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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

Nicole Evangelidis 1, 2 Benedicte Sautenet 3, 4 Magdalena Madero 5 Allison Tong 1, 2 Gloria Ashuntantang 6 Laura Cortes Sanabria 7 Ian H de Boer 8, 9 Samuel Fung 10 Daniel Gallego 11 Andrew S Levey 12 Adeera Levin 13 Eduardo Lorca 14 Ikechi G Okpechi 15, 16 Patrick Rossignol 17, 18, 19, 20 Laura Sola 21 Tim Usherwood 22, 23 David C Wheeler 24 Yeoungjee Cho 25, 26, 27 Martin Howell 22, 2 Chandana Guha 22, 2 Nicole Scholes-Robertson 22, 2 Katherine Widders 2 Andrea Matus Gonzalez 22, 2 Armando Teixeira-Pinto 22, 2 Andrea K Viecelli 28, 27 Amelie Bernier-Jean 22, 2 Samaya Anumudu 29 Louese Dunn 30 Martin Wilkie 30 Jonathan C Craig 31 
Abstract : 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.
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https://hal.univ-lorraine.fr/hal-03355340
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Submitted on : Monday, September 27, 2021 - 12:27:44 PM
Last modification on : Wednesday, April 27, 2022 - 4:19:02 AM
Long-term archiving on: : Tuesday, December 28, 2021 - 6:30:58 PM

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Nicole Evangelidis, Benedicte Sautenet, Magdalena Madero, Allison Tong, Gloria Ashuntantang, 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, BioMed Central, 2021, 22 (1), pp.612. ⟨10.1186/s13063-021-05574-1⟩. ⟨hal-03355340⟩

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