Polycystic kidney disease (PKD) affects approximately 12 million people worldwide. PKD is an irreversible life-threatening genetic disorder and is a major cause of end-stage kidney disease. Research in PKD aims to improve outcomes for patients yet they are rarely involved in outcome selection.The standardised outcomes in nephrology – polycystic kidney disease (SONG-PKD) project will establish core outcomes that are based on the shared priorities of patients with PKD, their family members, clinicians, researchers, and policy makers. Eight focus groups using nominal group technique will be conducted with patients with PKD and their caregivers who will be asked to identify and rank outcomes that are important to them, and describe reasons underpinning their priorities. An international Delphi consensus survey will conducted with stakeholders, including patients, caregivers, and health professionals, to distil and generate a prioritised list of “core outcomes” to include in trials, other forms of research and clinical care.
SONG-PKD will establish a new core outcome set in PKD. This will help to ensure that research is measuring and reporting outcomes that are meaningful and relevant to patients with PKD, their family, and clinicians; to improve patient-centred care for people living with PKD.
Gopala Rangan (Chair) | The University of Sydney, Australia
Albert Ong | University of Sheffield, United Kingdom
Arlene Chapman | University of Chicago, United States
Curie Ahn | Seoul National University Hospital, South Korea
Helen Coolican | PKD Foundation of Australia, Australia
Juliana Tze-Wah Kao | Fu Jen Catholic University Hospital, Taiwan
Kevin Fowler | Kidney Health Initiative, Patient Family Partnership Council; President, The Voice of the Patient, United States
Ron Gansevoort | University Medical Center Groningen, Netherlands
Ronald Perrone | Tufts Medical Center, United States
Tess Harris | PKD International, United Kingdom
Vicente Torres | Mayo Clinic, United States
York Pei | University of Toronto, Canada
Project coordinators: Yeoungjee Cho, University of Queensland; Talia Gutman, The University of Sydney; Benedicte Sautenet, University of Tours
- COS for clinical trials or clinical research
- Consensus conference
- Delphi process
- Focus group(s)
- Literature review
- Nominal group technique (NGT)
- Semi structured discussion
- Systematic review
The five phases of SONG-PKD are: a systematic review to identify outcomes that have been reported in existing PKD trials; focus groups with nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with health professionals to elicit individual values and perspectives on outcomes for trials involving patients with PKD; an international three-round Delphi survey with all stakeholder groups (including patients, caregivers, healthcare providers, policy makers, researchers, and industry) to gain consensus on critically important core outcome domains; and a consensus workshop to review and establish a set of core outcome domains and measures for trials in PKD.