Harming through Protection? (New Eng Jour Med)

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Harming through Protection?
Mary Ann Baily, Ph.D.

Editor's Note: On February 15, 2008, after this article had gone to press, the Office for Human Research Protections (OHRP) issued a statement (www.hhs.gov/ohrp/news/recentnews.html#20080215) expressing its new conclusion that Michigan hospitals may continue to implement the checklist developed by Pronovost et al. "without falling under regulations governing human subjects research," since it "is now being used . . . solely for clinical purposes, not medical research or experimentation." OHRP further stated that in the research phase, the project "would likely have been eligible for both expedited IRB review and a waiver of the informed consent requirement."

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About 80,000 catheter-related bloodstream infections occur in U.S. intensive care units (ICUs) each year, causing as many as 28,000 deaths and costing the health care system as much as $2.3 billion. If there were procedures that could prevent these infections, wouldn't we encourage hospitals to introduce them? And wouldn't we encourage the development, testing, and dissemination of strategies that would get clinicians to use them? Apparently not, judging from the experience of Peter Pronovost and other Johns Hopkins investigators who helped 103 ICUs in 67 Michigan hospitals carry out a highly successful infection-control effort,1 only to run into major problems with federal regulators.

The case demonstrates how some regulations meant to protect people are so poorly designed that they risk harming people instead. The regulations enforced by the Office for Human Research Protections (OHRP) were created in response to harms caused by subjecting people to dangerous research without their knowledge and consent. The regulatory system helps to ensure that research risks are not excessive, confidentiality is protected, and potential subjects are informed about risks and agree to participate. Unfortunately, the system has become complex and rigid and often imposes overly severe restrictions on beneficial activities that present little or no risk.

The Pronovost effort was part of a quality and safety initiative sponsored by the Michigan Hospital Association, with funding from the Agency for Healthcare Research and Quality (AHRQ). The intervention was designed to improve ICU care by promoting the use of five procedures recommended by the Centers for Disease Control and Prevention: washing hands, using full-barrier infection precautions during catheter insertion, cleaning the patient's skin with disinfectant, avoiding the femoral site if possible, and removing unnecessary catheters. The hospitals designated the clinicians who would lead the teams and provided the necessary supplies. The investigators provided an education program for the team leaders, who educated their colleagues about the procedures and introduced checklists to ensure their use. Infection-control practitioners in each hospital gave the teams feedback on infection rates in their ICUs.

The investigators studied the effect on infection rates and found that they fell substantially and remained low. They also combined the infection-rate data with publicly available hospital-level data to look for patterns related to hospital size and teaching status (they didn't find any). In this work, they used infection data at the ICU level only; they did not study the performance of individual clinicians or the effect of individual patient or provider characteristics on infection rates.

Source Information
Dr. Baily is an associate for ethics and health policy at the Hastings Center, Garrison, NY.

<more of the convoluted situation here:>

http://content.nejm.org/cgi/content/full/358/8/768?query=TOC

The New England Journal of Medicine is owned, published, and copyrighted © 2008 Massachusetts Medical Society. All rights reserved.

[Mojorabbit]

1. There are too many people with no

common sense. I am glad they left the protocols in place. It is basic infection control.

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2. Really.