Publications by authors named "Laurence B McCullough"

457 Publications

Undue Burdens Created by the Texas Abortion Law for Vulnerable Pregnant Women.

Am J Obstet Gynecol 2021 Dec 23. Epub 2021 Dec 23.

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, New York, Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, Texas.

The new Texas abortion law requires the physician to determine whether a fetal heartbeat is present and prohibits abortion after a heartbeat has been documented. An exception is allowed when a "medical emergency necessitated the abortion." These and the other provisions of the statute are to be enforced through "civil actions" brought by private citizens. This paper identifies three populations of vulnerable women who will experience undue burdens created by the Texas abortion law. We begin with an account of the concept of undue burden in the jurisprudence of abortion, as expressed in the 1992 U.S. Supreme Court Case, Casey v. Planned Parenthood of Southeastern Pennsylvania. We then provide an evidence-based account of the predictable, undue burdens for three populations of vulnerable women: pregnant women with decreased freedom of movement; pregnant minors; and pregnant women with major mental disorders and cognitive disabilities. The Texas law creates an undue burden on these three populations of vulnerable women by reducing or even eliminating access to abortion services outside of Texas. The Texas law also creates an undue burden by preventably increasing the risks of morbidity, including loss of fertility, and mortality for these three populations of vulnerable women. For these women it is indisputable that the Texas law will create undue burdens and is therefore not compatible with the jurisprudence of abortion as set forth in Casey, because a "significant number of women will likely be prevented from obtaining an abortion." Federal courts should therefore strike down this law.
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http://dx.doi.org/10.1016/j.ajog.2021.12.033DOI Listing
December 2021

Placental Location in Maternal-Fetal Surgery for Myelomeningocele.

Fetal Diagn Ther 2021 Dec 10. Epub 2021 Dec 10.

Introduction: Uterine incision based on placental location in open maternal-fetal surgery (OMFS) has never been evaluated in regards to maternal or fetal outcomes.

Objective: To investigate whether an anterior placenta was associated with increased rates of intraoperative, perioperative, antepartum, obstetric, or neonatal complications in mothers and babies who underwent OMFS for myelomeningocele (fMMC) closure.

Methods: Data from the international multi-center prospective registry of patients who underwent OMFS for fMMC closure (fMMC Consortium Registry, 12/15/2010-7/31/2019) was used to compare fetal and maternal outcomes between anterior and posterior placental locations.

Results: Placental location for 623 patients was evenly distributed between anterior (51%) or posterior (49%). Intraoperative fetal bradycardia (8.3% vs 3.0%, p=0.005) and performance of fetal resuscitation (3.6% vs 1.0%, p=0.034) occurred more frequently in cases with an anterior placenta when compared to those with a posterior placenta. Obstetric outcomes including membrane separation, placental abruption, and spontaneous rupture of membranes were not different among the two groups. However, thinning of the hysterotomy site (27.7% vs 17.7%, p=0.008) occurred more frequently in cases of anterior placenta. Gestational age at delivery (p=0.583) and length of stay in the neonatal intensive care unit (p=0.655) were similar between the two groups. Fetal incision dehiscence and wound revision were not significantly different between groups. Critical clinical outcomes including fetal demise, perinatal death, and neonatal death were all infrequent occurrences and not associated with placental location.

Conclusions: Anterior placental location is associated with increased risk of intraoperative fetal resuscitation and increased thinning at the hysterotomy closure site. Individual institutional experiences may have varied but the aggregate data from the fMMC Consortium did not show a significant impact on the gestational age at delivery or maternal or fetal clinical outcomes.
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http://dx.doi.org/10.1159/000521379DOI Listing
December 2021

Professional ethics and decision making in perinatology.

Semin Perinatol 2021 Nov 9:151520. Epub 2021 Nov 9.

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, New York, USA. Electronic address:

Objective: We describe the essential elements of professional ethics in perinatology and explain how professional ethics in perinatology should guide decision making with pregnant patients and with parents.

Findings: Professional ethics in perinatology draws on two ethical principles, beneficence and respect for patient autonomy, the ethical concept of the fetus as a patient, and the best interests of the child standard and the concept of parental permission. Counseling about intrapartum management should be based on the ethical concept of the fetus as a patient and on the role of the pregnant patient as the ultimate decision maker. Counseling about setting ethically justified limits on perinatal clinical management should be based on four specified concepts of futility, but not on quality-of-life futility. Counseling about innovation and research should emphasize that investigation clinical management is an experiment.

Conclusion: Professional ethics in perinatology is an essential component of perinatal practice, innovation, and research.
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http://dx.doi.org/10.1016/j.semperi.2021.151520DOI Listing
November 2021

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

Am J Obstet Gynecol 2021 Nov 8. Epub 2021 Nov 8.

Department of Obstetrics and Gynecology, Lenox Hill Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY. Electronic address:

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.
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http://dx.doi.org/10.1016/j.ajog.2021.11.017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8572733PMC
November 2021

Professionally Responsible Counseling About Fetal Analysis.

Obstet Gynecol Clin North Am 2021 Dec;48(4):777-785

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell and Lenox Hill Hospital, 100 East 77th Street, New York, NY 10075, USA. Electronic address:

Fetal analysis uses noninvasive and invasive methods to obtain images and tissues for interpretation that supports risk assessment and/or diagnosis of the fetus's condition. This article provides ethically justified, clinically applicable guidance for supporting the pregnant patient's decision making about fetal analysis. Topics include ethical reasoning using key ethical concepts, confidentiality, clarity about the pregnant woman as ultimate decision maker, offering fetal analysis, counseling about results, counseling about accepted maternal-fetal intervention, and counseling about innovation and research on maternal-fetal intervention. Professional ethics is an essential component of counseling pregnant patients about fetal analysis and referral for investigative maternal-fetal intervention.
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http://dx.doi.org/10.1016/j.ogc.2021.06.005DOI Listing
December 2021

Plato unmasks hidden limits of tele-education.

J Perinat Med 2021 Nov 8. Epub 2021 Nov 8.

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, NY, USA.

Plato's powerful metaphor of the Cave, from Republic, further advances a critical assessment of the hidden limits of distance learning. In the Cave, individuals are restrained to see only straight ahead to the images projected from behind them onto the wall in front of them. As in the Cave, in tele-education the dynamism of learning is replaced by passive learning. Not only do learners become largely passive with respect to their teacher, but also to each other. These effects are masked from teacher and learner alike by the technical prowess of distance learning and teaching, a version of Plato's Cave. Tele-education has at least three undeniably salient features: safety, convenience, and cost savings. Two and a half millennia after Plato gave us the concept of mimesis and the metaphor of the Cave, we can use these philosophical tools to unmask hidden limits of tele-education.
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http://dx.doi.org/10.1515/jpm-2021-0451DOI Listing
November 2021

Society for Maternal-Fetal Medicine Special Statement: Beyond the scalpel: in utero fetal gene therapy and curative medicine.

Am J Obstet Gynecol 2021 12 17;225(6):B9-B18. Epub 2021 Sep 17.

Society for Maternal-Fetal Medicine, 409 12 St. SW, Washington, DC 20024, USA.

With the recent advances in gene editing with systems such as CRISPR-Cas9, precise genome editing in utero is on the horizon. Sickle cell disease is an excellent candidate for in utero fetal gene therapy, because the disease is monogenic, causes irreversible harm, and has life-limiting morbidity. Gene therapy has recently been proven to be effective in an adolescent patient. Several hurdles still impede the progress for fetal gene therapy in humans, including an incomplete understanding of the fetal immune system, unclear maternal immune responses to in utero gene therapy, risks of off-target effects from gene editing, gestational age constraints, and ethical questions surrounding fetal genetic intervention. However, none of these barriers appears insurmountable, and the journey to in utero gene therapy for sickle cell disease and other conditions should be well underway.
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http://dx.doi.org/10.1016/j.ajog.2021.09.001DOI Listing
December 2021

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

J Perinat Med 2022 Jan 12;50(1):42-45. Epub 2021 Aug 12.

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell and Lenox Hill Hospital, New York, NY, USA.

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.
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http://dx.doi.org/10.1515/jpm-2021-0289DOI Listing
January 2022

John Gregory's medical ethics elucidates the concepts of compassion and empathy.

Med Teach 2021 Aug 9:1-5. Epub 2021 Aug 9.

Professor and Departmental Chair of Obstetrics and Gynecology, Associate Dean for International Education, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.

Purpose: This paper draws on eighteenth-century British medical ethics to elucidate compassion and empathy and explains how compassion and empathy can be taught, to rectify their frequent conflation.

Compassion In The History Of Medical Ethics: The professional virtue of compassion was first described in eighteenth-century British medical ethics by the Scottish physician-ethicist, John Gregory (1724-1773) who built on the moral psychology of David Hume (1711-1776) and its principle of sympathy.

Compassion And Empathy Defined: Compassion is the habitual exercise of the affective capacity to engage, with self-discipline, in the experience of the patient and therefore become driven to provide effective care for the patient. Empathy is the habitual exercise of the cognitive capacity to imagine the experience of patient and to have reasons to care for the patient. There are rare clinical circumstances in which empathy should replace compassion, for example, in responding to abusive patients. Because the abstract concepts of medical ethics are translated into clinical practice by medical educators, we identify the pedagogical implications of these results by setting out a process for teaching compassion and empathy.

The Task Ahead: Eighteenth-century British medical ethics provides a clinically applicable, philosophical response to conflation of the moral virtue of compassion and the intellectual virtue of empathy and applying them clinically.
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http://dx.doi.org/10.1080/0142159X.2021.1960295DOI Listing
August 2021

Neonatal outcomes of births in freestanding birth centers and hospitals in the United States, 2016-2019.

Am J Obstet Gynecol 2022 Jan 1;226(1):116.e1-116.e7. Epub 2021 Jul 1.

Department of Obstetrics and Gynecology, Lenox Hill Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New York, NY.

Background: Births in freestanding birth centers have more than doubled between 2007 and 2019. Although birthing centers, which are defined by the American College of Obstetricians and Gynecologists as ". . . freestanding facilities that are not hospitals," are being promoted as offering women fewer interventions than hospitals, there are limited recent data available on neonatal outcomes in these settings.

Objective: To compare several important measures of neonatal safety between 2 United States birth settings and birth attendants: deliveries in freestanding birth centers and hospital deliveries by midwives and physicians.

Study Design: This is a retrospective cohort study using the United States Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics, and Division of Vital Statistics natality online database for the years 2016 to 2019. All term, singleton, low-risk births were eligible for inclusion. The study outcomes were several neonatal outcomes including neonatal death, neonatal seizures, 5-minute Apgar scores of <4 and <7, and neonatal death in nulliparous and in multiparous women. Outcomes were compared between the following 3 groups: births in freestanding birth centers, in-hospital births by a physician, and in-hospital births by a midwife. The prevalence of each neonatal outcome among the different groups was compared using Pearson chi-squared test, with the in-hospital midwife births being the reference group. Multivariate logistic regression models were performed to account for several potential confounding factors such as maternal prepregnancy body mass index, maternal weight gain, parity, gestational weeks, and neonatal birthweight and calculated as adjusted odds ratio.

Results: The study population consisted of 9,894,978 births; 8,689,467 births (87.82%) were in-hospital births by MDs and DOs, 1,131,398 (11.43%) were in-hospital births by midwives, and 74,113 (0.75%) were births in freestanding birth centers. Freestanding birth center deliveries were less likely to be to non-Hispanic Black or Hispanic, less likely to women with public insurance, less likely to be women with their first pregnancy, and more likely to be women with advanced education and to have pregnancies at ≥40 weeks' gestation. Births in freestanding birth center had a 4-fold increase in neonatal deaths (3.64 vs 0.95 per 10,000 births: adjusted odds ratio, 4.00; 95% confidence interval, 2.62-6.1), a more than 7-fold increase in neonatal deaths for nulliparous patients (6.8 vs 0.92 per 10,000 births: adjusted odds ratio, 7.7; 95% confidence interval, 4.42-13.76), a more than 2-fold increase in neonatal seizures (3.91 vs 1.94 per 10,000 births: adjusted odds ratio, 2.19; 95% confidence interval, 1.48-3.22), and a more than 7-fold increase of a 5-minute Apgar score of <4 (194.84 vs 28.5 per 10,000 births: adjusted odds ratio, 7.46; 95% confidence interval, 7-7.95). Compared with hospital midwife deliveries, hospital physician deliveries had significantly higher adverse neonatal outcomes (P<0.001).

Conclusion: Births in United States freestanding birth centers are associated with an increased risk of adverse neonatal outcomes such as neonatal deaths, seizures, and low 5-minute Apgar scores. Therefore, when counseling women about the location of birth, it should be conveyed that births in freestanding birth centers are not among the safest birth settings for neonates compared with hospital births attended by either midwives or physicians.
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http://dx.doi.org/10.1016/j.ajog.2021.06.093DOI Listing
January 2022

Reply to professionally responsible COVID-19 vaccination counseling.

Am J Obstet Gynecol 2021 09 9;225(3):355-356. Epub 2021 Jun 9.

Lenox Hill Hospital, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hofstra University, 100 East 77th St., New York, NY 10075.

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http://dx.doi.org/10.1016/j.ajog.2021.05.047DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8188769PMC
September 2021

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

J Perinat Med 2021 Jun 11. Epub 2021 Jun 11.

Department of Obstetrics and Gynecology, Lenox Hill Hospital - Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA.

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.
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http://dx.doi.org/10.1515/jpm-2021-0254DOI Listing
June 2021

Professional integrity in maternal - fetal innovation and research: an essential component of perinatal medicine.

J Perinat Med 2021 Nov 19;49(9):1027-1032. Epub 2021 May 19.

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, NY, USA.

Objectives: Clinical innovation and research on maternal-fetal interventions have become an essential for the development of perinatal medicine. In this paper, we present an ethical argument that the professional virtue of integrity should guide perinatal investigators.

Methods: We present an historical account of the professional virtue of integrity and the key distinction that this account requires between intellectual integrity and moral integrity.

Results: We identify implications of both intellectual and moral integrity for innovation, research, prospective oversight, the role of equipoise in randomized clinical trials, and organizational leadership to ensure that perinatal innovation and research are conducted with professional integrity.

Conclusions: Perinatal investigators and those charged with prospective oversight should be guided by the professional virtue of integrity. Leaders in perinatal medicine should create and sustain an organizational culture of professional integrity in fetal centers, where perinatal innovation and research should be conducted.
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http://dx.doi.org/10.1515/jpm-2021-0090DOI Listing
November 2021

THE PROFESSION OF MEDICINE IS SECULAR: AN EIGHTEENTH-CENTURY IDEA WITH IMPLICATIONS FOR THE BOUNDARY BETWEEN MEDICINE AND RELIGION.

Psychiatr Danub 2021 05;33(Suppl 3):S292-S298

Department of Obstetrics and Gynecology, Lenox Hill Hospital, New York, New York USA.

The aim of this paper is to draw on John Gregory's (1724-1773) professional ethics in medicine to provide guidance to physicians for the responsible management of the potentially contested boundary between medicine and religion. The paper provides a philosophical and clinical interpretation of Gregory's method of argument by persuasion: setting out complementary considerations that together invite agreement. The cumulative effect of this argument by persuasion is that a contested boundary between medicine and religion is not required by the commitment to the evidence-based, scientific practice of medicine. Gregory's legacy to us is the concept of the profession of medicine as secular, in two senses. As scientific, medicine draws on evidence and not on divinity, transcendent reality, or sacred texts and practices. There is no necessary hostility of evidence-based medicine toward religion and faith communities.
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May 2021

Professionally responsible management of the ethical and social challenges of antenatal screening and diagnosis of β-thalassemia in a high-risk population.

J Perinat Med 2021 Sep 16;49(7):847-852. Epub 2021 Mar 16.

Department of Obstetrics and Gynecology, Prenatal and Preimplantation Genetic Diagnosis, Fetal Therapy, Microcitemico Pediatric Hospital "A. Cao", Cagliari, Sardinia, Italy.

Thalassemias are among the most frequent genetic disorders worldwide. They are an important social and economic strain in high-risk populations. The benefit of β-thalassemia screening programs is growing evident but the capacity to diagnose fetal β-thalassemia exceeds the treatment possibilities and even when treatment before birth becomes feasible, difficult decisions about the relative risks will remain. This paper can be of practical and ethically justified aid when counseling women about screening, diagnosis, and treatment of β-thalassemia. It takes in consideration various social challenges, medical issues such as antenatal screening, preimplantation genetic diagnosis, prenatal diagnosis, non-invasive prenatal testing and prenatal therapy. We also describe the Sardinian experience in applying and promoting high-risk population screening and diagnosis programs and future trends in the management of β-thalassemia.
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http://dx.doi.org/10.1515/jpm-2021-0021DOI Listing
September 2021

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

J Perinat Med 2021 Mar 24;49(3):255-261. Epub 2020 Dec 24.

Department of Medicine, University of Maryland School of Medicine, Emeritus Professor of Medicine and the Carolyn Frenkil and Selvin Passen History of Medicine Scholar-in-Residence at the University of Maryland School of Medicine, Baltimore, ML, USA.

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.
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http://dx.doi.org/10.1515/jpm-2020-0546DOI Listing
March 2021

Inclusion of pregnant individuals among priority populations for coronavirus disease 2019 vaccination for all 50 states in the United States.

Am J Obstet Gynecol 2021 05 2;224(5):536-539. Epub 2021 Feb 2.

Department of Obstetrics and Gynecology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, New York.

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http://dx.doi.org/10.1016/j.ajog.2021.01.026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7906826PMC
May 2021

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

Am J Obstet Gynecol 2021 05 1;224(5):470-478. Epub 2021 Feb 1.

Departments of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, NY.

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.
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http://dx.doi.org/10.1016/j.ajog.2021.01.027DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7849424PMC
May 2021

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

Acad Med 2020 10;95(10):1488-1491

F.A. Chervenak is professor and chair, Department of Obstetrics and Gynecology, and associate dean for international education, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, and chair, Department of Obstetrics and Gynecology, Lenox Hill Hospital, New York, New York.

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.
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http://dx.doi.org/10.1097/ACM.0000000000003434DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7179059PMC
October 2020

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.

J Perinat Med 2020 Nov;48(9):867-873

Department of Obstetrics and Gynecology, University of Zagreb, Zagreb, Croatia.

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.
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http://dx.doi.org/10.1515/jpm-2020-0329DOI Listing
November 2020

Violence against trainees: urgent ethical challenges for medical educators and academic leaders in perinatal medicine.

J Perinat Med 2020 Sep;48(7):728-732

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Lenox Hill Hospital, New York, NY, USA.

Objectives Violence against medical trainees confronts medical educators and academic leaders in perinatal medicine with urgent ethical challenges. Despite their evident importance, these ethical challenges have not received sufficient attention. The purpose of this paper is to provide an ethical framework to respond to these ethical challenges. Methods We used an existing critical appraisal tool to conduct a scholarly review, to identify publications on the ethical challenges of violence against trainees. We conducted web searches to identify reports of violence against trainees in Mexico. Drawing on professional ethics in perinatal medicine, we describe an ethical framework that is unique in the literature on violence against trainees in its appeal to the professional virtue of self-sacrifice and its justified limits. Results Our search identified no previous publications that address the ethical challenges of violence against trainees. We identified reports of violence and their limitations. The ethical framework is based on the professional virtue of self-sacrifice in professional ethics in perinatal medicine. This virtue creates the ethical obligation of trainees to accept reasonable risks of life and health but not unreasonable risks. Society has the ethical obligation to protect trainees from these unreasonable risks. Medical educators should protect personal safety. Academic leaders should develop and implement policies to provide such protection. Institutions of government should provide effective law enforcement and fair trials of those accused of violence against trainees. International societies should promulgate ethics statements that can be applied to violence against trainees. By protecting trainees, medical educators and academic leaders in perinatology will also protect pregnant, fetal, and neonatal patients. Conclusions This paper is the first to provide an ethical framework, based on the professional virtue of self-sacrifice and its justified limits, to guide medical educators and academic leaders in perinatal medicine who confront ethical challenges of violence against their trainees.
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http://dx.doi.org/10.1515/jpm-2020-0123DOI Listing
September 2020

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

J Perinat Med 2020 Jun;48(5):450-452

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, NY, USA.

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.
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http://dx.doi.org/10.1515/jpm-2020-0183DOI Listing
June 2020

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

J Perinat Med 2020 Jun;48(5):435-437

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.

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.
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http://dx.doi.org/10.1515/jpm-2020-0174DOI Listing
June 2020

In Response to COVID-19 Pandemic Physicians Already Know What to Do.

Am J Bioeth 2020 07 23;20(7):9-12. Epub 2020 Apr 23.

Zucker School of Medicine at Hofstra/Northwell.

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http://dx.doi.org/10.1080/15265161.2020.1754100DOI Listing
July 2020

How Extreme Religiosity and Nationalism Are Predatory on the Biopsychosocial Health of Patients and the Professionalism of Physicians.

Psychiatr Danub 2020 ;32(1):122-123

Department of Obstetrics and Gynecology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, USA, Department of Obstetrics and Gynecology, Lenox Hill Hospital New York, New York, USA,

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January 2021

Women and children first: the need for ringfencing during the COVID-19 pandemic.

J Perinat Med 2020 Apr 16. Epub 2020 Apr 16.

Lenox Hill Hospital, Zucker School of Medicine at Hofstra/Northwell, New York, NY, USA.

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http://dx.doi.org/10.1515/jpm-2020-0149DOI Listing
April 2020

Beneficence and Wellbeing: A Critical Appraisal.

Am J Bioeth 2020 03;20(3):65-68

Zucker School of Medicine at Hofstra/Northwell; Lenox Hill Hospital; Baylor College of Medicine.

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http://dx.doi.org/10.1080/15265161.2020.1714817DOI Listing
March 2020

Trustworthiness and Professionalism in Academic Medicine.

Acad Med 2020 06;95(6):828-832

L.B. McCullough is professor of obstetrics and gynecology, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, and ethics scholar, Lenox Hill Hospital, New York, New York. J.H. Coverdale is professor of psychiatry and behavioral sciences and of medical ethics, Baylor College of Medicine, Houston, Texas. F.A. Chervenak is professor and chair, Department of Obstetrics and Gynecology, and associate dean for international education, Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, and chair, Department of Obstetrics and Gynecology, Lenox Hill Hospital, New York, New York.

Trustworthiness is the cornerstone professional virtue in the practice of medicine. The authors' goals for this Invited Commentary were to provide an account of the professional virtue of trustworthiness and its historical origins as well as to suggest how trustworthiness in a professional curriculum can be taught and assessed. They identified 2 components of trustworthiness that originate in the work of John Gregory (1724-1773) and Thomas Percival (1740-1804), who invented the ethical concept of medicine as a profession. The first is intellectual trust, the commitment to scientific and clinical excellence. The second is moral trust, the primary commitment of physicians and health care organizations to promote and protect the interest of patients while keeping individual and group interests secondary. Teaching should focus first on the mastery and understanding of the conceptual vocabulary of intellectual and moral trust through a range of formats, including modeling by faculty on how they respect and treat patients and learners. Assessment should be behaviorally based and articulated in increasing, observable, and integrated levels of mastery through training. Medical educators and academic leaders also share the responsibility to inculcate and sustain an organizational culture of professionalism that is respectful, critically self-appraising, accountable, and committed to its learners and to the promotion of physician well-being. These proposals can be used by medical educators and academic leaders to assist learners to become and remain trustworthy physicians.
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http://dx.doi.org/10.1097/ACM.0000000000003248DOI Listing
June 2020

Neonatal mortality in the United States is related to location of birth (hospital versus home) rather than the type of birth attendant.

Am J Obstet Gynecol 2020 08 7;223(2):254.e1-254.e8. Epub 2020 Feb 7.

Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY.

Background: Planned home births have leveled off in the United States in recent years after a significant rise starting in the mid-2000s. Planned home births in the United States are associated with increased patient-risk profiles. Multiple studies concluded that, compared with hospital births, absolute and relative risks of perinatal mortality and morbidity in US planned home births are significantly increased.

Objective: To explore the safety of birth in the United States by comparing the neonatal mortality outcomes of 2 locations, hospital birth and home birth, by 4 types of attendants: hospital midwife; certified nurse-midwife at home; direct-entry ("other") midwife at home; and attendant at home not identified, using the most recent US Centers for Disease Control and Prevention natality data on neonatal mortality for planned home births in the United States. Outcomes are presented as absolute risks (neonatal mortality per 10,000 live births) and as relative risks of neonatal mortality (hospital-certified nurse-midwife odds ratio, 1) overall, and for recognized risk factors.

Study Design: We used the most current US Centers for Disease and Prevention Control Linked Birth and Infant Death Records for 2010-2017 to assess neonatal mortality (neonatal death days 0-27 after birth) for single, term (37+ weeks), normal-weight ( >2499 g) infants for planned home births and hospital births by birth attendants: hospital-certified nurse-midwives, home-certified nurse-midwives, home other midwives (eg, lay or direct-entry midwives), and other home birth attendant not identified.

Results: The neonatal mortality for US hospital midwife-attended births was 3.27 per 10,000 live births, 13.66 per 10,000 live births for all planned home births, and 27.98 per 10,000 live births for unintended/unplanned home births. Planned home births attended by direct-entry midwives and by certified nurse-midwives had a significantly elevated absolute and relative neonatal mortality risk compared with certified nurse-midwife-attended hospital births (hospital-certified nurse-midwife: 3.27/10,000 live births odds ratio, 1; home birth direct-entry midwives: neonatal mortality 12.44/10,000 live births, odds ratio, 3.81, 95% confidence interval, 3.12-4.65, P<.0001; home birth-certified nurse-midwife: neonatal mortality 9.48/10,000 live births, odds ratio, 2.90, 95% confidence interval, 2.90; P<.0001). These differences increased further when patients were stratified for recognized risk factors.

Conclusion: The safety of birth in the United States varies by location and attendant. Compared with US hospital births attended by a certified nurse-midwife, planned US home births for all types of attendants are a less safe setting of birth, especially when recognized risk factors are taken into account. The type of midwife attending US planned home birth appears to have no differential effect on decreasing the absolute and relative risk of neonatal mortality of planned home birth, because the difference in outcomes of US planned home births attended by direct-entry midwives or by certified nurse-midwives is not statistically significant.
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http://dx.doi.org/10.1016/j.ajog.2020.01.045DOI Listing
August 2020

Most Intended Home Births in the United States Are Not Low Risk: 2016-2018.

Am J Obstet Gynecol 2020 04 9;222(4):384-385. Epub 2019 Nov 9.

Zucker School of Medicine at Hofstra/Northwell.

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http://dx.doi.org/10.1016/j.ajog.2019.11.1245DOI Listing
April 2020
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