Malcolm Fisher Department of Intensive Care Medicine, Royal North Shore Hospital, St Leonards, New South Wales, Australia; Northern Clinical School, Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia.
Emerg Med Australas. 2013 Oct;25(5):406-15. doi: 10.1111/1742-6723.12116. Epub 2013 Sep 9.
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 ED with severe sepsis.
In keeping with current practice, and taking into considerations aspects of trial design and reporting specific to non-pharmacologic interventions, this document outlines the principles and methods for analysing and reporting the trial results. The document is prepared prior to 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 prior to completion of the two related international studies.
The statistical analysis plan was designed by the ARISE chief investigators, and reviewed and approved by the ARISE steering committee. The data collected by the research team as specified in the study protocol, and detailed in the study case report form were reviewed. Information related to baseline characteristics, characteristics of delivery of the trial interventions, details of resuscitation and other related therapies, and other relevant data are described with appropriate comparisons between groups. The primary, secondary and tertiary outcomes for the study are defined, with description of the planned statistical analyses.
A statistical analysis plan was developed, along with a trial profile, mock-up tables and figures. A plan for presenting baseline characteristics, microbiological and antibiotic therapy, details of the interventions, processes of care and concomitant therapies, along with adverse events are described. The primary, secondary and tertiary outcomes are described along with identification of subgroups to be analysed.
A statistical analysis plan for the ARISE study has been developed, and is available in the public domain, prior to the completion of recruitment into the study. This will minimise analytic 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，考虑到试验设计和报告方面的因素以及非药物干预的具体特点，本文件概述了分析和报告试验结果的原则和方法。本文件在 ARISE 研究完成招募之前编写，研究人员在不知道数据安全和监测委员会进行的中期分析结果的情况下编写，并且在完成两项相关的国际研究之前编写。
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。研究团队按照研究方案中规定的方法收集数据，并详细记录在病例报告表中。对基线特征、试验干预措施的实施情况、复苏和其他相关治疗的详细信息以及其他相关数据进行描述，并对组间进行适当的比较。对研究的主要、次要和次要结局进行了定义，并描述了计划的统计分析。
制定了统计分析计划，同时还制定了研究概况、模拟表格和图表。描述了基线特征、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。描述了主要、次要和次要结局，并确定了要分析的亚组。
在完成 ARISE 研究的招募之前，已经制定了 ARISE 研究的统计分析计划，并在公共领域提供。这将最大限度地减少分析偏差，并符合当前进行临床试验的最佳实践。
