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.
Keywords: PD failure; PD-related infection; Peritoneal dialysis (PD); cardiovascular disease (CVD); caregiver; consensus workshop; core outcome set; dialysis; fatigue; life participation; mortality; nephrology research; outcomes; patient perspective; patient-centered care; patient-reported outcome (PRO); quality of life (QoL); technique survival; trial design; trials.
Copyright © 2019 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.