Study Raises Ethical Questions About Limits of Informed Consent for "Big Surgery"

The study, which appears online in the journal Annals of Surgery, suggests that despite surgeons’ pre-operative explanations about procedural risk and their commitment to patient survival, there is little evidence that patients explicitly “buy in” to the use of aggressive interventions beyond the operation itself. The researchers say the study raises ethical questions about the boundaries of surgical informed consent.

“It is not possible for surgeons to determine a patient’s desire for prolonged life-supporting treatment based on the current patterns observed in pre-operative conversations,” says Dr. Margaret “Gretchen” Schwarze, an assistant professor of surgery at the UW School of Medicine and Public Health. “Although surgeons may believe they’ve had these conversations based on their assertion that the impending ’big surgery’ carries substantial risk, including death, there was no explicit discussion about how serious complications would be treated or whether patients would be willing to pursue additional aggressive interventions beyond the operating room.”

Researchers audiotaped and analyzed pre-operative conversations between nine doctors and a total of 48 patients from three different geographic locations (Toronto, Boston, and Madison, Wis.) and observed the following results:

  • one instance where a surgeon explicitly required a commitment to post-operative treatment from the patient before he would perform the surgery
  • three instances where surgeons implicitly asserted “buy-in” from their patients by expressing expectations about participation in post-operative care
  • In all other instances, surgeons conducted conversations in a way that suggested they assumed buy-in was achieved, although no explicit agreement was forged. 

“These findings are significant because they question the reliability of the pre-operative conversation to form a basis for post-operative care and raise concerns about whether patients fully understand the potential use of prolonged life support after high-risk surgery,” Schwarze says. “Physicians caring for patients who need prolonged or unanticipated post-operative interventions will need to revisit the patient’s willingness to pursue subsequent aggressive treatments, in order to be sure that such treatments are in line with the patient’s values and goals.”

For the study, the researchers selected surgeons who were considered by their peers to have good communication skills and who routinely performed “high-risk” operations. The patients ranged in age from 26 to 94, had a broad spectrum of educational backgrounds, and 83 percent had undergone a previous operation. The operations under consideration included abdominal aortic aneurysm repair, brain tumor resection, coronary artery bypass grafting, heart valve replacement, esophagectomy, lung volume reduction, and hepatabiliary resections for tumor.

The research was supported by grants from the National Center for Advancing Translational Sciences, the Greenwall Program for Bioethics and Patient Care, and the American Geriatrics Society. Other researchers who contributed to the study include registered nurse Kristen Pecanac, UW-Madison School of Nursing; Dr. Jacqueline Kehler, UW department of medicine; Dr. Karen Brasel, department of surgery, Medical College of Milwaukee; Dr. Zara Cooper, department of surgery, Brigham and Women’s Hospital in Boston; Nicole Steffens, UW department of surgery; and Dr. Martin McNeally, department of surgery, University of Toronto. 

University of Wisconsin School of Medicine and Public Health