A CORE OUTCOME SET FOR TRIALS IN CHRONIC KIDNEY DISEASE: REPORT OF THE STANDARDIZED OUTCOMES IN NEPHROLOGY – CHRONIC KIDNEY DISEASE (SONG-CKD) STAKEHOLDER WORKSHOPS
Miss Andrea Matus1, Mrs Rosanna Cazzolli1,2, Mrs Magdalena Madero3, Mrs Nicole Evangelidis1,2, Mr Martin Howell1,2, Mrs Allison Jaure1,2
1Sydney School of Public Health, The University of Sydney, Sydney, Sydney, Australia, 2Centre for Kidney Research, The Children’s Hospital at Westmead, Sydney, Australia, 3Division of Nephrology, Department of Medicine, Instituto Nacional de Cardiología Ignacio Chávez, México City, Mexico
Aim: As part of the global Standardized Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD) initiative, we aimed to establish a consensus-based set of core outcomes for trials in CKD (prior to the need for kidney replacement therapy).
Background: The omission of outcomes of importance to patients with chronic kidney disease (CKD) and their caregivers from trials can impede decision-making based on patient-centered outcomes.
Methods: In nephrology, the global Standardized Outcomes in Nephrology (SONG) initiative commenced in 2015 and has since established core outcome sets for haemodialysis, kidney transplantation, peritoneal dialysis, children with CKD, polycystic kidney disease, and glomerular disease. Most recently, the SONG-CKD was launched to establish core outcomes for trials in patients with CKD not requiring kidney replacement therapy. To finalize the set of core outcome domains for CKD, we convened two international multistakeholder workshops in English and Spanish language to discuss the proposed core outcomes that were identified through focus groups with nominal group technique conducted in four countries, an international Delphi survey, which collectively involved over 383 patients/caregivers and 407 health professionals from 63 countries.
Results: The discussions on establishing and implementing core outcomes for CKD are summarized into four themes:
- Reflecting a comprehensive approach to health
- Facilitating patient empowerment in their own care
- Ensuring applicability to broad geographic areas and populations
- Feasibility for implementation.
Conclusion: Patients, caregivers, and health professionals agreed that mortality, kidney function, life participation and cardiovascular disease should be established as core outcomes for trials in CKD.
Presentation Slides PDF – Click here
Biography:
Andrea Matus Gonzalez is a renal dietitian from Chile currently living in Sydney, PhD candidate and Research assistant in the Centre for Kidney Research at Sydney University. Andrea is a member of the global SONG initiative, currently working as a project coordinator for the SONG-Chronic Kidney Disease study, establishing a core outcome set for trials in patients with chronic kidney disease and not requiring kidney replacement therapy.