Malcolm Fisher Intensive Care Unit, Royal North Shore Hospital, Sydney, NSW, Australia.
Crit Care Resusc. 2013 Sep;15(3):162-71.
The Australasian Resuscitation in Sepsis Evaluation (ARISE) study is an international, multicentre, randomised, controlled trial designed to evaluate the effectiveness of early goal-directed therapy compared with standard care for patients presenting to the emergency department with severe sepsis.
In keeping with current practice, and considering aspects of trial design and reporting specific to non-pharmacological interventions, our plan outlines the principles and methods for analysing and reporting the trial results. The document is prepared before completion of recruitment into the ARISE study, without knowledge of the results of the interim analysis conducted by the data safety and monitoring committee and before completion of the two related international studies.
Our statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. We reviewed the data collected by the research team as specified in the study protocol and detailed in the study case report form. We describe information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation, other related therapies and other relevant data with appropriate comparisons between groups. We define the primary, secondary and tertiary outcomes for the study, with description of the planned statistical analyses.
We have developed a statistical analysis plan with a trial profile, mock-up tables and figures. We describe a plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies and adverse events. We describe the primary, secondary and tertiary outcomes with identification of subgroups to be analysed.
We have developed a statistical analysis plan for the ARISE study, available in the public domain, before the completion of recruitment into the study. This will minimise analytical bias and conforms to current best practice in conducting clinical trials.
澳大利亚复苏脓毒症评估研究（ARISE）是一项国际性、多中心、随机对照试验，旨在评估早期目标导向治疗与标准治疗相比，对急诊科严重脓毒症患者的有效性。
根据当前的实践，并考虑到试验设计和报告方面的特点，本文件概述了分析和报告试验结果的原则和方法。本文件是在 ARISE 研究完成招募之前编写的，当时不知道数据安全和监测委员会进行的中期分析结果，也不知道两项相关的国际研究完成。
我们的统计分析计划由 ARISE 首席研究员设计，并由 ARISE 指导委员会审查和批准。我们根据研究方案和研究病例报告表中详细规定，审查了研究小组收集的数据。我们描述了与基线特征、试验干预措施实施特征、复苏细节、其他相关治疗以及其他相关数据相关的信息，并对组间进行了适当比较。我们定义了研究的主要、次要和次要结局，并描述了计划的统计分析。
我们制定了一个具有试验概况、模拟表格和图形的统计分析计划。我们描述了呈现基线特征、微生物学和抗生素治疗、干预措施细节、护理过程和伴随治疗以及不良事件的计划。我们描述了主要、次要和次要结局，并确定了要分析的亚组。
我们在研究完成招募之前制定了 ARISE 研究的统计分析计划，并将其公开。这将最大限度地减少分析偏差，并符合当前临床试验的最佳实践。
