INTRODUCTION
This chapter discusses the second topic that is essential to the analysis of an ethical problem in clinical medicine, namely, the preferences of patients. By preferences of patients we mean the choices that persons make when they are faced with decisions about health and medical treatment. These choices reflect the patient’s own experience, beliefs, and values as informed by the physician’s recommendations. The previous topic, Medical Indications, concerns the physician’s clinical judgment about a patient’s medical condition and about interventions that might objectively improve deficits in that condition. When there are medical indications for treatment, a physician should propose a treatment plan that a patient may accept or refuse. We will discuss: (1) The ethical principle of respect for the autonomy of the patient; (2) the legal, clinical, and psychological significance of patient preferences; (3) informed consent; (4) decisional capacity; (5) truth in medical communication; (6) cultural and religious beliefs; (7) refusal of treatment; (8) advance directives; (9) surrogate decisions; (10) the challenging patient; and (11) alternative medicine.
Respect for autonomy is the guiding ethical principle of the Topic of Patient Preferences. Respect for autonomy is one aspect of a larger principle, namely, respect for persons, which is a fundamental principle of all morality. Respect for persons affirms that each and every person has moral value and dignity in his or her own right. In this sense, the principle of respect applies to every encounter between persons, regardless of their situation, stage, or state of life. One implication of respect for persons is a respect for personal autonomy, that is, acknowledging the moral right of every competent individual to choose and follow his or her own plan of life and actions.
In clinical ethics, respect for the autonomy of the patient signifies that physicians’ judgments about how to benefit their patients should include the values of the patients themselves. Physicians must never ignore or override the preferences of their patients. Patients’ responses to physicians’ recommendations should reflect their own values for their own lives. Patients have the right to freely accept or reject a physician’s recommendations.
As a moral principle, respect for autonomy is a “two-way street”: treating physicians also have autonomy to use on their best judgment about how best to benefit a patient medically. Therefore, respect for patient autonomy does not imply that patients have the right to demand inappropriate treatment; neither does it imply that a physician must accede to any and every request of a patient if it conflicts with the physician’s best judgment.
In clinical ethics, respect for patient preferences takes place within a patient-doctor relationship, that is, when some health problem prompts a patient to seek help from a physician and a physician responds with diagnosis, advice, and a proposed treatment. In this therapeutic relationship, physicians possess knowledge and skills that the patient needs. While physicians must always respect the autonomy of their patients, in practice, many obstacles may limit the ability of patients to express their preferences.
In most medical encounters, patients will be guided by physician’s recommendations because the goals of patients and physicians are aligned. Patients seek help for their medical problems, and physicians respond to their patients’ needs by proposing diagnostic or therapeutic approaches designed to achieve the patient’s goals. In situations where tensions or disagreements arise unexpectedly between medical indications and patient preferences, the physician is responsible for determining if these disagreements are the result of inadequate communication with the patient, fear, pain, or lack of trust on the part of the patient, or whether, for this particular problem, the goals of the patient and the physician are not aligned but are divergent.
Patients are sometimes so ill that they cannot clearly formulate or express preferences: they simply want and need help. Therefore, the therapeutic relationship can be distorted by what has been called “physician paternalism.” A physician assumes that the patient’s illness renders him or her incapable of clear judgment and the physician’s medical judgment alone should determine the course of care. Modern medical ethics repudiates this sort of paternalism. Instead, both the physician and the patient must form an alliance in which medical recommendations and patient preferences together guide the course of care. This constitutes the therapeutic physician-patient relationship and the shared decision-making that is central to it.
Despite medicine’s great scientific advances in the past century, the doctor-patient (therapeutic) relationship remains a central component of medicine in the 21st century. The principal reasons to explain the resilience of the doctor-patient relationship are that most medical care continues to be delivered in this therapeutic relationship; both patients and physicians want to preserve the personal aspects of medicine embodied in the therapeutic relationship; a strong doctor-patient relationship is likely to provide the best quality care.
This chapter discusses how the ethical principle of respect for autonomy should sustain the therapeutic relationship. It emphasizes the patient’s role in this relationship, namely, the expression of personal preferences and values. This chapter examines the conditions for free, informed choice by patients, the strategies that should be employed when the patient is unable to make such a choice, and situations in which a refusal of a physician’s recommendation appears to be contrary to the best interests of the patient or causes harm to others. Patient preferences have clinical, legal, and psychological significance.
Attending to patient preferences is essential to good clinical care. Patients who collaborate with their physicians to reach a shared health care decision have greater trust in the doctor-patient relationship, cooperate more fully to implement the shared decision, and express greater satisfaction with their health care. Research has shown that patients with chronic diseases, such as hypertension, noninsulin-dependent diabetes mellitus, peptic ulcer disease, and rheumatoid arthritis, enjoy better health outcomes when they ask questions, express opinions, and make their preferences known.
Similarly, studies show that some physicians are more likely than others to invite the expression of patient preferences and to encourage a participatory decision-making style rather than a controlling style in the therapeutic relationship. A participatory style is associated with primary care training, skill in interviewing that facilitates empathic listening and communication, and the opportunity to take time with patients. This approach, in which physicians and patients share authority and responsibility in order to build therapeutic alliances, is sometimes referred to as “patient-centered medicine.” The central activity of patient-centered medicine is the shared decision-making that brings together the physician’s medical recommendations and the patient’s choices and values.
In 1982, the President’s Commission for the Study of Ethical Problems in Medicine proposed a therapeutic model they called “shared decision-making.” The Commission stated that neither the beneficence model nor the autonomy model represents an accurate description of the ideal doctor-patient relationship. Both models assume an adversarial tension between physician and patient. By contrast, the shared decision-making model assumes that patients and physicians work as partners to achieve the patient’s goals that usually include the relief of symptoms, improvement of functions, cure of disease, and prevention of future illness. A 2007 national survey of patient’s preferences and experiences in clinical decision-making showed that 62% of patients preferred a shared decision-making model (28% preferred a consumerism—autonomy—model and 9% preferred a paternalism model); 52% of patients reported that they had in fact experienced a shared decision-making model in their therapeutic interactions with physicians.
Different patients may express different but entirely reasonable preferences when faced with the same medical indications. As medicine has become more effective, a particular problem can often be treated by several medically reasonable options, and each option is associated with different risks and benefits for the patient. For example, to avoid the risk of perioperative death, some patients with lung cancer may choose radiation therapy over surgery despite a lower 5-year survival rate. Similarly, some women may choose prophylactic mastectomy over watchful waiting when told they have a genetic propensity to breast cancer; some older men may choose watchful waiting over surgery for early cancer of the prostate. Respect for the autonomy of the patient implies that a physician should, after explaining his or her own preferences, honor the patient’s preference among medically reasonable options. Some people may even choose medically “unreasonable” options, such as declining life-saving treatments; after the physician attempts to persuade the patient to accept the recommended course, the patient’s choice should be respected.
It is increasingly common for patients to research their condition on Web sites or to learn about treatment options from the media, such as direct-to-consumer advertising of pharmaceuticals. This information may enhance understanding and cooperation, but it can also be erroneous or inappropriate for the patient’s actual condition. The physician should, to the extent possible, explain this difference to patients. Respect for the patient’s autonomy does not require the physician to accede to a patient’s wishes if they are medically inappropriate.
American law recognizes that all persons have a fundamental right to control their own body and the right to be protected from unwanted intrusions. Two classic judicial opinions state this principle succinctly:
Every human being of adult years and of sound mind has a right to determine what shall be done with his body.
Schloendorff v. Society of New York Hospital (NY, 1914).
Anglo-American law starts with the premise of thoroughgoing self-determination. It follows that each man is considered to be master of his own body, and he may, if he be of sound mind, prohibit the performance of life-saving surgery or other medical treatment.
Natanson v. Kline (Kan, 1960).
All states now have laws requiring informed consent for medical treatment, except in certain emergency situations. The legal requirement of explicit consent for specific treatment protects the legal right of patients to control what is done to their own bodies. Bodily intrusions without consent constitute an illegal battery. Also, failure to obtain adequate informed consent may also open a physician to a charge of negligence. Finally, apart from clinical skill and carefulness, a respect for patient preferences, good communication, and a participatory style of dealing with patients are known to be the most effective protection that physicians have against malpractice lawsuits. Studies show that patients are much less inclined to bring legal action against physicians who exhibit these behaviors.
Respect for patient preferences is psychologically significant because the ability to express preferences and have others respect them is crucial to a sense of personal worth. The patient, already threatened by disease, may have a vital need for some sense of control. Indeed, patients and families often struggle to control situations that are beyond human control (see Section 1.2.2). When patient preferences are ignored or devalued, patients are likely to distrust and perhaps disregard physician’s recommendations. When patients are overtly or covertly uncooperative, the effectiveness of therapy is threatened. Furthermore, patient preferences are important, because their expression may lead to the discovery of other factors, such as fears, fantasies, or unusual beliefs, that the physician should consider in dealing with the patient.
We ask six questions that must be raised in identifying and assessing an ethical problem regarding patient preferences:
Has the patient been informed of benefits and risks of diagnostic and treatment recommendations, understood this information, and given consent?
Is the patient mentally capable and legally competent or is there evidence of incapacity?
If mentally capable, what preferences about treatment is the patient stating?
If incapacitated, has the patient expressed prior preferences?
Who is the appropriate surrogate to make decisions for an incapacitated patient? What standards should govern the surrogate’s decisions?
Is the patient unwilling or unable to cooperate with medical treatment? If so, why?
2.1 INFORMED CONSENT
Informed consent is a practical application of respect for the patient’s autonomy. When patients consult a physician for a suspected medical problem, they usually state the problem as they see it. They then request help, either explicitly or implicitly. Physicians make a diagnosis and recommend treatment. Informed consent is a shorthand phrase that describes the information about diagnosis and treatment incorporated in the recommendations that the physician provides and the patient’s deliberate acceptance of that recommendation.
2.1.1 Question One—Has the Patient Been Informed of Benefits and Risks of Diagnostic and Treatment Recommendations, Understood This Information, and Given Consent?
In the process called informed consent, physicians explain their opinion about the nature of the patient’s problem, recommend a course of treatment, give the reasons for the recommendation, propose clinically acceptable alternatives to the recommended course, and explain the benefits and risks of all options. The patient ideally understands the information, assesses the treatment choices, and agrees (or disagrees) to accept the physician’s recommendation.
Informed consent is the central feature of an encounter between physician and patient, and should be characterized by mutual participation, good communication, mutual respect, and shared decision-making. Informed consent requires a dialogue between physician and patient leading to agreement about the course of medical care. Informed consent establishes a reciprocal relationship between physician and patient. After initial consent to treatment has occurred, an ongoing dialogue between patient and physician concerning the patient’s continuing medical needs reinforces the original consent.
A properly negotiated informed consent benefits both the physician and the patient: a therapeutic alliance is forged in which the physician’s work is facilitated because the patient has realistic expectations about results of the treatment, is prepared for possible complications, and is more likely to be a willing collaborator in the treatment. Despite a vast literature in law and ethics about the importance of informed consent, many studies reveal that some physicians are often deficient in observing the practice and the spirit of informed consent.
Law has long required explicit consent to surgery, a serious and possible lethal invasion of the human body. Consent for medical treatment was usually presumed by the very presence of the patient in need. However, the more elaborate practice of informed consent, described above, has become ethically and legally imperative, as medical and surgical care increasingly involves lengthy, perhaps life-long, modifications of personal life. Chemotherapy for many disease conditions lasts for life; organ and tissue transplantation requires continual immunosuppression and surveillance. The care of all chronic diseases requires the understanding, acceptance, and cooperation of patients. These features of modern medicine make informed consent much more than consent to a procedure; it is, in many cases, a personal acceptance of changes in one’s quality of life.
CASE I. Mr. Cure, the patient with pneumococcal meningitis, is told that he needs immediate antibiotic therapy. After he is informed of the nature of his disease, the benefits and burdens of treatment, and the possible consequences of nontreatment, he expresses his preference by consenting to the antibiotic therapy. A therapeutic alliance that is clinically, ethically, and emotionally satisfactory is formed and reinforced when the patient recovers.
CASE II. Ms. Cope is a 42-year-old woman who was diagnosed as having insulin-dependent diabetes at the age of 18 years. Insulin was prescribed, and a dietary regimen recommended. In the intervening years, she has complied with her dietary and medical regimen, but has experienced repeated episodes of ketoacidosis and hypoglycemia. Her physician has regularly discussed with Ms. Cope the course of her disease and the treatment plan, and has inquired about her difficulties in managing her condition. The physician proposes that Ms. Cope consider an implantable insulin pump that could improve glycemic control.
COMMENT. Case I exemplifies what might be called routine consent. The physician expresses clinical judgment by making recommendations to the patient regarding an appropriate course of care. The patient makes known his preference by accepting the physician’s recommendations. Case II is also an example of routine consent, but it occurs in a chronic disease setting. Ms. Cope’s doctor was meticulous about informing and educating her patient. Ms. Cope accepted the treatment regimen, and her compliance with it shows her preferences. She is now considering whether she will accept the benefits and risks of the insulin pump. Patients with chronic diseases, which often have variable courses far into the future, must consider a wider range of consequences. We shall see problems develop in both these cases in the following pages.
In the more particular sense, informed consent is defined as the willing acceptance of a medical intervention by a patient after adequate disclosure by the physician of the nature of the intervention, its risks and benefits, and also its alternatives with their risks and benefits. How should the adequacy of disclosure of information by a physician be determined? One approach is to ask what a reasonable and prudent physician would tell a patient. This approach, which was the legal standard in some early informed consent cases, is increasingly being replaced by a new standard, namely, what information do reasonable patients need to know to make reasonable decisions. The former standard affords greater discretion to the physician; the latter standard, called “the reasonable or prudent patient standard,” is more patient centered. A third standard, sometimes called a “subjective” standard, is patient specific. Under this standard, the information provided is specifically tailored to a particular patient’s need for information and understanding. Although the law usually requires that the physician meet only the reasonable patient standard, a physician who engages in a participatory style of shared decision-making should aspire to the requirements of a subjective standard. Stated another way, the subjective standard conforms to the highest ethical goals of clinical care, whereas the reasonable/prudent patient standard meets legal requirements.
Many studies show that patients desire more information from their physicians; many practitioners are aware that their patients appreciate information. In recent years, candid disclosure has become the norm. It is widely agreed that disclosure should include (1) the patient’s current medical status, including the likely course if no treatment is provided; (2) the interventions that might improve prognosis, including a description and the risks and benefits of those procedures, and some estimation of probabilities and uncertainties associated with the interventions; (3) a professional opinion about alternatives open to the patient; and (4) a recommendation that is based on the physician’s best clinical judgment.
In conveying this information, physicians should avoid technical terms, attempt to translate statistical data into everyday probabilities, ask whether the patient understands the information, and invite questions. Physicians are not obliged, as one court said, to give each patient “a mini-medical education.” Still, physicians should strive to educate their patients about their specific medical needs and options.
As we mentioned in Section 2.0.2, physicians are not the only source of medical information; media, Web sites, advocacy organizations, and many other sources provide information of varying quality. Persons often come to the physician with files full of articles. Many physicians will be familiar with such materials and can advise about it in general ways. They may prefer to say that when information about important developments becomes scientifically relevant to the patient’s care, it will appear in the medical literature which the physician regularly follows.
There is ethical debate about whether the scope of disclosure should include information about the experience of the physician, for example, disclosing the number of previous procedures performed and physician-specific rather than national, outcome data. Physicians routinely refer patients to specialists for problems and procedures in which they are not expert. Still, they may not be comfortable telling a patient about the extent of their experience with a procedure they are about to perform. It is our opinion that it is ethically appropriate to disclose levels of experience, and obligatory to do so in situations where the procedure is necessary but has significant risks or is elective. The patient is then able to make an informed choice about how to proceed.
The moral and legal obligations of disclosure vary with the situation; they become more stringent as the treatment situation moves from emergency through elective to experimental. In some emergency situations, very little information need be provided. Any attempt to inform may cost precious time. Ethically and legally, information can be curtailed in emergencies (see Section 2.4.3). For nonemergency or elective treatments, much more information should be provided. Finally, fully detailed and thorough information should accompany any experimental or innovative treatment. See Section 4.8.4.
Discussions of informed consent usually emphasize the amount and kind of information the doctor should provide. The patient’s comprehension is equally as important as the adequacy of the information. Many studies suggest that comprehension by patients of medical information is limited and inadequate. Information is often provided in settings and at times when the patient is distressed or distracted. At the same time, studies suggest that communication is often poorly accomplished and that little effort is made to overcome barriers to comprehension. The physician has an ethical obligation to make reasonable efforts to ensure comprehension. Explanations should be given clearly and simply; questions should be asked to assess understanding. Decision aids such as written instructions or printed materials should be provided. Video or computer programs should be provided to guide patients who face complicated decisions, such as choosing between options for treatment of breast cancer or prostate cancer. Educational programs for patients with chronic disease should be arranged. While physicians have the primary responsibility to inform their patients, other clinicians, particularly nurses, may supplement and enhance the information provided by the physician.
The process of informed consent is documented in a signed consent form that is entered in the patient’s record. Health care institutions require signed documentation before certain medical and most surgical or invasive diagnostic procedures are initiated. The document typically names the procedure and states that the risks and benefits have been explained to the patient. It is sometimes believed—wrongly—that a signed consent form is legal proof that a patient has given consent. In fact, the signed consent form in itself does not prove that the necessary discussion leading to an informed consent has taken place; it merely demonstrates that a provider has succeeded in getting a signature on paper. The actual process and details of the consent interview should be documented by the physician in the medical record. The signed consent form is not a substitute for this more complete documentation. To repeat, informed consent is a process of shared decision-making, and the written documents should attest that the process has been carried out between physician and patient. Informed consent is, in no sense, the signing of a form.
Many studies reveal that physicians often fail to conduct ethically and legally satisfactory consent negotiations. Physicians may be trapped in technical language, troubled by the uncertainty intrinsic to all medical information, worried about alarming the patient, or hurried and pressed by multiple duties. In addition, patients may have limited understanding, may be inattentive and distracted, or overcome by fear and anxiety. Selective hearing because of denial, fear, or preoccupation with illness may account for failure to comprehend what one might otherwise understand. Patients may believe that decisions are the physician’s prerogative; physicians may not appreciate the rationale for the patient’s participation.
These inadequacies in the informed consent process may be due to a belief by some physicians that the informed consent requirement imposes an undesirable and perhaps impossible task: undesirable because adequately informing a patient takes too much time and might create unnecessary anxiety, and impossible because no medically uneducated and clinically inexperienced patient can truly grasp the significance of the information the physician must disclose. For these reasons, physicians sometimes dismiss the informed consent requirement as a bureaucratically necessary ritual. This is a sadly limited view of the ethical purpose of informed consent. Informed consent is not merely pushing information at a patient. It is an opportunity to initiate a dialogue between physicians and their patients in which both attempt to arrive at a mutually satisfactory course of action. Informed consent should result in shared decision-making. The process, while difficult, is not impossible and is always open to improvement.
The informed consent process represents an opportunity for those physicians whose contact with the patient is brief, such as endoscopists, diagnostic radiologists, or anesthesiologists to form something of a therapeutic alliance.
Communications between physicians and patients should be truthful; that is, statements should be in accord with facts. If the facts are uncertain, that uncertainty should be acknowledged. Deception, by stating what is untrue or by omitting what is true, should be avoided. These ethical guidelines should govern all human communication. However, in the communication between patients and physicians, certain ethical problems about truthfulness may emerge. Does the patient really want to know the truth? What if the truth, once known, causes harm? Might not deception help by supporting hope? Traditionally, medical ethics has given ambiguous answers to these questions: while some past authors favored truthfulness, others recommended beneficent deception. More recently, with the prominence of the doctrine of informed consent, truthfulness has been commended as the ethical course of action.
CASE I. Mr. R.S., a 65-year-old man, comes to his physician with complaints of weight loss and mild abdominal discomfort. The patient, whom the physician knows well, has just retired from a busy career and has made plans for a round-the-world tour with his wife. Studies reveal mild elevation in liver functions and a questionable mass in the head of the pancreas. At the beginning of his interview with his physician to discuss the test results, Mr. R.S. remarks, “Doc, I hope you don’t have any bad news for me. We’ve got big plans.” Ordinarily, an endoscopic procedure to obtain cells to confirm pancreatic cancer would be the next step. The physician wonders whether he should put this off until Mr. R.S. returns from his trip. Should the physician’s opinion that Mr. R.S. may have pancreatic cancer be revealed to him at this time?
COMMENT. Contemporary bioethics strongly affirms the patient’s right to the truth. The arguments in support of this position are as follows:
General ethical arguments favor a strong moral duty to tell the truth as contributory to personal relationships and social cohesion. This general obligation is not easily overridden by speculative possible harms that might come from knowing the truth.
Suspicion on the part of the physician that truthful disclosure would be harmful to the patient may be founded on little or no evidence. It may arise more from the physician’s own uneasiness at being a “bearer of bad news” than from the patient’s inability to accept the information.
Patients have a need for the truth if they are to make rational decisions about actions and plans for life.
Truthful disclosure is a key element in shared decision-making and strengthens the patient-physician relationship. Concealment of the truth is likely to undermine the patient-physician relationship. In case of serious illness, it is particularly important that this relationship be strong.
Toleration of concealment by the physician may undermine the trust that the public should have in the profession. Widespread belief that physicians are not truthful would create an atmosphere in which persons who fear being deceived would not seek needed care.
Recent studies have shown that most patients with diagnoses of serious illness wish to know their diagnosis. Similarly, recent studies are unable to document that full disclosure leads patients to harm themselves.
RECOMMENDATION. Mr. R.S. should be told the truth. He probably has cancer of the pancreas and should have the procedure to obtain cells for pathological analysis. The considerations in favor of truthful disclosure, in our opinion, establish a strong ethical obligation on the physician to tell the truth to patients about their diagnosis and its treatment. The following considerations are relevant:
Speaking truthfully means relating the facts of the situation. This should be done in a manner measured to perceptions of the hearer’s emotional resilience and intellectual comprehension. The truth may be brutal, but the telling of it should not be. A measured and sensitive disclosure is demanded by respect for the patient’s autonomy. It reinforces the patient’s ability to deliberate and choose; it does not overwhelm this ability. It is advisable to open such a conversation with a question about how much detail the patient wishes to know and whether the patient may wish some other person to be informed.
Truthful disclosure has implications for Mr. R.S.’s plans. Further diagnostic studies might be done and appropriate treatments chosen. The trip might be delayed or canceled. Estate and advance care planning might be considered. Mr. R.S. should have the opportunity to reflect on these matters and to take control of his future.
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[JAMA and JAMA Network Journals Full Text]
CASE II. Mr. S.P., a 55-year-old teacher, has had chest pains and several fainting spells during the past three months. He reluctantly visits a physician at his wife’s urging. He is very nervous and anxious and tells the physician at the beginning of the interview that he abhors doctors and hospitals. On physical examination, he has classic signs of tight aortic stenosis, confirmed by echocardiogram. The physician wants to recommend cardiac catheterization and probably cardiac surgery. However, given his impression of this patient, he is worried that full disclosure of the risks of catheterization would lead the patient to refuse the procedure and perhaps drop out of medical care.
COMMENT. In this case, the anticipated harm is much more specific and dangerous than the harm contemplated in Case I. Hesitation about revealing the risks of a diagnostic or therapeutic procedure is based on the fear the patient will make a judgment detrimental to health and life.
RECOMMENDATION. The arguments in favor of truthful disclosure apply equally to this case and to Case I. Whether or not catheterization is accepted, the patient will need further medical care. In fact, the situation is urgent. This patient needs, above all, the benefits of a good and trusting relationship with a competent physician. Honesty is more likely to create that relationship than deception. Also, the physician’s fears about the patient’s refusal may be exaggerated. Although Mr. S.P. has avoided physicians in the past, now that he is seriously ill, he may become more accepting of the help that medicine can offer. The physician would be at serious fault if the patient died without having had the opportunity to consider the options for care.
Placebo treatment is a clinical intervention intended by the physician to benefit the patient, not by any known physiological mechanism of the intervention, but because of certain psychological or psychophysical effects due to the positive expectations, beliefs, and hopes of the patient. The intervention might be, as frequently in the past, an inert substance such as a sugar pill, or, as frequently today, vitamin pills, over-the-counter analgesics, or saline injections. It has long been demonstrated that such interventions do result in a placebo effect, such as relief of pain. Recent studies reveal that almost half of American physicians utilize placebo treatments on a regular basis.
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Placebo treatment raises a problem of truth telling, because it seems inevitably to involve deception. The physician knows that the intervention does not have the objective properties necessary for efficacy and the patient is kept ignorant of this fact. In some cases, the deception is an outright moral offense, motivated solely by the desire to charge the patient for a procedure or to “get the patient off my back”; in other cases, placebo deception may be motivated by the judgment that a harmless intervention may achieve a positive result. This raises a genuine ethical question: the duty not to deceive seems to conflict with the duty to benefit without doing harm. At present, there is a broad consensus among ethicists that clinical use of placebos is unethical.
Placebo agents are now commonly used in controlled clinical trials of therapy for non–life-threatening conditions. However, no deception is involved, because research participants must be informed that they will be randomized and may receive either an active drug or an inert substance. The use of placebo in an approved research protocol is ethical.
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CASE I. A 73-year-old widow lives with her son. He brings her to a physician because she has become extremely lethargic and often confused. The physician determines that, after being widowed two years before, she had difficulty sleeping, had been prescribed hypnotics, and she is now physically dependent on them. The physician determines the best course would be to withdraw her from her present medication by a trial on placebos.
CASE II. A 62-year-old man has had a total proctocolectomy and ileostomy for colon cancer. Evidence of any remaining tumor is absent; the wound is healing well, and the ileostomy is functioning. On the eighth day after surgery, he complains of cramping and abdominal pain and requests medication. The physician first prescribes antispasmodic drugs, but the patient’s complaints persist. The patient requests morphine, which had relieved his postoperative pain. The physician is reluctant to prescribe opiates; she believes that the pain is psychological, and repeated studies support her belief. The physician also is aware that opiates will cause constipation. She contemplates a trial of placebo.
COMMENT. Any situation in which placebo use involves deliberate deception should be viewed as ethically suspect. The strong moral obligations of truthfulness and honesty prohibit deception; the danger to the patient-physician relationship advises against it. Any exception to this strict obligation would have to fulfill the following conditions: (1) The condition to be treated should be known as one that has high response rates to placebo, for example, mild mental depression or postoperative pain; (2) the alternative to placebo is either continued illness or the use of a drug with known toxicity and addictability, for example, hypnotics as in Case I or opioids in Case II; (3) the patient wishes to be treated and cured, if possible; and (4) the patient insists on a prescription.
RECOMMENDATION. The use of a placebo in Case I is not justified. The patient is not demanding medication. The problem of addiction should be confronted directly. There will be ample opportunity to develop a good relationship with this patient. Subsequent discovery of deception might undermine this relationship. Use of placebo in Case II is tempting but not ethically justifiable. In favor of placebo use, the patient is demanding relief. A short trial of placebo may be effective in relieving pain and avoiding the harm associated with opioids. However, explanation may be as effective as placebo use. The deceptive placebo can destroy the trust that creates the therapeutic placebo effect and can undermine the patient’s confidence in the physician. A participatory style of decision-making is based on honest communication. Placebos may work even when the patient is told that they will be used. It may be possible, for example, to perform a “mini-experiment” with the patient’s consent: explain that two forms of pill will be offered, one active, the other inert, and the patient will blindly choose which one to take. Consultation with the hospital pain service is recommended.
Disclosure of options for treatment of a patient’s condition should be complete, that is, containing all information that a thoughtful person would need to make a good decision on their own behalf. It should provide the options that the physician recommends. It should also include other options that the physician may believe are less desirable but which are still medically reasonable. In so doing, physicians may make it clear why they consider these other options less desirable.
CASE I. A 41-year-old woman has a breast biopsy that reveals cancer. The physician knows that this patient has a history of noncompliance and cancellation of medical appointments. In light of this, the physician believes that the best treatment approach would be a modified radical mastectomy which would require less continued care than a lumpectomy and five weeks of outpatient radiotherapy. Should the physician omit mention of this second option because she is concerned that after a lumpectomy, the patient may not keep her radiotherapy appointments?
RECOMMENDATION. The entire range of options should be explained with careful delineation of the risks and benefits of each. It is ethically appropriate to make a strong argument in favor of the option the physician considers best. However, the patient should be left free to choose, even if the physician believes she may choose the less effective option. Coercion and manipulation of the patient must be carefully avoided. Ultimately, the patient must make decisions about breast surgery and keeping appointments. The physician must provide the patient with information and encourage her to complete whatever form of treatment she elects to receive.
COMMENT. The dialogue between physicians and patients is not only inhibited by limitations of physician communication and patient comprehension; it is also limited by the failure of many physicians to listen carefully to their patient’s words and the emotions underlying them. Finally, the time limits for patient visits imposed by some managed care plans and clinics, and reimbursement policies that compensate for procedures but not for education, discourage good communication. The importance of improved communication between doctors and patients should be obvious in this age of information.
Persons have a right to information about themselves. Similarly, they have the right to refuse information or to ask the physician not to inform them.
CASE I. Mr. A.J. is scheduled for surgery for spinal stenosis. The neurosurgeon begins to discuss the risks and benefits of this surgery. The patient responds, “Doctor, I don’t want to hear anything more. I want the surgery. I realize there are risks, and I have confidence in you.” The surgeon is concerned that he has not completed an adequate disclosure.
CASE II. Mr. Care, with multiple sclerosis (MS), had shown little interest during the early years of his illness in learning about the possible course of his disease. He refused frequent offers by the physician to discuss it. However, on one of his repeated admissions for treatment of urinary tract infection, he states that, had he known what life would be like, he would have refused permission for treatment of other life-threatening problems. The patient’s mental status is difficult to evaluate. His doctor thinks he is severely depressed; the intensivist believes he shows signs of early dementia. Should he have been informed of his prognosis at an earlier time even though unwilling to engage in such discussions with his physician?
RECOMMENDATION. In Case I, Mr. A.J.’s refusal of information should be respected. His surgeon has no obligation to press the matter, although he may repeat the offer of information at appropriate times. The surgeon must make a full notation in the chart that the patient has refused information. It is desirable to seek the patient’s permission to discuss the details of the procedure with an involved family member. If and when patients desire additional information, clinicians should be prepared to offer it.
In Case II, Mr. Care poses a difficult case. Here we opt for more rather than less disclosure, because the condition, though untreatable, is long lasting. The patient’s long-term autonomy is respected more by providing as much information as possible to enable him to make more choices while he is physically and mentally able to learn coping mechanisms in advance. Although it might be tempting to withhold information to protect the patient, a better alternative would be to give the patient general information sufficient to indicate the seriousness of his condition as well as the uncertainty about the time, the severity, and the extent of the problems that MS can cause. This avoids the extremes of withholding too much for too long or disclosing too much too soon. Considerable tact is required to find the proper balance of disclosure and reticence. Furthermore, the disclosures made as the condition worsens must be adjusted in the light of the impairments to the patient’s capacity. In some cases of late-stage MS, an associated dementia appears. It would be advisable to make disclosures before the patient’s capacity is so severely impaired that he cannot understand.
When medical errors, as defined in Section 1.4, occur, what obligations do the physician and the hospital have to disclose errors to patients? Some errors are due to negligence, but the majority are due to accident, misinformation, or organizational malfunction. Some errors do not cause harm; others affect serious harm. When medical errors occur, what obligations do physicians have to disclose them?
CASE. The patient described in Section 2.1.9 is treated by modified radical mastectomy and reconstructive breast surgery. Postoperatively, she develops persistent swelling and drainage of the breast and a fever consistent with a breast abscess. She is returned to the operating room for exploration of the operative site. The surgeon discovers that a sponge had been left in the surgical wound. It is removed, and the abscess is treated. The patient recovered and was discharged. Should the physician inform the patient that a mistake had been made?
RECOMMENDATION. Disclosure is required because a serious medical error occurred, causing harm to this patient. Even though the harmful result was remedied, the patient required a second operation with attendant risks; her hospital stay, with its attendant risks, was prolonged; chemotherapy was delayed, and costs were incurred. A fundamental duty of respect for persons dictates not only that the patient be informed of the error and its consequences, but also that an apology be offered to the patient for harms of this sort. The surgeon should inform and apologize to the patient and report the error to the hospital, whose authorities should also apologize. Appropriate compensation should be provided.
COMMENT. Any inclination to hide medical mistakes must be discouraged. Secrecy is unethical and may be counterproductive. Mistakes must be reported for risk management and quality assurance purposes, and organizations should have procedures for reporting and correcting and preventing errors. Charges should be waived and appropriate compensation provided; settlement of financial claims, even without suit, may be considered. A climate of disclosure and honesty is necessary to maintain patient confidence and trust in the relationship with their physicians and with the health care institutions. Malpractice actions are certainly possible, particularly if the error is the result of negligence, but threat of legal claims is reduced in a climate of confidence and honesty. Errors that are truly harmless, without any adverse effects for the patient (eg, an incorrect dosage of medication is prepared but corrected before administration), must be reported within the system for control purposes. Although it is not obligatory to disclose minor harmless errors, it is advisable to do so to sustain the climate of honesty in the relationship between the patient, physicians, and hospital (see Section 4.11.1).
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2.2 DECISIONAL CAPACITY
Informed consent and truthful disclosure presuppose that the patient possesses the legal competence and mental capacity to hear and comprehend communication. There are many situations in clinical care in which patients appear to, or obviously do, lack this capacity.
2.2.1 Question Two—Is the Patient Mentally Capable and Legally Competent or Is There Evidence of Incapacity?
Consent to treatment is compromised because some patients lack the mental capacity to understand information or to make choices. In the law, the terms competence and incompetence
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