Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease

The 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.

Contributors

Nicole Evangelidis, MPhil (Principal Investigator)1,2*, Benedicte Sautenet, MD, PhD3*, Magdalena Madero, MD, PhD4, Allison Tong, PhD1,2, Gloria Ashuntantang, MD5, Laura Cortes Sanabria, MD, PhD6, Ian H de Boer, MD7, Samuel Fung, MD8, Daniel Gallego9, Andrew S Levey, MD10, Adeera Levin, MD, PhD11, Eduardo Lorca, MD12, Ikechi G Okpechi, MD, PhD13, Patrick Rossignol, MD, PhD14, Laura Sola, MD15, Tim Usherwood, MD16, David C Wheeler, MD, PhD17, Yeoungjee Cho, MD, PhD18,19,20, Martin Howell, PhD1,2, Chandana Guha, MA1,2, Nicole Scholes-Robertson, BSc1,2, Katherine Widders2, Andrea Matus Gonzalez, BNutrSc1,2, Armando Teixeira-Pinto, PhD1,2, Andrea Viecelli, MD, PhD18,19, Martin Wilkie, Jonathan C Craig, MD, PhD21

1Sydney School of Public Health, The University of Sydney, Sydney, Australia.
2Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Sydney, Australia.
3Department of Nephrology, University of Tours, Tours, France.
4Division of Nephrology, Department of Medicine, Instituto Nacional de Cardiología Ignacio Chávez, Mexico City, Mexico.
5Department of Internal Medicine and Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaounde I, Yaounde, Cameroon.
6Unidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSS, Guadalajara, Mexico.
7Department of Medicine, Kidney Research Institute, University of Washington, Seattle, Washington, USA.
8Division of Nephrology, Department of Medicine & Geriatrics, Princes Margaret Hospital, Hong Kong.
9Federacion Nacional ALCER.
10Division of Nephrology, Tufts Medical Center, Boston, MA, USA.
11Division of Nephrology, University of British Columbia, Vancouver, Canada.
12Department of Nephrology, Hospital Salvador, Santiago, Chile.
13Division of Nephrology and Hypertension, University of Cape Town, Cape Town, South Africa.
14Université de Lorraine, Inserm, Centre d'Investigations Clinique 1433 and Inserm U1116; CHRU Nancy; F-CRIN INI-CRCT, Nancy, France.
15Dialysis Unit, CASMU-IAMPP, Montevideo, Uruguay.
16The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Department of General Practice, Westmead Clinical School, University of Sydney, Westmead, NSW, Australia.
17Centre for Nephrology, UCL Medical School, London, United Kingdom.
18Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia.
19Australasian Kidney Trials Network, Centre for Health Services Research, University of Queensland, Brisbane, QLD, Australia.
20Translational Research Institute, Brisbane, QLD, Australia.
21College of Medicine and Public Health, Flinders University, Adelaide, Australia.

Further Study Information

Current Stage: Ongoing
Date: August 2020 - December 2020
Funding source(s): This project is supported by the National Health and Medical Research Council (NHMRC) Program Grant 1092597. AT is supported by The University of Sydney Robinson Fellowship. The funding bodies do not have a role in the design, collection, analysis, and interpretation of data; in the writing of the manuscript; and in the decision to submit the manuscript for publication.


Health Area

Disease Category: Kidney disease

Disease Name: Chronic kidney disease

Target Population

Age Range: 18 - 120

Sex: Either

Nature of Intervention: Any

Stakeholders Involved

- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Families
- Governmental agencies
- Patient/ support group representatives
- Policy makers
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice

Method(s)

- 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.

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