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Author Notes:

Correspondence to: Greg S. Martin, MD, MSc Division of Pulmonary, Allergy and Critical Care, Emory University School of Medicine, greg.martin@emory.edu

NA, participated in the study design and primarily drafted the manuscript.

WC participated in the study design, analysis plan and revised sample size estimates by clustering as well as drafted the statistical manuscript sections.

DG developed the data collection and integrity plan and drafted the data collection section of the manuscript.

GM participated in the study design and site recruitment process and further drafted sections of the manuscript.

JS principally conceived of the study and led initial study protocol efforts and drafted portions of this manuscript.

SS participated in site communication planning and drafted portions of the manuscript.

All authors provided critical revisions to the manuscript and approved of the final manuscript content.

We acknowledge the leadership of the USCIITG in facilitating the execution of this study and providing invaluable advice on protocol development and execution.

None of the authors report they have a significant financial or other competing interest related to the content of this manuscript.


  • ICU
  • Critical Care
  • Outcomes
  • Protocols
  • ICU organization

Critical illness outcome study: an observational study of protocols and mortality in intensive care units


Journal Title:

Open Access Journal of Clinical Trials


Volume 2011, Number 3


, Pages 55-65

Type of Work:

Article | Final Publisher PDF


Individual intensive care unit (ICU) characteristics including staffing, expertise, continuity, and team structure, have been associated with patient outcomes. Separately, some aspects of care in ICUs have been implemented through treatment protocols. The United States Critical Illness and Injury Trials Group-Critical Illness Outcomes Study (USCIITG-CIOS) was designed to determine whether the extent of protocol use in ICUs is associated with hospital survival in a large number of US ICUs. Here, we describe the study protocol and analysis plan approved by the USCIITG-CIOS steering committee. USCIITG-CIOS is a prospective, observational, ecological, multicentered study of mixed ICUs in the US. The data to be collected include organizational information for the ICU (eg, protocol availability and utilization, multidisciplinary staffing assessment), and patient level information (eg, 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-protocol and low-protocol use ICUs, dichotomized according to protocol number at the median. The analysis will utilize multivariable regression approaches 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. We anticipate at least 60 ICUs participating in USCIITG-CIOS to enroll approximately 6000 study subjects. USCIITG-CIOS is a multicenter study examining the effect of ICU protocols on patient outcomes. These results will inform our understanding of the relationship between protocol availability, use, and patient outcomes in the ICU. Given the shortage of intensivists worldwide, the results of USCIITG-CIOS can be used to promote more effective and reproducible ICU care and outcomes.

Copyright information:

© 2011 Ali et al, publisher and licensee Dove Medical Press Ltd. This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

This is an Open Access work distributed under the terms of the Creative Commons Attribution-Noncommercial 3.0 Unported License (http://creativecommons.org/licenses/by-nc/3.0/).

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