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Objective We conducted a study to examine the impact of COVID on patients' access and utilization of prenatal genetic screens and diagnostic tests at the onset of the COVID‐19 pandemic in the United States. Methods We conducted telephone interviews with 40 patients to examine how the pandemic affected prenatal genetic screening and diagnostic testing decisions during the initial months of the pandemic in the United States. An interview guide queried experiences with the ability to access information about prenatal genetic testing options and to utilize the tests when desired. Audio recordings were transcribed and coded using NVivo 12. Analysis was conducted using Grounded Theory. Results The pandemic did not alter most participants' decisions to undergo prenatal genetic testing. Yet, it did impact how participants viewed the risks and benefits of testing and timing of testing. There was heightened anxiety among those who underwent testing, stemming from the risk of viral exposure and the fear of being alone if pregnancy loss or fetal abnormality was identified at the time of an ultrasound‐based procedure. Conclusion The pandemic may impact patients' access and utilization of prenatal genetic tests. More research is needed to determine how best to meet pregnant patients' decision‐making needs during this time., Key Points What is already known about this topic? Prenatal genetic screens and diagnostic tests are a core component to the delivery of high‐quality, evidence‐based prenatal care.It is critical that pregnant patients have the information and resources to make an informed decision about a growing array of prenatal genetic screening and diagnostic testing options.In the decision‐making process, pregnant patients commonly weigh the risks and benefits of gaining genetic information about the fetus with the risks and benefits of the available screens and diagnostic tests. What does this study add? The pandemic has led to significant changes in healthcare delivery and insurance benefits for prenatal genetic testing, raising key questions about how pregnant patient are weighing the risks and benefits of the available prenatal genetic screening and diagnostic testing options against the risks of COVID exposure by presenting to a healthcare facility for testing.COVID‐19 appears to impact how women view the utility of prenatal genetic testing, including how they weigh the risk and benefits of prenatal genetic screening and diagnostic testing in addition to when in the pregnancy they may elect to undergo testing.The COVID‐19 pandemic has resulted in increased levels of concern and anxiety that may be encountered by pregnant women in the testing process, raising awareness of the need for additional resources to support patients' decision‐making during the pandemic.

Uterus transplantation is a nascent but growing field. To support this growth, the United States Uterus Transplant Consortium proposes guidelines for nomenclature related to operative technique, vascular anatomy, and donor, recipient, and offspring outcomes. In terms of anatomy, the group recommends reporting donor arterial inflow and recipient anastomotic site delivering inflow to the graft and offers standardization of the names for the 4 veins originating from the uterus because of current inconsistency in this particular nomenclature. Seven progressive stages with milestones of success are defined for reporting on uterus transplantation outcomes: (1) technical, (2) menstruation, (3) embryo implantation, (4) pregnancy, (5) delivery, (6) graft removal, and (7) long-term follow-up. The 3 primary metrics for success are recipient survival (as reported for other organ transplant recipients), graft survival, and uterus transplant live birth rate (defined as live birth per transplanted recipient). A number of secondary outcomes should also be reported, most of which capture stage-specific milestones, as well as data on graft failure. Outcome metrics for living donors include patient survival, survival free of operative intervention, and data on complications and hospitalizations. Finally, we make specific recommendations on follow-up for offspring born from uterine grafts, which includes specialty surveillance as well as collection and reporting of routine pediatric outcomes. The goal of standardization in reporting is to create consistency and improve the quality of evidence available on the efficacy and value of the procedure.

Advances in genomic science and technology have had a significant impact on the delivery of reproductive healthcare. At the same time, these technologies generate a series of unprecedented challenges for patients and healthcare providers alike. Decision-making is at the core of the translational process bringing the use of genomics into reproductive and prenatal medicine. The full potential of these tests can only be realized if patients are able to make informed, values-based decisions about their use. This chapter examines the multi-faceted aspects that affect the translation of genomics in the reproductive context, with an emphasis on decision-making as a key component of this process, and argues that we must continue to invest in the research and development of women’s decision-making around the use of these genomic technologies.

Prenatal cell-free DNA screening (cfDNA) provides more genetic risk information about the fetus than has ever been possible. At the same time, the rapid expansion of new cfDNA panels raises important questions about how to structure patient-centered discussions that best support patients' decision-making about its use. To address this question, we conducted interviews with pregnant patients to identify decision-making needs and preferences with respect to cfDNA in patient-centered healthcare discussions, given its evolving capability to identify a range of fetal variants. Personal utility was a core concept guiding decision-making. Participants spoke of how their deeply personal values and beliefs about maternal responsibility, actionability, and tolerance of uncertainty framed their view of the personal utility of cfDNA screening. While discussing their notions of personal utility with their healthcare provider, participants also had concerns about potential ramifications for the provider-patient relationship and shared decision-making when disclosing values and preferences regarding disability, quality of life, and termination-particularly as it becomes possible to identify variants with different disease-associated severity and outcomes. The complexities associated with the introduction of genomics in prenatal care present unique challenges to structuring effective shared decision-making discussions between patients and their healthcare providers. While efforts are underway to determine how to best educate patients about the medical aspects of cfDNA, it is equally important to develop approaches in healthcare communication that enable patients to make informed, values-based decisions about the use of cfDNA and its impact on their pregnancy.

Residency programs across the United States are searching for ways to improve surgical skills and operative experiences in obstetrics and gynecology residencies. We developed an obstetrics and gynecology residency program that offers a flexible curriculum, referred to as tracking, to address these needs. Curriculum content was developed using a modified Delphi method, using input from experts in medical education and obstetrics and gynecology. Outcome data were collected on trainees who graduated between 2016 and 2019, including postgraduate fellowship placement and our residents' achievement of surgical minimum requirements based on procedure logs. Trainees from this program have consistently exceeded minimal surgical requirements in all areas, regardless of tracking preference. Since the beginning of the program in 2012, more than 60% of graduates have matriculated into fellowships. Flexible curricula, such as tracking, offer one approach to a changing climate of medicine. The ability to offer flexible, focused, and individualized training is an approach with great potential to produce graduates who excel in all areas of obstetrics and gynecology while sharpening skills specific to their areas of interest.

PURPOSE: To provide a comprehensive review of uterus transplantation in 2021, including a discussion of pregnancy outcomes of all reported births to date, the donor and recipient selection process, the organ procurement and transplant surgeries, reported complications, postoperative monitoring, preimplantation preparation, and ethical considerations. METHODS: Literature review and expert commentary. RESULTS: Reports of thirty-one live births following uterus transplantation have been published from both living and deceased donors. The proper selection of donors and recipients is a labor-intensive process that requires advanced planning. A multidisciplinary team is critical. Reported complications in the recipient include thrombosis, infection, vaginal stricture, antenatal complications, and graft failure. Graft rejection is a common occurrence but rarely leads to graft removal. While most embryo transfers are successful, recurrent implantation failures in uterus transplant patients have been reported. Rates of preterm delivery are high but appear to be declining; more data, including long-term outcome data, is needed. CONCLUSIONS: Uterus transplantation is an emerging therapy for absolute uterine factor infertility, a condition previously without direct treatment options. It is paramount that reproductive health care providers are familiar with the uterus transplantation process as more patients seek and receive this treatment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s10815-021-02245-7.

Ethical issues abound during this unprecedented international public health crisis of Covid‐19. While the trade‐off between societal and individual interests that occurs at the intersection of public health ethics and clinical ethics affects all populations, this calculus has particular relevance for pregnant women and the question of when they will have access to new Covid‐19 therapies and vaccines. Pregnant women are a “scientifically complex” population whose inclusion in clinical research must be done with consideration of the unique state of pregnancy. Yet research on the impact of Covid‐19 on pregnant women is lagging. In a rush to prevent and treat SARS‐CoV‐2 infection, it is crucial that the interests of pregnant women be prioritized to enable them to make autonomous, informed decisions about participating in clinical trials. The global pandemic calls for a revisiting of frameworks for the inclusion of pregnant women in research, as these women have an important stake in the prevention and treatment of Covid‐19.

The clinical integration of prenatal genetic technologies raises a series of important medical and ethical considerations for patients, families, health care providers, health care systems, and society. It is critical to recognize, understand, and address these issues in conjunction with the continued development of new prenatal genetic screens and tests. This article discusses some of the lead ethical issues as a starting point to further understanding their ramifications on patients, families, communities, and health care providers.

Purpose: The clinical introduction of innovative prenatal genetic technologies challenges patients and providers to find new ways of fostering informed decision-making in a setting characterized by complexity and uncertainty. As prenatal genetic technology advances, important questions remain about how to structure patient-centered conversations that effectively prepare pregnant patients to make informed choices about the different genetic conditions for which this new form screening may be used. Methods: Focus groups were conducted with 23 pregnant women to identify informational needs and decision-making preferences regarding emerging and anticipated applications of cell-free fetal DNA screening, the newest form of prenatal genetic screening. Results: Participants were in favor of obtaining more genetic information about the fetus than provided by conventional screens but acknowledged the challenges inherent in navigating the unique complexities of the decision-making process. The provider–patient relationship was seen as an important resource to navigate the associated uncertainties at each stage of the screening process. Participants emphasized the need for initiatives to support a personalized, accurate, and unbiased discussion about prenatal genetic risk and assessment. Conclusion: Continued advances in prenatal genetic screening call for new approaches to structure patient-centered communication to facilitate increasingly complex decisions about fetal genetic risk and assessment.

To describe patient outcomes after modified vestibulectomy for vulvodynia.This is a mixed-methods study of patients who had undergone modified vestibulectomy for vulvodynia at a tertiary care hospital from 2009 through 2016. Demographics, preoperative and postoperative examinations, symptoms, and treatments were obtained through retrospective review. Prospective semistructured interviews were conducted from 2018 through 2019 to address patient-reported changes in pain and sexual function. Qualitative analysis was performed using a grounded theory approach.Twenty-two patients underwent modified vestibulectomy from 2009 through 2016. Age ranged from 22 to 65 years and mean body mass index was 24.3±5.4. The majority of patients were premenopausal (57%), sexually active (68%), and partnered (76%). Postoperatively, data on pain improvement were retrieved on 18 patients, of which 17 (94%) reported improvement. Patients used pelvic floor physical therapy, medications, and lubricants both preoperatively and postoperatively. For the qualitative analysis, thematic saturation was achieved with 14 interviews. Of 14 participants interviewed, 13 (93%) reported improvement with pain after surgery, 11 (79%) reported satisfaction with surgery, 8 (57%) reported satisfaction with sexual function, and 11 (79%) reported recommending the surgery to others. The following lead themes were identified: vulvodynia symptoms significantly affect quality of life; there is difficulty and delay in diagnosis owing to lack of information and awareness among patients and health care providers; and surgical success and satisfaction are influenced by patient perceptions with sexual dysfunction often persisting despite vulvar pain improvement.Vulvodynia patients report improvement in pain and high overall satisfaction after modified vestibulectomy, but more variable long-term effects on sexual function.

Uterus transplantation is the only known potential treatment for absolute uterine factor infertility. It offers a unique setting for the investigation of immunologic adaptations of pregnancy in the context of the pharmacologic-induced tolerance of solid organ transplants, thus providing valuable insights into the early maternal-fetal interface. Until recently, all live births resulting from uterus transplantation involved living donors, with only 1 prior birth from a deceased donor. The Cleveland Clinic clinical trial of uterus transplantation opened in 2015. In 2017, a 35 year old woman with congenital absence of the uterus was matched to a 24 year old parous deceased brain-dead donor. Transplantation of the uterus was performed with vaginal anastomosis and vascular anastomoses bilaterally from internal iliac vessels of the donor to the external iliac vessels of the recipient. Induction and maintenance immunosuppression were achieved and subsequently modified in anticipation of pregnancy 6 months after transplant. Prior to planned embryo transfer, ectocervical biopsy revealed ulceration and a significant diffuse, plasma cell-rich mixed inflammatory cell infiltrate, with histology interpreted as grade 3 rejection suspicious for an antibody-mediated component. Aggressive immunosuppressive regimen targeting both cellular and humoral rejection was initiated. After 3 months of treatment, there was no histologic evidence of rejection, and after 3 months from complete clearance of rejection, an uneventful embryo transfer was performed and a pregnancy was established. At 21 weeks, central placenta previa with accreta was diagnosed. A healthy neonate was delivered by cesarean hysterectomy at 34 weeks' gestation. In summary, this paper highlights the first live birth in North America resulting from a deceased donor uterus transplant. This achievement underscores the capacity of the transplanted uterus to recover from a severe, prolonged rejection and yet produce a viable neonate. This is the first delivery from our ongoing clinical trial in uterus transplantation, including the first reported incidence of severe mixed cellular/humoral rejection as well as the first reported placenta accreta.

While uterus transplantation was once considered only a theoretical possibility for patients with uterine factor infertility, researchers have now developed methods of transplantation that have led to successful pregnancies with multiple children born to date. Because of the unique and significant nature of this type of research, it has been undertaken with collaboration not only with scientists and physicians but also with bioethicists, who paved the initial path for research of uterus transplantation to take place. As the science of uterus transplantation continues to advance, so too must the public dialogue among obstetrician/gynecologists, transplant surgeons, bioethicists, and other key stakeholders in defining the continued direction of research in addition to planning for the clinical implementation of uterus transplantation as a therapeutic option. Given the rapid advances in this field, the time has come to revisit the fundamental questions raised at the inception of uterus transplantation and, looking forward, determine the future of this approach given emerging data on the procedure's impact on individuals, families, and society.

Uterine factor infertility (UFI) is a condition that affects approximately 1.5 million women around the world. Advances in reproductive science have made it possible that uterine transplantation may be the first true treatment for women with UFI. While uterine transplantation is still in the experimental stages, the first successful live births from women who received a uterine transplant mark the real potential of this procedure. Although uterine transplant may offer an important new step for the management of women with UFI, it also poses important ethical questions that must be thoroughly considered and addressed before this procedure becomes a clinical reality. In this article, we review the major ethical issues associated with the study of and expected future clinical translation of uterine transplantation and propose a series of steps to reduce risks to all those involved in the process.

The aim of this study was to identify how physicians develop their knowledge base and practice patterns regarding noninvasive prenatal testing (NIPT).A survey was used to assess physicians' informational sources and practice patterns regarding NIPT.While most of the 258 participants acquire knowledge about NIPT from the medical literature or didactic educational programming, 74 (28.7%) cite commercial laboratories as an initial source and 124 (47.8%) as a way to keep current with changes in NIPT. About one-third (n = 94, 36.4%) seek information about ethical issues related to NIPT. Half of the OB/GYN respondents (n = 136, 52.7%) provide pretest counseling; fewer refer to a genetic counselor or maternal fetal medicine specialist (MFM) (n = 94, 34.6%, n = 29, 11.2%, respectively). Pretest counseling content and the comfort with which participants discuss topics pertinent to patients' utilization of NIPT varied between OB/GYNs and MFMs.Advances in cff DNA technology emphasize the need for effective strategies for physicians to develop competency and practice patterns regarding NIPT. Study findings speak to the need for effective educational resources for obstetric providers, not just early adopters of NIPT but also for primary OB/GYNs as they serve in the role of the first point of contact for women considering their prenatal testing options. © 2016 John Wiley & Sons, Ltd.

Current prenatal screening practices and the complexity of genomic science create a risk that early, noninvasive fetal genetic sequencing will be integrated into care without the robust informed consent processes necessary for respecting women’s autonomy.

Cell-free fetal DNA (cfDNA) screening is used to identify the presence of fetal genetic variants early in pregnancy. Patients’ informed decision-making is central to the success of this new screen in clinical practice. Although research has focused on pregnant women’s decision-making, little is known about partners’ role and preferences as a member of the decision-making dyad. Using a grounded theory approach, this study analyzed 23 in-depth interviews to examine partners’ perspectives about cfDNA screening and preferences with respect to their role in the decision-making process. Participants wished to be actively involved in testing decisions. They articulated a distinct set of needs and preferences in the decision-making process. Such involvement was hindered by several biological and logistical barriers. This study demonstrates the need to develop mechanisms that foster informed decision-making for cfDNA screening and related new reproductive genetic technologies that focus on not just the pregnant woman but also the decision-making dyad that includes her partner as well.

Non-invasive prenatal testing (NIPT) has been integrated into clinical care at a time when patients and healthcare providers increasingly utilize the internet to access health information. This study evaluated online direct-to-consumer information about NIPT produced by commercial laboratories accessible to both patients and healthcare providers. A coding checklist captured areas to describe content and assess concordance with clinical guidelines. We found that the information presented about NIPT is highly variable, both within a single website and broadly across all websites. Variability was noted in how NIPT is characterized, including test characteristics and indications. All laboratories offer NIPT to test for common sex chromosome aneuploidies, although there is a lack of consistency regarding the conditions offered and information provided about each. Although indicated for a subset of women at increased risk of aneuploidy, some laboratories describe the use of NIPT for all pregnant women. A subset of laboratories offers screening for microdeletions, although clinical practice guidelines do not yet recommend for general use for this indication. None of the online materials addressed the ethical issues associated with NIPT. This study highlights the need for clear, consistent, and evidence-based materials to educate patients and healthcare providers about the current and emerging applications of NIPT.

Approximately 0.5% of all births occur before the third trimester of pregnancy, and these very early deliveries result in the majority of neonatal deaths and more than 40% of infant deaths. A recent executive summary of proceedings from a joint workshop defined periviable birth as delivery occurring from 20 0/7 weeks to 25 6/7 weeks of gestation. When delivery is anticipated near the limit of viability, families and health care teams are faced with complex and ethically challenging decisions. Multiple factors have been found to be associated with short-term and long-term outcomes of periviable births in addition to gestational age at birth. These include, but are not limited to, nonmodifiable factors (eg, fetal sex, weight, plurality), potentially modifiable antepartum and intrapartum factors (eg, location of delivery, intent to intervene by cesarean delivery or induction for delivery, administration of antenatal corticosteroids and magnesium sulfate), and postnatal management (eg, starting or withholding and continuing or withdrawing intensive care after birth). Antepartum and intrapartum management options vary depending upon the specific circumstances but may include short-term tocolytic therapy for preterm labor to allow time for administration of antenatal steroids, antibiotics to prolong latency after preterm premature rupture of membranes or for intrapartum group B streptococci prophylaxis, and delivery, including cesarean delivery, for concern regarding fetal well-being or fetal malpresentation. Whenever possible, periviable births for which maternal or neonatal intervention is planned should occur in centers that offer expertise in maternal and neonatal care and the needed infrastructure, including intensive care units, to support such services. This document describes newborn outcomes after periviable birth, provides current evidence and recommendations regarding interventions in this setting, and provides an outline for family counseling with the goal of incorporating informed patient preferences. Its intent is to provide support and guidance regarding decisions, including declining and accepting interventions and therapies, based on individual circumstances and patient values.

Objective The aim of this study is to explore women's opinions about the use of noninvasive prenatal testing (NIPT) to assess the risk of sex chromosome aneuploidies and microdeletion syndromes. Methods Focus groups were conducted with women who were currently pregnant or had recently delivered. Qualitative analysis using interpretive description was used to generate study findings. Results Thirty-one women (mean age 32.4 years) participated in the focus groups. Participants were unfamiliar with sex chromosome aneuploidies but expressed support for the use of NIPT to detect these conditions. Participants were uncertain about the utility and actionability of receiving information about microdeletion syndromes with variable or unknown phenotypic expression. Participants voiced their desire to be informed of all conditions assessed by NIPT prior to testing. They considered clinicians to be the key provider of such information, although stated that patients have a responsibility to be knowledgeable prior to testing in order to support informed decision making. Conclusions The use of NIPT to identify sex chromosome aneuploidies and microdeletion syndromes will introduce new challenges for clinicians to ensure pregnant women have the information and resources to make informed choices about NIPT when used for these conditions. © 2015 John Wiley & Sons, Ltd.

Background: Noninvasive prenatal testing (NIPT) using cell-free fetal DNA is having a significant impact on the delivery of prenatal care. Our objective was to identify how pregnant women characterize the risks and benefits of this screening test and their preferences in order to guide an informed decision-making process about its use. Methods: We conducted focus groups with women who were either pregnant or recently postpartum who received outpatient prenatal care. A moderator guide was used to elicit participants’ perspectives on noninvasive prenatal testing. Results: Despite the low chance of a false positive result, this aspect of NIPT was a key determinant in participants’ decision making about the screening test. Participants discussed how many of the drawbacks and considerations associated with prenatal screening would remain intact regardless of the accuracy of a new approach to assess fetal health. Conclusions: NIPT affects how women think about risk not only in regard to prenatal genetic screeni...

Decisions related to births in the "gray zone" of periviability are particularly challenging. Despite published management guidelines, clinicians and families struggle to negotiate care management plans. Stakeholders must reconcile conflicting values in the context of evolving circumstances with a high degree of uncertainty within a short time period. Even skilled clinicians may struggle to guide the patient in making value-laden decisions without imposing their own values. Exploring the experiences of one pregnant woman and her caregivers, this case study highlights how bias may undermine caregivers' ability to meet their obligation to enhance patient autonomy and the moral distress they may experience when a patient's values do not align with their own. Management strategies to mitigate the potential impact of bias and related moral distress are identified. The authors then describe one management strategy used in this case, facilitated ethics consultation, which is focused on thoughtful consideration of the patient's perspective.

The expansion of cell-free fetal DNA (cfDNA) screening for a larger and diverse set of genetic variants, in addition for use among the low-risk obstetric population, presents important clinical challenges for all healthcare providers involved in the delivery of prenatal care. It is unclear how to leverage the different members of the healthcare team to respond to these challenges. We conducted interviews with 25 prenatal genetic counselors to understand their experience with the continued expansion of cfDNA screening. Participants supported the use of cfDNA screening for the common autosomal aneuploidies, but noted some reservations for its use to identify fetal sex and microdeletions. Participants reported several barriers to ensuring that patients have the information and support to make informed decisions about using cfDNA to screen for these different conditions. This was seen as a dual-sided problem, and necessitated additional education interventions that addressed patients seeking cfDNA screening, and obstetricians who introduce the concepts of genetic risk and cfDNA to patients. In addition, participants noted that they have a professional responsibility to educate obstetricians about cfDNA so they can be prepared to be gatekeepers of counseling and education about this screening option for use among the general obstetric population.

Uterine factor infertility (UFI) is a condition that affects thousands of women and is estimated to have a prevalence as high as one in five hundred reproductive-aged women. A wide range of circumstances can lead to UFI and include women with congenital absence of a uterus (Mayer Rokitansky Kuster Hauser or MRKH syndrome), women who have undergone iatrogenic removal of the uterus, or women who have uteri that are in situ but have been damaged by infection or surgical instrumentation. There have been 17 published reports of human uterine transplantation in the world. This article will summarize the history of human uterine transplantation and discuss our current understanding of the medical, surgical, and ethical considerations surrounding this innovative procedure.

Aims: In September, 2015, Mayo Clinic convened a panel of national thought leaders on prenatal screening, medical genetics, and obstetrics and gynecology practice. Results: During the 2-day symposium, participants discussed the implications of the shift toward broader prenatal screening using cell-free placental DNA in maternal serum (cfDNA screening). Key topics included challenges around the pace of change in the prenatal screening market, uncertainty around reimbursement, meeting the need for patient counseling, and potential challenges in interpreting and returning cfDNA screening results. Innovation: Here, we describe the challenges discussed and offer clinical recommendations for practices who are working to meet them. Conclusion: As the spread of prenatal genetic screening continues, providers will increasingly need to update their practice to accommodate new screening modalities.

Ohio's governor recently signed into law Senate Bill 127, a bill that makes it a fourth-degree felony for a health care provider to perform an abortion "when the probable post-fertilization age of the unborn child is 20 weeks or greater," joining a series of other states that have enacted such legislation or are moving toward similar legislation. Twenty-week bans have salient implications for women's health, quality of care, and access to services, particularly in the context of the delivery of prenatal care. Because of the timeline of the initiation of prenatal care and assessments of fetal genetic and anatomic anomalies, patients may increasingly find themselves at or near the 20-week postfertilization gestational threshold when they have insufficient information to decide about continuing or ending the pregnancy. This law thus leaves women and families with limited time to obtain a genetic or anatomic diagnosis, restricts access to abortion care at a crucial decision-making time in the pregnancy, and has significant implications for the patient-physician relationship. This law also has ramifications for women and health care providers outside of Ohio, because patients who have made the choice to end a pregnancy will have to cross state lines for abortion care. It is important for obstetric providers to be aware of the ramifications of 20-week bans and take steps to ensure that pregnant women receive high-quality care despite the burdens imposed on the health care decision-making process.

The State of Ohio is implementing an episode-based payment model for perinatal care. All costs of care will be tabulated for each live birth and assigned to the delivering provider, creating a three-tiered model for reimbursement for care. Providers will be reimbursed as usual for care that is average in cost and quality, while instituting rewards or penalties for those outside the expected range in either domain. There are few exclusions, and all methods of genetic screening and diagnostic testing are included in the episode cost calculation as proposed. Prenatal ultrasonography, genetic screening, and diagnostic testing are critical components of the delivery of high-quality, evidence-based prenatal care. These tests provide pregnant women with key information about the pregnancy, which, in turn, allows them to work closely with their health care provider to determine optimal prenatal care. The concepts of informed consent and decision-making, cornerstones of the ethical practice of medicine, are founded on the principles of autonomy and respect for persons. These principles recognize that patients' rights to make choices and take actions are based on their personal beliefs and values. Given the personal nature of such decisions, it is critical that patients have unbarred access to prenatal genetic tests if they elect to use them as part of their prenatal care. The proposed restructuring of reimbursement creates a clear conflict between patient autonomy and physician financial incentives.

Advocates for the professionalization of clinical bioethics argue that bioethics professionals play an important role in contemporary medicine and patient care, especially when addressing complex ethical questions that arise in the delivery of reproductive medicine. For bioethics consultants to serve effectively, they need adequate training in the medical and ethical issues that patients and clinicians will face, and they need skills to facilitate effective dialog among all parties. Because clinical ethics consultation is a "high-stakes endeavor" that can acutely affect patient care, efforts are under way to ensure that bioethics consultants have the competence to provide such guidance. Yet to date, no studies have examined whether the training of bioethics consultants meets the needs of health care professionals who are on the front lines of such issues. In fact, limited information is available on the reproductive health issues that bioethics training programs address or the degree to which these programs meet the needs of patients confronting reproductive health decisions and their clinicians. It is therefore important to answer this key question: What are the primary ethical issues encountered in reproductive medicine that currently affect patient care? Equally important, are bioethics training programs prepared to address those issues? To begin to answer these questions, we conducted parallel surveys of directors of graduate bioethics training programs and obstetrician-gynecologists. The goal of this project is to lay the groundwork to establish a working partnership between bioethics educators and reproductive medicine practitioners to address the often troubling and frequently complex ethical issues in reproductive medicine.

Objective Patients' use of the Internet as a source of health information is increasing. The objective of this study was to describe and evaluate Internet-based information about noninvasive prenatal testing (NIPT), an important new genetic test currently available to high-risk women in early pregnancy. Methods Websites were sampled using leading search engines to mirror Internet-based search patterns of individuals seeking information about NIPT. Content analysis was conducted to assess website reading level, quality, and content. Results Basic information about NIPT use as a screening test was accurately described. Overall, sampled websites lacked balance and comprehensive information about NIPT and the complexity of decision making involved in electing for its use. All websites were written at reading levels higher than currently recommended levels for public health information. Conclusion While online resources should be used with reservation, they can be an important tool to support effective communication and patient-centered care. Online information can help both health care providers and pregnant patients who face a growing number of fetal genetic testing options. © 2014 John Wiley & Sons, Ltd.

Noninvasive prenatal testing (NIPT) offers pregnant women a new risk assessment tool for fetal aneuploidy that is superior to conventional screening tests. We conducted focus groups with women who were currently pregnant or had recently delivered in the past year to characterize their perspectives about NIPT and to explore factors they would consider during decision making about its use. Women identified accuracy, early timing, testing ease, and determination of fetal sex as advantages of NIPT over other screens, and the noninvasive method of NIPT as an advantage over diagnostic tests. False positive and false negative results, anxiety, cost and insurance coverage were seen as disadvantages of NIPT. Women who do not want fetal aneuploidy information most likely will not undergo NIPT, despite its advantages over other screening tests. However, given its advantages, the decision to have NIPT is straightforward for women who want genetic information about the fetus. Women emphasized the need to make autonomous, private, and informed choices about NIPT, as they would with any prenatal genetic testing option. These perspectives may guide clinicians to conduct effective and clinically relevant counseling with pregnant women who consider utilizing this new genetic technology.

This commentary endeavors to share our practical experience in developing and implementing the first uterine transplant clinical trial in the United States. Uterine transplant is a promising novel treatment for uterine factor infertility. After reported successful live births after uterine transplant in Sweden, research teams around the world are either embarking on or are considering the development of uterine transplant protocols. Our observations on the applied rather than theoretical aspects of uterine transplantation research in human subjects are detailed in this article. Important among these considerations are composing a broad and experienced multidisciplinary team as well as performing adequate preclinical preparations, including ideally animal studies and practice organ procurements. Ethical preparation is tantamount to clinical preparation for the complexities inherent in uterine transplant, and our suggestions for updating the current ethical criteria for uterine transplant are outlined here. We also describe our perspectives on the strengths and weaknesses of living compared with deceased donor models. Finally, we describe how a strong program can recover and adapt in the face of setbacks to continue a path toward innovation.

Background Although many probiotic products are currently available in yogurt or pill form in the United States (US), there is uncertainty surrounding the structure of regulation of these products. As more therapeutic probiotics are developed, changes to existing regulatory process in the United States may be required to meet the needs of patients and users in the population. Objective This study examined how patients with chronic gastrointestinal (GI) diseases view the regulation of probiotics. Design We conducted a multi-site qualitative study consisting of focus groups of patients with chronic gastrointestinal diseases at three tertiary hospitals: at [institutions removed for blinded review]. Results We conducted 22 focus groups with 136 patients with major gastrointestinal (GI) diseases between March and August 2009. Participants were not familiar with the existing regulation of probiotic products but wanted assurances of accurate labelling of strain as well as safety. Participants raised concerns that regulation of probiotics might be accompanied by greater costs, reduced access and increased involvement of pharmaceutical companies. Although participants voiced significant doubt of government regulators, they felt that products containing genetically modified probiotic strains should have oversight comparable to that of pharmaceutical drugs. Discussion and conclusion If GI patient perspectives are indicative of public perceptions of therapeutic probiotics in the United States, consumers may expect more rigorous regulation in the future while simultaneously wanting low costs, easy access and low involvement of pharmaceutical companies. Manufacturers, translational scientists, clinicians and regulators should be sensitive to consumer attitudes when designing, testing and regulating new therapeutic probiotics.

BACKGROUND: Researchers have the potential to utilize genetic modification (GM) technologies to create a hybrid of "food" and "medicine" that may challenge traditional understandings of what is "natural". Moral and ethical concerns are likely to arise in any discussion of these therapeutic foods and will affect the integration of products into clinical care and daily life. This study examined how patients with chronic gastrointestinal (GI) diseases view probiotics as future bioengineered therapeutic foods. METHODS: A multi-site qualitative study consisting of focus groups with chronic GI diseases was conducted at Cleveland Clinic, Mayo Clinic, and Johns Hopkins University RESULTS: We conducted twenty-two focus groups with 136 patients with major GI diseases between March and August 2009. GI patients associated the term "natural" with concepts of diminished risk and morally "good"; conversely, patients associated the term "unnatural" with things that are "risky," "foreign", and morally "bad". Readily available unmodified probiotics were more commonly described as "natural" while genetically modified probiotics were more commonly labeled as "unnatural" and "risky". However, patients acknowledged that not all natural products are safe, nor are unnatural products always harmful. CONCLUSIONS: If GI patient perspectives are indicative of public perceptions of therapeutic foods, our findings suggest that the potential benefits and risks of clinical and public health initiatives employing therapeutic foods will be understood in moralistic terms. Bioethicists and others should be sensitive to the implicit normative appeals that are often embedded in the language of what is "natural" and "unnatural".

Objective First trimester aneuploidy screening introduces unique challenges to patient education and informed decision-making. Our study assessed the decision-making process among those pregnant patients presenting for this new form of aneuploidy screening. Method A survey instrument was used to assess components of decision-making among women who presented for first trimester aneuploidy screening. Knowledge and leading factors in the decision-making process were measured. Results Participants (n = 139) demonstrated understanding of the etiology of Down syndrome, but less understanding of its cognitive (65.2%) and physical manifestations (58.7%). Few were able to determine risk from first trimester screen results (36.7%). Participants were more familiar with amniocentesis (84.2%) than chorionic villus sampling (73.4%), though less familiar with procedural risks (29.5% and 28.1%, respectively). The majority of participants ranked the following as key information in their decision: knowledge of their intentions about the outcome of the pregnancy based on the test results (92.4%), knowledge of chorionic villus sampling to evaluate an abnormal result (92.0%), and values and beliefs about termination (89.1%). Conclusion First trimester aneuploidy screening generates education and decision-making benchmarks for patients and providers. It is important to address these barriers as this new screen becomes a growing part of current prenatal genetic testing offerings. Copyright © 2011 John Wiley & Sons, Ltd.

Purpose: Innovative applications of genetic testing have emerged within the field of assisted reproductive technology through preimplantation genetic diagnosis. As in all forms of genetic testing, adequate genetic counseling and informed consent are critical. Despite the growing recognition of the role of informed consent in genetic testing, there is little data available about how this process occurs in the setting of preimplantation genetic diagnosis. Methods: A cross-sectional study of in vitro fertilization clinics offering preimplantation genetic diagnosis in the United States was conducted to assess patient education and informed consent practices. Descriptive data were collected with a self-administered survey instrument. Results: More than half of the clinics offering preimplantation genetic diagnosis required genetic counseling before preimplantation genetic diagnosis (56%). Genetic counseling was typically performed by certified genetic counselors (84%). Less than half (37%) of the clinics required a separate informed consent process for genetic testing of embryonic cells. At a majority of those clinics requiring a separate informed consent for genetic testing (54%), informed consent for preimplantation genetic diagnosis and genetic testing took place as a single event before beginning in vitro fertilization procedures. Conclusions: The results suggest that patient education and informed consent practices for preimplantation genetic diagnosis have yet to be standardized. These findings warrant the establishment of professional guidelines for patient education and informed consent specific to embryonic genetic testing.

Unique ethical challenges arise in the context of research involving assisted reproductive technologies where outcomes must be established for both the woman who participates in the research and any children born as a result of that research. Uterine transplantation, the newest experimental procedure to assist women in their family-building efforts, entails a complex combination of fertility procedures and surgeries with the goal of having the uterine recipient achieve a pregnancy and give birth to a healthy child. Some of those procedures, such as in vitro fertilisation and embryo freezing, are now considered established therapeutic interventions for women outside of the context of uterine transplantation. Other procedures, including the transplantation surgery maintenance of a pregnancy in the transplant recipient, and removal of the uterus after pregnancy are more clearly still in a research phase. While there is data on the use of immunosuppressive drugs in pregnancy for individuals with other solid organ transplants, this data is not in the context of uterine transplantation where a distinct set of anatomical and physiological changes are anticipated as a result of pregnancy. Uterine transplantation research raises important ethical challenges for research involving women to advance the science of fertility medicine.

Much of the discourse in the bioethics literature on what is often called “cesarean delivery on maternal request” has focused on balancing respect for patient autonomy with attention to the short- and long-term risks of this procedure to maternal and neonatal well-being. And while there has been some analysis of the social and economic costs inherent in performing cesareans, much of the clinical and ethical analysis has concluded that, given the degree of risk to the mother and neonate from a primary or single repeat cesarean delivery, there is sufficient justification for pregnant women to request and obtain this procedure from obstetricians willing to meet such requests. However, these same analyses often caution that physicians should not offer these elective cesareans to all women, but only to those who initiate the request. This paper analyzes recommendations that do not promote universal access to these procedures and concludes that such a policy is ethically unjustifiable, as it treats women who do not inquire about such procedures differently. Depriving appropriate candidates—for example, healthy women who are good surgical candidates and desire only one or two children—of information about elective cesarean delivery is a form of undue influence on women's decision-making.

The first trimester aneuploidy screen (FTS) continues to be a leading approach to identify the risk of fetal aneuploidy. This study evaluated how obstetric (OB) professionals counsel women about FTS as one of a growing number of options to assess fetal health. A survey was completed by OB professionals (board-certified obstetrician/gynecologists and certified nurse midwives) between February and March 2011: (1) to identify knowledge and practice patterns with regard to FTS, and (2) to compare pregnant women's educational needs and decision-making preferences with clinicians' perceptions of these factors. A total of 216 surveys (11 percent) were completed by OB professionals and analyzed. Several barriers to effective patient counseling were identified, including gaps in obstetric professionals' mastery of the screening test characteristics and variable approaches to discuss concepts of aneuploidy risk. OB participants reported limited confidence in discussing patient-valued topics, specifically post-screen options and pregnancy termination. Discordance was identified between OB professionals' perceptions of pregnant women's educational needs and decision-making preferences specific to FTS and historical data recently collected from 139 pregnant women who underwent the FTS. Study findings illustrate the need for clinician-targeted strategies to support pregnant women as they formulate informed decisions about the tests that may have a salient impact on their prenatal care decisions.

Cancer treatment should address female-specific survivorship issues, including the hypoestrogenic- related adverse effects of cancer therapies or of natural menopause in survivors. Systemic and vaginal estrogen are widely used for symptomatic relief of vasomotor symptoms, sexual dysfunction, and lower urinary tract infections in the general population. However, given that some types of cancer are hormone sensitive, there are safety concerns about the use of local hormone therapy in women who currently have breast cancer or have a history of breast cancer. Nonhormonal approaches are the first-line choices for managing urogenital symptoms or atrophy-related urinary symptoms experienced by women during or after treatment for breast cancer. Among women with a history of estrogen-dependent breast cancer who are experiencing urogenital symptoms, vaginal estrogen should be reserved for those patients who are unresponsive to nonhormonal remedies. The decision to use vaginal estrogen may be made in coordination with a woman's oncologist. Additionally, it should be preceded by an informed decision-making and consent process in which the woman has the information and resources to consider the benefits and potential risks of low-dose vaginal estrogen. Data do not show an increased risk of cancer recurrence among women currently undergoing treatment for breast cancer or those with a personal history of breast cancer who use vaginal estrogen to relieve urogenital symptoms.

Though they claim to, direct-to-consumer genetic tests may not correctly identify an individual's ancestral background, and thus may overstate or understate one's risk for heritable disease.