(It Would Be Nice to Have Two Sorts of Boxes a Clinical Box
<h1>CLEO
The patient is the central subject of medical practice. The patient-physician relationship is the central vehicle by which medical practice occurs. The duties and entitlements that arise from the patient-physician relationship, and the organizational background in which the relationshiplives, comprise the MCCQE’s Considerations of the Legal, Ethical, and Organizational aspects of medicine (CLEO) objectives. CLEO relates the social aspects of the medical enterprise that are essential to sound clinical practice, as a physician.
The ethical aspects consider the values and customs, the notions of right and wrong behaviour, that underlie clinical relationships. Three approaches to ethics are dominant. First, consequentialists define actions as right or wrong by the nature of their outcomes. By this account, truth-telling is right insofar as honesty will lead to better outcomes. Second, virtue ethics considers the personal characteristics, i.e.: virtues or vices, underlying the action. Truth-telling is moral because it reflects habits of honesty and respect, virtuous qualities related to human flourishing. Third, the deontological approach defines right or wrong by reference to primary duties that are valuable in and of themselves, regardless of their outcomes: lying is categorically wrong. The deontological tradition, encapsulated in four classic principles of ethical medicine – patient autonomy, beneficence, non-maleficence, and justice – has been particularly influential.
Autonomy refers to the intrinsic power of individuals to guide their own lives. A decision is said to be autonomous, when it is led from within, when it follows from rules or preferences that the individual freely choses and adopts as her or his own. Respect for autonomyis a fundamental duty. Beneficence is the duty to do good. The patient-physician relationship is therapeutic: its purpose is to promote patient welfare. Non-maleficence is the duty not to do harm. Medical interventions come with risks, and unintended consequences. Physicians should be aware of their limits. Finally, justice refers to fairness in a society’s distribution of benefits and burdens, and in the means by which this distribution occurs. Physicians are to respect patient autonomy, and to pursue patient well-being, in a just fashion cognizant of their limits.
In certain situations, principles, whether they express a deontological, consequentialist, or virtue ethics perspective, may conflict and be resolved in different ways. The ethical aspects of clinical practice vary from situation to situation, and are topics of discussion and controversy.
Where social consensus is achieved regarding right and wrong behavior, ethical principles find their way into Canada’s formal system of rules. These are the legal aspects of clinical medicine. Some of these rules are statutes enacted by legislatures. On issues unaddressed in statute, the demands of the law may be determined from previous cases, i.e.: precedents created by a coherent body of judicial rulings in a common-law jurisdiction; or by invoking and applying the general principles laid out in aCivil Code, as occurs in a civil law jurisdiction. Most of Canada is common-law, except for Quebec, which observes a civil law legal system. Principles of law referred to in this chapter will be rooted in common law. In many instances, common and civil law formulations of physician duties and patient rights will be substantially similar, although subtleties of law and vocabulary will certainly differ.
The law recognizes the patient as a person with human and other legal rights, including the right to security of person and inviolability, and the right to freedom from discrimination. These rights are formulated at a constitutional level, in the CanadaCharter of Rights and Freedoms. As well, both common and civil law recognize a fundamental right to self-determination in judicial precedent and in the Civil Code of Quebec, respectively. Rights are trumps that can normally be expected to take precedence over other considerations. However, rights may be legitimately limited for an essential social good, and this is recognized at all levels of law.
The physician-patient relationship can be characterized in light of these ethical and legal values. It is a trust relationship, in that the physician is an agent acting on behalf of a vulnerable patient to whom she or he must be exactingly loyal. The physician must always place the best interests of the patient first. It is also a trust relationship in that the patient is entitled to have faith in the relationship’s integrity. Physicians must follow throughon undertakings made to patients, must not exploit the relationship for personal advantage, and must maintain and respect professional boundaries at all times. Physicians are obliged to provide for continuous and accessible care, and never to abandon their patients. These basic duties arise from the ethical and legal understanding of the patient-physician relationship, and are only terminated when care has been transferred, or after adequate notice has been given to allow the patient to make alternative arrangements. The patient-physician relationship is the central fixture in the practice of medicine. It pervades medicine’s legal, ethical, and organizational aspects.
<h1> Consent
Box 1: Consent – MCCQE Essentials
Consent
... is required, ethically, by respect for patient autonomy, and legally, by the patient’s common-law right to self-determination and by statute, where applicable.
… refers to specific interventions performed at particular times and places by certain personnel.
… requires disclosure, voluntarism, and capacity.
… is required whenever treatment or diagnostic options are recommended
–Disclosure
–What a reasonable person in the patient's circumstances would want to know.
–Usually includes
–nature of the intervention
–gravity of the patient's situation and of intervention
–material risks and benefits, including special or unusual risks
–alternatives and consequences of non-consent
–information regarding delegation of care
–Patient questions must be addressed.
–The treating physician must ensure patient understanding.
–Voluntarism
–minimize coercive influences, or influences that interfere with decision making
–e.g.: provide adequate pain control.
–Capacity
–A process standard of capacity applies: Is the patient able to understand and appreciate information? The consequences and alternatives to action or non-action?
–Capacity is specific for each decision.
–Capacity (does not equal) global cognitive status.
–Capacity may fluctuate.
–The patient should be allowed to direct treatment as much as possible.
–Refusal to consent (does not equal) incapacity.
–Minors and mentally disabled patients raise special issues for capacity.
–If the patient is not competent, consent may be obtained from a court, parent, or substitute decision-maker, according to provincial law and specific circumstances.
The patient has the right to refuse consent, even when this may lead to death. Consent may be withdrawn at any time without prejudice on the level of clinical care provided.
Consent is the autonomous authorization of a medical intervention, by individual patients. Valid consent – or refusal to consent – requires that a capable patient make a voluntary decision regarding a referable procedure or treatment, in light of a physician’s disclosure of information. Physicians are duty-bound to seek consent before any treatments or procedures. The treating physician is ultimately responsible for ensuring consent.
<h2> Ethical and Legal Basis
Self-determination is a fundamental right. An individual's physical state conditions their ability to pursue various life-projects, their perceptions, and their relations with the world around them. Control over one’s body is fundamental to determining the direction of one’s own life. This is recognized in common law, under which physicians find themselves liable for battery if they treat a patient without consent, or for negligence, if they treat a patient under inadequately formed consent and patient harm occurs as a result. Certain provinces have gone a step further and have legislated consent. Ontario's Health Care Consent Act, for example, “provides rules with respect to consent to treatment that apply consistently in all circumstances” (Health Care Consent Act, 1996).
Physician colleges also recognize a professional duty to seek consent. Failure to adequately uphold these norms could lead to professional disciplinary action, including suspension or loss of licence.
<h2> Disclosure
Meaningful decision-making requires that individuals are privy to information relevant to their circumstances. Only then can the decision be attributed to their authentic preferences, as opposed to some bias or inadequacy in the information on which the decision is based.
In Reibl v. Hughes, the court decided that disclosure should include whatever a reasonable person in the patient's circumstances would want to know to be adequate. This is an modified-objective standard that strikes a balance between objectivity and subjectivity in determining adequate disclosure on a case-by-case basis. An alternative standard could read: what the patient would have wanted to know. However, this alternative, being entirely subjective, is impossible to evaluate fairly. In the modified-objective standard, the reference to a reasonable person, a hypothetical legal construct, allows courts to infer the content of an adequate disclosure independent of the patient's whims, while remaining responsive to particular circumstances.
Supreme Court Chief Justice Laskin's formulation of the general content of an adequate disclosure in Hopp v. Lepp is instructive:
“... a surgeon, generally, should answer any specific questions posed by the patient as to the risks involved and should, without being questioned, disclose to him the nature of the proposed operation, its gravity, any material risks and any special or unusual risks ... However, having said that, it should be added that the scope of the duty of disclosure and whether or not it has been breached are matters which must be decided in relation to the circumstances of each particular case.”
Information should be presented in broad terms and simple language. Translation services should be sought to address linguistic barriers. Information should account for extra-medical (e.g.: social and financial) circumstances. And the treating physician should check for patient understanding.
<h2> Voluntarism
Voluntarism refers to freedom from coercion, so that a patient’s authentic sense of what is good, right, and best can guide the patient’s medical decisions. Is the patient free to act “in character”, in accordance with those values and interests formed and congealed throughout the patient’s life?
In the clinic, voluntarism can be thought of as freedom from external influences that interfere with decision making. These include: pain, a rushed environment, local resource scarcity, physical restraints, and coercive family dynamics. Medical staff should facilitate a voluntary decision by providing pain control; creating calm and supportive settings for discussing major decisions; ensuring that local resource scarcity does not restrict the patient's range of options, including arranging for patient transfer, as needed; using restraints only as necessary, and using the least restrictive modalities; and checking in with the patient regarding the role of the family, moderating a family conference, if needed. Hospital ethicists should be consulted for difficult cases.
<h2> Capacity
Capacity refers to the ability to consent or refuse consent to medical treatment. According to the OntarioHealth Care Consent Act, the capable patient is “able to understand the information that is relevant to making a decision”; and “able to appreciate the reasonably foreseeable consequences of a decision or lack of decision”.
There is no one-size-fits all or easy way of assessing capacity. Capacity does not refer to global cognitive or affective status, as assessed, for example, by the Folstein mini-mental state examination (MMSE), although bad MMSE performance may lead a physician to suspect the patient’s capacity. Capacity is specific. It refers to a patient’s ability to make a particular decision. A patient incapable of making one decision is not necessarily incapable with respect to another. Capacity is also dynamic. It changes with time and circumstance. Therefore, capacity should be assessed and re-assessed regularly, and for different sorts of decisions. Out of respect for autonomy, patients should direct their own care to the extent that they are capable. Where the stakes resting on a capacity determination are substantial, a formal assessment by psychiatrist and/or an ethicist consultation should be sought.
Capacity can be affected by many factors, including disease, drug-use, and depression. Reversible factors should be addressed, and important decisions delayed until capacity is restored, if possible.
Capacity goes beyond simple understanding: to appreciate one's circumstances, the patient must be able to recognize that she or he has a condition to which the treatment and its consequences might apply. This is not to say that the patient must characterize her or his condition as pathological, or as necessitating treatment. To presume this would be tantamount to saying that a patient is capable if she or he agrees with the medical opinion. Non-consent does not constitute evidence of incapacity, and medical staff must be open to idiosyncratic perceptions of health and wellness.
<h2> Exceptions to consent
When a patient presents in an urgent care setting, efforts should be undertaken to facilitate consent (e.g.: find a translator if the patient is capable, or locate a substitute decision maker for an incapable patient). This might not be feasible in emergencies, where a delay could lead to significant bodily harm. In such situations, it would be better to err on the side of physical integrity: treatment should occur without delay. However, this should occur only where there is no reason to believe that the patient would refuse treatment if she or he were capable.
Provincial public health statutes require compulsory diagnostic testing or treatment in suspected cases of certain infections. Mental health statutes may also provide for admission to hospital without consent, in certain instances. These vary from province to province. Legislation may also require that a substitute decision maker consent to diagnostic or therapeutic interventions, after admission.
<h1> The incapable patient
A patient may be unable to understand the medical problem, the proposed treatment, alternatives, or consequences of consent/non-consent. The patient may be unable to appreciate her or his situation, i.e.: unable to recognize that she or he has a condition to which this information applies. She or he may be unable to make a decision that is not substantially based on delusion or depression. This patient is incapable.
Figure 1: Consent algorithm for incapable patient
Caption:
Note 1: Unequivocal evidence of a patient preference, even in the event of a life-threatening emergency, must nonetheless guide decision-making.
Note 2: This flow chart is arranged hierarchically – thus, a valid personal directive must be obeyed, even in the face of objections from potential substitute decision makers.
Note 3: Substitute decision makers are duty-bound to act on what the patient would have wanted, if she or he were competent. If the patient was never previously competent to make health care decisions, substitutes are duty-bound to act in the patient's best interests.
Note 4: Applicable statutes include child welfare statutes (e.g.: Alberta's Child, Youth, and Family Protection and Enhancement Act), mental health statutes, and statutes concerning dependent adults.
<h2> Ethical and legal considerations
When patients are incapable, their decision-making – or lack thereof – may subject them to undue harm. Moreover, decisions made in these states cannot meaningfully be said to be rooted in the values and beliefs that comprise a consistent self-identity. That is to say, decision making is no longer autonomous.
Patients' illnesses should not deprive them of the right to live a full and complete life in light of their own values. To ensure that their preferences continue to guide their care during illness, physicians rely on personal directives, and on substitute decision makers duty-bound to consider what the patient would have wanted if she or he were capable. The right to control one's own body continues, even during a period of incapacity, even during a life-threatening emergency.
(Sidebar – A valid personal directive written by or on behalf of a previously capable individual must be obeyed.)
For some incapable patients, such as young children or patients who have had lifelong severe mental handicap, it is difficult to speak of a coherent set of care-guiding principles that reflects the authentic preferences of a core self. Respect for patient autonomy must be balanced against beneficence. Such a patient should be involved in decision making, to the extent that maturity or disability permits, out of respect for nascent capacity and/or a burgeoning sense of selfhood. However, consent should be sought from the patient’s guardian or an appropriate SDM, who is obliged to act in the patient's best interests. Here, the patient's circumstances privilege considerations of beneficence. Young children, lifelong severe mental handicap, and genuine uncertainty about a patient's preferences are examples of when the best interests standard should apply.
<h2> Age and capacity
Age does not necessarily correlate with capacity. Under the common law doctrine of the mature minor, minors are to be treated as adults.They are presumed capable, unless a specific assessment reveals incapacity. In extending the notion of capacity to encompass minors, their autonomy is privileged: The preferences of a capable minor must be respected.
For most minors, decision making will integrate medical opinion, patient preferences, and the family's preferences in varying degrees depending on the family's dynamics. It is therefore preferable to facilitate a therapeutic alliance inclusive of both the patient and her or his family. However, in the extreme case that this is not possible, the doctrine of the mature minor privileges the autonomy of a capable patient, age notwithstanding.