Ethics and Malpractice in Thyroid and Parathyroid Surgery

Optimizing Informed Consent

One of the central ethical challenges for surgeons is to ensure that patients have given adequate informed consent before having an operation. Certainly, informed consent for surgery is much more than just a patient’s signature on a consent form. In fact, informed consent for surgery is best thought of as a process whereby the surgeon informs a patient of the risks, benefits, and alternatives of a particular operation and the patient then freely agrees to undergo the procedure. Years ago, surgeons made choices for their patients based on the surgeon’s judgment about what was in the patient’s best interest. Today, the paternalism of the past has been supplanted by the important principle of respect for patient autonomy. In the current era of shared decision-making, surgeons must approach the informed consent process as a means of educating the patient about his or her condition so that the patient can participate in the decision about whether to have surgery or not. In an era where there are many approaches to thyroid and parathyroid surgery, it is essential for patients to play a significant role in decision making.

The quality of the interchange between a surgeon and a patient is dependent on the relationship between the parties. Although much has been written analyzing the doctor-patient relationship, little has been written about the significant challenges that surgeons face in engendering the level of trust required by patients to consent to surgery. In few other areas of medical care are patients asked to put themselves in such a vulnerable position as when they enter the operating room for surgery under general anesthesia. Patients must be willing to place enough trust in their surgeons that they are willing to risk disfigurement and potentially permanent disability or even death at the hands of the surgeon. This is not only a deep level of trust but also something that must be developed in a relatively short period of time in a preoperative visit. Rather than getting to know a patient over months or years, as many primary care physicians are able to do, surgeons must develop a rapport with patients in one or more relatively short preoperative visits.

As noted previously, the informed consent process for surgery involves the surgeon explaining to the patient the risks of the operation. It is critical that patients undergoing thyroid and parathyroid surgery understand the risks of recurrent laryngeal nerve (RLN) injury and permanent hypocalcemia, which are always present with these procedures. This explanation by the surgeon of these risks should be thought of as an opportunity to teach the patient and gain the patient’s trust. Some surgeons find it very helpful to give the patient diagrams or other written materials that describe not only the operation being recommended but also the risks. Others refer patients to appropriate websites, but it is essential that the surgeon give a thorough verbal explanation with ample opportunity for the patient to ask questions. It is more important that the surgeon document that such a discussion took place than to rely on the type of standard consent form required by all hospitals and frequently obtained by staff.

The legal standard of informed consent requires the surgeon to give the patient the opportunity to receive the information that a reasonable person would want to know to make an informed decision. In particular, the surgeon should offer the patient information about complications that might deter a reasonable person from undergoing surgery. As such, every consent discussion with a patient undergoing thyroidectomy or parathyroidectomy must include information about the risks of nerve injury, hypoparathyroidism, and bleeding. Although national rates may be valuable, surgeons should endeavor to know their own rates of complications so that surgeon-specific information can be provided to patients whenever possible. The detail of information that each individual patient needs to make an informed decision varies; therefore surgeons should strive to engage in a dialogue with patients about risks, adding more detail as directed by the patient’s desire for such detail.

Ethical Issues in Surgical Innovation and New Technology

Unlike new drugs, which in the United States are regulated by the Food and Drug Administration, surgeons who develop new or innovative surgical procedures have very little oversight or regulation. Not only is there little oversight of surgical innovation, but the lack of regulation is seen by many as essential to allowing surgeons to continually question how they can make an operation better. Although surgical research certainly must abide by all of the regulations for all research on human subjects—namely, oversight by institutional review boards (IRBs)—most commonly, innovation occurs in surgery outside of formal surgical research. This informal approach to innovation has led to many improvements in how contemporary surgery is performed. To see just one example of such improvements in surgical care, consider the change in the safety of thyroid surgery from the mid-19th century to the early 20th century. In 1866, the influential surgeon, Dr. Samuel Gross, wrote about thyroidectomy, “Thus whether we view this operation in relation to the difficulties which must necessarily attend its execution, or with reference to the severity of the subsequent inflammation, it is equally deserving of rebuke and condemnation. No honest and sensible surgeon, it seems to me, would ever engage in it.” In contrast, Dr. Theodor Kocher, who was awarded the Nobel Prize in Medicine in 1909, had been able to reduce operative mortality in benign goiter surgery from 13% in his first 101 cases to 2.4% in his subsequent 250 cases. By 1917, Kocher reported a mortality rate of 0.5% in approximately 5000 operations.

Unfortunately, there are many examples of surgical innovations that seemed promising to the surgeons who tried them but ultimately proved to have no benefit for patients. Consider the following surgical “innovations” that were either not helpful or actually harmful to patients. Prefrontal lobotomy was used to treat many psychiatric problems, even though it was not effective for any of them. Internal mammary artery ligation was performed on thousands of patients to treat angina, yet it had no affect on patient survival. As recently as 50 years ago, significant research and technological advancements were undertaken to refine gastric freezing for ulcer disease, but the technique ultimately proved to be ineffective. These “innovative” attempts at treating significant medical and psychiatric problems were all ineffective. Any consideration of how to approach the regulation of surgical innovation today must find the middle road between too much regulation so that patients are prevented from getting the latest and potentially best operations and too little oversight so that patients are harmed by overly enthusiastic surgeons who push innovative surgical techniques without data to show the benefits.

Given the mixed record of surgical “innovation” throughout history, what are the criteria for deciding whether a new technology or approach is better? For a new surgical technique to be accepted as surgical progress, it should be safe and effective in solving the surgical problem for the patient. As straightforward as this sounds, it is often difficult to determine whether a new technique or technology is truly safe and effective. Often, studies to assess safety are underpowered, and effectiveness can frequently only be determined with long-term follow-up. In addition, the determination of what outcomes are even considered important to assess becomes a value judgment and therefore a moral question.

If we turn our attention specifically to innovations in thyroid and parathyroid surgery, the difficulties noted earlier in deciding whether a new technique is an improvement are readily apparent. The risks of permanent RLN injury are in the 1% to 2% range in most series. Therefore to show even a doubling of the risk of permanent RLN injury, a study would need to be quite large. In addition, if the concern is over the long-term efficacy of a new technique for thyroidectomy for papillary cancer, given the biology of the disease, one would need to follow a very large number of patients for many years to show any difference in the outcome.

In recent years, many of the innovative techniques applied to thyroid and parathyroid surgery have focused on the attempt to improve the cosmetic results, shorten the convalescence, or reduce the morbidity of the procedure. Certainly, many authors have shown that thyroids can be removed through very small incisions or even without incisions visible on the neck. However, with the exception of a few widely used procedures such as the video-assisted thyroidectomy by Dr. Paolo Miccoli and the “scarless” transoral thyroidectomy by Dr. Angkoon Anuwong, it remains to be determined whether these new techniques can duplicate the safety of the conventional approaches. If the safety of the “minimally invasive” technique can be shown, then the additional question that will need to be addressed is how important a smaller or nonvisible scar is to the well-being of the patient. In other words, what is the improvement in quality of life that a smaller scar or nonvisible scar has for patients. Most surgeons accept that there is a benefit to patients by having smaller, less noticeable scars. However, it will be important to carefully assess patient-reported outcomes to determine whether the assumed improvements in quality of life are really seen when actual patients are carefully studied. We must be certain that the purported improvements that a new technique brings are truly beneficial to patients rather than being solely attempts by surgeons to increase their practices by suggesting that these new techniques are “better” for patients.

Some attempts at new surgical procedures are made to treat previously untreatable medical problems. Although the Vineberg operation (direct implantation of the internal mammary artery into the left ventricle) was ultimately considered a failure, the concept of myocardial revascularization was proven valid as the effectiveness of coronary artery bypass grafting was established. Although laparoscopic abdominal surgery and video-assisted thoracic surgery certainly result in smaller scars, the major advantage of these procedures is not cosmetic but rather fewer wound and respiratory complications as well as less pain, shorter hospitalization, and more rapid return to normal activity. Can the same be said about video-assisted, transaxillary robotic thyroidectomy and transoral thyroidectomy? At best, we anticipate that the surgical complication rates will be the same as conventional thyroidectomy. At best, the oncologic outcomes will also likely be the same. Recovery after surgery may be related in a minor way to the size of the incision, but many patients now undergo conventional thyroidectomy and parathyroidectomy and are discharged on the day of surgery. The only real benefit to the patient is a smaller or inconspicuous scar. The procedures may take longer to perform than the traditional operation and certainly have a substantial learning curve. Is it reasonable to consume scarce health care resources and possibly risk an increased incidence of complications for a small cosmetic benefit? This is a question for which the answer may become increasingly important in upcoming years and for which surgeons and patients may have less input in the future.