第3阶段随机对照治疗侵袭性通风成年人与早期活动和动员 (TEAM III) 试验的协议和统计分析计划
Jeffrey J Presneill1,2, Rinaldo Bellomo1,3, Kathy Brickell4
1Australian and New Zealand Intensive Care Research Centre, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia.
概括
侵袭性通风成人的治疗与早期活动和动员 (TEAM III) 试验将测试重症患者的早期动员. 该协议确保对临床数据进行公正的分析,以评估患者的治疗结果.
科学领域:
- 关键护理医学 关键护理医学
- 临床试验 临床试验
- 康复 康复 康复 康复
背景情况:
- 需要侵入性机械通风的重症患者经常经历长时间的ICU停留和不良的功能结果.
- 早期活动和动员策略是国际指南所建议的,但在大型试验中需要严格的评估.
- 侵袭性通风成人的治疗与早期活动和动员 (TEAM III) 试验解决了这一需求.
研究的目的:
- 概述国际,多中心,第三期TEAM III随机对照试验的协议和统计分析计划.
- 为提供一个框架,对侵袭性通风的成年人早期活动和动员进行公正的评估.
主要方法:
- 这是一项国际性的,多中心的,并行组的,随机对照的第三期试验,涉及750名成年患者.
- 干预:与标准护理相比,早期活动和动员时间长达28天.
- 主要结局:活着的日子和180天出院;次要结局包括死亡率,无ICU,无呼吸器和无妄想的日子.
主要成果:
- 招聘正在进行中,截至2021年3月,超过576名患者在46个地点注册.
- 750名患者的最终数据收集预计将于2022年5月完成.
- 该研究旨在提供关于早期动员有效性的可靠数据.
结论:
- 为TEAM III试验制定了一个全面的协议和统计分析计划,遵守国际准则.
- 该计划详细介绍了统计模型,共变量和探索性分析方法,用于对临床数据进行公正评估.
- 这种结构化的方法将有助于对临床试验的早期动员研究结果进行可靠的解释.
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