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. 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. 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. Not applicable. This study is registered with the Core Outcome Measures in Effectiveness Trials (COMET) database: http://www.comet-initiative.org/Studies/Details/1653 .

中文翻译：

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肾脏病学标准化结局 - 慢性肾脏病 (SONG-CKD)：为不需要肾脏替代治疗的慢性肾脏病成人建立核心结局集的协议

在全球范围内，每年有超过 120 万人死于慢性肾病 (CKD)。与发展为需要肾脏替代治疗的肾衰竭相比，CKD 患者过早死亡的可能性高达 10 倍。CKD 的症状负担和生活质量下降可能会因合并​​症和治疗副作用而加剧。然而，在 CKD 患者的试验中，患者重要的结果仍然不一致且很少报告，这可能会限制循证决策。肾脏病标准化结局——慢性肾脏病 (SONG-CKD) 旨在为尚未需要肾脏替代治疗的 CKD 患者的试验建立一个基于共识的核心结局集，以确保与患者、护理人员和卫生专业人员相关的结果始终如一在试验中报告。SONG-CKD 包括四个阶段：系统评价以确定随机对照试验中报告的结果（领域和措施），这些试验涉及不需要肾脏替代治疗的 CKD 成人；利益相关者关键知情人与参与 CKD 成人护理的卫生专业人员访谈，以确定他们对建立 CKD 核心结果的看法；与患者、护理人员、临床医生、研究人员、政策制定者和行业代表进行的国际两轮在线德尔福调查，以就至关重要的结果领域达成共识；和利益相关者共识研讨会，以审查和最终确定 CKD 试验的核心结果领域集。建立在 CKD 患者试验中报告的核心结果集将增强相关性，研究的透明度和影响，以改善 CKD 患者的生活。不适用。本研究已在有效性试验的核心结果指标 (COMET) 数据库中注册：http://www.comet-initiative.org/Studies/Details/1653。