title: Developing a Set of Core Outcomes for Trials in Hemodialysis: An International Delphi Survey.
abstract: BACKGROUND
  Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis.
  
  
  METHODS
  In a Delphi survey, participants rated the importance of outcomes using a 9-point Likert scale in round 1 and then re-rated outcomes in rounds 2 and 3 after reviewing other respondents' scores. For each outcome, the median, mean, and proportion rating as 7 to 9 (critically important) were calculated.
  
  
  METHODS
  1,181 participants (202 [17%] patients/caregivers, 979 health professionals) from 73 countries completed round 1, with 838 (71%) completing round 3.
  
  
  METHODS
  Outcomes included in the potential core outcome set met the following criteria for both patients/caregivers and health professionals: median score ≥ 8, mean score ≥ 7.5, proportion rating the outcome as critically important ≥ 75%, and median score in the forced ranking question < 10.
  
  
  RESULTS
  Patients/caregivers rated 4 outcomes higher than health professionals: ability to travel, dialysis-free time, dialysis adequacy, and washed out after dialysis (mean differences of 0.9, 0.5, 0.3, and 0.2, respectively). Health professionals gave a higher rating for mortality, hospitalization, decrease in blood pressure, vascular access complications, depression, cardiovascular disease, target weight, infection, and potassium (mean differences of 1.0, 1.0, 1.0, 0.9, 0.9, 0.8, 0.7, 0.4, and 0.4, respectively).
  
  
  CONCLUSIONS
  The Delphi survey was conducted online in English and excludes participants without access to a computer and internet connection.
  
  
  CONCLUSIONS
  Patients/caregivers gave higher priority to lifestyle-related outcomes than health professionals. The prioritized outcomes for both groups were vascular access problems, dialysis adequacy, fatigue, cardiovascular disease, and mortality. This process will inform a core outcome set that in turn will improve the relevance, efficiency, and comparability of trial evidence to facilitate treatment decisions.
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia. Electronic address: nicole.evangelidis@sydney.edu.au.
authors.forename: Nicole
authors.initials: N
authors.lastname: Evangelidis
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
authors.forename: Allison
authors.initials: A
authors.lastname: Tong
authors.affiliation: Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.
authors.forename: Braden
authors.initials: B
authors.lastname: Manns
authors.affiliation: Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.
authors.forename: Brenda
authors.initials: B
authors.lastname: Hemmelgarn
authors.affiliation: Centre for Nephrology, University College London, London, United Kingdom.
authors.forename: David C
authors.initials: DC
authors.lastname: Wheeler
authors.affiliation: Department of Medicine, University of Ottawa, Ottawa, Canada.
authors.forename: Peter
authors.initials: P
authors.lastname: Tugwell
authors.affiliation: Crowe Associates, Oxon, United Kingdom.
authors.forename: Sally
authors.initials: S
authors.lastname: Crowe
authors.affiliation: PKD International, Geneva, Switzerland.
authors.forename: Tess
authors.initials: T
authors.lastname: Harris
authors.affiliation: Renal Division, Ghent University Hospital, Ghent, Belgium.
authors.forename: Wim
authors.initials: W
authors.lastname: Van Biesen
authors.affiliation: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
authors.forename: Wolfgang C
authors.initials: WC
authors.lastname: Winkelmayer
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia; INSERM, U1153, Paris, France; Department of Nephrology and Clinical Immunology, University Hospital of Tours, Tours, France.
authors.forename: Benedicte
authors.initials: B
authors.lastname: Sautenet
authors.affiliation: Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom.
authors.forename: Donal
authors.initials: D
authors.lastname: O'Donoghue
authors.affiliation: Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada.
authors.forename: Helen
authors.initials: H
authors.lastname: Tam-Tham
authors.affiliation: Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom.
authors.forename: Sajeda
authors.initials: S
authors.lastname: Youssouf
authors.affiliation: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
authors.forename: Sreedhar
authors.initials: S
authors.lastname: Mandayam
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
authors.forename: Angela
authors.initials: A
authors.lastname: Ju
authors.affiliation: Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital; Translational Research Institute; Metro South and Ipswich Nephrology and Transplant Services (MINTS), Princess Alexandra Hospital, Brisbane, Australia.
authors.forename: Carmel
authors.initials: C
authors.lastname: Hawley
authors.affiliation: Renal Division, Kolling Institute, Sydney, Australia.
authors.forename: Carol
authors.initials: C
authors.lastname: Pollock
authors.affiliation: Centre for Transplantation and Renal Research, The Westmead Institute for Medical Research, University of Sydney, Westmead, New South Wales, Australia.
authors.forename: David C
authors.initials: DC
authors.lastname: Harris
authors.affiliation: Queensland School of Medicine, University of Queensland at Princess Alexandra Hospital; Translational Research Institute; Metro South and Ipswich Nephrology and Transplant Services (MINTS), Princess Alexandra Hospital, Brisbane, Australia.
authors.forename: David W
authors.initials: DW
authors.lastname: Johnson
authors.affiliation: Division of Nephrology, University of California, San Diego, CA; Division of Preventive Medicine, University of California, San Diego, CA.
authors.forename: Dena E
authors.initials: DE
authors.lastname: Rifkin
authors.affiliation: Arbor Research Collaborative for Health, Ann Arbor, MI.
authors.forename: Francesca
authors.initials: F
authors.lastname: Tentori
authors.affiliation: University Hospital Geelong, Geelong, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Agar
authors.affiliation: Monash Medical Centre and Monash University, Clayton, Australia; Department of Epidemiology & Preventative Medicine, Monash University, Clayton, Australia.
authors.forename: Kevan R
authors.initials: KR
authors.lastname: Polkinghorne
authors.affiliation: Concord Clinical School, The University of Sydney, Sydney, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Gallagher
authors.affiliation: Monash Medical Centre and Monash University, Clayton, Australia.
authors.forename: Peter G
authors.initials: PG
authors.lastname: Kerr
authors.affiliation: Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia; Faculty of Health Science, University of Adelaide, Adelaide, Australia.
authors.forename: Stephen P
authors.initials: SP
authors.lastname: McDonald
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia.
authors.forename: Kirsten
authors.initials: K
authors.lastname: Howard
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Howell
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW, Australia; Centre for Kidney Research, The Children's Hospital at Westmead, Sydney, NSW, Australia.
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003697:Delphi Technique; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D017063:Outcome Assessment, Health Care / Q000592:standards*; D006435:Renal Dialysis; D055815:Young Adult
keywords: Delphi survey; Hemodialysis (HD); Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD); biochemical end point; cardiovascular disease (CVD); core outcome set; dialysis adequacy; lifestyle-related outcomes; mortality; outcome domains; outcomes; patient-centered care; quality of life; research priorities; surrogate end points; trials; vascular access problems; well-being