SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis.
SOFA and mortality endpoints in randomized controlled trials: a systematic review and meta-regression analysis.
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DOI：
10.1186/s13054-017-1609-1
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发表时间：
2017-02-24
期刊：
影响因子：
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通讯作者：
Oudemans-van Straaten HM
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文献类型：
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作者：
de Grooth HJ;Geenen IL;Girbes AR;Vincent JL;Parienti JJ;Oudemans-van Straaten HM
序贯器官衰竭评估评分 (SOFA) 越来越多地用作重症监护随机对照试验 (RCT) 的终点。尽管连续测量的 SOFA 与观察队列中的死亡率独立相关，但 SOFA 的治疗效果与死亡率影响之间的关联尚未在随机对照试验中量化。本研究的目的是量化随机对照试验中 SOFA 与死亡率之间的关系，并确定哪种 SOFA 衍生物最能反映组间死亡率差异。审查方案已前瞻性注册（Prospero CRD42016034014）。我们对报告 SOFA 和死亡率的随机对照试验进行了文献检索（截至 2016 年 5 月 1 日），并分析了这些结果的组间差异。对 SOFA 和死亡率的治疗效果分别计算为组间 SOFA 标准化差和对数比值比 (OR)。我们使用随机效应元回归来 (1) 量化 RCT 治疗效果对死亡率 (logOR) 和 SOFA（即反应性）之间的线性关系，以及 (2) 量化残余异质性（即一致性，表示为 I 2）。在 110 项符合条件的随机对照试验中，有 87 项符合分析资格。使用所有 RCT，SOFA 与死亡率显着相关（斜率 = 0.49 (95% CI 0.17; 0.82)，p = 0.006，I 2 = 5%）； SOFA 评分 (R 2) 解释的总体死亡率影响为 9%。 58 项随机对照试验使用固定日 SOFA 作为终点（即随机化后固定日的得分），25 项研究使用 Delta SOFA 作为终点（即从基线得分开始的轨迹），15 项研究使用其他 SOFA 衍生物作为终点。固定日 SOFA 与死亡率没有显着相关性（斜率 = 0.35（95% CI -0.04; 0.75），p = 0.08，I 2 = 12%），并解释了 3% 的总体死亡率效应（R 2）。 Delta SOFA 与死亡率显着相关（斜率 = 0.70（95% CI 0.26；1.14），p = 0.004，I 2 = 0%），并解释了 32% 的总体死亡率效应（R 2）。随机对照试验中，Delta SOFA 的治疗效果似乎与死亡率可靠且一致地相关。固定日 SOFA 是所审查的随机对照试验中最常报告的结果，但与死亡率没有显着相关。根据这项研究，我们建议使用 Delta SOFA 而不是固定日 SOFA 作为未来随机对照试验的终点。本文的在线版本 (doi:10.1186/s13054-017-1609-1) 包含补充材料，可供授权用户使用。
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 2). 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 2 = 5%); the overall mortality effect explained by SOFA score (R 2) 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 2 = 12%) and explained 3% of the overall mortality effect (R 2). Delta SOFA was significantly associated with mortality (slope = 0.70 (95% CI 0.26; 1.14), p = 0.004, I 2 = 0%) and explained 32% of the overall mortality effect (R 2). 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. The online version of this article (doi:10.1186/s13054-017-1609-1) contains supplementary material, which is available to authorized users.