Between-trial heterogeneity in ARDS research.
Between-trial heterogeneity in ARDS research.
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DOI：
10.1007/s00134-021-06370-w
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发表时间：
2021-04
影响因子：
38.9
通讯作者：
de Grooth HJ
中科院分区：
文献类型：
--
作者：
Juschten J;Tuinman PR;Guo T;Juffermans NP;Schultz MJ;Loer SA;Girbes ARJ;de Grooth HJ
大多数针对急性呼吸窘迫综合征（ARDS）患者的随机对照试验（RCT）显示出不确定或相互矛盾的研究结果。我们的目的是系统地评估报告标准和试验结果方面的试验间异质性。对 2000 年至 2019 年间发表的随机对照试验进行了系统评价，其中包括接受肺保护性通气的成年 ARDS 患者。应用随机效应元回归模型来量化异质性（非随机变异性）并评估作为异质性来源的试验和患者特征。总共纳入了 67 项随机对照试验。 28天对照组死亡率为10%至67%，具有较大的非随机异质性（I2 = 88%，p < 0.0001）。报告的基线患者特征解释了一些结果异质性，但只有 6 项试验 (9%) 报告了所有四个独立预测变量（平均年龄、平均肺损伤评分、平均平台压和平均动脉 pH 值）。根据患者特征（即残余异质性）调整后的 28 天对照组死亡率为 18% 至 45%。主要结局显着获益的试验报告的对照组死亡率高于结局或危害不确定的试验（平均 28 天对照组死亡率：44% vs. 28%；p = 0.001）。在肺保护性通气时代的 ARDS 随机对照试验中，基线特征的描述存在很大差异，并且 28 天对照组死亡率存在显着的无法解释的异质性。这些发现表明 ARDS 研究的普遍性存在问题，并强调迫切需要对试验和基线特征进行标准化报告。本文的在线版本 (10.1007/s00134-021-06370-w) 包含补充材料，可供授权用户使用。
Most randomized controlled trials (RCTs) in patients with acute respiratory distress syndrome (ARDS) revealed indeterminate or conflicting study results. We aimed to systematically evaluate between-trial heterogeneity in reporting standards and trial outcome. A systematic review of RCTs published between 2000 and 2019 was performed including adult ARDS patients receiving lung-protective ventilation. A random-effects meta-regression model was applied to quantify heterogeneity (non-random variability) and to evaluate trial and patient characteristics as sources of heterogeneity. In total, 67 RCTs were included. The 28-day control-group mortality rate ranged from 10 to 67% with large non-random heterogeneity (I2 = 88%, p < 0.0001). Reported baseline patient characteristics explained some of the outcome heterogeneity, but only six trials (9%) reported all four independently predictive variables (mean age, mean lung injury score, mean plateau pressure and mean arterial pH). The 28-day control group mortality adjusted for patient characteristics (i.e. the residual heterogeneity) ranged from 18 to 45%. Trials with significant benefit in the primary outcome reported a higher control group mortality than trials with an indeterminate outcome or harm (mean 28-day control group mortality: 44% vs. 28%; p = 0.001). Among ARDS RCTs in the lung-protective ventilation era, there was large variability in the description of baseline characteristics and significant unexplainable heterogeneity in 28-day control group mortality. These findings signify problems with the generalizability of ARDS research and underline the urgent need for standardized reporting of trial and baseline characteristics. The online version of this article (10.1007/s00134-021-06370-w) contains supplementary material, which is available to authorized users.
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影响因子：
38.9
作者：
Bein, Thomas;Weber-Carstens, Steffen;Goldmann, Anton;Mueller, Thomas;Staudinger, Thomas;Brederlau, Joerg;Muellenbach, Ralf;Dembinski, Rolf;Graf, Bernhard M.;Wewalka, Marlene;Philipp, Alois;Wernecke, Klaus-Dieter;Lubnow, Matthias;Slutsky, Arthur S.
通讯作者：
Slutsky, Arthur S.
影响因子：
76.2
作者：
Calfee, Carolyn S.;Delucchi, Kevin;Parsons, Polly E.;Thompson, B. Taylor;Ware, Lorraine B.;Matthay, Michael A.
通讯作者：
Matthay, Michael A.
DOI：
10.1164/rccm.201603-0645oc
发表时间：
2017-02-01
影响因子：
24.7
作者：
Famous, Katie R.;Delucchi, Kevin;Calfee, Carolyn S.
通讯作者：
Calfee, Carolyn S.
影响因子：
8.8
作者：
Brower, RG;Shanholtz, CB;Piantadosi, S
通讯作者：
Piantadosi, S
影响因子：
120.7
作者：
Cavalcanti, Alexandre Biasi;Suzumura, Erica Aranha;Ribeiro de Carvalho, Carlos Roberto
通讯作者：
Ribeiro de Carvalho, Carlos Roberto