1.Consent and refusal
5. Informed consent and the pediatric patient
David Clendenin and David B. Waisel
During the preanesthetic discussion for resection of pulmonary metastases of osteosarcoma, the anesthesiologist advises the 14-year-old boy and his parents that a thoracic epidural catheter would be the best way to manage post-thoracotomy pain. The anesthesiologist initiates a discussion commensurate to the adolescent’s age, experiences and cognitive ability. The patient immediately refuses the thoracic epidural stating, “I don’t want a needle in my back while I’m awake.” Despite reassurance by the anesthesiologist and parents of adequate sedation and analgesia, the patient still refuses. The parents, frustrated, scared and wanting the best for their child still ask the anesthesiologist to insert the epidural.
The child’s role in medical decision-making
The American Academy of Pediatrics Committee on Bioethics 1995 recommended integration of children into the informed consent process1 (Table 5.1), and this has been reaffirmed both nationally and internationally.2 Indeed, the ASA has incorporated the principle of pediatric assent into its Guidelines for the Ethical Practice of Anesthesiology (Section I.2):
Anesthesiologists respect the right of every patient to self-determination [and] should include patients, including minors, in medical decision-making that is appropriate to their developmental capacity and the medical issues involved.3
Anesthesiologists should choose to involve children in medical decision-making with the ethical objective of enhancing the child’s self-determination, while keeping the child engaged in their care.
Anesthesiologists can use the patient’s age as a first approximation of a patient’s cognitive and emotional development. Children under the age of 7 generally do not have decision-making capacity. Children between ages 7 and 14 years are considered unlikely to have complete decision-making capacity but are able to voice preferences about increasingly complex questions. Children older than 14 are considered to have decision-making capacity unless proven otherwise.
This chapter will discuss the issues raised by incorporating the ethical concept of pediatric patient assent into the traditional process of parental (surrogate) informed consent.
Competency and decision-making capacity
In discussing pediatric decision-making, it is important to distinguish between competency and decision-making capacity. In the US, competency is a legal status determined by the judicial system and is not determined by clinicians, although the judicial system relies on clinical specialists such as psychiatrists when determining competency. By law, except under specific circumstances, children are not legally competent to authorize medical care for themselves.
Distinct from competency, decision-making capacity is the ability to make specific decisions at specific times.a Clinicians determine decision-making capacity. Children exhibit ranges of decision-making capacity, depending on age, risks and benefits of the decision, emotional and cognitive maturity, and temporary (e.g., sedation) and permanent limitations on cognitive function.
Developmental progression of pediatric assent
For children younger than 7 years old, anesthesiologists should focus on obtaining parentalb informed permission or “assent.” (Table 5.1) “Informed permission”
Table 5.1. Elements of consent and assent as defined by the American Academy of Pediatrics Committee on Bioethics
is used instead of informed “consent” because “consent” implies that the patient is providing the legal consent. The implication of “informed permission” is that, although clinicians nearly always honor parental decision-making, parental decision-making does have boundaries. Physicians honor parental decision-making because they assume that parents desire the best for their children, parents have to live with the consequences of that decision, and parental values and goals often approximate their child’s future values and goals.
Boundaries of parental decision-making are informed by the “best interests” standard, which requires that parents and clinicians choose their decisions from within a range of reasonable options. This standard does not require clinicians to dogmatically insist on what they think is best for the child. However, if the parents are making a decision that is unacceptably outside the boundaries of reasonable decision-making options, then clinicians are expected to intervene in an escalating manner as necessary to protect the child.4 For example, if the child in the introductory case were 9 years old, then it is acceptable, if perhaps suboptimal, for the parents to choose intravenous pain management instead of epidural analgesia. If, however, the parents wanted to forgo all pain management out of fear of exacerbating a known family risk of narcotic addiction, then that decision would be an unacceptable treatment option and would require intervention by the anesthesiologist.
As children increase in age from 7 to 14 years, they are beginning to seek independence and are progressively capable of assimilating, analyzing, and using complex information. As a result, anesthesiologists should begin seeking both age-appropriate assent and parental informed permission from these children. Age-appropriate assent varies by age and the complexity of the decision, with particular focus on the potential risks of the decision. It ranges from involving a 7-year-old in determining whether to use preoperative premedication, to discussing preoperative intravenous placement with a 10-year-old, to seeking assent from a 12-year-old for placement of a peripheral nerve block. More important than the specifics is that anesthesiologists make an effort to integrated children into the decision-making process based on their maturity. As these children approach adolescence, they become increasingly able to understand parental and physician motives. For example, a 13-year-old child fearful of an awake intubation may recognize the importance of a sound medical decision and assent to the process. Anesthesiologists who involve children in decisions related to their care frequently cite patient autonomy, education and the protection of a child’s rights as the focus of the involvement.
Adolescents older than age 14 prioritize independence and have fully developed abstract thought and complex reasoning. Anesthesiologists must engage these adolescents in decision-making.However, fully developed cognitive abilities do not necessarily translate into good decision-making skills. Adolescents do not fully develop impulse control and consideration for long-term consequences until their early twenties. For this reason, decisions of significant risk and consequences (such as refusal of potentially life-saving transfusion therapy in the child of a Jehovah’s Witness) must undergo greater scrutiny and require significant evidence of decision-making capacity. Evidence of decision making capacity includes internally coherent reasoning, appreciation of cause and effect, appreciation of the range of outcomes and the effects that the different possibilities would have on loved ones, and the ability to imagine what circumstances would have to be different for them to choose an alternate path. Determining the extent of risk includes considering the amount of potential harm to the child by the intervention or its absence, the likelihood of occurrence for each of the likely outcomes, and the overall risk-to-benefit ratio.
Engaging children in decision-making
The American Academy of Pediatrics emphasizes that “no one should solicit a patient’s views without intending to weigh them seriously.”1 Pro forma and insincere engagement of children is easily recognized and brings harms to current and future patient-doctor relationships. A common mistake is well-intentioned vagueness in explaining options to children, leading the child to choose untenable options.
In non-emergent care, anesthesiologists should honor a child’s refusal of care. Some suggest the ability to refuse elective procedures begins around the age of 10, although in practice is seems to be older, perhaps around age 12.5 Clinicians should explore the child’s refusal in the hopes of addressing specific concern. Short delays, a change of location, changing into street clothes, or using pediatric mental health professionals often help address most refusals. Given the harm of ignoring a child’s preferences, clinicians should disregard pressures to proceed forthwith from operating room administrators, physicians or parents. Strategies such as using the operating room for other cases may help ameliorate these production pressures. To minimize the harm of pro forma solicitation of a child’s opinion, children should never be offered illegitimate choices. Moreover, they should be directly informed when they will undergo procedures despite their objections.
Anesthesiologists can minimize the harm of limiting a child’s decision-making authority by overtly honoring their authority about more negotiable decisions. For example, while a 12-year-old girl may not be permitted to choose whether to have an anterior cruciate ligament reconstruction because of potential long-term harm, it would be reasonable to permit a healthy adolescent to choose between a peripheral nerve block or intravenous narcotics to provide postoperative analgesia. The anesthesiologist still should explain to the patient that a nerve block may provide superior pain management, but should respect the patient’s wishes should she choose the alternative. This approach helps balance the sometimes unaligned goals of self-determination and safe and quality care for the adolescent.
Medical decisions: who ultimately chooses?
Disagreements about the appropriate clinical plan occur in any combination within the patient–parent–clinician triad. As with all disagreements about patient care plans, clinicians should focus on continued communication and transparent exchanges among the parties. Divining misunderstandings may resolve disagreements. Unfortunately, clinicians tend to avoid patients and family members that are complicated or are considered to be “difficult.” Avoidance appears to be the easier option, but in the long term, it entrenches opinions and exacerbates discord.
When the preferences of the parent and patient diverge, clinicians should attempt to define the reason for the disagreement. Parental and adolescent disagreement often is rooted in the dynamic of the adolescent establishing independence from the parent. Clarifying the merits of the options, offering an objective opinion based on stated values, and improving intra-family communication can help resolve these challenging problems.
When differences persist within the patient–parent–clinician triad, clinicians may want to consult multidisciplinary conflict resolution experts such as social workers, ethics consultants, and chaplains. The enhanced communication that often results from third party consultation may increase decision-makers’ appreciation of the shared interest in the child’s well-being. Improved communication may also enable clinicians to recognize previously unappreciated fears or misunderstandings. Legal counsel may be necessary in the rare instances of impasse. Even when legal intervention is necessary, clinicians should continue to seek common ground and a functional patient–parent–clinician relationship.
In the situation of the 14-year-old with pulmonary metastases of osteosarcoma, the parents and the patient disagree about whether to have a thoracic epidural catheter placed. This patient’s fear of an epidural needle does not obviate the risks of inserting a thoracic epidural placement in an anesthetized patient. Exploration of his refusal reveals that his fear is based on “ward gossip’ that getting an epidural really hurts, despite what the anesthesiologist says. Such gossip is formidable. Extensive conversations emphasizing the differences among patients and their situations and the promise to stop if the procedure became too uncomfortable do not ameliorate his concerns.
Four options present themselves: (1) insert the thoracic epidural catheter after inducing anesthesia; (2) insert the thoracic epidural catheter after heavily sedating the patient, either surreptitiously or after informing the patient he did not have a choice about the epidural; (3) insert a lumbar epidural catheter after inducing anesthesia, although a lumbar epidural may be less effective; or (4) use intravenous postoperative pain management.
The decision rests heavily on the relative benefits of placing a thoracic epidural. If he would strongly benefit from the attributes of a functional thoracic epidural (such as pain control enhancing pulmonary hygiene in a patient with pulmonary disease or minimizing intravenous narcotics in a patient at risk for apnea), then with appropriate parental informed permission (consent), it may make sense to risk inserting the epidural catheter after inducing anesthesia or to inform him that his preference is being overridden in his best interest. Lying to the patient might be devastating in a child who will continue to undergo extensive therapy. On the other hand, if the clinically significant benefits of using a thoracic epidural for postoperative analgesic are minimal, then the benefits of not inserting a thoracic epidural catheter outweigh the risks of inserting the thoracic epidural catheter in an anesthetized, surreptitiously sedated, or coerced patient. In the example case, it is ethically proper to explain to the parents why it is more important to honor their child’s requests than to insert a thoracic epidural catheter.
Requests for non-disclosure to children
Parental non-disclosure requests range from “do not tell him he is having surgery” to “details will only scare him” to “she doesn’t know the diagnosis and we want to keep it that way.” Thoughtful consideration of parental nondisclosure requests should serve solely the goal of patient benefit. Although dishonesty jeopardizes the physician–patient relationship, frightening children for the sake of a principle is often unwise. A pragmatic approach is to disclose issues that the child will find out in the imminent future and is within the domain of anesthesiology, but to defer disclosure about issues that would be better served by discussions with other experts. For the most part, children should be told in age-appropriate terms that they are having surgery and anesthesia, but it would be inappropriate for the anesthesiologist to insist that the child be told that he has been diagnosed with cancer. Anesthesiologists who believe that information is being inappropriately withheld from the patient should approach the primary physicians to discuss their ethical concerns.
Emancipated minors and mature minors status
Emancipated minors can legally give informed consent for their medical decisions. Emancipated minor status is determined by state statuted, and varies from state to state, but commonly included determinants are pregnancy, marriage, military service, or being self-supporting. Mature minor status differs from emancipated minor status. Mature minor status is awarded by a judge and permits minors to be an autonomous decision-maker for specific decisions (such as refusing transfusion therapy for the perioperative period). These minors tend to be near the age of consent and are more likely to be granted mature minor status in decisions of lesser risk.
Consistent with the idea that nearly all people want emergency therapy to preserve life and functional status, emergency treatment should be initiated in children even if their parents are unavailable to provide consent.6 This unambiguous presumed consent wilts when unaccompanied adolescents refuse emergency care or when adolescents and parents differ in their preferences. Honoring an adolescent’s preferences in an emergency medical situation depends on the adolescent’s rationale and the extent of potential harm. If there is considerable risk in honoring the adolescent’s desires and the adolescent cannot exhibit substantial decision-making capacity, then it is appropriate to supersede the adolescent’s preferences and use the “best interests” standard. Indeed, in emergencies, it is rare for an adolescent to demonstrate sufficient decision-making capacity to convince other decision-makers to override standard medical practices.
Physicians are obligated to protect patient information from unauthorized disclosure. Breeches of confidentiality often cause adolescents to eschew future medical care.7 Clinicians should only consider breeching confidentially if they believe that maintaining confidentiality exposes the patient to serious risk. If the risk of non-disclosure is not significant, then clinicians may wish to encourage adolescents to confide in their parents, but clinicians should respect decisions not to confide. Emancipated and mature minors have a right to complete confidentiality.
Given the principles of confidentiality, it is nearly always ethically appropriate to inform only the adolescent of a positive pregnancy test. Similarly, most states have statutes that limit disclosure of a positive pregnancy test only to the adolescent.8 When an adolescent has a positive preoperative pregnancy test, the anesthesiologist should seek consultation with experts such as pediatricians, gynecologists and social workers as to how best to proceed. Informing parents or other family members may expose the minor to other serious risks, in part because family incest is not an uncommon etiology. If the adolescent, anesthesiologist, and surgeon were to postpone surgery, and the adolescent chooses not to tell her parents of the pregnancy, then the physicians must be careful not to inadvertently breech confidentiality when informing the parents about postponing surgery. (For more on pregnancy testing, see Chapter 14)
• Pediatric patients should be integrated into the process of informed consent.
• Competency is a legal term while decision-making capacity is the ability to make a specific decision at a specific time.
• Children exhibit ranges of decision-making capacity, and there is a developmental progression of the capacity of a child to assent.
• Insincere engagement of children is harmful.
• It is important to resolve disagreements among the pediatric patient–parent–physician triad about the appropriate clinical plan.
• Response to requests for nondisclosure by parents must weigh the goal of the “best interests” of the patient.
• Emancipated minor and mature minor status pose distinct ethical and practical issues.
• Confidentiality must be honored, and failure to do so may be harmful to the patient.
a Editor’s note: in the UK, the terms “competency” and “capacity” are reversed from the US. “Competency” generally refers to functional ability, and “capacity” to legal status.
b The term “parental” will be used in this chapter to refer to the adult decision-maker(s) and should be considered inclusive of all other adult surrogate decision-makers.
1* Committee on Bioethics, American Academy of Pediatrics. (1995). Informed consent, parental permission, and assent in pediatric practice. Pediatrics, 95, 314–17.
2* De Lourdes Levy, M., Larcher, V., and Kurz, R. (2003). Informed consent/assent in children. Statement of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP).Eur J Pediatr, 162, 629–33.
3 Guidelines for the Ethical Practice of Anesthesiology (2003). American Society of Anesthesiologists. Park Ridge, IL. (last amended 2008)http://www.asahq.org/publicationsAndServices/standards/10.pdf.
4* Edwards, S. D. (2008). The Ashley treatment: a step too far, or not far enough? J Med Ethics, 34, 341–3.
5* Diekema, D.S. Boldt v. Boldt: a pediatric ethics perspective. (2009). J Clin Ethics, 20, 251–7.
6 Committee on Pediatric Emergency Medicine. (2003). Consent for emergency medical services for children and adolescents. Pediatrics, 111, 703–6.
7* Council on Scientific Affairs, American Medical Association. (1993). Confidential health services for adolescents. JAMA, 269, 1420–4.
8* American Academy of Pediatrics. Committee on Adolescence. (1998). Counseling the adolescent about pregnancy options. Pediatrics, 101, 938–40.
Committee on Adolescence, American Academy of Pediatrics. (1996). The adolescent’s right to confidential care when considering abortion. Pediatrics, 97, 746–51.
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