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


CONCLUSIONS
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.
Sydney School of Public Health, The University of Sydney, Sydney, Australia. allison.tong@sydney.edu.au.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. allison.tong@sydney.edu.au.
Allison
A
Tong
Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada. braden.manns@albertahealthservices.ca.
Braden
B
Manns
Departments of Medicine and Community Health Sciences, Libin Cardiovascular Institute and O'Brien Institute of Public Health, University of Calgary, Calgary, Canada. brenda.hemmelgarn@albertahealthservices.ca.
Brenda
B
Hemmelgarn
Centre for Nephrology, University College London, London, United Kingdom. d.wheeler@ucl.ac.uk.
David C
DC
Wheeler
Department of Medicine, University of Ottawa, Ottawa, Canada. tugwell.bb@uottawa.ca.
Peter
P
Tugwell
Section of Nephrology, Baylor College of Medicine, Houston, United States. wolfgang.winkelmayer@bcm.edu.
Wolfgang C
WC
Winkelmayer
Renal Division, Ghent University Hospital, Ghent, Belgium. wim.vanbiesen@ugent.be.
Wim
W
van Biesen
Crowe Associates, Ltd, Oxon, United Kingdom. sally@crowe-associates.co.uk.
Sally
S
Crowe
Monash Medical Centre and Monash University, Clayton, Australia. peter.kerr@med.monash.edu.
Peter G
PG
Kerr
Monash Medical Centre and Monash University, Clayton, Australia. kevan.polkinghorne@monash.edu.|Department of Epidemiology and Preventative Medicine, Monash University, Melbourne, VIC, Australia. kevan.polkinghorne@monash.edu.
Kevan R
KR
Polkinghorne
The Institute for Choice, University of South Australia, Sydney, Australia. kirsten.howard@unisa.edu.au.
Kirsten
K
Howard
Renal Division, Kolling Institute, Sydney, New South Wales, Australia. carol.pollock@sydney.edu.au.
Carol
C
Pollock
Queesland School of Medicine, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia. carmel.hawley@health.qld.gov.au.|Translational Research Institute, Brisbane, Australia. carmel.hawley@health.qld.gov.au.|Metro South and Ipswich Nephrology and Transplant Services (MINTS), Brisbane, Australia. carmel.hawley@health.qld.gov.au.
Carmel M
CM
Hawley
Queesland School of Medicine, University of Queensland at Princess Alexandra Hospital, Brisbane, Australia. david.johnson2@health.qld.gov.au.|Translational Research Institute, Brisbane, Australia. david.johnson2@health.qld.gov.au.|Metro South and Ipswich Nephrology and Transplant Services (MINTS), Brisbane, Australia. david.johnson2@health.qld.gov.au.
David W
DW
Johnson
Central Northern Adelaide Renal and Transplantation Service, Royal Adelaide Hospital, Adelaide, Australia. stephen@anzdata.org.au.|Faculty of Health Science, University of Adelaide, Adelaide, Australia. stephen@anzdata.org.au.
Stephen P
SP
McDonald
Concord Clinical School, University of Sydney, Sydney, Australia. mgallagher@georgeinstitute.org.au.|Renal and Metabolic Division, The George Institute, Sydney, Australia. mgallagher@georgeinstitute.org.au.
Martin P
MP
Gallagher
Sydney School of Public Health, The University of Sydney, Sydney, Australia. rachel.urquhart-secord@sydney.edu.au.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. rachel.urquhart-secord@sydney.edu.au.
Rachel
R
Urquhart-Secord
Sydney School of Public Health, The University of Sydney, Sydney, Australia. jonathan.craig@sydney.edu.au.|Centre for Kidney Research, The Children's Hospital at Westmead, Westmead, Sydney, Australia. jonathan.craig@sydney.edu.au.
Jonathan C
JC
Craig
D002986:Clinical Trials as Topic / Q000592:standards*; D032921:Consensus; D003245:Consensus Statements as Topic; D003697:Delphi Technique; D006801:Humans; D009398:Nephrology / Q000592:standards*; D006435:Renal Dialysis / Q000592:standards*; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D012107:Research Design / Q000592:standards*; D000078202:Systematic Reviews as Topic; D016896:Treatment Outcome