Fig. 3.1
Principles of a geriatric ethic derived from Hauerwas’ dimensions of human nature (Based on data from Ref. [26])
Informed Consent in the Elderly
Respect for Personal Autonomy
Many ethical conundrums in medical ethics are the result of specific principles coming into conflict in specific cases. Personal autonomy is generally understood to refer to the capacity to be one’s own person, to live one’s life according to reasons and motives that are taken as one’s own and not the product of manipulative or distorting external forces. The principle of respect for personal autonomy, at least in most Western cultures, is sometimes taken to be the overriding principle in modern ethical deliberation. However, respect for personal autonomy does not, and should not, exhaust moral deliberation. Other principles are important and not only when autonomy reaches its limits. Childress notes that focusing on the principle of respect for personal autonomy can foster indifference and that the principles of care and beneficence are important even in discussions of informed consent. The role played by the principle of respect for personal autonomy is one of setting limits, such that, “without the limits set by the principle of respect for autonomy, these principles (beneficence, nonmaleficence, and justice) may support arrogant enforcement of “the good” for others.” [30]. Yet, the principle of respect for autonomy is not absolutely binding and does not outweigh all other principles at all times. Two different approaches have been used by ethicists to resolve conflicts or apparent contradictions between competing principles. First is to construct an a priori serial ranking of the principles, such that some take absolute priority over others. Second, principles can be viewed as prima facie binding, competing equally with other prima facie principles in particular circumstances. This view requires one to view more closely the complexities and particularities of individual cases and is more situational in context. The prima facieprinciple of respect for autonomy can be overridden or justifiably infringed when the following conditions are satisfied: (1) when there are stronger competing principles (proportionality); (2) when infringing on the principle of respect for personal autonomy would probably protect the competing principles (effectiveness); (3) when infringing the principle of respect for personal autonomy is necessary to protect the competing principle(s) (last resort); and (4) when the infringement of the principle of respect for personal autonomy is the least intrusive or restrictive in the circumstances, consistent with protecting the competing principle(s) (least infringement) [30].
Shared Decision Making
Aside from the legal requirements and the specter of malpractice, recent discussions of “informed consent” have focused on the concept of “shared decision making” and the clinical-therapeutic role of the informed consent process in improving patient care. These discussions recognize that there should be a collaborative effort between physicians and patients to arrive at appropriate treatment decisions. The physician brings knowledge and trained judgment to the process, whereas the patient brings individual and unique priorities, needs, concerns, beliefs, and fears. Focusing on the process of informed consent, as opposed to bare legal requirements, increases a patient’s participation in his or her own care, which has the practical benefit of increasing patient compliance and self-monitoring. Informed consent as “teaching” (indeed, the origin of the word “doctor” is from “teacher”) further diminishes patients’ misconceptions or inaccurate fears about their situation and prospects and may improve patient recovery or comfort with a better understanding of the care that is being provided. No good data are available regarding these “therapeutic” effects of informed consent, and further studies seem warranted. Despite these theoretical positive aspects, issues surrounding informed consent remain vexing for physicians in a number of clinical situations from both legal and ethical perspectives. Even the ideal model of “shared decision making” does not address many of the realities of medical practice, including emergency situations, conflicts of interest, and questions of futility.
By emphasizing informed consent as a temporal “process,” one can avoid the pitfalls of viewing informed consent as a single event. Informed consent can never be reduced to a signature on a consent form. “Perhaps the most fundamental and pervasive myth about informed consent is that informed consent has been obtained when a patient signs a consent form. Nothing could be further from the truth, as many courts have pointed out to physicians who were only too willing to believe this myth.” [31]. Although a matter of routine in many institutions because they are seen as providing protection against liability, informed consent forms actually provide very little. A review of more than 500 separate informed consent forms revealed these documents have limited educational value, go mostly unread, and are frequently misunderstood by patients [32]. The informed consent form does have value in that it provides an opportunity for the patient to read the information on the form and to create a locus for the appropriate patient–physician discussion that is the key element. An informed consent form merely documents that the “process” of informed consent has taken place.
Traditionally in the past, consent to anesthesia was subsumed under the consent for the surgical procedure and included within the surgery consent form. The anesthesiologist was one step removed from the formal consent process. Today, separate specific consent for anesthesia is required. It is imperative that the anesthesiologist make a concerted effort to adequately complete this process with the patient and, when appropriate, the patient’s family, regarding the anesthetic procedure. This should be adequately documented and may include an additional note with the patient’s consent on the chart or anesthetic record.
Beauchamp and Childress [25] have broken down the process of informed consent into seven elements (Table 3.1). These include threshold elements or preconditions, which include (1) decision-making capacity or competency of the patient, (2) freedom or voluntariness in decision making, including absence of overriding legal or state interests; informational elements including (3) adequate disclosure of material information, (4) recommendations, and (5) an understanding of the above; consent elements, which include (6) decision by the patient in favor of a plan and (7) authorization of that plan. Several of these elements can pose particular challenges in the elderly population.
Table 3.1
Elements of the process of informed consent
Threshold elements (preconditions) |
1. Decision-making capacity or competency |
2. Freedom or voluntariness and absence of overriding state or legal interests |
Informational elements |
1. Adequate disclosure of material information |
2. Recommendation |
3. Understanding |
Consent elements |
1. Decision |
2. Authorization |
Threshold Elements
Decision-Making Capacity
Physicians are frequently faced with the problem of making treatment decisions for elderly patients who no longer have decision-making capacity. Many diseases and conditions that can make continued life contingent on life-prolonging therapies can also destroy or substantially impair a person’s decision-making capacity and are more likely to do so in older people. In addition, Alzheimer’s disease and other forms of dementia are more likely to be present in older persons. One estimate is that 5–7% of persons over 65, and 25% of those over 84, suffer from severe dementia [33]. Assessment of decision-making capacity even in cases of mild dementia can be particularly difficult [34]. Decision-making capacity requires (1) a capacity to understand and communicate, (2) a capacity to reason and deliberate, and (3) possession of a set of values and goals [35–37]. Although there is general agreement regarding these three requirements, there is no single, universally accepted standard of decision-making capacity. This is because decision-making capacity is not an all-or-nothing concept. Decision making is also a task-related concept and the requisite skills and abilities vary according to the specific decision or task. The relevant criteria should also vary according to the risk to a patient. Basically, one must ask the following questions: Does the patient understand his or her medical condition? Does the patient understand the options and the consequences of his or her decision? Is the patient capable of reasonable deliberation? Is the patient able to communicate his or her decision? Does the patient possess a coherent set of values and/or goals? Several reviews provide helpful discussions of the clinical assessment of elderly patients’ decision-making capacity within these contexts [38–40]. Instruments such as the MacArthur Competence Assessment Tool-Treatment (MacCAT-T) may provide a flexible yet structured method with which physicians and other caregivers can assess, rate, and report patients’ abilities relevant for evaluating capacity to make treatment decisions [41]. Other standard cognitive assessment tests, such as the Folstein Mini-Mental State Examination (MMSE 1–20) [42], Alzheimer’s Disease Assessment Scale-cognition (ADAS-cog 1–76) [43], and the Global Deterioration Scale [44] have proved useful in providing background semiquantification of cognitive status in relation to competency. For the legal standard for reasoning, word fluency was the best single predictor of competency but the MMSE, memory testing, and verbal reasoning were not good multivariate predictors [45].
Informed consent in the elderly patient presents other unique aspects [46]. Sugarman et al. [47] conducted a structured literature review in the published empiric research on informed consent with older adults (aged 60 years and older). Diminished understanding of informed consent information was associated with older age and with fewer years of education. Although showing some impairment in their quality of reasoning, the elderly are able to reach reasonable risk-taking decisions to the same degree as young adults [48, 49].
To what extent must a patient “understand” his or her condition, treatment options, and risks? [50] If fully “informed” is meant to mean fully “educated” [51] then “informed” consent may be seen as an impossible standard. However, the primary object of information is to facilitate the patients’ care rather than providing a litany of possible complications in order to avoid a lawsuit. Factual knowledge is used, not as an end in itself, but as a means to extend the patients’ own understanding in such a way as to meet their own unique priorities, needs, concerns, beliefs, and fears so that they may decide about their care in the manner in which they normally make similar choices. This will vary from patient to patient and with the risks of the procedure involved. It is a mistake to assume that a patient must understand information to the same extent and in the same manner as a physician, or even as a well-educated layman. This may indeed be seen as just as paternalistic as not permitting patients to participate in decision making at all [31].
Visual and hearing impairments and diminished memory and comprehension in the elderly patient require the clinician to exercise particular caution when obtaining informed consent [52]. One must also be careful to avoid the mistake of equating recall, a standard endpoint in many studies on the adequacy of informed consent and which may be problematic in the elderly, with understanding and comprehension. Meisel and Kuczewski [31] note that, “While it may be true that someone who cannot retain information for a few seconds might not be said to understand it, people often make reasonable decisions but cannot later recall the premises that supported the reasoning or the process that led to the conclusion.” Distant recall of the informed consent process may be an indicator of the adequacy of a patient’s understanding, but its absence says little about what the patient understands at the time of consent. Physicians also tend to underestimate patients’ desire for information and discussion and, at the same time, overestimate patients’ desire to make decisions [53–55]. Elderly patients and their physicians often differ on patient quality-of-life assessments that may be associated with clinical decisions [56]. These studies and others underscore the need for clear communication, individualization, and compassion in obtaining adequate informed consent in the elderly. New strategies to maximize comprehension of informed consent information (e.g., storybooks, videos, and so forth) may be useful [47].
Assessment of patient capacity to enter into the process of informed consent or competency to make rational medical decisions is a complicated issue. Much has been written on the criteria for determining individual capacity and the legally defined characteristic of “competency.” [37, 57–60]. Competency, unlike the decision-making capacity, is a legal term and an all-or-nothing concept specific to a given task. Thus, competence is not a unitary concept: there are multiple competencies given specific tasks and the assessment must be fitted to the particular area or task in which competence is required [61, 62]. In the absence of a clear medical diagnosis such as delirium or unconsciousness, decisions regarding competency must be made with assistance from psychiatric services, ethics consult services, and/or legal counsel. In general, decisions must be made in these situations on the patient’s behalf, either by “substituted judgment” (a decision based on what the patient would have wanted, assuming some knowledge of what the patient’s wishes would have been) with or without the help of proxy consent or by a decision made according to the “best interests” of the patient on the basis of a balancing of a “benefit versus burdens” ratio. An appropriate hierarchy for surrogate decision makers is delineated, for example, in a provision of the Virginia Health Care Decisions Act (Code of Virginia §54.1–2981) as follows: 1. A legally appointed guardian or committee. 2. The patient’s spouse if no divorce action has been filed. 3. An adult son or daughter of the patient. 4. The patient’s parent. 5. An adult brother or sister of the patient. 6. Any other relative of the patient in descending order of relationship. It must be remembered that the caregiver has an ethical obligation to evaluate the competency of the surrogate’s decisions with regard to (1) lack of conflict of interest, (2) reliability of the evidence of the patient’s desires on which the surrogate is relying, (3) the surrogate’s knowledge of the patient’s own value system, and (4) the surrogate’s responsible commitment to the decision-making process [63]. All these situations involve complex issues and, again, may require the assistance of hospital ethics committees or consult services.
Voluntariness
A second threshold element is one of freedom or voluntariness. Here one asks the question of whether the patient’s decision is free from external constraints. These constraints can consist of myriad social, familial, and even financial factors that can be difficult, if not impossible, to sort out. However, it is not true that the principle of respect for autonomy is at odds with all forms of heteronomy, authority, tradition, etc. Competent individuals may autonomously choose to yield first-order decisions (i.e., their decisions about the rightness and wrongness of particular modes of conduct) to a professional, family, spouse, or to a religious institution. In these instances, the person is exercising second-order autonomy in selecting the professional, person, or institution to which they choose to be subordinate. In these cases, second-order autonomy becomes central [64]. The distinguishing feature becomes whether the second-order decision was free and voluntary. Frequently, elderly patients decide on specific treatment options with respect for the opinions of family members, or a concern for their psychologic, physical, and/or financial well-being. As Waymack and Taler observe, “It is often the case that health care professionals find themselves in the care of elderly patients where, because of the nature of chronic care, families often ask or are asked to play a significant role.” [65]. It is perfectly appropriate for elderly patients to consider the preferences of loved ones, and they should not automatically be encouraged to make decisions concerning treatment options, particularly life-extending treatments, for exclusively self-regarding or purely selfish reasons. Moreover, although undue pressure and influence are clearly improper, it is a mistake to assume that any advice and counsel from family members constitutes undue pressure or influence. However, when elderly patients possess decision-making capacity, generally they and only they have the moral authority to decide how much weight to give the preferences and interests of family members. While it is true that elderly patients can have ethical obligations toward family members who have a bearing on treatment decisions and the interests of family members can be “ethically relevant whether or not the patient is inclined to consider them,” [66], they should generally retain decision-making authority even if physicians believe that they are failing to give due consideration to the interests of family members [67].
Informational Elements
Adequate Disclosure
The first of the informational elements of informed consent is adequate disclosure. This is the process of properly informing the patient of his or her diagnosis, prognosis, treatment options, risks, and possible outcomes. The anesthesiologist should reveal the specific risks and benefits of each anesthetic option, the complications of instrumentation of the airway, the risks and benefits of invasive monitoring, the presence and use of a fallback plan, and basis for the anesthesiologist’s recommendations [68]. “Transparency” is a useful term describing the openness by which the anesthesiologist discusses the treatment plans with a patient. By “thinking out loud” regarding the options and plans, the anesthesiologist communicates the thought processes that he is making that is going into his or her recommendation, thus allowing the patient to understand and participate in this process. Most patients and parents of patients want assurance and explanation regarding anesthesia, not necessarily detailed and exhaustive information.
The discussion of risks and hazards of the diagnostic or therapeutic options, as well as information about anticipated pain or suffering, is, in theory and practice, the most troublesome aspects of informed consent. According to the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, “Adequate informed consent requires effort on the part of the physician to ensure comprehension; it involves far more than just a signature on the bottom of a list of possible complications. Such complications can be so overwhelming that patients are unable to appreciate the truly significant information and to make sound decisions.” [37]. The law does not require one to give a list of every possible complication of a planned procedure (which may inflict an undue amount of emotional distress), but only a “reasonable” amount of information. Negligence is neither failure to achieve a good outcome nor failure to disclose all remote risks [69].
But just how does one define “reasonable”? The courts have had difficulty as well assessing what a “reasonable” standard of disclosure may be. The most cited standard is the professional practice standard [70]. This standard defines reasonable disclosure as what a capable and reasonable medical practitioner in the same field would reveal to a patient under the same or similar circumstances. Some courts have ignored this prevailing standard of disclosure and shifted the focus from the professional community as forming the standard to the patients themselves. It focuses on the “new consumerism” in health care, an extension of the patient’s right of self-determination, where the patient is viewed as consumer of health care and the physician as provider [71]. The “reasonable patient standard” asks what a reasonable patient would consider reasonable and material to the decision of whether to consent to a procedure offered. The burden, however, is still on the physician to ascertain just what is reasonable and material for a hypothetical “reasonable patient.” This recognizes a significant shift in consent law. As legal standards continue to evolve, the reasonable patient standard may become more commonly accepted and eventually displace the professional practice standard as the majority opinion in American informed consent law. A further extension of this line of thinking is the “subjective person standard.” This standard recognizes that all patients are different, there is no hypothetical “reasonable person,” and hence the standard of disclosure must recognize not only the local standard of care but individual patient needs and idiosyncrasies as well. One important factor in all the above is the notion of “causality,” i.e., would additional information have affected this particular patient’s decision? What specific, individual concerns did the patient have that would have most affected his or her decision whether or not they are part of the local standard of care for disclosure? The risk of vocal cord damage from a routine intubation may be so small as to not require mentioning in the normal situation (although this is debatable). It may, however, be very important for a professional singer in opting between regional and general anesthesia.
Recommendation and Understanding
Providing a recommendation and patient understanding are the other two informational elements in the informed consent process. The principle of patient autonomy does not require the physician to present the information in a totally neutral manner, if this were even possible [4]. Indeed, part of the informed consent process is to present information to the patient in a way that buttresses a physician’s recommendations. Persuasion is a justifiable way for educating patients. This is different from manipulation, which is defined as inappropriately causing a certain behavior, and coercion, which is actually threatening a patient with a plausible punishment so the patient will act in a certain way.
Assessing patient understanding of the information presented can be a difficult issue, especially if “standard” consent forms are relied upon. In one study, 27% of postoperative surgical patients signing consent forms did not know which organ had been operated upon, and 44% did not know the nature of the procedure [72]. Cassileth et al. [73] showed that 55% of cancer patients could list only one of the major complications for chemotherapy within 1 day of signing consent forms. Other studies have shown that risk-specific consent forms do not aid retention [74] and that decision makers often sign consent forms that they do not understand [75]. Attempts must be made to educate patients according to their individual needs and, as has been stated previously, not to assume that a patient must have complete understanding, but only that which is necessary given their own particular situation to come to a reasonable decision. This will vary from patient to patient and from situation to situation, and consent forms cannot be relied upon to provide this information, no matter how detailed.
Consent Elements: Decision and Autonomous Authorization
Finally, there are the two consent elements: decision and autonomous authorization. The patient must be able to reach a decision and authorize the physician to provide the care decided upon. The physician must document the consented to technique as well as the invasive monitoring to be used. The patient may consent either verbally or in writing, both are ethically and legally just as valid. It may be more difficult to provide evidence of verbal consent after the fact, however, making it all the more important to document adequately the patient’s response in the chart. Although the lack of an objection is not equivalent to an authorization, cooperation of patients during performance of a procedure in the absence of overt verbal authorization has usually been deemed equivalent to implied consent and sufficient in cases specifically addressing these issues [76].
Advance Directives
Advance directives are statements that a patient makes, although still retaining decision-making capacity, about how treatment decisions should be made when they no longer have the capacity to make those decisions. California was the first state to legalize the “living will” in 1976; by 1985, 35 states and the District of Columbia had enacted similar laws. In 1991, the Patient Self-Determination Act (PSDA) became federal law involving all Medicare and Medicaid providers. The PSDA provides that all health care providers must give all patients written information at the time of their admission advising them of their rights to refuse any treatments and to have an advance directive. The presence of an advance directive must be documented in the patient’s record, and discrimination against a person because they do or do not have an advance directive is prohibited.
There are two general forms of advance directives. Living wills are documents stating the desires of the patient for treatment alternatives, usually to die a “natural” death and not to be kept alive by advanced life-support measures. In many states, the patient may also stipulate wishes regarding fluid and nutrition discontinuation in the event of persistent vegetative state. Living wills become effective on the determination of “terminal illness” or when death is imminent (e.g., within 6 months) or when two physicians make the diagnosis of persistent vegetative state. The strengths and weaknesses of the living will are outlined in Table 3.2. Living wills have several weaknesses, including the frequent lack of specific instructions and the impossibility of any person foreseeing all the contingencies of a future illness [77]. Therefore, many advocate an alternative form of advance directive known as a Power of Attorney for Healthcare (PAHC). A PAHC provides for the appointment of a person to act as a health care agent, proxy, or surrogate to make treatment decisions when the patient is no longer able. The PAHC allows a person to add specific directives, e.g., giving a designated agent authority to have feeding tubes withheld or withdrawn. Most PAHCs become effective when two physicians, or one physician and a psychologist, determine that the patient no longer has decision-making capacity. However, this requirement is not universal, and individual state statutes may vary. Table 3.3 lists the advantages of the PAHC that may make it a better option than a living will. Individual state statutes may differ regarding certain components such as witnesses and need for notarization. Whichever form of advance directive a patient chooses to use, both serve a valuable role in preventing ethical dilemmas if designed properly and implemented.
Table 3.2
Living Will (LW)
Strengths |
• Allows the physician to understand the patient’s wishes and motivations |
• Extends the patient’s autonomy, self-control, and self-determination |
• Relieves the patient’s anxiety about unwanted treatment |
• Relieves physician’s anxiety about legal liability |
• Reduces family strife and sense of guilt |
• Improves communication and trust between patient and physician |
Weaknesses |
• Applicable only to those in a persistent vegetative state (PVS) or the terminally ill (patients who have a disease that is incurable and who will die regardless of treatment) |
• Death must be imminent (e.g., may be statutorily defined as likely to occur within 6 months) |
• Ambiguous terms may be difficult to later interpret |
• There is no proxy decision maker, so: |
◦ It requires prediction of final illness scenario and available treatment |
◦ It requires physician to make decisions on the basis of an interpretation of a document |
Table 3.3
Power of Attorney for Healthcare (PAHC)
Activation of PAHC |
Lack of decision-making capacity must be certified by two physicians or one physician and a psychologist who have examined the patient. Until then, the patient makes all the decisions |
Advantages |
• Physician has someone to talk with—a proxy, a knowledgeable surrogate—who can provide a substituted judgment of how the patient would have chosen. If the agent is unable to provide a substituted judgment, the agent and physician together can use the best-interest standard (how a reasonable person might choose in consideration of the benefit–burden concept of proportionality) |
• Provides flexibility; this decreases ambiguity and uncertainty because there is no way to predict all possible scenarios |
• Authority of agent can be limited as person desires |
• Avoids family conflict about rightful agent |
• Provides legal immunity for physicians who follow dictates |
• Allows appointment of a nonrelative (especially valuable for persons who may be alienated from their families) |
• Most forms can be completed without an attorney |
• Principal may add specific instructions to the agent, such as the following: “I value a full life more than a long life. If my suffering is intense and irreversible, or if I have lost the ability to interact with others and have no reasonable hope of regaining this ability even though I have no terminal illness, I do not want to have my life prolonged. I would then ask not to be subjected to surgery or to resuscitation procedures, or to intensive care services or to other life-prolonging measures, including the administration of antibiotics or blood products or artificial nutrition and hydration .” |
In many instances, elderly patients who lack decision-making capacity have neither executed an advance directive nor previously discussed their preferences regarding treatment options. Even when surrogates are available, disagreements among parties (particularly family members with vested interests), legal or regulatory obstacles, or other problems may hinder a clear decision-making process. The American Geriatric Society Ethics Committee has published a position statement that outlines a strategy for dealing with these situations [78]. They recommend that health care providers and institutions have in place policies and procedures to make decisions for incapacitated persons without surrogates and to establish mechanisms for intrainstitutional conflict resolution, such as an ethics committee, to mediate conflicting situations. Surrogate decision-making laws and policies should not hinder the patient’s ability to die naturally and comfortably. Evidence from competent patients in similar circumstances should shape the plan of care for an individual patient in the absence of evidence that the patient’s wishes would be otherwise [78]. Other strategies include the “prior competent choice” standard, which stresses the values the patient held while competent. The “best interest standard” moves the focus to the patient’s subjective experience at the time the treatment is considered [39].
There remains an urgent role for physicians to educate their patients, their institutions, and their legislatures regarding the important role of advance directives in clinical decision making and the need to remove legislative and institutional hindrances to providing excellent care to dying patients and their families. Although playing an important role in unique circumstances, advance directives are not a substitute for adequate communication among physicians, patients, and family about end-of-life decision making and do not substantially enhance physician–patient communication or decision making [79].
EMRs and Patient Autonomy
The comprehensive EMR is becoming a ubiquitous feature of modern medical practice. EMRs have the potential to reduce the risks of error, improve care coordination, monitor care quality, enable patients to participate more fully in care management, and provide the data needed for research, compliance, and surveillance. Considerable funding has been made available for the development of “health information technology architecture that will support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner” (American Recovery and Reinvestment Act § 9202(a)(1) 2009). Yet even beneficial technologies almost always bring about unintended or unforeseen consequences and, especially in medicine, have the potential to change in fundamental ways the nature of the patient–physician relationship. Technology is always a two-edged sword. In terms of ethics, EMRs can greatly benefit patient care by providing legible, timely, accurate, and comprehensive data, prompts, reminders, alerts to preventable errors, and links to scholarly ethics resources and practice guidelines and policies. EMRs can also act to introduce new harms and interferences into the physician–patient relationship. Excessive attention to data entry and gazing at the computer screen can effectively remove the physician’s attention from a patient, resulting in limited socioemotional and psychosocial engagement [15]. This may be most critical for anesthesiologists and other perioperative health care providers where there is already a limited context for establishing adequate patient–physician/health care provider relationships.
The patient–physician relationship has traditionally been a fiduciary relationship based on trust and confidentiality. The American Medical Association Code of Medical Ethics states that, “The information disclosed to a physician during the course of the patient–physician relationship is confidential to the utmost degree” (American Medical Association Code of Medical Ethics) and this assurance of confidentiality has been seen as necessary for patient’s to be able to safely disclose sensitive personal information essential to the medical evaluation [16]. EMRs potentially multiply the immediate access to a patient’s record and confidences. Aside from unwarranted breaches of medical confidentiality, electronic access to individual patients’ medical records raises a host of ethical questions, including issues of informed consent and a patient’s ability to make autonomous decisions about whether to grant or refuse authorization for the use of their personal health information [80].
Aside from their direct application to patient care, EMRs and the more expansive vision of a National Health Information Network (NHIN) are being utilized to provide patient health data for quality improvement, research, public safety, and public health, as well as payment, advertising and other commercial uses [81]. These secondary uses of health data present numerous issues regarding individual informed consent. For instance, a recent report of the Institute of Medicine (IOM) supports exempting the use of patient data (whether for quality assurance or research) that does not involve actual patient intervention from patient authorization guarantees of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. On the other hand, a Kaiser Family Foundation poll found two-thirds of patients would not want the government to have access to their medical data in efforts to reduce medical errors (QI) if their individual names and addresses were needed [82], although the IOM recognizes poll data indicating a significant percentage of patients would like control of the use of their data in research by means of individual consent [83–85]. These discussions represent an ethical conflict between utilitarian arguments that participation in quality improvement and some forms of noninterventional research is a moral responsibility of patients receiving care and the argument from patient autonomy that restricts the use of data for purposes extrinsic to the trust relationship of patient care. These discussions highlight how new technologies raise new and unanticipated ethical questions while exposing the limitations and conflicts of underlying and often unstated and assumed moral principles that are guiding public policy and individual health care decisions.
A more troubling use of health care data is commercial, including the selling of data for financing regional health IT networks [81]. Such use violates patient trust as it is clearly outside the purpose of the physician–patient relationship. HIPAA requires specific authorization for the disclosure of data for marketing purposes [12].
Do-Not-Attempt-Resuscitation Orders in Perioperative Care
The anesthesiologist is most likely to come into contact with ethical issues involving advance directives when a patient is scheduled for surgery with a “do-not-resuscitate” (DNR, or the preferred and more realistic terminology “do-not-attempt-resuscitation,” DNAR [86]) order on the chart. As many as 15% of patients with DNAR orders will undergo a surgical procedure [87]. Wenger et al. [88] studied a subgroup of the SUPPORT (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatment) database and found that of 745 patients presenting to the operating room, 57 had a DNAR order. Operative procedures ranged in complexity and risk from tracheostomy and vascular access to liver transplantation and coronary artery bypass grafting. Twenty of the 57 patients had their DNAR order reversed preoperatively. Two of these patients suffered an intraoperative cardiac arrest and were resuscitated. Both patients subsequently died postoperatively. Only one patient without DNAR order reversal arrested during surgery and died without attempted resuscitation.
Anesthesiologists and surgeons are generally reluctant to proceed with surgical intervention if they are not allowed to intervene in the dying process. They feel that consent for anesthesia and surgery implies consent for resuscitation and is inconsistent with a DNAR order [89, 90]. Anesthesiologists tend to claim that the induction and maintenance of anesthesia can often involve creating conditions in which resuscitation is required [89]. Indeed, anesthesia itself has at times been referred to as a “controlled resuscitation.” Because anesthetic agents or procedures may create conditions requiring resuscitation, the anesthesiologist ought to have the right to correct those conditions when possible. Surgeons and physicians doing other procedures use similar arguments to claim that if cardiac or pulmonary arrest is a consequence of their actions they should be allowed to prevent or reverse those conditions. In a 1993 survey of anesthesiologists by Clemency and Thompson [90], almost two-thirds of the respondents assumed DNAR suspension in the perioperative period and only half discussed this assumption with the patient/guardian. A more recent survey of 500 consecutive patients in a preoperative evaluation clinic found that over half (57%) of patients agreed that preexisting DNAR requests should be suspended while undergoing a surgical procedure, but 92% believed a discussion with the physician regarding perioperative resuscitation plans should still occur. About 30% of physicians in the survey believed that DNAR orders should automatically be suspended intraoperatively. Anesthesiologists were significantly less likely to suspend DNAR orders (18%) than surgeons (38%) or internists (34%) [91].
This dilemma represents a classic problem in the principled approach to medical ethics: the conflict of two or more prima facie ethical principles. If the physician chooses to act paternalistically to provide what is believed to be the best treatment at the time, he or she is giving precedence to the concept of beneficence over the patient’s autonomy . If, however, the physician acts to preserve patient autonomy, he or she may feel that the duty to do good, as directed by the principle of beneficence, has been compromised. Further complicating the issue is that “DNAR” has multiple definitions and interpretations and involves a spectrum of procedures that the general public is not aware of [92].
Although automatic suspension of DNAR orders during a surgical procedure and for an arbitrary period postoperatively is the most unambiguous and straightforward policy, it is now argued that this is inappropriate [93, 94]. Statements from both the American Society of Anesthesiologists [94], the American College of Surgeons [95], the American Association of Nurse Anesthetists [96], and the Association of perioperative Registered Nurses [97] recognize that this policy effectively removes patients from the decision-making process, even if they are willing to accept the risk of operative mortality, and is inconsistent with the Patient Self-Determination Act of 1992. They recommend instead a policy of “required reconsideration” of the DNAR order, as the patient who undergoes a surgical procedure faces a different risk/benefit ratio. Both statements are, however, ambiguous about just how resuscitation is to be handled in the perioperative period. Two alternatives are presented: (1) to suspend the DNAR order in the perioperative period and (2) to limit resuscitation to certain procedures and techniques. Because of the complexities surrounding the nature of resuscitation, public misconceptions, and lack of awareness of these complexities, and the desire to honor the goals reflected in a patient’s decision to forgo CPR, a third alternative has been proposed involving a values-centered [92] or goal-directed [98] approach. By ascertaining the patient’s goals, values, and preferences rather than individual procedures, the anesthesiologist is given greater flexibility in honoring the objectives of the DNAR order within the clinical context of the arrest. Although seeking to honor both the autonomy of the patient and the physician’s duty to beneficence within the spirit of the original DNAR order, this alternative is not without its problems [99]. The establishment of a physician–patient relationship that will facilitate a full understanding of a patient’s values and goals is a daunting, if not impossible, task for the anesthesiologist confronted with the demands of a limited preoperative encounter. These concerns may be even more profound in the elderly population [100]. Physicians have not been good at predicting the wishes of their patients regarding resuscitation in other situations, even after discussion has taken place [101–103]. It does, however, provide a third alternative and recognizes that, despite its practical limitations and high regard for patient autonomy in our society, there must always exist a degree of physician–patient trust in any clinical encounter.
Anesthesiologists need to be actively involved in their own institutions to develop policies for DNAR orders in the perioperative period. Open communication among the anesthesiologist, surgeon, and patient or family must exist to reach an agreement about DNAR status. Appropriate exceptions to perioperative suspension of a DNAR order should be honored. Timing of reinstitution of DNAR status should also be addressed and agreed upon before the procedure. Actual experience shows that very few times will a patient insist on a DNAR status during the procedure.
Treatment Futility
With respect to informed consent, what if the patient’s decision is counter to the recommendations of the anesthesiologist or amounts to something the anesthesiologist regards as dangerous? Must the physician necessarily do whatever a patient wants? In short, no. In nonemergent circumstances, physicians are not obligated to provide care that they feel is not in their patients’ best interest. “First, do no harm” is the operative principle in these situations. It is important again to distinguish in these cases the negative and positive rights based on or related to the principle of respect for personal autonomy and to recognize that the limits on positive rights may be greater than the limits on negative rights. For example, the positive right to request a particular treatment may be severely limited by appropriate clinical standards of care, physician judgment, or just allocation schemes. Clinicians should, however, be very cautious when making this claim and should only do so if absolutely convinced that no other options are available.
Occasionally, physicians have found it necessary to justify unilaterally deciding that certain medical interventions (such as CPR) are “futile” and withhold these interventions even when a patient or a patient’s family wants them. The notion of medical futility is particularly confusing and open to different interpretations and abuses. “Futility” can be defined in several senses. “Strict sense futility” or “medical” futility is defined when a medical intervention has no demonstrable physiologic benefit, e.g., when there have been no survivors after CPR under the given circumstances in well-designed studies, or in cases of progressive septic or cardiogenic shock despite maximal treatment. There are no obligations for physicians to provide medically futile treatment, even when families want “everything done.” Unilateral decisions to withhold treatment (such as DNAR orders) are appropriate under these circumstances. Usually, a DNAR order may be written on the basis of “futility” when two or more staff physicians concur in writing and give justification for their decision. The patient or surrogate need not agree with the decision but must be notified. If there is disagreement, an ethics consultation may be appropriate and helpful.
It is rare that a given medical intervention is unlikely to have any physiologic effect whatsoever and hence futility may also be defined in a “less strict sense.” In this instance, there may be a low survival rate but the rate is not zero. In this case, although the physician may have the particular expertise to determine whether a particular intervention is reasonable according to a particular standard of reasonableness, setting a particular standard involves a value judgment that goes beyond that expertise. For example, a 79-year-old cancer patient wants CPR in the event that he suffers cardiopulmonary arrest because he believes that any chance that CPR will restore cardiopulmonary function is worthwhile and that any prolongation of his life is also valuable and worthwhile (for instance, by allowing for a family member to return from overseas). Whereas the physician may assess that the chance of CPR restoring function is x%, x is greater than zero and whether the chance of restoring function is reasonable, valuable, or worthwhile only if it is greater than x% depends primarily on the patient’s own values. Unilateral decisions may not be appropriate in this instance, and discussions with the patient and family should be initiated to provide information and advice.
Whereas a physician may have the expertise to assess whether a particular intervention is likely to achieve a specified outcome, determining whether an outcome is an appropriate or valuable objective for a patient is dependent on the patient’s own value judgments. A medical intervention can be futile in a third sense when it will have no reasonable chance to achieve the patient’s goals and objectives. For example, CPR is futile in this sense if there is no reasonable chance that it will achieve the patient’s goal of leaving the hospital and living an independent life. Because medical interventions are futile in relation to the patient’s goals, this sense of futility provides a very limited basis for unilateral decisions to withhold medication interventions that patients want. The American Medical Association Council of Judicial and Ethical Affairs have commented that resuscitative efforts “would be considered futile if they could not be expected to achieve the goals expressed by the informed patient. This definition of futility not only respects the autonomy and value judgments of individual patients but also allows for the professional judgment and guidance of physicians who render care to patients.” [104].
Because the term “futility” tends to communicate a false sense of scientific objectivity and finality and to obscure the inherent evaluative nature of the judgments, physicians should avoid using the term to justify unilateral decisions to withhold life-sustaining treatment. Rather, physicians should explain the specific grounds for concluding that interventions generally, or particular life-sustaining measures, are inappropriate in the given circumstances. Whereas the statement that a given intervention is futile tends to discourage discussion, explaining the grounds for a given judgment in light of the circumstances and with an understanding of the patient’s own values and goals tends to invite discussion and point it in the right direction.
Treatment Redirection and Palliative Care
Jean Paul Sartre said that “the meaning of life is found in death,” and how we deal with the aging process determines how we deal with death and our philosophy of life. This is most important for the physician and patient when faced with end-of-life decision making involving treatment redirection and palliative care options.
Treatment redirection refers to that point in the patient’s care plan when the patient or surrogate, along with the health care team, recognizes the need to move from aggressive curative treatment to supportive palliative care. The 1995 SUPPORT study found that as many as 50% of patients were subjected to burdensome, curative treatment because the patient, family, and physician had not recognized or discussed the realities of the patient’s condition [105]. Potter suggests three barriers to meeting the need for treatment redirection [106]. First, clinicians and patients often are narrowly focused on curative or ameliorative intervention. Lack of communication between the physician, who assumes that “they want everything done,” and the patients and families, who have different expectations, contributes to this problem. Furthermore, patients and their families often assume that physicians have reliable knowledge about what therapies are effective and which are not because of their intense focus on curative treatment. A study by Feinstein and Horwitz [107], however, shows that evidence-based medical decisions can only be claimed for less than 20% of clinical situations.
Second, physicians and patients are often reluctant or unable to discuss palliation as a treatment option [108]. Although evidence suggests that physicians are more willing to withhold or withdraw treatment from seriously ill patients [87], patients and families continue to report that there is a lack of physician communication in the area of shifting treatment to palliative care [109]. Disparity of beliefs and preferences causes much of this communication problem.
Finally, there is a lack of knowledge of and confidence in palliative care by both physicians [110] and society [111]. Part of the problem is that patients are referred to palliative care and hospice programs far too late in their hospital course to do any good. Furthermore, Potter notes that, “although there is a growing trend toward patients wanting to be in control of their own death, cultural diversity factors, belief in the power of medical technology, and a strong tendency to deny death prevent a working consensus about how to approach the experience of dying.” [106]. Patients and their families may also be suspicious that palliative care is a way to save money, a form of rationing, although there is no empirical evidence that palliative care is more cost effective [112].
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