Core Outcome Measures in Effectiveness Trials

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

General Information

Summary:
The Standardised Outcomes in Nephrology-Haemodialysis (SONG-HD) study aims to establish a core outcome set for haemodialysis [hemodialysis] trials, to improve the quality of reporting, and the relevance of trials conducted in people on haemodialysis.

Protocol: http://www.trialsjournal.com/content/16/1/364

Study website: www.songinitiative.org

Contributors:
Principal Investigators:
Jonathan C Craig (Chair) 1,2, Allison Tong1,2, Braden Manns3, Brenda Hemmelgarn3, David C Wheeler4, Peter Tugwell5 , Wolfgang C Winkelmayer6, Wim van Biesen7, Sally Crowe8, and Tess Harris9,10

1 Sydney School of Public Health, The University of Sydney, Sydney, Australia
2 Centre for Kidney Research, The Children’s Hospital at Westmead, Westmead, Sydney, Australia
3 Departments of Medicine and Community Health Sciences; Libin Cardiovascular Institute and O’Brien Institute of Public Health, University of Calgary, Calgary, Canada
4 Centre for Nephrology, University College London, London, United Kingdom
5 Department of Medicine, University of Ottawa, Ottawa, Canada
6 Section of Nephrology, Baylor College of Medicine, Houston, United States
7 Renal Division, Ghent University Hospital, Ghent, Belgium
8 Crowe Associates Ltd, Oxfordshire, United Kingdom
9 PKD International, Geneva, Switzerland
10 UK Polycystic Kidney Disease Charity, London, United Kingdom

Further Study Information

Current Stage:
Ongoing
Date:
January 2015 - January 2018
Funding source(s):
National Health and Medical Research Council Grant (1092957). Allison Tong is funded by a National Health and Medical Research Council Fellowship (ID1037162). Brenda Hemmelgarn is supported by the Roy and Vi Baay Chair in Kidney Research. David W Johnson is funded by a Queensland Government Health Research Fellowship.

Health Area

Disease Category
Kidney disease

Disease Name
Chronic kidney disease

Target Population

Age Range
18 - 100

Sex
Either


Nature / type of Intervention
Procedure

Method(s)

Consensus conference
Delphi process
Focus group(s)
Interview
Nominal group technique (NGT)
Systematic review

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.


Stakeholders Involved

Charities
Clinical experts
Conference participants
Consumers (caregivers)
Consumers (patients)
Governmental agencies
Guideline developers
Patient/ support group representatives
Pharmaceutical industry representatives
Policy makers
Researchers

Study Type

COS for clinical trials or clinical research
COS for practice

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