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Patient Eligibility for Randomized Controlled Trials in Critical Care Medicine: An International Two-Center Observational Study*

Ivie, Ryan M. J. MD1; Vail, Emily A. MD1; Wunsch, Hannah MD, MSc1–4; Goldklang, Monica P. MD1,5; Fowler, Robert MD2,3; Moitra, Vivek K. MD1

doi: 10.1097/CCM.0000000000002061
Clinical Investigations
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Objective: We conducted this study to determine the generalizability of information gained from randomized controlled trials in critically ill patients by assessing the incidence of eligibility for each trial.

Design: Prospective, observational cohort study. We identified the 15 most highly cited randomized controlled trials in critical care medicine published between 1998 and 2008. We examined the inclusion and exclusion criteria for each randomized controlled trial and then assessed the eligibility of each patient admitted to a study ICU for each randomized controlled trial and calculated rates of potential trial eligibility in the cohort.

Setting: Three ICUs in two academic medical centers in Canada and the United States.

Patients: Adults admitted to participating medical or surgical ICU in November 2010 or July 2011.

Measurements and Main Results: Among the 15 trials, the most common trial inclusion criteria were clinical criteria for sepsis (six trials) or acute respiratory distress syndrome (four trials), use of invasive mechanical ventilation (five trials) or related to ICU type or duration of ICU stay (five trials). Of the 93 patients admitted to a study ICU, 52% of patients (n = 48) did not meet enrollment criteria for any studied randomized controlled trial and 30% (n = 28) were eligible for only one of the 15. Trial ineligibility was mostly due to failure to meet inclusion criteria (87% of screening assessments) rather than meeting specific exclusion criteria (52% of screening assessments). Of the positive screening assessments, 85% occurred on the first day of ICU admission.

Conclusions: Slightly more than half of the patients assessed were not eligible for enrollment in any of 15 major randomized controlled trials in critical care, most often due to the absence of the specific clinical condition of study. The majority of patients who met criteria for a randomized controlled trial did so on the first day of ICU admission.

1Department of Anesthesiology, Columbia University College of Physicians and Surgeons, New York, NY.

2Department of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.

3Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Ontario, Canada.

4Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada.

5Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY.

*See also p. 372.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website (http://journals.lww.com/ccmjournal).

Supported by Columbia University and the University of Toronto.

A portion of this work was presented at the Society of Critical Care Anesthesiologists’ Twenty-sixth Annual Meeting, San Francisco, CA, October 11, 2013 (1).

Dr. Ivie received funding from the Society of Critical Care Anesthesiologists (SOCCA)—Young Investigator Award. The remaining authors have disclosed that they do not have any potential conflicts of interest.

For information regarding this article, E-mail: vm2161@cumc.columbia.edu

Copyright © 2017 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.