PDF(Pubmed)
Abstract：
Acute kidney injury (AKI) is associated with persistent renal dysfunction, the receipt of dialysis, dialysis dependence, and mortality. Accordingly, the concept of major adverse kidney events (MAKE) has been adopted as an endpoint for assessing the impact of AKI. However, applied criteria or observation periods for operationalizing MAKE appear to vary across studies. To evaluate this heterogeneity for MAKE evaluation, we performed a systematic scoping review of studies that employed MAKE as an AKI endpoint. Four major academic databases were searched, and we identified 122 studies with increasing numbers over time. We found marked heterogeneity in applied criteria and observation periods for MAKE across these studies, with some even lacking a description of criteria. Moreover, 13 different observation periods were employed, with 30 days and 90 days as the most common. Persistent renal dysfunction was evaluated by estimated glomerular filtration rate (34%) or serum creatinine concentration (48%); however, 37 different definitions for this component were employed in terms of parameters, cut-off criteria, and assessment periods. The definition for the dialysis component also showed significant heterogeneity regarding assessment periods and duration of dialysis requirement (chronic vs temporary). Finally, MAKE rates could vary by 7% [interquartile range: 1.7-16.7%] with different observation periods or by 36.4% with different dialysis component definitions. Our findings revealed marked heterogeneity in MAKE definitions, particularly regarding component assessment and observation periods. Dedicated discussion is needed to establish uniform and acceptable standards to operationalize MAKE in terms of selection and applied criteria of components, observation period, and reporting criteria for future trials on AKI and related conditions.
摘要：
急性肾损伤（AKI）与持续性肾功能不全有关，接受透析，透析依赖，和死亡率。因此，主要不良肾脏事件(MAKE)的概念已被用作评估AKI影响的终点.然而,用于操作MAKE的应用标准或观察期似乎因研究而异。为了评估这种异质性以进行MAKE评估，我们对采用MAKE作为AKI终点的研究进行了系统范围审查.搜索了四个主要的学术数据库，我们确定了122项随着时间的推移数量不断增加的研究。我们发现，在这些研究中，MAKE的应用标准和观察期存在明显的异质性，有些人甚至缺乏标准的描述。此外，采用了13个不同的观察期，最常见的是30天和90天。通过估计的肾小球滤过率（34％）或血清肌酐浓度（48％）评估持续性肾功能障碍；然而，在参数方面对该组件采用了37种不同的定义，截止标准，和评估期。透析部分的定义也显示出关于透析需求的评估期和持续时间(慢性与暂时性)的显著异质性。最后,在不同的观察时期，MAKE率可能会变化7％[四分位距：1.7-16.7％]，在不同的透析成分定义下，MAKE率可能会变化36.4％。我们的发现揭示了MAKE定义的明显异质性，特别是关于组件评估和观察期。需要专门讨论，以建立统一和可接受的标准，以在组件的选择和应用标准方面实施MAKE，观察期,以及未来AKI和相关疾病试验的报告标准。
