According to Harlan Krumholz, M.D., who was speaking at a conference recently, he opined that with no requirement that hospitals and clinicians be candid with patients about risks and costs, informed consent is a sham. Dr. Krumholz is a cardiologist. At the conference, he posed the question to his audience who were fellow physicians and patient advocates: “What if patient-centered informed consent actually meant something?” He is director of the Center for Outcome Research and Evaluation at Yale University School of Medicine, and he 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.
As he observed, there is no requirement that hospitals and health care providers 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 an elective coronary procedure and found that approximately 75% believed that the procedure would prevent a future heart attack and 71% thought it would prolong their life, even though there was no evidence that either was true.
What do we need to take from this? 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?
He found that people are often shocked at what they will have to pay out of pocket for the procedure to be done, and most of the time they don’t discover this till afterwards. He expects that if patients were informed that benefits and risks of several options are similar, but one procedure costs a lot more money than the other, patients might opt to do the procedure 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 limitation placed on the patient at the time consent forms are expected to be signed. As he observed, most of these discussions are taking place with people lying in a hospital bed. As Dr. Krumholz sees it, if we are going to take these consent forms seriously and give these patients time to actually know what they are signing, it should occur at a comfortable time period before they’re rolled in for the procedure.
So, what did I take away from this article? Physicians and health care providers should inform patients about risks and benefits in a way that patients understand and in a way that allows patients to seriously consider all treatment options.