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Best Practice & Research Clinical Obstetrics and Gynaecology journal homepage: www.elsevier.com/locate/bpobgyn
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Ethical Issues in Human Reproduction e Multiple Choice Answers vol. 43 1. a) F b) F
c) T d) T e) F
Disability-adjusted life years and mortality are expressed as DALYs, not as QALYs. Low-income countries use DALYs for evaluating interventions on mortality and disability. c is true and used by NICE also as costs/QALYs to decide for or against certain procedures. d is also true and can be used by policy makers as a model (not necessarily facts) to calculate the benefit for future life in good health. Return on investment calculations (ROI) measure rates of returned money invested. Thereby, ROI/ potential life years gained can also be calculated, but this is always based on assumptions, not on facts. A “YEAR 0” eliminates the problem to estimate measures based on uncertain assumptions. 2. a) F b) F
c) F
d) T e) T
The American College for Obstetrics and Gynecology recommends breastfeeding for 6 months followed by 1 year with complementary foods because shorter breastfeeding periods produce high direct and indirect health care costs due to increased rates of cancer, NNCDs and childrens' diseases. Breastfeeding for 6 months or longer is beneficial for low and high-income countries. d and e have indeed been shown to be reduced in mothers and babies. 3. a) F b) F
c) F
d) F e) T
Key sources of avoidable waste were identified as a cumulative effect of about 85% of biomedical research investment, equating to $200 billion without considering inefficiencies in regulation and management. 4. a) F b) T c) T d) T e) T In 2010, worldwide expenditure on life sciences research was $240 billion. In the US alone, about $70 billion in commercial and $40 billion in public and non-profit funding were spent annually, representing >5% of US health-care expenditure. Key sources of avoidable waste were identified as a cumulative effect of about 85% of biomedical research investment, equating to $200 billion without considering inefficiencies in regulation and management. 5. a) F b) F
c) F
d) F e) T
Both statements a and b are wrong because low-income countries were more compliant to hygiene instructions and although costs for hygiene are rising, they would even be higher if outbreaks of
http://dx.doi.org/10.1016/j.bpobgyn.2017.07.006 1521-6934
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infections increased. Although managers may think that their institution is perfect external audits (e.g. of logistics or of education) may improve the overall performance of an institution. Choosing wisely criteria are negative guidelines and define what obstetricians should better not do. Although managers might look for individual mistakes they would better be involved with what can be learned from mistakes respecting the system of responsible human resource management. The selection and classification of competency is an essential part of organizational responsibility. 6. a) F b) T c) F
d) F e) T
Beneficence does not support the rights of patients. The rights of patients are based solely on the ethical principle of respect for autonomy. The moral status of the fetus is not relevant to whether the pregnant woman has rights. This is a function of her moral status. Applicable law differs within and between countries, with few unequivocally endorsing unlimited rights of pregnant woman. Professional integrity is a professional virtue that can justifiably limit the rights of pregnant women. 7. a) T b) F
c) T d) T e) F
a, c, and d are essential components of the professional responsibility model of obstetric ethics. At best, claims that there are autonomy-based obligations to the fetus are controversial; at worst such claims are false. The professional responsibility model avoids controversy about fetal rights, which is one of the strengths of the model. 8. a) F b) T c) F
d) T e) F
Shared decision making plays only a limited role in response to requests for non-indicated caesarean delivery. Because non-indicated caesarean delivery is not supported in beneficence-based clinical judgment, the obstetrician should recommend against it. Routinely implementing such requests violates professional integrity. A very deliberative decision-making process describes an important exception to the professional responsibility not to implement the request for a nonindicated caesarean delivery. An ethics consultation is not necessary. 9. a) T b) T c) F
d) F e) F
a and b are both medically reasonable alternatives and therefore should be offered, although support for b is weaker than that for a. There is no evidence for the safety of three previous low transverse incisions and it is therefore not a medically reasonable alternative and should not be offered. There is strong consensus that with one or two previous classical caesareans it is not medically reasonable and therefore should not be offered or performed. 10. a) F b) T c) F d) T e) T a and c presuppose, mistakenly, that the fetus has independent moral status and therefore autonomy and rights. b, d, and e all must be considered in defining and clinically applying the ethical concept of the fetus as a patient. 11. a) F b) F
c) T d) T e) F
While making recommendations influences the pregnant woman's autonomy, recommendations do not interfere with her autonomy. Interference with autonomy is required for a physician's behaviour to be categorized as paternalism. The claim that the fetus has a right to life is, at best, controversial and so cannot serve as a reliable basis for professional responsibility in obstetric practice. The fetus as a patient can benefit from clinical management, creating a beneficence-based justification for
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recommendations for fetal benefit. The viable fetus is a patient. That a fetus is pre-viable does not by itself make the fetus a patient. The pregnant woman must confer this moral status on her fetus and present for care. Directive counselling for fetal benefit does not apply to non-patients. 12. a) T b) F c) T d) T e) F Respect for the pregnant woman's autonomy is a core principle of medical ethics generally. This ethical principle is also a basis for the ethical concept of the fetus as a patient. The fetus does not have the biopsychosocial capacity to be considered autonomous. Beneficence is a core principle of medical ethics generally and a basis for the ethical concept of the fetus as a patient. Non-maleficence is a limiting condition on the ethical principle of beneficence and is therefore included in the professional responsibility model of obstetric ethics under the ethical principle of beneficence. Non-malfeasance is a legal term. It is often used, mistakenly, as equivalent with non-maleficence. This mistake leads to imprecise and therefore unreliable ethical reasoning. 13. a) F b) T c) F d) F e) F A clinician is required to get the informed consent from a patient before carrying out medical intervention. Current practice does not appoint a “fetal surrogate” who participates in decisionmaking. Any woman with decision-making capacity has the legal and ethical right to make decisions about what happens with her body based on respect for autonomy. In accordance with requirements of justice, the fact that a woman is pregnant does not undermine that right. The pregnant woman's intimate partner may have an interest in the well-being of the fetus, but has no decisionmaking authority. Any intervention affecting the fetus will also affect the pregnant woman, giving that authority to her. The pregnant woman may solicit the input and perspective of her intimate partner but the decision is hers to make. Although the clinician plays an important part in counselling a pregnant woman, the authority to make the final decision belongs to the woman. 14. a) F b) T c) F d) T e) T Because there is more uncertainty about the possible benefits of experimental and innovative treatments than those that have been thoroughly researched, the ethical justification for holding that a pregnant woman should choose that approach is diminished. When the risks to the pregnant woman are minimal, the threshold of a reasonable balance between risks and benefits is easier to achieve, making the existence of a parental obligation more likely. The pregnant woman's obligations with respect to her role as a future parent are unrelated to her partner's opinions about what should be done. A pregnant woman only has parental obligations when she decides to bring a vulnerable person into the world. If she decides to terminate the pregnancy, she has no parental obligations because there will be no child in need of protection. When anticipated benefits are significant, it is more likely that those benefits will contribute to meeting the future child's minimal level of well-being and that the relative risks will be reasonable. 15. a) F b) F
c) F
d) T e) F
The preferences of the pregnant woman's intimate partner should not shape the clinician's counselling approach out of respect for the autonomy of the pregnant woman. When cultural differences are present, a clinician should be more cautious about directive counselling to avoid alienating the pregnant woman and deterring her from seeking further care. In cases in which the pregnant woman's interests are in conflict with fetal interests, the question of whether the risks to the pregnant woman are reasonable in relation to the benefits for the fetus determine whether a parental obligation exists and therefore whether a directive approach is appropriate. The fact that there is a conflict does not, in and of itself, determine whether a directive approach would be ethically justified. When a pregnant woman has a parental obligation to choose one treatment approach, a clinician has an obligation to
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recommend that the woman act in line with her parental obligations. Respect for autonomy does not prohibit a clinician from making a recommendation or explaining to the pregnant woman why that approach is recommended. 16. a) T b) F c) T d) F e) F Soliciting and understanding the values and preferences of a patient is part of shared decisionmaking and is ethically required of clinicians. While preferences based on cultural beliefs may be accommodated when they involve reasonable risks, deferring to the pregnant woman's preferences in any such case is not ethically justified. If the requested approach conflicts with a clinician's professional obligations, the clinician does not need to accommodate that request. If a pregnant woman feels disrespected or alienated by a clinician, she may decide to avoid seeking further care, resulting in worse outcomes for both the pregnant woman and the fetus. As a result, strongly directive counselling has the potential to bring about more good than harm in such cases. The clinician is ethically required to respect the pregnant woman's decisions regardless of whether they are in line with his or her own cultural beliefs. Because understanding cultural differences is necessary to engage in shared decisionmaking, avoiding discussion of such differences is not ethically justifiable. Clinicians should work to be aware of and compensate for their inherent biases. 17. a) F b) T c) F d) F e) F Although this patient may have wrong beliefs regarding the aetiology of her fetus' illness, she does not appear to have symptoms demonstrating an active psychotic illness that may alter her capacity for decision making. Therefore, consulting with risk management to determine hospital policy about a surrogate is not appropriate. All adult patients should be regarded as having capacity until proven otherwise. Moreover, assessing a patient's capacity is a basic skill and except for specific situations, specialist consultations are not usually required for determining patients' decision making capacity. Expressing autonomous choice is limited to those treatments or procedures that are legal, medically indicated, and consistent with the standard of care. Bilateral renal agenesis is a severe congenital malformation that is considered a lethal condition. As argued by Chervenak and McCullough, when the fetus is diagnosed with a condition with a high probability of death, non-aggressive fetal management is ethically justified and unnecessary interventions should be limited. In this case fetal therapy holds no benefit for the fetus and not referring the patient for the fetal surgery is not considered negligent. Moreover, physicians have ethical and professional responsibilities to preserve the integrity of their clinical practice by following evidence-based and scientifically sound practices. The initial and best possible approach is to conduct extensive, non-coercive discussions about the fetal condition and prognosis to ensure that the parents have a good understanding of their baby's condition. This approach not only relieves the parents' stress but also may help in securing a functional physicianpatient relationship which facilitates the patient's care and improves her decision making. 18. a) T b) T c) F
d) T e) T
Trisomy 18 (Edwards syndrome) is the second most common autosomal trisomy and is usually diagnosed prenatally in the second or third trimester using serum marker screening or ultrasound assessments. Although Trisomy 18 pregnancies have a high risk of fetal loss, stillbirth, and neonatal mortality, the commonly used term, lethal, is inaccurate, misleading, and inappropriate since 5%e10% of affected fetuses survive beyond the first year. Therefore reassuring a pregnant woman carrying a trisomy 18 baby that there will definitely be a short survival period is not appropriate. This group of patients may suffer from several severe associated anomalies and will need multiple follow-up visits and continued health care - a burden that may profoundly affect the patient's family life. A multidisciplinary team must provide parents with realistic information about survival, prognosis, and the outcomes of any potential interventions during the counselling session. Physicians should pay specific attention to word choice and should avoid using vague terms like lethal. Therefore, it should be clearly
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explained that the chances emergency Caesarean delivery because of hydrocephaly and cephalopelvic disproportion is higher at term, and that this procedure will not benefit the fetus because of the nature of underlying condition. If the pregnant woman wants to continue the pregnancy, the beneficencebased and integrity-based professional responsibility of the obstetrician is to recommend against Caesarean delivery and suggest vaginal delivery in combination with fetal cephalocentesis. Performing cephalocentesis to facilitate vaginal delivery is ethically permissible in fetuses with hydrocephalus and associated anomalies that are either incompatible with life or associated with the severest forms of neurologic dysfunction. In this case due to the beneficence-based obligation to the pregnant woman and the confirmed diagnosis of Trisomy 18, non-aggressive management of the fetus and the avoidance of caesarean delivery outweigh risk of fetal death and should be offered to the pregnant women. Q1
19. a) F b) F
c) T
d) F e) F
Open spina bifida or myelomeningocele (MMC) is the most common congenital malformation of the central nervous system and is commonly associated with lifelong disability and morbidity. Currently, prenatal repair of MMC is considered a novel management option for selected fetuses and mothers. Prenatal surgery has been associated with improved neurologic development and motor function. However, this treatment is also associated with an increased risk of preterm delivery and uterine dehiscence at delivery. While open MMC repair is in many communities considered as standard of care, there is also a growing body of evidence regarding the safety and advantages of the still experimental fetoscopic approach. Development of any kind of fetal therapy should proceed in an orderly fashion from animal experiments, innovation as a form of pre-research, Phase 1, and later-Phase research. The fetoscopic approach should only be accepted as a standard of care when a reasonable amount of evidence confirms the clinical benefit for the fetus and an acceptable risk/benefit ratio for both fetal and pregnant patients. When a suggested intervention is performed as research, physicians have ethical and professional obligations to inform pregnant women about the experimental nature of the intervention and to adhere to the approved protocols. Physicians should not propose or perform the suggested intervention outside of an approved and overseen research protocol. Obtaining consent for such interventions should be free of any kind of coercion and physicians are responsible to offer all available options to surgical candidates. 20. a) T
b) F
c) T d) T e) F
The early pioneers of genetic counselling were biologists and geneticists working in natural sciences. They were mainly self-trained, who dealt with population genetics and were more often interested in the effects of genetics on human evolution than on individuals. Classical genetic counselling aimed at helping families with emotional support as well as by disclosing and discussing the causes of hereditary problems, the risks of recurrence, the possibilities for prevention, or other options. The family history and pedigree were the only basis for providing risk assessment, education, and psychosocial support. Eugenic principles were first practiced in Ancient Greece; however, the modern eugenics movement began in the early 20th century, emerging and spreading from the UK. It was a set of beliefs and practices that aimed at improving the genetic quality of the human population by decreasing the prevalence of harmful traits and increasing the prevalence of desirable traits. Genetic counselling can follow two main principles: the more widely used non-directive genetic counselling and the directive genetic counselling. In spite of the fact that patients generally expect a decision-shaping process closely guided by physicians, there is a widespread support among genetic counsellors for the non-directive method and neutrality in genetic counselling. This arises from concerns about early abuses by the eugenics movement of the right to privacy and autonomy in reproductive decisions. In addition, the non-directive method is more widely accepted and more easily defendable in the current era that is dominated by legal claims against physicians. 21. a) T b) T c) T
d) T e) T
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Prenatal genetic counselling can rely on the availability of an increasing number of prenatal diagnostic and screening methods. The fetal phenotype can be examined by ultrasound for malformations or growth restriction and also by cell biochemistry for metabolic disorders. Prenatal genetic counselling relies on the examination of the fetal genotype by cytogenetic analysis for chromosome disorders, or by molecular methods (PCR, microarrays, sequencing) for the identification of gene mutations and chromosomal aberrations. In addition, prenatal genetic counselling also examines the pattern of inheritance for the genetic conditions, keeping in mind that there can be factors such as variable expressivity, reduced penetrance, heterogeneity, and mosaicism with genetic conditions that can affect interpretation of the pedigree. Prenatal genetic counselling implemented prenatal screening for genetic disease to assist the early diagnosis of congenital defects, mental restriction or genetic disorders at a point where parents may still be able to request the termination of the pregnancy. The pregnant woman should be informed when a fetal disorder is treatable and is not expected to affect future quality of life. In most cases prenatal diagnosis cannot result in any treatment of the fetus, since such treatment is not yet available. However, there are some exceptions, such as fetal anaemia due to isoimmunization, some immunodeficiency conditions, and fetal haemophilia. Preconception genetic counselling should be considered when certain conditions exist such as advanced maternal age, a previous fetus or child with a genetic disorder, a parent with a genetic disorder or trait, family history of a genetic disorder, maternal genetic disorders that pregnancy may aggravate or that may threaten fetal health and survival, history of infertility, and consanguinity. 22. a) F
b) T c) T
d) F e) F
Ultrasound screening has frequently led to situations characterized by clinical uncertainty due to the disclosure of soft markers (minor anatomical variations) in the unborn child. Ethical challenges have thus emerged as a direct result of advancing medical technology, and healthy fetal lives have been lost due to invasive diagnostic testing aimed at resolving this clinical uncertainty. Ultrasound examiners have warned against a policy of disclosing all findings of soft markers to expectant parents, but no exploration of the disclosure of fetal soft markers has yet been published. Although NIPT tests have very high sensitivity and specificity, these are screening and not diagnostic tests, and do not replace the accuracy and diagnostic precision of prenatal diagnosis with CVS or amniocentesis. Preimplantation genetic diagnosis has been developed since 1989 primarily for the identification of aneuploidies and other genetic disorders or defects in human zygotes and pre-embryos created by in vitro fertilization prior to their implantation for gestation. It is an attractive way of preventing genetic diseases, currently making it possible to select against more than hundred different genetic diseases. Preimplantation genetic diagnosis can select zygotes that are HLA-matched with an existing sick child and free of the disease. These saviour siblings can serve as a compatible stem cell donor to save a sick sibling in need of a hematopoietic stem cell transplant. In spite of the large debate on saviour siblings, legal framework has already been established for this technology in certain countries (e.g. UK). Third trimester abortion can be justified if the fetus will be unable to survive after birth even with intervention and the couple requests termination of pregnancy. 23. a) F
b) F c) F d) T e) F
Most systems use 12 months as the definition but by no means all. Fertility problems involve gender suffering for both sexes. There is a drop off in fertility from early 30s but a much larger one from around 38. Infertility affects more than 186 million ever-married women of reproductive age (15e49) in developing countries excluding China. 24. a) F
b) T c) F
d) F e) T
Access to ART is low in developing countries and so therefore are the number of cycles/mppy. 25. a) T
b) T c) F
d) T e) F
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Most global human right courts have confirmed that it is not admissible to grant the status of person to the embryo and it is indeed not co-insured as a person before 14 days after fertilization because it is still capable of division. Selective fetal reduction in multiple pregnancy is accepted by most religions as the least harm approach. 26. a) F
b) F c) F d) T e) F
There is a huge conflict of utility, justice and liberty when resources are limited. Positive rights are those that states are legally obliged to implement in all cases. 27. a) F
b) F c) T d) F e) F
Health care is a political issue in both low and high income countries. Inadequate financial resources and infrastructure and technologic obsolescence are also universal issues, only varying in scope and depending on local finances and resource acquisition. Brain drain from low income to high income countries for economic advantage and educational opportunity has long be a scourge for capacity building in low income countries. 28. a) F
b) T c) F
d) T e) F
Althabe showed in a multicentre trial in LMIC that routine antenatal steroids provided by a public health system statistically increased perinatal deaths and had no demonstrable population benefit. Routine access to obstetric surgery, specifically caesarean section and forceps have been reported to save lives (YLS) and reduce DALYS. The positive downstream public health benefits of training specialist obstetrician gynecologists to reduce maternal mortality and improve women's reproductive health, as well as providing expanded training and education for reproductive health cadres generally is reported by Anderson. 29. a) T
b) T c) T d) T e) F
In this scenario, the patient was given all information about her condition and treatment options necessary to make the decision as to whether or not to accept blood transfusion, thus, patient autonomy was respected. In procuring the blood for the patient, the resident adhered to the principle of beneficence as applied to her patient. She maximized the benefit and minimized harm by admitting her for blood transfusion. However, the resident violated both the principles of nonmaleficence and justice in her decision to transfuse the woman in the clinic. Though the young mother who hemorrhaged after delivery was not under the direct care of the resident, her actions resulted in direct harm to the patient. In allocating the sole pint of blood to an older patient with an incurable cancer rather than to the young mother with a newborn baby who would most likely have survived with transfusion failed to allocate resources in such a way as to maximize benefit and minimize burden to the healthcare system and to society. 30. a) F
b) F c) T d) F e) F
The medical student's compassion has been compromised. At this point, he is unable to access compassion for patients he cares for in a HIC after his experience working in a LMIC. He continues to engage in self-effacement as he is willing to care for the patients who come to the ED even though he disagrees with their choice of where to seek care. In continuing on as a medical student, he continues to self-sacrifice and delay his own financial and personal gains until he completes his training. There is no evidence that the integrity of the medical student is in any way diminisheddhe demonstrates continued commitment to excellence in patient care. There is hope that the medical student will regain his compassion in time and that these feelings will be renewed, otherwise, it is possible that the rest of the professional virtues will be impacted. 31. a) T
b) T c) T d) T e) T
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Recognized benefits of GHEs for learners include improved clinical acumen and skills, increased awareness of cultural issues and sensitives, enhanced understanding of public health and social justice issues, and the ability to function in resource limited settings. There are also recognized benefits to the medical profession as a wholedtrainees who participate in GHEs are more likely to enter general medical practice, work with underserved populations, focus on health policy and health disparity issues, and work in resource constrained environments.