IV. CLINICAL ASPECTS OF CONSENT IN HEALTHCARE

Decision making is an everyday event in healthcare, not only for doctors and patients, but also for nurses, psychologists, social workers, emergency medical technicians, dentists, and other health professionals. Since the 1960s, however, the cultural ideal of how these decisions should be made has changed considerably. The concept that medical decision making should rely exclusively on the physician's expertise has been replaced by a model in which healthcare professionals share information and discuss alternatives with patients who then make the ultimate decisions about treatment.

The concept of informed consent gained its initial support as part of the general societal trend toward broadening access to decision making during the 1960s. Thus, the initial support for informed consent came from legal and philosophic circles rather than healthcare professionals. In the legal arena, informed consent has been used to develop minimal standards for doctor–patient interactions and clinical decision making (Berg et al.). Although there are some differences by jurisdiction, widely accepted legal standards require that healthcare professionals inform patients of the risks, benefits, and alternatives of all proposed treatments, and then allow the patient to choose among acceptable therapeutic alternatives.

In academia, informed consent has served as a cornerstone for the development of the discipline of bioethics. Based on the importance of autonomy in moral discourse, philosophers have argued that healthcare professionals are obligated to engage patients in discussions regarding the goals of therapy and the alternatives for reaching those goals, and that patients are the final decision makers regarding all therapeutic decisions.

While many physicians would express some support to the concept of shared decision making, this support is largely theoretical and does not seem to have made its way into routine medical practice. Physicians typically think of informed consent as a legal requirement for a signed piece of paper that is at best a waste of time, and at worst a bureaucratic, legalistic interference with their care for patients. Rather than seeing informed consent as a process that promotes good communication and patient autonomy, many healthcare professionals view it as a complex, legally prescribed recitation of risks and benefits that only frightens or confuses patients.

Objections to Informed Consent

There are various objections to informed consent that clinicians often make, and it will be useful to review those objections here.

CONSENT CANNOT BE TRULY "INFORMED." Many practicing clinicians report that their patients are unable to understand the complex medical information necessary for a fully rational weighing of alternative treatments. There is considerable research support for this view. A variety of studies document that patients recall only a small percentage of the information that professionals present to them (Meisel and Roth); that they are not as good decision makers when they are sick as at other times (Sherlock; Cassell, 2001); and that they often make decisions based on medically trivial factors. Informed consent thus appears either to promote uninformed—and thus suboptimal—decisions, or to encourage patients to blindly accept healthcare professionals' recommendations. In either case informed consent appears to be a charade, and a dangerous one at that.

However, the fact that patients often do have difficulty understanding important aspects of medical decisions does not mean that healthcare professionals are the best decision makers about the patient's treatment. Knowledge about medical facts is not enough. Wise house buyers will have a structural engineer check over an old house, but few would be willing to allow the engineer to choose their house for them. Just as structural engineers cannot decide which house a family should buy—because they lack knowledge about the family's pattern of living, personal tastes, and potential family growth—healthcare professionals cannot scientifically deduce the best treatment for a specific patient simply from the medical facts. What matters to individuals about their health depends on their lifestyles, past experiences, and values, so choosing the optimal therapy is not a purely objective matter (U.S. President's Commission). Thus, patients and healthcare professionals both contribute essential knowledge to the decision-making process: patients bring their knowledge of their personal situation, goals, and values; and healthcare professionals bring their expertise on the nature of the problem and the technology that may be used to meet the patient's goals (see Brock).

Informed-consent disclosures, even if they are well done, may not lead to what clinicians might consider optimal decisions. Most people make major life decisions, such as whom to marry and which occupation to take up, based on faulty or incomplete information. Patients' lack of understanding of medical information in choosing treatment is probably no worse than their lack of information in choosing a spouse, nor are medical decisions more important than spousal choice. Respecting patient autonomy means allowing individuals to make their own decisions, even if the healthcare professional disagrees with them. The informed-consent process can improve patient decisions, but it cannot be expected to lead to perfect decisions.

Moreover, although sick persons have defects in their rational abilities, so do healthcare professionals. In fact, some of the most famous research on the difficulties individuals have with the rational use of probabilistic data involves physicians (Dawson and Ackes). Health professionals must be careful not to be too pessimistic about patients' ability to become informed decision makers. Patients may not be able to become as technically well-informed as professionals, but they clearly can understand and make decisions based on relevant information. One study, for example, showed that patients' decisions regarding life-sustaining treatment changed when they were given accurate information about the therapy's chance of success and that patients, when given increased information about screening tests for prostate cancer, were less likely to have the test change their decision on having the test (Murphy et al.). Moreover, what seems to be an irrational decision may turn out to be, from the patient's point of view, rational. Thus, a patient may turn down a recommended treatment because of personal experience with surgery or because the long-term benefit is not seen as being worth the short-term risk.

Most important, the difficulty of educating sick persons does not justify unilateral decision making. Rather, it places a special obligation on healthcare professionals to communicate clearly with patients. Using technical jargon, trying to give all of the available information in one visit, and not asking what the patient wants to know is a recipe for confusing even the most intelligent patient. A growing literature deals with informational aides—ranging from question prompt-sheets to giving patients audiotapes of the interaction and formal decision aides—that can be used to promote patient understanding and shared decision-making. New technologies like interactive DVD offer patients the opportunity to participate more fully in shared decision making at their own rate. A limitation of many of these aides is that they are limited helping with specific decisions and need to be updated frequently (Barry). Healthcare professionals also need to become more familiar with different cultural patterns of communication in order to talk with patients from different cultural backgrounds. For example, although a simple, factual discussion of depression and its treatment may be acceptable to most middle-class Americans, it would be seen as inappropriate by a first-generation Vietnamese male, whose culture discourages viewing depression as a disease (Hahn). There is no reason, in principle, why a person who makes decisions at home and work cannot, with help, understand the medical data sufficiently to become involved in medical decisions. Healthcare professionals must learn how best to present that help and involve patients in the decision-making process.

PATIENTS DO NOT WISH TO BE INVOLVED IN DECISION MAKING. Many healthcare professionals believe that it is unfair to force patients to make decisions regarding their medical care. After all, they argue, patients pay their healthcare professionals to make medical decisions. The empirical literature partially supports the view that patients want professionals to make treatment decisions for them (Steel et al.). For example, in a study of male patients' preferences about medical decision making regarding hypertension, only 53 percent wanted to participate at all in the decisionmaking process (Strull et al.). More recent data suggest that sicker patients are less interested in information about their disease and more willing to have doctors make decisions (Butow 1997; 2002).

There is no reason to force patients to be involved in decisions if they do not want to be. However, unless the health professional asks, he or she cannot know how involved a patient wants to be. Studies suggest that doctors' ability to predict their patients' interest in information, or their desire to be involved in decision making, is no better than flipping a coin (Butow 1997, 2002). In addition, roughly two-thirds of patients want to be involved in decision making, either by being the primary decision maker (the minority) or in shared decision making with the physician.

Patients may not always want to be involved in decision making, since many have been socialized into believing that "the doctor knows best." This is particularly true for poorer patients. Studies have shown that physicians wrongly assume that because patients with fewer socioeconomic resources ask fewer questions, they do not want as much information. These patients may in fact want just as much information, but they have been socialized into a different way of interacting with healthcare professionals (Waitzkin, 1984).

Patients may choose to allow someone else to make the decision for them. However, when a patient asks, "What would you do if you were me?" the underlying question may be, "As an expert in biomedicine, what alternative do you think will best maximize my values or interest?" If this is the case, the healthcare professional should respond by making a recommendation and justifying it in terms of the patient's values or interests. More frequently, the patient is asking, "If you had this disease, what therapy would you choose?" This question presumes that the professional and patient have the same values, needs, and problems, which is often not the case. Healthcare professionals should respond by pointing this out and emphasizing the importance of the patients' values in the decision-making process.

Although many patients do not want to be actively involved in decision making, they almost always want more information concerning their illness than the healthcare professional gives them. Healthcare professionals should not assume that just because patients do not wish to choose their therapy, they do not want information. Patients may desire information so as to increase compliance or make modifications in other areas of their lives, as well as to make medical decisions.

THERE ARE HARMFUL EFFECTS OF INFORMING PATIENTS.

Healthcare professionals often justify withholding information from patients because of their belief that informing patients would be psychologically damaging and therefore contrary to the principle of nonmaleficence. Many healthcare professionals, however, overestimate potential psychological harm and neglect the positive effects of full disclosure (Faden et al.). Some discussions that physicians assume are stressful, such as advance care-planning, have been shown to decrease patient anxiety and increase the patient's sense of control. Moreover, bad news can often be communicated in a way that ameliorates the psychological effects of the disclosure (Quill and Townsend). Truth-telling must be distinguished from "truth dumping." Explanation of the care that can be provided, and empathic attention to the patient's fears and uncertainties can often prevent or mitigate otherwise more painful news. Finally, sometimes the harm associated with bad news is unavoidable. It is normal to be sad after finding out that one has an incurable cancer, for example. That does not mean that one should not convey the information, only that it should be done in as sensitively and supportively as possible.

INFORMED CONSENT TAKES TOO MUCH TIME. Respecting autonomy and promoting patient well-being—the values served through informed consent—are fundamental to good medicine. However, adhering to the ideals of medical practice takes time—time to help patients understand their illness and work through their emotional reactions to stressful information, to discuss each party's preconceptions and to clarify the therapeutic goals, to decide on a treatment plan, and to elicit questions about diagnosis and treatment.

In U.S. healthcare, time is money. As many commentators have noted, physicians are less well reimbursed for talking to patients than for performing invasive tests. This may discourage doctors from spending enough time discussing treatment options with patients. This, along with the pressures of managed care has decreased the average outpatient encounter, allowing even less time for doctor–patient communication. The ultimate justification for spending time to facilitate patient decisions is the same as that for spending any time in medical care: that patients will be better cared for. Moreover, some of the new decision aides, such as question prompts, may in fact decrease the time spent in the patient visit, while simultaneously increasing patient understanding.

Clinical Approaches to Informed Consent

Many of the problems in implementing informed consent result, at least in part, from the way informed consent has been implemented in clinical practice. Informed consent has become synonymous with the consent form, a legal invention with a legitimate role in documenting that informed consent has taken place, but hardly a substitute for the discussion process leading to informed consent (Andrews).

A PRO FORMA APPROACH: AN EVENT MODEL OF INFORMED CONSENT. In many clinical settings, consent begins when it is time to get consent, typically just prior to the administration of treatment. The process of getting the patients' consent consists of the recitation by a physician or nurse of the list of material risks and benefits and a request that the patient sign for the proposed treatment. This "conversation" is a very limited one that emphasizes the transfer of information from the physician or nurse to the patient. While it does meet the minimal legal requirements for informed consent efficiently, it does not meet the higher ethical goal of informed consent, which is to empower patients by educating and involving them in their treatment plans. Instead, it imposes an almost empty ritual on an unchanged relationship between provider and patient (Katz).

The procedure just described assumes that care involves a series of discrete, circumscribed decisions. In fact, much of clinical medicine consists of a series of frequent, interwoven decisions that must be repeatedly reconsidered as more information becomes available. When "it is time to get consent," there may be nothing left to decide. Consider the operative consent form obtained the evening prior to an operation. After patients have discussed with their families whether to be admitted to the hospital, rearranged their work and child-care schedules, and undergone a long and painful diagnostic workup, the decision to have surgery seems preordained. The evening before the operation, patients do not seriously evaluate the operation's risks and benefits, so consent is pro forma. No wonder some healthcare professionals feel that consent is a waste of time and energy.

The event model for gathering informed consent falls far short of meeting the ethical goal of ensuring patient participation in the decision-making process. Rather than engaging the patient as an active participant in the decisionmaking process, the patient's role is to agree to or veto the healthcare professionals' recommendations. Little attempt is made to elicit patient preferences and consider how treatment might address them.

A DIALOGICAL APPROACH: THE PROCESS MODEL OF INFORMED CONSENT. Fortunately, it is possible to fulfill legal requirements for informed consent while maximizing active patient participation in the clinical setting. An alternative to the event model described above, which sees informed consent as an aberration from clinical practice, the process model attempts to integrate informed consent into all aspects of clinical care (Berg et al). The process model of informed consent assumes that each party has something to contribute to the decision-making process. The physician brings technical knowledge and experience in treating patients with similar problems, while patients bring knowledge about their life circumstances and the ability to assess the effect that treatment may have on them. Open discussion makes it possible for the patient and the physician to examine critically their views and to determine what might be optimal treatment.

The process model also recognizes that medical care rarely involves only one decision made at a single point in time. Decisions about care frequently begin with the suspicion that something is wrong and that treatment may be necessary, and they end only when the patient leaves follow-up care. Decisions involve diagnostic as well as therapeutic interventions. Some decisions are made in one visit, while others occur over a prolonged period of time. Although some interactions between provider and patient involve explicit decisions, decisions are made at each interaction, even if the decision is only to continue treatment. The process model also recognizes that various healthcare professionals may play a role in making sure that the patients' consent is informed. For example, a woman deciding on various breast cancer treatments may talk with an oncologist and a surgeon about the risks of various treatments, with a nurse about the side effects of medication, with a social worker about financial issues in treatment, and with a patient-support group about her husband's reaction to a possible mastectomy.

Ideally, then, informed consent involves shared decision making over a period of time; it a dialogue throughout the course of the patient's relationship with various healthcare professionals. Such a dialogue aims to facilitate patient participation and to strengthen the therapeutic alliance.

Tasks Involved in Informed Consent

Consent is a series of interrelated tasks. First, the patient and professional must agree on the problem that will be the focus of their work together (Eisenthal and Lazare). Most nonemergency consultations involve complex negotiations between healthcare professional and patient regarding the definition of the patient's problem. The patient may see the problem as a routine physical examination for a work release, the need for advice, or the investigation of a physical symptom. If professionals are to respond effectively to the patients' goals, they must find out the reason for the visit. Whereas physicians typically focus on biomedical information and its implications, patients typically view the problem in the context of their social situation (Fisher and Todd). The differences between the patient's perceptions of the problem and the professional's perceptions must be explicitly worked through, since agreement regarding the focus of the interactions will lead to increased patient satisfaction and compliance with further treatment plans (Meichenbaum and Turk).

Even when the professional and patient have agreed on what the problem is, substantial misunderstandings may arise regarding the treatment goals. Patients may expect the medically impossible, or they may expect outcomes based on knowledge of life circumstances about which the physician is unaware. Since assessing the risks and benefits of any treatment option depends on therapeutic goals, the professional and patient must agree on the goals the therapy aims to accomplish.

Finding out what the patient wants is more complicated than merely inquiring, "What do you want?" A patient typically does not come to the professional with well-developed preferences regarding medical therapy except "to get better," with little understanding of what this may involve (Cassell, 1985). As a patient's knowledge and perspective change over the course of an illness, so too may the patient's views regarding the therapeutic goals.

Because clinicians provide much of the medical information needed to ensure that the patient's preferences are grounded in medical possibility, healthcare professionals play a significant role in how a patient's preferences evolve. It is important that they understand that patients may reasonably hold different goals from those their practitioners hold. This is particularly true when they come from different economic strata. For example, a physician's emphasis on the most medically sophisticated care may pale in the light of the patient's financial problems. Therapeutic goals, like the definition of the problem, require ongoing clarification and negotiation.

After agreeing upon the problem and the therapeutic goals, the healthcare professional and the patient must choose the best way to achieve them. If patients have been involved in the prior two steps, the decision about a treatment plan will more likely reflect their values than if they are merely asked to assent to the clinician's strategy.

Healthcare professionals often ask how much information they must supply to ensure that the patient is an informed participant in the decision-making process (Mazur). There is, however, a more important question: Has the information been provided in a manner that the patient can understand? While the law only requires that healthcare professionals inform patients, morally valid consent requires that patients understand the information conveyed. Ensuring patient understanding requires attention to the quality as well as the quantity of information presented (Faden).

A great deal of empirical data has been collected concerning problems with consent forms. These forms have been criticized, for example, as being unintelligible because of their length and use of technical language (Berg et al.) Healthcare professionals thus need to be aware of, and facile in using, a variety of methods to increase patients' comprehension of information, including verbal techniques, written information, and interactive videodiscs (Stanley et al.).

Still, the question of how much information to present remains. The legal standards regarding information disclosure—what a reasonable patient would find essential to making a decision or what a reasonably prudent physician would disclose—are not particularly helpful. Howard Brody has suggested two important features: (1) the physician must disclose the basis on which the proposed treatment or the alternative possible treatments have been chosen; and (2) the patient must be encouraged to ask questions suggested by the the physician's reasoning—and the questions need to be answered to the patient's satisfaction (Brody). Healthcare professionals must also inform patients when controversy exists about the various therapeutic options. Similarly, patients should also be told the degree to which the recommendation is based on established scientific evidence rather than personal experience or educated guesses.

Two other factors will influence the amount of information that should be given: the importance of the decision (given the patient's situation and goals) and the amount of consensus within the healthcare professions regarding the agreed-upon therapy. For example, a low-risk intervention, such as giving influenza vaccines to elderly patients, offers a clear-cut benefit with minimal risk. In this case, the professional should describe the intervention and recommend it because of its benefits. A detailed description of the infrequent risks is not needed unless the patient asks or is known to be skeptical of medical interventions. Interventions that present greater risks or a less clear-cut risk-benefit ratio require a longer description—for example, the decision to administer AZT to an HIV (human immunodeficiency virus)-positive, asymptomatic woman with a CD4 cell count of 350. In this situation, the data regarding starting medications are unclear and a patient's preference is critical. In this situation, one would need to talk about the major side effects of the medicines, the burden of taking medicines daily, the immunological benefit of anti-virals, etc. In neither case is a discussion of pathophysiology or biochemistry necessary. It must be emphasized that there is no formula for deciding how much a patient needs to be told or the length of time this will take. The amount of information necessary will depend on the patient's individual situation, values, and goals.

Finally, an adequate decision-making process requires continual updating of information, monitoring of expectations, and evaluation of the patient's progress in reaching the chosen or revised goals. Thus, the final step in informed consent is follow-up. This step is particularly important for patients with chronic diseases for which modifications of the treatment plan are often necessary.

The process model of informed consent has many advantages. Because it assumes many short conversations over time rather than one long interaction, it can be more easily integrated into the professional's ambulatory practice than the event model. It also allows patients to be much more involved in decision making and ensures that treatment is more consistent with their values. Furthermore, the continual monitoring of patients' understanding of their disease, the treatment, and its progress is likely to reduce misunderstandings and increase their investment in, and adherence to, the treatment plan. Thus, the process model of informed consent is likely to promote both patient autonomy and well-being.

Unfortunately, there are situations in which this approach is not very helpful. Some healthcare professionals, anesthesiologists, or emergency medical technicians, for example, are not likely to have ongoing relationships with patients. In emergencies, there is not time for a decision to develop through a series of short conversations. In these cases, informed consent may more closely approximate the event model. However, since most medical care is delivered by primary-care practitioners in an ambulatory setting, the process model of informed consent is more helpful.

robert m. arnold

charles w. lidz (1995)

revised by authors

SEE ALSO: Autonomy; Clinical Ethics: Elements and Methodologies; Competency; Information Disclosure, Ethical Issues of; Hospital, Contemporary Ethical Problems; Law and Bioethics; Life, Quality of: Quality of Life in Clinical Decisions; Paternalism; Patients' Rights: Origin and Nature of Patients' Rights; and other Informed Consent subentries

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