A New Look at Informed Consent: Recent guidelines prompt patient-centered approach

Patient values and culture play roles in how a patient receives and processes information. It can be difficult to assess and consider those aspects of a patient in 15-minute chunks of time, Dr. Yaremchuk said. She remembers a patient for whom it was necessary to do a laryngectomy. “We didn’t realize until after the surgery that the patient could not read or write,” she says. After the surgery, the patient couldn’t communicate at all. The long-term implications were “overwhelming” for the patient.

Dr. Yaremchuk hopes the new rules will help physicians be more cognizant of all the factors that need to be considered for truly informed consent—and for better patient education in general. “It’s a legitimate concern to be able to communicate with the patient effectively,” and physicians must think about how to do that.

A series of studies published in The Laryngoscope indicates that patients and physicians are not always on the same page when it comes to what should be included in a discussion of risks in the informed consent process. Jeffrey Wolf, MD, and colleagues at the University of Maryland School of Medicine in Baltimore compared what the patient wanted to know about sinus surgery risks versus what the doctor believed was important to convey. “Patients wanted to know more about complications,” Dr. Wolf said. For example, in the study, doctors generally considered it important to tell patients about complications that happened in one in 10 or one in 100 cases, but patients wanted to know about complications that might happen in one in 1,000 cases.

“Doctors do these [procedures] every day,” Dr. Wolf said. “We know the risk of heart attack from general anesthesia is very low. But patients want to know anyway.”

Dr. Wolf’s study has medico-legal implications: Informed consent plays a role in about 30 percent of medical malpractice cases. Although states differ on what must be included in informed consent, most use the “prudent patient” standard. Dr. Wolf’s research implies that the average patient wants to know more than the doctor may include in the discussion. He emphasizes that because people are different, the process has to be individualized so that patients get the information they need and providers protect themselves legally.

Emphasis on Documentation

The new guidelines, Dr. Wolf said, may be part of a movement toward more specificity in informed consent documents. Although many hospitals and practices still use a standard form in which physicians fill in the blanks for the particular procedure to be performed, an increasing number are making available informed consent forms that actually spell out the risks and benefits of a particular surgery.