Damiani Lucas Petri, Berwanger Otavio, Paisani Denise, Laranjeira Ligia Nasi, Suzumura Erica Aranha, Amato Marcelo Britto Passos, Carvalho Carlos Roberto Ribeiro, Cavalcanti Alexandre Biasi
HCor Research Institute - São Paulo (SP), Brasil.
Divisão de Pneumologia, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo - São Paulo (SP), Brasil.
Rev Bras Ter Intensiva. 2017 Apr-Jun;29(2):142-153. doi: 10.5935/0103-507X.20170024.
The Alveolar Recruitment for Acute Respiratory Distress Syndrome Trial (ART) is an international multicenter randomized pragmatic controlled trial with allocation concealment involving 120 intensive care units in Brazil, Argentina, Colombia, Italy, Poland, Portugal, Malaysia, Spain, and Uruguay. The primary objective of ART is to determine whether maximum stepwise alveolar recruitment associated with PEEP titration, adjusted according to the static compliance of the respiratory system (ART strategy), is able to increase 28-day survival in patients with acute respiratory distress syndrome compared to conventional treatment (ARDSNet strategy).
To describe the data management process and statistical analysis plan.
The statistical analysis plan was designed by the trial executive committee and reviewed and approved by the trial steering committee. We provide an overview of the trial design with a special focus on describing the primary (28-day survival) and secondary outcomes. We describe our data management process, data monitoring committee, interim analyses, and sample size calculation. We describe our planned statistical analyses for primary and secondary outcomes as well as pre-specified subgroup analyses. We also provide details for presenting results, including mock tables for baseline characteristics, adherence to the protocol and effect on clinical outcomes.
According to best trial practice, we report our statistical analysis plan and data management plan prior to locking the database and beginning analyses. We anticipate that this document will prevent analysis bias and enhance the utility of the reported results.
ClinicalTrials.gov number, NCT01374022.
急性呼吸窘迫综合征肺泡复张试验（ART）是一项国际多中心随机实用对照试验，采用了分配隐藏，涉及巴西、阿根廷、哥伦比亚、意大利、波兰、葡萄牙、马来西亚、西班牙和乌拉圭的120个重症监护病房。ART的主要目标是确定与根据呼吸系统静态顺应性进行调整的PEEP滴定相关的最大逐步肺泡复张（ART策略）与传统治疗（ARDSNet策略）相比，是否能够提高急性呼吸窘迫综合征患者的28天生存率。
描述数据管理过程和统计分析计划。
统计分析计划由试验执行委员会设计，并经试验指导委员会审查和批准。我们概述了试验设计，特别关注描述主要结局（28天生存率）和次要结局。我们描述了我们的数据管理过程、数据监测委员会、中期分析和样本量计算。我们描述了我们对主要和次要结局以及预先指定的亚组分析的计划统计分析。我们还提供了呈现结果的详细信息，包括基线特征的模拟表格、方案依从性和对临床结局的影响。
根据最佳试验实践，我们在锁定数据库并开始分析之前报告我们的统计分析计划和数据管理计划。我们预计本文档将防止分析偏差并提高报告结果的效用。
ClinicalTrials.gov编号，NCT01374022。
