Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease Tong, Allison; Samuel, Susan; Zappitelli, Michael; Dart, Allison; Furth, Susan; Eddy, Allison; Groothoff, Jaap; Webb, Nicholas J A; Yap, Hui-Kim; Bockenhauer, Detlef; Sinha, Aditi; Alexander, Stephen I; Goldstein, Stuart L; Gipson, Debbie S; Hanson, Camilla S; Evangelidis, Nicole; Crowe, Sally; Harris, Tess; Hemmelgarn, Brenda R; Manns, Braden; Gill, John; Tugwell, Peter; Van Biesen, Wim; Wheeler, David C; Winkelmayer, Wolfgang C; Craig, Jonathan C
Background: 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. Methods/Design: 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). Discussion: 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.
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