Re-designing informed consent for the 21st century


A shared decision-making model focuses on how patients view outcomes.

Sometimes a picture is worth a thousand statistics. Using a simple diagram and narrative, surgeons in Wisconsin are training to use a new kind of informed consent for the 21st century.

The goals are to give patients a better understanding of possible outcomes and to prevent unwanted surgeries.

Courtesy UW-Madison

Dr. Gretchen Schwarze (right) stresses the importance of getting informed consent and the value of shared decision-making.

Scheduled to begin in early 2015, the study has already attracted attention for lead researcher and vascular surgeon Dr. Gretchen Schwarze at the University of Wisconsin-Madison. “A communication tool to assist older adults facing difficult surgical decisions” was awarded funding from the National Institute on Aging’s GEMSSTAR (Grants for Early Medical/Surgical Specialists’ Transition to Aging Research) and also earned a supplemental Jahnigen Award. The SVS Foundation provided supplemental funds to the AGS for the Jahnigen award in support of Dr. Schwarze’s research.

Dr. Schwarze, a trained clinical ethicist, has hypothesized that too often, elderly patients don’t understand what a surgical outcome will really be like.

“Informed consent has been around since the ‘60s and hasn’t evolved at all,” Dr. Schwarze said. “I can fix a ruptured aneurysm through a tiny hole in the groin and send people home two days later. I have watched this technology evolve, but I’m still using this big, clunky informed consent tool, which functions very poorly for decision-making. It satisfies the legal obligation to disclose risk but doesn’t help you deliberate.”

The standard protocol for informed consent is to tell patients the statistical likelihood of various outcomes based on percentages and data. In this study, surgeons tell a story describing “best case/worst case” scenarios while drawing diagrams that help the patient gauge how he feels about possible outcomes. Once the surgeon and patient have a plan, the surgeon still provides the risk disclosure required by law.

“There is lots of evidence to suggest that unwanted care for frail elderly patients is a real problem,” Dr. Schwarze said.

“I suspect patients need more interpretation about what surgery is really like. Informed consent doesn’t necessarily describe how patients might experience different outcomes. Rather than statistics, we use narrative to show patients the range of possible postoperative scenarios.”

The research was inspired in part by the fact that surgeons, especially vascular surgeons, too often find that they go through hours of intense surgery, only to find that several days later, patients or their families decline postoperative interventions that would save their lives. The catalyst event for Dr. Schwarze was hearing about an elderly woman whose difficult post-op course led her relatives to stop all treatments just a few days after surgery.

“It’s hard for surgeons to operate on patients when later [patients] don’t want the subsequent interventions,” Dr. Schwarze said. “Doctors say, ‘if I knew he was going to give up so soon, I wouldn’t have operated. But that’s a cultural thing because – for some patients – there is real value in trying.”

Because technology has outpaced medical ethics, she said, “We think about ‘should we do it?’ but we don’t have the tools to figure that out any more. Technology is only valuable when we use it appropriately. And that’s where we have fallen behind.”

Dr. Schwarze and the study team have trained eight surgeons to use a “best case, worst case” conversational approach. Over the next few months they hope to enroll 30 patients who have an acute but non-emergent need for surgery.

Trained surgeons will discuss possible treatments and outcomes with the patients, but differently. The discussion model ought to work with all patients, even those considering surgery in the outpatient setting, but she sees an urgent need among the frail elderly with acute surgical illness, and that’s an area where surgeons are also in agreement.

Surgeons might view an operative death is the worst outcome, she said, but quite a few seniors have a different opinion. To them, dying in the operating room sounds peaceful and painless.

“You have no choices to make, you tried to stay alive, and it’s not such a terrible outcome,” she said.

“But the fact is that most people don’t die in the OR, they die in ICU on a ventilator and unable to interact with family, and that’s not a peaceful death, indeed it’s something patients fear.”

One of her favorite academics, she said, is Dr. Sharon Kaufman, author of “And a Time to Die: How American Hospitals Shape the End of Life.” “She says, ‘At the end of life, patients don’t need more information but more interpretation of the information.’ We are trying to use this structured framework to interpret the usual information that surgeons provide. So far, the eight surgeons we have taught to use our framework have done really well.”


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