bluuebunny/crossref_metadata_2025_split huggingface dataset:
An Alternative Consent Process for Minimal Risk Research in the ICU*
Authors: Terry Melissa A. , Freedberg Daniel E. , Morris Marilyn C. 
Published: June 2017

Objectives:
Seeking consent for minimal risk research in the ICU poses challenges, especially when the research is time-sensitive. Our aim was to determine the extent to which ICU patients or surrogates support a deferred consent process for a minimal risk study without the potential for direct benefit.

Design:
Prospective cohort study.

Setting:
Five ICUs within a tertiary care hospital.

Patients:
Newly admitted ICU patients 18 years old or older.

Interventions:
We administered an eight-item verbal survey to patients or surrogates approached for consent to participate in a minimal risk, ICU-based study. The parent study involved noninvasive collection of biosamples and clinical data at the time of ICU admission and again 3 days later. If patients had capacity at the time of ICU admission, or if a surrogate was readily available, consent was sought prior to initial sample collection; otherwise, a waiver of consent was granted, and deferred consent was sought 3 days later. Quantitative and qualitative data were analyzed.

Measurements and Main Results:
One hundred fifty-seven individuals were approached for consent to participate in the parent study; none objected to the consent process. One hundred thirty-five of 157 (86%) competed the survey, including 94 who consented to the parent study and 41 who declined. Forty-four of 60 individuals (73%) approached for deferred consent responded positively to the question “Did we make the right choice in waiting until now to ask your consent?” three of 60 (5%) responded negatively, and 13 of 60 (22%) made a neutral or unrelated response. The most common reason given for endorsing the deferred consent process was the stress of the early ICU experience 25 of 44 (61%).

Conclusions:
Most patients and surrogates accept a deferred consent process for minimal risk research in the ICU. For appropriate ICU-based research, investigators and Institutional Review Boards should consider a deferred consent process if the subject lacks capacity and an appropriate surrogate is not readily available.
Extraskeletal Osteosarcoma
Authors: Paludo Jonas , Fritchie Karen , Haddox Candace L. , Rose Peter S. , Arndt Carola A.S. , Marks Randolph S. , Galanis Evanthia , Okuno Scott H. , Robinson Steven I. 
Published: June 2017

Objectives:
Extraskeletal osteosarcoma (EO) is a malignant neoplasm that produces osteoid, bone, and chondroid material without direct attachment to bone or periosteum. Surgical resection is the mainstay of treatment; the role of chemotherapy is not well defined. Therefore, we evaluated the impact of chemotherapy in the survival of patients with EO.

Methods:
All EO patients seen at Mayo Clinic between 1990 and 2014 were assessed. Forty-three patients were included after all archived pathology slides were reviewed to confirm the diagnosis of EO.

Results:
Of 43 patients, 37 patients had localized disease and 6 patients had metastatic disease at diagnosis. Chemotherapy was used in 73% and 75% of patients, respectively. Chemotherapy was predominantly anthracycline based, and included platinum in 22 patients (84%).
Median overall survival (OS) and progression-free survival (PFS) were 50 months (95% confidence interval, 25-99), and 21 months (95% confidence interval, 13-not reached), respectively. There was a trend towards longer OS and PFS in patients who received chemotherapy. Those who received platinum-based therapy had remarkably prolonged OS (median, 182 vs. 18 mo; 5-year, 61% vs. 0%; P=0.01) and PFS (median, not reached vs. 10 mo; 5-year, 56% vs. 0%; P=0.005). Baseline characteristics were similar in the platinum and nonplatinum group.
In patients who received chemotherapy, relapse/recurrence rate was lower in the platinum-based group (41%) as opposed to the nonplatinum-based group (100%; P=0.02). In the neoadjuvant setting, the overall response rate of platinum-containing regimens was 27%.

Conclusions:
Our results suggest a clinical benefit when platinum-based chemotherapy is incorporated in the management of patients with EO. We plan to validate this further with an expanded multicenter analysis.
Local Application of Statins Significantly Reduced Hypertrophic Scarring in a Rabbit Ear Model
Authors: Jia Shengxian , Xie Ping , Hong Seok J. , Galiano Robert D. , Mustoe Thomas A. 
Published: June 2017

Background:
We previously showed that intradermal injection of statins is a successful treatment for hypertrophic scarring. Topical application has many advantages over intradermal injection. In this study, we demonstrate the efficacy of topical statin treatment in reducing scar in our validated rabbit ear scar model.

Methods:
Twenty New Zealand White rabbits were divided into 2 study groups, with 6 rabbits receiving 10 μm pravastatin intradermally at postoperative days 15, 18, and 21, and 14 rabbits receiving 0.4%, 2%, and 10% simvastatin topical application at postoperative days 14–25. Four or 6 full-thickness circular dermal punches 7 mm in diameter were made on the ventral surface of the ear down to but not including the perichondrium. Specimens were collected at 28 days to evaluate the effects of statins on hypertrophic scarring.

Results:
Treatment with pravastatin intradermal administration significantly reduced scarring in terms of scar elevation index. Topical treatment with both medium- and high-dose simvastatin also significantly reduced scarring. High-dose simvastatin topical treatment showed a major effect in scar reduction but induced side effects of scaling, erythema, and epidermal hyperplasia, which were improved with coapplication of cholesterol. There is a dose response in scar reduction with low-, medium- and high-dose simvastatin topical treatment. High-dose simvastatin treatment significantly reduced the messenger ribonucleic acid (mRNA) expression of connective tissue growth factor, consistent with our previously published work on intradermally injected statins. More directly, high-dose simvastatin treatment also significantly reduced the mRNA expression of collagen 1A1.

Conclusions:
Topical simvastatin significantly reduces scar formation. The mechanism of efficacy for statin treatment through interference with connective tissue growth factor mRNA expression was confirmed.
Intracorneal Inlays for the Correction of Presbyopia
Authors: Binder Perry S. 
Published: June 2017

Abstract:
The current nonsurgical approaches for the correction of presbyopia are spectacles or contact lenses or the use of pharmaceuticals to create an artificial pupil and/or to stimulate residual accommodation. Refractive surgical procedures use a monovision approach and/or a multifocal corneal laser ablation with or without the induction of negative spherical aberration to improve near vision. More recently, new surgical approaches include intracorneal inlays. Inlay approaches include increasing corneal curvature alone, implanting a multifocal inlay, or by implanting a small aperture device that functions as a pinhole to restore unaided near and intermediate visual acuity. This review presents an analysis of the history and development of the various inlay approaches designed to improve presbyopia. Unlike other refractive surgical approaches, these newer techniques are removable. Each has its advantages and disadvantages.
A Comparison of the Effects of Orthokeratology Lens, Medcall Lens, and Ordinary Frame Glasses on the Accommodative Response in Myopic Children
Authors: Han Xiaoxia , Xu Dongjun , Ge Weizhong , Wang Zhi , Li Xiaodong , Liu Weihua 
Published: June 2017

Objective:
To observe and compare changes in accommodative response between myopic children wearing ordinary frame glasses (OFG), Mouldway orthokeratology lenses (M-OK), and medcall lenses (ML).

Methods:
A total of 240 myopic children were divided into three groups: OFG [n=90]; M-OK [n=90]; and ML [n=60]). The diopter, accommodative lag, and binocular accommodative facility before wearing glasses (T0) and 1-year after wearing glasses (T1) were compared among the three groups.

Results:
Commercially available software was used to perform statistical analysis, and the data were expressed as mean±SD. There were no significant differences among the three groups at T0. The accommodative lags in M-OK and ML at T1 were significantly lower than those at T0; this finding was most evident in M-OK. Although accommodative facility increased in all three groups, the increase was most evident in M-OK and ML.

Conclusion:
Mouldway orthokeratology lenses and ML can reduce the accommodative lag and increase the accommodative facility in myopic children. Compared with ML, M-OK showed considerably more marked effects to myopia progression in children.
Depth Profile Assessment of the Early Phase Deposition of Lysozyme on Soft Contact Lens Materials Using a Novel In Vitro Eye Model
Authors: Qiao Han , Phan Chau-Minh , Walther Hendrik , Subbaraman Lakshman N. , Jones Lyndon 
Published: June 2017

Objective:
To characterize the location of fluorescently labeled lysozyme on commercial contact lenses (CLs) using an in vitro eye model that simulates tear volume, tear flow, air exposure, and mechanical wear.

Methods:
One commercially available conventional hydrogel CL material (etafilcon A) and three silicone hydrogel CL materials (balafilcon A, lotrafilcon B, and senofilcon A) were evaluated in this study. The CLs were mounted on the in vitro eye model and exposed to artificial tear fluid containing fluorescein isothiocyanate (FITC)-labeled lysozyme for 2 and 10 hrs. After these short incubation periods, circular discs were punched from the CLs at the center and periphery and were prepared for confocal laser scanning microscopy (CLSM). The CLSM captured a series of consecutive images spaced 5 μm apart, and the resulting images were rendered into two dimensional cross-sectional views of the CL. The mean fluorescence at each 5 μm slice was used to generate a histogram depicting the penetration of FITC-lysozyme into CLs.

Results:
For both incubation periods, the CLSM images and histogram of etafilcon A showed that FITC-lysozyme is more concentrated at the lens surface, with a moderate amount of deposition in the lens matrix. For balafilcon A, FITC-lysozyme was evenly distributed throughout the lens. For lotrafilcon B, there was a greater amount of FITC-lysozyme deposition on the surfaces of the lens versus the matrix. Senofilcon A had differential FITC-lysozyme distribution profiles depending on the location of the lens. At the lens periphery, FITC-lysozyme primarily deposited on the surface, whereas FITC-lysozyme was uniformly distributed at the center of the lens.

Conclusions:
With the use of a sophisticated in vitro eye model, the study revealed a complex deposition pattern of FITC-labeled lysozyme on various CL materials after short periods of exposure. An understanding of the early deposition pattern of lysozyme on different CL material may elucidate new insights into the processes behind CL discomfort.
Pseudomonas Aeruginosa Bacteremia in Patients With Hematologic Malignancies
Authors: Denham James Dustin , Nanjappa Sowmya , Greene John N. 
Published: June 2017

Introduction

Pseudomonas aeruginosa is a gram-negative rod that is a major cause of bacteremia in patients with a hematologic malignancy. Neutropenia from induction chemotherapy is the main risk factor for P. aeruginosa bacteremia and sepsis in this population. We analyzed risk factors, antibiotic susceptibility patterns, and outcomes due to P. aeruginosa bacteremia in these patients from our institution and compared these with those of similar studies.

Methods
This is a retrospective chart review analyzing P. aeruginosa bacteremia in patients with hematologic malignancies.

Results
Between January 2012 and February 2016, a total of 71 patients met the requirements for inclusion in our study. The average age of study participants was 57.9 years. Of the 71 patients included, 43 (60.6%) were neutropenic at the time of positive blood culture, 28 (39.4%) were not neutropenic at the time of positive of blood culture, 23 (32.4%) developed either sepsis or severe sepsis during the course of their hospital stay, 8 (11.3%) developed septic shock, 10 (14.1%) required vasopressor administration, 8 (11.3%) required mechanical ventilation, and 6 (8.5%) required both vasopressor administration and mechanical ventilation.

Discussion
Our research reaffirms the general severity of P. aeruginosa infections. Ultimately, 9 of 71 patients died as a result of their infection, with a mortality rate of 12.7%. Individuals whose bacteremia progressed to septic shock were much more likely to die. The case fatality rate of septic shock was 62.5%. Our data are congruent with other research that finds advanced age to be a significant risk factor for mortality. Our study also found that individuals who received a bone marrow transplant before developing bacteremia were more likely to survive than individuals who did not receive a bone marrow transplant.
Microbiology of Acute Rhinosinusitis in Immunosuppressed Patients
Authors: Ito Christopher J. , Jackson Ryan S. , Castro-Borobio Manuel , Nanjappa Sowmya , Klinkova Olga , Phommachanh Viengsouk , Keeler Jarrod A. , Greene John N. , Padhya Tapan A. , Tabor Mark H. 
Published: June 2017

ObjectiveThe aim of this study was to identify causative organisms of acute rhinosinusitis in immunosuppressed patients by a retrospective chart review.MethodsRecords were reviewed usingInternational Classification of Disease, Ninth Editioncodes for inpatient treatment of acute sinusitis. Patients were included only if they had formal sinus cultures obtained and were immunosuppressed, either carrying a diagnosis of a hematologic malignancy or receiving chemotherapy. Demographics, underlying malignancy, and culture results were recorded.ResultsRecords of 74 patients with 104 cultures were obtained. There were 43 males and 31 females. The mean age was 51. The most common primary diagnoses were leukemia (65%) and lymphoma (23%). Sixty cultures resulted in either no growth or growth of usual respiratory flora. Of the 44 positive cultures, 5 were polymicrobial, resulting in 61 organisms isolated in total. Bacteria cultured were 73% Gram positive, whereas 27% were Gram negative. The most common Gram-positive organisms cultured wereStaphylococcusspecies.Pseudomonasspecies were the predominant Gram-negative bacteria. Thirteen samples grew fungal organisms.ConclusionsMedical management of sinusitis in an immunosuppressed patient seems to be adequate in most cases. Patients who fail to improve should undergo evaluation by an otolaryngologist to obtain cultures for directed antibiotic therapy. Infections byStaphylococcusspecies as well as quinolone- and cephalosporin-resistant Gram-negative organisms may be encountered, and clinicians should suspect their presence in patients with persistent disease and expand their antibiotic coverage appropriately.
Fecal Microbiota Transplant in Severe/Complicated Clostridium difficile Infection
Authors: Gundacker Nathan D. , Walker Jeremey B. , Rodriguez J. Martin , Morrow Casey D. 
Published: June 2017

Abstract

Clostridium difficile infection (CDI) is the most common hospital-acquired infection in the United States. Fecal microbiota transplant (FMT) has become a highly efficacious therapy for recurrent mild/moderate disease; however, the efficacy and optimal delivery method in severe/complicated disease is unknown. A retrospective chart review was performed for all FMT recipients at the University of Alabama at Birmingham. Those with severe/complicated disease were isolated and their clinical course documented via chart review and phone calls. Eight patients with severe/complicated CDI who received FMT via both lower and/or upper routes were documented. Six experienced eventual cure, 2 died, with 1 death attributed to CDI, the other to another nosocomial infection. Fecal microbiota transplant is a reasonable option and should be considered in patients who are not surgical candidates. If lower endoscopy is not possible, delivery of FMT via nasogastric tube should also be considered. More studies comparing the efficacy of these routes are needed.
Myroides Soft Tissue Infections
Authors: Alkiswany Doaa , Bush Larry M. 
Published: June 2017

Abstract
Previously classified as Flavobacterium odoratum, Myroides species, although not regular constituents of the normal endogenous human flora may occasionally cause clinical disease. Most infections follow either exposure to environmental sources or acquired nosocomially often linked to contaminated water. The bulk of nonhealthcare-associated infections involve skin and soft tissues resulting from a traumatic event frequently accompanied by bacteremia. Once considered to be “opportunistic pathogens,” infections with Myroides also occur in immunocompetent individuals. Their unanticipated involvement and inherent multidrug resistance often lead to treatment failures when empiric and practice guideline recommended antimicrobial regimens be administered. However, other than in specific circumstances, it remains in the best interest of “good practice,” antibiotic stewardship efforts, and patient care to adhere to evidence-based guidelines and avoid influences such as the case we present and anecdotal experiences suggesting that broad-spectrum empiric antibiotic prescribing is a prudent practice in the initial treatment of undefined skin and soft tissues.
Short-duration physical activity prevents the development of activity-induced hyperalgesia through opioid and serotoninergic mechanisms
Authors: Lima Lucas V. , DeSantana Josimari M. , Rasmussen Lynn A. , Sluka Kathleen A. 
Published: June 2017

Abstract
Regular physical activity prevents the development of chronic muscle pain through the modulation of central mechanisms that involve rostral ventromedial medulla (RVM). We tested if pharmacological blockade or genetic deletion of mu-opioid receptors in physically active mice modulates excitatory and inhibitory systems in the RVM in an activity-induced hyperalgesia model. We examined response frequency to mechanical stimulation of the paw, muscle withdrawal thresholds, and expression of phosphorylation of the NR1 subunit of the N-methyl-D-aspartate receptor (p-NR1) and serotonin transporter (SERT) in the RVM. Mice that had performed 5 days of voluntary wheel running prior to the induction of the model were compared with sedentary mice. Sedentary mice showed significant increases in mechanical paw withdrawal frequency and a reduction in muscle withdrawal threshold; wheel running prevented the increase in paw withdrawal frequency. Naloxone-treated and MOR−/− mice had increases in withdrawal frequency that were significantly greater than that in physically active control mice and similar to sedentary mice. Immunohistochemistry in the RVM showed increases in p-NR1 and SERT expression in sedentary mice 24 hours after the induction of the model. Wheel running prevented the increase in SERT, but not p-NR1. Physically active, naloxone-treated, and MOR−/− mice showed significant increases in SERT immunoreactivity when compared with wild-type physically active control mice. Blockade of SERT in the RVM in sedentary mice reversed the activity-induced hyperalgesia of the paw and muscle. These results suggest that analgesia induced by 5 days of wheel running is mediated by mu-opioid receptors through the modulation of SERT, but not p-NR1, in RVM.
Pain sensation in human osteoarthritic knee joints is strongly enhanced by diabetes mellitus
Authors: Eitner Annett , Pester Julia , Vogel Franziska , Marintschev Ivan , Lehmann Thomas , Hofmann Gunther O. , Schaible Hans-Georg 
Published: June 2017

Abstract
The major burden of knee joint osteoarthritis (OA) is pain. Since in elder patients diabetes mellitus is an important comorbidity of OA, we explored whether the presence of diabetes mellitus has a significant influence on pain intensity at the end stage of knee OA, and we aimed to identify factors possibly related to changes of pain intensity in diabetic patients. In 23 diabetic and 47 nondiabetic patients with OA undergoing total knee arthroplasty, we assessed the pain intensity before the operation using the “Knee Injury and Osteoarthritis Outcome Score”. Furthermore, synovial tissue, synovial fluid (SF), cartilage, and blood were obtained. We determined the synovitis score, the concentrations of prostaglandin E2 and interleukin-6 (IL-6) in the SF and serum, and of C-reactive protein and HbA1c and other metabolic parameters in the serum. We performed multivariate regression analyses to study the association of pain with several parameters. Diabetic patients had on average a higher Knee Injury and Osteoarthritis Outcome Score pain score than nondiabetic patients (P < 0.001). Knee joints from diabetic patients exhibited on average higher synovitis scores (P = 0.024) and higher concentrations of IL-6 in the SF (P = 0.003) than knee joints from nondiabetic patients. Multivariate regression analysis showed that patients with higher synovitis scores had more intense pain independent of all investigated confounders, and that the positive association between pain intensities and IL-6 levels was dependent on diabetes mellitus and/or synovitis. These data suggest that diabetes mellitus significantly increases pain intensity of knee OA, and that in diabetic patients higher pain intensities were determined by stronger synovitis.
Clinical/Biomedical Quality Management System
Authors: Tomaino Kelsea , Ngoie Jean 
Published: June 2017

This article discusses the process and importance of a clinical engineering quality management system (QMS). The goal is to guarantee that the Clinical Engineering Department delivers their services at a consistent level with a high degree of effectiveness. Before the creation of the QMS, there were inconsistencies in service delivery in our organization. This was due to the fact that technologists performed service and maintenance based on their own experience and guidance from manufacturer service manuals.
The QMS at Niagara Health is developed by implementing standardized general and specific device procedures and checklists. These fit into a clinical engineering quality manual. The written procedures and checklists are then loaded onto a mobile application to be used by technologists at any time or place.
The implementation of a QMS is important for any department or organization regardless of specialty. It promotes quality, consistency, and accuracy in the delivery of service. It ensures that individuals are performing their duties in the same way across the department or organization. The mobile application is a component of the QMS that provides the Clinical Engineering Department of Niagara Health with a tool to enhance the quality system. It allows users to access all quality documents at anytime and anywhere.
As equipment, processes, and procedures are the same across the healthcare system, the long-term goal is to share this mobile application with other hospitals, as well as to use it as a quality management document control and audit tool for clinical engineering–related activities.