bluuebunny/crossref_metadata_2025_split huggingface dataset:
Validation of a Model Predicting De Novo Stress Urinary Incontinence in Women Undergoing Pelvic Organ Prolapse Surgery
Authors: Jelovsek J. Eric , Ploeg J. Marinus van der , Roovers Jan-Paul , Barber Matthew D. 
Published: March 2019

OBJECTIVE:
To validate a previously developed prediction model for de novo stress urinary incontinence (SUI) after undergoing vaginal surgery for pelvic organ prolapse (POP).

METHODS:
Model performance was determined using a cohort of women who participated in two, 14-center randomized trials in the Netherlands that evaluated whether postoperative SUI 1 year after surgery was reduced with or without concomitant midurethral sling at the time of surgery for symptomatic women who had at least stage 2 POP. Age, number of previous vaginal births, urine leakage associated with urgency, history of diabetes, body mass index, preoperative stress test result, and placement of a midurethral sling were used to calculate the predicted probability of an individual developing de novo SUI. Predicted probabilities were compared with outcomes and quantitated using the concordance index and calibration curves. Model accuracy was compared with and without the preoperative stress test, and net reclassification improvement was measured using probability cutoffs of 0.2, 0.3, and 0.4.

RESULTS:
Of 239 participants who did not report preoperative SUI and underwent surgery, 152 were eligible for analysis with complete baseline and outcome data. Model discrimination was acceptable and consistent with performance in the original development cohort when the preoperative stress test result was included (concordance index 0.63; 95% CI 0.52–0.74) and had lower discrimination than when the stress test variable was not included (concordance index 0.57; 95% CI 0.46–0.67, P=.048). The model that included the stress test variable was most accurate when predicted probabilities of de novo SUI were between 0 and 50%, and it correctly reclassified upward 5.9% (95% CI −14.8 to 26.8) of participants with de novo SUI and correctly reclassified downward 16.9% (95% CI 6.6–27.7) of participants without de novo SUI.

CONCLUSION:
On external validation, the model was predictive of de novo SUI after vaginal prolapse surgery and may facilitate decision making regarding concomitant sling placement.

CLINICAL TRIAL REGISTRATION:
Nederlands Trial Register, NTRR 1197 en 1070.
Comparing Force of Stream With a Standard Fill Voiding Trial After Surgical Repair of Apical Prolapse
Authors: Pilkinton Marjorie L. , Williams Kathryn S. , Sison Cristina P. , Shalom Dara F. , Winkler Harvey A. 
Published: March 2019

OBJECTIVE:
To estimate whether the urinary force of stream method is noninferior to a standard fill voiding trial for rate of catheterization within 6 weeks after apical prolapse surgery in those discharged without a catheter.

METHODS:
A noninferiority randomized controlled trial was conducted in postoperative women comparing force of stream with standard fill voiding trials after vaginal, abdominal, or laparoscopic–robotic apical pelvic organ prolapse (POP) surgery. Before discharge, women in both groups were backfilled with 300 mL normal saline. Successful voiding criteria in the force of stream group was subjective force of stream of at least 50 using a visual analog scale; reporting less than 50 prompted a bladder scan. Successful voiding was defined as a postvoid residual volume of less than 500 mL. For the standard fill voiding trial group, voiding two thirds of the instilled amount indicated success. The primary outcome was the rate of catheterization within the 6-week postoperative period after surgical repair of apical prolapse among those discharged without a urinary catheter. Secondary endpoints included trial of void failure rates. A sample size of 59 patients per group who passed trial of void at discharge was needed to achieve 80% power using a noninferiority margin (delta of 10%). Total enrollment of 169 patients was necessary to account for an estimated 30% trial of void failure rate.

RESULTS:
From April 2016 and April 2017, 184 patients were enrolled (six enrolled before the trial registration date), with the first patient enrolled on April 1, 2016. One hundred seventy-four patients were randomized (86 in the force of stream group and 88 in the standard fill voiding trial group). No differences were observed in demographic or perioperative characteristics, except for stage 2 apical prolapse (52% in the force of stream group vs 36% in the standard fill voiding trial group). For the primary outcome, similar rates were found in those patients who passed their trial of void but subsequently needed catheterization for voiding dysfunction (force of stream 2.8% [2/71] vs standard fill voiding trial 3.1% [2/64]; difference −0.3%, 95% CI −8.69% to 8.08%). The incidence of trial of void failures at discharge was similar (force of stream 17.4% [15/86] vs standard fill voiding trial 26.4% [23/87]; risk ratio 0.65, 95% CI 0.37–1.18, P=nonsignificant).

CONCLUSION:
Force of stream was noninferior to standard fill voiding trial when comparing the rate of catheter insertion during the 6-week postoperative period after apical POP surgery in those discharged without a catheter.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov, NCT02753920.
U.S. Food and Drug Administration–Approved Poly (ADP-Ribose) Polymerase Inhibitor Maintenance Therapy for Recurrent Ovarian Cancer
Authors: Dottino Joseph A. , Moss Haley A. , Lu Karen H. , Secord Angeles A. , Havrilesky Laura J. 
Published: March 2019

OBJECTIVE:
We sought to determine whether use of a poly (ADP-ribose) polymerase inhibitor is cost effective for maintenance treatment of platinum-sensitive recurrent ovarian cancer.

METHODS:
A decision analysis model compared four maintenance strategies: 1) observation, 2) BRCA germline mutation testing and selective treatment of carriers (gBRCA only), 3) BRCA germline and tumor homologous recombination deficiency testing and selective treatment of either BRCA carriers or those with tumor HRD (gBRCA and HRD only), and 4) treat all with niraparib to progression (treat all). Costs were estimated in 2016 U.S. dollars. Incremental cost-effectiveness ratios were in dollars per progression-free quality-adjusted life-year (QALY). One-way sensitivity analyses tested multiple assumptions.

RESULTS:
Maintenance poly (ADP-ribose) polymerase inhibitor was costlier and more effective than observation. Mean costs and progression-free QALYs were $827 and 3.4 months for observation, $46,157 and 5.7 for a BRCA-only strategy, $109,368 and 8.5 for a gBRCA and homologous recombination deficiency–only strategy, and $169,127 and 8.8 for a treat-all strategy. gBRCA-only had an incremental cost-effectiveness ratio of $243,092/progression-free QALY compared with observation; other strategies did not approach cost effectiveness. Using the current U.S. Food and Drug Administration label for maintenance poly (ADP-ribose) polymerase inhibitor regardless of biomarker status, the third-party payer cost per month (28-day supply) would need to be reduced from approximately $14,700 to $3,600 to be considered cost effective compared with observation using a willingness to pay threshold of $100,000/progression-free QALY.

CONCLUSION:
Maintenance poly (ADP-ribose) polymerase inhibitor therapy for platinum-sensitive recurrent ovarian cancer is not cost effective. Treatment of patients with BRCA mutation alone or with homologous recombination deficiency–positive tumors are preferred strategies compared with a treat-all strategy. Lowering the cost may make selective niraparib maintenance therapy cost effective compared with observation.
Hysterectomy Practice Patterns in the Postmorcellation Era
Authors: Jorgensen Elisa M. , Modest Anna M. , Hur Hye-Chun , Hacker Michele R. , Awtrey Christopher S. 
Published: March 2019

OBJECTIVE:
To characterize long-term national trends in surgical approach for hysterectomy after the U.S. Food and Drug Administration (FDA) warning against power morcellation for laparoscopic specimen removal.

METHODS:
This was a descriptive study using data from the American College of Surgeons National Surgical Quality Improvement Program from 2012 to 2016. We identified hysterectomies using Current Procedural Terminology codes. We used an interrupted time-series analysis to evaluate abdominal and supracervical hysterectomy trends surrounding The Wall Street Journal article first reporting morcellation safety concerns and the FDA safety communication. We compared categorical and continuous variables using χ2, t, and Wilcoxon rank sum tests.

RESULTS:
We identified 179,950 hysterectomies; laparoscopy was the most common mode of hysterectomy in every quarter. Before The Wall Street Journal article, there was no significant change in proportion of abdominal hysterectomies (0.3% decrease/quarter, P=.14). After The Wall Street Journal article, use of abdominal hysterectomy increased 1.1% per quarter for two quarters through the FDA warning (P<.001), plateaued for three quarters until March 2015 (P=.65), then decreased by 0.8% per quarter through 2016 (P<.001). Supracervical hysterectomy volume continuously decreased after the FDA warning (1.0% decrease per quarter, P<.001) and after three quarters (0.7% decrease per quarter, P=.01), then plateaued from April 2015 through 2016 (0.05% decrease per quarter, P=.40). Mode of supracervical hysterectomy was unchanged from 2012 to 2013 (P=.43), followed by two quarters of significant increase in proportion of supracervical abdominal hysterectomies (11.7%/quarter, P<.001). This change in mode of supracervical hysterectomy then plateaued through 2016 (P=.06).

CONCLUSION:
Despite early studies suggesting that minimally invasive hysterectomy decreased in response to safety concerns regarding power morcellation, we found that this effect reversed 1 year after the FDA safety communication. However, there was a sustained decline in supracervical hysterectomy, and the remaining supracervical hysterectomies were more likely to be performed using laparotomy.
Influence of Genetic Variants on Steady-State Etonogestrel Concentrations Among Contraceptive Implant Users
Authors: Lazorwitz Aaron , Aquilante Christina L. , Oreschak Kris , Sheeder Jeanelle , Guiahi Maryam , Teal Stephanie 
Published: March 2019

OBJECTIVE:
To identify genetic variants that influence steady-state etonogestrel concentrations among contraceptive implant users.

METHODS:
We enrolled healthy, reproductive-age women in our pharmacogenomic study using etonogestrel implants for 12–36 months without concomitant use of hepatic enzyme inducers or inhibitors. We collected participant characteristics, measured serum etonogestrel concentrations, and genotyped each participant for 120 single nucleotide variants in 14 genes encoding proteins involved in steroid hormone (ie, estrogens, progestins) metabolism, regulation, or function. We performed generalized linear modeling to identify genetic variants associated with steady-state etonogestrel concentrations.

RESULTS:
We enrolled 350 women, who had a median serum etonogestrel concentration of 137.4 pg/mL (range 55.8–695.1). Our final generalized linear model contained three genetic variants associated with serum etonogestrel concentrations: NR1I2(PXR) rs2461817 (β=13.36, P=.005), PGR rs537681 (β=−29.77, P=.007), and CYP3A7*1C (β=−35.06, P=.025). Variant allele frequencies were 69.4%, 84.9%, and 5.1%, respectively. Our linear model also contained two nongenetic factors associated with etonogestrel concentrations: body mass index (BMI) (β=−3.08, P=7.0×10−7) and duration of implant use (β=−1.60, P=5.8×10−5); R2 for the model =0.17.

CONCLUSION:
Only BMI and duration of implant use remained significantly associated with steady-state etonogestrel concentrations. Of the three novel genetic associations found, one variant associated with increased etonogestrel metabolism (CYP3A7*1C) causes adult expression of fetal CYP3A7 proteins and can consequently alter steroid hormone metabolism. Women with this variant may potentially have increased metabolism of all steroid hormones, as 27.8% (5/18) of CYP3A7*1C carriers had serum etonogestrel concentrations that fell below the threshold for consistent ovulatory suppression (less than 90 pg/mL). More pharmacogenomic investigations are needed to advance our understanding of how genetic variation can influence the effectiveness and safety of hormonal contraception, and lay the groundwork for personalized medicine approaches in women's health.

CLINICAL TRIAL REGISTRATION:
ClinicalTrials.gov, NCT03092037.
Which Children Are at Risk for Contralateral Anterior Cruciate Ligament Injury After Ipsilateral Reconstruction?
Authors: Patel Neeraj M. , Bram Joshua T. , Talathi Nakul S. , DeFrancesco Christopher J. , Lawrence John Todd R. , Ganley Theodore J. 
Published: March 2019

Background:
Following anterior cruciate ligament (ACL) reconstruction, children are at significant risk for complications, including contralateral ACL rupture. The purpose of this study is to determine which children are at risk for a contralateral ACL tear after ipsilateral reconstruction.

Methods:
After review of medical records, we contacted patients who underwent primary ACL reconstruction between 2009 and 2016. Patients were included in the study if they were able to provide follow-up data either in person or remotely at least 2 years after surgery. Demographic data, sports participation, and intraoperative findings and techniques were recorded. All patients were also asked to confirm returning to sport information and postoperative complications (including contralateral ACL tear). Univariate analysis consisted of χ2 and independent samples t tests. Purposeful entry logistic regression was then conducted to control for confounding factors. Kaplan-Meier analysis was performed to assess contralateral ACL survival.

Results:
A total of 498 children with average follow-up of 4.3±2.1 years were included in the analysis. The mean age was 15.0±2.3 years and 262 patients (52.6%) were female. Thirty-five subjects (7.0%) sustained a contralateral ACL tear at a mean of 2.7±1.7 years following index reconstruction. Kaplan-Meier analysis revealed the median contralateral ACL survival time to be 8.9 years [95% confidence interval (CI): 8.3, 9.5 y]. In univariate analysis, 11.5% of female patients had a contralateral rupture compared with 2.1% of male patient (P<0.001). Patients with a contralateral tear had a mean age of 14.4±2.0 years compared with 15.1±2.3 years for those without an ACL injury in the opposite knee (P=0.04). After controlling for numerous factors in a multivariate model, female patients had 3.5 times higher odds of sustaining a contralateral ACL tear than male patients (95% CI: 1.1, 10.6; P=0.03). Each year of decreasing age raised the odds of contralateral injury by a factor of 1.3 (95% CI: 1.1, 1.6; P=0.02). Furthermore, children younger than 15 years had 3.1 times higher odds of contralateral rupture than those aged 15 and older (95% CI: 1.3, 7.2; P=0.01).

Conclusions:
After adjusting for confounding factors in a multivariate model, female patients were at increased risk of contralateral ACL tear following ipsilateral reconstruction, as were younger children. Specifically, ACL rupture in the opposite knee was more likely in patients below the age of 15 years.

Level of Evidence:
Level III—prognostic study.
Cellulite: Patient Selection and Combination Treatments for Optimal Results—A Review and Our Experience
Authors: Davis DiAnne S. , Boen Monica , Fabi Sabrina G. 
Published: March 2019

BACKGROUND
More than 90% of women have reported concerns of cellulite on their skin. Both commercially advertised creams and topical pharmacological agents have shown limited improvement. Thus far, there has been a paucity of thorough review articles on how to address and treat this condition.

OBJECTIVE
To investigate how the etiology and pathogenesis of cellulite can help guide treatment combinations and provide a more algorithmic approach to comprehensively address a condition that affects so many women.

MATERIALS AND METHODS
A review of the literature surrounding treatment options for cellulite and the authors' experience in this area are provided.

CONCLUSION
This review summarizes available treatment options for cellulite, including topical agents, controlled subcision, energy-based devices, dermal fillers, and new injectable medications. Furthermore, the various ways that these treatments can be combined in an algorithmic and sequential approach based on the degree of volume loss, skin laxity, and excess adiposity associated with cellulite are addressed. These combination therapies for cellulite are supported both in the published literature and the authors' experience to help clinicians tailor a comprehensive treatment plan for the multiple factors that contribute to cellulite. Further clinical trials are needed to compare various devices and techniques for cellulite as well as combination treatments.
Effect of Postoperative Telephone Calls on Patient Satisfaction and Scar Satisfaction After Mohs Micrographic Surgery
Authors: Vance Stephen , Fontecilla Natalia , Samie Faramarz H. , Patel Vishal , Lewin Jesse M. 
Published: March 2019

BACKGROUND
Mohs micrographic surgery is considered the gold standard for high-risk nonmelanoma skin cancer. Postoperative telephone follow-up (TFU) is linked to higher patient satisfaction; however, there are no randomized, blinded studies examining whether TFU after Mohs surgery improves patient satisfaction.

OBJECTIVE
To perform a randomized single-blinded prospective survey study examining whether patient satisfaction or scar satisfaction varied between Mohs patients who received a postoperative call and patients who did not.

METHODS
Patients were enrolled into “post-op call” or “no post-op call” groups. Both arms completed surveys at suture removal and 3-month follow-up visits.

RESULTS
One hundred four subjects were enrolled, and demographics, the number of Mohs stages, and type of repair were controlled. At suture removal, both arms reported similar overall high satisfaction on the 5-point Likert scale (4.90 “call arm” vs 4.88 “no-call arm”, p = .80). Patient and Observer Scar Assessment Scale (POSAS) scores were 3.37 in the “call arm” versus 3.81 in the “no-call arm”, p = .31. At 3-month follow-up, results were similar.

CONCLUSION
High overall satisfaction was reported in both arms. The TFU group reported higher overall satisfaction, but this difference was not significant. Scar satisfaction did not vary statistically between the arms, but POSAS scores in the call arm trended favorably.
Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review
Authors: Constantine Ginger D. , Graham Shelli , Lapane Kate , Ohleth Kathleen , Bernick Brian , Liu James , Mirkin Sebastian 
Published: March 2019

AbstractObjective:The aim of the study was to systematically review studies that evaluated endometrial hyperplasia or cancer incidence with unopposed vaginal estrogens.Methods:PubMed and EMBASE were searched from inception to August 2017 for relevant articles and abstracts. Bibliographies of review articles and abstracts of major women's health medical meetings were examined. Eligible studies (independently reviewed by 4 authors) had to report menopausal vaginal estrogen use and endometrial histology, or incidence of endometrial hyperplasia or cancer.Results:Of 5,593 abstracts from the literature search and 47 articles from other sources, 36 articles and 2 abstracts were eligible, describing 20 randomized controlled studies, 8 interventional studies, and 10 observational studies. Collectively, the studies did not support an increased risk of endometrial hyperplasia or cancer with low-dose vaginal estrogens. Rates of endometrial cancer and hyperplasia were 0.03% and 0.4%, respectively, from 20 randomized controlled trials (2,983 women) of vaginal estrogens. Overall, reports of endometrial hyperplasia were observed with various doses and durations and appeared sporadic (except 1.25 mg conjugated equine estrogens), consistent with endometrial hyperplasia rates in the general population. A Denmark registry study was an exception and may be of limited applicability to the United States. The Women's Health Initiative Observational Study showed no association (1.3 cases/1,000 women-years with vaginal estrogens versus 1.0/1,000 women-years for nonuse).Conclusion:This systematic review supports the use of low-dose vaginal estrogens for treating vulvar and vaginal atrophy in menopausal women without a concomitant progestogen. This review does not support increased endometrial hyperplasia or cancer risk with low-dose, unopposed vaginal estrogens; however, longer-term, real-world data are needed.
Life-long endogenous estrogen exposure is associated with prevalence of allergic rhinitis in postmenopausal women
Authors: Lee Kijeong , Hong Yeji , Choi Jimi , Lee Sang Hag , Kim Tae Hoon 
Published: March 2019

Abstract

Objectives:
The aim of the study was to investigate the influence of life-long endogenous estrogen exposure on prevalence of chronic rhinitis including allergic rhinitis (AR) in the postmenopausal period.

Methods:
In this cross-sectional study, a total of 3,043 postmenopausal women who participated in the Korea National Health and Nutrition Examination Survey V were included. Participants with symptoms including sneezing, rhinorrhea, nasal obstruction, or nasal itching were considered to have chronic rhinitis. In subgroup analysis, the AR group comprised participants with rhinitis with positive findings in at least one of three specific immunoglobulin E. Univariable and multivariable logistic analyses were performed to evaluate the relationship between rhinitis and estrogen-related factors including age at menarche, age at menopause, age at first delivery, parity, and duration of breast-feeding.

Results:
Participants with chronic rhinitis (17.6%) had higher parity (odd ratio [OR] = 1.17, P = 0.0135) and shorter duration of breast-feeding (OR = 0.98, P = 0.0388) than controls. In subgroup analysis, participants with AR (7.1%) had younger age at menarche (OR = 0.56, P = 0.0028) and older age at menopause (OR = 1.42, P = 0.0060) after adjustment of confounding factors. There was a positive association between age at menopause and specific immunoglobulin E for both cockroach (OR = 1.38, P = 0.0132) and dogs (OR = 1.38, P = 0.0302). Longer postmenopausal duration was positively associated with cockroach allergen sensitization (OR = 1.25, P = 0.201).

Conclusions:
Longer duration of reproductive period was associated with higher prevalence of AR and aeroallergen sensitization in the postmenopausal period. Moreover, cockroach allergen sensitization was associated with a longer postmenopausal period.