bluuebunny/crossref_metadata_2025_split huggingface dataset:
Menstrual Cycle Influence on COVID-19 Detection Using Machine Learning and a Wearable Medical Device [A120]
Authors: Kovacevic Vladimir , Markovic Andjela , Veen Duco , Brakenhoff Timo B. , Mitratza Marianna , Goodale Brianna M. 
Published: June 2022

INTRODUCTION:
Prior research has demonstrated how immune functioning and physiological signals fluctuate across the menstrual cycle, with eumenorrheic women more likely to become ill during the luteal phase. Examining such changes during the current pandemic, we explored how the relationship between menstrual cycle phase and physiological signals impacts a wearable medical device’s ability to detect COVID-19.

METHODS:
The largest institutional review board‒approved wearable device study monitoring SARS-CoV-2’s effects on biophysiology to date, COVID-RED aims to develop a machine learning algorithm predicting an infection up to 3 days prior to symptom onset. Wearing the device nightly, participants (N=17,824) sync it with a mobile application and log SARS-CoV-2 diagnostic tests, symptoms, and menses in the app’s Daily Diary. The algorithm ingests physiological and self-reported features to provide each user with a real-time update about their likelihood of infection.

RESULTS:
Daily infection likelihood and predictions of ovulation using proprietary algorithms were generated during a 9-month period for 1,574 eumenorrheic women (n=3,281 menstrual cycles) not currently on hormonal birth control. The negative/positive ratio of predicted COVID-19 cases during the 5-day period preceding ovulation was 2.94 compared to 4.83 in the 5 days post-ovulation (chi-square (1, N=33,920)=343.34, P<.0001). Participants reported 22 SARS-CoV-2 positive test results, with five times as many confirmed infections occurring in the postovulatory period (n=10) compared to the preceding 10-day window (n=2).

CONCLUSION:
Demonstrating that machine-learning algorithms ingesting wearable data should consider menstrual cycle impact, our findings suggest that women may be more susceptible to SARS-CoV-2 during their luteal phase, with further studies needed to disentangle underlying mechanisms.
Phase 3 Study of Fezolinetant for Treatment of Moderate-to-Severe Vasomotor Symptoms Associated With Menopause [A132]
Authors: Lederman Samuel , Shapiro CM Marla , Stute Petra , Lee Misun , Wang Xuegong , Neal-Perry Genevieve 
Published: June 2022

INTRODUCTION:
SKYLIGHT 1 was conducted to evaluate the efficacy and safety of the novel non-hormonal treatment, fezolinetant, versus placebo in women with moderate-to-severe vasomotor symptoms (VMS) associated with menopause.

METHODS:
This phase 3, institutional review board approved, double-blind trial (NCT04003155) randomized women aged 40–65 years with moderate-to-severe VMS (≥7 hot flashes/day) to once-daily placebo, fezolinetant 30 mg, or fezolinetant 45 mg. Co-primary efficacy endpoints were mean change from baseline to week 4 and 12 in frequency and severity of moderate-to-severe VMS. Treatment-emergent adverse events (TEAEs) were assessed.

RESULTS:
Overall, 527 women were randomized; 522 took ≥1 dose (placebo n=175, fezolinetant 30 mg n=173, fezolinetant 45 mg n=174). Both fezolinetant doses were shown to statistically reduce VMS frequency and severity at both timepoints. For VMS frequency, least squares mean (standard error) reductions versus placebo at week 4 were –1.87 (0.42), P<.001 for fezolinetant 30 mg and –2.07 (0.42), P<.001 for 45 mg. At week 12, these values were –2.39 (0.44), P<.001 for 30 mg and –2.55 (0.43), P<.001 for 45 mg. For VMS severity at week 4, reductions were –0.15 (0.06), P=.012 for 30 mg and –0.19 (0.06), P=.002 for 45 mg; at week 12, reductions were –0.24 (0.08), P=.002 for 30 mg and –0.20 (0.08), P=.007 for 45 mg. TEAEs were reported by 37.4% (fezolinetant 30 mg), 43.4% (fezolinetant 45 mg), and 44.6% (placebo) of women. Headache was the most common TEAE: 5.2% (30 mg), 6.4% (45 mg), and 7.4% (placebo).

CONCLUSION:
Fezolinetant 30 mg and 45 mg were efficacious for the treatment of moderate-to-severe VMS associated with menopause. No safety signals of concern were apparent for either fezolinetant dose.
Inclusion of Limited English Proficiency Individuals in Obstetric Randomized Controlled Trials [A161]
Authors: Mulhall Joseph C. , Zhao Zhiguo , Limperg Tobias 
Published: June 2022

INTRODUCTION:
Limited English proficiency (LEP) individuals are historically underrepresented in clinical research. This study aims to quantify the inclusion of LEP individuals in high-impact obstetric studies performed in the United States, compared to the general population.

METHODS:
This literature review with a systematic search identified the 100 most cited randomized controlled trials within the field of obstetrics published from 2010 to 2019 (10 per year). Subanalyses or follow-up reports of previously published RCTs or meta-analyses were excluded. The primary outcome was the proportion of LEP individuals among trial participants compared to LEP individuals as a percentage of the U.S. population. Secondary outcomes included percentage of studies excluding LEP individuals.

RESULTS:
In Web of Science/MEDLINE, 1,227 articles were screened and 100 articles were selected for data extraction. A total of 64,179 participants were included (per-article median, 161; range, 12–2,827). The median number of citations per article was 78 (range, 14–980). A total of 66% (95% CI, 55.6–75.2%) received National Institutes of Health funding. LEP individuals were excluded in 31% (95% CI, 22.1–41.0%) of studies, as described in the article or study protocol. Inclusion was specifically allowed in 19 studies that represented 30.1% (95% CI, 30.6–31.4%) of the total study population. Only three studies reported actual inclusion of 828 LEP individuals, representing 1.3% (95% CI, 1.2–1.4%) of total participants, as compared to 8.5% of the U.S. population.

CONCLUSION:
A significant portion of high-impact obstetric studies either exclude LEP individuals or do not address inclusion, which has important implications for external validity of these studies. Future directions include surveying the investigators of identified studies to more accurately approximate included individuals.
Overview of the Rapid Antidepressant Effects Observed in the Zuranolone Clinical Development Program [A164]
Authors: Clayton Anita H. , Deligiannidis Kristina M. , Kotecha Mona , Doherty James 
Published: June 2022

INTRODUCTION:
Zuranolone is an investigational oral neuroactive steroid in clinical development for once-daily, 2-week treatment of postpartum depression (PPD) and major depressive disorder (MDD) in the NEST and LANDSCAPE clinical development programs, respectively. Here we review the rapid antidepressant effects and the safety of zuranolone in four completed placebo-controlled studies in these programs.

METHODS:
ROBIN (NCT02978326; Phase 3; zuranolone 30 mg [ZRN30]; baseline 17-item Hamilton Rating Scale for Depression total score [HAMD-17] ≥26; N=153) in PPD; MDD-201B (NCT03000530; Phase 2; ZRN30; baseline HAMD-17 ≥22; N=89 [62% women]), MOUNTAIN (NCT03672175; Phase 3; zuranolone 20 mg or ZRN30; baseline HAMD-17 ≥22; N=581 [70% women]), and WATERFALL (NCT04442490; Phase 3; zuranolone 50 mg; baseline HAMD-17 ≥24; N=543 [66% women]) in MDD. All studies were institutional review board‒approved.

RESULTS:
Treatment with zuranolone led to rapid and nominally significant improvements in depressive symptoms versus placebo (as assessed by least squares mean treatment difference [SE] in change from baseline in HAMD-17) as early as Day 3 in ROBIN (−2.7 [1.19], P=.025), MOUNTAIN (ZRN30, −1.5 [0.64], P=.0160), and WATERFALL (−3.0 [0.52], P<.0001) and Day 2 in MDD-201B (−2.3 [0.99], P=.0223). Treatment-emergent adverse events (incidence ≥5% in zuranolone arms) included headache, somnolence, dizziness, nausea, sedation, diarrhea, upper respiratory tract infection, fatigue, and dry mouth (≥94% mild to moderate in severity). No loss of consciousness or excessive sedation were observed in any of the studies.

CONCLUSION:
These data from the NEST and LANDSCAPE clinical development programs demonstrate that treatment with zuranolone can lead to rapid improvement in depressive symptoms with a generally well-tolerated safety profile.
COVID-19 Vaccine Hesitancy in the California Central Valley: Why Are Pregnant Patients Saying “No”? [A201]
Authors: Franks Jennifer M. , Chavez-Sturman Taide , Kavipurapu Kiran , Lopez Juan 
Published: June 2022

INTRODUCTION:
Rates of COVID-19 continue to be elevated in the California Central Valley, despite improved access to vaccination. Pregnant women are at increased risk for severe illness and preterm labor with COVID-19 infection. The American College of Obstetricians and Gynecologists and the Centers for Disease Control and Prevention recommend vaccination of pregnant women. Yet, many still decline vaccination. This study is an effort to understand the rate at which patients decline vaccination and the reasons they do so.

METHODS:
Pregnant and peripartum participants were recruited from inpatient and outpatient clinical settings. We obtained demographics, history of exposure, vaccination status, intention to vaccinate, reasons for hesitancy, and knowledge of current recommendations and risks. Information was obtained using a standardized questionnaire, in English and Spanish.

RESULTS:
Of 160 surveyed, 146 participated, of whom 28% were vaccinated. Average age was 28 years; 68% Hispanic and 25% primarily Spanish-speaking. Education level was significantly associated with vaccination status (P=.03), with 53% of those with an associate’s degree or higher vaccinated, while only 22% of those with less education were vaccinated. Political party affiliation was significantly associated with vaccination status (P=.01). Having a friend or family member who had COVID-19 did not predict vaccination status. The most commonly selected reason for vaccine hesitancy was “What I have heard from the internet/media about the vaccine concerns me.”

CONCLUSION:
Our results demonstrate that level of education and political affiliation are associated with vaccination status in pregnant and peripartum patients in our population. Future counseling should be aimed at counteracting misinformation spread via internet/media sources.
CHARM 2: A Gender Synchronized Family Planning Intervention for Couples in Rural India, a Cluster Randomized Trial [A05]
Authors: Raj Anita , Ghule Mohan , Johns Nicole , Battala Madhusudana , Begum Shahina , Averbach Sarah 
Published: June 2022

INTRODUCTION:
Gender synchronized family planning interventions are posited to be an important means of engaging men while supporting women’s reproductive agency and increasing modern contraceptive use, particularly in contexts where traditional gender norms prevail. The Counseling Husbands to Achieve Reproductive Health and Marital Equity (CHARM) intervention counsels men, women, and couples on gender equity and family planning.

METHODS:
This is an institutional review board (IRB)-approved cluster randomized controlled trial evaluating the effect of the CHARM2 intervention on contraceptive use, communication and agency, pregnancy, and quality of care among married couples across 20 clusters in rural Maharashtra, India.

RESULTS:
We enrolled 1,201 couples. Full-couple retention at 18 months was 90.5%. Contraceptive use was higher among intervention participants at 9 but not 18 months (adjusted ratio of odds ratio [AROR] 1.5, 95% CI 1.03-2.3 and AROR 0.8, 95% CI 0.4-1.4). Communication (9-month AROR 1.9, 95% CI 1.0-3.6; 18-month AROR 2.7, 95% CI 1.5-4.8) and agency (9-month AROR 5.1, 95% CI 1.2-22.4; 18-month AROR 8.1, 95% CI 1.4-48.2) improved at both times. Intervention participants had significantly higher mean Interpersonal Quality of Family Planning scale scores at both times (9-month intervention 3.2 vs control 2.3, P<.001; 18-month intervention 3.2 vs control 2.8, P<.001). There was no significant difference in pregnancy between groups over the 18-month period (AOR 0.8, 95% CI 0.7-1.1) However, unintended pregnancy was marginally less likely among intervention participants (47% vs 19%) (P=.07).

CONCLUSION:
Broad implementation of the CHARM2 intervention has the potential to improve contraceptive use, communication, agency, and quality of care and to possibly decrease unplanned pregnancies in rural India.
Complex Family Planning Fellowship Graduates’ Practice Plans and Barriers to Practicing in Areas of Unmet Need [A42]
Authors: Pomerantz Tali S. , Creinin Mitchell D. 
Published: June 2022

INTRODUCTION:
With recent changes in the political climate, complex family planning (CFP) fellowship directors have noted an increasing proportion of applicants expressing the intent to practice in areas with a dearth of abortion providers. However, data does not exist documenting fellowship graduates’ intended and post-training practice areas.

METHODS:
We anonymously surveyed 2017-2020 CFP fellowship graduates to inquire about demographics, intended and obtained post-fellowship positions, and successes and challenges in obtaining jobs. We used descriptive statistics and coded and analyzed open-ended responses for thematic content using grounded theory.

RESULTS:
One hundred (91%) of 110 invited CFP fellowship graduates responded. Most (92%) expected to practice in an academic environment. Half (49%) pursued fellowships with the intent to practice in a location with an unmet need for abortion providers. Of those, only 22 (45%) did so. When asked why they ultimately did not practice where intended, common themes included job availability, family-related concerns, safety concerns, and relationship status changes.

CONCLUSION:
CFP fellowship graduates primarily intend to practice in academic environments, with half planning to do so in underserved locations. However, the majority of those who entered fellowship hoping to fill an unmet need for abortion providers were unable to do so. While the CFP fellowship has laid the groundwork for training leaders in abortion provision, more work is needed to eliminate barriers that interfere with fellowship graduates’ willingness and ability to obtain positions in locations with unmet need.
Cost-Effectiveness of Opportunistic Salpingectomy Following Vaginal Delivery for Ovarian Cancer Prevention [A102]
Authors: Wagar Matthew K. , Forlines Grayson L. , Moellman Nicholas , Carlson Anisa , Matthews Michael , Williams Makeba 
Published: June 2022

INTRODUCTION:
Opportunistic salpingectomy at the time of benign gynecologic surgery and cesarean delivery is a cost-effective strategy for ovarian cancer risk reduction. We sought to evaluate the cost-effectiveness of opportunistic salpingectomy compared to standard tubal ligation in the immediate postpartum period following vaginal deliveries.

METHODS:
Using two decision analytic models, we simulated a hypothetical cohort of 10,000 women undergoing bilateral salpingectomy or tubal ligation immediately following vaginal delivery. We derived probabilities of ovarian cancer risk reduction following tubal sterilization from published literature. We used institutional charge data to determine cost inputs. The primary outcome was the incremental cost-effectiveness ratio (ICER) per quality-adjusted life year (QALY) at a cost-effectiveness threshold of $100,000/QALY. Institutional review board (IRB) approval was obtained.

RESULTS:
Opportunistic salpingectomy is more cost-effective than tubal ligation following vaginal delivery in a theoretical cohort, with an ICER of $24,176/QALY. Compared to tubal ligation, opportunistic salpingectomy yields a theoretical total cost savings of $6.48 million. Discounted costs of ovarian cancer were $2.9 million lower for the salpingectomy cohort compared to tubal ligation. Opportunistic salpingectomy avoided 12 fewer ovarian cancer cases and 8 fewer ovarian cancer deaths compared to tubal ligation.

CONCLUSION:
Our analytic model demonstrates that following vaginal delivery, opportunistic salpingectomy is a cost-effective strategy for reducing risk of ovarian cancer. Compared to tubal ligation, opportunistic salpingectomy reduces ovarian cancer cases and mortality.
Knowledge Retention and Clinical Skills Acquisition in Sexual and Gender Minority Health Curricula: A Systematic Review
Authors: Mains-Mason Janke B. , Ufomata Eloho , Peebles J. Klint , Dhar Cherie P. , Sequeira Gina , Miller Rebekah , Folb Barbara , Eckstrand Kristen L. 
Published: June 2022

Purpose
To identify exemplary medical education curricula, operationalized as curricula evaluating knowledge retention and/or clinical skills acquisition, for health care for sexual and gender minoritized (SGM) individuals and individuals born with a difference in sex development (DSD).

Method
The authors conducted a systematic review of the literature using Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Searches were performed in PubMed/MEDLINE, The Cochrane Library, Web of Science, ERIC, Embase, PsycINFO, and the gray literature to identify studies that (1) pertained to undergraduate and/or graduate medical education, (2) addressed education on health care of SGM/DSD individuals, and (3) assessed knowledge retention and/or clinical skills acquisition in medical trainees. The final searches were run in March 2019 and rerun before final analyses in June and October 2020.

Results
Of 670 full-text articles reviewed, 7 met the inclusion criteria. Five of the 7 studies assessed trainee knowledge retention alone, 1 evaluated clinical skills acquisition alone, and 1 evaluated both outcomes. Studies covered education relevant to transgender health, endocrinology for patients born with DSDs, and HIV primary care. Only 1 study fully mapped to the Association of American Medical Colleges (AAMC) SGM/DSD competency recommendations. Six studies reported institutional funding and development support. No studies described teaching SGM/DSD health care for individuals with multiply minoritized identities or engaging the broader SGM/DSD community in medical education curriculum development and implementation.

Conclusions
Curriculum development in SGM/DSD health care should target knowledge retention and clinical skills acquisition in line with AAMC competency recommendations. Knowledge and skill sets for responsible and equitable care are those that account for structures of power and oppression and cocreate curricula with people who are SGM and/or born with DSDs.
Barriers, Challenges, and Solutions: What Can We Learn About Leadership in Academic Medicine From a Qualitative Study of Emergency Medicine Women Chairs?
Authors: Hobgood Cherri D. , Draucker Claire 
Published: June 2022

Purpose
Women have made significant gains in leadership across all disciplines in academic medicine but have not yet achieved leadership parity as department chairs. The authors investigated the challenges experienced by one cohort of women department chairs in emergency medicine (EM) and the solutions they proposed to address these challenges.

Method
The authors conducted a qualitative descriptive study of 19 of 20 possible current and emeritus emergency medicine women department chairs at academic medical centers between April and December 2020. Participant interviews elicited self-reported demographic characteristics and narrative responses to a semistructured interview template that focused on the role of gender in their leadership and career trajectories. Interviews were transcribed, blinded, and iteratively coded and categorized.

Results
The analysis demonstrated 4 common challenges and 5 enacted or proposed solutions. The challenges discussed by the participants were: feeling unprepared for the role of department chair, being one of few women in leadership, inheriting unhealthy department cultures, and facing negative faculty reactions. The individual- and institutional-level solutions discussed by the participants were: gaining and maintaining confidence (individual), maintaining accountability and mission alignment (individual), facilitating teamwork (individual), supporting women’s leadership (institution), and creating safe leadership cultures (institution).

Conclusions
Women department chairs in EM were successful academic leaders despite confronting several challenges to their leadership. Considering the study findings through the lens of the concept of second-generation gender bias further illuminates the influence of gender on leadership in academic medicine. These findings suggest several possible strategies that can combat gender bias, increase gender parity among academic medicine’s leadership, and improve the leadership experience for women leaders.
Efficacy and Underlying Mechanism of Berberine Against Atherosclerosis: A Meta-Analysis in Preclinical Animal Studies
Authors: Jia Dongdong , Zhang XinYue , Guo Qianqian , Yang Rui , Yu Haitao , Zhao Mengzhu , Shi Liu , Liu Menghua , Wu Aiming , Zhang Dongmei 
Published: June 2022

Abstract:
Atherosclerosis is the primary cause of many cardiovascular diseases, and an increasing number of studies have shown that berberine could delay plaque formation and development. Therefore, we aimed to evaluate its effects and explore its mechanisms in this meta-analysis. We searched PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, Wanfang, and VIP databases for original preclinical studies to conduct meta-analysis. Twelve articles (16 studies; 312 ApoE−/− mice) were included, and all the studies scored 3–5 points according to SYRCLE's risk of bias tool. Berberine could significantly decrease plaque area and plaque macrophage content (plaque area, SMD = −2.02, 95% CI: −2.80 to −1.24, P = 0.000; plaque macrophage content, SMD = −4.28, 95% CI: −7.67 to −0.88, P = 0.013); lower the levels of TC, triglyceride, and low-density lipoprotein (TC, SMD = −1.47, 95% CI: −2.20 to −0.74, P = 0.000; triglyceride, SMD = −0.77, 95% CI: −1.21 to −0.33, P = 0.000; low-density lipoprotein, SMD = −0.61, 95% CI: −1.11 to −0.11, P = 0.000), and change the secretion of inflammatory cytokines (IL-1β, SMD = −2.29, 95% CI: −3.40 to −1.18, P = 0.000; interleukin-6, SMD = −1.48, 95% CI: −2.11 to −0.85, P = 0.008; tumor necrosis factor-α, SMD = −1.98, 95% CI: −3.01 to −0.94, P = 0.000; interleukin-10, SMD = 1.78, 95% CI: 0.76 to 2.80, P = 0.015), but there were no significant differences in high-density lipoprotein levels and plaque lipid content (high-density lipoprotein, SMD = 0.02, 95% CI: −0.35 to 0.40, P = 0.021; plaque lipid content, SMD = −6.85, 95% CI: −21.09 to 7.39, P = 0.007). The results were robust across a range of sensitivity analyses. Therefore, the results indicate that berberine is a promising drug for the treatment of atherosclerosis through regulating lipid metabolism, inflammation, and plaque composition. However, some potential mechanisms remain to be further elucidated.