Surgical innovation and ethical dilemmas: A panel discussion

HOW MUCH RISK IS ACCEPTABLE?

Dr. Lieberman: Let’s build on this issue of credentialing by turning to the concept of risk. What is an acceptable level of risk with a new device? Is a 50% risk of an adverse outcome appropriate? What about 10%? And who determines the acceptable risk? The profession? The regulatory bodies? Patients?

Dr. Fins: Our expectation about risks in clinical practice should evolve from what was anticipated and actually observed in the clinical trial of an intervention. Adverse events should be envisioned prospectively in the design of a trial, with the magnitude of risks delineated in the protocol. Any unexpected risks that occur, even if small, could be a major reporting issue. Beyond that, it is difficult to say what an acceptable level of risk is without a particularistic clinical trial. Whatever the risk of an intervention, the assessment of the risk must account for regional variation, variation among surgeons, and also systems issues.

The Institute of Medicine report, To Err is Human, attributed medical errors to faulty systems, processes, and conditions. So when we think about errors and risk, we have to consider more than just the individual operator. Just as To Err is Human analogized medical errors to airplane crashes, we might think of surgical retraining in the context of how pilots get retrained using flight simulators. If pilots have not flown a particular aircraft in a long time, they lose their flight certification for that type of craft and then must be retrained to operate it.

As surgical technology gets more advanced, specific, and nuanced, the discordance between one’s training and the potential things one can do becomes greater. Paradoxically, innovation can at least potentially make situations more dangerous in that the operator may not be able to perform the task with the improved technology. For example, pilots who know how to fly a Cessna can fly another simply constructed plane, but if they attempt to fly a higher-technology aircraft, like an F-16, they have a greater risk of having a catastrophic event even though the F-16 flies better, faster, and higher.

Dr. Lieberman: But are you willing to identify a level of acceptable risk?

Dr. Fins: It is based on the patient’s preference, after informed consent. An acceptable level of risk is the level that people are willing to accept. What I am concerned about is the variance around a known risk, whatever it may be, that is attributable to human errors that may be preventable through training or by solving systems problems.

Dr. Lieberman: Dr. Rezai, you place needles into the brain. Who should decide the risk of that action? You? The patient? And what do you feel is an acceptable risk level?

Dr. Rezai: It is a complex question, of course, and a number of variables come into play. Whether or not the patient’s condition is life-threatening or disabling is a very important factor in the risk-benefit ratio. Regulatory guidance from the FDA is strong with respect to defining device-related adverse effects as serious or nonserious, and our peers, both surgeons and nonsurgeons, help to further dictate the risk and tolerability of a procedure and its alternatives. For example, in considering a surgical procedure, one must weigh its risk against the risks of medications to treat the disorder, such as side effects, the ease of medication adherence, and the number of emergency room visits that may result from adverse effects of the medications.

Determining acceptable risk rests fundamentally and first with the patient and then with the surgeon and his or her peers (surgeons and nonsurgeons) in conjunction with regulatory components and oversight. All of these factors contribute.

In my field of deep brain stimulation, the threshold for acceptable risk can be high since we see patients with chronic conditions in whom all previous medication attempts have failed, many of whom are disabled, intractable to current therapies, and with a significant compromise of quality of life. Examples include wheelchair-dependent patients with severe Parkinson’s disease, severely depressed patients who will not leave the house and have attempted suicide, and obsessive-compulsive disorder patients who need 10 hours just to take a shower. This type of intractability to current therapies and the suffering of patients and families with limited options and little hope infl uence assessments of procedural risk.

Dr. Hahn: Performing a controlled clinical trial of a surgical procedure is difficult at best. I recall a clinical trial in which patients with parkinsonism were to be randomized either to have stem cells implanted in their brain or to undergo a sham operation with no stem cells. Well, very few patients signed up for the trial because everyone wanted the stem cells. So, obtaining a large enough denominator to define the risk of, for example, hemorrhage from sticking a needle into a vessel is almost impossible.

Dr. Herndon: Except when there are risks of serious life-threatening events, I believe the patient is the one who makes the decision after having the risks fully explained to him or her. Surgeons are educated in a system in which we learn to accept complications. It is the risk of doing business. We have not learned very well how to differentiate a complication from an adverse event or an error. We must learn to do that. We live with complications every day. Those complications must be conveyed to patients so that they understand what they are about to undergo, what can happen, and what cannot happen. The patient is the ultimate decider, in my opinion.

Dr. Lieberman: That reminds me of something one of my mentors often said: “If you are going to run with the big dogs, expect to get bitten in the butt once in a while.”