Emerging ethical issues in pediatric surgery
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- Nwomeh, B.C. & Caniano, D.A. Pediatr Surg Int (2011) 27: 555. doi:10.1007/s00383-011-2907-3
With the rapid pace of technological advancement and changing political, social, and legal attitudes, physicians face new ethical dilemmas. For pediatric surgeons, these emerging issues affect our relationship with, and the care we provide, to our patients and their families. In this review, we explore issues related to professionalism in pediatric surgery practice, the value of apology, and the risks associated with sleep deprivation. Furthermore, we discuss how the imperative of patient safety presents an opportunity for specialty-driven effort to define standards for the surgical care of children and a responsible process for introducing surgical innovations. Finally, we remind pediatric surgeons of their ethical and professional duty to support clinical research, and advocate the acceptance of community equipoise as sufficient basis for enrolling children in clinical trials.
Evolving cultural norms and the rapid pace of technological advancement pose new ethical challenges for all physicians. Pediatric surgeons may find themselves caught in the vortex of changing political, social, and legal attitudes in an increasingly multi-cultural society, thereby seeking answers to a variety of difficult ethical questions. For example, what are the currently acceptable rules of conduct during clinical encounters? Should pediatric surgeons admit errors to parents and patients, and should they apologize for their errors? Do pediatric surgeons have an ethical responsibility to support research for the purpose of improving the care of our patients? And, do we have an ethical duty to ensure that surgical innovations are safe and effective before we adopt them in our practice?
Although medical ethics never presents easy answers, a useful framework can be found in the foundational principles of bioethics namely beneficence, non-maleficence, autonomy, and justice . The principles of beneficence and non-maleficence trace their origins to Hippocrates who enjoined physicians to “act in the best interests of the patient” and to “do no harm”. The principles of autonomy and justice are relatively modern concepts. Autonomy respects the right of competent persons to give informed consent for medical treatment and have control over their bodies, whereas social justice calls for the fair and equitable distribution of the benefits (and risks) of medical care to all persons. Our view is that these core principles of medical ethics provide a sufficient basis for addressing the emerging ethical issues related to professionalism, innovation, research, and standardization of care in pediatric surgery.
Professionalism has been defined as “constituting those attitudes and behaviors that serve to maintain patient interest above physician self-interest” . Many specialist societies, including the American College of Surgeons (ACS) and the American Academy of Pediatrics (AAP), have embraced the “Charter on Medical Professionalism”, developed as a joint project of the European Federation of Internal Medicine, the American College of Physicians–American Society of Internal Medicine, and the American Board of Internal Medicine . The charter’s preamble declared that professionalism is the basis of medicine’s contract with society and requires placing the interests of the patient above those of the physician, setting, and maintaining standards of competency and integrity, and providing expert advice to society on matters of health. It goes further to state that the conditions of medical practice, those imposed by “external forces of change within our societies”, are tempting physicians to abandon their commitment to the primacy of patient welfare.
Among those forces that confront physicians and threaten their professionalism include the explosion of technology, the intrusion of business models on health delivery systems, globalization, increasingly sophisticated and educated patients with higher expectations and demands, the constant and looming threat of legal recourse, and the imposition of corporations, government, and other bureaucratic agencies with regard to allocation of medical resources [3, 4]. Despite these pressures, it is clear that for physicians to maintain the public trust, they must preserve their individual and collective integrity, particularly when they are challenged by market forces or other perverse financial incentives (or constraints). In no specialty is this more critical than pediatric surgery, which entails consideration of issues distinctive to the surgery professions but also those that are unique to the care of infants and children. For pediatric surgeons, it is vital that we resist any threat to the special relationship with our patients and their families. In this effort, the physicians’ best ammunition is to constantly validate their actions against those universal ethical principles of beneficence, non-maleficence, autonomy, and social justice.
The AAP Committee on Bioethics has specified the eight components of professionalism in pediatrics as follows: honesty and integrity, reliability and responsibility, respect for others, compassion/empathy, self-improvement, self-awareness/knowledge of limits, communication and collaboration, and altruism and advocacy . Although the core concept underlying professionalism is a person’s character , this statement of core professional values is designed to serve as a moral compass for all pediatric specialists as they grapple with the difficult ethical challenges of modern practice.
Despite our best efforts, sometimes medical errors will occur, and some will be harmful to patients . When a surgical error occurs, patients and families expect a prompt explanation about what happened, why the error occurred, how the error’s consequences will be mitigated, and how recurrences will be prevented in the future . When a surgical error occurs in a child, regardless of severity, parents want to be informed of the errors and also expect that an explanation will be given directly to their child [9, 10]. Disclosure practices of medical and surgical errors that address patients’ needs have become commonplace in many countries and are required by various regulatory and professional bodies. Presently, there is a broad consensus that disclosure helps physicians to fulfill an ethical commitment to honesty and open communication with patients and families . Beyond disclosure, however, many physicians still grapple with whether an apology should be offered for those errors. Proponents of apologies cite studies showing that it can decrease blame, decrease anger, increase trust, and improve physician–patient relationships. However, feelings of embarrassment, fear of litigation and damage to one’s reputation may inhibit physicians from admitting errors and offering apologies. Such fears of negative consequences have been blamed for the so-called “white coat of silence” among physicians and surgeons.
Apology refers to an encounter between two parties in which one party, the offender, acknowledges responsibility for an offense or grievance and expresses regret or remorse to a second party, the aggrieved . Building on this core definition, Lazare  outlines the vital components of an apology to include: (1) acknowledging offense; (2) explanation for committing the offense; (3) expressing remorse; and (4) offering reparations. For the patient, an apology can restore self-respect and dignity, facilitate forgiveness and provide the basis for reconciliation. For the physician, an apology can help diminish guilt, shame, and fear of retaliation. For both parties, it may strengthen a previously satisfactory relationship, or restore one that has been damaged .
To foster transparency in disclosure of surgical errors and to promote patient safety, many European countries established no-fault compensation systems, which have allowed more honest disclosure practices with fewer malpractice claims. A similar trend toward reduced malpractice suits has been seen in the US with the move towards greater disclosure and early settlement of claims. In addition, several states and Canadian provinces have introduced the so-called “apology laws”, which encourage physicians to express remorse and disclose errors without fear that the act of apology will imply the admission or assignment of fault. However, apology laws usually do not protect physicians who expressly admit fault or use explanations or statements that can be interpreted as admitting fault. In such cases, physician could find themselves navigating potential minefields regarding explanations and disclosure of actual error .
The lack of explicit legal protection for the admission of faults and the fears that apologies will expose physicians to higher risk of malpractice suits remain legitimate concerns. In fact, while risk managers tend to support disclosure, they are much less enthusiastic than physicians about offering an overt apology [15, 16]. In 2005, the Sorry Works! Coalition was formed to promote an approach to medical and surgical errors that incorporates full disclosure, apology, and reparation . While surveys indicate that neither disclosure of errors nor even apology will deter patients from seeking litigation , there has been a net positive effect for disclosure and apology policies. These measures have led to less frequent litigation as well as lower litigation costs .
Even so, disclosing errors and apologizing to patients and families requires skill that is not typically taught during surgical training. This has prompted a proposal that error recognition and disclosure be recognized as a seventh core competency for residency programs in the US .
Due to concern that sleep-deprivation impairs judgment and the performance of motor skills [20, 21, 22], work-hour restrictions for residents, first implemented in Europe, became US law nearly 10 years ago . The effect has been a moderate improvement in the quality of life of residents, but several studies showed increased errors and decline in the quality of some aspects of patient care . Although studies do not show an overall positive effect for work hour restrictions, and despite the poor correlation between fatigue and medical/surgical errors [20, 25, 26, 27, 28], it is clear that the days of unregulated resident work hours are over.
In fact, it long seemed inevitable that the sleep habits of practicing surgeons would come under similar scrutiny, as the focus of research on the effect of sleep deprivation gradually turned to practicing physicians [22, 29]. Although physiologic data shows that sleep deprivation adversely affects clinical performance and impairs psychomotor performance as severely as alcohol intoxication , some studies continue to question whether this applies to routine surgical procedures [31, 32]. Of greater concern to many surgeons is the potential negative impact that further regulations may have on their professional obligation to provide continuity of care to their patients. Those concerns, and the potentially disruptive effect such restrictions may have on the current model of 24-h call and 30-h shifts, could be swept aside in the face of public clamor for well-rested physicians .
In recent years, the issue of sleep deprivation for surgeons has been presented as a matter of patient safety, inviting comparisons with airline pilots and passenger safety. A recent commentary in the New England Journal of Medicine has called for institutions to adopt policies to reduce the exposure of patients to sleep-deprived surgeons, and to facilitate rescheduling of elective procedures when a surgeon is sleep-deprived . Citing recent recommendations by the Sleep Research Society (SRS), the authors further endorsed a recommendation that would require surgeons who are sleep-deprived to “inform their patients of the extent and potential safety impact of their sleep deprivation and to obtain consent from such patients prior to providing clinical care or performing any medical or surgical procedures.”
Proponents of duty hour restrictions ground their position on the surgeon’s professional obligation to the patient; citing the surgeon’s duty to ensure patient safety. Yet, opponents worry that such restrictive work policy will disrupt continuity of care, based on their notion of professionalism. The American College of Surgeons (ACS) swiftly rejected calls for “mandatory disclosure” of the surgeons’ sleep status, noting that similar disclosure requirement does not exist for several other factors that could negatively affect performance, such as marital difficulties, an ill child, or financial worries.
The debate on duty hours for practicing surgeons is far from over, and will likely move into the public domain. However, it is vital that pediatric surgeons take steps to assure families of their commitment to providing safe surgical care for children, and to avoid errors due to sleep deprivation. As cautioned by the ACS, surgeons need to understand how fatigue degrades their mental and physical capabilities and “learn to use this knowledge to determine whether they should disclose their condition to their patients, whether operations should be rescheduled, and whether they should seek assistance” .
Standardization of care
Standardization of care has become the focus of many quality improvement efforts in the healthcare system. A typical standardized protocol consists of a structured plan of care that is based on one of several approaches such as the use of clinical practice guidelines, clinical pathways, templates for electronic medical records, and surgical checklists. Other terms used to describe such ‘inventory of actions’ include care map, care pathway, and critical pathway, among others. Clinical guidelines are often developed by specialty organizations, government, or other publicly funded institutions (e.g. Centers for Disease Control, National Institutes of Health, etc.), expert panels, health systems, an individual hospital, or group practices. The Cochrane Collaboration and others dedicated to promoting evidence-based practice have also published numerous guidelines. Most pediatric surgeons are familiar with practice guidelines issued by the American Academy of Pediatrics, American Pediatric Surgical Association and the International Pediatric Endosurgery Group. These guidelines usually aim to reduce practice variability by incorporating the best evidence available, and are modified as new evidence emerges.
Recent evidence in pediatric surgery suggests that standardization of care reduces variability, increases patient safety, and improves patient outcomes. For example, survival rates in infants with congenital diaphragmatic hernia increased significantly following the implementation of a standardized treatment protocol . Clinical pathways for uncomplicated appendicitis in children led to fewer unnecessary laboratory tests and antibiotics, reduced hospital stay, lower hospital charges, and less frequent readmission [37, 38]. Also, following the introduction of a clinical pathway for pyloric stenosis, there was a measurable reduction in practice variability, length of hospital stay, and hospital charges . Beneficial effects of standardized protocols have been noted for other conditions, including burns , thoracic empyema , and inguinal hernia .
Critics of practice guidelines decry the trend toward “cookbook medicine” that interferes with the ability of experienced physicians to provide individualized care for their patients . A related concern is that such guidelines establish consensus on a minimal standard of care, thereby denying the patient the right to seek reasonable treatment options beyond what is offered in the standard guideline . Some physicians also worry that while guidelines may, in some instances, lower the standard of care, in others they could raise the standard of care to levels difficult for the average physician to attain . Many publishers of guidelines acknowledge their limitations, and often issue disclaimers that the guidelines do not dictate an exclusive course of action and should not be construed as “standard of care”. This is, in part, recognition that such guidelines are sometimes based on low-level scientific evidence. Yet, while standardization of care has been credited with improving outcomes and reducing medico-legal exposure  legal scholars caution that proliferation of guidelines has perils for both the developer and target user . There is legal vulnerability for both the individual physician who fails to follow or even rigidly adhere to the guidelines, and for the promulgator of the guidelines who does not incorporate all the key evidence. Also, critics of standardized care have noted that the evidence is mixed in regard to its usefulness. For instance, an evaluation of a clinical pathway with the goal to reduce the volume of imaging studies performed in infants with pyloric stenosis failed to demonstrate any difference, as surgeons continued to request ultrasound in the vast majority of patients .
While some pediatric surgeons may resent guidelines that interfere with their autonomy to provide individualized care for patients, it is likely that the imperatives of cost control, patient safety, and consumer satisfaction will lead to disciplinary and credentialing pressures to comply with standardized protocols. With the increasing focus on health services research in pediatric surgery, additional evidence will help clarify whether standardized care provides benefit for children, and for what conditions. By being active participants in generating such data, and subjecting them to peer review, pediatric surgeons will take the lead in defining the quality standards that will apply to their practice. Ultimately, the most compelling ethical position is in favor of those guidelines that have proven benefits for children.
Support for innovation and research
Because innovation and research are linked to the development of new therapies, they are often considered together. However, clinical innovation and clinical research are distinct entities. Clinical innovation occurs with the introduction of something new (new treatment, new operation, or new device). The goal of innovation is to solve a clinical problem in a manner that provides direct benefit to an individual patient or group of patients with a specific condition (e.g., rectosigmoidectomy and pull-through introduced by Ovar Swenson for Hirschsprung’s disease; diamond duodenoduodenostoy for duodenal atresia, by Ken Kimura; minimally invasive repair of pectus excavatum, by Donald Nuss). In contrast, clinical research involves the systemic investigation of mechanisms or distribution of disease, or studies of treatments, or interventions, and services. Research generates new knowledge with the goal to benefit mankind as a whole, and often with no direct benefit to study subjects. Thus, the results of formal research are generalizable, but the results of innovation initially apply only to a single patient . Despite these distinctions, innovation and research are intertwined, and one cannot proceed effectively without the other .
While much of the progress that has been achieved in pediatric surgery can be attributed to innovation in medical technology and operative techniques, research is crucial in maintaining oversight on these innovations and determining whether existing or alternative approaches serve the best interests of our patients. The discussion that follows emphasizes the role of careful oversight in the responsible development of surgical innovations and advocates acceptance of community equipoise as a rational basis for supporting clinical research in pediatric surgery.
Oversight for surgical innovation
Unlike new drugs, biologics, and medical devices that are closely monitored by the Federal Food and Drug Administration (FDA) and similar agencies in other countries, surgeons have great latitude in developing new operations. With minimal or no oversight of surgical innovation, surgeons have the freedom to develop new operations, modify existing procedures, and introduce new treatment, motivated by the belief that the innovation will improve the care of an individual patient. Such innovations often proceed without prior study, and occur in real time, beginning with a small series of patients and then using an iterative process to perfect the technique, one patient at a time. While some innovative techniques undergo peer review as case reports or case series presented at a professional meeting or published in surgical journals, there are probably a great many that are not subjected to any oversight.
Stage 1 (Innovation): a new procedure is prompted by the need for a new solution to a clinical problem. If time allows, the surgeon should notify the hospital before performing procedure, and in any case the procedure should be reported afterwards, whether successful or not. A mechanism for anonymous reporting within each hospital might aid acceptance among surgeons.
Stage 2a (Development): this involves a planned use of procedure in an initial small group of patients (10–30 patients). Any technical modifications of procedure during this stage should be meticulously recorded. Precautions to minimize risks and requirements for mentoring during learning curves are specified, and strict guidelines followed for reporting to peer groups.
Stage 2b (Exploration): during this stage, surgeons in other centers, encouraged by initial reporting, adopt procedure. Data should be systematically captured in prospective databases or registries.
Stage 3 (Assessment): randomized trials should be performed, except when there is clear and substantial evidence from previous stages that the advance cannot be explained by either chance or bias.
Step 4 (Long-term study): established procedures are evaluated for rare and long-term outcomes and for variations in outcome.
In addition, the Society of University Surgeons (SUS) has published guidelines for the responsible introduction of surgical innovations , along similar lines as the IDEAL recommendations, and which emphasizes the obligation of the surgeon to obtain specific patient consent in addition to the permission of an oversight body. The SUS statement proposed a local surgical innovations committee (SIC) to provide initial oversight, and if it determines that further rigorous evaluation is needed, will direct the innovator to the Institutional Review Board (IRB) for approval. However, we agree with the concern raised by Morgenstern that many IRBs lack the necessary expertise or ability in the oversight needed to assure proper evaluation of surgical innovations . We believe that more appropriate expertise will be found in regional or national professional groups or subspecialty societies.
Ultimately, individual pediatric surgeons must bear responsibility for the safe introduction of innovative procedures in their practices. Untested procedures should always be considered as potentially risky to patients. McKneally  has noted the perverse seduction attached to the terminology of innovation, which has the connotation of added value that attracts patients who are seeking the “latest and greatest” treatment. Perhaps it should be replaced by the term non-validated, as proposed by Levine , because it more accurately reflects the ethical and medical hazard entailed in untested procedures. We subscribe to the concept of a non-validated operation because it is more transparent and honest, and acknowledges the fact that the proposed operation has not been subjected to rigorous investigation.
Research in pediatric surgery
The Nuremberg war crimes trial US versus Karl Brandt, et al. revealed numerous unethical medical and surgical experiments that had been conducted by the Nazis during World War II, showing the dangers of unregulated human research. From this trial arose a set of ten research ethics principles known as the “Nuremberg Code” that enshrined the principle of informed consent as an essential requirement of human subject research. In 1964, the World Medical Association developed the Helsinki Declaration, which though it had no intrinsic force of law, spurred the enactment of laws in many countries to protect human research subjects. In 1966, Dr. Henry K. Beecher, a respected anesthesiologist, published an article in The New England Journal of Medicine about risky and unethical research on humans that led the US government to enact the National Research Act of 1974 that brings all medical research under the purview of an Institutional Review Board (IRB). About this period, revelation of the Tuskegee syphilis study prompted the US Congress to establish a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, a multi-disciplinary group of prominent scientists, physicians, ethicists, lawyers, and religious leaders, to develop guidelines about the ethical conduct of human experimentation. Their findings culminated in the Belmont Report, published in 1979, which serves as the ethical foundation for all human research conducted in the United States. The Belmont Report, and more recent interpretations of its essential relevance for research on infants and children, has special significance for pediatric surgeons: (1) the development of new operations, intended to have immediate patient benefit rather than the generation of new knowledge, should be made part of a formal research effort at the early stages to determine their benefit, safety, and outcomes; (2) that 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; and (3) children belong to a dependent and vulnerable class that require extra protection from exploitation as potential subjects of research.
The most important recent regulation with implications for clinical research is the Health Insurance Portability and Accountability Act (HIPAA) of 1996, including the Privacy Rule, which requires investigators to protect both the safety and privacy of research subjects. Compliance with the core ethical principles and applicable laws are enforced by IRBs and similar entities in much of the industrialized countries. Also, evidence of IRB approval for a research protocol is now required by the editors of most pediatric surgery journals prior to publication of results of research studies.
Community equipoise and research in pediatric surgery
One of the best examples of clinical research in pediatrics involves the treatment of solid tumors, which is characterized by ongoing prospective randomized investigation directed by the collaboration of multiple specialists from surgery, pediatric oncology, radiation therapy, and pathology. Beginning in 1969, the National Wilms Tumor Study (NWTS) began to accrue patients and currently nearly 80% of all incident cases of Wilms tumor are enrolled in one of the protocols. As a result, there has been a steady improvement in survival as these trials have focused on reducing treatment morbidity, minimizing long-term adverse sequelae, and understanding the unique biological and genetic characteristics of this malignancy. With survival currently above 90%, the success of NWTS illustrates the potential for the pediatric surgery community to participate in a cooperative effort to address an important clinical problem through clinical trials.
Given this degree of success, it is surprising that, outside of the realm of childhood cancer, the specialty of pediatric surgery has lagged behind many other surgical specialties in the numbers of randomized clinical trials (RCTs) that guide our practice. Despite their drawbacks, RCTs remain the most effective method to evaluate new procedures. While RCTs comprise 3–6% of studies reported in adult surgical literature, Moss and colleagues  have lamented that only a trivial 0.17% of pediatric surgical studies were RCTs. Some have cited the perceived lack of equipoise as the main reason for the reluctance among pediatric surgeons to participate in RCT [55, 56].
The concept of equipoise was introduced by Fried  to express the uncertainty about which treatment or operation provides the best outcome, given two or more alternatives. However, the meaning of equipoise is often misunderstood. Some pediatric surgeons tend to hold firm in the belief that a “favorite” operation (one that she/he has performed with good results) is better than other procedures, despite lack of substantiated evidence from published reports. While the above definition of equipoise is useful in guarding the physician’s fiduciary relationship with his/her patient, it could intensify the state of uncertainty about whether a patient should be enrolled in a clinical trial.
A more nuanced view of clinical equipoise (or community equipoise), proposed by Freedman , is one in which there is a state of uncertainty within a professional specialty regarding the relative merits of competing procedures or treatments. This interpretation of community equipoise allows the individual pediatric surgeon to have strong preference for a given operation, yet acknowledge that there is reasonable uncertainty within the profession (often supported by the published literature) about the best operation or treatment. Acceptance of clinical equipoise as sufficient ethical and moral justification for RCTs should increase enrollment in such trials.
Members shall strive to maintain existing skills and to develop or acquire new medical and surgical knowledge through continuing practice in order to benefit patients… Members shall recognize a responsibility to participate in activities benefitting the community .
As a distinct surgical group pediatric surgeons are uniquely positioned to engage in clinical research through cooperative prospective investigation for the following reasons: (1) uniformity of many common congenital anomalies in their anatomic derangements and pathophysiology, such as Hirschsprung’s disease and gastroschisis; (2) concentration of pediatric surgeons in major children’s hospitals that offer institutional support for clinical investigation; (3) significant variability among pediatric surgeons in the management of common conditions, such as appendicitis; and (4) a history of patient benefit and professional cooperation as an outgrowth of the prospective childhood cancer clinical trials.
From the few RCTs that have been performed in pediatric surgery, we have developed new areas for investigation and defined new standards for treatment. An additional benefit of multi-center prospective investigation concerns the very real hope that unintended negative consequences and unanticipated early morbidity may be discovered much sooner than studies that rely on single institutions and limited patient enrollment.
In this review, we have focused only on issues that have not typically been addressed in reviews or book chapters on pediatric surgery ethics. Among these, professionalism in our clinical conduct, including recognition of the value of apology and the risks associated with sleep deprivation, is a matter of immediate importance to all pediatric surgeons. The imperative of patient safety will increasingly demand standardization of care, and this is best achieved through peer consensus within the specialty, to avoid more restrictive and potentially harmful regulations being imposed by external bodies. Similarly, a more formal system of oversight for innovative procedures, developed within the profession, is preferable to one based on individual surgeon’s competence and integrity . In considering a new procedure, the surgeon must balance competing ethical principles and relevant questions include whether they should be performed outside of a formal research protocol, what level of disclosure is needed to achieve an adequate informed consent, and how the burdens and benefits of such research can be distributed fairly . Finally, we urge pediatric surgeons to adopt a view of community equipoise that will reduce the inherent reluctance to participate in clinical trials, and to regard support for research that produces high-level evidence as an important ethical duty.