Ethical Issues in Pediatric Epilepsy
Medicine frequently comes up against ethical dilemmas, for which there are no clear “right” answers. This special issue aims to highlight some of those occurring in pediatric epileptology and raise awareness of potential frameworks to aid clinicians.
What readers may recognize through the papers presented is that despite the contributors coming from a wide geographical range, there are recurrent themes that appear throughout 21st-century clinical practice. A child who may benefit from surgical intervention may be living in the United States, Spain, Italy, Romania, and so on, and similar discussion may be required involving health care professionals (HCPs), the patient, and patient advocates. Similar questions arise regardless of country: How much weight should be given to patients' requests? Who ultimately decides on current treatment? If the patient cannot make a contribution, who should be their representative? How do we balance the “pros and cons” of a particular therapeutic regime? Is it ethical to try pediatric patients on drugs that have not been licensed for use in children? Despite the cultural pluralities in the countries represented, the same dilemmas emerge.
This suggests that there is a need for an overarching understanding of medical ethics in a way that can be practically employed by the HCPs wherever they work.
It would be nice to have a flowchart telling HCPs which “morally correct” action should be taken in each situation, but this unfortunately is not possible. What is possible, however, is that practitioners are equipped with knowledge about moral theories and ethical approaches that enable them to make ethically sound (and justifiable) decisions, which take into account cultural, social, religious, and legal pluralities. These types of considerations are vital for developing ethically justifiable decisions. It is by learning various approaches to medical ethics that the practitioner can navigate their field.
The practice of medicine was, at least initially, considered to be an art. Although science has helped medicine develop therapies, diagnostic tests, and classification of diseases (for example), the importance of medical ethics demonstrates that the clinician still needs an ability to practice their art.
The hypothetical questions listed above are unsurprisingly present in the papers included in this issue. There are also particular themes that emerge (again, regardless of geographical region), showing that there is a need for HCPs to be fully ethically equipped for their role in pediatric epileptology.
A quick check of medicine legislation in many countries highlights the separation of licensing drugs for pediatric use and adult use. In this issue, Rose et al's contribution on clinical trials and use of various epilepsy treatments in pediatric patients go some way to examining whether this is simply a regulatory issue or whether children may be thought of as “little adults” with regard to pharmacokinetics and pharmacodynamics, asking whether pediatric clinical trials for some treatments may be unnecessary. A clash between the legal and physiological meaning of “child,” Rose et al argues, places medical treatment of children with epilepsy in a somewhat precarious position, balanced between pharmacology and legislation.
Continuing on this theme, Vintan provides the relevant example of Dravet syndrome. Stiripentol has been previously shown to be effective for this condition, alongside valproate and clobazam. However, the Summary of Product Characteristics for Diacomit (the United Kingdom licensed stiripentol medicine) states that its use in younger children must be carefully monitored and that data are limited regarding the use of stiripentol in infants under 12 months of age. Clinicians are therefore expected to use their discretion when prescribing for very young children. At the end of the piece, Vintan highlights that parents of these children must be kept informed of possible new treatments, efficacies, and adverse events. Informed consent has long been a cornerstone of medical ethics and is essential when guiding parents and patients. As Vintan points out, HCPs realize that desperation for symptom reduction may significantly affect the autonomy of decisions made.
This type of informed consent and awareness of patient autonomy is the focus of Borlot et al's paper. Borlot et al demonstrate, using an example of a patient with Rasmussen's encephalitis, how difficult the decision-making process can be for all concerned. Rasmussen's encephalitis is often resistant to antiepileptic drugs and an alternative option for treatment is surgery. However, there is no guaranteed benefit and significant potential side effects. The decision about hemispherectomy is therefore a particularly difficult one. Given this, Borlot et al briefly propose the creation of a value-based decision-making framework, enabling interested parties to clearly weigh potential pros and cons of treatments. What is proposed here is application of one approach to medical ethics: utilitarianism. This, and other moral theories, is explored in the commentary provided by Lancaster.
What about those patients unable to take part in treatment decision-making? As both Vintan and Borlot et al recognize, the involvement of patients, including children, is an expected part of medical decision-making. There are a significant number of epilepsy patients, however, for whom this is not possible. In her brief overview, Tran brings to the fore some of the dilemmas occurring when the patient is unable to participate in decision-making and has no clear representative (such as a family member). This situation is exacerbated further when the patient is living within a care system (such as foster care or a nursing or residential care home). Appropriate treatment for epilepsy patients relies heavily on their medical history, which again, Tran notes, is often missing for children without a select small group of advocates (such as immediate family). As a consequence of this, children may need to undergo repeated testing and extended periods of less useful therapy, and experience unrecorded and additional adverse events. This is clearly unethical. However, what changes could be made to such systems? Is it possible to develop devoted representatives for these children?
Another important aspect of medical ethics highlighted by Gulati is that there are various factors that impact decision-making, beyond the confines of the hospital. Through describing a case of childhood epilepsy in India (as an example of a low-middle income country), Gulati shows that social, cultural, and economic factors are essential considerations. This, inevitably, impacts ethical discourse. For example, is it ethical to inform parents of treatments for their child that they could never afford? Is there an obligation for the clinician to offer all information and best-case scenario for their patients even if it is unattainable?
This issue also includes three case studies from North America. Describing adverse reactions and lack of efficacy, we first ask when particular treatments should be discontinued. Individualization of treatment regimes for people with epilepsy is common practice, often requiring continuous follow-up and small adjustments. At which point in this journey should treatments be withdrawn, and who should be involved in this discussion?
A second case study explains the difficulties of medical decision-making when caregivers cannot agree. Given our focus on pediatric epilepsy, when often patients require advocates or may have several caregivers, there is an increased likelihood of disagreements. This situation touches on various nuances of ethics, such as consideration for various types of parenthood and their place in the family legal system. Although a thorough appreciation of legal guardianship is clearly outside any clinician's role, an understanding of how parenting or caregiving is perceived in each culture, and the legal status, is important for inclusive decision-making.
Continuing on this theme, the third case study by Sweney shows the impact of religious, social, legal, and economic factors, as it tells the tale of a family from Latin America receiving medical care from a hospital in the United States. Similar issues arise to those previously highlighted by Gulati, as factors beyond the control of HCPs or the family of the affected child were shown to have a significant impact on diagnosis, treatment, and prognosis.
To add to these case studies, we have included some commentary. These provide additional focal points, teasing-out some of the ethical dilemmas in each case and highlighting how such dilemmas apply not only to pediatric epilepsy but also throughout various aspects of medical practice. There are some recurring themes here, such as paternalism, informed consent, autonomy, and managing “uncertainty,” important throughout medicine but perhaps especially so in pediatric epileptology.
Up to this point in the issue, there are many questions asked. While it is clear that HCPs worldwide generally act with moral integrity, focus on best outcomes for their patient, and aim for informed consent in all situations, there are few hints at how clinicians may reach ethically sound conclusions. In an effort to provide HCPs with a sort-of ‘ethical toolkit,’ Lancaster offers a short review of the moral theories and ethical approaches that may be useful to clinicians. Focusing on the themes emerging in this issue, Lancaster‘s commentary reflects on the similarity of dilemmas emerging across healthcare systems and demonstrates that there is no “one size fits all” fix. However, an understanding of various approaches to medical ethics is essential to equip HCPs with tools to help them work through such problems and act with ethical justification, whatever dilemmas they face.
13 August 2020 (online)
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