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.
—Jeffrey Wolf, MD
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.”
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.
Cedars-Sinai, for example, recently introduced the Emmi system, which gives physicians an access code to their patients, who can then read online materials or view videos about their condition, procedure and other treatment options. At first, Dr. Hopp’s colleagues reviewed the content and decided against using it, because although they liked the concept, they did not like the ENT portions. Hospital and Emmi staff, however, returned to them a year later and gave them the opportunity to re-write the materials. Dr. Hopp will start using the resultant materials in the coming months.
Providing extra detail can make some physicians uncomfortable. They may worry that they’ll leave something off the list or that a long list of specific risks will scare the patient away from needed treatment. But, Dr. Hopp pointed out, “More detail is better. It’s how you handle it that makes the difference. [More information] makes the patient a participant in their health care. The more they understand about the healing process, the better a patient they are.”
According to a study in the March 2010 issue of Archives of Otolaryngology-Head & Neck Surgery, additional detail may increase recall of the risks of surgery. In the study, conducted at Walter Reed Army Medical Center in Washington, D.C., parents of children scheduled for tonsillectomy or ear tube placement were split into two groups: Parents in one group went through the standard informed consent process and received an informational sheet about the general risks of surgery, while the other group received information that described the risks associated with the specific procedure. In addition, the physicians in the second group were given a checklist of risks to ensure that they covered each one in their discussions with the parents. The group of parents that received the more specific information remembered an average of six out of 10 risks, while the control group remembered an average of 4.44 risks.
But it’s not just the content of the information that affects how the patient receives it—it’s also how that content is presented.
Most patient education materials are written at a high school reading level, and informed consent forms are so vague and full of legalese that they can be difficult for even a college-educated patient to understand. Re-writing those materials so that the average patient, with a fifth or sixth grade reading level, can understand them is a very good step. Dr. Yaremchuk noted that Microsoft Word offers an option to “show readability statistics” in its grammar check, and this is a good way to get an idea of the reading level of in-house documents.
Dr. Yaremchuk said otolaryngologists in her department are making an effort to pre-populate the blanks in informed consent forms with some of the known complications of each surgery to help ensure that the essentials are covered. She added that she and her colleagues are including more in their outpatient notes about what they discussed with patients about the proposed treatment and alternatives. For example, for a patient with sleep apnea, she might note in her files that she discussed the risks and benefits of using a continuous positive airway pressure machine, losing weight, or going without treatment.
Additional tools and support from hospitals can only help with the informed consent process, Dr. Hopp said. This may lead to some duplication of effort but, he pointed out, repetition is a time-honored instructional technique.