Bioethics in the End of Life

Placebo-controlled trials for patients with a terminal illness typically present complex ethical considerations. These trials have the potential to provide valuable data and lead to the development of new treatments, but are not without potential harm. Patients in the control group of trials (those who receive a placebo) are likely to be denied a potentially life-extending or life-saving treatment. And while they are already likely going to die from their condition, the treatment may extend their lives for some time. This may conflict with the ethical principle of beneficence.

Additionally, sometimes patients with certain terminal illnesses can access experimental drugs through expanded access or “compassionate use”. Expanded access allows patients with rare or life-threatening diseases to receive treatment with a medication not approved by the FDA, often outside a clinical trial. However, drug manufacturers involved in clinical trials may determine that providing patients with expanded access to experimental medications is unethical while trial participants are receiving a placebo. Similarly, participants in a trial may have their autonomy limited if they are required to use only the trial medication and avoid other potentially beneficial treatments. 

A final consideration surrounds informed consent. Patients participating in clinical trials should fully understand that they may receive a placebo before agreeing to participate. However, patients with terminal illnesses may experience compromised decision-making capacity due to their circumstances and the symptoms of their condition. Some ethicists believe that providers should evaluate a participant’s decision-making capacity before enrolling them in a study to ensure the patients know what they are agreeing to.

Placebo-controlled trials involving terminal patients can quickly become a complicated ethical dilemma, depending on the circumstances. While these trials have significant potential to achieve the greater good through medical innovation, ensuring that core principles are maintained can be challenging. Ultimately, these studies should aim to maximize the potential advantages of clinical research while emphasizing the reduction of harm to patients who are vulnerable due to end-stage disease or a terminal prognosis. 

Sources 

“Placebo—To be or not to be? Are there really alternatives to placebo-controlled trials?” European Neuropsychopharmacology. https://www.sciencedirect.com/science/article/pii/S0924977X19318917 

“How Patients with Terminal Illnesses Get Access to Experimental Drugs”. Brain & Life. https://www.brainandlife.org/articles/patients-terminal-illnesses-access-experimental-drugs 

Some common ethical issues present at the end of life include compromised patient autonomy, shared decision-making, and the principle of double effect. Ethical dilemmas often arise in end-of-life scenarios where medical best practices conflict with patient or family preferences. Understanding the likelihood of these ethical issues and the principles at their foundation can help you anticipate and navigate them in the future should the need arise. 

Respect for autonomy is characterized as the ability to respect the patient’s right to determine the next steps in their care and support their decision-making capability. When patient autonomy is compromised, issues can manifest in a variety of different ways. When patients have specific preferences regarding their treatment, the care team must respect the patient’s autonomy and deliver the most appropriate care without compromising that autonomy. However, ethical issues may emerge when the patient’s wishes and preferences are not acknowledged and supported by their partner, family or surrogate. Without proper documentation, such as advance directives, patient autonomy can be compromised and can have negative implications on the patient’s care. 

Decision-making is integral to end-of-life care settings, but can quickly become an ethical issue when shared decision-making is used to make decisions on the patient’s behalf that are not aligned with their preferences and values. Being mindful of who is designated as a surrogate decision-maker can be crucial, especially in instances where the patient is incapacitated and unable to make decisions on their own. Ethical issues are likely to occur when faced with decisions regarding artificial nutrition and hydration, mechanical ventilation, terminal sedation, withholding or withdrawing treatments, and resuscitation. 

Additionally, although actions may be taken to ease or relieve the patient’s symptoms, sometimes these can intersect with ethical concerns as well. For example, medication may be administered to manage a patient’s pain levels, but may hasten the patient’s death due to the potential to decrease respiration. This is known as a double effect; the intended effect is to decrease the patient’s pain, whereas the unintended effect results in decreasing their respiratory rate. Although the care team aims to provide appropriate pain management for the patient and minimize as much harm as possible, the patient’s family may perceive that the undesired effect of the medication causes harm. In many instances, the care team will need to discuss the moral and ethical intent of such treatments with the patient’s family or loved ones so that they understand the implications of these decisions.  

Sources 

“Ethical concerns in end of life care.” Milne Library. https://milnepublishing.geneseo.edu/nursingcare/chapter/ethical-concerns-in-end-of-life-care/ 

“Ethical considerations at the end of life care.” SAGE Open Medicine. https://pmc.ncbi.nlm.nih.gov/articles/PMC7958189/ 

“Ethics and palliative care: a case of patient’s autonomy”. Journal of Medical Ethics and History of Medicine. https://pmc.ncbi.nlm.nih.gov/articles/PMC10151720/ 

According to the University of Minnesota’s Center for Bioethics, medically futile treatments are those that are “highly unlikely to benefit the patient” either by extending survival or enhancing quality of life. However, there is disagreement among bioethicists as to how to define “benefit” in this context and how to proceed when healthcare providers and patients or their surrogate decision makers disagree. 

The issues around medical futility are complex. Ethical considerations include the lack of objective criteria for determining medical futility, which leads to reliance on the judgments of healthcare providers as to whether the care being provided is benefiting the patient or not. Some ethicists have expressed concern that vulnerable populations — the elderly, racial minorities, the disabled and economically and socially disadvantaged — will be denied access to life-saving treatments under the guise of futile care. Others worry that the high cost of life-saving treatments could lead healthcare providers to label some care as “futile” when there is a possibility that some benefit, however small, might be gained. 

Complicating the issue further is the fact that few states in the U.S. have enacted laws that address medical futility. According to the American Bar Association, most states have tackled the issue by creating statutes that allow healthcare providers to refuse to provide treatment on a number of grounds. These include provisions for refusing on the basis of moral, philosophical, religious or personal beliefs, as well as refusing based on the fact that the requested care differs from the accepted standard of care. Fifteen states specifically allow providers to refuse to provide care that they believe will be medically ineffective or inappropriate. Only two states, Maryland and Texas, have outlined procedures for the resolution of disputes about medical futility between patients or their surrogates. Most states simply require that the provider attempt to transfer the patient to another physician or facility who will provide the requested care. 

With that being said, many bioethicists believe that futility can be defined objectively if one considers prognosis, the possibility of recovery and the functional status of the patient. What’s more, by identifying care that is ultimately futile, providers can offer patients and their families more appropriate options, such as hospice, palliative care or a dignified, natural death.  

Sources

University of Minnesota Center for Bioethics. https://health.umn.edu/ 

An advance directive is a legal document that instructs healthcare providers how you wish to be cared for if you are very ill and unable to speak for yourself. It also designates a healthcare proxy who will have the right to make decisions about your care if you can’t make them yourself. As such, it is a very important tool that helps doctors and other healthcare professionals understand what kinds of care you do and do not want if you are seriously ill. To that extent, it definitely promotes more ethical care. 

With that being said, however, just having an advance directive doesn’t always ensure that a person’s wishes will be carried out. In fact, despite the growing number of seniors who have documented their wishes in an advance directive, studies show that these documents are often inaccessible or ignored. According to a 2010 study published in the Journal of Palliative Medicine, for example, fewer than half of all advance directives actually make it into patients’ charts. What’s more, electronic health records, which were first implemented in the U.S. in the 1960s and ‘70s to improve communication among healthcare providers, have not made finding these documents any easier. Although about 96% of hospitals in the U.S. have adopted EHRs, there is still no consistent location in the medical record where advance directives are stored. 

Perhaps more importantly, an advance directive is a static document that may not address the patient’s wishes at the time a health crisis occurs. People typically prepare an advance directive in advance of a health crisis, believing they can predict what they will want when said crisis occurs. But people, being people, change their minds.  Even a terminally ill person whose advance directive says “Do not resuscitate” may wish to avail themselves of life-saving measures to achieve a new goal (for example, attend a wedding or meet a grandchild for the first time). But in most cases, this change of heart won’t find its way into the advance directive or the EHR. 

Certainly, it is far better to have an advance directive than not to have one. But the best way to ensure that your values and goals are respected when you can’t speak for yourself is to appoint a surrogate who clearly understands what you care about, what’s important to you, and how you would like to be cared for at the end of life, not just in some hypothetical future, but right now. 

Sources

“Advance Directive Completion by Elderly Americans: A Decade of Change”. Journal of the American Geriatrics Society. https://agsjournals.onlinelibrary.wiley.com/doi/abs/10.1111/jgs.12736?referrer_access_token=sMwxEMkBssB1FtMSlXNer4ta6bR2k8jH0KrdpFOxC65I4FZRG-Z9LHoyRde0tFdOgZxECjzfM0WDVXTQWKvZNb5IDrNmpAXqPKEFrluSEOxTQ3IKmbY_MqFRpwtlZ-8T 

“Documentation of Advance Care Planning for Community-Dwelling Elders”. Journal of Palliative Medicine. https://www.liebertpub.com/doi/abs/10.1089/jpm.2009.0341 

The care of elderly persons and those facing the end of life due to a life-limiting illness presents some unique challenges for care providers. These include but certainly aren’t limited to the need to maintain patient autonomy in the face of “broken” communication (e.g. when the patient can’t speak for themselves); the need to balance “goods and harms,” and the need to elicit goals of care and optimize quality of life. 

Although every situation is unique, there are certain guiding principles that are a hallmark of ethical end-of-life care. These can be summed up as follows:

• The overarching goal of ethical end-of-life care is to provide care that is consistent with the dying person’s values, goals, and preferences in a compassionate, nonjudgmental, and respectful way. 
• Communication with the patient and/or their surrogates should be honest, open, and transparent. Care providers need to communicate promptly and sensitively about changes in the patient’s condition that may impact goals of care. 
• Before beginning any treatment, doctors should make every effort to elicit the patient’s wishes either through verbal discussion or an advance directive and/or POLST. When the patient cannot speak for themselves, and there is no advance directive, surrogate decision makers should be provided the information they need to make informed decisions based on their knowledge of the person’s preferences, values, and goals. These include the decision to forego treatment and pursue palliative or hospice care. 
• Family members and other loved ones should be encouraged to interact with the dying person to provide emotional comfort and support.
• Care should be provided in a way that respects and honors a person’s cultural and spiritual or religious beliefs.
• End-of-life care should minimize suffering and physical discomfort to the greatest extent possible. When issues around risks and benefits arise (e.g., when escalating doses of painkillers might hasten the person’s death) care providers should seek input from all stakeholders (including the healthcare team) to determine a course of action that is in the patient’s best interests. 

When ethical concerns arise that cannot be resolved with input from the patient, their surrogates, and members of the healthcare team, any stakeholder (the patient or his loved ones, a care provider or a disinterested third party) can request an ethics consult, which will allow trained intermediaries with expertise in bioethics to step in and help guide decisions about care. 

Sources

“Ethics consultations”. AMA Code of Medical Ethics. https://code-medical-ethics.ama-assn.org/ethics-opinions/ethics-consultations