You are in: eMedicine Specialties > Pediatrics: Surgery > General Surgery Ethical and Legal Considerations in Pediatric SurgeryArticle Last Updated: Apr 24, 2006AUTHOR AND EDITOR INFORMATIONSection 1 of 9
 
Author: Mary E Fallat, MD, Professor, Department of Surgery, Division of Pediatric Surgery, University of Louisville School of Medicine Mary E Fallat is a member of the following medical societies: Alpha Omega Alpha, American Academy of Pediatrics, American Association for the Surgery of Trauma, American College of Surgeons, American Medical Association, American Society of Andrology, American Trauma Society, Association for Academic Surgery, Kentucky Medical Association, North American Society for Pediatric and Adolescent Gynecology, Society of University Surgeons, Southeastern Surgical Congress, and Southern Medical Association Coauthor(s): G Kevin Donovan, MD, Professor and Vice Chair of Pediatrics, Director, Oklahoma Bioethics Center, Schusterman Health Sciences Center, University of Oklahoma College of Medicine at Tulsa Editors: Denis Bensard, MD, Director, Pediatric Trauma, Division of Pediatric Surgery, Children's Hospital of Denver; Associate Professor, University of Colorado Health Sciences Center; Mary L Windle, PharmD, Adjunct Assistant Professor, University of Nebraska Medical Center College of Pharmacy, Pharmacy Editor, eMedicine.com, Inc; Gail E Besner, MD, Professor of Surgery and Pediatrics, Department of Surgery, Ohio State University College of Medicine and Public Health; Director, Pediatric Surgical Research, Department of Surgery, Children's Hospital; H Biemann Othersen Jr, MD, Professor of Surgery and Pediatrics, Emeritus Head, Division of Pediatric Surgery, Medical University of South Carolina; Harsh Grewal, MD, FACS, FAAP, Professor of Surgery and Pediatrics, Temple University School of Medicine; Chief, Section of Pediatric Surgery, Temple University Children's Medical Center Author and Editor Disclosure Synonyms and related keywords: ethical and legal considerations in pediatric surgery, Hippocratic oath, ethics, medical ethics, informed consent, do not resuscitate, DNR, do-not-resuscitate order, DNR order, do not attempt resuscitation, DNAR, do-not-attempt-resuscitation order, DNAR order ETHICAL PRINCIPLESSection 2 of 9
 
The pediatric surgeon works at the juncture between surgery and pediatrics and, consequently, must deal with the surgical, medical, and ethical issues that concern both areas. Unique new challenges as well as ancient traditions in medicine can influence the pediatric surgeon's approach to ethical dilemmas. Historically, the Hippocratic oath defined the ethical principles guiding medicine, instructing physicians to use their knowledge and skills for the benefit of their patients and to protect their patients from harm. This tradition did not define a role for the patient, surrogate, or parents in the decision-making process. Consequently, a collaborative process has evolved, incorporating the ethical principles of patient autonomy, respect for persons, nonmaleficence, beneficence, and justice. In this model the physician contributes medical knowledge, skill, and judgment; the patient or the patient advocate contributes a personal evaluation of the potential benefits and risks inherent in the proposed treatment. In cases involving the treatment of minors, special challenges may arise in shared decision-making, as well as the balancing of beneficence and burdens. For excellent patient education resources, visit eMedicine's Public Health Center. Also, see eMedicine's patient education articles Patient Rights and Informed Consent. PHYSICIAN AND PATIENT RELATIONSHIPSection 3 of 9
Physicians enter a professional relationship with a pediatric patient by one of two routes, either electively or emergently. Usually, a parent or guardian of a child makes an appointment to see a physician about a medical problem, and the physician agrees to provide treatment in exchange for compensation. Alternatively, surgeons, as emergency call physicians, may encounter situations in which care must be rendered without a prior relationship. In such cases, a surgeon may need to operate on a pediatric trauma patient without informed consent from the parent. Responsibilities in emergent care If a children's hospital or a hospital with pediatric expertise represents itself as operating an emergency department or a trauma center for children, that hospital has several legal duties that reflect its ethical responsibilities, including the following:
The hospital is considered an entity composed of both administrative and medical staff (paid and volunteer), each sharing joint responsibility for the development of standards and monitoring the quality of patient care. Therefore, the capable attending pediatric surgeon must provide competent emergency medical care, including surgical care as needed. Once treatment is undertaken, the surgeon may not unilaterally terminate the legal relationship unless or until one of the following conditions is met:
Responsibilities in routine care Responsibilities found in the routine care of pediatric surgery patients do not vary greatly from those of other pediatric patients, or indeed patients in general. The same ethical principles that guide all decision-making are pertinent, with attention to the special circumstances in the care of children. Thus, the obligation exists for nonmaleficence, ie, "in the first place, we should do no harm." Equally, treatment offered must be beneficent and offer some good or benefit to the patient, and care must be competent and compassionate. The physician's professional obligation to place the patient's interest before his own may be sorely tested in the care of children, not only by the large number of underserved and uninsured patients in the field, but also by occasional difficulties in agreeing on what the child's best interest may be. Respect for persons and their autonomy has a different meaning when the patients cannot make decisions at all, as in the case of infants and small children, or in the case of the evolving capacity of adolescents. When the patient is a child, a potential for conflict is introduced into the patient-professional relationship. Issues may include the following:
Parents are allowed considerable latitude for medical decisions on behalf of their children, and the law protects the natural rights of parents to raise children free from unwanted interference. The presumption is that parents act in the best interests of their children and these rights are conditional on parental fulfillment of the duty to provide necessary care for minor children. INFORMED CONSENTSection 4 of 9
In respecting patient autonomy and self-determination, physicians must obtain informed consent from a parent or surrogate before a child can undergo medical interventions, other than in the case of emergencies. As a component of informed consent, the surgeon must consider and discuss with the family the risks and benefits involved with each surgical procedure. Truly informed decisions require that parents or surrogates receive and understand accurate information about their child's condition and prognosis, the nature of the proposed intervention, the alternatives, and the risks and benefits. Parents or surrogates must be able to do the following:
Informed consent in children presents special problems, both philosophically and legally. In the United States, adult patients are presumed to have decision-making capacity unless a court of law has declared them incompetent to make such decisions. Children are persons in the social sense and they have rights, but they are not judged legally competent to make decisions about their medical treatments until they reach the age of majority, ie, 18 years. Therefore, children cannot give consent for themselves, but they can assent to procedures, either indirectly (by their acquiescence) or directly when they are involved in the discussion. Because nothing miraculous happens on an 18th birthday to make a person a mature adult, it is a legal status only. Many young people can make morally mature decisions before they are legally entitled to do so. Therefore, older children and adolescents should be included in the decision-making process (patient assent), depending on their neurologic status, development, and level of maturity; however, legally, they require a surrogate decision-maker to act on their behalf (ie, parental permission). What parents actually do, therefore, is give permission for a treatment or surgery on their child; only a competent, fully autonomous individual is capable of giving consent, and then only for himself. In fact, some minors are considered emancipated and, therefore, able to make legally autonomous decisions in most states. This category often includes: 1) those in the military; 2) those legally married; 3) those economically independent; or 4) those who are parents of a child. Moreover, in most jurisdictions, even unemancipated minors may legally consent to certain specific medical procedures, such as contraception, abortion, or treatment for sexually transmitted diseases (STDs) or drug abuse. These vary from state to state. Some state's courts have even recognized a status of mature minor, an adolescent who does not fall into the above legal categories but possesses sufficient maturity and intellect to be allowed to make autonomous decisions over parental objections. This last category offers no predefined legal protection for the minor or the physician who would allow him or her full decision-making authority. A child's surrogate, usually a parent, should be the person judged to be the most competent to determine what actions are in the best interest of the child. This presumption holds when the parent or surrogate appears to be acting in the child's best interest and otherwise can be challenged. Whether or not the child is able to participate in decision-making, treatment decisions should consider potential benefits to the child; potential harmful consequences (eg, physical suffering, psychological or spiritual distress, fatality); and the moral, spiritual, and cultural values of the child's family. Special circumstancesReligious objections Conflicts of interest or religious preferences may lead parents to make decisions that may not be in the perceived best interests of the child. The children of Jehovah's Witnesses, particularly those who require an operative procedure that is associated with a risk of significant blood loss, are best considered in a distinct consent process that incorporates the religious views but upholds the rights of the child. An example of such a consent form is illustrated in Image 1, which was the product of a concurrence among members of the Jehovah's Witnesses, physicians, and lawyers. Emergency care When a child is brought to an emergency department by prehospital care providers, no parent is in attendance, and the child needs emergency treatment or surgery, most hospitals and operating rooms allow treatment to be initiated under the theory of implied consent for emergency treatment. Aggressive attempts should be made by emergency department personnel to locate the child's parent(s) or guardian, but life-saving maneuvers, including surgical procedures, should not be withheld. Under the circumstance of need for urgent surgery, an institutional requirement may be in place for two or more physicians, generally those who are not involved in the technical procedure, to sign a consent form on behalf of the child, indicating their agreement that a true emergency exists and the proposed surgery is warranted. Children of divorced parents Many parents are divorced, and custodial arrangements for their child may be complex. If a child's parents are divorced, the custodial parent usually has the authority to make medical decisions on behalf of the child. For new pediatric patients coming to the clinic or office, registration forms should denote with whom the child lives and who has legal custody. At times, the custodial parent may indicate a desire to limit visitation or provision of information to a noncustodial parent. In some states, statutes provide that medical records of a minor may be released to both the custodial and noncustodial parent. However, a parent may be denied access to a child's records if the information is being sought for the purpose of the parent and not for the benefit of, or on behalf of, the child, as for instance, an unmarried father seeking the address of his children. Antagonistic parental relationships may interfere with the physician's ability to render appropriate care to the child. Examining written divorce settlements may be necessary to determine what is legally appropriate. These tasks can be delegated to a member of the hospital legal department if necessary. Unfortunately, a parent may occasionally become offensive, abusive, or aggressive, and the security services of the hospital may have to be involved and/or visitation privileges may have to be restricted or rescinded. Neonates with major malformations Baby Doe cases involve decisions by physicians and parents to withhold life-sustaining treatment from severely handicapped or critically ill newborns. The name was given to legal cases in which babies with Down syndrome or spinal bifida required surgeries, but their parents refused consent. These resulted in court challenges, executive rulings, and congressional action. At times these solutions were highly intrusive, even requiring the posting of hot-line numbers in the NICU for the use of anyone who was concerned that infants were being denied necessary care. Multiple ethical and legal concepts must guide those involved in the decision-making process. These include the physician-patient relationship, informed consent, rights of the incompetent, and conflict between the family and the community. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research offered an approach to a best interests analysis in these cases, and congress subsequently established somewhat controversial guidelines. Treatment may be withheld from neonates under the following conditions:
The Department of Health and Human Services interpreted these provisions narrowly to specifically exclude consideration of the potential quality of life of the affected infant and to require that infants be provided with sufficient nutrition and hydration to sustain life whenever medically possible. Neonatologists differ in their opinions regarding whether these guidelines lead to excessive treatment of infants who are hopelessly ill. The main ethical dilemma in these complex cases involves balancing the benefits of prolonging life through the use of multiple invasive medical and surgical procedures against the potential burden on the child and family. DO-NOT-ATTEMPT-RESUSCITATION STATUS AND IMPLICATIONS FOR PEDIATRIC SURGEONSSection 5 of 9
Do-not-resuscitate (DNR) is the traditional order given for an individual who should not receive cardiopulmonary resuscitation (CPR) in the event of a cardiopulmonary arrest. This term suggests that resuscitation would be successful if undertaken. The term do-not-attempt-resuscitation (DNAR) may be a clearer indication that success at resuscitation is often not achieved. Unlike other medical interventions, CPR is generally initiated without a physician's order under the theory of implied consent for emergency treatment. In the United States, a physician's order is necessary to withhold CPR. The scope of a DNAR order may need clarification. A DNAR order does not and should not preclude interventions such as administration of parenteral fluids, nutrition, oxygen, analgesia, sedation, antiarrhythmic agents, or vasopressors. When appropriate, a DNAR order should be written for a child in specific clinical circumstances and should be reviewed at regular intervals. Decisions to limit resuscitative efforts should be communicated to all individuals involved with the care of the child. DNAR orders are written for children when an attempt to resuscitate would not benefit the child and if the parent or surrogate expresses his or her preference that CPR be withheld in the event that the child experiences a cardiopulmonary arrest, provided this is in the child's best interest. Orders for DNAR are written on the assumption that cardiopulmonary arrest would be a spontaneous event that is the culmination of the dying process of a child who has a terminal illness or a poor quality of life. CPR is inappropriate when survival is not expected or if the patient is expected to survive with a devastating neurologic impairment that was not preexisting. Criteria for not starting CPR The American Heart Association has recently issued new guidelines for withholding CPR. A special circumstance for the pediatric surgeon involves the newly born child with certain chromosomal or anatomic defects with a uniformly poor prognosis or extreme prematurity. For the newly born, antenatal information about gestational age or congenital anomalies may be uncertain, and prediction of outcome may not be possible or accurate. In these cases, a trial of therapy and additional assessment of the infant may allow the surgeon to better assess diagnostic and prognostic data for family counseling and allow better-informed discussions about continuation or withdrawal of support. However, current data support the belief that resuscitation of infants with extremely low birth weight (<23 wk or <400 g) with certain chromosomal or anatomical defects is unlikely to result in survival or in survival without extreme disability. This constitutes quantitative or qualitative futility, and noninitiation of resuscitation in the delivery room is appropriate. Criteria for terminating resuscitative efforts Surgeons and health care professionals must understand the patient's disease process, potential for arrest, and systemic factors that have prognostic importance for resuscitation. These include the following:
None of these factors alone or in combination is clearly predictive of outcome. The most important factor associated with poor outcome is length of resuscitative efforts. The likelihood of discharge from the hospital alive and neurologically intact decreases as resuscitation time increases. No reliable criteria are available to determine neurologic outcome during cardiac arrest. Prolonged resuscitative efforts for adults and children are unlikely to be successful and can be discontinued if spontaneous circulation does not return at any time during 30 minutes of cumulative advanced life support. If return of spontaneous circulation occurs at any time, considering extending the resuscitative effort may be appropriate. Confounding factors, such as drug overdose and severe prearrest hypothermia, should be considered when determining whether to extend resuscitative efforts. For the newly born infant, discontinuation of resuscitative efforts may be appropriate if spontaneous circulation has not returned after 15 minutes. Lack of response to intensive resuscitation for more than 10 minutes is associated with an extremely poor prognosis for survival or survival without disability. APPROACH TO PEDIATRIC DNAR PATIENTS WHO REQUIRE ANESTHESIA AND SURGERYSection 6 of 9
When an operative procedure is planned for children with DNAR orders, 2 confounding issues confront surgeons and anesthesiologists: (1) anesthesia promotes some degree of hemodynamic abnormality that may result in cardiopulmonary arrest, and (2) many anesthetic manipulations can be separately classified as resuscitative measures. Resuscitative interventions may be broadly defined as maneuvers and techniques used to prevent or reverse cardiopulmonary arrest. This definition is inappropriate in the operative setting where anesthetic agents routinely promote cardiovascular instability. Perioperatively, resuscitative measures should refer only to measures undertaken to restore life once a cardiopulmonary arrest has occurred. Surgery and anesthesia constitute a change in the child's medical status because both introduce additional risks to the patient. Surgeons and anesthesiologists are rarely involved in the original DNAR decision, and they cannot be certain that the implications of the DNAR status in a perioperative setting have been discussed with a patient's parent or surrogate. The parent or surrogate, the surgeon, and the anesthesiologist should reevaluate the DNAR order when a pediatric DNAR patient is considered for an operative procedure. This reevaluation process is called required reconsideration and should be incorporated into the informed consent process for surgery and anesthesia. The surgeon and/or anesthesiologist must approach the parents and child with compassion. If the procedure is urgent or semi-urgent, the patient, parents, and surgical team often have no prior relationship, precluding an extensive preoperative assessment. The parent or surrogate should be asked about specific interventions of resuscitation, with airway management to be determined by the child's condition and the nature of the surgical procedure. For example, specific prohibition of tracheal intubation could prove to be problematic and must be discussed carefully with parents or surrogates. Intervention exceptions should be specifically noted in the patient's medical record. In 1999, the [link]American Society of Anesthesiologists (ASA) released an updated statement regarding its recommendations for caring for surgical patients with active DNAR orders. These guidelines reject the practice of automatically rescinding a DNAR order before procedures involving the use of anesthesia because this practice "may not sufficiently address a patient's rights to self-determination in a responsible and ethical manner." The purpose of the required reconsideration of DNAR orders is to determine what is best for the patient under the circumstances and not to convince the patient and family to have the DNAR order suspended. The 1999 guidelines distinguish between goal-oriented and procedure-directed DNAR orders. A goal-directed approach focuses on the child's goals, values, and preferences rather than on individual procedures. The primary goal is to do everything to prevent the need for resuscitation, but if the need occurs, this approach recognizes that children and families often are less concerned with technical details of the resuscitation than with more subjective and personal issues regarding quality of life following a resuscitation. This approach protects the patient's autonomy while reflecting the reality and unique aspects of the perioperative environment. A procedure-directed approach is more appropriate in circumstances in which the anesthesiologist and surgeon caring for the child have no preexisting relationship with the family. This approach involves a careful consideration of a series of specific interventions but has limited flexibility when an unexpected situation occurs. Some anesthesiologists consider perioperative suspension of the DNAR order to be an ideal compromise because it enables a physician to act without restraint while providing the patient with a realistic chance of achieving his or her operative goals. Anesthetic agents and techniques may promote some degree of hemodynamic and respiratory abnormality, especially in children with a deteriorated health condition. The deliberate depression of vital functions by an anesthetic may require resuscitative maneuvers to stabilize the patient. Many of the routine anesthetic interventions performed as part of operative maintenance are considered resuscitative measures under different circumstances. These include the use of paralytic agents, vasoactive drugs, blood products, and positive-pressure ventilation. In the case of children with DNAR orders, the success of CPR applications may be gauged on the length of patient survival or expected quality of life following resuscitation. Required reconsideration as part of the process of informed consent for anesthesia eliminates the ambiguities and misunderstandings associated with patients with DNAR orders. The child's needs are individualized and potentially better served by giving parents, surrogates, and clinicians the option of deciding among complete DNAR order suspension, limitations based on procedures, or limitations based on goals. In some cases, the family and physicians involved in a child's care chooses to suspend DNAR orders during anesthesia and surgery. The duration of suspension must be defined. Physiologic effects of anesthesia and surgery rarely terminate at the end of a surgical procedure but generally resolve within several hours or a day following surgery. Recovery of respiratory function following surgery is dependent on preoperative pulmonary function, chronicity of illness, and duration of the procedure. Employing mechanical ventilation following surgery is appropriate as long as a child continues to show significant and sustained improvement. The suspension of DNAR orders may continue until the postanesthetic visit by the anesthesiologist, until the child has been weaned from mechanical ventilation, or until all physicians involved in the patient's care and the family agree to reinstate the DNAR order. Regardless of the decision made by a parent or surrogate, the individual acting on behalf of the child should be readily available for consultation during the procedure. If the DNAR order has been suspended and a cardiac arrest occurs during the surgical procedure, the surgeon and anesthesiologist should be allowed to reinstate the DNAR orders intraoperatively through consultation with the family under certain conditions. This includes incidences in which the cause of the arrest is due to the irreversible underlying disease or an uncorrectable complication and CPR would only allow continued deterioration. If resuscitation measures are withheld and intraoperative arrest occurs, such deaths should be classified as expected rather than unexpected for quality assurance purposes. Expected deaths do not require mandatory quality assurance review. ISSUES INVOLVING FAMILY NOTIFICATION AND COMMUNICATIONSection 7 of 9
Family presence during invasive procedures and CPR A growing body of literature exists concerning the topic of family presence during invasive procedures and CPR. The Emergency Nurses Association (ENA) first developed family presence guidelines in 1995 and later revised them in 2001. Health care providers have expressed a variety of concerns regarding family presence, including the concern that it has the potential to interrupt or hinder patient care or to predispose members of the team to litigation if the family perceives that mistakes or wrong decisions have been made. Conversely, studies indicate that most family members want to be at the bedside. In cases when the patient dies, family presence removes the family's doubts and reassures that everything possible was done for their loved one; their presence facilitates grief and does not disrupt the actions of the medical team. To be effective, a family presence program should be standardized throughout an institution. A family support person should be assigned to escort the family to the bedside, stay with the family, escort them out of the room if necessary, and privately address questions and concerns. Each situation must be assessed on a case-by-case basis for suitability. This includes assessment of the family and notification of the physician in charge. All must agree (including the patient if appropriate) that family presence is appropriate and desirable. Few formal studies have been performed in pediatric patients. Those that are available indicate that children prefer to have parents present both for the emotional support and to help them cope with pain during invasive procedures. Similar arguments support the presence of parents with their children until preoperative anesthesia is fully induced. Death by neurologic criteria (brain death) Neurologic criteria for determination of brain death have been established as a legal standard in the United States. Brain death statutes generally conform to the Model Uniform Determination of Death Act and state that a person is legally dead when (1) irreversible cessation of circulation or respiratory function or (2) irreversible cessation of all functions of the entire brain, including the brain stem, has been determined according to accepted medical standards. Some states may have unique modifications to the definition. The diagnosis of brain death in children may be difficult and should be approached with particular caution in circumstances in which neurologic function may be altered by hypothermia, use of neuromuscular blocking agents or barbiturates, or an unknown cause of the brain insult. A brain flow study to assess blood flow to the brain may be helpful in some circumstances. Cardiopulmonary support systems may be withdrawn from patients with brain death without fear of legal repercussions. Courts have authorized the discontinuance of support systems for brain-dead victims of child abuse without affecting criminal charges against the alleged abuser. It is a necessary precondition for some types of organ donations, but the concept may be rejected by various religions and cultural traditions. Organ and tissue recovery Patients who meet neurologic criteria for death may be appropriate candidates for organ or tissue recovery. In cases in which CPR is unsuccessful, tissue donation is possible. The shortage of recoverable organs has led to the enactment of required request laws, requiring documentation that families of potential donors are offered the option of organ and tissue donation and that the local organ procurement organization is notified of all potential donors. The declaration of brain death in cases of child abuse does not preclude the option of organ or tissue donation. Practicing resuscitation skills on the newly dead The use of newly dead patients for research and training raises ethical and legal issues. Obtaining consent of family members is ideal and respectful of the newly dead. Relevant procedures applicable to infants and children include placement of an endotracheal tube and vascular access procedures. This practice has the potential to be brief, beneficial to others, and an effective teaching technique. However, the cultural and emotional issues of family and staff may influence the suitability of this practice in a given institution. Several ethical principles are involved in this controversy, including whether patient autonomy is preserved after death or transfers to the family and whether presumed consent is appropriate. In certain circumstances when the child's death will be investigated by a medical examiner (eg, child abuse, trauma), postmortem insertion or removal of the tracheal tube or vascular access catheters may be prohibited. MULTIMEDIASection 8 of 9
REFERENCESSection 9 of 9
Ethical and Legal Considerations in Pediatric Surgery excerpt Article Last Updated: Apr 24, 2006 | |||||||
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