bluuebunny/crossref_metadata_2025_split huggingface dataset:
Polysubstance Use Among Pregnant Women With Opioid Use Disorder in the United States, 2007–2016
Authors: Jarlenski Marian P. , Paul Nicole C. , Krans Elizabeth E. 
Published: August 2020

OBJECTIVE:
To assess trends in polysubstance use among pregnant women with opioid use disorder in the United States.

METHODS:
We conducted a time trend analysis of pooled, cross-sectional data from the National Inpatient Sample, an annual nationally representative sample of U.S. hospital discharge data. Among 38.0 million females aged 15–44 years with a hospitalization for delivery from 2007 to 2016, we identified 172,335 pregnant women with an International Classification of Diseases, Ninth Revision, Clinical Modification or International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis of opioid use disorder. Polysubstance use among pregnant women with opioid use disorder was defined as at least one co-occurring diagnosis of other substance use, including alcohol, amphetamine, cannabis, cocaine, sedative, or tobacco. We fit weighted multivariable logistic regression models to produce nationally representative estimates, including an interaction between year and rural compared with urban county of residence; controlled for age, race, and insurance type. Average predicted probabilities and 95% CIs were derived from regression results.

RESULTS:
Polysubstance use among women with opioid use disorder increased from 60.5% (95% CI 58.3–62.8%) to 64.1% (95% CI 62.8%–65.3%). Differential time trends in polysubstance use among women with opioid use disorder were found in rural compared with urban counties. Large increases in amphetamine use occurred among those in both rural and urban counties (255.4%; 95% CI 90.5–562.9% and 150.7%; 95% CI 78.2–52.7%, respectively), similarly to tobacco use (30.4%; 95% CI 16.9–45.4% and 23.2%; 95% CI 15.3–31.6%, respectively). Cocaine use diagnoses declined among women with opioid use disorder at delivery in rural (−70.5%; 95% CI −80.4% to −55.5%) and urban (−61.9%; 95% CI −67.6% to −55.1%) counties. Alcohol use diagnoses among those with opioid use disorder declined −57% (95% CI −70.8% to −37.7%) in urban counties but did not change among those in rural counties.

CONCLUSION:
Over the past decade, polysubstance use among pregnant women with opioid use disorder has increased more rapidly in rural compared with urban counties in the United States, with amphetamines and tobacco use increasing most rapidly.
Health-Related Quality of Life Improvements in Patients With Endometriosis Treated With Elagolix
Authors: Taylor Hugh S. , Soliman Ahmed M. , Johns Beverly , Pokrzywinski Robin M. , Snabes Michael , Coyne Karin S. 
Published: August 2020

OBJECTIVE:
To evaluate the effects of elagolix on clinically meaningful improvements in health-related quality of life (HRQOL) measured by the EHP-30 (Endometriosis Health Profile-30).

METHODS:
Data from two phase III trials of elagolix for moderate to severe pain associated with endometriosis were pooled and analyzed as three groups: placebo, elagolix 150 mg once daily, or elagolix 200 mg twice daily. Patients were administered the EHP-30 questionnaire at baseline, and at months 1, 3, and 6 of treatment. Previously established responder definitions were applied to determine percentages of patients with clinically meaningful EHP-30 improvements. The probability of meeting EHP-30 responder definitions with elagolix compared with placebo at months 3 and 6 was determined by Poisson regression analysis, controlling for baseline scores.

RESULTS:
At month 6, the probabilities of meeting EHP-30 subscale responder definitions for pain, control and powerlessness, self-image, social support, emotional well-being, and sexual intercourse were 169% (adjusted relative risk [aRR]: 2.69, 95% CI 2.26–3.21), 129% (aRR 2.29, 95% CI 1.96–2.67), 80% (aRR 1.80, 95% CI 1.54–2.11), 70% (aRR 1.70, 95% CI 1.47–1.97), 67% (aRR 1.67, 95% CI 1.45–1.92), and 62% (aRR 1.62, 95% CI 1.36–1.92) greater, respectively (all P<.001), in the 200-mg group than in the placebo group. Although lower in magnitude than the 200-mg group, the 150-mg group also had greater probabilities of meeting responder definitions than the placebo group for all subscales except sexual intercourse. The probabilities of meeting responder definitions for pain, control and powerlessness, self-image, social support, and emotional well-being were 75% (aRR 1.75, 95% CI 1.44–2.14), 50% (aRR 1.50, 95% CI 1.25–1.80), 22% (aRR 1.22, 95% CI 1.01–1.47), 30% (aRR 1.30, 95% CI 1.09–1.53), and 35% (aRR 1.35, 95% CI 1.16–1.57) greater, respectively (all P<.05), in the 150-mg group than in the placebo group.

CONCLUSION:
Patients with moderate to severe pain associated with endometriosis and were treated with elagolix experienced clinically meaningful HRQOL improvements.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT01620528 and NCT01931670.

FUNDING SOURCE:
AbbVie Inc.
Characteristics Associated With Treatment Failure 1 Year After Midurethral Sling in Women With Mixed Urinary Incontinence
Authors: Sung Vivian W. , Richter Holly E. , Moalli Pamela , Weidner Alison C. , Nguyen John N. , Smith Ariana L. , Dunivan Gena , Ridgeway Beri , Borello-France Diane , Newman Diane K. , Mazloomdoost Donna , Carper Benjamin , Gantz Marie G. ,   for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network*
Published: August 2020

OBJECTIVE:
To evaluate characteristics associated with treatment failure 1 year after midurethral sling in women with mixed urinary incontinence.

METHODS:
Four hundred three women who participated in a randomized trial that compared midurethral sling and behavioral and pelvic floor muscle therapy (combined group) against midurethral sling alone for mixed incontinence with 1 year of follow-up data were eligible for this planned secondary analysis. Overall treatment failure was defined as meeting criteria for subjective failure, objective failure, or both. Subjective failure was defined as not meeting the minimal clinically important difference for improvement on the UDI (Urogenital Distress Inventory)-total score (26.1 points). Objective failure was not achieving 70% improvement on mean incontinence episodes of any type per day or having undergone any additional treatment for urinary symptoms at 12 months postoperative. Logistic regression models for treatment failure were constructed. Independent variables included site and treatment group, and clinical and demographic variables based on bivariate comparisons (P<.2). Treatment group interaction effects were evaluated.

RESULTS:
Previous overactive bladder medication use (unadjusted odds ratio [OR] 2.19, adjusted odds ratio [aOR] 1.89, 95% CI 1.10–3.25), detrusor overactivity on cystometrogram (OR 2.25, aOR 2.72, 95% CI 1.53–4.84), body mass index (OR 1.29, aOR 1.27, 95% CI 1.03–1.57), and Valsalva leak point pressure less than 60 cm H2O (OR 1.96, aOR 3.13, 95% CI 1.65–5.94) were associated with overall failure. Worse UDI urgency scores were associated with failure in the midurethral sling–alone group. Sling type (retropubic vs transobturator) was not associated with failure.

CONCLUSION:
Certain clinical and urodynamic variables are associated with treatment failure after midurethral sling among women with mixed urinary incontinence. Women with more severe urgency symptoms at baseline may benefit from perioperative behavioral and pelvic floor muscle therapy combined with midurethral sling. This information is helpful for counseling women with mixed incontinence who are considering surgery.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT01959347.
Sexual Activity and Dyspareunia 1 Year After Surgical Repair of Pelvic Organ Prolapse
Authors: Lukacz Emily S. , Sridhar Amaanti , Chermansky Christopher J. , Rahn David D. , Harvie Heidi S. , Gantz Marie G. , Varner R. Edward , Korbly Nicole B. , Mazloomdoost Donna ,   for the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pelvic Floor Disorders Network (PFDN)
Published: August 2020

OBJECTIVE:
To describe sexual activity and risks for dyspareunia after pelvic organ prolapse surgery.

METHODS:
This was a secondary analysis of data from four randomized trials conducted between 2002 and 2018. Standard assessments and validated measures of sexual function were assessed at baseline and at 12 months postoperatively. Anterior apical surgeries were grouped by approach: transvaginal native tissue repairs, transvaginal mesh or graft-augmented repairs, and abdominal sacrocolpopexy. Additional surgeries, which included posterior repair, hysterectomy, and slings, were analyzed. Bivariate analyses and logistic regression models identified risk factors for postoperative dyspareunia.

RESULTS:
Of the 1,337 women enrolled in the trials, 932 had sufficient outcome data to determine dyspareunia status. Of these before surgery, 445 (47.8%) were sexually active without dyspareunia, 89 (9.6%) were sexually active with dyspareunia, 93 (10.0%) were not sexually active owing to fear of dyspareunia, and 305 (32.7%) were not sexually active for other reasons. At 12 months, dyspareunia or fear of dyspareunia was present in 63 of 627 (10.0%); occurred de novo in 17 of 445 (3.8%) and resolved in 136 of 182 (74.7%). Multivariable regression demonstrated baseline dyspareunia as the only factor associated with postoperative dyspareunia (adjusted odds ratio 7.8, 95% CI 4.2–14.4). No other factors, including surgical approach, were significantly associated with postoperative dyspareunia. Too few had de novo dyspareunia to perform modeling.

CONCLUSION:
Dyspareunia is common in one in five women before undergoing prolapse surgery. Surgical repair resolves dyspareunia in three out of four women with low rates of de novo dyspareunia at less than 4%. Preoperative dyspareunia appears to be the only predictor of postoperative dyspareunia.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT00065845, NCT00460434, NCT00597935, and NCT01802281.
Reducing the Risk for Postpartum Depression in Adolescent Mothers
Authors: Phipps Maureen G. , Ware Crystal F. , Stout Robert L. , Raker Christina A. , Zlotnick Caron 
Published: August 2020

OBJECTIVE:
To estimate the effect of an interpersonal therapy-based intervention on reducing the risk of postpartum depression in adolescents.

METHODS:
A randomized controlled trial enrolled 250 pregnant adolescents who were aged 18 years or younger at conception. The initial sample size calculation estimated 276 participants (324 with attrition) were needed to detect a 50% reduction in risk of the primary outcome, postpartum major depressive episode, with an alpha of 0.05% and 80% power. An interim analysis by the Data Safety and Monitoring Committee informed a revision in the sample size target to 250. Participants were randomized to the intervention (n=129) or a time-matched control group (n=121) who attended sessions about pregnancy topics. Each group received five prenatal sessions and a postpartum booster session. A structured diagnostic interview was administered at baseline and specific time points through 12-months postpartum to assess for major depressive episode onset.

RESULTS:
Participants were recruited from December 2011 to May 2016 through urban prenatal care sites in the state of Rhode Island. Of the 250 participants, 58% identified as Hispanic and 20% as black or African American. The rate of major depressive episode by 12 months postpartum was 7.0% (95% CI 2.3–11.7%) in the control group and 7.6% (95% CI 2.5–12.7%) in the intervention group, with no significant difference between groups at any time point (P=.88 by log-rank test).

CONCLUSION:
No benefit was shown between the intervention and control groups in the rates of major depressive episode, which is likely related to a lower than predicted rate of this outcome in the control group (7.6% actual vs 25% predicted). Enhanced local community resources available to pregnant and parenting adolescents during the study period may be an explanation for this result.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT01482832.
Opioid Prescription and Persistent Opioid Use After Ectopic Pregnancy
Authors: Wall-Wieler Elizabeth , Shover Chelsea L. , Hah Jennifer M. , Carmichael Suzan L. , Butwick Alexander J. 
Published: August 2020

OBJECTIVE:
To evaluate outpatient opioid dispensing and the incidence of persistent opioid use after ectopic pregnancy.

METHODS:
This cohort study used U.S. employer-based claims data to identify opioid-naïve individuals experiencing ectopic pregnancy from November 1, 2008, to September 30, 2015. Treatment was categorized as surgical, medical (using methotrexate), or unknown. New opioid prescriptions were defined as prescriptions filled from 1 week before to 1 week after an ectopic pregnancy treatment. For those who filled a new opioid prescription, we calculated the incidence and risk factors for persistent opioid use, defined as having filled at least one opioid prescription both from 8 to 90 days after treatment and from 91 to 365 days after treatment.

RESULTS:
Of the 15,338 individuals in our study, 7,047 (45.9%, 95% CI 45.2–46.7%) filled an opioid prescription at the time of treatment, of whom 4.1% (95% CI 3.6–4.6%) developed persistent opioid use. The risk of persistent opioid use was lower among those who had surgical compared with medical treatment (3.7% and 6.8%, respectively; relative risk [RR] 0.54, 95% CI 0.38–0.77). Variables most strongly associated with persistent opioid use were a history of benzodiazepine use (RR 1.99; 95% CI 1.43–2.78; adjusted relative risk [aRR] 1.57, 95% CI 1.11–2.22), antidepressant use (RR 1.91, 95% CI 1.45–2.53; aRR 1.53, 95% CI 1.08–2.18), and a pre-existing pain disorder (RR 1.58, 95% CI 1.26–1.99; aRR 1.47, 95% CI 1.16–1.85) in the year before treatment.

CONCLUSION:
New opioid use is common after an ectopic pregnancy; approximately 4% of those with new opioid use develop persistent opioid use, with the rate higher in those treated medically. New pain-management guidelines need to be developed to prevent persistent opioid use after ectopic pregnancy.
An Expanded Obstetric Comorbidity Scoring System for Predicting Severe Maternal Morbidity
Authors: Leonard Stephanie A. , Kennedy Chris J. , Carmichael Suzan L. , Lyell Deirdre J. , Main Elliott K. 
Published: August 2020

OBJECTIVE:To develop and validate an expanded obstetric comorbidity score for predicting severe maternal morbidity that can be applied consistently across contemporary U.S. patient discharge data sets.METHODS:Discharge data from birth hospitalizations in California during 2016–2017 were used to develop the score. The outcomes were severe maternal morbidity, defined using the Centers for Disease Control and Prevention index, and nontransfusion severe maternal morbidity (excluding cases where transfusion was the only indicator of severe maternal morbidity). We selected 27 potential patient-level risk factors for severe maternal morbidity, identified using International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes. We used a targeted causal inference approach integrated with machine learning to rank the risk factors based on adjusted risk ratios (aRRs). We used these results to assign scores to each comorbidity, which sum to a single numeric score. We validated the score in California and national data sets and compared the performance to that of a previously developed obstetric comorbidity index.RESULTS:Among 919,546 births, the rates of severe maternal morbidity and nontransfusion severe maternal morbidity were 168 and 74 per 10,000 births, respectively. The highest risk comorbidity was placenta accreta spectrum (aRR of 30.5 for severe maternal morbidity and 54.7 for nontransfusion severe maternal morbidity) and the lowest was gestational diabetes mellitus (aRR of 1.06 for severe maternal morbidity and 1.12 for nontransfusion severe maternal morbidity). Normalized scores based on the aRR were developed for each comorbidity, which ranged from 1 to 59 points for severe maternal morbidity and from 1 to 36 points for nontransfusion severe maternal morbidity. The overall performance of the expanded comorbidity scores was good (C-statistics were 0.78 for severe maternal morbidity and 0.84 for nontransfusion severe maternal morbidity in California data and 0.82 and 0.87, respectively, in national data) and improved on prior comorbidity indices developed for obstetric populations. Calibration plots showed good concordance between predicted and actual risks of the outcomes.CONCLUSION:We developed and validated an expanded obstetric comorbidity score to improve comparisons of severe maternal morbidity rates across patient populations with different comorbidity case mixes.
Two Intraoperative Techniques for Midurethral Sling Tensioning
Authors: Brennand Erin A. , Wu Guosong , Houlihan Sara , Globerman Dobrochna , Gagnon Louise-Helene , Birch Colin , Hyakutake Momoe , Carlson Kevin V. , Al-Shankiti Hanan , Robert Magali , Lazare Darren , Kim-Fine Shunaha ,   for the Calgary Women's Pelvic Health Research Group
Published: August 2020

OBJECTIVE:
To evaluate whether the use of a Mayo Scissor as a suburethral spacer compared with a Babcock clamp holding a loop of tape under the urethra results in different rates of abnormal bladder outcomes 12 months after retropubic midurethral sling surgery.

METHODS:
The MUST (Mid-Urethral Sling Tensioning) trial was a block-randomized, double-blind, multicenter clinical trial that allocated women to have their retropubic midurethral slings tensioned by Scissor or Babcock technique. The primary outcome (abnormal bladder) was a composite of persistent stress urinary incontinence (SUI), overactive bladder, and urinary retention. Secondary outcomes included outcomes of the composite, postoperative catheterization, incontinence-related questionnaires, repeat incontinence treatment, and uroflowmetry. Sample size of 159 in each arm (N=318) was planned for a superiority trial, hypothesizing a 10% difference in primary outcome.

RESULTS:
From September 2015 to December 2017, 506 women were screened and 318 were randomized. Baseline characteristics were similar in each arm. At 12 months, 253 (79.6%) women provided information on primary outcome: 40 of 128 (31.3%) patients with midurethral slings tensioned by Scissor experienced abnormal bladder, compared with 23 of 125 (18.4%) of those with midurethral slings tensioned by Babcock (P=.018, relative difference 12.9%). Secondary analyses favored Babcock for median duration of catheterization and the proportions of women experiencing urinary retention requiring sling lysis. Uroflowmetry parameters suggest the Scissor technique is more restrictive. Rates of mesh erosion were lower for the Scissor arm. No differences occurred in proportions of women experiencing patient reported persistent SUI after surgery.

CONCLUSION:
Abnormal bladder outcomes were 12.9% less frequent for women with midurethral slings tensioned by Babcock. Both techniques provided a comparable patient reported cure for SUI at 12 months. Women with midurethral slings tensioned by Scissors experienced more intervention for obstruction, whereas those with midurethral slings tensioned by Babcock experienced higher rates of mesh erosion. This information about how the postoperative courses differ allows surgeons to better counsel patients preoperatively or tailor their choice of technique.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT02480231.

FUNDING SOURCE:
Boston Scientific.
The Challenge of Listening at Home: Speech and Noise Levels in Homes of Young Children With Hearing Loss
Authors: Benítez-Barrera Carlos R. , Grantham D. Wesley , Hornsby Benjamin W.Y. 
Published: August 2020

Objectives:
The objective of this study was to characterize the acoustics of the home environment of young children with hearing loss. Specifically, we aimed to quantify the range of speech levels, noise levels, and signal-to-noise ratios (SNRs) encountered by children with hearing loss in their homes.

Design:
Nine families participated in the study. The children with hearing loss in these families were between 2 and 5 years of age. Acoustic recordings were made in the children’s homes over one weekend (Saturday and Sunday) using Language ENvironmental Analysis (LENA) recorders. These recordings were analyzed using LENA’s proprietary software to determine the range of speech and noise levels in the child’s home. A custom Matlab program analyzed the LENA output to estimate the SNRs in the children’s homes.

Results:
The average SNR encountered by children with hearing loss in our sample was approximately +7.9 dB SNR. It is important to note that our analyses revealed that approximately 84% of the SNRs experienced by these children with hearing loss were below the +15 dB SNR recommended by the American Speech-Language Hearing Association. Averaged across families, speech and noise levels were 70.1 and 62.2 C-weighted decibels, respectively.

Conclusions:
These data show that, for much of the time, young children with hearing loss are forced to listen under suboptimal conditions in their home environments. This has important implications as listening under these conditions could negatively affect learning opportunities for young children with hearing loss. To mitigate these potential negative effects, the use of assistive listening devices that improve the SNR (e.g., remote microphone systems) should be considered for use at home by young children with hearing loss.
Age and mitochondrial DNA copy number influence the association between outdoor temperature and cognitive function
Authors: Dolcini Jacopo , Kioumourtzoglou Marianthi-Anna , Cayir Akin , Sanchez-Guerra Marco , Brennan Kasey J. , Dereix Alexandra E. , Coull Brent A. , Spiro Avron , Vokonas Pantel , Schwartz Joel , Baccarelli Andrea A. 
Published: August 2020

Background:
General cognitive function deteriorates with aging, a change that has been linked to outdoor temperature. Older individuals have reduced ability to adapt to changes in outdoor temperature than younger people. However, to what extent short-term changes in outdoor temperature interact with mitochondria to affect cognition in older people has not yet been determined.

Methods:
Our study included 591 participants of the Normative Aging Study who underwent multiple examinations between 2000 and 2013. Cognitive function was evaluated via the Mini-Mental State Examination. Outdoor temperature was estimated at residential addresses 1 day before the examination using on a validated spatiotemporal temperature model. Mitochondrial DNA copy number (mtDNAcn) was determined using buffy coat samples.

Results:
We found an interaction between temperature, age, mtDNAcn, and cognition. In individuals 84 years of age or older, cooler temperature was associated with low cognition (odds ratio = 1.2; 95% confidence interval = 1.05, 1.35 for a 1°C decrease in temperature; P = 0.007). We found higher odds ratio per 1°C decrease in temperature among individuals with lower mtDNAcn (β3 = 0.12; 95% confidence interval = 0.01, 0.22; P
interaction = 0.02).

Conclusions:
Our findings, albeit potentially underpowered, suggest that older individuals may be more susceptible to the influence of short-term temperature exposure on cognition. Moreover, the level of mtDNAcn may also modify the association between temperature and cognitive function, indicating a possible role of these cellular elements in this relationship.