Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

Keynote webinar | Spotlight on medication adherence

LIVE: Thursday 27th June 2024, 18:00-19:30 (CEST)
Join our expert panel to discover why you need to understand the drivers of non-adherence in your patients, and how you can optimize medication adherence in your clinics to drastically improve patient outcomes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease

Authors: 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, John Gill, Peter Tugwell, Wim Van Biesen, David C. Wheeler, Wolfgang C. Winkelmayer, Jonathan C. Craig, on behalf of the SONG-Kids Investigators

Published in: Trials | Issue 1/2016

Login to get access

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.
Literature
1.
McDonald SP, Craig JC. Long-term survival of children with end-stage renal disease. N Eng J Med. 2004;350(26):2654–62.CrossRef
2.
Moreira JM, Bouissou Morais Soares CM, Teixeira AL, Simões E Silva AC, Kummer AM. Anxiety, depression, resilience and quality of life in children and adolescents with pre-dialysis chronic kidney disease. Pediatr Nephrol. 2015;30(12):2153–62.CrossRefPubMed
3.
Lopes M, Ferraro A, Koch VH. Health-related quality of life of children and adolescents with CKD stages 4-5 and their caregivers. Pediatr Nephrol. 2014;29(7):1239–47.CrossRefPubMed
4.
Tong A, Wong G, McTaggart S, Henning P, Mackie F, Carroll RP, Howard K, Craig JC. Quality of life of young adults and adolescents with chronic kidney disease. J Pediatr. 2013;163(4):1179–85.CrossRefPubMed
5.
Tong A, Lowe A, Sainsbury P, Craig JC. Experiences of parents who have children with chronic kidney disease: a systematic review of qualitative studies. Pediatr. 2008;121(2):349–60.CrossRef
6.
Gerson AC, Wentz A, Abraham AG, Mendley SR, Hooper SR, Butler RW, Gipson DS, Lande MB, Shinnar S, Moxey-Mims MM, et al. Health-related quality of life of children with mild to moderate chronic kidney disease. Pediatr. 2010;125(2):e349–357.CrossRef
7.
Tong A, Tjaden L, Howard K, Wong G, Morton R, Craig JC. Quality of life of adolescent kidney transplant recipients. J Pediatr. 2011;159(4):670–5.CrossRefPubMed
8.
Davis ID, Greenbaum LA, Gipson D, Wu LL, Sinha R, Matsuda-Abedini M, Emancipator JL, Lane JC, Hodgkins K, Nailescu C, et al. Prevalence of sleep disturbances in children and adolescents with chronic kidney disease. Pediatr Nephrol. 2012;27(3):451–9.CrossRefPubMed
9.
Roumelioti ME, Wentz A, Schneider MF, Gerson AC, Hooper S, Benfield M, Warady BA, Furth SL, Unruh ML. Sleep and fatigue symptoms in children and adolescents with CKD: a cross-sectional analysis from the chronic kidney disease in children (CKiD) study. Am J Kidney Dis. 2010;55(2):269–80.CrossRefPubMedPubMedCentral
10.
Tong A, Henning P, Wong G, McTaggart S, Mackie F, Carroll RP, Craig JC. Experiences and perspectives of adolescents and young adults with advanced CKD. Am J Kidney Dis. 2013;61(3):375–84.CrossRefPubMed
11.
Lande MB, Gerson AC, Hooper SR, Cox C, Matheson M, Mendley SR, Gipson DS, Wong C, Warady BA, Furth SL, et al. Casual blood pressure and neurocognitive function in children with chronic kidney disease: a report of the children with chronic kidney disease cohort study. Clin J Am Soc Nephrol. 2011;6(8):1831–7.CrossRefPubMedPubMedCentral
12.
Haavisto A, Korkman M, Holmberg C, Jalanko H, Qvist E. Neuropsychological profile of children with kidney transplants. Nephrol Dial Transplant. 2012;27(6):2594–601.CrossRefPubMed
13.
Hooper SR, Gerson AC, Johnson RJ, Mendley SR, Shinnar S, Lande MB, Matheson MB, Gipson DS, Morgenstern B, Warady BA, et al. Neurocognitive, social-behavioural, and adaptive functioning in preschool children with mild to moderate kidney disease. J Dev Behav Pediatr. 2016:Feb 17. [E-pub head of print].
14.
Thys K, Schwering KL, Siebelink M, Dobbels F, Borry P, Schotsmans P, Aujoulat I. Psychosocial impact of pediatric living-donor kidney and liver transplantation on recipients, donors, and the family: a systematic review. Transplant Int. 2015;28(3):270–80.CrossRef
15.
Tjaden LA, Vogelzang J, Jager KJ, van Stralen KJ, Maurice-Stam H, Grootenhuis MA, Groothoff JW. Long-term quality of life and social outcome of childhood end-stage renal disease. J Pediatr. 2014;165(2):336–42.CrossRefPubMed
16.
Lewis H, Mark SD. Differences between paediatric and adult presentation of ESKD in attainment of adult social goals. Pediatr Nephrol. 2014;29(12):2379–85.CrossRefPubMed
17.
Chalmers I, Bracken MB, Djulbegovic B, Garattini S, Grant J, Gülmezoglu AM, Howells DW, Ioannidis JP, Oliver S. How to increase value and reduce waste when research priorities are set. Lancet. 2014;383(9912):156–65.CrossRefPubMed
18.
19.
Bacchetta J, Wesseling-Perry K, Kuizon B, Pereira RC, Gales B, Wang HJ, Elashoff R, Salusky IB. The skeletal consequences of growth hormone therapy in dialyzed children: a randomized trial. Clin J Am Soc Nephrol. 2013;8(5):824–32.CrossRefPubMedPubMedCentral
20.
Schmitt CP, Nau B, Gemulla G, Bonzel KE, Hölttä T, Testa S, Fischbach M, John U, Kemper MJ, Sander A, et al. Effect of the dialysis fluid buffer on peritoneal membrane function in children. Clin J Am Soc Nephrol. 2013;8(1):108–15.CrossRefPubMed
21.
Goldstein SL, Morris D, Warady BA. Comparison of the safety and efficacy of 3 iron sucrose iron maintenance regimens in children, adolescents, and young adults with CKD: a randomized controlled trial. Am J Kidney Dis. 2013;61(4):588–97.CrossRefPubMed
22.
Hokken-Koelega A, Mulder P, De Jong R, Lilien M, Donckerwolcke R, Groothof J. Long-term effects of growth hormone treatment on growth and puberty in patients with chronic renal insufficiency. Pediatr Nephrol. 2000;14(7):701–6.CrossRefPubMed
23.
Hahn D, Hodson EM, Craig JC. Interventions for metabolic bone disease in children with chronic kidney disease. Cochr Data Sys Rev. 2015;11:D008327.
24.
Hodson EM, Willis NS, Craig JC. Growth hormone for children with chronic kidney disease. Cochrane Database Syst Rev. 2012;2:CD003264.
25.
Chaturvedi S, Jones C. Protein restriction for children with chronic kidney disease. Cochr Data Sys Rev. 2007;4:CD006863.
26.
Albaramki J, Hodson EM, Craig JC, Webster AC. Parenteral versus oral iron therapy for adults and children with chronic kidney disease. Cochrane Database Syst Rev. 2012;1:CD007857.PubMed
27.
Sattoe JN, Hilberink SR, Peeters MA, van Staa A. ‘Skills for growing up’: supporting autonomy in young people with kidney disease. J Ren Care. 2014;40(2):131–9.CrossRefPubMed
28.
Nicholas DB, Picone G, Selkirk EK. The lived experiences of children and adolescents with end-stage renal disease. Qual Health Res. 2011;21(2):162–73.CrossRefPubMed
29.
Tjaden L, Tong A, Henning P, Groothoff J, Craig JC. Children’s experiences of dialysis: a systematic review of qualitative studies. Arch Dis Child. 2012;97(5):395–402.CrossRefPubMed
30.
Ruebner RL, Laney N, Kim JY, Hartung EA, Hooper SR, Radcliffe J, Furth SL. Neurocognitive dysfunction in children, adolescents, and young adults with CKD. Am J Kidney Dis. 2016;67(4):567–75.CrossRefPubMed
31.
Prinsen CA, Vohra S, Rose MR, King-Jones S, Ishaque S, Bhaloo Z, Adams D, Terwee CB. Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’. Trials. 2014;15:247.CrossRefPubMedPubMedCentral
32.
Porter ME, Larsson S, Lee TH. Standardizing patient outcomes measurement. N Eng J Med. 2016;376(6):504–6.CrossRef
33.
Harman NL, Bruce IA, Callery P, Tierney S, Sharif MO, O’Brien K, Williamson PR. MOMENT—Management of Otitis Media with Effusion in Cleft Palate: protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials. 2013;14:70.CrossRefPubMedPubMedCentral
34.
Harman NL, Bruce IA, Kirkham JJ, Tierney S, Callery P, O’Brien K, Bennett AM, Chorbachi R, Hall PN, Harding-Bell A, et al. The importance of integration of stakeholder views in core outcome set development: otitis media with effusion in children with cleft palate. PLoS One. 2015;10(6):e0129514.CrossRefPubMedPubMedCentral
35.
Sinha IP, Gallagher R, Williamson PR, Smyth RL. Development of a core outcome set for clinical trials in childhood asthma: a survey of clinicians, parents, and young people. Trials. 2012;13:103.CrossRefPubMedPubMedCentral
36.
Morris C, Janssens A, Shilling V, Allard A, Fellowes A, Tomlinson R, Williams J, Thompson Coon J, Rogers M, Beresford B, et al. Meaningful health outcomes for paediatric neurodisability: stakeholder prioritisation and appropriateness of patient reported outcome measures. Health Qual Life Outcomes. 2015;13:87.CrossRefPubMedPubMedCentral
37.
McConachie H, Parr JR, Glod M, Hanratty J, Livingstone N, Oono IP, Robalino S, Baird G, Beresford B, Charman T, et al. Systematic review of tools to measure outcomes for young children with autism spectrum disorder. Health Technol Assess. 2015;19(41):1–506.CrossRefPubMedPubMedCentral
38.
Vargus-Adams JN, Martin LK. Measuring what matters in cerebral palsy: a breadth of important domains and outcome measures. Arch Phys Med Rehabil. 2009;90(12):2089–95.CrossRefPubMed
39.
Selewski DT, Massengill SF, Troost JP, Wickman L, Messer KL, Herreshoff E, Bowers C, Ferris ME, Mahan JD, Greenbaum LA, et al. Gaining the patient reported outcomes measurement information system (PROMIS) perspective in chronic kidney diseases: a Midwest Pediatric Nephrology Consortium Study. Pediatr Nephrol. 2014;29(12):2347–56.CrossRefPubMedPubMedCentral
40.
Williams K, Thomson D, Seto I, Contopoulos-Ioannidis DG, Ioannidis JP, Curtis S, Constantin E, Batmanabane G, Hartling L, Klassen T. Standard 6: age groups for pediatric trials. Pediatr. 2012;129(S3):S153–160.CrossRef
41.
Boers M, Kirwan JR, Tugwell P, Beaton D, Binghma III CO, Conaghan PG, D’Agostino MA, de Wit M, Gossec L, March L, et al. The OMERACT Handbook. 2014.
42.
Stucki G, Boonen A, Tugwell P, Cieza A, Boers M. The World Health Organisation International Classification of Functioning, Disability and Health: a conceptual model and interface for the OMERACT process. J Rheumatol. 2007;34(3):600–6.PubMed
43.
Corner J, Wright D, Hopkinson J, Gunaratnam Y, McDonald JW, Foster C. The research priorities of patients attending UK cancer treatment centres: findings from a modified nominal group study. Br J Cancer. 2007;96(6):875–81.CrossRefPubMedPubMedCentral
44.
Howell M, Tong A, Wong G, Craig JC, Howard K. Important outcomes for kidney transplant recipients: a nominal group and qualitative study. Am J Kidney Dis. 2012;60(2):186–96.CrossRefPubMed
45.
Sanderson T, Hewlett S, Richards P, Morris M, Calnan M. Utilizing qualitative data from nominal groups: exploring the influences on treatment outcome prioritization with rheumatoid arthritis patients. J Health Psychol. 2012;17:132–42.CrossRefPubMed
46.
Urquhart-Secord R, Craig JC, Hemmelgarn B, Tam-Tham H, Manns B, Howell M, Polkinghorne KR, Kerr PG, Harris DC, Thompson S, et al. Patient and caregiver priorities for outcomes in hemodialysis: an international nominal group technique stud. Am J Kidney Dis. 2016. doi: 10.​1053/​j.​ajkd.​2016.​02.​037. [Epub ahead of print].
47.
48.
MacPhail A. Nominal group technique: a useful method for working with young people. Br Educ Res J. 2001;27(2):161–70.CrossRef
49.
Tunnicliffe DJ, Singh-Grewal D, Chaitow J, Mackie F, Manolios N, Lin MW, O’Neill SG, Ralph AF, Craig JC, Tong A. Lupus means sacrifices – the perspectives of adolescents and young adults with systemic lupus erythematosus. Arthritis Care Res. 2016;68(6):828–37.CrossRef
50.
Ronen GM, Rosenbaum P, Law M, Streiner DL. Health-related quality of life in childhood disorders: a modified focus group technique to involve children. Qual Life Res. 2001;10:17–79.CrossRef
51.
Tong A, Sainsbury P, Craig JC. Consolidated criteria for reporting qualitative research (COREQ): a 32 item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):249–57.CrossRef
52.
Blackwood B, Ringrow S, Clarke M, Marshall J, Rose L, Williamson P, McAuley D. Core Outcomes in Ventilation Trials (COVenT): protocol for a core outcome set using a Delphi survey with a nested randomised trial and observational cohort study. Trials. 2015;16:368.CrossRefPubMedPubMedCentral
53.
Chiarotto A, Terwee CB, Deyo RA, Boers M, Lin CW, Buchbinder R, Corbin TP, Costa LO, Foster NE, Grotle M, et al. A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set. Trials. 2014;15:511.CrossRefPubMedPubMedCentral
54.
MacLennan S, Bekema HJ, Williamson PR, Campbell MK, Stewart F, MacLennan SJ, N’Dow JM, Lam TB. A core outcome set for localised prostate cancer effectiveness trials: protocol for a systematic review of the literature and stakeholder involvement through interviews and a Delphi survey. Trials. 2015;16:76.CrossRefPubMedPubMedCentral
55.
Chiarotto A, Deyo RA, Terwee CB, Boers M, Buchbinder R, Corbin TP, Costa LO, Foster NE, Grotle M, Koes BW, et al. Core outcome domains for clinical trials in non-specific low back pain. Eur Spine J. 2015;24(6):1127–42.CrossRefPubMed
56.
van’t Hooft J, Duffy JM, Daly M, Williamson PR, Meher S, Thom E, Saade GR, Alfirevic Z, Mol BW, Khan KS. A core outcome set for evaluation of interventions to prevent preterm birth. Obstet Gynecol. 2016;127(1):49–58.CrossRef
57.
Potter S, Holcombe C, Ward JA, Blazeby JM. Development of a core outcome set for research and audit studies in reconstructive breast surgery. Br J Surg. 2015;102(11):1360–71.CrossRefPubMedPubMedCentral
58.
Sinha IP, Smyth RL, Williamson PR. Using the Delphi technique to determine which outcomes to measure in clinical trials: recommendations for the future based on a systematic review of existing studies. PLoS Med. 2011;8(1):e1000393.CrossRefPubMedPubMedCentral
59.
Linstone HA, Turoff M. The Delphi Method: techniques and applications. London UK: Addison Wesley Publishing Company; 1975.
60.
Atkins R, Tolson H, Cole BR. Stability of response characteristics of a Delphi panel: application of bootstrap data expansion. BMC Med Res Methodol. 2005;5:37.CrossRef
61.
Schunemann H, Brozek J, Oxman AD. GRADE handbook for grading quality of evidence and strength of recommendation, vol. version 3.2. 2009.
Metadata
Title
Standardised Outcomes in Nephrology—Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease
Authors
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
John Gill
Peter Tugwell
Wim Van Biesen
David C. Wheeler
Wolfgang C. Winkelmayer
Jonathan C. Craig
on behalf of the SONG-Kids Investigators
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1528-5

Other articles of this Issue 1/2016

Trials 1/2016 Go to the issue

Study protocol

“FIND Technology”: investigating the feasibility, efficacy and safety of controller-free interactive digital rehabilitation technology in an inpatient stroke population: study protocol for a randomized controlled trial

Study protocol

Using a smartphone app to reduce cognitive vulnerability and mild depressive symptoms: Study protocol of an exploratory randomized controlled trial

Research

What is the impact of obtaining medical clearance to participate in a randomised controlled trial examining a physical activity intervention on the socio-demographic and risk factor profiles of included participants?

Study protocol

Cost-effectiveness analysis of the single-implant mandibular overdenture versus conventional complete denture: study protocol for a randomized controlled trial

Study protocol

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial

Study protocol

One-stage or two-stage revision surgery for prosthetic hip joint infection – the INFORM trial: a study protocol for a randomised controlled trial