bluuebunny/crossref_metadata_2025 huggingface dataset:
Predictors of the Best Outcomes Following Minimally Invasive Surgery for Grade 1 Degenerative Lumbar Spondylolisthesis
Authors: Chan Andrew K , Bisson Erica F , Bydon Mohamad , Glassman Steven D , Foley Kevin T , Shaffrey Christopher I , Potts Eric A , Shaffrey Mark E , Coric Domagoj , Knightly John J , Park Paul , Wang Michael Y , Fu Kai-Ming , Slotkin Jonathan R , Asher Anthony L , Virk Michael S , Kerezoudis Panagiotis , Alvi Mohammed A , Guan Jian , Haid Regis W , Mummaneni Praveen V
Published: April 2020

BACKGROUND

The factors driving the best outcomes following minimally invasive surgery (MIS) for grade 1 degenerative lumbar spondylolisthesis are not clearly elucidated.

OBJECTIVE

To investigate the factors that drive the best 24-mo patient-reported outcomes (PRO) following MIS surgery for grade 1 degenerative lumbar spondylolisthesis.

METHODS

A total of 259 patients from the Quality Outcomes Database lumbar spondylolisthesis module underwent single-level surgery for degenerative grade 1 lumbar spondylolisthesis with MIS techniques (188 fusions, 72.6%). Twenty-four-month follow-up PROs were collected and included the Oswestry disability index (ODI) change (ie, 24-mo minus baseline value), numeric rating scale (NRS) back pain change, NRS leg pain change, EuroQoL-5D (EQ-5D) questionnaire change, and North American Spine Society (NASS) satisfaction questionnaire. Multivariable models were constructed to identify predictors of PRO change.

RESULTS

The mean age was 64.2 ± 11.5 yr and consisted of 148 (57.1%) women and 111 (42.9%) men. In multivariable analyses, employment was associated with superior postoperative ODI change (β-7.8; 95% CI [−12.9 to −2.6]; P = .003), NRS back pain change (β −1.2; 95% CI [−2.1 to −0.4]; P = .004), EQ-5D change (β 0.1; 95% CI [0.01-0.1]; P = .03), and NASS satisfaction (OR = 3.7; 95% CI [1.7-8.3]; P < .001). Increasing age was associated with superior NRS leg pain change (β −0.1; 95% CI [−0.1 to −0.01]; P = .03) and NASS satisfaction (OR = 1.05; 95% CI [1.01-1.09]; P = .02). Fusion surgeries were associated with superior ODI change (β −6.7; 95% CI [−12.7 to −0.7]; P = .03), NRS back pain change (β −1.1; 95% CI [−2.1 to −0.2]; P = .02), and NASS satisfaction (OR = 3.6; 95% CI [1.6-8.3]; P = .002).

CONCLUSION

Preoperative employment and surgeries, including a fusion, were predictors of superior outcomes across the domains of disease-specific disability, back pain, leg pain, quality of life, and patient satisfaction. Increasing age was predictive of superior outcomes for leg pain improvement and satisfaction.
Antidepressant drug use in glioblastoma patients: an epidemiological view
Authors: Gramatzki Dorothee , Rogers James Louis , Neidert Marian Christoph , Hertler Caroline , Le Rhun Emilie , Roth Patrick , Weller Michael
Published: April 2020

Background

Antidepressant drugs have shown antitumor activity in preclinical glioblastoma studies. Antidepressant drug use, as well as its association with survival, in glioblastoma patients has not been well characterized on a population level.

Methods

Patient characteristics, including the frequency of antidepressant drug use, were assessed in a glioblastoma cohort diagnosed in a 10-year time frame between 2005 and 2014 in the Canton of Zurich, Switzerland. Cox proportional hazards regression models were applied for multivariate analysis. Kaplan-Meier survival curves were used to estimate overall survival (OS) data and the log-rank test was performed for comparisons.

Results

A total of 404 patients with isocitrate dehydrogenase wild-type glioblastoma were included in this study. Sixty-five patients (16.1%) took antidepressant drugs at some point during the disease course. Patients were most commonly prescribed selective serotonin reuptake inhibitors at any time (N = 46, 70.8%). Nineteen patients (29.2%) were on antidepressant drugs at the time of their tumor diagnosis. No differences were observed in OS between those patients who had taken antidepressants at some point in their disease course and those who had not (P = .356). These data were confirmed in a multivariate analysis including age, Karnofsky Performance Scale (KPS), sex, extent of resection, O6-methylguanine DNA methyltransferase (MGMT) promoter methylation status, and first-line treatment as cofounders (P = .315). Also, there was no association of use of drugs modulating voltage-dependent potassium channels (citalopram; escitalopram) with survival (P = .639).

Conclusions

This signal-seeking study does not support the hypothesis that antidepressants have antitumor efficacy in glioblastoma on a population level.
Plasma metabolomic and lipidomic alterations associated with COVID-19
Authors: Wu Di , Shu Ting , Yang Xiaobo , Song Jian-Xin , Zhang Mingliang , Yao Chengye , Liu Wen , Huang Muhan , Yu Yuan , Yang Qingyu , Zhu Tingju , Xu Jiqian , Mu Jingfang , Wang Yaxin , Wang Hong , Tang Tang , Ren Yujie , Wu Yongran , Lin Shu-Hai , Qiu Yang , Zhang Ding-Yu , Shang You , Zhou Xi
Published: April 2020

The pandemic of the coronavirus disease 2019 (COVID-19) has become a global public health crisis. The symptoms of COVID-19 range from mild to severe, but the physiological changes associated with COVID-19 are barely understood. In this study, we performed targeted metabolomic and lipidomic analyses of plasma from a cohort of patients with COVID-19 who had experienced different symptoms. We found that metabolite and lipid alterations exhibit apparent correlation with the course of disease in these patients, indicating that the development of COVID-19 affected their whole-body metabolism. In particular, malic acid of the TCA cycle and carbamoyl phosphate of the urea cycle result in altered energy metabolism and hepatic dysfunction, respectively. It should be noted that carbamoyl phosphate is profoundly down-regulated in patients who died compared with patients with mild symptoms. And, more importantly, guanosine monophosphate (GMP), which is mediated not only by GMP synthase but also by CD39 and CD73, is significantly changed between healthy subjects and patients with COVID-19, as well as between the mild and fatal cases. In addition, dyslipidemia was observed in patients with COVID-19. Overall, the disturbed metabolic patterns have been found to align with the progress and severity of COVID-19. This work provides valuable knowledge about plasma biomarkers associated with COVID-19 and potential therapeutic targets, as well as an important resource for further studies of the pathogenesis of COVID-19.
Candida Infective Endocarditis During the Infectious Diseases and Substance Use Disorder Syndemic: A Six-Year Case Series
Authors: Sankar N P , Thakarar K , Rokas Kristina E
Published: April 2020

Treatment for Candida infective endocarditis (IE) has not been extensively studied in the setting of rising injection drug use. There were 12 cases of Candida IE at the Maine Medical Center between 2013 and 2018. The patient characteristics, treatment regimens, and outcomes were retrospectively analyzed.
Medical Cannabis for the Management of Pain and Quality of Life in Chronic Pain Patients: A Prospective Observational Study
Authors: Safakish Ramin , Ko Gordon , Salimpour Vahid , Hendin Bryan , Sohanpal Imrat , Loheswaran Gena , Yoon Sun Young Rosalia
Published: April 2020

Objective

To evaluate the short-term and long-term effects of plant-based medical cannabis in a chronic pain population over the course of one year.

Design

A longitudinal, prospective, 12-month observational study.

Setting

Patients were recruited and treated at a clinic specializing in medical cannabis care from October 2015 to March 2019.

Subjects

A total of 751 chronic pain patients initiating medical cannabis treatment.

Methods

Study participants completed the Brief Pain Inventory and the 12-item Short Form Survey (SF-12), as well as surveys on opioid medication use and adverse events, at baseline and once a month for 12 months.

Results

Medical cannabis treatment was associated with improvements in pain severity and interference (P < 0.001) observed at one month and maintained over the 12-month observation period. Significant improvements were also observed in the SF-12 physical and mental health domains (P < 0.002) starting at three months. Significant decreases in headaches, fatigue, anxiety, and nausea were observed after initiation of treatment (P ≤ 0.002). In patients who reported opioid medication use at baseline, there were significant reductions in oral morphine equivalent doses (P < 0.0001), while correlates of pain were significantly improved by the end of the study observation period.

Conclusions

Taken together, the findings of this study add to the cumulative evidence in support of plant-based medical cannabis as a safe and effective treatment option and potential opioid medication substitute or augmentation therapy for the management of symptoms and quality of life in chronic pain patients.
High-Intensity Exercise Improves Fatigue, Sleep, and Mood in Patients With Axial Spondyloarthritis: Secondary Analysis of a Randomized Controlled Trial
Authors: Sveaas Silje Halvorsen , Dagfinrud Hanne , Berg Inger Jorid , Provan Sella Arrestad , Johansen Melissa Woll , Pedersen Elisabeth , Bilberg Annelie
Published: April 2020

Objective

Although exercise is recommended in the treatment of axial spondyloarthritis (axSpa), the focus has been on flexibility, and the effect of high-intensity exercises is unknown. The purpose of this study was to investigate the effect of high-intensity exercises on fatigue, sleep, and mood in patients with axSpA.

Methods

In this secondary analysis of a randomized controlled trial, participants were recruited from outpatient clinics at 4 hospitals in Scandinavia. A total of 100 patients with axSpA were randomized to either an exercise group (n = 50) or a control group (n = 50). High-intensity exercise was provided 3 times per week for 3 months and supervised by a physical therapist. The controls received no intervention. Measurements were self-reported at baseline, 3 months, and 12 months: fatigue, using the Fatigue Severity Scale (range = 0–7, 7 = worst, ≥5 = severe); vitality, using the RAND 36-item short-form health survey (SF-36, range = 0–100, 100 = best); sleep, using the Pittsburgh Sleep Quality Index (range = 0–21, 21 = worst, >5 = poor quality); mood, using the General Health Questionnaire 12 (range = 0–36, 36 = worst); and general health, using the EUROQoL (range = 0–100, 100 = best).

Results

A total of 38 participants (76%) in the exercise group followed ≥80% of the exercise protocol. At 3 months, there was a significant beneficial effect on fatigue (mean group differences = −0.4, 95% CI = −0.7 to −0.1), vitality (5.0, 95% CI = 1.1 to 10.5), mood (−2, 95% CI = −3.7 to −0.04), and general health (9.0, 95% CI = 3.3 to 14.7) but no effect on sleep (−1.1, 95% CI = −2.1 to 0.2). Compared with the control group, the exercise group had a reduced rate of severe fatigue and poor sleep. No differences were seen between the groups at 12 months.

Conclusions

A 3-month exercise program had a beneficial effect on fatigue, sleep, mood, and general health in patients with axSpA at the end of the intervention; however, no long-term effects were seen.

Impact

High-intensity cardiorespiratory and strength exercises should be considered as important in exercise programs for patients with axSpA.
Cell-derived extracellular matrix-coated silk fibroin scaffold for cardiogenesis of brown adipose stem cells through modulation of TGF-β pathway
Authors: Liu Wei , Sun Yanfeng , Dong Xiaohui , Yin Qi , Zhu Huimin , Li Siwei , Zhou Jin , Wang Changyong
Published: April 2020

The cell-derived extracellular matrix (ECM)-modified scaffolds have advantages of mimic tissue specificity and been thought to better mimic the native cellular microenvironment in vitro. ECM derived from cardiac fibroblasts (CFs) are considered as key elements that provide a natural cell growth microenvironment and change the fate of cardiomyocytes (CMs). Here, a new hybrid scaffold is designed based on silk fibroin (SF) scaffold and CFs-derived ECM. CFs were seeded on the SF scaffold for 10 days culturing and decellularized to produce CFs-derived ECM-coated SF scaffold. The results showed that the cell-derived ECM-modified silk fibroin scaffold material contained collagen, laminin, fibronectin and other ECM components with myocardial-like properties. Further to explore its effects on brown adipose stem cells (BASCs) differentiation into CMs. We found that the CF-derived ECM-coated scaffold also increased the expression of CM-specific proteins (e.g. cardiac troponin T and α-actinin) of BASCs. Notably, the β1-integrin-dependent transforming growth factor-β1 signaling pathway was also involved in the regulation of CF-derived ECM by promoting the differentiation of BASCs into CMs. Overall, these findings provide insights into the bionic manufacturing of engineered cardiac tissues (ECTs) and establish a theoretical basis for the construction of ECTs.
Weak Governance by Informed Active Shareholders
Authors: Goldman Eitan , Wang Wenyu
Published: April 2020

Do informed shareholders who can influence corporate decisions improve governance? We demonstrate this may not be generally true in a model of takeovers. The model suggests that a shareholder’s ability to collect information and trade ex post may cause him, ex ante, to support pursuing value-destroying takeovers or oppose value-enhancing takeovers. Surprisingly, we find conditions under which giving the active shareholder greater influence weakens governance and reduces firm value, even if such influence power can be used to reject bad takeovers ex post. Our model sheds light on the limitations of relying on informed, active shareholders to improve governance.
Sleep inconsistency between weekends and weekdays is associated with changes in brain function during task and rest
Authors: Zhang Rui , Tomasi Dardo , Shokri-Kojori Ehsan , Wiers Corinde E , Wang Gene-Jack , Volkow Nora D
Published: April 2020

Study Objectives

Sleep deprivation and circadian disruptions impair brain function and cognitive performance, but few studies have examined the effect of sleep inconsistency. Here, we investigated how inconsistent sleep duration and sleep timing between weekends (WE) and weekdays (WD) correlated with changes in behavior and brain function during task and at rest in 56 (30 female) healthy human participants.

Methods

WE–WD differences in sleep duration and sleep midpoint were calculated using 1-week actigraphy data. All participants underwent 3 Tesla blood-oxygen-level-dependent functional Magnetic Resonance Imaging (fMRI) to measure brain activity during a visual attention task (VAT) and in resting-state condition.

Results

We found that WE–WD inconsistency of sleep duration and sleep midpoint were uncorrelated with each other (r = .08, p = .58) and influenced behavior and brain function differently. Our healthy participants showed relatively small WE–WD differences (WE–WD: 0.59 hours). Longer WE sleep duration (relative to WD sleep duration) was associated with better attentional performance (3-ball: β = .30, t = 2.35, p = .023; 4-ball: β = .30, t = 2.21, p = .032) and greater deactivation of the default mode network (DMN) during VAT (p < .05, cluster-corrected) and greater resting-state functional connectivity (RSFC) between anterior DMN and occipital cortex (p < .01, cluster-corrected). In contrast, later WE sleep timing (relative to WD sleep timing) (WE–WD: 1.11 hours) was associated with worse performance (4-ball: β = −.33, t = −2.42, p = .020) and with lower occipital activation during VAT and with lower RSFC within the DMN.

Conclusions

Our results document the importance of consistent sleep timing for brain function in particular of the DMN and provide evidence of the benefits of WE catch-up sleep in healthy adults.
The Limits of Expectations and the Minimization of Collateral Consequences: The Experience of Electronic Home Monitoring
Authors: Kirk Gabriela
Published: April 2020

Electronic home monitoring (EHM), also known as house arrest, is often described by policy makers as a less punitive, more humane alternative to incarceration. However, studies on its use have found it is often not used as an alternative, but rather as an increase in the level of supervision for individuals in the criminal justice system. This fact calls into question whether the language of alternatives and direct comparisons to incarceration obscures our understanding of both the sanction and how individuals experience it. Although previous studies of the experience of EHM have concluded that individuals do not find the sanction overly burdensome, this article articulates the importance of considering 1) how respondents frame their experience on EHM in comparison to incarceration and 2) how they draw on expectations surrounding their legal alternatives. Using 30 interviews with individuals who have been on EHM in Chicago, Illinois, I argue that the pervasiveness of the prison distorts expectations of the legal process and causes respondents to minimize the hardships they detail. Both the existing framing of studies on EHM and the ways in which individuals experience it demonstrate the hegemony of carceral logics in an era of mass incarceration.
When Mothers Can’t “Pay the Cost to Be the Boss”: Roles and Identity within Doubled-Up Households
Authors: Harvey Hope
Published: April 2020

Although the independent nuclear family remains the ideal family form in most Americans’ minds, rising housing costs have made residential independence increasingly difficult. Sharing a home provdes a common safety net for lower-income mothers, yet we know little about how mothers experience and interpret this household form. Drawing on data from in-depth interviews with 52 mothers, I find that doubling up as a guest in someone else’s home – though not hosting someone else in their home – threatens mothers’ identities as adults and good parents. Mothers describe doubling up in someone else’s home as incompatible with their ideals of adulthood and family life, which are organized around the independent nuclear family. While mothers expect to control their daily lives and childrearing, householders retain authority over the home and its inhabitants, and there is no taken-for-granted way of reconciling household members’ conflicting expectations. In response to the stress on their identities, mothers who live doubled-up in someone else’s home often seek to establish themselves as head of their nuclear family, even when they are not the household head, by engaging in identity work: defining physical space as their own, emphasizing their contributions to the household, and asserting their status as parents.
Demobilizing or Activating? The Effect of Anti-Muslim Discrimination on Muslims’ Counter-Extremism Engagement
Authors: Shanaah Sadi
Published: April 2020

Scholars have reported mixed findings on the effect of discrimination on political and social behavior. In some cases, experiences of discrimination reduce mainstream political and social engagement; in other cases, the opposite seems to be true. The indeterminate outcome of discrimination has important bearing on counter-extremism policies in the West. These policies aim at galvanizing Muslim communities’ engagement in countering extremism, but they do so in the context of heightened levels of anti-Muslim discrimination. This article investigates the effect of anti-Muslim discrimination on the willingness of Muslims to take action against Islamist extremism. I analyze data from unique large-N nationally representative surveys of British Muslims, using both cross-sectional and experimental designs. Neither analysis found support for the hypothesis that anti-Muslim discrimination reduces the willingness of Muslims to engage in counter-extremism. Furthermore, the investigated relationship appears to be curvilinear, where few experiences with anti-Muslim discrimination increase the likelihood of Muslims’ engagement in counter-extremism in comparison to those who did not have such experiences and those who encountered discrimination more frequently. If confirmed by further research, this finding can potentially help to reconcile the mixed results in the literature.
Anaemia among Kenyan children: a call for improved monitoring and intervention in school-aged children
Authors: Okiro Emelda A , Joseph Noel K , Gitonga Caroline W , Snow Robert W
Published: April 2020

Background

Anaemia has long been recognised as a major public health problem among young children in lower- and middle-income countries and is an indicator of both poor nutrition and health status. There has been little progress towards improvement of anaemia in part due to its complex aetiology. An added impediment to the progress is that the monitoring of anaemia does not routinely target the whole population, with school-aged children (SAC) largely overlooked.

Methods

We re-examined data on the prevalence of anaemia among children aged <15 y sampled from 2008–2015 in Kenya.

Results

Approximately one in four Kenyan children aged <15 y were described as anaemic, including 12% with WHO-defined moderate anaemia and 1% who were severely anaemic. Average haemoglobin concentrations increased with age and the risk of having anaemia decreased with age. However, one in five SAC in Kenya were suffering from anaemia; most were either mild (11.4%) or moderately (10.9%) anaemic.

Conclusions

The monitoring of anaemia in SAC continues to be a neglected area limiting a careful articulation of the need to target interventions in this age group.
Menstrual Cup Use and Intrauterine Device Expulsion in a Copper Intrauterine Device Contraceptive Efficacy Trial [OP01-1B]
Authors: Long Jill , Schreiber Courtney , Creinin Mitchell D. , Kaneshiro Bliss , Nanda Kavita , Blithe Diana
Published: April 2020

INTRODUCTION:

Menstrual cup use for menstrual hygiene is increasingly popular. We evaluated relationship of menstrual cup use and intrauterine device (IUD) expulsion in a prospective trial of two copper IUDs.

METHODS:

An ongoing 3-year contraceptive efficacy trial randomized women to one of two copper IUDs, with successful placement in 1,092 women. Institutional Review Board approval was obtained, and all subjects provided informed consent. Follow-up visits in the first year occurred at 6 weeks, and then 3, 6, and 12 months after insertion. At nine months after initiating enrollment, we modified the protocol to advise subjects against concurrent menstrual cup use with the IUD. We evaluated the association of menstrual cup use and expulsion risk over the first 24 months of study conduct.

RESULTS:

Overall, 266 (24.4%) women reported menstrual cup use. At 24 months after initiating enrollment, 46 (17.3%) cup users and 43 (5.2%) non-users experienced expulsion (odds ratio 3.81 [95% CI 2.45-5.92]). Fourteen (30.4%) menstrual cup users with expulsion reported the event occurred during menstrual cup removal. At Year 1 of the study, expulsion rates among menstrual cup users and non-users were 14.3% and 4.7%, respectively (P<.001). By the end of Year 2, these rates were 23.2% and 6.5% (P<.001).

CONCLUSION:

We found higher than expected IUD expulsion rates in menstrual cup users amongst participants in a prospective trial of two copper IUDs. Copper IUD users should be cautioned that concurrent menstrual cup use increases the risk of IUD expulsion and expulsion risk continues with ongoing menstrual cup use.
Use of Multi-modal Analgesia in Enhanced Recovery After Surgery (ERAS) for Cesarean Sections to Reduce the Use of Opioids [OP02-1B]
Authors: Gwacham Nnamdi I. , Goral Jan , Miller Richard , Pitera Richard , Cinicolo Luciana
Published: April 2020

INTRODUCTION:

Enhanced recovery after surgery (ERAS) protocols are mechanisms for obtaining value-based improvements in surgery and they have become embedded within multiple surgical disciplines including colorectal, urological, gynecological, and hepatobiliary surgery. ERAS has been shown to result in both clinical and health system benefits1. The objective of this study is to evaluate the effect of such a program on opioid use in cesarean sections (CS) at a community teaching hospital.

METHODS:

The ERAS pathway was applied to all patients undergoing CS since its implementation. 98% of patients received transversus abdominis plane (TAP) blocks in the immediate postoperative period. All patients were started on scheduled multimodal analgesia with a combination of ibuprofen, acetaminophen, and dextromethorphan until discharge. Patients whose pain was not well controlled with the above regimen were given opioids for pain control. A retrospective review of patients undergoing CS after the implementation of the ERAS pathway (January 2019-current) was performed. The number of opioid units utilized, as well as mean morphine equivalents were compared to a historical patient cohort (January 2018 – June 2018).

RESULTS:

An historical cohort of patients (n = 2109) was compared to patients in the ERAS pathway (n = 1463). Patients that were admitted to the hospital > 3 days prior to cesarean section were excluded in an effort to remove antepartum cases (n = 110). Planned CS were designated as those that were scheduled prior to patient check-in to hospital. There was no difference in age, race or body mass index (BMI). There was a significant difference in average length of stay in days between the two cohorts (3.19 vs 2.63, p<0.001). There was also a significant difference in average direct cost in dollars (4290 vs 3957, p < 0.001). The number of patients requiring opioids was also significantly reduced (1766 vs 341, p<0.001). There were 8082 opioid units utilized prior to the implementation of the ERAS pathway whereas 803 opioid units have been utilized since the advent of ERAS for CS.

CONCLUSIONS:

Post-operative pain control can be achieved in a majority of patients undergoing CS without routine use of opioids in a standardized ERAS pathway.
Does Use of Testicular Sperm Improve Outcomes in Nonazoospermic Couples With Previous IVF Failure Using Ejaculated Sperm? [OP02-2B]
Authors: Eubanks Allison A.
Published: April 2020

INTRODUCTION:

Due to controversial evidence that testicular sperm is associated with lower sperm DNA fragmentation (SDF) and improved outcomes compared to ejaculated sperm (ES), this study evaluates intracytoplasmic sperm injection (ICSI) outcomes using testicular sperm in nonazoospermic couples with prior IVF failure using ES.

METHODS:

From Jan 2015-Aug 2018, nonazoospermic couples with ≥1 prior failed ART cycles using ES underwent testicular sperm extraction (TESE) for IVF/ICSI. Outcomes using TESE sperm were compared to the mean values of couples’ prior cycles using ES. Primary outcomes: clinical pregnancy and live birth rates (CPR & LBR). Secondary outcomes: fertilization and blastocyst conversion.

RESULTS:

64 couples were evaluated with an average of 2.5 prior failed ART cycles using ES. There were 76 total transfers including fresh/frozen transfers and supernumerary embryo transfers. Compared to prior failed cycles with ES, TESE sperm resulted equivalent fertilization rates (61.4% vs. 59.0%, p=0.66), but significantly improved blastocyst conversion rates (61.9% vs. 42.9%, p<0.001) and blastocysts available for vitrification (1.6 vs. 0.6, p<0.003). CPR and LBR were improved (42.1% and 35.5%, respectively), but not statistically compared to the prior failed cycles due to regression of the mean. A comparison of TESE-ICSI cycles in couples with ≥2 prior failed ART cycles using ES did not change the findings.

CONCLUSION:

In nonazoospermic couples with failed ART using ES, ICSI using TESE sperm may improve blastocyst development, number of embryos available for vitrification, CPRs, and LBRs. Testicular sperm may bypass adverse effects of elevated SDF from ES and improve pregnancy outcomes.
Influence of Medicaid Expansion on Short Interpregnancy Interval Rates in the US [OP03-1C]
Authors: Patel Kriya , Bakk Juliana , Pensak Meredith , DeFranco Emily
Published: April 2020

INTRODUCTION:

To assess the impact of improved access to contraception through Medicaid expansion (ME) on the rate of short interpregnancy intervals (IPIs) in the US.

METHODS:

Population-based retrospective cohort study using US live birth data of multiparous women with data on IPI in 2012 and 2016 (pre and post expansion in 2014). Rate differences of short IPI (<12 months) from 2012 to 2016 were compared between ME vs non-ME states.

RESULTS:

The rate of short IPI in the US was slightly lower in 2016 (17.3%) compared to 2012 (17.4%), p=0.0006; rate difference 0.13% (95% CI 0.05-0.20). Short IPIs occurred more frequently in non-ME states compared to ME states in both 2012 (18.08% vs 16.55%, p<.001) and 2016 (18.12% vs 16.44%, p<.001). The rate of short IPI decreased 0.11% (95% CI 0.01%-0.22%) in ME states vs increased 0.04% (95% CI 0.09-0.17) in non-ME states over the time period.

CONCLUSION:

The rate of short interpregnancy interval increased over time in non-expansion states but decreased in the states that adopted Medicaid expansion. If non-ME states had experienced the same rate of decrease in short IPI as ME states, 1122 fewer women would have experienced a short IPI in the US in 2016. Considering the known association between short IPI and adverse maternal and infant outcomes, these findings indicate Medicaid expansion could have an impact on improvement of perinatal outcomes in the US.
The Effects of Postpartum Long-Acting Reversible Contraceptive Insertion From the Medicaid Payer Perspective [OP03-2C]
Authors: Swiatlo Alison , Miele Kathryn , Morse Jessica E. , Lich Kristen , Krashin Jamie
Published: April 2020

INTRODUCTION:

This model was created to determine the difference in short interval pregnancies, costs, and cost effectiveness with immediate versus standard placement of postpartum long-acting reversible contraception (ppLARC), which includes intrauterine devices and implants.

METHODS:

This Markov model examines a theoretical cohort of 1,000 women whose obstetrical care was paid for by North Carolina Medicaid (NC Medicaid) and who requested ppLARC prior to discharge from their delivery hospitalization from the perspective of NC Medicaid. Short interval pregnancy was defined as conception prior to 18 months from delivery. Probability inputs came from the literature and cost inputs are from NC Medicaid fee schedules. Markov cycles were weekly with an 18 month time horizon. During the time horizon postpartum, a woman could continue with her current contraceptive method, change to a different method, or become pregnant. Pregnancy is an absorbing state with five different outcomes. Probabilistic sensitivity analyses were conducted on key model parameters.

RESULTS:

Immediate ppLARC would result in 182 fewer unintended short interval pregnancies and save North Carolina $624,372 over 18 months. Immediate ppLARC was cost saving, with an incremental cost-effectiveness ratio of $3,435 saved per short interval pregnancy prevented. In sensitivity analyses, immediate ppLARC remained cost saving except when parameters were varied widely from expected values.

CONCLUSION:

Immediate post-partum insertion of long-acting reversible contraceptives was associated with cost-savings and fewer short interval pregnancies.
Assessment of Adequacy of Oxytocin Use in Pregnant Women Undergoing Induction of Labor [OP03-4C]
Authors: Eid Joe , Moutos Christopher , Jacobs Sara , Goslawski Melissa , Saade George R. , Saad Antonio
Published: April 2020

INTRODUCTION:

Evaluation of adequacy of intrapartum management often includes quantification of oxytocin use, such as maximum rate of oxytocin used or length of time on oxytocin. Our objective was to evaluate a calculated measure that combines rate and time of oxytocin and its relationship with mode of delivery.

METHODS:

This is a secondary analysis of a randomized trial comparing speculum vs digital placement of Foley balloon for cervical ripening. Trial participants who did not receive oxytocin were excluded. Total dose of oxytocin received (OXYTOT) was calculated as the sum of the product of oxytocin rate and time on that rate for each concentration used. Area under the curve (AUC) was determined. Receiver operator characteristic (ROC) curves, and Wilcoxon rank sum test were used for analysis. OXYTOT was also categorized into deciles and its relationship to rate of cesarean section (CS) was studied.

RESULTS:

This analysis included 368 patients. Patients’ characteristics were similar in both CS and vaginal delivery (VD) groups. OXYTOT was predictive of mode of delivery (AUC of 0.62 95% CI 0.55-0.69). Women who underwent CS had a significant higher OXYTOT compared to women who had VD (9,308 vs 6,307 mIU, P<.0001). Rate of CS started significantly increasing at the 7th decile of OXYTOT (8,120 mIU).

CONCLUSION:

OXYTOT is a useful measure to assess adequacy of oxytocin use in induction of labor. CS rate remains low until high levels of this measure are reached. This measure may be a useful adjunct in assessing the quality of induction of labor and monitoring CS rates.
Labor Induction Outcomes With Outpatient Misoprostol for Cervical Ripening Among Low-Risk Patients [OP03-6C]
Authors: Schneider Allison N. , Tucker Lue-Yen , Kandahari Nazineen , Raine-Bennett Tina , Mohta Vanitha J.
Published: April 2020

INTRODUCTION:

Labor induction is becoming increasingly common. The objective of this study is to evaluate the effect of outpatient misoprostol for cervical ripening on inpatient time-to-delivery and maternal and neonatal outcomes.

METHODS:

We conducted an IRB approved retrospective cohort study of 10,467 patients (559 outpatient, 9,908 inpatient) who received misoprostol for cervical ripening at Kaiser Permanente Northern California hospitals between 2012 and 2017. Time-to-delivery and maternal and neonatal outcomes after misoprostol administration were analyzed with standard statistical tests.

RESULTS:

Patients induced with misoprostol in the outpatient and inpatient settings were comparable in demographics and predominantly nulliparous (70.3% and 64.3%, respectively). Patients who received outpatient misoprostol were more likely to have a cervical dilation of 3cm on admission (39.5% vs 9.7%, P < .0001). The outpatient misoprostol cohort had a shorter time between admission and delivery (20.6 [interquartile range (IQR) 12.4-31.7] vs 27.5 [IQR 19.2-37.4] hours, P < .0001), with no difference in mode of delivery or neonatal outcomes. Patients who received outpatient misoprostol were more likely to have a C-section for failure to progress in labor (14.0% vs 11.2%, P=.04), however the overall C-section rate was not significantly different between groups. Patients who received outpatient misoprostol had a higher rate of chorioamnionitis and a trend towards a lower maternal blood transfusion (14.3% vs 10.6%, P=.01; 0.7% vs 1.8%, P=.06, respectively).

CONCLUSION:

Outpatient misoprostol reduced inpatient time-to-delivery by a median of 7 hours with no significant differences in maternal or neonatal outcomes. An outpatient misoprostol protocol has the potential to decrease inpatient burden on Labor and Delivery.
Bone Mineral Density Assessment With Relugolix Combination Therapy: Results From the Phase 3 LIBERTY Program [OP04-2D]
Authors: McClung Michael R. , Santora Arthur C. , Al-Hendy Ayman , McKain Laura , Pazirandeh Jessica , Wagman Rachel B.
Published: April 2020

INTRODUCTION:

In phase 3 Institutional Review Board-approved LIBERTY 1 and 2 studies, relugolix combination therapy (Relugolix-CT [once daily relugolix 40 mg, estradiol 1.0 mg, norethindrone acetate 0.5 mg]) significantly reduced menstrual blood loss (MBL) in women with heavy menstrual bleeding associated with uterine fibroids (UF). We assessed the effects of Relugolix-CT in preventing bone loss from estrogen deprivation associated with GnRH receptor antagonist monotherapy.

METHODS:

Premenopausal women (age 18–50 years) with MBL volume ≥80 mL/cycle were randomized 1:1:1 to receive Relugolix-CT for 24 weeks, relugolix 40 mg alone for 12 weeks followed by Relugolix-CT for 12 weeks (delayed Relugolix-CT), or placebo for 24 weeks. Bone mineral density (BMD) by dual energy X-ray absorptiometry of the lumbar spine (LS) (L1–4), total hip, and femoral neck was assessed at screening and Weeks 12 and 24. Percent change from baseline between treatment groups was summarized by location using a mixed-effect model adjusted for region, visit and selected baseline characteristics.

RESULTS:

In LIBERTY 1 (N: 387), mean % changes from baseline at 24 weeks in LS BMD for Relugolix-CT and placebo were -0.36% and 0.05%, respectively and delayed Relugolix-CT was -1.82%. In LIBERTY 2 (N: 381), mean % changes from baseline in BMD at LS for Relugolix-CT and placebo were -0.13% and 0.32%, respectively, and delayed Relugolix-CT was -2.12%.

CONCLUSION:

Compared with relugolix monotherapy, relugolix-CT preserves bone mass over 24 weeks. Initiating treatment for UF with relugolix combined with E2/NETA represents a potential method for preserving BMD while providing therapeutic benefit over the long-term.
Up to 12 Months of Elagolix Sustained Menstrual Blood Loss Reduction in Women With Uterine Fibroids [OP04-5D]
Authors: Simon James A. , Bradley Linda D. , Liu Ran , Owens Charlotte , Schlaff William
Published: April 2020

INTRODUCTION:

An investigational, IRB-approved, phase 3 extension study (Elaris UF-EXTEND) of two 6-month, phase 3 studies evaluated the efficacy and safety of an additional 6-months (up to 12-months) of elagolix (oral gonadotropin-releasing hormone antagonist) with hormonal add-back therapy in women with heavy menstrual bleeding (HMB) and uterine fibroids (UF).

METHODS:

Women who received elagolix 300 mg twice-daily with add-back (estradiol 1 mg/norethindrone acetate 0.5 mg once-daily [E2/NETA]) or elagolix alone in the preceding studies continued the same treatment for an additional 6-months in the extension study. Primary endpoint was the percentage of women with menstrual blood loss (MBL) <80 mL during final month of treatment and ≥50% MBL reduction from baseline to final month of treatment; MBL measured by alkaline hematin method. Safety assessments included bone mineral density (BMD) changes.

RESULTS:

433 women who completed the 6-month treatment period in either of the two preceding studies were enrolled in the extension study. In women who received up to 12-months of elagolix+E2/NETA, 87.9% met the primary endpoint; 74.8% had suppression of bleeding (no bleeding, spotting allowed) at final month; 72.5% with baseline hemoglobin ≤10.5g/dL had an hemoglobin increase >2 g/dL at extension month 6. Mean baseline MBL (mean±SD=224.7±147.9 mL) was reduced with elagolix+E2/NETA as early as extension month 1 (mean [95% CI]=-186.5 [-209.2, -163.9] mL) and sustained through extension month 6 (mean [95% CI]=-221.4 [-239.11, -183.68] mL). Mean BMD decreases from baseline to extension month 6 were significantly less with elagolix+E2/NETA than elagolix alone.

CONCLUSION:

Up to 12-months of elagolix+E2/NETA provided sustained MBL reduction in women with UF. Inclusion of add-back attenuated BMD decreases associated with elagolix alone.
Breastfeeding and HIV in the Era of Undetectable=Untransmittable: Research, Policy, and Lived Experiences [01A]
Authors: Martel Krista , Conley Jenna
Published: April 2020

INTRODUCTION:

Evidence that maintaining undetectable HIV viral load eliminates risk of sexual transmission (Undetectable=Untransmittable or “U=U”) has shifted paradigms in HIV care, introducing the potential for safe and natural conception and decreasing stigma. In this setting, U.S. women living with HIV (WLHIV) are questioning the recommendation against breastfeeding, particularly given breastfeeding's known personal and health benefits for infants and women.

METHODS:

We perform scoping review of infant feeding for WLHIV, highlight available evidence on breastfeeding, provide international context, and present preliminary findings from healthcare provider and patient interviews and surveys.

RESULTS:

Research on breastfeeding with HIV predominantly occurs in low-resource settings, limiting applicability to U.S. populations. The World Health Organization guidelines recommend breastfeeding for WLHIV in low-resource settings due to improved infant outcomes. U.S. policy aims to minimize perinatal HIV transmission, without considering the potential health risks of avoiding breastfeeding for infants and women; however in 2018, US guidelines have incorporated harm reduction language to help clinicians support women who breastfeed despite current recommendations. WLHIV identify concerns of stigma, inequity, feelings of maternal inadequacy, and fears around HIV criminalization related to breastfeeding. Providers express need for more education and relevant research. Both groups indicate that evidence-based shared decision-making, rather than harm reduction, may be a more appropriate approach in the U=U era.

CONCLUSION:

Further medical research and ethical evaluation of the recommendation against breastfeeding for U.S. WLHIV is needed. Provider and patient education should be prioritized to promote informed decisions and observational research participation. We advocate for more nuanced policy and individualized recommendations.
Physician Survey Results: Clinical Practice Training Is Needed to Improve Ob/Gyn PrEP Adoption [02A]
Authors: Simoncini Gina M. , Koren David E. , D'Avanzo Paul A. , Diaz Quinones Juan J. , Brajuha Jesse , Bass Sarah B.
Published: April 2020

INTRODUCTION:

Human immunodeficiency (HIV) disease prevention with pre-exposure prophylaxis (PrEP) is marred by disparities, especially among women and other high risk groups. PrEP prescribing adoption by primary care physicians including obstetrics and gynecology (Ob/Gyn) providers is crucial to improve HIV prevention.

METHODS:

We modified a previously validated PrEP provider survey and administered it online through REDCap to faculty and categorical residents in the Departments of Ob/Gyn and General Internal Medicine (GIM) of a large urban hospital. T-tests and chi-square tests were performed with an alpha significance value of 0.05.

RESULTS:

61 provider-surveys were completed (24 Ob/Gyn, 37 GIM). No statistically significant differences were observed by age or race, however there were a higher proportion of female-identified providers in Ob/Gyn (87.5%) compared to GIM (54.1%) (P=.01). The Ob/Gyn surveys demonstrated significant differences in the clinical processes for PrEP management. Surveys demonstrated perceived deficiencies in provider training/education (P=.006), clinical practice guidelines (P=.001), availability of resource access (such as PrEP guidelines/protocols) (P=.003), peers/colleagues who are knowledgeable about or supportive of PrEP provision within their practice (P=.008), and lab monitoring requirements (P=.019). GIM respondents were more likely to believe they knew enough about PrEP to feel comfortable prescribing it (P=.005), thought it was feasible to prescribe in GIM and OB/Gyn settings compared to HIV prevention/care clinics (P=.019) and to say they would be likely to prescribe PrEP in the next 6 months (P=.01).

CONCLUSION:

Overall, results indicate that improved clinical practice training and processes are necessary to increase PrEP adoption in OB/Gyn clinical settings.
Early Prediction of Sepsis: Cohort Study of Maternal Pyelonephritis [07A]
Authors: Kidd Jennifer M. J. , Gimovsky Martin
Published: April 2020

INTRODUCTION:

Guidelines from the Society of Critical Care Medicine (SCCM) on maternal sepsis are limited. The Sepsis in Obstetrics Score has been proposed as a maternal specific sepsis score. This study attempts to identify sepsis before diagnosis using a modified form of this score. For consistent pathology across patients, a cohort of maternal pyelonephritis cases were used to capture sepsis cases.

METHODS:

An IRB approved retrospective cohort study included maternal admissions for pyelonephritis from 2016 to 2019. Exclusion criteria were absence of fetal tracing, alternative diagnosis on admission, or multiple gestation. Chart review included maternal demographics, obstetric history, insurance status, prenatal care access, cultures, and sepsis status. Sepsis score was calculated by presentation maternal vitals and fetal heart rate.

RESULTS:

The cohort included 72 patients diagnosed with pyelonephritis of which 22% had sepsis. The average cohort patient was black, insured, and reported prenatal care access. The sepsis group was younger, more nulliparous, and more likely to have positive urine cultures. Only 59% of positive urine cultures were E. coli. As expected the sepsis group had more positive blood cultures. However, the sepsis score did not identify sepsis status.

CONCLUSION:

This study is strengthened by a homogeneous cohort of singular disease pathology. However, the duration of pathology varied at presentation and could not be case matched potentially affecting the sepsis cohort. This study does not support the proposed sepsis scoring. The scoring could be improved by the addition of patient risk factors. Further study is needed to identify predictors of sepsis in the gravid patient.
Posaconazole as a Highly Efficacious Alternative for Treating Recurrent and Resistant Vulvovaginal Candidiasis [13A]
Authors: Tiran-Saucedo Jose , Garza Humberto , Godinez Jesus Alfonso , León Camacho Yvette Karina , Sepúlveda Argáez Ana Gabriela , Méndez Bertrand Jean-Carla
Published: April 2020

INTRODUCTION:

Candidiasis is the second most common type of vaginal infection. Sometimes successful treatment due to underlying conditions, long standing disease, or even resistance emerging against antifungals, make it a real challenge. New alternative options are needed to help our patients heal faster and for longer periods of time.

METHODS:

We conducted a longitudinal descriptive study, in a private clinic setting IMIGO in Monterrey Mexico between January 2017 to October 2019, on 11 female patients with a diagnosis of recurrent and/or resistant vulvovaginal candidiasis between 23 to 59 years of age who after receiving multiple unsuccessful antifungal treatments, were treated with posaconazole as an alternative treatment option. Analysis of outcomes on recurrence of disease, disease free intervals, and number of treatment schedules needed for successful treatment of vulvovaginal candidiasis were evaluated.

RESULTS:

The 11 patients included in the study previously received multiples cycles of antifungals ranging from 1 to 7 (fluconazole, itraconazole, nystatin, terbinafine) with remission periods from 3 days to a maximum of 5 months. All patients were treated with posaconazole without need of a second cycle with remissions ranging from 6 months to 21 months.

CONCLUSION:

Posaconazole showed great results in patients with vulvovaginal candida resistant and recurrent infections with longer remission periods. This first 11 patients results show posaconazole to be considered as an antifungal of choice in this cases.