bluuebunny/crossref_metadata_2025_split huggingface dataset:
Endometriosis Analysis: Current Healthcare Utilization and Costs in Women With Endometriosis [17B]
Authors: Williams Kristina , Paris Andy , Duch Dan , Kozma Chris , Bender Stephen 
Published: April 2020

INTRODUCTION:
To develop a greater understanding of endometriosis patients' clinical characteristics, provider characteristics, and costs.

METHODS:
Longitudinal data from a 1/1/2010–9/30/2018 national commercial claims and encounters database, were examined. Person-specific (blinded) clinical utilization, expenditures, and enrollment were examined. There were 975 patients with a confirmed endometriosis diagnosis (e.g., laparoscopy, hysterectomy, oophorectomy). Data from 5 years prior to confirmed diagnosis and 1-year after were included.

RESULTS:
In 5 years prior to confirmed endometriosis diagnosis 93.7% of patients visited an Ob/Gyn; 79.3% family medicine; and 52.9% emergency medicine. More than half the patients (60.1%) visited an emergency room (mean 3.46 visits). Approximately 27% had visits to a chiropractic office (mean 17.94 visits over 5 years); 17.6% had physical therapy (mean 10.53 visits). Confirmed diagnosis averaged 984 days (2.7 years) from initial symptoms. Diagnoses for painful periods, heavy menses, infertility, and intercourse pain increased in the year before diagnosis. Oral contraceptive was the most common hormonal therapy. Gonadotropin use was 0.8% prior to diagnosis;12.4% in 6 months following; declined to 8.2% in the next 6 months. Average annual costs in years 5–2 prior to diagnosis were $4, 318; $6,791 year immediately prior to diagnosis; $17,230 in first 6 months post-diagnosis; and $6,129 in months 7–12 post-diagnosis.

CONCLUSION:
This analysis provides insight into patient clinical needs leading up to and following confirmed diagnosis of endometriosis. Understanding these characteristics may lead to more efficient healthcare utilization and lower costs.
Impact of Anesthesia on Estimated Blood Deficit With Dilation and Curettage for Early Pregnancy Loss [21B]
Authors: Conn Allison , Davis Beth R. 
Published: April 2020

INTRODUCTION:
To evaluate the route of anesthesia [general endotracheal tube (GETA) inhalational agents versus total intravenous anesthesia (TIVA)] affects estimated blood loss (EBL) during dilation and curettage (D&C) for early pregnancy loss.

METHODS:
Women with early pregnancy loss that underwent D&C January 1, 2016 to May 31, 2017 had their medical records reviewed. Groups were compared that had GETA versus TIVA. The primary outcome was surgical EBL. To detect a 39% decrease in EBL, with a standard deviation of 200 ml at P<.05 with an 80% power, 70 women receiving each anesthetic agent were needed in each group.

RESULTS:
Of 140 charts evaluated (70 per cluster), no statistical differences were noted in sociodemographic variables between groups. Significantly greater EBL was noted in women receiving GETA (290 ml) versus TIVA (88 ml), P<.001. No differences were noted in operative room time or length of surgery. However length of anesthesia was less with TIVA (35 minutes) compared to GETA (39 minutes), P=.03. While no differences were noted in the proportion being given any type of uterotonic agent, only women receiving GETA received a blood transfusion (2.9%), returned to the operating room for bleeding (1.4%), or required hospital admission for 24 hour observation (4.3%).

CONCLUSION:
Women that require surgical intervention for early pregnancy loss, the use of GETA results in significantly greater blood loss compared to TIVA. Gynecologic providers should use TIVA as the preferred method of anesthesia for women undergoing surgical treatment for early pregnancy loss.
Outcomes of Endoscopic Cesarean Scar Defect Repair—A Retrospective Observational Study [22B]
Authors: Nezhat Camran , Vang Nataliya , Miranda-Silva Catarina , Tavakkolizadeh Shirin , Roman Robert 
Published: April 2020

INTRODUCTION:
Cesarean scar defects may cause abnormal uterine bleeding, pelvic pain and infertility. We present our preliminary results after laparoscopic and/or hysteroscopic surgical repair.

METHODS:
We performed a retrospective review of clinical data and preliminary outcomes of patients with cesarean scar defect who underwent surgery at the Camran Nezhat Institute.

RESULTS:
We included a total of 27 women. Average age was 36 years, with an average BMI of 23.1 kg/m2. Most patients (74%) had 1 prior cesarean section, while 26% had 2 or more. The most common presenting symptom was pelvic pain (81%), followed by dysmenorrhea (70%), irregular vaginal bleeding (67%) and infertility (48%). Nearly half (44%) of the patients had a previous diagnosis of endometriosis. Prior to presenting to our center, 52% of patients with infertility had attempted IVF, and 30% attempted IUI. Defect repair was performed by a combined laparoscopic and hysteroscopic approach in 85% of patients, while 7% underwent hysteroscopic repair and 11% a hysterectomy. There were 2 postoperative complications, namely umbilical scar revision and umbilical cellulitis. A diagnosis of endometriosis was established by pathology in 67% of cases. Symptoms resolved in 33% of patients, improved in 44%, and persisted in 18%. In those who desired future fertility, the clinical pregnancy rate after repair was 47% (n=7), with five resulting in live births (33%) and two miscarriages (7%).

CONCLUSION:
Cesarean scar defect repair proved beneficial with improved symptoms in 77% of patients and restored fertility in 47%. Lower pregnancy rates may be related to the increased prevalence of endometriosis in this sample.
Informing Patient Selection for Elagolix Treatment of Heavy Menstrual Bleeding Associated With Fibroids [23B]
Authors: Al-Hendy Ayman , Simon James A. , Bradley Linda D. , Owens Charlotte , Wang Hui , Barnhart Kurt 
Published: April 2020

INTRODUCTION:
Evaluate the efficacy of elagolix (300 mg BID) with add-back therapy (1 mg estradiol/0.5 mg norethindrone acetate [E2/NETA]) in various subgroups of women with heavy menstrual bleeding (HMB) associated with uterine fibroids (UF).

METHODS:
Data were pooled from two investigational, IRB approved, 6-month, phase 3 studies, Elaris UF-1 and UF-2, that evaluated premenopausal women (18–51 years) with HMB [>80 mL menstrual blood loss (MBL)/cycle; alkaline hematin methodology] and ultrasound-confirmed UF diagnosis. Subgroups analyzed include age, BMI, ethnicity, race, fibroid location based on FIGO classification, uterine and primary fibroid volume, and pregnancy history. Primary endpoint was the proportion of women with <80 mL MBL during the final month of treatment and ≥50% MBL reduction from BL to the final month of treatment. Secondary and other efficacy endpoints included mean change in MBL from baseline to final treatment month and amenorrhea. Adverse events (AEs) were monitored.

RESULTS:
In all subgroups of women who received elagolix+E2/NETA the proportion of responders to the primary endpoint, mean change in MBL from baseline to final treatment month, and proportion of women who achieved amenorrhea were statistically significant compared to placebo, consistent with the overall study population for the primary endpoint (72.2% vs 9.3%, P<.001), mean change in MBL (-172.5 mL vs -0.8 mL, P<.001), and amenorrhea (50.4% vs 4.5%, P<.001). Each subgroup AEs were consistent with the overall study population.

CONCLUSION:
Elagolix with add-back therapy was effective in reducing HMB associated with UF regardless of age, BMI, ethnicity, race, fibroid location based on FIGO classification, uterine and primary fibroid volume, and pregnancy history.
Investigating the Association Between Metabolic Syndrome and Adenomyosis [24B]
Authors: Hanson Frances K. , Kishan Raina , MacLeay Katelyn , de Riese Cornelia 
Published: April 2020

INTRODUCTION:
Adenomyosis is characterized by endometrial tissue dispersed in the myometrium of the uterus, causing heavy menses and dysmenorrhea. As of today, there is no confirmed etiology, although associations with obesity have been documented. The objective of this study is to identify additional factors such as metabolic syndrome and to determine if there is an association with adenomyosis.

METHODS:
We performed a retrospective electronic chart review of pelvic ultrasounds and clinical charts to extract surrogate markers suggestive of metabolic syndrome such as weight, BMI, HbA1c, and serum lipid profile.

RESULTS:
Preliminary data analysis of 200 patient charts, with 100 patients in each of the control (CON) and adenomyosis (AM) groups, was performed. This analysis showed that there was a statistically significant difference in weight between the two groups, with the AM group having a BMI 3.62kg/m2 higher than those in the CON group. Prior pregnancy also presented as a statistically significant difference, with the AM group (85.9%) being more likely to have been previously pregnant compared to the CON group (60%). Our data did not show statistically significant differences between the two groups among the other markers of metabolic syndrome.

CONCLUSION:
Limitations to this study include sample size, retrospective nature of the study, and the impact of medications used to treat hypertension, hyperlipidemia, and/or diabetes on the development of adenomyosis. Additional analysis is currently being performed to exclude patients who are taking medication for comorbidities relating to metabolic syndrome in order to better understand the association between metabolic syndrome and adenomyosis.
National Trends and Outcomes of Obesity and Morbid Obesity Complicating Benign Hysterectomy [28B]
Authors: Mandelbaum Rachel S. , Matsuzaki Shinya , Klar Maximilian , Roman Lynda , Wright Jason , Matsuo Koji 
Published: April 2020

INTRODUCTION:
Nearly 40% of women in the United States are obese, presenting unique challenges and considerations for gynecologic surgeons. We sought to examine trends and outcomes of benign hysterectomy in obese women.

METHODS:
A population-based retrospective study utilizing the National Inpatient Sample was conducted including benign total hysterectomies from 2001–2015 (N=2,680,788). Temporal trends of obesity, perioperative complications, and mortality rates were assessed with piecewise linear regression with log transformation. Pairwise propensity score inverse probability of treatment weighting with a generalized estimating equation was then used to estimate risk of perioperative complications and mortality.

RESULTS:
Of all women who underwent hysterectomy, 172,517 (6.4%) had Class I-II obesity and 83,513 (3.1%) had Class III (morbid) obesity. During the study period, Class III obesity increased from 0.6% to 6.4% (11.1-fold increase) and Class I-II obesity increased from 1.8% to 11.4% (6.5-fold increase) (both, P<.001). Compared to non-obese women, women with Class I-II (13.2% versus 11.0%, odds ratio [OR] 1.22, 95% confidence interval [CI] 1.18–1.27) and Class III (17.0% versus 11.0%, OR 1.40, 95% CI 1.34–1.47) obesity had significantly increased risk of perioperative complications. Mortality was increased two-fold in women with Class III obesity compared to non-obese women (0.06% versus 0.02%, OR 2.01, 95% CI 1.06–3.81). Over the study period, hysterectomy complication rates increased from 7.4% to 17.0% (2.3-fold increase, P<.001), and there was statistically non-significant increase in surgical mortality (0.01% to 0.03%, 2.4-fold increase, P=.052).

CONCLUSION:
Obesity, particularly morbid obesity, complicating benign hysterectomy has significantly increased in the United States and is associated with increased perioperative morbidity and mortality.
Quality of Life Results After 52 Weeks of Treatment With Linzagolix for Endometriosis-Associated Pain [30B]
Authors: Bestel Elke , Gotteland Jean-Pierre , Donnez Jacques , Taylor Robert N. , Garner Elizabeth I. 
Published: April 2020

INTRODUCTION:
Linzagolix is a new investigational, non-peptide, oral GnRH receptor antagonist being developed to treat endometriosis-associated pain (EAP). The EDELWEISS trial was a Phase 2b, double-blind, randomized, placebo-controlled, multicenter, dose-ranging trial in USA and Europe evaluating once daily oral doses of 50, 75, 100 and 200 mg taken for up to 52 weeks. Subjects randomized to placebo were crossed over to 100 mg after 12 weeks and those randomized to 200 mg were crossed over to 100 mg after 24 weeks.

METHODS:
IRB approval was obtained. Participants were women with surgically confirmed endometriosis and moderate to severe EAP. Assessment of EAP included dyspareunia, non-menstrual pelvic pain, dyspareunia and dyschezia symptoms. Quality of life endpoints included the difficulty of doing daily activities, Patient Global Impression of Change/Severity (PGIC/S) and Endometriosis Health Profile-30 (EHP-30).

RESULTS:
327 patients were randomized and treated. Mean age was 32 years and mean BMI was 26. In the treatment groups receiving linzagolix 75 mg and above there were significant improvements compared to placebo in EAP symptoms as well as the EHP-30 domain scores, PGIC and difficulty of doing daily activities at 12 weeks. These improvements were maintained or increased after 52 weeks of treatment.

CONCLUSION:
Linzagolix doses of 75 to 200 mg taken once daily for 52 weeks significantly decreased EAP and improved quality of life in women with moderate to severe endometriosis-associated pain.
Relugolix Combination Therapy Reduced Uterine Fibroid-Associated Pain in Two Phase 3 LIBERTY Studies [32B]
Authors: Stewart Elizabeth A. , Lukes Andrea S. , Venturella Roberta , Li Yulan , Hunsche Elke , Al-Hendy Ayman 
Published: April 2020

INTRODUCTION:
Currently, pain (menstrual and non-menstrual), is poorly studied in women with uterine fibroids (UF). Relugolix combination therapy (Relugolix-CT; once-daily relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) significantly improved UF-associated heavy menstrual bleeding in the two LIBERTY randomized phase 3 trials.

METHODS:
In the LIBERTY 1 and 2 Institutional Review Board-approved studies, a key secondary endpoint was the proportion of women with no/minimal pain (maximal pain score ≤1 on the 0–10 numerical rating scale [NRS] during the last 35 days of treatment) in the pain-evaluable population (women with maximum pain NRS ≥4 during the 35 days prior to randomization). Pain was also evaluated on menstrual bleeding and on non-menstrual days during the last 35 days of treatment. Treatment comparisons were performed in both studies and the pooled dataset using the Cochran–Mantel–Haenszel test stratified by baseline menstrual blood loss volume.

RESULTS:
After 24 weeks of treatment, a significantly greater proportion of pain-evaluable patients in the Relugolix-CT groups (43.1% and 47.1% in LIBERTY 1 and 2, respectively) had no/minimum UF-associated pain during the last 35 days of treatment compared with placebo (10.1% and 17.1%, respectively; P<.0001). The proportions of women with no/minimum dysmenorrhea and non-menstrual pain were significantly higher with Relugolix-CT (pooled data: 65.0% and 44.6%, respectively) vs placebo (19.3% and 21.6%, respectively).

CONCLUSION:
Over 24 weeks, once-daily Relugolix-CT reduced UF-associated pain, with a more pronounced effect on menstrual vs non-menstrual pain. Thus, Relugolix-CT improved two common symptoms (menstrual bleeding and pain) associated with UF.
State Level Treatment Differences in Heavy Menstrual Bleeding and Uterine Fibroids: Claims Analysis [33B]
Authors: Wang Alice , Wang Siting , Vora Jamie , Diamond Michael 
Published: April 2020

INTRODUCTION:
Heavy menstrual bleeding (HMB) is one of the most common and bothersome symptoms among women with uterine fibroids (UF). There is no published data to illustrate treatment differences by state and diagnosis of UF and/or HMB.

METHODS:
Retrospective study based on Truven MarketScan® Commercial Claims Database over the period 2007–2017. Women age 18–51 years were grouped into three cohorts upon diagnosis: a. UF only (ICD-9 218.x or ICD-10 D25.x); b. HMB only (ICD-9 626.2 or 627.0, ICD-10 N92.0, N92.1 or N92.4); c. UF and HMB. Treatment type (medical, surgical, no treatment) in the 12 months post-diagnosis was examined descriptively for each cohort and state.

RESULTS:
Study population included over one million women diagnosed with UF and/or HMB. During the 12 months post-diagnosis, about one-third of women with both UF and HMB were untreated. National surgery rate among diagnosed patients was 52% in those with UF and HMB, 20% in HMB only and 18% in UF only. At state level, surgery rate among UF and HMB diagnosed women ranged 31% - 79%; the five states with the highest surgery rates were all in the West/Midwest, and four out of the five states with the lowest surgery rates were in the Northeast. Hysterectomies represented 67% of all surgeries nationally in UF and HMB; 31 states had hysterectomy rates higher than the national average, 35% of them were in the South.

CONCLUSION:
Surgery rates were the highest among women with UF and HMB. Treatment differences among the states were substantial.
The Use of Indocyanine Green to Identify Endometriosis Intraoperatively [34B]
Authors: Meram Mary , Bealer Anne Baker , Tam Teresa 
Published: April 2020

INTRODUCTION:
The gold standard for diagnosis of endometriosis is a tissue biopsy. Endometriosis can be a debilitating cause of pelvic pain. Since symptoms can be nonspecific, presumptive diagnosis without tissue biopsy may be difficult. Recently, indocyanine green (ICG), a fluorescent dye that identifies vascular areas, has been used to help identify the vascular lesions of endometriosis, specifically the “clear” lesions that can easily be missed during surgery.

METHODS:
A retrospective chart review and data analysis was performed on patients upon whom ICG was used from July 2014 to January 2019. Preoperative symptoms, including abnormal uterine bleeding, pelvic pain, dyspareunia, and fibroids were analyzed using Fisher exact test. identification of “clear” lesions with ICG was analyzed using Fisher exact test.

RESULTS:
Of 56 patients who underwent laparoscopic excision of endometriosis with ICG, 46 with positive fluorescence had pathology-confirmed endometriosis; 10 had negative pathology with no ICG fluorescence and 10 had fluorescence but no endometriosis. This indicates a positive predictive value of 82% and a sensitivity of 100%. There was no statistically significant difference with preoperative symptoms. Clear lesions were identified using ICG in 100% of patients with endometriosis; however, there was no statistically significant difference when compared to patients without endometriosis.

CONCLUSION:
ICG dye utilization offered a diagnosis of endometriosis in 46 of 56 patients. ICG is safe, inexpensive, and may help physicians diagnose endometriosis. Additional patients should be recruited to add power to the data. A future research study could analyze the possible differences in uptake of ICG in different stages of endometriosis.
A Comprehensive Approach to Maternal Mortality and Disparate Racial Outcomes [02C]
Authors: Wilcox Wendy C. , James-Conterelli Sascha 
Published: April 2020

INTRODUCTION:
New York State ranks 30th in the nation for maternal mortality despite over a decade of statewide efforts to address the crisis. Although there has been a decrease in overall maternal mortality, the disparity between black, non-Latina women and white women have dramatically increased. Black women are 3–4 times more likely to die relative to their white counterparts in New York State and 12–14 times more likely to die in New York City. In April 2018 Governor Cuomo's Task Force was convened to address the issues of maternal mortality and racial disparities. This multidisciplinary task force consisted of a diverse group of stakeholders with Wendy Wilcox, MD, MBA, MPH, FACOG and Sascha James-Conterelli, DNP, CNM, FACNM as co-chairs.

METHODS:
Global, national and statewide data on maternal mortality data was reviewed using published data from the Centers for Disease Control, New York State and New York City Department of Health. We examined early statewide efforts to decrease maternal mortality which focused solely on addressing clinical issues. We convened community Listening Sessions across New York State in the summer of 2018, as well as a Symposium on Implicit Bias and Racial Disparities in Obstetrical Care.

RESULTS:
A comprehensive approach was adopted to address pervasive issue of maternal mortality which remains high in New York State, as well as the increasing rate of racial disparity.

CONCLUSION:
The Maternal Mortality Task force crafted recommendations to focus on more inclusivity between physicians and midwives, including the voice of the patient and addressing racial and discrimination.
Abdominopelvic Compression for Obstetric Hemorrhage in Resource-Limited Locations [04C]
Authors: Kerr Nancy L. , Hauswald Mark , Tamrakar Suman R. 
Published: April 2020

INTRODUCTION:
This quality improvement project evaluated obstetric hemorrhage patient outcomes following adoption of low cost simple pneumatic circumferential abdominopelvic compression devices.

METHODS:
Two resource-limited locations added low cost inflatable compression devices to their standard protocols for obstetric hemorrhage. Providers in small medical facilities in rural Nepal and Papua New Guinea used devices that incorporated either a bicycle tube or soccer ball to provide abdominopelvic pressure after all available routine treatments had failed. Data collected included obstetric event, etiology of bleeding, need for surgery, transfusion, transport, length of transports, maternal survival and complications.

RESULTS:
The device was used a total of 106 times: the soccer ball “Ball and Binder” device was used thirty-eight times; the prototype bicycle tube device was used sixty-eight times. Devices were used primarily after vaginal birth with atony, but also for obstetrical lacerations, miscarriages and post-abortion bleeding. In all cases the bleeding stopped promptly after inflation of the device. All 106 women survived, none required hysterectomy or abdominal surgery, and no complications were reported from device use. Only fifteen patients were transported to a referral hospital, primarily for blood transfusion.

CONCLUSION:
Obstetric hemorrhage was controlled after an abdominopelvic circumferential pressure device was applied after usual care had failed. This device provided an additional method for treatment in resource-limited settings with limitations in surgical, transfusion and transport capability.