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
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...
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2021-09-01
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Online Access: | https://doi.org/10.1186/s13063-021-05574-1 |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Nicole Evangelidis Benedicte Sautenet Magdalena Madero Allison Tong Gloria Ashuntantang Laura Cortes Sanabria Ian H. de Boer Samuel Fung Daniel Gallego Andrew S. Levey Adeera Levin Eduardo Lorca Ikechi G. Okpechi Patrick Rossignol Laura Sola Tim Usherwood David C. Wheeler Yeoungjee Cho Martin Howell Chandana Guha Nicole Scholes-Robertson Katherine Widders Andrea Matus Gonzalez Armando Teixeira-Pinto Andrea K. Viecelli Amelie Bernier-Jean Samaya Anumudu Louese Dunn Martin Wilkie Jonathan C. Craig on behalf of the SONG-CKD Investigators |
spellingShingle |
Nicole Evangelidis Benedicte Sautenet Magdalena Madero Allison Tong Gloria Ashuntantang Laura Cortes Sanabria Ian H. de Boer Samuel Fung Daniel Gallego Andrew S. Levey Adeera Levin Eduardo Lorca Ikechi G. Okpechi Patrick Rossignol Laura Sola Tim Usherwood David C. Wheeler Yeoungjee Cho Martin Howell Chandana Guha Nicole Scholes-Robertson Katherine Widders Andrea Matus Gonzalez Armando Teixeira-Pinto Andrea K. Viecelli Amelie Bernier-Jean Samaya Anumudu Louese Dunn Martin Wilkie Jonathan C. Craig on behalf of the SONG-CKD Investigators 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 Core outcome set Outcomes research Patient-centred outcomes Clinical trials Chronic kidney disease |
author_facet |
Nicole Evangelidis Benedicte Sautenet Magdalena Madero Allison Tong Gloria Ashuntantang Laura Cortes Sanabria Ian H. de Boer Samuel Fung Daniel Gallego Andrew S. Levey Adeera Levin Eduardo Lorca Ikechi G. Okpechi Patrick Rossignol Laura Sola Tim Usherwood David C. Wheeler Yeoungjee Cho Martin Howell Chandana Guha Nicole Scholes-Robertson Katherine Widders Andrea Matus Gonzalez Armando Teixeira-Pinto Andrea K. Viecelli Amelie Bernier-Jean Samaya Anumudu Louese Dunn Martin Wilkie Jonathan C. Craig on behalf of the SONG-CKD Investigators |
author_sort |
Nicole Evangelidis |
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 |
title_short |
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 |
title_full |
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 |
title_fullStr |
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 |
title_full_unstemmed |
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 |
title_sort |
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 |
publisher |
BMC |
series |
Trials |
issn |
1745-6215 |
publishDate |
2021-09-01 |
description |
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 . |
topic |
Core outcome set Outcomes research Patient-centred outcomes Clinical trials Chronic kidney disease |
url |
https://doi.org/10.1186/s13063-021-05574-1 |
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doaj-5c1520d43d134097835d130e24af59b32021-09-12T11:34:06ZengBMCTrials1745-62152021-09-012211810.1186/s13063-021-05574-1Standardised 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 therapyNicole Evangelidis0Benedicte Sautenet1Magdalena Madero2Allison Tong3Gloria Ashuntantang4Laura Cortes Sanabria5Ian H. de Boer6Samuel Fung7Daniel Gallego8Andrew S. Levey9Adeera Levin10Eduardo Lorca11Ikechi G. Okpechi12Patrick Rossignol13Laura Sola14Tim Usherwood15David C. Wheeler16Yeoungjee Cho17Martin Howell18Chandana Guha19Nicole Scholes-Robertson20Katherine Widders21Andrea Matus Gonzalez22Armando Teixeira-Pinto23Andrea K. Viecelli24Amelie Bernier-Jean25Samaya Anumudu26Louese Dunn27Martin Wilkie28Jonathan C. Craig29on behalf of the SONG-CKD InvestigatorsSydney School of Public Health, The University of SydneyDepartment of Nephrology, CHU Tours, INSERM SPHERE U1246, University of Tours, University of NantesDivision of Nephrology, Department of Medicine, Instituto Nacional de Cardiología Ignacio ChávezSydney School of Public Health, The University of SydneyDepartment of Internal Medicine and Specialties, Faculty of Medicine and Biomedical Sciences, University of Yaounde IUnidad de Investigación Médica en Enfermedades Renales, Hospital de Especialidades, CMNO, IMSSDepartment of Medicine, Kidney Research Institute, University of WashingtonDivision of Nephrology, Department of Medicine & Geriatrics, Princess Margaret HospitalFederacion Nacional ALCER (Spanish Kidney Patient’s Federation)Division of Nephrology, Tufts Medical CenterDivision of Nephrology, University of British ColumbiaDepartment of Nephrology, Hospital SalvadorDivision of Nephrology and Hypertension, University of Cape TownUniversité de Lorraine, Inserm, Centre d’Investigations Clinique 1433 and Inserm U1116; CHRU Nancy; F-CRIN INI-CRCTDialysis Unit, CASMU-IAMPPThe University of Sydney, Westmead Clinical SchoolCentre for Nephrology, UCL Medical SchoolDepartment of Nephrology, Princess Alexandra HospitalSydney School of Public Health, The University of SydneySydney School of Public Health, The University of SydneySydney School of Public Health, The University of SydneyCentre for Kidney Research, The Children’s Hospital at WestmeadSydney School of Public Health, The University of SydneySydney School of Public Health, The University of SydneyDepartment of Nephrology, Princess Alexandra HospitalSydney School of Public Health, The University of SydneySelzman Institute for Kidney Health, Section of Nephrology, Baylor College of MedicineSheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation TrustSheffield Kidney Institute, Sheffield Teaching Hospitals NHS Foundation TrustCollege of Medicine and Public Health, Flinders UniversityAbstract 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 .https://doi.org/10.1186/s13063-021-05574-1Core outcome setOutcomes researchPatient-centred outcomesClinical trialsChronic kidney disease |