重症结局研究:一项关于重症监护病房方案和死亡率的观察性研究。

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL
Naeem A Ali, David Gutteridge, Sajid Shahul, William Checkley, Jonathan Sevransky, Greg S Martin
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引用次数: 14

摘要

许多个体重症监护室(ICU)特征与患者预后相关,包括人员配置、专业知识、连续性和团队结构。另外,通过制定复杂的治疗方案,icu临床护理的许多方面已经实现了操作化。美国危重疾病和损伤试验组危重疾病结局研究(USCIITG-CIOS)旨在确定重症监护病房方案的可用性和使用程度是否与美国重症监护病房的住院生存相关。在这里,我们描述了usciitg - cio指导委员会批准的研究方案和分析计划。方法:USCIITG-CIOS是一项针对美国混合ICU的前瞻性、观察性、生态多中心“队列”研究。收集的数据包括ICU的组织信息(如方案的可用性和利用率、多学科人员配置评估)和患者水平信息(如人口统计学、急慢性疾病)。主要结局是全因住院死亡率,目的是确定方案编号与ICU患者住院死亡率之间是否存在关联。USCIITG-CIOS能够检测到高和低方案使用icu之间的粗医院死亡率差异为3%,根据中位数的方案编号进行二分类。分析将利用回归模型来调整ICU的结果聚类,并对方案编号和死亡率以及各种先验计划的辅助研究进行二次线性分析。目前有60个icu参与USCIITG-CIOS,招募约6,000名研究对象。结论:USCIITG-CIOS是一项大型多中心研究,旨在研究ICU方案使用对患者预后的影响。本研究的主要结果将使我们了解方案的可用性、使用和ICU患者预后之间的关系。此外,鉴于全球范围内重症医师的短缺,USCIITG-CIOS的结果可用于促进更有效的ICU和护理团队设计,并将影响个体从业人员以外的重症监护服务的提供。试验注册:ClinicalTrials.gov标识符NCT01109719。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units.

Critical Illness Outcome Study: An Observational Study on Protocols and Mortality in Intensive Care Units.

Introduction: Many individual Intensive Care Unit (ICU) characteristics have been associated with patient outcomes, including staffing, expertise, continuity and team structure. Separately, many aspects of clinical care in ICUs have been operationalized through the development of complex treatment protocols. The United State Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol availability and use in ICUs is associated with hospital survival in a large cohort of United States ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS Steering Committee.

Methods: USCIITG-CIOS is a prospective, observational, ecological multi-centered "cohort" study of mixed ICUs in the U.S. The data collected include organizational information for the ICU (e.g., protocol availability and utilization, multi-disciplinary staffing assessment) and patient level information (e.g. demographics, acute and chronic medical conditions). The primary outcome is all-cause hospital mortality, with the objective being to determine whether there is an association between protocol number and hospital mortality for ICU patients. USCIITG-CIOS is powered to detect a 3% difference in crude hospital mortality between high and low protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize regression modeling to adjust for outcome clustering by ICU, with secondary linear analysis of protocol number and mortality and a variety of a priori planned ancillary studies. There are presently 60 ICUs participating in USCIITG-CIOS to enroll approximately 6,000 study subjects.

Conclusions: USCIITG-CIOS is a large multicentric study examining the effect of ICU protocol use on patient outcomes. The primary results of this study will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Moreover, given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective ICU and care team design and will impact the delivery of intensive care services beyond individual practitioners.

Trial registration: ClinicalTrials.gov Identifier NCT01109719.

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来源期刊
Open Access Journal of Clinical Trials
Open Access Journal of Clinical Trials MEDICINE, RESEARCH & EXPERIMENTAL-
CiteScore
3.90
自引率
0.00%
发文量
2
审稿时长
16 weeks
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