Cardiologist: Informed consent is a 'complete sham'

Patients need to understand cost and other treatment options

One prominent physician says doctors need to better inform patients about the risks and benefits of treatment, saying the health system pays only "lip service" to the informed consent routine, HealthLeaders Media reports.

Harlan Krumholz, director of the Center for Outcome Research and Evaluation at Yale University School of Medicine, told attendees at a Lown Institute conference last week that clinicians need to rethink informed consent. "What if patient-centered informed consent actually meant something?" he asked.

Hospitals may be in hot water for not getting informed consent

Krumholz says many patients are "undergoing procedures under assumptions of benefit that do not exist." For example, research has found about 75% of patients undergoing elective percutaneous coronary intervention believe it will prevent a future heart attack, and 71% thought the procedure would extend their life. According to Krumholz, neither assumption is scientifically proven.

In its current form, Krumholz says informed consent is a "complete sham." To make it more meaningful, he says patients should be prompted to consider five questions before giving consent:

  • Are there other treatment options?
  • Is the provider skilled?
  • What are the provider's relevant statistics?
  • Are they in the right facility for this procedure?
  • What is the out-of-pocket cost?

Krumholz says discussing cost is an important part of evaluating treatment options. If two procedures are similarly effective but one is cheaper, a patient "might do the thing that costs less money because they're having trouble paying the rent or putting food on the table," he says.

It is also important to obtain informed consent when the patient is in a position to carefully evaluate treatment options. "These discussions are taking place with people lying horizontal, and sometimes sedated," he says, adding, "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."

Moreover, when doctors explain risks and benefits they need to use language that patients understand. For instance, doctors should avoid saying a drug benefits 2% of patients, and instead explain that "98% [of patients] will get the same result no matter whether they take the drug or not," Krumholz says.

Krumholz says rethinking informed consent is not about "withholding care" or "keeping costs down." Rather, "It's about finding the right thing for… [the patient]; about the informed patient getting an informed choice based on the right information," he says (Clark, HealthLeaders Media, 3/12).

The takeaway: One physician argues that health providers should proactively inform patients about risks and benefits in a way that patients understand and in a context that allows patients to deliberately consider treatment options. One key issue: Doctors need to learn to talk about costs with patients.


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