• Lucas Petri Damiani, Otavio Berwanger, Denise Paisani, Ligia Nasi Laranjeira, Erica Aranha Suzumura, Amato Marcelo Britto Passos MBP Divisão de Pneumologia, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo - São Paulo (SP), Br, Carvalho Carlos Roberto Ribeiro CRR Divisão de Pneumologia, Instituto do Coração, Hospital das Clínicas, Faculdade de Medicina, Universidade de São Paulo - São Paulo (SP), and Alexandre Biasi Cavalcanti.
• HCor Research Institute - São Paulo (SP), Brasil.
• Rev Bras Ter Intensiva. 2017 Apr 1; 29 (2): 142-153.

BackgroundThe 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).ObjectiveTo describe the data management process and statistical analysis plan.MethodsThe 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.ConclusionAccording 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.Trial RegistrationClinicalTrials.gov number, NCT01374022.

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