sets for various CKD stages.
- Identification of key patient-reported outcomes such as fatigue, life participation, and pain.
Main Results:
- Seven core outcome sets have been developed by the SONG initiative for different stages of CKD.
- Each core outcome set includes at least one patient-reported outcome.
- Established PROs include fatigue (hemodialysis), life participation (kidney transplantation, peritoneal dialysis, early CKD, pediatric CKD, glomerular disease), and pain (polycystic kidney disease).
Conclusions:
- Patient-reported outcomes are crucial for improving the relevance and consistency of trial reporting in kidney disease.
- Implementing core outcome sets, including PROs, will enhance the value of CKD trials for patients and caregivers.
- Standardized outcome reporting is essential for advancing kidney disease research and patient care.
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