bluuebunny/crossref_metadata_2025_split huggingface dataset:
IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study
Authors: Trevidic Patrick , Connolly Simon A. , Biwer Bernard , Ellers-Lenz Barbara , Harrington Laura S. , Kestemont Philippe , Noah Ernst M. , Sattler Gerhard , Weissenberger Petra , Kerscher Martina 
Published: November 2017

BACKGROUND
In clinical practice, different upper facial areas are commonly treated together.

OBJECTIVE
To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period.

MATERIALS AND METHODS
In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of “none” or “mild” or a ≥1-point improvement in MAS scores.

RESULTS
A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection.

CONCLUSION
IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).
Pharmacoeconomic and associated cost savings among women who were prescribed systemic conjugated estrogens therapy compared with those without menopausal therapy
Authors: Tang Wing Yu , Grothe Dale , Keshishian Allison , Morgenstern Diana , Haider Seema 
Published: November 2017

Abstract

Objective:
To explore changes in healthcare costs among postmenopausal women in a commercial population who were prescribed conjugated estrogens for menopausal symptoms.

Methods:
Using the MarketScan dataset from April 1, 2008 through September 30, 2012, postmenopausal women aged ≥45 years, who were prescribed conjugated estrogen tablets (Premarin), were identified. A comparative cohort of postmenopausal women with vasomotor symptoms without any menopause therapy was also identified. Women included were required to have continuous medical and pharmacy benefits for 6 months before and 12 months after index date, with baseline characteristics compared using chi-square and t tests. The 6 and 12-month change (difference in follow-up and baseline costs) in direct healthcare costs was calculated and a difference-in-differences model was used to compare the incremental change at 6 and 12 months in healthcare costs between the cohorts, adjusting for demographic and clinical characteristics.

Results:
The study included 1,404 women who were prescribed conjugated estrogens, and 3,096 untreated women. Women prescribed conjugated estrogens were significantly younger (52 vs 54 years; P < 0.0001) and had a lower Charlson comorbidity index score (0.29 vs 0.41; P < 0.001) compared with the untreated women. After adjusting for baseline characteristics, women treated with conjugated estrogens showed a greater difference in the change in total healthcare costs (−$1,601 vs −$503; P = 0.044), including inpatient stay costs (−$1,431 vs −$28; P < 0.0001), between the baseline and follow-up periods compared with untreated women.

Conclusions:
Women who were prescribed oral conjugated estrogens had a significantly greater reduction in healthcare costs after treatment initiation compared with untreated postmenopausal women.
Reconstruction of Congenital Sternal Clefts: Surgical Experience and Literature Review
Authors: Alshomer F. , Aldaghri Faris , Alohaideb Nawaf , Aljehani Reem , Murad Mohamed Amir , Hashem Fuad 
Published: November 2017

Background:
Sternal cleft is a rare anomaly with a reported incidence of 1:100,000 cases per live births. Surgical intervention represents a crucial factor altering the overall patient prognosis, since they are at high risk of impaired oxygenation, as well as multiple chest infections. Herein, we are reporting our experience of surgical management of such rare cases, alerting plastic surgeons to their possibly crucial role in the reconstructive team.

Methods:
A retrospective chart review of 2 cases presenting with chest wall defects. All perioperative data were collected and presented.

Results:
Two patients with sternal clefts of variable degrees were managed. The first was an 18-month-old boy with partial inferior sternal cleft, who was otherwise asymptomatic. The patient underwent reconstruction at the same age using autologous rib graft and pectoralis major flaps due to ectopia cordis that was putting the patient at higher risk for cardiac trauma. The second patient was a 3-month-old girl having a V-shaped partial superior cleft with lung herniation. Surgical reconstruction was applied due to difficulty in weaning the patient off of ventilator support. Initially, reconstruction was applied with SurgiMend dermal matrix, but this was complicated by chest retraction and high oxygen requirement. Definitive reconstruction was later applied with allogeneic bone graft and pectoralis major flaps.

Conclusions:
Meticulous patient assessment and screening for associated anomalies are crucial. Surgical intervention is warranted at an early age. The use of acellular dermal matrix products in the reconstruction is of interest, but should be approached with caution.
CHOROIDAL THICKNESS CHANGES IN ACUTE ZONAL OCCULT OUTER RETINOPATHY
Authors: Maehara Hiroki , Sekiryu Tetsuju , Sugano Yukinori , Maruko Ichiro 
Published: November 2017

Purpose:
To investigate the longitudinal morphologic choroidal changes in eyes with acute zonal occult outer retinopathy.

Methods:
In this retrospective observational case series, we studied 10 patients (11 eyes) with unilateral acute zonal occult outer retinopathy at the first visit who were followed more than 12 months by enhanced depth optical coherence tomography. The retinal and choroidal thicknesses (CTs) were measured at six sites in the macula.

Results:
The integrity of the ellipsoid zone was lost 1,500 μm and 3,000 μm nasally in all 11 eyes at the first visit. Compared with the unaffected fellow eyes, the mean total retinal thickness at the first visit was significantly (P = 0.03) thinner 3,000 μm nasal to the fovea in the affected eyes. The mean CTs in the affected eyes did not differ from that in the unaffected eyes at any evaluation; the mean subfoveal CT in the affected eyes gradually decreased during the follow-up period. Compared with the first visit, the mean subfoveal CT decreased significantly (P = 0.011) at the foveal center and nasal, superior, and temporal to the fovea 12 months after disease onset.

Conclusion:
The subfoveal CT in eyes with acute zonal occult outer retinopathy can decrease during follow-up.
Evaluation of the Influence of Gastrointestinal Coinfections on Rotavirus Vaccine Effectiveness in Botswana
Authors: Mokomane Margaret , Tate Jacqueline E. , Steenhoff Andrew P. , Esona Mathew D. , Bowen Michael D. , Lechiile Kwana , Pernica Jeffrey M. , Kasvosve Ishmael , Parashar Umesh D. , Goldfarb David M. 
Published: November 2017

Background:
Studies have demonstrated reduced rotavirus vaccine effectiveness (VE) in resource-limited settings. Enteropathogen coinfections in rotavirus cases have been hypothesized to contribute to the lower VE in such settings. We sought to determine if coinfections affect rotavirus VE in Botswana.

Methods:
Between June 2013 and April 2015, children <60 months old, presenting with severe gastroenteritis at 4 hospitals as part of a national rotavirus surveillance were enrolled. Rotavirus enzyme immunoassay (EIA)–positive samples were tested with an in-house real-time polymerase chain reaction (PCR) panel that detected 9 pathogens and a commercial 15 multiplex PCR gastrointestinal pathogen panel. Coinfection was defined as detection of rotavirus plus 1 of the 5 pathogens with the highest attributable fractions for diarrhea. Vaccine status was compared between rotavirus case patients and non-rotavirus “test-negative” controls. VE was also calculated restricting cases to those with rotavirus as the only pathogen detected.

Results:
Two hundred and forty-two children tested rotavirus EIA positive, and 368 children were negative. Of the 182 rotavirus EIA-positive samples tested with the gastrointestinal pathogen panel assay, coinfections were detected in 60 (33%). The overall adjusted 2-dose VE was 59% (95% confidence interval [CI]: 27–77) in the rotavirus coinfection group and 51% (95% CI: −14 to 79) in the rotavirus monoinfection subgroup. Using in-house multiplex PCR panel, of 213 rotavirus EIA-positive subjects, coinfections were detected in 98 samples (46%). The overall adjusted VEs for 2 doses were 48% (95% CI: −2 to 74) and 62% (95% CI: 25–80) in rotavirus monoinfection subgroup.

Conclusions:
We could not find evidence of an effect of enteric coinfections on the effectiveness of rotavirus vaccine.
High Prevalence of Lipid Abnormalities and Insulin Resistance Among Antiretroviral Naïve HIV-infected Children in India
Authors: Padmapriyadarsini C. , Shet Anita , Srinivasan R. , Ramachandran Geetha , Sanjeeva G. N. , Devi Poornaganga , Ramesh K. , Bhavani Perumal K. , Reddy Devaraj , Suresh E. , Chandrasekhar C. , Wanke Christine , Swaminathan Soumya 
Published: November 2017

Background:
As large numbers of children are accessing antiretroviral therapy (ART) in India, we evaluated the dietary intake, growth pattern and risk of metabolic complications like dyslipidemia and insulin resistance among ART-naïve HIV-infected children (CLHIV).

Methods:
CLHIV 2–12 years of age, at the time of initiating ART in Chennai and Bangalore, were assessed for their dietary intake, anthropometry, blood CD4 cell count, HIV-1 viral load, fasting serum lipids, glucose and insulin. Homeostatic model assessment-insulin resistance was derived.

Results:
Three hundred and ninety CLHIV (mean age [SD]: 8 [3] yrs; median viral load: 141,000 [25,876–436,000] copies/mL) were started on non-nucleoside reverse transcriptase inhibitor-based ART. Perinatal infection was documented among 97%. Sixty percent of children were in stage 3 or 4 of World Health Organization clinical staging of HIV/AIDS. Food insecurity was seen in 40% of households. A total of 204 children (52.4%) were stunted and 224 (57.6%) were underweight. Stunting seemed to be more prevalent with increasing age (0–4 years: 48%; >9 years: 60%). Mean intakes of calories, iron, folate and calcium were significantly less than recommended dietary allowances across all age groups. Dyslipidemia, in terms of any abnormal triglycerides or total cholesterol or low-density lipoprotein cholesterol (excluding high-density lipoprotein cholesterol), was seen in approximately 40% of children; insulin resistance in 17%; and C-reactive protein in risk range of metabolic syndrome in 24% of children.

Conclusions:
In the background of high food insecurity and malnutrition, cardiometabolic abnormalities were seen in 20%–35% of ART-naïve CLHIV in India emphasizing close monitoring of these children for long-term cardiovascular morbidities after initiation of ART.
Implementation of a Routine Health Literacy Assessment at an Academic Medical Center
Authors: Warring Carrie D. , Pinkney Jacqueline R. , Delvo-Favre Elaine D. , Rener Michelle Robinson , Lyon Jennifer A. , Jax Betty , Alexaitis Irene , Cassel Kari , Ealy Kacy , Hagen Melanie Gross , Wright Erin M. , Chang Myron , Radhakrishnan Nila S. , Leverence Robert R. 
Published: November 2017

ABSTRACT
Limited health literacy is a common but often unrecognized problem associated with poor health outcomes. Well-validated screening tools are available to identify and provide the opportunity to intervene for at-risk patients in a resource-efficient manner. This is a multimethod study describing the implementation of a hospital-wide routine health literacy assessment at an academic medical center initiated by nurses in April 2014 and applied to all adult inpatients. Results were documented in the electronic health record, which then generated care plans and alerts for patients who screened positive. A nursing survey showed good ease of use and adequate patient acceptance of the screening process. Six months after hospital-wide implementation, retrospective chart abstraction of 1,455 patients showed that 84% were screened. We conclude that a routine health literacy assessment can be feasibly and successfully implemented into the nursing workflow and electronic health record of a major academic medical center.
Precision medicine in pediatric oncology
Authors: Forrest Suzanne J. , Geoerger Birgit , Janeway Katherine A. 
Published: November 2017

Purpose of review
The current review describes recent advances and unique challenges in precision medicine for pediatric cancers and highlights clinical trials assessing the clinical impact of targeted therapy matched to molecular alterations identified by tumor profiling.

Recent findings
Multiple prospective clinical sequencing studies in pediatric oncology have been reported in the last 2 years. These studies demonstrated feasibility of sequencing in the clinic and revealed a rate of actionable variants that justifies the development of precision trials for childhood cancer. A number of precision medicine trials are recently completed, underway or in development and these will be reviewed herein, with a focus on highlighting aspects of precision medicine trial design relevant to pediatric oncology.

Summary
The primary results of the first round of pediatric precision oncology clinical trials will provide us with a greater understanding of the clinical impact of linking tumor profiling to selection of targeted therapies. The aggregation of sequencing and clinical data from these trials and the results of biologic investigations linked to these trials will drive further discoveries and broaden opportunities for precision medicine for children with cancer.
Does a Rehabilitation Program of Aerobic and Progressive Resisted Exercises Influence HIV-Induced Distal Neuropathic Pain?
Authors: Maharaj Sonill S. , Yakasai Abdulsalam M. 
Published: November 2017

Objective
Distal symmetrical polyneuropathy is a common neurological sequela after HIV, which leads to neuropathic pain and functional limitations. Rehabilitation programs with exercises are used to augment pharmacological therapy to relieve pain but appropriate and effective exercises are unknown. This study explored the safety and effect of moderate-intensity aerobic exercises and progressive resisted exercises for HIV-induced distal symmetrical polyneuropathy neuropathic pain.

Design
A randomized pretest, posttest of 12 wks of aerobic exercise or progressive resisted exercise compared with a control. Outcome measures were assessed using the subjective periphery neuropathy, brief peripheral neuropathy screening, and numeric pain rating scale. Pain was assessed at baseline, 6 and 12 wks. Data between groups were compared using Kruskal-Wallis, Mann-Whitney U test, and within-groups Friedman and Wilcoxon signed rank tests.

Results
There were 136 participants (mean [SD] age = 36.79 [8.23] yrs) and the exercise groups completed the protocols without any adverse effects. Pain scores within and between aerobic exercise and progressive resisted exercise groups showed significant improvement (P < 0.05) from baseline to 6 and 12 wks compared with the control (P > 0.05).

Conclusions
This study supports a rehabilitation program of moderate-intensity aerobic exercise and progressive resisted exercise being safe and effective for reducing neuropathic pain and is beneficial with analgesics for HIV-induced distal symmetrical polyneuropathy.
The Pancreatic Cancer Microenvironment
Authors: Dougan Stephanie K. 
Published: November 2017

Abstract
Pancreatic ductal adenocarcinoma (PDAC) is composed of a minority of malignant cells within a microenvironment of extracellular matrix, fibroblasts, endothelial cells, and immune cells. Therapeutic failures of chemotherapy, targeted therapy, and immunotherapy have all been attributed to the PDAC microenvironment. In this review, we dissect the components of the microenvironment and explain how each cell type contributes to form a highly immunosuppressive, hypoxic, and desmoplastic cancer. New efforts in single-cell profiling will enable a better understanding of the composition of the microenvironment in primary and metastatic PDAC, as well as an understanding of how the microenvironment may respond to novel therapeutic approaches.
Targeting Reflux-Free Veins with a Vein Visualizer to Identify the Ideal Recipient Vein Preoperatively for Optimal Lymphaticovenous Anastomosis in Treating Lymphedema
Authors: Yang Johnson Chia-Shen , Wu Shao-Chun , Chiang Min-Hsien , Lin Wei-Che 
Published: November 2017

Summary:
Lymphaticovenous anastomosis is one of the main surgical treatments nowadays for alleviating lymphedema. A successful lymphaticovenous anastomosis relies on being able to identify “functional” lymphatic collecting vessels that are still capable of transporting lymph, and a nearby vein that is, ideally, reflux-free. This is a retrospective study. A total of 28 lymphedema patients were enrolled from October of 2016 to March of 2017 in Kaohsiung Chang Gung Hospital, Kaohsiung, Taiwan. A noninvasive vein visualizer was used to preselect reflux-free veins for lymphaticovenous anastomosis from five female patients. As a control, the total number of veins used for lymphaticovenous anastomoses without the use of a vein visualizer from 23 consecutive lymphedema patients was also recorded and compared. In the experimental group, a total of 12 of 13 veins (92 percent sensitivity) preselected by using the VeinViewer were confirmed to be reflux-free intraoperatively during lymphaticovenous anastomosis. In the control group, 21 of 56 veins (37.5 percent sensitivity) showed no venous reflux. Statistical analysis with the chi-square test showed a value of p < 0.001 (number needed to treat = 2.706). The odds of identifying reflux-free veins can be increased significantly with the use of a vein visualizer.

CLINICAL QUESTION/LEVEL OF EVIDENCE:
Diagnostic, II.
Assessing Patients' Perceptions of Safety Culture in the Hospital Setting: Development and Initial Evaluation of the Patients' Perceptions of Safety Culture Scale
Authors: Monaca Clara , Bestmann Beate , Kattein Martina , Langner Daria , Müller Hardy , Manser Tanja 
Published: November 2017

Objectives
Both patient satisfaction and hospital safety culture have been recognized as key characteristics of healthcare quality and patient safety. Thus, both characteristics are measured widely to support quality and safety improvement efforts. However, because safety culture surveys focus exclusively on the perspective of hospital staff, the complimentary information to be gained from patients' perceptions of safety culture has received little research attention so far. We aimed to develop a measure explicitly focusing on patients' perceptions of safety culture in the hospital setting and perform an initial evaluation of its measurement properties.

Methods
We employed a multistep development approach including (a) literature review of survey instruments for patient experience and safety culture and (b) item categorization and selection. We evaluated the measurement properties of the final item set focusing on factor structure, internal consistency, item difficulty, and discrimination. Data were collected from June to December 2015 via an online patient survey conducted routinely by a health insurer.

Results
Overall, 112,814 insured persons participated in the online survey (response rate = 19.7%). The final 11-item set formed a single scale that was named Patients' Perceptions of Safety Culture scale. Its measurement properties were deemed satisfactory based on this initial evaluation.

Conclusions
The Patients' Perceptions of Safety Culture scale contributes to both a more comprehensive view of patients' experience of healthcare and a more balanced approach to safety culture measurement in healthcare. It contributes to an increased recognition of patients' views on safety-relevant aspects of their care that provide important inputs to patient safety improvement.
Evaluation of a Broad-Spectrum Partially Automated Adverse Event Surveillance System: A Potential Tool for Patient Safety Improvement in Hospitals With Limited Resources
Authors: Saikali Melody , Tanios Alain , Saab Antoine 
Published: November 2017

Objective
The aim of the study was to evaluate the sensitivity and resource efficiency of a partially automated adverse event (AE) surveillance system for routine patient safety efforts in hospitals with limited resources.

Methods
Twenty-eight automated triggers from the hospital information system’s clinical and administrative databases identified cases that were then filtered by exclusion criteria per trigger and then reviewed by an interdisciplinary team. The system, developed and implemented using in-house resources, was applied for 45 days of surveillance, for all hospital inpatient admissions (N = 1107). Each trigger was evaluated for its positive predictive value (PPV). Furthermore, the sensitivity of the surveillance system (overall and by AE category) was estimated relative to incidence ranges in the literature.

Results
The surveillance system identified a total of 123 AEs among 283 reviewed medical records, yielding an overall PPV of 52%. The tool showed variable levels of sensitivity across and within AE categories when compared with the literature, with a relatively low overall sensitivity estimated between 21% and 44%. Adverse events were detected in 23 of the 36 AE categories defined by an established harm classification system. Furthermore, none of the detected AEs were voluntarily reported.

Conclusions
The surveillance system showed variable sensitivity levels across a broad range of AE categories with an acceptable PPV, overcoming certain limitations associated with other harm detection methods. The number of cases captured was substantial, and none had been previously detected or voluntarily reported. For hospitals with limited resources, this methodology provides valuable safety information from which interventions for quality improvement can be formulated.