The SunBEAm birth cohort: Protocol design.

Background: Food allergy (FA) and atopic dermatitis (AD) are common conditions that often present in the first year of life. Identification of underlying mechanisms and environmental determinants of FA and AD is essential to develop and implement effective prevention and treatment strategies. Objectives: We sought to describe the design of the Systems Biology of Early Atopy (SunBEAm) birth cohort. Methods: Funded by the National Institute of Allergy and Infectious Diseases (NIAID) and administered through the Consortium for Food Allergy Research (CoFAR), SunBEAm is a US population-based, multicenter birth cohort that enrolls pregnant mothers, fathers, and their newborns and follows them to 3 years. Questionnaire and biosampling strategies were developed to apply a systems biology approach to identify environmental, immunologic, and multiomic determinants of AD, FA, and other allergic outcomes. Results: Enrollment is currently underway. On the basis of an estimated FA prevalence of 6%, the enrollment goal is 2500 infants. AD is defined on the basis of questionnaire and assessment, and FA is defined by an algorithm combining history and testing. Although any FA will be recorded, we focus on the diagnosis of egg, milk, and peanut at 5 months, adding wheat, soy, cashew, hazelnut, walnut, codfish, shrimp, and sesame starting at 12 months. Sampling includes blood, hair, stool, dust, water, tape strips, skin swabs, nasal secretions, nasal swabs, saliva, urine, functional aspects of the skin, and maternal breast milk and vaginal swabs. Conclusions: The SunBEAm birth cohort will provide a rich repository of data and specimens to interrogate mechanisms and determinants of early allergic outcomes, with an emphasis on FA, AD, and systems biology.

Intra-Amniotic Hemorrhage Imitating Gastroschisis: A Case Report and Review of the Literature.

BACKGROUND A spontaneous intra-amniotic hemorrhage is rarely encountered during pregnancy. The correct diagnosis and management are problematic because of the infrequency of this condition and the high likelihood of a misdiagnosis. CASE REPORT A primigravida with an uncomplicated pregnancy and a normal targeted ultrasound presented late in the second trimester of pregnancy with antepartum bleeding of unknown origin. A repeat ultrasound was suggestive of an abdominal wall defect (gastroschisis). The patient continued to have antepartum bleeding and developed uterine contractions and abdominal pain necessitating frequent visits to labor and delivery. An MRI ruled out gastroschisis and diagnosed intra-amniotic hematoma. The patient presented with acute abdominal pain and was clinically considered to be having an abruption, and was delivered by cesarean. Old blood was noted in the abdominal cavity and within the uterine cavity. At the time of the cesarean, an area of intra-amniotic hematoma was identified, as well as a retroplacental blood clot. CONCLUSIONS An intra-amniotic hematoma is unusual and may be misdiagnosed. MRI may be helpful in determining the correct diagnosis and subsequent management.

A phase I dose-escalation clinical trial of a peptide-based human papillomavirus therapeutic vaccine with Candida skin test reagent as a novel vaccine adjuvant for treating women with biopsy-proven cervical intraepithelial neoplasia 2/3.

PURPOSE: Non-surgical treatments for cervical intraepithelial neoplasia 2/3 (CIN2/3) are needed as surgical treatments have been shown to double preterm delivery rate. The goal of this study was to demonstrate safety of a human papillomavirus (HPV) therapeutic vaccine called PepCan, which consists of four current good-manufacturing production-grade peptides covering the HPV type 16 E6 protein and Candida skin test reagent as a novel adjuvant. PATIENTS AND METHODS: The study was a single-arm, single-institution, dose-escalation phase I clinical trial, and the patients (n = 24) were women with biopsy-proven CIN2/3. Four injections were administered intradermally every 3 weeks in limbs. Loop electrical excision procedure (LEEP) was performed 12 weeks after the last injection for treatment and histological analysis. Six subjects each were enrolled (50, 100, 250, and 500 µg per peptide). RESULTS: The most common adverse events (AEs) were injection site reactions, and none of the patients experienced dose-limiting toxicities. The best histological response was seen at the 50 µg dose level with a regression rate of 83% (n = 6), and the overall rate was 52% (n = 23). Vaccine-induced immune responses to E6 were detected in 65% of recipients (significantly in 43%). Systemic T-helper type 1 (Th1) cells were significantly increased after four vaccinations (P = 0.02). CONCLUSION: This study demonstrated that PepCan is safe. A significantly increased systemic level of Th1 cells suggests that Candida, which induces interleukin-12 (IL-12) in vitro, may have a Th1 promoting effect. A phase II clinical trial to assess the full effect of this vaccine is warranted.

Optimizing appointment template and number of staff of an OB/GYN clinic--micro and macro simulation analyses.

BACKGROUND: The Department of Obstetrics and Gynecology (OB/GYN) at the University of Arkansas for Medical Sciences (UAMS) tested various, new system-restructuring ideas such as varying number of different types of nurses to reduce patient wait times for its outpatient clinic, often with little or no effect on waiting time. Witnessing little progress despite these time-intensive interventions, we sought an alternative way to intervene the clinic without affecting the normal clinic operations. AIM: The aim is to identify the optimal (1) time duration between appointments and (2) number of nurses to reduce wait time of patients in the clinic. METHODS: We developed a discrete-event computer simulation model for the OB/GYN clinic. By using the patient tracker (PT) data, appropriate probability distributions of service times of staff were fitted to model different variability in staff service times. These distributions were used to fine-tune the simulation model. We then validated the model by comparing the simulated wait times with the actual wait times calculated from the PT data. The validated model was then used to carry out "what-if" analyses. RESULTS: The best scenario yielded 16 min between morning appointments, 19 min between afternoon appointments, and addition of one medical assistant. Besides removing all peak wait times and bottlenecks around noon and late in the afternoon, the best scenario yielded 39.84 % (p<.001), 30.31 % (p<.001), and 15.12 % (p<.001) improvement in patients' average wait times for providers in the exam rooms, average total wait time at various locations and average total spent time in the clinic, respectively. This is achieved without any compromise in the utilization of the staff and in serving all patients by 5 pm. CONCLUSIONS: A discrete-event simulation model is developed, validated, and used to carry out "what-if" scenarios to identify the optimal time between appointments and number of nurses. Using the model, we achieved a significant improvement in wait time of patients in the clinic, which the clinic management initially had difficulty achieving through manual interventions. The model provides a tool for the clinic management to test new ideas to improve the performance of other UAMS OB/GYN clinics.