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.
AimThe Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD) aims to establish a consensus-based core outcome set for all trials in patients with CKD not yet requiring kidney replacement therapy to ensure outcomes of relevance to patients, caregivers an health professionals are consistently reported in trials. SONG-CKD involves four phases: a systematic review to identify outcomes (domains and measures) that have been reported in randomised controlled trials involving adults with CKD who do not require kidney replacement therapy; stakeholder key informant interviews with health professionals involved in care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an international two-round online Delphi survey with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and a stakeholder workshop to review and finalise the set of core outcome domains for trials in CKD.
ContributorsAndrea Matus Gonzalez, Rosanna Cazzolli, Magdalena Madero, Nicole Evangelidis, Martin Howell, Benedicte Sautenet, Amelie Bernier-Jean, Yeoungjee Cho, Laura Cortes Sanabria, Jonathan C Craig, Ian H de Boer, Samuel Fung, Daniel Gallego, Chandana Guha, Jenny I Shen, Andrew S Levey, Adeera Levin, Eduardo Lorca, Sebastian Cabrera, Haydee Mellado, Soledad Molina, Ximena Atilano, Lorena Sandino, Macarena Arancibia, Alejandro Sepulveda, Marcelo Urra, Maria de Los Angeles Bravo, Karine Manera, Javier Recabarren, Ikechi G Okpechi, Patrick Rossignol, Nicole Scholes-Robertson, Laura Sola, Armando Teixeira-Pinto, Tim Usherwood, Andrea K Viecelli, David C Wheeler, Katherine Widders, Allison Jaure; SONG-CKD Stakeholder Workshop Investigators
Disease Category: Kidney disease
Disease Name: Chronic kidney disease
Age Range: 18 - 120
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Governmental agencies
- Patient/ support group representatives
- Policy makers
- Researchers
- Prioritising
- Consensus meeting
- Delphi process
- Interview
- Systematic review
SONG-CKD involves four phases: a systematic review, stakeholder key informant interviews, an online international Delphi survey, and a consensus workshop.