Informed Consent Challenges with High-Risk Surgery
When Susan C. Pitt, MD, MPHS, FACS, was training in abdominal organ transplant surgery, she observed many patients were not engaged in the informed consent process. The patients were narrowly focused on the possibility of dying of their liver or kidney disease, and on receiving an organ. “This observation made me wonder about the quality of informed consent and informed decision-making in high-risk surgery,” says Pitt, an associate professor of surgery at the University of Michigan.
To learn more, Pitt and colleagues recorded 90 conversations between patients and surgeons before major procedures (cardiothoracic, vascular, oncologic, and neurosurgical) at three U.S. and Canadian centers.1 They observed how surgeons often described the nature of the illness, the operation, and potential complications most frequently. However, surgeons often failed to discuss the patients’ role in the decision, the patient’s daily life, uncertainty, or patient preference.
If patients deferred a final decision on treatment, Pitt and colleagues noted surgeons were more likely to discuss uncertainty and treatment alternatives. For example, a patient might be offered coronary artery bypass graft surgery and want to go home to think about their decision vs. making a snap decision and signing a consent form right in the office.
Overall, surgeons did not always assess how well the patient understood the information. Pitt says surgeons could do this by simply asking the patient, “Do you understand the information that I have shared?”
To receive credit for a specific facet of informed consent or informed decision-making, surgeons had to initiate the discussion. “This method of scoring biases the system toward lower scores. We made sure to highlight this limitation in the manuscript,” Pitt notes.
Scores also tended to be lower because the authors did not account for some components of consent in the study, including unspoken communication (e.g., a patient nodding her head in agreement) and buy-in that was not discussed out loud (e.g., previous conversations with staff that laid the groundwork for decision-making). “Because the study was about clinical consent and not informed consent for research, it is hard to draw any direct conclusions about the implications of our findings for researchers and IRB members,” Pitt says.
Informed consent for research tends to be more standardized and replicable. “However, research participants may also be desperate to find a cure for their disease, which is why IRB protections exist,” Pitt notes.
Clinical trial participants receive a large packet of information about the studies in which they are consenting to participate. In contrast, consent in the clinical world typically involves a signature on paper. Patients often receive little written consent-related communication — or none at all. “Fortunately, research to improve the consent and decision-making processes is underway,” Pitt says.
Asking family members to be present to hear the consent discussion is helpful, considering the information is hard to process for patients facing high-risk surgery. Even so, describing what life will be like after surgery is not the same as seeing it firsthand. “Let’s say someone comes in with a bad stroke. Sometimes, if you have the luxury of time, you can go to the rehab center in the hospital so they can see what people look like after their course,” says Maya A. Babu, MD, a neurosurgeon with Cleveland Clinic Florida, Martin Health.
Just telling someone his or her family member might have to reside in a nursing home, might be unable to talk, or may need help going to the bathroom does not always hit home. “Until someone sees it with their own eyes, it’s very difficult to understand it,” Babu offers.
Using plain language about the activities of daily living also is important. For example, clinicians might explain how the person will be unable to take a bath without assistance, might need an indwelling catheter, or will never be able to move their left arm or leg again. “I try not to proselytize or say, ‘Here’s what you need to do,’” Babu reports.
Instead, Babu gives the most accurate possible picture of both options. There are some cases where the risk/benefit ratio is clearly slanted toward or against surgery. In those cases, Babu states, “it’s very reasonable to proceed because the chance of a decent outcome is fairly high — 50 to 60%.”
Still, it is reasonable to decide against surgery if the chance of a decent outcome is fairly low. If family members remain undecided, consulting with others who know the patient can be helpful. “Families who never had a discussion about goals of care may want aggressive treatment upfront. Oftentimes, if they talk to other people that gets scaled back,” Babu says.
Problems arise when clinicians are too vague about the reality of high-risk surgery. “The ICU team might say, ‘You can have surgery, or you can do medical management,’ and it’s almost presented as equivalent options, which is problematic,” Babu says.
Patients often focus on surgery survival rates without factoring in the serious risks of the aftermath, including pneumonia and pressure ulcers. Babu recalls one surrogate decision-maker who was about to consent for a craniectomy for a relative until she learned the surgery entailed removing half the patient’s skull to relieve pressure on the brain. These details brought home the reality of the risks of the surgery, and the family member ended up declining the procedure. “People sometimes ask, ‘Why would anyone agree to surgery in this situation?’ You almost want them to think in those terms. Do I really want to go through with it?” Babu explains.
Engaging in an honest risk/benefit analysis can prevent decisional regret. Some families make comments such as, “If I would have known this, I never would have gone through with it.” This is not something surgeons like to hear. “It makes you feel you didn’t do a good job setting the expectations. That’s a horrible feeling,” Babu says.
Undecided people often put this question to surgeons: “What would you do?” Babu gives them a straight answer — many times, there is no clear answer. She tells the family, “It’s impossible to make the wrong choice. Your gut sense is the right sense.”
Recently, a daughter declined surgery on her mother’s behalf. She made the decision after learning her mother would have to live with permanent one-sided weakness. The daughter said her mother would never want to spend a single week in a nursing home. The mother had been crystal clear and adamant on this point. Babu told the daughter, “You are honoring her the best way you can, by honoring her wishes. I would have chosen the way you chose.”
- Long KL, Ingraham AM, Wendt EM, et al. Informed consent and informed decision-making in high-risk surgery: A quantitative analysis. J Am Coll Surg 2021;233:337-345.
There appears to be room for improvement when it comes to surgeons talking with patients about shared decision-making and providing specifics about quality of life after procedures.
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