ABSTRACT: Acknowledgment of the importance of patient autonomy and increased patient access to information has prompted more patient–generated requests for surgical interventions not necessarily recommended by their physicians. Decision making in obstetrics and gynecology should be guided by the ethical principles of respect for patient autonomy, beneficence, nonmaleficence, justice, and veracity. Each physician should exercise judgment when determining whether information presented to the patient is adequate. When working with a patient to make decisions about surgery, it is important for obstetricians and gynecologists to take a broad view of the consequences of surgical treatment and to acknowledge the lack of firm evidence for the benefit of one approach over another when evidence is limited.
|*Update of "Surgery and Patient Choice," in Ethics in Obstetrics and Gynecology, Second Edition, 2004.
Is it ethical to perform an elective cesarean delivery for a woman with a normal pregnancy, a prophylactic oophorectomy for a 30–year–old patient with no family history of ovarian cancer, or a tubal ligation for an 18–year–old nulligravid woman? How should the physician respond to a patient who requests a specific surgical therapy without having an accepted medical indication? Should health care options be regarded in the same way as choice of cereal in the supermarket: the consumer makes a choice based on appearance, content, and cost, and the grocer takes the money and bags the cornflakes, without providing any direction? Is choosing a medical procedure so radically different and complex that this analogy is inappropriate?
Years ago, patients presented to their physicians with symptoms, and the physicians would establish diagnoses then make recommendations for therapy; usually recommendations were accepted by patients without question. An example of that paternalistic model was the widespread practice of "twilight sleep" for labor and delivery. Physicians administered a narcotic and scopolamine, and decisions during labor and delivery were delegated to the medical team. In contrast, today the first prenatal visit may open with a discussion of the patient's birth plan, including her preferences for anesthesia, episiotomy, forceps use, cesarean delivery, and breastfeeding. The purpose of this Committee Opinion is to provide the obstetrician–gynecologist with an approach to decision making based on ethics in an environment of increased patient information, recognition of patient autonomy, direct–to–consumer marketing, often incomplete evidence, and a plethora of alternative, investigational, or unproven treatments for many conditions.
Decision making in obstetrics and gynecology should be guided by the ethical principles of respect for patient autonomy, beneficence, nonmaleficence, justice, and veracity and as set forth throughout this document and in the "Code of Professional Ethics of the American College of Obstetricians and Gynecologists" (1). Although obligations to the patient are paramount, in addition, the obstetrician–gynecologist must consider resolution of conflicts of interest, acknowledgment of the profession's responsibility to society as a whole, and the maintenance of the dignity and honor of the discipline of obstetrics and gynecology and its standards of care. Issues related to surgery are addressed in this Committee Opinion; however, the ethical principles are the same as for other health care decisions (eg, diagnostic testing or medical therapy).
Patient autonomy and the concept of informed consent or refusal are central to issues regarding patient choice to have or not have a surgical procedure. It is the obligation of the obstetrician–gynecologist to fully inform the patient regarding treatment options and the potential risks and benefits of those options. In discussing these options, the physician should take into account the context of the patient's decision making, including the potential influences of family and society (2). Once the physician is satisfied that the patient fully comprehends the options, her autonomous decision ordinarily should be respected and supported. Patients should be encouraged to seek second opinions when in doubt or in need of reassurance. However, even though the decision of the patient should be respected, respect might not include supporting the decision, particularly when doing so is in direct conflict with other guiding ethical principles. At times, these other principles may take priority over supporting the patient's decisions.
The principle of beneficence refers to the ethical obligation of the physician to promote the health and welfare of the patient. The complementary principle of nonmaleficence refers to the physician's obligation to not harm the patient. When a patient refuses surgery or another treatment that the obstetrician–gynecologist believes is necessary for her health and welfare, beneficence and nonmaleficence can conflict with respect for patient autonomy. In almost all situations, the patient has a right to refuse unwanted treatment. She does not, however, have a parallel right of access to treatment that the physician believes is unwise or overly risky.
Justice, as an ethical principle, applies to the physician, the hospital, the payer, and society, as well as to the individual patient. Although there are many theories of justice, in the medical context, this principle requires that medical professionals treat individuals fairly. Further, it is important for the physician to consider the impact on not only the individual patient but also society. At the level of the physician–patient relationship, justice implies, for instance, that physicians consider a patient's request for an elective procedure in the context of similar types of requests by other patients. At the societal level, justice directs physicians to consider the impact of their decision to perform a procedure in terms of the allocation of scarce resources.
Veracity, or truth telling, is important in surgical counseling and decision making. When the patient requests a procedure to which the physician is morally opposed (such as abortion or permanent sterilization), the physician may have a limited right to refuse to provide the service; however, the physician must disclose scientifically accurate information, convey to the patient that this refusal is based on moral (not medical) grounds, and refer the patient in a timely manner (3). The obstetrician–gynecologist should not misrepresent his or her experience with the proposed treatment or knowledge regarding potential long–term outcomes.
The Physician–Patient Relationship
Four models of the relationship between the physician and patient have been described: 1) paternalistic, 2) informative, 3) interpretive, and 4) deliberative (4). Depending on which model is used, different ethical principles emerge as relevant to ethical decision making. The ideal model for the physician–patient relationship has been the subject of considerable debate. In fact, physicians probably use all four models, depending on the individual patient, her situation, and the disease process involved (4).
In the paternalistic physician–patient model (4), the physician might present only information on risks and benefits of a procedure that he or she thinks will lead the patient to make the "right" decision (ie, in this model, the physician–supported decision) regarding health care. One example of the paternalistic model would be the ethically and professionally problematic practice of recommending amniocentesis for a 35–year–old pregnant patient but offering no alternatives.
This model is not appropriate when the patient is competent to make informed decisions, but it may be the best choice in situations of last resort, such as unconscious patients in the emergency department when no surrogate decision maker is present. When the patient is ill and unable to engage, either physically or mentally, in a discussion of the risks and benefits of a particular surgical intervention and there is neither an advance directive nor an assigned proxy for health care decisions, a paternalistic physician–patient relationship may be the only way to adhere to the ethical principles of beneficence and nonmaleficence with impaired patient autonomy.
At the opposite end of the spectrum, the informative model describes a physician–patient relationship in which the physician is a provider of objective and technical information regarding the patient's medical problem and its potential therapeutic solutions. The patient has complete control over surgical decision making, and the physician's values are not discussed. An example is a physician offering a patient with an abnormal cervical cytology result the options of watchful waiting, colposcopy, loop electrosurgical excision procedure, laser ablation, cold knife conization, and hysterectomy. The discussion includes a complete description of advantages, disadvantages, risks, and complications of each option. The discussion does not include any statement about the physician's recommendations or prioritization of the options.
A serious drawback of this model is the physician's abandonment of the role of a caring partner and medical expert in the decision–making process. This model also assumes that patients have set values and are able to completely integrate the sometimes complex medical and surgical treatment decisions with those values. However, when the physician–patient relationship is necessarily brief and there are multiple treatment options with comparable risks and benefits, the informative model may be appropriate. One example is the choice of having a genetic amniocentesis for advanced maternal age versus multiple marker testing or no testing.
One of the many unfortunate consequences of the professional liability crisis is the unsubstantiated belief of some physicians that the informative model reduces the physician's risk of liability. Such a belief raises concerns about physicians protecting themselves rather than working in the best interests of their patients.
This model may not be ideal for patient care in most situations because the physician's professional judgment generally is of considerable value to patients. In any case, it probably is impossible for a physician to counsel a patient with complete objectivity and without introducing some implied preference for one of many options (5).
Other models for physician–patient relationships strike a middle ground between the extremes of the paternalistic and informative models. In the interpretive model, the physician helps the patient clarify and integrate her values into the decision–making process while acting as an information source regarding the technical aspects of any given medical procedure. In this model, the physician aids the patient in "self–understanding; the patient comes to know more clearly who he or she is and how various medical options bear on his or her identity" (4).
Application of this model to an example of cervical dysplasia might result in the physician noting that the patient had a history of moderate symptoms associated with menses, had completed her childbearing, and was very fearful of cancer. On that basis, the physician recommends hysterectomy over other options, although he or she describes and discusses other options and their potential implications for the patient. When implementing this model, the physician must be careful to help the patient clarify her values while not imposing his or her own values or beliefs on the patient.
In the deliberative model, the physician's role is to guide the patient in taking the most admirable or moral (based on her values, needs, and fears) course of treatment or health–related action (4). It is similar to the interpretive model in that it includes a discussion of not only the medical benefits and risks but also the patient's individual priorities, values, and fears. It goes beyond the interpretive model in that the physician must consciously communicate to the patient his or her health values; however, the physician should not use the moral discussion to dictate to the patient the best course of action (4). Because of the potential for an unequal balance of power in the physician–patient relationship, great care should be taken in this model to avoid subjecting the patient to undue pressure.
The case of a patient with a history of tubal ligation considering her fertility options may illustrate the deliberative model. In this case, the patient's understanding of the moral status of the human embryo might influence whether tubal anastomosis or in vitro fertilization is pursued. The physician would provide technical information about the options but might also convey information about how individuals and organizations have formulated the discussion of the moral status of embryos. This deliberation then may assist the patient by providing tools with which the patient might examine her values in support of a treatment decision.
The Process of Decision Making
Each physician should exercise judgment when determining whether information presented to the patient is adequate. The practice of evidence–based medicine involves understanding the scientific basis of treatment and the strength of the evidence and applying the results of the strongest evidence available to medical decision making. Frequently, both surgical and medical decisions need to be made in a context in which the scientific evidence supporting one treatment option over another is incomplete, of poor quality, or totally lacking. There is no ethical imperative to initiate discussion of treatment options that are either unproven or not part of accepted medical practice. The physician may, however, want to discuss investigational options so that the patient understands the unproven nature of these options and can make an informed decision about them. Surgical and medical advice or guidance for many obstetric and gynecologic problems is based in part on science, in part on the experience and values of the physician, and in part on the physician's understanding of the patient's preferences, values, and desired outcome.
When working with a patient to make decisions about surgery, it is important for obstetricians and gynecologists to take a broad view of the consequences of surgical treatment and to acknowledge the lack of firm evidence for the benefit of one approach over another when evidence is limited. For example, a discussion of treatment options for menorrhagia associated with leiomyoma should include the fact that the long–term risks and benefits of some treatment options have not been compared directly (6). Recommendation for a particular option is dictated by many factors, including patient age, leiomyoma size, bleeding severity, and coexisting medical conditions, but in many cases two or more therapeutic options probably would be regarded as equally medically sound. Comparing possible long–term complications of hysterectomy, such as bowel obstruction and loss of vaginal support, with the risks of more conservative surgical approaches, such as the possible need for future treatment of recurrent leiomyomata, is an important part of informed consent. Helping patients understand potential long– and short–term consequences of any given decision as well as giving patients an appreciation of the quality of evidence on which each option is based are critical parts of informed consent. In addition, the physician must be aware of potential personal conflicts of interest that may be present, such as personal financial gain related to the provision or nonprovision of surgical care, and he or she must guard against this as an influence when giving guidance to patients as they make treatment choices.
An Example of the Process
Elective cesarean delivery is offered as an example to illustrate an ethical framework physicians may use in responding to patient requests for treatment for which evidence of benefit is absent or imperfect or which the health care professional would not usually recommend. In using this example, the Committee on Ethics does not mean to comment on the clinical appropriateness of or medical evidence supporting elective cesarean delivery, which would require a review beyond the scope of this document and the Committee on Ethics and have recently been addressed by the Committee on Obstetric Practice (7).
In obstetrics, the ethical issues of informed consent and patient choice are exemplified in the current debate regarding whether elective cesarean delivery should be offered as a birth option in normal pregnancy (8). The wide range of opinion on this issue is reflected in the language that is used, with varying terms reflecting different views of the physician–patient relationship. "Cesarean delivery on demand" reflects the informative model, in which the physician simply describes options and provides the service chosen by the patient. The phrase "elective cesarean delivery" is more suggestive of the deliberative and interpretive models, in which the physician and patient also discuss concerns, needs, and values.
The ethical evaluation is clouded by the limitations of data regarding relative short– and long–term risks and benefits of cesarean delivery versus vaginal delivery (9). For example, limitations that need to be acknowledged on both sides of the debate include evidence for long–term reduction in pelvic floor disorders in women undergoing elective cesarean delivery and lack of extensive morbidity and mortality data comparing routine cesarean delivery with vaginal delivery.
Each of the ethical principles contributes to the decision–making process regarding elective cesarean delivery. However, none alone is sufficient for making the decision.
If taken in a vacuum, the principle of respect for patient autonomy would lend support to the permissibility of elective cesarean delivery in a normal pregnancy (after adequate informed consent). To ensure that the patient's consent is in fact informed, the physician should explore the patient's concerns. For example, a patient may request elective cesarean delivery because she is afraid of discomfort during labor (10). In this case, providing her with information about procedures available for effective pain relief during labor would actually enhance the patient's capacity for autonomous choice and may result in an agreement to proceed without surgery (11).
The ethical principle of justice regarding the allocation of medical resources must be considered in the debate over elective cesarean delivery and informed patient choice. It is not clear whether widespread implementation of elective cesarean delivery would increase or decrease resources required to provide delivery services. Comprehensive analysis of costs and benefits for current and subsequent pregnancies would provide a basis for application of the principle of justice (12).
Application of the principles of beneficence and nonmaleficence (a physician should offer only treatments that promote the health and welfare of the patient) is made problematic by the limitations of the scientific data described previously. Different interpretations of the risks and benefits are the basis for reasonable differences among obstetricians regarding this challenging issue. In addition, different patients may place considerably different values on known risks and benefits. How certain is it that elective cesarean delivery really protects pelvic support 20 years later? How different is the maternal mortality rate of elective or repeat cesarean delivery in healthy women compared with that of women who have had one or two vaginal deliveries? Are there any desirable or undesirable psychosocial effects of elective cesarean delivery? The currently available data do not adequately represent the comparative populations in question. For instance, data regarding outcomes of cesarean delivery usually involve complicated pregnancies or women in whom a trial of labor has failed. These outcomes are compared with those involving probably healthier women who were able to give birth vaginally. As better data accumulate, the principle of beneficence may result in a shift in clinical practice.
Based on these principles, is it ethical to agree to a patient request for elective cesarean delivery in the absence of an accepted medical indication? The response must begin with the physician's assessment of the current data regarding the relative benefits and risks of the two approaches. In the absence of significant data on the risks and benefits of cesarean delivery, the burden of proof should fall on those who are advocates for a change in policy in support of elective cesarean delivery (ie, the replacement of usual care in labor with a major surgical procedure). If the physician believes that cesarean delivery promotes the overall health and welfare of the woman and her fetus more than vaginal delivery, he or she is ethically justified in performing a cesarean delivery. Similarly, if the physician believes that performing a cesarean delivery would be detrimental to the overall health and welfare of the woman and her fetus, he or she is ethically obliged to refrain from performing the surgery. In this case, a referral to another health care provider would be appropriate if the physician and patient cannot agree on a route of delivery.
Given the lack of data, it currently is not ethically necessary to initiate discussion regarding the relative risks and benefits of elective cesarean delivery versus vaginal delivery with every pregnant patient. There is no obligation to initiate discussion about procedures that the physician does not consider medically acceptable or that are unproven.
On the basis of the ethical principles of beneficence and respect for patient autonomy, an algorithm has been proposed for deciding between the performance of a cesarean delivery and making a referral in cases in which the physician's recommendation is vaginal delivery and the informed patient makes the autonomous decision to request a cesarean delivery (13). The Committee on Ethics addresses other special considerations involving patient choice in obstetric decision making elsewhere (14).
Although informed refusal of care by the patient is a familiar situation for most clinicians in the practice of both obstetrics and gynecology, acknowledgment of the importance of patient autonomy and increased patient access to information, such as information on the Internet, has prompted more patient–generated requests for surgical interventions not necessarily recommended by their physicians. A patient request for elective cesarean delivery, prompted by a perception of lower risk to the woman (of pelvic floor and sexual dysfunction) and her fetus with cesarean delivery, is an obstetric example. Other examples include requests for prophylactic oophorectomy to reduce risk of ovarian cancer in otherwise healthy women at low risk.
The response to such requests must begin with the physician having a good understanding of the scientific evidence for and against the requested procedure. With that information, the physician should counsel the patient within the framework of the ethical principles of respect for autonomy, beneficence, nonmaleficence, veracity, and justice. The ethical models described in this document provide an approach for using these principles. The physician should use the opportunity that this kind of request presents to explore the patient's concerns and values. In most cases, providing information and careful counseling will allow patients and their physicians to reach a mutually acceptable decision. If an acceptable balance cannot be reached by the patient and physician, the patient may choose to continue care with another provider.
- American College of Obstetricians and Gynecologists. Code of professional ethics of the American College of Obstetricians and Gynecologists. Washington, DC: ACOG; 2008. Available at: http://www.acog.org/~/media/About ACOG/acogcode.ashx. Retrieved January 2, 2008.
- Mackenzie C, Stoljar N. Relational autonomy: feminist perspectives on autonomy, agency, and the social self. New York (NY): Oxford University Press; 2000.
- The limits of conscientious refusal in reproductive medicine. ACOG Committee Opinion No. 385. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;110;1203–8.
- Emanuel EJ, Emanuel LL. Four models of the physician–patient relationship. JAMA 1992;267:2221–6.
- Mahowald MB. On the treatment of myopia: feminist standpoint theory and bioethics. In: Wolf S, editor. Feminism and bioethics: beyond reproduction. New York (NY): Oxford University Press; 1996. p. 95–115.
- Myers ER, Barber MD, Gustilo–Ashby T, Couchman G, Matchar DB, McCrory DC. Management of uterine leiomyomata: what do we really know? Obstet Gynecol 2002;100: 8–17.
- Cesarean delivery on maternal request. ACOG Committee Opinion No. 394. American College of Obstetricians and Gynecologists. Obstet Gynecol 2007;110:1501–4.
- Minkoff H, Chervenak FA. Elective primary cesarean delivery. N Engl J Med 2003;348:946–50.
- Cesarean delivery on maternal request March 27–29, 2006. National Institutes of Health state–of–the–science conference statement. Obstet Gynecol 2006;107:1386–97.
- Bewley S, Cockburn J. Responding to fear of childbirth. Lancet 2002;359:2128–9.
- Saisto T, Salmela–Aro K, Nurmi JE, Kononen T, Halmesmaki E. A randomized controlled trial of intervention in fear of childbirth. Obstet Gynecol 2001;98:820–6.
- Morrison J, MacKenzie IZ. Cesarean section on demand. Semin Perinatol 2003;27:20–33.
- Chervenak FA, McCullough LB. An ethically justified algorithm for offering, recommending, and performing cesarean delivery and its application in managed care practice. Obstet Gynecol 1996;87:302–5.
- Maternal decision making, ethics, and the law. ACOG Committee Opinion No. 321. American College of Obstetricians and Gynecologists. Obstet Gynecol 2005; 106:1127–37.