Reversing physician hesitancy to recommend COVID-19 vaccination for pregnant patients.

Physician hesitancy is said to occur when physicians do not recommend COVID-19 vaccination, and it is a contributing factor for the low vaccination rate for COVID-19 in pregnant women. Physician hesitancy has become a major, unaddressed problem with regard to the quality and safety of obstetrical care. We identify 3 root causes of physician hesitancy and describe how professional ethics in obstetrics should guide in reversing these root causes. They are clinical misapplications of key components of professionally responsible obstetrical practice: therapeutic nihilism, shared decision-making, and respect for patient autonomy. Therapeutic nihilism directs the obstetrician to avoid any clinical interventions during pregnancy to prevent teratogenic effects that might be unknown. Therapeutic nihilism is misapplied when there is a documented net clinical benefit with no evidence of clinical harm. Shared decision directs the obstetrician to only offer but not recommend clinical management. Shared decision-making plays a major role when there is uncertainty in clinical judgment but is misapplied when it becomes a universal model. It does not apply when there is a net clinical benefit. When there is a net clinical benefit, clinical management should be recommended, not simply offered. The ethical principle of respect for patient autonomy plays an indispensable role in decision-making with patients. It is misapplied when it is assumed that respect for autonomy requires physicians not to make recommendations and to defer to and implement patients' decisions without exception. There is evidence that the obstetrician's recommendations about the management of pregnancy are the most important factor in a pregnant woman's decision-making. Simply deferring to the patient's decisions makes for misapplied respect for patient autonomy. Obstetricians must end physician hesitancy about COVID-19 vaccination of pregnant women by reversing these 3 root causes of physician hesitancy. Reversing the root causes of physician hesitancy is an urgent matter of patient safety. The longer physician hesitancy continues and the longer the low vaccine acceptance rate of pregnant women lasts, preventable serious diseases, deaths of pregnant women, intensive care unit admissions, stillbirths, and other maternal and fetal complications of unvaccinated women will continue to occur. Physician hesitancy should not be permitted to influence the response to future pandemics.

Induced abortion and COVID-19 as contributing factors to declining fertility in Sardinia.

OBJECTIVES: Decreasing fertility implies considerable public health, societal, political, and international consequences. Induced abortion (IA) and the recent COVID-19 pandemic can be contributing factors to it but these have not been adequately studied so far. The purpose of this paper is to explore the relation of IA incidence and the COVID-19 pandemic to declining rates of delivery, as per our Sardinian experience. METHODS: We analyzed the registered data from the official Italian statistics surveys of deliveries and IA in the last 10 years from 2011 to 2020 in Sardinia. RESULTS: A total of 106,557 deliveries occurred and a progressive decrease in the birth rate has been observed. A total of 18,250 IA occurred and a progressive decline has been observed here as well. The ratio between IA and deliveries remained constant over the decade. Between 2011 and 2019 a variation of -4.32% was observed for IA while in the last year, during the COVID-19 pandemic the decrease of the procedures was equal to -12.30%. For the deliveries, a mean variation of the -4.8% was observed between the 2011 and the 2019 while in the last year, during the COVID-19 pandemic the decrease was about -9%. Considering the about 30% reduction of live births between 2011 and 2020, there is an almost proportional reduction in IA. CONCLUSIONS: Public policy responses to decreasing fertility, especially pronatalist ones, would be provided with evidence base about trends in delivery and IA and women's decision making.

Ethical challenges in management of critically ill pregnant patients with coronavirus disease 2019 (COVID-19).

Despite the overwhelming number of coronavirus disease 2019 (COVID-19) cases worldwide, data regarding the optimal clinical guidance in pregnant patients is not uniform or well established. As a result, clinical decisions to optimize maternal and fetal benefit, particularly in patients with critical COVID-19 in the early preterm period, continue to be a challenge for obstetricians. There is often uncertainty in clinical judgment about fetal monitoring, timing of delivery, and mode of delivery because of the challenge in balancing maternal and fetal interests in reducing morbidity and mortality. The obstetrician and critical care team should empower pregnant patients or their surrogate decision maker to make informed decisions in response to the team's clinical evaluation. A clinically grounded ethical framework, based on the concepts of the moral management of medical uncertainty, beneficence-based obligations, and preventive ethics, should guide the decision-making process.

Professionally responsible coronavirus disease 2019 vaccination counseling of obstetrical and gynecologic patients.

The development of coronavirus disease 2019 vaccines in the current and planned clinical trials is essential for the success of a public health response. This paper focuses on how physicians should implement the results of these clinical trials when counseling patients who are pregnant, planning to become pregnant, breastfeeding or planning to breastfeed about vaccines with government authorization for clinical use. Determining the most effective approach to counsel patients about coronavirus disease 2019 vaccination is challenging. We address the professionally responsible counseling of 3 groups of patients-those who are pregnant, those planning to become pregnant, and those breastfeeding or planning to breastfeed. We begin with an evidence-based account of the following 5 major challenges: the limited evidence base, the documented increased risk for severe disease among pregnant coronavirus disease 2019-infected patients, conflicting guidance from government agencies and professional associations, false information about coronavirus disease 2019 vaccines, and maternal mistrust and vaccine hesitancy. We subsequently provide evidence-based, ethically justified, practical guidance for meeting these challenges in the professionally responsible counseling of patients about coronavirus disease 2019 vaccination. To guide the professionally responsible counseling of patients who are pregnant, planning to become pregnant, and breastfeeding or planning to breastfeed, we explain how obstetrician-gynecologists should evaluate the current clinical information, why a recommendation of coronavirus disease 2019 vaccination should be made, and how this assessment should be presented to patients during the informed consent process with the goal of empowering them to make informed decisions. We also present a proactive account of how to respond when patients refuse the recommended vaccination, including the elements of the legal obligation of informed refusal and the ethical obligation to ask patients to reconsider. During this process, the physician should be alert to vaccine hesitancy, ask patients to express their hesitation and reasons for it, and respectfully address them. In contrast to the conflicting guidance from government agencies and professional associations, evidence-based professional ethics in obstetrics and gynecology provides unequivocal and clear guidance: Physicians should recommend coronavirus disease 2019 vaccination to patients who are pregnant, planning to become pregnant, and breastfeeding or planning to breastfeed. To prevent widening of the health inequities, build trust in the health benefits of vaccination, and encourage coronavirus disease 2019 vaccine and treatment uptake, in addition to recommending coronavirus disease 2019 vaccinations, physicians should engage with communities to tailor strategies to overcome mistrust and deliver evidence-based information, robust educational campaigns, and novel approaches to immunization.

How fever is defined in COVID-19 publications: a disturbing lack of precision.

OBJECTIVES: Fever is the single most frequently reported manifestation of COVID-19 and is a critical element of screening persons for COVID-19. The meaning of "fever" varies depending on the cutoff temperature used, the type of thermometer, the time of the day, the site of measurements, and the person's gender and race. The absence of a universally accepted definition for fever has been especially problematic during the current COVID-19 pandemic. METHODS: This investigation determined the extent to which fever is defined in COVID-19 publications, with special attention to those associated with pregnancy. RESULTS: Of 53 publications identified in which "fever" is reported as a manifestation of COVID-19 illness, none described the method used to measure patient's temperatures. Only 10 (19%) publications specified the minimum temperature used to define a fever with values that varied from a 37.3 °C (99.1 °F) to 38.1 °C (100.6 °F). CONCLUSIONS: There is a disturbing lack of precision in defining fever in COVID-19 publications. Given the many factors influencing temperature measurements in humans, there can never be a single, universally accepted temperature cut-off defining a fever. This clinical reality should not prevent precision in reporting fever. To achieve the precision and improve scientific and clinical communication, when fever is reported in clinical investigations, at a minimum the cut-off temperature used in determining the presence of fever, the anatomical site at which temperatures are taken, and the instrument used to measure temperatures should each be described. In the absence of such information, what is meant by the term "fever" is uncertain.

Teaching Professional Formation in Response to the COVID-19 Pandemic.

In response to the COVID-19 pandemic, the Association of American Medical Colleges has called for a temporary suspension of clinical teaching activities for medical students. Planning for the continued involvement of learners in patient care during this pandemic should include teaching learners professional formation. The authors provide an ethical framework to guide such teaching, based on the ethical principle of beneficence and the professional virtues of courage and self-sacrifice from professional ethics in medicine. The authors show that these concepts support the conclusion that learners are ethically obligated to accept reasonable, but not unreasonable, risk. Based on this ethical framework, the authors provide an account of the process of teaching professional formation that medical educators and academic leaders should implement. Medical educators and academic leaders should embrace the opportunity that the COVID-19 pandemic presents for teaching professional formation. Learners should acquire the conceptual vocabulary of professional formation. Learners should recognize that risk of infection from patients is unavoidable. Learners should become aware of established ethical standards for professional responsibility during epidemics from the history of medicine. Learners should master understandable fear. Medical educators and academic leaders should ensure that didactic teaching of professional formation continues when it becomes justified to end learners' participation in the processes of patient care; topics should include the professionally responsible management of scarce medical resources. The COVID-19 pandemic will not be the last major infectious disease that puts learners at risk. Professional ethics in medicine provides powerful conceptual tools that can be used as an ethical framework to guide medical educators to teach learners, who will bear leadership responsibilities in responses to future pandemics, professional formation.

Professionally responsible advocacy for women and children first during the COVID-19 pandemic: guidance from World Association of Perinatal Medicine and International Academy of Perinatal Medicine.

The goal of perinatal medicine is to provide professionally responsible clinical management of the conditions and diagnoses of pregnant, fetal, and neonatal patients. The New York Declaration of the International Academy of Perinatal Medicine, "Women and children First - or Last?" was directed toward the ethical challenges of perinatal medicine in middle-income and low-income countries. The global COVID-19 pandemic presents common ethical challenges in all countries, independent of their national wealth. In this paper the World Association of Perinatal Medicine provides ethics-based guidance for professionally responsible advocacy for women and children first during the COVID-19 pandemic. We first present an ethical framework that explains ethical reasoning, clinically relevant ethical principles and professional virtues, and decision making with pregnant patients and parents. We then apply this ethical framework to evidence-based treatment and its improvement, planned home birth, ring-fencing obstetric services, attendance of spouse or partner at birth, and the responsible management of organizational resources. Perinatal physicians should focus on the mission of perinatal medicine to put women and children first and frame-shifting when necessary to put the lives and health of the population of patients served by a hospital first.

Professionally responsible counseling about birth location during the COVID-19 pandemic.

If the worries about the coronavirus disease 2019 (COVID-19) pandemic are not already enough, some pregnant women have been questioning whether the hospital is a safe or safe enough place to deliver their babies and therefore whether they should deliver out-of-hospital during the pandemic. In the United States, planned out-of-hospital births are associated with significantly increased risks of neonatal morbidity and death. In addition, there are obstetric emergencies during out-of-hospital births that can lead to adverse outcomes, partly because of the delay in transporting the woman to the hospital. In other countries with well-integrated obstetric services and well-trained midwives, the differences in outcomes of planned hospital birth and planned home birth are smaller. Women are empowered to make informed decisions when the obstetrician makes ethically justified recommendations, which is known as directive counseling. Recommendations are ethically justified when the outcomes of one form of management is clinically superior to another. The outcomes of morbidity and mortality and of infection control and prevention of planned hospital birth are clinically superior to those of out-of-hospital birth. The obstetrician therefore should recommend planned hospital birth and recommend against planned out-of-hospital birth during the COVID-19 pandemic. The COVID-19 pandemic has increased stress levels for all patients and even more so for pregnant patients and their families. The response in this difficult time should be to mitigate this stress and empower women to make informed decisions by routinely providing counseling that is evidence-based and directive.

Fetal Diagnosis and Therapy during the COVID-19 Pandemic: Guidance on Behalf of the International Fetal Medicine and Surgery Society.

The COVID-19 pandemic has stressed patients and healthcare givers alike and challenged our practice of antenatal care, including fetal diagnosis and therapy. This document aims to review relevant recent information to allow us to optimize prenatal care delivery. We discuss potential modifications to obstetric management and fetal procedures in SARS-CoV2-negative and SARS-CoV2-positive patients with fetal anomalies or disorders. Most fetal therapies are time sensitive and cannot be delayed. If personnel and resources are available, we should continue to offer procedures of proven benefit, acknowledging any fetal and maternal risks, including those to health care workers. There is, to date, minimal, unconfirmed evidence of spontaneous vertical transmission, though it may theoretically be increased with some procedures. Knowing a mother's preoperative SARS-CoV-2 status would enable us to avoid or defer certain procedures while she is contagious and to protect health care workers appropriately. Some fetal conditions may alternatively be managed neonatally. Counseling regarding fetal interventions which have a possibility of additional intra- or postoperative morbidity must be performed in the context of local resource availability. Procedures of unproven benefit should not be offered. We encourage participation in registries and trials that may help us to understand the impact of COVID-19 on pregnant women, their fetuses, and neonates.

Expanding the concept of the professional integrity of obstetrics during a public health emergency.

The coronavirus disease 2019 (COVID-19) pandemic has placed great demands on many hospitals to maximize their capacity to care for affected patients. The requirement to reassign space has created challenges for obstetric services. We describe the nature of that challenge for an obstetric service in New York City. This experience raised an ethical challenge: whether it would be consistent with professional integrity to respond to a public health emergency with a plan for obstetric services that would create an increased risk of rare maternal mortality. We answered this question using the conceptual tools of professional ethics in obstetrics, especially the professional virtue of integrity. A public health emergency requires frameshifting from an individual-patient perspective to a population-based perspective. We show that an individual-patient-based, beneficence-based deliberative clinical judgment is not an adequate basis for organizational policy in response to a public health emergency. Instead, physicians, especially those in leadership positions, must frameshift to population-based clinical ethical judgment that focuses on reduction of mortality as much as possible in the entire population of patients served by a healthcare organization.