Critical Care Plus

Universal Consent Forms Raise Questions of Ethics

Using a universal consent form for multiple procedures anticipated for a patient can nearly double the consent rate for most of the invasive procedures performed in an intensive care unit, according to researchers in Chicago. But observers say the tactic may violate the spirit of the informed consent process.

The suggestion for such a consent form arose in one of the first detailed studies of the informed consent process in an ICU. In that study, the researchers found that the rapid, unpredictable pace of critical illness combined with the inability of very sick patients to make decisions took a serious toll on patient autonomy. When caregivers relied on standard practice, patients or their proxies had the opportunity to consent to or refuse invasive procedures recommended by their doctors only 53% of the time.1 A large fraction of procedures were performed with implied consent because they were deemed necessary by caregivers.

After the authors devised a universal consent form that explained the risks and benefits for the eight most common ICU procedures and presented the options to patients and families as soon as they were admitted to the ICU, they were able to raise the consent rate to 90%, says Jesse Hall, MD, professor of medicine and chief of pulmonary and critical care at the University of Chicago.

"Precise, widely accepted guidelines for obtaining consent in the ICU environment do not exist," Hall says. "Physicians can’t even agree on which procedures require consent. Our goal was to begin to standardize the process and to find ways to make it more effective."

The study was performed in a 16-bed ICU at a university hospital. For two months, from Nov. 1 to Dec. 31, 2001, the researchers charted the consent rate for invasive procedures. They found that only 53.1% of the time (155 out of 292 procedures) did patients have the opportunity to consent to or refuse treatment. ICU physicians attributed their inability to get consent to the emergent nature of the procedure and the lack of an available proxy when needed.

Consent Rates Higher With Universal Form

In the intervention period, March 1 to April 30, 2002, a universal consent form that explained the risks and benefits of each procedure was presented to patients and families soon after they came to the unit. For this period, the consent rate increased to 90.5%, with consent secured in advance for 308 out of 340 procedures. "This is a far more acceptable level of patient participation," Hall says. "It enabled us to be more responsive to family wishes and also allowed patients themselves to make more decisions."

Before the universal consent form was introduced, patients made their own decisions in only 28.4% of cases. Proxies made the rest. The comprehensive form allowed the patient to make the call in 34.4% of cases. Comprehension by both patients and proxy decision makers was high and did not differ between the two periods. "We have shown that education of clinicians, patients and proxies regarding the process of informed consent can improve this process in critically ill patients," the authors conclude.