Back
Clinical trials in patients with chronic kidney disease report a diverse range of outcomes that may not always reflect the priorities of patients, their families, and clinicians. The Standardized Outcomes in Nephrology-Chronic Kidney Disease (SONG-CKD) initiative aimed to establish a consensus-based core outcomes set to facilitate consistent reporting of critically important outcomes.
We held two international SONG-CKD consensus workshops using Zoom videoconference in March 2021 (in English) and October 2021 (in Spanish). A total of 65 patients/caregivers and 90 health professionals participated in two workshops to discuss the development and implementation of a potential core outcome set for trials in CKD before the need for kidney replacement therapy (mortality, kidney function, life participation and cardiovascular disease).
Three themes that related to the development of core outcome domains were identified: reflecting a comprehensive approach to health, facilitating patient empowerment in their own care, ensuring applicability to broad geographic areas and populations. Feasibility for implementation was the fourth theme including standardising definitions and measures, harnessing the patient-centred culture and engaging triallists, industry and regulators.
The core outcomes for CKD have been established as mortality, kidney function, life participation, and cardiovascular disease.