This article summarizes the contemporary ethics framework for helping to guide physicians in challenging medical decision-making. It provides a definition and a rationale for using the best interest standard, the harm principle, shared decision making, and the patient’s right to an open future. It then applies these principles to a series of common ethical scenarios encountered in clinical practice.
Key points
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Every child has a right to a future well-being that optimizes both functional and psychosocial health.
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The best interest standard is the prevailing contemporary ethics framework for medical decision-making in pediatrics.
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Children should be included in a shared-decision model as early as feasible to promote autonomy and inclusion in medical decision-making.
Introduction
Decision-making to surgically correct a craniofacial anomaly is predicated on the normative belief that every child has a right to a future well-being that optimizes both functional and psychosocial health. This includes a person’s ability to grow, develop, participate in healthy human relationships, and maximize potential in areas of human endeavors. The face is central to these functions and the presence of congenital abnormalities presents a unique set of challenges with psychosocial morbidity that may follow children into adulthood. , Early intervention in the pursuit of normalcy is often advocated to avoid the internalization of the associated stigmatization as the connection between positive body image and elevated self-esteem is firmly established.
The concept of normalcy is complex and is affected by cultural norms and individual values on function and appearance. Moreover, the degree of normal that is possible to achieve depends on the severity of the deformity and associated comorbidities. Some argue that the focus should be on changing social values to encourage the acceptance of those who appear different rather than pursuing an accepted norm. This argument notwithstanding the surgical pursuit of normalcy is reasonable insofar as it promotes the overall well-being of the child and acknowledges the limitations of what is surgically possible to correct.
Parental decision-making is driven by a combination of cultural, social, and religious values as well as the complex emotional burden associated with caring for a child with congenital anomalies. Parents may harbor feelings of guilt and shame as well as fear both for the future potential of their child and of causing further harm through any proposed surgical intervention. Nonetheless, most parents or caretakers feel a sense of moral obligation to pursue “normalizing” surgeries for their children to facilitate social inclusion and to optimize quality of life. In this context, the parents often see the surgeon as a competent and authoritative guide to make appropriate decisions, reinforcing the notion of the power differential that places the surgeon in a privileged moral position to influence the decisions regarding care.
By contrast, other families are more accepting of an abnormal appearance and may feel that the potential risks of an intervention do not warrant the proposed benefits. In some cases, it is the right of the family to make that decision, especially in cases of minor esthetic concerns without implications of functional delay or permanent disability. However, in cases where timely intervention is essential to promote the child’s safety and well-being, the surgeon has an ethical imperative to intervene. The challenge for the surgeon lies in determining the appropriate limit to the parents’ latitude in decision-making. It is for this purpose that the authors provide an ethical framework for approaching these challenging clinical discussions.
Discussion
Ethical Framework
The prevailing contemporary medical ethics is rooted in the 4 principles delineated by Beauchamp and Childress, which consist foremost of respect for individual autonomy in making decisions, beneficence (doing good), non-maleficence (to do no harm), and justice (ensuring fairness). The following discussion describes how these principles are applied in the case of pediatric decision-making.
Autonomy
The concept of informed consent in medical decision-making is grounded in the idea of autonomy that is the right of a person to make decisions as guided by reason within that individual’s value system. This is derived from Kantian moral philosophy, with key elements of liberty, the capacity to live life according to your own reasons and motives, and agency, the rational capacity for intentional action.
However, respect for autonomy hinges on the patient’s ability to make rational decisions. This requires an understanding of the illness as well as the ability to deliberate upon the risks and benefits of different treatment alternatives and to make decisions that are consistent with an “authentic self” guided by personal values and logical thought patterns. , These functions evolve during adolescence but are not adequately developed in most children. The application of autonomy in pediatric cases, therefore, initially relies on the judgment and values of the parent or caretaker and the medical expertise of the surgeon. As the child ages, it demands an intricate balance between cognitive development, parental involvement, and the child’s evolving capacity for decision-making. In the interim, the following ethical standards are used to guide decision-making in pediatric cases.
Best interest standard
The best interest standard forms the basis of the fiduciary relationship between the pediatric patient and both the parent or caregiver and the surgeon. It represents the guiding principle for choosing among available treatment options and requires that each party considers all relevant factors to choose a treatment that best promotes the overall well-being of the child. There is an important distinction between the best interest standard and the principle of substituted judgment, which is often used in surrogate decision-making for incapacitated adults. An incompetent adult previously had the capacity to make medical decisions and surrogates merely apply or substitute their understanding of their preferences and values in determining the most appropriate treatment. This cannot be applied to pediatric decision-making because children and many adolescents have not been able to develop or communicate their own preferences based on core values. This creates a challenging situation requiring parents to weigh the future desires of the child with their own value system. Disagreements may arise when those values conflict with medical recommendations, in particular in cases when non-intervention presents a significant risk to the future well-being of the child.
While it may be true that parents are uniquely situated to appreciate the needs of their children, it is important to note that respect for autonomy and parental authority in medical decision-making for children is constrained compared to that of fully competent adults. In pediatric cases, the surgeon has an ethical duty to challenge parental authority and encourage state intervention, if necessary, in situations in which the child or young adult is put at risk. The distinction between the best interest and substituted judgment standards is important here because parents or caretakers may justify their decisions via imposition of their own values on the child in a substituted fashion, which may directly undermine what is in the child’s best medical interest.
Harm principle
Critics of the best interest standard argue that the criteria are too vague and that what the surgeon feels is best for the patient may not be reflective of the family’s values and wishes for the child. Indeed, it may create a risk of imposing 1 set of values on all parents, which would undermine respect for the autonomy of the family unit. More specifically, critics note that the best interest standard is not adequate as a limiting standard that is in determining the threshold for state intervention in parental decision- making. The harm principle, which presents an alternative to the best interest standard, provides significant allowance for parental discretion in decision-making so long as they do not constitute harm to the patient. The principle has its philosophic basis in John Stuart Mill’s, On Liberty , in which he argues that the only circumstance in which action can justifiably be taken against someone’s will is to prevent harm to others. In a clinical context, action can be taken against the will of a parent or caregiver in defense of preventing harm to the child.
However, the harm principle would permit parents to make decisions that do not necessarily comply with the best interest of the child so long as they do not fall below the harm threshold. In many ways, it is more opaque in its interpretation than the best interest standard. Harm can be equally difficult to define as the best interest. Moreover, it fails to provide any guidance for medical decision-making in cases where the treatment options may not fall below the harm threshold but nonetheless have different impacts on the patient’s best interest. In defense of the best interest standard, Bester argues that adherence to the harm principle would collapse all ethical obligations into harm avoidance rather than promotion of well-being. Discussions between parents and surgeons regarding medical decision-making is more nuanced and the surgeon has an obligation to take a holistic approach rather than limiting the standards for adequate care to harm prevention.
Right to an open future
Another solution to address competing interests for the child in medical decision-making is to invoke the child’s right to an open future. This principle encompasses a set of moral rights derived from the autonomy rights of adults. In essence, it protects children from having important decisions made for them by others before they develop the ability to make them for themselves. Moreover, decisions should be made that would place the future autonomous adult in a position to choose from all possible treatment options. In another interpretation, it requires that surgical interventions be pursued that will satisfy the rights of the future adult. For example, each adult has a right to optimal speech and feeding. A parental desire to avoid cleft palate surgery therefore would violate that right and would not be permissible. In the case of a child with microtia, the argument can be made that the child has the right to an open future to determine the form of reconstruction and the decision should be delayed until the child has reasonable capacity to make that decision.
Shared decision-making
Shared, family-centered decision-making is increasingly used for pediatric medical decision-making. It recognizes the importance of individual values and treatment goals and seeks input from the child and adolescent in the decision-making progress. The level of involvement depends on the child’s willingness, which rests in large part on the degree of psychological development and capacity to understand the implications of different treatment alternatives. , While the age of legal consent remains 18, an expanding body of literature suggests that by age 14, most children are ready from a neurocognitive standpoint to participate meaningfully in medical decision-making. By this time, they have typically developed a coherent sense of identify with an appreciable understanding of their individual beliefs, values, and priorities. By contrast, minors below the ages of 11 to 13 do not yet possess these attributes. This is reflected in patient preferences regarding decision-making as younger children (<10 year old) are more likely to defer to caregivers compared to adolescents and teenagers. Older adolescents emphasized the desire to “have a voice” during decision-making and sometimes felt “left in the dark” by professional or under pressure from parents.
This evidence notwithstanding, there is a benefit in eliciting assent from patients before they are capable to participate meaningfully in decision-making. Based in English common law, most agree that assent should be obtained from children even as young as 7 year old to foster a sense of agency and inclusion. The committee on bioethics from the American Academy of Pediatrics outlines the assent process to involve creating a developmentally appropriate awareness of the condition, establishing expectations, making an assessment of the child’s understanding, and soliciting an expression of the patient’s willingness to accept the proposed care.
It must be noted that shared decision-making is particularly useful for elective surgeries or for cases with multiple acceptable treatment options but has a limited role in decisions regarding essential interventions. It is important also for the surgeon to note that there may frequently be disagreement between the parent and the patient about the desired degree of the other’s involvement in decision-making, especially as the patient matures into adolescence. One study demonstrated that only 34% of surveyed children and their caregivers agreed upon their decision-making preferences. Another study based on semi-structured interviews with patients with cleft lip and palate and their caregivers found differences in opinions regarding the necessity of surgery. Additionally, while a large proportion of patients believed their opinions mattered in decision-making, less than half of caregivers agreed. In navigating discussions in cases where multiple treatment options are acceptable, it is important for the surgeon to be aware that these differences in opinion may exist and possibly to elicit the patient’s opinion in private if it feels that they are being pressured into a decision.
Clinical context
There is a wide spectrum of severity in craniofacial conditions with varying functional and esthetic concerns. As such, interventions can be classified into essential, life-saving operations, functionally essential operations with threat of permanent disability, and those that are non-essential to life or function and serve only to correct an esthetic deformity. The approach to decision-making and the ethical concerns vary accordingly. The following clinical scenarios examine challenging situations and apply the ethical framework laid out in the previous section to guide ethical decision-making.
Parental Refusal in Essential Surgeries
The scenario of parental refusal to consent to an essential operation fortunately is rare. However, there are times when fear and anxiety regarding potential risks of an operation or a misguided acceptance of a deformity compromises decision-making and creates a potential for harm. Consider, for example, a syndromic child with multi-suture craniosynostosis presenting with early signs of elevated intracranial pressure (ICP). The parents see the deformity as an esthetic concern only, failing to recognize the implications for neurocognitive development and risk to vision loss.
There are several ethical justifications for challenging parental authority in this scenario. The best interest standard is clearly compromised as the decision fails to pass the test of clinical reasonability. In the context of the harm standard, failing to act in this scenario falls below the harm threshold and demands state intervention. In a patient-centered argument, failure to proceed with cranial vault reconstruction deprives the child of the right to an open future—namely, the right to normal cognitive function and the right to full vision. Intervening on the child’s behalf optimizes his or her future potential.
Craniosynostosis is a challenging condition to manage from an ethical perspective because treatment recommendations often vary by institution with evidence purporting similar outcomes. Parents who may seek multiple opinions can be exposed to conflicting recommendations, which can be confusing to parents and also undermine trust in the institution. Consider again a syndromic patient with bicoronal craniosynostosis presenting this time without elevated ICP. While one institution may favor an open approach cranial vault reconstruction or posterior vault distraction, others have shown that a less invasive endoscopic strip craniectomy can achieve similar outcomes. There is clinical equipoise between these treatment options and it would be reasonable for the family to proceed with the less invasive option even if this runs counter to the recommendations of the first institution. However, if that same child were to return later with signs of elevated ICP and parents received conflicting information from another institution that observation was a viable option, there would be ethical justification to challenge parental authority. The critical difference between these cases is that the latter presents clear and obvious harm to the patient.
Cleft palate repair is another essential operation with important functional implications. Parental refusal to consent to the repair does not present a risk to the child’s life. But it clearly fails to meet the best interest standard and deprives the child to an open future of being able to communicate effectively. It would have detrimental effects on social integration and constrain the ability to lead a productive life. Moreover, it could compromise feeding, which could lead to a failure to thrive.
Semi-Elective Surgery
However, there are times when the essentiality or clinical benefit of a procedure is less certain. If we refer back to the previous example of the child with craniosynostosis but change the presentation to a non-syndromic child with single-suture synostosis without concerning behavioral or ophthalmologic findings, the decision to intervene becomes less clear. Given the inherent surgical risks of cranial vault reconstruction, is it reasonable to allow the parents to pursue an observation approach? In this case, a shared-decision approach may meet the standard of reasonability as long as the family is deemed capable of close follow-up and monitoring.
Selvaggi and colleagues have written about the ethical implications of intervening in this scenario and highlight the mixed clinical evidence regarding the benefit of surgery for single-suture craniosynostosis on the child’s neurocognitive development and social acceptance. Considering the uncertainty in benefit to the patient, failing to intervene in mild cases certainly does not meet the harm threshold. However, does it undermine the best interest standard or violate the patient’s right to an open future? Some would argue that it does. Consider the potential consequences of a type 2 error in these cases that is a failure to reject the notion that no difference in future neurocognitive function exists. The decision to forego surgery in that case introduces the possibility, however small, of limiting that child’s future potential and would represent a loss of equal opportunity. In this calculation, the desire to avoid the potential to do harm by inaction typically outweighs the uncertain benefit of the intervention. Most parents, hoping to avoid the guilt and regret associated with a potentially negative consequence, choose to intervene.
In dealing with uncertainty in medical decision-making, it is sometimes best to invoke the standard of reasonableness, wherein the benefit to burden ratio is balanced such that most people in a similar situation would agree with the course of action. Ultimately, a shared-decision approach is reasonable in this situation as multiple treatment options are acceptable under specific conditions. The surgeon must be able to trust the family and evaluate their ability to monitor the child for the development of behavioral symptoms and the family for their part must demonstrate the ability to comply with regular visits.
Alternatively, consider a patient with an isolated incomplete cleft lip. Parents are uncomfortable with the risk of anesthesia and refuse to consent to surgical repair. There is very limited functional concern and the patient is not likely to suffer delays in speech or feeding as a consequence. The potential for harm is less severe as in the previous case. However, along the spectrum of severity in incomplete cleft lips, there is a threshold at which it becomes a noticeable facial deformity. As such, it has the potential to interfere with social functioning and early repair can help mitigate the risk of the child being ostracized for appearing different. It would be in the best interest of the patient to undergo repair in this case and the surgeon has the moral responsibility to make this argument to the parents on the child’s behalf. However, in the context of the harm standard, this decision would not meet the threshold for superseding the parental authority over the child.
Elective Surgery
There are many reconstructive craniofacial surgeries that are performed to “normalize” appearance without functional implications. In these circumstances, it is important to ascertain the specific parental and patient motivations for surgery as studies have shown significant incongruity can exist between them. The best approach to decision-making in these cases is a shared-decision model. Consider a prominent ear deformity or microtia repair. These operations are sometimes sought by parents prior to the child’s ability to participate in the decision-making. Or alternatively, the child may disagree with the perceived necessity of the repair. The argument often presented by parents in favor of pursuing surgical repair is to avoid exposing the child to stigmatization that may be associated with the particular deformity. The question is whether proceeding with surgery in purely elective cases is ethical.
Taking again elective otoplasty as an example: Is it harmful? Not exactly. It is a safe, frequently performed procedure with reliable outcomes. The best interest standard better accounts for the factors that should be considered beyond the likelihood of causing harm. In this context, it must be noted that many patients in late adolescence and early adulthood are content with their “abnormal” attribute and elect to forego repair of a microtia or prominent ear deformity. In these cases, the parental desire for a normal appearance and the surgeon’s willingness and ability to correct the deformity sometimes conflicts with the patient’s own desire. It is imperative to seek the opinion of and respect the autonomy, present and future, of the developing child.
It may be helpful to view this scenario through the lens of the right to an open future. In particular, in microtia repair, there are multiple surgical options that vary significantly in morbidity and potential complications. Initial treatment choices may limit future reconstructive options and thereby restrict the ability of the patient to choose once he or she becomes fully autonomous to make such decisions. In these instances, it is therefore better to delay surgery until patients express a desire of their own volition that is motivated by a well-defined set of values and expressed motivations. It is the ethical responsibility of the surgeon to protect the child’s autonomy, at times against the request or desires of the parent or caregiver.
Surgery in Patients with Severe Comorbidity
Unfortunate cases occasionally arise, where an operation is sought for a patient with severe neurologic or multi-system comorbidities. These cases can evoke questions of whether the intervention can meaningfully contribute to that child’s overall well-being or quality of life. Would it be ethical, for example, to perform a cleft lip repair on a child with significant neurologic compromise who is not expected to develop the ability to communicate or feed orally, or interact in a meaningful way with others? The most appropriate way to approach this question is by analyzing the risks associated with the procedure given any existing comorbidities. The foremost priority should be to do no harm. At times, significant cardiologic or pulmonary pathology can make any intervention requiring anesthesia a high-risk event, which would then fail to comply with the best interest standard.
However, the notion that subjective valuations on quality of life alone should drive decision-making is flawed. It is impossible to surmise how a seemingly trivial correction in facial appearance can impact another person’s life, even in the context of severe disability. , There is legal precedence for this argument in the “Baby Doe Rules.” These were established by federal regulations in 1985 and declare that surgery ought not to be denied based on a subjective opinion of the patient’s perceived quality of life because of his or her disabilities. However, there is no ethical mandate to perform surgery and the decision remains within the surgeon’s discretion. This position is supported by the American Medical Association, which states that physicians are not ethically obligated to deliver care that, in their best professional judgment, will not have a reasonable chance of benefiting their patients. The best interest standard is again invoked to help with medical decision-making in these difficult situations with emphasis on minimizing the risk of surgery.
Summary
Determining an ethical standard can be challenging in craniofacial care and situations arise where clinical uncertainty and parental disagreement can lead the surgeon to question what is best for the well-being of the child. Maintaining a patient-centered ethos that focuses on the best interest standard while maintaining the patient’s right to an open future can guide the surgeon in negotiating with the patient and caregiver the implications and clinical significance of any proposed surgical intervention.
Clinics care points
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The best interest standard is the prevailing contemporary ethics framework for medical decision-making in pediatrics.
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Parental autonomy to make medical decisions is not absolute and should be challenged when the patient’s best interest is compromised.
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Children should be included in a shared-decision model as early as feasible to promote autonomy and inclusion in medical decision-making.
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Pediatric assent should be obtained from patients as early as 7 years of age.
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