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Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy Evangelidis, Nicole; Sautenet, Benedicte; Madero, Magdalena; Tong, Allison; Ashuntantang, Gloria; Sanabria, Laura C.; de Boer, Ian H.; Fung, Samuel; Gallego, Daniel; Levey, Andrew S.; et al.
Abstract
Background Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacement therapy. The burden of symptoms and impaired quality of life in CKD may be compounded by comorbidities and treatment side effects. However, patient-important outcomes remain inconsistently and infrequently reported in trials in patients with CKD, which can limit evidence-informed decision-making. The Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD) aims to establish a consensus-based core outcome set for trials in patients with CKD not yet requiring kidney replacement therapy to ensure outcomes of relevance to patients, caregivers and health professionals are consistently reported in trials. Methods SONG-CKD involves four phases: a systematic review to identify outcomes (domains and measures) that have been reported in randomised controlled trials involving adults with CKD who do not require kidney replacement therapy; stakeholder key informant interviews with health professionals involved in the care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an international two-round online Delphi survey with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and stakeholder consensus workshops to review and finalise the set of core outcome domains for trials in CKD. Discussion Establishing a core outcome set to be reported in trials in patients with CKD will enhance the relevance, transparency and impact of research to improve the lives of people with CKD. Trial registration Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/Studies/Details/1653 .
Item Metadata
Title |
Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD): a protocol for establishing a core outcome set for adults with chronic kidney disease who do not require kidney replacement therapy
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Creator |
Evangelidis, Nicole; Sautenet, Benedicte; Madero, Magdalena; Tong, Allison; Ashuntantang, Gloria; Sanabria, Laura C.; de Boer, Ian H.; Fung, Samuel; Gallego, Daniel; Levey, Andrew S.; Levin, A. (Adeera); Lorca, Eduardo; Okpechi, Ikechi G.; Rossignol, Patrick; Sola, Laura; Usherwood, Tim; Wheeler, David C.; Cho, Yeoungjee; Howell, Martin; Guha, Chandana; Scholes-Robertson, Nicole; Widders, Katherine; Gonzalez, Andrea M.; Teixeira-Pinto, Armando; Viecelli, Andrea K.; Bernier-Jean, Amelie; Anumudu, Samaya; Dunn, Louese; Wilkie, Martin; Craig, Jonathan C.
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Publisher |
BioMed Central
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Date Issued |
2021-09-09
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Description |
Background
Globally, over 1.2 million people die from chronic kidney disease (CKD) every year. Patients with CKD are up to 10 times more likely to die prematurely than progress to kidney failure requiring kidney replacement therapy. The burden of symptoms and impaired quality of life in CKD may be compounded by comorbidities and treatment side effects. However, patient-important outcomes remain inconsistently and infrequently reported in trials in patients with CKD, which can limit evidence-informed decision-making. The Standardised Outcomes in Nephrology – Chronic Kidney Disease (SONG-CKD) aims to establish a consensus-based core outcome set for trials in patients with CKD not yet requiring kidney replacement therapy to ensure outcomes of relevance to patients, caregivers and health professionals are consistently reported in trials.
Methods
SONG-CKD involves four phases: a systematic review to identify outcomes (domains and measures) that have been reported in randomised controlled trials involving adults with CKD who do not require kidney replacement therapy; stakeholder key informant interviews with health professionals involved in the care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an international two-round online Delphi survey with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and stakeholder consensus workshops to review and finalise the set of core outcome domains for trials in CKD.
Discussion
Establishing a core outcome set to be reported in trials in patients with CKD will enhance the relevance, transparency and impact of research to improve the lives of people with CKD.
Trial registration
Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database:
http://www.comet-initiative.org/Studies/Details/1653
.
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Subject | |
Genre | |
Type | |
Language |
eng
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Date Available |
2021-10-06
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Provider |
Vancouver : University of British Columbia Library
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Rights |
Attribution 4.0 International (CC BY 4.0)
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DOI |
10.14288/1.0402452
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URI | |
Affiliation | |
Citation |
Trials. 2021 Sep 09;22(1):612
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Publisher DOI |
10.1186/s13063-021-05574-1
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Peer Review Status |
Reviewed
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Scholarly Level |
Faculty; Researcher
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Copyright Holder |
The Author(s)
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Rights URI | |
Aggregated Source Repository |
DSpace
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Item Media
Item Citations and Data
Rights
Attribution 4.0 International (CC BY 4.0)