SQUEEZE试验的统计分析计划：一项旨在确定随机接受早期目标导向性液体节约策略与常规治疗的儿科患者中，感染性休克逆转是否更快的试验（SQUEEZE）。
Statistical analysis plan for the SQUEEZE trial: A trial to determine whether septic shock reversal is quicker in pediatric patients randomized to an early goal-directed fluid-sparing strategy vs. usual care (SQUEEZE).
作者信息
Parker Melissa J, Foster Gary, Fox-Robichaud Alison, Choong Karen, Mbuagbaw Lawrence, Thabane Lehana
机构信息
Division of Pediatric Critical Care, Department of Pediatrics, McMaster Children's Hospital and McMaster University, 1280 Main St W. HSC 3E-20, Hamilton, L8S 4K1, Ontario, Canada.
Department of Health Research Methods, Evidence, and Impact, McMaster University, 1200 Main St W. Hamilton, L8N 3Z5, Ontario, Canada.
出版信息
Crit Care Resusc. 2024 Jun 22;26(2):123-134. doi: 10.1016/j.ccrj.2024.02.002. eCollection 2024 Jun.
BACKGROUND
The SQUEEZE trial is a multicentred randomized controlled trial which seeks to determine the optimal approach to fluid resuscitation in paediatric septic shock. SQUEEZE also includes a nested translational study, SQUEEZE-D, investigating the value of plasma cell-free DNA for prediction of clinical outcomes.
OBJECTIVE
To present a pre-specified statistical analysis plan (SAP) for the SQUEEZE trial prior to finalizing the trial data set and prior to commencing data analysis.
DESIGN
SQUEEZE is a pragmatic, two-arm, open-label, prospective multicentre randomized controlled trial.
SETTING
Canadian paediatric tertiary care centres.
PARTICIPANTS
Paediatric patients with suspected sepsis and persistent signs of shock in need of ongoing resuscitation. Sample size target: 400 participants.
INTERVENTIONS
The trial is designed to compare a fluid-sparing resuscitation strategy to usual care.
MAIN OUTCOME MEASURES
The primary outcome for the SQUEEZE trial is the time to shock reversal (in hours). The primary outcome analysis will assess the difference in time to shock reversal between the intervention and control groups, reported as point estimate with 95% confidence intervals. The statistical test for the primary analysis will be a two-sided t-test. Secondary outcome measures include clinical outcomes and adverse events including measures of organ dysfunction and mortality outcomes.
RESULTS
The SAP presented here is reflective of and where necessary clarifies in detail the analysis plan as presented in the trial protocol. The SAP includes a mock CONSORT diagram, figures and tables. Data collection methods are summarized, primary and secondary outcomes are defined, and outcome analyses are described.
CONCLUSIONS
We have developed a statistical analysis plan for the SQUEEZE Trial for transparency and to align with best practices. Analysis of SQUEEZE Trial data will adhere to the SAP to reduce the risk of bias.
REGISTRATION
ClinicalTrials.gov identifiers: Definitive trial NCT03080038; Registered Feb 28, 2017. Pilot Trial NCT01973907; Registered Oct 27, 2013.
背景
SQUEEZE试验是一项多中心随机对照试验，旨在确定小儿感染性休克液体复苏的最佳方法。SQUEEZE还包括一项嵌套的转化研究SQUEEZE-D，研究游离血浆DNA对临床结局预测的价值。
目的
在确定试验数据集并开始数据分析之前，为SQUEEZE试验提供一份预先指定的统计分析计划（SAP）。
设计
SQUEEZE是一项实用的双臂、开放标签、前瞻性多中心随机对照试验。
地点
加拿大儿科三级护理中心。
参与者
疑似脓毒症且有持续休克体征需要持续复苏的儿科患者。样本量目标：400名参与者。
干预措施
该试验旨在比较液体节约型复苏策略与常规治疗。
主要结局指标
SQUEEZE试验首要结局是休克逆转时间（小时）。首要结局分析将评估干预组和对照组休克逆转时间的差异，以点估计值及95%置信区间报告。首要分析的统计检验将采用双侧t检验。次要结局指标包括临床结局和不良事件，包括器官功能障碍指标和死亡率结局。
结果
此处呈现的统计分析计划反映了试验方案中提出的分析计划，并在必要时进行了详细说明。统计分析计划包括一份模拟CONSORT流程图、图表。总结了数据收集方法，定义了首要和次要结局，并描述了结局分析。
结论
我们为SQUEEZE试验制定了统计分析计划，以提高透明度并符合最佳实践。SQUEEZE试验数据的分析将遵循统计分析计划，以降低偏倚风险。
注册信息
ClinicalTrials.gov标识符：确定性试验NCT03080038；2017年2月28日注册。试点试验NCT01973907；2013年10月27日注册。
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