Microarray evidence that 8-cell human embryos express some hormone family members including oxytocin.

OBJECTIVE: This study is to discover hormone pathways active in early cleaving human embryos. METHODS: A list of 152 hormones and receptors were compiled to query the microarray database of mRNAs in 8-cell human embryos, two lines of human embryonic stem cells plus human fibroblasts before and after induced pluripotency. RESULTS: Over half of the 152 hormones and receptors were silent on the arrays of all cell types, and more were detected at high or moderate levels on the 8-cell arrays than on the pluripotent cell or fibroblast arrays. Eight hormone family genes were uniquely detected at least 22-fold higher on the 8-cell arrays than the stem cell arrays: AVPI1, CCK, CORT, FSTL4, GIP, GPHA2, OXT, and PPY suggesting novel roles for these proteins in early development. Oxytocin was detected by pilot immunoassay in culture media collected from Day 3 embryos. Robust detection of CRHR1 and EPOR suggests the 8-cell embryo may be responsive to maternal CRH and EPO. The over-expression of POMC and GHITM suggests POMP peptide products may have undiscovered roles in early development and GHITM may contribute to mitochondrial remodeling. Under-detected on the 8-cell arrays at least tenfold were two key enzymes in steroid biosynthesis, DHCR24 and FDPS. CONCLUSIONS: The 8-cell human embryo may be secreting oxytocin, which could stimulate its own progress down the fallopian tube as well as play a role in early neural precursor development. The 8-cell embryo does not synthesize reproductive steroid hormones. As previously reported for growth factor families, the early embryo over-expresses more hormones than hormone receptors.

Development of the HIV360 international core set of outcome measures for adults living with HIV: A consensus process.

OBJECTIVES: HIV outcomes centre primarily around clinical markers with limited focus on patient-reported outcomes. With a global trend towards capturing the outcomes that matter most to patients, there is agreement that standardizing the definition of value in HIV care is key to their incorporation. This study aims to address the lack of routine, standardized data in HIV care. METHODS: An international working group (WG) of 37 experts and patients, and a steering group (SG) of 18 experts were convened from 14 countries. The project team (PT) identified outcomes by conducting a literature review, screening 1979 articles and reviewing the full texts of 547 of these articles. Semi-structured interviews and advisory groups were performed with the WG, SG and people living with HIV to add to the list of potentially relevant outcomes. The WG voted via a modified Delphi process - informed by six Zoom calls - to establish a core set of outcomes for use in clinical practice. RESULTS: From 156 identified outcomes, consensus was reached to include three patient-reported outcomes, four clinician-reported measures and one administratively reported outcome; standardized measures were included. The WG also reached agreement to measure 22 risk-adjustment variables. This outcome set can be applied to any person living with HIV aged > 18 years. CONCLUSIONS: Adoption of the HIV360 outcome set will enable healthcare providers to record, compare and integrate standardized metrics across treatment sites to drive quality improvement in HIV care.

Placental pathology in live births conceived with in vitro fertilization after fresh and frozen embryo transfer.

BACKGROUND: The availability and use of frozen embryos after ovarian hyperstimulation for assisted reproduction has increased with improvement in vitrification techniques and the rise of preimplantation genetic testing. However, there are conflicting data regarding whether obstetric outcomes differ between fresh and frozen embryo transfer cycles. OBJECTIVE: To compare placental pathology from live births arising from fresh and frozen embryo transfer cycles. MATERIALS AND METHODS: A cohort of 1140 live births with placental pathology arising from autologous in vitro fertilization cycles with fresh or frozen programmed transfer performed at MGH Fertility Center between 2004 and 2017 was retrospectively reviewed. An experienced placental pathologist categorized the reported placental pathology as anatomic, infectious, inflammatory, or vascular/thrombotic. Our primary outcomes were differences in these placental pathologies between the 2 groups. Patient demographic, cycle, and birth outcomes were compared with the use of χ2 tests, Student t test, or nonparametric tests, as appropriate. Multivariate logistic regression models were used to compare placental pathology between the fresh and frozen transfer groups. RESULTS: Of the 1140 cycles included in our analysis, 929 arose from fresh embryo transfers (81.3%) and 211 arose from programmed frozen embryo transfers (18.5%). For both transfer types, the average age of the women at time of treatment was 35 years; mean body mass indices were within the normal range (23.6 kg/m2 for fresh transfers and 23.2 kg/m2 for frozen transfers, P = .26), and mean day 3 follicle-stimulating hormone values were 7.1 and 7.0 IU/L (P = .44), respectively. Deliveries occurred on average at 37.5 and 38.0 weeks' gestational age (P = .04) in the fresh versus frozen transfer group, with similar rates of obstetric complications. However, frozen transfers were more likely to be associated with marginal cord insertion (adjusted odds ratio, 1.87; confidence interval, 1.21, 2.91; P = .01), accessory lobe formation (adjusted odds ratio, 2.96; confidence interval, 1.12, 7.79; P = 0.03), subchorionic thrombi (adjusted odds ratio, 3.72; confidence interval, 1.80, 7.71; P < .001), and fetal vascular malperfusion characteristics with cord anomalies (adjusted odds ratio, 2.34; confidence interval, 1.22, 4.46; P = .01). These trends persisted when we analyzed day 5 transfers alone, and single frozen embryo transfers remained associated with increased rates of subchorionic thrombi compared to single fresh embryo transfers. CONCLUSION: Pregnancies arising from frozen embryo transfers demonstrated more anatomic and vascular placental pathology than those from fresh transfers in our cohort of patients, despite similar maternal outcomes. More research is needed to explore how these differences in pathology may influence obstetric and perinatal outcomes.

Impact of obesity on male and female reproductive outcomes.

PURPOSE OF REVIEW: The association between obesity and infertility has gained increasing provider and public awareness. The purpose of this review is to outline the recent research into the pathophysiology regarding obesity and its impact of reproductive function in both women and men. RECENT FINDINGS: A BMI more than 25 has a detrimental impact on the hypothalamus-pituitary-gonadal (HPG) axis in both men and women, leading to alterations of HPG hormones, gametogenesis, as well as an increase in inflammation and lipotoxicity from excessive adipose tissue. Additionally, BMI likely impacts assisted reproductive technology (ART) outcomes, with a greater influence on women than men. Studies regarding weight loss interventions are heterogenous in methods and outcomes, and it is difficult to extrapolate from current data if weight loss truly leads to improved outcomes. SUMMARY: Elevated BMI induces changes in the HPG axis, hormone levels, gametogenesis, and adverse ART outcomes. Inconsistencies regarding weight loss interventions make it difficult to assess the impact on outcomes after weight loss interventions.

Nurse-led behavioral management of diabetes and hypertension in community practices: a randomized trial.

BACKGROUND: Several trials have demonstrated the efficacy of nurse telephone case management for diabetes (DM) and hypertension (HTN) in academic or vertically integrated systems. Little is known about the real-world potency of these interventions. OBJECTIVE: To assess the effectiveness of nurse behavioral management of DM and HTN in community practices among patients with both diseases. DESIGN: The study was designed as a patient-level randomized controlled trial. PARTICIPANTS: Participants included adult patients with both type 2 DM and HTN who were receiving care at one of nine community fee-for-service practices. Subjects were required to have inadequately controlled DM (hemoglobin A1c [A1c] ≥ 7.5%) but could have well-controlled HTN. INTERVENTIONS: All patients received a call from a nurse experienced in DM and HTN management once every two months over a period of two years, for a total of 12 calls. Intervention patients received tailored DM- and HTN- focused behavioral content; control patients received non-tailored, non-interactive information regarding health issues unrelated to DM and HTN (e.g., skin cancer prevention). MAIN OUTCOMES AND MEASURES: Systolic blood pressure (SBP) and A1c were co-primary outcomes, measured at 6, 12, and 24 months; 24 months was the primary time point. RESULTS: Three hundred seventy-seven subjects were enrolled; 193 were randomized to intervention, 184 to control. Subjects were 55% female and 50% white; the mean baseline A1c was 9.1% (SD = 1%) and mean SBP was 142 mmHg (SD = 20). Eighty-two percent of scheduled interviews were conducted; 69% of intervention patients and 70% of control patients reached the 24-month time point. Expressing model estimated differences as (intervention--control), at 24 months, intervention patients had similar A1c [diff = 0.1 %, 95 % CI (-0.3, 0.5), p = 0.51] and SBP [diff = -0.9 mmHg, 95% CI (-5.4, 3.5), p = 0.68] values compared to control patients. Likewise, DBP (diff = 0.4 mmHg, p = 0.76), weight (diff = 0.3 kg, p = 0.80), and physical activity levels (diff = 153 MET-min/week, p = 0.41) were similar between control and intervention patients. Results were also similar at the 6- and 12-month time points. CONCLUSIONS: In nine community fee-for-service practices, telephonic nurse case management did not lead to improvement in A1c or SBP. Gains seen in telephonic behavioral self-management interventions in optimal settings may not translate to the wider range of primary care settings.

Heart failure patients' perceptions and use of technology to manage disease symptoms.

BACKGROUND: Technology use for symptom management is beneficial for both patients and physicians. Widespread acceptance of technology use in healthcare fuels continued development of technology with ever-increasing sophistication. Although acceptance of technology use in healthcare by medical professionals is evident, less is known about the perceptions, preferences, and use of technology by heart failure (HF) patients. This study explores patients' perceptions and current use of technology for managing HF symptoms (MHFS). MATERIALS AND METHODS: A qualitative analysis of in-depth individual interviews using a constant comparative approach for emerging themes was conducted. Fifteen participants (mean age, 64.43 years) with HF were recruited from hospitals, cardiology clinics, and community groups. RESULTS: All study participants reported use of a home monitoring device, such as an ambulatory blood pressure device or bathroom scale. The majority of participants reported not accessing online resources for additional MHFS information. However, several participants stated their belief that technology would be useful for MHFS. Participants reported increased access to care, earlier indication of a worsening condition, increased knowledge, and greater convenience as potential benefits of technology use while managing HF symptoms. For most participants financial cost, access issues, satisfaction with current self-care routine, mistrust of technology, and reliance on routine management by their current healthcare provider precluded their use of technology for MHFS. CONCLUSIONS: Knowledge about HF patients' perceptions of technology use for self-care and better understanding of issues associated with technology access can aid in the development of effective health behavior interventions for individuals who are MHFS and may result in increased compliance, better outcomes, and lower healthcare costs.

Growth capacity of a Wharton's Jelly derived mesenchymal stromal cells tissue engineered vascular graft used for main pulmonary artery reconstruction in piglets.

Background: Surgical treatment of congenital heart defects affecting the right ventricular outflow tract (RVOT) often requires complex reconstruction and multiple reoperations due to structural degeneration and lack of growth of currently available materials. Hence, alternative approaches for RVOT reconstruction, which meet the requirements of biocompatibility and long-term durability of an ideal scaffold, are needed. Through this full scale pre-clinical study, we demonstrated the growth capacity of a Wharton's Jelly derived mesenchymal stromal cells (WJ-MSC) tissue engineered vascular graft used in reconstructing the main pulmonary artery in piglets, providing proof of biocompatibility and efficacy. Methods: Sixteen four-week-old Landrace pigs were randomized to undergo supravalvar Main Pulmonary Artery (MPA) replacement with either unseeded or WJ-MSCs-seeded Small Intestinal Submucosa-derived grafts. Animals were followed up for 6 months by clinical examinations and cardiac imaging. At termination, sections of MPAs were assessed by macroscopic inspection, histology and fluorescent immunohistochemistry. Results: Data collected at 6 months follow up showed no sign of graft thrombosis or calcification. The explanted main pulmonary arteries demonstrated a significantly higher degree of cellular organization and elastin content in the WJ-MSCs seeded grafts compared to the acellular counterparts. Transthoracic echocardiography and cardiovascular magnetic resonance confirmed the superior growth and remodelling of the WJ-MSCs seeded conduit compared to the unseeded. Conclusion: Our findings indicate that the addition of WJ-MSCs to the acellular scaffold can upgrade the material, converting it into a biologically active tissue, with the potential to grow, repair and remodel the RVOT.

Protocol to decellularize porcine right ventricular outflow tracts using a 3D printed flow chamber.

Surgical treatment of pediatric congenital heart disease with tissue grafts is a lifesaving intervention. Decellularization to reduce immunogenicity of tissue grafts is an increasingly popular alternative to glutaraldehyde fixation. Here, we present a protocol to decellularize porcine right ventricular outflow tracts using a 3D printed flow chamber. We describe steps for 3D printing the flow rig, preparing porcine tissue, and using the flow rig to utilize shear forces for decellularization. We then detail procedures for characterizing the acellular scaffold. For complete details on the use and execution of this protocol, please refer to Vafaee et al.1.

Graft rejection in paediatric congenital heart disease.

Congenital heart disease (CHD) affects around 1.35 million neonates worldwide per annum, and surgical repair is necessary in approximately 25% of cases. Xenografts, usually of bovine or porcine origin, are often used for the surgical reconstruction. These xenografts elicit an immune response due to significant immunological incompatibilities between host and donor. Current techniques to dampen the initial hyperacute rejection response involve aldehyde fixation to crosslink xenoantigens, such as galactose-α1,3-galactose and N-glycolylneuraminic acid. While this temporarily masks the epitopes, aldehyde fixation is a suboptimal solution, degrading over time, resulting in cytotoxicity and rejection. The immune response to foreign tissue eventually leads to chronic inflammation and subsequent graft failure, necessitating reintervention to replace the defective bioprosthetic. Decellularisation to remove immunoincompatible material has been suggested as an alternative to fixation and may prove a superior solution. However, incomplete decellularisation poses a significant challenge, causing a substantial immune rejection response and subsequent graft rejection. This review discusses commercially available grafts used in surgical paediatric CHD intervention, looking specifically at bovine jugular vein conduits as a substitute to cryopreserved homografts, as well as decellularised alternatives to the aldehyde-fixed graft. Mechanisms of biological prosthesis rejection are explored, including the signalling cascades of the innate and adaptive immune response. Lastly, emerging strategies of intervention are examined, including the use of tissue from genetically modified pigs, enhanced crosslinking and decellularisation techniques, and augmentation of grafts through in vitro recellularisation or functionalisation with human surface proteins.

Biological Scaffolds for Congenital Heart Disease.

Congenital heart disease (CHD) is the most predominant birth defect and can require several invasive surgeries throughout childhood. The absence of materials with growth and remodelling potential is a limitation of currently used prosthetics in cardiovascular surgery, as well as their susceptibility to calcification. The field of tissue engineering has emerged as a regenerative medicine approach aiming to develop durable scaffolds possessing the ability to grow and remodel upon implantation into the defective hearts of babies and children with CHD. Though tissue engineering has produced several synthetic scaffolds, most of them failed to be successfully translated in this life-endangering clinical scenario, and currently, biological scaffolds are the most extensively used. This review aims to thoroughly summarise the existing biological scaffolds for the treatment of paediatric CHD, categorised as homografts and xenografts, and present the preclinical and clinical studies. Fixation as well as techniques of decellularisation will be reported, highlighting the importance of these approaches for the successful implantation of biological scaffolds that avoid prosthetic rejection. Additionally, cardiac scaffolds for paediatric CHD can be implanted as acellular prostheses, or recellularised before implantation, and cellularisation techniques will be extensively discussed.

Feasibility and Acceptability of Using Ecological Momentary Assessment to Evaluate Alcohol Use with American Indian Women.

BACKGROUND: Ecological momentary assessments (EMA) are one way to collect timely and accurate alcohol use data, as they involve signaling participants via cell phones to report on daily behaviors in real-time and in a participant's natural environment. EMA has never been used with American Indian populations to evaluate alcohol consumption. The purpose of this project was to determine the feasibility and acceptability of EMA for American Indian women. METHODS: Eligible participants were American Indian women between the ages of 18 and 44 who were not pregnant and had consumed more than one drink within the past month. All participants received a TracFone and weekly automated messages. Self-reported measures of daily quantity and frequency of alcohol consumption, alcohol type, and context were assessed once per week for four weeks. Baseline measurements also included the Drinking Motives Questionnaire-Revised (DMQ-R) and the Interpersonal Support Evaluation List (ISEL). RESULTS: Fifteen participants were enrolled in the study. All but one participant completed all data collection time points, and drinking patterns were consistent across the study period. A total of 420 records were completed across 86 drinking days and 334 non-drinking days. Participants reported drinking an average of 5.7 days over the 30-day period and typically consumed 3.99 drinks per drinking occasion. Sixty-six percent of participants met gender-specific cut-points for heavy episodic drinking, with an average of 2.46 binge drinking occasions across the four week study period. CONCLUSIONS: This proof-of-concept project showed that EMA was both feasible and acceptable for collecting alcohol data from American Indian women. Additional studies are necessary to fully implement EMA with American Indian women to better understand the drinking motives, contexts, patterns, and risk factors in this population.

Further investigation of the validity and reliability of the photographic figure rating scale for body image assessment.

Previous studies have not fully investigated the psychometric properties of the Photographic Figure Rating Scale (PFRS). In 2 studies, we report on the test-retest reliability and convergent validity of ratings derived from the PFRS. In Study 1, 322 female university students in Britain provided self-ratings on the PFRS and objectively measured body mass index (BMI); a subsample of 132 women also completed the task after 5 weeks. In Study 2, 243 women from the community in Austria completed the PFRS along with a battery of other body image scales. Results of Study 1 showed that ratings on the PFRS had good test-retest reliability (all rs > .87) and good convergent validity in relation to BMI. Results of Study 2 showed that PFRS-derived body dissatisfaction scores were significantly correlated with a range of body image variables. These results provide evidence for the convergent validity and good test-retest reliability of the PFRS.

That Fierce Edge: Sibling Conflict and Politics in Georgian England.

[[siblingsbrotherssistersEnglandbirth ordermarital status ]] Using a combination of brief case studies and statistical analysis of probate disputes in eighteenth-century England, this article argues for an expanded interpretation of Georgian family life­an interpretation that understands the tugs and pulls of siblinghood. In the eighteenth century, emerging ideas about social equality based on idealized siblinghood tangled with engrained family hierarchies to produce messy, constantly shifting, sibling politics. Confronting competing social expectations that classified them as equals yet ranked them hierarchically by gender, birth order, and marital status, Georgian sisters and brothers fiercely wrestled over material and emotional investments from their parents and from one another. Sibling conflict was most common when reality sharply diverged from expectations of equality, such as between older sisters and younger brothers or between men and their brothers' widows.

A Pilot Randomized Control Trial to Assess the Impact of Lavender on Anxiety and Comfort After Cesarean Birth and the Barriers Encountered.

PURPOSE: This study aimed to assess the effect of lavender aromatherapy on anxiety and comfort after cesarean birth. STUDY DESIGN: Randomized control trial. METHODS: Forty-eight patients who had a cesarean birth were asked to complete the six-item State and Trait Anxiety (STAI-6) score to assess their level of anxiety pre- and postapplication of either lavender aromatherapy or placebo during their inpatient postpartum stay. Their comfort and pain levels pre- and postadministration were assessed, and differences between groups were analyzed. Results: There was no difference in postintervention STAI-6 scores between the aromatherapy and placebo groups (p = .56). Women who received the lavender aromatab® had significantly (p = .037) higher self-reported levels of comfort (M 2.6 SD .82) when compared with those who received placebo (M 2.0 SD 1.0). CLINICAL IMPLICATIONS: Many women use aromatherapy at home to promote comfort and relaxation. Women feel lavender aromatherapy improves their comfort in the hospital setting after cesarean birth. Clinicians should consider ways to safely use aromatherapy as one option to promote postoperative cesarean birth care.

Voice Therapy Expectations for Injured Singers.

OBJECTIVES/HYPOTHESIS: Voice therapy is a mainstay treatment modality in the management of phonotrauma in singers. However, the typical duration of therapy an injured singer undergoes is unknown. The primary aims of the study were to determine (1) the number of therapy sessions preceding a decision for surgery and (2) the number of sessions and length of time to achieve improvement in singers who did not undergo surgery. Whether specific singer factors were associated with the length of therapy was also investigated. STUDY DESIGN: Retrospective. METHODS: Records of singers with phonotraumatic vocal fold lesions seen over a 9-year period at a tertiary care voice center were reviewed. RESULTS: Sixty singers who underwent surgery and 183 singers who did not undergo surgery were included in the final analysis. In nearly ¾ of the surgical patients, five or fewer voice therapy sessions were completed prior to the decision for surgery. Singers who did not undergo surgery required on average 3-4 sessions before noting improvement. Over 60% of the non-surgical singers improved within 3 months and 84% were judged to be improved by 6 months. Lesion type, professional/amateur status, formal voice training, and having a current voice teacher/coach were not associated with the length of voice therapy. CONCLUSIONS: The length of voice therapy prior to decision for surgery was limited, and so was the length of therapy leading to initial improvement in singers who did not require surgery. These findings provide a framework for voice therapy expectations and could be reassuring for this unique population.

Adaptations of an RCT during COVID: Case Study in one Rural American Indian Community.

The COVID-19 pandemic is global in nature but especially threatens American Indian and Alaska Native (AI/AN) communities due to pre-existing conditions and social determinants of health. Because of the higher risk to AI/AN communities, many tribal nations have been proactive in their policies to keep the virus at bay, including travel restrictions and lockdowns. This affected tribal programs as well as collaborative research projects. One project impacted is the Native CHOICES project, an ongoing randomized controlled trial with an AI/AN community that is focused on the prevention of alcohol-exposed pregnancies. Originally designed to be conducted via in-person motivational interviewing sessions, COVID-19 restrictions precluded the intervention from being delivered in-person as it was designed. The study team received valuable input from the project's Community Advisory Board (CAB) and community-based staff to establish a feasible and acceptable way of conducting the intervention while respecting tribally-enacted COVID-19 restrictions. The goal of this brief report is to outline not just the process to adapting to COVID-19 but also to provide recommendations for future public health programs, including the ongoing need to consider gaps in access affecting resource-poor settings.

The State of Web Accessibility for People with Cognitive Disabilities: A Rapid Evidence Assessment.

Increased digitisation of day-to-day activities was occurring prior to the COVID-19 pandemic. The pandemic only accelerated the virtual shift, making web accessibility an urgent issue, especially for marginalised populations. Despite decades of work to develop, refine, and implement web accessibility standards, people with cognitive disabilities regularly experience many barriers to web accessibility. To inform ongoing work to improve web accessibility for people with cognitive disabilities, a systematic review was conducted. The main question guiding this review is: what are the state-of-the-art of interventions that support web accessibility for citizens, 9 years of age and up, living with cognitive impairment? A set of 50 search strings were entered into three academic databases: SCOPUS, ProQuest, and Web of Science. Systematic screening procedures narrowed the search returns to a total of 45 included papers. A data analysis revealed themes associated with the lived experiences of people with cognitive disabilities, tools for improving web accessibility, and methodological best practices for involving people with cognitive disabilities in research. These findings have immediate implications for ongoing research and the development of meaningful solutions to the problem of web accessibility for people with cognitive disabilities.

Placental pathology of term singleton live births conceived with fresh embryo transfer compared with those conceived without assisted reproductive technology.

OBJECTIVE: To compare placental pathology from term singleton live births conceived with fresh embryo transfer vs. those conceived without assisted reproductive technology (ART). DESIGN: Retrospective cohort study. SETTING: Academic fertility center. PATIENT(S): Women with a term singleton live birth who conceived after fresh autologous in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles (ART group) and those who conceived without ART. INTERVENTION(S): An experienced placental pathologist categorized placental pathology as anatomic, inflammatory, or vascular. Patient characteristics were compared by chi-squared tests, Student's t-test, or nonparametric tests. Multivariate logistic regression models were used to compare placental pathology between pregnancies conceived with and without ART. MAIN OUTCOME MEASURE(S): Incidence of anatomic, inflammatory, and vascular placental pathology. RESULT(S): There was a higher incidence of placental pathology in the ART group (n = 511) than in the non-ART group (n = 121), specifically anatomic (adjusted odds ratio [aOR] 2.50, 95% confidence interval [CI] 1.42-4.40) and vascular (aOR 2.00, 95% CI 1.13-3.53) pathology. These findings were driven primarily by the significantly higher odds of anatomic (aOR 2.97, 95% CI 1.55-5.66) and vascular (aOR 1.98, 95% CI 1.04-3.75) pathology observed in ICSI pregnancies. Single blastocyst transfers remained associated with increased anatomic pathology (ART: aOR 4.89, 95% CI 2.28-10.49; ICSI: aOR 3.38, 95% CI 1.49-7.71). CONCLUSION(S): Fresh embryo transfer is associated with increased anatomic and vascular placental pathology in term singleton live births compared with conception without ART. This finding should be investigated prospectively in a larger cohort of patients.

West Nile virus in a patient with Good's syndrome.

We describe the association between thymoma and hypogammaglobulinemia (Good's Syndrome) and a fulminant, seronegative West Nile Virus neuroinvasive infection confirmed by nucleic acid amplification. Diagnostic difficulties are emphasized and historical minutiae are highlighted.

Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment.

OBJECTIVE: To evaluate noninferiority of virtual transvaginal ultrasonography compared with in-clinic ultrasonography for ovarian reserve assessment. METHODS: We conducted a single-site, head-to-head crossover trial. Participants performed self-administered virtual transvaginal ultrasonography at home, guided by a remote-certified ultrasound technologist, then underwent transvaginal ultrasonography in-clinic with another ultrasound technologist. Participants were women in the greater Boston area interested in evaluating ovarian reserve and recruited through social media, health care referrals, and professional networks. The uterus and ovaries were captured in sagittal and transverse views. These randomized recordings were reviewed by two or three independent, blinded reproductive endocrinologists. The primary outcome was noninferiority of the rate of clinical quality imaging produced at home compared with in clinic. Sample size was selected for greater than 90% power, given the 18% noninferiority margin. Secondary outcomes included antral follicle count equivalency and net promoter score superiority. RESULTS: Fifty-six women were enrolled from December 2020 to May 2021. Participants varied in age (19-35 years), BMI (19.5-33.9), and occupation. Ninety-six percent of virtual and 98% of in-clinic images met "clinical quality." The difference of -2.4% (97.5% CI lower bound -5.5%) was within the noninferiority margin (18%). Antral follicle counts were equivalent across settings, with a difference in follicles (0.23, 95% CI -0.36 to 0.82) within the equivalence margin (2.65). Virtual examinations had superior net promoter scores (58.1 points, 97.5% CI of difference 37.3-79.0, P<.01), indicating greater satisfaction with the virtual experience. CONCLUSION: Virtual transvaginal ultrasonography remotely guided by an ultrasonography technologist is noninferior to in-clinic transvaginal ultrasonography for producing clinical quality images and is equivalent for estimating antral follicle count. Virtual transvaginal ultrasonography had superior patient satisfaction and has potential to significantly expand patient access to fertility care. FUNDING SOURCE: This study was sponsored by Turtle Health. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04687189.