Title STANDARDIZED OUTCOMES IN NEPHROLOGY-PERITONEAL DIALYSIS (SONG-PD): STUDY PROTOCOL FOR ESTABLISHING A CORE OUTCOME SET IN PD
Authors Manera, Karine E.
Tong, Allison
Craig, Jonathan C.
Brown, Edwina A.
Brunier, Gillian
Dong, Jie
Dunning, Tony
Mehrotra, Rajnish
Naicker, Sarala
Pecoits-Filho, Roberto
Perl, Jeffrey
Wang, Angela Y.
Wilkie, Martin
Howell, Martin
Sautenet, Benedicte
Evangelidis, Nicole
Shen, Jenny I.
Johnson, David W.
Affiliation Univ Sydney, Sydney Sch Publ Hlth, Sydney, NSW, Australia.
Childrens Hosp Westmead, Ctr Kidney Res, Sydney, NSW 2145, Australia.
Hammersmith Hosp, Imperial Coll, Renal & Transplant Ctr, London, England.
Univ Toronto, Lawrence S Bloomberg Fac Nursing, Toronto, ON, Canada.
Peking Univ, Hosp 1, Dept Med, Renal Div, Beijing, Peoples R China.
South Bank TAFE, Brisbane, Qld, Australia.
Univ Washington, Kidney Res Inst, Seattle, WA 98195 USA.
Univ Washington, Harborview Med Ctr, Dept Med, Div Nephrol, Seattle, WA 98104 USA.
Univ Witwatersrand, Fac Hlth Sci, Sch Clin Med, Dept Internal Med, Johannesburg, South Africa.
Pontificia Univ Catolica Parana, Sch Med, Curitiba, Parana, Brazil.
Univ Toronto, St Michaels Hosp, Dept Med, Div Nephrol, Toronto, ON, Canada.
Univ Hong Kong, Queen Mary Hosp, Dept Med, Hong Kong, Hong Kong, Peoples R China.
Sheffield Teaching Hosp NHS Fdn Trust, Dept Nephrol, Sheffield, S Yorkshire, England.
Univ Tours, Tours, France.
Tours Hosp, Dept Nephrol & Clin Immunol, Tours, France.
INSERM, Tours, France.
Harbor UCLA Med Ctr, Los Angeles Biomed Res Inst, Div Nephrol & Hypertens, Torrance, CA 90509 USA.
Univ Queensland, Princess Alexandra Hosp, Ctr Kidney Dis Res, Brisbane, Qld, Australia.
Translat Res Inst, Brisbane, Qld, Australia.
Metro South & Ipswich Nephrol & Transplant Serv M, Brisbane, Qld, Australia.
Keywords Core outcome set
outcomes research
patientreported outcomes
patient-centered outcomes
clinical trials
dialysis
peritoneal dialysis
chronic kidney disease
SURROGATE END-POINTS
QUALITY-OF-LIFE
CLINICAL-TRIALS
KIDNEY-DISEASE
TECHNIQUE FAILURE
DELPHI SURVEY
NOMINAL GROUP
HEALTH
HEMODIALYSIS
TRANSPLANTATION
Issue Date 2017
Publisher PERITONEAL DIALYSIS INTERNATIONAL
Citation PERITONEAL DIALYSIS INTERNATIONAL. 2017, 37(6), 639-647.
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.
URI http://hdl.handle.net/20.500.11897/499465
ISSN 0896-8608
DOI 10.3747/pdi.2017.00022
Indexed SCI(E)
SSCI
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