Ethical Considerations in the Practice of Rehabilitation Medicine—A Contextual Framework for Addressing Ethical Issues in Rehabilitation Medicine

Sarita Patel


William Donovan


Adrian Cristian


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5: Ethical Considerations in the Practice of Rehabilitation Medicine—A Contextual Framework for Addressing Ethical Issues in Rehabilitation Medicine


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GOALS


Reflect a professional commitment to carrying out ethical responsibilities and an adherence to ethical principles in the practice of rehabilitation medicine.


OBJECTIVES



1.  Demonstrate knowledge of the general principles of ethics and the steps in the methodology of making ethical decisions in the practice of rehabilitation medicine.


2.  Demonstrate knowledge of ethical issues in clinical research.


Physiatrists, like other physicians, are taught throughout their training to place the interests and welfare of their patients as their primary responsibility and are familiar with the mantra to “first do no harm.” However, all physicians, practicing in this day and age, realize that there are societal factors that continuously insert themselves into the physician’s judgment as to what may be the best for one’s patient, particularly when treating those with chronic conditions as physiatrists do.


Issues such as quality of life, “futile care,” advance directives, funding limits imposed by insurance companies, state and federal governments, and other factors can impact the physician–patient relationship, not only during acute care and acute rehabilitation but also afterward. Such factors can confront the physiatrist and his or her team with the need for decisions far more complex than just how to create an environment and treatment plan geared to maximize and maintain health and quality of life.


It is clear from the examination of different cultures from both a historical and contemporary point of view that doing the right thing by physicians has varied among civilizations and societies depending upon the resources available and prevailing beliefs (1).


The purpose of this chapter, therefore, is not to provide a universal roadmap to guide the physiatrist’s judgment for every decision he or she must make, but to provide a vista of general principles to keep in mind and to provide directions to resources when engaged in research and clinical care.


HISTORY


From the dawn of history, humankind has been concerned with doing the “right thing.” However, this has been expressed in many forms from primitive societies, including the barbaric, such as allowing human sacrifice, up to civil societies employing the rule of law. In essence, then, it can be said that the “right thing” corresponds to behaviors that the societies in which people live regard as acceptable. Over the years, whether the societies were nomadic, agricultural, peaceful, or hostile, rules of behavior were established and communicated to members by word or script. Those who developed a script that allowed information to be passed through generations and that subsequently allowed archeologists to discover them include civilizations on both hemispheres such as those of ancient Egypt and the Mayas of Mesoamerica (2). These and many other discoveries have confirmed people’s desire for order and rules to live by. One of the most famous was the Ten Commandments in Mosaic Law. Others can be found in religious texts such as the Hindu Vedas, Judaic Torah, Christian Bible, and Islamic Quran, or among the edicts of pharaohs and kings who were regarded as gods. Regardless, divine inspiration was deemed by believers to be the source (3).


Since the invention of Gutenberg’s printing press in the 15th century and the emergence of philosophers and scientists, especially during the period of the European Enlightenment, authors, particularly John Locke, David Hume, John Stuart Mill, and others, have expanded on rules found in the religious texts, often by exercising reason without claiming divine inspiration (4). Basically, their emphases, particularly those concerned with government and civil society, were on instilling in all people, regardless of their faiths, the virtues of trust, respect, responsibility, and consideration for one another, all of which can be expressed in a single term: ethics (5). Authors who have written on the topic of ethics as it applies to the healing arts are many, the more notable among them being Hippocrates, John Gregory, Francesco Petrarch, and, more recently, Lawrence McCullough (1).


Unlike the holy books mentioned earlier, these authors did not claim divine inspiration but rather were guided by reasoning that people could achieve and live peacefully in a civil society. The idea that the people could do this by governing themselves instead of being governed by a monarch or dictator was a doctrinaire concept until Thomas Jefferson and his 4 colleagues proclaimed it could be done by a nation. Governments, he said, derive “their just powers from the consent of the governed” (6). Since the “governed” rarely speak with one mind, democracies required that all agree to abide by the will of the majority as opposed to the will of a ruler.


Subsequently, as more nations adopted democratic governments with separation of religion and state, it was inevitable that ethics (i.e., doing the right thing in civil societies) became more mutable depending on the choices of the majority. Thus, sometimes disparities can arise between rules created by the majority and rules that certain believers avow were created by God. Abortion is one example. To believers of many faiths, even though it may be legal and ethical to the majority, it is morally wrong and therefore abjured for “how can God be wrong?” Therefore, their views are more refractive to change (1). Some have therefore prescinded those rules of behavior derived from the spiritual from those derived from the secular realms. By placing the former under the rubric of morals and the latter under the rubric of ethics, it is possible to avoid the pejorative of “situational ethics.” By designating ethics as derived from man’s rules as far as the majority is concerned, it can be realized that ethics can vary within any society, be they primitive or advanced. On the other hand, if we designate morals as derived from God’s rules as far as believers are concerned, the era and prevailing opinion do not matter.


When the ethics decided by the majority conflict with the morals held by a minority, avenues are available for resolution through debates, essays, blogs, even litigation and the political process, but not violence since that would be a primitive society’s methodology, not a civil one’s. It would seem the more diverse a society is, the more Jefferson’s ideals could be realized, since as James Madison said, it would be harder for one segment of society to force its will on all the others, thereby fostering compromise—a concept often referred to as “Madisonian democracy” (7).


As health care providers, we have guidelines for ethical behaviors reached by the majority of our representatives in our professional organizations. As will be discussed later, these have evolved over the years and have been influenced by the Hippocratic Oath, the Nuremberg Code, the Helsinki Declarations, the Belmont Report, the Code of Federal Regulations, and the American Medical Association’s Code of Medical Ethics, which was compiled by its Council on Ethical Affairs (1). The latter provides guidance for hospital ethics committees and all health care providers. It contains judicial rulings and expert opinions garnered by the committee and is an extremely valuable resource that provides precedence for difficult decisions one may be called upon to make, helping the reader to balance patient autonomy with professional beneficence in the society in which we live.


RESEARCH


All practicing physiatrists, whether contributing to the advancement of knowledge in physical medicine and rehabilitation (PM&R) through research activities or keeping pace with that advancement through educational activities, have an interest in the quality of research, whether it might be anticipated as a breakthrough, simply an explanation of an existing phenomenon, or an improvement upon a prevailing treatment.


Durable, credible research must be planned, executed, and analyzed honestly, without bias. The Nuremberg Code, crafted in 1947 following the atrocities committed by Nazi researchers, provided the first path for medical investigators to follow.


Its essential ingredients include: (a) The voluntary consent of the human subject is essential. There must be no coercion, no deceit, and a full explanation of risks and benefits by the investigator(s). (b) There must be an expectation of gaining useful knowledge. (c) Thorough preliminary studies must be conducted before human studies. (d) Avoidance of unnecessary suffering or injury is mandatory. (e) There must be no expectation of death or injury as an outcome. (f) Risks must not exceed benefits. (g) Proper facilities are required. (h) Only qualified investigators should be allowed. (i) Subject(s) can withdraw at any time. (j) Investigator must terminate the study if harm seems likely (8,9).


Subsequently, the Helsinki Declarations, the Belmont Report, and 45CFR46, as noted earlier, expanded on the Nuremberg Code’s initial guidelines. 45CFR46 is now law in the United States, which all investigators in the health care realm must abide by. Academic researchers also have on-site guidance from their Institutional Review Board (IRB). Manufacturers of pharmaceuticals and medical devices have the Food and Drug Administration (FDA) to advise them and approve their discoveries before they can be marketed (1).


While these entities provide guidance to researchers for the conduct of credible, scientific research, other regulatory and advisory bodies exist to protect the subjects and the public. The Office of Research Integrity (ORI) in the U.S. Department of Health and Human Services (HHS) has published “points for discussion,” which addresses many pitfalls that should be avoided in order to conduct research that is honest and unbiased. These include research misconduct (lying during any phase of the research), conflicts of interest (receiving payment from a commercial entity whose product one is investigating), data mismanagement (“bending” the data to fit a preconceived expectation), pressures to speed discovery and bring products to market, inadequate mentoring and supervision (by the principal investigator and the institution), and inadequate peer review by the institution and/or the scientific journals (being alert for “repetitive publications, supernumerary authorship, lack of disclosure, among others”) when publication of a manuscript is sought (10,11).


Readers of published work and society in general expect that researchers will truthfully report what works, what just seems to work, what seems not to work, and what doesn’t work at all. Patients in turn trust that practitioners will truthfully convey that information to them. The National Academy of Sciences (NAS) has warned that trust in all these areas must never become eroded or the results would be calamitous; they have even expressed the fear that such breaches of ethics could be an expression of a broader pattern of deviation from traditional norms. Hopefully, this fear will never materialize (12). Nevertheless, realizing that scientists are only human and subject to the same temptations and distractions as anyone else, the ORI has pointed out that the responsibilities to safeguard adherence to honesty and ethical principles lie with several entities along the research process. The scientists, their scientific societies, and their institutions must create an environment where carelessness, apathy, and fraud will not be tolerated. This applies not only to the conduct of the research but also to other aspects such as honest time–effort reporting, full disclosure of funding sources, priorities of coauthorship, conflicts of interest, pressures to ascend the academic or business ladder, and/or overstatement of conclusions, which must not be allowed to stain the process of discovery (13). By adherence to such ethics in research, a proper example is shown to young investigators as they in turn strive to seek funding, secure space and recognition, and pass on their respect for honesty in their investigations to their protégés.


ETHICAL FRAMEWORKS


Medical ethics has been described as a system of moral principles that apply values and judgments to the practice of medicine. As a scholarly discipline, medical ethics encompasses its main practical application in clinical settings (14).


The art and science of medical ethics on one level is fundamental and timeless and on the other level is constantly changing and evolving. A physician must be prepared to reaffirm what is fundamental, like the physician–patient relationship, and learn new emerging issues ranging from confidentiality and electronic medical records to human biological material and research.


From genetic testing before conception to dilemmas at the end of life, physicians, patients, and their families are called upon to make difficult decisions. This section is intended to facilitate the process of making ethical decisions in clinical practice. The goal is to teach and explain underlying ethics principles, as well as the physician’s role in society and with colleagues, with specific issues and cases relevant to the field of physical medicine and rehabilitation.


In the medical profession, practitioners put the welfare of the client or patients above their own welfare. Professionals have a duty that might be thought of as a contract with society. As modern medicine brings a plethora of diagnostic and therapeutic options, the interaction of the physician with the patient and society becomes more complex, potentially raising the ethical dilemmas. The American Board of Internal Medicine and the European Federation of Internal Medicine have jointly proposed that medical professionalism should emphasize 3 fundamental principles (15).



1.  Primacy of patient welfare


2.  Patient autonomy


3.  Social justice


The professional responsibility of primacy of patient welfare emphasizes the fundamental principle of the medical profession and helps provide a moral compass that is not only grounded in tradition but also adaptable to the current practice of medicine. The physician’s altruism must not be affected by economic, bureaucratic, and political challenges that are faced by the physician and the patient.


Altruism is a central trust factor in the physician–patient relationship. Market forces, societal pressures, and administrative exigencies must not compromise this principle. There is concern, however, that, in today’s health care environment, the physician’s commitment to the patient is being challenged by the conditions of medical practice and external sources (16).


The principle of patient autonomy asserts that physicians make the recommendations, but patients make the final decisions. The physician is an expert advisor who must inform and empower the patients to base a decision on scientific data and how this information can and should be integrated with the patient’s preferences. The patient’s decision about his or her care must be paramount, as long as those decisions are in keeping with ethical practice and do not lead to demands for inappropriate care. Only in the latter part of the 20th century did the public begin to view the physician as an advisor.


The importance of social justice symbolizes that a patient–physician interaction exists in a community or society. The physician has a responsibility to the individual patient and a broader society to promote access and to eliminate the disparities in health and the health care system. This calls upon the profession to promote a fair distribution of health care resources (17).


Physicians should work actively to eliminate discrimination in health care, whether based on race, gender, socioeconomic status, religion, or any other social category. Physicians who use these and other attributes to improve their patent’s satisfaction with care are not only promoting professionalism but also reducing their own risk for liability and malpractice (18).


METHODOLOGY—ETHICAL DECISION MAKING


The Decision-Making Process


The conjoint decisions made by patients with physical impairments and disabilities and their physicians can profoundly affect the quality of a patient’s life. When physicians and patients face ethical decisions about emotionally charged issues such as withholding or withdrawing life-sustaining treatment, the model of shared decision making can ensure communication and respect for the multiple and sometimes conflicting needs of physicians, patients, and family members.


When making decisions about ethical issues, all parties should be involved in an identified decision-making process. One example of such a decision-making process was developed by the Hastings Center and has been modified for use in this book (19).


Steps in the Process for Making Ethical Decisions


1.  Professional commitment


2.  Systematic evaluation of the case


3.  Communication among all involved


4.  Consider ethical principles


5.  Make the decision


6.  Document the decision


7.  Implement the decision and change it when necessary


8.  Respond to objections and challenges


Step 1. Professional Commitment

Every physician has an obligation to uphold ethical and professional behavior and redouble his or her commitment to professionalism, especially when dealing with ethical dilemmas. The American Board of Internal Medicine, ACP-ASIM Foundation, and the European Federation of Internal Medicine have jointly proposed “the charter on Medical Professionalism” (15) that comprises three principles and ten commitments:



A.  Three fundamental principles: (a) primacy of patient welfare, (b) patient autonomy, and (c) social justice.


B.  Ten professional commitments: (a) professional competence, (b) honesty with patients, (c) patient confidentiality, (d) maintaining appropriate relations with patients, (e) improving the quality of care, (f) improving access to care, (g) just distribution of finite resources, (h) scientific knowledge, (i) maintaining trust by managing conflicts of interest, and (j) professional responsibilities.


Step 2. Systematic Evaluation of the Case

When complicated issues require a formal decision-making process, a thorough evaluation of the patient’s situation is the necessary first step. Often what appears to be a complex moral dilemma may be nothing more than a disagreement based on inaccurate or inadequate knowledge of clinical facts, biographical facts, or cultural facts. It is the responsibility of the care provider to gather all relevant information about the decision to be made. Potentially important questions to be answered are related to the aspects of clinical status, preferences of the patient, surrogate and others involved, life history, risks and benefits of proposed treatments, and decision making. Every clinical case, when seen as an ethical problem, should be analyzed by means of four topics (20).



1.  Medical indications


2.  Patient preferences


3.  Quality of life


4.  Contextual features


Adapting to this method, a practical approach in the form of a “four-box model” is organized and presented by the American Academy of Hospice and Palliative Medicine.


 













CLINICAL FACTS


BIOGRAPHICAL FACTS


QUALITY OF LIFE


CULTURAL FACTS



1.  Clinical Facts:


     image  What is the patient’s diagnosis and prognosis?


     image  How has the patient’s condition changed? Are symptoms adequately controlled?


     image  What is the proposed intervention?


     image  What is the intention of the proposed intervention?


     image  What are the potential benefits and burdens of each proposed intervention?



2.  Biographical Facts:


     image  What is known about the patient’s wishes and values?


     image  How does the patient describe his or her quality of life?


     image  What is known about the wishes of surrogates, family members, and other involved parties?


     image  Does the patient have the capacity to make decisions about medical treatments?


     image  Who is involved in making the decision and what is his or her involvement?


     image  What is the recommendation of the interdisciplinary team?



3.  Quality of Life:


     image  How does this patient describe his or her quality of life?


     image  What brings meaning to or sustains the patient?


     image  How has the patient made treatment decisions in the past?


     image  What types of treatments would provide a satisfactory outcome for the patient’s life?


     image  What is achievable with regard to the patient’s preferences?



4.  Cultural Facts:


     image  Who is this patient?


     image  What are the patient’s life story and primary values?


     image  What is the patient’s relationship with family members and significant others?


     image  What are the patient’s cultural, religious, and spiritual values?


     image  What are the potential benefits and burdens of each alternative for the patient and family, including financial and emotional costs?


     image  What are possible alternatives?


     image  What are the legal considerations?


     image  How will the decision affect the patient and family physically, emotionally, spiritually, socially, and economically?


This four-box model can help evaluate the vast majority of ethical dilemmas in clinical practice.


This model also provides a hierarchy to keep in mind: Clinical and biographical facts focus on what makes sense medically, respects the patient’s wishes, and are given more weight than quality of life or cultural facts. The quality of life and cultural facts are not insignificant and attuned to the avoidance of unnecessary conflicts or dilemmas. The sample case analysis demonstrates how this model can be practically used.


Step 3. Communication Among All Involved

Effective communication is honest, compassionate, open, and unhurried, and it is essential to understanding and alleviating a patient’s suffering. Sharing of adequate and accurate knowledge of the patient’s condition, the patient’s wishes, and the potential benefits and burdens of proposed treatments, as well as consequences of nonintervention, are cornerstones of effective communication. The wishes of a competent, well-informed patient take priority over other opinions. On occasion, patients may wish to withhold information from family members or members of the interdisciplinary team. Balancing a patient’s right to privacy with the family and team’s need for information can present ethical dilemmas. In most cases, patients are willing to negotiate the sharing of information, a process that protects the patient’s right to privacy and helps ensure the families and team’s ability to intervene effectively when needed. In any case, the patient’s right to confidentiality should be given great weight.


Step 4. Consider Ethical Principles

There are some main beliefs that can be invoked to address bioethical dilemmas encountered in clinical activities. These can be broadly categorized into four groups—principle based, virtue based, caring based, and respect for personhood.


A. PRINCIPLE BASED. The four generally accepted values that make up the foundation of modern medical ethics are beneficence, autonomy, nonmaleficence, and justice (21,22).


Beneficence: Promote the patient’s well-being. The principle of beneficence, which is synonymous with the Hippocratic obligation to always act in the best interests of the patient, is grounded in the concept of promoting the patient’s well-being. In physical and rehabilitating settings, the principle of beneficence implies positive acts, including effective treatments for physical and cognitive impairments and pain and the provision of psychosocial and emotional support.


Limitations: Although the obligation to promote a patient’s well-being is basic to the physician–patient relationship, its implementation can be problematic. For example, the development of medical technologies such as ventilators and total parenteral nutrition has resulted in confusion about when and for how long such treatments should be provided to ensure a patient’s well-being and the provision of ethical patient care. Their existence makes it difficult to remember that they are ethically neutral; when considered alone, medical treatments offer neither benefit nor burden. It is only within the context of applying a particular medical intervention to a specific patient that the treatment’s contribution to a patient’s well-being can be determined.


Autonomy: Respect the patient’s self-determination. The principle of autonomy, or patient’s self-determination, recognizes the right of a patient with decision-making capacity to make decisions about treatments according to his or her own beliefs, cultural and personal values, and life plan, even when these decisions differ from what has been advised or recommended by a physician.


Patient autonomy means any patient with decision-making capacity is free to reject, without coercion or fear of retribution, any form of medical therapy, including life-prolonging or life-sustaining therapy. A patient’s right to refuse unwanted treatment, including nutrition and hydration, is absolute. In physical and rehabilitation settings, the principle of autonomy includes the patient’s right not only to refuse a particular course of treatment but also to ask that the treatment be modified to meet other needs, such as the need for privacy, mental alertness, or care in a particular setting at a specific time.


Limitations: Although the emphasis on patient autonomy may challenge health care professionals, they are obligated to respect a patient’s considered choices about treatment. Autonomy is not served when a physician makes unilateral decisions or recognizes a patient’s right to make health care decisions only when those decisions concur with the physician’s opinion. Furthermore, a patient’s disagreement is not grounds for a determination of diminished capacity to make decisions (19).


The principle of autonomy upholds the patient’s right to reject any form of medical therapy, but it does not extend to the patient a right to demand any and all treatment regardless of its likely benefit or cost. The principle does not require the provision of treatments that, in the judgment of the physician and the interdisciplinary team, are likely to be harmful or futile or that counter the ethical principle of justice, nor does autonomy always outweigh other ethical principles.


Nonmaleficence: Do no harm. The principle of nonmaleficence is synonymous with the Hippocratic obligation to avoid doing harm to a patient. Nonmaleficence obligates respect for the inherent worth and dignity of every patient and the avoidance of treatments and interventions that may harm them. The principle of avoiding harm is particularly applicable to patients in the physical and rehabilitation setting, many of who are frail, frightened, and vulnerable when receiving care.


The following are examples of possible violations of the principle of nonmaleficence:



image  Failure to minimize the risk of iatrogenic hypoglycemia or hypotension in patients undergoing inpatient rehabilitation


image  Prescribing medications that can lead to cognitive and balance impairments and subsequent falls in an inpatient rehabilitation setting


image  Prolonged or inappropriate use of indwelling urinary catheters that can predispose the patient to urinary tract infections


image  Failure to follow aspiration precautions in high-risk patients that can subsequently lead to aspiration-related complications


image  Failure to prescribe adequate prophylaxis for prevention of venous thromboembolic events in high-risk patients


image  Aggressive range of motion of limbs in spinal cord-injured patients that can lead to fractures


image  Aggressive pulmonary physical therapy interventions over ribs that have metastatic lesions


image  Failure to observe limited weight-bearing status precautions (e.g., patients with metastatic lesions in limbs; hip fracture repair)


image  Promoting polypharmacy


image  Failing to provide adequate pain relief with appropriate medications


image  Failure to provide immunization in patients with spinal cord injuries and at risk for pneumonia


image  Insisting that patients confront the reality of their disability


image  Destroying or creating false hope


image  Providing unnecessary devices.


image  Failing to stop treatments when their burdens begin to exceed their benefits (e.g., continuing the provision of artificial nutrition when patients are actively dying or continuing IV fluids for dyspneic patients with congestive heart failure).

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Mar 13, 2017 | Posted by in PHYSICAL MEDICINE & REHABILITATION | Comments Off on Ethical Considerations in the Practice of Rehabilitation Medicine—A Contextual Framework for Addressing Ethical Issues in Rehabilitation Medicine

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