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Original Research: CRITICAL CARE MEDICINE |

Reasons for Nonenrollment in a Clinical Trial of Acute Lung Injury

Andrea E. Glassberg, MD, PhD; John M. Luce, MD; Michael A. Matthay, MD, FCCP; the National Heart, Lung, and Blood Institute Clinical Trials Network
Author and Funding Information

*From the Permanente Medical Group (Dr. Glassberg), Fremont; and University of California, San Francisco (Drs. Luce and Matthay), San Francisco, CA.

Correspondence to: Andrea Glassberg, MD, PhD, The Permanente Medical Group, 39400 Paseo Padre Parkway, Fremont, CA 94538; e-mail: andrea.e.glassberg@kp.org


†A list of participants is given in the Appendix.

This work was performed at the University of California, San Francisco.

This work was supported in part by National Institutes of Health grants HL51856 (Dr. Matthay), P50 HL74005 (Dr. Matthay), and N01-HR746059.

The authors have no conflicts of interest to disclose.

Reproduction of this article is prohibited without written permission from the American College of Chest Physicians (www.chestjournal.org/misc/reprints.shtml).


Chest. 2008;134(4):719-723. doi:10.1378/chest.08-0633
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Background:  Enrolling critically ill patients in clinical trials is challenging. We observed that eligible patients at San Francisco General Hospital (SFGH), a public hospital that cares largely for indigent patients, were less likely to be enrolled in a clinical trial of acute lung injury (ALI) than eligible patients at the University of California, San Francisco (UCSF), a university referral center. We examined the reasons for nonenrollment and the impact of the availability of a surrogate decision maker on critical care clinical trials enrollment.

Methods:  Data collected from the ARDS Network trial of lower vs traditional tidal volume ventilation for patients with ALI was analyzed. Patient demographics and reasons for nonenrollment were analyzed among 531 consecutively screened patients at the two hospitals: UCSF and SFGH.

Results:  At UCSF, 1% of screened patients were not enrolled because they lacked surrogates, whereas 18% of screened patients were not enrolled at SFGH because they lacked surrogates. Lack of surrogate was the most common reason for nonenrollment among eligible patients at SFGH.

Conclusions:  Critically ill patients with ALI at a public hospital were less likely to be enrolled in a clinical trial than patients at a university hospital primarily because they lacked surrogates. Lack of a surrogate also was a major factor in nonenrollment in other ARDS Network hospitals. In order to provide all affected patients an opportunity to participate in research, innovative strategies for increasing enrollment in critical care research without compromising protection from research risks are needed.


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