Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids)

A protocol for establishing a core outcome set for children with chronic kidney disease

Allison Tong, Susan Samuel, Michael Zappitelli, Allison Dart, Susan Furth, Allison Eddy, Jaap Groothoff, Nicholas J A Webb, Hui Kim Yap, Detlef Bockenhauer, Aditi Sinha, Stephen I. Alexander, Stuart L. Goldstein, Debbie S. Gipson, Camilla S. Hanson, Nicole Evangelidis, Sally Crowe, Tess Harris, Brenda R. Hemmelgarn, Braden Manns & 7 others John Gill, Peter Tugwell, Wim Van Biesen, David C. Wheeler, Wolfgang C. Winkelmayer, Jonathan C. Craig, and on behalf of the SONG-Kids Investigators

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish (US)
Article number401
JournalTrials
Volume17
Issue number1
DOIs
StatePublished - Aug 12 2016
Externally publishedYes

Fingerprint

Nephrology
Chronic Renal Insufficiency
Kidney Transplantation
Caregivers
Dialysis
Pediatrics
Child Care
Focus Groups
Administrative Personnel
Fatigue
Consensus
Industry
Randomized Controlled Trials
Quality of Life
Research Personnel
Interviews
Education

Keywords

  • Chronic kidney disease
  • Clinical trials
  • Core outcome set
  • Dialysis
  • Haemodialysis
  • Outcomes research
  • Paediatrics
  • Patient-centred outcomes

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

Cite this

Tong, A., Samuel, S., Zappitelli, M., Dart, A., Furth, S., Eddy, A., ... and on behalf of the SONG-Kids Investigators (2016). Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids): A protocol for establishing a core outcome set for children with chronic kidney disease. Trials, 17(1), [401]. https://doi.org/10.1186/s13063-016-1528-5

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.; and on behalf of the SONG-Kids Investigators.

In: Trials, Vol. 17, No. 1, 401, 12.08.2016.

Research output: Contribution to journalArticle

Tong, A, Samuel, S, Zappitelli, M, Dart, A, Furth, S, Eddy, A, Groothoff, J, Webb, NJA, Yap, HK, Bockenhauer, D, Sinha, A, Alexander, SI, Goldstein, SL, Gipson, DS, Hanson, CS, Evangelidis, N, Crowe, S, Harris, T, Hemmelgarn, BR, Manns, B, Gill, J, Tugwell, P, Van Biesen, W, Wheeler, DC, Winkelmayer, WC, Craig, JC & and on behalf of the SONG-Kids Investigators 2016, 'Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids): A protocol for establishing a core outcome set for children with chronic kidney disease', Trials, vol. 17, no. 1, 401. https://doi.org/10.1186/s13063-016-1528-5
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. ; and on behalf of the SONG-Kids Investigators. / Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids) : A protocol for establishing a core outcome set for children with chronic kidney disease. In: Trials. 2016 ; Vol. 17, No. 1.
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abstract = "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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T2 - A protocol for establishing a core outcome set for children with chronic kidney disease

AU - Tong, Allison

AU - Samuel, Susan

AU - Zappitelli, Michael

AU - Dart, Allison

AU - Furth, Susan

AU - Eddy, Allison

AU - Groothoff, Jaap

AU - Webb, Nicholas J A

AU - Yap, Hui Kim

AU - Bockenhauer, Detlef

AU - Sinha, Aditi

AU - Alexander, Stephen I.

AU - Goldstein, Stuart L.

AU - Gipson, Debbie S.

AU - Hanson, Camilla S.

AU - Evangelidis, Nicole

AU - Crowe, Sally

AU - Harris, Tess

AU - Hemmelgarn, Brenda R.

AU - Manns, Braden

AU - Gill, John

AU - Tugwell, Peter

AU - Van Biesen, Wim

AU - Wheeler, David C.

AU - Winkelmayer, Wolfgang C.

AU - Craig, Jonathan C.

AU - and on behalf of the SONG-Kids Investigators

PY - 2016/8/12

Y1 - 2016/8/12

N2 - 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.

AB - 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.

KW - Chronic kidney disease

KW - Clinical trials

KW - Core outcome set

KW - Dialysis

KW - Haemodialysis

KW - Outcomes research

KW - Paediatrics

KW - Patient-centred outcomes

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