Outcomes reported in randomized controlled trials in peritoneal dialysis (PD) are diverse, are measured inconsistently, and may not be important to patients, families, and clinicians. The Standardized Outcomes in Nephrology–Peritoneal Dialysis (SONG-PD) initiative aims to establish a core outcome set for trials in PD based on the shared priorities of all stakeholders. We convened an international SONG-PD stakeholder consensus workshop in May 2018 in Vancouver, Canada. Nineteen patients/caregivers and 51 health professionals attended. Participants discussed core outcome domains and implementation in trials in PD. Four themes relating to the formation of core outcome domains were identified: life participation as a main goal of PD, impact of fatigue, empowerment for preparation and planning, and separation of contributing factors from core factors. Considerations for implementation were identified: standardizing patient-reported outcomes, requiring a validated and feasible measure, simplicity of binary outcomes, responsiveness to interventions, and using positive terminology. All stakeholders supported inclusion of PD-related infection, cardiovascular disease, mortality, technique survival, and life participation as the core outcome domains for PD.
ContributorsKarine E. Manera1,2, Allison Tong1,2, Jonathan C. Craig1,2, Edwina A. Brown3, Gillian Brunier4, Jie Dong5, Tony Dunning6, Rajnish Mehrotra7, Sarala Naicker8, Roberto Pecoits-Filho9, Jeffrey Perl10, Angela Y. Wang11, Martin Wilkie12, Martin Howell1,2, Benedicte Sautenet1,2,13, Nicole Evangelidis1,2, Jenny I. Shen14, and David W. Johnson15,16,17 on behalf of the SONG-PD Investigators1
Disease Category: Kidney disease
Disease Name: Chronic kidney disease
Age Range: 18 - 100
Sex: Either
Nature of Intervention: Procedure
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Pharmaceutical industry representatives
- Policy makers
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
Participants received the workshop program 1 week in advance. During the workshop, an overview of the SONG-PD process, results of the Delphi survey, and a list of potential core outcomes were presented. Participants were allocated to 7 breakout groups with 8 to 12 members, and each group included patients/caregivers, physicians, policymakers, and industry representatives to allow for a diverse exchange of ideas, knowledge, and experience. Each facilitator was provided with a question guide before the workshop.