Surgical innovation and ethical dilemmas: A panel discussion
END RESULTS: WHY SO ELUSIVE STILL?
Dr. Isador Lieberman, Moderator: Let me begin this discussion with a 1910 quote from Ernest Codman, a general surgeon at Massachusetts General Hospital, who stated:
In 1900 I became interested in what I called the “end result” idea, which was merely the commonsense notion that every hospital should follow every patient it treats long enough to determine whether or not the treatment has been successful, and then should inquire, “If not, why not?” with a view to preventing similar failure in the future.
My questions to the panel are: What has changed in the last 100 years? Are we documenting our end results? Have we gone wrong and, if so, where have we gone wrong?
Dr. James Herndon: Although Codman’s ideas in this area were not well received at the time, today we do have some “end result” ideas. We have outcomes data, but I would argue that they are far too limited and not to the level required in the 21st century. I have asked myself many times why the surgical profession has not focused on this issue more than it has. I agree with Dr. [Joseph] Fins’ comments in his presentation [see previous article in this supplement] that it would be nice to have a bottom-up approach rather than a top-down approach, but I do not see a change until we as physicians step up to the plate and make a change.
Why haven’t we? There are a number of reasons. The malpractice climate in the United States has been one major factor. Surgeons fear disclosure. The relationship between a surgeon and the patient is professional and private, and physicians do not want transparency—they do not want their patient or anyone to know that an adverse event or bad outcome has occurred.
Also, doctors, especially surgeons, are reluctant to use guidelines or follow protocols. I participated a number of years ago in an American Academy of Orthopaedic Surgeons project called MODEMS; it was an attempt to set up guidelines for orthopedic surgeons to manage back pain, shoulder pain, and other orthopedic conditions. By the time we finished we had accomplished nothing, because the protocols and guidelines were so extensive that almost any type of management for any patient would be compliant.
Additionally, hospitals in the United States have become more like for-profit businesses, with a focus on short-term profits and with short tenures for their chief executive officers (CEOs)—4 or 5 years, on average. With nearly 50% of US hospitals bordering on bankruptcy, they are not able or willing to invest in major patient safety protocols and guidelines because the CEOs do not see a short-term benefit to them. Witness the fact that only 15% of US hospitals have computerized physician order entry systems and electronic medical records. From what I have read, it takes about 5 years before a hospital recoups such investments from the resulting safety improvements and efficiencies.
These are some, but by no means all, of the reasons we do not have appropriate outcomes in all specialty fields. My plea is that physicians lead the effort to measure and report outcomes down the road.
Dr. Lieberman: Dr. Hahn, why do you think we have not kept up with Dr. Codman’s premise from 100 years ago?
Dr. Joseph Hahn: We hold a yearly Medical Innovation Summit at the Cleveland Clinic, and what has emerged from many of those meetings is a lack of interest in paying for outcomes analyses. The providers, the government, and industry all say that they do not have the money for these analyses. So the first reason that Codman’s premise has not been lived up to is that the source of funding remains undetermined. Second, most surgical innovations have been geared toward inventing devices to overcome very specific problems that arise during or following surgery rather than toward substantiating the worth of a procedure through collection of evidence. A third reason involves the pressure that investors place on industry to make money, which tends to lead to investments in getting products to market rather than outcomes research. With all of these factors and the pressures from so many directions, the surgical profession hasn’t stepped back to thoroughly consider what we are doing to our patients and just how worthwhile it is.
Dr. Lieberman: Who do you think should be paying for outcomes analyses?
Dr. Hahn: I think the government should. The role of government is to take care of its citizens. The Centers for Medicare and Medicaid Services (CMS) does its best with the information it has, but it admits that it pays for some procedures without knowing whether or not they are truly worthwhile. An example is the use of artificial discs in the cervical spine. I am sure that the artificial disc manufacturers made a case for their product to CMS by claiming it was associated with less pain and resulted in a superior outcome compared to fusion using bone from the hip, regardless of whether they had the scientific evidence to prove it.
Dr. Lieberman: Dr. Fins, would you like to weigh in on Codman’s “end result” premise?
Dr. Joseph Fins: I would just point out that the history is not homogeneous. I have been involved in deep brain stimulation work, and the legacy of psychosurgery has been an egregious lack of outcomes studies, but now we do have outcomes studies and scales. For example, there is now the Yale-Brown Obsessive Compulsive Scale to rate the severity of symptoms in obsessive-compulsive disorder. In our deep brain stimulation study,1 we are using a coma recovery scale, and the Food and Drug Administration’s (FDA’s) investigational device exemption (IDE) process requires us to produce outcomes data to protect potential subjects. It may be an example of neuropsychiatric exceptionalism that neurology and psychiatry are areas of increased focus while somatic therapies are somehow presumed to be okay.
Dr. Hahn: FDA may be requiring the outcomes data, but I have not heard that they are willing to pay for it.
Dr. Fins: You are correct.
Dr. Ali Rezai: Part of the problem is the translation of rapid scientific discoveries and technological advances into the field, and education has a role here. Surgeons’ reluctance to integrate guidelines and outcomes measures into practice must be addressed very early in their training—in medical school—and then continued throughout residency and fellowship programs. The same early and continuing approach should be taken with respect to how to conduct and properly interpret a clinical trial.
Dr. Herndon: That is a good point. Surgical education programs have slipped a bit in the past 5 to 10 years, at least in orthopedics. With the reductions in residents’ work hours and the fast pace of residency programs, our residents spend most of their time in the operating room, struggling to master the multitude of procedures in orthopedics. As a result, they are not discussing outcomes or adequately following patients long-term after surgery. I have a hard time getting our faculty to bring residents into their offices so that the residents can examine patients and see why they are operating on certain kinds of patients, as well as the types of follow-up information that can and should be obtained from patients. Training today is so oriented to operative techniques that residencies have difficulty dealing with these other important issues.
