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

Otolaryngologists are likely to see some changes in the way informed consent is handled at the hospitals where they perform surgery. Recent changes from the Centers for Medicare and Medicaid Services (CMS), along with Joint Commission rules, have prompted many hospitals and health systems to get more involved in what previously fell firmly in the physician’s purview.

The idea of “informed consent” is often associated with the piece of paper signed before a procedure rather than the continuum of communication that happens during the course of the medical care of patients. The new guidelines do not necessarily change that process, but they emphasize the patient education aspect of informed consent and encourage physicians and hospitals to make sure patients fully understand their options and risks.

According to CMS’ Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, revised on June 5, 2009, hospitals are required to ensure that “patients or their representatives are given the information and disclosures needed to make an informed decision.” The CMS guidelines also assign hospitals the responsibility to ensure that informed consent documentation is in the patient’s record prior to surgery.

The Joint Commission requirements for informed consent, issued in 2009 as part of its effort to ensure “culturally competent patient-centered care,” call for organizations to “honor the patient’s right to give or withhold informed consent” by considering “patient needs and preferences” as well as legal requirements. Meeting this requirement includes ensuring that the information is presented in a language and format the patient can understand.

Martin Hopp, MD, PhD, medical director of the Cedars-Sinai Sinus Center in Los Angeles, called the new rules a “welcome clarification” of how informed consent should be obtained, adding that they introduce checks and balances that give hospitals a bigger role in and responsibility for the process. The effect of the rules has been “neutral on the practice” but good for informed consent in general and patients specifically, he said.

“We know the risk of heart attack from general anesthesia is very low. But patients want to know anyway.”
—Jeffrey Wolf, MD

Patient-Centered Care

Kathleen Yaremchuk, MD, chair of otolaryngology at Henry Ford Hospital in Detroit, sees the new guidelines “spreading the same ideas of patient-centered care and shared-decision making” promoted by the Institute of Medicine, CMS, Joint Commission and other organizations. “It brings it all into alignment,” she said.

A more comprehensive informed consent process “helps manage expectations,” Dr. Yaremchuk explained. “We [physicians] are thinking about curing disease and they’re thinking about their lives,” Dr. Yaremchuk said. “Even if you say it in plain language, it can be hard for patients to comprehend the reality of it.”