The ethics of informed consent and shared decision-making in pediatric surgery

Informed consent is a required feature in the practice of pediatric surgery. Surgeons cannot practice the trade without it and most of us learned to do it as part of our “apprenticeship” in surgical training. We were bystanders when the senior resident or attending spoke to the patient and family and we were silent witnesses to the signing of the document called a “consent.” Intentional instruction about informed consent is rudimentary in most residencies. By the time we become surgical fellows, it is assumed that we have the requisite skill set to perform this “task” so we can get on with what we like to do best; operating. For many, it is viewed as a perfunctory step which, if done properly, will comply with hospital policies, might someday be exhibited during medical litigation, and ultimately it will occupy a tiny bit of memory in the hospital EMR system. However, this “thing” called the informed consent is much more than an item on a pre-op check list. The re-branding of the term “informed consent” into “shared decision-making” underscores the “re-evolution” that has occurred in thought and practice from the act of obtaining an individual's permission for treatment toward the process leading up to that act.¹ It reflects some of our most important ethical values in healthcare and is still the source of scholarly inquiry and controversy. In this paper, the terms “informed consent” and “shared decision-making” will be used interchangeably but the intention is focused on the process of how physicians and their patients make choices together. If you have not thought about this topic recently, I encourage you to take a moment and explore some of the interesting and challenging questions which are still unanswered. Although the ethical principles underlying informed consent are shared by adult and pediatric medicine, there are many aspects which are unique to the medical care of children. This article highlights some of those challenges and controversies illustrated by two case studies and viewed through the lens of bioethics.     

Acute care issues in internationally adopted children

Over the past decade there has been a dramatic increase in international adoptions in the United States. While most adopted children will have common illnesses, others may have unique medical issues as a result of the conditions in their birth country requiring a broadened differential diagnosis. Knowledge of these issues is essential in the management of these patients. This review will predominately focus on infectious disease issues commonly seen in international adoptees but will also discuss other medical conditions and some of the psychosocial issues which may be encountered by caregivers in the emergency department.     

Legal and ethical issues of newborn screening

Newborn screening raises many ethical and legal concerns, from the bioethics issues commonly faced with genetic testing and the practice of informed consent to the classical medical ethics questions that surround resource allocation. This mandatory, state-based healthcare intervention has not met with the resistance that one might have anticipated, yet it is still not integrated into society to its full potential. While there is room for newborn screening programs to improve on the technical, ethical, and legal fronts, this should not discourage policymakers, physicians, scientists, and other stak-holders from learning from the successful aspects of its implementation and applying these lessons to other, related technologies.     

Historical aspects of rheumatic fever

Few diseases have experienced such a remarkable change in their epidemiology over the past century, without the influence of a vaccine, than rheumatic fever. Rheumatic fever has all but disappeared from industrialised countries after being a frequent problem in the 1940s and 1950s. That the disease still occurs at high incidence in resource limited settings and in Indigenous populations in industrialised countries, particularly in Australia and New Zealand, is an indication of the profound effect of socio‐economic factors on the disease. Although there have been major changes in the epidemiology of rheumatic fever, diagnosis remains reliant on careful clinical judgement and management is remarkably similar to that 50 years ago. Over the past decade, increasing attention has been given to rheumatic fever and rheumatic heart disease as public health issues, including in Australia and particularly in New Zealand, as well as in selected low and middle income countries. Perhaps the greatest hope for public health control of rheumatic fever is the development of a vaccine against Streptococcus pyogenes, and there are encouraging initiatives in this area. However, an effective vaccine is some time away and in the meantime public health efforts need to focus on effective translation of the known evidence around primary and secondary prophylaxis into policy and practice.     

Primary care issues for the healthy premature infant.

Premature infants born between 32 to 35 weeks' gestation have a 98% survival rate and comprise 84% of all preterm infants in the United States. These infants may have a relatively benign hospital course and may be considered by some to be a "healthy premature infant." At the time of discharge from the neonatal intensive care unit, infants will be gaining weight, feeding by mouth, and maintaining temperature homeostasis. Support of growth, feeding choices, management of gastroesophageal reflux, developmental issues, monitoring at home, and recommended special vaccinations are issues that primary care nurse practitioners will face in caring for preterm infants. This article is Part II of a three-part series focusing on the care of preterm infants after discharge from the neonatal intensive care unit. This installment will look specifically at preterm infants who are considered to be healthy preterm infants. Part I addressed issues related to all premature infants. Part III will focus on the primary care issues in medically complex premature infants.     

Barriers to education of overseas doctors in paediatrics: a qualitative study in South Yorkshire.

OBJECTIVE: To explore the factors that may influence the progress of doctors who come from the Indian subcontinent to train in paediatrics in the UK. METHODS: Overseas doctors training in paediatrics in Rotherham, Sheffield and Doncaster participated in the study. Focus groups were used to collect data; two focus groups, each with 4-5 participants, were conducted at 6-week intervals. Semistructured, one-to-one interviews were conducted to add more understanding and depth to issues highlighted in the focus groups. The focus groups and interviews were audiotaped; the tapes were transcribed and data were analysed using the Grounded Theory; open codes were formed and concepts identified using microanalysis, and initial theories were built. RESULTS: Lack of information about the National Health Service (NHS)/Royal Colleges, inappropriate communication skills, difficulties in team working, difficulties in preparing for Royal College examinations, visa and job hunting, and social and cultural isolation were identified as major barriers. Problems arose not only from difficulties with language but also from use of local and colloquial words, different accents and difficulty in communicating sensitive issues. Lack of understanding of role in teams and difficulties in working in multiprofessional setting all contributed to the problems. Cultural differences inside and outside the workplace, and social isolation were also highlighted. Induction programmes, mentoring, awareness of the issues within the teams, and courses in communication specifically directed at overseas doctors were identified as means to overcome these barriers. CONCLUSIONS: Several intercultural factors were identified that could act as barriers to the progress of overseas doctors training in paediatrics in the UK. Increased awareness of these factors within the teams would be the first step in resolving some of the issues.     

Doctorate of nursing practice: blueprint for excellence.

A great deal of work has been done during the past several years since the American Association of Colleges of Nursing voted in October 2004 to move advanced practice nursing to the doctoral level by 2015. Following the approval, task forces were formed to address curriculum issues and the strategies for transitioning advanced practice nursing education from the master's level to the doctorate of nursing practice (DNP). The DNP curriculum contains content on leadership, management, and other topics that are needed to address some of the issues in the health care system that traditionally have not been included in most master of science in nursing curricula, as well as additional essential content and nurse practitioner competencies. As pediatric nurse practitioners and other advanced practice nurses go forward in their careers, the DNP may have an impact on their role. In this article, the background of the DNP movement, changes in advanced practice nursing education, and the concerns of currently practicing pediatric nurse practitioners prepared at the master's level will be addressed.     

Ethical aspects of care in the newborn surgical patient

This article places focus on three main subjects that are all related to the ethical aspects of care of newborns undergoing major surgical interventions. The first concerns the communication between the surgeon, as a representative of the treatment team, and the parents. The second is the way to handle new developments in neonatal surgery. The third issue covers several aspects of the ethical decision-making process with regard to forgoing life support in surgical neonates. These issues will be discussed on the basis of two clinical case reports.     

Clinical trials in neonates: ethical issues

If neonates are to receive the best possible treatment, they must be involved in clinical trials. However, doing such trials raises complicated ethical issues. These issues are not unique to neonatology but some are more common or acute than in other areas of medicine. In practice, two particular issues -- equipoise and informed consent -- arise as many different types of problem. The question 'What is an ethical issue?' is important because issues that are not ethical are sometimes mistakenly thought to be so, and vice versa. When we can recognize what types of problem are ethical, we can also recognize the correct means to tackle them.     

Content barriers to pediatric uptake of electronic health records

EHR systems provide significant opportunities to enhance pediatric care. Well-constructed clinical content, HIE, automated reminders and alerts, and reporting at practice, community, and public health levels are available in several current systems and products. However, the general focus on inpatient and adult populations in the design and marketing of these systems should be seen as a significant barrier to EHR adoption among pediatric primary care providers. Weight-based medication dosing, specialty growth charts, units of measurement and time, and measures to address minor consent and adolescent confidentiality are not universal in quality and availability to the pediatric practice. However, there are opportunities for pediatricians to provide input and to clearly state minimum requirements when dealing with vendors or when government agencies (eg, ONCHIT and AHRQ) seek comment on standards, practices, and expectations. This article uses cases and examples to describe some areas in which pediatricians should take an active role to advocate for pediatric-appropriate EHR tools. Virtually every child born and cared for in the United States today will have their data and information recorded in an EHR. The quality of the information and the HIT in which it is recorded can affect the care they get as children, and the information they carry into adulthood.     

Championing Choice��Lessons Learned from Children and Young People About Research and Their Involvement

Over the past 5 years researchers from the Institute of Child Protection Studies have talked with vulnerable children and young people in an attempt to better understand their lives, their perceptions and how they might be better supported around issues such as homelessness, parental drug and alcohol use, caring, juvenile justice and out of home care. Researchers have confronted a myriad of challenges in recruiting, meaningfully engaging and supporting the participation of children with diverse needs and preferences as well as presenting their findings in a way that is helpful to both commissioning bodies and for children and young people. This paper, whilst drawing on current literature, predominantly provides a series of reflections from researchers working with vulnerable children and young people and from young participants themselves about some of the ethical and practical challenges that have emerged when talking to children and young people about sensitive issues. Specifically this paper will discuss issues concerning gatekeepers, children’s participation and their rights to whether how and when to be involved.     

Proxy informed consent in pediatric research: a review

This paper is aimed at discussing the issue of proxy consent for medical research with children carried out in the context of developed countries. First, requirements for valid informed consent are reviewed, and differences with clinical practice highlighted. In the second part the findings from empirical studies, and implications for improving the consent process, are discussed. Perceived benefit for their child is the most important factor motivating parents to grant consent, but also a desire to contribute to medical research and benefit others are frequently mentioned. Abstract concepts such as randomization are more difficult to grasp and remember than practical issues. The type and style of the consent-seeking process (quality of the information, physician's attitude, allocated time, readability of consent forms) have an influence on how the invitation to participate is received. Rather than as a one-sided delivery of information, consent should be viewed as a continuous, two-way communication process developing in a context of transparency and partnership between the investigator and potential research subjects.     

Consent for neonatal research

Inherent to all medical research is respect for the rights of the individual. Neonatal research is made more complex by the issue of proxy consent. Obtaining valid informed consent for entry of an infant into a research project needs to deal with this complexity. New evidence on the role and responsibilities of parents in giving consent has implications for all clinical staff that are considering embarking on and/or recruiting infants in research projects. This review explores the issues around informed consent for neonatal research and provides a framework by which consent could be improved. It is to be hoped that such improvements to the process will increase recruitment of infants to research studies while enhancing the validity of the consent process.     

Attention‐deficit/hyperactivity disorder: The past 50 years

Attention‐deficit/hyperactivity disorder (ADHD) is a common neurodevelopmental disorder and one of the main diagnoses seen by general paediatricians today. Despite the impression often portrayed in the media, it is not a new condition; in fact it has been described for over 200 years. The past 50 years has seen a progressive increase in our understanding of the underlying neurocognitive deficits in ADHD, and over the past 20 years behavioural genetics and neuroimaging studies have shed light on the complex causal factors and neurobiological processes operating. The plethora of ADHD research has advanced our knowledge of the condition, but so far has had little impact on improving clinical practice. Stimulant medication has been the mainstay of symptomatic treatment for over 30 years; however, it is still unclear how developmental trajectories can be modified to achieve best outcomes. It is hoped that novel therapies and more individualised management will evolve over the coming decades.     

Velo-cardio-facial syndrome

PURPOSE OF REVIEW: Velo-cardio-facial syndrome has emerged from obscurity to become one of the most researched disorders this past decade. It is one of the most common genetic syndromes in humans, the most common contiguous gene syndrome in humans, the most common syndrome of cleft palate, and the most common syndrome of conotruncal heart malformations. Velo-cardio-facial syndrome has an expansive phenotype, a factor reflected in the wide range of studies that cover both clinical features and molecular genetics. In this review, we cover multiple areas of research during the past year, including psychiatric disorders, neuroimaging, and the delineation of clinical features. RECENT FINDINGS: The identification of candidate genes for heart anomalies, mental illness, and other clinical phenotypes has been reported in the past year with a focus on TBX1 for cardiac and craniofacial phenotypes and COMT and PRODH for psychiatric disorders. The expansive phenotype of velo-cardio-facial syndrome continues to grow with new behavioral and structural anomalies reported. Treatment issues are beginning to draw attention, although most authors continue to focus on diagnostic issues. SUMMARY: Its high population prevalence, estimated to be as common as 1:2000 has sparked a large amount of research, as has the model the syndrome serves for identifying the causes of mental illness and learning disabilities, but it is obvious that more information is needed. Intensive scrutiny of velo-cardio-facial syndrome will undoubtedly continue for many years to come with the hope that researchers will turn more of their attention to treatment and treatment outcomes.     

Incorporating psychological approaches into routine paediatric venepuncture.

Studies of paediatric procedural distress have flourished over the past two decades, with psychological intervention strategies showing consistently high efficacy in reducing pain and fear. This review concentrates briefly on the acquisition and treatment of fear, arguing that what is witnessed clinically is not needle fear or phobia, but anticipatory or procedural distress. The main focus is on how such procedures could be amended to incorporate psychological techniques routinely, outlining specific guidelines for clinical practice.     

Incorporating psychological approaches into routine paediatric venepuncture

Studies of paediatric procedural distress have flourished over the past two decades, with psychological intervention strategies showing consistently high efficacy in reducing pain and fear. This review concentrates briefly on the acquisition and treatment of fear, arguing that what is witnessed clinically is not needle fear or phobia, but anticipatory or procedural distress. The main focus is on how such procedures could be amended to incorporate psychological techniques routinely, outlining specific guidelines for clinical practice.     

Congenital heart disease never goes away, even when it has been 'treated': the adult with congenital heart disease

PURPOSE OF REVIEW: As the specialties of pediatrics and pediatric cardiology continue to forge ahead with better diagnoses, medical care, and surgical results, an expanding population of patients with congenital heart disease (CHD) outgrows the pediatric age group, yet does not quite graduate to routine adult cardiology or general medicine. The adult with congenital heart disease (ACHD) faces medical, surgical, and psychosocial issues that are unique to this population and must be addressed as such. This review attempts to discuss and highlight some of the important advances and controversies brought up in the past year, in the care and management of these patients. RECENT FINDINGS: The past five to 10 years have seen dynamic interest in understanding sequelae of corrected, uncorrected, or palliated congenital heart disease. The search for the ideal surgery, optimal prosthesis, and a smooth transition to adult care continues and is reflected in the vast amount of academic work and publications in this field. Of particular interest, conduit reoperations and single ventricle pathway modifications are still an art and a science in evolution. SUMMARY: While all are agreed that there is a pressing need to focus on the delivery of care to the adult with congenital heart disease, this essentially requires a clearer understanding of late sequelae of CHD. The sheer heterogeneity of anatomy, age, surgery, and institutional management protocols can make it difficult to develop clear guidelines. This review attempts to give an up-to-date perspective on some of the new findings related to the more common lesions and problems faced in this group.     

Informed consent in pediatric clinical trials

PURPOSE OF REVIEW: Clinical research in children is increasing. Concerns have been raised about both the inclusion and the exclusion of children in such research. Corresponding to these concerns, issues in informed consent for pediatric trials have become more pressing. This review discusses informed consent in pediatric trials and characterizes the latest literature. RECENT FINDINGS: Research into the consent process has shown that central concepts in pediatric research such as randomization and the distinctions between phases of clinical trials are not uniformly understood by parents or older pediatric patients. Newer approaches that are being developed to help remedy these deficits include the use of staged informed consent, the incorporation of interactive computer technologies to convey complex ideas, and variations in approaches to assent of the child based on multifactorial assessments of competence. Other variables in the consent process that are being studied for their impact on the process include individual life experiences and cultural background. Gaps in federal regulation and oversight of "informed consent" are emerging as new cases test established assumptions. SUMMARY: Lessons learned from recent studies regarding oversight of the consent process in pediatric clinical trials, the complex nature of assent, the impact of cultural variables, and more effective means of communicating what is involved in a clinical trial will shape future studies in consent and help to improve the process.