bluuebunny/crossref_metadata_2025_split huggingface dataset:
Prevention of Postoperative Adhesion Formation Using Noninvasive Technology [38F]
Authors: Recanati Maurice-Andre , Kramer Katherine , Rambhatla Anupama , Berman Jay Michael , Huttemann Maik 
Published: May 2019

INTRODUCTION:
Postoperative adhesions occur following laparoscopic and open procedures, cause pain, infertility, bowel obstruction and other complications. Surgically-induced tissue injury causes inflammation and hypoxia resulting in alterations in cytochrome c oxidase (COX) activity, mitochondrial membrane potential (ΔΨm) hyperpolarization and reactive oxygen species (ROS) production. ROS initiate a cascade causing the irreversible transformation of fibroblasts to adhesion phenotype in injured peritoneum. Infrared light (IRL) can modulate COX activity through the following mechanism: IRL → COX activity↓ → ΔΨm↓ → ROS↓ → TGF-β1↓→ prevention of adhesion phenotype, making adhesion-free surgery possible.

METHODS:
Mitochondrial respiration, ROS, and ΔΨm were analyzed. Adhesion markers were measured by ELISA. Electrocautery and cytobrush were used to traumatize peritoneal tissue in Sprague-Dawley rats. Tissues, evaluated and harvested on day 7, were cryosectioned, hematoxylin/eosin stained, and immunofluorescence analyzed with confocal microscopy. IRL was generated by light emitting diodes.

RESULTS:
COX activity increases in injured peritoneum. IRL significantly decreased COX activity, whole cell respiration, ΔΨm, and ROS production. Hypoxia, ischemia/reperfusion and hyperoxia increased ROS, ΔΨmand TGFβ1 in macrophages, neutrophils and fibroblasts and transformed fibroblasts to adhesion phenotype. IRL robustly decreased ROS, ΔΨmand TGF-β1 and abrogated conversion to adhesion phenotype in vitro. Rats treated with IRL following adhesion surgery had lower numbers and severity of adhesions on gross examination, less fibrosis on histology and less adhesion marker expression on immunofluorescence compared to untreated controls.

CONCLUSION:
IRL may be used to non-invasively modulate COX activity, decrease ROS and decrease the conversion of fibroblasts to adhesion phenotype limiting postoperative adhesions.
Bremelanotide for Hypoactive Sexual Desire Disorder: Contraceptive Subgroups Efficacy Analysis [15OP]
Authors: Clayton Anita H. , Kingsberg Sheryl , Simon James A. , Jordan Robert , Williams Laura , Krop Julie 
Published: May 2019

INTRODUCTION:
Bremelanotide, an investigational new drug, demonstrated efficacy in premenopausal women with hypoactive sexual desire disorder (HSDD) in the RECONNECT studies. In this analysis, bremelanotide efficacy was investigated across hormonal contraceptive subgroups.

METHODS:
RECONNECT comprised two replicate, phase 3, double-blind, randomized, placebo-controlled, IRB-approved studies. Subjects self-administered bremelanotide 1.75 mg or placebo subcutaneously for 24 weeks, using an autoinjector pen on demand prior to sexual activity. Subjects were evaluated (“yes” and “no” subgroups) based on concurrent use of hormonal contraceptives (including oral contraceptives and other estrogen-containing products). Efficacy was assessed using RECONNECT co-primary endpoints: change from baseline to end-of-study (EOS) for Female Sexual Function Index-desire domain (FSFI-D) and Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) Item 13 scores.

RESULTS:
In the integrated population (N=1202), difference in mean change in FSFI-D and FSDS-DAO Item 13 from baseline to EOS (bremelanotide-placebo) was 0.35 and -0.33, respectively (P<.0001 for both endpoints). In the study, 18.4% (N=221) concurrently used hormonal contraceptives (“yes” subgroup). Subjects in "no" subgroup who were treated with bremelanotide (N=484) showed a statistically significant increase in FSFI-D relative to placebo (N=497; 0.39, P<.0001). Those in "yes" subgroup showed a numerical difference in favor of bremelanotide (N=112) versus placebo (N=109; 0.19, P=.1557). Change from baseline to EOS in FSDS-DAO Item 13 was statistically significant in favor of bremelanotide relative to placebo in both subgroups (-0.30 and -0.34; P=.0471 and P<.0001, respectively).

CONCLUSION:
Independent of the type of contraceptive used, bremelanotide demonstrated improvements in sexual desire and related distress in premenopausal women with HSDD.
Engaging Obstetric and Gynecology Patients in Safety and Quality through Shared Visit Notes [03OP]
Authors: Herlihy Mary , Harcourt Kendall , Fossa Alan , Folcarelli Patricia H. , Golen Toni , Bell Sigall 
Published: May 2019

INTRODUCTION:
OpenNotes, a national initiative inviting patients to read their ambulatory visit notes through the patient portal reaches 27 million patients, but little is known about OBGYN patient OpenNotes experiences.

METHODS:
In a quality improvement initiative from April 2016 - September 2017, patients from generalist OBGYN and gynecologic subspecialty practices at an academic hospital who accessed their notes were invited to give feedback through a reporting tool comprised of 10 items including: understanding of their notes and care plan, identification of errors, sensitive words, and concerning labs. Two physicians with safety expertise reviewed all patient-reported errors to determine their potential to affect care.

RESULTS:
212 patients submitted 232 reports. In 92-95% of reports, patients reported understanding the notes, the care plan, and that notes accurately described their visit. Of all reports, 27% identified inaccuracies in the notes including: Symptoms: 29%; Family History 21%; Medications: 15%; Problem list 15%; Social History and Physical Exam, including elements that were documented but not performed, each 11%. Patients rated inaccuracies as important in 58% of reports, and 75% of inaccuracies had the potential to affect care on clinician review. Seven percent of reports indicated bothersome words, including: “denied” (vs “does not”) “depressed” (vs “grieving”), and “not sexually active” (vs respect for context).

CONCLUSION:
Overall, patients were positive about OpenNotes, describing appreciation for, and reassurance from, such access. Addressing bothersome words may further improve engagement. About a quarter of patient reports identified documentation inaccuracies, the majority of which were relevant to care on clinician review
MATE Survey: Men’s Attitudes Toward Menopause and Their Role in Partner’s Menopause Transition [18OP]
Authors: Parish Sharon J , Faubion Stephanie S , Weinberg Marc , Bernick Brian , Mirkin Sebastian 
Published: May 2019

INTRODUCTION:
Men's perceptions about menopause are largely unknown. This survey characterized men's understanding and knowledge of their partner's menopause transition and key symptoms.

METHODS:
A 35-question, online survey was sent to men recruited from the Cint online research exchange. Men were eligible if their female partner (45-64 y) experienced â≥1 symptom(s): hot flashes, night sweats, sleepless nights, difficulty sleeping, low libido, mood swings, pain during sex, or vaginal dryness. Couples could live together full time or separately, but reside together often.

RESULTS:
Of 1356 surveys sent, 450 were completed (33% response rate). The majority of men were between 50 and 59 years (51%), married (90%), and were in their relationship more than 20 years (62%). Men were able to recognize their partners experienced sleepless nights/difficulty sleeping (54%), tiredness/lack of energy (48%), low libido/less desire for sexual contact (47%), mood swings (47%), and hot flashes (46%). Men attributed symptoms to menopause (55%) and associated menopause with physiological changes (53%). Men reported menopausal symptoms negatively impacted them (76%), their partner (70%), and relationship (55%). Men engaged with their partner (72%) in a predominately positive manner (85%) regarding menopausal symptoms and tried to be supportive (31%). While less than half were aware of treatment options (47%), men believed they were very/somewhat influential (74%) in their partner's seeking treatment and lifestyle modifications.

CONCLUSION:
Men are aware of the menopause transition and willing to discuss symptoms. As men may influence decisions relating to management, educating them about menopause and available treatment options should be part of menopausal care strategies.
DONALD F. RICHARDSON PRIZE PAPERComparing Risk Stratification Criteria for Predicting Lymphatic Dissemination in Endometrial Cancer [06OP]
Authors: Kilts Toni P. , Kilts Toni P. , Glaser Gretchen E. , Langstraat Carrie L. , Kumar Amanika , Weaver Amy L. , McGree Michaela E. , Gostout Bobbie S. , Podratz Karl C. , Dowdy Sean C. , Cliby William A. , Mariani Andrea , Bakkum-Gamez Jamie N. 
Published: May 2019

INTRODUCTION:
To compare two published risk stratification criteria (Milwaukee Model vs. Mayo Criteria) to predict lymphatic dissemination (LD) in endometrioid endometrial cancer (EC).

METHODS:
Patients who underwent surgery for EC between 1/1/2004-9/30/2013 and had endometrioid histology without stage IV disease were included and classified as either low-risk or at-risk for LD using two independent risk stratification systems. LD was defined as positive nodes at time of surgery or lymph node recurrence within 2 years of surgery after negative lymph node assessment (LNA) or when LNA was not performed. False positive (FP) and false negative (FN) rates for each risk model were calculated.

RESULTS:
Among 1103 patients, 81 (7.3%) had LD (72 positive LN and 9 LN recurrences). Most patients (90.2%) had stage I disease. Integration of the Milwaukee Model was associated with a low at-risk rate for LD (38.1%) but a relatively high FN rate (13.6%, 95% CI 7.0-23.0). Conversely, the traditional Mayo Criteria using a tumor diameter (TD) cutoff of ≤2 cm (vs >2 cm) had a higher at-risk rate for LD (69.5%) but a FN rate of 0.0% (95% CI, 0-4.5). Modifying Mayo Criteria using a TD cutoff of ≤3 cm (vs >3 cm) identified fewer women at-risk than using ≤2 cm cutoff (56.8% vs. 69.5%), but had a higher FN rate of 3.7% (95% CI, 0.8-10.4).

CONCLUSIONS:
The Milwaukee Model had the lowest at-risk rate of LD but an unacceptable FN rate. Modifying the Mayo Criteria by increasing the TD cutoff from the traditional ≤2 cm to ≤3 cm would spare an estimated 12.7% of patients LNA, but the accompanying FN rate is unacceptably high. The traditional Mayo Criteria for low-risk EC remains the most accurate in determining which patients LNA can be omitted.
THIRD PLACE Provider Adherence to Surgical Guidelines for Risk Reducing Salpingo-oophorectomy in BRCA Mutation Carriers [08OP]
Authors: Wilhite Annelise Marie , Oestreich Makinna Caitlin , Coetzee Donna , Khalifa Mahmoud , Erickson Britt 
Published: May 2019

INTRODUCTION:
The ACOG clinical management guidelines for Hereditary Breast and Ovarian Cancer Syndrome endorse the strict surgical protocol recommended by the National Comprehensive Cancer Network at the time of risk reducing salpingo-oophorectomy (RRSO) for BRCA mutation carriers. The purpose of this study is to compare the rate of provider compliance to this protocol between gynecologic oncologists (GOs) and obstetrician gynecologists (OB/GYNs).

METHODS:
This multi-center retrospective cohort study included women with deleterious BRCA mutations who underwent RRSO between 2011 and 2017. Patients were identified using ICD 9/10 codes and a regional genetic counseling database. Compliance was measured by collection of washings, complete resection of the fallopian tube, and serial sectioning with microscopic examination (SEE-FIM protocol). Statistical analysis was performed.

RESULTS:
Of the 290 patients who met inclusion criteria, 160 patients were treated by 18 GOs and 130 patients were treated by 75 OB/GYNs at 10 different hospitals within a large metropolitan area. Overall, 68.5% of cases were compliant. GOs were over twice as likely to fully comply with the surgical protocol as OB/GYNs (OR 2.2, 95% CI 1.7-3.0). Specifically, they were more likely to collect washings (94.3% vs 49.2%), resect the whole tube (99.3% vs 95.4%), and adhere to SEE-FIM protocol (97.5% vs 82.3%). Complication rates did not differ between groups.

CONCLUSION:
Despite clear surgical guidelines, only 2/3 of patients received full guideline-based care. GOs were more likely to follow national guidelines compared to general OB/GYNs. Rates of risk reducing surgery will likely continue to increase as genetic testing becomes more widespread, highlighting the importance of provider education for this important procedure.
Cost Effectiveness of Mifepristone Pretreatment for the Medical Management of Nonviable Early Pregnancy [09OP]
Authors: Nagendra Divyah , Schreiber Courtney A. , Koelper Nathanael , Sonalkar Sarita , Loza-Avalos Sandra , Harvie Heidi 
Published: May 2019

INTRODUCTION:
To compare the cost effectiveness of pretreatment with mifepristone to misoprostol alone in women seeking medical management of nonviable early pregnancy.

METHODS:
This within-trial comparison included 300 women with anembryonic gestation or embryonic/fetal demise randomized to off-label misoprostol 800 mcg vaginally or off-label mifepristone 200 mg followed 24 hours later by misoprostol. The primary outcome was gestational sac expulsion with one dose of misoprostol. Both healthcare and societal sector perspectives were adopted to calculate the incremental cost effectiveness ratio (ICER), expressed as cost per quality-adjusted life-year (QALY) gained. Costs included medical treatment and complications, patient and caregiver time, transportation, and lost productivity over the 30-day study period. Results are in 2018 US dollars. QALYs were based on a modified utility score, with successful medical therapy defined as 1 and need for uterine aspiration defined as 0.95. This study was approved by the University of Pennsylvania Institutional Review Board.

RESULTS:
Complete expulsion rate after one misoprostol dose was 124/148 (83.8%) with mifepristone pretreatment versus 100/149 (67.1%) after misoprostol alone. Uterine aspiration was required for 13 (8.8%) women after mifepristone pretreatment and 35 (23.5%) women after misoprostol alone. In the healthcare sector analysis mifepristone pretreatment was less expensive ($657 vs. $658 mean per-person cost) and more effective (0.08 vs. 0.07 QALYs gained) than misoprostol alone. Analysis from the societal perspective again demonstrated that mifepristone pretreatment was both less expensive ($3,807 vs. $4,819) and more effective than misoprostol alone.

CONCLUSION:
Pretreatment with mifepristone is the economically dominant strategy as it is both cost saving and more effective.
Longitudinal Effect of United States Military Policy on Contraception Use and Childbirth Among Junior Enlisted [10OP]
Authors: Roberts Timothy , Smalley Joshua , Baker Laura , Weir Larissa F. , Adelman William 
Published: May 2019

INTRODUCTION:
Contraceptive use and unintentional pregnancy rates among junior enlisted vary between United States service-branches, despite equal access to no-cost contraception. Therefore, branch-specific policy may influence contraceptive use.

METHODS:
Secondary analysis of insurance records from 92,072 servicewomen, who attended basic training between 2013 and 2017, assessing the longitudinal effect of changes in branch-specific contraceptive policy on rates of: longer-acting (depot-medroxyprogesterone, implant, and intrauterine) contraception use at six months on active duty; and childbirth during the first 24-months of active duty. Multivariable Logistic (contraception use) and Cox (time to childbirth) Regression models were used to compare outcomes before and after the intervention, between the service making the intervention and the other three branches, and the interaction between these variables. IRB approved.

RESULTS:
Group contraceptive education emphasizing implantable and intrauterine methods followed by individual contraceptive consultation with a provider for all female, Navy basic trainees increased longer-acting method use (11.8% to 24.3%, Interaction Term OR: 2.14 (95% CI: 1.92-2.39), P<.001) and decreased childbirth rates (7.5% to 6.3%, HR: 0.86 (0.76-0.88), P=.015). Restricting time away from training for implant or intrauterine method insertion during Marine Corps basic training and providing education emphasizing use of depot-medroxyprogesterone for menstrual control decreased overall longer-acting method use (16.2% to 10.0%, OR: 0.43 (0.38-0.49), P<.001) and increased childbirth rates (8.0% to 9.7%, HR: 1.24 (1.02-1.51), P=.027). Allowing contraceptive implant placement during basic training increased use of longer-acting contraception among Air Force recruits 4.4% to 6.9%, OR: 1.31 (1.14-1.51), P<.001).

CONCLUSION:
Branch-specific changes in military contraceptive policy significantly impact contraceptive use and childbirth rates among junior enlisted.
Efficacy of the 1-Year Segesterone Acetate/Ethinyl Estradiol Contraceptive Vaginal System [21OP]
Authors: Westhoff Carolyn L. , Darney Philip , Jensen Jeffrey T. , Bahamondes Luis , Apter Dan , Merkatz Ruth B. 
Published: May 2019

INTRODUCTION:
A novel, ring-shaped, contraceptive vaginal system (CVS) containing segesterone acetate (SA), also known as Nestorone®, and ethinyl estradiol (EE) is designed to last 1 year (13 cycles), delivering an average of SA 0.15/EE 0.013 mg/day. Efficacy was evaluated in 2 multicenter, 1-year, open-label studies (one at 15 US sites; one at 5 US/7 international sites).

METHODS:
Women (18-40 yrs) used the CVS for 21 days/cycle followed by having it out for 7 days. Women were not to remove the CVS for >2 hours during the 21 days of use. The primary efficacy outcome was the Pearl Index (PI) for women ≤35 years of age, excluding cycles with adjunctive contraception. Secondary outcomes included the PI for subgroups and intention-to-treat Kaplan-Meier life-table analyses.

RESULTS:
Of 2265 participants analyzed, 1303 (57.5%) completed. The primary PI was 2.98 (95% CI [2.13-4.06]). The PI was 2.10 (95% CI [1.37-3.06]) in women who followed use instructions versus 5.89 (95% CI [3.46-9.27]) for women who documented removals >2 hours (P=0.0024). Significantly higher PIs were also observed in subgroups by age (18-19 yrs vs ≥36yrs), parity (≥1 vs 0), race (Black vs white), ethnicity (Hispanic vs non-Hispanic), and site (non-Europe vs Europe), but not by BMI. Life-table analyses revealed the CVS is 97.3% effective in preventing pregnancy. Pregnancies did not increase across cycles.

CONCLUSION:
The SA/EE CVS is an effective 1-year, procedure-free contraceptive controlled by women that can help address an unmet worldwide contraceptive need. Counseling to ensure correct use is essential for optimizing efficacy.
Elagolix Reduced Heavy Menstrual Bleeding With Uterine Fibroids: Primary, 6-Month, Phase 3 Results [11OP]
Authors: Schlaff William , Al-Hendy Ayman , Barnhart Kurt , Owens Charlotte D. , Liu Ran , Muneyyirci-Delale Ozgul 
Published: May 2019

INTRODUCTION:
The objective was to evaluate the efficacy and safety of elagolix, an oral, non-peptide, gonadotropin-releasing hormone antagonist, with add-back therapy, in women with heavy menstrual bleeding (HMB, >80 mL/cycle menstrual blood loss [MBL]) associated with uterine fibroids (UF).

METHODS:
These were two replicate, investigational, double-blind, randomized, placebo-controlled, 6-month, phase 3 studies (Elaris UF-1 and Elaris UF-2) where patients were randomized in a 1:1:2 ratio to placebo, elagolix 300 mg twice daily (BID) and elagolix 300 mg BID in combination with 1mg estradiol (E2)/0.5 mg norethindrone acetate (NETA) once daily add-back. Patients were premenopausal, 18-51 year-old women. The primary endpoint was the percentage of women at Final Month with <80 mL MBL and ≥50% reduction in MBL from baseline. Adverse events (AEs) and bone mineral density (BMD) were monitored. IRB approval was obtained.

RESULTS:
In Elaris UF-1, 412 patients were randomized and treated; 328 patients completed treatment. Elagolix with and without E2/NETA, reduced HMB at Final Month, with significantly more women achieving the primary endpoint compared with placebo (Elaris UF-1: elagolix+E2/NETA=68.5%, P<0.001; elagolix-alone=84.1%, P<0.001; placebo=8.7%). 50% of women treated with elagolix+E2/NETA experienced a treatment-related AE (elagolix-alone=80%; placebo=38%); 68-90% of women experienced any AE. The least-squared mean [SE] percentage change from baseline to month 6 for lumbar spine BMD was not significantly different from placebo for elagolix+E2/NETA (elagolix+E2/NETA=-0.75%[0.19], P=0.092; placebo=-0.21%[0.26]), but was significantly different for elagolix alone compared with placebo (-3.03%[0.28], P<0.001). Elaris UF-2 results were similar and will be presented at the meeting.

CONCLUSION:
Elagolix with and without E2/NETA reduced MBL in women with HMB associated with UF. The addition of E2/NETA attenuated BMD decreases seen with elagolix alone.
The Impact of First Trimester Sonography on Pregnancy Dating [36S]
Authors: Seasely Angela Rose , Bird Ashley , Zink Ashley , Lutich Ann , McKiever Monique , Patel Shivani R. 
Published: May 2019

INTRODUCTION:
To evaluate accuracy of last menstrual period (LMP) in pregnancy dating at time of presentation for prenatal care.

METHODS:
An IRB-approved retrospective study of all women presenting in 2016 for pregnancy confirmation was performed. All women received a sonogram to confirm gestation. Dating was based on American College of Obstetricians and Gynecologists guidelines. Charts were reviewed for utilization of genetic screening and scheduled delivery. Logistic regression models assessed the association between estimated due date (EDD) changes and patient characteristics.

RESULTS:
Of 1,724 individuals presenting for pregnancy confirmation, 1,376 patients sought care in the first trimester with known LMP. Of these, 23.5% had their EDD changed based on ultrasound. When changed, 43.9% were at less than 9 weeks' gestation. 21.2% who underwent first trimester screening would have missed the opportunity for screening during the 13th week if EDD was not changed. Of the 41.6% who underwent medically indicated or elective scheduled delivery, 41.1% would have been scheduled too early if their EDD were not changed. Obese (OR 1.98, 95% CI 1.39-2.84) and underweight (OR 2.96, 95% CI 1.29-6.77) women were most likely to require alteration of EDD. There was a trend towards EDD modification with increasing gravidity and biphasic oral contraceptive use.

CONCLUSION:
Nearly 1 in 4 women presenting for prenatal care in the first trimester with known LMP required adjustment of their EDD based on first trimester ultrasound. The characteristic most significantly associated with EDD adjustment was BMI. First trimester ultrasound is vital as it affects timing of genetic screening and scheduled delivery.