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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.

Background The COVID-19 pandemic brought significant changes in health care, specifically the accelerated use of telehealth. Given the unique aspects of prenatal care, it is important to understand the impact of telehealth on health care communication and quality, and patient satisfaction. This mixed methods study examined the challenges associated with the rapid and broad implementation of telehealth for prenatal care delivery during the pandemic. Objective In this study, we examined patients’ perspectives, preferences, and experiences during the COVID-19 pandemic, with the aim of supporting the development of successful models to serve the needs of pregnant patients, obstetric providers, and health care systems during this time. Methods Pregnant patients who received outpatient prenatal care in Cleveland, Ohio participated in in-depth interviews and completed the Coronavirus Perinatal Experiences-Impact Survey (COPE-IS) between January and December 2021. Transcripts were coded using NVivo 12, and qualitative analysis was used, an approach consistent with the grounded theory. Quantitative data were summarized and integrated during analysis. Results Thematic saturation was achieved with 60 interviews. We learned that 58% (35/60) of women had telehealth experience prior to their current pregnancy. However, only 8% (5/60) of women had used both in-person and virtual visits during this pregnancy, while the majority (54/60, 90%) of women participated in only in-person visits. Among 59 women who responded to the COPE-IS, 59 (100%) felt very well supported by their provider, 31 (53%) were moderately to highly concerned about their child’s health, and 17 (29%) reported that the single greatest stress of COVID-19 was its impact on their child. Lead themes focused on establishing patient-provider relationships that supported shared decision-making, accessing the information needed for shared decision-making, and using technology effectively to foster discussions during the COVID-19 pandemic. Key findings indicated that participants felt in-person visits were more personal, established greater rapport, and built better trust in the patient-provider relationship as compared to telehealth visits. Further, participants felt they could achieve a greater dialogue and ask more questions regarding time-sensitive information, including prenatal genetic testing information, through an in-person visit. Finally, privacy concerns arose if prenatal genetic testing or general pregnancy conversations were to take place outside of the health care facility. Conclusions While telehealth was recognized as an option to ensure timely access to prenatal care during the COVID-19 pandemic, it also came with multiple challenges for the patient-provider relationship. These findings highlighted the barriers and opportunities to achieve effective and patient-centered communication with the continued integration of telehealth in prenatal care delivery. It is important to address the unique needs of this population during the pandemic and as health care increasingly adopts a telehealth model.

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.

Objective Advances in prenatal genetics place additional challenges as patients must receive information about a growing array of screening and testing options. This raises concerns about how to achieve a shared decision-making process that prepares patients to make an informed decision about their choices about prenatal genetic screening and testing options, calling for a reconsideration of how healthcare providers approach the first prenatal visit. Methods We conducted interviews with 40 pregnant women to identify components of decision-making regarding prenatal genetic screens and tests at this visit. Analysis was approached using grounded theory. Results Participants brought distinct notions of risk to the visit, including skewed perceptions of baseline risk for a fetal genetic condition and the implications of screening and testing. Participants were very concerned about financial considerations associated with these options, ranking out-of-pocket costs on par with medical considerations. Participants noted diverging priorities at the first visit from those of their healthcare provider, leading to barriers to shared decision-making regarding screening and testing during this visit. Conclusion Research is needed to determine how to restructure the initiation of prenatal care in a way that best positions patients to make informed decisions about prenatal genetic screens and tests.

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.

Although women are inextricably involved in the study of germline editing, their interests have not been significantly represented in debates about the evolution of genome editing technology. Discussions have taken place about effects of germline editing on women as parents and members of families, but key discussions about women's health and well-being as patients and subjects are lacking. This neglect is due in part to restrictions on uterine transfer of modified human embryos, a boundary that has now been crossed. As a result, only scant discussion has taken place about safeguards needed to ensure that women who participate in germline modification research are not exposed to disproportionate risk in exchange for benefits they might expect for future offspring. This omission sets the stage for serious ethical implications for women and their families.

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.

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.

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.

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.

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".

A variety of microbial communities and their genes (the microbiome) exist throughout the human body, with fundamental roles in human health and disease. The National Institutes of Health (NIH)-funded Human Microbiome Project Consortium has established a population-scale framework to develop metagenomic protocols, resulting in a broad range of quality-controlled resources and data including standardized methods for creating, processing and interpreting distinct types of high-throughput metagenomic data available to the scientific community. Here we present resources from a population of 242 healthy adults sampled at 15 or 18 body sites up to three times, which have generated 5,177 microbial taxonomic profiles from 16S ribosomal RNA genes and over 3.5 terabases of metagenomic sequence so far. In parallel, approximately 800 reference strains isolated from the human body have been sequenced. Collectively, these data represent the largest resource describing the abundance and variety of the human microbiome, while providing a framework for current and future studies.

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.

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.

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.

Background Irritable bowel syndrome (IBS) and inflammatory bowel disease (IBD) are chronic conditions affecting millions of individuals in the United States. The symptoms are well-documented and can be debilitating. How these chronic gastrointestinal (GI) conditions impact the daily lives of those afflicted is not well documented, especially from a patient's perspective. Methods Here we describe data from a series of 22 focus groups held at three different academic medical centers with individuals suffering from chronic GI conditions. All focus groups were audio recorded and transcribed. Two research team members independently analyzed transcripts from each focus group following an agreed upon coding scheme. Results One-hundred-thirty-six individuals participated in our study, all with a chronic GI related condition. They candidly discussed three broad themes that characterize their daily lives: identification of disease and personal identity, medications and therapeutics, and daily adaptations. These all tie to our participants trying to deal with symptoms on a daily basis. We find that a recurrent topic underlying these themes is the dichotomy of experiencing uncertainty and striving for control. Conclusions Study participants' open dialogue and exchange of experiences living with a chronic GI condition provide insight into how these conditions shape day-to-day activities. Our findings provide fertile ground for discussions about how clinicians might best facilitate, acknowledge, and elicit patients' stories in routine care to better address their experience of illness.

Author Manuscript date: 2013 February 05., Studies of the human microbiome have revealed that even healthy individuals differ remarkably in the microbes that occupy habitats such as the gut, skin and vagina. Much of this diversity remains unexplained, although diet, environment, host genetics and early microbial exposure have all been implicated. Accordingly, to characterize the ecology of human-associated microbial communities, the Human Microbiome Project has analysed the largest cohort and set of distinct, clinically relevant body habitats so far. We found the diversity and abundance of each habitat’s signature microbes to vary widely even among healthy subjects, with strong niche specialization both within and among individuals. The project encountered an estimated 81–99% of the genera, enzyme families and community configurations occupied by the healthy Western microbiome. Metagenomic carriage of metabolic pathways was stable among individuals despite variation in community structure, and ethnic/racial background proved to be one of the strongest associations of both pathways and microbes with clinical metadata. These results thus delineate the range of structural and functional configurations normal in the microbial communities of a healthy population, enabling future characterization of the epidemiology, ecology and translational applications of the human microbiome.

The past 2 decades have yielded profound advances in the fields of prenatal diagnosis and fetal intervention. Although fetal interventions are driven by a beneficence-based motivation to improve fetal and neonatal outcomes, advancement in fetal therapies raises ethical issues surrounding maternal autonomy and decision-making, concepts of innovation versus research, and organizational aspects within institutions in the development of fetal care centers. To safeguard the interests of both the pregnant woman and the fetus, the American College of Obstetricians and Gynecologists and the American Academy of Pediatrics make recommendations regarding informed consent, the role of research subject advocates and other independent advocates, the availability of support services, the multidisciplinary nature of fetal intervention teams, the oversight of centers, and the need to accumulate maternal and fetal outcome data.

Purpose: The clinical introduction of first trimester aneuploidy screening uniquely challenges the informed consent process for both patients and providers. This study investigated key aspects of the decision-making process for this new form of prenatal genetic screening. Methods: Qualitative data were collected by nine focus groups that comprised women of different reproductive histories (N = 46 participants). Discussions explored themes regarding patient decision making for first trimester aneuploidy screening. Sessions were audio recorded, transcribed, coded, and analyzed to identify themes. Results: Multiple levels of uncertainty characterize the decision-making process for first trimester aneuploidy screening. Baseline levels of uncertainty existed for participants in the context of an early pregnancy and the debate about the benefit of fetal genetic testing in general. Additional sources of uncertainty during the decision-making process were generated from weighing the advantages and disadvantages of initiating screening in the first trimester as opposed to waiting until the second. Questions of the quality and quantity of information and the perceived benefit of earlier access to fetal information were leading themes. Barriers to access prenatal care in early pregnancy presented participants with additional concerns about the ability to make informed decisions about prenatal genetic testing. Conclusions: The option of the first trimester aneuploidy screening test in early pregnancy generates decision-making uncertainty that can interfere with the informed consent process. Mechanisms must be developed to facilitate informed decision making for this new form of prenatal genetic screening.

Large-scale infectious epidemics present the medical community with numerous medical and ethical challenges. Recent attention has focused on the likelihood of an impending influenza pandemic caused by the H5N1 virus. Pregnant women in particular present policymakers with great challenges to planning for such a public health emergency. By recognizing the specific considerations needed for this population, we can preemptively address the issues presented by infectious disease outbreaks. We reviewed the important ethical challenges presented by pregnant women and highlighted the considerations for all vulnerable groups when planning for a pandemic at both the local and the national level.

Applications of probiotics in the treatment of gastrointestinal disorders are gaining acceptance among patients, despite evidence that probiotics can present substantial health risks, particularly for patients who are immunocompromised or seriously ill. Patients will likely formulate their attitudes and beliefs about probiotic therapies with reference to interpretive frameworks that compare probiotics with more familiar therapeutic modalities, including complementary and alternative medicines, pharmacological therapies, and gene-transfer technologies. Each of these frameworks highlights a different set of benefit-to-risk considerations regarding probiotic usage and reinforces extreme characterizations of both the therapeutic promise and peril of probiotics. Considerable effort may be required to help patients make informed choices about probiotic therapies.