Surgeons' Silence: A History of Informed Consent in Orthopaedics

Abstract

The moment of decision to proceed with surgical intervention is charged with some of the deepest uncertainties in medicine, but has long been cloaked under the confidence asserted by the traditionally custodial surgeon. This paper reviews the history and ethical basis for informed surgical consent. Beginning with theoretical foundations and the changing ethics of medical decision making since the ancient Greeks, it then reviews how the stage was set for informed consent by technological breakthroughs that made surgical interventions tolerable and acceptably safe. Finally, the legal generation of the doctrine of informed consent is reviewed and the current state of disclosure, shared decision-making, and uncertainty explored.

INTRODUCTION

Medical and surgical therapies arise from a series of judgments. These judgments include a number of physician-intrinsic judgments such as what the leading diagnosis appears to be, what additional tests—be they additional verbal questions, specific physical examination maneuvers, imaging studies, serological tests, etc.—may confirm or refine the diagnosis, or whether a case requires input from a consulting service or colleague. However, most judgments arise through the reciprocity of the doctor-patient relationship. This relationship is plagued with complexities.

Surgical decisions are somewhat unique in the world of medicine in that part of the decision to undertake surgery usually includes a corollary decision that a patient will experience some period of time during which they will not be capable of making decisions from the effects of analgesic and sedative drugs or frank anesthesia. This adds further complexity to the surgeon-patient relationship. Also, while all medical interventions have risks and benefits, the morbidity and mortality that complicate surgical procedures and the sometimes dramatic benefits surgery can accomplish are usually so readily attributable to the surgical event itself, that the decision to proceed with surgery is easily isolated as a distinct decision.

In the period from 1957 to 1972, the concept of informed consent became legally codified. While this punctuated some of the flux of the surgeon-patient relationship, it did not simplify that relationship whatsoever. New challenges such as direct-to-patient advertising, the medical liability crisis, and the problematic relationship that many surgeons have with the implant and pharmaceutical industries can give the suggestion that this relationship is actually spiraling out of control. Nonetheless, every hour of every day surgeries are indicated and performed. In fact, the sheer volume of care yields little time to consider where we are in this sacrosanct relationship, let alone how we got here. While we may be legally documenting more, are we truly sharing the burden of decision making more with our patients?

THEORETICAL FOUNDATIONS

The technological imperative, or the decision to provide a given treatment simply because it is technologically feasible, is dangerous in surgery. From the early Aesculapian medical tradition came the doctrinal recognition that some technically feasible treatments should, indeed, not be implemented. In the myth of Aesculapius, he applied his surgical arts to a patient whom Zeus had decided was marked for death.¹ When Aesculapius' treatments were successful, Zeus was furious and struck Aesculapius down with a thunderbolt. Clearly, a finite decision to proceed with an available treatment was recognized, but in this myth the surgeon shouldered all the responsibility for this decision.

Underlying the surgeon's heavy decision making burden is the basic assumption that a surgeon's will is unified with a patient's. This assumption has had varied underpinnings at various moments in history, but it has really only been questioned recently.

The Ancients

The Hippocratic medical tradition is frequently cited as the philosophical basis for the beneficent, custodial medical care of patients. The Hippocratic Oath in its varied forms usually includes some mention of “be of benefit and do no harm.”² Hippocrates did not entirely deny the concept of a physician-patient relationship, but this relationship was only a utilitarian one. “The physician must be ready … to secure the cooperation of the patient, the attendants, and of externals.” Conversation with a patient was a tool in the physicians' armentarium to promote cooperation or compliance with treatments rendered.

Plato is even quoted as writing that “physicians employ lies for good and noble purposes.” His and Hippocrates' foundations for the basic assumption that the physician's will and patient's will are unified came from the concept of philanthropia, or the physician's love of humanity, and philotechnia, the patient's love of medicine.³ It was felt that patients intrinsically trusted physicians as the source of relief from what ailed them. Physicians, of course, had only altruistic and noble desires and would only choose what was best for a patient. In the doctor-patient relationship, trust and obedience, which were critical to the generation of both philanthropia and philotechnia, might be compromised by full disclosure of uncertainty or poor prognosis.

Medieval Medicine

In medieval times, divine authority replaced philanthropia as the doctor's contribution to the physician-patient unity of will. Faith replaced philotechnia as the patient's contribution. The typical routine prior to surgery included the laying out of instruments, prayer with the patient, and finally the technical process of care.

This worked smoothly as the Catholic church had a significant monopoly on medicine in Europe during this period. Most physicians were monks. It was felt that faith itself was the key to healing and that the technical treatments administered were merely adjuncts to this faith. Doctor-patient conversations during the time period were intended to stimulate hope, and provide comfort and reassurance—faith, but not necessarily truth.

A medieval French surgeon, Henri de Mondeville, had much to say about what conditions promoted successful surgery:

The surgeon...should promise that if the patient...will obey the surgeon for a short time he will soon be cured and will escape all the dangers which have been pointed out to him....If the patient is defiant, seldom will the result be successful.²

While this quotation does note that some “dangers” have been “pointed out” to the patient, there is no sense that any decision has been made on the patient's part. It was felt that when patients exerted will with defiance, it was truly dangerous for them. Faith was their safest focus, even if that faith was based on a promise that no surgeon could routinely keep.

Another physician, Samuel de Sorbiere, wrote a book in 1672 entitled Advice to a Young Physician Respecting the Way in Which He is to Conduct Himself in the Practice of Medicine. In one passage, Dr. de Sorbiere conjures a fictitious doctor-patient conversation that surprisingly approximates the documentation found on modern surgical consent forms in most hospitals. However, he considered this conversation a satire, reducing a young doctor's introduction to a patient to what he thought was absurdity.

I must tell you that medicine is a very imperfect science, that it is quite full of guesswork, that it scarcely understands its subject matter, nor is it familiar with the things employed to maintain it; that the more enlightened only feel their way in it groping amidst a thick gloom.³

Dr. de Sobiere concluded, not satirically, that a wise physician should always have “a few doses of nonsense to bestow.” He felt honesty with patients was a danger to be avoided. What is most interesting about Dr. de Sobiere's advice to young physicians is his reason for dishonesty, which remains a powerful influence on consent discussions today: That if a physician is honest with patients, they will simply seek another physician.

Age of Enlightenment

As the age of enlightenment closed in upon the Western world, the thought that faith and obedience to physicians was paramount (with resultant divine authority of physicians) began to crumble. No longer were physicians directly associated with the church. Reason and superior knowledge became the only physician claim to authority in the physician-patient unity of will. Patients were thought to defer to superior knowledge as their contribution. Again, the assumption remained that the patient and physician wills were unified, but that assumption stood on increasingly contestable ground. Unity of will was acceptable only as long as physicians had answers that promoted benefit for patients. Unfortunately, as treatments were increasingly brought under scrutiny, it was recognized that many of them had no benefit to offer. Not surprisingly, it was at this point that courts began to get involved.

SETTING THE TECHNOLOGICAL STAGE

A number of technological advances that were part of the creation of modern surgery were also critical in creating the opportunity, necessity, and even urgency for informed consent. Four characteristics of surgical practice prior to the mid-1800s limited both the need and possibility for informed consent. These included the fact that most surgical treatments were wholly intolerable, unsafe, and based upon poor diagnostic and prognostic information.

Intolerable Treatments

Most surgical interventions, even as late as the early eighteen hundreds, were intolerable except in the most dire of circumstances. There was much emphasis on the intolerability of treatments in the surgical literature. An editorial in The Lancet in 1836, noted the following:

Much also depends on the steadiness, and mild, though confident manner, in which the surgeon himself sets about his painful duty, inspiring his victim with reliance on a certain tee of relief at the expense of the temporary amount of suffering.⁴

There were major efforts to create faster surgeries to minimize the duration of extreme discomfort in patients. Surgeons' reputations were largely based on their speed, perhaps even more than their efficacy. Such was the case with Dr. Robert Liston, a British surgeon, famous in his time for his masterfully quick amputations, but infamous in historical perspective for his high mortality rates.

Herman Melville, in his novel, Whitejacket, published in 1850, was keenly aware of the grotesque absurdity of some surgical scenarios of the pre-anesthetic era. In one scene, he depicts a ship surgeon invoking informed consent prior to an amputation of a lower extremity of a seaman who sustained a gunshot to the thigh. In grand display before the entire ship crew, the surgeon tries to inspire the patient with confidence:

I would advise perfect repose of your every limb, my man. The precision of an operation is often impaired by the inconsiderate restlessness of the patient. It is better to live with three limbs then to die with four.⁴

Herman Melville next describes a lengthy lecture to the crew about the gory details of the surgery that is about to take place. In the process, the patient faints, in a sense, proving Melville's thought that what awaited him was too intolerable for a conscious discussion of it ahead of time. After the amputation is performed, the patient is taken to a back room. The surgeon continues to lecture, perhaps emphasizing that the consent discussion was more with the crew than the patient himself. After a few minutes, attendants announce that the patient has died, despite the amputation.

As Melville illustrates, intolerable treatments made the possibility of informed consent almost laughable. Only patients in the worst state could even consider undergoing an operation, and then likely could not tolerate discussion of its details ahead of time.

In 1846, this situation began to change as ether anesthetics were first tested in the United States. Ether brought a broad new tolerability to surgical intervention. Dr. Robert Liston, a British surgeon who tried ether anesthetics a little over a year after their use in the United States commented, “this Yankee dodge beats mesmerism hollow.”⁴ His comments are not far off. Certainly ether anesthetics made treatments much more tolerable than any form of hypnotism, mesmerism, or even drunkenness. However, the use of ether anesthetics also created a situation in which a patient was wholly unable to communicate or exert any will after the initiation of treatment. This brought into close focus the necessity for pre-operative unity of will between patient and surgeon.

Unsafe Treatments

In addition to being intolerable, most surgical interventions without anesthesia were so unsafe that their application was limited to clearly moribund patients. It is recorded that Dr. Robert Liston's most notorious surgery yielded 300% mortality. The patient, the surgical assistant, and a family member bystander, each of whom felt the blade of Dr. Liston's slashing amputation knife, died of gangrene in the days following.

The safety of surgical intervention had its greatest improvement through the efforts of Joseph Lister. In 1867 he used carbolic acid asepsis to surgically debride—rather than amputate—an open fracture in an eleven-year-old boy, James Greenlees. The case was successful and the boy's limb was saved. Three years later, Dr. Lister published his “aseptic technique" in the Lancet. He noted that only six of 40 patients with open fractures died using carbolic acid-cleansed surgical debridement, compared to 16 deaths out of 35 patients treated prior to carbolic acid. Lister's spray became widely used almost immediately.⁴

Suddenly, surgery was not a deadly undertaking. Just a few years after Lister's famous report, Scottish surgeon William Macewen published a series of 1800 osteotomies for limb deformity corrections in children.⁵ No deaths occurred in the series. With asepsis, surgeons could address problems of function and deformity, rather than only life-threatening conditions.

In 1894, Jules Emile Pean even performed a semi-elective arthroplasty. He replaced the proximal humerus with a metallic and rubber endoprosthesis after tuberculosis had destroyed a man's shoulder.⁵ While no long-term follow-up of the arthroplasty was ever reported, the mere performance of the case and subsequent short-term survival were proof that the era of elective surgery had arrived.

With the advent of elective surgery came an increased recognition that in some fashion a decision was made prior to proceeding, even if surgeons were yet primarily making these decisions alone during this period. Patients were deciding to seek surgical treatment, at least.

Diagnostic Confidence

Every surgeon can remember obtaining consent from a patient early in training and explaining—often from poor knowledge of what the surgical plan actual was—that details would have to be sorted out after the surgeons “get in there,” but such stark uncertainty was the rule, not the exception, early in surgical history. For other than open fractures or frankly draining wounds, diagnosis was frequently not known prior to embarking upon surgery. It is not surprising that most early orthopaedic operations corrected deformities which were obviously visible from outside the body. Even if the source of the deformity may not have been known, there was an identifiable goal for intervention.

In 1895, Wilhelm Konrad Roentgen began to report experimentation with radiographs.⁴ Like ether anesthetics and aseptic technique, roentgenograms became popular very quickly. They provided a method by which diagnosis might be known prior to surgery. This not only created the opportunity to explain to a patient what the diagnosis and interventional plan might be prior to an operation, but it also provided the opportunity to follow surgeries that had been performed.

It is interesting that not three months had passed from the initial report of the invention of radiographs before editorials began to note medicolegal concerns with the use of x-rays. An editorial in the British Journal of Photography stated “the surgeons” new ally may become a tacit witness against them." Thus, while pre-operative conversations with patients gained additional substance with radiographic diagnostic methods available, post-operative conversations began to be informed as well.

Surgery, especially orthopaedic surgery, became slightly less mystical with radiographs. There was somewhat less uncertainty for surgeons to hide; there was also less uncertainty to hide behind.

Prognostic Confidence

A final technological advance that was required prior to any useful informed consent conversation could take place was the awareness of the outcomes of treatment. The importance of outcomes was a new concept to many physicians and surgeons in the early twentieth century.

An Orthopaedic surgeon, Ernest Amory Codman, was a pioneer of what he called the end-result concept.⁶ However, the extremely forward-thinking nature of his concept was most clearly evidenced by the fact that it was not supported by his fellow Harvard faculty. Unswayed, he decided to start a hospital on the other side of Boston based on the end-result concept and follow-up of patients after treatments, including surgeries. At a medical meeting shortly after his move, he went so far as to poke fun at his colleagues remaining at the Massachusetts General Hospital, much to his societal discredit. He depicted the rich patients of Boston's Back Bay, who supported the Harvard hospitals, as an ostrich with its head stuck in the sand. The resultant public outrage at Codman's suggestion that the lack of end results might be the source of such a blind devotion to the Harvard hospitals certainly is not so difficult to understand. Not all patients want to know the true results of the treatments that they seek. Some simply want treatment and want to trust the deliverers of that treatment. Very few, if any, want to admit that such trust is necessarily blind.

Codman's perseverance eventually paid off, with others (including his former colleagues at Massachusetts General Hospital) putting results-based surgery into practice. Outcomes became the language of comparison within the medical community. However, in the adoption of the concept, the public transparency of end results that Codman initially intended was lost until only very recently.

Whether publicized or discussed privately within the medical community, the drive to study outcomes greatly increased the knowledge of what patients can expect in the course of surgical treatment. Not only could risks be better predicted, but benefits could as well. Such prognostic information is critical not only to an informative consent conversation, but to the decision-making process itself.

Legal Establishment of Informed Consent

With tolerable treatments, sufficiently safe treatments, planable treatments, and at least partly predictable treatments, elective surgery flourished. With it came an increased legal focus on the decisions made to get a patient into the surgical suite.

With the age of enlightenment, when modern medical treatment came under the scrutiny of reason, there was opportunity for more of a discussion between the patient and surgeon. No longer was the blind faith of the medieval patient expected. As these conversations became increasingly frequent, not only patients, but the courts began to question the unity of will between patient and surgeon. While this did not begin with a questioning of a surgeon's autonomy in treatment selection, it eventually arrived there.

Duty to Inform

In 1767 in England, a patient, Slater, sued his surgeons, Baker and Staplton, for intentional refracture of his healing tibia rather than the agreed-upon dressing change.² Apparently, the two surgeons applied an iron device to the leg hoping to remove a protuberance from the union site by realignment. The details of how they managed to restrain the patient in this pre-anesthestic, delayed-fracture manipulation are not clear. In fact, the court did not rule that the surgeons should have obtained the willingness of the patient at all. The court did rule that there is a “requirement to inform” the patient of an intended treatment.

With language hearkening back to the philotechnia of the ancients, the faith of the medieval patients, and the deference to superior intellect and knowledge in the age of enlightenment, the court felt that information given to the patient was critical so that the patient “may take courage, and put himself in such a situation as to enable him to undergo the operation.” Thus, even at the legal birth of consent, the justification had everything to do with more effective custodial and beneficent care on the part of the surgeon, rather than the patient's right to autonomy. Nonetheless, it was codified that the patient's will and the physician's will may not be unified, and that this should at least be noted prior to proceeding.

Right to Self-Determination

In 1914, Schloendorff sued the society of New York Hospitals after a uterine fibroid was surgically removed rather than a manual examination performed under anesthesia.³ The court convicted the surgeon of assault. What was especially astonishing from this case was that a conversation had taken place between the patient and the surgeon prior to anesthetic; the patient expressed clear determination that no surgery was to be performed beyond the simple examination. The court's ruling of assault became the first documentation of the overriding power of the patient's will over the surgeon's will in a medical treatment. The judge concluded that “every human being…. has a right to determine what shall be done with his own body.”³ Not only were patient and physician wills not unified, but priority was for the first time granted to the will of the patient.

Combining Knowledge and Consent

The first mention of both knowledge and consent in a single case happened in an orthopaedics-related case in 1935.2 A sixty-year-old man, Mr. Fortner, developed syphilitic distal femur osteomyelitis. His treating surgeon, Dr. Koch, felt that the patient had developed a large sarcoma in his distal femur. Oncologic treatments failed miserably. The diagnosis and treatments had been inappropriate. While this court ruling did discuss the importance of both knowledge and consent to treatment, the case was really a question of the standard of care. The ruling failed to combine knowledge and consent with any right to autonomy on the patient's part.

The patient's right to information and necessary subsequent consent to a procedure was not technically ruled until 1957. In one case, consent for research and consent for surgical therapeutic interventions finally met. Martin Salgo won his case against the Leland Stanford, Jr. University Board of Trustees after he was left paralyzed following experimental translumbar aortography.² The court ruled that the duty to disclose “any facts which are necessary to form the basis of an intelligent consent by the patient to a proposed treatment” was evident.

The next twenty years brought further refinements to the legal definition of the informed consent conversation. Another orthopaedic case during this period continues to receive a lot of attention in the informed consent literature.In 1972, Canterbury versus Spence was decided in favor of the patient.² What is most intriguing about this ruling is that it was regarding paralysis that developed after a patient fell out of a hospital bed the day after a laminectomy. The patient had been neurologically intact after the laminectomy and prior to the fall. Nonetheless, in the discussions that followed it was noted that paralysis is a potential outcome of a laminectomy that was not specifically discussed with the patient. The court ruled for the necessity of risk disclosure. Their statement included the comment, “the context in which the duty of risk disclosure arises is invariable on the occasion for decision as to whether a particular treatment procedure is to be undertaken.” This case is noted as one of the first times that a patient's right to decide for or against a treatment or procedure is truly codified. Serendipitously, it may have flowed from what was no more than a freak accident, rather than a complication clearly related to surgical morbidity.

THE FUTURE OF UNCERTAINTY

While the necessity of an informed consent conversation is now legally clear and the absence of its documentation legally indefensible, the real doctor-patient conversation is only getting more complex. Consent for an operation may no longer be the issue at hand. It is clear, at least, that the ancient assumptions of unified patient and physician will are no longer accepted by the public. We are in an era of increasing desire for self-determination. This is closely connected with an increasing demand for surgical interventions that may or may not be of benefit to patients. Surgeons, especially, find themselves torn between roles as beneficent custodians of a specific knowledge base and the unique providers of highly sought after services. Are surgeons primarily service providers, or first advisors and then service providers. How much physician judgment can and should be applied to cases in which patients want something done?

It is arguable that one judgment surgeons have made poorly is in the communication both to patients individually and to society as a whole of the uncertainties involved in medical decisions.³ It remains psychologically and philosophically difficult to hedge surgical decision-making with the acknowledgment that uncertainty, even if slight, always remains in diagnosis, in the selection of treatment plans, and in the outcomes to be expected. Nonetheless, the reluctance of surgeons to clearly communicate the uncertainties they silently shoulder complicates the surgeon-patient relationship more now than ever.

First, the failure of surgeons to adequately communicate uncertainty to patients has brought much focus from society on the potential biases surgeons may have in decisions they make. The lack of transparency in the judgments made within these uncertainties has fueled distrust of the decisions made. In March 2005, The United States Department of Justice began investigating orthopaedic surgeons' relationships with implant companies. If the federal government has decided to involve itself, it is clear that the public is no longer necessarily assuming that surgeons have only the patients' best interests in mind.

Second, implant and pharmaceutical companies have begun advertising to patients directly, usually with the notation that patients should ask their doctors about the implant or drug. The opacity of the physician-patient relationship has prompted a desire for others to influence it from the patient's side. Even the press and the politicians in Washington could not remove themselves from a recent family's individual debate about a physician- family discussion concerning the right to determine a loved one's fate after cessation of demonstrable brain function. If physicians and surgeons could better train themselves to communicate the uncertainty in medical decision-making, perhaps the public would not be so angry and surprised when such uncertainties are blatantly paraded in the media.

The most tragic result of the prior failure to communicate uncertainty is that the ability to diminish uncertainty in the future is increasingly constricted. One of the principle mechanisms by which uncertainty decreases in medical and surgical diagnosis and treatment is randomized controlled trials. Surgeons have found the concept of consenting patients for randomized controlled trials nearly intolerable. Surgeons may correctly feel that patients expect them to have a confident surgical plan. This expectation, however, is based on a long tradition of communicating confidence even in the frank absence of fact-based certainty. While surgeons remain comfortable in effectively randomizing patients by their own decisions (despite the lack of hard evidence for the varied treatments between which they choose) they are often unwilling to communicate the uncertainty necessary for a patient to understand and agree to be (ostensibly) randomized.

The crisis of uncommunicated uncertainty is quickly coming to the public eye. The Institute of Medicine's report on errors in medicine re-punctuated the fact, long-known among physicians and surgeons, that errors in judgment are real and frequent. Surgeons' sluggish entry into the discussion may have left the courts, the politicians, and the media with an open invitation to criticize.

Perhaps the key to regaining the trust of patients and the public will come from honesty about what we can and cannot accomplish surgically and about what we do and do not know. Patients want to be involved in decisions about their care, but judgment about how they are informed and what they are/are not told during the surgeon-patient conversation will always rest on the shoulders of surgeons. Increased transparency is now demanded by the public. Hopefully, as orthopaedic surgeons we will think more about how we will answer these demands, rather than having our answers written for us by external sociopolitical forces.