Updating informed consent in the era of patient-centered care

Nine U.S. medical centers--including the Mayo Clinic in Rochester, Minn., and the Henry Ford Hospital in Detroit--are testing a new informed consent process designed to provide patients relevant, personalized data about their individual risks of undergoing nonemergent cardiac catheterization and potential angioplasty. The web-based program, known as Patient Refined Expectations for Deciding Invasive Cardiac Treatments (PREDICT) draws on information from the American College of Cardiology's National Cardiovascular Data Registry, which in May surpassed 10 million cath-lab patient records, according to the American Medical News.

By combining this data with a patient's age, comorbidities and other characteristics to estimate an individual's risk profile, PREDICT provides each patient's bleeding, death and restenosis risks, as well as the pros and cons of bare-metal versus drug-eluting stents using an easy-to-understand bar chart.

The idea behind the updated system, developed by John Spertus, MD, MPH, with $5.6 million in grants from the American Heart Association and the National Institutes of Health, is to address the troubling statistic that 60 to 70 percent of patients do not read or understand informed-consent forms.

"This is the most innovative informed-consent tool in, literally, a decade," said Glenn McGee, PhD, editor-in-chief of the American Journal of Bioethics. "There is no question that this will be rapidly followed in many fields, because the problem in informed consent right now is that it is the most impersonalized medicine there is. These forms are usually in 7-point font, 14 pages long, doctors haven't read them, they are handed out, and we are not even sure whether they're a legal shield."

While PREDICT in many ways offers patients more transparency about surgical risks, it focuses less on barraging patients with every possible consequence and instead informs patients how likely they are to experience certain problems. "Informed consent was always just a dreadful process," Charles F. Bethea, MD, chief medical officer at Integris Heart Hospital in Oklahoma City, which started testing PREDICT in March, told AM News. "Sure, a meteorite can crash through the ceiling, but you know that's not going to happen. You read this long list of potentials, and you see the patients' eyes glaze over." The PREDICT form, on the other hand, provides an objective calculation based on experience in hundreds of hospitals."

Elsewhere, researchers have begun to explore the use of video and 'picture books' to help explain to patients the details and risks about undergoing a procedure or participating in a medical study, notes Robert Klitzman, MD, in a Huffington Post blog entry about the ethical dilemmas and shortcomings of the informed consent process.

Part of the resistance to changing the current legalese-heavy documents, Klitzman says, is the fear that legal details would be lost in simplification. But while new processes such as PREDICT may expose physicians to different legal issues than older forms, they're unlikely to worsen overall liability, says McGee.

According to Harlan M. Krumholz, MD, director of the hospital's Center for Outcomes Research and Evaluation, informed consent has the potential to provide an even broader array of patient-centered information. Specifically, he believes forms should explain to patients how they would fare with pharmaceutical alternatives to a given surgical procedure, how many procedures the physician has performed, and what the out-of-pocket costs will be for the overall episode of care. 

To learn more:
- read this American Medical News article
- check out this Huffington Post blog post