Informed consent: Hospitals explore personalizing risks
■ Some facilities are giving surgical patients individualized risk estimates. Will cost and quality data be the next elements included in informed consent documents?
Informed consent has long been a bedrock principle of medical ethics, but the form intended to document a patient's understanding of a proposed intervention is too often written at a college reading level and is ambiguous about risks.
Some doctors are out to change that, bringing a personalized medical approach to informed consent.
Nine medical centers around the country -- including the Mayo Clinic in Rochester, Minn., and the Henry Ford Hospital in Detroit -- are testing an informed-consent process for patients undergoing nonemergent cardiac catheterization and potential angioplasty. The Web-based program draws on a national cardiovascular database to predict individualized risks of death, bleeding or restenosis.
Proponents of the effort say informed consent should include even more data, telling patients about cost, alternative treatments, and doctors' and hospitals' quality performance.
"It is well-known from the medical literature that informed consent is neither informed nor consensual," said John Spertus, MD, MPH. He developed the cath-lab informed-consent process being pilot-tested with $5.6 million in grants from the American Heart Assn. and the National Institutes of Health.
"Largely, it is a legalese document that risk managers have crafted that doesn't communicate well and is vague and uninformative. [The new form] represents a major effort to simplify and give far more information about what the angioplasty is doing and gives realistic estimates about the risks and benefits for the patients undergoing this procedure. ... It represents a paradigmatic shift in the practice of medicine."
Dr. Spertus and others are tackling a serious problem. Some 60% to 70% of patients do not read or understand informed-consent forms, and nearly half cannot recall the exact nature of the planned operation, according to a 2005 National Quality Forum report.
Dr. Spertus' program, known as Patient Refined Expectations for Deciding Invasive Cardiac Treatments, or PREDICT, allows physicians to draw on information from the American College of Cardiology's massive National Cardiovascular Data Registry, which in May surpassed 10 million cath-lab patient records.
PREDICT takes into account a patient's age, comorbidities and other characteristics to estimate an individual's risk profile, given how similar patients have fared. The bleeding, death and restenosis risks, as well as the pros and cons of bare-metal versus drug-eluting stents, are presented in an easy-to-understand bar chart.
As part of PREDICT, additional information is provided separately to interventional cardiologists that can alert them to use different medical and procedural tactics to reduce risks during angioplasties.
The program has been tested with patients at the Mid America Heart Institute at Saint Luke's Hospital in Kansas City, Mo., where Dr. Spertus is clinical director of outcomes research. Compared with patients using the hospital's typical informed-consent document, patients using the new form were more likely to read it and recall the risks, felt more involved in their medical decision-making, and felt less anxious about their care, according to a study in the September 2008 Circulation: Cardiovascular Quality and Outcomes.
"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.
"Everything that could be wrong with informed consent is wrong," said McGee, John B. Francis Chair in Bioethics at the Center for Practical Bioethics in Kansas City, Mo. "This process takes us out of the dark ages in which informed consent was constructed primarily as a protective mechanism."
Risk managers at Saint Luke's have approved the new informed-consent process, arguing that it is unlikely to hurt legally because it is more transparent about the risks facing patients, Dr. Spertus said. McGee said the form could create potential legal problems different from those associated with older consent documents, but it is unlikely to worsen overall liability.
Replacing a "dreadful process"
The 14 interventional cardiologists at Integris Heart Hospital in Oklahoma City started testing PREDICT in March. The new process is a vast improvement, said Charles F. Bethea, MD, chief medical officer.
"Informed consent was always just a dreadful process," he said. The forms had to include all potential events, no matter how rare.
"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."
But with the PREDICT form, "now, I know my risk," Dr. Bethea said. "It's black and white. If it's a 4% death risk, which is kind of high for this procedure, well, most patients look at it like, 'I've got a 96% chance of eating breakfast tomorrow.' And it's an objective calculation based on experience in hundreds of hospitals. ... I know it's got validity."
Yale-New Haven Hospital in Connecticut also is testing the new process. Harlan M. Krumholz, MD, director of the hospital's Center for Outcomes Research and Evaluation, said PREDICT is "a big step forward" in providing individualized patient-risk estimates. But, he said, medicine still has a long way to go in upgrading the informed-consent process.
"We're very early in this kind of effort to improve the kind of information we're giving patients and making sure they're understanding it and acting on it," Dr. Krumholz said. "We're in the first half of the first inning."
In a commentary in the March 24/31 Journal of the American Medical Association, Dr. Krumholz argued that forms should divulge much more information to patients, such as 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.
Dr. Krumholz needed surgery a few years ago, yet despite being a physician, he felt intimidated when talking to his doctor. "I wanted to ask the surgeon, 'How many of these have you done?' But I don't want to offend the person doing the surgery," he said. "With my idea, nobody has to ask for that information. It's just what's provided as a result of what we consider to be patient-centered care."
Dr. Krumholz's proposal has generated some positive feedback, but no hospital yet is adopting the idea. McGee, the bioethicist, said the proposed form is wrongly premised "on the idea that autonomy equals having as much information as possible. It's totally missed the boat. The goal is to provide really relevant information."
McGee added that better forms can improve medical decision-making but cannot replace a substantive give-and-take between physician and patient. Securing informed consent from a patient is a skill, he said.
"Training people to get a good informed consent is every bit as difficult as training them to get a good history."