Current Moral Priorities and Decision Making in Neonatal-Perinatal Medicine
Robert J. Boyle
John C. Fletcher
(deceased)
GOALS OF NEONATAL-PERINATAL MEDICINE
The first part of this chapter discusses broad goals and moral priorities of neonatal-perinatal medicine (NPM) in relation to patients, American society, and developing nations. The second part reviews some specific ethical issues that frequently arise in clinical decision making in the neonatal period.
Medicine is a goal-oriented profession. One approach might argue that healing is the sole and overriding goal of medicine. This view is unconvincing, because some valid goals of medicine (e.g., prevention) cannot be collapsed into healing. The practice of NPM illustrates that medicine has multiple, complex, and sometimes conflicting goals:
To save life and cure disease
To relieve pain, suffering, and disability
To rehabilitate and restore function
To prevent disease
To improve the quality of living and dying
To seek new knowledge
The highest moral priority of these subspecialties is to implement medicine’s goals in the perinatal period. In a recent review, Carter and Stahlman broadly discuss the successes (and limits) of neonatal intensive care in the United States over the past 40 years (1).
SOCIETAL AND PROFESSIONAL ISSUES
Medicine is also accountable to society and to the international community. Critics may validly argue that American medicine and public policy have neglected primary prevention and fostered the technological imperative. To counter these criticisms, the moral priorities of NPM specialists need to include advocacy for comprehensive prenatal care, improved nutrition, prevention of premature delivery and appropriate family support and services for the infant after discharge. NPM in the United States is also part of a global community of science, medicine, and humanitarian outreach. The moral priorities of the field ought to include commitment to global infant health. An editorial by Sidney Brenner, a leading figure in genetics, also applies to neonatal medicine. He wrote: “Somehow, in our abstruse discussions about the high technology of the developed world, we need to balance the equation by thinking about the rest of the world as well” (2). Nations where newborns are in greatest danger of death or lifelong disability could benefit from transferable knowledge and technology, for example, maternal folic acid supplementation, prevention of HIV transmission, vitamin K prophylaxis, eye prophylaxis for gonorrhea, and prevention of neonatal tetanus.
Preterm delivery—live birth prior to 37 completed weeks’ gestation—grew in the United States from 8.9% in 1980 to 11.9% in 2001, more than 476,000 annual preterm births (3,4). The increase is caused by an 11% rise in moderately preterm births (32 to 36 weeks’ gestation) in the 1990’s. In 2001; charges for hospital stays for prematurity-related illness reached $13.6 billion. There are large differences in preterm births by race and ethnicity, although non-Hispanic white women give birth to the majority of the 4 million annual live births.
Paradoxically, both poverty and economic success are harmful to many infants. Poverty, race, class, and substance abuse are linked to a large percentage of prematurity, extremely low-birth-weight, and brain injury. However,
multifetal pregnancies after assisted reproductive technologies (ART) and non-ART procedures have reached epidemic proportions (5,6,7,8). Epidemiologic studies also suggest an increased risk of major birth defects after assisted reproduction (9). Neonatologists see first hand the human damage and costs of these polar social determinants of gestational harm. Infertile individuals who want their own genetic child suffer psychologically and spiritually. Fertility treatments have allowed literally millions of women to have children who otherwise would not have been able to conceive. The primary responsibility to reduce these harms falls on reproductive medicine and policy makers. NPM specialists can facilitate research and remedies for the problem. To date, reliance on professional self-regulation has not been effective in reducing multifetal pregnancy in the United States. There is currently a debate about whether social controls of infertility treatment and research are fitting for a pluralistic society that highly values reproductive liberty. The President’s Council on Bioethics is now considering a set of very strong federal controls to protect human embryos and constrain infertility treatment (8). At this point, all could agree that women undergoing ART should be informed about the risks of multiple gestation and preterm delivery.
multifetal pregnancies after assisted reproductive technologies (ART) and non-ART procedures have reached epidemic proportions (5,6,7,8). Epidemiologic studies also suggest an increased risk of major birth defects after assisted reproduction (9). Neonatologists see first hand the human damage and costs of these polar social determinants of gestational harm. Infertile individuals who want their own genetic child suffer psychologically and spiritually. Fertility treatments have allowed literally millions of women to have children who otherwise would not have been able to conceive. The primary responsibility to reduce these harms falls on reproductive medicine and policy makers. NPM specialists can facilitate research and remedies for the problem. To date, reliance on professional self-regulation has not been effective in reducing multifetal pregnancy in the United States. There is currently a debate about whether social controls of infertility treatment and research are fitting for a pluralistic society that highly values reproductive liberty. The President’s Council on Bioethics is now considering a set of very strong federal controls to protect human embryos and constrain infertility treatment (8). At this point, all could agree that women undergoing ART should be informed about the risks of multiple gestation and preterm delivery.
What perspective ought to be taken on the social ethics of the medical profession and its mission? Many in the United States believe that the ‘answer’ is simply to let markets work in the interests of liberty (10). In this model, health care is a two-tiered marketplace. The costs for those who can pay include a pool of money and charity care for those who cannot pay. When the overriding value is justice, medicine ought to be a largely subsidized service in a society that guarantees security in health care for all to increase solidarity among its people. However, even when health policy guarantees universal access, disparities persist in disease and health care that reflect class, race, and sex.
Following Buchanan, we propose that in a pluralistic democracy, the relation between society and medicine ought to be understood as a self-correcting contract or bargain (11). Instead of resting on one supreme value easily captured by ideology, the contract reflects a commonwealth of values. These values govern the complex goals of medicine and interests of society in health. A commonwealth has a primary locus of loyalty. In this society, the preeminent value is fidelity to patients or loyalty to the patient at hand. Using the right procedural principles, patient-centered medicine is not inconsistent with viewing the patient in a population with needs for a finite supply of expensive community health care resources. (12) Within constraints of fidelity to patients and their rights, physicians ought to promote the welfare of the many, to practice fairness in access and distribution of resources, and to be efficient and effective in their practices. Physicians in this society are also members of a scientific community with a high standard of evidence in practicing medicine. Guided by these values, society grants the profession a privileged place, permits its members to earn high incomes, and subsidizes their training. In return, society expects the net health benefits of pursuit of the goals of medicine to outweigh the net costs.
In the United States, the increasing investment in perinatal-neonatal care has not produced proportional improvements in crude infant survival and low-birth-weight. Thompson and associates (13) compared the neonatal intensive care (NICU) resources of the United States with those of Australia, Canada, and the United Kingdom. Compared to the other three nations, the United States has far greater resources but higher rates of low-birth-weight and death among newborns. The United States has 6.1 neonatologists per 10,000 live births compared with 3.7, 3.3, and 2.7 in the other nations, respectively. NICU beds in the United States are 3.3 per 10,000 live births, compared with 2.6 in the first two nations and 0.67 in the UK. Resources are not linked with low-birth-weight. In the United States, 1.45% of all neonates have a very low-birth-weight (<1500 g) compared with approximately 1% in the other nations. Newborns weighing less than 2500 g are born more frequently in the United States. Low-birth-weight is the single most accurate predictor of neonatal death. The crude neonatal mortality rate is 4.7% deaths per 1000 births in the United States, compared with 3.0% in Australia, 3.7% in Canada, and 3.8% in England and Wales.
Why does success not follow from greater resources? Thompson and associates (13) point to cultural and political differences between the nations. Australia, Canada, and the United Kingdom provide health insurance for all children under 18 years of age and all women ages 18 to 44 years. In the United States only 86% of children and 78% of women had health insurance at the time of the study. These three nations provide free family planning advice and prenatal and perinatal care, and the United States does not. The influence of race, poverty, and poor nutrition must also be factored into the answers. Longstanding recommendations of the Committee on Perinatal Health to address the root problems have not been implemented (14). The current March of Dimes campaign on prematurity is a valuable step but does not replace missing federal support (3).
ETHICS AND MORAL DELIBERATION
Ethics is a body of practical knowledge comprised of principles and values, judgments about cases and policies, and beliefs and theories about the world and persons (15). John Dewey’s view of the main purpose of ethics is integration of beliefs about the world with beliefs about the values and purposes that should direct human conduct (16). Decision making for infants and children should follow the same general approaches taken for all patients who are unable to make decisions for themselves.
John Dewey wrote, “life is a moving affair in which old truth ceases to apply” (16). Making judgments in novel situations can lead to change of background beliefs and practices. Since the advent of modern neonatal care in the 1960’s, rapid advances in technology and aggressive care of smaller and sicker neonates have focused philosophical, theological, professional, legal, consumer, and media attention (both
positive and negative) on the use of technology and the processes for decision making in life or death choices for newborns. One can trace changes in background beliefs and values in the history of ethics in neonatal decision making using the “landmark” cases in which medical decisions for infants have been scrutinized by the United States government or the legal system. Table 2-1 gives samples of important cases, events, articles, and studies in that history. In addition, several recent reviews trace this evolution and multinational differences in approach (1,17,18,19).
positive and negative) on the use of technology and the processes for decision making in life or death choices for newborns. One can trace changes in background beliefs and values in the history of ethics in neonatal decision making using the “landmark” cases in which medical decisions for infants have been scrutinized by the United States government or the legal system. Table 2-1 gives samples of important cases, events, articles, and studies in that history. In addition, several recent reviews trace this evolution and multinational differences in approach (1,17,18,19).
TABLE 2-1 LANDMARK CASES IN NEONATAL ETHICS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Neonatologists, nurses, and parents of newborns today stand on the cumulative moral experience of the past. The
process for decision making in NPM is more transparent and shared between clinicians and parents than in the past. However, it is never immune from confusion, especially when cultural beliefs about medicine collide. Practitioners are arguably better trained to identify ethical issues, participate in shared decision making, and seek help with ethical problems. For example, most try to be empathetic, nonbiased, and honest in disclosing a poor or uncertain prognosis to anxious parents.
process for decision making in NPM is more transparent and shared between clinicians and parents than in the past. However, it is never immune from confusion, especially when cultural beliefs about medicine collide. Practitioners are arguably better trained to identify ethical issues, participate in shared decision making, and seek help with ethical problems. For example, most try to be empathetic, nonbiased, and honest in disclosing a poor or uncertain prognosis to anxious parents.
Neonatologists, nurses, and their colleagues are fallible. They have made serious mistakes in excluding parents from decisions and imputing guilt to them for wanting to withdraw treatment (20). Some events and cases test the limits of moral concepts, for example, the best interests of the infant, parental autonomy, professional integrity, futility, and fairness in use of resources, or quality of life. These cases brew storms that can throw experienced neonatologists, nurses, other staff, parents, and administrators off balance and into conflict with one another. In these situations, Martin Buber’s metaphor of a “narrow rocky ridge between the gulfs” (21) can ring true. Ethics helps human beings to keep enough balance, when taking hazardous, puzzling, or new paths in social and personal life, to maintain moral insight and equilibrium. It is a self-correcting, constantly evolving body of practical knowledge about human problems—conflicts of moral principles, duties, or loyalties in relationships.
CULTURAL AND RELIGIOUS DIVERSITY
Because ethics is a self-correcting body of knowledge, open societies require a public process of debate about continuity and change in the moral aspects of social and professional practices. The United States is now the world’s most diverse religious and cultural society. These differences are very difficult to sort out in debate about ethics. To change public policy in this society, faith-based reasons standing alone are insufficient. Secular and presumably rational reasons are required to persuade a court, legislature, or commission. In debatable health care decisions, we see cases involving newborns that break down the limits of rationality. For example, should physicians continue to respect parents’ faith-based rejection of futility of treatment when the baby has total intestinal necrosis or renal agenesis and pulmonary hypoplasia? In our view, the case of Baby K (22) shows that the federal courts can approve parental faith-based demands as a legally justified reason to continue futile treatment of an anencephalic newborn, because the society has been unwilling to ration resources for this category of newborns.
Cross-cultural issues deeply complicate debate on ethics. For example, should any moral weight be given to a request to withdraw life support if the parents of a neonate are immigrants from a society with very different moral beliefs about medicine and what constitutes a seriously impaired newborn? What if the parents’ culture requires that a traditional healer participate in the care of the infant? Should weight be given to parents’ religious views when the infant is in pain and not benefiting from additional procedures and the parents flatly reject the concept of futility? What is best, all things considered, for the infant? Does concern for the infant absolutely override competing concerns?
The authors take a broadly pragmatic approach to ethics and to cross-cultural issues in ethical debates. Moral norms and ways of life are, in fact, relative to culture and personality. However, cultural and psychological relativity does not drain ethics of content or moral force. Although ethics is a phenomenon within and not independent of human experience, it has objectivity in two senses. First, ethics is objective as a growing and evolving body of knowledge about practices in society and the professions. Secondly, the basic imperatives of ethics are “no less objective than law or medicine” (23) when it comes to destructive acts like murder, torture, genocide, rape, cruelty for its own sake, and so forth. Such acts “violate our most basic convictions” about the intrinsic value of human life and community. As Benjamin writes, “If these things aren’t wrong, nothing is” (24). Some argue that moral judgments are not binding across cultural boundaries or that ethics is “merely” a matter of personal taste. If ethics is merely subjective or relative, there is no basis for a moral judgment about any horrific act that occurs in subcultures or beyond one’s own culture, such as forcing children to wage war against their own people or to suffer loss of limb or life. The case of Baby K ought not be judged as “horrific acts” because the parents’ intentions are loving and not destructive. The moral failure in these cases is societal in its failure to assume responsibility for setting democratically debated limits on health care resources. Societal failures can result in horrific consequences, but the parents and staff involved in these cases do not deserve moral blame.
Working Through Ethical Problems
Although important moral values and principles are binding, there is no prefabricated way to work through ethical problems in cases or events when principles collide. Different methods of moral deliberation compete for selection. When compared with highly theoretical or case-by-case approaches, the method of “wide reflective equilibrium” (25) has proven useful in bioethics. In this approach, one weighs ethical problems in cases by creating a dialogue (internally or externally) that moves between three interactive elements: the values and principles at stake, the problem at hand, and relevant background beliefs and theories.
“Principlism” is a dialectical method that analyzes ethical problems in a framework of prima facie principles of biomedical ethics (10). This approach is widely used in ethics courses and in the literature of neonatal ethics. In our view, a method that moves only between values or principles and the problem at hand lacks larger constraints and correctives. Cultural influences and personal bias are at work in selecting principles and putting them to work in cases. Judgments made in past cases, such as Baby K (22)
and Baby Doe (26), are fallible and need evaluation. Background beliefs and theories are sources of critical distance and constraint—beliefs and theories about the nature of personhood, community, the world as revealed by science and metaphysics, human psychology, sociology, and political and economic behavior; the nature of nonhuman animals, and so forth. In short, our uses of principles and judgments in cases ought to make sense in terms of intelligible background beliefs and in-depth knowledge of the issues at hand.
and Baby Doe (26), are fallible and need evaluation. Background beliefs and theories are sources of critical distance and constraint—beliefs and theories about the nature of personhood, community, the world as revealed by science and metaphysics, human psychology, sociology, and political and economic behavior; the nature of nonhuman animals, and so forth. In short, our uses of principles and judgments in cases ought to make sense in terms of intelligible background beliefs and in-depth knowledge of the issues at hand.
When parents and clinicians are unable to reach agreement on an approach to care, additional resources should be available to assist the process. Many “ethical conflicts” are actually problems in communication and misunderstanding. Involvement of social workers, chaplains, parent support groups, or other clinical staff often improves the interaction and leads to a resolution of the conflict. One of the outcomes of the Baby Doe controversy (27) in the early 1980’s was the recommendation that infant bioethics review committees be established to prospectively and retrospectively review cases where life-sustaining therapy was withheld or withdrawn. While the function of these committees was short-lived, they were the forerunners of the current ethics committees in most institutions. Ethics committees serve multiple functions including policy development and review, staff education, and review of difficult cases brought to them. In many institutions, both medical staff and families may bring cases to the committee. Committee process varies widely from institution to institution in terms of membership, involvement of family, and decision-making models (28,29,30). Other institutions use a less intimidating model of an ethics consultation service, where an individual consultant, or, more often, a team of consultants (who usually have multidisciplinary backgrounds), will review the situation with those involved, provide background or policy information, facilitate communication, and, when necessary, bring the parties together to work toward a consensus. In most institutions the committee or consultation service recommendations are advisory rather than binding. Finally, when consensus is cannot be reached and the clinician, family or institution feels the issues are sufficiently serious, the court system can be petitioned to intervene. While the court system is seen as the voice of society weighing in on a difficult issue, this is often a time-consuming, not necessarily objective process that by its nature is adversarial and may negatively impact the relationship between the clinician and parents. A court decision may be appealed and overturned or may result in an outcome that with greater societal scrutiny may be seen as questionable. Most would argue that approaching the court should be a last resort.
Moral Status of the Newborn
Part of the evolution in clinical ethics in neonatal-perinatal medicine has involved ascribing greater moral status and protection at birth to seriously ill newborns. There has been a dramatic transition from frequent nontreatment of trisomy 21 (31) to the Baby Doe Rules (22) and support for appropriate assessment of extremely low-birth-weight (ELBW) infants.(32) However, there remains a philosophical impression that decisions to withhold or withdraw treatment for newborns, especially the extremely premature newborn, may be less troublesome than decisions for older children and adults, because the newborn does not have the same moral worth or is not fully a person. Tooley (33) argued that because a newborn lacks advanced brain function, has no self-consciousness, ability to suffer, or sense of the future, it should not be considered a person. Engelhardt (34) agrees that neonates are not persons in the strict sense at the time but affirms that they are persons in a social and cultural sense. Others have further defined this view, identifying the bonding, affection, and care given newborns by parents and other adults (35).
While detailed plans for conception, antenatal ultrasound, and fetal movement may support parental attachment early in and progressing through gestation, it cannot be denied these emotions are not as strong in the perinatal period, especially when the infant is extremely preterm, as they are at several months or years of age. In addition, many preterm infants are the result of unplanned, often unwanted, or sometimes unknown pregnancies. Blustein describes the neonate as “not born into the family circle so much as outside it, awaiting inclusion or exclusion. The moral problem the family must confront is whether the child should become part of the family unit” (36). Ross notes that respect for the person is “owed to all individuals on the basis of the individual’s personhood (and developing personhood)… proportionate to the actualized capacities of the individual and his or her potential to attain full personhood” (37). It is therefore problematic that the infant’s moral worth is variable, dependent on acceptance by its family rather than on any innate socially or even legally accepted character. This worth may change over a short period of time, and this change may then affect differences in or difficulties with decision making prior to birth versus at a week or month of life. Decisions made in the labor room regarding a child who has never been seen by the parent and who may have an increased risk of mental retardation become much more difficult when the 6-month-old child has confirmed severe developmental delay.
Decision Making
Sound clinical decision making should be based on sound data, a careful and thorough diagnostic assessment, and, based on that diagnostic assessment, accurate prognostic estimates. Sometimes this is relatively easily accomplished: chromosomal analysis has documented trisomy 13 and the natural history of this disease is well-known. In other situations the diagnosis may not be well-defined or the prognosis is uncertain. For both the ELBW infant about to be born or the premature infant with grade III intraventricular hemorrhage, there is an increased statistical risk of developmental delay, but it is not certain how this particular
infant will progress. Rhoden (38) has defined strategies that have been or might be used when there is uncertainty about prognosis:
infant will progress. Rhoden (38) has defined strategies that have been or might be used when there is uncertainty about prognosis:
Wait until certain: Continue until the patient is actually dying or will survive but with definite severe disability. There is an underlying discomfort with infants, admittedly few in number, who are dying but who might survive with aggressive care. There is little attention paid to suffering, burden-benefit ratios, or the number of infants needed to be treated for one additional intact survivor.
Statistical prognosis: Use statistical cutoffs and aggressively treat all those selected. This might be described as the “evidence-based approach.” Selection might be by birth weight or gestational age. This approach may be used when resources are limited. Professional, regional, or national guidelines might exist to define these cutoffs. This approach ignores individual variation and may sacrifice some potentially normal infants who may behave outside of the norm. It relies on data that may or may not accurately reflect the clinical situation at hand. Decision making is psychologically “easier,” because it is allegedly “objective.” Most clinicians justifiably use some criteria for limiting treatment for some populations, for example, resuscitation at 21 to 22 weeks gestation.
Individualized prognosis: Decide for each infant using the available data, the present condition, and a benefit-burden analysis. This approach allows for clinical change, evaluation and reevaluation, and ongoing communication. There is more of a role for the family in decision making. It also can be a source of confusion, uncertainty, error, and agony. However, Rhoden believes that this is justified, given the tragic nature of the situations. Fischer and Stevenson (39), and more recently Kraybill (40), have expanded on this approach beginning with a “nonprobabilistic paradigm” of attempting to save every ELBW infant’s life (“provisional intensive care for all”) modified by an “individualized prognostic strategy” when prognosis could be better defined. The American Academy of Pediatrics has endorsed this approach (41).
Withholdin/Withdrawing
Most agree that it is ethically superior to withdraw a therapy compared to withholding it (42,43). If therapy is begun and is effective, the patient benefits. If the therapy is begun but is not effective, it can be stopped. If the therapy is never initiated, the patient can never benefit. Initiation of therapy also provides the clinician with additional time to collect data, which may lead to a more accurate diagnosis and therefore more reliable prognosis and allows the family more time to understand the situation. While a preference to withdrawing rather than withholding is sound philosophically, in actual clinical settings there are often emotional responses and in some settings religious restrictions to withdrawal of a therapy. It is much easier emotionally to be passive than to make an active decision to withdraw aggressive care. “Pulling the plug” and “killing my baby” are not infrequently heard. “Letting God decide” and “waiting for a miracle” are examples of the same phenomenon. Doron and associates (44) document the relatively frequent disagreement of parents when clinicians recommend withholding aggressive care. There is a potential for weeks or months of care, and possible pain and suffering, before the infant’s death or an eventual decision to withdraw. The clinical situation may reach the point that there is no aggressive care to withdraw, and the outcome is poor. Some clinicians are reluctant, based on this experience, to initiate care as freely. If a clinician is less willing to withdraw care than not to initiate it because of uncertainty or philosophical reasons, this should influence their decision process and be made clear during discussions with parents.
Clinically the withdrawal of life-sustaining therapy does not require that the patient have multiorgan system failure or meet criteria for brain death. If the organ that has failed or been irreversibly injured is a vital one, decision making should be based on the infant’s prognosis for recovery, long-term survival, quality of life, and so forth. Technology would be withdrawn, and the infant would be allowed to die. “Brain death” or “death by neurological criteria” is a clinical and legal definition of a type of death. Criteria for brain death in the newborn are somewhat different than for older children and adults (45,46,47). Some jurisdictions allow for a religious exemption. However, in most circumstances, once the criteria have been met, the patient is pronounced dead. These families need to be compassionately informed about what this means ethically and legally and appropriately prepared for withdrawal of the ventilator. There should be no discussion of removing “life-sustaining treatment” or “keeping the baby alive” because the patient is legally dead.
The term “euthanasia” generates a great deal of confusion and debate in legal, legislative, media, and clinical spheres. Active versus passive euthanasia, voluntary versus involuntary euthanasia, physician-assisted suicide, and other descriptors have created unfortunate ambiguity about the actual issue at hand. If one defines euthanasia or active euthanasia as directly and actively causing the death of a patient who may not be imminently dying or is dependent on life-sustaining technology, usually by administering a lethal dose of a drug, most state law and policies of the American Medical Association and the American Academy of Pediatrics would prohibit that action (48,49). How often active euthanasia of neonates actually occurs in the United States is not known. However, there is a significantly different approach in Europe. Recent studies suggest that while active euthanasia is illegal and rarely occurs in most countries, it appears to be acceptable practice in the Netherlands and France. Approximately 70% of neonatal physicians in France and 45% in the Netherlands have been involved in a decision of active euthanasia (50). Confusion arises when the term “passive euthanasia” is used for decisions to withdraw life-sustaining therapy with the expectation that the patient will die (51). The use of medication to treat symptoms of pain or dyspnea or other suffering in the context of comfort or palliative care further compounds the confusion,
in spite of an ethical duty to provide this type of care. Some would argue that the overall intention may be the same as or may certainly blur into “active euthanasia.” However, others would suggest that intention is an important determinant (52). Describing what actually is being considered as a plan of care and avoiding the terminology may prevent the confusion and the associated emotion.
in spite of an ethical duty to provide this type of care. Some would argue that the overall intention may be the same as or may certainly blur into “active euthanasia.” However, others would suggest that intention is an important determinant (52). Describing what actually is being considered as a plan of care and avoiding the terminology may prevent the confusion and the associated emotion.
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