Standardised outcomes in nephrology - Haemodialysis (SONG-HD): Study protocol for establishing a core outcome set in haemodialysis

Tong, Allison, Manns, Braden, Hemmelgarn, Brenda, Wheeler, David C., Tugwell, Peter, Winkelmayer, Wolfgang C., van Biesen, Wim, Crowe, Sally, Kerr, Peter G., Polkinghorne, Kevan R., Howard, Kirsten, Pollock, Carol, Hawley, Carmel M., Johnson, David W., McDonald, Stephen P., Gallagher, Martin P., Urquhart-Secord, Rachel and Craig, Jonathan C. (2015) Standardised outcomes in nephrology - Haemodialysis (SONG-HD): Study protocol for establishing a core outcome set in haemodialysis. Trials, 16 364: 464-475. doi:10.1186/s13063-015-0895-7

Author Tong, Allison
Manns, Braden
Hemmelgarn, Brenda
Wheeler, David C.
Tugwell, Peter
Winkelmayer, Wolfgang C.
van Biesen, Wim
Crowe, Sally
Kerr, Peter G.
Polkinghorne, Kevan R.
Howard, Kirsten
Pollock, Carol
Hawley, Carmel M.
Johnson, David W.
McDonald, Stephen P.
Gallagher, Martin P.
Urquhart-Secord, Rachel
Craig, Jonathan C.
Title Standardised outcomes in nephrology - Haemodialysis (SONG-HD): Study protocol for establishing a core outcome set in haemodialysis
Journal name Trials   Check publisher's open access policy
ISSN 1745-6215
Publication date 2015-08-19
Year available 2015
Sub-type Article (original research)
DOI 10.1186/s13063-015-0895-7
Open Access Status DOI
Volume 16
Issue 364
Start page 464
End page 475
Total pages 9
Place of publication London, United Kingdom
Publisher BioMed Central
Language eng
Subject 2727 Nephrology
Abstract Survival and quality of life for patients on hemodialysis therapy remain poor despite substantial research efforts. Existing trials often report surrogate outcomes that may not be relevant to patients and clinicians. The aim of this project was to generate a consensus-based prioritized list of core outcomes for trials in hemodialysis.
Formatted abstract
Chronic kidney disease is a significant contributor to mortality and morbidity worldwide, and the number of people who require dialysis or transplantation continues to increase. People on dialysis are 15 times more likely to die than the general population. Dialysis is also costly, intrusive, and time-consuming and imposes an enormous burden on patients and their families. This escalating problem has spurred a proliferation of trials in dialysis, yet health and quality of life remain poor. The reasons for this are complex and varied but are attributable in part to problems in the design and reporting of studies, particularly outcome selection. Problems related to outcomes include use of unvalidated surrogates, outcomes of little or no relevance to patients, highly variable outcome selection limiting comparability across studies, and bias in reporting outcomes. The aim of the Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study is to establish a core outcome set for haemodialysis trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis.

SONG-HD is a five-phase project that includes the following: a systematic review to identify outcomes that have been reported in haemodialysis systematic reviews and trials; nominal group technique with patients and caregivers to identify, rank, and describe reasons for their choices; qualitative stakeholder interviews with patients, caregivers, clinicians, researchers, and policy makers to elicit individual values and perspectives on outcomes for haemodialysis trials; a three-round Delphi survey with stakeholder groups to distil and generate a prioritised list of core outcomes; and a consensus workshop to establish a core outcome set for haemodialysis trials.

Establishing a core outcome set to be consistently measured and reported in haemodialysis trials will improve the integrity, transparency, usability, and contribution of research relevant to patients requiring haemodialysis; ensure that outcomes of relevance to all stakeholders are consistently reported across trials; and mitigate against outcome reporting bias. Ultimately, patients will be more protected from potential harm, patients and clinicians will be better able to make informed decisions about treatment, and researchers and policy makers will be more able to maximise the value of research to the public
Keyword Core outcome set
Outcomes research
Patient-centred outcomes clinical trials
Chronic kidney disease
Q-Index Code C1
Q-Index Status Confirmed Code
Grant ID 1106716 | 1098815
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: Official 2016 Collection
School of Medicine Publications
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Citation counts: TR Web of Science Citation Count  Cited 24 times in Thomson Reuters Web of Science Article | Citations
Scopus Citation Count Cited 22 times in Scopus Article | Citations
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