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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

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

Authors: Allison Tong, Braden Manns, Brenda Hemmelgarn, David C. Wheeler, Peter Tugwell, Wolfgang C. Winkelmayer, Wim van Biesen, Sally Crowe, Peter G. Kerr, Kevan R. Polkinghorne, Kirsten Howard, Carol Pollock, Carmel M. Hawley, David W. Johnson, Stephen P. McDonald, Martin P. Gallagher, Rachel Urquhart-Secord, Jonathan C. Craig, on behalf of the SONG-HD Collaboration

Published in: Trials | Issue 1/2015

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Abstract

Background

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.

Methods/design

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.

Discussion

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
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Metadata
Title
Standardised outcomes in nephrology – Haemodialysis (SONG-HD): study protocol for establishing a core outcome set in haemodialysis
Authors
Allison Tong
Braden Manns
Brenda Hemmelgarn
David C. Wheeler
Peter Tugwell
Wolfgang C. Winkelmayer
Wim van Biesen
Sally Crowe
Peter G. Kerr
Kevan R. Polkinghorne
Kirsten Howard
Carol Pollock
Carmel M. Hawley
David W. Johnson
Stephen P. McDonald
Martin P. Gallagher
Rachel Urquhart-Secord
Jonathan C. Craig
on behalf of the SONG-HD Collaboration
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0895-7

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