bluuebunny/crossref_metadata_2025_split huggingface dataset:
Rheumatoid arthritis and risk of spontaneous abortion: a Danish nationwide cohort study
Authors: Nathan Nina O , Mørch Lina S , Wu Chun S , Olsen Jørn , Hetland Merete L , Li Jiong , Rom Ane L 
Published: November 2019

Abstract

Objectives
To investigate the influence of RA or preclinical RA on the risk of spontaneous abortion (SA) while taking age and duration of RA into consideration.

Methods
By linkage of data from Danish national registries, we established a nationwide cohort of pregnancies in Denmark from 1 January 1977 to 31 December 2014. We used multiple logistic regression to estimate; odds ratios (OR) for SA in women with RA or preclinical RA, compared with women without, and OR for SA by maternal age in women with RA or preclinical RA.

Results
A total of 2 612 529 pregnancies were included. Women aged &lt;35 years diagnosed with RA &lt;5 years before pregnancy had an increased risk of SA (OR = 1.25 95% CI: 1.07, 1.48), compared with women without RA aged &lt;35. Women at the same age diagnosed with RA ≥5 years before pregnancy had an OR of 1.14 (0.96–1.34), compared with women without. Among women with RA aged ≥35 years and women with preclinical RA at time of pregnancy, no increased risk of SA was found. The risk of SA increased by maternal age in both women with RA, preclinical RA and in women without.

Conclusion
Among women aged &lt;35 years, the risk of SA was higher in women with RA compared with women without. After the age of 35 years, the risk of SA was no different from that among women without RA, even though the risk of SA increased with increasing age.
How boundary objects help to perform roles of science arbiter, honest broker, and issue advocate
Authors: Sarkki Simo , Heikkinen Hannu I , Komu Teresa , Partanen Mari , Vanhanen Karoliina , Lépy Élise 
Published: November 2019

AbstractWe examine roles and knowledge by which researchers can enhance connections between science, policy, and society. We arranged a participatory scenario workshop with representatives from environmental administration to discuss how different land-use governance arrangements link to sustainability of reindeer herding in northern Finland. We used fast track scenarios as boundary objects that aimed to bring reindeer herders’ problem definitions to be discussed with administrators. First, we performed the role of science arbiter by using our previous research with reindeer herders as the starting point for the discussions. Next, we discussed and elaborated diverse future alternatives via the role of honest broker. Finally, we were interpreted as issue advocates because the scenario exercise reduced the scope of preferable policy options for administrators. Performing these boundary-spanning roles in the same process, but each, in turn, enables researchers to offer views on sustainability via scenarios that break easily acceptable conventions.
Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea
Authors: Malhotra Atul , Shapiro Colin , Pepin Jean-Louis , Hedner Jaz , Ahmed Mansoor , Foldvary-Schaefer Nancy , Strollo Patrick J , Mayer Geert , Sarmiento Kathleen , Baladi Michelle , Chandler Patricia , Lee Lawrence , Schwab Richard 
Published: November 2019

Abstract

Study Objectives
To evaluate long-term safety and maintenance of efficacy of solriamfetol treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA).

Methods
Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible. A 2-week titration period was followed by a maintenance phase (up to 50 weeks). Efficacy was assessed by Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively). After approximately 6 months of treatment, a subgroup entered a 2-week placebo-controlled randomized withdrawal (RW) phase. Change in ESS from beginning to end of the RW phase was the primary endpoint; PGI-C and CGI-C were secondary endpoints. Safety was assessed throughout the study.

Results
In the maintenance phase, solriamfetol-treated participants demonstrated clinically meaningful improvements on ESS, PGI-C, and CGI-C. In the RW phase, least squares mean change on ESS was 1.6 in participants continuing solriamfetol versus 5.3 in participants switched to placebo (p &lt; .0001). For both secondary endpoints, higher percentages of participants receiving placebo were reported as worse at the end of the RW phase versus solriamfetol (p &lt; .0001). Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants experienced at least one serious TEAE, and 61 (9.5%) withdrew because of TEAEs.

Conclusions
This study demonstrated long-term maintenance of efficacy of solriamfetol under open-label and double-blind, placebo-controlled conditions. Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified.

Trial Registration
NCT02348632
The Long Road to Gender Equality
Authors: Daly Mary 
Published: November 2019

AbstractThis piece reflects upon the significance of The Logics of Gender Justice. I make the case that this is one of the most significant works on the development of women's rights and gender justice. It offers depth of understanding of the policy and politics precipitating or blocking the roll-out of a range of such rights across time and place. Its geographical scope is both global and local. It offers a framework of analysis and a set of empirical insights that will galvanize scholarship, and not just in the field of gender. I am particularly intrigued by the differentiation between class- and status-based gender policies. I can see promise here—especially from a politics perspective—but to my mind this is not a watertight differentiation between policies. The possibility of an intersectional understanding of gender-related rights and policies is also downplayed by the Htun and Weldon's framework on my reading.
On Reading The Logics of Gender Justice
Authors: Madhok Sumi 
Published: November 2019

AbstractThis ambitious and remarkable book provides us with a new, creative, and critical site for feminist scholarship and leads the way in producing historically and contextually specific empirical datasets and analysis of the deeply complex area of global women's rights. As is often the case with important work, the book engenders a supplementary set of hard questions to be asked both of itself and of the wider literature. In particular, the book enables us to raise two sets of further questions: first, about the links between law, policy making, women's rights, and social transformation, and second, to raise methodological and conceptual questions in the wake of empirically operationalizing intersectionality on a global scale.
Technical Fixes as Challenges to State Legitimacy: Australian Separated Fathers’ Suggestions for Child Support Policy Reform
Authors: Cook Kay , Skinner Christine 
Published: November 2019

Abstract
This article assesses fathers’ evidence presented to an Australian inquiry into the child support scheme. We examine these data in order to address how fathers’ proposed child support policy solutions compared against Eekelaar’s critique of parents’ moral responsibilities to children and his identification of three substitute social bases for parents’ continued support. We find that despite the inquiry’s technical remit, fathers’ solutions challenged the very basis of child support as maintaining, reinforcing, or redressing their responsibilities to children. Here, we illustrate that such procedures may be unable to contain fundamental challenges to state legitimacy when dealing with contested social issues.
Neuromuscular Electrical Stimulation (NMES) in the Management of Glioblastoma Multiforme: A Case Report
Authors: O'Connor Dominic , Caulfield Brian , Wright Sarah , Lennon Olive 
Published: November 2019

Background and Purpose:
Glioblastoma multiforme (GBM) is associated with debilitating physical and psychosocial side effects. Voluntary exercise recommended as an adjunct therapy is often limited by physical and neurological impairments. The potential effect of aerobic and muscle-strengthening neuromuscular electrical stimulation (termed concurrent NMES) exercise (4 weeks, 2-5 times/week, 30 minutes to 1 hour) delivered to the lower limbs in patients with GBM has not been examined. This case study explores the effect of a short-term concurrent NMES intervention progressing to NMES and supervised voluntary exercise (aerobic and resistance training) over a 10-week period in a patient with GBM undergoing adjuvant treatment.

Case Description:
The case was a 61-year-old man with GBM who had completed radiotherapy treatment (40 Gy) and was undergoing adjuvant chemotherapy. Eastern Cooperative Oncology Group level was 3. Assessments were conducted at baseline, and at weeks 4 and 10 of the intervention. Outcomes included 30-second sit-to-stand (30STS), Timed Up and Go (TUG), European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30, and Godin Leisure Time Questionnaire.

Outcomes:
The intervention was well tolerated, with more than 70% NMES exercise adherence over 10 weeks and progression to combined NMES and voluntary exercise at week 5. No adverse events were reported. Despite self-reported increases in fatigue levels, clinically meaningful improvements were observed at weeks 4 and 10 for 30STS, TUG, and physical quality of life (QoL). Self-report physical activity levels increased at week 10.

Discussion:
In this first clinical case report, a 10-week NMES/voluntary exercise intervention led to improvements in physical and QoL outcomes. This initial evidence suggests NMES exercise is safe and feasible and may act as a bridge to voluntary exercise. NMES demonstrated promise as an effective supportive intervention in the management of GBM. Future clinical trials are required to expand on these initial findings.
Urinary Placental Growth Factor for Prediction of Placental Adverse Outcomes in High-Risk Pregnancies
Authors: Lecarpentier Edouard , Gris Jean Christophe , Cochery-Nouvellon Eva , Mercier Erick , Abbas Houria , Thadhani Ravi , Karumanchi Subbian Ananth , Haddad Bassam 
Published: November 2019

OBJECTIVE:
To evaluate whether urinary levels of placental growth factor (PlGF) during pregnancy are associated with the subsequent development of composite adverse outcomes (preeclampsia, fetal growth restriction, placental abruption, perinatal death, maternal death) occurring at less than 34 weeks of gestation.

METHODS:
This is a preplanned ancillary study of the Heparin-Preeclampsia trial, a randomized trial in pregnant women with a history of severe early-onset preeclampsia (less than 34 weeks of gestation). In the parent study, all women were treated with aspirin and then randomized to receive either low-molecular-weight (LMW) heparin or aspirin alone. For this substudy we measured urinary levels of PlGF and urinary creatinine at the following gestational windows: 10–13 6/7, 14–17 6/7, 18–21 6/7, 22–25 6/7, 26–29 6/7, 30–33 6/7, and 34–37 6/7 weeks of gestation.

RESULTS:
Urine samples were available from 187 patients: LMW heparin plus aspirin (n=93) and aspirin alone (n=94). The two groups had comparable baseline characteristics and had similar adverse composite outcomes at less than 34 weeks of gestation (14/93 [15.1%] vs 11/94 [11.7%]; P=.50). There were no significant differences in urine PlGF levels in the patients who received LMW heparin plus aspirin compared with those who received aspirin alone. However, median [interquartile range] urinary PlGF/creatinine concentrations (pg/mg) measured at mid-pregnancy (22–26 weeks of gestation) were significantly lower among women who developed composite adverse outcome at less than 34 weeks of gestation (42.7 [32.4–80.8] vs 255.6 [118.7–391.8] P<.001) and significantly lower among women who developed preeclampsia at less than 34 weeks of gestation (42.7 [27.5–80.7] vs 244.6 [112.9–390.6] P<.001). For a fixed false-positive rate of 10% the sensitivity of urinary PlGF concentrations at mid-pregnancy was 75.2% (area under the curve 0.93) for the subsequent development of composite adverse outcomes.

CONCLUSION:
Decreased urinary PlGF at mid-gestation (22–26 weeks of gestation) is associated with the subsequent development of preeclampsia-related adverse outcomes at less than 34 weeks of gestation.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT00986765.
Evaluation of Risk-Assessment Tools for Severe Postpartum Hemorrhage in Women Undergoing Cesarean Delivery
Authors: Kawakita Tetsuya , Mokhtari Neggin , Huang Jim C. , Landy Helain J. 
Published: November 2019

OBJECTIVE:
To examine and compare the validity of three known risk-assessment tools (CMQCC [California Maternal Quality Care Collaborative], AWHONN [Association of Women's Health, Obstetric and Neonatal Nurses], and NYSBOH [New York Safety Bundle for Obstetric Hemorrhage]) in women undergoing cesarean delivery.

METHODS:
We conducted a retrospective cohort study that evaluated all women undergoing cesarean delivery at 23 weeks of gestation or longer from 2012 to 2017 at an urban hospital with average of 1,200 cesarean deliveries per year. Data were obtained by chart review. Severe postpartum hemorrhage was defined as transfusion of at least four units of packed red blood cells during the intrapartum or postpartum period. For each risk-assessment tool, women were stratified into low-risk, medium-risk, and high-risk groups. Risk factors were examined using multivariable logistic regression.

RESULTS:
Of 6,301 women who underwent cesarean delivery, a total of 76 (1.2%) had severe postpartum hemorrhage. Women classified as low- or medium-risk had lower rates of severe postpartum hemorrhage (0.4–0.6%) compared with women classified as high-risk (1.8–5.1%) (P<.001). Risk factors that were included in all three tools that were associated with severe postpartum hemorrhage included placenta accreta, placenta previa or low-lying placenta, placental abruption, hematocrit less than 30%, and prior uterine scar. Factors included in only one or two tools that were associated with severe postpartum hemorrhage included having more than four previous vaginal deliveries (CMQCC and AWHONN), stillbirth (AWHONN), and more than four prior births (NYSBOH). Area under the curve and 95% CI for CMQCC, AWHONN, and NYSBOH were all moderate—CMQCC 0.77 (0.71–0.84), AWHONN 0.69 (0.65–0.74), and NYSBOH 0.73 (0.67–0.79), respectively (AWHONN being most sensitive [88% with high-risk as cut-off] and CMQCC being most specific [87% with high-risk as cut-off]).

CONCLUSIONS:
Risk-assessment tools had moderate prediction to identify high-risk groups at risk for severe postpartum hemorrhage after cesarean delivery.
Opioid Analgesia for Medical Abortion
Authors: Colwill Alyssa Covelli , Bayer Lisa L. , Bednarek Paula , Garg Bharti , Jensen Jeffery T. , Edelman Alison B. 
Published: November 2019

OBJECTIVE:
To estimate the effect of oral opioids on patient pain during first-trimester medical abortion.

METHODS:
We conducted a randomized, double-blind, placebo-controlled trial where patients up to 10 0/7 weeks of gestation undergoing a medical abortion with mifepristone and misoprostol took 10 mg oral oxycodone or placebo at onset of painful cramping. Additionally, all patients received 800-mg ibuprofen tablets, 4-mg ondansetron oral dissolving tablets, and a written prescription for adjunctive pain medication (six tablets oxycodone 5 mg). Participants used a text-messaging service to report pain scores on a numerical rating scale from 0 to 10 (0 being no pain, 10 being worst pain) for 24 hours at start of misoprostol dosing. The primary outcome was maximum pain experienced within 24 hours postmisoprostol. Our secondary outcomes were maximum pain stratified by gestational age (less than 7 weeks of gestation, 7–10 weeks of gestation), duration of maximum pain, use of adjunctive medication, presence of nausea or vomiting, and satisfaction. We needed at least 76 participants per group to differentiate a clinically important pain difference of 2 points on the numerical rating scale.

RESULTS:
From May 2017 to May 2018, we randomized 172 participants (placebo group with 86, oxycodone group with 86). The study groups had comparable baseline characteristics. We found no difference between groups in median maximum pain scores (placebo 8 [range 1–10], oxycodone 8 [range 2–10], P=.92) and the median duration of maximum pain (placebo 0.75 hours range 0.01–15 vs oxycodone 1 hour range 0.02–10, P=.39). Groups were also similar in the proportion obtaining (placebo 62%, oxycodone 49%, P=.09) and using (placebo 48%, oxycodone 40%, P=.28) adjunctive medication, experiencing nausea or vomiting (placebo 59%, oxycodone 65%, P=.43) and reported satisfaction with pain medications (placebo 62%, oxycodone 65%, P=.63).

CONCLUSION:
Oxycodone does not reduce the maximum level of pain experienced by women undergoing medical abortion up to 10 0/7 weeks of gestation or improve satisfaction.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT03139240.
Preemptive Oral Compared With Intravenous Acetaminophen for Postoperative Pain After Robotic-Assisted Laparoscopic Hysterectomy
Authors: Lombardi Tresa M. , Kahn Bruce S. , Tsai Lily J. , Waalen Jill M. , Wachi Nicole 
Published: November 2019

OBJECTIVE:
To compare pain after robotic-assisted laparoscopic hysterectomy when giving preoperative oral compared with intravenous acetaminophen.

METHODS:
This double-blind randomized trial included women undergoing robotic-assisted laparoscopic hysterectomy for benign indications. Participants received either acetaminophen 1 g orally then normal saline 100 mL intravenously before surgery, or a placebo orally then acetaminophen 1 g intravenously. The primary outcome measured was difference in pain between the groups 2 hours postoperatively. A sample size of 74 participants (37/group) was needed to achieve 80% power to detect noninferiority using a one-sided, two-sample t-test with an alpha of 0.025 and a noninferiority margin of 10 mm.

RESULTS:
From April 2016 through August 2017, 77 patients were enrolled, with 75 participants included in the final analysis. Characteristics were similar between groups. No difference in average pain score was noted 2 hours after surgery, nor at any of the measured time points. Average scores for the oral and intravenous group, respectively, at 2 hours were 35 and 36 mm (P=.86), at 4 hours 36 and 37 mm (P=.96), and at 24 hours 35 and 36 mm (P=.79). Thirty-eight percent of participants in the oral group and 19% of participants in the intravenous group experienced nausea (P=.12). The oral group used 9.7 morphine equivalents in the recovery room, and the intravenous group used 9.5 morphine equivalents (P=.9). The oral group requested analgesia in 45 minutes on average, and the intravenous group requested analgesia in 43 minutes (P=.79).

CONCLUSION:
No difference in pain was observed 2 hours postoperatively when comparing preoperative administration of oral compared with intravenous acetaminophen. Given the ease of administration and lower cost of oral dosing, this study supports the oral route as part of the enhanced recovery after surgery protocol for minimally invasive gynecologic surgery.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT03391284.
Effects of Gastrointestinal-Type Chemotherapy in Women With Ovarian Mucinous Carcinoma
Authors: Kurnit Katherine C. , Sinno Abdulrahman K. , Fellman Bryan M. , Varghese Aaron , Stone Rebecca , Sood Anil K. , Gershenson David M. , Schmeler Kathleen M. , Malpica Anais , Fader Amanda N. , Frumovitz Michael 
Published: November 2019

OBJECTIVE:
To estimate whether gastrointestinal-type chemotherapy was associated with improved survival compared with standard gynecologic regimens for women with ovarian mucinous carcinoma.

METHODS:
We conducted a retrospective cohort study of patients with ovarian mucinous carcinoma who received postoperative adjuvant chemotherapy at two academic centers. Demographic and clinical information was abstracted from the medical records. Gastrointestinal-type chemotherapy contained 5-fluorouracil, capecitabine, irinotecan, or oxaliplatin. Gynecologic regimens included standard carboplatin or cisplatin. Bevacizumab treatment was allowed in both groups. Summary statistics were used to compare baseline characteristics; Kaplan-Meier product-limit estimator was used to compare survival outcomes.

RESULTS:
Fifty-two patients received either gastrointestinal-type chemotherapy (n=26; 50%) or a standard gynecologic regimen (n=26; 50%). Three-quarters of tumors were early-stage (I or II), 68% grade 1 or 2 and 88% of patients had no gross residual disease after surgery. Patients receiving gastrointestinal-type chemotherapy were more likely to receive bevacizumab (50% vs 4%; P<.001), but there were no other differences in clinical or demographic characteristics. Unadjusted overall survival analyses showed that gastrointestinal-type chemotherapy was associated with better overall survival (hazard ratio 0.2, 95% CI 0.1–0.8), as were early stage tumors and having no gross residual disease.

CONCLUSION:
Gastrointestinal-type chemotherapy with or without bevacizumab was associated with improved survival and should be considered in patients with ovarian mucinous carcinoma requiring adjuvant therapy.
Caring for Patients With Uterine Cancer in Rural and Public Hospitals in New York State
Authors: Gamble Charlotte R. , Huang Yongmei , Frey Melissa K. , Wright Jason D. 
Published: November 2019

OBJECTIVE:
To evaluate perioperative outcomes for women with uterine cancer undergoing hysterectomy at rural and public hospitals in New York State.

METHODS:
The New York Statewide Planning And Research Cooperative System database was used to identify women with uterine cancer who underwent hysterectomy from 2000 to 2015. Perioperative complications, inpatient mortality, and resource utilization were compared at rural, public and private hospitals. Multilevel mixed effect log-linear models were developed to evaluate the association between hospital type and outcomes of interest. Patient characteristics, hospital and surgeon clustering were accounted for within the model.

RESULTS:
Over the years studied, there were 193 hospitals that cared for 46,298 women with uterine cancer. Of these, 9.8% were public, 15.0% were rural, and 75.1% were private metropolitan. They cared for 11.0%, 2.2% and 86.8% of patients, respectively. The proportion of patients cared for at rural hospitals decreased significantly from 5.2% in 2000 to 0.6% in 2014 (P<.001). There was no change in the volume of patients cared for at public hospitals (11.3 to 10.3%, P>.05). In a multivariable model adjusting for patient risk, there were no significant differences in perioperative morbidity, transfusion and length of stay across the three hospital types (P>.05). Compared with private hospitals, treatment at a rural hospital was associated with increased inpatient mortality (adjusted risk ratio 4.03, 95% CI 1.02–15.97).

CONCLUSION:
In New York State, operative uterine cancer care is shifting away from rural hospitals. Public hospitals have similar risk-adjusted outcomes compared with private metropolitan facilities.