With no requirement that hospitals and clinicians be candid with patients about risks and costs, informed consent is "a complete sham," says Harlan Krumholz, MD, speaking at the Lown Institute conference this week.
The healthcare system only gives "lip service" to the informed consent routine, says cardiologist Harlan Krumholz, MD, SM. "What if patient-centered informed consent actually meant something?" he asked clinicians and patient advocates attending a Lown Institute conference in San Diego this week.
Harlan Krumholz, MD, SM |
Krumholz, director of the Center for Outcome Research and Evaluation at Yale University School of Medicine, wants to know what would happen if the consent process included a period of time when a patient could consider all of the risks and benefits of a treatment whether they would be appropriate, and whether there were alternatives with lower risks but similar outcomes.
"There's a structural moment in time when people sign something that says yes, [the doctor] can proceed [with the treatment]... But it's a complete sham. It's a complete sham."
Krumholz's words appeared to strike a chord with the attendees, not just because he is an influential member of numerous policy-making boards such as the Patient Centered Outcomes Research Institute (PCORI). At Yale, the center he directs has a contract with the Centers for Medicare & Medicaid Services to develop a portfolio of measures for hospital pay for performance programs.
Unfortunately, he continued, there is no expectation or requirement that hospitals and clinicians be candid with patients about the downside risks and costs of procedures, or whether there are cheaper options.
Krumholz gave an example: Researchers looked at patients who had signed informed consent forms before undergoing elective percutaneous coronary intervention and found that "about 75% believed that PCI would prevent a future heart attack and 71% thought it would prolong their life, even though there was no evidence that either was true."
"We have people undergoing procedures under assumptions of benefit that do not exist," Krumholz said.
He appeared to be preaching to the choir. The fledgling Lown Institute is a Boston-based organization founded by Bernard Lown, MD, the cardiologist who developed the direct current defibrillator, but who now questions the necessity for some 50% of interventional cardiology procedures and many other medical interventions.
The institute's unofficial motto: "Do as much as possible FOR the patient and as little as possible TO the patient."
The three-day conference hosted only about 300 attendees, but featured some big names in the informed patient movement, including: Diane E. Meier, MD, Director, Center to Advance Palliative Care Professor of Geriatrics and Palliative Medicine at Mount Sinai in New York; Michael Fine, MD, Director, Rhode Island Department of Health; and Steven Nissen, MD, Department Chair, Cleveland Clinic Cardiovascular Medicine.
Patients need to know not just about the risks and benefits of the drugs and procedures their doctors recommend, but about their options, Krumholz insisted. He suggested that every informed consent document should include these five questions:
- What are the options? Many patients don't know there are reasonable alternatives to the path they're on.
- Who is going to do the procedure and how good are they?
- What are the provider's stats?
- Am I in the right place to have this done? Do you do two of these a year or 2,000?
- What is the out-of-pocket cost?
"I've found that people are often surprised at how much they have to pay out of pocket, and only discover this afterwards," he said. If they were informed that benefits and risks of several options are similar, but one procedure costs a lot more money, "they might do the thing that costs less money because they're having trouble paying the rent or putting food on the table."
And when patient consent forms are pushed in front of the patient, there's often another indignity, he continued. "These discussions are taking place with people lying horizontal, and sometimes sedated… If we're going to give some official blessing to this decision, to an informed consent, we should respect it and say it should occur at a comfortable time period before they're rolled in for the procedure."
Krumholz detailed other strategies to help resolve problems in the way clinicians practice today. One problem is the failure of doctors to explain the benefit of an intervention in terms patients understand.
For example one way of explaining how likely an anticoagulant like the drug warfarin will reduce a patient's chance of having a stroke is to say that the drug carries a 2% benefit.
A better way of explaining it to patients, he said, is to cite the chance of achieving the same result without the drug. In the case of warfarin, "98% will get the same result no matter whether they take the drug or not, and that starts to put it into a different light."
Another idea is for doctors to create a list or a network of fellow clinicians around the country "who have signed on to this way of thinking—people who believe in the same kinds of things that permeate this conference."
"It's not about withholding care, and not about doing less or keeping costs down. It's about finding the right thing for… [the patient]; about the informed patient getting an informed choice based on the right information."
Lastly, Krumholz said, he's working on a project that would enable patients to "own, possess and share their own records, so they can get second opinions and can easily move their health information in ways that don't trap them within the place they happen to be" when they need to make a decision about their medical care.