Karine E Manera1,2, Allison Tong3,2, Jonathan C Craig3,2, Edwina A Brown4, Gillian Brunier5, Jie Dong6, Tony Dunning7, Rajnish Mehrotra8, Sarala Naicker9, Roberto Pecoits-Filho10, Jeffrey Perl11, Angela Y Wang12, Martin Wilkie13, Martin Howell3,2, Benedicte Sautenet3,2,14, Nicole Evangelidis3,2, Jenny I Shen15, David W Johnson16,17,18. 1. Sydney School of Public Health, The University of Sydney, Sydney, Australia karine.manera@sydney.edu.au. 2. Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. 3. Sydney School of Public Health, The University of Sydney, Sydney, Australia. 4. Imperial College Renal and Transplant Centre, Hammersmith Hospital, London, UK. 5. Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada. 6. Renal Division, Department of Medicine, Peking University First Hospital, Beijing, China. 7. South Bank TAFE, Brisbane, Australia. 8. Kidney Research Institute and Harborview Medical Center, Division of Nephrology/Department of Medicine, University of Washington, Seattle, WA, USA. 9. Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. 10. School of Medicine, Pontifícia Universidade Católica do Paraná, Curitiba, Paraná, Brazil. 11. Division of Nephrology, Department of Medicine, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada. 12. Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong. 13. Department of Nephrology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK. 14. University François Rabelais, Tours, France, Department of Nephrology and Clinical Immunology, Tours Hospital, Tours, France, INSERM, Tours, France. 15. Division of Nephrology and Hypertension, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, CA, USA. 16. Centre for Kidney Disease Research, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia. 17. Translational Research Institute, Brisbane, Australia. 18. Metro South and Ipswich Nephrology and Transplant Services (MINTS), Brisbane, Australia.
Abstract
BACKGROUND: Worldwide, approximately 11% of patients on dialysis receive peritoneal dialysis (PD). Whilst PD may offer more autonomy to patients compared with hemodialysis, patient and caregiver burnout, technique failure, and peritonitis remain major challenges to the success of PD. Improvements in care and outcomes are likely to be mediated by randomized trials of innovative therapies, but will be limited if the outcomes measured and reported are not important for patients and clinicians. The aim of the Standardised Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) study is to establish a set of core outcomes for trials in patients on PD based on the shared priorities of all stakeholders, so that outcomes of most relevance for decision-making can be evaluated, and that interventions can be compared reliably. METHODS: The 5 phases in the SONG-PD project are: a systematic review to identify outcomes and outcome measures that have been reported in randomized trials involving patients on PD; focus groups using nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choice of outcomes; semi-structured key informant interviews with health professionals; a 3-round international Delphi survey involving a multi-stakeholder panel; and a consensus workshop to review and endorse the proposed set of core outcome domains for PD trials. DISCUSSION: The establishment of 3 to 5 high-priority core outcomes, to be measured and reported consistently in all trials in PD, will enable patients and clinicians to make informed decisions about the relative effectiveness of interventions, based upon outcomes of common importance.
BACKGROUND: Worldwide, approximately 11% of patients on dialysis receive peritoneal dialysis (PD). Whilst PD may offer more autonomy to patients compared with hemodialysis, patient and caregiver burnout, technique failure, and peritonitis remain major challenges to the success of PD. Improvements in care and outcomes are likely to be mediated by randomized trials of innovative therapies, but will be limited if the outcomes measured and reported are not important for patients and clinicians. The aim of the Standardised Outcomes in Nephrology-Peritoneal Dialysis (SONG-PD) study is to establish a set of core outcomes for trials in patients on PD based on the shared priorities of all stakeholders, so that outcomes of most relevance for decision-making can be evaluated, and that interventions can be compared reliably. METHODS: The 5 phases in the SONG-PD project are: a systematic review to identify outcomes and outcome measures that have been reported in randomized trials involving patients on PD; focus groups using nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choice of outcomes; semi-structured key informant interviews with health professionals; a 3-round international Delphi survey involving a multi-stakeholder panel; and a consensus workshop to review and endorse the proposed set of core outcome domains for PD trials. DISCUSSION: The establishment of 3 to 5 high-priority core outcomes, to be measured and reported consistently in all trials in PD, will enable patients and clinicians to make informed decisions about the relative effectiveness of interventions, based upon outcomes of common importance.
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