A Core Outcome Set for Trials in CKD: Report of the Standardized Outcomes in Nephrology-Chronic Kidney Disease (SONG-CKD) Stakeholder Workshops

Abstract

Omitting outcomes of importance to patients with chronic kidney disease (CKD) and their caregivers from trials can impede decision making based on patient-centered outcomes. As part of the global Standardized Outcomes in Nephrology-Chronic Kidney Disease (SONG-CKD) initiative, we established a consensus-based set of core outcomes for trials in CKD (prior to the need for kidney replacement therapy). To finalize the proposed set of core outcomes that were identified through focus groups and an international Delphi survey, we convened 2 international stakeholder workshops in English and Spanish languages that involved 61 patients/caregivers and 75 health professionals from 18 countries. Participants were asked to discuss and endorse the potential core outcomes (mortality, kidney function, life participation, and cardiovascular disease), and to provide suggestions for implementing the core outcomes. The discussions were summarized into 4 themes: reflecting a comprehensive approach to health, facilitating patient empowerment in their own care, ensuring applicability to broad geographic areas and populations, and feasibility for implementation. 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.

Keywords: Chronic kidney disease; core outcome set; outcomes; patient-centered care; trials.