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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dc.contributor.authorEvangelidis, Nicole
dc.contributor.authorSautenet, Benedicte
dc.contributor.authorMadero, Magdalena
dc.contributor.authorTong, Allison
dc.contributor.authorAshuntantang, Gloria
dc.contributor.authorSanabria, Laura C
dc.contributor.authorde Boer, Ian H
dc.contributor.authorFung, Samuel
dc.contributor.authorGallego, Daniel
dc.contributor.authorLevey, Andrew S
dc.contributor.authorLevin, Adeera
dc.contributor.authorLorca, Eduardo
dc.contributor.authorOkpechi, Ikechi G
dc.contributor.authorRossignol, Patrick
dc.contributor.authorSola, Laura
dc.contributor.authorUsherwood, Tim
dc.contributor.authorWheeler, David C
dc.contributor.authorCho, Yeoungjee
dc.contributor.authorHowell, Martin
dc.contributor.authorGuha, Chandana
dc.contributor.authorScholes-Robertson, Nicole
dc.contributor.authorWidders, Katherine
dc.contributor.authorGonzalez, Andrea M
dc.contributor.authorTeixeira-Pinto, Armando
dc.contributor.authorViecelli, Andrea K
dc.contributor.authorBernier-Jean, Amelie
dc.contributor.authorAnumudu, Samaya
dc.contributor.authorDunn, Louese
dc.contributor.authorWilkie, Martin
dc.contributor.authorCraig, Jonathan C
dc.date.accessioned2021-10-04T15:31:42Z
dc.date.available2021-10-04T15:31:42Z
dc.date.issued2021-09-09
dc.date.updated2021-09-12T03:07:38Z
dc.description.abstractBackground 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 .en_US
dc.identifier.apacitationEvangelidis, N., Sautenet, B., Madero, M., Tong, A., Ashuntantang, G., Sanabria, L. C., ... Craig, J. C. (2021). 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. <i>Trials</i>, 22(1), 612. http://hdl.handle.net/11427/34077en_ZA
dc.identifier.chicagocitationEvangelidis, Nicole, Benedicte Sautenet, Magdalena Madero, Allison Tong, Gloria Ashuntantang, Laura C Sanabria, Ian H de Boer, et al "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." <i>Trials</i> 22, 1. (2021): 612. http://hdl.handle.net/11427/34077en_ZA
dc.identifier.citationEvangelidis, N., Sautenet, B., Madero, M., Tong, A., Ashuntantang, G., Sanabria, L.C., de Boer, I.H. & Fung, S. et al. 2021. 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. <i>Trials.</i> 22(1):612. http://hdl.handle.net/11427/34077en_ZA
dc.identifier.ris TY - Journal Article AU - Evangelidis, Nicole AU - Sautenet, Benedicte AU - Madero, Magdalena AU - Tong, Allison AU - Ashuntantang, Gloria AU - Sanabria, Laura C AU - de Boer, Ian H AU - Fung, Samuel AU - Gallego, Daniel AU - Levey, Andrew S AU - Levin, Adeera AU - Lorca, Eduardo AU - Okpechi, Ikechi G AU - Rossignol, Patrick AU - Sola, Laura AU - Usherwood, Tim AU - Wheeler, David C AU - Cho, Yeoungjee AU - Howell, Martin AU - Guha, Chandana AU - Scholes-Robertson, Nicole AU - Widders, Katherine AU - Gonzalez, Andrea M AU - Teixeira-Pinto, Armando AU - Viecelli, Andrea K AU - Bernier-Jean, Amelie AU - Anumudu, Samaya AU - Dunn, Louese AU - Wilkie, Martin AU - Craig, Jonathan C AB - 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 . DA - 2021-09-09 DB - OpenUCT DP - University of Cape Town IS - 1 J1 - Trials KW - Core outcome set KW - Outcomes research KW - Patient-centred outcomes KW - Clinical trials KW - Chronic kidney disease LK - https://open.uct.ac.za PY - 2021 T1 - 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 TI - 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 UR - http://hdl.handle.net/11427/34077 ER - en_ZA
dc.identifier.urihttps://doi.org/10.1186/s13063-021-05574-1
dc.identifier.urihttp://hdl.handle.net/11427/34077
dc.identifier.vancouvercitationEvangelidis N, Sautenet B, Madero M, Tong A, Ashuntantang G, Sanabria LC, et al. 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. Trials. 2021;22(1):612. http://hdl.handle.net/11427/34077.en_ZA
dc.language.rfc3066en
dc.publisher.departmentDivision of Nephrology and Hypertensionen_US
dc.publisher.facultyFaculty of Health Sciencesen_US
dc.rights.holderThe Author(s)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.sourceTrialsen_US
dc.source.journalissue1en_US
dc.source.journalvolume22en_US
dc.source.pagination612en_US
dc.source.urihttps://trialsjournal.biomedcentral.com/
dc.subjectCore outcome seten_US
dc.subjectOutcomes researchen_US
dc.subjectPatient-centred outcomesen_US
dc.subjectClinical trialsen_US
dc.subjectChronic kidney diseaseen_US
dc.titleStandardised 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 therapyen_US
dc.typeJournal Articleen_US
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