Damiani Lucas P, Cavalcanti Alexandre B, Moreira Frederico R, Machado Flavia, Bozza Fernando A, Salluh Jorge I F, Campagnucci Valquiria P, Normilio-Silva Karina, Chiattone Viviane C, Angus Derek C, Berwanger Otavio, Chou H Chang Chung-
Research Institute, Hospital do Coração, São Paulo, Brazil.
Hospital Universitário, Universidade Federal de São Paulo, São Paulo, Brazil.
Crit Care Resusc. 2015 Jun;17(2):113-21.
The Checklist During Multidisciplinary Visits for Reduction of Mortality in Intensive Care Units (Checklist- ICU) trial is a pragmatic, two-arm, cluster-randomised trial involving 118 intensive care units in Brazil, with the primary objective of determining if a multifaceted qualityimprovement intervention with a daily checklist, definition of daily care goals during multidisciplinary daily rounds and clinician prompts can reduce inhospital mortality.
To describe our trial statistical analysis plan (SAP).
This is an ongoing trial conducted in two phases. In the preparatory observational phase, we collect three sets of baseline data: ICU characteristics; patient characteristics, processes of care and outcomes; and completed safety attitudes questionnaires (SAQs). In the randomised phase, ICUs are assigned to the experimental or control arms and we collect patient data and repeat the SAQ.
Our SAP includes the prespecified model for the primary and secondary outcome analyses, which account for the cluster-randomised design and availability of baseline data. We also detail the multiple mediation models that we will use to assess our secondary hypothesis (that the effect of the intervention on inhospital mortality is mediated not only through care processes targeted by the checklist, but also through changes in safety culture). We describe our approach to sensitivity and subgroup analyses and missing data.
We report our SAP before closing our study database and starting analysis. We anticipate that this should prevent analysis bias and enhance the utility of results.
重症监护病房多学科会诊降低死亡率检查表（Checklist-ICU）试验是一项务实的双臂整群随机试验，涉及巴西的118个重症监护病房，其主要目的是确定一项多方面的质量改进干预措施，包括每日检查表、多学科每日查房期间的每日护理目标定义以及临床医生提示，是否可以降低住院死亡率。
描述我们试验的统计分析计划（SAP）。
这是一项分两个阶段进行的正在进行的试验。在准备性观察阶段，我们收集三组基线数据：重症监护病房特征；患者特征、护理过程和结果；以及完整的安全态度问卷（SAQ）。在随机阶段，重症监护病房被分配到试验组或对照组，我们收集患者数据并重复进行安全态度问卷调查。
我们的统计分析计划包括用于主要和次要结局分析的预先指定模型，该模型考虑了整群随机设计和基线数据的可用性。我们还详细说明了将用于评估我们次要假设（即干预对住院死亡率的影响不仅通过检查表所针对的护理过程介导，还通过安全文化的变化介导）的多重中介模型。我们描述了我们进行敏感性分析、亚组分析和处理缺失数据的方法。
我们在关闭研究数据库并开始分析之前报告我们的统计分析计划。我们预计这将防止分析偏差并提高结果的效用。
