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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 \u2013 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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>SONG-CKD involves four phases: <jats:italic>a systematic review<\/jats:italic> 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; <jats:italic>stakeholder key informant interviews<\/jats:italic> with health professionals involved in the care of adults with CKD to ascertain their views on establishing core outcomes in CKD; an <jats:italic>international two-round online Delphi survey<\/jats:italic> with patients, caregivers, clinicians, researchers, policy makers and industry representatives to obtain consensus on critically important outcome domains; and <jats:italic>stakeholder consensus workshops<\/jats:italic> to review and finalise the set of core outcome domains for trials in CKD.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Discussion<\/jats:title>\n                <jats:p>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.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.comet-initiative.org\/Studies\/Details\/1653\">http:\/\/www.comet-initiative.org\/Studies\/Details\/1653<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s13063-021-05574-1","type":"journal-article","created":{"date-parts":[[2021,9,9]],"date-time":"2021-09-09T10:06:48Z","timestamp":1631182008000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":25,"title":["Standardised Outcomes in Nephrology \u2013 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"],"prefix":"10.1186","volume":"22","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9184-680X","authenticated-orcid":false,"given":"Nicole","family":"Evangelidis","sequence":"first","affiliation":[]},{"given":"Benedicte","family":"Sautenet","sequence":"additional","affiliation":[]},{"given":"Magdalena","family":"Madero","sequence":"additional","affiliation":[]},{"given":"Allison","family":"Tong","sequence":"additional","affiliation":[]},{"given":"Gloria","family":"Ashuntantang","sequence":"additional","affiliation":[]},{"given":"Laura Cortes","family":"Sanabria","sequence":"additional","affiliation":[]},{"given":"Ian H.","family":"de Boer","sequence":"additional","affiliation":[]},{"given":"Samuel","family":"Fung","sequence":"additional","affiliation":[]},{"given":"Daniel","family":"Gallego","sequence":"additional","affiliation":[]},{"given":"Andrew S.","family":"Levey","sequence":"additional","affiliation":[]},{"given":"Adeera","family":"Levin","sequence":"additional","affiliation":[]},{"given":"Eduardo","family":"Lorca","sequence":"additional","affiliation":[]},{"given":"Ikechi G.","family":"Okpechi","sequence":"additional","affiliation":[]},{"given":"Patrick","family":"Rossignol","sequence":"additional","affiliation":[]},{"given":"Laura","family":"Sola","sequence":"additional","affiliation":[]},{"given":"Tim","family":"Usherwood","sequence":"additional","affiliation":[]},{"given":"David C.","family":"Wheeler","sequence":"additional","affiliation":[]},{"given":"Yeoungjee","family":"Cho","sequence":"additional","affiliation":[]},{"given":"Martin","family":"Howell","sequence":"additional","affiliation":[]},{"given":"Chandana","family":"Guha","sequence":"additional","affiliation":[]},{"given":"Nicole","family":"Scholes-Robertson","sequence":"additional","affiliation":[]},{"given":"Katherine","family":"Widders","sequence":"additional","affiliation":[]},{"given":"Andrea Matus","family":"Gonzalez","sequence":"additional","affiliation":[]},{"given":"Armando","family":"Teixeira-Pinto","sequence":"additional","affiliation":[]},{"given":"Andrea K.","family":"Viecelli","sequence":"additional","affiliation":[]},{"given":"Amelie","family":"Bernier-Jean","sequence":"additional","affiliation":[]},{"given":"Samaya","family":"Anumudu","sequence":"additional","affiliation":[]},{"given":"Louese","family":"Dunn","sequence":"additional","affiliation":[]},{"given":"Martin","family":"Wilkie","sequence":"additional","affiliation":[]},{"given":"Jonathan C.","family":"Craig","sequence":"additional","affiliation":[]},{"name":"on behalf of the SONG-CKD Investigators","sequence":"additional","affiliation":[]}],"member":"297","published-online":{"date-parts":[[2021,9,9]]},"reference":[{"issue":"10225","key":"5574_CR1","doi-asserted-by":"publisher","first-page":"709","DOI":"10.1016\/S0140-6736(20)30045-3","volume":"395","author":"B Bikbov","year":"2020","unstructured":"Bikbov B, Purcell CA, Levey AS, Smith M, Abdoli A, Abebe M, et al. 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Kidney Int. 2018;94(6):1053\u201368. https:\/\/doi.org\/10.1016\/j.kint.2018.08.018.","journal-title":"Kidney Int"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05574-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-021-05574-1\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-021-05574-1.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,9,9]],"date-time":"2021-09-09T10:14:03Z","timestamp":1631182443000},"score":1,"resource":{"primary":{"URL":"https:\/\/trialsjournal.biomedcentral.com\/articles\/10.1186\/s13063-021-05574-1"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,9]]},"references-count":42,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["5574"],"URL":"https:\/\/doi.org\/10.1186\/s13063-021-05574-1","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,9]]},"assertion":[{"value":"17 March 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"27 August 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"9 September 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The University of Sydney (2015\/228) provided ethical review and approval. Sheffield Teaching Hospitals NHS Foundation Trust provided ethical review and approval for the Delphi study in the United Kingdom (Sheffield and London, Imperial sites), London Bridge Research Ethics Committee granted ethics approval (ref: 17\/LO\/1630) and for the consensus workshops, (Sheffield, York and Imperial London sites), West of Scotland London Bridge Research Ethics Committee granted ethics approval (ref: 18\/WS\/0084). We will obtain informed consent from all participants in the study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"612"}}