Recently we posted on the insanity of requiring informed consent for posting a hygiene checklist in the ICU. This week the New England Journal of Medicine weighed in.
Here’s some background from the NEJM Commentary:
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 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. (Dr. Mary Ann Baily, NEJM, hat tip reader KR)
It’s this last part that created the problem. The investigators bothered to evaluate the intervention. It was “research” so the Office of Human Research Protection (OHRP) within the Department of Health and Human Services ruled it violated federal regulations by not requiring informed consent from patients and doctors. A Johns Hopkins review board had already ruled it wasn’t necessary. But OHRP got a written complaint and decided the complaint had merit. Full review and informed consent were required.
The NEJM commentary chose to focus on the fact that this meant the regulations weren’t clear. What wasn’t clear was the thinking at OHRP. “Not clear” is a euphemism. Stupid and devoid of all commonsense is more like it. The OHRP position that the checklist is fine as long as no evaluation of its effectiveness is done says it all.
Well, not quite all. Someone at DHHS got the message. This note prefaced the NEJM Commentary quoted above:
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.”
In other words, “Nevermind.”