Prenatal Vaccination Patterns among Birthing Individuals with History of Preterm Birth in the Pre- and Post-COVID Era.

OBJECTIVE: This study aims to explore vaccination acceptance among individuals with a history of preterm birth between March and June during the pre-COVID (2019), early-COVID (2020), and late-COVID (2021) periods. STUDY DESIGN: This is a cross-sectional, retrospective cohort study of pregnant individuals with a history of preterm birth (<37 weeks' gestation) who initiated care of a subsequent pregnancy during pre-COVID (March-June 2019), early-COVID (March-June 2020), or late-COVID (March-June 2021). The primary outcome of interest was vaccination status for influenza, Tdap, and COVID-19 vaccines. Fisher's exact and chi-square tests were used to investigate association between vaccination status and time periods, race/ethnicity, and insurance. RESULTS: Among 293 pregnancies, influenza vaccination rate was highest in early-COVID (p < 0.05). There was no statistically significant difference in Tdap or COVID-19 vaccination between time periods. COVID-19 vaccination was highest in individuals with private insurance (p < 0.05). There was no statistically significant difference in vaccination status by race/ethnicity. CONCLUSION: In this study on high-risk pregnant individuals, the majority of our cohort remained unvaccinated against COVID-19 into the late-COVID period. Additionally, their influenza vaccination rates were greater than the national average in early-COVID and substantially lower than the national average in late-COVID. This shift in influenza vaccination acceptance may have been sparked by COVID-19 vaccine distribution beginning in January 2021 leading to overall vaccination hesitancy. Standardized guidelines and counseling concerning prenatal safety in recommended immunizations may serve as important tools of reassurance and health promotion. KEY POINTS: · Maternal infections during pregnancy are a risk factor for preterm birth.. · High-risk cohort had low influenza vaccination post-COVID possibly due to COVID-19 vaccine hesitancy.. · Vaccination education may be a uniquely important tool among high-risk pregnant patients..

Timing and Magnitude of Peak Body Mass Index and Peak Weight Velocity in Infancy Predict Body Mass Index at 2 Years in a Retrospective Cohort of Electronic Health Record Data.

OBJECTIVES: To use growth data from electronic health records to describe and model infant growth (weight velocity and peak body mass index [pBMI]) characteristics. STUDY DESIGN: We extracted data from all children born at ≥34 weeks of gestation within one health system between 2014 and 2017. After excluding implausible growth data with an algorithm created for childhood growth, we estimated pBMI, peak weight and length velocities, and the odds of obesity at 2 years, adjusted for race, sex, ethnicity, and birth weight, by the magnitude of peak weight velocity, peak length velocity, and pBMI. RESULTS: Among 6425 children (41% White, 28% Black, 26% other race; 16% Hispanic ethnicity), mean pBMI was 17.9 kg/m2 (SD 1.5) and mean age at pBMI was 9.6 months (SD 2.7). Mean peak weight velocity was 949 g (SD 165) per 2 weeks, and the mean peak length velocity was 3.4 cm (SD 0.3) per 2 weeks. Children with obesity at 2 years (n = 931, 14.5%) were more likely to be Hispanic, had greater peak weight and peak length velocities, and had 2 kg/m2 greater magnitude of pBMI than children without obesity. For each unit increase in pBMI, children had more than 4 times greater odds of obesity at age 2 years. CONCLUSIONS: In a large sample of infants with clinical growth data tracked via electronic health records, we found associations between the magnitude and timing of peak infant BMI and obesity at 2 years of age.

Implementing guidelines for risk-stratified thromboprophylaxis among gynecologic oncology patients: A quality improvement initiative.

OBJECTIVE(S): Risk-stratified thromboprophylaxis is recommended for oncology patients with a Khorana risk score (KS) ≥ 2 receiving cancer-directed therapy. We describe a quality improvement (QI) initiative designed to increase adherence to thromboprophylaxis guidelines for patients with gynecologic malignancies initiating outpatient treatment. METHODS: Provider awareness and documentation of venous thromboembolism (VTE) risk assessment and thromboprophylaxis eligibility were identified as key QI drivers. Starting May 2021, a KS calculator and thromboprophylaxis algorithm were incorporated into outpatient documentation templates. Patients with gynecologic malignancies initiating outpatient therapy from January - December 2021 were eligible. The primary process measure was the percentage of patients with KS eligibility documented each month during the baseline (Jan - Apr) versus implementation (May - Dec) periods. Rate of appropriate thromboprophylaxis initiation and incidence of VTE served as outcome measures. Incidence of adverse bleeding events served as the balancing measure. RESULTS: 337 patients accounted for the initiation of 383 treatment regimens, including 128 in the baseline period and 255 in the implementation period. KS documentation increased significantly between the baseline and implementation periods (7% vs 62.4%, p < 0.001). 73 of the 177 eligible patients (46.2%; 166 unique patients) had appropriate documentation; of these, 57 initiated thromboprophylaxis. There was no difference in VTE rates or adverse bleeding events between eligible patients who initiated thromboprophylaxis compared with those who did not (12.3% vs 15.6%; p = 0.65 and 7.0% vs 8.2%; p = 1.0, respectively). CONCLUSION(S): This QI initiative resulted in greater adherence to risk-stratified thromboprophylaxis guidelines. No bleeding signals were identified. Studies addressing cost, medication adherence, and long-term outcomes are necessary.

Factors Associated With Triage Decisions in Older Adult Trauma Patients: Impact on Mortality and Morbidity.

INTRODUCTION: As medical advances have significantly increased the life expectancy among older adults, the number of older patients requiring trauma care has risen proportionately. Nevertheless, it is unclear among this growing population which sociodemographic and economic factors are associated with decisions to triage and transfer to level I/II centers. This study aims to assess for any association between patient sociodemographic characteristics, triage decisions, and outcomes during acute trauma care presentations. METHODS: The National Trauma Data Bank was queried for patients aged 65 and older with an injury severity score > 15 between the years 2007 to 2017. Factors associated with subsequent levels of triage on presentation were assessed using multivariate logistic regression, and associations of levels of triage with outcomes of mortality, morbidity, and hospital length of stay are examined using logistic and linear regression models. RESULTS: Triage of 210,310 older adult trauma patients showed significant findings. American Indian patients had higher odds of being transferred to level I/II centers, while Asian, Black, and Native Hawaiian patients had lower odds of being transferred to level I/II centers when compared to Caucasian patients (P < 0.001). Regarding insurance, self-pay (uninsured) patients were less likely to be transferred to a higher level of care; however, this was also demonstrated in private insurance holders (P < 0.001). Caucasian patients had significantly higher odds of mortality, with Black patients (odds ratio [OR] 0.80 [0.75, 0.85]) and American Indian patients (OR 0.87 [0.72, 1.04]) having significantly lower odds (P < 0.001). Compared to government insurance, private insurance holders (OR 0.82 [0.80, 0.85]) also had significantly lower odds of mortality, while higher odds among self-pay were observed (OR 1.75 [1.62, 1.90]), (P < 0.001). CONCLUSIONS: Access to insurance is associated with triage decisions involving older adults sustaining trauma, with lower access increasing mortality risk. Factors such as race and gender were less likely to be associated with triage decisions. However, due to this study's retrospective design, further prospective analysis is necessary to fully assess the decisions that influence trauma triage decisions in this patient population.

Prospective Observational Study of N-terminal Pro-Brain Natriuretic Peptide Levels in Obese and Nonobese Women during Pregnancy.

OBJECTIVE: N-terminal pro-brain natriuretic peptide (NT-proBNP), a marker of ventricular dysfunction, varies by body mass index (BMI) outside of pregnancy. This study aimed to determine whether obesity affects NT-proBNP levels in pregnancy. STUDY DESIGN: This was a prospective observational study of healthy pregnant people in the third trimester (3TM) and postpartum (PP). Patients were excluded if they had significant medical comorbidities or if their fetuses had anomalies, growth restriction or aneuploidy. NT-proBNP was measured at 28 weeks (3TM), predelivery (PD), 1 to 2 days PP (immediate postpartum [IPP]), and 4 to 6 weeks PP (delayed postpartum [DPP]). LogNT-proBNP levels were analyzed using linear mixed effects models, including BMI < or ≥30, time, and time-by-BMI interactions. RESULTS: Fifty-five people (28 [51%] with BMI ≥ 30 and 27 [49%] with BMI < 30) were enrolled. A greater proportion of obese than nonobese subjects developed hypertensive disorders of pregnancy (50 vs. 15%, p = 0.010) and obese patients had higher systolic blood pressures at all time points (p < 0.05). NT-proBNP levels (median [interquartile range] in pg/mL) were 18 (6-28) versus 26 (17-48) at 3TM, 16 (3-38) versus 43 (21-60) at PD, 58 (20-102) versus 63 (38-155) at IPP, and 33 (27-56) versus 23 (8-42) at DPP for obese compared with nonobese patients. In linear mixed effects models, logNT-proBNP was lower in obese patients at 3TM (ß = -0.89 [95% confidence interval, CI: -1.51, -0.26]) and PD (ß = -1.05 [95% CI: -1.72, -0.38]). The logNT-proBNP trends over time differed by BMI category, with higher values in obese patients at both PP time points compared with the 3TM (IPP ß = 1.24 [95% CI: 0.75, 1.73]; DPP ß = 1.08 [95% CI: 0.52, 1.63]), but only IPP for nonobese patients (ß = 0.87 [95% CI: 0.36, 1.38]). CONCLUSION: Obese patients had lower NT-proBNP levels than nonobese patients during pregnancy but not PP. The prolonged PP elevation in NT-proBNP in obese patients suggests that their PP cardiac recovery may be more prolonged. KEY POINTS: · NT-proBNP levels are lower in obese than nonobese patients during pregnancy.. · Levels remain elevated in obese, but not nonobese, patients up to 4 to 6 weeks' postpartum.. · A lower threshold for concern regarding NT-proBNP levels may be needed in obese pregnant people..

Factors Associated with Guideline Concordant Clinician Counseling about Low-Dose Aspirin to Prevent Preeclampsia in Nulliparous Patients.

OBJECTIVE: The primary aim of this study was to examine the United States Preventative Services Task Force (USPSTF) guidelines concordant low-dose aspirin (LDA) counseling and factors associated with counseling in nulliparous birthing individuals. STUDY DESIGN: We conducted a retrospective cohort study of nulliparous birthing individuals who delivered between January 1, 2019 and June 30, 2020 and received prenatal care at the Duke High Risk Obstetrical Clinics (HROB). All nulliparous patients over 18 years old who established or transferred care to HROB by 16 weeks, 6 days were included in the analysis. We excluded patients with more than two previous first-trimester pregnancy losses, multiple gestation, a known contraindication to LDA, initiation of LDA prior to their prenatal care, or documented medical history of coagulation disorder. Bivariate associations between demographic/medical characteristics and our primary outcome, receipt of counseling (yes/no), were assessed using two-sample t-tests for continuous variables and chi-square or Fisher's exact test for categorical variables. Factors significantly associated with the primary outcome (p < 0.05) were entered into the multivariable logistic regression model. RESULTS: Among 391 birthing individuals included in the final analysis cohort, 51.7% of eligible patients received guideline consistent LDA counseling. Factors associated with increased odds of LDA counseling were advanced maternal age (adjusted odds ratio [aOR]: 1.05, 95% confidence interval [CI]: 1.01-1.09), Black race compared with White race (aOR:1.75, 95% CI: 1.03-2.98), chronic hypertension (aOR: 4.17, 95% CI: 1.82-9.55), and obesity (aOR: 5.02, 95% CI: 3.12-8.08). CONCLUSION: Approximately half of all nulliparous birthing individuals had appropriately documented LDA counseling. The USPSTF guidelines on LDA for preeclampsia risk reduction are complex, which may lead to ineffective provider adherence. Efforts to simplify guidelines and improve LDA counseling are vital to ensuring this low-cost, evidence-based preeclampsia prevention is used in a consistent and equitable manner. KEY POINTS: · A total of 51.7% of eligible patients received guideline consistent LDA counseling.. · Advanced maternal age , body mass index > 30, Black race, and chronic hypertension associated with increased odds of counseling.. · Among patients most likely to be counseled, high numbers did not receive LDA counseling..

Malnutrition as a risk factor for post-operative morbidity in gynecologic cancer: Analysis using a national surgical outcomes database.

OBJECTIVE: To assess, using a national surgical outcomes database, the association of various malnutrition definitions with post-operative morbidity in three gynecologic malignancies. METHODS: Patients undergoing resection of ovarian, uterine, or cervical cancer between 2005 and 2019 were identified using the National Surgical Quality Improvement Program (NSQIP) database. Patients were classified based on specific, pre-defined malnutrition criteria: severe malnutrition (Body Mass Index (BMI) <18.5 + 10% weight loss), European Society for Clinical Nutrition and Metabolism ((ESPEN1); BMI 18.5-22 + 10% weight loss), ESPEN2 (BMI < 18.5), American Cancer Society ((ACS); normal/overweight BMI + 10% weight loss), mild malnutrition (BMI 18.5-22), or albumin (<3.5 g/dL). Outcomes included 30-day major complications, readmission, reoperation. Modified Poisson regression estimated associations between definitions and outcomes. RESULTS: Of 76,290 total patients undergoing surgery, those meeting malnutrition definitions were: severe-98 (0.1%), ESPEN1-148 (0.2%), ESPEN2-877 (1.1%), ACS-1028 (1.3%), mild-2853 (3.7%), and albumin (11.1%). Complication rates were: unplanned readmission-5.5%, reoperation-1.7%, major complications-13.5%. For ovarian cancer, ESPEN2 malnutrition was associated with higher readmissions (risk ratio 1.69; 95% confidence interval 1.29-2.20), reoperations (2.53; 1.70-3.77), and complications (1.36; 1.20-1.54). For uterine cancer, ACS malnutrition was associated with readmissions (2.74; 2.09-3.59), reoperations (3.61; 2.29-5.71) and complications (3.92; 3.40-4.53). For cervical cancer, albumin<3.5 g/dL was associated with readmissions (1.48; 1.01-2.19), reoperations (2.25; 1.17-4.34), and complications (2.59; 2.11-3.17). Albumin<3.5 was associated with adverse outcomes in ovarian and uterine cancer. CONCLUSIONS: Preoperative risk assessments might be tailored using cancer-specific malnutrition criteria. Major complications, readmissions, and reoperations are all associated with the ESPEN2 definition for ovarian cancer, the ACS definition for uterine cancer, and with albumin<3.5 for all cancers.

Promoting timely goals of care conversations between gynecologic cancer patients at high-risk of death and their providers.

OBJECTIVE: We designed a multi-faceted intervention to increase the rate of outpatient goals of care (GOC) conversations in women with gynecologic cancers who are at high-risk of death. METHODS AND MATERIALS: A multidisciplinary team developed an educational program around GOC conversations at end-of-life and chose criteria to prospectively identify patients at high-risk of death who might benefit from timely GOC conversations: recurrent or metastatic endometrial, cervical or vulvar cancer or platinum-resistant ovarian cancer. Gynecologic oncology provider consensus was built regarding the need to improve the quality and timing of GOC conversations. Eligible outpatients were prospectively identified and providers alerted pre-encounter; timely GOC documentation within 3 visits of high-risk identification was tracked. Our institution concurrently and subsequently tracked GOC documentation during the last 6 months of life among all established oncology patients. RESULTS: Of 220 pilot period high-risk patients (96 pre- and 124 during pilot period 2017-2018), timely GOC discussion documentation increased from 30.2% to 88.7% (p < 0.001) and this increase was sustained over time. In the post-pilot period (2019-2020), among patients seen by oncologists during last 6 months of life, compared to other cancer types, gynecologic cancer patients had a higher rate of GOC documentation (81% versus 9%; p < 0.001), a lower rate of receiving chemotherapy during the last 14 days of life (2% vs 5%; p = 0.051), and no difference in end-of-life admissions (29% vs 31%; p = NS). CONCLUSIONS: Implementation of systematic outpatient identification of high-risk gynecologic oncology patients is feasible, sustainable, and increases the timely conduct of GOC conversations.

Racial and ethnic representation in 17-hydroxyprogesterone caproate preterm birth prevention studies: a systematic review.

OBJECTIVES: The US preterm birth rate varies dramatically by race and ethnicity yet the racial and ethnic representation within studies evaluating 17-hydroxprogesterone caproate (17-P) for preterm birth prevention is unknown. The objectives of our study were to 1) examine the racial and ethnic representation of participants in 17-P preterm birth prevention studies, 2) evaluate adherence to the NIH race and ethnicity reporting guidelines and 3) compare racial and ethnic representation in research studies to national preterm birth incidence. METHODS: We systematically reviewed US studies published between January 2000 and December 2019. Study participant's race and ethnicity were reported using descriptive statistics then compared to US 2017//2018 preterm birth data using Pearson's chi-square. RESULTS: Eighteen studies met the inclusion criteria, 17 studies reported race, 11 studies reported ethnicity, and yet none of the studies followed the NIH criteria. Compared to 2017/2018 US preterm births, the proportion of black/African American study participants was significantly higher whereas the proportions of all other race categories were lower. CONCLUSIONS: More detailed reporting of race and ethnicity is needed in 17-P literature. Black women appear to be well represented while other racial and ethnic groups may be understudied.

Fertility awareness and attitudes among resident physicians across different specialties.

PURPOSE: To evaluate knowledge of age-related fertility decline and oocyte cryopreservation among resident physicians in obstetrics and gynecology (ob-gyn) compared to residents in other specialties. METHODS: An online survey was sent to the US residency program directors for ob-gyn, internal medicine, emergency medicine, family medicine, general surgery, pediatrics, and psychiatry. They were asked to forward the survey to their respective residents. The survey consisted of three sections: fertility knowledge, oocyte cryopreservation knowledge, and attitudes toward family building and fertility preservation. Multivariable logistic regression models were used to compare outcomes between ob-gyn and non-ob-gyn residents. RESULTS: Of the 2,828 completed surveys, 450 (15.9%) were by ob-gyn residents and 2,378 (84.1%) were by residents in other specialties. 66.3% of respondents were female. The median number of correct answers was 2 out of 5 on the fertility knowledge section and 1 out of 3 on the oocyte cryopreservation knowledge section among both ob-gyn and non-ob-gyn residents. After adjusting for covariates, residents in ob-gyn were no more likely to answer these questions correctly than residents in other specialties (fertility knowledge, adjusted OR .97, 95% CI .88-1.08; oocyte cryopreservation knowledge, adjusted OR 1.05, 95% CI .92-1.19). Ob-gyn residents were significantly more likely than non-ob-gyn residents to feel "somewhat supported" or "very supported" by their program to pursue family building goals (83.5% vs. 75.8%, OR 1.62, 95% CI 1.23-2.14). CONCLUSIONS: Resident physicians, regardless of specialty, have limited knowledge of natural fertility decline and the opportunity to cryopreserve oocytes. These data suggest need for improved fertility education.

Early Identification of Patients at Risk for Incident Heart Failure With Preserved Ejection Fraction: Novel Approach to Echocardiographic Trends.

BACKGROUND: Heart failure with preserved ejection fraction (HFpEF) continues to increase in prevalence with a 50% mortality rate within 3 years of diagnosis, but lacking effective evidence-based therapies. Specific echocardiographic markers are not typically used to trigger alarm before acute HFpEF decompensation. The goal of this study was to retrospectively track changes in echocardiographic markers leading to the time of incident HFpEF hospitalization. METHODS AND RESULTS: In a single-center, retrospective analysis, patients with HFpEF admitted between 2007 and 2014 were identified using the International Classification of Diseases, 9th Revision with search refined using the European Society of Cardiology HFpEF guidelines. Using linear mixed effects models, changes in echocardiographic markers preceding acute HF decompensation owing to incident HFpEF were analyzed. We report on an incident HFpEF cohort of 242 patients, extending 18 years retrospectively, and including 675 echocardiograms analyzed from the overall sample at 14 distinct time intervals before acute decompensation. The regression models demonstrated 3 echocardiographic markers with statistically significant increases across multiple time intervals including, arterial elastance (P = .006), right atrial pressure estimate (P < .001), and right ventricular systolic pressure (P = .006). Other echocardiographic markers had individual time intervals with significant increases before acute decompensation, including (a) left atrial diameter, 8 to 10 years before HFpEF diagnosis, (b) left ventricular filling pressure 2 to 6 years before HFpEF diagnosis, (c) ventricular elastance 3 to 6 months before HFpEF diagnosis, and (d) ventricular elastance/arterial elastance as early as 10 to 20 years and as late as 3 to 6 months before HFpEF diagnosis. Furthermore, African Americans presented with incident HFpEF at an average younger age than White patients (65.6 ± 15.2 years vs. 76.7 years ± 11.7, P < .001). CONCLUSIONS: Noninvasive echocardiographic markers associated with incident HFpEF diagnosis showed long, mid, and acute range, significant changes as far back as 10 to 20 years and as close as 3 to 6 months before acute HFpEF decompensation. Including a diverse study cohort is critical to understanding the phenotypic differences of HFpEF. This hypothesis-generating study identified a novel approach to identifying trends in echocardiographic markers that may be used as a signal of impending incident HFpEF.

Chemotherapy discontinuation processes in a gynecologic oncology population.

OBJECTIVE: We sought to categorize the processes by which gynecologic oncology patients stop chemotherapy and to evaluate associations between these processes and end-of-life outcome metrics. METHODS: A cohort of patients with metastatic or recurrent gynecologic cancer in an outpatient setting from January 2016 to May 2018 was identified. All deceased patients in this cohort were included for analysis. Processes of discontinuing chemotherapy were categorized as: 1) definitive decision inpatient; 2) definitive decision outpatient; 3) delayed decision (eg: treatment break and never resumed chemotherapy); 4) no decision. Associations between patient characteristics and clinical outcomes of those who made a definitive outpatient decision versus those who made any other type of decision were assessed. RESULTS: 220 patients were identified; 205 patients were deceased at time of analysis. Of these, 36.6% made a definitive decision to stop chemotherapy as an outpatient, while 41.5% never made a decision to discontinue chemotherapy. Making a definitive decision as an outpatient, when compared to all other decision types, was associated with significantly lower incidence of death in the hospital (5.6% vs 21.1%, p < 0.004) and hospitalization within 30 days of death (20.8% vs 56.6%, p < 0.001), and significantly increased median time from last chemotherapy to death (135.5 vs 62 days, p < 0.001). CONCLUSION: Only one in three women in this cohort of patients deceased from gynecologic cancer made a definitive decision to discontinue chemotherapy in an outpatient setting, and this process was associated with improved end-of-life outcomes. Future efforts should examine the impact of interventions designed to increase the proportion of patients who transition away from chemotherapy via shared decision making in the outpatient setting.

Exploring Factors Associated With Morbidity and Mortality in Patients With Do-Not-Resuscitate Orders: A National Surgical Quality Improvement Program Database Analysis Within Surgical Groups.

BACKGROUND: Anesthesiologists caring for patients with do-not-resuscitate (DNR) orders may have ethical concerns because of their resuscitative wishes and may have clinical concerns because of their known increased risk of morbidity/mortality. Patient heterogeneity and/or emphasis on mortality outcomes make previous studies among patients with DNR orders difficult to interpret. We sought to explore factors associated with morbidity and mortality among patients with DNR orders, which were stratified by surgical subgroups. METHODS: Exploratory retrospective cohort study in adult patients undergoing prespecified colorectal, vascular, and orthopedic surgeries was performed using the American College of Surgeons National Surgical Quality Improvement Program Participant Use File data from 2010 to 2013. Among patients with preoperative DNR orders (ie, active DNR order written in the patient's chart before surgery), factors associated with 30-day mortality, increased length of stay, and inpatient death were determined via penalized regression. Unadjusted and adjusted estimates for selected variables are presented. RESULTS: After selection as above, 211,420 patients underwent prespecified procedures, and of those, 2755 (1.3%) had pre-existing DNR orders and met above selection to address morbidity/mortality aims. By specialty, of these patients with a preoperative DNR, 1149 underwent colorectal, 870 vascular, and 736 orthopedic surgery. Across groups, 36.2% were male and had a mean age 79.9 years (range 21-90). The 30-day mortality was 15.4%-27.2% and median length of stay was 6-12 days. Death at discharge was 7.0%, 13.1%, and 23.0% in orthopedics, vascular, and colorectal patients with a DNR, respectively. The strongest factors associated with increased odds of 30-day mortality were preoperative septic shock in colorectal patients, preoperative ascites in vascular patients, and any requirement of mechanical ventilation at admission in orthopedic patients. CONCLUSIONS: In patients with DNR orders undergoing common surgical procedures, the association of characteristics with morbidity and mortality varies in both direction and magnitude. The DNR order itself should not be the defining measure of risk.

Assessing patient perceptions of cytomegalovirus infection in pregnancy.

Pregnant women impacted by cytomegalovirus (CMV) make clinical decisions despite uncertain outcomes. Intolerance of uncertainty score (IUS) is a validated measure of tendency for individuals to find unacceptable that a negative event might occur. We investigated patient perceptions of CMV infection during pregnancy and correlated IUS and knowledge with decision-making. Electronic questionnaire was sent to women from July to August 2017. The questionnaire evaluated knowledge of CMV, IUS, and responses regarding management to three clinical scenarios with escalating risk of CMV including choices for no further testing, ultrasound, amniocentesis, or abortion. For each scenario, logistic regression was used to model IUS on responses. A total of 815 women were included. The majority of participants was white (63.1%) and 42% had a postgraduate degree. Over 70% reported that they had not previously heard of CMV. In the scenario with only CMV exposure, participants with increasing IUS were more likely to choose abortion (odds ratio [OR] = 1.04; 95% confidence interval [CI]: 1.01, 1.06) and no further testing (OR = 0.97; 95% CI: 0.95, 0.99). In the scenario with mild ultrasound findings in setting of CMV exposure, increasing IUS was associated with higher odds of choosing no further testing (OR = 0.97; 95% CI, 0.94, 0.99). No significant association was observed between IUS and responses in the scenario with severe ultrasound abnormalities in setting of CMV exposure. The majority of patients had no knowledge of CMV. Higher IUS was associated more intervention in low severity scenarios, but in severe scenarios, IUS was not associated with participants' choices.

Birth outcomes are superior after transfer of fresh versus frozen embryos for donor oocyte recipients.

STUDY QUESTION: For donor oocyte recipients, are birth outcomes superior for fresh versus frozen embryos? SUMMARY ANSWER: Among fresh donor oocyte recipients, fresh embryos are associated with better birth outcomes when compared with frozen embryos. WHAT IS KNOWN ALREADY: Frozen embryo transfer (ET) with vitrification has been associated with improved pregnancy rates, but also increased rates of large for gestational age infants. Donor oocyte recipients represent an attractive biological model to attempt to isolate the impact of embryo cryopreservation on IVF outcomes, yet there is a paucity of studies in this population. STUDY DESIGN, SIZE, DURATION: A retrospective cohort of the US national registry, the Society for Assisted Reproductive Technology Clinic Outcome Reporting System, of IVF cycles of women using fresh donor oocytes resulting in ET between 2013 and 2015. Thawed oocytes were excluded. PARTICIPANTS/MATERIALS, SETTINGS, METHODS: Good obstetric outcome (GBO), defined as a singleton, term, live birth with appropriate for gestational age birth weight, was the primary outcome measure. Secondary outcomes included live birth, clinical pregnancy, spontaneous abortion, preterm birth, multiple births and gestational age-adjusted weight. Outcomes were modeled using the generalized estimating equation approach. MAIN RESULTS AND THE ROLE OF CHANCE: Data are from 25 387 donor oocyte cycles, in which 14 289 were fresh and 11 098 were frozen ETs. A GBO was 27% more likely in fresh ETs (26.3%) compared to frozen (20.9%) (adjusted risk ratio 1.27; 95% confidence interval (CI) 1.21-1.35; P < 0.001). Overall, fresh transfer was more likely to result in a live birth (55.7% versus 39.5%; adjusted risk ratio 1.21; 95% CI 1.18-1.26; P < 0.001). Among singleton births, there was no difference in gestational age-adjusted birth weight between groups. LIMITATION, REASONS FOR CAUTION: Our cohort findings contrast with data from autologous oocytes. Prospective studies with this population are warranted. WIDER IMPLICATIONS OF THE FINDINGS: Among donor oocyte recipients, fresh ETs may be associated with better birth outcomes. Reassuringly, given its prevalent use, modern embryo cryopreservation does not appear to result in phenotypically larger infants. STUDY FUNDING/COMPETING INTEREST(S): None. TRIAL REGISTRATION NUMBER: N/A.

A comparison of antibiotic prophylaxis regimens to decrease the risk of post-procedure urinary tract infection after onabotulinum toxin A injection.

INTRODUCTION AND HYPOTHESIS: To evaluate the risk of post-injection urinary tract infection (UTI) after onabotulinumtoxin A (BTX-A) treatment based on the timing of when antibiotic prophylaxis is started. METHODS: This is a retrospective cohort study of 111 women with refractory idiopathic overactive bladder who underwent intradetrusor injection of BTX-A. Two cohorts were identified: (1) 67 women who started antibiotic prophylaxis with ciprofloxacin 1 day prior to injection; (2) 44 women who received antibiotic prophylaxis with ciprofloxacin after injection only. We assessed for post-injection UTI within 90 days after BTX-A. Multivariable logistic regression was performed to adjust for potential confounders. RESULTS: One hundred eleven women underwent BTX-A. In total, 30 (27%) had a UTI within 90 days; these included 15/67 (22%) of those who started antibiotics 1 day prior to injection and 15/44 (34%) of those receiving antibiotics after injection. While the unadjusted analysis showed no significant associations between timing of antibiotic administration and UTI (OR = 0.56; 95% CI = 0.24, 1.30; p = 0.18), an adjusted analysis showed the pre-procedure antibiotic group had a significant reduction in post-procedure UTI after controlling for age, history of UTI, diabetes, and urinary retention requiring catheterization (OR = 0.23; 95% CI = 0.07, 0.73; p = 0.01). CONCLUSIONS: Starting antibiotics 1 day prior to BTX-A injection decreases the odds of post-injection UTI compared with women who use post-procedure antibiotic prophylaxis over shorter duration. Consideration should be given to beginning antibiotic prophylaxis prior to the procedure and continuing it for 4 total days to decrease the risk of UTI.

Pre-implantation genetic testing alters the sex ratio: an analysis of 91,805 embryo transfer cycles.

PURPOSE: To determine if pre-implantation genetic testing (PGT) shifts the sex ratio (SER), the ratio of male to female births in a population normalized to 100 and typically stable at 105, following in vitro fertilization (IVF). METHODS: Data from 2014 to 2016 was requested from the Society for Assisted Reproductive Technologies (SART) database including fresh and frozen transfer cycles. Women with a singleton live birth following a fresh or frozen autologous embryo transfer of a PGT blastocyst, non-PGT blastocyst, or non-PGT cleavage stage embryo were included. The SER between groups was compared using chi-square tests. Modified Poisson regression modeled the relative risk (RR) of having a male compared to a female among PGT blastocyst transfers versus non-PGT cleavage and blastocyst transfers adjusting for age, BMI, smoking status, race, parity, number of oocytes retrieved, and clinic region. RESULTS: The SER was 110 among PGT blastocyst offspring, 107 among non-PGT blastocyst offspring (p = 0.005), and 99 among non-PGT cleavage offspring (p < 0.001). The risk of having a male infant was 2% higher among PGT blastocyst transfers compared to non-PGT blastocyst transfers (RR 1.02; 95% CI: 1.01, 1.04). The risk was 5% higher among PGT blastocyst transfers compared to non-PGT cleavage transfers (RR 1.05; 95% CI: 1.02, 1.07). The association between PGT and infant gender did not significantly differ by region (p = 0.57) or parity (p = 0.59). CONCLUSION: Utilizing PGT shifts the SER in the IVF population from the standard of 105 to 110, increasing the probability of a male offspring.

Efficient estimation of grouped survival models.

BACKGROUND: Time- and dose-to-event phenotypes used in basic science and translational studies are commonly measured imprecisely or incompletely due to limitations of the experimental design or data collection schema. For example, drug-induced toxicities are not reported by the actual time or dose triggering the event, but rather are inferred from the cycle or dose to which the event is attributed. This exemplifies a prevalent type of imprecise measurement called grouped failure time, where times or doses are restricted to discrete increments. Failure to appropriately account for the grouped nature of the data, when present, may lead to biased analyses. RESULTS: We present groupedSurv, an R package which implements a statistically rigorous and computationally efficient approach for conducting genome-wide analyses based on grouped failure time phenotypes. Our approach accommodates adjustments for baseline covariates, and analysis at the variant or gene level. We illustrate the statistical properties of the approach and computational performance of the package by simulation. We present the results of a reanalysis of a published genome-wide study to identify common germline variants associated with the risk of taxane-induced peripheral neuropathy in breast cancer patients. CONCLUSIONS: groupedSurv enables fast and rigorous genome-wide analysis on the basis of grouped failure time phenotypes at the variant, gene or pathway level. The package is freely available under a public license through the Comprehensive R Archive Network.

Identification, diagnosis, treatment, and in-hospital outcomes of acute pulmonary embolism: Results from a single integrated health system.

BACKGROUND: Although the high-risk acute pulmonary embolism (PE) population has been described, little is known about the contemporary inpatient experience and practice patterns of the PE population as a whole. METHODS: All patients with a diagnosis of acute PE from January 1, 2016, to June 30, 2017 within our academic, multihospital health system were retrospectively identified using International Classification of Diseases, 10th Revision, codes, and data were manually abstracted by 2 clinical investigators. Descriptive analyses were performed according to clinical risk stratification categories from the European Society of Cardiology. RESULTS: Of 829 total patients, 372 (44.8%) patients had intermediate or high-risk PE. Mean age was 62.1 years old, and 42.1% of patients had a history of malignancy. One hundred fifty-three (18.5%) patients had an acute PE during a hospitalization for another indication. A total of 6.0% underwent invasive PE therapies, 26.1% required intensive care unit admission, and 9.0% experienced in-hospital death or hospice discharge. In a subgroup description, patients who developed acute PE during a hospitalization for another indication had a higher incidence of incomplete risk stratification and a higher mortality (9.8%) than the primary cohort. Mortality was attributed to PE in 48.4% of cases. CONCLUSIONS: This contemporary description of acute PE managed at a single large, multihospital academic health system highlights substantial health care utilization and high mortality despite the available of advanced therapeutics. Additional work is needed to standardize care for the heterogeneous PE population to ensure appropriate allocation of resources and improved outcomes for all PE patients.

Carotid stenting and endarterectomy and contralateral carotid occlusion.

BACKGROUND: The presence of contralateral carotid occlusion (CCO) has been controversial throughout the history of carotid intervention. Some studies cite a higher stroke risk in the setting of CCO, whereas other studies document no difference in stroke risk. We investigated the risk of stroke after intervention in the setting of CCO in a large, national, validated dataset. METHODS: Data were obtained from the 2011-2014 American College of Surgeons National Surgical Quality Initiative Project files using targeted carotid endarterectomy (CEA), carotid angioplasty, and carotid artery stenting (CAS) data. Patient and procedural characteristics, and 30-day postoperative outcomes were compared using Pearson χ2 tests for categorical variables and Wilcoxon rank-sum tests for continuous variables. Logistic regression was used for multivariable analysis. The primary outcome measure was the stroke rate, with a secondary outcome of major adverse cardiovascular events. RESULTS: During the study period, 11,948 CEA and 422 CAS procedures were available for study, with significantly fewer CEA (4.73% of all CEA) than CAS (9.95%; P < .0001) occurring in the setting of CCO. CAS was associated with more severe degree of stenosis than CEA (P = .045). Multivariable logistic regression showed that stroke after procedures was higher in patients with CCO than without CCO (odds ratio, 1.73; 95% confidence interval, 1.08-2.76; P = .02), but specific procedure (CEA vs CAS) was not associated with stroke while controlling for confounders. However, when evaluating our secondary composite outcome, CCO was not associated with the outcome while controlling for confounders. CONCLUSIONS: There is currently a bias that CCO confers a higher risk on patients undergoing carotid procedures and this notion is manifest in the proportion of CEA and CAS procedures done in the setting of CCO. Our study observes that CCO provides only a minor influence on periprocedural stroke risk and that other factors are more closely tied to outcomes of CEA and CAS.