bluuebunny/crossref_metadata_2025_split huggingface dataset:
Research in Pregnancy: The Ethics of Risk-Benefit Tradeoffs Between Woman, Fetus, and Future Child [21G]
Authors: Little Maggie , Wickremsinhe Marisha , Lyerly Anne 
Published: May 2017

INTRODUCTION:
In contrast to many areas of health research, the field of HIV/AIDS has pursued research with pregnant women as a key component of its research agenda. Several large trials have made vivid a number of critical ethical questions for research with pregnant women broadly--including how risks and benefits can and should be traded off between the woman, the fetus, and the future child--offering an important opportunity for building an adequate ethical framework for research in pregnancy, more generally.

METHODS:
As a part of a multidisciplinary research project addressing barriers and opportunities to conducting research with pregnant women (the PHASES project--Pregnancy and HIV/AIDS: Seeking Equitable Study), we examined several large HIV network studies conducted in the last five years that required risk/benefit tradeoffs between woman, fetus and future child in conjunction with U.S. research regulations and the research ethics literature. Selected studies were analyzed in conjunction with U.S. research regulations and the research ethics literature.

RESULTS:
We describe three challenging tradeoff scenarios encountered in HIV network studies and develop an approach that is consistent with US regulations governing research with pregnant women.

CONCLUSION:
The inclusion of pregnant women in clinical research can be justified based on 1) the prospect of direct and indirect benefit to fetus; 2) the imposition of no more than minimal risk for studies involving no prospect of benefit to fetus; or 3) a reasonable ratio of maternal benefit to fetal risk. Tradeoffs between the fetus and the future child risk should be responsive to potential participants’ values.
Listening to Women's Comments: Text Mining Will Revolutionize How We Organize and Act on Women's Concerns [23G]
Authors: Adams Ted , Mo Wenbin , Amey Annette , Burlingame Esther 
Published: May 2017

INTRODUCTION:
Listening and acting upon women's comments is central to the relationship we have with patients. Doing this systematically and scientifically is difficult and sometimes involves thematic analyses which are time consuming and costly to perform. We present a new way of analyzing thousands of comments and seeing how each comment affects the HCAHPs rate hospital score (RHS).

METHODS:
We utilized text mining to analyze 27,335 free text comments. Comments were provided by women from Jan 2008 to June 2014 as supplemental comments to the HCAPHs survey. We used SAS text miner (v13.1). Similar words were combined. We then calculated the frequency of each word and the frequency of its relationships to other words using an expectation maximization algorithm. This produced a set of most frequently linked words which are statistically significantly related to each other. We then performed multiple regression analyses to determine magnitude of positive or negative effect on HCAHPs RHS.

RESULTS:
Negative comments have a larger effect on rate hospital score than positive comments. Comments regarding midwives had the highest positive effect on RHS. Topics generated were helpfulness of staff, cleanliness, feeding, pain control and postpartum care. All these areas had a statistically significant effect (p=0.05) on the RHS given by the person giving the comment.

CONCLUSION:
The systematic nature of this analysis is important. Our output is not subject to interpretation bias or comment reading fatigue. Whilst we present national level data the analysis could be performed on different subsets of data, providing results at regional or hospital level.
Obstetric Informatics: Quality Improvement Using Peer-Based Anonymous Physician Score Card [24G]
Authors: Labbad Gabriel , Martens Mark 
Published: May 2017

INTRODUCTION:
With the widespread adoption of Computerized Physician Order Entry, auditing physician prescribing practices is technically simplified. We propose leveraging data from aggregate audits to develop a visual tool for quality improvement - the peer-based anonymous physician score card.

METHODS:
For our pilot quality improvement project, we have selected the prescribing of ondansetron for nausea and vomiting of pregnancy. This is a common condition for which recent evidence based recommendations have been updated by APGO and the American College of Obstetricians and Gynecologists in 2014 and 2015 respectively. Data was collected through a retrospective database query from our EMR for all medical records associated with pregnant patients who received a prescription of ondansetron in the ambulatory setting from January 2012 through August 2016 at our suburban hospital. Aggregate prescribing data was then tabularized onto bar graphs and anonymized.

RESULTS:
A total of 56 physicians were identified prescribing ondansetron as a first line medication. A total 484 patients were identified as having received ondansetron. 344 (71%) of which were not prescribed a first line medication. Of the 140 (29%) patients that did receive a first line medication only 64 (13%) patients received the prescription prior to or on the same date as ondansetron.

CONCLUSION:
By presenting peer prescribing habits to our physicians in an anonymous fashion, we propose this will serve as a non-invasive tool to raise awareness and reveal barriers to adoption of recent clinical guidelines. We will track prescribing patterns for an additional 6 months and re-evaluate individual and aggregate prescribing patterns after this intervention.
Multidisciplinary Approach to the Perinatal Care of Families Affected by Fetal Anomalies [25G]
Authors: Kodeih Hanna , Maher James , Schlabritz-Lutsevich Natalia , Angelis Dimitrios , Kelly Randall , Hampton Moss 
Published: May 2017

INTRODUCTION:
The prenatal diagnosis of a congenital anomaly occurs in 2-3% of all pregnancies and affects 120,000 births annually. Ultrasonographic diagnosis has dramatically changed the neonatal care of affected infants, allowing for effective matching of the delivery site with the neonate’s post-delivery needs, when instability is anticipated. We believe our perinatal conference improves neonatal outcomes, resource utilization, and patient satisfaction. Additionally, this conference offers coordination of care essential for optimal delivery planning, patient education, and neonatal consultation. We would like to study these parameters.

METHODS:
At Texas Tech University Health Sciences Center School of Medicine Permian Basin Obstetrics and Gynecology Department, perinatal conference is a multidisciplinary conference which is used as a tool for: 1) Dissemination of information about complex problems to the health care team 2) Discussion of core needs and delivery plans, 3) Education in ultrasound for residents and faculty in families affected by fetal anomalies. This conference includes review of antenatal patients with fetal anomalies, followed by review of ultrasound images and discussion of care plan. Fetuses with structural problems often require delivery at a surgical center. This conference aids in avoiding inappropriate local deliveries, emergent delivery, and neonatal transport. This conference serves to facilitate communication on status of affected pregnancies, updates of delivered babies, and quality improvement opportunities for future infants.

RESULTS:
Retrospective analysis has shown fewer inappropriate deliveries and associated decrease in utilization of resources.

CONCLUSION:
Prenatal ultrasound diagnosis of congenital anomalies in combination with multidisciplinary management provides a critical opportunity to improve patients’ care and physician education.
Class I Medical Device Recalls in Women’s Health: 2002 - 2016 [27G]
Authors: Janetos Timothy , Ghobadi Comeron , Xu Shuai , Walter Jessica 
Published: May 2017

INTRODUCTION:
Class I recalls are defined by the Food and Drug Administration (FDA) as the most serious type of recall where a medical device problem could lead to death or serious health problems. Understanding the factors leading to these events in women’s health may provide policy implications to improve medical device safety.

METHODS:
We performed a retrospective review of the FDA’s database for Class I device recalls in women’s health from 2002-2016. The reason for recall was defined as either a premarket (e.g. device design problems) or a postmarket (e.g. manufacturing problems) issue.

RESULTS:
75 unique Class I recalls affecting more than 88,000 medical devices were identified from 2002-2016. Recalls included diagnostic assays for chlamydia/gonorrhea, a laparoscopic tissue morcellator, and surgical kits used in women’s health. 95% of recalls were due to postmarketing problems such as improper packaging and labeling. Only 5% of recalls were due to premarket issues (device or software design). In regards to the original approval pathway, 4% of recalled products were cleared via the 510K pathway, while 96% were essentially exempt from premarket approval by the FDA. No recalls were attributed to devices approved along the most stringent post-market approval pathway. The majority of recalls occurred after 2013 with 93% of total recalls occurring in 2014; this spike was attributed to sterility problems with surgical kits used in obstetrics and gynecological procedures.

CONCLUSION:
The majority of recalled devices in women’s health required minimal regulatory scrutiny prior to approval suggesting the need for continued postmarket vigilance.
Ulipristal Acetate Treatment of Uterine Fibroids in Black and Obese Women: Venus I Subgroup Analyses [28G]
Authors: Simon James A. , Catherino William , Blakesley Rick , Chan Anna , Sniukiene Vilma , Al-Hendy Ayman 
Published: May 2017

INTRODUCTION:
Ulipristal acetate (UPA) is an oral selective progesterone receptor modulator. This phase 3, multicenter, prospective, randomized, double-blind, study (VENUS I; NCT02147197) was designed to evaluate the efficacy of UPA for treatment of uterine fibroids (UF) and included a large proportion of Black (self-identification) and obese (BMI ≥30 kg/m2) patients.

METHODS:
Premenopausal women (18-50 years) with cyclic excessive uterine bleeding, and ≥1 discrete UF were randomized to once daily UPA 10 mg, UPA 5 mg, or placebo for 12 weeks, with a 12-week drug-free follow-up. Amenorrhea was defined as no bleeding (spotting permitted) for the last 35 days of treatment. Least squares mean change in activity scores were assessed using the UF symptom and quality of life questionnaire revised activity subscale.

RESULTS:
Of 157 patients randomized, 68.8% were Black and 50.3% were obese. In Black and non-Black patients, amenorrhea rates were higher with UPA 10 mg (59.5% and 54.5%) and UPA 5 mg (44.4% and 52.9%) versus placebo (0.0% and 4.8%); activity scores were also improved with UPA 10 mg (60.5 and 43.6) and UPA 5 mg (51.4 and 50.9) versus placebo (16.9 and 26.0). For obese and non-obese patients, amenorrhea rates were higher with UPA 10 mg (66.7% and 47.6%) and UPA 5 mg (50.0% and 44.4%) versus placebo (3.8% and 0.0%); activity scores were also improved with UPA 10 mg (66.4 and 48.7) and UPA 5 mg (54.2 and 49.1) versus placebo (18.0 and 24.1).

CONCLUSION:
In this first US-based phase 3 study, UPA efficacy was observed regardless of race and BMI.
Characterization of Hysterectomy/Uterine Ablation Rates in VWD and Undiagnosed Bleeding Using Claims Data [32G]
Authors: Sidonio Robert F. , Woods Kalinda , Fallaize Dana 
Published: May 2017

INTRODUCTION:
Heavy menstrual bleeding (HMB) is common in women and adolescents post menarche, in some cases resulting in hysterectomy or uterine ablation. Based on retrospective studies 10-62% of women with HMB may have an underlying bleeding disorder (BD), such as von Willebrand Disease (VWD), the most common bleeding disorder. Despite public awareness campaigns, a diagnosis of a potential bleeding disorder is often missed or significantly delayed. Here we characterize the rates of hysterectomy/uterine ablation in a symptomatic undiagnosed (SUD) vs. symptomatic diagnosed VWD (SVWD) population.

METHODS:
We utilized the IMS Health Real-World Data Adjudicated Claims, looking at patients continuously enrolled for 2+ years (July 2013 ‒ July 2015) with 1+ severe bleed or 2+ bleed claims. These symptomatic patients were classified based on presence (SVWD; n=837) or absence (SUD; n=2,760) of a VWD diagnosis claim.

RESULTS:
The incidence of hysterectomies/uterine ablation was similar between the SUD vs. the SVWD patients (5.9% and 7.3% respectively). However, the mean age at the time of hysterectomy was significantly (P < 0.05) younger in SUD (35 years) versus the SVWD patients (42 years). 8% of the procedures performed in the SUD occurred in patients 18-25 years old versus 1% in the SVWD patients.

CONCLUSION:
Treatment options for HMB require an evaluation of the etiology, which may be, in many cases, an underlying BD. A timely diagnosis of VWD allows patients access to therapies specifically targeting VWD, including antifibrinolytics, DDAVP and factor replacement, potentially avoiding or delaying the need for more terminal therapies such as hysterectomy/uterine ablation.
Pregnant Women Experiencing Violent Trauma Have Higher Death Rates Despite Less Severe Injuries [36G]
Authors: Deshpande Neha , Kucirka Lauren , Deshpande Sujay , Smith Randi , Oxford Corrina 
Published: May 2017

INTRODUCTION:
Trauma is the leading non-obstetric cause of maternal death with 5-8% incidence in the United States. We compared violence-related outcomes between pregnant women and their non-pregnant counterparts.

METHODS:
We studied 197 pregnant and 4658 non-pregnant women of reproductive age (14-49) who experienced violent trauma between 2005-2015 as captured in the Pennsylvania Trauma Outcomes Study. We used modified Poisson regression to estimate relative rates of trauma-related outcomes. All models were adjusted for injury severity score and age.

RESULTS:
Compared to non-pregnant women, pregnant women were younger (mean age=24.3 versus 30.6 years, p < 0.001), more likely to be African-American (54.3% versus 40.1%, p< 0.001), and to have Medicaid insurance (63.1% versus 57.6%, p=0.04). They were less likely to have preexisting psychiatric, drug use, and alcohol use disorders (18.8%, 8.6%, and 2.0% for pregnant women versus 30.1%, 14.2%, and 8.8% for non-pregnant women, respectively, p < 0.03 for all). Pregnant women had a mean injury severity score of 8.7 compared to 9.5 for non-pregnant women (p=0.3), and were significantly more likely to suffer trauma secondary to assault (adjusted relative rate-aRR)=1.06, 95%CI: 1.00-1.12, p=0.04). Pregnant women were more likely to require surgery (aRR=1.06, 95%CI1.01-1.12, p=0.03), and were 3.4 times more likely to undergo hospital transfer (aRR=3.41, 95%CI: 2.32-5.00, p < 0.001). Pregnant women had mortality rates twice that of their non-pregnant counterparts despite lower injury severity scores (aRR=1.98, 95%CI: 1.24-3.07, p=0.004).

CONCLUSION:
After violent trauma, pregnant women have twice the death rate of their non-pregnant counterparts. Screening for violence during pregnancy is paramount for prevention of trauma-related death.
Five Year Experience With Total Vaginal Hysterectomy [7H]
Authors: Morano Jessica Y. , Tiu Andrew C. 
Published: May 2017

INTRODUCTION:
The vast majority of hysterectomies in our country are done through the abdominal route. A minimally invasive approach is recommended due to better outcomes, lower rates of complications, and shorter operative time. This study is to present our five year experience with total vaginal hysterectomy.

METHODS:
We reviewed the medical records of 470 patients from 2009 ‒ 2013 who underwent hysterectomy in a community hospital. We had a total of 183 patients who underwent total vaginal hysterectomy.

RESULTS:
We averaged 93 hysterectomies per year and total vaginal hysterectomies comprised 39% while total abdominal, total laparoscopic, and laparoscopy-assisted vaginal hysterectomy comprised 10%, 2%, and 49%, respectively. The total minimally invasive rate was 90%. Concomitant bilateral oophorectomy was 61.7%. The mean patient age was 48 ± 14 years with mean BMI of 30.07 ± 7.83 kg/m2. Thirteen percent had no previous vaginal deliveries. The top three preoperative indications for the procedure were prolapsed uterus (36%), postmenopausal bleeding with thickened endometrium (27%), and enlarged fibroid uterus (18%). The mean uterine weight, operative time, estimated blood loss, and length of hospital stay were 102 ± 70 grams, 34.51 ± 16.86 minutes, 89 ± 91 ml, and 1.09 ± 0.39 days, respectively, which were all smaller compared with our experience with laparoscopy-assisted vaginal hysterectomy and abdominal hysterectomy. There were 2 patients who had bladder injuries, all repaired without sequelae.

CONCLUSION:
Total vaginal hysterectomy is safe, effective, with short learning curve and a low rate of complications. Enlarged (fibroid) uterus and nulliparity are not contraindications for the procedure.
A 10 Year Analysis of Chronic Pelvic Pain (CPP) and Chronic Narcotic Use (CNU) in the Female Veteran Population [8H]
Authors: Cichowski Sara , Rogers Rebecca , Murata Allison , Murata Erin , Murata Glen 
Published: May 2017

INTRODUCTION:
Narcotics are prescribed to treat debilitating pelvic pain without proved efficacy, and with significant harm risk. Our objective was to compare chronic narcotic use (CNU) and average narcotic doses prescribed 5 years prior and following chronic pelvic pain (CPP) diagnosis.

METHODS:
We used the validated Veteran’s affairs corporate database warehouse. Time 0 was the 1st CPP diagnosis date by ICD-9 codes. Outpatient narcotic prescriptions were summed for the 5 years preceding and following CPP diagnosis; oral narcotics were converted to morphine equivalents (ME). CNU was defined as greater than 90 narcotic use days per year; drug abuse/overdose rates were defined by ICD-9 codes.

RESULTS:
73,319 women met inclusion criteria of non-cancer CPP with average age of 40.1 ± 11.5 years; 37.3% minority, with an average BMI of 29.4± 6.0 kg/m2 and 34.6% had a history of military sexual trauma. Five years prior to CPP diagnosis, 10-12% of women were on CNU. Five years following diagnosis, CNU increased to 14-16% (or by 10,477 women/5 years, p < 0.001). Average narcotic doses ranged from 31.4 mg to 37.7 mg ME per dose and did not increase over the years (p=0.158). During the 10 year period, 12.7% (9,304) women were diagnosed as drug abusers and 3.3% (2,384 women) had an overdose. Drug overdose significantly increased after the diagnosis of CPP from 1.2% (954 women) to 2.0% (1430 women) of the entire CPP population (P < 0.001).

CONCLUSION:
Drug abuse is common in women with CPP, CNU increases after CPP diagnosis, as does drug overdose.
Management of Abnormal Uterine Bleeding in the Emergency Department Setting: Trends Over the Last 10 Years [10H]
Authors: Sidana Neetika , Liu Grace , Kroft Jamie , Kung Rose , Murji Ally , Robertson Deborah 
Published: May 2017

INTRODUCTION:
Abnormal uterine bleeding is an issue facing many premenopausal women. Despite the risks of parenteral estrogen it continues to be first line treatment in clinical guidelines (AJOG 2016, American College of Obstetricians and Gynecologists 2013). We hypothesize that prescribing practices will demonstrate a decreased reliance on parenteral estrogen.

METHODS:
A retrospective chart review is underway to analyze emergency department charts for premenopausal women presenting to academic centers located in the Toronto area, between 2006 and 2016. 144 charts have been sampled from a proposed sample size of 6,412. Exclusion criteria included: postmenopausal bleeding, pregnancy related, malignancy or iatrogenic.

RESULTS:
The average patient in our pool was 37 years old (range 16-56). Hemoglobin at presentation ranged between 34 to 145 with 9.72% of patients requiring transfusion. The average length of stay was 5.18 hours. 50.69% of women did not receive tranexamic acid and NSAIDs were used only 6.25% of the time. OCP use occurred in only 4.86% of cases compared to 1.39% of women being treated with progestins. Parenteral estrogen was used in 2.08% of cases. Selective progesterone receptor modulators and GnRH agonists were never prescribed or utilized. Endometrial biopsy was performed in less than 1% of patients.

CONCLUSION:
Our data demonstrates that clinical practice guidelines are out of date. Parenteral estrogen is not being used as first line treatment. Despite average lengths of stay greater than 5 hours, endometrial biopsies are still not being performed for undiagnosed abnormal uterine bleeding. Revised guidelines and better utilization of newer medical therapies by physicians in the emergency setting are needed.
Safety and Efficacy of Dinoprostone and Misoprostol Vaginal Inserts for Labor Induction [11H]
Authors: Miller Hugh , Billips Benjamin , Dutia Roxanne , Raymond Kyle , Powers Barbara 
Published: May 2017

INTRODUCTION:
The purpose of this study was to compare the safety and efficacy of the removable dinoprostone vaginal inserts (DVI) and misoprostol vaginal inserts (MVI) using a pooled analysis.

METHODS:
Data were obtained from a pooled analysis of three phase II/III trials that randomized 1,925 women with longer than 36 0/7 weeks gestation with a modified Bishop score of 4 or less to DVI (mean release rate 0.3 mg/h) (n=1,116) or MVI (mean release rate 7 µg/h) (n=809). The distribution of time to vaginal delivery in both treatment groups was assessed using a log-rank test. Fisher exact test was used to test whether treatment was associated with peripartum adverse events. Data are presented as mean±standard deviation.

RESULTS:
Certain adverse events were significantly less common with DVI compared to MVI, including meconium in amniotic fluid (12.2% vs 17.6%; P=.001), abnormal labor affecting fetus (ie, hyperstimulation syndrome) (4.2% vs 10.6%; P < .001), and fetal acidosis (0.04% vs 1.2%; P=.030), while chorioamnionitis was more common with DVI compared to MVI (7.3% vs 4.9%, P=.037). There were no significant differences between treatment groups for fetal heart rate disorder, postpartum hemorrhage, and arrested labor; neonatal intensive care unit admissions and cesarean delivery incidence were similar between groups. Time to vaginal delivery (hours) was longer with DVI compared to MVI (25.2±12.8 vs 19.0±10.7, P < .001).

CONCLUSION:
DVI use was associated with decreased rates of meconium, abnormal labor affecting fetus, and fetal acidosis as well as with higher rates of chorioamnionitis and a slower time to delivery compared to MVI.