Volume-outcome disparities and informed consent: what should surgeons disclose?

Abstract

It has been repeatedly shown that higher procedure volumes, by hospital and by physician, are associated with better outcomes. Buttressed by large-scale selective service purchasing, surgical care for many volume-sensitive operations has been regionalized. However, the implications of outcome disparity data for obtaining valid patient consent remain uncertain. When the first large scale outcome study appeared showing empirically that outcomes are volume-related, two prominent bioethicists promptly insisted that such information was material to a reasonable patient's decision whether and where to have a volume-sensitive operation and that surgeons at low-volume hospitals should disclose it. More recently, two surgical oncologists have reiterated that argument, most especially when patients are making decisions about pancreatic or esophageal resections. This proposal tantalizingly appeals to the concept of patient empowerment, supposedly showing appropriate respect for the patient's interest in self-determination by having his surgeon (or physician), rather than others, outline for him personally the risks and benefits associated with surgical care delivered at different hospitals. But on the contrary, a surgeon's conducting a truthful, non-misleading, non-confusing informed consent discussion of statistical outcome disparities in the relentlessly shrinking time typically allowed for this conversation is unrealistic as a general requirement. The traditional approach to informed consent is simpler, less fraught and preferable. By law, a surgeon who is licensed to practice independently and who evidences willingness to examine and to offer an operation to a patient conveys (1) an implicit standard of care assurance, and (2) a fiduciary assurance. In other words, it goes without saying that the surgeon holds it out to the patient that s/he possesses the training and skill necessary to perform the offered service with reasonable skill and safety as measured by the applicable standard of care; that s/he will act in good faith and use his/her best medical judgment on the patient's behalf. Liability attaches when patient harm results from a surgeon's failure on either count. It also goes without saying that the surgeon extends similar assurances for care provided by trainees who are under his or her direct supervisory authority and control. The traditional theory of informed consent forestalls requiring desultory discussions of volume-outcome disparities and will be defended here.