What Is Informed Consent?

As Miles has observed, there is moral, legal, and social agreement that patients should participate in decision making about medical treatment and direct their medical care. The moral view is based on respect for personal autonomy and the belief that a person’s subjective view of the condition, options, and prognosis should shape one’s medial decision making. Legally, this view is supported by the right to privacy and the right to be secure in one’s person. The social view is affirmed by the desire of contemporary Western society to be fully informed about medical conditions and therapeutic options and to be allowed to make treatment decisions for themselves.

The idea of informed consent has evolved over the past century. Today, informed consent consists of explaining to alert, competent patients the nature of their illness or disability balanced against the risks and benefits of the recommended treatment. Approval is then sought from the patient to proceed. Truly valid consent is most likely achieved through effective personal communication within the physician-patient covenant, as opposed to the simple signing of a legal consent form. Even in cases of surrogate consent for patients who are unable to comprehend treatment decisions, informed consent is a communication process. The presumption in favor of prolonging life and the difficulty of decision making for these patients should not lead the clinician to discount discoverable information about how a patient would weigh the burdens and benefits of therapy in choosing a treatment course.

Three criteria must be satisfied for a consent or refusal to be valid. First, adequate information must be presented. In the United States, the legal requirements for informed consent contents are controlled at the state level. Some states support the view that it is necessary to inform the patient of risks that reasonable prudent physicians would disclose to their patient, whereas other states have enacted the “prudent patient standard,” in which the physician must disclose all risks that a reasonable prudent patient would consider material to the decision to undergo or refuse a particular procedure. It is the physician’s responsibility to provide material information regarding treatment issues in clear, jargon-free language, which includes information about the patient’s medical condition and likely course with and without the preferred treatment as well as availability and effect of alternative therapies. In addition to prognostic information, the physician should help patients to anticipate and plan for their disability. As the patient’s values, goals, and fears are identified, the physician should encourage the patient to ask questions to clarify the treatment issues related to these values. The personal nature of material information means that the informing physician must listen with the ear of a counselor rather than merely comprehensively list the effects of treatment.

Second, the communication process must be free of coercion. The patient should choose the treatment voluntarily rather than acquiescing to a necessary or inevitable course of action. This decision can be compromised by presentation of incomplete or biased information. It can also be compromised when patients are compelled by unnecessary institutional policies. A physician, however, has a right and sometimes an obligation to make recommendations, but these recommendations must not be manipulative (by disclosing biased facts) or coercive.

Third, the patient must be competent to consent or refuse. In regard to informed consent for medical procedures, emphasis is generally placed on capacity, which is a much more clinical and task-specific idea, than the more global legal concept of competence . Although there is no gold standard definition of capacity or competence, most ethicists agree that at minimum, the patient must be able to understand that a decision must be made and the relevant options and consequences that attend that decision. Furthermore, they should be able to reason about the alternatives and effectively communicate with caregivers regarding the decision. The fact that the patient needs to apply their own values in their reasoning process leaves considerable ambiguity in the process.

Obtaining informed consent is a legal standard for practice and an incompletely realized ethical ideal. The courtroom process has emphasized the aspect of consent that pertains to informing patients of the risks and uncertainties of a single medical treatment and stressed the importance of documented evidence of a patient’s consent. Moreover, the definition of consent that has emerged from malpractice actions has led some physicians to conclude that informed consent is a legal ritual that is satisfied by simply obtaining the patient’s signature. Most physicians are acutely aware of the difficulty in achieving the ideal of informed consent in clinical practice because of differences in understanding of medical facts between physician and patient, the emotional impact of the diagnosis, and the patient’s unique world views, preferences, and values.

Informed Consent for ESS

As an elective surgical procedure, ESS can present a unique challenge in achieving informed consent. Consideration must be given to many issues, including which complications are discussed with patients, which complication rates are quoted, who obtains the consent, and the circumstances under which consent is obtained. The impact of cultural and demographic differences must be appreciated. Finally, the informed consent process as perceived by the patient and the effectiveness of the process must be considered.

Discussion of Complications

Although there is no set standard in regard to which complications are to be discussed, a frequently quoted rule of thumb has been to discuss complications specific to a procedure that occur in more than 1% of cases or are considered catastrophic in nature. In ESS, the rates of complication are generally lower than this figure, a common example being orbital ecchymosis, which occurs in only about 0.44% of cases. However, the severe and incapacitating nature of the potential complications of ESS requires their discussion, especially because the procedure is not being performed for a life-threatening condition. Wolf and colleagues reported that approximately 60% of surveyed physicians believed that an incidence of 1% is significant enough to warrant discussion; however, 69% of patients wanted to know of complications with an incidence of more than 0.1%.

When discussing complications with a patient, it is unclear whether one should present one’s personal incidence of a complication or that found in the literature. Wolf and colleagues found that 19% of surveyed US physicians described their personal incidence, 37.5% quoted that found in the literature, and 35% used both. However, nearly half of respondents of a similar survey in England did not quote any figures, with 33% of surgeons quoting their own series for complication rates, 11% quoting national rates, and 10% quoting both. The researchers suggested that quotation of one’s individual figures and results would be preferable, as it would be a better reflection of actual experience, whereas national rates are only estimates of practice. Kennedy and colleagues in a 1994 survey found that physicians who discussed potential complications were more likely to have encountered those complications. They speculate that this tendency may be because once surgeons experience a complication, they are more likely to discuss it with their subsequent patients or simply because physicians who are forthcoming with their patients are also likely to be forthcoming in reporting their complications.

How Much Information Is Enough?

Morally and legally, medical practitioners have an obligation to their patients to attempt to explain a procedure, to offer the therapeutic options, and to specify possible risks and complications. Some, especially in North America, believe that the best way to meet these requirements, especially in the face of the increasingly educated patient, is to provide an exhaustive list of all possible complications. There is concern, however, that patients might be burdened with unwanted information and that such information may increase the patient’s anxiety. This controversy highlights the irreconcilable conflict between medical paternalism and patient autonomy in the informed consent process.

Kerrigan and colleagues specifically addressed the issue of the amount of information presented and patient anxiety and found that a very detailed account of what might go wrong does not increase patient anxiety significantly but has the advantage of allowing the patient to make a fully informed choice before consent, thus reducing the potential for subsequent litigation.

Stanley and colleagues likewise found that patient anxiety levels were unaltered by the increase in the amount of information they were given. Bowden and colleagues noted that although a thorough discussion of potential complications frequently provoked anxiety, this rarely resulted in cancellation of surgery.

Clearly, the manner in which potential complications are discussed may have significant effect on patient anxiety. Simply providing a list of potential complications and their incidence rates is inadequate. Common courtesy demands an explanation in layman’s terms of what the patient would experience with each complication, along with discussion of how that complication would be managed. The look of terror on the face of a patient preparing for ESS who has just been described a skull base violation will often vanish with additional information: “Should this happen, I will repair the damaged area during the surgery. This has about a 95% success rate in my experience and rarely causes any long-term problems.”

Who Should Obtain Consent?

There is also debate as to who should obtain informed consent from a patient. Previous studies found that surgeons consistently overestimate the mortality risk of elective surgery. It was also found, however, that when informed consent was obtained by nurses, medical students, or residents, there was greater inaccuracy of risk estimation than when obtained by attending physicians, suggesting that attending physicians are the most appropriate members of the surgical team to discuss informed consent. Nevertheless, the American College of Surgeons stated that the surgeon who is “responsible for obtaining informed consent from the patient…need not personally obtain the patient’s signature on the consent form”.

In a recent study by Houghton and colleagues, data for informed consent of 100 consecutive patients were analyzed. In all of the cases, consent was obtained by a junior doctor, who was unlikely to be performing the surgery. Even though most patients were satisfied with the explanation of the operation given to them and considered themselves fully informed, 45% believed that the doctor who signed the consent form with them would be performing the procedure and the majority felt that this should be the standard of practice. When junior doctors obtaining the consents were interviewed, approximately one-third of them admitted to obtaining consent for procedures of which they had little understanding and more than half of them thought that the surgeon who performed the surgery should sign the consent form. Looking at these data, it is reasonable to conclude that if the act of signing the consent form is to be more meaningful, it should be signed by the surgeon who is going to perform the operation.

Cultural Differences

Is the discussion of informed consent different between different health systems or cultures? In Great Britain, material risk is identified as an incidence of 10%, with a risk of 1% for complications that are vital to the informed consent choice, such as death, paralysis, or blindness. In the United States, no such standards have been set.

Interpretations of informed consent requirements vary greatly among cultures in terms of content and whether this should be verbal or in writing. Generally, a consent form is not signed in France, Sweden, or the Netherlands, although practitioners are advised to register in general terms in the notes that such a discussion took place. The amount of information provided ranges from relatively little to every specific and general complication. In Germany, it is necessary to discuss not only the complications of the operation but also rarities such as cardiac arrest resulting from the use of local anesthesia and even the potential side effects of a blood transfusion.

Studies have also examined patients’ views of informed consent based on racial, educational, and socioeconomic backgrounds. Taylor and colleagues reported on the link between demographics and patient desires regarding informed consent in ESS. They found that younger, white, and more educated patients wished to know about complications at the lowest risk levels, regardless of severity. With regards to specific complications, black patients and those with less formal education were less interested in being informed about the potential risks of orbital complications, cerebrospinal fluid (CSF) leak, or possible need for revision surgery. Women wished to discuss more frequently than men such complications as bleeding and infections.

Informed Consent in ESS: Patient Perspective

What are patients’ expectations on informed consent prior to ESS? In comparing patient responses with physician responses, it is apparent that physicians do an excellent job of discussing complications that are specifically related to ESS. More than 95% of physicians discuss risks such as CSF leak, eye injury, and bleeding, whereas only 72% to 83% of patients would want to be informed of these complications. For general complications pertaining to all surgeries (myocardial infarction or cerebrovascular accident), only 8% to 18% of physicians inform patients of these preoperatively, whereas the majority of patients would want to be informed of them. This low rate might be explained by the fact that most of the surgeons expect that the anesthesia staff would discuss these during a separate informed consent discussion.

There is discrepancy in the literature regarding patients’ desire to know all possible complications. Bowden and colleagues reported that more than 85% of patients wished to be informed of all potential complications, regardless of the incidence of these complications. Wolf and colleagues, however, found that only 44% of patients wanted to be informed of all potential complications, whereas Burns and colleagues stated this figure as 73%. Adhikari and Pradhananga found that 90% of patients in their study expected that all known complications would be discussed. Differences in study design, size of the study, and geographic regions can attribute to this discrepancy; however, it is notable that a significant percentage of patients expect their surgeon to inform them about even rare complications.

In the time of widespread availability of information through the Internet and other means of media, it would be naive to think that patients solely rely on their doctors for providing them with information regarding their upcoming procedure. Burns and colleagues reported that two-thirds of patients in their study had sought information elsewhere before signing their consent form, including relatives, friends, and the Internet, which reflects an increased awareness and interest of patients in their own treatment and a desire to become more involved in the decision-making process. It may also show that information provided by surgeons may not meet the expectations of today’s informed patient and that doctors need to adjust their standards of a “prudent patient.”

What do patients see as the purpose of informed consent? Cassileth and colleagues reported that 80% of patients studied viewed consent forms as a protection for the physician. They suggested that the legalistic and adversarial overtones of the consent form may appear inconsistent to the patient who has a fundamental orientation to and preference for a doctor-patient relation based on trust. Dawes and colleagues found that three-quarters of patients studied viewed the consent form as a legal document and felt obliged to sign the form, especially when they underwent a brief, unstructured, purely formal consent process.

Effectiveness of Informed Consent

Several studies have evaluated patients’ recollection of the contents of informed consent for ESS. Even though most patients are satisfied with the information given by doctors before surgery, the majority of them (56%–77%) could not list even a single complication, even after a relatively short time period. This observation is consistent with studies of information retention in other surgical specialties. Godwin assessed recall 6 days after reduction mammoplasty and found that although 97% of patients felt that the procedure of obtaining consent was adequate, the average number of retained facts was 3 of 12. Adhikari and Pradhananga found that low educational status, increasing time since consent, and patients’ lack of enthusiasm were factors related to poor recall.

Taking into consideration that for elective surgeries considerable time can elapse between informed consent and the actual procedure, it has been suggested that patients may benefit from written consent documents that would serve as “aide-mémoire” and improve patients’ understanding of their condition and treatment as well as compliance. Stanley and colleagues, however, found that providing additional written information did not improve their patients’ understanding of the risks and complications of surgery.

Visual aids may also be helpful because of the fact that informed consent communications are sometimes too complex and difficult for many patients to grasp despite the fact that many patients may report understanding the information. The correlation between educational background and the patient’s ability to recall complications may also support the use of visual materials.

Bedridden patients are less able to recall information than patients in a better physical condition. Cassileth and colleagues found that as patients become increasingly ill, their sense of control over their own destinies may give way to intensified dependence on their physicians, and this dependence may result in poorer attention to, interest in, and recall of information about consent.

When evaluating the causes of poor retention of information after informed consent, one must consider both patient and surgeon factors. From the patient’s point of view, especially after procedures with high satisfaction rates such as ESS, it is difficult to recall what could have gone wrong with the operation. Another reason for poor recall could be related to the stress of a hospital admission. The patient is often bombarded with questions from the surgeon, anesthetist, and nursing staff. Too much information can have a confusing effect on the patient. The doctor needs to act as the patient’s adviser, counselor, advocate, and support. Two-way discussions and complex questions are possible with the articulate patient. Some elements of trust must exist that doctors give accurate information to the best of their ability. There would be no need to ask questions or seek medical advice if the patient had all the answers. With pressure on the surgeon to cover all risks, they tread a fine line between informing patients and confusing them with too much information.

Valid Informed Consent: a Process, Not a Signature

Meaningful communication and negotiation are absolute necessities in the patient-physician relationship. Successfully imparting the professional’s insights enables patients to make a truly informed decision about their care. Providing only technical services to a patient is inadequate and reduces the patient-physician relationship to a mere contract.

The ethical imperative for the practice of informed consent is the principle of respect for self-determination. Medical professionals may become insensitive to the fact that invasive and sometimes dangerous interventions are exceptional. Patients accept loss of privacy; painful, uncomfortable, and anxiety-introducing procedures; sharing of intimate information; and sometimes risks to life that are not part of normal human experience. To be sure such acceptance is usually understood by a patient as in his or her health interest, but the sacrifices are not routine. Respect for the autonomy of another is practiced by gaining the other’s reasoned and deliberate agreement for tests, treatments, and invasive procedures.

This process can be enhanced by giving the patient a sense of control during the consent interview. Dawes and colleagues described the so-called structured interview techniques when an informational sheet is used to guide the interview with patients before they sign the consent form. These materials are designed to explain why the operation was being done and what it involves, to list and explain complications, to explain how the patient would feel after the operation, and to explain the chance of success and any alternative treatment. When the information sheet was read with patients before they signed the consent form and then given to them so that they could read it on their own, it resulted in patients feeling less obliged to sign the consent, more likely to think that they had been involved in the decision to operate, and less likely to consider the interview a formality. Furthermore, despite the fact that patients interviewed with the information sheet–guided technique were given a much more comprehensive description of their surgery, anxiety was not increased. Techniques such as these may provide patients with a greater feeling of autonomy about the decision to operate. They also may feel more confident to refuse treatment because they feel less dependent on the doctor to make the final decision. This may also enable patients to be more accepting of an unexpected outcome.

Surgeons have obligations of education. Anxiety is ever present and is reduced by helping the patient to know what to expect and by responding to particular concerns. The educational process is not limited to the preoperative period. Daily instruction and clarification of anticipated problems and their prevention will often be needed during recovery. Written instructions, including means of access for calls and appointments and notes about activity, diet, and wound care, are more useful aids to patients than the brief oral instructions.

Informed consent must be understood as a process, not as an event. The goals of informed consent are impossible to satisfy in a single sitting but are accomplished through an ongoing educational process beginning at the first visit and extending through recovery. Practicing the skill of placing oneself in the patient’s shoes allows the ESS surgeon to meet the demands of informed consent and to account for variations in personality and circumstance.