Surgical innovation and ethical dilemmas: A panel discussion
WHO DEFINES THE INDICATIONS?
Dr. Lieberman: As new devices and new techniques emerge, who defines their indications? The inventor of the device, a government authority that may or may not have the medical background, patient advocacy groups, or the device manufacturer? And how should we regulate those indications?
Dr. Fins: I would echo Dr. Wilder Penfield’s words, “No man alone.” The orthopedic surgeon or neurosurgeon does not have to do this alone; it is really about teams. And those teams can and should include biostatisticians, recognizing that the biostatistician needs to fully understand what the surgeon is doing. There also has to be attention given to patients’ individualistic outcomes. I recently met with some FDA staff and learned that the FDA is very interested in novel methodologies to better understand what counts as an outcome for individual patients. So I think indications should be guided by individualistic outcomes coupled with the surgical possibilities and with the rigorous biostatistical methods that are now evolving. A conference like this represents an opportunity to generalize the conversation and support more collaboration on indications going forward.
Dr. Rezai: Indications should be defined using a team-oriented approach. Part of the problem of psychosurgery in the past was that the surgeon was defining indications without collaborating with the psychiatrist. In my field of deep brain stimulation and brain pacemakers, everything we have done for the past 20 years—surgery for Parkinson’s disease, depression, obsessive-compulsive disorder, traumatic brain injury, epilepsy—has involved working closely with neurologists, epileptologists, brain injury specialists, psychiatrists, and psychologists to agree on indications. These teams also need to have close partnerships with ethicists. Teamwork is a vital aspect of proper development of an indication.
Dr. Hahn: It has to be the clinicians who set forth the indications. Of course, that may be done by a team of clinicians, but as a surgeon I certainly do not want the manufacturers of an artificial disc telling me what they think the indications for an artificial disc are.
As for the role of patients, some of them are very well informed about their problem. I cannot tell you how many have shown up in my office with reprints of articles I have written. This is a trend that has really mushroomed over the past 10 years. But even though patients are catching up, they are still at a disadvantage. Patients are going to have a say, but it is still the clinicians whose role is to decide the indications and then provide patients with a risk-benefit analysis.
Dr. Herndon: I agree. Although patients are becoming more involved in the process, real shared decision-making has not yet happened in my field.
More broadly, I feel that our professional organizations have to become more actively involved in the process of defining indications. Otherwise, after the innovators develop a device or procedure that will significantly change the approach to a particular problem, it will enter the market at large without any critical assessment of the technology involved and without accounting for the learning curve for each individual surgeon.
Take the example of minimally invasive total hip replacement, which involves a 1-inch incision in the front of the hip and a 1-inch incision in the back of the hip. The learning curve for this procedure appears to be about 40 cases, based on the opinion of experts around the country. Yet when this minimally invasive approach emerged, every surgeon who had been performing total hip replacements wanted this new operation at his or her fingertips because patients were demanding it. Some surgeons adopted it too quickly, without adequate training. I know one distraught surgeon who abandoned the procedure because of numerous failures during his first 100 cases. He returned to the standard hip replacement approach.
Our profession cannot let this experience continue or proliferate. Yet the professional organizations in orthopedics have walked away from technology assessment because industry does not want it; technology assessment is not in industry’s best interest. We have had a number of conflicts in our professional organizations when attempting to move technology assessment forward. It is also very expensive to do.
Finally, indications can sometimes be governed more by economics than by science. I was asked to write a letter to the editor about two technologies for managing intertrochanteric fractures of the hip that were recently featured in the Journal of Bone and Joint Surgery.2,3 One technology involves a compression screw that has been shown to be effective in outcomes studies. The other is an intramedullary nail that has not been well studied and has no proven benefit over the compression screw. In doing research for my letter,4 I found that Medicare assigns more relative value units (RVUs) for the intramedullary nail than for the compression screw. In Boston, the total dollar difference in RVUs between the two is $300: the surgeon makes $1,500 for the procedure that involves the intramedullary nail versus $1,200 for using the compression screw. Not surprisingly, use of the intramedullary nail has been climbing rapidly in the United States without any evidence to justify its use over the other, less expensive technique.
