Department of Anesthesiology and Critical Care, Lariboisière University Hospital, AP-HP, Paris, France.
ECSTRA Team, CRESS, Epidemiology and Statistics Center, Sorbonne Paris Cité, UMR 1153, INSERM, Paris, France.
PLoS One. 2019 May 28;14(5):e0217134. doi: 10.1371/journal.pone.0217134. eCollection 2019.
End-of-life (EOL) decisions are a serious ethical dilemma and are frequently carried out in intensive care units (ICUs). The aim of this systematic review was to investigated the different approaches used in ICUs and reported in randomized controlled trials (RCTs) to address EOL decisions and compare the impact of these different strategies regarding potential bias and mortality estimates.
We identified relevant RCTs published in the past 15 years via PubMed, EMBASE, and CINAHL. In addition, we searched The Cochrane Library and checked registries, including ClinicalTrials.gov to assess concordance between declared and published outcomes. Among the journals we screened were the 3 ICU specialty journals and the four general medicine journals with the highest impact factor. Only RCTs were selected in which in-ICU mortality was the primary or secondary outcome. The primary outcome was information regarding EOL decisions, and the secondary outcome was how EOL decisions were treated in the study analysis.
A total of 178 relevant trials were identified. The details regarding the methodological aspects resulting from EOL decisions were reported in only 62 articles (35%). The manner in which EOL decisions were considered in the study analysis was very heterogeneous, often leading to a high risk of bias.
There is a heterogeneity regarding the management of data on EOL decisions in randomized control trials with mortality endpoints. Recommendations or rules are required regarding the inclusion of patients with potential EOL decisions in RCT analyses and how to manage such decisions from a methodological point of view.
PROSPERO website (CRD42013005724).
生命末期（EOL）决策是一个严重的伦理困境，经常在重症监护病房（ICU）中进行。本系统评价的目的是调查 ICU 中使用的不同方法，并报告随机对照试验（RCT）中解决 EOL 决策的方法，比较这些不同策略对潜在偏倚和死亡率估计的影响。
我们通过 PubMed、EMBASE 和 CINAHL 检索了过去 15 年发表的相关 RCT。此外，我们还搜索了 Cochrane 图书馆，并检查了注册处，包括 ClinicalTrials.gov，以评估申报结果和发表结果之间的一致性。我们筛选的期刊包括 3 种 ICU 专业期刊和 4 种影响因子最高的一般医学期刊。仅选择以 ICU 死亡率为主要或次要结局的 RCT。主要结局是有关 EOL 决策的信息，次要结局是 EOL 决策在研究分析中的处理方式。
共确定了 178 项相关试验。仅在 62 篇文章（35%）中报告了与 EOL 决策相关的方法学方面的详细信息。EOL 决策在研究分析中的处理方式非常多样化，通常导致高度偏倚风险。
在以死亡率为终点的随机对照试验中，关于 EOL 决策管理的数据存在异质性。需要有关如何将可能面临 EOL 决策的患者纳入 RCT 分析以及如何从方法学角度处理此类决策的建议或规则。
PROSPERO 网站（CRD42013005724）。
