Jacobs Institute of Women's Health
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Bioactive lipid profiles as non-invasive biomarkers of advanced fibrosis in people with HIV/HCV co-infection
No full textNon-invasive assessments for advanced liver fibrosis have limited accuracy in persons with human immunodeficiency virus (HIV) (PWH) who have hepatitis C virus (HCV) co-infection, and new tools are needed. Our aim was to discover oxylipin profiles associated with advanced liver fibrosis in treatment-naïve patients with HIV/HCV co-infection. Serum samples from 40 PWH with HCV were subjected to targeted oxylipin analysis. A model with AST and seven metabolites, including 5(S)-HEPE, 8-HETE, 14,15-DiHETrE, 4-HDoHE, 14- HDoHE, 7-HDoHE, and 9,10-DiHOME yielded an area under the receiver operating characteristic curve of 0.93, with optimal sensitivity and specificity of 86% and 88%, respectively
Directional flow of brain connections and neurodevelopmental outcomes in healthy full-term newborns
No full textOBJECTIVE: We examined whether directional flow among brain hubs in healthy-term infants is associated with neurodevelopmental outcomes at two years of age. METHODS: High-density electroencephalography (EEG) was collected within 72 h after birth. Neurodevelopmental outcomes (cognitive, language, and motor scores) were measured using Bayley Scales of Infant Development-III (BSID-III) at two years. Source signals were extracted from the hubs, and directed information flow from hub was calculated using partial directed coherence method in delta band. The relationship between information flow and BSID-III scores was assessed using stepwise regression. RESULTS: Forty-seven newborns had EEG and BSID-III scores. Efferent flow from the left amygdala (t-statistic = -2.97, p = 0.027), right amygdala (t-statistic = -2.15, p = 0.03), and right caudate nucleus (t-statistic = -2.16, p = 0.036) were negatively associated, while the left pallidum (t-statistic = 2.72, p = 0.02) was positively associated with cognitive scores. The efferent flow from the right amygdala (t-statistic = -2.34, p = 0.03) was negatively associated with language scores, while efferent flow from the brainstem (t-statistic = 2.38, p = 0.03) was positively associated with motor scores. CONCLUSIONS: Efferent output from specific hubs at birth is associated with neurodevelopmental outcomes at two years of age
Reproductive Outcomes Following Open Maternal-Fetal Surgery for Myelomeningocele Closure: Analysis of MOMS Trial Participants
No full textBACKGROUND: In utero closure of myelomeningocele has become an accepted alternative in the management of prenatally diagnosed spina bifida. Maternal reproductive risk has been previously described based on registry data and institutional outcomes. Here we aim to provide maternal reproductive outcomes from participants in the Management of Myelomeningocele Study. OBJECTIVE: Open maternal fetal surgery (OMFS) for in utero closure of myelomeningocele (MMC) is associated with childhood benefit through school age, however obstetric and maternal reproductive risk are also factors to consider. The objective of this analysis was to evaluate reproductive outcomes after OMFS compared to standard postnatal MMC closure. STUDY DESIGN: The Management of Myelomeningocele Study (MOMS) was a randomized trial comparing prenatal versus postnatal closure of MMC. Women in the prenatal closure arm underwent OMFS at 21-26 weeks and were delivered by cesarean at 37 weeks if not delivered prior to that. In the postnatal closure arm, cesarean delivery was performed at 37 weeks and neonates underwent surgical closure soon after birth. Families returned for follow-up at 30 months and again at school age between 6-10 years. Maternal reproductive questionnaires were administered at the time of the follow-up visits to assess menstruation, fertility, gynecologic issues, and subsequent pregnancy outcomes. We compared continuous variables using the Wilcoxon test and categorical variables using the chi-square or Fisher\u27s exact test, as appropriate. RESULTS: 174 randomized women (86 in the prenatal closure group and 88 in the postnatal closure group) completed reproductive questionnaires with 91 women reporting no subsequent pregnancies since MOMS. 36 women in the prenatal closure group reported 60 subsequent, of which 45 (75%) progressed ≥ 20 weeks. 43 women in the postnatal closure group reported 71 pregnancies, of which 50 (70%) progressed ≥ 20 weeks. The prenatal closure group was more likely to deliver \u3c 37 weeks (p \u3c 0.001). One uterine rupture (2.2%) and two uterine dehiscence cases (4.4%) were reported among the prenatal closure group; none in the postnatal closure group (p\u3c0.001). Use of fertility treatments or gynecologic surgeries were not different between the groups. CONCLUSIONS: Preterm delivery was more common in subsequent pregnancies after OMFS. The risk for uterine rupture and dehiscence in the prenatal group was higher than the postnatal group, but lower than what has been previously reported with OMFS. Reproductive outcomes were otherwise similar between women undergoing OMFS for MMC closure compared to the postnatal closure group in the MOMS trial
A Bayesian approach towards the identification of latent subgroups
No full textIn clinical trials, it is often of interest to know whether treatment works differently for some groups than others, known as heterogeneity of treatment effect. Such subgroup analysis is complicated to conduct because trials are typically not powered to find subgroups. Furthermore, it is difficult to identify characteristics of patients pertaining to such subgroups. In this article, we propose a semiparametric mixture model to identify subgroups with time-to-event outcomes. Specifically, we assume a proportional hazards model with subgroup-specific piecewise constant baseline hazards, where the subgroup-specific treatment effect is assumed to be the same within each subgroup. The probability of belonging to a certain subgroup is a function of patient prognostic factors. Adopting a Bayesian approach, classification uncertainty is taken into account. We demonstrate the utility of our approach via simulation and an application to data from a real clinical trial in HIV research
Tracking Engagement with Remote Patient Monitoring in Prenatal Care and Detection of Preeclampsia: A Retrospective Review
No full textMobile technology may enhance traditional prenatal care by supporting screening and patient compliance. Although prior studies report high satisfaction with mobile prenatal technologies, the impact of integrating remote patient monitoring (RPM) into routine workflows on clinical outcomes remains uncertain. This retrospective study assessed whether higher engagement with RPM via the Babyscripts™ digital health platform was associated with increased detection of preeclampsia (PEC). In this university-based obstetric practice, pregnant patients received the Babyscripts™ platform in addition to standard care. The platform enabled tracking of gestational weight gain and blood pressure and delivered scheduled education on symptoms and screening tests. Patients were included if they initiated RPM use before the end of the first trimester; those without available pregnancy outcomes were excluded. Chart reviews were performed using structured data forms by trained abstractors. RPM engagement was defined as the percentage of weeks with at least one remote blood pressure measurement. Outcomes included PEC and a composite of maternal complications. Multivariate logistic regression identified predictors of engagement. A total of 823 patients were included: 28% identified as Black, 32% were Medicaid/Medicare recipients, 43% were over age 35, and 5% had a history of hypertension. Thirty-seven patients developed PEC or pregnancy-induced hypertension. Living in a distressed community and having at least one prior full-term pregnancy were associated with reduced engagement, with decreases of 7.9% (95% confidence interval [CI]: 1.2-14.6%) and 12.2% (95% CI: 5.2-19.1%), respectively. There was a nonsignificant trend toward increased detection of PEC with higher RPM engagement (odds ratio: 1.014, 95% CI: 0.999-1.846). Higher maternal age and first-time pregnancy were associated with increased RPM engagement, while living in a distressed community was linked to lower engagement. There was a nonsignificant positive association between RPM engagement and detection of PEC. Future studies should explore whether engagement with digital health platforms in prenatal care can modify risk factors for pregnancy complications
Oxytocin Receptor Expression and Activation in Parasympathetic Brainstem Cardiac Vagal Neurons
No full textAutonomic imbalance-particularly reduced activity from brainstem parasympathetic cardiac vagal neurons (CVNs)-is a major characteristic of many cardiorespiratory diseases. Therapeutic approaches to selectively enhance CVN activity have been limited by the lack of defined, translationally relevant targets. Previous studies have identified an important excitatory synaptic pathway from oxytocin (OXT) neurons in the paraventricular nucleus of the hypothalamus to brainstem CVNs, suggesting that OXT could provide a key selective excitation of CVNs. In clinical studies, intranasal OXT has been shown to increase parasympathetic cardiac activity, improve autonomic balance, and reduce obstructive event durations and oxygen desaturations in obstructive sleep apnea patients. However, the mechanisms by which activation of hypothalamic OXT neurons, or intranasal OXT, enhance brainstem parasympathetic cardiac activity remain unclear. CVNs are located in two cholinergic brainstem nuclei: nucleus ambiguus (NA) and dorsal motor nucleus of the vagus (DMNX). In this study, we characterize the colocalization of OXT receptors (OXTRs) in both CVNs and non-CVN cholinergic neurons in the male and female mouse NA and DMNX nuclei. We found that OXT receptors are highly expressed in CVNs in the DMNX, but not in the NA. OXT increases the firing of DMNX CVN, with no effect on NA CVNs. Selective chemogenetic excitation of OXTR+ CVNs in the DMNX-achieved by a combination of Cre- and flp-dependent DREADD expression-evoked a rapid and sustained bradycardia. These findings suggest that activation of DMNX CVNs expressing OXTR with oxytocin may represent a novel translational therapeutic target for restoring autonomic balance in cardiorespiratory disorders
Graduate Record Examination Removal From Admissions and Physician Assistant/Associate Student Diversity
No full textINTRODUCTION: This study examined demographic characteristics among physician assistant/associate (PA) program applicants who were offered admission and among matriculants at 5 PA programs that eliminated the Graduate Record Examination (GRE) admissions requirement. METHODS: Collated admissions data for 4 cycles were categorized into 2 periods, one representing 2 cycles before GRE removal (GRE period) and one representing 2 cycles after GRE removal (no-GRE period). Chi-square analyses were used to compare percentages of applicants offered admission and percentages of matriculants who were from backgrounds underrepresented in medicine (URiM), were first-generation college students, and who reported economic disadvantage (ED) across the 2 periods. RESULTS: Individual program outcomes varied. Some experienced statistically significant increases in various measures; others experienced increases or decreases that were insignificant. Collectively, compared with the GRE period, the proportion of applicants offered admission during the no-GRE period who were URiM was 6.2% higher (P = .002, 95% confidence interval [CI] [2.3%, 10.1]); the proportion who were first-generation was 11.2% higher (P \u3c .001, 95% CI [7.3%, 15.0%]); and the proportion with ED was 9.4% higher (P \u3c 0.001, 95% CI [5.8%, 13.0%]). Among matriculants, the proportion who were URiM was 8.7% higher (P = 0.001, 95% CI [3.7%, 13.6%]), the proportion who were first-generation was 8.6% higher (P = 0.001, 95% CI [3.8%, 13.5%]); and the proportion with ED was 8.8% higher (P \u3c 0.001, 95% CI [4.2%, 13.3%]). DISCUSSION: Study results suggest that for some PA programs, eliminating the GRE admissions requirement may positively contribute to various approaches to admitting more students from diverse backgrounds
Early surgical stabilization of multiple rib fractures and flail chest is associated with better outcomes compared with nonoperative management
No full textBACKGROUND: Surgical stabilization of rib fractures (SSRF) is increasingly performed. Nationwide data comparing its outcomes with nonoperative management (NOM) and defining the best timing for SSRF are scarce. METHODS: We analyzed data from the American College of Surgeons Trauma Quality Improvement Program, 2017-2021. Adults with three or more blunt rib fractures and no major extrathoracic injury were included. Surgical fixation was compared with risk-weighted NOM using inverse probability of treatment weighting. Primary outcome was in-hospital mortality. Secondary outcomes were hospital and intensive care length of stay, ventilator duration, ventilator-free days, acute respiratory distress syndrome, and ventilator-associated pneumonia. Subgroup analyses examined flail chest and the impact of timing of fixation, which was modeled as a continuous exposure with a generalized additive spline; its discriminatory performance was evaluated with receiver-operating-characteristic curve analysis to calculate the Youden\u27s index. RESULTS: A total of 3,806 patients underwent SSRF, and 3,753 weighted controls received NOM. After weighting, an association of SSRF with lower mortality (1.5% vs. 2.7%, p \u3c 0.001) but longer hospital (median, 10 vs. 5 days) and intensive care stays (5 vs. 3 days, both p \u3c 0.001) were observed. In the flail chest subgroup, SSRF was associated with a mortality of 4.2% compared with 10.1% with NOM (p = 0.002). In the nonflail group, mortality was 1.3% after SSRF versus 2.0% in NOM (p = 0.003). Early SSRF within 82 hours had similar mortality to delayed fixation (1.6% vs. 1.4%, p = 0.647). However, early SSRF was associated with lower rates of acute respiratory distress syndrome (0.5% vs. 1.5%), ventilator-associated pneumonia (0.9% vs. 2.3%), and shorter hospital stays compared with delayed SSRF. CONCLUSION: Nationwide data demonstrated that SSRF is associated with higher survival, particularly in patients with flail chest, at the cost of increased resource utilization. Surgical stabilization of rib fractures performed within 82 hours is associated with higher survival, lower pulmonary morbidity, and additional resource utilization. LEVEL OF EVIDENCE: Therapeutic/Care Management; Level III
Free vs. Local Tissue Transfer and Reconstruction in Pediatric Head and Neck Cancer Patients: A Comparable Complication Outcome Review
No full textBackground and Objectives: Reconstructive outcomes following head and neck (H&N) cancer resection in pediatric patients remain understudied, particularly regarding the comparative efficacy of free versus local tissue transfer. Materials and Methods: A retrospective review was conducted on pediatric patients undergoing malignant H&N tumor resection at a tertiary center from 2007 to 2024. Patients were stratified by reconstruction type (free vs. local flap), and outcomes assessed included flap failure, wound complications, revision rates, operative time, hospital stay, and 30-day readmission. Results: A total of 41 patients (mean age: 10.6 years) met inclusion criteria; 18 underwent free flaps and 23 received local flaps. Common diagnoses included osteosarcoma (21.9%) and rhabdomyosarcoma (12.2%). Anterolateral thigh (44.4%) and fibula (33.3%) were the most common free flaps; temporalis (21.7%) and pectoralis (13.0%) were common local flaps. Flap survival was high in both groups (94.4% vs. 100%). However, local flaps had significantly higher rates of hardware exposure (34.7% vs. 5.5%, p = 0.025) and wound dehiscence (39.1% vs. 5.5%, p = 0.045). Free flaps were associated with longer operative times (10.3 vs. 6.5 h, p = 0.011) and hospital stays (29.1 vs. 13.9 days, p = 0.036). Conclusions: While both approaches achieved high flap survival, free flaps may offer more durable reconstruction and reduce wound-related complications in complex pediatric H&N oncologic cases
Using the ATra Black Box to Improve Public Health Data Linkages and Analytics in the DC Cohort Longitudinal HIV Study: Viewpoint on the Process and Findings
No full textThe DC Cohort is a longitudinal HIV cohort study of people with HIV receiving care at 14 clinical sites in Washington, DC, led by George Washington University. Data are routinely linked to the DC Department of Health (DC Health) HIV surveillance databases to increase data completeness and accuracy and to help identify people with HIV enrolled at multiple sites. The ATra Black Box (Black Box henceforth) is a novel privacy technology developed by Georgetown University, which is currently deployed in 40 public health jurisdictions. The Black Box provides a secure mechanism to link private health information across data systems. The Black Box was modified for the purposes of linking data from the DC Cohort to DC Health surveillance data and increasing the ease, feasibility, accuracy, and timeliness of future linkages. These modifications included providing deidentified data to George Washington University and developing analytic code to compare data between the DC Cohort and DC Health to report on data discrepancies. This paper reports on the results of the initial linkage using the Black Box. DC Cohort data on all consented participants from January 2011 through September 2022 were submitted to the Black Box. Simultaneously, all DC Health HIV surveillance data were also submitted to the Black Box. The data were matched using a predetermined algorithm, match-level scores were assigned, and matches were manually verified. The new Black Box graphical user interface allows users to check files for errors and easily track the Black Box processes and provides analytic plugins for running SAS code. A total of 9744 records of DC Cohort participants were submitted for matching to DC Health. Of these, 9060 participants (93.0%) matched to surveillance data and were validated through manual review. Match-level scores ranged from 20 to 100, and the validation found that scores of 61 and above were true matches. The SAS output files provided information on missing or conflicting data, including lab records, date of HIV diagnosis, and other key demographics. The linkage resulted in the addition of 48,970 CD4 T-lymphocyte counts, 33,413 viral load lab records, and 767 previously unrecognized deaths. Among the DC Cohort participants, 470 were enrolled at more than one site and 17 at more than two sites. The implementation of the Black Box for sharing DC Cohort and DC Health data resulted in better capture of HIV lab records, improved vital status information, and enhanced characterization of care patterns for people with HIV enrolled in the DC Cohort. Future linkages will include DC Health data on diagnoses of sexually transmitted infections, hepatitis, and tuberculosis