Department of Intensive Care, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, The Netherlands.
Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.
Crit Care. 2017 Feb 24;21(1):38. doi: 10.1186/s13054-017-1609-1.
The sequential organ failure assessment score (SOFA) is increasingly used as an endpoint in intensive care randomized controlled trials (RCTs). Although serially measured SOFA is independently associated with mortality in observational cohorts, the association between treatment effects on SOFA vs. effects on mortality has not yet been quantified in RCTs. The aim of this study was to quantify the relationship between SOFA and mortality in RCTs and to identify which SOFA derivative best reflects between-group mortality differences.
The review protocol was prospectively registered (Prospero CRD42016034014). We performed a literature search (up to May 1, 2016) for RCTs reporting both SOFA and mortality, and analyzed between-group differences in these outcomes. Treatment effects on SOFA and mortality were calculated as the between-group SOFA standardized difference and log odds ratio (OR), respectively. We used random-effects meta-regression to (1) quantify the linear relationship between RCT treatment effects on mortality (logOR) and SOFA (i.e. responsiveness) and (2) quantify residual heterogeneity (i.e. consistency, expressed as I ).
Of 110 eligible RCTs, 87 qualified for analysis. Using all RCTs, SOFA was significantly associated with mortality (slope = 0.49 (95% CI 0.17; 0.82), p = 0.006, I = 5%); the overall mortality effect explained by SOFA score (R ) was 9%. Fifty-eight RCTs used Fixed-day SOFA as an endpoint (i.e. the score on a fixed day after randomization), 25 studies used Delta SOFA as an endpoint (i.e. the trajectory from baseline score) and 15 studies used other SOFA derivatives as an endpoint. Fixed-day SOFA was not significantly associated with mortality (slope = 0.35 (95% CI -0.04; 0.75), p = 0.08, I = 12%) and explained 3% of the overall mortality effect (R ). Delta SOFA was significantly associated with mortality (slope = 0.70 (95% CI 0.26; 1.14), p = 0.004, I = 0%) and explained 32% of the overall mortality effect (R ).
Treatment effects on Delta SOFA appear to be reliably and consistently associated with mortality in RCTs. Fixed-day SOFA was the most frequently reported outcome among the reviewed RCTs, but was not significantly associated with mortality. Based on this study, we recommend using Delta SOFA rather than Fixed-day SOFA as an endpoint in future RCTs.
序贯器官衰竭评估评分（SOFA）越来越多地被用作重症监护随机对照试验（RCT）的终点。尽管连续测量的 SOFA 与观察队列的死亡率独立相关，但治疗对 SOFA 的影响与对死亡率的影响之间的关系尚未在 RCT 中定量。本研究的目的是定量评估 RCT 中 SOFA 与死亡率之间的关系，并确定哪个 SOFA 衍生指标最能反映组间死亡率差异。
本综述方案前瞻性注册（Prospero CRD42016034014）。我们对报告 SOFA 和死亡率的 RCT 进行了文献检索（截至 2016 年 5 月 1 日），并分析了这些结局的组间差异。治疗对 SOFA 和死亡率的影响分别计算为组间 SOFA 标准化差异和对数比值比（OR）。我们使用随机效应荟萃回归来（1）定量评估 RCT 治疗对死亡率（对数 OR）和 SOFA（即反应性）的线性关系，以及（2）定量评估剩余的异质性（即一致性，用 I 表示）。
在 110 项合格的 RCT 中，有 87 项符合分析条件。使用所有 RCT，SOFA 与死亡率显著相关（斜率为 0.49（95%CI 0.17；0.82），p=0.006，I=5%）；SOFA 评分（R ）解释的总体死亡率效应为 9%。58 项 RCT 使用固定日 SOFA 作为终点（即随机分组后固定日的评分），25 项研究使用 Delta SOFA 作为终点（即从基线评分的轨迹），15 项研究使用其他 SOFA 衍生指标作为终点。固定日 SOFA 与死亡率无显著相关性（斜率为 0.35（95%CI -0.04；0.75），p=0.08，I=12%），解释总体死亡率效应的 3%（R ）。Delta SOFA 与死亡率显著相关（斜率为 0.70（95%CI 0.26；1.14），p=0.004，I=0%），解释总体死亡率效应的 32%（R ）。
RCT 中治疗对 Delta SOFA 的影响似乎与死亡率可靠且一致地相关。固定日 SOFA 是综述 RCT 中最常报告的结局，但与死亡率无显著相关性。基于本研究，我们建议在未来的 RCT 中使用 Delta SOFA 而不是固定日 SOFA 作为终点。
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