Page 160 - Hall et al (2015) Principles of Critical Care-McGraw-Hill

126 PART 1: An Overview of the Approach to and Organization of Critical Care

critical care context has been noted. Today, “European intensive care legal authority. This element of consent may be especially problematic in
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physicians [as well as physicians in other parts of the globe] are well critical care and is discussed in the next section.
aware that the decisions made in end-of-life situations, or in other cases A note of caution regarding the legal value of written consent forms
when recovery of essential vital functions is not possible, are governed must be added here. Contrary to popular belief, a written consent form
by different laws in different countries.” 2 is not the equivalent of legally effective informed consent. True informed
Because critical care is evolving rapidly throughout the world, the consent is the process of mutual communication, negotiation, and
contributions of the respective legal systems, positive and negative, to ultimate patient or surrogate choice as described earlier. The written
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health care and society are difficult to pin down precisely. It is clear, form is only tangible documentation or evidence that the communi-
though, that legal concerns become less dominating and intrusive, and cation and negotiation process occurred. This evidence may be very
more likely to be supplanted by ethical considerations, when critical care important to the physician in defending against a lawsuit claiming that
teams initiate and continue sensitive, consistent, and honest communi- medical intervention was inflicted in the absence of informed consent,
cation with their patients and significant others. by creating a legal presumption that consent was properly obtained.
However, when inadequate communication actually took place, the
INFORMED CONSENT AND REFUSAL presumption created by the consent form may be successfully rebutted
or overcome by the plaintiff.
The established legal doctrine of informed consent (more properly, While broad blanket consent forms used in many hospitals are suf-
informed decision making) is based on the ethical principles of autonomy ficient to authorize routine, noninvasive medical interventions, more
(personal self-determination) and beneficence (doing good for the specifically tailored and informative forms are preferable for interven-
patient). Early lawsuits growing out of medical interventions conducted tions that are nonroutine or invasive. Certainly, specifically detailed
in the absence of any semblance of consent were predicated on a battery written consent forms are necessary for interventions that might be
theory (the wrong of touching the patient without permission). Most characterized as investigational or innovative.
modern legal cases, however, are framed as negligence actions, in which Application of these general principles is somewhat complicated in
the alleged unintentional wrong is the physician’s violation of the fiduciary critical care by the fact that in the intensive care unit (ICU), interven-
or trust duty to serve the patient’s best interests by informing the patient tions can be nearly continuous for the most unstable patients. Informed
adequately as part of the testing and treatment authorization process. consent is required any time the physician proposes doing anything
In order to be considered legally effective, consent to medical treat- to a patient (ie, any medical intervention). For quasi-continuous
ment must meet three tests (in the absence of a valid exception such as interventions, informed consent must be obtained at the initiation of
an unforeseeable emergency). the intervention, and the patient or surrogate must be afforded the
opportunity to withdraw that consent at any later point.
• Voluntariness Most interventions in critical care may be categorized as risky or
• Information invasive, that is, an intervention involving a higher degree of risk or
• Decisional capacity intrusion for the patient than he or she would ordinarily face in nor-
mal, everyday life. However, this categorization is relevant only to the
First, consent must be voluntary—that is, not coerced or based on the question of the extent of advisable documentation; the requirement of
exercise of undue influence, in nature. In a patient and family-centered a meaningful informed consent process itself applies regardless of an
model of critical care delivery, the patient (or surrogate decision maker) intervention’s level of risk or invasiveness.
must retain the ultimate power to accept or reject the available medical
interventions.
Second, consent must be adequately informed or knowing. About half DECISIONAL CAPACITY AND SURROGATE
of the jurisdictions within the United States still enforce a physician-ori- DECISION MAKING
ented standard of information disclosure, inquiring whether the amount Minor children (defined by the states for medical purposes as those indi-
of information shared by the physician with the patient or surrogate was viduals younger than 18 years old) are presumed legally to be incapable
consistent with the usual practice of other prudent physicians in simi- of making their own medical decisions. In the absence of an exception
lar circumstances. By comparison, the remaining states have adopted based on the minor’s “emancipated” or “mature” status, the natural
a more patient-oriented standard, requiring physicians to disclose all parent or court-appointed guardian/conservator is legally empowered
the information that a reasonable patient would want to know under to act as the medical decision maker. In sharp contrast, adults are pre-
the circumstances. This latter approach is also termed the materiality sumed legally to be decisionally capable to act on their own behalf. In
standard, because it mandates the disclosure of information that would critical care, some patients remain capable of making and expressing
be material—that is, information that might affect the decision-making medical choices, or at least participating in the decision-making process
calculus—of a reasonable patient. to some extent (with or without the assistance of family or friends),
Under either a physician- or patient-oriented approach, several par- based on a rational thought process of digesting and weighing informa-
ticular kinds of information need to be disclosed in understandable tion about the benefits and risks of different alternatives. Many critical
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lay language (rather than using medical jargon). These informational care patients, though, are so ill and debilitated that they lack sufficient
items include
present decisional capacity.
• Nature of the patient’s medical problem Although in theory the same degree of mental capacity is neces-
• Prognosis with and without the intervention sary whether the patient is accepting or declining the recommended
medical intervention, in practice, a formal inquiry into patient capacity
• Nature of the suggested intervention usually occurs only in the case of patient refusal. Ideally, a judgment
• Likely benefits from the intervention about patient decisional capacity, which may fluctuate widely over time
• Reasonable alternatives because of a variety of natural and iatrogenic factors, is being made at
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• Foreseeable risks or side effects of the suggested intervention and the least implicitly by the attending physician each time the patient is seen.
various alternatives Such an inquiry ought to be built automatically into every physician-
• The probable financial ramifications of the medical decision patient encounter. When decisional capacity is questioned seriously,
a more focused examination needs to be conducted. In especially
Third, informed consent is sufficient only when given by an individ- ambiguous cases, documentation in the patient’s medical record by con-
ual with adequate mental (both cognitive and emotional) capacity and sultants who have evaluated the patient’s decisional capacity is prudent

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