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Until the 1950s, physicians routinely obtained assent, the general agreement of the patient to have a procedure. A mid-century, society-wide rights reorientation brought about a new interpretation of individual liberties and autonomy.[1] The 1957 legal case of Salgo v Trustees of Leland Stanford Hospital codified the modern concept of informed consent. The judge clarified the difference between informed consent and assent by declaring, "A physician violates his duty to his patient and subjects himself to liability if he withholds any facts which are necessary to form [the] basis of an intelligent consent by the patient to a proposed treatment ... ."[2]
Informed consent is the cornerstone of the patient-physician relationship. The idea of informed consent is rooted in the ethical principle of respect for patients' autonomy, which asserts that patients have a right to self-determination. The goal of informed consent is to
Decision-making capacity is defined as the ability to make a particular decision at a specific time. Evidence of decision-making capacity includes the ability to understand medical problems, proposed treatments, alternatives, options to refuse treatment, foreseeable consequences of accepting or refusing proposed treatments, and express a preference based on rational, internally consistent reasoning. Decision-making capacity is distinct from the legal concept of competency. Courts determine competency and often make a global determination of competency, declaring that a person is either competent or incompetent for all matters. Adults are presumed to be legally competent unless declared otherwise by a court. However, anesthesiologists are responsible for assessing decision-making capacity, and anesthesiologists make this determination only for specific situations.
Anesthesiologists should permit patients to make decisions to the extent of their abilities.[5] For most patients, there are no questions about decision-making capacity, but anesthesiologists need to actively evaluate the decision-making capacity for patients whose decision-making capacity has been temporarily altered, who do not have legal decision-making authority, or who have preexisting limitations in decision-making capacity. Consider the patient who has received pain medication before giving informed consent. The level of impairment varies depending on the medication, the tolerance of the patient to the medication, and the decision to be made. Some patients may have improved decision-making capacity when pain is decreased. To determine if a patient has decision-making capacity for a specific decision, anesthesiologists need to balance the medication given, its expected effects, and the ability of the patient to show evidence of rational reasoning and understanding. When a patient has temporarily lost decision-making capacity, such as when the patient is anesthetized, anesthesiologists should not implement nonemergent care until after the patient regains decision-making capacity and gives consent. However, in emergencies, such as the need to implement more extensive monitoring, the anesthesiologist should proceed without obtaining informed consent, based on justification as used in emergency situations.
Physicians should perform procedures only on competent patients who participate willingly. Anesthesiologists compromise voluntariness through manipulation and coercion. Manipulation involves the deliberate distortion or omission of information in an attempt to persuade the patient to accept a treatment, such as downplaying or omitting information to influence a patient to make a specific decision. Coercion involves the use of a credible threat to ensure complicity.
Anesthesiologists also hinder voluntariness when they physicially restrain or sedate patients who have sufficient decision-making capacity. Competent patients have the legal and moral right to refuse treatment even in life-threatening emergency situations. It is often hard for physicians to accept that a patient wishes to make what the physician perceives to be a foolish decision. The case of Shine v Vega exhibits the complexity of these situations.[6] In 1990, Shine, a competent adult, went to the hospital and received oxygen and an unspecified medication for an asthma attack. Vega, the emergency department attending physician, thought she was very ill and recommended endotracheal intubation. Shine stated her long-standing refusal of endotracheal intubation (confirmed contemporaneously by her sister and father) and continued to receive oxygen by mask. Later, Shine's sister came into her room in the emergency department, noticed that Shine was breathing more easily, but was arguing with the staff. Shortly thereafter, Shine and her sister attempted to leave but were forcibly detained by a physician and security. Shine was placed in four-point restraints, and Vega, choosing to disregarded Shine's objection, intubated her trachea.[6] [7] On appeal, the Massachusetts Supreme Court stated that the competent patient has a right to refuse potentially life-sustaining treatment, even if her decision is considered unwise.
The goal of disclosure is to provide information relevant to the decision-maker and the decision to be made. Skilled disclosure builds trust, helps patients make good decisions, and is a fundamental component of the obligation to respect a patient's autonomy.
Established in 1960, the professional practice standard of disclosure, also known as the physician-based standard and the reasonable doctor standard, requires the level of disclosure to be dictated by the practices of the local physician community. [8] The problem with this standard is that the extent of disclosure lies with physicians rather than with patients, the preferred center of decision-making. This standard is falling out of favor in the United States.
Established in 1972, the reasonable person standard requires that the extent of the disclosure should be based on what a reasonable person would consider important for decision-making. One benefit of the reasonable person standard is that its requirements should be fairly uniform within a community and thus legally accessible. This is the most common standard in the United States.
The ethically ideal approach, known as the subjective person standard, is to tailor the extent of disclosure to the individual patient.[9] For example, although the average patient is minimally concerned with the remote possibility of trivial neuromuscular compromise from a radial arterial catheter, a concert violinist would consider such information important and may choose to have an arterial catheter placed in a lower extremity. This approach is difficult to use as a legal standard because it does not offer objective criteria.
The discussion of the risk of death in the anesthesia preoperative interview illustrates the use of these standards. The professional practice standard bases the disclosure on the prevalent practice in the local physician community. Practitioners following the reasonable person standard advocate informing every patient about the risk of death, because most decision-makers want to know.[10] Because not all patients want to know the risk of death, an anesthesiologist using the subjective person standard would, during the course of the preoperative discussion, determine whether the patient wanted to know rare but significant risks, such as death.[11]
Patients vary in their desire to receive information.[12] [13] [14] For example, more than 85% of surgical patients preferred extensive information in a variety of areas such as alternative anesthetic methods, preoperative medication, dangerous and common complications, and postoperative expectations.[15] However, 10% did not want to know about alternative methods for anesthesia, 7% did not want to know about preoperative medications, 11% did not want to know all possible complications, 10% did not want to know about dangerous complications, and 7% did not want to know about common complications. The study also found that women wanted more information than men, divorced subjects wanted more information than single or married subjects, and history of previous surgery was associated with a relatively increased desire for information. Among parents of minors having surgery, 74% of respondents wanted to know all possible risks of anesthesia, 24% wanted to know only those likely to occur, and 2% wanted to know only those that might result in a significant injury.[16] In a study of information preferences for parents, 96% of parents "liked to know" or felt they had a "right to know" all possible complications, whereas 4% would "prefer not to know."[17] In some cases, increased parental education was associated with increased desire for information.
What these and other studies indicate is that patients have specific preferences about the extent and type of information they receive and that these preferences vary.[12] [13] [14] [15] [17] It is difficult to base informed consent practices on known but imperfect tendencies of sociodemographic variables such as age, sex, ethnicity, gender, marital status, and history of previous surgery in a relative. Several studies have concluded that only about 15% to 20% of decision-making variability can be attributed to sociodemographic and acuity variables.[18]
Anesthesiologists have a duty to disclose material information. Institutional requirements based on local statutes define the appropriate information standard and the manner in which it must be documented. The most common theory of suit relating to informed consent is negligence.[19] Negligence relating to the informed consent process may occur if the anesthesiologist provides a disclosure that is insufficient to allow a patient to make an informed decision and an injury subsequently occurs, even if the injury was foreseeable and in the absence of a treatment error.[20] To determine if sufficient information was given, the courts look for materiality and causation. Materiality assesses whether the information given met the standard of care. If the disclosure did not meet the standard of care, it may be considered a breach of duty. Causation then assesses whether sharing the omitted information would have caused the patient to choose a different option.[20] [21] Most jurisdictions use the objective standard, which bases causation on whether a hypothetical reasonable person would have used the additional information to make a different decision. Some jurisdictions use the subjective standard, which is contingent on whether the specific patient involved would have made a different decision. A few jurisdictions combine the two standards by heeding the objective standard while considering factors specific to the patient and situation.
Courts also consider how the information was given. The informed consent discussion should occur in a setting conducive to decision-making, giving the patient a chance to ask questions and consider answers. Preprinted consent forms should not be relied on to reliably impart information, although video may be an effective way of communicating information.[22] [23] [24]
The disclosure process is not intended to be armor against medical malpractice liability if an adverse event happens. Informing a patient about a risk does not eliminate liability for its occurrence. Liability is based on negligence theory and depends mainly on whether the standard of care was met and whether the failure to meet the standard of care was a proximate cause of injury.
Exceptions to the obligation to disclose material information include patients who choose not to be informed, emergencies in which a valid informed consent cannot be obtained, and situations of therapeutic privilege. Physicians employ therapeutic privilege when they choose to withhold information because they believe disclosure would cause the patient to become "so ill or emotionally distraught on disclosure as to foreclose a rational decision, or complicate or hinder treatment, or perhaps even pose psychological damage to the patient."[25] Therapeutic privilege has a narrow scope and should be used prudently. Because information is undesirable or upsetting to the patient, it does not mean that such information should be withheld. For example, it may be reasonable to invoke therapeutic privilege when discussing the risk of death with a patient who is acutely having an infarction of his myocardium; it would not be reasonable to do the same when discussing the risk of death with the parents of an infant.
No defined disclosure technique can guarantee legal protection and ethical excellence. Informed consent discussions should routinely include the specific risks and benefits of reasonable anesthetic options and monitoring techniques and the presence and use of a fallback plan.[20] If appropriate, the patient should be informed of the quality of the data, such as whether the information has questionable certainty. Anesthesiologists should also inform the patient whether an individual or an anesthesia care team will be providing anesthesia services and, if the latter, the names and specific roles of the team members. Patients should be told about other practical matters, such as the likely sequence of events on arrival to the surgical unit, who will be with them at the various stages,
Anesthesiologists should offer an opinion about which options are preferable and the advantages and disadvantages of each option. By explaining the value judgments and the quality of data supporting their opinions, anesthesiologists allow the patient to receive the benefit of their expertise and to understand the reasons for the recommendations. Patients can then decide for themselves which choices best fit their priorities.
Patients need to understand the risks and benefits of the proposed procedures, the recommendations made, and why those recommendations were made. It is difficult to determine whether a patient fully understands the informed consent discussion, and many patients may not.[28] [29] [30] [31] Patients misunderstand terms that are common to physicians such as nasogastric tube, fasting, and antibiotics. [32] Pain and distress do not seem to compromise the ability to recall risks, particularly among parturients.[14] [33] [34] [35] One way to improve understanding is to highlight important information and options without cluttering the discussion with a rote recitation of risks.[19]
Most research relating to understanding is based on surrogate end points of recall of information or patient satisfaction. Recall is an inexact science and does not fully test understanding. Good recall of information may not accurately reflect the patient's understanding and ability to use the information to make decisions, and poor recall is not equivalent to poor understanding. Written information for patients to review may improve recall.[36] In a study of patients undergoing hip procedures, written information sheets improved patients' recall of information a fortnight after consultation.[37] For patients receiving head and neck surgery, a pamphlet with written information and illustrations improved recall.[38] Other studies do not support these claims. For example, patients interviewed immediately after a preoperative visit for joint replacement surgery recalled very little information, particularly about postoperative recovery times and operative complications. Provision of information leaflets did not significantly improve recall.[39]
A patient's subjective assessment of the adequacy of the informed consent process has sociologic, ethical, and legal importance, but it is not an assessment of the patient's ability to comprehend the data. Parents who received a pediatric anesthesia information leaflet had greater satisfaction with the disclosure process than those who did not receive the booklet.[40] Gynecology patients scheduled for laparoscopy were more satisfied with a leaflet with detailed information, including potential side effects, than with a less detailed leaflet.[41] The private and patient-controlled nature of take-home leaflets may contribute to its role in enhancing satisfaction.
After considering the information and the anesthesiologist's recommendation, the patient chooses an anesthetic technique. Patients vary in their preferences for participation in decision-making. In a study assessing the acceptance of an invasive medical device, 10% of patients wanted patient-based decision-making, and 21% wanted physician-based decision-making.[42] Data from a 4-year study of patients with chronic diseases such as hypertension, diabetes, heart disease, and depression found that 27% wanted active participation in decision-making and 69% of the patients wanted to leave decision-making to physicians. [43] In this and other studies, younger patients and more formally educated patients had an increased likelihood of desiring significant participation in decision-making.[12] [43] [44] [45] [46] In hypothetical vignettes administered to outpatients in a Veteran Affairs clinic, patients wanted more participation in decision-making about major decisions and less participation in minor decisions.[47] A study of emergency department patients found that although the desire for information was uniformly high, many of the very acutely ill patients preferred greater participation in medical decision-making than their less ill cohorts.[44] On the other hand, 75% of primary care patients wanted to participate more in decision-making during minor illnesses compared with major illnesses, and 25% wanted to participate more in decision-making during major illnesses than during minor illnesses.[12] Similarly, 16% of patients undergoing angiograms desired high levels of participation in decision-making, and 64% wanted low levels of participation. The desire to participate in the decision-making process may be a function of the individual, extent of illness, gender, age, and level of education. Anesthesiologists should attempt to tailor the extent of patient and physician decision-making to the patient and the situation.
When a patient refuses an anesthesiologist's recommendation or requests a technique the anesthesiologist feels is inappropriate, the focus of the conversation moves from informed consent to informed refusal. Informed refusal requirements are similar to informed consent requirements in that the patient should be substantially well versed about the risks, benefits, and alternatives before declining. Although it may be reasonable to permit a patient agreeing with a recommended or acceptable procedure to refuse extensive information (especially if the likelihood of harm is low), it is more difficult to honor a patient's preference to receive limited information when the patient desires a suboptimal approach.[48] The anesthesiologist may wish to provide additional information about the choice to be sure that the patient has all possible information. If the patient chooses without sufficient information, the anesthesiologist has not fulfilled the obligation of informed refusal. A patient still may refuse to hear information, but it is ethically more correct to make substantial efforts to educate the patient than to accept at face value the patient's refusal to be educated. In either case, when a patient chooses a technique the anesthesiologist believes inappropriate, anesthesiologists are not ethically
Obtaining informed consent is how anesthesiologists acknowledge the responsibility to respect a patient's right to self-determination and to follow a self-chosen plan. The informed consent process concludes with the patient intentionally authorizing the anesthesiologist to perform a specific procedure. This authorization is the expression of the patient's self-determination and is the basis of informed consent.
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