bluuebunny/crossref_metadata_2025_split huggingface dataset:
Immediate Postoperative Pelvic Organ Prolapse Quantification Measures and 2-Year Risk of Prolapse Recurrence
Authors: Siff Lauren N. , Barber Matthew D. , Zyczynski Halina M. , Rardin Charles R. , Jakus-Waldman Sharon , Rahn David D. , Smith Ariana L. , Mazloomdoost Donna , Sridhar Amaanti , Gantz Marie G. ,   for the NICHD Pelvic Floor Disorders Network
Published: September 2020

OBJECTIVE:
To assess whether resting genital hiatus, perineal body, and total vaginal length measured intraoperatively at the conclusion of surgery are associated with prolapse recurrence 2 years after native tissue pelvic organ prolapse reconstruction.

METHODS:
This ancillary analysis of the OPTIMAL (Operations and Pelvic Muscle Training in the Management of Apical Support Loss) trial included women who had an immediate postoperative pelvic organ prolapse quantification (POP-Q) examination and 2-year follow-up. Primary outcome was bothersome bulge symptoms. Secondary outcomes were anatomic failure, surgical failure (either anatomic failure or bothersome bulge symptoms), and sexual function. Descriptive statistics assessed relationships between postprocedure POP-Q measures and these four outcomes. Multivariable models were fit to the data to control for baseline differences in bivariate comparisons. Receiver operating characteristic curves were generated to identify an optimal genital hiatus cut point associated with bothersome bulge, and this threshold was explored.

RESULTS:
This analysis included 368 participants. Bivariate analyses identified age, body mass index, vaginal deliveries, baseline genital hiatus, perineal body, and advanced POP-Q stage (3 or higher vs 2) as clinically relevant variables to include in multivariable models. After adjusting for these variables, the association between immediate postoperative genital hiatus and bothersome bulge (adjusted odds ratio [aOR] 1.4; 95% CI 0.9–2.1) was not significant at the P<.05 level; however, immediate postoperative genital hiatus was associated with anatomic (aOR 1.6; 95% CI 1.1–2.3) and surgical failure (aOR 1.5; 95% CI 1.0–2.1). Immediate postoperative genital hiatus of 3.5 cm was the selected cutoff (area under the curve 0.58, 95% CI 0.50–0.66 from the bothersome bulge model). Women with genital hiatus 3.5 cm or greater were more likely to have anatomic and surgical failures at 2 years. No POP-Q measures were correlated with 2-year sexual function.

CONCLUSION:
A larger immediate postoperative genital hiatus measurement of 3.5 cm or greater is not associated with bothersome bulge symptoms or sexual dysfunction but is associated with anatomic and surgical failures 2 years after native tissue vaginal reconstructive surgery.
Mifepristone Combination Therapy Compared With Misoprostol Monotherapy for the Management of Miscarriage
Authors: Berkley Holly H. , Greene Howard L. , Wittenberger Michael D. 
Published: September 2020

OBJECTIVE:
To assess whether mifepristone pretreatment adversely affects the cost of medical management of miscarriage.

METHODS:
Decision tree analyses were constructed, and Monte Carlo simulations were run comparing costs of combination therapy (mifepristone and misoprostol) with monotherapy (misoprostol alone) for medical management of miscarriage in multiple scenarios weighing clinical practice, patient income, and surgical evacuation modalities for failed medical management. Rates of completed medical evacuation for each were obtained from a recent randomized controlled trial.

RESULTS:
In every scenario, combination therapy offered a significant cost advantage over monotherapy. Using a Monte Carlo analysis, cost differences favoring combination therapy ranged from 6.3% to 19.5% in patients making federal minimum wage. The cost savings associated with combination therapy were greatest in scenarios using a staged approach to misoprostol administration and in scenarios using in–operating room dilation and curettage as the only modality for uterine evacuation, a savings of $190.20 (99% CI 189.35–191.07) and $217.85 (99% CI 217.19–218.50) per patient in a low-income wage group, respectively. A smaller difference was seen in scenarios using in-office manual vacuum aspiration to complete medical management failures. As patients' wages increased, the difference in cost between combination therapy and monotherapy increased.

CONCLUSION:
Mifepristone combined with misoprostol is, overall, more cost effective than monotherapy, and therefore cost should not be a deterrent to its adoption in the management of miscarriage.
Cochrane Review Summaries—October 2020
Authors: O’Mathuna Donal , Berghella Vincenzo , Bellussi Federica , Kumar Nimisha , Haas David M. 
Published: September 2020

With the current issue, the journal continues to bring new insights from Cochrane Systematic Reviews to the readers of Obstetrics & Gynecology. This month, we focus on potential interventions to improve pregnancy outcomes for women with recurrent pregnancy loss and antiphospholipid antibodies, the utility of pelvic floor muscle training in the perinatal period to prevent incontinence, and the use of adhesion barriers in gynecologic surgery. The summaries are published below, and the complete references with hyperlinks are listed in Box 1.

Box 1. Abstracts Discussed in This Summary

Hamulyák EN, Scheres LJJ, Marijnen MC, Goddijn M, Middeldorp S. Aspirin or heparin or both for improving pregnancy outcomes in women with persistent antiphospholipid antibodies and recurrent pregnancy loss. The Cochrane Database of Systematic Reviews 2020, Issue 5. Art. No.: CD012852. Available at: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD012852.pub2/full.Woodley SJ, Lawrenson P, Boyle R, Cody JD, Mørkved S, Kernohan A, et al. Pelvic floor muscle training for preventing and treating urinary and faecal incontinence in antenatal and postnatal women. The Cochrane Database of Systematic Reviews 2020, Issue 55. Art. No.: CD007471. Available at: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD007471.pub4/full.Ahmad G, Kim K, Thompson M, Agarwal P, O'Flynn H, Hindocha A, Watson A. Barrier agents for adhesion prevention after gynaecological surgery. The Cochrane Database of Systematic Reviews 2020, Issue 3. Art. No.: CD000475. Available at: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD000475.pub4/full.
Impact of Body Mass Index on Serum Concentrations of Antidepressants and Antipsychotics
Authors: Warrings Bodo , Samanski Lydia , Deckert Jürgen , Unterecker Stefan , Scherf-Clavel Maike 
Published: September 2020

Background:
Rates of overweight and obesity are higher in patients suffering from psychiatric disorders than in the general population. Body composition and enzyme functions are affected by overweight, and consequently, the pharmacokinetics of drugs may vary in overweight patients. Thus, overweight and obesity are important factors in psychiatric disorders and their treatment. This analysis aimed to investigate the impact of body mass index (BMI) on serum concentrations of the antidepressant drugs amitriptyline, doxepin, escitalopram, mirtazapine, and venlafaxine, and the antipsychotic drugs clozapine, quetiapine, and risperidone, taking into account the following confounding parameters: age, sex, and smoking habit.

Methods:
Inpatients and outpatients (N = 1657) who took at least one of the target drugs were included in this retrospective analysis. Serum concentrations of the target drugs and their metabolites were determined at the Department of Psychiatry, Psychosomatics, and Psychotherapy of the University Hospital of Würzburg during routine therapeutic drug monitoring (January 2009–December 2010), which was performed in the morning (trough level) at steady state.

Results:
Dose-corrected serum concentrations (CD) of the active moiety of doxepin and venlafaxine and of O-desmethylvenlafaxine were negatively associated with BMI (partial Pearson correlation, R = −0.267, P = 0.002; R = −0.206, P ≤ 0.001; R = −0.258, P ≤ 0.001), and the CDs were different in normal weight, overweight, and obese patients (analysis of covariance, P = 0.004, P < 0.001, P ≤ 0.001). No association was found between BMI and serum concentrations of amitriptyline, escitalopram, mirtazapine, clozapine, quetiapine, and risperidone.

Conclusions:
In obese patients, higher doses of doxepin and venlafaxine are necessary to achieve similar serum concentrations as in normal weight patients and to avoid treatment-resistant depression.
Physical Function Outcomes in Patients with Lower-Limb Amputations Due to Trauma: A Systematic Review
Authors: Kaur Yuvreet , Cimino Stephanie R. , Albarico Mikhaela , Mayo Amanda L. , Guilcher Sara J.T. , Robinson Lawrence R. , Hanada Ed , Hitzig Sander L. 
Published: September 2020

ABSTRACT

Introduction
Lower-limb amputation (LLA) due to trauma is a life-changing medical event that challenges daily physical functioning. The aim of this systematic review was to summarize the physical function outcomes in patients with major traumatic LLA.

Methods
A literature search was conducted using MEDLINE, EMBASE, CINAHL, and PsycINFO. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed for the review methodology. Observational studies on physical function outcomes post major traumatic LLA, with sample sizes of at least 10 adults in an outpatient setting and published in English were included. The Downs and Black scale was used to assess methodological quality and articles were assigned a level of evidence.

Results
The initial search retrieved 4626 articles, and 69 met the inclusion criteria. On average, papers had poor methodological quality. The traumatic LLA population was found to have numerous mobility challenges and reduced physical fitness, with unilateral transtibial amputation resulting in the best outcomes. There was a lack of literature on female populations, civilians, and patients from low- and middle-income countries.

Conclusions
Given the changes in mobility and physical health, multidisciplinary care teams are essential to manage traumatic LLA individuals' rehabilitation programs and health. Higher-quality research is needed to support evidence-based clinical recommendations.
Roll-Over Shape–Based Design of Novel Biomimetic Ankle-Foot Prosthesis
Authors: Schlafly Millicent , Reed Kyle B. 
Published: September 2020

ABSTRACT

Introduction
Past research suggests that able-bodied individuals actively control their gait kinematics to produce one invariant roll-over shape (ROS). The ROS is a spatial representation of the center of pressure in a shank-based coordinate system. Because individuals with an amputation do not have adaptive control over their center of pressure during gait, the ankle-foot prosthesis determines the resultant ROS. This study aimed to design the mechanical properties of ankle-foot prostheses to achieve specific ROSs during gait.

Methods
The authors developed a mathematical model that, when used in combination with ground reaction force and shank angle experimental data, predicts the ROS created by the novel Compliant and Articulating Prosthetic Ankle (CAPA) foot. The CAPA consists of four articulating components connected by torsion springs. Able-bodied individuals walked wearing a prosthetic simulator with the solid ankle cushioned heel foot, a dynamic response foot (the Renegade AT), and versions of the CAPA with distinctly different predicted ROSs. The experimental ROS of each trial was presented, and quantitative ROS characteristics were evaluated for statistical significance. Predicted and experimental shapes for each version of the CAPA were compared by computing the distance between the shapes and ROS characteristics. Finally, we evaluated whether our method predicts the same ROS regardless of the experimental data used for the prediction.

Results
Changes to the mechanical properties of the CAPA resulted in statistically significant differences in ROS characteristics, notably forward position, forward length, and orientation (P < 0.05). The mean distance between points on the predicted and experimental ROSs is 1.54% of the length of the CAPA. We demonstrated that experimental ROSs can be predicted using gait data from a different version of the CAPA and a different individual.

Conclusions
This study presents and experimentally validates a method to predict the ROSs created by eight versions of the CAPA during gait. The method enables prosthetists and researchers to design ankle-foot prostheses based on the ROS created during gait.
Implementing High-Reliability Organization Principles Into Practice: A Rapid Evidence Review
Authors: Veazie Stephanie , Peterson Kim , Bourne Donald , Anderson Johanna , Damschroder Laura , Gunnar William 
Published: September 2020

Objective
To promote a safety culture and reduce harm, health care systems are adopting high-reliability organization (HRO) principles. This rapid review synthesizes HRO frameworks, metrics, and implementation effects to help inform health systems’ efforts toward becoming HROs.

Methods
Bibliographic databases were searched from 2010 to 2019. One reviewer used prespecified criteria to assess articles for inclusion, evaluate study quality, extract data, and grade strength of evidence with second reviewer checking.

Results
Twenty-three articles were identified: 8 described frameworks, 9 examined metrics, and 9 evaluated implementation outcomes. Five common strategies for HRO implementation emerged (developing leadership, supporting a culture of safety, providing training and learning, building data systems, and implementing quality improvement interventions). The Joint Commission’s and Institute for Healthcare Improvement’s frameworks emerged as the most comprehensive and widely applicable. The Joint Commission’s Oro 2.0 metric for evaluating HRO progress similarly stood out as it was developed through broad stakeholder input and was validated by external researchers. Multicomponent HRO interventions delivered for at least 2 years were associated with improved process and patient safety outcomes. Because each HRO intervention was only supported by a single poor or fair-quality study—none of which contained a concurrent control group—a causal relationship between any HRO initiative and outcomes could not be established.

Conclusions
Health care system adoption of HRO principles is associated with improved safety outcomes, yet the level of evidence is low. Priorities for future HRO studies include use of concurrent control groups and examination of specific outcomes measurements.
Associations between methamphetamine use and lack of viral suppression among a cohort of HIV-positive persons who inject drugs in Hai Phong, Vietnam
Authors: Feelemyer Jonathan , Arasteh Kamyar , Huong Duong T. , Oanh Khuat T.H. , Khue Pham M. , Giang Hoang T. , Thanh Nham T.T. , Moles Jean Pierre , Vinh Vu H. , Vallo Roselyne , Quillet Catherine , Rapoud Delphine , Le Sao M. , Michel Laurent , Laureillard Didier , Nagot Nicolas , Des Jarlais Don C. 
Published: September 2020

Objective:
We assessed the association between methamphetamine use and lack of viral suppression among a cohort of HIV-seropositive persons who inject drugs (PWID) in Hai Phong, Vietnam.

Design:
Cohort study with random effects logit modeling and mediation analysis for antiretroviral therapy (ART) adherence.

Methods:
PWID were recruited from October 2016 to October 2017; HIV-seropositive PWID were enrolled in a cohort to assess HIV viral loads, changes in drug use, risk behaviors, and ART adherence during 24-month follow-up. Methamphetamine use in last 30 days was divided into three categories: 0 days (no use), 1–19 days (intermediate), and 20 or more days (heavy). Bivariate and a multivariable random effects logit models were used to assess the relationship between methamphetamine use and not being virally suppressed. We also assessed self-reported ART adherence as a mediating factor.

Results:
A total of 645 HIV-seropositive PWID were included at baseline; 95% male, average age 40 (SD = 6.4). At baseline, methamphetamine use in last 30 days was 64% no use, 32% intermediate use, 4% heavy use. Approximately 74% of PWID reported high/complete adherence; 76% were at viral suppression. In random effects analysis, recent methamphetamine use was associated with not being virally suppressed during follow-up (adjusted odds ratio: 1.84, 95% confidence interval: 1.06, 3.17); the effect was not explained by a mediating effect of self-reported adherence to ART.

Conclusion:
Recent methamphetamine use is associated with not being virally suppressed among PWID. The results of this study indicate the need for targeted interventions for methamphetamine use with special focus on those with HIV infection.
Mechanistic differences underlying HIV latency in the gut and blood contribute to differential responses to latency-reversing agents
Authors: Telwatte Sushama , Kim Peggy , Chen Tsui-Hua , Milush Jeffrey M. , Somsouk Ma , Deeks Steven G. , Hunt Peter W. , Wong Joseph K. , Yukl Steven A. 
Published: September 2020

Objective:
While latently HIV-infected cells have been described in the blood, it is unclear whether a similar inducible reservoir exists in the gut, where most HIV-infected cells reside. Tissue-specific environments may contribute to differences in the mechanisms that govern latent HIV infection and amenability to reactivation. We sought to determine whether HIV-infected cells from the blood and gut differ in their responses to T-cell activation and mechanistically distinct latency reversing agents (LRAs).

Design:
Cross sectional study using samples from HIV-infected individuals (n = 11).

Methods:
Matched peripheral blood mononuclear cells (PBMC) and dissociated total cells from rectum ± ileum were treated ex vivo for 24 h with anti-CD3/CD28 or LRAs in the presence of antiretrovirals. HIV DNA and ‘read-through’, initiated, 5′ elongated, completed, and multiply-spliced HIV transcripts were quantified using droplet digital PCR.

Results:
T-cell activation increased levels of all HIV transcripts in PBMC and gut cells, and was the only treatment that increased multiply-spliced HIV RNA. Disulfiram increased initiated HIV transcripts in PBMC but not gut cells, while ingenol mebutate increased HIV transcription more in gut cells. Romidepsin increased HIV transcription in PBMC and gut cells, but the increase in transcription initiation was greater in PBMC.

Conclusion:
The gut harbors HIV-infected cells in a latent-like state that can be reversed by T-cell activation involving CD3/CD28 signaling. Histone deacetylation and protein kinase B may contribute less to HIV transcriptional initiation in the gut, whereas protein kinase C may contribute more. New LRAs or combinations are needed to induce multiply-spliced HIV and should be tested on both blood and gut.
The Impact of a Comprehensive Simulation-Based Training and Certification Program on Resident Central Venous Catheter Complication Rates
Authors: Day Jonathan , Winchester Zachary B. , Cairns Cassandra A. , Goyal Munish , Kumar Anagha , Bell Jacob , Katz Jared , Fitzgibbons Shimae C. 
Published: September 2020

Introduction
Millions of central venous catheters (CVCs) are placed annually in the United States, many by resident physicians. Simulation training has been proposed as a means to increase resident physician competence with CVC placement and decrease the incidence of line-associated mechanical complications. We aimed to evaluate the impact of a novel simulation-based CVC training program for resident physicians on CVC-associated mechanical complication rates. We hypothesized that the CVC-related mechanical complication rates would be lower among simulation-trained residents (STRs) compared with nonsimulation, traditionally trained residents (TTRs).

Methods
A retrospective chart review was performed of patients with a CVC placed by a resident physician between October 2014 and January 2017 at MedStar Georgetown University Hospital in Washington, DC. Incidence of CVC mechanical complications, including pneumothorax, hemothorax, arterial injury, or retained guidewire, were extracted from the electronic medical record and compared between STR and TTR cohorts. In contrast to TTRs who were trained to place CVCs in a supervised clinical setting, STRs underwent a CVC training program using online modules, a hands-on simulation training and testing checklist, and a series of successful supervised insertions before being credentialed to place lines independently.

Results
Nine hundred twenty-four CVCs placed by resident physicians during the study period were analyzed. There was no statistically significant difference in total mechanical complication rates between the STRs and TTRs in this study period (2.4% vs. 2.2%, P = 1). Simulation-trained residents were more likely to use ultrasound guidance when indicated during CVC insertion compared with TTRs (94.8% vs. 70.5%, P < 0.001).

Conclusions
Mechanical complication rates associated with CVC insertion were similar between the simulation and TTRs and were consistent with previously published literature. These findings suggest that residents who underwent simulation training and certification demonstrated performance on par with more experienced TTRs. In addition, they were more likely to use best practices including ultrasound guidance in line placement.
Pelvic Organ Prolapse Severity and Genital Hiatus Size With Long-Term Pessary Use
Authors: Boyd Sarah S. , Subramanian Divya , Propst Katie , O’Sullivan David , Tulikangas Paul 
Published: September 2020

Objectives
To evaluate the association between pessary use more than 1 year and change in prolapse severity.

Methods
This is a secondary analysis of a previously published randomized controlled trial of women undergoing office management of pessaries for management of symptomatic pelvic organ prolapse and incontinence. Primary outcome was change in pelvic organ prolapse quantification measurement genital hiatus (GH). Secondary outcomes included change in prolapse stage, type of pessary, size of pessary, number of pessary changes, and duration of use. Baseline data were collected from the earliest documented examination within the hospital record before pessary placement and compared with their final study visit. Demographics were analyzed using descriptive statistics. Student t test and Mann-Whitney tests were used for categorical comparisons. Pearson and Spearman correlation coefficients were used to evaluate change over time.

Results
The cohort was 132 predominantly non-Hispanic White (75%) women with symptomatic prolapse >stage 2 (70.5%). All were postmenopausal. Median duration of pessary use was 39.5 months (interquartile range, 17–64.5 months). Genital hiatus (P = 0.014) and prolapse stage (P = 0.001) decreased as duration of pessary use increased. Those with baseline stages ≥3 had a significant decrease in GH as duration of pessary use increased compared with stages <3 (−0.5 cm vs 0 cm, P < 0.001). There was no difference in change in GH when comparing women with baseline GH less than 3 to 3 cm or greater.

Conclusions
Pessary use by women with pelvic organ prolapse causes a change in vaginal anatomy over time as seen by decreasing stage and point GH.