The Ethics of Pelvic Surgery



The Ethics of Pelvic Surgery


Mindy S. Christianson

Edward E. Wallach





THEORY AND PRACTICE OF ETHICS IN MEDICINE

The practice of medicine is governed by a system of beliefs that guide the actions of physicians and other health care professionals to act and make decisions that are regarded as ethically acceptable. Throughout the practice of medicine, different sets of standards and concepts of ethically acceptable behavior have existed as the predominant code for health care professionals. Codes such as those set by the Hippocratic oath served as the mainstay of professional behavior for centuries until a different system took its place in the first half of the 20th century. This transition reflects changing societal values of health and well-being that evolved over time as a result of political, cultural, scientific, and technologic advancement.

The field of bioethics emerged in the 1950s. Before that time, ethical principles of the Hippocratic oath were regarded as the ethical standards for medicine. The guiding principle of physician action was primum non nocere—first do no harm. In the Hippocratic tradition, the model of paternalism structured the therapeutic relationship. The physician was designated as the most qualified person to make decisions about treatment options for a patient. As such, it was the physician’s judgment that determined what was to be considered as harm or benefit resulting from a medical procedure, not that of the patient or the patient’s family. This convention was based on the belief that only an expert in science and medicine was qualified enough to make the best choice among treatment options for patients. During a time when medical therapies were limited and choices were few, this approach was not viewed as problematic to patient care. However, as changes in society, science, and medicine unfolded, patients and the general public began to question these traditional views of the physician-patient relationship.

With the introduction of significant scientific and cultural revolutions that characterized the post-World War II period in the United States, these standards set by the Hippocratic oath were considered to be ineffectual to meet the growing demands of medicine and ethics. Movements advancing civil rights, women’s issues, and the growing recognition of individual rights and autonomy dominated the social climate. Carried over into medicine and science, a new set of health care innovations introduced new moral debates to society and the medical profession about the purpose of medical care, the definition of health, and the ability of mankind to regulate the physiology of the human body. The birth control pill, organ transplant, and dialysis are just a few examples of the significant lifealtering innovations of the time. The ethical questions raised in response to the cultural and scientific climate challenged the previous notions of ethical behavior of physicians. In particular, the notion that physicians were the most appropriate members in the therapeutic relationship to make choices for the patient was rejected. Decisions about the vast array of available medical therapies and choices seemed inherently incongruent with the concept of paternalism. With the rise in the importance of autonomy and individual rights, society campaigned to replace the paternalistic structure of medicine with a model that established the patient as the primary decision maker.

This movement resulted in the establishment of a system of principle-based ethics as the driving force behind modern medicine. In 1977, the Belmont Report outlined what these principles or standards should be. This massive effort to reshape modern bioethics resulted in the establishment of the following principles as the cornerstone of contemporary medical ethics: autonomy, beneficence, nonmaleficence, and justice.

Autonomy—The concept of autonomy embodies the ideal of self-determination—that a person shapes his or her own life through his or her own decisions, actions, and beliefs. As such, individuals have the right to make decisions about their lives that reflect their own beliefs of well-being and values. Inherent in the principle of autonomy is the requirement that others (i.e., physicians) must respect a patient’s right of self-determination.

Nonmaleficence—Nonmaleficence, defined as “do no harm,” has its origins in the original tenets of the Hippocratic oath. This principle encompasses the need both to prevent harm and to refrain from harmful acts.

Beneficence—The definition of the principle of beneficence is to do good on the behalf of others. In the case of the principle of beneficence, physicians are expected to actively promote the good of the patient, not just shelter him or her from harm. Though this may seem to be a subtle distinction from the principle of nonmaleficence, it is critical to the principle-based theory of ethics, as it requires the performance of positive acts to advance the well-being of others.

Justice—The principle of justice addresses the need to treat all persons fairly. In the case of health care, this pertains to both the physician-patient relationship and the public health obligations of physicians in the allocation of scarce medical resources.

In this principle-based ethics model, all four core elements hold, in theory, equal importance. In many of the clinical situations that physicians routinely address, these elements may seem to be in conflict with one another. The solution to complex ethical dilemmas requires the balancing of these principles and, oftentimes, a prioritization of one over the others. An example of this is in an emergent medical situation when the principle of beneficence may temporarily overrule autonomy. However these principles are weighted, they must ultimately be used in a way that results in medical choices serving the good of the patient by reflecting his or her values and beliefs.


Though the system of principle-based ethics as established by the Belmont Report is the forerunner of ethical standards of behavior in modern medicine, other legitimate models of bioethical theory exist. They are broad in nature and are guiding principles, but all come from the view that the system of principle-based ethics does not offer enough to guide behavior in the complex setting of health care. Two examples of this are feminist ethics and casuistry. Feminist ethics is based on the notion that decisions are made in the context of relationships and personal virtues, such as compassion, friendship, and love. Principle-based ethics does not take these factors into consideration, neglecting the problems raised in a society in which men and women are not viewed as equals, and, as a result, does not serve the true interests of the patient. A second example is casuistry, or case-based ethics. This theory is founded on the principle that moral lessons gained from the resolution of actual cases in medicine have more value than do a set of theoretic and unchanging principles. Using this model, ethical reasoning results from weighing the outcomes of real cases as examples and forming a set of modifiable principles from those conclusions. These are just two examples of the diversity of ethical theories that guide medicine and serve as solutions to ethical puzzles that cannot be solved using the standard principle-based ethics commonly in place today.

The very nature of the field of obstetrics and gynecology sets the stage for a variety of ethical dilemmas. Issues surrounding the beginnings of human life and reproductive function naturally facilitate profound and often controversial questions and debate. In addition, the women’s rights movement has raised other issues specific to the care of women, such as subjugation and control of women’s bodies through society and medicine. Despite this broad range of issues, ethical discussions in obstetrics and gynecology have often been perceived in terms of a single controversial issue: abortion. Yet, the field of bioethics in women’s health has a rich and broad set of important implications for the practice of medicine and the health of women. Recent advances in medicine and science have introduced novel therapeutic options to many of the conditions that gynecologists face, such as cervical cancer, uterine fibroids, and infertility. Genetic and pharmaceutical therapies, new diagnostic modalities, noninvasive surgical options, and the emergence of assisted reproductive technologies, including in vitro fertilization, set the stage for a multitude of multifaceted ethical questions and debates. This chapter will present some of the foundational concepts in bioethics and women’s health that serve as a launching point for addressing the more complex and novel ethical issues as they arise in the present setting of medicine and the future.


AUTONOMY AND INFORMED CONSENT

Informed consent is a mechanism whereby the autonomy of a patient is recognized, respected, and preserved in health care decisions. It is the result of a process whereby a patient makes a voluntary decision to proceed with a medical intervention with a sound understanding of the benefits and risks of the procedure, as well as alternative therapies if the procedure is declined. The respect of informed consent has two purposes. On the one hand, the process of achieving informed consent respects and recognizes the patient’s autonomy. On the other hand, patients benefit when they make decisions on their own behalf because they themselves are most familiar with their own values, beliefs, and ideas of well-being and health. When patients make informed and voluntary decisions about their health care, they can make choices that meet their own concept of what’s good and what’s beneficial.

The term informed consent has legal and ethical dimensions. Legally, informed consent can be viewed as an end point. The legal requirements of informed consent are met when the conversation between the physician and the patient is documented, either on an informed consent form or in the medical record. Often, getting a signature on a form is synonymous with achieving informed consent, but informed decision making goes well beyond the legal form. Ethically, informed decision making involves a process of communication between the physician and the patient through which the patient is able to make an autonomous decision either to authorize the intervention (informed consent) or reject it (informed refusal).

The legal and ethical dimensions of informed consent are often used interchangeably but can have very different meanings and implications. Unfortunately, the function and meaning of informed consent is often misinterpreted, and it is viewed primarily as a legal document with a patient’s signature denoting full understanding and authorization. It is important to keep in mind that both the legal and ethical requirements of informed consent are essential in health care. However, as important legal documentation is, it should not be placed before the ethical duties to the patient. Legal documentation in a chart or on a form does not substitute for the process of communication and autonomous decision making. Not all legal documents with a patient’s signature reflect that an adequate informed consent process has taken place.

A valid informed consent is both informed and autonomously authorized. To achieve this, the physician must ensure that five core components are met in the decision-making process: (a) competence, (b) voluntariness, (c) disclosure, (d) understanding, and (e) authorization or refusal. These core components serve as a guide for physicians when discussing medical interventions with patients to ensure that a patient makes the most appropriate decision possible. Without satisfying all five of these core components, an adequate informed consent process has not been achieved.


Competence

In the usual clinical setting, other than situations involving formal psychiatric evaluation, the determination of competence tends to be more of a working judgment than a formal assessment. Beauchamp and Childress describe decision-making capacity as follows: “Although the properties most crucial to the determination of competence are controversial, in biomedical contexts a person has generally been viewed as competent if able to understand a therapy or research procedure, to deliberate regarding major risks and benefits, and to make a decision in light of this deliberation.”


Voluntariness

Ethically valid informed consent can only be obtained through the voluntary authorization by a patient for a medical intervention. It is not sufficient merely to meet the criteria of decisionmaking capacity, disclosure, and understanding. The patient must be able to use this information to formulate a decision that is not controlled by others. If a patient is manipulated or coerced into making a decision, then valid informed consent will not have been achieved.


Disclosure

Autonomous decision making must be made in the context of information about the medical intervention. The physician must disclose sufficient information that allows the patient to make an informed decision reflecting his or her beliefs and values, including the risks, benefits, and alternatives of the
proposed medical intervention. The core of ethical disclosure is about facilitating the patient’s autonomous choice to accept or reject health care. Although there is no definitive rule about how much information should be given to the patient, a valid informed consent does not require that the patient be informed of every conceivable risk that could occur, no matter how remote or how trivial. Listing risks, either verbally or in writing, that do not have applicability to the patient does not promote autonomy. Instead, a balance must be achieved between the patient and the physician to determine how much information and detail is necessary for the patient to make a meaningful decision.


Understanding

The patient must make a decision based on an understanding of the information provided. It is not sufficient to mention or list the possible risks to an intervention. The patient must comprehend the ramifications of these risks when considering whether to proceed with an intervention. The physician must be certain to convey information about the risks, including the possible procedures involved to address a bad outcome if it occurs. The patient should then be able to weigh the risks and the benefits of the procedure in his or her own terms.


Authorization

The corollary of informed consent is informed refusal. Informed refusal is the decision of the patient to decline the proposed medical intervention. The respect for the patient’s autonomy that is implicit in informed consent extends to the choice to refuse treatment, even when the decision is made against the recommendation of the physician. Informed refusal can be as minor as refusing a simple elective procedure to refusing lifesaving treatments. A patient may refuse treatment for a variety of reasons. One reason may be that the intervention or the outcome is misaligned with his or her concept of good. For example, a patient may refuse a medical therapy because he or she believes it to be harmful or incongruous with his or her personal beliefs (e.g., blood transfusion refusal for a Jehovah’s Witness).

A balance must be met between respect for the autonomy of the patient and the physician’s duty to beneficence. It is the job of the physician to be as certain as possible that this decision is informed and consistent with the values and beliefs of the patient. In situations when the refusal may result in significant impairment, pain, or death, the physician should make every attempt to ensure that these decisions are consistent with the patient’s beliefs and have been so over time. Physicians may still be considering their patient’s best interest by giving preference to his or her spiritual or personal convictions over the medical good. Another important aspect of informed refusal is that it can occur either at the initiation of a treatment or later during the course of the treatment. This becomes apparent when a patient refuses to continue a treatment or undergo a similar or identical intervention. The willingness of the patient to undergo a therapy in the past does not mean that consent is implied in the future.

Under certain circumstances, a physician must proceed with a medical intervention without the informed consent of the patient. Generally, these circumstances involve emergent situations. For example, the patient may be suddenly incapacitated or unconscious and therefore incapable of providing any sort of autonomous authorization. Alternatively, the patient may be conscious and otherwise able to make decisions but, because of the emergent and critical nature of her condition, it is medically necessary to initiate an immediate intervention, and there is no time to engage in a discussion with the patient. In the first situation, there may be time to obtain authorization from an appropriate family member or designated medical decision maker. In the second situation (and sometimes in the first), there is no time, and the physician must make a decision on behalf of the patient. This decision should be made based on what is judged to be in the best medical interest of the patient and usually assumes most people would opt on the side of instituting lifesaving measures.

Informed consent plays a vital role in the practice of obstetrics and gynecology because this field of medicine pertains to the anatomy and function of a woman’s reproductive system and sexuality. Issues specific to women’s health have been brought to the forefront because of concerns of historical control and subjugation of women and their bodies through society and medicine. In addition, there is a growing trend to recognize the vital role of relationships in a patient’s medical decision making with respect to reproductive issues. Patients rarely make decisions about their sexuality and reproduction in a vacuum but instead do so within the context of relationships with others, whether friends, partners, or families. It is critical to recognize these qualities inherent in obstetrics and gynecology when obtaining informed consent for a medical therapy or procedure to maximize the autonomous expression of the patient’s personal preferences.


ETHICAL ISSUES IN SURGICAL TRAINING

Competence of the surgeon is a moral commitment to the patient, especially before undertaking a novel surgical procedure. Adequate preparation in the basic and clinical sciences and training in surgical techniques must have been accomplished before any new surgical procedure is introduced into clinical medicine. An overenthusiastic rush into the use of a procedure is exemplified by the sudden popularity of cardiac transplantation in the 1960s. The preparatory laboratory work in cardiac transplantation started in 1905, but the first successful replacement of the heart in a dog took place in 1960. Immune suppression, which is crucial to the procedure, was introduced in 1958, and longtime survival of grafts occurred by 1965. Christian Barnard reported the first successful human heart transplantation in December 1967 in South Africa. By the end of 1968, 101 human heart transplantations had been performed by 64 surgical groups in 22 countries. Most patients improved briefly and then died of rejection of the transplant or infections. In 2 years, the procedure was largely discredited, and it took more than 10 additional years to reestablish wide acceptance of the operation. This experience illustrates the need to limit difficult and complex procedures to specialized centers that have the resources and adequately trained surgeons to perform them.

This is equally true for complex pelvic surgery. The adoption of subspecialty boards by the American Board of Obstetrics & Gynecology, each with requirements for postresidency fellowship training and evaluation standards for certification, has helped to emphasize the need for specialized training in surgical techniques for pelvic surgeons. The rapid expansion of the use of robotic surgery training procedures prompts the responsibility for providing future gynecologists who are technically skilled to serve society effectively and safely. In addition to underlying knowledge, clinical experience, training, and practice, the competent surgeon operates with the attentiveness and focus commensurate with the surgical theater. Indeed, legitimate concerns regarding the potential impairment of overfatigued house staff managing and operating on patients have led to changes in house staff work hours and training.
Training programs are now charged with the simultaneous challenge of vigilantly protecting the welfare of their patients from potentially suboptimal care while ensuring that their surgeons, after completion of training, operate competently under emergent and suboptimal conditions.

Many surgeons trained before World War II participated in residency programs affiliated with large inner-city hospitals where patients without adequate resources or health insurance received care. It was accepted that these patients would receive treatment or even surgery by physicians-in-training (including senior medical students, interns, and residents), preferably under the supervision of skilled volunteers or paid clinical faculty and only when the trainee had reached the necessary level of competence. When health care became an entitlement under Medicare and Medicaid government-funded health insurance became more prevalent, many patients sought the services of private physicians. The so-called free care or resident services were often unable to recruit sufficient patients to provide adequate training for new surgeons. This was particularly true in pelvic surgery; given the choice, these patients sought refuge from the clinic, where privacy and dignity were hard to maintain, and fled in large numbers to private doctors’ offices. Surgical teaching thereafter often involved the private patient, with the resident now performing complete procedures under the supervision and assistance of the patient’s private physician. This arrangement potentially left patients either poorly informed or uninformed about the participation of physiciansin-training. This arrangement often became apparent when complications arose or the medical records were reviewed during litigation. Although patients are typically better informed now, it remains ethically necessary to inform them about teaching or training in each case so that objections can be dealt with before the planned procedure. Most surgeons involved in teaching programs inform their patients that surgery demands a team effort and that residents may be involved in assisting or operating with them, but that, as the private surgeons of record, they not only will be present but also will be in charge and responsible for everything that takes place during the procedure. Teaching should not take place in the operating room without such a disclosure and the patient’s informed consent in this regard. The resident’s role, status, and experience should be clear to the patient. We are long past the era of introducing medical students to patients as doctors rather than revealing their actual status.

Because of the limitation on the number of hours a doctorin-training may work, producing competent surgeons today has become even more challenging than in the past. This situation has necessitated approaches to supplement and amplify the residency program specifically as it affects surgical training. Novel training methods designed to accelerate the learning curve have been devised. These are directed at familiarizing the trainee with instrumentation and the handling of surgical instruments, improving manual dexterity, sharpening hand-eye coordination, and heightening awareness of pelvic anatomy. In addition, decision-making skills and essentials of emergency management need to be developed during the course of residency training. One valuable approach in use is the animal surgical laboratory, for instance, using pigs for training in laparoscopic surgery. Obviously, the size of structures in laboratory animals does not precisely simulate that in humans, and anatomic relationships do not reflect those of a human patient. Simulation training has expanded in residency training. For example, computer simulators have been developed to enhance resident training in laparoscopic and robotic surgery. Simulators for endoscopic surgical procedures use mannequins or human models. Fabricated pelvic models are also frequently used to heighten skills for practicing maneuvers for normal and operative delivery. These innovative exercises assist in preparing the student for experiences encountered in the operating room and may even succeed in refreshing the already practicing surgeon in performance of specific techniques. Simulated programs have also been developed that incorporate computerized lessons for improving history-taking skills and for simulating emergency management in the form of skill stations. The final arbiter for gaining surgical skills is the surgical procedure itself, carried out in actual patients under the guidance and supervision of an accomplished surgeon who has the ability to communicate effectively about both the procedure and techniques. The only way to learn to manage surgical complexities adroitly is through personal experience while under the direct tutelage of a preceptor who has previously experienced unplanned occurrences. In addition to foundational medical and surgical knowledge, clinical experience, training, and practice, the competent physicians must act in a responsible and professional manner, whether in the clinical or surgical setting. Impairment of a physician’s skills must be fully evaluated so that he or she may be given assistance to improve and injury to his or her patients is avoided. Health care institutions must have peer-accessible mechanisms in place to facilitate this process.

Jun 4, 2016 | Posted by in GYNECOLOGY | Comments Off on The Ethics of Pelvic Surgery

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