title: Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease.
abstract: Children with chronic kidney disease (CKD), requiring dialysis or kidney transplantation, have a mortality rate of up to 30-fold higher than the general aged-matched population, and severely impaired quality of life. Symptoms such as fatigue and pain are prevalent and debilitating. Children with CKD are at risk of cognitive impairment, and poorer educational, vocational, and psychosocial outcomes compared with their well peers, which have consequences through to adulthood. Treatment regimens for children with CKD are long-term, complex, and highly intrusive. While many trials have been conducted to improve outcomes in children with CKD, the outcomes measured and reported are often not relevant to patients and clinicians, and are highly variable. These problems can diminish the value of trials as a means to improve the lives of children with CKD. The Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids) study aims to develop a core outcome set for trials in children and adolescents with any stage of CKD that is based on the shared priorities of all stakeholders.
  
  
  
  SONG-Kids involves five phases: a systematic review to identify outcomes (both domains and measures) that have been reported in randomised controlled trials involving children aged up to 21 years with CKD; focus groups (using nominal group technique) with adolescent patients and caregivers of paediatric patients (all ages) to identify outcomes that are relevant and important to patients and their family and the reasons for their choices; semistructured key informant interviews with health professionals involved in the care of children with CKD to ascertain their views on establishing core outcomes in paediatric nephrology; an international three-round online Delphi survey with patients, caregivers, clinicians, researchers, policy-makers, and members from industry to develop consensus on important outcome domains; and a stakeholder workshop to review and finalise the set of core outcome domains for trials in children with CKD (including nondialysis-dependent, dialysis, and kidney transplantation).
  
  
  
  Establishing a core outcome set to be reported in all trials conducted in children with any stage of CKD will enhance the relevance, transparency, and impact of research to improve the lives of children and adolescents with CKD.
authors: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia. allison.tong@sydney.edu.au.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, 2145, Australia. allison.tong@sydney.edu.au.
authors: Allison
authors: A
authors: Tong
authors: Department of Pediatrics, Section of Nephrology, University of Calgary, Calgary, AB, Canada.
authors: Susan
authors: S
authors: Samuel
authors: Department of Pediatrics, Division of Pediatric Nephrology, Montreal Children's Hospital, McGill University Health Centre, McGill University, Montreal, QC, Canada.
authors: Michael
authors: M
authors: Zappitelli
authors: Department of Pediatrics and Child Health, The Children's Hospital Research Institute of Manitoba, University of Manitoba, Winnipeg, MB, Canada.
authors: Allison
authors: A
authors: Dart
authors: Departments of Pediatrics and Epidemiology, Perelman School of Medicine and Division of Nephrology, The Children's Hospital of Philadelphia, Philadelphia, PA, USA.
authors: Susan
authors: S
authors: Furth
authors: Department of Pediatrics, University of British Columbia, Vancouver, BC, Canada.
authors: Allison
authors: A
authors: Eddy
authors: Department of Pediatric Nephrology, Emma Children's Hospital AMC Academic Medical Center, Amsterdam, The Netherlands.
authors: Jaap
authors: J
authors: Groothoff
authors: Department of Paediatric Nephrology and NIHR/Wellcome Trust Clinical Research Facility, University of Manchester, Manchester Academic Health Science Centre, Royal Manchester Children's Hospital, Manchester, UK.
authors: Nicholas J A
authors: NJ
authors: Webb
authors: Department of Pediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Singapore.
authors: Hui-Kim
authors: HK
authors: Yap
authors: UCL Centre for Nephrology and Great Ormond Street Hospital for Children NHS Foundation Trus, London, UK.
authors: Detlef
authors: D
authors: Bockenhauer
authors: Division of Nephrology, Department of Pediatrics, All India Institute of Medical Sciences, New Delhi, India.
authors: Aditi
authors: A
authors: Sinha
authors: Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, 2145, Australia.
authors: Stephen I
authors: SI
authors: Alexander
authors: Division of Nephrology and Hypertension, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
authors: Stuart L
authors: SL
authors: Goldstein
authors: Department of Pediatrics, School of Medicine, University of Michigan, Ann Arbor, MI, USA.
authors: Debbie S
authors: DS
authors: Gipson
authors: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, 2145, Australia.
authors: Camilla S
authors: CS
authors: Hanson
authors: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, 2145, Australia.
authors: Nicole
authors: N
authors: Evangelidis
authors: Crowe Associates Ltd, London, UK.
authors: Sally
authors: S
authors: Crowe
authors: PKD International, London, UK.
authors: Tess
authors: T
authors: Harris
authors: Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, AB, Canada.
authors: Brenda R
authors: BR
authors: Hemmelgarn
authors: Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, AB, Canada.
authors: Braden
authors: B
authors: Manns
authors: Division of Nephrology, University of British Columbia, Vancouver, BC, Canada.
authors: John
authors: J
authors: Gill
authors: Department of Medicine, University of Ottawa, Ottawa, ON, Canada.
authors: Peter
authors: P
authors: Tugwell
authors: Renal Division, Ghent University Hospital, Ghent, Belgium.
authors: Wim
authors: W
authors: Van Biesen
authors: Centre for Nephrology, University College London, London, UK.
authors: David C
authors: DC
authors: Wheeler
authors: Selzman Institute for Kidney Health, Section of Nephrology, Baylor College of Medicine, Houston, TX, USA.
authors: Wolfgang C
authors: WC
authors: Winkelmayer
authors: Sydney School of Public Health, The University of Sydney, Sydney, NSW, Australia.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, NSW, 2145, Australia.
authors: Jonathan C
authors: JC
authors: Craig
mesh_terms: D000293:Adolescent; D000367:Age Factors; D002648:Child; D032921:Consensus; D003299:Cooperative Behavior; D003697:Delphi Technique; D023381:Endpoint Determination / Q000592:standards*; D005260:Female; D017144:Focus Groups; D006304:Health Status; D006801:Humans; D033183:Interdisciplinary Communication; D007407:Interviews as Topic; D016030:Kidney Transplantation / Q000009:adverse effects / Q000401:mortality; D008297:Male; D063868:Patient Outcome Assessment; D011788:Quality of Life; D006435:Renal Dialysis / Q000009:adverse effects / Q000401:mortality; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000401:mortality / Q000523:psychology / Q000628:therapy*; D012107:Research Design / Q000592:standards; D012307:Risk Factors; D000073597:Stakeholder Participation; D000078202:Systematic Reviews as Topic; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
keywords: Chronic kidney disease; Clinical trials; Core outcome set; Dialysis; Haemodialysis; Outcomes research; Paediatrics; Patient-centred outcomes