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Available online at www.sciencedirect.com
www.elsevier.com/locate/semperi
Ethical issues in periviable birth Frank A. Chervenak, MDa,n, and Laurence B. McCullough, PhDb a
Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, 525 East 68th St–J130, New York, NY 10065 Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX
b
A RT I C L E IN F O
A B S T R A C T Ethics is an essential dimension of the management of periviable birth in both clinical
Keywords:
practice and research. The goal of clinical care in periviable birth is to improve outcomes
Professional responsibility
for current pregnant and fetal patients. The goal of research in periviable birth is to
Fetus as a patient
improve outcomes for future pregnant patients and fetal patients. This paper provides an
Periviability
ethical framework for professionally responsible clinical management and research to
Futility
improve the outcomes of periviable birth. The ethical framework is based on the professional responsibility model of obstetric ethics, which rejects rights-based reductionism. This model elaborates the ethical concept of the fetus as a patient in terms of beneficence-based and autonomy-based obligations to the pregnant woman and beneficence-based obligations to the fetus and emphasizes that the fetus is not a separate patient. Guidance is provided for counseling pregnant women about the management of pregnancies at 22 weeks of well-documented gestation, for which directive counseling in the form recommending non-aggressive obstetric management is ethically justified. At 24 weeks and later of gestation, directive counseling in the form of recommending aggressive obstetric management is ethically justified. For the period between 22 and 24 weeks gestation, non-directive counseling is ethically justified. Guidance is also provided for counseling pregnant women about participation in clinical trials and in innovative intervention for fetal benefit. Non-directive counseling should be strictly followed for both. & 2013 Elsevier Inc. All rights reserved.
1.
Introduction
Ethics is an essential dimension of the management of periviable birth in both clinical practice and research. The goal of clinical care in periviable birth is to improve outcomes for currently pregnant patients and fetal patients. The goal of research in periviable birth is to improve outcomes for future pregnant and fetal patients. The purpose of this paper is to provide an ethical framework for professionally responsible clinical management and research to improve the outcomes of periviable birth.
2.
Ethical concepts and reasoning
Three ethical principles ground and direct professionally responsible patient care and research.1,2 The first is the ethical principle of beneficence. This is the oldest ethical principle in the history of Western medical ethics. The earliest known version is the injunction in the Hippocratic Oath to benefit the sick while keeping them from harm and injustice.3 One of the first uses of “beneficence” in the subsequent history of Western medical ethics occurred in Thomas Percival's (1740–1804) Medical Ethics, the first book
Presented at NICHD/SMFM/ACOG/AAP Workshop on Periviable Birth, February 2013. n Corresponding author. E-mail address: [email protected] (F.A. Chervenak). 0146-0005/13/$ - see front matter & 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1053/j.semperi.2013.06.027
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with that title in the global history of medical ethics.4 Percival used this word the way it is used in contemporary medical ethics: The physician is obligated to provide clinical management that, in deliberative (evidence-based, rigorous, and accountable) clinical judgment, is reliably expected to result in a greater balance of clinical good over clinical harm for the patient. Technically possible clinical management that is supported in beneficence-based clinical judgment is known as “medically reasonable.” The second ethical principle, respect for the patient's autonomy, has its origins in seventh-century British surgery.5 Surgeons at that time provided their services on the basis of contracts. Making contracts, then and now, requires the contractor of services to provide information about them and obtain consent. A more sophisticated process of what came in the twentieth century to be called informed consent was practiced by the Brooklyn gynecologist, Alexander Skene (1837–1900).6 Dr. Skene provided his female patients with information about their gynecological diseases, explained the need for surgery, and obtained consent. When women refused, he provided medical management and engaged women in discussion aimed at reconsideration of their refusal. In the twentieth century, the ethical principle of respect for autonomy was articulated: The physician is obligated to empower the pregnant woman's autonomy by providing her with information about her diagnosis, the medically reasonable alternatives for the clinical management of her diagnosis, and the clinical benefits and risks of each medically reasonable alternative. The third ethical principle is justice. In its most general formulation, this ethical principle requires that like cases be treated alike by seeing to it that all individuals similarly situated receive what is due to them.2 Of the accounts in the history of moral and political philosophy of what “due” should mean, the concept of exploitation is relevant here. Exploitation occurs in a population of patients when a small percent experience, as the outcome of clinical care, significant benefit with little or no clinical harm but a much a larger percent experience significant clinical harm—such as death and serious disability—without the opportunity to experience offsetting clinical benefit. The perinatologist's obligations to pregnant patients and fetal patients should be based on the professional responsibility model of obstetric ethics.7 This model serves as an antidote to the fallacy of rights-based reductionism. Rightsbased reductionism is a subset of ethical reductionism. Ethical reductionism occurs when ethical reasoning appeals exclusively to one ethical concept in clinical circumstances that by their very nature require consideration of multiple, complementary concepts if those circumstances are to be adequately understood and responsibly managed. Rights-based reductionism commits the fallacy of reasoning about ethical issues in perinatal medicine on the basis of exclusively the rights of the fetus or the rights of the pregnant woman. Fetal rights-based reductionism occurs when reasoning about ethical issues in obstetrics appeals only to the rights of the fetus. On such accounts, the rights of the fetus become the controlling source of the perinatologist's obligations in patient care at all gestational ages. The pregnant woman's rights become systematically secondary. Fetal rights-based
37 (2013) 422–425
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reductionism would support the primacy of any fetal interest at the expense of the pregnant woman's autonomy and regardless of adverse clinical outcomes for her. Pregnant-woman rights-based reductionism occurs when reasoning about ethical issues in obstetrics appeals only to the rights of the pregnant woman. The woman's right to control her body overrides fetal rights at all gestational ages. Fetal rights become systematically secondary to the pregnant woman's rights. Pregnant-woman rights-based reductionism would support the pregnant woman's preferences regardless of adverse clinical outcomes for the fetal or neonatal patient. The result of rights-based reductionism in obstetric ethics is a clinical and ethical disaster. At first blush, rights-based reductionism offers an appealing simplicity: identify the right at stake and provide clinical management that implements the right. On closer examination however, rights-based reductionism is ethically incomplete because it ignores altogether or unjustifiably discounts beneficence-based obligations to both the pregnant and fetal patients. The result is to distort the integrity of clinical judgment beyond recognition and reduce the perinatologist to a mere technician. In our view therefore, rights-based reductionism is unprofessional and has no legitimate place in obstetric ethics. The rights of women play an important role in perinatal ethics but not an exclusive role. The authors have argued elsewhere that obstetric ethics should be based on the ethical concept of medicine as a profession.1,7 This concept was introduced into the global history of medical ethics by two remarkable physician–ethicists, John Gregory (1772–1773) of Scotland and Thomas Percival of England. The concept has three components: (1) the physician should become and remain scientifically and clinically competent, engaging in the deliberative practice of medicine and clinical research; (2) the physician should protect and promote the health-related and other interests of the patient as the physician's primary concern and motivation, keeping self-interest systematically secondary; and (3) physicians should not regard medicine as a merchant guild (which it had been for centuries) but as a “public trust” (Percival's phrase) that exists for the benefit of present patients and should be improved for the benefit of future patients.8 Professional responsibility in obstetric patient care and research is based on the ethical principles of beneficence and respect for autonomy. The obstetrician has beneficence-based obligations and autonomy-based obligations to the pregnant patient and beneficence-based obligations to the fetal patient. All three sets of obligations must be taken into account and balanced against each other in deliberative clinical judgment. We emphasize that that the fetal patient is not a separate patient, in the sense that obligations to the fetal patient are the whole of the ethical story. Our position explicitly rejects such an account, which is both clinically and ethically inadequate. When the fetus is a patient and the evidence for obstetric management for fetal and neonatal benefit is reliable, counseling of the pregnant woman is justifiably directive. The nature of such clinical management as medically reasonable should be explained and the obstetrician should then recommend it. When the evidence is weak or non-reliable, the nature of such clinical management as medically reasonable should be explained and then the obstetrician should offer but not recommend it.
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In the responsible management of periviability, the ethical concept of the dying fetal patient becomes relevant. When a fetal patient is dying, non-aggressive obstetric management (such as avoiding cesarean delivery) and non-aggressive neonatal management (avoiding resuscitation and intubation) in the event of a live birth protect the fetal and neonatal patient from the unacceptable iatrogenic harms of clinical intervention that is not reliably expected to alter the outcome. In such cases, non-aggressive obstetric and neonatal management should be recommended. There is an additional beneficence-based consideration when managing the limits of periviability, the hard-won lesson of critical ethics: not every incremental reduction of mortality justifies the disease-related or iatrogenic burdens of morbidity, disability, lost functional status, pain, distress, and suffering that can result for the patient. Professionally responsible clinical management also requires recognition of the clinical applicability or futility. In general, this concept means that there is no reasonable expectation that the expected outcomes of a clinical intervention will occur. The first three of the four types of this general concept, listed in Table 1, are relevant to the responsible management of periviability. We emphasize that the fourth, quality-of-life futility, does not apply to the neonate because it is developmentally incapable of having life tasks, which are not the same as developmental milestones.9 Moreover, future quality of life is notoriously difficult to predict10 and physicians tend to underestimate the quality of life of disabled patients.11
3.
Implications for clinical care
At or less than 22 weeks of well-documented gestation, with delivery imminent, the fetal patient has become a dying patient. This is because either physiologic or imminentdemise futility apply: given current evidence about outcomes, there is no reasonable expectation that the death of the fetal patient can be prevented.12 Aggressive obstetric and neonatal management are contra-indicated in deliberative beneficence-based clinical judgment, because they only add iatrogenic burden with no offsetting clinical benefit. All indications for obstetric management should be based on beneficence-based obligations to the pregnant woman. Nonaggressive obstetric and neonatal management should be recommended. Cesarean delivery should not be offered. If it is requested, the obstetrician should recommend against it and not perform it. Organizational leaders and policy should support this exercise of professional responsibility.
37 (2013) 422–425
At 24 weeks of well-documented gestation or later, with delivery imminent, current evidence supports the expectation of survival in a substantial majority of cases.12 It is true that some survivors will experience some degree of sensory, motor, or cognitive disability, which in most cases will not be profound. None of the concepts of futility therefore apply. Aggressive obstetric and neonatal management are indicated in deliberative beneficence-based clinical judgment. When the evidence base for survival is reliable such intervention should be recommended. Neonatal management should be recommended as a trial of intervention. Resuscitation, intubation, and admission to the NICU will be initiated to prevent imminent death and will be continued unless physiologic, imminent-demise, or overall futility later become clinically applicable. The perinatologist should respond to refusal of the recommendation of aggressive obstetric and neonatal management with repeat of the recommendation and its justification. This should be followed by respectful persuasion,1 i.e., an appeal to the common ground between the obstetrician and pregnant woman of achieving a good outcome for her pregnancy, and emphasis on neonatal care as a trial of intervention. The management of imminent delivery of fetuses between 22 and 24 weeks of well-documented gestation is ethically controversial and subject to conflicting and evolving data about outcomes.12 Neonatal intervention with this population of patients has been described as an “uncontrolled experiment.”13 Such clinical management is not obligatory in deliberative, beneficence-based clinical judgment. Current evidence indicates that the majority of infants either die or survive with major complications and only a small percent survive intact. Therefore, serious concerns remain in beneficence-based clinical judgment that intervention could involve imminent or overall futility. The ethical principle of justice also applies to this patient population. A justice-based interpretation of current evidence, which continues to evolve, suggests that exploitation remains a risk of a uniform aggressive obstetric and neonatal management. In our view therefore, for both beneficence-based and justice-based reasons, both obstetric and neonatal intervention should be regarded as investigational and not obligatory for the pregnant woman to accept as a matter of beneficence-based obligations to either the fetal or neonatal patient. Respect for her autonomy requires the provision of evidence-based information about local outcomes, a process in which the neonatologist has an essential role to play as a consultant to the pregnant woman. Well-designed, multi-center trials are needed to more reliably characterize the outcomes in this population and whether those outcomes can be improved.
Table 1 – Four types of futility.18 Physiologic futility: There is no reasonable expectation in deliberative clinical judgment that the usually expected physiologic outcomes of an intervention will occur. The outcome should be specified precisely, e.g., restoration of spontaneous circulation from cardiopulmonary resuscitation. Imminent-demise futility: The patient is expected to die during current admission and not recover interactive capacity beforehand. Overall futility: The patient is reliably expected to survive but has irreversibly lost interactive capacity. Quality-of-life futility: The patient's reliably expected functional status will not support engagement in life tasks valued by the patient or enough satisfaction from engaging in valued life tasks.
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Implications for research
Research, as per current U.S. regulations, “means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”14 The current approach to research is to undertake preliminary investigation (Phase I and II trials) to determine is equipoise exists. Equipoise exists when deliberative clinical evaluation of the outcomes of preliminary research creates uncertainty about the comparative benefit of current and investigational clinical management. When equipoise exists, it is consistent with the professional responsibility model of obstetric ethics to permit enrollment of pregnant patients, with their informed consent, in randomized, controlled clinical trials.15 Counseling pregnant patients who are potential research subjects should be non-directive, because the pregnant woman has no beneficence-based obligation to the fetal or neonatal patient to undergo an experiment.15 Non-directive counseling should therefore make clear the experimental nature of the clinical trial, especially randomization and clinical interventions required by study design and not current standard of care, to prevent therapeutic misconception.16 An additional measure to prevent therapeutic misconception is to emphasize that research is designed to benefit future patients. Current federal regulations require that perinatal research for fetal benefit minimize risk to the fetus. This is a beneficencebased consideration that should be elaborated on the basis of the ethical concept of the fetus as a patient by investigators and IRBs in the design and review of such clinical trials.15 Intervention for fetal benefit is also an area of ongoing innovation, which occurs before research. An innovation is an experimental clinical intervention (i.e., its outcome cannot be reliably predicted) undertaken for the benefit of a patient, not to create generalizable scientific and clinical information for the benefit of future patients. Innovation can occur spontaneously or as planned. The emerging ethical standard, originating with the Society of University Surgeons,17 is that planned innovation should, like research, be prospectively reviewed for it scientific, clinical, and ethical justification and an appropriate informed consent process. The ethical justification of innovation for potential fetal benefit must take into account beneficencebased obligations to both the fetal and pregnant patients. The informed consent process for innovation should be strictly non-directive, because neither the perinatologist nor the pregnant woman has a beneficence-based obligation to the fetal patient to perform an experiment for potential fetal benefit. Responsibly conducted innovation should be integrated with research by evaluating its results to determine whether the results generate clinically grounded hypotheses for subsequent organized and approved investigation.
5.
Conclusion
The professional responsibility model of obstetric ethics is essential for ethically justified clinical care and research in periviable birth, in order to fulfill obligations to current and future pregnant and fetal patients.
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refere nces
1. Beauchamp TL, Childress JF. Principles of Biomedical Ethics, 7th ed. New York: Oxford University Press; 2012. 2. McCullough Laurence B, Chervenak Frank A. Ethics in Obstetrics and Gynecology. New York: Oxford University Press; 1994. 3. Von Staden H. The discourses of practitioners in ancient Europe. In: Baker RB, McCullough LB, eds, The Cambridge World History of Medical Ethics. New York: Cambridge University Press; 2009:352–358. 4. Baker RB, McCullough LB. What is the History of Medical Ethics? In The Cambridge World History of Medical Ethics. New York: Cambridge University Press; 3–15. 5. Wear A Medical ethics in early modern England. In: Wear A, Geyer-Kordesch J, French R, eds. Doctors and Ethics: The Earlier History Setting of Professional Ethics. Amsterdam: Rodopi; 1993:145–169. 6. Powderly KE. Patient consent and negotiation in the Brooklyn gynecological practice of Alexander J.C. Skene 1863–1900. J Med Philos. 2000;25:12–27. 7. Chervenak FA, McCullough LB, Brent RL. The professional responsibility model of obstetric ethics: avoiding the perils of clashing rights. Am J Obstet Gynecol. 2011;205(315):e1–e5. 8. McCullough LB. The ethical concept of medicine as a profession: its origins in modern medical ethics and implications for physicians. In: Kenny N, Shelton W, eds, Lost Virtue: Professional Character Development in Medical Education. New York: Elsevier; 2006:17–27. 9. McCullough LB. Neonatal ethics at the limits of viability. Pediatrics. 2005;116:1019–1021. 10. Tyson JE, Saigal S. Outcomes for extremely low-birth-weight infants: disappointing news. J Am Med Assoc. 2005;294: 371–373. 11. Leplege A, Hunt S. The problem of quality of life in medicine. J Am Med Assoc. 1997;278:47–50. 12. Chervenak FA, McCullough LB, Levene MI. An ethically justified, clinically comprehensive, approach to peri-viability: gynaecological, obstetric, perinatal, and neonatal dimensions. J Obstet Gynaecol. 2007;27(1):3–7. 13. Lucey JF, Rowan CA, Shiono P, Wilkinson AR, Kilpatrick S, Payne NR, et al. Fetal infants: the fate of 4172 infants with birth weights of 401 to 500 grams—the Vermont Oxford Network experience (1996–2000). Pediatrics. 2004;113: 1559–1566. 14. Code of Federal Regulations. Title 45 Public welfare. Department of health and human services. Part 46. Protection of human subjects. 2009. 〈http://www.hhs.gov/ohrp/humansubjects/guid ance/45cfr46.html〉 Accessed 12.01.13. 15. Chervenak FA, McCullough LB. An ethically justified framework for clinical investigation to benefit pregnant and fetal patients. Am J Bioeth. 2011;11:39–49. 16. Lidz CW, Appelbaum PS, Grisso T, Renaud M. Therapeutic misconception and the appreciation of risks in clinical trials. Soc Sci Med. 2004;58(9):1689–1697. 17. Biffl WL, Spain DA, Reitsma AM, Minter RM, Upperman J, Wilson M, et al. Society of University Surgeons Surgical Innovations Project Team. Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons. J Am Coll Surg. 2008;206: 1204–1209 (J). 18. Jones JW, McCullough LB. Postoperative futility: a clinical algorithm for setting limits. Br J Surg. 2001;88:1153–1154.
M I N A R S I N
P
E R I N A T O L O G Y
37 (2013) 422–425
Available online at www.sciencedirect.com
www.elsevier.com/locate/semperi
Ethical issues in periviable birth Frank A. Chervenak, MDa,n, and Laurence B. McCullough, PhDb a
Department of Obstetrics and Gynecology, Weill Medical College of Cornell University, 525 East 68th St–J130, New York, NY 10065 Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX
b
A RT I C L E IN F O
A B S T R A C T Ethics is an essential dimension of the management of periviable birth in both clinical
Keywords:
practice and research. The goal of clinical care in periviable birth is to improve outcomes
Professional responsibility
for current pregnant and fetal patients. The goal of research in periviable birth is to
Fetus as a patient
improve outcomes for future pregnant patients and fetal patients. This paper provides an
Periviability
ethical framework for professionally responsible clinical management and research to
Futility
improve the outcomes of periviable birth. The ethical framework is based on the professional responsibility model of obstetric ethics, which rejects rights-based reductionism. This model elaborates the ethical concept of the fetus as a patient in terms of beneficence-based and autonomy-based obligations to the pregnant woman and beneficence-based obligations to the fetus and emphasizes that the fetus is not a separate patient. Guidance is provided for counseling pregnant women about the management of pregnancies at 22 weeks of well-documented gestation, for which directive counseling in the form recommending non-aggressive obstetric management is ethically justified. At 24 weeks and later of gestation, directive counseling in the form of recommending aggressive obstetric management is ethically justified. For the period between 22 and 24 weeks gestation, non-directive counseling is ethically justified. Guidance is also provided for counseling pregnant women about participation in clinical trials and in innovative intervention for fetal benefit. Non-directive counseling should be strictly followed for both. & 2013 Elsevier Inc. All rights reserved.
1.
Introduction
Ethics is an essential dimension of the management of periviable birth in both clinical practice and research. The goal of clinical care in periviable birth is to improve outcomes for currently pregnant patients and fetal patients. The goal of research in periviable birth is to improve outcomes for future pregnant and fetal patients. The purpose of this paper is to provide an ethical framework for professionally responsible clinical management and research to improve the outcomes of periviable birth.
2.
Ethical concepts and reasoning
Three ethical principles ground and direct professionally responsible patient care and research.1,2 The first is the ethical principle of beneficence. This is the oldest ethical principle in the history of Western medical ethics. The earliest known version is the injunction in the Hippocratic Oath to benefit the sick while keeping them from harm and injustice.3 One of the first uses of “beneficence” in the subsequent history of Western medical ethics occurred in Thomas Percival's (1740–1804) Medical Ethics, the first book
Presented at NICHD/SMFM/ACOG/AAP Workshop on Periviable Birth, February 2013. n Corresponding author. E-mail address: [email protected] (F.A. Chervenak). 0146-0005/13/$ - see front matter & 2013 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1053/j.semperi.2013.06.027
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with that title in the global history of medical ethics.4 Percival used this word the way it is used in contemporary medical ethics: The physician is obligated to provide clinical management that, in deliberative (evidence-based, rigorous, and accountable) clinical judgment, is reliably expected to result in a greater balance of clinical good over clinical harm for the patient. Technically possible clinical management that is supported in beneficence-based clinical judgment is known as “medically reasonable.” The second ethical principle, respect for the patient's autonomy, has its origins in seventh-century British surgery.5 Surgeons at that time provided their services on the basis of contracts. Making contracts, then and now, requires the contractor of services to provide information about them and obtain consent. A more sophisticated process of what came in the twentieth century to be called informed consent was practiced by the Brooklyn gynecologist, Alexander Skene (1837–1900).6 Dr. Skene provided his female patients with information about their gynecological diseases, explained the need for surgery, and obtained consent. When women refused, he provided medical management and engaged women in discussion aimed at reconsideration of their refusal. In the twentieth century, the ethical principle of respect for autonomy was articulated: The physician is obligated to empower the pregnant woman's autonomy by providing her with information about her diagnosis, the medically reasonable alternatives for the clinical management of her diagnosis, and the clinical benefits and risks of each medically reasonable alternative. The third ethical principle is justice. In its most general formulation, this ethical principle requires that like cases be treated alike by seeing to it that all individuals similarly situated receive what is due to them.2 Of the accounts in the history of moral and political philosophy of what “due” should mean, the concept of exploitation is relevant here. Exploitation occurs in a population of patients when a small percent experience, as the outcome of clinical care, significant benefit with little or no clinical harm but a much a larger percent experience significant clinical harm—such as death and serious disability—without the opportunity to experience offsetting clinical benefit. The perinatologist's obligations to pregnant patients and fetal patients should be based on the professional responsibility model of obstetric ethics.7 This model serves as an antidote to the fallacy of rights-based reductionism. Rightsbased reductionism is a subset of ethical reductionism. Ethical reductionism occurs when ethical reasoning appeals exclusively to one ethical concept in clinical circumstances that by their very nature require consideration of multiple, complementary concepts if those circumstances are to be adequately understood and responsibly managed. Rights-based reductionism commits the fallacy of reasoning about ethical issues in perinatal medicine on the basis of exclusively the rights of the fetus or the rights of the pregnant woman. Fetal rights-based reductionism occurs when reasoning about ethical issues in obstetrics appeals only to the rights of the fetus. On such accounts, the rights of the fetus become the controlling source of the perinatologist's obligations in patient care at all gestational ages. The pregnant woman's rights become systematically secondary. Fetal rights-based
37 (2013) 422–425
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reductionism would support the primacy of any fetal interest at the expense of the pregnant woman's autonomy and regardless of adverse clinical outcomes for her. Pregnant-woman rights-based reductionism occurs when reasoning about ethical issues in obstetrics appeals only to the rights of the pregnant woman. The woman's right to control her body overrides fetal rights at all gestational ages. Fetal rights become systematically secondary to the pregnant woman's rights. Pregnant-woman rights-based reductionism would support the pregnant woman's preferences regardless of adverse clinical outcomes for the fetal or neonatal patient. The result of rights-based reductionism in obstetric ethics is a clinical and ethical disaster. At first blush, rights-based reductionism offers an appealing simplicity: identify the right at stake and provide clinical management that implements the right. On closer examination however, rights-based reductionism is ethically incomplete because it ignores altogether or unjustifiably discounts beneficence-based obligations to both the pregnant and fetal patients. The result is to distort the integrity of clinical judgment beyond recognition and reduce the perinatologist to a mere technician. In our view therefore, rights-based reductionism is unprofessional and has no legitimate place in obstetric ethics. The rights of women play an important role in perinatal ethics but not an exclusive role. The authors have argued elsewhere that obstetric ethics should be based on the ethical concept of medicine as a profession.1,7 This concept was introduced into the global history of medical ethics by two remarkable physician–ethicists, John Gregory (1772–1773) of Scotland and Thomas Percival of England. The concept has three components: (1) the physician should become and remain scientifically and clinically competent, engaging in the deliberative practice of medicine and clinical research; (2) the physician should protect and promote the health-related and other interests of the patient as the physician's primary concern and motivation, keeping self-interest systematically secondary; and (3) physicians should not regard medicine as a merchant guild (which it had been for centuries) but as a “public trust” (Percival's phrase) that exists for the benefit of present patients and should be improved for the benefit of future patients.8 Professional responsibility in obstetric patient care and research is based on the ethical principles of beneficence and respect for autonomy. The obstetrician has beneficence-based obligations and autonomy-based obligations to the pregnant patient and beneficence-based obligations to the fetal patient. All three sets of obligations must be taken into account and balanced against each other in deliberative clinical judgment. We emphasize that that the fetal patient is not a separate patient, in the sense that obligations to the fetal patient are the whole of the ethical story. Our position explicitly rejects such an account, which is both clinically and ethically inadequate. When the fetus is a patient and the evidence for obstetric management for fetal and neonatal benefit is reliable, counseling of the pregnant woman is justifiably directive. The nature of such clinical management as medically reasonable should be explained and the obstetrician should then recommend it. When the evidence is weak or non-reliable, the nature of such clinical management as medically reasonable should be explained and then the obstetrician should offer but not recommend it.
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In the responsible management of periviability, the ethical concept of the dying fetal patient becomes relevant. When a fetal patient is dying, non-aggressive obstetric management (such as avoiding cesarean delivery) and non-aggressive neonatal management (avoiding resuscitation and intubation) in the event of a live birth protect the fetal and neonatal patient from the unacceptable iatrogenic harms of clinical intervention that is not reliably expected to alter the outcome. In such cases, non-aggressive obstetric and neonatal management should be recommended. There is an additional beneficence-based consideration when managing the limits of periviability, the hard-won lesson of critical ethics: not every incremental reduction of mortality justifies the disease-related or iatrogenic burdens of morbidity, disability, lost functional status, pain, distress, and suffering that can result for the patient. Professionally responsible clinical management also requires recognition of the clinical applicability or futility. In general, this concept means that there is no reasonable expectation that the expected outcomes of a clinical intervention will occur. The first three of the four types of this general concept, listed in Table 1, are relevant to the responsible management of periviability. We emphasize that the fourth, quality-of-life futility, does not apply to the neonate because it is developmentally incapable of having life tasks, which are not the same as developmental milestones.9 Moreover, future quality of life is notoriously difficult to predict10 and physicians tend to underestimate the quality of life of disabled patients.11
3.
Implications for clinical care
At or less than 22 weeks of well-documented gestation, with delivery imminent, the fetal patient has become a dying patient. This is because either physiologic or imminentdemise futility apply: given current evidence about outcomes, there is no reasonable expectation that the death of the fetal patient can be prevented.12 Aggressive obstetric and neonatal management are contra-indicated in deliberative beneficence-based clinical judgment, because they only add iatrogenic burden with no offsetting clinical benefit. All indications for obstetric management should be based on beneficence-based obligations to the pregnant woman. Nonaggressive obstetric and neonatal management should be recommended. Cesarean delivery should not be offered. If it is requested, the obstetrician should recommend against it and not perform it. Organizational leaders and policy should support this exercise of professional responsibility.
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At 24 weeks of well-documented gestation or later, with delivery imminent, current evidence supports the expectation of survival in a substantial majority of cases.12 It is true that some survivors will experience some degree of sensory, motor, or cognitive disability, which in most cases will not be profound. None of the concepts of futility therefore apply. Aggressive obstetric and neonatal management are indicated in deliberative beneficence-based clinical judgment. When the evidence base for survival is reliable such intervention should be recommended. Neonatal management should be recommended as a trial of intervention. Resuscitation, intubation, and admission to the NICU will be initiated to prevent imminent death and will be continued unless physiologic, imminent-demise, or overall futility later become clinically applicable. The perinatologist should respond to refusal of the recommendation of aggressive obstetric and neonatal management with repeat of the recommendation and its justification. This should be followed by respectful persuasion,1 i.e., an appeal to the common ground between the obstetrician and pregnant woman of achieving a good outcome for her pregnancy, and emphasis on neonatal care as a trial of intervention. The management of imminent delivery of fetuses between 22 and 24 weeks of well-documented gestation is ethically controversial and subject to conflicting and evolving data about outcomes.12 Neonatal intervention with this population of patients has been described as an “uncontrolled experiment.”13 Such clinical management is not obligatory in deliberative, beneficence-based clinical judgment. Current evidence indicates that the majority of infants either die or survive with major complications and only a small percent survive intact. Therefore, serious concerns remain in beneficence-based clinical judgment that intervention could involve imminent or overall futility. The ethical principle of justice also applies to this patient population. A justice-based interpretation of current evidence, which continues to evolve, suggests that exploitation remains a risk of a uniform aggressive obstetric and neonatal management. In our view therefore, for both beneficence-based and justice-based reasons, both obstetric and neonatal intervention should be regarded as investigational and not obligatory for the pregnant woman to accept as a matter of beneficence-based obligations to either the fetal or neonatal patient. Respect for her autonomy requires the provision of evidence-based information about local outcomes, a process in which the neonatologist has an essential role to play as a consultant to the pregnant woman. Well-designed, multi-center trials are needed to more reliably characterize the outcomes in this population and whether those outcomes can be improved.
Table 1 – Four types of futility.18 Physiologic futility: There is no reasonable expectation in deliberative clinical judgment that the usually expected physiologic outcomes of an intervention will occur. The outcome should be specified precisely, e.g., restoration of spontaneous circulation from cardiopulmonary resuscitation. Imminent-demise futility: The patient is expected to die during current admission and not recover interactive capacity beforehand. Overall futility: The patient is reliably expected to survive but has irreversibly lost interactive capacity. Quality-of-life futility: The patient's reliably expected functional status will not support engagement in life tasks valued by the patient or enough satisfaction from engaging in valued life tasks.
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Implications for research
Research, as per current U.S. regulations, “means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”14 The current approach to research is to undertake preliminary investigation (Phase I and II trials) to determine is equipoise exists. Equipoise exists when deliberative clinical evaluation of the outcomes of preliminary research creates uncertainty about the comparative benefit of current and investigational clinical management. When equipoise exists, it is consistent with the professional responsibility model of obstetric ethics to permit enrollment of pregnant patients, with their informed consent, in randomized, controlled clinical trials.15 Counseling pregnant patients who are potential research subjects should be non-directive, because the pregnant woman has no beneficence-based obligation to the fetal or neonatal patient to undergo an experiment.15 Non-directive counseling should therefore make clear the experimental nature of the clinical trial, especially randomization and clinical interventions required by study design and not current standard of care, to prevent therapeutic misconception.16 An additional measure to prevent therapeutic misconception is to emphasize that research is designed to benefit future patients. Current federal regulations require that perinatal research for fetal benefit minimize risk to the fetus. This is a beneficencebased consideration that should be elaborated on the basis of the ethical concept of the fetus as a patient by investigators and IRBs in the design and review of such clinical trials.15 Intervention for fetal benefit is also an area of ongoing innovation, which occurs before research. An innovation is an experimental clinical intervention (i.e., its outcome cannot be reliably predicted) undertaken for the benefit of a patient, not to create generalizable scientific and clinical information for the benefit of future patients. Innovation can occur spontaneously or as planned. The emerging ethical standard, originating with the Society of University Surgeons,17 is that planned innovation should, like research, be prospectively reviewed for it scientific, clinical, and ethical justification and an appropriate informed consent process. The ethical justification of innovation for potential fetal benefit must take into account beneficencebased obligations to both the fetal and pregnant patients. The informed consent process for innovation should be strictly non-directive, because neither the perinatologist nor the pregnant woman has a beneficence-based obligation to the fetal patient to perform an experiment for potential fetal benefit. Responsibly conducted innovation should be integrated with research by evaluating its results to determine whether the results generate clinically grounded hypotheses for subsequent organized and approved investigation.
5.
Conclusion
The professional responsibility model of obstetric ethics is essential for ethically justified clinical care and research in periviable birth, in order to fulfill obligations to current and future pregnant and fetal patients.
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refere nces
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