The Joint Commission requires that hospitals develop and implement a process to handle ethical issues in patient care but does not specify how this should be done. It may be done by an ethics consultant, an ethics committee, or on an ad hoc basis. Ethics committees consist of physicians, social workers, attorneys, theologians, and others representative of the immediate community that the hospital serves. Ideally, the committee should be intellectually rich with devoted members capable of ethics mediation. Importantly, the authority of ethics committees is limited to an advisory body that seeks to achieve a consensus through mediation. Recent surveys have demonstrated that ethics committees consult on a range of issues across the life cycle helping patients, families, and staff grapples with challenging questions that require expert assistance.
The Ethics Committee at New York Presbyterian
Weill Cornell Medical Center typically conducts 150 to 200 consults a year. In a recent year, 62% pertained to end-of-life care issues, 40% related to family conflict, and the remainder was evenly distributed across treatment refusals, comorbid medical and psychiatric issues, pediatrics, geriatrics, and team conflict requiring mediation. Since the initiation of the service in 1994, case volume, acuity, and complexity has risen with a clear ICU predominance of 57% in 2008.
Informed Consent and Refusal
Informed consent is the ethical lynchpin of modern medical ethics in which the dialogue between the patient and physician preserves the patient's voice in directing care. This doctrine is rooted in respect for persons and the promotion of autonomy and patient self-determination through an interpersonal process whereby physicians and patients interact with each other in order to select an appropriate course of medical care, with the patient critically assessing his or her own values and preferences (Table 33-1).
Table 33-1 Decision-Making Capacity and Competence ||Download (.pdf)
Table 33-1 Decision-Making Capacity and Competence
- Ability to communicate a choice
- Understand the nature and consequences of the choice
- Manipulate rationally the information necessary to make the choice
- Reason consistently with previously expressed values and goals
Once a patient has made a choice, consent must be maintained over time to remain the moral warrant for permission to infringe upon the patient's zone of privacy. Patients who provide consent retain the ability to revise that decision and withdraw it.
Indications for Ethics Consultation
- Advance directive
- Brain death
- Capacity/informed consent
- Isolated incapacitated patient
- Maternal/fetal conflict
- Medical error
- Pain management
- Refusal of recommended treatment
- Research ethics
- Resource allocation
- Surrogate decision making
- Transplant issues
- Truth telling
- Withdrawal of ventilator
- Withdrawal of other life sustaining therapy
- Withdrawal or withholding artificial nutrition and hydration
- Withholding of other life-sustaining therapy
- Patient or family in denial
- Physician attitude toward treatment
- Quality of life
Data from Nilson EG, Acres CA, Tamerin NG and Fins JJ. Clinical Ethics and the Quality Initiative: A pilot study for the empirical evaluation of ethics case consultation. Am J Med Qual. 2008;23(5):356–364.
- Decision-making capacity is not a global assessment of cognitive ability or intelligence, or knowledge of serial sevens, but rather a discrete capability of understanding the consequences of specific choices offered and made. Determining decision-making capacity is a clinical judgment that is distinct from the juridical judgment of competence. Moreover, for a patient to be competent legally as dictated by law, he or she must possess both decision-making capacity and be of age or an emancipated minor.
While informed consent imposes responsibilities on both the patient and the hospitalist, it creates an opportunity to build a trusting doctor-patient relationship. A properly executed informed consent is founded upon mutual respect, good communication, and results in a shared agreement about the course of medical care. A relationship forged through the informed consent process can facilitate realistic patient expectations and help prevent disputes. Barriers to the informed consent process include:
Poor care coordination. Mixed communication, or even contradictory information to the patient and/or family, may cause confusion undermining care decisions.
Fragmentation of care. Lack of clarity about one's overall condition may also encumber the patient's ability to make informed choices.
Adaptation to the new set of potentially limited choices imposed on the patient by hospitalization and progressive illness. This displacement of the locus of control, outside of the patient's prior sphere of autonomous decision making, requires both the patience and compassion of the hospitalist in order to help the patient understand how his experience of hospitalization might influence his response to illness.
The all too common refrain, “I consented the patient,” mistakenly prizes outcome (agreement to a proposed procedure) over process (a clear and informed decision whether that choice resulted in the acceptance or refusal of a treatment). The importance of the informed consent process is the act of deliberation in making a sound medical choice (Table 33-2).
Table 33-2 Informed Consent and Refusal ||Download (.pdf)
Table 33-2 Informed Consent and Refusal
- Informed consent is a patient right.
- Not all patients retain this right, predicated on the ability to be self-determining, which requires capacity.
- Patients must have decision-making capacity to participate in informed consent.
- Informed consent is neither the recitation of facts by the physician nor the placement of a signature on a document. Instead, informed consent is the provision of information to a capacitated patient or surrogate decision maker necessary to make a medical choice either to accept or refuse a medical intervention. For this process to have integrity there must be adequate disclosure in clear language of the nature and purpose of the contemplated procedure and associated risks and benefits. The decision need be noncoerced and voluntary and the patient or surrogate must be apprised of any alternatives to the proposed intervention, if there is one available.
Concern about patient decision-making capacity typically occurs with refusal rather than with agreement of a proposed therapy. The treatment refusal may be equated with a loss of decision-making capacity because the decision challenges the doctor's expert recommendation. Under the rubric of self-determination, patients retain the right to refuse treatments and physicians have a orollary obligation to be sure that the patient understands the consequences of that choice. Mere refusal by itself does not mean a patient lacks capacity for decision making.
The philosopher James Drane developed a capacity assessment tool to assist in the assessment of patient choices. Invoking a “sliding scale of competence,” Drane sought to link the increasing gravity of a patient's decision with a progressive degree of explication. If a patient were to refuse life-sustaining therapy, he would have to more fully demonstrate his reasons, rationale, and appreciation of the consequences than if he were refusing an elective procedure. The level of decision-making capacity should be in accordance with the risks and benefits of the decision to be made. These reasons can be founded on personal, religious, or cultural beliefs. The stringency of the standard of capacity at each level is correlated with the dangerousness of the treatment decision. Refusal of care by a capacitated patient who is well informed needs to be respected, even if that refusal would lead to serious harm. This is ethically supported by the principle of autonomy and legally by the patient's right to privacy and dominion over one's self.
Every effort should be made to discern the patient's rationale for refusal of recommended treatment and counter any misinformation with appropriate facts. Ethics consultation may help resolve ethical issues when treatment refusals are made by a surrogate on behalf of an incapacitated patient.
Truth Telling and Sharing Bad News
In our pluralistic society, some patients may prefer nondisclosure of medical information. In traditional Japanese culture, withholding of medical information is the norm founded upon ishin denshin, the Japanese term for the nonverbal communication of the truth. Many Islamic societies operate with less doctor-patient dialogue and a greater reliance on cultural and contextual clues in order to implicitly, versus explicitly, communicate information to the patient. In such contexts of overt nondisclosure, patients eventually deduce their status because they observe the nature of their treatments and the reactions of those around them (Table 33-3).
Table 33-3 Truth Telling ||Download (.pdf)
Table 33-3 Truth Telling
Truth telling and sharing bad news
- The physician is under an obligation to communicate specific information to the patient necessary for making informed and deliberate choices.
- While there is no precise metric to determine what patients need to know to make choices, most physicians adhere to a “reasonable person” standard with the provision of that amount of information that an “average” person would need to have to make a choice.
- Full medical disclosure is the norm for most Western people.
Part of the art in doctor-patient communication is titrating generic advice to the particular patient's willingness to know and use information. The burdens and benefits of “truth telling” and breaking bad news are weighed against the information necessary to make an informed treatment choice.
Approach the patient by stating that in this country standard practice requires sharing all medical information with the patient, unless he decides to delegate the dialogue and the implicit authority to make choices using that information to a surrogate as the health care agent.
Therapeutic Exception or Privilege
On that rare occasion when the risks associated with disclosure outweigh the benefits, practitioners can deliberately withhold information in contravention of the patient's self-determination and right to know. Typically, such a deviation from standard practice, referred to as “therapeutic exception” or “privilege,” would involve a severely depressed patient who might become suicidal with grievous news. We recommend that a psychiatrist assess such cases and that the local ethics committee be involved in the deliberative process.
Seventy percent of seriously ill patients are unable to decide treatment options at the end of life. The majority of these patients do not have advance directives at the time of hospitalization. By taking on discussions at the onset of care, practitioners can establish a doctor-patient/family relationship and mitigate many ethical dilemmas that could ensue should the patient deteriorate.
Advance directives allow the patient the opportunity to specify preferences in advance of incapacity through a living will and/or designate a surrogate to speak on his behalf through the identification of a “durable power of attorney” or “health care agent” or “proxy.” With an advance directive, an incapacitated patient can be treated in accordance with his prior wishes. Such advance care planning can decrease speculation about what the patient would have wanted and decrease the moral angst associated with the proxy role, a burden that is often understated (Table 33-4).
Table 33-4 Standards for Surrogate Decision Making ||Download (.pdf)
Table 33-4 Standards for Surrogate Decision Making
- First and foremost, adhere to the explicit wishes of the patient.
- If unknown, determine what decision the patient probably would have made based on the patient's values, beliefs, and past decisions as interpreted by the surrogate.
- When neither knowledge of expressed wishes nor inference of substituted wishes exists, make a best-interests judgment based on what a generic patient would want in a given circumstance.
When there is no surrogate (a health care agent) appointed by the patient or a guardian appointed by a court, ethical norms and the law assign standing to these surrogates:
The patient's spouse (and in many jurisdictions to domestic partners)
Thereafter, a relative such as an adult child, parent, sibling
Finally, a close friend
Each state may have its own hierarchy for this prioritization. We recommend the use of a health care agent over a living will, when there is a surrogate who the patient trusts. In the living will, an adult with capacity sets forth directions regarding medical interventions and other actions that should or should not be taken in specific circumstances if he becomes incapacitated in the future. Often ambiguous and difficult to interpret, this document may contain inherent contradictions and fail to anticipate possible scenarios. In contrast, embodying surrogacy in a designated surrogate—versus a document as in the case of living will—allows for more dynamic decision making and provides an individual who can interpret the patient's prior wishes in light of evolving circumstances and the patient-proxy covenant.
All 50 states recognize an advance directive as an extension of the patient's voice under the Patient Self-Determination Act (PSDA) of 1990, which requires health care institutions that participate in Medicare and Medicaid programs to ask patients whether they have an advance directive, inform patients of their right to complete an advance directive, and incorporate advance directives into the medical record.
Surrogates make decisions for incapacitated patients according to three distinct decision-making standards: patients' expressed wishes, substituted judgments, and best interests. When invoking substituted judgment, the surrogate places herself in the shoes of the patient and tries to make a decision as the patient would. When neither knowledge of expressed wishes nor inference of substituted wishes exist, the surrogate makes a decision based on what a reasonable person would make balancing benefits and burdens.
Even when surrogates consider the patient's values, the stress of the surrogate role coupled with family dynamics and imprecise prior patient wishes can lead to morally ambiguous situations. Conflicts can also arise between surrogates of equal standing, such as two sisters who cannot agree on their mother's care. A rigid hierarchical approach to surrogate decision making oversimplifies a process that is complex, dynamic, and personal. When two surrogates disagree, ask them to set aside their own preferences and articulate what each believes is in the patient's best interest. This minimizes potential conflicts of interest and may lead to a concordance of views. When this approach fails, hospitalists may give ethical—if not legal—precedence to that surrogate who has been assuming more of the care responsibilities.
Sometimes the conflict about goals of care arises from an incongruity between a written directive and an oral one. Given the objective reality of documentation, deference will more likely be given to a previous written rather than verbal directive, even if more contemporaneous verbal preferences emerge—which ethically would take precedence. Hence, all practitioners should clearly document, in the medical record, any and all articulations of preference on the part of the patient. The discharge summary should include documentation of advance care planning as a guide to future care.
Ethics Consultation at the End of Life
Establishing clear goals of care and having a working awareness of the inherent conflicts and biases that may arise at life's end can help prevent conflict and enhance patient care at a time when comfort and tranquility are at a premium. Decisions to accept or refuse life-sustaining therapy are all predicated upon the aforementioned principle of self-determination as exercised through a process of informed consent or refusal. Clinicians need to distinguish responsibility and culpability when considering their role in helping patients die comfortably.
Withholding Life-Sustaining Therapy: Do Not Resuscitate Orders
Causality is least complex in cases where a decision is made to withhold life-sustaining therapy (LST). By withholding LST, we mean a decision to not institute an intervention that could prevent death or prolong a dying process. The prototypic example of withholding LST is a do-not-resuscitate (DNR) order, which, in the hospital setting, means the forgoing of cardiopulmonary resuscitation (CPR) or basic cardiac life support (BCLS) as well as advanced cardiac life support (ACLS) to patients who have sustained a cardiopulmonary arrest. When a patient, health care agent, or other surrogate consents to a DNR order, an intervention will not interrupt the natural course of events. In such cases, the cause of death is clearly the underlying disease process.
Unlike other treatments to withhold CPR requires consent, based on the emergency presumption of providing care if consent cannot be obtained. Traditionally, physicians are obligated to perform CPR unless there is a contrarian request for a DNR order, which constitutes an informed refusal.
Essentially, all patients who undergo cardiopulmonary arrest will receive CPR unless the patient or their surrogate consents to a DNR order. When a patient or surrogate provides consent, the order should be clearly placed into the medical record and the medical and nursing teams informed in a standard manner. The patient's DNR status should travel with the patient when he or she goes off the floor and be readily available for consultation should an event occur. A DNR order should be reviewed periodically and may be reversed by the patient at any time and by the surrogate decision maker if the decision does not undermine a patient's decision while capacitated.
Seventy percent to 80% of deaths occur with DNR orders in place for hospitalized dying patients. In the modern hospital, DNR orders take many forms, ensconcing the patient's negative right to be left alone. Despite the prevalence and resonance of a dying patient with DNR orders on a general medical ward, it is important to appreciate that DNR orders do not preclude other treatments or interventions. It solely applies to decisions about cardiopulmonary arrest. Ethically, patients with DNR orders may receive care in the intensive care unit (ICU) or in the operating room. DNR status should be honored across specialties and not impede access to appropriate palliative care if it can only be offered through an intensive care or operative intervention. Indeed, some assert that it is patently unethical to condition appropriate care upon the presence or absence of a DNR order.
In practice, institutions vary in their triage of patients with a DNR order regarding ICU or surgical care or other interventions requiring intubation such as endoscopy. The Task Force of the American College of Critical Care Medicine and the Society of Critical Care Medicine argues against ICU admissions, for example, noting that: “ICU admissions should be reserved for patients with reversible medical conditions who have a ‘reasonable prospect of substantial recovery’.”
Significant variation may relate to how to precisely identify patients who have a “reasonable prospect of substantial recovery.” Moreover, if allocation or scarce resources (eg, ICU beds) or cost containment motivates triage decisions, adherence for individual clinicians creates ethical conflicts because of their primary fiduciary obligation to the patient. Existing data suggests that the presence of a DNR order at the time of MICU consultation was significantly associated with the decision to refuse a patient to the MICU.
Because any arrest during surgery could be considered reversible, secondary to the procedure, physicians, patients, and/or surrogates should discuss DNR status prior to surgery. We echo the recommendation of the American College of Surgeons for a process of “required reconsideration” of the preexisting DNR order as part of the informed consent process for surgery. If the patient or surrogate rescinds the DNR order perioperatively, a decision is made to reinstitute it upon arrival in the recovery room or at a specified time interval after surgery.
If the patient, or surrogate, wants to maintain a DNR status during the procedure, this must be documented in the preoperative consent. If the patient dies in the OR, it is considered an “expected death” under the rubric that DNR situations result in the patient's demise. In some institutions the physicians may find honoring an intraoperative DNR order to be against their conscience. In these cases there should be a provision of conscientious objection and removal from the case, so long as the primary physician responsibility of nonabandonment is not breached.
Both decisions to treat patients with a DNR order to the ICU or in the surgical suite ultimately hinges on achieving clarity about the goals of care. In each care decision, there is a conflict between a negative right to be left alone (the DNR order not to resuscitate) and the positive right to needed care. This balance of negative and positive engagement makes sense when the goals cohere, such as in the example of a palliative colostomy for an obstructing colon cancer. In that case, the surgical diversion is meant to provide comfort to a dying patient who had a DNR order, an ethically balanced plan of care.
In summary, the choice to forgo cardiopulmonary resuscitation supports the patients' right to refuse medical care even if this refusal leads to death. Notably, surrogate decision makers make up close to 80% of DNR requests. Hospitalists and primary care physicians are encouraged to initiate DNR discussion with the patient or proxy as soon as possible, preferably not when patients are immediately faced with cardiopulmonary cessation and imminent death.
The Do-Not-Intubate (DNI) Conundrum
Do-Not-Intubate (DNI) or partial DNR orders compromise the integrity of practitioners because they imply resuscitation without intubation as a medically efficacious intervention despite the marginal effectiveness of comprehensive cardiopulmonary resuscitation itself. Most patients who have asystole or a ventricular tachyarrhythmia requiring cardioversion and/or chest compressions will also need intubation. Restoration of a viable cardiac rhythm places clinicians in the untenable position of being unable to fully complete resuscitation efforts.
In our experience, a DNI decision suggests ambivalence about goals of care, ie, a desire to survive without remaining on a ventilator for a protracted period of time. We recommend that these patients be fully resuscitated and also complete an advance directive that would allow a withdrawal of the ventilator if they were to linger beyond an aforementioned time limit.
Some patients or their surrogates would choose to be DNR but desire intubation in nonarrest situations in order to “pull through an illness.” This might occur in the management of a COPD exacerbation, acute congestive heart failure, or pneumonia. Analogous to patients who are DNR in the OR, such patients want to be palliated (as per the aforementioned, diverting colostomy for obstructive colon cancer) or treated for potentially reversible conditions (sepsis) while setting limits on resuscitation should they deteriorate and sustain a cardiac arrest or complete respiratory failure. Intubation of patients with DNR orders might be regarded as a time trial.
Withdrawing Life-Sustaining Therapy
Accepted as a norm, dating from the blue-ribbon President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, there is no ethical distinction between withholding and withdrawing treatment. The statement that the removal of LST device causes a patient to die, especially if the death is closely related temporally, is a misconstrual of causality. Withdrawal of LST simply removes an impediment to death. The intent is freedom from interventions that are perceived as burdensome. Death after refusal or withdrawal of an intervention results from the underlying disease. A decision to withdraw life-sustaining therapies may be challenging due to:
- Transference and counter transference often embedded in end-of-life decisions
- Physicians reluctance due to a misconstrued view that there is an ethical, and certainly psychological, difference between withholding and withdrawal of LST
- A sense of failure or sense of culpability
- Uncertainty about prognostication
- Inadequate communication with patients and/or surrogates about goals of care
- Differences between how physicians and lay people view these decisions
State and federal law regulate who is entitled to authorize the plan when the patient cannot speak for himself regarding a decision to withdraw LST. In the wake of the U.S. Supreme Court decision in the Cruzan case and the federalism of the aforementioned Patient Self-Determination Act, each state can set an evidentiary standard about the amount of evidence from the patient's prior wishes or values, if known, would be necessary to grant authority to a surrogate or physician to withdraw the intervention. Although the Supreme Court in Cruzan observed that there is no difference between the withdrawal of artificial nutrition and hydration and the withdrawal of a ventilator, some religious traditions view the provision of food and water as normative obligations that require a higher degree of foreknowledge of the patient's wishes.
Medical Devices at Life's End
When automated implanted cardioverter defibrillators (AICDs) and permanent pacemakers (PPMs) only provide stand-by interventions, we view deactivation of their resuscitative role as withholding of care. In contrast, when a patient is paced continuously with a permanent pacemaker, either in a PPM or as a function of the AICD, deactivation is defined as a withdrawal of LST. Deactivation decisions should adhere to evidentiary decision-making standards as consistent with applicable state law, and ethics consultation may provide expert guidance. In our view, consider disabling the AICD and/or the episodic functions of the PPM when a patient or surrogate consents to a DNR, given the similarity between internal and external defibrillation.
Relief of Suffering and Palliative Sedation
Suffering is defined as an existential threat to the self and distinct from pain. Palliative sedation is defined as the use of specific sedative medications to relieve intolerable pain and suffering from refractory symptoms, even at the risk of death. Palliative sedation aims to control symptoms rather than to end life; archaic, misleading terminology such as “terminal sedation” should be avoided. Palliative sedation provides different levels:
Ordinary sedation (for relief of heightened anxiety or stress without reduction of consciousness)
Proportionate sedation (for reduction of patient's awareness of distressing symptoms with the minimum dose necessary to promote the patient's ability to engage with his family and his immediate environment)
Palliative sedation to unconsciousness (when less extreme measures have not relieved suffering)
The initiation of palliative sedation to unconsciousness often invokes ethical dilemmas due to confusion about physician-assisted suicide or euthanasia. The doctrine of double effect, originating from Catholic theology, refers to the doctrine where a physician uses a treatment, or gives a medication, for an intended effect where the potential outcome is good (eg, relief of a symptom), knowing that there could be an undesired secondary effect (such as death). Double effect distinguishes between the ethically mandated goal of treating intolerable patient suffering from hastening death by engaging in physician-assisted suicide or euthanasia. In all circumstances, the degree of sedation must be proportional to the severity of suffering and is given only after the process of informed consent has ensued with the patient and or surrogate.
Broadly defined, medical futility can be broken down into several domains:
- Physiologic futility (when it is absolutely—or to a reasonable degree of medical certainty—impossible to achieve a physiologic effect such as CPR in the setting of persistent acidosis)
- Qualitative futility (when the patient's physiology may improve, but there is no patient-centered benefit)
- Quantitative futility (when the intervention has not worked in similar patients within an accepted confidence interval)
Disagreement about the effectiveness of ongoing care may evoke strong emotions on the part of patients, families, and physicians entrusted to provide care. Multiple prior admissions when the patient “pulled through” despite negative odds, many clinicians with disparate views about aggressiveness of care at the end of life, communication failures, and cultural differences all contribute to a family's view of the patient's overall condition, prognosis, and how they would want him to spend the end of his life. It is important to try and prevent these disputes through ongoing communication during the course of the illness, to be reflective about the implicit force of one's countertransference and avoid mixed messages from different physicians by ensuring coherent comanagement.
- Comanagement of patients by a hospitalist and a specialist, whether medical or surgical, requires both parties to see the patient in the hospital. If the primary specialist is out of the hospital, care must be transferred to the inpatient doctor just as a primary care physician transfers care to the inpatient doctor. The primary specialist should not be dictating management from afar.
The best way to overcome fragmentation is to have a meeting including all key clinicians involved (physicians, social work, nursing, etc), significant others designated by the patient, and family members. The aim of the discussion is to create a comprehensive factual understanding of patient's condition and prognosis. Then, after achieving a broad understanding of the medical facts, a fruitful discussion regarding both family and clinician expectations can ensue over the course of multiple meetings.
Ultimately, the imperative for members of the health care team rests on exploring the intricacy of their patient's history and values and appreciate that many surrogates may be reluctant to immediately accept a physician's prediction of medical futility. In these circumstances it is helpful to ask the surrogate to make judgments believed to be in the patient's best interest and to articulate goals of care. On many occasions a surrogate may desire something that is unachievable through the provision of care. Having the surrogate articulate these goals provides an opportunity for reality testing and an occasion to redirect a beneficent impulse, so long as practitioners appreciate why they are so potentially distressed by family demands for futile care.