Hammond Naomi E, Billot Laurent, Finfer Simon, Myburgh John
Critical Care and Trauma Division, The George Institute for Global Health, Sydney, NSW, Australia.
Sydney Medical School, University of Sydney, Sydney, NSW, Australia.
Crit Care Resusc. 2014 Sep;16(3):206-13.
Recent randomised controlled trials have compared the effects of albumin and hydroxyethyl starch (HES) v crystalloids on patient-centred outcomes in critically ill patients. The Saline v Albumin Fluid Evaluation (SAFE) trial reported patient-centred outcomes at 28 days in 6933 patients assigned to fluid resuscitation with either 4% albumin or 0.9% saline; the Crystalloid v Hydroxyethyl Starch Trial (CHEST) reported patient-centred outcomes at 28 days in 6644 patients assigned to fluid resuscitation with either 6% HES (130/0.4) or 0.9% saline. As the two trials used a common reference fluid (0.9% saline) and had most trial methods and data collection points harmonised, a comparison of 4% albumin and 6% HES (130/0.4) on patient-centred outcomes at 28 days in critically ill patients using the individual patient data from the two trials is feasible.
To prepublish the statistical analysis plan (SAP) of an individual patient data comparative analysis of the SAFE and CHEST studies.
The statistical analyses are described in detail with the appropriate statistical analysis specified.
The planned statistical analyses are described in detail for the SAFE and CHEST individual patient data comparative analysis. We outline the proposed statistical analysis for the baseline characteristics, processes of care and the outcomes. Subgroups are defined with statistical comparisons between the fluid groups and in each subgroup explained.
We have developed a SAP for the SAFE/ CHEST individual patient data comparative analysis to increase the internal validity of the study and minimise bias.
近期的随机对照试验比较了白蛋白和羟乙基淀粉（HES）与晶体液对危重症患者以患者为中心的结局的影响。生理盐水与白蛋白液体评估（SAFE）试验报告了6933例被分配接受4%白蛋白或0.9%生理盐水液体复苏患者在28天时以患者为中心的结局；晶体液与羟乙基淀粉试验（CHEST）报告了6644例被分配接受6% HES（130/0.4）或0.9%生理盐水液体复苏患者在28天时以患者为中心的结局。由于这两项试验使用了共同的对照液体（0.9%生理盐水），且大多数试验方法和数据收集点是统一的，因此利用这两项试验的个体患者数据比较4%白蛋白和6% HES（130/0.4）对危重症患者28天时以患者为中心的结局是可行的。
预发表SAFE和CHEST研究个体患者数据比较分析的统计分析计划（SAP）。
详细描述统计分析并指定适当的统计分析方法。
详细描述了SAFE和CHEST个体患者数据比较分析计划中的统计分析。我们概述了针对基线特征、治疗过程和结局提出的统计分析。定义了亚组，并解释了液体组之间以及每个亚组内的统计比较。
我们已制定了SAFE/CHEST个体患者数据比较分析的SAP，以提高研究的内部效度并最大限度地减少偏倚。
