Ethical Considerations in Pediatric Surgery

ABSTRACT

Pediatric surgeons need to learn to give as much importance to the ethical approach as they have been giving to the systemic methodology in their clinical approach all along. The law of the land and the governmental rules also need to be kept in mind before deciding the final solution. They need to always put medical problems in the background of ethical context, reach a few solutions keeping in mind the available resources, and apply the best solution in the interest of their pediatric patients.

Before dwelling on the subject, let me share some examples where we, the pediatric surgeons, are embroiled in difficult ethical dilemmas:

• A 38-year-old mother from a poor socioeconomic background has given birth to a term baby who has both Down’s syndrome with anorectal malformation (ARM). The doctors at Taluka Hospital sent the newborn home feeling that it would be a futile exercise to treat, but the parents chose to come to you for a second opinion

• An infertile couple, after 20 years of infertility treatment, has a newborn with an open meningomyelocele and hydrocephalus. The parents want your opinion on whether to consider aggressive management or palliative care

• A newborn is born with a small hypospadiac phallus. Investigations reveal that it is a 46XX disorder of sexual development, but the father wants the hypospadias repaired as he wants to raise the baby as a son

• An 11-year-old girl comes to you with her parents with complaints of burning micturition and vaginal discharge. During the examination, she confides that she was sexually abused by a family member. However, parents do not want this to be reported to the police. Ask you to only provide clinical treatment

• A couple comes with a baby girl who has esophageal atresia. You determine that surgery is urgently needed. However, the parents are unwilling to give consent for the surgery as the baby is a dark-skinned girl. They use the excuse of not having the financial means to afford the surgery.

Ethics is the philosophical discipline concerned with what is morally good and bad, and morally right and wrong.[1] The Hippocratic Oath is probably the oldest (25 centuries old) document available that has guided us, the physicians, to maintain the highest standard of professional conduct and to serve humanity with nobility and dignity, uninfluenced by the motive of profit.[2] Primum nonnocere (do no harm) is its most important dictum.

The technological advances in medicine after World War II, the activism of the 1960s, and the recognition that the traditional paternalistic approach to patient care contradicted contemporary notions of individual rights about half a century ago led to ethics in our super specialty. The four major events that gave the impetus in the 1970s-early 1980s included a public display of a documentary film from Johns Hopkins Hospital about a newborn with trisomy 21 whose parents refused to permit lifesaving surgical care to repair congenital intestinal obstruction (1971), an article in the New England Journal of Medicine that highlighted that 14% deaths in the neonatal intensive care unit (ICU) at the Yale-New Haven Hospital resulted from decisions to withdraw or withhold lifesaving treatment (1973), a survey of the attitudes of the pediatric surgeons and the pediatricians published about difficult choices in treating and not treating infants with a variety of congenital anomalies (1977) and the famous Baby Doe case in 1998.[3,4] Recently, the Madras High Court directed the State Government of Tamil Nadu to prohibit genital-normalizing surgery (referred to as sex reassignment surgery in the case) for intersex infants and children except on life-threatening situations. This forced our Indian Association of Pediatric Surgeons to clarify few issues and publish relevant guidelines on the management of differences in sex development.[5] The latest in this row is the Supreme Court of India’s decision, a few days ago, denying an abortion to a mother at 26 weeks of gestation quoting the rights of the fetus.[6] Hence, an intense political, legal, medical, and moral debate is ongoing that has parental autonomy, clinical prognosis, and children’s rights in focus.

The foundations and core principles of ethics are discussed here keeping in view the values and beliefs, health-care interactions, and ensuing conflicts between the different co-fiduciaries. Of the foundations of ethics, the two most important ones include co-fiduciaries and Best Interest Standards.[7,8] Here, a fiduciary is a person or organization that acts on behalf of a child and is legally bound to act solely in the child’s best interests, and when two or more fiduciaries are jointly working in a fiduciary capacity, then they are known as co-fiduciaries. The pediatric patient, the parents or a legally authorized representative (LAR), and the pediatric surgeon are three co-fiduciaries and have a sacrosanct triadic relationship.

The four core principles of ethics include Beneficence (to do good), Nonmaleficence (to do no harm), Autonomy (freedom and capability of making a considered informed choice), and Justice (fairness, equal distribution, and prioritization of special groups).[9] The first three core principles relate to individual children’s health, whereas the fourth, Justice, is more relevant to public health. In children, the principle of Beneficence overrides all other principles. In adolescents and “mature minors,” the principle of Autonomy also gains importance. On reaching adulthood, the patient’s autonomy takes over as the most important ethical principle. However, this autonomy is not absolute even in adults. The harm principle says people should be free to act, however, they wish unless their actions cause harm to somebody else.[10] For example, a government cannot make its citizens use a potentially life-saving cancer treatment because no one else is harmed by a person’s decision to refuse this treatment, but if it is COVID where one’s decision not to take vaccination could harm other members of the society, then one’s autonomy gets overridden by the government’s authority for the larger good of the society.

Besides these four core principles, there are three Cs (Consent, Capacity, and Confidentiality), and Capacity is defined as being able to understand and retain the information relevant to the decision, use or weigh up the information, and communicate the decision by any means.[11]

Children are emotionally and cognitively naive. The consent for surgical procedures is given by either their parents or a LAR till they turn adults.[12] Consent is an instrument of mutual communication between doctor and parent/LAR with an expression of authorization/permission/choice by the latter for the doctor to act in a particular way. There are many types of consent – implied, blanket, third-party, exceeding, proxy, and informed. It is well known that only informed written consent is valid legally. Information regarding diagnosis, nature of treatment, prognosis if treatment is not done, risk involved, prospects of success, alternative treatment, and finance has to be explained in the language using nonmedical terms that the parents comprehend well. It is important to know that the consenting individual is of sound mind and has the capacity to understand, rationalize facts, and give consent with free will. At least one hospital staff and one neutral witness should countersign the consent. The consent could be waived off in emergencies and natural calamities when working under court orders or when there is fear of infection to others.

Assent is the process when we take permission from children over 7 years of age for history taking, examination, and procedures to promote good rapport with the child.[13] Children between 7 and 12 years give oral assent that is documented. Older children between 12 and 18 years are expected to give written assent. This is done keeping in mind the autonomy of “mature minors.” The adolescents need special understanding in a few situations, e.g., an alleged history of sexual assault and/or pregnancy, thereof, and a proposed gender reassignment surgery or bariatric surgery. POCSO Act (2012) dictates that all sexual encounters/sexual assault, mutual, or otherwise need to be informed to the police.[14] While communicating with the adolescents, the Home, Education, Eating, Activities, Drugs, Sexuality, Suicide, and Safety Questionnaire is used.[15] Some of these questions may upset the parents and embarrass the adolescents, but drugs and sexuality do exist in them. Tact must be used while questioning. The adolescents would occasionally approach the pediatric surgeon unattended and insist on confidentiality and that we should not reveal the facts to their parents. Situations in which confidentiality for adolescents is especially important but essential to get parental consent (legally mandatory) include contraception, abortion, sexually transmitted infections, substance misuse (particularly illicit drugs), and mental health issues.

Then, there is an important element of Veracity (truth-telling above personal interests and openness). Both patient and physician must be truthful since this forms the basis of trust between the physician and patient.

The last few decades have witnessed an evolution as regards patient–doctor relationship (PDR) models.[16] The Paternalistic model that was in vogue till the last century meant that the doctor decides for the patient was replaced by the Informative model (the doctor gives the facts to other co-fiduciaries), which eventually paved the path for the Deliberative model (where the doctor gives the facts and in additions informs about his/her preferences). The PDR model that prevails in our profession today is the Interpretative model where the doctor gives the facts and helps the other co-fiduciaries to find their preferences. This model involves active dialog between the co-fiduciaries for mutual understanding and agreement on a treatment plan, thus laying the foundation of shared decision-making. Here, all invested are satisfied and invested in the outcome, and there is improved treatment adherence and disease coping.

Triadic encounters with all openness are likely to generate differences of opinion if not a more major rift.[17,18] Hence, shared decision-making would come with its perils; it has various barriers and facilitators at the decision, innovation, adopter, and relational and environmental levels. The most important barriers are parental. These include financial, informational, sociocultural, religious, and gender-related barriers. The gender-related barriers in a patriarchal society like ours do not only include gender-based discrimination against girls as regards whether to avail treatment or not, but parents may have a preference for a pediatric surgeon of a particular gender. Consent for care may be expected to be given only by the father of the child.

PDR components that are vital to resolving such issues would include Professionalism, Competency, and Communication. To address that there must be no language barrier during communication; parent health literacy should be encouraged and all surgical procedure-related myths should be busted, and instead, correct and complete information should be provided. Communication must be nonjudgmental and empathetic with the intention of providing trust and support to the other co-fiduciaries.

The conflict between doctors and other co-fiduciaries could be mild (poor inter-relationships), moderate (deterioration of trust) to severe (disintegrating of working relationships). We have witnessed multiple examples of outrageous behavior and violence by the family of the child against doctors in recent years, and the government rules made in this context have failed to show any deterrent effect on such instances. To resolve or avoid conflicts, we should use the interpretive model of PDR, avoid giving unrealistic expectations, and ensure that everyone in the team is giving the same message. Follow institutional policies on handling media-related issues. Media interactions should be managed by designated and appropriately trained staff resorting to “no comment” is often unhelpful and the media should be engaged positively. Confidentiality should be maintained. Be careful in your engagement on social media.

Next, let us discuss the ethical issues involved in the treatment of sick surgical pediatric patients in neonatal and pediatric ICUs.[19,20] Parents are not always able to make fully informed or voluntary choices about their critically ill child’s treatment incapacitated by grief, despair, and exhaustion. Undoubtedly, beneficence and best treatment standards would be the guiding principles; however, there is always ambivalence and moral distress when we weigh the potential benefit of sustaining life through aggressive therapies and the use of medical technology against the potential harm and suffering that comes from the use of these same treatments. Moral distress is felt when one has the impression that the pediatric surgeon is required to act against a core personal or ethical obligation based on an external force. There is no one right “answer” or resolution, and in severe illness, decisions are rarely happy and are usually painful. It is not clear when chances for a cure are completely gone and when to give up hope.

Medical futility refers to interventions that are unlikely to produce any significant benefit to the patient.[21] Futility refers to a particular intervention at a particular time for a specific patient. Two kinds of futility are known – Quantitative futility (the likelihood that an intervention will benefit the patient is exceedingly poor) and Qualitative futility (the quality of benefit an intervention will produce is exceedingly poor). Ethics behind withholding therapy apply in “No chance situation” (where life-sustaining therapy only serves to delay death without relieving suffering), “no purpose situation” (the child may survive with curative treatment but be left with severe physical or mental impairment), and “unbearable situation” (where in the face of progressive and irreversible illness, the burden of further treatment is more than could be borne). The conflict between the ethical principles of beneficence (acting in the best interests of the infant) and autonomy (the parents’ decision-making authority for their infant) would often ensue. Remember the resources (ventilators and oxygen) are always scarce in public hospitals.

Medical ethics discussed above generally applies to individual interactions between physicians/surgeons and patients. Conversely, public health ethics typically applies to interactions between an agency or institution and a community or population. Public health ethics involves a systematic process to clarify, prioritize, and justify possible courses of public health action based on ethical principles, values and beliefs of stakeholders, and scientific and other information.[22] Other than the four core principles of ethics, equity, social justice, participation, efficiency, effectiveness, acceptability, affordability, and accessibility are the other principles involved.

SOPs, surgical checklists, and preoperative surgical marking of the side of surgery are all done, but still, errors and complications occur.[23,24] There is an occasional failure to recognize a complication or delay in instituting treatment promptly. Surgical morbidity and mortality conference within the department allows us to introspect to avoid these errors. If an error occurs, the pediatric surgeon has the responsibility to inform patients and families about it and its consequent adverse events and offer a genuine apology. Failure to do so is a breach of professional and ethical norms. The pediatric surgeon should share any predictable adverse sequelae, discuss how the patient will be treated henceforth, and be clear that all resources of the hospital will be available for future treatment related to the error. The pediatric surgeon should also explain how he/she and the institution will prevent future errors. It should be seen as an endeavor to preserve the patient and parents’ trust, the underlying principle in the PDR.

A surgical innovation is defined as a new or modified procedure that differs from currently accepted local practice or “gold standard,” with outcomes yet to be described, and which may carry risk to the patient.[25] Traditionally, unlike phased drug and vaccine trials, there has been minimal or no oversight of surgical innovation, giving surgeons the freedom to develop new operations, modify existing procedures, and introduce new treatments. Most “new” operations are performed at a single academic center, the results of the institutional series are presented at a professional meeting, and one or more papers detailing the clinical outcomes are published in surgical peer-reviewed journals. Surgeons then adopt the “new” operation, several clinical series in multiple institutions are evaluated, and a more realistic assessment of its benefits, risks, and outcomes can be determined over an extended period. Proponents of surgical progress applaud the freedom to create and innovate, while others caution that lack of organized oversight carries risks of injuring patients or not helping them with overzealous operative innovations.

A process that safeguards the patient’s interests must be followed. A review of the planned surgical innovation by a local surgical innovations committee or IEC, submission to the National Innovations Registry, and additional and specific informed consent that outlines the experimental nature of the proposed innovation are mandatory. The informed consent standards for research need to be higher than those for clinical practice because of the presumption that participation may not necessarily benefit the subject.[26] During a commonly accepted operation, surgeons are often required to make unanticipated modifications based on unique patient anatomy and other circumstances. These situations, often considered tinkering, do not rise to the level of surgical innovation but do warrant full disclosure to the patient and family postoperatively.

The death of a patient who was operated upon by a Japanese surgeon as part of a live surgery workshop at the All India Institute of Medical Sciences in Delhi in July 2015 has rekindled a debate on the ethics of organizing such workshops and the rights of patients on whom the procedures are carried out. Only a few days ago, the Supreme Court has issued notice to the Center and the National Medical Commission (NMC) in a public interest litigation (PIL) plea challenging the live demonstration of surgeries.[27] The PIL petitioners have claimed that advertising and sponsorship are the primary motivations behind such live procedures, which are then broadcasted at surgical conferences. This, they argued, compromises the purity of medical education and patient safety. There may be an element of truth in this allegation, and one of the editorials published in JIAPS in 2018 had earlier discussed this tricky issue.[28]

The topic under consideration is vast and dynamic as new issues keep arising and we as an association would need to keep setting new boundaries in those issues that are not anticipated. NMC needs to keep updating the code of medical ethics that was formulated by the erstwhile Medical Council of India in 2002, more than 2 decades ago.[29] The Indian Council of Medical Research also needs to come out with an updated version of the National Ethical Guidelines for Biomedical and Health Research Involving Children; it was last published in 2017.[30]

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.