Experts discuss the process of assessing decision-making capacity in patients with cancer.
ABSTRACT: Patients with cancer face many difficult decisions and encounter many clinical situations that undermine decisional capacity. For this reason, assessing decision-making capacity should be thought of at every medical encounter. The culmination of variable disease trajectories, following patients to the end of life, use of high-risk treatments, and other weighty personal decisions require attention to patients’ ability to engage in decisions. Oncologists develop meaningful relationships with their patients. This familiarity may lead to forgoing the process of diligently assessing a patient’s cognitive ability and/or decisional capacity when important decisions need to be made. While the process may feel like it takes place spontaneously, many subtle and overt details are involved with the decisions around cancer care that require pointed questioning and probing. Thus, there are many ways to fall short in determining decisional capacity. Clinicians are inconsistent in their decisional capacity determinations and generally assume more decisional capacity than the patient has. Consult and referral services such as ethics and psychiatry can help with treatment decisions and with assessing underlying psychosocial and psychiatric conditions. Decisional capacity may fluctuate and requires a variable amount of decisional ability depending on the clinical situation; hence, it is time-specific and decision-specific. This review is intended to provide a summary of key components of decisional capacity while highlighting areas in need of clinical refinement.
Alici is the clinical director, psychiatry service, Memorial Sloan Kettering Cancer Center, New York, NY.
Blackler is program manager & clinical ethics consultant, Ethics Committee at Memorial Sloan Kettering Cancer Center, New York, NY.
Chin is a psychiatrist, Memorial Sloan Kettering Cancer Center, New York, NY.
Hlubocky is a clinical health psychologist, section of Hematology/Oncology, Department of Medicine, University of Chicago, Chicago, IL.
Saracino is a clinical psychologist at Memorial Sloan Kettering Cancer Center in New York, NY.
Voigt is on the Ethics Committee, Memorial Sloan Kettering Cancer Center, New York, NY and is a member of the Department of Anesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Center, New York, NY and the Department of Anesthesiology, Weill Cornell Medical College.
Decisional capacity assessment should be an integral part of routine clinical care with patients, and it is especially important in oncology settings.1 Cancer care is dynamic. It involves the coordination of multiple teams of clinicians whose decisions affect patients, families, and communities.2 While some decisions in oncology may seem straightforward or procedural, others are clearly more complicated or entail higher risk for patients. Each of these clinical decisions requires the consent of a patient who is able to engage in reviewing multiple potential options with their clinicians; assessing and weighing complicated
information as it becomes available; and deciding for themselves based on life experience, values, and an idiosyncratic approach to novelty. In other words, the context of a clinical decision for patients is often much more complex than the actual decision the patient is being asked to make. There is a temptation to simplify decisions to their clinical parts and apply the “reasonable person” standard to all patients. This approach is inherently flawed and will lead to inadvertently compromised clinical care. Therefore, clinicians should be curious about decisional capacity during all clinical encounters in which patient engagement is required. An assessment could vary from minimal (no questions) to formal, depending on the situation; the latter requires specific documentation.
Unfortunately, the assessment of patients’ decision-making abilities is not routinely taught in a methodological way throughout medical training and into practice.3 Many patients with cancer face periods of cognitive impairment or compromise due to a multiplicity of risk factors and medical situations.4 The ability to think clearly and consistently can be compromised by polypharmacy, metabolic disturbances, infection, high rates of brain metastasis (especially nearing the end of life), sleep dysregulation, emotional distress, and other premorbid conditions that may impair decisional capacity.5 A review of psychiatric consultations for decisional capacity among hospitalized patients with cancer found that refusal of treatment was the most common reason for consult requests.6 Also, patients with personality disorders tended to retain decisional capacity, while patients with delirium and dementia did not, and decisional capacity of patients with mood disorders was more variable.6
An approach to patients that integrates the assessment of decisional capacity should be the cornerstone of personalized medicine, because clinicians are able to align care in accordance with a patient’s ability to validate their choices. Ultimately, responsible care in which physicians consider a patient’s ability to make decisions that are consistent with their values leads to a more coordinated practice that honors patients as autonomous partners in a truly therapeutic alliance.
Decisional capacity is often thought of as a prerequisite for consent to treatment, but it actually pervades all aspects of medical care and should be an inherent aspect of clinician–patient interactions. At the very least, decisional capacity is required for the provision of informed consent.
The idea of informed consent originates from a series of ethically charged medical cases from the mid-1950s through the 1970s, after which the American Medical Association published, in 1981, an official policy on informed consent.7 Informed consent was preceded by an era of “simple consent,” in which the doctor was presumed to know what was best for the patient; the role of the patient was to either accept or refuse the expert recommendation provided by the physician, not to evaluate the necessary elements of a medical decision. The goal of simple consent was to protect patients from “battery” (unwanted touching, usually surgical) in the spirit of self-determination regarding a procedure, but not necessarily to protect patient autonomy. It was not uncommon for physicians to deceive patients in an effort to protect them, and to do “what’s best” for the patient. A disclosure about what was to be done to the patient (eg, a procedure) along with a nod from the patient was all that was needed for simple consent in accordance with accepted medical practice. There was no need to assess the patient’s ability to engage in the decision-making process because the physician determined what was best for the patient and all the patient had to do was agree or disagree.8
The legal evolution of informed consent began with patients being allowed to determine what would happen to their bodies regardless of understanding (Schloendorff v Society of New York Hospital, 1914) and eventually evolved into a right to understand the medical decision affecting them.7 In this famous case, Justice Benjamin Cardozo stated, “Every human being of adult years and sound mind has a right to determine what shall be done with his own body, and a surgeon who performs an operation without his patient’s consent commits an assault.”7 Patients’ rights for informed decision-making and consent were brought forth in 1957 by a court proclamation that “physicians have a duty to disclose any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment” (Salgo v Leland Stanford Jr University Board of Trustees). While “intelligent” or informed consent is now the standard of care, courts deferred to the medical professional standards at that time to decide how much information was necessary for informed consent. Therefore, the level of understanding required for informed consent was not universal or quantified, and it relied on professional responsibility alone to determine patients’ ability to make decisions.
In oncology, significant and life-altering decisions require a sophisticated level of intelligent, informed consent. A demonstration of adequate decisional capacity often becomes more difficult for patients as diseases progress. Cognitive processing may become slowed because of medications, biochemical changes, or the emotional weight of cancer. These factors and significant relationship strains impair the patient’s ability to process information, placing a greater pressure on clinicians to appropriately assess decisional capacity.9 An overestimation of decisional capacity is common, but this can be disastrous for some patients and undermine the care of others.10
A man with metastatic lung cancer, aged 57 years, has undergone 3 lines of therapy over the last 2 years with partial but long durations of response. He has no other significant medical comorbidities but has a significant history of depression that was reported on initial evaluation. He has remained on sertraline at the same dose over the last couple of years. You are not sure whether he’s seen a psychiatrist since he received the lung cancer diagnosis. His lung cancer has progressed, and a recent biopsy has revealed a potentially actionable mutation. He is in good condition physically despite progression of disease. He may be eligible for an early-stage clinical trial targeting this mutation that requires a heavy patient commitment (eg, 12-hour days for pharmacokinetic data, frequent follow-up, and substantial adverse effect burden). The patient asks only simple logistic questions about the trial when you review it with him, but he agrees to participate because you feel it is the next best treatment. In reviewing even some of the basic information with him, he is unable to recall significant details, but he seems to “get it” once prompted. He is clearly more withdrawn than he has been in the past, but you attribute this to learning about the latest progression of disease. Upon reviewing his history, it becomes even more apparent that his cognitive ability is compromised. While his demeanor had always been somewhat reserved and hesitant, at this meeting he also lacked his usual conversational tempo. You were also surprised by his inability to recall basic facts of the trial because this was not consistent with his usual presentation.
This scenario presents the oncologist with a difficult situation, especially when it involves a patient they may have known for some time and for whom they feel an experimental treatment holds promise. The patient’s newly advancing disease may be presenting in the central nervous system; a clinical depression may be resurfacing, causing pseudodementia; or he may just be distracted given his clinical situation. The oncologist should begin with an assessment of decision-making capacity, determining whether appropriate referrals and testing are necessary before deciding to move on with trial participation (Table).16, 29
Table. Evaluation of 4 Core Dimensions of Decisional Capacity(16,29)
The ability to make competent treatment decisions is generally organized around 4 commonly used medico-legal standards: (1) ability to understand information relevant to the treatment decision; (2) ability to appreciate the relevance of the decision; (3) ability to reason/describe the information about the risks and benefits of the decision in light of individual goals and values; and (4) ability to express a consistent choice.11
Understanding. The patient should demonstrate the ability to communicate the primary facts of the situation. The patient demonstrates that they know the purpose and meaning of the information that has been provided. Several different aspects of the decisional landscape must be probed to ensure that key components of the decision are understood by the patient. It is also imperative that the evaluator has a clear understanding of the actual medical decision so that the patient’s understanding of their medical condition can be adequately examined. Understanding might include the purpose of the proposed intervention (eg, diagnostic or therapeutic), the rationale for the intervention, typically hoped-for benefits, the most important risks and their likelihood of occurrence, the alternatives to the proposed intervention (including doing nothing at all), and the associated benefits and risks of each alternative. The assessment must also vet a patient’s discernment of courses of action that are not options due to safety, logistics, or limitations of science. A patient’s ability to communicate does not need to be ideal, but an understanding of the essential facts relevant to the situation should be demonstrated.
In severely symptomatic or life-limiting illness, as may be the case for cancer, the patient may be unhappy with the options available. Sometimes patients would persist in choosing a cure with return to a prediagnosis state of health when that option is not available. In this case, the patient may perseverate between toxic treatment or a comfort-focused plan and fail to “make a decision” because neither option is desirable. This failure to “choose” may not indicate an impaired decisional capacity. Simply put, a decision is not required if there are no options and only a single course of action is possible. Reframing the situation from one requiring a decision to one requiring acknowledgment may allow resolution of the impasse.
The assessment of understanding may begin with disclosing information to the patient and assessing their ability to repeat it. Memory and the ability to retain information is a prerequisite to a patient’s ability to understand. Patients need to retain information long enough to provide a consistent, stable setting for effective implementation of the chosen option. Memory or cognitive impairment does not necessarily preclude decisional capacity. Understanding precedes the ability to demonstrate appreciation of the information; therefore, understanding needs to be assessed prior to gauging appreciation.
Appreciation. The patient should be able to apply the known facts to their own life situation, such that the personal implications of the choice are clear. A lack of an ability to appreciate how facts of the situation are relevant to the patient may stem from impaired insight or delusional beliefs; for example, a patient might not believe that the diagnosis of cancer is correct. While the ability to demonstrate appreciation will vary from patient to patient based on education and health literacy, the patient simply needs to demonstrate how the information is relevant to their medical needs. After asking for an explanation of what the patient has absorbed, the clinician may follow up with, “What do you think about what I’ve told you? Can you tell me what it means for your situation?”
Impaired ability to appreciate the decision may stem from a thought disorder that is psychiatric in nature, such as a fixed belief or psychotic thinking that is out of touch with reality. This may stem from one of several psychiatric conditions (eg, bipolar disorder, serious major depression with psychotic thinking, delusional disorder, paranoia); however, the presence of such a condition, in less severe form or when treated, may not impair a patient’s ability to appreciate the decision. More commonly, patients without a psychiatric disorder exhibit a narrowed “field of vision” that may be a distortion of their own values (ie, premorbid values and beliefs). Perversion of values or thoughts can be difficult to ascertain. For example, a depressed patient who is not psychotic may display a rigid pessimism and not be able to “see” other options. Similarly, a patient’s acceptance of death may be a manifestation of their own choosing or influenced by underlying depressive symptoms. At the same time, some patients simply lack insight into their own situation, which may be due to a reason or condition such as underlying cognitive impairment, brain injury, stroke, seizure, etc.
A gentle, nonthreatening approach to probing appreciation is paramount because patients often do not want to disclose beliefs or thoughts that they may know will be perceived as odd or controversial. A confidential, trusting environment that communicates the desire to provide patients with purposeful care is helpful in obtaining their cooperation and openness.
Reasoning. The patient should be able to compare options and infer consequences of each choice (ie, consequential reasoning). Reasoning may draw on a patient’s core values and beliefs, which should be demonstrated in a conversation and be consistent with what is known about the patient. A careful and curious interviewer will elicit elements of ability to reason throughout an interview. Reasoning ability can be simply probed by the question, “Can you tell me why you are refusing/asking for treatment X?” At the same time, an attempt should be made to understand whether the choice is consistent with the patient’s known values and/or historical choices, ie, “Why is this choice better than that choice?”
Clinicians should be attentive to cultural or religious bias in assessing reasoning. They must be both deliberate in their efforts to appraise patients’ reasoning objectively (eg, uncovering personal biases that disfavor certain styles of thought expression) and nimble in accepting some degree of relativism. Patients may hold to convictions regarding the use of blood products, end-of-life care, or other medical interventions that may seem unreasonable to the examiners or other individuals who do not share the patient’s cultural context. However, cultural determinants of reasoning are not immutable and are often imbued with “mosaicism.”
Expressing a choice. The patient should be capable of clearly communicating a choice when presented with multiple treatment options. A frequent change in choice may indicate a lack of decisional capacity; therefore, it may be helpful to ask the patient to communicate a choice more than once during an interview: “Now that we have talked about your condition and the recommended treatment, what would you like to do?” A communication of choice frequently leads to the clinical questioning of decisional capacity. Thus, attempting to gain an understanding of the choice enhances rapport and can lead to an assessment of the patient’s understanding, appreciation, and reasoning around the decision.
Each of these areas needs to be assessed and to form a convincingly integrated whole that is woven into the understanding of the decision at hand. The clinician should consider the level of scrutiny or threshold of determination that must be used when investigating each of these 4 components. An in-depth investigation of 1 or more of these components may be required, depending on the specific situation, to call into question the patient’s decisional capacity. That is, clinical interventions that involve high risk for minimal benefit require substantially more ability to manipulate the information beyond a basic understanding, so a higher threshold for reaching decisional capacity is needed. Clinical interventions that carry little risk for a large clinical benefit require a less nuanced or sophisticated level of understanding, and a lower threshold for decisional capacity may be sufficient. This risk/benefit approach can be used to guide the frequency and rigor of decisional capacity determinations (Figure).29 This is referred to as a “sliding scale” approach to decisional capacity assessments. This approach is ethically appropriate because an incapacitated patient cannot exercise autonomy, so it is the clinician’s fiduciary responsibility to ensure that the best interest or reasonable person standards or the ethical principle of beneficence is followed. Health care institutions also have a fiduciary responsibility to patients to care for them in a way that prioritizes their interests.
Figure. Threshold Determination(29)
In an effort to respect a patient’s dignity and autonomy, the assessment should identify the proximal cause of decisional incapacity. Potential interventions (eg, decreasing sedation, treating infection) and prognosis for restoring decisional capacity should also be listed if appropriate. Likewise, the potential for fluctuation in capacity, eg, delirium or evolving sepsis, should be documented.
Decisional capacity should be assessed for each significant clinical decision. That is, one determination of decisional incapacity does not extend to all other diagnostic or therapeutic interventions because the knowledge or understanding that needs to be demonstrated is unique for each clinical decision.
Decisional capacity should be documented and form part of the patient record. A licensed clinician (eg, physician or nurse practitioner) providing medical care can legally perform a determination of decisional capacity, but acceptable surrogate decision makers vary across jurisdictions.12 Decisional capacity assessments are best when made and documented by the clinicians who will perform the procedure or treatment. For most decisions, medical considerations are best addressed by clinicians who are experts in the proposed interventions. Psychiatrists and bioethicists are frequently called upon to help make determinations regarding decisional capacity. Ethicists can speak to the underlying ethical principles and their applicability to a particular decision. Psychiatrists and mental health clinicians are experts in mental status evaluations and can assist in capacity assessments when psychiatric symptoms that may interfere with decisional capacity are present. In some jurisdictions, assessment by a psychiatric practitioner is required when severe mental illness, such as schizophrenia, is present. In the current case scenario, a referral to psychiatry may be appropriate especially if the patient has a significant clinical history of depression requiring ongoing psychiatric care (eg, hospitalizations, suicide attempts, etc).
The most common reasons for lack of decisional capacity are cognitive impairment and altered mental status. Any illness or treatment that compromises cognition may be associated with reduced decisional capacity. The likelihood of diminished capacity is related to the severity of the cognitive impairment, although brief measures of overall cognition such as the Mini-Cog or the Mini Mental Status Examination (MMSE) are not substitutes for an assessment of capacity.13 High scores on these instruments are not always correlated with intact capacity to make decisions, although decisional incapacity does increase in patients with lower MMSE scores (eg, dementia).14 The presence of illness associated with cognitive impairment, or of a thought disorder such as dementia or schizophrenia, is insufficient for the determination of decisional capacity or incapacity and should not substitute for an assessment of capacity that is explicitly documented.15 Decision-making incapacity due to cognitive impairment is not static, as cognition may be impaired by reversible factors such as fleeting delirium or medications. Mitigation of these factors may restore a patient’s decision-making capacity.
The groups with the highest risk for decisional incapacity are patients with neurodegenerative diseases, of which dementia is the most common.16 Psychiatric disorders that affect thought content and processing such as psychotic disorders (eg, schizophrenia), severe depression, bipolar episodes, or substance-abuse disorders also increase risk of decisional incapacity, but they do not necessarily compromise decisional capacity. Disease severity and domain of dysfunction are important corollaries of impaired capacity. Patients with psychosis may retain capacity for some decisions if there is overall minor executive dysfunction.17 Finally, patients with a history of traumatic brain injury, cognitive developmental delay, or protracted hospitalization, as well as those approaching the end of life, are all at elevated risk of decisional incapacity.18
Patients with cancer who receive surgery, radiation, and systemic therapies will experience physical, mental, psychological, and neuropsychological adversity. Therefore, decisional capacity variability and fluctuation are common and should be assessed routinely. Decisional capacity should certainly be reassessed with changes in clinical status and as new decision points arise. In general, hospitalized patients more commonly exhibit decisional incapacity due to their increased risk factors for limited decisional ability and cognitive impairment.10 Similarly, patients with primary or secondary central nervous system involvement demonstrate a 25% to 50% rate of decisional incapacity.19 At the same time, patients who might be assumed to lack decisional capacity may demonstrate surprisingly high rates of insight and ability to discriminate among various choices.20 Performance status (eg, Karnofsky or ECOG) is not helpful, as many patients with an elevated Karnofsky performance score of 90 to 100 do not demonstrate decisional capacity; conversely, decisional capacity may be variable with a lower score.21 Neuropsychological testing in patients with advanced cancer may not be informative due to lack of significant correlations between specific domains of neuropsychological dysfunction and decision-making incapacity.22 While neuropsychological dysfunction lessens decisional capacity, the mechanism is more or less global, rather than affecting domain-specific abilities. In one study, about one-third of patients with advanced cancer had decisional incapacity that was associated with impaired verbal ability and cognitive function, but not with depression or anxiety.23
Cancer often affects an aging population; independent of their disease, patients may demonstrate differences in decisional style.24 Elderly patients may prefer to agree with treating clinicians, but they are also at higher risk for cognitive impairment. Therefore, formal screening tools, such as the MacArthur Competency Tool for Treatment, informal interview techniques, and clear ideas of when to assess for decisional capacity, are all important.25 While age is a consideration, biological age does not always follow chronologic age linearly. The nuances and complexities of determining decisional capacity for elderly patients with cancer may warrant an evaluation by geriatric, psychiatric, or ethics consultants, especially when the risk/benefit ratio of the proposed intervention is high.26
The prevalence of decisional incapacity is much higher than the rate at which consult services (eg, psychiatry and ethics) are called to provide a formal assessment. A rate of decisional incapacity in the hospital has been reported in 25% to 35% of inpatients, yet only 0.2% to 0.4% of admissions prompted a decisional capacity consultation.27,28 Of those consultations, half the patients were found to not have decisional capacity. The rest of the time, clinical decisions are made either tacitly or more conscientiously by busy clinicians.
There are 4 clinical scenarios that should regularly trigger decisional capacity assessments by either the treating clinical team or consultation services: (1) an abrupt change in mental status or cognitive ability, which may be secondary to infection, hypoxia, metabolic disturbances, or an acute neurologic or psychiatric process; (2) refusal of recommended treatments, especially when unwilling to discuss the refusal or when the basis of refusal seems illogical or inconsistent with the patient’s history; (3) consent to invasive or high-risk treatments without careful consideration by the patient of the risks, benefits, and alternatives; and (4) risk factors for limited or fluctuating decisional capacity, eg, neurologic diseases, chronic psychiatric conditions, limited health literacy, or barriers due to language or culture.29
These formal scenarios certainly require attention to decisional capacity, but impairment can occur unpredictably in many situations. Therefore, every clinical encounter should include a minimum assessment of decisional capacity, especially in ongoing cancer treatment during which the risks of therapeutic misestimation and treatment-related toxicity can be substantive (eg, first-in-human studies).30,31 Impairment in cognitive ability and its influence on decisional capacity can be subtle and requires a high degree of suspicion to detect.32 In patients with cancer, especially patients undergoing treatments, cognitive ability should be assessed regularly.
Cognitive assessment is not akin to a determination of decisional capacity. These 2 exercises have different goals. However, they often go hand-in-hand because cognitive impairment is frequently the underlying cause of decisional incapacity. Also, understanding a patient’s cognitive status or ability helps the clinician personalize decision-making questions according to the patient’s cognitive level. A complete Mental Status Exam (MSE) assesses multiple domains of neuropsychiatric functioning, including appearance, behavior, mood, affect, thought content, thought process, cognition, insight, and judgment. Each domain includes many components; for example, the examination of thought process may include logic, abstraction, and practical judgment. MSE can be used in addition to the 4 components of capacity to understand a patient’s underlying cognitive capacity, which may fluctuate in very ill patients.
Cognitive assessment involves formal and specific questioning that exercises specific domains of thought processing. Cognitive examination tools vary in the emphasis placed on each domain, resulting in different characteristics. The Folstein MSE has high sensitivity but low specificity, and the Montreal Cognitive Assessment demonstrates higher specificity and lower sensitivity.33 These tools are insufficient for diagnosis of cognitive disorders, but they can precede more formal neuropsychological testing that can require several hours.34 An assessment of cognitive ability should formally test specific cognitive skills such as attention, abstraction, orientation, and reasoning, while a decisional capacity interview should be tailored to the specific decision of concern.
Decisional capacity is distinct from competency, which is a judicial determination that is binding; it is neither decision specific nor temporal.35 On the other hand, decisional capacity assessments are time and decision specific. Each situation is unique and combines patient factors with clinical factors. Every opportunity should be afforded to the patient to participate in their treatment, which means that causes for decisional incapacity should be identified, prognosticated, and mitigated to the extent possible. A capacity determination should include probability of either regaining decisional capacity or the tenuousness of the patient’s decisional capacity.
While a clear yes-or-no outcome of an evaluation of decisional capacity is desirable, for some patients this may not be possible. Decisional capacity presents a spectrum in which a patient may retain decisional capacity for some less-weighty decisions, eg, dietary restrictions or refusal of blood work, yet lack decisional capacity for more substantial decisions, eg, code status or enrollment into a clinical trial. The situation may be more complex when the capacity to refuse a procedure is different from the capacity to consent to the same procedure. Careful consideration will reveal that consenting to a life-preserving procedure, such as initiating hemodialysis, is distinct from refusing that same procedure, and that the capacity to consent to a procedure may not imply that the capacity to refuse the same procedure is also intact. The gravity of the consequences of refusing versus consenting—eg, death—may warrant a much higher level of scrutiny of the decision to refuse. The patient must demonstrate higher levels of understanding, appreciation, and reasoning that may lead to the conclusion that while the patient retains the ability to consent, the patient lacks the decisional capacity to refuse. In practice, this is illustrated by the relative lack of ethics or psychiatric consult requests when patients consent to procedures compared with when patients refuse.
In many cases, the patient cannot demonstrate sufficient levels of understanding, appreciation, and reasoning to conclude that their decisional capacity is intact, yet the patient may be able to express a preference. Therefore, patients should still be included in clinical decisions to the extent possible given the medical situation. Consideration of the patient’s preferences by surrogate decision makers may be important in obtaining the patient’s assent.
Assent is a bridge between simple consent and informed consent. Assent is a conceptthat is frequently used in pediatric populations; it occurs when a patient who is too young to provide informed consent agrees to and cooperates with a procedure. Informed consent is obtained from a parent. The same principle may be used with patients who have impaired decisional capacity but have identified surrogate decision makers. In most cases, agreement and cooperation, or assent, by the patient is required for safe and effective performance of procedures. Careful consideration should be given in situations where assent from the patient is not expected, especially when there is no humane way to compel adherence to the procedure. If a patient is legally incompetent, clinicians can attempt to pursue assent, but they should recognize that beneficence is the prima facie rationale for decision-making, particularly in emergent situations.
If incapacity is determined, a surrogate decision maker should be identified and enlisted to make the decision on the patient’s behalf. Ideally, the patient would have already selected an agent through a health care proxy, power of attorney, living will, or advance directive. If a health care agent or power of attorney has not been previously identified, is unavailable, or is unable or unwilling to decide, the clinician must locate a reasonable surrogate to act on behalf of the patient. While a patient may lack decisional capacity to consent, the patient may possess decisional capacity to select a surrogate or may express a preference for a surrogate. Therefore, the patient should be asked about surrogate decision makers, especially if circumstances of decisional incapacity can be foreseen.
If the patient is not able or refuses to select a surrogate decision maker, then a reasonable surrogate must be sought. Usually the order of reasonable surrogates starts with spouse and then extends to other immediate family and other interested parties, even friends in some instances, depending on the municipality, state, or country. In most jurisdictions, a formal application to a court for a determination of incompetency and assignment of a guardian to act on the patient’s behalf is required. This can be a lengthy process, and many urgent clinical decisions compete with the protracted time required for a court-appointed guardian. In such instances, other mechanisms may be available for surrogate decision-making. In some circumstances, ethics committees, patient advisory committees, or health care providers are permitted to make time-sensitive decisions on behalf of a patient who lacks both decisional capacity and a surrogate decision maker. Again, this process varies by jurisdiction, and consultation with knowledgeable legal counsel may be helpful in clarifying the local approach. To avoid delays in care due to lengthy court processes, every measure should be undertaken to identify suitable surrogates in advance and to ensure that appropriate documents are completed and easily retrievable in the medical record. Communication with any potential surrogate should be very deliberate, and clinical information should not be shared until all parties are in agreement that the surrogate has been chosen and is willing to use the responsibility.
A patient’s autonomy and right to self-determination should be the first consideration. Therefore, decisions made by surrogates must be guided by the standard of substituted judgment.36 In other words, surrogates should be asked to make a decision based on what the patient would have wanted under the circumstances. Surrogates should be coached to use the patient’s wishes and values based on the surrogate’s knowledge of the patient’s previous actions and statements, or on other experiences with the patient. If the patient lacks decisional capacity but can state a preference, the surrogate must consider the patient’s preferences in making the decision.
If the surrogate is not able to opine on the wishes or values of the patient, the decision should be based on what any reasonable person would select under the circumstances. The best-interest standard does not necessarily reflect the wishes or values of the individual and is therefore a less preferred standard for surrogate decision-making.
Patients are entitled to know the outcomes of decisional capacity determinations that apply to them. This information should be provided by the primary or consultant clinicians. However, treating clinicians can decide whether and/or when disclosing that information would be detrimental to the patient (eg, risk of agitation and treatment disruption). Management of a patient who objects to the findings should be respectful and commensurate with the patient’s level of understanding to the extent possible. Considerations may be made for the necessity of the intervention (postponement), reason for decisional incapacity (eg, reversibility), and goals of care. Recruitment of and communication with individuals who are close to the patient are essential. Despite decisional incapacity, treating clinicians should continue to identify and treat underlying causes of decisional incapacity and offer comfort and support, as the patient may be undergoing a procedure or intervention that they do not understand.
Treating clinicians should exercise a low threshold for escalating any clinical situation that may jeopardize a patient’s autonomy to their relatives and friends, the ethics committee, hospital administration, and/or legal counsel. The process of soliciting outside, objective evaluation ensures that various perspectives are sought, considered, and utilized to guide a potentially contentious treatment decision, to protect the patient’s welfare, and to shield clinicians and health care organizations against potential conflicts of interests.
Close and deliberate follow-up is a necessary part of managing a patient’s decisional incapacity (and capacity), especially given clinical factors that influence the reversibility or tenuousness of the determination. Clinicians should resist the temptation to use a single interview (eg, a consult) or point in time as a template for future care because decisional capacity fluctuates and needs to be determined for all decisions where patient engagement and cooperation are appropriate.
The need for decisional capacity determinations is inevitable when treating patients with cancer. From genomic investigations to choosing among2 or more diagnostic or treatment options, clinical decisions in oncology are complex. Cancer and its treatments impact many aspects of patients’ lives and mingle with premorbid factors that may compromise decisional capacity. Patients with cancer may be willing to try risky interventions out of desperation. Decisional capacity must be integrated into all patient encounters and with each clinical decision. Clinicians generally overestimate patients’ abilities to make decisions, and they should avoid assumptions about patients’ understanding, appreciation, and reasoning. Ultimately, to preserve the patient’s autonomy, it is essential to ensure that the patient’s decisions are properly and appropriately informed, particularly when they seem aligned with their physicians’ recommendations.
Daniel C. McFarland, DO
Department of Psychiatry and Behavioral Sciences
New York, NY 10034
Conflict of Interests: We have reviewed and approved the manuscript as it is submitted and have no conflict of interest to declare. Additionally, each author met each of the authorship requirements as stated in the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. We had multiple roles in writing the manuscript including the conception, design, acquisition, analysis and interpretation of the data.
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