title: Establishing Core Outcome Domains in Hemodialysis: Report of the Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Consensus Workshop.
abstract: Evidence-informed decision making in clinical care and policy in nephrology is undermined by trials that selectively report a large number of heterogeneous outcomes, many of which are not patient centered. The Standardized Outcomes in Nephrology-Hemodialysis (SONG-HD) Initiative convened an international consensus workshop on November 7, 2015, to discuss the identification and implementation of a potential core outcome set for all trials in hemodialysis. The purpose of this article is to report qualitative analyses of the workshop discussions, describing the key aspects to consider when establishing core outcomes in trials involving patients on hemodialysis therapy. Key stakeholders including 8 patients/caregivers and 47 health professionals (nephrologists, policymakers, industry, and researchers) attended the workshop. Attendees suggested that identifying core outcomes required equitable stakeholder engagement to ensure relevance across patient populations, flexibility to consider evolving priorities over time, deconstruction of language and meaning for conceptual consistency and clarity, understanding of potential overlap and associations between outcomes, and an assessment of applicability to the range of interventions in hemodialysis. For implementation, they proposed that core outcomes must have simple, inexpensive, and validated outcome measures that could be used in clinical care (quality indicators) and trials (including pragmatic trials) and endorsement by regulatory agencies. Integrating these recommendations may foster acceptance and optimize the uptake and translation of core outcomes in hemodialysis, leading to more informative research, for better treatment and improved patient outcomes.
authors: 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: allison.tong@sydney.edu.au.
authors: Allison
authors: A
authors: Tong
authors: Department of Medicine, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada.
authors: Braden
authors: B
authors: Manns
authors: Department of Medicine, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada.
authors: Brenda
authors: B
authors: Hemmelgarn
authors: Centre for Nephrology, University College London, London, United Kingdom.
authors: David C
authors: DC
authors: Wheeler
authors: 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: Nicole
authors: N
authors: Evangelidis
authors: Department of Medicine, University of Ottawa, Ottawa, Canada.
authors: Peter
authors: P
authors: Tugwell
authors: Crowe Associates Ltd, London, United Kingdom.
authors: Sally
authors: S
authors: Crowe
authors: Renal Division, Ghent University Hospital, Ghent, Belgium.
authors: Wim
authors: W
authors: Van Biesen
authors: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
authors: Wolfgang C
authors: WC
authors: Winkelmayer
authors: Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom.
authors: Donal
authors: D
authors: O'Donoghue
authors: Department of Medicine, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada; Department of Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Alberta, Canada.
authors: Helen
authors: H
authors: Tam-Tham
authors: Department of Nephrology, Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Los Angeles, CA.
authors: Jenny I
authors: JI
authors: Shen
authors: 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: Jule
authors: J
authors: Pinter
authors: 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: Nicholas
authors: N
authors: Larkins
authors: Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, United Kingdom.
authors: Sajeda
authors: S
authors: Youssouf
authors: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX.
authors: Sreedhar
authors: S
authors: Mandayam
authors: 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: Angela
authors: A
authors: Ju
authors: 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: Jonathan C
authors: JC
authors: Craig
mesh_terms: D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy*; D009398:Nephrology; D017063:Outcome Assessment, Health Care / Q000592:standards*; D006435:Renal Dialysis / Q000592:standards*
keywords: Clinical research; consensus; core outcome set; end-stage renal disease (ESRD); hemodialysis; nephrology research; outcomes; patient-centered care; research priorities; research quality; standardized reporting; workshop report