In the New Yorker, Atul Gawande describes a study designed by Dr Peter Pronovost of Johns Hopkins to prevent a frequent problem in the ICU -- intravenous catheter infections. The intervention was a checklist:
On a sheet of plain paper, he plotted out the steps to take in order to avoid infections when putting a line in. Doctors are supposed to (1) wash their hands with soap, (2) clean the patient’s skin with chlorhexidine antiseptic, (3) put sterile drapes over the entire patient, (4) wear a sterile mask, hat, gown, and gloves, and (5) put a sterile dressing over the catheter site once the line is in. Check, check, check, check, check. These steps are no-brainers; they have been known and taught for years. So it seemed silly to make a checklist just for them.The results were astounding. In 103 intensive care units in Michigan that adopted the checklist, the rate of catheter related bloodstream infections dropped 66%. (The paper, published in the New England Journal of Medicine, is here.)
Naturally, you'd expect an intervention this simple, successful, and lifesaving to have government support . But unexpectedly, the checklist program has now been shut down by the Office for Human Research Protections. Gawande provides an update in the Op-Ed page of the New York Times:
The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.Apparently, the program and the government regulators are now at an impasse. The requirement that informed consent be obtained from every patient and physician is unworkable, and further research on checklists cannot continue. The only solution, according to Gawande's Op-Ed, is to have Congress step in.