The goal of informed consent is to enable patients to make substantially autonomous informed decisions.1,2 The modifier "substantial" emphasizes that the realistic goal for consent is to sufficiently, as compared to fully, inform the patient.
Components of Informed Consent
Patients have decision-making capacity when they are capable of making a specific decision at a specific time. Patients show capacity by understanding proposed treatments, alternatives, consequences of proceeding or not proceeding, and the ability to express a preference based on rational, internally consistent reasoning. Decision-making capacity is different than competency. The clinician at the bedside determines decision-making capacity for a specific decision, whereas competency is a legal determination of the global abilities required to provide legal and other authorizations. Adults are presumed competent.
Anesthesiologists should pay particular attention to the decision-making capacity of patients with temporary or more permanent limitations in decision-making capacity.3 Patients with more permanent limitations in decision-making capacity should be encouraged to participate in decision making to the extent of their abilities. Sedated patients with temporarily limited decision-making capacity should be assessed for decision-making capacity with regard to the specific decision. Decisions with riskier consequences require more comprehensive decision-making capacity. In patients with temporarily insufficient decision-making capacity, anesthesiologists should delay nonemergent care until patients regain sufficient decision-making capacity.
Physicians should only perform procedures on competent patients who participate willingly. Anesthesiologists manipulate patients by distorting, downplaying, or omitting information to influence decision making. Anesthesiologists hinder voluntariness when they chemically or physically restrain patients who have sufficient decision-making capacity.4 For example, in Shine v Vega, Shine, a competent adult, went to the hospital for treatment for an asthma attack.5 The emergency department attending Vega recommended tracheal intubation. Shine refused. Later, Shine and her sister tried to leave but were forcibly detained. Shine was restrained and Vega intubated her trachea.6 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.
Disclosure is the process of supplying relevant information to the decision maker. Skilled disclosure builds trust and facilitates patient self-determination.
The predominant legal standard in the United States is the reasonable person standard that requires disclosure of information based on what a theoretical reasonable person would consider material for decision making.7 However, the preferences of the reasonable person are not precisely defined by statute or case law. Further, patients vary in their desire to receive information. For example, one typical study found that 10% of patients did not want to know alternative methods for anesthesia, 7% did not want to know about preoperative medications, 11% did not want to know all possible complications, and 10% did not want to know dangerous complications.8 Patient preferences for disclosure cannot be wholly predicted from socioeconomic status, age, sex, ethnicity, and history of previous surgery.9-11 Variation in anesthesiologists' customary practices of risk disclosure indicates the complexity of using the "reasonable person" standard to guide clinical practice.12,13 For example, in one typical survey, approximately half of the respondents disclosed transient or persistent neuropathy as a risk for central neuraxial blockade.14
These data indicate that rather than presenting a standard laundry list of data, anesthesiologists should tailor information to the preferences of the patient. Anesthesiologists do this by highlighting options that affect the perioperative experience, such as regional versus general anesthesia, and by informing patients about significant risks that the anesthesiologist considers relevant to decision making. Anesthesiologists should also prepare patients for common but less severe risks, such as postoperative nausea and vomiting. Patients should be informed whether trainees are participating in care.15,16
To customize disclosure, anesthesiologists may then ask patients whether they want more information. For example, if there are no significant risks relevant to decision making, the anesthesiologists can say, "There are significant but very rare risks of receiving anesthesia. Would you like me to tell you about them"? Although the likelihood of being sued based on informed consent malpractice issues is very rare, increasing satisfaction by meeting the patients' needs likely decreases complaints and lawsuits. In any case, disclosure does not prevent medical malpractice liability for adverse events. Liability is based on negligence theory and depends mainly on whether the standard of care was met and if the failure to meet the standard of care was a proximate cause of injury.
The original concept of therapeutic privilege permitted physicians to withhold information if disclosure would prevent patients from making a rational decision. More recently, some suggest a valid use for therapeutic privilege is to give patients time to adjust to jarring events, to prevent stress-impaired decision making, and to preserve hope.17,18
Anesthesiologists should highlight the advantages and disadvantages of options, and recommend a plan by explaining how well each option suits the patient's preferences.
It is difficult to determine if a patient substantially understands the risks, benefits, and indications of the proposed procedures.19-21 Translating population data into data relevant and understandable to the patient is problematic.22 Numerous biases affect both physician and patient understanding of risks. In addition, patients commonly misunderstand frequently used terms such as anaphylaxis, antibiotics, aspiration, fasting, local anesthesia, reflux, and sedation.23,24
"Teach-back" has been suggested to assess patient understanding during the informed consent process. Patients are asked to articulate key information about the proposed treatment to help physicians redress gaps or misunderstandings. There is insufficient literature about whether "teach-back" improves the quality of understanding and therefore improves informed consent. Although superficially this seems like a potentially beneficial and harmless technique, how "teach-back" is performed will likely affect whether patients view this as a positive interaction. Perhaps the benefit of "teach-back" simply will be the greater focus on assessing patient understanding.
Most research relating to understanding is based on the less applicable surrogate end points of recall of information or patient satisfaction. Recalling information does not reflect the ability of patients to understand and use information, and lack of recall does not mean inadequate understanding and use of information. Recall is generally poor.25,26 Even the most successful interventions improve recall only to about 50% of the presented information. Written information for patients to review may improve recall.27-29 Pain and distress do not seem to compromise the ability to recall risks, particularly among parturients.10,30-32
Patients vary in their preferences for participation in decision making. 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. Older studies indicate that younger patients and more formally educated patients tended to prefer more significant participation in decision making.9,33-36,37 These preferences are more likely due to generational differences than absolute age, and therefore it should be assumed that older patients are by now also more likely to prefer greater participation in decision making. It is legally and ethically superior for anesthesiologists to tailor participation in decision making to the patient.38
Anesthesiologists should obtain informed refusal when patients refuse recommendations or request a relevantly suboptimal technique. The concept underlying informed refusal is that these patients need to be more extensively informed about risks, benefits, and alternatives when they desire inadvisable techniques. Anesthesiologists are not ethically obligated to provide care for these patients in nonemergent situations, although they may wish to assist in finding a willing colleague.
Anesthesiologists should seek the patient's explicit authorization to perform a specific procedure.
Issues in Informed Consent
Society's interest in preserving the moral fabric of individual physicians permits anesthesiologists to withdraw from care with which they morally disagree, such as the elective termination of pregnancy. Anesthesiologists may be obligated to make a reasonable effort to find a willing colleague, although some find this recommendation ethically objectionable.39 There is controversy about whether anesthesiologists should perform emergent care that violates their conscience. Some argue that the altruistic obligation toward patients cannot supersede a physician's most cherished values. Others argue that medicine is first and foremost a service profession, and in extreme circumstances physician are obligated to put patients first. This argument is in part based on the social contract the profession of medicine has with society.40 Although this situation rarely occurs in clinical practice, the role of the physician vis-à-vis the patient is worthy of consideration.
Although anesthesiologists may refuse to provide care when a patient makes a sufficiently inappropriate request, this determination should be made only after extensive consideration and perhaps consultation with colleagues. Anesthesiologists may not refuse to care for patients based on race, gender, or disease status, such as the patient with an infectious disease.41 Anesthesiologists should refuse to provide nonemergent care if they do not feel that the environment, including their own and other clinicians' abilities, operating room capabilities, and consultative and postoperative care, provides a sufficient quality of care.
Anesthesiologists should seek informed consent as practicable in emergency situations. The assumption is that patients want potentially life-sustaining therapy. Reversibility is the key to determining how to intervene when there is incomplete evidence that the patient would prefer not to receive emergency treatment. For example, because tracheal intubation is reversible, it is appropriate to intubate the trachea of the unconscious patient when there is insufficient documentation of preferences, even if a relative declares that the patient's preferences would be to refuse tracheal intubation. Therapy may be withdrawn later if appropriate. In this case, the slight burden of temporary tracheal intubation is traded for improved clarification and certainty of the patient's wishes.
Irreversible interventions do not offer this opportunity. Consider the unconscious Jehovah's Witness patient with a critically low hemoglobin. Transfusion represents irreversible contamination. However, because the standard is an explicit refusal of potentially life-sustaining treatment, anesthesiologists should probably provide transfusion in the absence of unambiguous evidence.
Jehovah's Witnesses interpret biblical scripture to mean that those who take in human blood shall be "cut off" from eternal life.42 Case law unequivocally supports the rights of adult patients to refuse transfusion therapy.43 In particular, physicians have not been held liable when honoring a parturient's properly documented refusal of transfusion therapy, even in the face of maternal or fetal death.44
Jehovah's Witness patients consider transfusion therapy preferences as a "matter of conscience." Primary concerns center on whether it is blood from another human and whether their own blood has been outside of the body. Thus blood components, autologous blood, and banked blood are generally unacceptable. Some patients will accept blood harvested intraoperatively and returned while being kept in a closed loop, such as with cell salvage of shed blood or presurgical removal of blood. Some patients will accept recombinant erythropoietin, which depending on the brand contains small amounts of human albumin. Acceptable techniques include synthetic colloid solutions, erythropoietin-stimulating protein, and preoperative iron.
Precisely documenting patient preferences forces clarification of acceptable interventions. Nonemergent care should proceed only if all clinicians are wholly certain they can satisfy the patient's requirements.
Physicians are obligated to protect patient information from unauthorized and unnecessary disclosure. For example, anesthesiologists should seek permission from patients before sharing information with family members. Anesthesiologists should be aware of and should seek to comply with public privacy guidelines. In particular, electronic medical and financial records may lead to inappropriate distribution of sensitive personal information.45 Exceptions to confidentiality rules include when a patient makes a credible threat to harm someone.
Patients, parents, other surrogate decision makers, and physicians use the concepts of best interest, informed assent, and informed permission to guide decision making about health care for minors (Table 5-1).46 The best interest standard is used when the ability to apply self-determination is impossible, such as with an infant or a child with severe developmental delay. The parent or surrogate decision maker should then apply what they believe to be in the best interests of the child, but this decision must be within an acceptable range of decision making. Parents may not opt for grossly inappropriate overtreatment or undertreatment.47 Whether anesthesiologists should intervene about potentially inappropriate treatment depends primarily on the amount of harm to the child by the therapy or its absence, the likelihood of a successful therapy, and the overall risk-to-benefit ratio. Interventions include ethics consultation, legal consultation, and legal intervention. The term informed permission has been suggested to emphasize that only the individual receiving care can provide informed consent and therefore the parent or surrogate decision maker is more accurately providing permission.
Table 5-1 Graduated Involvement of Minors in Medical Decision Making ||Download (.pdf)
Table 5-1 Graduated Involvement of Minors in Medical Decision Making
|This broad outline should be viewed as a guide. Specific circumstances should be taken into consideration.|
|< 6 y||None||Best interest standard|
|6-12 y||Developing||Informed permission|
|13-18 y||Mostly developed||Informed assent|
|Mature minor||Developed, as legally determined by a judge, for a specific decision||Informed consent|
|Emancipated minor||Developed, as determined by statutes defining eligible situations (eg, being married, in the military, economically independent)||Informed consent|
Pediatric patients should participate in decision making to the extent their development permits. Anesthesiologists therefore should incorporate informed assent with older children. The extent of participation of children should increase throughout adolescence depending on the patient's maturity and the consequences of the decision. Anesthesiologists should go out of their way to respect the right of adolescents not to assent to a procedure. In those cases, achieving assent may necessitate further discussions with patients, parents, and other clinicians, and such discussions may best take place away from the operating room.
Loss of confidentiality may lead adolescent to curtail or delay seeking medical care, or be less forthright about information, particularly when care involve sexually transmitted infections, contraception, and mental health.48-50 Anesthesiologists may want to ask sensitive questions privately. Although anesthesiologists should encourage adolescents to be forthright with their parents, anesthesiologists should maintain the confidentiality of adolescents unless prohibited by reporting statues.51 Of particular relevance, state statutes may limit the anesthesiologist to informing only the adolescent about a positive pregnancy test.
Emancipated minors and adolescents declared mature minors are authorized to make their own health care decisions. States statutes may award emancipated minor status to adolescents in the military, who are married, who have children, and who are economically independent. Judges may award mature minor status if the adolescent is capable of giving legal consent in a specific situation.52 Judges base mature minor decisions on the maturity of the child and the consequences of the decision.
Patients desire appropriate disclosures and apologies about medical errors.53 On the whole, physicians and administrators agree. But fear, lack of training, and inadequate support limits the ability of physicians to disclose and apologize.53-56
More than half the states have laws prohibiting the admission of apology or sympathy as evidence of wrongdoing.57 Nonetheless, the quality of these laws vary and an apology conceivably may influence whether legal action is sought or is successful.58,59 But in the long run, sincere disclosures and apologies followed by appropriate post-event actions improve patient satisfaction and trust, possibly forestalling legal action.38 Consider the alternative: Hiding or dissembling about an event infuriates patients and will likely spur a lawsuit.
When disclosing potential errors, anesthesiologists should be very precise about communicating only what is known. Anesthesiologists should not speculate about what is not known, particularly about fault. Initial disclosure should occur promptly and should focus on the medical implications of the event.60 A specific permanent contact person should be identified to be the liaison for the patient and family. The contact person should be able to answer questions, arrange meetings, explain the results of the investigation, and describe the plan to prevent comparable events.
The quality of the apology matters. It is very appropriate to apologize for the effects of an event. Although anesthesiologists should generally not assume responsibility for an event during the initial disclosure and apology, it seems bizarre to evade responsibility for a clear error. Dodging responsibility in that situation likely delegitimizes the apology in the patient's eyes.