A multicenter study of plasma use in the United States

PubMed Central

Triulzi, Darrell; Gottschall, Jerome; Murphy, Edward; Wu, Yanyun; Ness, Paul; Kor, Daryl; Roubinian, Nareg; Fleischmann, Debra; Chowdhury, Dhuly; Brambilla, Donald

2016-01-01

Background Detailed information regarding plasma use in the United States is needed to identify opportunities for practice improvement and design of clinical trials of plasma therapy. Study Design and Methods Ten US hospitals collected detailed medical information from the electronic health records for 1 year (2010-2011) for all adult patients transfused with plasma. Results A total of 72,167 units of plasma were transfused in 19,596 doses to 9269 patients. The median dose of plasma was 2 units (interquartile range, 2-4; range 1-72); 15% of doses were 1 unit, and 45% were 2 units. When adjusted by patient body weight (kg), the median dose was 7.3 mL/kg (interquartile range, 5.5-12.0). The median pretransfusion international normalized ratio (INR) was 1.9 (25%-75% interquartile range, 1.6-2.6). A total of 22.5% of plasma transfusions were given to patients with an INR of less than 1.6 and 48.5% for an INR of 2.0 or more. The median posttransfusion INR was 1.6 (interquartile range, 1.4-2.0). Only 42% of plasma transfusions resulted in a posttransfusion INR of less than 1.6. Correction of INR increased as the plasma dose increased from 1 to 4 units (p < 0.001). There was no difference in the INR response to different types of plasma. The most common issue locations were general ward (38%) and intensive care unit (ICU; 42%). Conclusion This large database describing plasma utilization in the United States provides evidence for both inadequate dosing and unnecessary transfusion. Measures to improve plasma transfusion practice and clinical trials should be directed at patients on medical and surgical wards and in the ICU where plasma is most commonly used. PMID:25522888

Text messaging versus email for emergency medicine residents’ knowledge retention: a pilot comparison in the United States

PubMed Central

2016-01-01

We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required. PMID:27780350

Text messaging versus email for emergency medicine residents' knowledge retention: a pilot comparison in the United States.

PubMed

Hoonpongsimanont, Wirachin; Kulkarni, Miriam; Tomas-Domingo, Pedro; Anderson, Craig; McCormack, Denise; Tu, Khoa; Chakravarthy, Bharath; Lotfipour, Shahram

2016-01-01

We evaluated the effectiveness of text messaging versus email, as a delivery method to enhance knowledge retention of emergency medicine (EM) content in EM residents. We performed a multi-centered, prospective, randomized study consisting of postgraduate year (PGY) 1 to PGY 3 & 4 residents in three United States EM residency programs in 2014. Fifty eight residents were randomized into one delivery group: text message or email. Participants completed a 40 question pre- and post-intervention exam. Primary outcomes were the means of pre- and post-intervention exam score differences. Data were analyzed using descriptive statistics, paired t-test, and multiple linear regressions. No significant difference was found between the primary outcomes of the two groups (P=0.51). PGY 2 status had a significant negative effect (P=0.01) on predicted exam score difference. Neither delivery method enhanced resident knowledge retention. Further research on implementation of mobile technology in residency education is required.

A Multicenter Evaluation of Prolonged Empiric Antibiotic Therapy in Adult ICUs in the United States.

PubMed

Thomas, Zachariah; Bandali, Farooq; Sankaranarayanan, Jayashri; Reardon, Tom; Olsen, Keith M

2015-12-01

The purpose of this study is to determine the rate of prolonged empiric antibiotic therapy in adult ICUs in the United States. Our secondary objective is to examine the relationship between the prolonged empiric antibiotic therapy rate and certain ICU characteristics. Multicenter, prospective, observational, 72-hour snapshot study. Sixty-seven ICUs from 32 hospitals in the United States. Nine hundred ninety-eight patients admitted to the ICU between midnight on June 20, 2011, and June 21, 2011, were included in the study. None. Antibiotic orders were categorized as prophylactic, definitive, empiric, or prolonged empiric antibiotic therapy. Prolonged empiric antibiotic therapy was defined as empiric antibiotics that continued for at least 72 hours in the absence of adjudicated infection. Standard definitions from the Centers for Disease Control and Prevention were used to determine infection. Prolonged empiric antibiotic therapy rate was determined as the ratio of the total number of empiric antibiotics continued for at least 72 hours divided by the total number of empiric antibiotics. Univariate analysis of factors associated with the ICU prolonged empiric antibiotic therapy rate was conducted using Student t test. A total of 660 unique antibiotics were prescribed as empiric therapy to 364 patients. Of the empiric antibiotics, 333 of 660 (50%) were continued for at least 72 hours in instances where Centers for Disease Control and Prevention infection criteria were not met. Suspected pneumonia accounted for approximately 60% of empiric antibiotic use. The most frequently prescribed empiric antibiotics were vancomycin and piperacillin/tazobactam. ICUs that utilized invasive techniques for the diagnosis of ventilator-associated pneumonia had lower rates of prolonged empiric antibiotic therapy than those that did not, 45.1% versus 59.5% (p = 0.03). No other institutional factor was significantly associated with prolonged empiric antibiotic therapy rate. Half of all empiric antibiotics ordered in critically ill patients are continued for at least 72 hours in absence of adjudicated infection. Additional studies are needed to confirm these findings and determine the risks and benefits of prolonged empiric therapy in the critically ill.

Accuracy and Reliability of Emergency Department Triage Using the Emergency Severity Index: An International Multicenter Assessment.

PubMed

Mistry, Binoy; Stewart De Ramirez, Sarah; Kelen, Gabor; Schmitz, Paulo S K; Balhara, Kamna S; Levin, Scott; Martinez, Diego; Psoter, Kevin; Anton, Xavier; Hinson, Jeremiah S

2018-05-01

We assess accuracy and variability of triage score assignment by emergency department (ED) nurses using the Emergency Severity Index (ESI) in 3 countries. In accordance with previous reports and clinical observation, we hypothesize low accuracy and high variability across all sites. This cross-sectional multicenter study enrolled 87 ESI-trained nurses from EDs in Brazil, the United Arab Emirates, and the United States. Standardized triage scenarios published by the Agency for Healthcare Research and Quality (AHRQ) were used. Accuracy was defined by concordance with the AHRQ key and calculated as percentages. Accuracy comparisons were made with one-way ANOVA and paired t test. Interrater reliability was measured with Krippendorff's α. Subanalyses based on nursing experience and triage scenario type were also performed. Mean accuracy pooled across all sites and scenarios was 59.2% (95% confidence interval [CI] 56.4% to 62.0%) and interrater reliability was modest (α=.730; 95% CI .692 to .767). There was no difference in overall accuracy between sites or according to nurse experience. Medium-acuity scenarios were scored with greater accuracy (76.4%; 95% CI 72.6% to 80.3%) than high- or low-acuity cases (44.1%, 95% CI 39.3% to 49.0% and 54%, 95% CI 49.9% to 58.2%), and adult scenarios were scored with greater accuracy than pediatric ones (66.2%, 95% CI 62.9% to 69.7% versus 46.9%, 95% CI 43.4% to 50.3%). In this multinational study, concordance of nurse-assigned ESI score with reference standard was universally poor and variability was high. Although the ESI is the most popular ED triage tool in the United States and is increasingly used worldwide, our findings point to a need for more reliable ED triage tools. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

A Multicenter Phase I/II Study of the BCNU Implant (Gliadel ® Wafer) for Japanese Patients with Malignant Gliomas

PubMed Central

AOKI, Tomokazu; NISHIKAWA, Ryo; SUGIYAMA, Kazuhiko; NONOGUCHI, Naosuke; KAWABATA, Noriyuki; MISHIMA, Kazuhiko; ADACHI, Jun-ichi; KURISU, Kaoru; YAMASAKI, Fumiyuki; TOMINAGA, Teiji; KUMABE, Toshihiro; UEKI, Keisuke; HIGUCHI, Fumi; YAMAMOTO, Tetsuya; ISHIKAWA, Eiichi; TAKESHIMA, Hideo; YAMASHITA, Shinji; ARITA, Kazunori; HIRANO, Hirofumi; YAMADA, Shinobu; MATSUTANI, Masao

2014-01-01

Carmustine (BCNU) implants (Gliadel® Wafer, Eisai Inc., New Jersey, USA) for the treatment of malignant gliomas (MGs) were shown to enhance overall survival in comparison to placebo in controlled clinical trials in the United States and Europe. A prospective, multicenter phase I/II study involving Japanese patients with MGs was performed to evaluate the efficacy, safety, and pharmacokinetics of BCNU implants. The study enrolled 16 patients with newly diagnosed MGs and 8 patients with recurrent MGs. After the insertion of BCNU implants (8 sheets maximum, 61.6 mg BCNU) into the removal cavity, various chemotherapies (including temozolomide) and radiotherapies were applied. After placement, overall and progression-free survival rates and whole blood BCNU levels were evaluated. In patients with newly diagnosed MGs, the overall survival rates at 12 months and 24 months were 100.0% and 68.8%, and the progression-free survival rate at 12 months was 62.5%. In patients with recurrent MGs, the progression-free survival rate at 6 months was 37.5%. There were no grade 4 or higher adverse events noted due to BCNU implants, and grade 3 events were observed in 5 of 24 patients (20.8%). Whole blood BCNU levels reached a peak of 19.4 ng/mL approximately 3 hours after insertion, which was lower than 1/600 of the peak BCNU level recorded after intravenous injections. These levels decreased to less than the detection limit (2.00 ng/mL) after 24 hours. The results of this study involving Japanese patients are comparable to those of previous studies in the United States and Europe. PMID:24739422

Defibrillator implantations for primary prevention in the United States: Inappropriate care or inadequate documentation: Insights from the National Cardiovascular Data ICD Registry.

PubMed

Kaiser, Daniel W; Tsai, Vivian; Heidenreich, Paul A; Goldstein, Mary K; Wang, Yongfei; Curtis, Jeptha; Turakhia, Mintu P

2015-10-01

Prior studies have reported that more than 20% of implantable cardioverter-defibrillator (ICD) implantations in the United States do not adhere to trial-based criteria. We sought to investigate the patient characteristics associated with not meeting the inclusion criteria of the clinical trials that have demonstrated the efficacy of primary prevention ICDs. Using data from the National Cardiovascular Data Registry's ICD Registry, we identified patients who received ICDs for primary prevention from January 2006 to December 2008. We determined whether patients met the inclusion criteria of at least 1 of the 4 ICD primary prevention trials: Multicenter Automatic Defibrillator Implantation Trial (MADIT), MADIT-II, Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT), and the Multicenter Unsustained Tachycardia Trial (MUSTT). Among 150,264 patients, 86% met criteria for an ICD implantation based on trial data. The proportion of patients who did not meet trial-based criteria increased as age decreased. In multivariate analysis, the significant predictors for not meeting trial criteria included prior cardiac transplantation (odds ratio [OR] 2.1), pediatric electrophysiology operator (OR 2.0), and high-grade atrioventricular conduction disease (OR 1.4). Among National Cardiovascular Data Registry registrants receiving first-time ICDs for primary prevention, the majority met trial-based criteria. Multivariate analyses suggested that many patients who did not meet the trial-based criteria may have had clinical circumstances that warranted ICD implantation. These findings caution against the use of trial-based indications to determine site quality metrics that could penalize sites that care for younger patients. The planned incorporation of appropriate use criteria into the ICD registry may better characterize patient- and site-level quality and performance. Published by Elsevier Inc.

The effect of social integration on outcomes after major lower extremity amputation.

PubMed

Hawkins, Alexander T; Pallangyo, Anthony J; Herman, Ayesiga M; Schaumeier, Maria J; Smith, Ann D; Hevelone, Nathanael D; Crandell, David M; Nguyen, Louis L

2016-01-01

Major lower extremity (MLE) amputation is a common procedure that results in a profound change in a patient's life. We sought to determine the association between social support and outcomes after amputation. We hypothesized that patients with greater social support will have better post amputation outcomes. From November 2011 to May 2013, we conducted a cross-sectional, observational, multicenter study. Social integration was measured by the social integration subset of the Short Form Craig Handicap Assessment and Reporting Technique. Systemic social support was assessed by comparing a United States and Tanzanian population. Walking function was measured using the 6-minute walk test and quality of life (QoL) was measured using the EuroQol-5D. We recruited 102 MLE amputees. Sixty-three patients were enrolled in the United States with a mean age of 58.0. Forty-two (67%) were male. Patients with low social integration were more likely to be unable to ambulate (no walk 39% vs slow walk 23% vs fast walk 10%; P = .01) and those with high social integration were more likely to be fast walkers (no walk 10% vs slow walk 59% vs fast walk 74%; P = .01). This relationship persisted in a multivariable analysis. Increasing social integration scores were also positively associated with increasing QoL scores in a multivariable analysis (β, .002; standard error, 0.0008; P = .02). In comparing the United States population with the Tanzanian cohort (39 subjects), there were no differences between functional or QoL outcomes in the systemic social support analysis. In the United States population, increased social integration is associated with both improved function and QoL outcomes among MLE amputees. Systemic social support, as measured by comparing the United States population with a Tanzanian population, was not associated with improved function or QoL outcomes. In the United States, steps should be taken to identify and aid amputees with poor social integration. Copyright © 2016 Society for Vascular Surgery. Published by Elsevier Inc. All rights reserved.

Dermatology Medical Education: A Multicenter Survey Study of the Undergraduate Perspective of the Dermatology Clinical Clerkship.

PubMed

Davari, Parastoo; Millsop, Jillian W; Johnson, Mary Ann N; Takahashi, Stefani R; Peng, David H; Badger, Joanna; Bahr, Brooks A; Shinkai, Kanade; Li, Chin-Shang; Fazel, Nasim

2017-12-15

Limited data are available regarding the undergraduate dermatology clinical clerkship curriculum in the United States. Our primaryaim is to assess medical students' perspectives of the dermatology clinical clerkship. A multicenter survey study was conducted, which included four California dermatology academic programs. A 17-item questionnaire was designed to investigate medical student perception with regard tothe overall educational value of the various teaching aspects of the dermatology clinical clerkship. A total of 152 medical student surveys were completed. Over half of the medical students felt proficient in diagnosing the most commondermatologic conditions. Eighty-seven percent of medical students were very satisfied with the dermatology clerkship. Ninety-one percent of students felt the length of the clerkship was appropriate. The vast majority of medical students reported a high level of proficiency in the treatment and diagnosis of common skin disorders. In contrast, our findings suggest that medical students may not begaining sufficient hands-on experience in conducting certain dermatologic procedures following the dermatology clerkship. Overall, medical studentperception of the dermatology clinical clerkship was mostly positive.

Habitat Demonstration Unit Project Leadership and Management Strategies

NASA Technical Reports Server (NTRS)

Kennedy, Kriss J.

2011-01-01

This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project leadership and management strategies. The HDU project team constructed and tested an analog prototype lunar surface habitat/laboratory called the Pressurized Excursion Module (PEM) during 2010. The prototype unit subsystems were integrated in a short amount of time, utilizing a tiger team approach that brought together over 20 habitation-related technologies and innovations from a variety of NASA centers. This paper describes the leadership and management strategies as well as lessons learned pertaining to leading and managing a multi-center diverse team in a rapid prototype environment. The PEM configuration went from a paper design to an operational surface habitat demonstration unit in less than 12 months. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 HDU-Deep Space Habitat (DSH) configuration will build upon the PEM work, and emphasize validity of crew operations (remote working and living), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The 2011 HDU-DSH will be field-tested during the 2011 Desert Research and Technologies Studies (DRaTS) field tests. The HDU project is a "technology-pull" project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU 2010 demo unit that was field tested in the 2010 DRaTS, adding habitation functionality to the prototype unit. This paper will describe the strategy of establishing a multi-center project management team that put in place the key multi-center leadership skills and disciplines to enable a successful tiger team approach. Advocacy was established with key stakeholders and NASA Headquarters (HQ) by defining a strategic vision, mission, goals and objectives for the project and team. As a technology-pull testbed capability the HDU project was able to collaborate and leverage the Exploration Technology Development Program (ETDP) and individual NASA center investments which capitalized on their respective center core competencies and skills. This approach enable the leveraging of over $7.5m of value to create an operational habitat demonstration unit 2010 PEM configuration.

A Prospective Multicenter Evaluation of the Value of the On-Call Orthopedic Resident.

PubMed

Jackson, J Benjamin; Vincent, Scott; Davies, James; Phelps, Kevin; Cornett, Chris; Grabowski, Greg; Scannell, Brian; Stotts, Alan; Bice, Miranda

2018-02-01

Funding for graduate medical education is at risk despite the services provided by residents. We quantified the potential monetary value of services provided by on-call orthopedic surgery residents. We conducted a prospective, cross-sectional, multicenter cohort study design. Over a 90-day period in 2014, we collected data on consults by on-call orthopedic surgery residents at 4 tertiary academic medical centers in the United States. All inpatient and emergency department consults evaluated by first-call residents during the study period were eligible for inclusion. Based on their current procedural terminology codes, procedures and evaluations for each consult were assigned a relative value unit and converted into a monetary value to determine the value of services provided by residents. The primary outcome measures were the total dollar value of each consult and the percentage of resident salaries that could be funded by the generated value of the resident consult services. In total, 2644 consults seen by 33 residents from the 4 institutions were included for analysis. These yielded an average value of $81,868 per center for the 90-day study period, that is, $327,471 annually. With a median resident stipend of $53,992, the extrapolated average percentage of resident stipends that could be funded by these consult revenues was 73% of the stipends of the residents who took call or 36% of the stipends of the overall resident cohort. The potential monetary value generated by on-call orthopedic surgery residents is substantial.

Technical tips during implantation of selective upper airway stimulation.

PubMed

Heiser, Clemens; Thaler, Erica; Soose, Ryan J; Woodson, B Tucker; Boon, Maurits

2018-03-01

Selective upper airway stimulation is now well-established in the United States and in several European countries, with more than 1,000 patients implanted since U.S. Food and Drug Administration approval in April 2014. The authors herein, all head and neck surgeons, account for approximately one of every five implants completed to date. Several of the authors also provide comprehensive longitudinal care of their patients as dual-specialty sleep medicine physicians. Multi-center, retrospective clinical analysis. More than 300 implants have been evaluated and reviewed in five different implant centers (Germany, United States). This analysis shares tips and techniques from the collective experiences with more than 300 implants, which can help newer implanters learn vicariously both for standard practices in executing routine implants through activation and, importantly, for working through more challenging encounters with anatomy, special patient phenotypes, system testing, and troubleshooting. These tips should help new implanters handle most of the situations arising during implantation and avoid common pitfalls. Laryngoscope, 128:756-762, 2018. © 2017 The American Laryngological, Rhinological and Otological Society, Inc.

Habitat Demonstration Unit Project: Leadership and Management Strategies for a Rapid Prototyping Project

NASA Technical Reports Server (NTRS)

Kennedy, Kriss J.; Toup, Larry; Gill, Tracy; Tri, Terry; Howe, Scott; Smitherman, David

2011-01-01

This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project leadership and management strategies being used by the NASA HDU team for a rapid prototyping project. The HDU project team constructed and tested an analog prototype lunar surface habitat/laboratory called the Pressurized Excursion Module (PEM) during 2010. The prototype unit subsystems were integrated in a short amount of time, utilizing a tiger team rapid prototyping approach that brought together over 20 habitation-related technologies and innovations from a variety of NASA centers. This paper describes the leadership and management strategies as well as lessons learned pertaining to leading and managing a multi-center diverse team in a rapid prototype environment. The PEM configuration went from a paper design to an operational surface habitat demonstration unit in less than 12 months. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 HDU-Deep Space Habitat (DSH) configuration will build upon the PEM work, and emphasize validity of crew operations (remote working and living), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The 2011 HDU-DSH will be field-tested during the 2011 Desert Research and Technologies Studies (DRaTS) field tests. The HDU project is a "technology-pull" project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU 2010 demo unit that was field tested in the 2010 DRaTS, adding habitation functionality to the prototype unit. This paper will describe the strategy of establishing a multi-center project management team that put in place the key multi-center leadership skills and disciplines to enable a successful tiger team approach. Advocacy was established with key stakeholders and NASA Headquarters (HQ) by defining a strategic vision, mission, goals and objectives for the project and team. As a technology-pull testbed capability the HDU project was able to collaborate and leverage the Exploration Technology Development Program (ETDP) and individual NASA center investments which capitalized on their respective center core competencies and skills. This approach enable the leveraging of over $7.5m of value to create an operational habitat demonstration unit 2010 PEM configuration.

HeartMate II left ventricular assist system: from concept to first clinical use.

PubMed

Griffith, B P; Kormos, R L; Borovetz, H S; Litwak, K; Antaki, J F; Poirier, V L; Butler, K C

2001-03-01

The HeartMate II left ventricular assist device (LVAD) (ThermoCardiosystems, Inc, Woburn, MA) has evolved from 1991 when a partnership was struck between the McGowan Center of the University of Pittsburgh and Nimbus Company. Early iterations were conceptually based on axial-flow mini-pumps (Hemopump) and began with purge bearings. As the project developed, so did the understanding of new bearings, computational fluid design and flow visualization, and speed control algorithms. The acquisition of Nimbus by ThermoCardiosystems, Inc (TCI) sped developments of cannulas, controller, and power/monitor units. The system has been successfully tested in more than 40 calves since 1997 and the first human implant occurred in July 2000. Multicenter safety and feasibility trials are planned for Europe and soon thereafter a trial will be started in the United States to test 6-month survival in end-stage heart failure.

Multicenter Evaluation Of Coronary Dual-Source CT angiography in patients with intermediate Risk of Coronary Artery Stenoses (MEDIC): study design and rationale.

PubMed

Marwan, Mohamed; Hausleiter, Jörg; Abbara, Suhny; Hoffmann, Udo; Becker, Christoph; Ovrehus, Kristian; Ropers, Dieter; Bathina, Ravi; Berman, Dan; Anders, Katharina; Uder, Michael; Meave, Aloha; Alexánderson, Erick; Achenbach, Stephan

2014-01-01

The diagnostic performance of multidetector row CT to detect coronary artery stenosis has been evaluated in numerous single-center studies, with only limited data from large cohorts with low-to-intermediate likelihood of coronary disease and in multicenter trials. The Multicenter Evaluation of Coronary Dual-Source CT Angiography in Patients with Intermediate Risk of Coronary Artery Stenoses (MEDIC) trial determines the accuracy of dual-source CT (DSCT) to identify persons with at least 1 coronary artery stenosis among patients with low-to-intermediate pretest likelihood of disease. The MEDIC trial was designed as a prospective, multicenter, international trial to evaluate the diagnostic performance of DSCT for the detection of coronary artery stenosis compared with invasive coronary angiography. The study includes 8 sites in Germany, India, Mexico, the United States, and Denmark. The study population comprises patients referred for a diagnostic coronary angiogram because of suspected coronary artery disease with an intermediate pretest likelihood as determined by sex, age, and symptoms. All evaluations are performed by blinded core laboratory readers. The primary outcome of the MEDIC trial is the accuracy of DSCT to identify the presence of coronary artery stenoses with a luminal diameter narrowing of 50% or more on a per-vessel basis. Secondary outcome parameters include per-patient and per-segment diagnostic accuracy for 50% stenoses and accuracy to identify stenoses of 70% or more. Furthermore, secondary outcome parameters include the influence of heart rate, Agatston score, body weight, body mass index, image quality, and diagnostic confidence on the accuracy to detect coronary artery stenoses >50% on a per-vessel basis. The results of the MEDIC trial will assess the clinical utility of coronary CT angiography in the evaluation of patients with intermediate pretest likelihood of coronary artery disease. Copyright © 2014 Society of Cardiovascular Computed Tomography. All rights reserved.

Fracture risk by HIV infection status in perinatally HIV-exposed children.

PubMed

Siberry, George K; Li, Hong; Jacobson, Denise

2012-03-01

The objective of this study was to examine the incidence of fractures in HIV-infected children and comparable HIV-exposed, uninfected (HEU) children in a multicenter, prospective cohort study (PACTG 219/219C) in the United States. The main outcome was first fracture during the risk period. Nine fractures occurred in 7 of 1326 HIV-infected and 2 of 649 HEU children, corresponding to incidence rates of 1.2 per 1000 person-years and 1.1 per 1000 person-years, respectively. The incidence rate ratio was 1.1 (95% CI 0.2, 5.5). There was no evidence of a substantially increased risk of fracture in HIV-infected compared to HEU children.

Challenges in the design and implementation of the Multicenter Uveitis Steroid Treatment (MUST) Trial--lessons for comparative effectiveness trials.

PubMed

Holbrook, Janet T; Kempen, John H; Prusakowski, Nancy A; Altaweel, Michael M; Jabs, Douglas A

2011-12-01

Randomized clinical trials (RCTs) are an important component of comparative effectiveness (CE) research because they are the optimal design for head-to-head comparisons of different treatment options. To describe decisions made in the design of the Multicenter Uveitis Steroid Treatment (MUST) Trial to ensure that the results would be widely generalizable. Review of design and implementation decisions and their rationale for the trial. The MUST Trial is a multicenter randomized controlled CE trial evaluating a novel local therapy (intraocular fluocinolone acetonide implant) versus the systemic therapy standard of care for noninfectious uveitis. Decisions made in protocol design in order to broaden enrollment included allowing patients with very poor vision and media opacity to enroll and including clinical sites outside the United States. The treatment protocol was designed to follow standard care. The primary outcome, visual acuity, is important to patients and can be evaluated in all eyes with uveitis. Other outcomes include patient-reported visual function, quality of life, and disease and treatment related complications. The trial population is too small for subgroup analyses that are of interest and the trial is being conducted at tertiary medical centers. CE trials require greater emphasis on generalizability than many RCTs but otherwise face similar challenges for design choices as any RCT. The increase in heterogeneity in patients and treatment required to ensure generalizability can be balanced with a rigorous approach to implementation, outcome assessment, and statistical design. This approach requires significant resources that may limit implementation in many RCTs, especially in clinical practice settings.

Follicular Lymphoma in the United States: First Report of the National LymphoCare Study

PubMed Central

Friedberg, Jonathan W.; Taylor, Michael D.; Cerhan, James R.; Flowers, Christopher R.; Dillon, Hildy; Farber, Charles M.; Rogers, Eric S.; Hainsworth, John D.; Wong, Elaine K.; Vose, Julie M.; Zelenetz, Andrew D.; Link, Brian K.

2009-01-01

Purpose Optimal therapy of follicular lymphoma (FL) is not defined. We analyzed a large prospective cohort study to identify current demographics and patterns of care of FL in the United States. Patients and Methods The National LymphoCare Study is a multicenter, longitudinal, observational study designed to collect information on treatment regimens and outcomes for patients with newly diagnosed FL in the United States. Patients were enrolled between 2004 and 2007. There is no study-specific prescribed treatment regimen or intervention. Results Two thousand seven hundred twenty-eight subjects were enrolled at 265 sites, including the 80% of patients enrolled from nonacademic sites. Using the Follicular Lymphoma International Prognostic Index (FLIPI), three distinct groups independent of histologic grade could be defined. Initial therapeutic strategy was: observation, 17.7%; rituximab monotherapy, 13.9%; clinical trial 6.1%; radiation therapy, 5.6%; chemotherapy only, 3.2%; chemotherapy plus rituximab, 51.9%. Chemotherapy plus rituximab regimens were: rituximab plus cyclophosphamide, doxorubicin, vincristine, prednisone, 55.0%; rituximab plus cyclophosphamide, vincristine, and prednisone, 23.1%; rituximab plus fludarabine based, 15.5%; other, 6.4%. The choice to initiate therapy rather than observe was associated with age, FLIPI, stage, and grade (P < .01). Significant differences in treatment (P < .01) across regions of the United States were noted. Contrary to practice guidelines, treatment of stage I FL frequently omits radiation therapy. Conclusion Widely disparate therapeutic approaches are utilized for FL. Initial therapy is deferred in a small subset of patients. There is no single standard of care for the treatment of de novo FL, although antibody use is ubiquitous when therapy is initiated. These disparate approaches to the initial care of patients with FL render a heterogeneous group of patients at relapse. PMID:19204203

[Utilization of multimodal therapy concepts in stomach carcinoma in Germany].

PubMed

Bösing, N M; Heise, J W; Röher, H D

2000-01-01

In view of disappointing results after surgery alone multimodal therapeutic regimes are used to improve long-term prognosis in locally advanced gastric carcinomas. In presence of many reports about encouraging results ("down staging", improved R0-resection rates) but simultaneously missing evidence of efficiency of neoadjuvant therapies in respect to long-term survival (large randomized multicenter trials do not exist until today) and the herewith related uncertainties, we started an inquiry among many surgical units with the intention to evaluate the clinical practice of multimodal treatment for gastric cancer patients in Germany today. In a questionnaire (3/99) we asked among 97 surgical units (41 university hospitals, 56 big community hospitals) in Germany for the management of gastric cancer patients with special interest to practice and state of adjuvant and neoadjuvant therapeutic strategies. Further we analyzed all resected gastric cancer patients (1986-1995) without neoadjuvant treatment in advanced stage of disease (pT3/4NxMx; stage III/IV (UICC'92) in respect to R0-resection rate and long-term prognosis (Kaplan-Meier). Overall feedback amounted to 78% (76/97) and was higher in university hospitals (90%) than in big community hospitals (70%). Today, neoadjuvant therapies are of more interest than adjuvant therapeutic regimes. But also neoadjuvant therapy is only used in 32% as a rule (in 16% with, in 16% without study conditions). 25% of all surgical units do not employ any neoadjuvant therapy in locally advanced gastric cancer until today. In all other surgical units neoadjuvant treatment is performed more individually and sporadically (43%) only in some patients. Neoadjuvant therapies are practiced by haematooncologists in 50%, gastroenterologists in 32% and surgeons in 27%. The predominant neoadjuvant therapeutic strategy is chemotherapy alone (84%). Many surgical units in Germany are interested to participate in a multicenter trial with more interest in neoadjuvant than adjuvant therapy. 185 of 309 resected gastric cancer patients (60%) were classified as stage IIIa, stage IIIb or stage IV patients. R0-resection rate of these advanced gastric cancer patients amounted to 37%; only 24% of them survived 5 years or more. Considering the missing evidence that multimodal therapies are able to prolong long-term survival in advanced gastric cancer patients, its use without study conditions is questionable. Conclusions, taken from data of clinical trials regarding carcinomas of the esophagus and esophagealgastric junction, are inconsistent in respect to long-term prognosis and results are not transferable to gastric carcinomas. A prospective randomized multicenter trial in advanced gastric cancer patients is of great importance. Following our data, in Germany a high readiness to participate in the forthcoming EORTC-study is present.

Alcohol Consumption among University Students in North Rhine-Westphalia, Germany--Results from a Multicenter Cross-Sectional Study

ERIC Educational Resources Information Center

Akmatov, Manas K.; Mikolajczyk, Rafael T.; Meier, Sabine; Kramer, Alexander

2011-01-01

Objective: To assess alcohol use and problem drinking among university students in the German Federal State of North Rhine-Westphalia (NRW) and to examine the associated factors. Method: A multicenter cross-sectional study was conducted in 16 universities in 2006-2007 in NRW by a standardized questionnaire and 3,306 students provided information…

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C

PubMed Central

Belle, Steven H; Fried, Michael W; Afdhal, Nezam; Navarro, Victor J; Hawke, Roy L; Wahed, Abdus S; Doo, Edward; Meyers, Catherine M

2012-01-01

Background Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. Purpose We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. Methods This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. Results Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. Potential limitations Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. Conclusions The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products. PMID:22058086

Rationale, challenges, and participants in a Phase II trial of a botanical product for chronic hepatitis C.

PubMed

Reddy, K Rajender; Belle, Steven H; Fried, Michael W; Afdhal, Nezam; Navarro, Victor J; Hawke, Roy L; Wahed, Abdus S; Doo, Edward; Meyers, Catherine M

2012-02-01

Chronic hepatitis C is associated with significant morbidity and mortality as a consequence of progression to cirrhosis, hepatocellular carcinoma, and liver failure. Current treatment for chronic hepatitis C with pegylated interferon (IFN) and ribavirin is associated with suboptimal responses and numerous adverse effects. A number of botanical products have been used to treat hepatic disorders. Silymarin, extracted from the milk thistle plant, Silybum marianum (L) Gaertn. (Asteraceae), has been most widely used for various liver disorders, including chronic hepatitis C, B, and alcoholic liver disease. However, the safety and efficacy of silymarin have not been studied systematically in chronic hepatitis C. We describe our strategy for a phased approach for studying the impact of silymarin in hepatitis C, in the context of the unique challenges of botanical product clinical trials and the development of specific and curative antiviral therapy. This multicenter, randomized, double-masked, placebo-controlled trial was conducted with four clinical centers and a data-coordinating center in the United States, to assess the impact of silymarin therapy in patients with chronic hepatitis C who failed conventional antiviral therapy. Key aspects relevant to performing clinical trials of botanical products include early identification of an appropriate product with standard product chemistry, acquisition of pharmacokinetic and dosing information, selection of the appropriate study group, and choosing rigorous outcome variables. POTENTIAL LIMITATIONS: Trial participants were chronic hepatitis C patients who were nonsustained virologic responders to IFN-based therapy; therefore, the findings are not generalizable to all hepatitis C populations. Further, alanine aminotransferase, a biochemical liver test, rather than hepatitis viral RNA or liver histology was the primary end point. The challenges identified and addressed during development of this United States multicenter Phase II trial to evaluate silymarin for treatment of patients with chronic hepatitis C infection who had failed to respond successfully to previous IFN-based therapy are common and must be addressed to conduct rigorous trials of botanical products.

Using School-Level Interviews to Develop a Multisite PE Intervention Program

PubMed Central

Moe, Stacey G.; Pickrel, Julie; McKenzie, Thomas L.; Strikmiller, Patricia K.; Coombs, Derek; Murrie, Dale

2008-01-01

The Trial of Activity for Adolescent Girls (TAAG) is a randomized, multicenter field trial in middle schools that aims to reduce the decline of physical activity in adolescent girls. To inform the development of the TAAG intervention, two phases of formative research are conducted to gain information on school structure and environment and on the conduct of physical education classes. Principals and designated staff at 64 eligible middle schools were interviewed using the School Survey during Phase 1. The following year (Phase 2), physical education department heads of the 36 schools selected into TAAG were interviewed. Responses were examined to design a standardized, multicomponent physical activity intervention for six regions of the United States. This article describes the contribution of formative research to the development of the physical education intervention component and summarizes the alignment of current school policies and practices with national and state standards. PMID:16397159

Intrawound Vancomycin Decreases the Risk of Surgical Site Infection After Posterior Spine Surgery: A Multicenter Analysis.

PubMed

Devin, Clinton J; Chotai, Silky; McGirt, Matthew J; Vaccaro, Alexander R; Youssef, Jim A; Orndorff, Douglas G; Arnold, Paul M; Frempong-Boadu, Anthony K; Lieberman, Isador H; Branch, Charles; Hedayat, Hirad S; Liu, Ann; Wang, Jeffrey C; Isaacs, Robert E; Radcliff, Kris E; Patt, Joshua C; Archer, Kristin R

2018-01-01

Secondary analysis of data from a prospective multicenter observational study. The aim of this study was to evaluate the occurrence of surgical site infection (SSI) in patients with and without intrawound vancomycin application controlling for confounding factors associated with higher SSI after elective spine surgery. SSI is a morbid and expensive complication associated with spine surgery. The application of intrawound vancomycin is rapidly emerging as a solution to reduce SSI following spine surgery. The impact of intrawound vancomycin has not been systematically studied in a well-designed multicenter study. Patients undergoing elective spine surgery over a period of 4 years at seven spine surgery centers across the United States were included in the study. Patients were dichotomized on the basis of whether intrawound vancomycin was applied. Outcomes were occurrence of SSI within postoperative 30 days and SSI that required return to the operating room (OR). Multivariable random-effect log-binomial regression analyses were conducted to determine the relative risk of having an SSI and an SSI with return to OR. .: A total of 2056 patients were included in the analysis. Intrawound vancomycin was utilized in 47% (n = 966) of patients. The prevalence of SSI was higher in patients with no vancomycin use (5.1%) than those with use of intrawound vancomycin (2.2%). The risk of SSI was higher in patients in whom intrawound vancomycin was not used (relative risk (RR) -2.5, P < 0.001), increased number of levels exposed (RR -1.1, P = 0.01), and those admitted postoperatively to intensive care unit (ICU) (RR -2.1, P = 0.005). Patients in whom intrawound vancomycin was not used (RR -5.9, P < 0.001), increased number of levels were exposed (RR-1.1, P = 0.001), and postoperative ICU admission (RR -3.3, P < 0.001) were significant risk factors for SSI requiring a return to the OR. The intrawound application of vancomycin after posterior approach spine surgery was associated with a reduced risk of SSI and return to OR associated with SSI. 2.

Electrophysiological signal analysis and visualization using Cloudwave for epilepsy clinical research.

PubMed

Jayapandian, Catherine P; Chen, Chien-Hung; Bozorgi, Alireza; Lhatoo, Samden D; Zhang, Guo-Qiang; Sahoo, Satya S

2013-01-01

Epilepsy is the most common serious neurological disorder affecting 50-60 million persons worldwide. Electrophysiological data recordings, such as electroencephalogram (EEG), are the gold standard for diagnosis and pre-surgical evaluation in epilepsy patients. The increasing trend towards multi-center clinical studies require signal visualization and analysis tools to support real time interaction with signal data in a collaborative environment, which cannot be supported by traditional desktop-based standalone applications. As part of the Prevention and Risk Identification of SUDEP Mortality (PRISM) project, we have developed a Web-based electrophysiology data visualization and analysis platform called Cloudwave using highly scalable open source cloud computing infrastructure. Cloudwave is integrated with the PRISM patient cohort identification tool called MEDCIS (Multi-modality Epilepsy Data Capture and Integration System). The Epilepsy and Seizure Ontology (EpSO) underpins both Cloudwave and MEDCIS to support query composition and result retrieval. Cloudwave is being used by clinicians and research staff at the University Hospital - Case Medical Center (UH-CMC) Epilepsy Monitoring Unit (EMU) and will be progressively deployed at four EMUs in the United States and the United Kingdomas part of the PRISM project.

Organizational structure and communication strategies of the bypass angioplasty revascularization investigation: a multicenter clinical trial.

PubMed

Naydeck, B L; Sutton-Tyrrell, K; Burek, K; Sopko, G S

1996-06-01

Efficient communication is a challenge for the many operating components of a multicenter randomized clinical trial. Traditional management theory states that communications generally flow along a path established by a hierarchical organizational structure. A multicenter clinical trial does not fit traditional organizational models well and requires modification of traditional communication techniques. While the scientific community typically views a clinical trial as one large and cohesive enterprise, at each site the trial may actually be conducted as a small project related to the medical specialty of the investigator. Therefore overall trial management must be accomplished through collaboration rather than through direct management. In the Bypass Angioplasty Revascularization Investigation (BARI), the BARI clinical coordinating center has designed and utilized several mechanisms that facilitate effective communication and administrative control of a multicenter clinical trial. These mechanisms provide a framework of communication techniques that accommodate the specific needs of a complex organization.

Weight loss endoscopy: Development, applications, and current status

PubMed Central

Kumar, Nitin

2016-01-01

Obesity and its comorbidities - including diabetes and obstructive sleep apnea - have taken a large and increasing toll on the United States and the rest of the world. The availability of commercial, clinical, and operative therapies for weight management have not been effective at a societal level. Endoscopic bariatric therapy is gaining acceptance as more effective than diet and lifestyle measures, and less invasive than bariatric surgery. Various endoscopic therapies are analogues of the restrictive or bypass components of bariatric surgery, utilizing gastric remodeling or intestinal anastomosis to achieve proven weight loss and metabolic benefits. Others, such as aspiration therapy, employ novel mechanisms of action. Intragastric balloons have recently been approved by the United States Food and Drug Administration, and a number of other technologies have completed large multicenter trials (such as AspireAssist aspiration therapy and Primary Obesity Surgery Endolumenal). Endoscopic sleeve gastroplasty and transoral outlet reduction for endoscopic revision of gastric bypass have proven safe and effective in a number of studies. As devices are approved for use, data will continue to accumulate for safety, effectiveness, and cost effectiveness. Bariatric endoscopists should be prepared to appropriately target and apply various endoscopic bariatric therapies in the context of a comprehensive long-term weight management program. PMID:27610017

Point-of-care Helicobacter pylori urine antibody detection in a multi-ethnic adult population in the United States.

PubMed

Opekun, Antone R; Luu, Phong; Gotschall, Ann B; Abdalla, Nageeb; Torres, Elizabeth; Rudd, Summer B; Graham, David Y; Nurgalieva, Zhannat Z; Tsuchiya, Kyoko

2006-07-01

A need exists for accurate point-of-care tests for diagnosis of Helicobacter pylori (H. pylori) infection to evaluate a rapid urine-H. pylori antibody test device for detection of H. pylori infection in a point-of-care setting in the United States. A multi-center study in a multi-ethnic population compared the RAPIRUN urine antibody test with the (13)C-urea breath test (C-UBT) and a traditional serologic test, the high-molecular-weight cell-associated protein enzyme immunoassay (HM-CAP EIA). The primary comparator was with "definite positive" and "definite negative" patients defined as a concordance of combined results of the UBT and the HM-CAP IgG EIA. Overall, 188 eligible patients were enrolled (61 men, age range: 18-73 years, including 84 Hispanics, 73 Asian-Pacific Americans, 22 Black African-Americans, 6 non-Hispanic Caucasians, and 3 of "other" ethnicity). Compared with "definite positive" and "definite negative" results, the sensitivity and specificity of the urine antibody test were 0.9 and 1.0, respectively. The urine antibody test proved suitable for point-of-care rapid diagnosis of anti-H. pylori antibodies indicative of active or past H. pylori infection.

Learning styles and teaching/learning strategy preferences: implications for educating nurses in critical care, the operating room, and infection control.

PubMed

Goldrick, B; Gruendemann, B; Larson, E

1993-01-01

To assess the learning styles and educational strategy preferences among critical care nurses, operating room nurses, and infection control practitioners. Descriptive multicenter survey using a self-report questionnaire. 108 hospitals from nine geographic regions of the United States. A random sample of 303 (93%) nurses in the three specialties responded to the survey questionnaires. The majority of participants (64%) had an abstract learning style and preferred the self-directed, discovery approach to learning. Nurses may be more abstract in their learning styles than previously reported. Experiential learning theory is an effective means of identifying nurses' learning styles and teaching/learning preferences, which can then be used to plan basic and continuing educational programs.

Multicenter Evaluation of the Cepheid Xpert Methicillin-Resistant Staphylococcus aureus (MRSA) Test as a Rapid Screening Method for Detection of MRSA in Nares▿

PubMed Central

Wolk, D. M.; Picton, E.; Johnson, D.; Davis, T.; Pancholi, P.; Ginocchio, C. C.; Finegold, S.; Welch, D. F.; de Boer, M.; Fuller, D.; Solomon, M. C.; Rogers, B.; Mehta, M. S.; Peterson, L. R.

2009-01-01

The first U.S. multicenter clinical trial to assess the performance of the Cepheid Xpert MRSA assay (Xpert MRSA) was conducted. The assay is a qualitative test designed for the rapid detection of methicillin-resistant Staphylococcus aureus (MRSA) directly from nares swabs. This novel test combines integrated nucleic acid extraction and automated real-time PCR for the detection of a MRSA-specific signature sequence. A total of 1,077 nares specimens were collected from seven geographically distinct health care sites across the United States with prevalence rates ranging from 5.2% to 44%. Nares specimens were tested by (i) the Xpert MRSA assay, (ii) direct culture on CHROMagar MRSA medium (direct CM culture), and (iii) broth-enriched culture (Trypticase soy broth with 6.5% sodium chloride) followed by plating onto CHROMagar MRSA medium (broth-enriched CM culture). When direct CM culture was designated the reference method, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the Xpert MRSA assay were 94.3%, 93.2%, 73.0%, and 98.8%, respectively. When broth-enriched CM culture was used as the reference method, the clinical sensitivity, specificity, PPV, and NPV of the Xpert MRSA assay were 86.3%, 94.9%, 80.5%, and 96.6%, respectively. The BD GeneOhm MRSA (BDGO) assay was performed as a comparative molecular method. No statistical performance differences were observed between the Xpert MRSA and BDGO assays when they were compared to culture methods. From this large-scale, multicenter clinical comparison, we conclude that the Xpert MRSA assay is a simple, rapid, and accurate method for performing active surveillance for MRSA in a variety of health care populations. PMID:19129414

A 10-Gene Classifier for Indeterminate Thyroid Nodules: Development and Multicenter Accuracy Study

PubMed Central

González, Hernán E.; Martínez, José R.; Vargas-Salas, Sergio; Solar, Antonieta; Veliz, Loreto; Cruz, Francisco; Arias, Tatiana; Loyola, Soledad; Horvath, Eleonora; Tala, Hernán; Traipe, Eufrosina; Meneses, Manuel; Marín, Luis; Wohllk, Nelson; Diaz, René E.; Véliz, Jesús; Pineda, Pedro; Arroyo, Patricia; Mena, Natalia; Bracamonte, Milagros; Miranda, Giovanna; Bruce, Elsa

2017-01-01

Background: In most of the world, diagnostic surgery remains the most frequent approach for indeterminate thyroid cytology. Although several molecular tests are available for testing in centralized commercial laboratories in the United States, there are no available kits for local laboratory testing. The aim of this study was to develop a prototype in vitro diagnostic (IVD) gene classifier for the further characterization of nodules with an indeterminate thyroid cytology. Methods: In a first stage, the expression of 18 genes was determined by quantitative polymerase chain reaction (qPCR) in a broad histopathological spectrum of 114 fresh-tissue biopsies. Expression data were used to train several classifiers by supervised machine learning approaches. Classifiers were tested in an independent set of 139 samples. In a second stage, the best classifier was chosen as a model to develop a multiplexed-qPCR IVD prototype assay, which was tested in a prospective multicenter cohort of fine-needle aspiration biopsies. Results: In tissue biopsies, the best classifier, using only 10 genes, reached an optimal and consistent performance in the ninefold cross-validated testing set (sensitivity 93% and specificity 81%). In the multicenter cohort of fine-needle aspiration biopsy samples, the 10-gene signature, built into a multiplexed-qPCR IVD prototype, showed an area under the curve of 0.97, a positive predictive value of 78%, and a negative predictive value of 98%. By Bayes' theorem, the IVD prototype is expected to achieve a positive predictive value of 64–82% and a negative predictive value of 97–99% in patients with a cancer prevalence range of 20–40%. Conclusions: A new multiplexed-qPCR IVD prototype is reported that accurately classifies thyroid nodules and may provide a future solution suitable for local reference laboratory testing. PMID:28521616

No sex differences in use of dopaminergic medication in early Parkinson disease in the US and Canada - baseline findings of a multicenter trial.

PubMed

Umeh, Chizoba C; Pérez, Adriana; Augustine, Erika F; Dhall, Rohit; Dewey, Richard B; Mari, Zoltan; Simon, David K; Wills, Anne-Marie A; Christine, Chadwick W; Schneider, Jay S; Suchowersky, Oksana

2014-01-01

Sex differences in Parkinson disease clinical features have been reported, but few studies have examined sex influences on use of dopaminergic medication in early Parkinson disease. The objective of this study was to test if there are differences in the type of dopaminergic medication used and levodopa equivalent daily dose between men and women with early Parkinson disease enrolled in a large multicenter study of Creatine as a potential disease modifying therapy - the National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease Long-Term Study-1. Baseline data of 1,741 participants from 45 participating sites were analyzed. Participants from the United States and Canada were enrolled within five years of Parkinson Disease diagnosis. Two outcome variables were studied: type of dopaminergic medication used and levodopa equivalent daily dose at baseline in the Long-Term Study-1. Chi-square statistic and linear regression models were used for statistical analysis. There were no statistically significant differences in the frequency of use of different types of dopaminergic medications at baseline between men and women with Parkinson Disease. A small but statistically significant difference was observed in the median unadjusted levodopa equivalent daily dose at baseline between women (300 mg) and men (325 mg), but this was not observed after controlling for disease duration (years since Parkinson disease diagnosis), disease severity (Unified Parkinson's Disease Rating Scale Motor and Activities of Daily Living Scores), and body weight. In this large multicenter study, we did not observe sex differences in the type and dose of dopaminergic medications used in early Parkinson Disease. Further research is needed to evaluate the influence of male or female sex on use of dopaminergic medication in mid- and late-stage Parkinson Disease.

Multicenter case-control study of risk factors associated with development of vaccine-associated sarcomas in cats.

PubMed

Kass, Philip H; Spangler, William L; Hendrick, Mattie J; McGill, Lawrence D; Esplin, D Glen; Lester, Sally; Slater, Margaret; Meyer, E Kathryn; Boucher, Faith; Peters, Erika M; Gobar, Glenna G; Htoo, Thurein; Decile, Kendra

2003-11-01

To determine whether particular vaccine brands, other injectable medications, customary vaccination practices, or various host factors were associated with the formation of vaccine-associated sarcomas in cats. Prospective multicenter case-control study. Cats in the United States and Canada with soft tissue sarcomas or basal cell tumors. Veterinarians submitting biopsy specimens from cats with a confirmed diagnosis of soft tissue sarcoma or basal cell tumor were contacted for patient medical history. Time window statistical analyses were used in conjunction with various assumptions about case definitions. No single vaccine brand or manufacturer within antigen class was found to be associated with sarcoma formation. Factors related to vaccine administration were also not associated with sarcoma development, with the possible exception of vaccine temperature prior to injection. Two injectable medications (long-acting penicillin and methyl prednisolone acetate) were administered to case cats more frequently than to control cats. Findings do not support the hypotheses that specific brands or types of vaccine within antigen class, vaccine practices such as reuse of syringes, concomitant viral infection, history of trauma, or residence either increase or decrease the risk of vaccine-associated sarcoma formation in cats. There was evidence to suggest that certain long-acting injectable medications may also be associated with sarcoma formation.

Management of in-flight medical emergencies: are senior medical students prepared to respond to this community need?

PubMed

Katzer, Robert J; Duong, David; Weber, Matthew; Memmer, Amy; Buchanan, Ian

2014-11-01

In-flight medical emergencies on commercial aircraft are common in both domestic and international flights. We hypothesized that fourth-year medical students feel inadequately prepared to lend assistance during in-flight medical emergencies. This multicenter study of two U.S. medical schools obtains a baseline assessment of knowledge and confidence in managing in-flight medical emergencies. A 25-question survey was administered to fourth-year medical students at two United States medical schools. Questions included baseline knowledge of in-flight medicine (10 questions) and perceived ability to respond to in-flight medical emergencies. 229 participants completed the survey (75% response rate). The average score on the fund of knowledge questions was 64%. Responses to the 5-point Likert scale questions indicated that, on average, students did not feel confident or competent responding to an in-flight medical emergency. Participants on average also disagreed with statements that they had adequate understanding of supplies, flight crew training, and ground-based management. This multicenter survey indicates that fourth-year medical students do not feel adequately prepared to respond to in-flight medical emergencies and may have sub-optimal knowledge. This study provides an initial step in identifying a deficiency in current medical education.

Management of In-Flight Medical Emergencies: Are Senior Medical Students Prepared to Respond to this Community Need?

PubMed Central

Katzer, Robert J.; Duong, David; Weber, Matthew; Memmer, Amy; Buchanan, Ian

2014-01-01

Introduction In-flight medical emergencies on commercial aircraft are common in both domestic and international flights. We hypothesized that fourth-year medical students feel inadequately prepared to lend assistance during in-flight medical emergencies. This multicenter study of two U.S. medical schools obtains a baseline assessment of knowledge and confidence in managing in-flight medical emergencies. Methods A 25-question survey was administered to fourth-year medical students at two United States medical schools. Questions included baseline knowledge of in-flight medicine (10 questions) and perceived ability to respond to in-flight medical emergencies. Results 229 participants completed the survey (75% response rate). The average score on the fund of knowledge questions was 64%. Responses to the 5-point Likert scale questions indicated that, on average, students did not feel confident or competent responding to an in-flight medical emergency. Participants on average also disagreed with statements that they had adequate understanding of supplies, flight crew training, and ground-based management. Conclusion This multicenter survey indicates that fourth-year medical students do not feel adequately prepared to respond to in-flight medical emergencies and may have sub-optimal knowledge. This study provides an initial step in identifying a deficiency in current medical education. PMID:25493155

Energy and Protein in Critically Ill Patients with AKI: A Prospective, Multicenter Observational Study Using Indirect Calorimetry and Protein Catabolic Rate.

PubMed

Sabatino, Alice; Theilla, Miriam; Hellerman, Moran; Singer, Pierre; Maggiore, Umberto; Barbagallo, Maria; Regolisti, Giuseppe; Fiaccadori, Enrico

2017-07-26

The optimal nutritional support in Acute Kidney Injury (AKI) still remains an open issue. The present study was aimed at evaluating the validity of conventional predictive formulas for the calculation of both energy expenditure and protein needs in critically ill patients with AKI. A prospective, multicenter, observational study was conducted on adult patients hospitalized with AKI in three different intensive care units (ICU). Nutrient needs were estimated by different methods: the Guidelines of the European Society of Parenteral and Enteral Nutrition (ESPEN) for both calories and proteins, the Harris-Benedict equation, the Penn-State and Faisy-Fagon equations for energy. Actual energy and protein needs were repeatedly measured by indirect calorimetry (IC) and protein catabolic rate (PCR) until oral nutrition start, hospital discharge or renal function recovery. Forty-two patients with AKI were enrolled, with 130 IC and 123 PCR measurements obtained over 654 days of artificial nutrition. No predictive formula was precise enough, and Bland-Altman plots wide limits of agreement for all equations highlight the potential to under- or overfeed individual patients. Conventional predictive formulas may frequently lead to incorrect energy and protein need estimation. In critically ill patients with AKI an increased risk for under- or overfeeding is likely when nutrient needs are estimated instead of measured.

Use of a novel virus inactivation method for a multicenter avian influenza real-time reverse transcriptase-polymerase chain reaction proficiency study.

PubMed

Spackman, Erica; Suarez, David L

2005-01-01

Proficiency assessments are important elements in quality control for diagnostic laboratories. Traditionally, proficiency testing for polymerase chain reaction (PCR)-based assays has involved the use of clinical samples, samples "spiked" with live agents or DNA plasmids. Because of government regulations and biosecurity concerns, distribution of live high-consequence pathogens of livestock and poultry, such as avian influenza, is not possible, and DNA plasmids are not technically suitable for evaluating RNA virus detection. Therefore, a proficiency testing panel using whole avian influenza in a diluent containing a phenolic disinfectant that inactivates the virus while preserving the RNA for at least 8 weeks at -70 C was developed and used in a multicenter proficiency assessment for a type A influenza real-time reverse transcriptase (RT)-PCR test. The test, which was highly standardized, except for variation in the real-time RT-PCR equipment used, was shown to be highly reproducible by proficiency testing in 12 laboratories in the United States, Canada, and Hong Kong. Variation in cycle threshold values among 35 data sets and 490 samples was minimal (CV = 5.19%), and sample identifications were highly accurate (96.7% correct identifications) regardless of real-time PCR instrumentation.

A Cross-Sectional Survey of Near-Infrared Spectroscopy Use in Pediatric Cardiac ICUs in the United Kingdom, Ireland, Italy, and Germany.

PubMed

Hoskote, Aparna U; Tume, Lyvonne N; Trieschmann, Uwe; Menzel, Christoph; Cogo, Paola; Brown, Katherine L; Broadhead, Michael W

2016-01-01

Despite the increasing use of near-infrared spectroscopy across pediatric cardiac ICUs, there is significant variability and equipoise with no universally accepted management algorithms. We aimed to explore the use of near-infrared spectroscopy in pediatric cardiac ICUs in the United Kingdom, Ireland, Italy, and Germany. A cross-sectional multicenter, multinational electronic survey of one consultant in each pediatric cardiac ICU. Pediatric cardiac ICUs in the United Kingdom and Ireland (n = 13), Italy (n = 12), and Germany (n = 33). Questionnaire targeted to establish use, targets, protocols/thresholds for intervention, and perceived usefulness of near-infrared spectroscopy monitoring. Overall, 42 of 58 pediatric cardiac ICUs (72%) responded: United Kingdom and Ireland, 11 of 13 (84.6%); Italy, 12 of 12 (100%); and Germany, 19 of 33 (57%, included all major centers). Near-infrared spectroscopy usage varied with 35% (15/42) reporting that near-infrared spectroscopy was not used at all (7/42) or occasionally (8/42); near-infrared spectroscopy use was much less common in the United Kingdom (46%) when compared with 78% in Germany and all (100%) in Italy. Only four units had a near-infrared spectroscopy protocol, and 18 specifically used near-infrared spectroscopy in high-risk patients; 37 respondents believed that near-infrared spectroscopy added value to standard monitoring and 23 believed that it gave an earlier indication of deterioration, but only 19 would respond based on near-infrared spectroscopy data alone. Targets for absolute values and critical thresholds for intervention varied widely between units. The reasons cited for not or occasionally using near-infrared spectroscopy were expense (n = 6), limited evidence and uncertainty on how it guides management (n = 4), difficulty in interpretation, and unreliability of data (n = 3). Amongst the regular or occasional near-infrared spectroscopy users (n = 35), 28 (66%) agreed that a multicenter study is warranted to ascertain its use. Although most responding units used near-infrared spectroscopy for high-risk patients, the majority (31/35 [88%]) did not have any protocols or guidelines for intervention. Target thresholds and intervention algorithms are needed to support the use of near-infrared spectroscopy in pediatric cardiac ICUs; an international multicenter study is warranted.

A multicenter tractography study of deep white matter tracts in bipolar I disorder: psychotic features and interhemispheric disconnectivity.

PubMed

Sarrazin, Samuel; Poupon, Cyril; Linke, Julia; Wessa, Michèle; Phillips, Mary; Delavest, Marine; Versace, Amelia; Almeida, Jorge; Guevara, Pamela; Duclap, Delphine; Duchesnay, Edouard; Mangin, Jean-François; Le Dudal, Katia; Daban, Claire; Hamdani, Nora; D'Albis, Marc-Antoine; Leboyer, Marion; Houenou, Josselin

2014-04-01

Tractography studies investigating white matter (WM) abnormalities in patients with bipolar disorder have yielded heterogeneous results owing to small sample sizes. The small size limits their generalizability, a critical issue for neuroimaging studies of biomarkers of bipolar I disorder (BPI). To study WM abnormalities using whole-brain tractography in a large international multicenter sample of BPI patients and to compare these alterations between patients with or without a history of psychotic features during mood episodes. A cross-sectional, multicenter, international, Q-ball imaging tractography study comparing 118 BPI patients and 86 healthy control individuals. In addition, among the patient group, we compared those with and without a history of psychotic features. University hospitals in France, Germany, and the United States contributed participants. Participants underwent assessment using the Diagnostic Interview for Genetic Studies at the French sites or the Structured Clinical Interview for DSM-IV at the German and US sites. Diffusion-weighted magnetic resonance images were acquired using the same acquisition parameters and scanning hardware at each site. We reconstructed 22 known deep WM tracts using Q-ball imaging tractography and an automatized segmentation technique. Generalized fractional anisotropy values along each reconstructed WM tract. Compared with controls, BPI patients had significant reductions in mean generalized fractional anisotropy values along the body and the splenium of the corpus callosum, the left cingulum, and the anterior part of the left arcuate fasciculus when controlling for age, sex, and acquisition site (corrected for multiple testing). Patients with a history of psychotic features had a lower mean generalized fractional anisotropy value than those without along the body of the corpus callosum (corrected for multiple testing). In this multicenter sample, BPI patients had reduced WM integrity in interhemispheric, limbic, and arcuate WM tracts. Interhemispheric pathways are more disrupted in patients with than in those without psychotic symptoms. Together these results highlight the existence of an anatomic disconnectivity in BPI and further underscore a role for interhemispheric disconnectivity in the pathophysiological features of psychosis in BPI.

Contemporary patterns of spontaneous labor with normal neonatal outcomes.

PubMed

Zhang, Jun; Landy, Helain J; Branch, D Ware; Burkman, Ronald; Haberman, Shoshana; Gregory, Kimberly D; Hatjis, Christos G; Ramirez, Mildred M; Bailit, Jennifer L; Gonzalez-Quintero, Victor H; Hibbard, Judith U; Hoffman, Matthew K; Kominiarek, Michelle; Learman, Lee A; Van Veldhuisen, Paul; Troendle, James; Reddy, Uma M

2010-12-01

To use contemporary labor data to examine the labor patterns in a large, modern obstetric population in the United States. Data were from the Consortium on Safe Labor, a multicenter retrospective study that abstracted detailed labor and delivery information from electronic medical records in 19 hospitals across the United States. A total of 62,415 parturients were selected who had a singleton term gestation, spontaneous onset of labor, vertex presentation, vaginal delivery, and a normal perinatal outcome. A repeated-measures analysis was used to construct average labor curves by parity. An interval-censored regression was used to estimate duration of labor, stratified by cervical dilation at admission and centimeter by centimeter. Labor may take more than 6 hours to progress from 4 to 5 cm and more than 3 hours to progress from 5 to 6 cm of dilation. Nulliparous and multiparous women appeared to progress at a similar pace before 6 cm. However, after 6 cm, labor accelerated much faster in multiparous than in nulliparous women. The 95 percentiles of the second stage of labor in nulliparous women with and without epidural analgesia were 3.6 and 2.8 hours, respectively. A partogram for nulliparous women is proposed. In a large, contemporary population, the rate of cervical dilation accelerated after 6 cm, and progress from 4 cm to 6 cm was far slower than previously described. Allowing labor to continue for a longer period before 6 cm of cervical dilation may reduce the rate of intrapartum and subsequent repeat cesarean deliveries in the United States.

NAFLD prevalence differs among hispanic subgroups: the Multi-Ethnic Study of Atherosclerosis.

PubMed

Fleischman, Michael Wayne; Budoff, Matthew; Zeb, Ifran; Li, Dong; Foster, Temitope

2014-05-07

To compare prevalence rates of non-alcoholic fatty liver disease (NAFLD) between Hispanics of Mexican origin and Hispanics of Dominican and Puerto Rican origin. We evaluated prevalence rates of NAFLD between the two largest sub-populations of Hispanics in the United States; Hispanics of Mexican origin and Hispanics of Caribbean origin (Dominican and Puerto Rican), in the multi-ethnic study of atherosclerosis (MESA) cohort. MESA is a large, population based, multi-center cohort study comprised of 6814 healthy Caucasian, African-American, Hispanic, and Asian men and women aged 45-84. We utilized the baseline serum, anthropometric and radiographic measurements obtained between 2000 and 2002. NAFLD was measured via computed tomography scan and was defined as liver/spleen attenuation ratio < 1. There were 788 Hispanic participants included in the study after exclusions. The prevalence of NAFLD was 29% (n = 225). Hispanics of Mexican origin had a significantly higher prevalence of NAFLD (33%), compared to Hispanics of Dominican origin (16%), (P < 0.01) and Hispanics of Puerto Rican origin (18%), (P < 0.01). After controlling for age, sex, BMI, waist circumference, hypertension, serum HDL, triglyceride and CRP level and insulin resistance, Hispanics of Mexican origin remained significantly more likely to have NAFLD than those of Dominican and Puerto Rican origin. United States Hispanics of Mexican origin have a significantly higher prevalence of NAFLD when compared to United States Hispanics of Dominican or Puerto Rican origin after controlling for known risk factors. Care should be taken when performing risk assessment in Hispanic populations not to make assumptions of homogeneity.

Contemporary Patterns of Spontaneous Labor With Normal Neonatal Outcomes

PubMed Central

Zhang, Jun; Landy, Helain J.; Branch, D. Ware; Burkman, Ronald; Haberman, Shoshana; Gregory, Kimberly D.; Hatjis, Christos G.; Ramirez, Mildred M.; Bailit, Jennifer L.; Gonzalez-Quintero, Victor H.; Hibbard, Judith U.; Hoffman, Matthew K.; Kominiarek, Michelle; Learman, Lee A.; Van Veldhuisen, Paul; Troendle, James; Reddy, Uma M.

2013-01-01

Objective To use contemporary labor data to examine the labor patterns in a large, modern obstetric population in the United States. Methods Data were from the Consortium on Safe Labor, a multicenter retrospective study that abstracted detailed labor and delivery information from electronic medical records in 19 hospitals across the United States. A total of 62,415 parturients were selected who had a singleton term gestation, spontaneous onset of labor, vertex presentation, vaginal delivery, and a normal perinatal outcome. A repeated-measures analysis was used to construct average labor curves by parity. An interval-censored regression was used to estimate duration of labor stratified by cervical dilation at admission and centimeter by centimeter. Results Labor may take over 6 hours to progress from 4 to 5 cm and over 3 hours to progress from 5 to 6 cm of dilation. Nulliparas and multiparas appeared to progress at a similar pace before 6 cm. However, after 6 cm labor accelerated much faster in multiparas than in nulliparas. The 95th percentile of the 2nd stage of labor in nulliparas with and without epidural analgesia was 3.6 and 2.8 hours, respectively. A partogram for nulliparas is proposed. Conclusion In a large, contemporary population, the rate of cervical dilation accelerated after 6 cm and progress from 4 to 6 cm was far slower than previously described. Allowing labor to continue for a longer period before 6 cm of cervical dilation may reduce the rate of intrapartum and subsequent repeat cesarean deliveries in the United States. PMID:21099592

Prospective multi-center study of an automatic online seizure detection system for epilepsy monitoring units.

PubMed

Fürbass, F; Ossenblok, P; Hartmann, M; Perko, H; Skupch, A M; Lindinger, G; Elezi, L; Pataraia, E; Colon, A J; Baumgartner, C; Kluge, T

2015-06-01

A method for automatic detection of epileptic seizures in long-term scalp-EEG recordings called EpiScan will be presented. EpiScan is used as alarm device to notify medical staff of epilepsy monitoring units (EMUs) in case of a seizure. A prospective multi-center study was performed in three EMUs including 205 patients. A comparison between EpiScan and the Persyst seizure detector on the prospective data will be presented. In addition, the detection results of EpiScan on retrospective EEG data of 310 patients and the public available CHB-MIT dataset will be shown. A detection sensitivity of 81% was reached for unequivocal electrographic seizures with false alarm rate of only 7 per day. No statistical significant differences in the detection sensitivities could be found between the centers. The comparison to the Persyst seizure detector showed a lower false alarm rate of EpiScan but the difference was not of statistical significance. The automatic seizure detection method EpiScan showed high sensitivity and low false alarm rate in a prospective multi-center study on a large number of patients. The application as seizure alarm device in EMUs becomes feasible and will raise the efficiency of video-EEG monitoring and the safety levels of patients. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Six-Month Multicenter Study on Invasive Infections Due to Streptococcus pyogenes and Streptococcus dysgalactiae subsp. equisimilis in Argentina

PubMed Central

Lopardo, Horacio A.; Vidal, Patricia; Sparo, Monica; Jeric, Paola; Centron, Daniela; Facklam, Richard R.; Paganini, Hugo; Pagniez, N. Gaston; Lovgren, Marguerite; Beall, Bernard

2005-01-01

During a 6-month period, 95 invasive infections due to Streptococcus pyogenes and group C or group G Streptococcus dysgalactiae subsp. equisimilis were recorded from 40 centers of 16 cities in Argentina. We describe here epidemiologic data available for 55 and 19 patients, respectively, associated with invasive infections due to S. pyogenes and S. dysgalactiae subsp. equisimilis. The associated isolates and 58 additional pharyngeal isolates were genotyped and subjected to serologic and/or antibiotic susceptibility testing. Group A streptococcal emm type distribution and strain association with toxic shock appeared to differ somewhat from results found within the United States; however, serologic characterization and sof sequence typing suggested that emm types found in both countries are reflective of shared clonal types. PMID:15695683

Impact of the Cancer Prevention and Control Research Network

PubMed Central

Ribisl, Kurt M.; Fernandez, Maria E.; Friedman, Daniela B.; Hannon, Peggy; Leeman, Jennifer; Moore, Alexis; Olson, Lindsay; Ory, Marcia; Risendal, Betsy; Sheble, Laura; Taylor, Vicky; Williams, Rebecca; Weiner, Bryan J.

2018-01-01

The Cancer Prevention and Control Research Network (CPCRN) is a thematic network dedicated to accelerating the adoption of evidence-based cancer prevention and control practices in communities by advancing dissemination and implementation science. Funded by the Centers for Disease Control and Prevention and National Cancer Institute, CPCRN has operated at two levels: Each participating Network Center conducts research projects with primarily local partners as well as multicenter collaborative research projects with state and national partners. Through multicenter collaboration, thematic networks leverage the expertise, resources, and partnerships of participating centers to conduct research projects collectively that might not be feasible individually. Although multicenter collaboration often is advocated, it is challenging to promote and assess. Using bibliometric network analysis and other graphical methods, this paper describes CPCRN’s multicenter publication progression from 2004 to 2014. Searching PubMed, Scopus, and Web of Science in 2014 identified 249 peer-reviewed CPCRN publications involving two or more centers out of 6,534 total. The research and public health impact of these multicenter collaborative projects initiated by CPCRN during that 10-year period were then examined. CPCRN established numerous workgroups around topics such as: 2-1-1, training and technical assistance, colorectal cancer control, federally qualified health centers, cancer survivorship, and human papillomavirus. The paper discusses the challenges that arise in promoting multicenter collaboration and the strategies that CPCRN uses to address those challenges. The lessons learned should broadly interest those seeking to promote multisite collaboration to address public health problems, such as cancer prevention and control. PMID:28215371

Origin of Transitions between Metallic and Insulating States in Simple Metals

DOE PAGES

Naumov, Ivan I.; Hemley, Russell J.

2015-04-17

Unifying principles that underlie recently discovered transitions between metallic and insulating states in elemental solids under pressure are developed. Using group theory arguments and first principles calculations, we show that the electronic properties of the phases involved in these transitions are controlled by symmetry principles not previously recognized. The valence bands in these systems are described by simple and composite band representations constructed from localized Wannier functions centered on points unoccupied by atoms, and which are not necessarily all symmetrical. The character of the Wannier functions is closely related to the degree of s-p(-d) hybridization and reflects multi-center chemical bondingmore » in these insulating states. The conditions under which an insulating state is allowed for structures having an integer number of atoms per primitive unit cell as well as re-entrant (i.e., metal-insulator-metal) transition sequences are detailed, resulting in predictions of novel behavior such as phases having three-dimensional Dirac-like points. The general principles developed are tested and applied to the alkali and alkaline earth metals, including elements where high-pressure insulating phases have been identified or reported (e.g., Li, Na, and Ca).« less

Verteporfin therapy in age-related macular degeneration (VAM): an open-label multicenter photodynamic therapy study of 4,435 patients.

PubMed

Bessler, Neil M

2004-08-01

To provide broad clinical experience and to gather safety data on photodynamic therapy with verteporfin (Visudyne, Novartis AG, Basel, Switzerland), also termed verteporfin therapy, in patients with predominantly classic subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). The Verteporfin in Age-related Macular Degeneration (VAM) Study was designed to provide expanded access to verteporfin therapy after beneficial results for these cases were reported but before regulatory approval in North America. This open-label multicenter study from September 1999 through June 2000 enrolled among 222 centers patients 50 years or older in the United States, or 40 years or older in Canada, with age-related macular degeneration and subfoveal CNV with a lesion composition that was predominantly classic CNV on fluorescein angiography. Corrected visual acuity with habitual eyewear in the office setting was 20/40 to 20/200, inclusive. All patients received verteporfin therapy and returned for follow-up every 3 months. At those follow-up examinations, additional courses of treatment were recommended if any fluorescein leakage from CNV was identified. Safety information was collected from patient self-reporting, questioning (in person and by telephone), and physician evaluation. Safety was assessed by evaluating the effect of treatment on corrected distance visual acuity and by evaluating adverse events. A total of 4,435 patients were enrolled of whom 4,051 (91%) completed the study after receiving 6,701 treatments. Most patients received only one treatment in VAM before regulatory approval of verteporfin in the United States and Canada. Three hundred patients (6.8%) experienced an adverse event considered by the treating ophthalmologist to be associated with treatment, including 115 (2.6%) with abnormal or decreased vision, of whom 25 (0.6%) experienced acute severe visual acuity decrease, and 14 (0.3%) with transient infusion-related back pain. Patients were advised to avoid exposure to direct sunlight for 24 hours; however, after verteporfin administration only 2 (0.05%) reported a photosensitivity reaction. An additional course of verteporfin therapy was administered to 1,739 of 2,314 patients (75.2%) who had a month 3 examination that was not their close-out visit and 177 of 266 (66.5%) who had a month 6 examination that was not their close-out visit. Verteporfin therapy exhibited no additional or new safety concerns. The therapy associated with a low incidence of adverse events when expanded access was provided in a large, open-label, multicenter study, including a low incidence (0.05%) of reported photosensitivity reactions despite a short photosensitivity protection period (24 hours) following verteporfin administration.

Multicenter study of optical low-coherence interferometry and partial-coherence interferometry optical biometers with patients from the United States and China.

PubMed

Hoffer, Kenneth J; Shammas, H John; Savini, Giacomo; Huang, Jinhai

2016-01-01

To evaluate the agreement between the measurements provided by a new optical biometer, the Aladdin, based on optical low-coherence interferometry (OLCI), and those provided by the most commonly used optical biometer (IOLMaster 500), based on partial-coherence interferometry (PCI). Multicenter clinical trial. Prospective evaluation of diagnostic test. In this study, 2 samples of adult patients were enrolled, 1 in the United States and the other in China. The U.S. group included a sample of consecutive patients scheduled for cataract surgery. The China group included a sample of healthy subjects with no cataracts. In both cases, only 1 eye of each patient was analyzed. Axial length (AL), corneal power (in diopters [D]) (K), anterior chamber depth (ACD) (corneal epithelium to lens), and corneal astigmatism were measured. All values were analyzed using a paired t test, the Pearson product-moment correlation coefficient (r), and Bland-Altman plots. In the U.S. and China groups, the OLCI mean AL values did not show a statistically significant difference from PCI values and showed excellent agreement and correlation. On the contrary, OLCI measured a lower mean K (-0.14 D) and a deeper ACD measurements (U.S. +0.16 mm and China +0.05 mm). These differences were statistically significant (P < .0001). Vector analysis did not show a statistically significant difference in astigmatism measurements. Agreement between OLCI and PCI was good. However, the small but statistically significant differences in K and ACD measurements make constant optimization necessary when calculating the intraocular lens power using theoretical formulas. Dr. Hoffer licenses the registered trademark name Hoffer to Carl Zeiss-Meditec (PCI), Haag-Streit (Lenstar), Movu (Argos), Oculus (Pentacam, AXL), Nidek (AL-Scan), Tomey (OA-2000), Topcon EU Visia Imaging (Aladdin), Ziemer (Galilei G6), and all A-scan biometer manufacturers. Dr. Shammas licenses his formulas to Carl Zeiss-Meditec (PCI), Haag-Streit (Lenstar), Nidek (AL-Scan), and Topcon EU (Visia Imaging) (Aladdin). None of the other authors has a financial or proprietary interest in any material or method mentioned. Copyright © 2016 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

A multicenter, observational study of lanreotide depot/autogel (LAN) in patients with acromegaly in the United States: 2-year experience from the SODA registry.

PubMed

Salvatori, Roberto; Gordon, Murray B; Woodmansee, Whitney W; Ioachimescu, Adriana G; Carver, Don W; Mirakhur, Beloo; Cox, David; Molitch, Mark E

2017-12-01

This analysis evaluates the 2-year effectiveness and safety of lanreotide depot/autogel (LAN), as well as treatment convenience and acromegaly symptom relief, from the Somatuline ® Depot for Acromegaly (SODA) registry, a post-marketing, open-label, observational, multicenter, United States registry study. Patients with acromegaly treated with LAN were eligible for enrollment. Demographics, LAN dose, extended dosing interval (EDI) (interval of injections ≥42 days), insulin-like growth factor 1 (IGF-1), growth hormone (GH), glycated hemoglobin, adverse events (AEs), injection convenience, and symptom data were collected. As of September 29, 2014, 241 patients were enrolled in SODA. IGF-1 levels below age- and gender-adjusted upper normal limit (ULN) were achieved in 71.2% at month (M) 12 and 74.4% at M24; GH ≤2.5 µg/L in 83.3% at M12 and 80.0% at M24; GH <1.0 µg/L in 61.7% at M12 and 61.4% at M24. Both IGF-1 < ULN and GH ≤2.5 µg/L were achieved in 65.0% at M12 and 54.8% at M24; both IGF-1 < ULN and GH < 1.0 µg/L were achieved in 51.7 and 42.9% at M12 and M24, respectively. EDI regimen was 5.0% at baseline and 12.0% at M24. At M24, acromegaly symptoms appeared stable or improved. The most common AE was arthralgia (25.7%). Among 106 serious AEs reported by 42 patients, 10 were deemed related to therapy in 9 patients. At M24, 73.1% of patients rated LAN as convenient. SODA indicates 2-year biochemical control with majority of patients achieving both IGF-1 < ULN and GH ≤2.5 µg/L. LAN was generally well tolerated with no new or unexpected safety signals reported during the observation period. clinicaltrials.gov Clinical Trial Identifier: NCT00686348.

Vasopressor Use for Severe Hypotension-A Multicentre Prospective Observational Study.

PubMed

Lamontagne, Francois; Cook, Deborah J; Meade, Maureen O; Seely, Andrew; Day, Andrew G; Charbonney, Emmanuel; Serri, Karim; Skrobik, Yoanna; Hebert, Paul; St-Arnaud, Charles; Quiroz-Martinez, Hector; Mayette, Michaël; Heyland, Daren K

2017-01-01

The optimal approach to titrate vasopressor therapy is unclear. Recent sepsis guidelines recommend a mean arterial pressure (MAP) target of 65 mmHg and higher for chronic hypertensive patients. As data emerge from clinical trials comparing blood pressure targets for vasopressor therapy, an accurate description of usual care is required to interpret study results. Our aim was to measure MAP values during vasopressor therapy in Canadian intensive care units (ICUs) and to compare these with stated practices and guidelines. In a multicenter prospective cohort study of critically ill adults with severe hypotension, we recorded MAP and vasopressor doses hourly. We investigated variability across patients and centres using multivariable regression models and Analysis of variance (ANOVA), respectively. We included data from 56 patients treated in 6 centers. The mean (standard deviation [SD]) age and Acute Physiology and Chronic Health Evaluation (APACHE) II score were 64 (14) and 25 (8). Half (28 of 56) of the patients were at least 65 years old, and half had chronic hypertension. The patient-averaged MAP while receiving vasopressors was 75 mm Hg (6) and the median (1st quartile, 3rd quartile) duration of vasopressor therapy was 43 hours (23, 84). MAP achieved was not associated with history of underlying hypertension (p = 0.46) but did vary by center (p<0.001). In this multicenter, prospective observational study, the patient-level average MAP while receiving vasopressors for severe hypotension was 75 mmHg, approximately 10 mmHg above current recommendations and stated practices. Moreover, our results do not support the notion that clinicians tailor vasopressor therapy to individual patient characteristics such as underlying chronic hypertension but MAP achieved while receiving vasopressors varied by site.

Vasopressor Use for Severe Hypotension—A Multicentre Prospective Observational Study

PubMed Central

Cook, Deborah J.; Meade, Maureen O.; Seely, Andrew; Day, Andrew G.; Charbonney, Emmanuel; Serri, Karim; Skrobik, Yoanna; Hebert, Paul; St-Arnaud, Charles; Quiroz-Martinez, Hector; Mayette, Michaël; Heyland, Daren K.

2017-01-01

Background The optimal approach to titrate vasopressor therapy is unclear. Recent sepsis guidelines recommend a mean arterial pressure (MAP) target of 65 mmHg and higher for chronic hypertensive patients. As data emerge from clinical trials comparing blood pressure targets for vasopressor therapy, an accurate description of usual care is required to interpret study results. Our aim was to measure MAP values during vasopressor therapy in Canadian intensive care units (ICUs) and to compare these with stated practices and guidelines. Method In a multicenter prospective cohort study of critically ill adults with severe hypotension, we recorded MAP and vasopressor doses hourly. We investigated variability across patients and centres using multivariable regression models and Analysis of variance (ANOVA), respectively. Results We included data from 56 patients treated in 6 centers. The mean (standard deviation [SD]) age and Acute Physiology and Chronic Health Evaluation (APACHE) II score were 64 (14) and 25 (8). Half (28 of 56) of the patients were at least 65 years old, and half had chronic hypertension. The patient-averaged MAP while receiving vasopressors was 75 mm Hg (6) and the median (1st quartile, 3rd quartile) duration of vasopressor therapy was 43 hours (23, 84). MAP achieved was not associated with history of underlying hypertension (p = 0.46) but did vary by center (p<0.001). Conclusions In this multicenter, prospective observational study, the patient-level average MAP while receiving vasopressors for severe hypotension was 75 mmHg, approximately 10 mmHg above current recommendations and stated practices. Moreover, our results do not support the notion that clinicians tailor vasopressor therapy to individual patient characteristics such as underlying chronic hypertension but MAP achieved while receiving vasopressors varied by site. PMID:28107357

Early Exercise in the Burn Intensive Care Unit Decreases Hospital Stay, Improves Mental Health, and Physical Performance

DTIC Science & Technology

2017-10-01

Decreases Hospital Stay, Improves Mental Health , and Physical Performance 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) Oscar E. Suman, PhD...Multicenter Study of the Effect of In-Patient Exercise Training on Length of Hospitalization, Mental Health , and Physical Performance in Burned...Intensive Care Unit Decreases Hospital Stay, Improves Mental Health , and Physical Performance,” Proposal Log Number 13214039, Award Number W81XWH-14

The Phase of Illness Paradigm: A Checklist Centric Model to Improve Patient Care in the Burn Intensive Care Unit

DTIC Science & Technology

2014-04-01

6. PUBLICATIONS, ABSTRACTS, AND PRESENTATIONS: Submitted abstracts to the 2014 Military Health Research Symposium: 1. Pamplin, J.C., Murray...Intensive Care Unit ERMS/Log Number: 12340054 W81XWH-13-2-0011 PI: LTC Jeremy Pamplin, MD Org: The Geneva Foundation/San Antonio Military Medical Center...improve clinician work related quality of life. Approach and Military Relevance This multicenter, prospective, case-matched cohort study will improve the

Temporal trends in patient characteristics and survival of intensive care admissions with sepsis: a multicenter analysis*.

PubMed

Dreiher, Jacob; Almog, Yaniv; Sprung, Charles L; Codish, Shlomi; Klein, Moti; Einav, Sharon; Bar-Lavie, Yaron; Singer, Pierre P; Nimrod, Adi; Sachs, Jeffrey; Talmor, Daniel; Friger, Michael; Greenberg, Dan; Olsfanger, David; Hersch, Moshe; Novack, Victor

2012-03-01

To estimate in-hospital, 1-yr, and long-term mortality and to assess time trends in incidence and outcomes of sepsis admissions in the intensive care unit. A population-based, multicenter, retrospective cohort study. Patients hospitalized with sepsis in the intensive care unit in seven general hospitals in Israel during 2002-2008. None. Survival data were collected and analyzed according to demographic and background clinical characteristics, as well as features of the sepsis episode, using Kaplan-Meier approach for long-term survival. A total of 5,155 patients were included in the cohort (median age: 70, 56.3% males; median Charlson comorbidity index: 4). The mean number of intensive care unit admissions per month increased over time, while no change in in-hospital mortality was observed. The proportion of patients surviving to hospital discharge was 43.9%. The 1-, 2-, 5-, and 8-yr survival rates were 33.0%, 29.8%, 23.3%, and 19.8%, respectively. Mortality was higher in older patients, patients with a higher Charlson comorbidity index, and those with multiorgan failure, and similar in males and females. One-year age-standardized mortality ratio was 21-fold higher than expected, based on the general population rates. Mortality following intensive care unit sepsis admission remains high and is correlated with underlying patients' characteristics, including age, comorbidities, and the number of failing organ systems.

Multicenter cohort association study of SLC2A1 single nucleotide polymorphisms and age-related macular degeneration

PubMed Central

Baas, Dominique C.; Ho, Lintje; Tanck, Michael W.T.; Fritsche, Lars G.; Merriam, Joanna E.; van het Slot, Ruben; Koeleman, Bobby P.C.; Gorgels, Theo G.M.F.; van Duijn, Cornelia M.; Uitterlinden, André G.; de Jong, Paulus T.V.M.; Hofman, Albert; ten Brink, Jacoline B.; Vingerling, Johannes R.; Klaver, Caroline C.W.; Dean, Michael; Weber, Bernhard H. F.; Allikmets, Rando; Hageman, Gregory S.

2012-01-01

Purpose Age-related macular degeneration (AMD) is a major cause of blindness in older adults and has a genetically complex background. This study examines the potential association between single nucleotide polymorphisms (SNPs) in the glucose transporter 1 (SLC2A1) gene and AMD. SLC2A1 regulates the bioavailability of glucose in the retinal pigment epithelium (RPE), which might influence oxidative stress–mediated AMD pathology. Methods Twenty-two SNPs spanning the SLC2A1 gene were genotyped in 375 cases and 199 controls from an initial discovery cohort (the Amsterdam-Rotterdam-Netherlands study). Replication testing was performed in The Rotterdam Study (the Netherlands) and study populations from Würzburg (Germany), the Age Related Eye Disease Study (AREDS; United States), Columbia University (United States), and Iowa University (United States). Subsequently, a meta-analysis of SNP association was performed. Results In the discovery cohort, significant genotypic association between three SNPs (rs3754219, rs4660687, and rs841853) and AMD was found. Replication in five large independent (Caucasian) cohorts (4,860 cases and 4,004 controls) did not yield consistent association results. The genotype frequencies for these SNPs were significantly different for the controls and/or cases among the six individual populations. Meta-analysis revealed significant heterogeneity of effect between the studies. Conclusions No overall association between SLC2A1 SNPs and AMD was demonstrated. Since the genotype frequencies for the three SLC2A1 SNPs were significantly different for the controls and/or cases between the six cohorts, this study corroborates previous evidence that population dependent genetic risk heterogeneity in AMD exists. PMID:22509097

Cigarette smoking and the risk of epithelial ovarian cancer.

PubMed

Franks, A L; Lee, N C; Kendrick, J S; Rubin, G L; Layde, P M

1987-07-01

Cigarette smoking may affect each of the currently proposed mechanisms of ovarian carcinogenesis. Whether cigarette smoking has any effect on the development of ovarian cancer has not been adequately evaluated. To study this issue, the authors examined data from the Cancer and Steroid Hormone Study, a multicenter, case-control study of gynecologic cancers conducted between December 1, 1980, and December 31, 1982, in eight geographic areas of the United States. This analysis utilized data on 494 women with newly diagnosed epithelial ovarian cancer and 4,238 population-based control women 20-54 years of age. There was no association of epithelial ovarian cancer with dose of cigarette smoking, age smoking started, time since smoking started, or time since smoking last occurred. Simultaneous adjustment for age, parity, history of oral contraceptive use, and other potentially confounding factors did not alter these results.

Development of a Reference Information Model and Knowledgebase for Electronic Bloodstream Infection Detection

PubMed Central

Borlawsky, Tara; Hota, Bala; Lin, Michael Y.; Khan, Yosef; Young, Jeremy; Santangelo, Jennifer; Stevenson, Kurt B.

2008-01-01

The most prevalent hospital-acquired infections in the United States are bloodstream infections (BSIs) associated with the presence of a central venous catheter. There is currently a movement, including national organizations such as the Centers for Medicare and Medicaid Services as well as consumer, quality improvement and patient safety groups, encouraging the standardization of reporting and aggregation of such nosocomial infection data to increase and improve reporting, and enable rate comparisons among healthcare institutions. Domain modeling is a well-known method for designing interoperable processes that take advantage of existing data and legacy systems. We have combined such a model-driven design approach with the use of partitioned clinical and business logic knowledgebases in order to employ a previously validated electronic BSI surveillance algorithm in the context of a multi-center study. PMID:18999213

Comparison of resource utilization of pulmonary vein isolation: cryoablation versus RF ablation with three-dimensional mapping in the Value PVI Study.

PubMed

DeVille, J Brian; Svinarich, J Thomas; Dan, Dan; Wickliffe, Andrew; Kantipudi, Charan; Lim, Hae W; Plummer, Lisa; Baker, James; Kowalski, Marcin; Baydoun, Hassan; Jenkins, Mark; Chang-Sing, Peter

2014-06-01

Point-to-point focal radiofrequency (RF) catheter ablation for aberrant pulmonary vein triggers that manifest into atrial fibrillation (AF) is the traditional method for treating symptomatic drug-resistant paroxysmal AF (PAF) when an ablation procedure is warranted. More recently, pulmonary vein isolation (PVI) using the cryoballoon has been demonstrated to be safe and effective (STOP AF clinical trial). Currently, two small studies have reviewed the procedural efficiency when comparing cryoballoon to focal RF catheter ablation procedures; however, no multicenter study has yet reported on this comparison of the two types of ablation catheters. A multicenter retrospective chart extraction and evaluation was conducted at seven geographically mixed cardiac care centers. The study examined procedural variables during ablation for PVI in PAF patients. In several procedural measurements, the two modalities were comparable in efficiencies, including: acute PVI >96%; length of hospital stay at approximately 27 hours; and about 30% usage of adenosine after procedural testing. However, when compared to RF catheters, the cryoballoon procedure demonstrated a 13% reduction in laboratory occupancy time (247 min vs 283 min), a 13% reduction in procedure time (174 min vs 200 min), and a 21% reduction in fluoroscopy time (33 min vs 42 min). Additionally, when comparing the material usage of both cryoballoon and RF catheters, the cryoballoon used more radiopaque contrast agent (78 cc vs 29 cc) while using less intraprocedural saline (1234 cc vs 2386 cc), intracardiac echocardiography (88% vs 99%), three-dimensional electroanatomic mapping (30% vs 87%), and fewer transseptal punctures (1.5 vs 1.9). This study is the first United States multicenter examination to report the procedural comparisons between the cryoballoon and focal RF catheters when used for the treatment of PAF patients. In this hospital chart review study, potential advantages were found when operating the cryoballoon with regard to hospital resource allocation. There was no statistical difference between cryoballoon and RF catheters for acute PVI success during the ablation procedure.

A Multicenter Radiographic Evaluation of the Rates of Preoperative and Postoperative Malalignment in Degenerative Spinal Fusions.

PubMed

Leveque, Jean-Christophe A; Segebarth, Bradley; Schroerlucke, Samuel R; Khanna, Nitin; Pollina, John; Youssef, Jim A; Tohmeh, Antoine G; Uribe, Juan S

2018-07-01

Multicenter, retrospective, institutional-review-board -approved study at 18 institutions in the United States with 24 treating investigators. This study was designed to retrospectively assess the prevalence of spinopelvic malalignment in patients who underwent one- or two-level lumbar fusions for degenerative (nondeformity) indications and to assess the incidence of malalignment after fusion surgery as well as the rate of alignment preservation and/or correction in this population. Spinopelvic malalignment after lumbar fusion has been associated with lower postoperative health-related quality of life and elevated risk of adjacent segment failure. The prevalence of spinopelvic malalignment in short-segment degenerative lumbar fusion procedures from a large sample of patients is heretofore unreported and may lead to an under-appreciation of these factors in surgical planning and ultimate preservation or correction of alignment. Lateral preoperative and postoperative lumbar radiographs were retrospectively acquired from 578 one- or two-level lumbar fusion patients and newly measured for lumbar lordosis (LL), pelvic incidence (PI), and pelvic tilt. Patients were categorized at preop and postop time points as aligned if PI-LL < 10° or malaligned if PI-LL≥10°. Patients were grouped into categories based on their alignment progression from pre- to postoperative, with preserved (aligned to aligned), restored (malaligned to aligned), not corrected (malaligned to malaligned), and worsened (aligned to malaligned) designations. Preoperatively, 173 (30%) patients exhibited malalignment. Postoperatively, 161 (28%) of patients were malaligned. Alignment was preserved in 63%, restored in 9%, not corrected in 21%, and worsened in 7% of patients. This is the first multicenter study to evaluate the preoperative prevalence and postoperative incidence of spinopelvic malalignment in a large series of short-segment degenerative lumbar fusions, finding over 25% of patients out of alignment at both time points, suggesting that alignment preservation/restoration considerations should be incorporated into the decision-making of even degenerative lumbar spinal fusions. 3.

Pain severity and mobility one year after spinal cord injury: a multicenter, cross-sectional study.

PubMed

Marcondes, Bianca F; Sreepathi, Shruti; Markowski, Justin; Nguyen, Dung; Stock, Shannon R; Carvalho, Sandra; Tate, Denise; Zafonte, Ross; Morse, Leslie R; Fregni, Felipe

2016-10-01

Following a spinal cord injury, patients are often burdened by chronic pain. Preliminary research points to activation of the motor cortex through increased mobility as a potential means of alleviating postinjury chronic pain. The aim of this study was to assess the relationship between pain severity and mobility among patients who have sustained a traumatic spinal cord injury while controlling for clinically-relevant covariates. A multi-center, cross-sectional study. The SCIMS is composed of 14 centers, all located in the United States and funded by the National Institute on Disability and Rehabilitation Research (NIDRR). The study cohort included 1980 patients who completed the one-year SCIMS follow-up assessment between October 2000- December 2013. A multi-center, cross-sectional study was performed to assess the impact of mobility on self-reported pain using information from 1980 subjects who sustained a traumatic spinal cord injury and completed a year-one follow-up interview between October 2000 and December 2013. Patient information was acquired using the Spinal Cord Injury National Database, compiled by the affiliated Spinal Cord Injury Model Systems. Analyses included a multivariable linear regression of patients' self-reported pain scores on mobility, quantified using the CHART-SF mobility total score, and other clinically relevant covariates. After controlling for potential confounders, a significant quadratic relationship between mobility and patients' self-reported pain was observed (P=0.016). Furthermore, female gender, "unemployed" occupational status, paraplegia, and the presence of depressive symptoms were associated with significantly higher pain scores (P<0.02 for all variables). Statistically significant quadratic associations between pain scores and age at injury, life satisfaction total score, and the CHART-SF occupational total subscale were also observed (P≤0.03 for all variables). Among patients with moderate to high levels of mobility, pain scores decreased with increasing mobility. Enhancing a patient's physical activity by increasing his or her mobility may reduce neuropathic pain if begun shortly after a spinal cord injury.

D-Dimer Use and Pulmonary Embolism Diagnosis in Emergency Units: Why Is There Such a Difference in Pulmonary Embolism Prevalence between the United States of America and Countries Outside USA?

PubMed

Pernod, Gilles; Caterino, Jeffrey; Maignan, Maxime; Tissier, Cindy; Kassis, Jeannine; Lazarchick, John

2017-01-01

Although diagnostic guidelines are similar, there is a huge difference in pulmonary embolism (PE) prevalence between the United States of America (US) and countries outside the USA (OUS) in the emergency care setting. In this study, we prospectively analyze patients' characteristics and differences in clinical care that may influence PE prevalence in different countries. An international multicenter prospective diagnostic study was conducted in a standard-of-care setting. Consecutive outpatients presenting to the emergency unit and suspected for PE were managed using the Wells score, STA-Liatest® D-Dimers and imaging. The prevalence of PE in the study was 7.9% in low and moderate risk patients. Among the 1060 patients with low or moderate pre-test probability (PTP), PE prevalence was four times higher in OUS (10.7%) than in the US (2.5%) (P < 0.0001). The mean number of imaging procedures performed for one new PE diagnosis was 3.3 in OUS vs 17 in the US (P < 0.001). Stopping investigation in the case of negative D-dimers (DD combined) with low/moderate PTP was more frequent in OUS (92.7%) than in the US (75.7%) (P < 0.01). Moreover, the use of imaging was much higher in the US (44.4% vs 19.2% in OUS) in the case of moderate PTP combined with negative DD. Differences between US and OUS PE prevalence in emergency setting might be explained by differences in patients' characteristics and mostly in care patterns. US physicians performed computed tomographic pulmonary angiography more often than in Europe in cases of low/moderate PTP combined with negative DD. ClinicalTrials.gov NCT01221805.

Early resuscitation intensity as a surrogate for bleeding severity and early mortality in the PRospective, Observational, Multicenter, Major Trauma Transfusion (PROMMTT) Study

PubMed Central

Rahbar, Elaheh; Fox, Erin E.; del Junco, Deborah J.; Harvin, John A.; Holcomb, John B.; Wade, Charles E.; Schreiber, Martin A.; Rahbar, Mohammad H.; Bulger, Eileen M.; Phelan, Herb A.; Brasel, Karen J.; Alarcon, Louis H.; Myers, John G.; Cohen, Mitchell J.; Muskat, Peter; Cotton, Bryan A.

2013-01-01

Background The classic definition of MT, ≥10 units red blood cells (RBCs) in 24 hours, has never been demonstrated as a valid surrogate for severe hemorrhage and can introduce survival bias. In addition, the definition fails to capture other products that the clinician may have immediately available during the initial resuscitation. Assuming that units of resuscitative fluids reflect patient illness, our objective was to identify a rate of resuscitation intensity (RI) that could serve as an early surrogate of sickness for patients with substantial bleeding post-injury. Methods Adult patients surviving at least 30 minutes post-admission and receiving ≥1 RBC within 6 hours of admission from ten US Level 1 trauma centers were enrolled in the PRospective Observational Multicenter Major Trauma Transfusion study. Total fluid units were calculated as the sum of the number of crystalloid units (1 L=1 unit), colloids (0.5 L=1 unit) and blood products (1 RBC=1 unit, 1 plasma=1 unit, 6 pack platelets=1 unit). Univariable and multivariable logistic regressions were used to evaluate associations between RI and 6-hour mortality, adjusting for age, center, penetrating injury, weighted Revised Trauma Score, and Injury Severity Score. Results 1096 eligible patients received resuscitative fluids within 30 minutes, including 620 transfused with blood products. Despite varying products utilized, the total fluid RI was similar across all sites (3.2±2.5 units). Patients who received ≥4 units of any resuscitative fluid had a 6-hour mortality rate of 14.4% vs. 4.5% in patients who received <4 units. The adjusted odds ratio of 6-hour mortality for patients receiving ≥4 units within 30 minutes was 2.1 (95% Confidence Interval: 1.2–3.5). Conclusions Resuscitation with ≥4 units of any fluid was significantly associated with 6-hour mortality. This study suggests that early RI regardless of fluid type can be used as a surrogate for sickness and mortality in severely bleeding patients. Level of Evidence PROMMTT is a prospective observational study, Level II. PMID:23778506

Postintensive care unit psychological burden in patients with chronic obstructive pulmonary disease and informal caregivers: A multicenter study.

PubMed

de Miranda, Sandra; Pochard, Frédéric; Chaize, Marine; Megarbane, Bruno; Cuvelier, Antoine; Bele, Nicolas; Gonzalez-Bermejo, Jesus; Aboab, Jérome; Lautrette, Alexandre; Lemiale, Virginie; Roche, Nicolas; Thirion, Marina; Chevret, Sylvie; Schlemmer, Benoit; Similowski, Thomas; Azoulay, Elie

2011-01-01

To determine the prevalence and risk factors of symptoms of anxiety, depression, and posttraumatic stress disorder-related symptoms in patients with chronic obstructive pulmonary disease and their relatives after an intensive care unit stay. Prospective multicenter study. Nineteen French intensive care units. One hundred twenty-six patients with chronic obstructive pulmonary disease who survived an intensive care unit stay and 102 relatives. None. Patients and relatives were interviewed at intensive care unit discharge and 90 days later to assess symptoms of anxiety and depression using Hospital Anxiety and Depression Scale (HADS) and posttraumatic stress disorder-related symptoms using the Impact of Event Scale (IES). At intensive care unit discharge, 90% of patients recollected traumatic psychological events in the intensive care unit. At day 90, we were able to conduct telephone interviews with 53 patients and 47 relatives. Hospital Anxiety and Depression Scale scores indicated symptoms of anxiety and depression in 52% and 45.5% of patients at intensive care unit discharge and in 28.3% and 18.9% on day 90, respectively. Corresponding prevalence in relatives were 72.2% and 25.7% at intensive care unit discharge and 40.4% and 14.9% on day 90, respectively. The Impact of Event Scale indicated posttraumatic stress disorder-related symptoms in 20.7% of patients and 29.8% of relatives on day 90. Peritraumatic dissociation assessed using the Peritraumatic Dissociative Experiences Questionnaire was independently associated with posttraumatic stress disorder-related symptoms in the patients and relatives. Previous intensive care unit experience and recollection of bothersome noise in the intensive care unit predicted posttraumatic stress disorder-related symptoms in the patients. Psychiatric symptoms were found to be common in a group of 126 patients with chronic obstructive pulmonary disease who survived an intensive care unit stay and their relatives at intensive care unit discharge and 90 days later. Peritraumatic dissociation at intensive care unit discharge was found to independently predict posttraumatic stress disorder-related symptoms in this sample of patients and relatives.

Causes and Characteristics of Death in Intensive Care Units: A Prospective Multicenter Study.

PubMed

Orban, Jean-Christophe; Walrave, Yannick; Mongardon, Nicolas; Allaouchiche, Bernard; Argaud, Laurent; Aubrun, Frédéric; Barjon, Geneviève; Constantin, Jean-Michel; Dhonneur, Gilles; Durand-Gasselin, Jacques; Dupont, Hervé; Genestal, Michèle; Goguey, Chloé; Goutorbe, Philippe; Guidet, Bertrand; Hyvernat, Hervé; Jaber, Samir; Lefrant, Jean-Yves; Mallédant, Yannick; Morel, Jerôme; Ouattara, Alexandre; Pichon, Nicolas; Guérin Robardey, Anne-Marie; Sirodot, Michel; Theissen, Alexandre; Wiramus, Sandrine; Zieleskiewicz, Laurent; Leone, Marc; Ichai, Carole

2017-05-01

Different modes of death are described in selected populations, but few data report the characteristics of death in a general intensive care unit population. This study analyzed the causes and characteristics of death of critically ill patients and compared anticipated death patients to unexpected death counterparts. An observational multicenter cohort study was performed in 96 intensive care units. During 1 yr, each intensive care unit was randomized to participate during a 1-month period. Demographic data, characteristics of organ failures (Sequential Organ Failure Assessment subscore greater than or equal to 3), and organ supports were collected on all patients who died in the intensive care unit. Modes of death were defined as anticipated (after withdrawal or withholding of treatment or brain death) or unexpected (despite engagement of full-level care or sudden refractory cardiac arrest). A total of 698 patients were included during the study period. At the time of death, 84% had one or more organ failures (mainly hemodynamic) and 89% required at least one organ support (mainly mechanical ventilation). Deaths were considered unexpected and anticipated in 225 and 473 cases, respectively. Compared to its anticipated counterpart, unexpected death occurred earlier (1 day vs. 5 days; P< 0.001) and had fewer organ failures (1 [1 to 2] vs. 1 [1 to 3]; P< 0.01) and more organ supports (2 [2 to 3] vs. 1 [1 to 2]; P< 0.01). Withdrawal or withholding of treatments accounted for half of the deaths. In a general intensive care unit population, the majority of patients present with at least one organ failure at the time of death. Anticipated and unexpected deaths represent two different modes of dying and exhibit profiles reflecting the different pathophysiologic underlying mechanisms.

Impact of the Cancer Prevention and Control Research Network: Accelerating the Translation of Research Into Practice.

PubMed

Ribisl, Kurt M; Fernandez, Maria E; Friedman, Daniela B; Hannon, Peggy A; Leeman, Jennifer; Moore, Alexis; Olson, Lindsay; Ory, Marcia; Risendal, Betsy; Sheble, Laura; Taylor, Vicky M; Williams, Rebecca S; Weiner, Bryan J

2017-03-01

The Cancer Prevention and Control Research Network (CPCRN) is a thematic network dedicated to accelerating the adoption of evidence-based cancer prevention and control practices in communities by advancing dissemination and implementation science. Funded by the Centers for Disease Control and Prevention and National Cancer Institute, CPCRN has operated at two levels: Each participating network center conducts research projects with primarily local partners as well as multicenter collaborative research projects with state and national partners. Through multicenter collaboration, thematic networks leverage the expertise, resources, and partnerships of participating centers to conduct research projects collectively that might not be feasible individually. Although multicenter collaboration is often advocated, it is challenging to promote and assess. Using bibliometric network analysis and other graphical methods, this paper describes CPCRN's multicenter publication progression from 2004 to 2014. Searching PubMed, Scopus, and Web of Science in 2014 identified 249 peer-reviewed CPCRN publications involving two or more centers out of 6,534 total. The research and public health impact of these multicenter collaborative projects initiated by CPCRN during that 10-year period were then examined. CPCRN established numerous workgroups around topics such as: 2-1-1, training and technical assistance, colorectal cancer control, federally qualified health centers, cancer survivorship, and human papillomavirus. This paper discusses the challenges that arise in promoting multicenter collaboration and the strategies that CPCRN uses to address those challenges. The lessons learned should broadly interest those seeking to promote multisite collaboration to address public health problems, such as cancer prevention and control. Copyright © 2016 American Journal of Preventive Medicine. Published by Elsevier Inc. All rights reserved.

Stewart analysis of apparently normal acid-base state in the critically ill.

PubMed

Moviat, Miriam; van den Boogaard, Mark; Intven, Femke; van der Voort, Peter; van der Hoeven, Hans; Pickkers, Peter

2013-12-01

This study aimed to describe Stewart parameters in critically ill patients with an apparently normal acid-base state and to determine the incidence of mixed metabolic acid-base disorders in these patients. We conducted a prospective, observational multicenter study of 312 consecutive Dutch intensive care unit patients with normal pH (7.35 ≤ pH ≤ 7.45) on days 3 to 5. Apparent (SIDa) and effective strong ion difference (SIDe) and strong ion gap (SIG) were calculated from 3 consecutive arterial blood samples. Multivariate linear regression analysis was performed to analyze factors potentially associated with levels of SIDa and SIG. A total of 137 patients (44%) were identified with an apparently normal acid-base state (normal pH and -2 < base excess < 2 and 35 < PaCO2 < 45 mm Hg). In this group, SIDa values were 36.6 ± 3.6 mEq/L, resulting from hyperchloremia (109 ± 4.6 mEq/L, sodium-chloride difference 30.0 ± 3.6 mEq/L); SIDe values were 33.5 ± 2.3 mEq/L, resulting from hypoalbuminemia (24.0 ± 6.2 g/L); and SIG values were 3.1 ± 3.1 mEq/L. During admission, base excess increased secondary to a decrease in SIG levels and, subsequently, an increase in SIDa levels. Levels of SIDa were associated with positive cation load, chloride load, and admission SIDa (multivariate r(2) = 0.40, P < .001). Levels of SIG were associated with kidney function, sepsis, and SIG levels at intensive care unit admission (multivariate r(2) = 0.28, P < .001). Intensive care unit patients with an apparently normal acid-base state have an underlying mixed metabolic acid-base disorder characterized by acidifying effects of a low SIDa (caused by hyperchloremia) and high SIG combined with the alkalinizing effect of hypoalbuminemia. © 2013.

Association of prehospitalization aspirin therapy and acute lung injury: results of a multicenter international observational study of at-risk patients.

PubMed

Kor, Daryl J; Erlich, Jason; Gong, Michelle N; Malinchoc, Michael; Carter, Rickey E; Gajic, Ognjen; Talmor, Daniel S

2011-11-01

To evaluate the association between prehospitalization aspirin therapy and incident acute lung injury in a heterogeneous cohort of at-risk medical patients. This is a secondary analysis of a prospective multicenter international cohort investigation. Multicenter observational study including 20 US hospitals and two hospitals in Turkey. Consecutive, adult, nonsurgical patients admitted to the hospital with at least one major risk factor for acute lung injury. None. Baseline characteristics and acute lung injury risk factors/modifiers were identified. The presence of aspirin therapy and the propensity to receive this therapy were determined. The primary outcome was acute lung injury during hospitalization. Secondary outcomes included intensive care unit and hospital mortality and intensive care unit and hospital length of stay. Twenty-two hospitals enrolled 3855 at-risk patients over a 6-month period. Nine hundred seventy-six (25.3%) were receiving aspirin at the time of hospitalization. Two hundred forty (6.2%) patients developed acute lung injury. Univariate analysis noted a reduced incidence of acute lung injury in those receiving aspirin therapy (odds ratio [OR], 0.65; 95% confidence interval [CI], 0.46-0.90; p = .010). This association was attenuated in a stratified analysis based on deciles of aspirin propensity scores (Cochran-Mantel-Haenszel pooled OR, 0.70; 95% CI, 0.48-1.03; p = .072). After adjusting for the propensity to receive aspirin therapy, no statistically significant associations between prehospitalization aspirin therapy and acute lung injury were identified; however, a prospective clinical trial to further evaluate this association appears warranted.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery: A Randomized Controlled Feasibility Trial.

PubMed

Deschamps, Alain; Hall, Richard; Grocott, Hilary; Mazer, C David; Choi, Peter T; Turgeon, Alexis F; de Medicis, Etienne; Bussières, Jean S; Hudson, Christopher; Syed, Summer; Seal, Doug; Herd, Stuart; Lambert, Jean; Denault, André; Deschamps, Alain; Mutch, Alan; Turgeon, Alexis; Denault, Andre; Todd, Andrea; Jerath, Angela; Fayad, Ashraf; Finnegan, Barry; Kent, Blaine; Kennedy, Brent; Cuthbertson, Brian H; Kavanagh, Brian; Warriner, Brian; MacAdams, Charles; Lehmann, Christian; Fudorow, Christine; Hudson, Christopher; McCartney, Colin; McIsaac, Dan; Dubois, Daniel; Campbell, David; Mazer, David; Neilpovitz, David; Rosen, David; Cheng, Davy; Drapeau, Dennis; Dillane, Derek; Tran, Diem; Mckeen, Dolores; Wijeysundera, Duminda; Jacobsohn, Eric; Couture, Etienne; de Medicis, Etienne; Alam, Fahad; Abdallah, Faraj; Ralley, Fiona E; Chung, Frances; Lellouche, Francois; Dobson, Gary; Germain, Genevieve; Djaiani, George; Gilron, Ian; Hare, Gregory; Bryson, Gregory; Clarke, Hance; McDonald, Heather; Roman-Smith, Helen; Grocott, Hilary; Yang, Homer; Douketis, James; Paul, James; Beaubien, Jean; Bussières, Jean; Pridham, Jeremy; Armstrong, J N; Parlow, Joel; Murkin, John; Gamble, Jonathan; Duttchen, Kaylene; Karkouti, Keyvan; Turner, Kim; Baghirzada, Leyla; Szabo, Linda; Lalu, Manoj; Wasowicz, Marcin; Bautista, Michael; Jacka, Michael; Murphy, Michael; Schmidt, Michael; Verret, Michaël; Perrault, Michel-Antoine; Beaudet, Nicolas; Buckley, Norman; Choi, Peter; MacDougall, Peter; Jones, Philip; Drolet, Pierre; Beaulieu, Pierre; Taneja, Ravi; Martin, Rene; Hall, Richard; George, Ronald; Chun, Rosa; McMullen, Sarah; Beattie, Scott; Sampson, Sonia; Choi, Stephen; Kowalski, Stephen; McCluskey, Stuart; Syed, Summer; Boet, Sylvain; Ramsay, Tim; Saha, Tarit; Mutter, Thomas; Chowdhury, Tumul; Uppal, Vishal; Mckay, William

2016-04-01

Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, -294; 95% CI, -562 to -26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

Long-Term Follow-Up of the Edmonton Protocol of Islet Transplantation in the United States.

PubMed

Brennan, D C; Kopetskie, H A; Sayre, P H; Alejandro, R; Cagliero, E; Shapiro, A M J; Goldstein, J S; DesMarais, M R; Booher, S; Bianchine, P J

2016-02-01

We report the long-term follow-up of the efficacy and safety of islet transplantation in seven type 1 diabetic subjects from the United States enrolled in the multicenter international Edmonton Protocol who had persistent islet function after completion of the Edmonton Protocol. Subjects were followed up to 12 years with serial testing for sustained islet allograft function as measured by C-peptide. All seven subjects demonstrated continued islet function longer than a decade from the time of first islet transplantation. One subject remained insulin independent without the need for diabetic medications or supplemental transplants. One subject who was insulin-independent for over 8 years experienced graft failure 10.9 years after the first islet transplant. The remaining six subjects demonstrated continued islet function upon trial completion, although three had received a supplemental islet transplant each. At trial completion, five subjects were receiving insulin and two remained insulin independent, although one was treated with liraglutide. The median hemoglobin A1c was 6.3% (45 mmol/mol). All subjects experienced progressive decline in the C-peptide/glucose ratio. No patients experienced severe hypoglycemia, opportunistic infection, or lymphoma. Thus, although the rate and duration of insulin independence was low, the Edmonton Protocol was safe in the long term. Alternative approaches to islet transplantation are under investigation. © Copyright 2015 The American Society of Transplantation and the American Society of Transplant Surgeons.

Neural Tube Defects and Maternal Folate Intake Among Pregnancies Conceived After Folic Acid Fortification in the United States

PubMed Central

Mosley, Bridget S.; Cleves, Mario A.; Siega-Riz, Anna Maria; Shaw, Gary M.; Canfield, Mark A.; Waller, D. Kim; Werler, Martha M.

2009-01-01

Rates of neural tube defects have decreased since folic acid fortification of the food supply in the United States. The authors’ objective was to evaluate the associations between neural tube defects and maternal folic acid intake among pregnancies conceived after fortification. This is a multicenter, case-control study that uses data from the National Birth Defects Prevention Study, 1998–2003. Logistic regression was used to compute crude and adjusted odds ratios between cases and controls assessing maternal periconceptional use of folic acid and intake of dietary folic acid. Among 180 anencephalic cases, 385 spina bifida cases, and 3, 963 controls, 21.1%, 25.2%, and 26.1%, respectively, reported periconceptional use of folic acid supplements. Periconceptional supplement use did not reduce the risk of having a pregnancy affected by a neural tube defect. Maternal intake of dietary folate was not significantly associated with neural tube defects. In this study conducted among pregnancies conceived after mandatory folic acid fortification, the authors found little evidence of an association between neural tube defects and maternal folic acid intake. A possible explanation is that folic acid fortification reduced the occurrence of folic acid-sensitive neural tube defects. Further investigation is warranted to possibly identify women who remain at increased risk of preventable neural tube defects. PMID:18953063

Renal sympathetic denervation in the treatment of resistant hypertension.

PubMed

Sánchez-Álvarez, Catalina; González-Vélez, Miguel; Stilp, Erik; Ward, Charisse; Mena-Hurtado, Carlos

2014-12-01

Arterial hypertension (HTN) is a major health problem worldwide. Treatment-resistant hypertension (trHTN) is defined as the failure to achieve target blood pressure despite the concomitant use of maximally tolerated doses of three different antihypertensive medications, including a diuretic. trHTN is associated with considerable morbidity and mortality. Renal sympathetic denervation (RDn) is available and implemented abroad as a strategy for the treatment of trHTN and is currently under clinical investigation in the United States. Selective renal sympathectomy via an endovascular approach effectively decreases renal sympathetic nerve hyperactivity leading to a decrease in blood pressure. The Symplicity catheter, currently under investigation in the United States, is a 6-French compatible system advanced under fluoroscopic guidance via percutaneous access of the common femoral artery to the distal lumen of each of the main renal arteries. Radiofrequency (RF) energy is then applied to the endoluminal surface of the renal arteries via an electrode located at the tip of the catheter. Two clinical trials (Symplicity HTN 1 and Symplicity HTN 2) have shown the efficacy of RDn with a post-procedure decline of 27/17 mmHg at 12 months and 32/12 mmHg at 6 months, respectively, with few minor adverse events. Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study currently under way and will provide further insights about the safety and efficacy of renal denervation in patients with trHTN.

Multi-center evaluation of analytical performance of the Beckman Coulter AU5822 chemistry analyzer.

PubMed

Zimmerman, M K; Friesen, L R; Nice, A; Vollmer, P A; Dockery, E A; Rankin, J D; Zmuda, K; Wong, S H

2015-09-01

Our three academic institutions, Indiana University, Northwestern Memorial Hospital, and Wake Forest, were among the first in the United States to implement the Beckman Coulter AU5822 series chemistry analyzers. We undertook this post-hoc multi-center study by merging our data to determine performance characteristics and the impact of methodology changes on analyte measurement. We independently completed performance validation studies including precision, linearity/analytical measurement range, method comparison, and reference range verification. Complete data sets were available from at least one institution for 66 analytes with the following groups: 51 from all three institutions, and 15 from 1 or 2 institutions for a total sample size of 12,064. Precision was similar among institutions. Coefficients of variation (CV) were <10% for 97%. Analytes with CVs >10% included direct bilirubin and digoxin. All analytes exhibited linearity over the analytical measurement range. Method comparison data showed slopes between 0.900-1.100 for 87.9% of the analytes. Slopes for amylase, tobramycin and urine amylase were <0.8; the slope for lipase was >1.5, due to known methodology or standardization differences. Consequently, reference ranges of amylase, urine amylase and lipase required only minor or no modification. The four AU5822 analyzers independently evaluated at three sites showed consistent precision, linearity, and correlation results. Since installations, the test results had been well received by clinicians from all three institutions. Copyright © 2015. Published by Elsevier Inc.

"They're younger… it's harder." Primary providers' perspectives on hypertension management in young adults: a multicenter qualitative study.

PubMed

Johnson, Heather M; Warner, Ryan C; Bartels, Christie M; LaMantia, Jamie N

2017-01-03

Young adults (18-39 year-olds) have the lowest hypertension control rates among adults with hypertension in the United States. Unique barriers to hypertension management in young adults with primary care access compared to older adults have not been evaluated. Understanding these differences will inform the development of hypertension interventions tailored to young adults. The goals of this multicenter study were to explore primary care providers' perspectives on barriers to diagnosing, treating, and controlling hypertension among young adults with regular primary care. Primary care providers (physicians and advanced practice providers) actively managing young adults with uncontrolled hypertension were recruited by the Wisconsin Research & Education Network (WREN), a statewide practice-based research network. Semi-structured qualitative interviews were conducted in three diverse Midwestern clinical practices (academic, rural, and urban clinics) using a semi-structured interview guide, and content analysis was performed. Primary care providers identified unique barriers across standard hypertension healthcare delivery practices for young adults. Altered self-identity, greater blood pressure variability, and unintended consequences of medication initiation were critical hypertension control barriers among young adults. Gender differences among young adults were also noted as barriers to hypertension follow-up and antihypertensive medication initiation. Tailored interventions addressing the unique barriers of young adults are needed to improve population hypertension control. Augmenting traditional clinic structure to support the "health identity" of young adults and self-management skills are promising next steps to improve hypertension healthcare delivery.

Counseling to reduce high-risk sexual behavior in HIV care: a multi-center, direct observation study.

PubMed

Flickinger, Tabor E; Berry, Stephen; Korthuis, P Todd; Saha, Somnath; Laws, M Barton; Sharp, Victoria; Moore, Richard D; Beach, Mary Catherine

2013-07-01

A key opportunity to reduce HIV transmission lies with healthcare providers counseling HIV-infected patients about safer sex. We audio-recorded and transcribed clinical encounters between 45 healthcare providers and 417 of their HIV-infected patients at four outpatient sites in the United States. We used logistic regressions to evaluate associations between patient and provider characteristics, and the occurrence of discussion (any talk about sex) and counseling (advice about safer sex). Of the 417 encounters, discussion of sex occurred in 187 (45% of encounters, 95% CI: 40-50%). Counseling occurred for 49% (95% CI: 35-63%) of patients reporting unsafe sex. Discussion of sex was more likely with younger or less-educated patients and with less cultural difference between patient and provider, while counseling was associated with greater provider mindfulness and lower provider empathy. These findings suggest targets to improve communication regarding sexual risk reduction in HIV care.

Zoster vaccine live for the prevention of shingles in the elderly patient

PubMed Central

Zussman, Jamie; Young, Lorraine

2008-01-01

Shingles, also known as herpes zoster, is a common disease in the elderly population that is caused by reactivation of latent varicella zoster virus. Its manifestations and complications can lead to significant short- and long-term morbidity. In 2006, the United States Food and Drug Administration approved Zoster Vaccine Live (Zostavax®) for the prevention of herpes zoster in immunocompetent adults age 60 and over. The approval was based on the results of a large, multi-center clinical trial, the Shingles Prevention Study. This study showed that vaccination significantly decreased shingles incidence, burden of illness due to disease, and the development of, and severity of postherpetic neuralgia. This review offers an overview of varicella zoster virus infection and complications, a summary of the Shingles Prevention Study, and a critical analysis designed to aid the practicing physician who has questions about vaccine administration. PMID:18686747

Implementation of clinical practice guidelines for ventilator-associated pneumonia: a multicenter prospective study.

PubMed

Sinuff, Tasnim; Muscedere, John; Cook, Deborah J; Dodek, Peter M; Anderson, William; Keenan, Sean P; Wood, Gordon; Tan, Richard; Haupt, Marilyn T; Miletin, Michael; Bouali, Redouane; Jiang, Xuran; Day, Andrew G; Overvelde, Janet; Heyland, Daren K

2013-01-01

Ventilator-associated pneumonia is an important cause of morbidity and mortality in critically ill patients. Evidence-based clinical practice guidelines for the prevention, diagnosis, and treatment of ventilator-associated pneumonia may improve outcomes, but optimal methods to ensure implementation of guidelines in the intensive care unit are unclear. Hence, we determined the effect of educational sessions augmented with reminders, and led by local opinion leaders, as strategies to implement evidence-based ventilator-associated pneumonia guidelines on guideline concordance and ventilator-associated pneumonia rates. Two-year prospective, multicenter, time-series study conducted between June 2007 and December 2009. Eleven ICUs (ten in Canada, one in the United States); five academic and six community ICUs. At each site, 30 adult patients mechanically ventilated >48 hrs were enrolled during four data collection periods (baseline, 6, 15, and 24 months). Guideline recommendations for the prevention, diagnosis, and treatment of ventilator-associated pneumonia were implemented using a multifaceted intervention (education, reminders, local opinion leaders, and implementation teams) directed toward the entire multidisciplinary ICU team. Clinician exposure to the intervention was assessed at 6, 15, and 24 months after the introduction of this intervention. The main outcome measure was aggregate concordance with the 14 ventilator-associated pneumonia guideline recommendations. One thousand three hundred twenty patients were enrolled (330 in each study period). Clinician exposure to the multifaceted intervention was high and increased during the study: 86.7%, 93.3%, 95.8%, (p < .001), as did aggregate concordance (mean [SD]): 50.7% (6.1), 54.4% (7.1), 56.2% (5.9), 58.7% (6.7) (p = .007). Over the study period, ventilator-associated pneumonia rates decreased (events/330 patients): 47 (14.2%), 34 (10.3%), 38 (11.5%), 29 (8.8%) (p = .03). A 2-yr multifaceted intervention to enhance ventilator-associated pneumonia guideline uptake was associated with a significant increase in guideline concordance and a reduction in ventilator-associated pneumonia rates.

Immunogenicity and safety of a second booster dose of an acellular pertussis vaccine combined with reduced antigen content diphtheria-tetanus toxoids 10 years after a first booster in adolescence: An open, phase III, non-randomized, multi-center study.

PubMed

Kovac, Martina; Kostanyan, Lusiné; Mesaros, Narcisa; Kuriyakose, Sherine; Varman, Meera

2018-04-09

Pertussis is a highly contagious disease, for which periodic peaks in incidence and an increasing number of outbreaks have been observed over the last decades. The reduced-antigen-content tetanus-diphtheria-acellular pertussis vaccine (Tdap) can be used to boost individuals aged ≥10 years, vaccinated in infancy with a diphtheria-tetanus-acellular pertussis vaccine (DTaP), to reduce pertussis morbidity and maintain protection against diphtheria and tetanus throughout adolescence and adulthood. This phase III, open-label, non-randomized, multicenter follow-up study (NCT01738477) enrolled 19-30-year-old participants from the United States who had received booster vaccination 10 years earlier with either Tdap (Tdap group) or Td (Td group). In total, 128 (Tdap group) and 37 (Td group) participants received Tdap vaccination. After administration of Tdap, all participants were seroprotected (antibody concentrations ≥0.1 international units [IU]/ml) against diphtheria and tetanus. Immune responses to a second Tdap dose in the Tdap group were shown to be non-inferior to responses elicited by a first Tdap dose in the Td group for diphtheria and tetanus and to a 3-dose DTaP vaccination during infancy for pertussis antigens (primary objectives). Post-booster vaccination, all participants in both groups had antibody concentrations above assay cut-offs and antibody geometric mean concentrations increased by 3.8-15.5-fold compared to pre-booster levels for all antigens. The incidence of adverse events was similar in the Td (80.6%) and Tdap (85.6%) groups (no serious adverse events reported). A Tdap dose administered after previous Td or Tdap vaccination was shown to be immunogenic and well-tolerated in young adults, supporting repeated vaccination with Tdap at 10-year intervals.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Bena, Iosif; Bobev, Nikolay; Warner, Nicholas P.

We discuss 'spectral-flow' coordinate transformations that take asymptotically four-dimensional solutions into other asymptotically four-dimensional solutions. We find that spectral flow can relate smooth three-charge solutions with a multicenter Taub-NUT base to solutions where one or several Taub-NUT centers are replaced by two-charge supertubes, and vice versa. We further show that multiparameter spectral flows can map such Taub-NUT centers to more singular centers that are either D2-D0 or pure D0-brane sources. Since supertubes can depend on arbitrary functions, we establish that the moduli space of smooth horizonless black-hole microstate solutions is classically of infinite dimension. We also use the physics ofmore » supertubes to argue that some multicenter solutions that appear to be bound states from a four-dimensional perspective are in fact not bound states when considered from a five- or six-dimensional perspective.« less

Retreatment With Varenicline for Smoking Cessation in Smokers Who Have Previously Taken Varenicline: A Randomized, Placebo-Controlled Trial

PubMed Central

Gonzales, D; Hajek, P; Pliamm, L; Nackaerts, K; Tseng, L-J; McRae, T D; Treadow, J

2014-01-01

The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥10 cigarettes/day) with ≥1 prior quit attempt (≥2 weeks) using varenicline and no quit attempts in ≤3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide–confirmed (≤10 ppm) continuous abstinence rate for weeks 9–12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers. PMID:24911368

Early rehabilitation for severe acquired brain injury in intensive care unit: multicenter observational study.

PubMed

Bartolo, Michelangelo; Bargellesi, Stefano; Castioni, Carlo A; Bonaiuti, Donatella; Antenucci, Roberto; Benedetti, Angelo; Capuzzo, Valeria; Gamna, Federica; Radeschi, Giulio; Citerio, Giuseppe; Colombo, Carolina; Del Casale, Laura; Recubini, Elena; Toska, Saimir; Zanello, Marco; D'Aurizio, Carlo; Spina, Tullio; Del Gaudio, Alredo; Di Rienzo, Filomena; Intiso, Domenico; Dallocchio, Giulia; Felisatti, Giovanna; Lavezzi, Susanna; Zoppellari, Roberto; Gariboldi, Valentina; Lorini, Luca; Melizza, Giovanni; Molinero, Guido; Mandalà, Giorgio; Pignataro, Amedeo; Montis, Andrea; Napoleone, Alessandro; Pilia, Felicita; Pisu, Marina; Semerjian, Monica; Pagliaro, Giuseppina; Nardin, Lorella; Scarponi, Federico; Zampolini, Mauro; Zava, Raffaele; Massetti, Maria A; Piccolini, Carlo; Aloj, Fulvio; Antonelli, Sergio; Zucchella, Chiara

2016-02-01

The increased survival after a severe acquired brain injury (sABI) raise the problem of making most effective the treatments in Intensive Care Unit (ICU)/Neurointensive Care Unit (NICU), also integrating rehabilitation care. Despite previous studies reported that early mobilization in ICU was effective in preventing complications and reducing hospital stay, few studies addressed the rehabilitative management of sABI patients in ICU/NICU. To collect clinical and functional data about the early rehabilitative management of sABI patients during ICU/NICU stay. Prospective, observational, multicenter study. Fourteen facilities supplied by intensive neurorehabilitation units and ICU/NICUs. Consecutive sABI patients admitted to ICU/NICU. Patients were evaluated at admission and then every 3-5 days. Clinical, functional and rehabilitative data, including Glasgow Coma Scale (GCS), Disability Rating Scale (DRS), The Rancho Los Amigos Levels of Cognitive Functioning Scale (LCF), Early Rehabilitation Barthel Index (ERBI), Glasgow Outcome scale (GOS) and Functional Independence Measure (FIM) were collected. One hundred and two patients (F/M 44/58) were enrolled. The mean duration of ICU stay was 24.7±13.9 days and the first rehabilitative evaluation occurred after 8.7±8.8 days. Regular postural changes and multijoint mobilization were prescribed in 63.7% and 64.7% cases, respectively. The mean session duration was 38±11.5 minutes. Swallowing evaluation was performed in 14.7% patients, psychological support was provided to 12.7% of patients' caregivers, while 17.6% received a psycho-educational intervention, and 28.4% were involved in interdisciplinary team meetings. The main discharge destinations were Severe Acquired Brain Injury rehabilitation units for 43.7%, intensive neurorehabilitation units for 20.7%. Data showed that early rehabilitation was not diffusely performed in sABI subjects in ICU/NICU and rehabilitative interventions were variable; one-third of subjects were not referred to dedicated rehabilitation unit at discharge. The study stresses the need to spread and implement a rehabilitative culture also for critical ill patients due to neurological diseases.

Impact of case volume on survival of septic shock in patients with malignancies.

PubMed

Zuber, Benjamin; Tran, Thi-Chien; Aegerter, Philippe; Grimaldi, David; Charpentier, Julien; Guidet, Bertrand; Mira, Jean-Paul; Pène, Frédéric

2012-01-01

Septic shock is a frequent and severe complication in the course of malignancies. In a large multicenter cohort of septic shock patients with hematologic malignancies and solid tumors, we assessed the temporal trend in survival and the prognostic factors, with particular emphasis on case volume. A 12-yr multicenter retrospective cohort study of prospectively collected data. Cancer patients with septic shock were selected over a 12-yr period (1997-2008) from a French regional database (CUB-Réa). The following variables were extracted: demographic characteristics, type of malignancy, characteristics of infection, severity-of-illness score (Simplified Acute Physiology Score II), organ failure supports, and vital status. For each unit, a running mean annual volume of admissions was calculated for the purpose of categorization into volume tertiles. Prognostic factors were analyzed by a conditional multivariate logistic model after matching on a propensity score of being admitted to a high-volume unit and on the year of admission. None. A total of 3,437 patients were included in the study. The intensive care unit mortality rate dramatically dropped over time (from 70.4% in 1997 to 52.5% in 2008, relative decrease 25.4%, p < .001). Participating units were distributed into low-volume (< five patients per year), medium-volume (five to 12 patients per year), and high-volume (≥ 13 patients per year) tertiles. A medical cause for intensive care unit admission, Simplified Acute Physiology Score II, invasive mechanical ventilation, renal replacement therapy, fungal infections, and unknown microorganism were identified as poor prognostic factors. Case volume demonstrated a strong influence on survival, admission in a high-volume unit being associated with a marked decrease in mortality as compared to low-volume units (adjusted odds ratio 0.63; 95% confidence interval [0.46-0.87], p = .002). Survival of septic shock patients with malignancies markedly increased over the recent years. Furthermore, we identified case volume as a major prognostic factor in this setting.

Measurement and Evaluation of Quantitative Performance of PET/CT Images before a Multicenter Clinical Trial.

PubMed

Zhu, Yanjia; Geng, Caizheng; Huang, Jia; Liu, Juzhen; Wu, Ning; Xin, Jun; Xu, Hao; Yu, Lijuan; Geng, Jianhua

2018-06-13

To ensure the reliability of the planned multi-center clinical trial, we assessed the consistence and comparability of the quantitative parameters of the eight PET/CT units that will be used in this trial. PET/CT images were scanned using a PET NEMA image quality phantom (Biodex) on the eight units of Discovery PET/CT 690 from GE Healthcare. The scanning parameters were the same with the ones to be used in the planned trial. The 18 F-NaF concentration in the background was 5.3 kBq/ml, while the ones in the spheres of diameter 37 mm, 22 mm, 17 mm and 10 mm were 8:1 as to that of the background and the ones in the spheres of diameter 28 mm and 13 mm were 0 kBq/ml. The consistency of hot sphere recovery coefficient (HRC), cold sphere recovery coefficient (CRC), hot sphere contrast (Q H ) and cold sphere contrast (Q c ) among these 8 PET/CTs was analyzed. The variation of the main quantitative parameters of the eight PET/CT systems was within 10%, which is acceptable for the clinical trial.

Study Design and Rationale of "A Multicenter, Open-Labeled, Randomized Controlled Trial Comparing MIdazolam Versus MOrphine in Acute Pulmonary Edema": MIMO Trial.

PubMed

Dominguez-Rodriguez, Alberto; Burillo-Putze, Guillermo; Garcia-Saiz, Maria Del Mar; Aldea-Perona, Ana; Harmand, Magali González-Colaço; Mirò, Oscar; Abreu-Gonzalez, Pedro

2017-04-01

Morphine has been used for several decades in cases of acute pulmonary edema (APE) due to the anxiolytic and vasodilatory properties of the drug. The non-specific depression of the central nervous system is probably the most significant factor for the changes in hemodynamics in APE. Retrospective studies have shown both negative and neutral effects in patients with APE and therefore some authors have suggested benzodiazepines as an alternative treatment. The use of intravenous morphine in the treatment of APE remains controversial. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE. The MIMO trial will evaluate as a primary endpoint whether intravenous morphine administration improves clinical outcomes defined as in-hospital mortality. Secondary endpoint evaluation will be mechanical ventilation, cardiopulmonary resuscitation, intensive care unit admission rate, intensive care unit length of stay, and hospitalization length. In the emergency department, morphine is still used for APE in spite of poor scientific background data. The data from the MIMO trial will establish the effect-and especially the risk-when using morphine for APE.

Early Enteral Nutrition in Burns: Compliance With Guidelines and Associated Outcomes in a Multicenter Study

PubMed Central

Mosier, Michael J.; Pham, Tam N.; Klein, Matthew B.; Gibran, Nicole S.; Arnoldo, Brett D.; Gamelli, Richard L.; Tompkins, Ronald G.; Herndon, David N.

2013-01-01

Early nutritional support is an essential component of burn care to prevent ileus, stress ulceration, and the effects of hypermetabolism. The American Burn Association practice guidelines state that enteral feedings should be initiated as soon as practical. The authors sought to evaluate compliance with early enteral nutrition (EN) guidelines, associated complications, and hospitalization outcomes in a prospective multicenter observational study. They conducted a retrospective review of mechanically ventilated burn patients enrolled in the prospective observational multicenter study “Inflammation and the Host Response to Injury.” Timing of initiation of tube feedings was recorded, with early EN defined as being started within 24 hours of admission. Univariate and multivariate analyses were performed to distinguish barriers to initiation of EN and the impact of early feeding on development of multiple organ dysfunction syndrome, infectious complications, days on mechanical ventilation, intensive care unit (ICU) length of stay, and survival. A total of 153 patients met study inclusion criteria. The cohort comprised 73% men, with a mean age of 41 ± 15 years and a mean %TBSA burn of 46 ± 18%. One hundred twenty-three patients (80%) began EN in the first 24 hours and 145 (95%) by 48 hours. Age, sex, inhalation injury, and full-thickness burn size were similar between those fed by 24 hours vs after 24 hours, except for higher mean Acute Physiology and Chronic Health Evaluation II scores (26 vs 23, P = .03) and smaller total burn size (44 vs 54% TBSA burn, P = .01) in those fed early. There was no significant difference in rates of hyperglycemia, abdominal compartment syndrome, or gastrointestinal bleeding between groups. Patients fed early had shorter ICU length of stay (adjusted hazard ratio 0.57, P = 0.03, 95% confidence interval 0.35–0.94) and reduced wound infection risk (adjusted odds ratio 0.28, P = 0.01, 95% confidence interval 0.10–0.76). The investigators have found early EN to be safe, with no increase in complications and a lower rate of wound infections and shorter ICU length of stay. Across institutions, there has been high compliance with early EN as part of the standard operating procedure in this prospective multicenter observational trial. The investigators advocate that initiation of EN by 24 hours be used as a formal recommendation in nutrition guidelines for severe burns, and that nutrition guidelines be actively disseminated to individual burn centers to permit a change in practice. PMID:21116188

Prematurity and respiratory outcomes program (PROP): study protocol of a prospective multicenter study of respiratory outcomes of preterm infants in the United States.

PubMed

Pryhuber, Gloria S; Maitre, Nathalie L; Ballard, Roberta A; Cifelli, Denise; Davis, Stephanie D; Ellenberg, Jonas H; Greenberg, James M; Kemp, James; Mariani, Thomas J; Panitch, Howard; Ren, Clement; Shaw, Pamela; Taussig, Lynn M; Hamvas, Aaron

2015-04-10

With improved survival rates, short- and long-term respiratory complications of premature birth are increasing, adding significantly to financial and health burdens in the United States. In response, in May 2010, the National Institutes of Health (NIH) and the National Heart, Lung, and Blood Institute (NHLBI) funded a 5-year $18.5 million research initiative to ultimately improve strategies for managing the respiratory complications of preterm and low birth weight infants. Using a collaborative, multi-disciplinary structure, the resulting Prematurity and Respiratory Outcomes Program (PROP) seeks to understand factors that correlate with future risk for respiratory morbidity. The PROP is an observational prospective cohort study performed by a consortium of six clinical centers (incorporating tertiary neonatal intensive care units [NICU] at 13 sites) and a data-coordinating center working in collaboration with the NHLBI. Each clinical center contributes subjects to the study, enrolling infants with gestational ages 23 0/7 to 28 6/7 weeks with an anticipated target of 750 survivors at 36 weeks post-menstrual age. In addition, each center brings specific areas of scientific focus to the Program. The primary study hypothesis is that in survivors of extreme prematurity specific biologic, physiologic and clinical data predicts respiratory morbidity between discharge and 1 year corrected age. Analytic statistical methodology includes model-based and non-model-based analyses, descriptive analyses and generalized linear mixed models. PROP incorporates aspects of NICU care to develop objective biomarkers and outcome measures of respiratory morbidity in the <29 week gestation population beyond just the NICU hospitalization, thereby leading to novel understanding of the nature and natural history of neonatal lung disease and of potential mechanistic and therapeutic targets in at-risk subjects. Clinical Trials.gov NCT01435187.

Effect of Armodafinil on Cortical Activity and Working Memory in Patients with Residual Excessive Sleepiness Associated with CPAP-Treated OSA: A Multicenter fMRI Study

PubMed Central

Greve, Douglas N.; Duntley, Stephen P.; Larson-Prior, Linda; Krystal, Andrew D.; Diaz, Michele T.; Drummond, Sean P. A.; Thein, Stephen G.; Kushida, Clete A.; Yang, Ronghua; Thomas, Robert J.

2014-01-01

Study Objective: To assess the effect of armodafinil on task-related prefrontal cortex activation using functional magnetic resonance imaging (fMRI) in patients with obstructive sleep apnea (OSA) and excessive sleepiness despite continuous positive airway pressure (CPAP) therapy. Methods: This 2-week, multicenter, prospective, randomized, double-blind, placebo-controlled, parallel-group study was conducted at five neuroimaging sites and four collaborating clinical study centers in the United States. Patients were 40 right-handed or ambidextrous men and women aged between 18 and 60 years, with OSA and persistent sleepiness, as determined by multiple sleep latency and Epworth Sleepiness Scale scores, despite effective, stable use of CPAP. Treatment was randomized (1:1) to once-daily armodafinil 200 mg or placebo. The primary efficacy outcome was a change from baseline at week 2 in the volume of activation meeting the predefined threshold in the dorsolateral prefrontal cortex during a 2-back working memory task. The key secondary measure was the change in task response latency. Results: No significant differences were observed between treatment groups in the primary or key secondary outcomes. Armodafinil was generally well tolerated. The most common adverse events (occurring in more than one patient [5%]) were headache (19%), nasopharyngitis (14%), and diarrhea (10%). Conclusions: Armodafinil did not improve fMRI-measured functional brain activation in CPAP-treated patients with OSA and excessive sleepiness. Study Registration: Double-Blind, Placebo-Controlled, Functional Neuroimaging Study of Armodafinil (200 mg/Day) on Prefrontal Cortical Activation in Patients With Residual Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea. ClinicalTrials.gov Identifier: NCT00711516. http://www.clinicaltrials.gov/ct2/show/study/NCT00711516 Citation: Greve DN; Duntley SP; Larson-Prior L; Krystal AD; Diaz MT; Drummond SP; Thein SG; Kushida CA; Yang R; Thomas RJ. Effect of armodafinil on cortical activity and working memory in patients with residual excessive sleepiness associated with CPAP-treated OSA: a multicenter fMRI study. J Clin Sleep Med 2014;10(2):143-153. PMID:24532997

Universal Screening for Intimate Partner and Sexual Violence in Trauma Patients - What About the Men? An EAST Multicenter Trial.

PubMed

Zakrison, Tanya L; Rattan, Rishi; Milian Valdés, Davel; Ruiz, Xiomara; Gelbard, Rondi; Cline, John; Turay, David; Luo-Owen, Xian; Namias, Nicholas; George, Jessica; Yeh, Dante; Pust, Daniel; Williams, Brian H

2018-02-14

A recent EAST-supported, multicenter trial demonstrated a similar rate of intimate partner and sexual violence (IPSV) between male and female trauma patients, regardless of mechanism. Our objective was to perform a subgroup analysis of our affected male cohort as this remains an understudied group in the trauma literature. We conducted a recent EAST-supported, cross-sectional, multicenter trial over one year (03/15-04/16) involving four Level I trauma centers throughout the United States. We performed universal screening of adult trauma patients using the validated HITS (Hurt, Insult, Threaten, Scream) and SAVE (sexual violence) screening surveys. Risk factors for male patients were identified. Chi-squared test compared categorical variables with significance at p<0.05. Parametric data is presented as mean +/-standard deviation. A total of 2,034 trauma patients were screened, of which 1,281 (63%) were men. Of this cohort, 119 men (9.3%) screened positive for intimate partner violence, 14.1% for IPSV and 6.5% for sexual violence. On categorical analysis of the HITS screen, the proportion of men that were physically hurt was 4.8% compared to 4.3% for women (p = 0.896). A total of 4.8% of men screened positive for both intimate partner and sexual violence. The total proportion of men who presented with any history of intimate partner violence, sexual violence or both (IPSV) was 15.8%. More men affected by penetrating trauma screened positive for IPSV (p < 0.00001). IPSV positivity in men was associated with mental illness, substance abuse, and trauma recidivism. One out of every twenty men that present to trauma centers is a survivor of both intimate partner and sexual violence, with one out of every six men experiencing some form of violence. Men are at similar risk for physical abuse as women when this intimate partner violence occurs. IPSV is associated with penetrating trauma in men. Support programs for this population may potentially impact associated mental illness, substance abuse, trauma recidivism and even societal-level violence. III STUDY TYPE: Diagnostic.

Renal Sympathetic Denervation in the Treatment of Resistant Hypertension

PubMed Central

Sánchez-Álvarez, Catalina; González-Vélez, Miguel; Stilp, Erik; Ward, Charisse; Mena-Hurtado, Carlos

2014-01-01

Arterial hypertension (HTN) is a major health problem worldwide. Treatment-resistant hypertension (trHTN) is defined as the failure to achieve target blood pressure despite the concomitant use of maximally tolerated doses of three different antihypertensive medications, including a diuretic. trHTN is associated with considerable morbidity and mortality. Renal sympathetic denervation (RDn) is available and implemented abroad as a strategy for the treatment of trHTN and is currently under clinical investigation in the United States. Selective renal sympathectomy via an endovascular approach effectively decreases renal sympathetic nerve hyperactivity leading to a decrease in blood pressure. The Symplicity catheter, currently under investigation in the United States, is a 6-French compatible system advanced under fluoroscopic guidance via percutaneous access of the common femoral artery to the distal lumen of each of the main renal arteries. Radiofrequency (RF) energy is then applied to the endoluminal surface of the renal arteries via an electrode located at the tip of the catheter. Two clinical trials (Symplicity HTN 1 and Symplicity HTN 2) have shown the efficacy of RDn with a post-procedure decline of 27/17mmHg at 12 months and 32/12 mmHg at 6 months, respectively, with few minor adverse events. Symplicity HTN-3 study is a, multi-center, prospective, single-blind, randomized, controlled study currently under way and will provide further insights about the safety and efficacy of renal denervation in patients with trHTN. PMID:25506285

Cross-sectional multicenter study of patients with urea cycle disorders in the United States.

PubMed

Tuchman, Mendel; Lee, Brendan; Lichter-Konecki, Uta; Summar, Marshall L; Yudkoff, Marc; Cederbaum, Stephen D; Kerr, Douglas S; Diaz, George A; Seashore, Margaretta R; Lee, Hye-Seung; McCarter, Robert J; Krischer, Jeffrey P; Batshaw, Mark L

2008-08-01

Inherited urea cycle disorders comprise eight disorders (UCD), each caused by a deficiency of one of the proteins that is essential for ureagenesis. We report on a cross-sectional investigation to determine clinical and laboratory characteristics of patients with UCD in the United States. The data used for the analysis was collected at the time of enrollment of individuals with inherited UCD into a longitudinal observation study. The study has been conducted by the Urea Cycle Disorders Consortium within the Rare Diseases Clinical Research Network (RDCRN) funded by the National Institutes of Health. One-hundred eighty-three patients were enrolled into the study. Ornithine transcarbamylase (OTC) deficiency was the most frequent disorder (55%), followed by argininosuccinic aciduria (16%) and citrullinemia (14%). Seventy-nine percent of the participants were white (16% Latinos), and 6% were African American. Intellectual and developmental disabilities were reported in 39% with learning disabilities (35%) and half had abnormal neurological examination. Sixty-three percent were on a protein restricted diet, 37% were on Na-phenylbutyrate and 5% were on Na-benzoate. Forty-five percent of OTC deficient patients were on L-citrulline, while most patients with citrullinemia (58%) and argininosuccinic aciduria (79%) were on L-arginine. Plasma levels of branched-chain amino acids were reduced in patients treated with ammonia scavenger drugs. Plasma glutamine levels were higher in proximal UCD and in neonatal type disease. The RDCRN allows comprehensive analyses of rare inherited UCD, their frequencies and current medical practices.

Cross-Sectional Multi-Center Study of Patients with Urea Cycle Disorders in the United States

PubMed Central

Tuchman, Mendel; Lee, Brendan; Lichter-Konecki, Uta; Summar, Marshall L.; Yudkoff, Marc; Cederbaum, Stephen D.; Kerr, Douglas S.; Diaz, George A.; Seashore, Margaretta R.; Lee, Hye-Seung; McCarter, Robert J.; Krischer, Jeffrey P.; Batshaw, Mark L.

2008-01-01

Inherited urea cycle disorders comprise eight disorders (UCD), each caused by a deficiency of one of the protein that is essential for ureagenesis. We report on a cross sectional investigation to determine clinical and laboratory characteristics of patients with UCD in the United States. The data used for the analysis was collected at the time of enrollment of individuals with inherited UCD into a longitudinal observation study. The study has been conducted by the Urea Cycle Disorders Consortium (UCDC) within the Rare Diseases Clinical Research Network (RDCRN) funded by the National Institutes of Health. One hundred eighty three patients were enrolled into the study. Ornithine transcarbamylase (OTC) deficiency was the most frequent disorder (55%), followed by argininosuccinic aciduria (17%) and citrullinemia (11%). 79% of the participants were white (16% Latinos), and 6% were African American. Intellectual and developmental disabilities were reported in 39% with learning disabilities (35%) and half had abnormal neurological examination. 63% were on a protein restricted diet, 37% were on Na-phenylbutyrate and 5% were on Na-benzoate. 45% of OTC deficient patients were on L-citrulline, while most patients with citrullinemia (58%) and argininosuccinic (79%) were on L-arginine. Plasma levels of branched-chain amino acids were reduced in patients treated with ammonia scavenger drugs. Plasma glutamine levels were higher in proximal UCD disorders and in the neonatal type disease. The RDCRN allows comprehensive analyses of rare inherited UCD, their frequencies and current medical practices. PMID:18562231

The practical problem of improving quality in multicenter dialysis facilities.

PubMed

Balter, Paul

2003-01-01

Multifacility dialysis groups are frequently interested in improving overall quality and find that there are major differences between individual units. Upper management must consider what strategy is needed for the whole company and what strategy must be formulated by individual facilities. To make substantive changes, management must decide to adopt a new culture of true teamwork, drive out fear, and emphasize leadership and education both at the management level and in the individual unit. Both at the corporate and unit levels, leaders must be chosen who are able to recognize people who have the ability, the educational background, the enthusiasm, and the time to direct change. Empowering the individual units and individual employees to make changes and be enthusiastic about improvement is the key to success.

A Multi-center Milestone Study of Clinical Vertebral CT Segmentation

PubMed Central

Yao, Jianhua; Burns, Joseph E.; Forsberg, Daniel; Seitel, Alexander; Rasoulian, Abtin; Abolmaesumi, Purang; Hammernik, Kerstin; Urschler, Martin; Ibragimov, Bulat; Korez, Robert; Vrtovec, Tomaž; Castro-Mateos, Isaac; Pozo, Jose M.; Frangi, Alejandro F.; Summers, Ronald M.; Li, Shuo

2017-01-01

A multiple center milestone study of clinical vertebra segmentation is presented in this paper. Vertebra segmentation is a fundamental step for spinal image analysis and intervention. The first half of the study was conducted in the spine segmentation challenge in 2014 International Conference on Medical Image Computing and Computer Assisted Intervention (MICCAI) Workshop on Computational Spine Imaging (CSI 2014). The objective was to evaluate the performance of several state-of-the-art vertebra segmentation algorithms on computed tomography (CT) scans using ten training and five testing dataset, all healthy cases; the second half of the study was conducted after the challenge, where additional 5 abnormal cases are used for testing to evaluate the performance under abnormal cases. Dice coefficients and absolute surface distances were used as evaluation metrics. Segmentation of each vertebra as a single geometric unit, as well as separate segmentation of vertebra substructures, was evaluated. Five teams participated in the comparative study. The top performers in the study achieved Dice coefficient of 0.93 in the upper thoracic, 0.95 in the lower thoracic and 0.96 in the lumbar spine for healthy cases, and 0.88 in the upper thoracic, 0.89 in the lower thoracic and 0.92 in the lumbar spine for osteoporotic and fractured cases. The strengths and weaknesses of each method as well as future suggestion for improvement are discussed. This is the first multi-center comparative study for vertebra segmentation methods, which will provide an up-to-date performance milestone for the fast growing spinal image analysis and intervention. PMID:26878138

A Multicenter Analysis of Factors Associated With Apixaban-Related Bleeding in Hospitalized Patients With End-Stage Renal Disease on Hemodialysis.

PubMed

Steuber, Taylor D; Shiltz, Dane L; Cairns, Alex C; Ding, Qian; Binger, Katie J; Courtney, Julia R

2017-11-01

In 2014, the United States Food and Drug Administration approved a labeling change for apixaban to include recommendations for patients with severe renal impairment and patients with end-stage renal disease (ESRD) on hemodialysis (HD), though these recommendations are largely based on pharmacokinetic and pharmacodynamic data. Identify variables associated with bleeding events in hospitalized patients with ESRD on HD receiving apixaban. This retrospective, multicenter cohort study evaluated hospitalized patients with ESRD on HD receiving apixaban from January 1, 2013, through March 31, 2016. Correlational analysis and logistic regression were completed to identify factors associated with bleeding. A total of 114 adults were included in the analysis. The median length of stay (LOS) was 6.2 (interquartile range = 3.8-11.9) days and bleeding events occurred in a total of 17 patients (15%). A weak correlation was identified for higher cumulative apixaban exposure, increased number of HD sessions while receiving apixaban, and increased hospital LOS ( P < 0.05; correlation coefficient < 0.40). When controlling for confounders, logistic regression revealed that composite bleeding events were independently increased by continuation of outpatient apixaban (odds ratio = 13.07; 95% CI = 1.54-110.54; P = 0.018), increased total daily dose of apixaban (odds ratio = 1.72; 95% CI = 1.20 to 2.48; P = 0.003), and total HD sessions while receiving apixaban (odds ratio = 2.04; 95% CI = 1.06-3.92; P = 0.033). The association between these factors and increased bleeding should prompt concern for long-term anticoagulation with apixaban in patients with ESRD receiving chronic HD.

Retrograde CTO-PCI of Native Coronary Arteries Via Left Internal Mammary Artery Grafts: Insights From a Multicenter U.S. Registry.

PubMed

Tajti, Peter; Karatasakis, Aris; Karmpaliotis, Dimitri; Alaswad, Khaldoon; Jaffer, Farouc A; Yeh, Robert W; Patel, Mitul; Mahmud, Ehtisham; Choi, James W; Doing, Anthony H; Toma, Catalin; Uretsky, Barry; Garcia, Santiago; Moses, Jeffrey W; Parikh, Manish; Kirtane, Ajay; Ali, Ziad A; Hatem, Raja; Karacsonyi, Judit; Danek, Barbara A; Rangan, Bavana V; Banerjee, Subhash; Ungi, Imre; Brilakis, Emmanouil S

2018-03-01

Retrograde percutaneous coronary intervention (PCI) of native coronary artery chronic total occlusion (CTO) via left internal mammary artery (LIMA) graft has received limited study. We compared the clinical and procedural characteristics and outcomes of retrograde CTO-PCI through LIMA grafts vs other conduits in a contemporary multicenter CTO registry. The LIMA was used as the collateral channel in 20 of 990 retrograde CTO-PCIs (2.02%) performed at 18 United States centers. The mean age of the study patients was 69 ± 7 years and 95% were men. The most common CTO target vessel was the right coronary artery (55%). The mean J-CTO score in the LIMA group was high (3.45 ± 0.76). The technical success rates were 70% for retrograde PCI via LIMA graft vs 81.05% for retrograde via other conduits (P=.25), while procedural success rates were 70% for retrograde PCI via LIMA graft and 78.19% for retrograde via other conduits (P=.41). The incidence of major in-hospital complications was also similar between the LIMA and non-LIMA retrograde groups (5% vs 6%; P>.99). Use of guide-catheter extensions (40% vs 28%; P=.22), intravascular ultrasound (45% vs 31%; P=.20), and left ventricular assist devices (24% vs 10%; P=.08) was numerically higher in retrograde CTO-PCIs via LIMA grafts. Retrograde CTO-PCI is infrequently performed via LIMA grafts and is associated with similar success and major in-hospital complication rates as retrograde CTO-PCI performed via other conduits.

Inter-ethnic marriages and severity of coronary artery disease: A multicenter study of Arabian Gulf States

PubMed Central

Daoulah, Amin; Al-kaabi, Salem; Lotfi, Amir; Al-Murayeh, Mushabab; Nasseri, S Ali; Ahmed, Waleed; Al-Otaibi, Salah N; Alama, Mohamed N; Elkhateeb, Osama E; Plotkin, Amy J; Malak, Majed M; Alshali, Khalid; Hamzi, Mohamed; Al Khunein, Saleh; Abufayyah, Mohammed; Alsheikh-Ali, Alawi A

2017-01-01

AIM To assess the association of inter-ethnic vs intra-ethnic marriage with severity of coronary artery disease (CAD) in men undergoing angiography. METHODS We conducted a prospective multicenter, multi-ethnic, cross sectional observational study at five hospitals in Saudi Arabia and the United Arab Emirates, in which we used logistic regression analysis with and without adjustment for baseline differences. RESULTS Data were collected for 1068 enrolled patients undergoing coronary angiography for clinical indications during the period of April 1st, 2013 to March 30th, 2014. Ethnicities of spouses were available only for male patients. Of those enrolled, 687 were married men and constituted the cohort for the present analysis. Intra-ethnic marriages were reported in 70% and inter-ethnic marriages in 30%. After adjusting for baseline differences, inter-ethnic marriage was associated with lower odds of having significant CAD [adjusted odds ratio 0.52 (95%CI: 0.33, 0.81)] or multi-vessel disease (MVD) [adjusted odds ratio 0.57 (95%CI: 0.37, 0.86)]. The adjusted association with left main disease showed a similar trend, but was not statistically significant [adjusted odds ratio 0.74 (95%CI: 0.41, 1.32)]. The association between inter-ethnic marriage and the presence of significant CAD and MVD was not modified by number of concurrent wives (P interaction > 0.05 for both). CONCLUSION Among married men undergoing coronary angiography, inter-ethnic, as compared to intra-ethnic, marriage is associated with lower odds of significant CAD and MVD. PMID:28515856

A prospective multicenter study of factors associated with hospital admission among adults with acute asthma.

PubMed

Weber, Ellen J; Silverman, Robert A; Callaham, Michael L; Pollack, Charles V; Woodruff, Prescott G; Clark, Sunday; Camargo, Carlos A

2002-10-01

We sought to determine patient characteristics associated with hospital admission after emergency treatment for asthma, and whether disposition guidelines are followed. We performed a prospective multicenter cohort study involving 64 emergency departments in the United States and Canada. Consecutive adult patients with asthma exacerbations were interviewed, and their charts were reviewed using standardized protocols. Telephone follow-up at 2 weeks determined relapse. Of 1805 patients, 363 (20%; 95% confidence interval [CI]: 18% to 22%) were hospitalized. Among patients with severe exacerbations (final peak flow <50% of predicted), 122 (49%; 95% CI: 43% to 55%) were hospitalized. Admission was associated with final peak flow, female sex, nonwhite race, severity of chronic illness, and severity of exacerbation. Admission predictors were similar regardless of hospital funding, region, or size. Among patients with mild or moderate exacerbations of asthma (peak flow >or=50% predicted), the likelihood of admission was associated significantly with the number of predefined risk factors for death from asthma. Of patients who were discharged from the emergency department, 62 (5%; 95% CI: 4% to 6%) relapsed within 72 hours. Relapse was not associated with final peak flow (P = 0.39). Associations between patient characteristics and disposition were similar across sites. Despite guidelines to the contrary, half of patients with final peak flow <50% were discharged. After emergency department treatment and discharge, short-term relapse was uncommon among patients with asthma, suggesting that strict peak flow cutoffs may be unnecessary if risk factors in patients with mild or moderate exacerbations are considered.

Effects of hydroxyurea treatment for patients with hemoglobin SC disease.

PubMed

Luchtman-Jones, Lori; Pressel, Sara; Hilliard, Lee; Brown, R Clark; Smith, Mary G; Thompson, Alexis A; Lee, Margaret T; Rothman, Jennifer; Rogers, Zora R; Owen, William; Imran, Hamayun; Thornburg, Courtney; Kwiatkowski, Janet L; Aygun, Banu; Nelson, Stephen; Roberts, Carla; Gauger, Cynthia; Piccone, Connie; Kalfa, Theodosia; Alvarez, Ofelia; Hassell, Kathryn; Davis, Barry R; Ware, Russell E

2016-02-01

Although hemoglobin SC (HbSC) disease is usually considered less severe than sickle cell anemia (SCA), which includes HbSS and HbS/β(0) -thalassemia genotypes, many patients with HbSC experience severe disease complications, including vaso-occlusive pain, acute chest syndrome, avascular necrosis, retinopathy, and poor quality of life. Fully 20 years after the clinical and laboratory efficacy of hydroxyurea was proven in adult SCA patients, the safety and utility of hydroxyurea treatment for HbSC patients remain unclear. Recent NHLBI evidence-based guidelines highlight this as a critical knowledge gap, noting HbSC accounts for ∼30% of sickle cell patients within the United States. To date, only 5 publications have reported short-term, incomplete, or conflicting laboratory and clinical outcomes of hydroxyurea treatment in a total of 71 adults and children with HbSC. We now report on a cohort of 133 adult and pediatric HbSC patients who received hydroxyurea, typically for recurrent vaso-occlusive pain. Hydroxyurea treatment was associated with a stable hemoglobin concentration; increased fetal hemoglobin (HbF) and mean corpuscular volume (MCV); and reduced white blood cell count (WBC), absolute neutrophil count (ANC), and absolute reticulocyte count (ARC). Reversible cytopenias occurred in 22% of patients, primarily neutropenia and thrombocytopenia. Painful events were reduced with hydroxyurea, more in patients >15 years old. These multicenter data support the safety and potentially salutary effects of hydroxyurea treatment for HbSC disease; however, a multicenter, placebo-controlled, Phase 3 clinical trial is needed to determine if hydroxyurea therapy has efficacy for patients with HbSC disease. © 2015 Wiley Periodicals, Inc.

Prevention of Posttraumatic Contractures with Ketotifen (PERK)

DTIC Science & Technology

2016-10-01

the Peer Reviewed Orthopaedic Research Program (PRORP) Clinical Trial Award (CTA), W81XWH-16-PRORP-CTA, was submitted. Database development and Pre...and Safety Months Identify database and partner – Clinical Research Unit 1-2 Completed Develop Case Report Forms, consent forms 6-12 Case...report forms completed, consent forms pending – 80% completed Develop database and multicenter submission process 12-18 In progress, 30% completed

Integrating a Patient-Controlled Admission Program Into Mental Health Hospital Service: A Multicenter Grounded Theory Study.

PubMed

Ellegaard, Trine; Bliksted, Vibeke; Mehlsen, Mimi; Lomborg, Kirsten

2018-05-01

Patient-controlled admissions (PCAs) enable mental health patients by means of a contract to initiate an admission at a mental health hospital unit without using traditional admission procedures. This study was part of a 3-year Danish multicenter project, and we explored how mental health professionals experienced and managed the implementation of a PCA program. The methodology was grounded theory and the sample included 26 participants. We performed a constant comparative analysis to explore the concerns, attitudes, and strategies of mental health professionals. We developed a model of how the mental health professionals strived to integrate PCA into clinical practice. The process was motivated by the idea of establishing a partnership with patients and involved two interrelated strategies to manage (a) the patient-related duties and (b) the admission contracts. The professionals moved from a phase of professional discomfort to a phase of professional awareness, and ended up with professional comprehension.

Admission of the very elderly to the intensive care unit: family members' perspectives on clinical decision-making from a multicenter cohort study.

PubMed

Heyland, Daren K; Dodek, Peter; Mehta, Sangeeta; Cook, Deborah; Garland, Allan; Stelfox, Henry T; Bagshaw, Sean M; Kutsogiannis, Demetrios J; Burns, Karen; Muscedere, John; Turgeon, Alexis F; Fowler, Rob; Jiang, Xuran; Day, Andrew G

2015-04-01

Little is known about the perspectives and experiences of family members of very elderly patients who are admitted to the intensive care unit. To describe family members' perspectives about care provided to very elderly critically ill patients. Multicenter, prospective, cohort study. In total, 535 family members of patients aged 80 years or older admitted to 22 intensive care units for more than 24 h. Family members reported that the "patient be comfortable and suffer as little as possible" was their most important value and "the belief that life should be preserved at all costs" was their least important value considered in making treatment decisions. Most family members (57.9%) preferred that life support be used for their family member, whereas 24.1% preferred comfort measures only, and 14.4% were unsure of their treatment preferences. Only 57.3% reported that a doctor had talked to them about treatment options for the patient. Overall, 29.7% of patients received life-sustaining treatments for more than 7 days and 50.3% of these died in hospital. Families were most satisfied with the skill and competency of nurses and least satisfied with being included and supported in the decision-making process and with their sense of control over the patient's care. There is incongruity between family values and preferences for end-of-life care and actual care received for very elderly patients who are admitted to the intensive care unit. Deficiencies in communication and decision-making may be associated with prolonged use of life-sustaining treatments in very elderly critically ill patients, many of whom ultimately die. © The Author(s) 2015.

Development of a Multicenter Density Functional Tight Binding Model for Plutonium Surface Hydriding.

PubMed

Goldman, Nir; Aradi, Bálint; Lindsey, Rebecca K; Fried, Laurence E

2018-05-08

We detail the creation of a multicenter density functional tight binding (DFTB) model for hydrogen on δ-plutonium, using a framework of new Slater-Koster interaction parameters and a repulsive energy based on the Chebyshev Interaction Model for Efficient Simulation (ChIMES), where two- and three-center atomic interactions are represented by linear combinations of Chebyshev polynomials. We find that our DFTB/ChIMES model yields a total electron density of states for bulk δ-Pu that compares well to that from Density Functional Theory, as well as to a grid of energy calculations representing approximate H 2 dissociation paths on the δ-Pu (100) surface. We then perform molecular dynamics simulations and minimum energy pathway calculations to determine the energetics of surface dissociation and subsurface diffusion on the (100) and (111) surfaces. Our approach allows for the efficient creation of multicenter repulsive energies with a relatively small investment in initial DFT calculations. Our efforts are particularly pertinent to studies that rely on quantum calculations for interpretation and validation, such as experimental determination of chemical reactivity both on surfaces and in condensed phases.

Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

PubMed

Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

2016-04-01

The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

Application of the cultured epidermal autograft "JACE(®") for treatment of severe burns: Results of a 6-year multicenter surveillance in Japan.

PubMed

Matsumura, Hajime; Matsushima, Asako; Ueyama, Masashi; Kumagai, Norio

2016-06-01

In the 1970s, Green et al. developed a method that involved culturing keratinocyte sheets and used for treatment of burns. Since then, the take rate of cultured epidermal autograft (CEA) onto fascia, granulation tissue, or allografts has been extensively reported, while that on an artificial dermis in a large case series is not. Moreover, the contribution of CEA to patient survival has not been analyzed in a multicenter study. We conducted a 6-year multicenter surveillance on the application of the CEA "JACE(®") for treatment of burns >30% total body surface area (TBSA) across 118 Japanese hospitals. This surveillance included 216 patients and 718 graft sites for efficacy analysis. The CEA take rate at 4 weeks after grafting was evaluated, and safety was monitored until 52 weeks. In addition, the survival curve obtained in this study and the data obtained from the Tokyo Burn Unit Association (TBUA) were compared. The mean CEA take rates at week 4 were 66% (sites) and 68% (patients), and the rate on the artificial dermis was 65% for 226 sites. CEA application combined with wide split-thickness auto or patch autograft increased the CEA take rate. On comparison with the data obtained from the TBUA, which included data on individuals with burns of the same severity, CEA application was found to contribute to patient survival until 7 weeks after burn. We reported the take rate of CEA based on a 6-year multicenter surveillance. From our results, we found that the application of CEA is a useful treatment for the patients with extensive burns. Copyright © 2016 Elsevier Ltd and ISBI. All rights reserved.

A Multicenter, Randomized Controlled Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury

DTIC Science & Technology

2017-10-01

PRINCIPAL INVESTIGATOR: Nicholas Theodore, MD CONTRACTING ORGANIZATION: Dignity Health San Francisco, CA 94107-1773 REPORT DATE: October 2017...theodore@jhmi.edu 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Dignity Health 8. PERFORMING ORGANIZATION REPORT NUMBER 185...at all three active centers, which include: Barrow Neurological Institute/Dignity Health (the main study site) in Arizona, the University of Arizona

A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs)

ClinicalTrials.gov

2018-05-15

Hematologic Malignancies; Inherited Disorders of Metabolism; Inherited Abnormalities of Platelets; Histiocytic Disorders; Acute Myelogenous Leukemia (AML or ANLL); Acute Lymphoblastic Leukemia (ALL); Other Acute Leukemia; Chronic Myelogenous Leukemia (CML); Myelodysplastic (MDS) / Myeloproliferative (MPN) Diseases; Other Leukemia; Hodgkin Lymphoma; Non-hodgkin Lymphoma; Multiple Myeloma/ Plasma Cell Disorder (PCD); Inherited Abnormalities of Erythrocyte Differentiation or Function; Disorders of the Immune System; Automimmune Diseases; Severe Aplastic Anemia

Development of Medical Technology for Contingency Response to Marrow Toxic Agents

DTIC Science & Technology

2014-07-25

Research in Transplantation : Create a platform that facilitates multicenter collaboration and data management. 15. SUBJECT TERMS Research in HLA ...Confirmatory Testing OTTR Organ Transplant Tracking Record CTA Clinical Trial Application P2P Peer-to-Peer PBMC Peripheral Blood Mononuclear Cells...NUMBER Project 1, 2, 3, 4 5f. WORK UNIT NUMBER N/A 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) National Marrow Donor Program 3001

Antimicrobial resistance incidence and risk factors among Helicobacter pylori-infected persons, United States.

PubMed

Duck, William M; Sobel, Jeremy; Pruckler, Janet M; Song, Qunsheng; Swerdlow, David; Friedman, Cindy; Sulka, Alana; Swaminathan, Balasubra; Taylor, Tom; Hoekstra, Mike; Griffin, Patricia; Smoot, Duane; Peek, Rick; Metz, David C; Bloom, Peter B; Goldschmidt, Steven; Parsonnet, Julie; Triadafilopoulos, George; Perez-Perez, Guillermo I; Vakil, Nimish; Ernst, Peter; Czinn, Steve; Dunne, Donald; Gold, Ben D

2004-06-01

Helicobacter pylori is the primary cause of peptic ulcer disease and an etiologic agent in the development of gastric cancer. H. pylori infection is curable with regimens of multiple antimicrobial agents, and antimicrobial resistance is a leading cause of treatment failure. The Helicobacter pylori Antimicrobial Resistance Monitoring Program (HARP) is a prospective, multicenter U.S. network that tracks national incidence rates of H. pylori antimicrobial resistance. Of 347 clinical H. pylori isolates collected from December 1998 through 2002, 101 (29.1%) were resistant to one antimicrobial agent, and 17 (5%) were resistant to two or more antimicrobial agents. Eighty-seven (25.1%) isolates were resistant to metronidazole, 45 (12.9%) to clarithromycin, and 3 (0.9%) to amoxicillin. On multivariate analysis, black race was the only significant risk factor (p < 0.01, hazard ratio 2.04) for infection with a resistant H. pylori strain. Formulating pretreatment screening strategies or providing alternative therapeutic regimens for high-risk populations may be important for future clinical practice.

Antimicrobial Resistance Incidence and Risk Factors among Helicobacter pylori–Infected Persons, United States

PubMed Central

Sobel, Jeremy; Pruckler, Janet M.; Song, Qunsheng; Swerdlow, David; Friedman, Cindy; Sulka, Alana; Swaminathan, Balasubra; Taylor, Tom; Hoekstra, Mike; Griffin, Patricia; Smoot, Duane; Peek, Rick; Metz, David C.; Bloom, Peter B.; Goldschmid, Steven; Parsonnet, Julie; Triadafilopoulos, George; Perez-Perez, Guillermo I.; Vakil, Nimish; Ernst, Peter; Czinn, Steve; Dunne, Donald; Gold, Ben D.

2004-01-01

Helicobacter pylori is the primary cause of peptic ulcer disease and an etiologic agent in the development of gastric cancer. H. pylori infection is curable with regimens of multiple antimicrobial agents, and antimicrobial resistance is a leading cause of treatment failure. The Helicobacter pylori Antimicrobial Resistance Monitoring Program (HARP) is a prospective, multicenter U.S. network that tracks national incidence rates of H. pylori antimicrobial resistance. Of 347 clinical H. pylori isolates collected from December 1998 through 2002, 101 (29.1%) were resistant to one antimicrobial agent, and 17 (5%) were resistant to two or more antimicrobial agents. Eighty-seven (25.1%) isolates were resistant to metronidazole, 45 (12.9%) to clarithromycin, and 3 (0.9%) to amoxicillin. On multivariate analysis, black race was the only significant risk factor (p < 0.01, hazard ratio 2.04) for infection with a resistant H. pylori strain. Formulating pretreatment screening strategies or providing alternative therapeutic regimens for high-risk populations may be important for future clinical practice. PMID:15207062

Counseling to Reduce High-Risk Sexual Behavior in HIV Care: A Multi-Center, Direct Observation Study

PubMed Central

Berry, Stephen; Korthuis, P. Todd; Saha, Somnath; Laws, M. Barton; Sharp, Victoria; Moore, Richard D.; Beach, Mary Catherine

2013-01-01

Abstract A key opportunity to reduce HIV transmission lies with healthcare providers counseling HIV-infected patients about safer sex. We audio-recorded and transcribed clinical encounters between 45 healthcare providers and 417 of their HIV-infected patients at four outpatient sites in the United States. We used logistic regressions to evaluate associations between patient and provider characteristics, and the occurrence of discussion (any talk about sex) and counseling (advice about safer sex). Of the 417 encounters, discussion of sex occurred in 187 (45% of encounters, 95% CI: 40–50%). Counseling occurred for 49% (95% CI: 35–63%) of patients reporting unsafe sex. Discussion of sex was more likely with younger or less-educated patients and with less cultural difference between patient and provider, while counseling was associated with greater provider mindfulness and lower provider empathy. These findings suggest targets to improve communication regarding sexual risk reduction in HIV care. PMID:23802144

[New growth references of the World Health Organization based on breast fed infants].

PubMed

Lozano de la Torre, Maria J

2007-02-01

The World Health Organization Multicenter Growth Reference Study is a multinational project to develop new growth references for infants and young children. The design combines a longitudinal study from birth to 24 months with a cross-sectional study of children aged 18 to 71 months. The pooled sample from the six participating countries (Brazil, Ghana, India, Norway, Oman, and the United States) consists of 8440 children. The new WHO Child Growth Standards confirm that all children worldwide, given an optimum start in life, have the same potential for growth and prove that differences in children's growth to the age of 5 years are more influenced by nutrition, feeding practices, environment, and healthcare than by genetics or ethnicity. The new standards are based on the breast fed child as the norm for growth and development. For the first time, this ensures coherence among the tools used to assess growth and national and international infant feeding guidelines, which recommend breast feeding as the optimal source of nutrition during infancy.

Video-Only Cardiopulmonary Resuscitation Education for High-Risk Families Before Hospital Discharge: A Multicenter Pragmatic Trial.

PubMed

Blewer, Audrey L; Putt, Mary E; Becker, Lance B; Riegel, Barbara J; Li, Jiaqi; Leary, Marion; Shea, Judy A; Kirkpatrick, James N; Berg, Robert A; Nadkarni, Vinay M; Groeneveld, Peter W; Abella, Benjamin S

2016-11-01

Cardiopulmonary resuscitation (CPR) training rates in the United States are low, highlighting the need to develop CPR educational approaches that are simpler, with broader dissemination potential. The minimum training required to ensure long-term skill retention remains poorly characterized. We compared CPR skill retention among laypersons randomized to training with video-only (VO; no manikin) with those trained with a video self-instruction kit (VSI; with manikin). We hypothesized that VO training would be noninferior to the VSI approach with respect to chest compression (CC) rate. We performed a prospective, cluster randomized trial of CPR education for family members of patients with high-risk cardiac conditions on hospital cardiac units, using a multicenter pragmatic design. Eight hospitals were randomized to offer either VO or VSI training before discharge using volunteer trainers. CPR skills were assessed 6 months post training. Mean CC rate among those trained with VO compared with those trained with VSI was assessed with a noninferiority margin set at 8 CC per min; as a secondary outcome, mean differences in CC depth were assessed. From February 2012 to May 2015, 1464 subjects were enrolled and 522 subjects completed a skills assessment. The mean CC rates were 87.7 (VO) CC per min and 89.3 (VSI) CC per min; we concluded noninferiority for VO based on a mean difference of -1.6 (90% confidence interval, -5.2 to 2.1). The mean CC depth was 40.2 mm (VO) and 45.8 mm (VSI) with a mean difference of -5.6 (95% confidence interval, -7.6 to -3.7). Results were similar after multivariate regression adjustment. In this large, prospective trial of CPR skill retention, VO training yielded a noninferior difference in CC rate compared with VSI training. CC depth was greater in the VSI group. These findings suggest a potential trade-off in efforts for broad dissemination of basic CPR skills; VO training might allow for greater scalability and dissemination, but with a potential reduction in CC depth. URL: https://www.clinicaltrials.gov. Unique identifier: NCT01514656. © 2016 American Heart Association, Inc.

Incidence and Outcomes of Cardiopulmonary Resuscitation in Pediatric Intensive Care Units

PubMed Central

Berg, Robert A.; Nadkarni, Vinay M.; Clark, Amy E.; Moler, Frank; Meert, Kathleen; Harrison, Rick E.; Newth, Christopher J. L.; Sutton, Robert M.; Wessel, David L.; Berger, John T.; Carcillo, Joseph; Dalton, Heidi; Heidemann, Sabrina; Shanley, Thomas P.; Zuppa, Athena F.; Doctor, Allan; Tamburro, Robert F.; Jenkins, Tammara L.; Dean, J. Michael; Holubkov, Richard; Pollack, Murray M.

2015-01-01

Objective To determine the incidence of cardiopulmonary resuscitation (CPR) in pediatric intensive care units (PICU) and subsequent outcomes. Design, Setting, and Patients Multi-center prospective observational study of children 30 minutes, p30 minutes of CPR. Conclusions These data establish that contemporary PICU CPR, including long durations of CPR, results in high rates of survival to hospital discharge (45%) and favorable neurologic outcomes among survivors (89%). Rates of survival with favorable neurologic outcomes were similar among cardiac and non-cardiac patients. The rigorous prospective, observational study design avoided the limitations of missing data and potential selection biases inherent in registry and administrative data. PMID:26646466

The impact of the lung allocation score on short-term transplantation outcomes: a multicenter study.

PubMed

Kozower, Benjamin D; Meyers, Bryan F; Smith, Michael A; De Oliveira, Nilto C; Cassivi, Stephen D; Guthrie, Tracey J; Wang, Honkung; Ryan, Beverly J; Shen, K Robert; Daniel, Thomas M; Jones, David R

2008-01-01

The lung allocation score restructured the distribution of scarce donor lungs for transplantation. The algorithm ranks waiting list patients according to medical urgency and expected benefit after transplantation. The purpose of this study was to evaluate the impact of the lung allocation score on short-term outcomes after lung transplantation. A multicenter retrospective cohort study was performed with data from 5 academic medical centers. Results of patients undergoing transplantation on the basis of the lung allocation score (May 4, 2005 to May 3, 2006) were compared with those of patients receiving transplants the preceding year before the lung allocation score was implemented (May 4, 2004, to May 3, 2005). The study reports on 341 patients (170 before the lung allocation score and 171 after). Waiting time decreased from 680.9 +/- 528.3 days to 445.6 +/- 516.9 days (P < .001). Recipient diagnoses changed with an increase in idiopathic pulmonary fibrosis and a decrease in emphysema and cystic fibrosis (P = .002). Postoperatively, primary graft dysfunction increased from 14.1% (24/170) to 22.9% (39/171) (P = .04) and intensive care unit length of stay increased from 5.7 +/- 6.7 days to 7.8 +/- 9.6 days (P = .04). Hospital mortality and 1-year survival were the same between groups (5.3% vs 5.3% and 90% vs 89%, respectively; P > .6) This multicenter retrospective review of short-term outcomes supports the fact that the lung allocation score is achieving its objectives. The lung allocation score reduced waiting time and altered the distribution of lung diseases for which transplantation was done on the basis of medical necessity. After transplantation, recipients have significantly higher rates of primary graft dysfunction and intensive care unit lengths of stay. However, hospital mortality and 1-year survival have not been adversely affected.

Multicenter Comparison of Machine Learning Methods and Conventional Regression for Predicting Clinical Deterioration on the Wards.

PubMed

Churpek, Matthew M; Yuen, Trevor C; Winslow, Christopher; Meltzer, David O; Kattan, Michael W; Edelson, Dana P

2016-02-01

Machine learning methods are flexible prediction algorithms that may be more accurate than conventional regression. We compared the accuracy of different techniques for detecting clinical deterioration on the wards in a large, multicenter database. Observational cohort study. Five hospitals, from November 2008 until January 2013. Hospitalized ward patients None Demographic variables, laboratory values, and vital signs were utilized in a discrete-time survival analysis framework to predict the combined outcome of cardiac arrest, intensive care unit transfer, or death. Two logistic regression models (one using linear predictor terms and a second utilizing restricted cubic splines) were compared to several different machine learning methods. The models were derived in the first 60% of the data by date and then validated in the next 40%. For model derivation, each event time window was matched to a non-event window. All models were compared to each other and to the Modified Early Warning score, a commonly cited early warning score, using the area under the receiver operating characteristic curve (AUC). A total of 269,999 patients were admitted, and 424 cardiac arrests, 13,188 intensive care unit transfers, and 2,840 deaths occurred in the study. In the validation dataset, the random forest model was the most accurate model (AUC, 0.80 [95% CI, 0.80-0.80]). The logistic regression model with spline predictors was more accurate than the model utilizing linear predictors (AUC, 0.77 vs 0.74; p < 0.01), and all models were more accurate than the MEWS (AUC, 0.70 [95% CI, 0.70-0.70]). In this multicenter study, we found that several machine learning methods more accurately predicted clinical deterioration than logistic regression. Use of detection algorithms derived from these techniques may result in improved identification of critically ill patients on the wards.

Early Prediction of Intensive Care Unit-Acquired Weakness: A Multicenter External Validation Study.

PubMed

Witteveen, Esther; Wieske, Luuk; Sommers, Juultje; Spijkstra, Jan-Jaap; de Waard, Monique C; Endeman, Henrik; Rijkenberg, Saskia; de Ruijter, Wouter; Sleeswijk, Mengalvio; Verhamme, Camiel; Schultz, Marcus J; van Schaik, Ivo N; Horn, Janneke

2018-01-01

An early diagnosis of intensive care unit-acquired weakness (ICU-AW) is often not possible due to impaired consciousness. To avoid a diagnostic delay, we previously developed a prediction model, based on single-center data from 212 patients (development cohort), to predict ICU-AW at 2 days after ICU admission. The objective of this study was to investigate the external validity of the original prediction model in a new, multicenter cohort and, if necessary, to update the model. Newly admitted ICU patients who were mechanically ventilated at 48 hours after ICU admission were included. Predictors were prospectively recorded, and the outcome ICU-AW was defined by an average Medical Research Council score <4. In the validation cohort, consisting of 349 patients, we analyzed performance of the original prediction model by assessment of calibration and discrimination. Additionally, we updated the model in this validation cohort. Finally, we evaluated a new prediction model based on all patients of the development and validation cohort. Of 349 analyzed patients in the validation cohort, 190 (54%) developed ICU-AW. Both model calibration and discrimination of the original model were poor in the validation cohort. The area under the receiver operating characteristics curve (AUC-ROC) was 0.60 (95% confidence interval [CI]: 0.54-0.66). Model updating methods improved calibration but not discrimination. The new prediction model, based on all patients of the development and validation cohort (total of 536 patients) had a fair discrimination, AUC-ROC: 0.70 (95% CI: 0.66-0.75). The previously developed prediction model for ICU-AW showed poor performance in a new independent multicenter validation cohort. Model updating methods improved calibration but not discrimination. The newly derived prediction model showed fair discrimination. This indicates that early prediction of ICU-AW is still challenging and needs further attention.

NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research.

PubMed

Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D; Cui, Licong

2015-11-10

A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f1, f2, ..., fk. The input for each function fi has 3 components: a random number r, an integer n, and input data m. The result, fi(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f1(r1, n1, m1), f2(r2, n2, m2), ..., fk(rk, nk, mk). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result of the encryption, concatenated with the random number r, is the final NHash study identifier. We performed experiments using a large synthesized dataset comparing NHash with random strings, and demonstrated neglegible probability for collision. We implemented NHash for the Center for SUDEP Research (CSR), a National Institute for Neurological Disorders and Stroke-funded Center Without Walls for Collaborative Research in the Epilepsies. This multicenter collaboration involves 14 institutions across the United States and Europe, bringing together extensive and diverse expertise to understand sudden unexpected death in epilepsy patients (SUDEP). The CSR Data Repository has successfully used NHash to link deidentified multimodal clinical data collected in participating CSR institutions, meeting all desired objectives of NHash.

Decision making in liver transplant selection committees: a multicenter study.

PubMed

Volk, Michael L; Biggins, Scott W; Huang, Mary Ann; Argo, Curtis K; Fontana, Robert J; Anspach, Renee R

2011-10-18

To receive a liver transplant, patients must first be placed on a waiting list-a decision made at most transplant centers by a multidisciplinary committee. The function of these committees has never been studied. To describe decision making in liver transplant committees and identify opportunities for process improvement. Observational multicenter study. 4 liver transplant centers in the United States. 68 members of liver transplant committees across the 4 centers. 63 meetings were observed, and 50 committee members were interviewed. Recorded transcripts and field notes were analyzed by using standard qualitative sociologic methods. Although the structure of the meetings varied by center, the process was uniform and primarily involved inductive reasoning to review possible reasons for patient exclusion. Patients were excluded if they were too well, too sick (in the setting of advanced liver disease), or too old or had nonhepatic comorbid conditions, substance abuse problems, or other psychosocial barriers. Dominant themes in the discussions included member angst over deciding who lived or died, a high correlation between psychosocial barriers to transplantation and the patient's socioeconomic status, and the influence of external forces on decision making. Unwritten center policies and confusion regarding advocacy versus stewardship roles were consistently identified as barriers to effective group decision making. The use of qualitative methods provides broad understanding but limits specific inferences. The 4 centers may not reflect the practices of every transplant center nationwide. The difficult decisions made by liver transplant committees are reasonably consistent and well-intentioned, but the process might be improved by having more explicit written policies and clarifying roles. This may inform resource allocation in other areas of medicine. The Greenwall Foundation and the National Institutes of Health.

Prevalence and epidemiology of overweight and obesity in children with inflammatory bowel disease.

PubMed

Long, Millie D; Crandall, Wallace V; Leibowitz, Ian H; Duffy, Lynn; del Rosario, Fernando; Kim, Sandra C; Integlia, Mark J; Berman, James; Grunow, John; Colletti, Richard B; Schoen, Bess T; Patel, Ashish S; Baron, Howard; Israel, Esther; Russell, George; Ali, Sabina; Herfarth, Hans H; Martin, Christopher; Kappelman, Michael D

2011-10-01

Obesity is a significant public health threat to children in the United States. The aims were to: 1) Determine the prevalence of obesity in a multicenter cohort of children with inflammatory bowel disease (IBD); 2) Evaluate whether overweight and obese status is associated with patient demographics or disease characteristics. We used data from the ImproveCareNow Collaborative for pediatric IBD, a multicenter registry of children with IBD, collected between April 2007 and December 2009. Children ages 2-18 years were classified into body mass index (BMI) percentiles. Bivariate analyses and multivariate logistic regression were used to compare demographic and disease characteristics by overweight (BMI >85%) and obese (BMI >95%) status. The population consisted of 1598 children with IBD. The prevalence of overweight/obese status in pediatric IBD is 23.6%, (20.0% for Crohn's disease [CD] and 30.1% for ulcerative colitis [UC] and indeterminate colitis [IC]). African American race (odds ratio [OR] 1.64, 95% confidence interval [CI] 1.10-2.48) and Medicaid insurance (OR 1.67, 95% CI 1.19-2.34) were positively associated with overweight/obese status. Prior IBD-related surgery (OR 1.73, 95% CI 1.07-2.82) was also associated with overweight and obese status in children with CD. Other disease characteristics were not associated with overweight and obesity in children with IBD. Approximately one in five children with CD and one in three with UC are overweight or obese. Rates of obesity in UC are comparable to the general population. Obese IBD patients may have a more severe disease course, as indicated by increased need for surgery. Sociodemographic risk factors for obesity in the IBD population are similar to those in the general population. Copyright © 2010 Crohn's & Colitis Foundation of America, Inc.

Depression and Cognitive Impairment in Peritoneal Dialysis: A Multicenter Cross-sectional Study.

PubMed

Dong, Jie; Pi, Hai-Chen; Xiong, Zu-Ying; Liao, Jin-Lan; Hao, Li; Liu, Gui-Ling; Ren, Ye-Ping; Wang, Qin; Duan, Li-Ping; Zheng, Zhao-Xia

2016-01-01

Depression and cognitive impairment have been identified as independent risk factors for mortality in peritoneal dialysis (PD) patients. The relationship between depression and global and specific cognitive functions in PD patients was investigated in this study. Multicenter cross-sectional study. 458 clinically stable patients, drawn from 5 PD units, who performed PD for at least 3 months were enrolled. Depression, defined as depression severity index score > 0.5 using the Zung Self-rating Depression Scale. Global and specific cognitive impairment. Global cognitive function was measured using the Modified Mini-Mental State Examination (3MS), Trail-Making Test forms A and B for executive function, and subtests of the Battery for the Assessment of Neuropsychological Status for immediate and delayed memory, visuospatial skills, and language ability. Prevalences of depression and cognitive impairment evaluated by the 3MS were 52% and 28.4%, respectively. Patients with mild or moderate/severe depression had higher prevalences of general cognitive impairment, executive dysfunction, and impaired immediate and delayed memory. After adjusting for demographics, comorbid conditions, and clinical parameters, depression scores were independently associated with lower 3MS scores, lower immediate and delayed memory and language ability scores, and longer completion times of Trails A and B. Even mild depression was independently associated with higher risk for cognitive impairment, executive dysfunction, and impaired immediate and delayed memory after multivariable adjustments. The causal relationship between depression and cognitive impairment could not be determined, and the potential copathogenesis behind depression and cognitive impairment was not fully investigated. Even mild depression is closely associated with global and specific cognitive impairment in PD patients. Copyright © 2016 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

A Novel Tool for Assessment of Emergency Medicine Resident Skill in Determining Diagnosis and Management for Emergent Electrocardiograms: A Multicenter Study.

PubMed

Hartman, Nicholas D; Wheaton, Natasha B; Williamson, Kelly; Quattromani, Erin N; Branzetti, Jeremy B; Aldeen, Amer Z

2016-12-01

Reading emergent electrocardiograms (ECGs) is one of the emergency physician's most crucial tasks, yet no well-validated tool exists to measure resident competence in this skill. To assess validity of a novel tool measuring emergency medicine resident competency for interpreting, and responding to, critical ECGs. In addition, we aim to observe trends in this skill for resident physicians at different levels of training. This is a multi-center, prospective study of postgraduate year (PGY) 1-4 residents at five emergency medicine (EM) residency programs in the United States. An assessment tool was created that asks the physician to identify either the ECG diagnosis or the best immediate management. One hundred thirteen EM residents from five EM residency programs submitted completed assessment surveys, including 43 PGY-1s, 33 PGY-2s, and 37 PGY-3/4s. PGY-3/4s averaged 74.6% correct (95% confidence interval [CI] 70.9-78.4) and performed significantly better than PGY-1s, who averaged 63.2% correct (95% CI 58.0-68.3). PGY-2s averaged 69.0% (95% CI 62.2-73.7). Year-to-year differences were more pronounced in management than in diagnosis. Residency training in EM seems to be associated with improved ability to interpret "critical" ECGs as measured by our assessment tool. This lends validity evidence for the tool by correlating with a previously observed association between residency training and improved ECG interpretation. Resident skill in ECG interpretation remains less than ideal. Creation of this sort of tool may allow programs to assess resident performance as well as evaluate interventions designed to improve competency. Copyright © 2016 Elsevier Inc. All rights reserved.

A randomized multicenter trial of Crotalidae polyvalent immune F(ab) antivenom for the treatment of rattlesnake envenomation in dogs.

PubMed

Peterson, Michael E; Matz, Michael; Seibold, Karen; Plunkett, Signe; Johnson, Scott; Fitzgerald, Kevin

2011-08-01

To determine clinical efficacy of the Crotalidae polyvalent immune F(ab) (ovine) antivenom (OPCA) against progressive crotalid envenomation in the dog as reflected in stabilization or improvement of snakebite severity scores (SSS). Additionally, due to the potential decreased half-life of the F(ab) antibodies in dogs we compared SSS between dogs receiving 2 different dosing regimes. Prospective, clinical trial. Five veterinary emergency and critical care facilities. One hundred and fifteen client-owned Crotalid (rattlesnake) snake bitten dogs in whom worsening of the envenomation syndrome was observed before OPCA treatment. In a multicenter randomized clinical trial a single dose (1 vial) of OPCA alone was compared with 2 doses (1/2 vial each) administered 6 hours apart. Standard supportive care was provided in all cases. Data were available for 115 patients, 9 of which were fatalities. All patients' clinical condition was documented with a standardized SSS system accounting for each major body system. Each fatality received maximum severity scores of 20. The mean severity score of the 115 patients decreased from 4.19 to 3.29 points and there was no difference between the 2 treatment groups. The mean severity score of the 107 patients without fatalities decreased from 4.16 to 2.15. Antivenin-related acute reactions occurred in 6 dogs (6%), and no serum sickness occurred within the 95 cases contacted at the 2-week posttreatment follow-up. In the first randomized trial in dogs of antivenin in the United States, OPCA effectively stabilized or terminated venom effects. There were no statistical differences detected between treatment groups within the study time frame. © Veterinary Emergency and Critical Care Society 2011.

Technical Note: Independent component analysis for quality assurance in functional MRI.

PubMed

Astrakas, Loukas G; Kallistis, Nikolaos S; Kalef-Ezra, John A

2016-02-01

Independent component analysis (ICA) is an established method of analyzing human functional MRI (fMRI) data. Here, an ICA-based fMRI quality control (QC) tool was developed and used. ICA-based fMRI QC tool to be used with a commercial phantom was developed. In an attempt to assess the performance of the tool relative to preexisting alternative tools, it was used seven weeks before and eight weeks after repair of a faulty gradient amplifier of a non-state-of-the-art MRI unit. More specifically, its performance was compared with the AAPM 100 acceptance testing and quality assurance protocol and two fMRI QC protocols, proposed by Freidman et al. ["Report on a multicenter fMRI quality assurance protocol," J. Magn. Reson. Imaging 23, 827-839 (2006)] and Stocker et al. ["Automated quality assurance routines for fMRI data applied to a multicenter study," Hum. Brain Mapp. 25, 237-246 (2005)], respectively. The easily developed and applied ICA-based QC protocol provided fMRI QC indices and maps equally sensitive to fMRI instabilities with the indices and maps of other established protocols. The ICA fMRI QC indices were highly correlated with indices of other fMRI QC protocols and in some cases theoretically related to them. Three or four independent components with slow varying time series are detected under normal conditions. ICA applied on phantom measurements is an easy and efficient tool for fMRI QC. Additionally, it can protect against misinterpretations of artifact components as human brain activations. Evaluating fMRI QC indices in the central region of a phantom is not always the optimal choice.

Post-Traumatic Stress Disorder among Older Adults Experiencing Motor Vehicle Collision: A Multicenter Prospective Cohort Study.

PubMed

Platts-Mills, Timothy F; Nebolisa, Bo C; Flannigan, Sean A; Richmond, Natalie L; Domeier, Robert M; Swor, Robert A; Hendry, Phyllis L; Peak, David A; Rathlev, Niels K; Jones, Jeffrey S; Lee, David C; Jones, Christopher W; McLean, Samuel A

2017-09-01

To characterize risk factors for and consequences of post-traumatic stress disorder (PTSD) among older adults evaluated in the emergency department (ED) following motor vehicle collision (MVC). Prospective multicenter longitudinal study (2011-2015). 9 EDs across the United States. Adults aged 65 years and older who presented to an ED after MVC without severe injuries. PTSD symptoms were assessed 6 months after the ED visit using the Impact of Event Scale-Revised. Of 223 patients, clinically significant PTSD symptoms at 6 months were observed in 21% (95% CI 16%-26%). PTSD symptoms were more common in patients who did not have a college degree, had depressive symptoms prior to the MVC, perceived the MVC as life-threatening, had severe ED pain, and expected their physical or emotional recovery time to be greater than 30 days. Three factors (ED pain severity [0-10 scale], perceived life-threatening MVC [0-10 scale], and pre-MVC depressive symptoms [yes to either of two questions]), predicted 6-month PTSD symptoms with an area under the curve of 0.76. Compared to patients without PTSD symptoms, those with PTSD symptoms were at higher risk for persistent pain (72% versus 30%), functional decline (67% versus 42%), and new disability (49% versus 18%). Among older adults treated in the ED following MVC, clinically significant PTSD symptoms at 6 months were present in 21% of patients and were associated with adverse health outcomes. Increased risk for PTSD development can be identified with moderate accuracy using information readily available in the ED. Copyright © 2017 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

A Prospective, Holistic, Multicenter Approach to Tracking and Understanding Bloodstream Infections in Pediatric Hematology-Oncology Patients.

PubMed

Gaur, Aditya H; Bundy, David G; Werner, Eric J; Hord, Jeffrey D; Miller, Marlene R; Tang, Li; Lawlor, John P; Billett, Amy L

2017-06-01

OBJECTIVE To assess the burden of bloodstream infections (BSIs) among pediatric hematology-oncology (PHO) inpatients, to propose a comprehensive, all-BSI tracking approach, and to discuss how such an approach helps better inform within-center and across-center differences in CLABSI rate DESIGN Prospective cohort study SETTING US multicenter, quality-improvement, BSI prevention network PARTICIPANTS PHO centers across the United States who agreed to follow a standardized central-line-maintenance care bundle and track all BSI events and central-line days every month. METHODS Infections were categorized as CLABSI (stratified by mucosal barrier injury-related, laboratory-confirmed BSI [MBI-LCBI] versus non-MBI-LCBI) and secondary BSI, using National Healthcare Safety Network (NHSN) definitions. Single positive blood cultures (SPBCs) with NHSN defined common commensals were also tracked. RESULTS Between 2013 and 2015, 34 PHO centers reported 1,110 BSIs. Among them, 708 (63.8%) were CLABSIs, 170 (15.3%) were secondary BSIs, and 232 (20.9%) were SPBCs. Most SPBCs (75%) occurred in patients with profound neutropenia; 22% of SPBCs were viridans group streptococci. Among the CLABSIs, 51% were MBI-LCBI. Excluding SPBCs, CLABSI rates were higher (88% vs 77%) and secondary BSI rates were lower (12% vs 23%) after the NHSN updated the definition of secondary BSI (P<.001). Preliminary analyses showed across-center differences in CLABSI versus secondary BSI and between SPBC and CLABSI versus non-CLABSI rates. CONCLUSIONS Tracking all BSIs, not just CLABSIs in PHO patients, is a patient-centered, clinically relevant approach that could help better assess across-center and within-center differences in infection rates, including CLABSI. This approach enables informed decision making by healthcare providers, payors, and the public. Infect Control Hosp Epidemiol 2017;38:690-696.

Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial.

PubMed

Iwata, Satoshi; Nakata, Shuji; Ukae, Susumu; Koizumi, Yoshitugu; Morita, Yasuyuki; Kuroki, Haruo; Tanaka, Yoshiyuki; Shizuya, Toshiyuki; Schödel, Florian; Brown, Michelle L; Lawrence, Jody

2013-08-01

Rotavirus is the most common cause of severe gastroenteritis in children under 5 y of age. Estimates of disease burden in Japan suggest that between 26,500 and 78,000 children in this age group need hospitalization each year, resulting in a direct medical cost of 10 to 24 billion Yen. Since being introduced in routine infant immunization schedules in the United States in 2006, the oral live pentavalent rotavirus vaccine RV5 (RotaTeq™) has contributed to dramatic reductions in the incidence of rotavirus gastroenteritis (RVGE) and in health care resource utilization. This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of a 3-dose regimen of RV5 in healthy infants, age 6 to 12 weeks, at 32 sites across Japan. The results indicate that RV5 was significantly efficacious in preventing any severity [74.5% (95% confidence interval [CI]: 39.9%, 90.6%; p<0.001)], moderate-to-severe [80.2% (95% CI: 47.4%, 94.1%)], and severe [100% (95% CI: 55.4%, 100%)] RVGE caused by viruses with serotypes contained in the vaccine. The observed cases of RVGE included rotavirus types G1 (n=19), G3 (n=9), G9 (n=5) and one unspecified G serotype with P1A[8]. No G2 or G4 RVGE cases were observed, and this study was not powered to evaluate efficacy against individual serotypes. RV5 was generally safe and well tolerated in Japanese infants. These results are comparable to those observed in clinical studies conducted in other developed countries. Introduction of the vaccine in Japan may reduce disease burden and associated health care costs.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

Impaired default network functional connectivity in autosomal dominant Alzheimer disease

PubMed Central

Chhatwal, Jasmeer P.; Schultz, Aaron P.; Johnson, Keith; Benzinger, Tammie L.S.; Jack, Clifford; Ances, Beau M.; Sullivan, Caroline A.; Salloway, Stephen P.; Ringman, John M.; Koeppe, Robert A.; Marcus, Daniel S.; Thompson, Paul; Saykin, Andrew J.; Correia, Stephen; Schofield, Peter R.; Rowe, Christopher C.; Fox, Nick C.; Brickman, Adam M.; Mayeux, Richard; McDade, Eric; Bateman, Randall; Fagan, Anne M.; Goate, Allison M.; Xiong, Chengjie; Buckles, Virginia D.; Morris, John C.

2013-01-01

Objective: To investigate default mode network (DMN) functional connectivity MRI (fcMRI) in a large cross-sectional cohort of subjects from families harboring pathogenic presenilin-1 (PSEN1), presenilin-2 (PSEN2), and amyloid precursor protein (APP) mutations participating in the Dominantly Inherited Alzheimer Network. Methods: Eighty-three mutation carriers and 37 asymptomatic noncarriers from the same families underwent fMRI during resting state at 8 centers in the United States, United Kingdom, and Australia. Using group-independent component analysis, fcMRI was compared using mutation status and Clinical Dementia Rating to stratify groups, and related to each participant's estimated years from expected symptom onset (eYO). Results: We observed significantly decreased DMN fcMRI in mutation carriers with increasing Clinical Dementia Rating, most evident in the precuneus/posterior cingulate and parietal cortices (p < 0.001). Comparison of asymptomatic mutation carriers with noncarriers demonstrated decreased fcMRI in the precuneus/posterior cingulate (p = 0.014) and right parietal cortex (p = 0.0016). We observed a significant interaction between mutation carrier status and eYO, with decreases in DMN fcMRI observed as mutation carriers approached and surpassed their eYO. Conclusion: Functional disruption of the DMN occurs early in the course of autosomal dominant Alzheimer disease, beginning before clinically evident symptoms, and worsening with increased impairment. These findings suggest that DMN fcMRI may prove useful as a biomarker across a wide spectrum of disease, and support the feasibility of DMN fcMRI as a secondary endpoint in upcoming multicenter clinical trials in Alzheimer disease. PMID:23884042

A Multicenter, Randomnized Controlled Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury

DTIC Science & Technology

2016-10-01

PRINCIPAL INVESTIGATOR: Nicholas Theodore, MD CONTRACTING ORGANIZATION: Dignity Health San Francisco, CA 94107-1773 REPORT DATE: October 2016...nicholas.theodore@bnaneuro.net 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Dignity Health 8. PERFORMING ORGANIZATION REPORT...and query resolution. As new study staff are assigned to the study on the site-level, the CRO provides remote training to familiarize them with the

A Multicenter, Randomized Controlled Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury

DTIC Science & Technology

2015-10-01

Injury PRINCIPAL INVESTIGATOR: Nicholas Theodore, MD CONTRACTING ORGANIZATION: Dignity Health San Francisco, CA 94107-1773 REPORT DATE: October 2015...TASK NUMBER E-Mail: Nicholas.Theodore@bnaneuro.net 5f. WORK UNIT NUMBER 7. PERFORMING ORGANIZATION NAME(S) AND ADDRESS(ES) Dignity Health AND ADDRESS...patients aims to reduce cell death and axonal damage leading to improved neurological function in patients. 2. KEYWORDS acute spinal cord injury

Change in Care Dependency of Stroke Patients: A Longitudinal and Multicenter Study.

PubMed

Nursiswati, Nursiswati; Halfens, Ruud J G; Lohrmann, Christa

2017-06-01

The study was conducted to investigate the change of care dependency in stroke patients from inpatient wards and outpatient units in Indonesia. This study is longitudinal and multicentered. One hundred and nine patients were included from four hospitals on the island of Java. Care dependency was assessed using the Indonesian version of the 15-item Care Dependency Scale (CDS) at five points in time: at inpatient wards for admission and discharge and at outpatient units after discharge in the 1st week, the 5th week, and the 13th week. Most of the patients were male (65.1%), and diagnosed with ischemic stroke (71.5%). The results showed that care dependency in stroke patients decreased significantly from admission to discharge, as well as from the 5th to the 13th week as measured by the CDS. At admission, 23.0% of the patients were completely dependent on care, and at the 13th week about 1.0% were. Patients' care dependency decreased significantly in all care dependency items of the CDS in the inpatient ward, but five care dependency items of the CDS did not significantly decrease in the outpatient unit. Based on the findings of this study, we recommend that hospital-based and community-based services should include continual care dependence monitoring using this comprehensive instrument. Care dependency is subject to change over time, therefore nurses have to plan and tailor adequate nursing care measures to patient needs in the different stages, especially with respect to the aspect of mobility. Copyright © 2017. Published by Elsevier B.V.

The Value of Trainee Networks in Pediatric Surgical Research.

PubMed

Skerritt, Clare; Hall, Nigel J

2015-12-01

In 2007, the first trainee-led surgical research network was founded in the United Kingdom (UK). The West Midlands Research Collaborative was started by a group of enthusiastic adult surgical trainees who saw the benefits of altruistic collaboration to generate high quality, multicenter research. Seeing the success of their research projects, including randomized controlled trials, trainees in other regions and specialties were spurred on to founding their own research collaboratives. The Pediatric Surgical Trainee Research Network was started in 2011 by a group of UK trainees with the aim to promote, facilitate, and encourage trainee-led research in pediatric surgery. This article summarizes the history and evolution of the trainee collaborative surgical research. It examines the challenges which multicenter research entails and the steps the collaboratives have taken to overcome them. We describe some of the projects which have been successfully completed and the benefits that the trainee networks have for patients and surgeons alike. Georg Thieme Verlag KG Stuttgart · New York.

Inter-vender and test-retest reliabilities of resting-state functional magnetic resonance imaging: Implications for multi-center imaging studies.

PubMed

An, Hyeong Su; Moon, Won-Jin; Ryu, Jae-Kyun; Park, Ju Yeon; Yun, Won Sung; Choi, Jin Woo; Jahng, Geon-Ho; Park, Jang-Yeon

2017-12-01

This prospective multi-center study aimed to evaluate the inter-vendor and test-retest reliabilities of resting-state functional magnetic resonance imaging (RS-fMRI) by assessing the temporal signal-to-noise ratio (tSNR) and functional connectivity. Study included 10 healthy subjects and each subject was scanned using three 3T MR scanners (GE Signa HDxt, Siemens Skyra, and Philips Achieva) in two sessions. The tSNR was calculated from the time course data. Inter-vendor and test-retest reliabilities were assessed with intra-class correlation coefficients (ICCs) derived from variant component analysis. Independent component analysis was performed to identify the connectivity of the default-mode network (DMN). In result, the tSNR for the DMN was not significantly different among the GE, Philips, and Siemens scanners (P=0.638). In terms of vendor differences, the inter-vendor reliability was good (ICC=0.774). Regarding the test-retest reliability, the GE scanner showed excellent correlation (ICC=0.961), while the Philips (ICC=0.671) and Siemens (ICC=0.726) scanners showed relatively good correlation. The DMN pattern of the subjects between the two sessions for each scanner and between three scanners showed the identical patterns of functional connectivity. The inter-vendor and test-retest reliabilities of RS-fMRI using different 3T MR scanners are good. Thus, we suggest that RS-fMRI could be used in multicenter imaging studies as a reliable imaging marker. Copyright © 2017 Elsevier Inc. All rights reserved.

Growth hormone treatment of adults with Prader-Willi syndrome and growth hormone deficiency improves lean body mass, fractional body fat, and serum triiodothyronine without glucose impairment: results from the United States multicenter trial.

PubMed

Mogul, Harriette R; Lee, Phillip D K; Whitman, Barbara Y; Zipf, William B; Frey, Michael; Myers, Susan; Cahan, Mindy; Pinyerd, Belinda; Southren, A Louis

2008-04-01

GH replacement in Prader-Willi syndrome (PWS) children has well-defined benefits and risks and is used extensively worldwide. Its use in PWS adults has been limited by documentation of benefits and risks, as determined by larger multisite studies. Our objective was to evaluate the effectiveness and safety of GH in GH-deficient genotype-positive PWS adults. We conducted a 12-month open-label multicenter trial with 6-month dose-optimization and 6-month stable treatment periods. The study was conducted at outpatient treatment facilities at four U.S. academic medical centers. Lean and obese PWS adults with diverse cognitive skills, behavioral traits, and living arrangements were recruited from clinical populations. Human recombinant GH (Genotropin) was initiated at 0.2 mg/d with monthly 0.2-mg increments to a maximum 1.0 mg/d, as tolerated. Lean body mass and percent fat were measured by dual-energy x-ray absorptiometry. Lean body mass increased from 42.65 +/- 2.25 (se) to 45.47 +/- 2.31 kg (P < or = 0.0001), and percent fat decreased from 42.84 +/- 1.12 to 39.95 +/- 1.34% (P = 0.025) at a median final dose of 0.6 mg/d in 30 study subjects who completed 6-12 months of GH. Mean fasting glucose of 85.3 +/- 3.4 mg/dl, hemoglobin A1c of 5.5 +/- 0.2%, fasting insulin of 5.3 +/- 0.6 microU/ml, area under the curve for insulin of 60.4 +/- 7.5 microU/ml, and homeostasis model assessment of insulin resistance of 1.1 +/- 0.2 were normal at baseline in 38 study initiators, including five diabetics, and remained in normal range. Total T(3) increased 26.7% from 127.0 +/- 7.8 to 150.5 +/- 7.8 ng/dl (P = 0.021) with normalization in all subjects, including six (20%) with baseline T(3) values at least 2 sd below the mean. Mildly progressive ankle edema was the most serious treatment-emergent adverse event (five patients). This multicenter study demonstrates that GH improves body composition, normalizes T(3), and is well tolerated without glucose impairment in PWS genotype adults.

[Factors associated with neonatal death in high-risk infants: a multicenter study in High-Risk Neonatal Units in Northeast Brazil].

PubMed

Silva, Cristiana Ferreira da; Leite, Álvaro Jorge Madeiro; Almeida, Nádia Maria Girão Saraiva de; Leon, Antonio Carlos Monteiro Ponce de; Olofin, Ibironke

2014-02-01

This study aimed to identify factors associated with in-hospital mortality in High-Risk Neonatal Units (NICU) belonging to the North-Northeast Perinatal Health Network in Northeast Brazil. The explanatory variables were individual maternal characteristics, prenatal care, childbirth and neonatal care, and infant characteristics. This was a longitudinal, multicenter hospital-based study. The study population consisted of 3,623 live born infants admitted to 34 NICUs. After adjusting for the three hierarchical levels in the model for determination of death in the NICU up to the 27 th day of life, the following showed statistically significant association: type of delivery - cesarean section (OR = 0.72; 95%CI: 0.56-0.95), non-use of prenatal steroids (OR =1.51; 95%CI: 1.01-2.25), preeclampsia (OR = 0.73; 95%CI: 0.56-0.95), oligohydramnios (OR = 1.57; 95%CI: 1, 17-2.10), birth weight < 2500g (OR = 1.40; 95%CI: 1.03-1.90), 5-minute Apgar score < 7 (OR = 2.63; 95%CI: 2.21-3.14), endotracheal intubation (OR = 1.95; 95%CI: 1.31-2.91), and non-use of surfactant (OR = 0.54; 95%CI: 0.43-0.69). Death during NICU care is determined by conditions of the pregnancy, childbirth, and the newborn.

Demographic and epidemiologic characterization of transfusion recipients from four US regions: evidence from the REDS-III recipient database.

PubMed

Karafin, Matthew S; Bruhn, Roberta; Westlake, Matt; Sullivan, Marian T; Bialkowski, Walter; Edgren, Gustaf; Roubinian, Nareg H; Hauser, Ronald G; Kor, Daryl J; Fleischmann, Debra; Gottschall, Jerome L; Murphy, Edward L; Triulzi, Darrell J

2017-12-01

Blood transfusion is one of the most common medical procedures during hospitalization in the United States. To understand the benefits of transfusion while mitigating potential risks, a multicenter database containing detailed information on transfusion incidence and recipient outcomes would facilitate research. The Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) program has developed a comprehensive transfusion recipient database utilizing data from hospital electronic health records at 12 participating hospitals in four geographic regions. Inpatient and outpatient data on transfusion recipients from January 1, 2013 to December 31, 2014 included patient age, sex, ethnicity, primary diagnosis, type of blood product provided, issue location, pretransfusion and post-transfusion hemoglobin (Hgb), and hospital outcomes. Transfusion incidence per encounter was calculated by blood product and various patient characteristics. During the 2-year study period, 80,362 (12.5%) inpatient encounters involved transfusion. Among inpatients, the most commonly transfused blood products were red blood cells (RBCs; 10.9% of encounters), followed by platelets (3.2%) and plasma (2.9%). Among patients who received transfusions, the median number of RBC units was one, the pretransfusion Hgb level was 7.6 g/dL, and the Hgb increment per unit was 1.4 g/dL. Encounter mortality increased with patient age, the number of units transfused, and the use of platelet or plasma products. The most commonly reported transfusion reaction was febrile nonhemolytic. The database contains comprehensive data regarding transfusion use and patient outcomes. The current report describes an evaluation of the first 2 years of a planned, 4-year, linked blood donor-component-recipient database, which represents a critical new resource for transfusion medicine researchers. © 2017 AABB.

Prevalence of Low Cardiovascular Risk Profile Among Diverse Hispanic/Latino Adults in the United States by Age, Sex, and Level of Acculturation: The Hispanic Community Health Study/Study of Latinos.

PubMed

Daviglus, Martha L; Pirzada, Amber; Durazo-Arvizu, Ramon; Chen, Jinsong; Allison, Matthew; Avilés-Santa, Larissa; Cai, Jianwen; González, Hector M; Kaplan, Robert C; Schneiderman, Neil; Sorlie, Paul D; Talavera, Gregory A; Wassertheil-Smoller, Sylvia; Stamler, Jeremiah

2016-08-20

Favorable levels of all readily measurable major cardiovascular disease risk factors (ie, low risk [LR]) are associated with lower risks of cardiovascular disease morbidity and mortality. Data are not available on LR prevalence among Hispanic/Latino adults of diverse ethnic backgrounds. This study aimed to describe the prevalence of a low cardiovascular disease risk profile among Hispanic/Latino adults in the United States and to examine cross-sectional associations of LR with measures of acculturation. The multicenter, prospective, population-based Hispanic Community Health Study/Study of Latinos examined 16 415 men and women aged 18 to 74 years at baseline (2008-2011) with diverse Hispanic/Latino backgrounds. Analyses involved 14 757 adults (mean age 41.3 years; 60.6% women). LR was defined using national guidelines for favorable levels of serum cholesterol, blood pressure, and body mass index and by not having diabetes mellitus and not currently smoking. Age-adjusted LR prevalence was low (8.4% overall; 5.1% for men, 11.2% for women) and varied by background (4.2% in men of Mexican heritage versus 15.0% in women of Cuban heritage). Lower acculturation (assessed using proxy measures) was significantly associated with higher odds of a LR profile among women only: Age-adjusted odds ratios of having LR were 1.64 (95% CI 1.24-2.17) for foreign-born versus US-born women and 1.96 (95% CI 1.49-2.58) for women residing in the United States <10 versus ≥10 years. Among diverse US Hispanic/Latino adults, the prevalence of a LR profile is low. Lower acculturation is associated with higher odds of a LR profile among women but not men. Comprehensive public health strategies are needed to improve the cardiovascular health of US Hispanic/Latino adults. © 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.

Ethical validity of palliative sedation therapy: a multicenter, prospective, observational study conducted on specialized palliative care units in Japan.

PubMed

Morita, Tatsuya; Chinone, Yoshikazu; Ikenaga, Masayuki; Miyoshi, Makoto; Nakaho, Toshimichi; Nishitateno, Kenji; Sakonji, Mitsuaki; Shima, Yasuo; Suenaga, Kazuyuki; Takigawa, Chizuko; Kohara, Hiroyuki; Tani, Kazuhiko; Kawamura, Yasuo; Matsubara, Tatsuhiro; Watanabe, Akihiko; Yagi, Yasuo; Sasaki, Toru; Higuchi, Akiko; Kimura, Hideyuki; Abo, Hirofumi; Ozawa, Taketoshi; Kizawa, Yoshiyuki; Uchitomi, Yosuke

2005-10-01

Although palliative sedation therapy is often required in terminally ill cancer patients to achieve acceptable symptom relief, empirical data supporting the ethical validity of this approach are lacking. The primary aim of this study was to systematically investigate whether empirical evidence supports the ethical validity of sedation. This was a multicenter, prospective, observational study, which was conducted by 21 specialized palliative care units in Japan. One-hundred two consecutive adult cancer patients who received continuous deep sedation were enrolled. Continuous deep sedation was defined as the continuous use of sedative medications to relieve intolerable and refractory distress by achieving almost or complete unconsciousness until death. Prior to the study, we conceptualized the ethical validity of sedation from the viewpoints of physicians' intent, proportionality, and autonomy. Sedation was performed mainly with midazolam and phenobarbital. The initial doses of midazolam and phenobarbital were 1.5 mg/hour and 20 mg/hour, respectively. Main administration routes were continuous subcutaneous infusion and continuous intravenous infusion, and no rapid intravenous injection was reported. Of 59 patients who received artificial hydration or could intake adequate fluids/foods orally before sedation, 63% received artificial hydration therapy after sedation, and in the remaining patients, artificial hydration was withheld or withdrawn due to fluid retention symptoms and/or patient wishes. Of 66 patients who were able to verbally express themselves, 95% explicitly stated that symptoms were intolerable. The etiologies of the symptoms requiring sedation were primarily related to the progression of the underlying malignancy, such as cancer cachexia and organ failure, and standard palliative treatments had failed: steroids in 68% of patients with fatigue, opioids in 95% of patients with dyspnea, antisecretion medications in 75% of patients with bronchial secretion, antipsychotic medications in 74% of patients with delirium, and opioids in all patients with pain. On the basis of the Palliative Prognostic Index, 94% of the patients were predicted to die within 3 weeks. Before sedation, 67% of the patients expressed explicit wishes for sedation. In the remaining 34 patients, previous wishes for sedation were noted in 4 patients, and in the other 30 patients, the families were involved in the decision-making process. The chief reason for patient non-involvement in the decision making was cognitive impairment. These data indicate that palliative sedation therapy performed in specialized palliative care units in Japan generally followed the principles of double effect, proportionality, and autonomy.

Job Satisfaction and Associated Factors among Anesthetists Working in Amhara National Regional State, Northwest Ethiopia, May 2017: A Multicenter Cross-Sectional Study.

PubMed

Yilkal Fentie, Demeke; Enyew Ashagrie, Henos; Getinet Kasahun, Habtamu

2018-01-01

Job satisfaction is an important determinant of health staff's motivation, retention, and performance. Difficulties in critical decision-making and problems with lack of respect and recognition lead to lower job satisfaction level among anesthetists. It leads to high turnover intention, dropout from the profession, burnout, impaired health status of anesthetists, and lower work performance. The aim of this multicenter cross-sectional study was to assess the level of job satisfaction and associated factors among anesthetists working in Amhara National Regional State. A multicenter cross-sectional study was conducted from April 1 to June 30, 2017. Ninety-eight anesthetists that were working in Amhara National Regional State Hospitals were involved in this study. The structured questionnaire was scored on five-point Likert scales. Data were analyzed using Statistical Package for Social Sciences version 20. Binary logistic regression was used to measure statistical significance between dependent and each independent variable. Variables with P value of ≤0.2 on crude analysis were taken into multivariate analysis, and P value 0.05 and 95% CI was used as cut off point. 98 out of 104 participants were involved in this study with a response rate of 94.3%. The overall level of job satisfaction was 46.9%. Anesthetists in academic working position were satisfied with the odds of about 2.3 (AOR = 2.269; CI = 1.137-6.740) compared to those in clinical working position. Anesthetists were least satisfied with coworker relationships (37.8%), work schedule (43.9%), professional opportunity (46.9%), and recognition (49%) while they were most satisfied from their control of responsibility (59.2%), social interaction (55%), and salary and benefits (51%). Job satisfaction of anesthetists was low, and we suggest that facilitation of professional development, creation of smooth relationship in working environment, increasing the number of anesthetists, and recognition of the anesthesia professional are of paramount importance to increase job satisfaction of anesthetists.

The efficacy and resource utilization of remifentanil and fentanyl in fast-track coronary artery bypass graft surgery: a prospective randomized, double-blinded controlled, multi-center trial.

PubMed

Cheng, D C; Newman, M F; Duke, P; Wong, D T; Finegan, B; Howie, M; Fitch, J; Bowdle, T A; Hogue, C; Hillel, Z; Pierce, E; Bukenya, D

2001-05-01

We compared (a) the perioperative complications; (b) times to eligibility for, and actual time of the following: extubation, less intense monitoring, intensive care unit (ICU), and hospital discharge; and (c) resource utilization of nursing ratio for patients receiving either a typical fentanyl/isoflurane/propofol regimen or a remifentanil/isoflurane/propofol regimen for fast-track cardiac anesthesia in 304 adults by using a prospective randomized, double-blinded, double-dummy trial. There were no differences in demographic data, or perioperative mortality and morbidity between the two study groups. The mini-mental status examination at postoperative Days 1 to 3 were similar between the two groups. The eligible and actual times for extubation, less intense monitoring, ICU discharge, and hospital discharge were not significantly different. Further analyses revealed no differences in times for extubation and resource utilization after stratification by preoperative risk scores, age, and country. The nurse/patient ratio was similar between the remifentanil/isoflurane/propofol and fentanyl/isoflu-rane/propofol groups during the initial ICU phase and less intense monitoring phase. Increasing preoperative risk scores and older age (>70 yr) were associated with longer times until extubation (eligible), ICU discharge (eligible and actual), and hospital discharge (eligible and actual). Times until extubation (eligible and actual) and less intense monitoring (eligible) were significantly shorter in Canadian patients than United States' patients. However, there was no difference in hospital length of stay in Canadian and United States' patients. We conclude that both anesthesia techniques permit early and similar times until tracheal extubation, less intense monitoring, ICU and hospital discharge, and reduced resource utilization after coronary artery bypass graft surgery. An ultra-short opioid technique was compared with a standard fast-track small-dose opioid technique in coronary artery bypass graft patients in a prospective randomized, double-blinded controlled study. The postoperative recovery and resource utilization, including stratification of preoperative risk score, age, and country, were analyzed.

Inclusion and definition of acute renal dysfunction in critically ill patients in randomized controlled trials: a systematic review.

PubMed

da Hora Passos, Rogerio; Ramos, Joao Gabriel Rosa; Gobatto, André; Caldas, Juliana; Macedo, Etienne; Batista, Paulo Benigno

2018-04-24

In evidence-based medicine, multicenter, prospective, randomized controlled trials (RCTs) are the gold standard for evaluating treatment benefits and ensuring the effectiveness of interventions. Patient-centered outcomes, such as mortality, are most often the preferred evaluated outcomes. While there is currently agreement on how to classify renal dysfunction in critically ill patients , the application frequency of this new classification system in RCTs has not previously been evaluated. In this study, we aim to assess the definition of renal dysfunction in multicenter RCTs involving critically ill patients that included mortality as a primary endpoint. A comprehensive search was conducted for publications reporting multicenter randomized controlled trials (RCTs) involving adult patients in intensive care units (ICUs) that included mortality as a primary outcome. MEDLINE and PUBMED were queried for relevant articles in core clinical journals published between May 2004 and December 2017. Of 418 articles reviewed, 46 multicenter RCTs with a primary endpoint related to mortality were included. Thirty-six (78.3%) of the trial reports provided information on renal function in the participants. Only seven articles (15.2%) included mean or median serum creatinine levels, mean creatinine clearance or estimated glomerular filtration rates. Sequential organ failure assessment (SOFA) score was the most commonly used definition of renal dysfunction (20 studies; 43.5%). Risk, Injury, Failure, Loss, End-stage renal disease (RIFLE), Acute Kidney Injury Network (AKIN) and Kidney Disease Improving Global Outcomes (KDIGO) criteria were used in five (10.9%) trials. In thirteen trials (28.3%), no renal dysfunction criteria were reported. Only one trial excluded patients with renal dysfunction, and it used urinary output or need for renal replacement therapy (RRT) as criteria for this diagnosis. The presence of renal dysfunction was included as a baseline patient characteristic in most RCTs. The RIFLE, AKIN and KDIGO classification systems were infrequently used; renal dysfunction was generally defined using the SOFA score.

A Prospective Multi-Center Audit of Nutrition Support Parameters Following Burn Injury.

PubMed

Kurmis, Rochelle; Heath, Kathryn; Ooi, Selena; Munn, Zachary; Forbes, Sharon; Young, Vicki; Rigby, Paul; Wood, Kate; Phillips, Frances; Greenwood, John

2015-01-01

The importance of nutrition support delivery to the severe burn-injured patient is well recognized, however, nutrition provision to the patient may be sub optimal in practice. The aim of this study was to conduct a prospective multi-center audit across Australia and New Zealand using the Joanna Briggs Institute Burns Node Nutrition audit criteria. Thirty-four patients with severe burn injury (≥20% TBSA in adults and ≥10% TBSA in children) were identified on admission or on referral to the Dietitian at the eight participating Burn Units between February 1, 2012 and April 30, 2012 for inclusion in the study. De-identified patient data was analyzed using the Joanna Briggs Institute, Practical Application of Clinical Evidence System. Compliance with individual audit criterion ranged from 33 to 100%. Provision of prescribed enteral feed volumes and weekly weighing of patients were highlighted as key areas for clinical improvement. Clinical audit is a valuable tool for evaluating current practice against best evidence to ensure that quality patient care is delivered. The use of the Joanna Briggs Institute Burns Node audit criteria has allowed for a standardized multi-center audit to be conducted. Improving nutrition support delivery in burn patients was identified as a key area requiring ongoing clinical improvement across Australia and New Zealand. Clinician feedback on use of the audit criteria will allow for future refinement of individual criterion, and presentation of results of this audit has resulted in a review of the Bi-National Burns Registry nutrition quality indicators.

Prospective Validation of Objective Prognostic Score for Advanced Cancer Inpatients in South Korea: A Multicenter Study.

PubMed

Yoon, Seok Joon; Suh, Sang-Yeon; Lee, Yong Joo; Park, Jeanno; Hwang, Sunwook; Lee, Sanghee Shiny; Ahn, Hong Yup; Koh, Su-Jin; Park, Keon Uk

2017-01-01

Objective Prognostic Score (OPS) was developed as an easy and simple prognosticating tool in South Korea. It has been validated retrospectively in a single center in South Korea. We aimed to validate the OPS prospectively for advanced cancer inpatients in South Korea using a multicenter study. This was a prospective cohort study. We enrolled 243 advanced cancer patients admitted in five palliative care units in South Korea from May 2013 till March 2015. Seven members of the Korean Palliative Medicine Research Network who are experts of palliative care led the study. Clinical variables (dyspnea/anorexia/performance status) and laboratory variables (total leukocyte counts/serum total bilirubin/serum creatinine/lactate dehydrogenase) were collected at the enrollment. Survival time was calculated as days from enrollment to death during admission. A total of 217 patients were included in the final analysis (feasibility: 89.3%). Survival time of the higher OPS group (OPS ≥3) and the lower OPS group (OPS <3) was 10.0 (95% confidence interval (CI) 7.72-12.28) days and 32.0 (95% CI 25.44-38.56) days, respectively. There were significant differences between the 2 groups (p < 0.001). Overall accuracy of OPS ≥3 for predicting survival less than three weeks was 71.0%. OPS was successfully validated using a prospective multicenter study in South Korea. It is a useful method to predict three-week survival of Korean inpatients with advanced cancer.

Transfusion Requirement in Burn Care Evaluation (TRIBE): A Multicenter Randomized Prospective Trial of Blood Transfusion in Major Burn Injury.

PubMed

Palmieri, Tina L; Holmes, James H; Arnoldo, Brett; Peck, Michael; Potenza, Bruce; Cochran, Amalia; King, Booker T; Dominic, William; Cartotto, Robert; Bhavsar, Dhaval; Kemalyan, Nathan; Tredget, Edward; Stapelberg, Francois; Mozingo, David; Friedman, Bruce; Greenhalgh, David G; Taylor, Sandra L; Pollock, Brad H

2017-10-01

Our objective was to compare outcomes of a restrictive to a liberal red cell transfusion strategy in 20% or more total body surface area (TBSA) burn patients. We hypothesized that the restrictive group would have less blood stream infection (BSI), organ dysfunction, and mortality. Patients with major burns have major (>1 blood volume) transfusion requirements. Studies suggest that a restrictive blood transfusion strategy is equivalent to a liberal strategy. However, major burn injury is precluded from these studies. The optimal transfusion strategy in major burn injury is thus needed but remains unknown. This prospective randomized multicenter trial block randomized patients to a restrictive (hemoglobin 7-8 g/dL) or liberal (hemoglobin 10-11 g/dL) transfusion strategy throughout hospitalization. Data collected included demographics, infections, transfusions, and outcomes. Eighteen burn centers enrolled 345 patients with 20% or more TBSA burn similar in age, TBSA burn, and inhalation injury. A total of 7054 units blood were transfused. The restrictive group received fewer blood transfusions: mean 20.3 ± 32.7 units, median = 8 (interquartile range: 3, 24) versus mean 31.8 ± 44.3 units, median = 16 (interquartile range: 7, 40) in the liberal group (P < 0.0001, Wilcoxon rank sum). BSI incidence, organ dysfunction, ventilator days, and time to wound healing (P > 0.05) were similar. In addition, there was no 30-day mortality difference: 9.5% restrictive versus 8.5% liberal (P = 0.892, χ test). A restrictive transfusion strategy halved blood product utilization. Although the restrictive strategy did not decrease BSI, mortality, or organ dysfunction in major burn injury, these outcomes were no worse than the liberal strategy (Clinicaltrials.gov identifier NCT01079247).

Pharmacist-driven antimicrobial stewardship in intensive care units in East China: A multicenter prospective cohort study.

PubMed

Li, Zhongwang; Cheng, Baoli; Zhang, Kai; Xie, Guohao; Wang, Yan; Hou, Jinchao; Chu, Lihua; Zhao, Jialian; Xu, Zhijun; Lu, Zhongqiu; Sun, Huaqin; Zhang, Jian; Wang, Zhiyi; Wu, Haiya; Fang, Xiangming

2017-09-01

Antimicrobial stewardship programs, particularly pharmacist-driven programs, help reduce the unnecessary use of antimicrobial agents. The objective of this study was to assess the influence of pharmacist-driven antimicrobial stewardship on antimicrobial use, multidrug resistance, and patient outcomes in adult intensive care units in China. We conducted a multicenter prospective cohort study with a sample of 577 patients. A total of 353 patients were included under a pharmacist-driven antimicrobial stewardship program, whereas the remaining 224 patients served as controls. The primary outcome was all-cause hospital mortality. The pharmacist-driven antimicrobial stewardship program had a lower hospital mortality rate compared with the nonpharmacist program (19.3% vs 29.0%; P = .007). Furthermore, logistic regression analysis indicated that the pharmacist-driven program independently predicted hospital mortality (odds ratio, 0.57; 95% confidence interval, 0.36-0.91; P = .017) after adjustment. Meanwhile, this strategy had a lower rate of multidrug resistance (23.8% vs 31.7%; P = .037). Moreover, the strategy optimized antimicrobial use, such as having a shorter duration of empirical antimicrobial therapy (2.7 days; interquartile range [IQR], 1.7-4.6 vs 3.0; IQR, 1.9-6.2; P = .002) and accumulated duration of antimicrobial treatment (4.0; IQR, 2.0-7.0 vs 5.0; IQR, 3.0-9.5; P = .030). Pharmacist-driven antimicrobial stewardship in an intensive care unit decreased patient mortality and the emergence of multidrug resistance, and optimized antimicrobial agent use. Copyright © 2017 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Clinical Utilisation and Usefullness of the Rating Scale of Mixed States, ("Gt-Msrs"): a Multicenter Study.

PubMed

Tavormina, Giuseppe; Franza, Francesco; Stranieri, Giuseppe; Juli, Luigi; Juli, Maria Rosaria

2017-09-01

The rating scale "G.T. MSRS" has been designed to improve the clinical effectiveness of the clinician psychiatrists, by enabling them to make an early "general" diagnosis of mixed states. The knowledge of the clinical features of the mixed states and of the symptoms of the "mixity" of mood disorders is crucial: to mis-diagnose or mis-treat patients with these symptoms may increase the suicide risk and make worse the evolution of mood disorders going to the dysphoric state. This study is the second validation study of the "G.T. MSRS" rating scale, in order to demonstrate its usefullness.

Computed Tomography Aortic Valve Calcium Scoring in Patients With Aortic Stenosis.

PubMed

Pawade, Tania; Clavel, Marie-Annick; Tribouilloy, Christophe; Dreyfus, Julien; Mathieu, Tiffany; Tastet, Lionel; Renard, Cedric; Gun, Mesut; Jenkins, William Steven Arthur; Macron, Laurent; Sechrist, Jacob W; Lacomis, Joan M; Nguyen, Virginia; Galian Gay, Laura; Cuéllar Calabria, Hug; Ntalas, Ioannis; Cartlidge, Timothy Robert Graham; Prendergast, Bernard; Rajani, Ronak; Evangelista, Arturo; Cavalcante, João L; Newby, David E; Pibarot, Philippe; Messika Zeitoun, David; Dweck, Marc R

2018-03-01

Computed tomography aortic valve calcium scoring (CT-AVC) holds promise for the assessment of patients with aortic stenosis (AS). We sought to establish the clinical utility of CT-AVC in an international multicenter cohort of patients. Patients with AS who underwent ECG-gated CT-AVC within 3 months of echocardiography were entered into an international, multicenter, observational registry. Optimal CT-AVC thresholds for diagnosing severe AS were determined in patients with concordant echocardiographic assessments, before being used to arbitrate disease severity in those with discordant measurements. In patients with long-term follow-up, we assessed whether CT-AVC thresholds predicted aortic valve replacement and death. In 918 patients from 8 centers (age, 77±10 years; 60% men; peak velocity, 3.88±0.90 m/s), 708 (77%) patients had concordant echocardiographic assessments, in whom CT-AVC provided excellent discrimination for severe AS (C statistic: women 0.92, men 0.89). Our optimal sex-specific CT-AVC thresholds (women 1377 Agatston unit and men 2062 Agatston unit) were nearly identical to those previously reported (women 1274 Agatston unit and men 2065 Agatston unit). Clinical outcomes were available in 215 patients (follow-up 1029 [126-2251] days). Sex-specific CT-AVC thresholds independently predicted aortic valve replacement and death (hazard ratio, 3.90 [95% confidence interval, 2.19-6.78]; P <0.001) after adjustment for age, sex, peak velocity, and aortic valve area. Among 210 (23%) patients with discordant echocardiographic assessments, there was considerable heterogeneity in CT-AVC scores, which again were an independent predictor of clinical outcomes (hazard ratio, 3.67 [95% confidence interval, 1.39-9.73]; P =0.010). Sex-specific CT-AVC thresholds accurately identify severe AS and provide powerful prognostic information. These findings support their integration into routine clinical practice. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01358513, NCT02132026, NCT00338676, NCT00647088, NCT01679431. © 2018 American Heart Association, Inc.

A Comparison of Environmental Contamination by Patients Infected or Colonized with Methicillin-Resistant Staphylococcus aureus or Vancomycin-Resistant Enterococci: A Multicenter Study

PubMed Central

Knelson, Lauren P.; Williams, David A.; Gergen, Maria F.; Rutala, William A.; Weber, David J.; Sexton, Daniel J.; Anderson, Deverick J.

2014-01-01

A total of 1,023 environmental surfaces were sampled from 45 rooms with patients infected or colonized with methicillin-resistant Staphylococcus aureus (MRSA) or vancomycin-resistant enterococci (VRE) before terminal room cleaning. Colonized patients had higher median total target colony-forming units (CFU) of MRSA or VRE than did infected patients (median, 25 CFU [interquartile range, 0–106 CFU] vs 0 CFU [interquartile range, 0–29 CFU]; P = .033). PMID:24915217

Blood donations from previously transfused or pregnant donors: a multicenter study to determine the frequency of alloexposure.

PubMed

Rios, Jorge A; Schlumpf, Karen S; Kakaiya, Ram M; Triulzi, Darrell J; Roback, John D; Kleinman, Steve H; Murphy, Edward L; Gottschall, Jerome L; Carey, Patricia M

2011-06-01

Transfusion-related acute lung injury (TRALI) mitigation strategies include the deferral of female donors from apheresis platelet (PLT) donations and the distribution of plasma for transfusion from male donors only. We studied the implications of these policies in terms of component loss at six blood centers in the United States. We collected data from allogeneic blood donors making whole blood and blood component donations during calendar years 2006 through 2008. We analyzed the distribution of donations in terms of the sex, transfusion and pregnancy histories, and blood type. A TRALI mitigation policy that would not allow plasma from female whole blood donors to be prepared into transfusable plasma components would result in nearly a 50% reduction in the units of whole blood available for plasma manufacturing and would decrease the number of type AB plasma units that could be made from whole blood donations by the same amount. Deferral of all female apheresis PLT donors, all female apheresis PLT donors with histories of prior pregnancies, or all female apheresis PLT donors with histories of prior pregnancies and positive screening test results for antibodies to human leukocyte antigens (HLAs) will result in a loss of 37.1, 22.5, and 5.4% of all apheresis PLT donations, respectively. A TRALI mitigation policy that only defers female apheresis PLT donors with previous pregnancies and HLAs would result in an approximately 5% decrease in the inventory of apheresis PLTs, but would eliminate a large proportion of components that are associated with TRALI. © 2010 American Association of Blood Banks.

Inherited metabolic disorders in Thailand.

PubMed

Wasant, Pornswan; Svasti, Jisnuson; Srisomsap, Chantragan; Liammongkolkul, Somporn

2002-08-01

The study of inborn errors of metabolism (IEM) in Thailand is in its infancy. The majority are clinically diagnosed since there are only a handful of clinicians and scientists with expertise in inherited metabolic disorders, shortage of well-equipped laboratory facilities and lack of governmental financial support. Genetic metabolic disorders are usually not considered a priority due to prevalence of infectious diseases and congenital infections. From a retrospective study at the Medical Genetics Unit, Department of Pediatrics, Siriraj Hospital; estimated pediatrics patients with suspected IEM were approximately 2-3 per cent of the total pediatric admissions of over 5,000 annually. After more than 10 years of research and accumulated clinical experiences, a genetic metabolic center is being established in collaboration with expert laboratories both in Bangkok (Chulabhorn Research Institute) and abroad (Japan and the United States). Numerous inherited metabolic disorders were identified--carbohydrate, amino acids, organic acids, mitochondrial fatty acid oxidation, peroxisomal, mucopolysaccharidoses etc. This report includes the establishment of genetic metabolic center in Thailand, research and pilot studies in newborn screening in Thailand and a multicenter study from 5 institutions (Children's National Center, King Chulalongkorn Memorial Hospital, Pramongkutklao Hospital, Ramathibodi and Siriraj Hospitals). Inherited metabolic disorders reported are fructose-1,6-bisphosphatase deficiency, phenylketonuria, homocystinuria, nonketotic hyperglycinemia, urea cycle defect (arginino succinate lyase deficiency, argininosuccinate synthetase deficiency), Menkes disease, propionic acidemia and mucopolysaccharidoses (Hurler, Hurler-Scheie).

Listening to Girls and Boys Talk about Girls' Physical Activity Behaviors

ERIC Educational Resources Information Center

Vu, Maihan B.; Murrie, Dale; Gonzalez, Vivian; Jobe, Jared B.

2006-01-01

As part of the formative assessment for the Trial of Activity for Adolescent Girls (TAAG), a multicenter study to reduce the decline of physical activity in adolescent girls, girls and boys with diverse ethnicity from six states participated in focus groups and semistructured interviews. Data from 13 girls' focus groups (N = 100), 11 boys' focus…

Looking to a future of improved diabetes management: interview with Professor Steve Bain.

PubMed

Bain, Steve

2016-12-01

Steve Bain talks to Francesca Lake, Managing Editor: Steve is currently a Professor at Swansea University Medical School (Wales), Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Unit, Wales. His clinical training included research into the genetics of Type 1 diabetes, with his current clinical interests surrounding exercise in Type 1 diabetes, new therapies and the provision of diabetes services. His background has led him to be Principal Investigator for several multicenter trials, and to be involved in various ethical committees concerning genetics. He led the UK Human Genetics Commission's report on DNA testing in 2009, and in 2007 was invited to sit on the National DNA Database Ethics Group, established by the Secretary of State for the Home Department. Steve is also a member of the Wales Diabetes & Endocrine Society executive committee and chairs the Specialist Training Committee for Diabetes & Endocrinology for Wales. He also chairs the Board that oversees the Institute of Life Science Joint Clinical Research Facility, the premier clinical research institute in Wales.

Decreasing prematurity in twin gestations: predicaments and possibilities.

PubMed

Zork, Noelia; Biggio, Joseph; Tita, Alan; Rouse, Dwight; Gyamfi-Bannerman, Cynthia

2013-08-01

The twin birth rate has been steadily increasing in the United States over the past 10 years attributable in large part to the increased use of reproductive technologies. Despite advancements in the prevention of preterm labor for singletons, the overall rate of preterm birth has decreased only minimally. Several interventions to prevent preterm birth in twins have been studied, but none has proven effective. Inpatient bedrest has not been shown to be effective and can cause significant maternal morbidity. Although intramuscular 17α-hydroxyprogesterone caproate is effective in decreasing the risk of recurrent preterm delivery in singletons, neither it nor cerclage is effective in twin gestations, even in those with a short cervix. However, small trials, subgroup analyses, and a meta-analysis suggest that vaginal progesterone and the Arabin cervical pessary may reduce rates of preterm birth in twins of mothers with a short cervix. Given the current lack of effective therapies to prevent preterm birth in twins, large multicenter trials are needed to assess the effectiveness of vaginal progesterone and pessary in twins of mothers with a short cervix.

Characterization of Childhood Obesity and Behavioral Factors.

PubMed

Olson, Jessica; Aldrich, Heather; Callahan, Tiffany J; Matthews, Ellyn E; Gance-Cleveland, Bonnie

2016-01-01

Childhood obesity is a major public health threat in the United States. Recent data indicate that 34.2% of children ages 6 to 11 years are overweight or obese. The purpose of this study is to describe childhood obesity levels and identify risk behaviors in two school-based health centers in Michigan, one urban and one rural. This study is a secondary data analysis from a multicenter comparative effectiveness trial. Multiple logistic regression was used to examine behavioral factors associated with overweight/obesity in children. In this sample (n = 105), 41.9% were obese and 16.2% were overweight. The duration of sleep per night (p = .04) and the frequency of eating breakfast (p = .04) were significant predictors of being overweight/obese. Health care providers in school-based health centers must be comfortable assessing, preventing, and treating childhood obesity in this high-risk group of patients. Interventions should encourage children to eat breakfast daily and to get adequate sleep. Copyright © 2015 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Complications related to a cosmetic eye-whitening procedure.

PubMed

Vo, Rosalind C; Stafeeva, Ksenia; Aldave, Anthony J; Stulting, R Doyle; Moore, Quianta; Pflugfelder, Stephen C; Chungfat, Neil C; Holsclaw, Douglas S; Margolis, Todd P; Deng, Sophie X

2014-11-01

To report sight-threatening complications following extensive bulbar conjunctival resection and postoperative mitomycin C therapy for cosmetic eye-whitening in the United States. Retrospective noncomparative case series. Multicenter report of 9 patients referred for evaluation and management of complications following bilateral cosmetic eye whitening. Seventeen eyes of 9 patients underwent cosmetic eye-whitening performed between 2 and 48 months prior to referral to one of the centers. Sixteen of the 17 eyes had persistent conjunctival epithelial defects, with 10 eyes requiring amniotic membrane grafting to facilitate re-epithelialization. Four eyes of 2 patients developed limbal stem cell compromise confirmed with in vivo confocal laser scanning microscopy. One patient developed infectious scleritis and diplopia resulting from Tenon capsule scarring. Another patient developed scleral necrosis, secondary infectious scleritis, and infectious endophthalmitis. This patient subsequently developed noninfectious scleritis that required 3-drug-regimen immunosuppression. Severe adverse effects can occur after extensive cosmetic conjunctival resection followed by topical mitomycin C application. Patients and physicians should be aware of the potential sight-threatening complications associated with this eye-whitening procedure. Published by Elsevier Inc.

Knowledge about epilepsy in university health students: A multicenter study.

PubMed

Souza, Priscila; Portes, Leslie A; Thomas, Robert K; Bonito, Jorge R; Rua, Marilia; Pacheco, Fabio J; Plaatjes, Phillip; Oliveira, Natalia C

2018-02-01

Even with economic development and improvements in health care around the world, it is estimated that nowadays, 50 million people have epilepsy. It is one of the most prevalent neurological diseases, yet it is still surrounded by prejudice, stigma, lack of awareness, and wrong attitudes of the population towards the disease. The aim of this study was to evaluate and compare the knowledge about epilepsy in health students from different countries: Brazil, Argentina, Portugal, United States, and South Africa. Students were asked to complete a survey regarding knowledge about epilepsy (the Epilepsy Knowledge Questionnaire). One hundred and two students participated, 62.2% of them were female. Portuguese students had significantly higher values than the American ones (p=0.025). Regarding the medical aspects, on average, students hit 63.8% of the questions, and the students from Portugal had significantly higher average than the ones from the United States (p=0.0007). Statements with lower percent of correct answers were about pathophysiology, medication, and treatment of the disease. There were no differences between the scores obtained by the students of each country in the social aspects of the disease. Statements with higher percent of mistakes were about sports practice, labor, proceedings in case of convulsion, and ability to drive vehicles. General knowledge of senior health students about epilepsy was considered low, however, regarding the medical aspects of the disease, students from Brazil and Portugal exhibited a slightly superior knowledge. Changing the way of seeing and treating people with epilepsy brings, as a consequence, increased opportunities for these people in different sectors of society. Copyright © 2017 Elsevier Inc. All rights reserved.

Bordetella pertussis is an uncommon pathogen in children hospitalized with bronchiolitis during the winter season.

PubMed

Piedra, Pedro A; Mansbach, Jonathan M; Jewell, Alan M; Thakar, Sneha D; Grant, Cameron C; Sullivan, Ashley F; Espinola, Janice A; Camargo, Carlos A

2015-06-01

In the United States (U.S.), Bordetella pertussis incidence has increased. Cough and apnea are common findings in pertussis and also in bronchiolitis, the most common cause of hospitalization in U.S. infants. The objective was to determine the prevalence of B. pertussis infection in children hospitalized with bronchiolitis and to describe its clinical course. Children hospitalized with bronchiolitis and age <2 years were eligible for a prospective, multicenter cohort study during 3 consecutive winter seasons (November-March) from 2007 to 2010. Sixteen sites in 12 states participated using a standardized enrollment protocol. Families were asked the 2010 Centers for Disease Control and Prevention pertussis classification questions. Nasopharyngeal aspirates were obtained and tested by real-time polymerase chain reaction for 16 viruses, Mycoplasma pneumoniae and B. pertussis. Two thousand sixty-eight (94%) of 2207 children had 1 or more respiratory pathogens. B. pertussis was identified in 4 children [0.2%; 95% confidence interval (CI): 0.1-0.5%] with 3 having a viral co-infection. All 4 were younger than 4 months; 2 met the Centers for Disease Control and Prevention definition of probable pertussis; and 3 had received at least 1 dose of an acellular pertussis vaccine. During the hospitalization, 2 had paroxysmal cough, 1 required intensive care unit care and the median length of stay was 13 days. Our data support that B. pertussis is an uncommon pathogen in U.S. children hospitalized with bronchiolitis in the winter. Making a diagnosis of pertussis can be challenging because the disease can be atypical and may not meet the Centers for Disease Control and Prevention definition of probable infection.

Benefits Analysis of Multi-Center Dynamic Weather Routes

NASA Technical Reports Server (NTRS)

Sheth, Kapil; McNally, David; Morando, Alexander; Clymer, Alexis; Lock, Jennifer; Petersen, Julien

2014-01-01

Dynamic weather routes are flight plan corrections that can provide airborne flights more than user-specified minutes of flying-time savings, compared to their current flight plan. These routes are computed from the aircraft's current location to a flight plan fix downstream (within a predefined limit region), while avoiding forecasted convective weather regions. The Dynamic Weather Routes automation has been continuously running with live air traffic data for a field evaluation at the American Airlines Integrated Operations Center in Fort Worth, TX since July 31, 2012, where flights within the Fort Worth Air Route Traffic Control Center are evaluated for time savings. This paper extends the methodology to all Centers in United States and presents benefits analysis of Dynamic Weather Routes automation, if it was implemented in multiple airspace Centers individually and concurrently. The current computation of dynamic weather routes requires a limit rectangle so that a downstream capture fix can be selected, preventing very large route changes spanning several Centers. In this paper, first, a method of computing a limit polygon (as opposed to a rectangle used for Fort Worth Center) is described for each of the 20 Centers in the National Airspace System. The Future ATM Concepts Evaluation Tool, a nationwide simulation and analysis tool, is used for this purpose. After a comparison of results with the Center-based Dynamic Weather Routes automation in Fort Worth Center, results are presented for 11 Centers in the contiguous United States. These Centers are generally most impacted by convective weather. A breakdown of individual Center and airline savings is presented and the results indicate an overall average savings of about 10 minutes of flying time are obtained per flight.

Clinical validation of an epigenetic assay to predict negative histopathological results in repeat prostate biopsies.

PubMed

Partin, Alan W; Van Neste, Leander; Klein, Eric A; Marks, Leonard S; Gee, Jason R; Troyer, Dean A; Rieger-Christ, Kimberly; Jones, J Stephen; Magi-Galluzzi, Cristina; Mangold, Leslie A; Trock, Bruce J; Lance, Raymond S; Bigley, Joseph W; Van Criekinge, Wim; Epstein, Jonathan I

2014-10-01

The DOCUMENT multicenter trial in the United States validated the performance of an epigenetic test as an independent predictor of prostate cancer risk to guide decision making for repeat biopsy. Confirming an increased negative predictive value could help avoid unnecessary repeat biopsies. We evaluated the archived, cancer negative prostate biopsy core tissue samples of 350 subjects from a total of 5 urological centers in the United States. All subjects underwent repeat biopsy within 24 months with a negative (controls) or positive (cases) histopathological result. Centralized blinded pathology evaluation of the 2 biopsy series was performed in all available subjects from each site. Biopsies were epigenetically profiled for GSTP1, APC and RASSF1 relative to the ACTB reference gene using quantitative methylation specific polymerase chain reaction. Predetermined analytical marker cutoffs were used to determine assay performance. Multivariate logistic regression was used to evaluate all risk factors. The epigenetic assay resulted in a negative predictive value of 88% (95% CI 85-91). In multivariate models correcting for age, prostate specific antigen, digital rectal examination, first biopsy histopathological characteristics and race the test proved to be the most significant independent predictor of patient outcome (OR 2.69, 95% CI 1.60-4.51). The DOCUMENT study validated that the epigenetic assay was a significant, independent predictor of prostate cancer detection in a repeat biopsy collected an average of 13 months after an initial negative result. Due to its 88% negative predictive value adding this epigenetic assay to other known risk factors may help decrease unnecessary repeat prostate biopsies. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Clinical trials for drug registrations in Asian-Pacific countries: proposal for a new paradigm from a statistical perspective.

PubMed

Shih, W J

2001-08-01

The world has become more interdependent in the movement of free trade and global markets. The regulations for approval of new drugs in the Asian markets have always been an important issue in the free trade negotiation between the U.S.- and E.U.-based international manufacturers and the Asian-Pacific countries, since pharmaceuticals are of large trade value for them. In 1998 the University of Hong Kong and the Singapore National Medical Research Council jointly hosted the first Asian Clinical Trials Conference. The Society for Clinical Trials was invited as a collaborator for the event, which signified a milestone for interaction between the East and West in the discussion of clinical trials. Many have participated in the discussion of drug approval and registration issues for the Asian region based on the drug development experience in the United States. However, there are many interesting differences between the two regions, which lead to different approval processes for new drugs developed by the U.S.- and E.U.-based international manufacturers. This article highlights some regulatory dilemmas and some key statistical concepts pertinent to these differences. The purpose of this paper is to resolve the regional regulatory and scientific dilemma. A new paradigm of sample size design and data analysis for drug approval for countries in the Asian-Pacific region is proposed. The central premise is that substantial information from multicenter studies has already shown efficacy in the United States or the European Union when a drug manufacturer seeks marketing approval in an Asian country. This leads to the idea of a "consistency trial" using the method of Bayesian most plausible prediction. The method is illustrated with an example.

NHash: Randomized N-Gram Hashing for Distributed Generation of Validatable Unique Study Identifiers in Multicenter Research

PubMed Central

Zhang, Guo-Qiang; Tao, Shiqiang; Xing, Guangming; Mozes, Jeno; Zonjy, Bilal; Lhatoo, Samden D

2015-01-01

Background A unique study identifier serves as a key for linking research data about a study subject without revealing protected health information in the identifier. While sufficient for single-site and limited-scale studies, the use of common unique study identifiers has several drawbacks for large multicenter studies, where thousands of research participants may be recruited from multiple sites. An important property of study identifiers is error tolerance (or validatable), in that inadvertent editing mistakes during their transmission and use will most likely result in invalid study identifiers. Objective This paper introduces a novel method called "Randomized N-gram Hashing (NHash)," for generating unique study identifiers in a distributed and validatable fashion, in multicenter research. NHash has a unique set of properties: (1) it is a pseudonym serving the purpose of linking research data about a study participant for research purposes; (2) it can be generated automatically in a completely distributed fashion with virtually no risk for identifier collision; (3) it incorporates a set of cryptographic hash functions based on N-grams, with a combination of additional encryption techniques such as a shift cipher; (d) it is validatable (error tolerant) in the sense that inadvertent edit errors will mostly result in invalid identifiers. Methods NHash consists of 2 phases. First, an intermediate string using randomized N-gram hashing is generated. This string consists of a collection of N-gram hashes f 1, f 2, ..., f k. The input for each function f i has 3 components: a random number r, an integer n, and input data m. The result, f i(r, n, m), is an n-gram of m with a starting position s, which is computed as (r mod |m|), where |m| represents the length of m. The output for Step 1 is the concatenation of the sequence f 1(r 1, n 1, m 1), f 2(r 2, n 2, m 2), ..., f k(r k, n k, m k). In the second phase, the intermediate string generated in Phase 1 is encrypted using techniques such as shift cipher. The result of the encryption, concatenated with the random number r, is the final NHash study identifier. Results We performed experiments using a large synthesized dataset comparing NHash with random strings, and demonstrated neglegible probability for collision. We implemented NHash for the Center for SUDEP Research (CSR), a National Institute for Neurological Disorders and Stroke-funded Center Without Walls for Collaborative Research in the Epilepsies. This multicenter collaboration involves 14 institutions across the United States and Europe, bringing together extensive and diverse expertise to understand sudden unexpected death in epilepsy patients (SUDEP). Conclusions The CSR Data Repository has successfully used NHash to link deidentified multimodal clinical data collected in participating CSR institutions, meeting all desired objectives of NHash. PMID:26554419

[Impact of intrauterine device insertion surgery on women's mental state].

PubMed

Chu, Guang-hua; Zou, Yan; Wang, Xiao-ye; Li, Su-xia; Huang, Zi-rong; Fang, Ai-hua; Tian, Ai-ping

2013-06-01

To evaluate the impact of the intrauterine device (IUD) insertion on the mental state of women. From Jan. 2009 to Jun. 2010, a multi-center clinical observational study was performed. Totally 641 women were selected in the six provinces' 18 family planning service stations and hospitals for IUD insertion surgery study. Analysis of the change of women's mental state which was evaluated by symptom checklist-90 (SCL-90) scale before and after IUD insertion surgery. Before and after IUD insertion surgery, 10 factors' scores in SCL-90 of the observed objects were between 1.1 to 1.2, total scores were 107±27 and 105±25, respectively. Before and after surgery, total average score both were 1.2, the average score of positive items both were 2.1. The difference of the above results were not statistically significance (all P>0.05). Preoperative and postoperative, the rate of positive items was 9.2%-19.6% and 7.7%-17.6%, respectively.In addition to anxiety and fear, the rate of other factors' positive items postoperative was significantly lower than those in the preoperative (all P<0.05). The incidence of the observed objects postoperative of each factor score, "deteriorated" was in the range of 4.9% to 23.0%, "improved" was in the range of 26.3%-50.1%. The incidence of total scores, "deterioration" was 28.8% (166/575), "improved" was 45.6% (262/575). The incidence of the average score of positive items, "deterioration" was 3.7% (21/575), "improved" was 52.3% (301/575). Logistic analysis showed that, in addition to unit level, there were no other significant influencing factors for women' mental state of postoperative (all P>0.05). IUD insertion surgery has no adverse effect on women's mental state.

A multicenter observational study of US adults with acute asthma: who are the frequent users of the emergency department?

PubMed

Hasegawa, Kohei; Sullivan, Ashley F; Tovar Hirashima, Eva; Gaeta, Theodore J; Fee, Christopher; Turner, Stuart J; Massaro, Susan; Camargo, Carlos A

2014-01-01

Despite the substantial burden of asthma-related emergency department (ED) visits, there have been no recent multicenter efforts to characterize this high-risk population. We aimed to characterize patients with asthma according to their frequency of ED visits and to identify factors associated with frequent ED visits. A multicenter chart review study of 48 EDs across 23 US states. We identified ED patients ages 18 to 54 years with acute asthma during 2011 and 2012. Primary outcome was frequency of ED visits for acute asthma in the past year, excluding the index ED visit. Of the 1890 enrolled patients, 863 patients (46%) had 1 or more (frequent) ED visits in the past year. Specifically, 28% had 1 to 2 visits, 11% had 3 to 5 visits, and 7% had 6 or more visits. Among frequent ED users, guideline-recommended management was suboptimal. For example, of patients with 6 or more ED visits, 85% lacked evidence of prior evaluation by an asthma specialist, and 43% were not treated with inhaled corticosteroids. In a multivariable model, significant predictors of frequent ED visits were public insurance, no insurance, and markers for chronic asthma severity (all P < .05). Stronger associations were found among those with a higher frequency of asthma-related ED visits (eg, 6 or more ED visits). This multicenter study of US adults with acute asthma demonstrated many frequent ED users and suboptimal preventive management in this high-risk population. Future reductions in asthma morbidity and associated health care utilization will require continued efforts to bridge these major gaps in asthma care. Copyright © 2014 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

The pediatric heart network: meeting the challenges to multicenter studies in pediatric heart disease

PubMed Central

Burns, Kristin M.; Pemberton, Victoria L.; Pearson, Gail D.

2017-01-01

Purpose of review Because of the relatively small numbers of pediatric patients with congenital heart disease cared for in any individual center, there is a significant need for multicenter clinical studies to validate new medical or surgical therapies. The Pediatric Heart Network (PHN), with 15 years of experience in multicenter clinical research, has tackled numerous challenges when conducting multicenter studies. Recent findings This review describes the challenges encountered and the strategies employed to conduct high-quality, collaborative research in pediatric cardiovascular disease. Summary Sharing lessons learned from the PHN can provide guidance to investigators interested in conducting pediatric multicenter studies. PMID:26196261

Both the intratumoral immune and microbial microenvironment are linked to recurrence in human colon cancer: results from a prospective, multicenter nodal ultrastaging trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Noguti, Juliana; Chan, Alfred A.; Bandera, Bradley

Background: Colon cancer (CC) is the third most common cancer diagnosed in the United States and the incidence has been rising among young adults. We and others have shown a relationship between the immune infiltrate and prognosis, with improved disease-free survival (DFS) associated with a higher expression of CD8+ T cells. Additionally, numerous studies indicate the gut microbiota is linked to colon cancer and clinical outcomes. Therefore, we hypothesized a microbial signature might be associated with both the intratumoral immune cells as well as DFS. Results: Ninety-one patients were randomly selected from a prospective NCI-sponsored multicenter trial evaluating ultrastaging inmore » CC to investigate the intratumoral microbiota by 16S rRNA gene amplicon sequencing. Operational taxonomic units (OTUs) were grouped by 97% sequence similarity. A series of clinical, immunohistochemical, and microbiota-related data were first evaluated by univariable cox regression to determine candidate variables associated with DFS. DFS was influenced by three parameters: N-stage, CD8+ labeling, and one microbiota principal component by multivariate analysis (MVA). Not only were the microbiota and CD8 significant contributors to the DFS model, but they were also significantly associated with each other. Alpha diversity showed an inverse correlation to CD8+ T cells (p=0.010, R=-0.278) and beta diversity showed an association with the CD8+ T cells (u-UniFrac p=0.026, w-UniFrac p=0.034). Further analysis at the OTU level with false discovery correction revealed one OTU, OTU_104, belonging to the order Clostridiales to be associated with increased recurrence (HR 1.21, CI 1.08 to 1.36). This OTU_104 was then found to be inversely correlated to CD8+ T cells (p=0.031, R=-0.35). Conclusions: This study is the first to demonstrate an association between the intratumoral microbiota, CD8+ T cells, and recurrence in CC. An increased relative abundance of a specific OTU_104 was inversely associated with CD8+ T cells and increased CC recurrence. The link between this microbe, CD8+ T cells and DFS has not been previously shown. Further studies are warranted to examine the role of infiltrating immune cells and the microbiota on colon cancer.« less

Multicenter evaluation of the Bayer Immuno I CA 15-3 assay.

PubMed

Cheli, C D; Morris, D L; Kish, L; Goldblatt, J; Neaman, I; Allard, W J; Yeung, K K; Wu, A H; Moore, R; Chan, D W; Fritsche, H A; Schwartz, M K; Very, D L

1998-04-01

We conducted a multicenter evaluation of the analytical and clinical features of the automated Bayer Immuno 1 CA 15-3 assay and compared assay performance to two manual tests. Results of the 10-day imprecision study of the Bayer Immuno 1 assay pooled across four evaluation sites and three lots of reagent produced total CV < or = 4%. Lot-to-lot reproducibility for 26 different lots of reagents and calibrators manufactured over a 2-year period was demonstrated (CV, 1.1%). Results for the Bayer Immuno 1 assay correlated well with the Biomira TRUQUANT BR 27.29 and Centocor CA 15-3 RIAs (r > or = 0.94). The upper limit of the reference interval for the Bayer Immuno 1 assay was 35.9 kilounits/L (35.9 units/mL); values were similar for all methods. Longitudinal monitoring of healthy women yielded assay values with an average CV of 11% and 21% for the Bayer Immuno 1 and Biomira assays, respectively. The Bayer Immuno 1 assay demonstrated the analytical features, intermethod correlation, and long-term performance characteristics that are essential for longitudinal monitoring of breast cancer patients.

Bronchopulmonary infection-colonization patterns in Spanish cystic fibrosis patients: Results from a national multicenter study.

PubMed

de Dios Caballero, Juan; Del Campo, Rosa; Royuela, Ana; Solé, Amparo; Máiz, Luis; Olveira, Casilda; Quintana-Gallego, Esther; de Gracia, Javier; Cobo, Marta; de la Pedrosa, Elia Gómez G; Oliver, Antonio; Cantón, Rafael

2016-05-01

Clinical and demographical knowledge on Spanish cystic fibrosis (CF) patients is incomplete as no national registry exists. CF-microbiology has not been studied at national level. The results of the first Spanish multicenter study on CF microbiology are presented. 24 CF-Units for adult (n=12) and pediatric (n=12) patients from 17 hospitals provided sputa and clinical data from 15 consecutive patients. Cultures and susceptibility testing were performed. Colonization impact on pulmonary function was assessed. 341 patients [mean (SD) age 21 (11) years, 180≥18years, mean (SD) FEV1=68 (25)%] were included. Pseudomonas aeruginosa was reported as chronic, intermittent or absent in 46%, 22% and 32% of patients, respectively. The annual prevalence was 62%. Positive P. aeruginosa and methicillin-resistant Staphylococcus aureus cultures were significantly associated with lower FEV1 (p<0.001 and p=0.003, respectively). The representative subset of the Spanish CF-population which has been clinically, demographically and microbiologically characterized will serve as a reference for future CF studies in Spain. Copyright © 2015 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

NASA Ares I Crew Launch Vehicle Upper State Overview

NASA Technical Reports Server (NTRS)

Davis, Daniel J.

2008-01-01

By incorporating rigorous engineering practices, innovative manufacturing processes and test techniques, a unique multi-center government/contractor partnership, and a clean-sheet design developed around the primary requirements for the International Space Station (ISS) and Lunar missions, the Upper Stage Element of NASA s Crew Launch Vehicle (CLV), the "Ares I," is a vital part of the Constellation Program s transportation system.

Preventing CLABSIs among pediatric hematology/oncology inpatients: national collaborative results.

PubMed

Bundy, David G; Gaur, Aditya H; Billett, Amy L; He, Bing; Colantuoni, Elizabeth A; Miller, Marlene R

2014-12-01

Central lines (CLs) are essential for the delivery of modern cancer care to children. Nonetheless, CLs are subject to potentially life-threatening complications, including central line-associated bloodstream infections (CLABSIs). The objective of this study was to assess the feasibility of a multicenter effort to standardize CL care and CLABSI tracking, and to quantify the impact of standardizing these processes on CLABSI rates among pediatric hematology/oncology inpatients. We conducted a multicenter quality improvement collaborative starting in November 2009. Multidisciplinary teams at participating sites implemented a standardized bundle of CL care practices and adopted a common approach to CLABSI surveillance. Thirty-two units participated in the collaborative and reported a mean, precollaborative CLABSI rate of 2.85 CLABSIs per 1000 CL-days. Self-reported adoption of the CL care bundle was brisk, with average compliance approaching 80% by the end of the first year of the collaborative and exceeding 80% thereafter. As of August 2012, the mean CLABSI rate during the collaborative was 2.04 CLABSIs per 1000 CL-days, a reduction of 28% (relative risk: 0.71 [95% confidence interval: 0.55-0.92]). Changes in self-reported CL care bundle compliance were not statistically associated with changes in CLABSI rates, although there was little variability in bundle compliance rates after the first year of the collaborative. A multicenter quality improvement collaborative found significant reductions in observed CLABSI rates in pediatric hematology/oncology inpatients. Additional interventions will likely be required to bring and sustain CLABSI rates closer to zero for this high-risk population. Copyright © 2014 by the American Academy of Pediatrics.

EORTC, ISCL, and USCLC consensus recommendations for the treatment of primary cutaneous CD30-positive lymphoproliferative disorders: lymphomatoid papulosis and primary cutaneous anaplastic large-cell lymphoma*

PubMed Central

Pfaltz, Katrin; Vermeer, Maarten H.; Cozzio, Antonio; Ortiz-Romero, Pablo L.; Bagot, Martine; Olsen, Elise; Kim, Youn H.; Dummer, Reinhard; Pimpinelli, Nicola; Whittaker, Sean; Hodak, Emmilia; Cerroni, Lorenzo; Berti, Emilio; Horwitz, Steve; Prince, H. Miles; Guitart, Joan; Estrach, Teresa; Sanches, José A.; Duvic, Madeleine; Ranki, Annamari; Dreno, Brigitte; Ostheeren-Michaelis, Sonja; Knobler, Robert; Wood, Gary; Willemze, Rein

2011-01-01

Primary cutaneous CD30+ lymphoproliferative disorders (CD30+ LPDs) are the second most common form of cutaneous T-cell lymphomas and include lymphomatoid papulosis and primary cutaneous anaplastic large-cell lymphoma. Despite the anaplastic cytomorphology of tumor cells that suggest an aggressive course, CD30+ LPDs are characterized by an excellent prognosis. Although a broad spectrum of therapeutic strategies has been reported, these have been limited mostly to small retrospective cohort series or case reports, and only very few prospective controlled or multicenter studies have been performed, which results in a low level of evidence for most therapies. The response rates to treatment, recurrence rates, and outcome have not been analyzed in a systematic review. Moreover, international guidelines for staging and treatment of CD30+ LPDs have not yet been presented. Based on a literature analysis and discussions, recommendations were elaborated by a multidisciplinary expert panel of the Cutaneous Lymphoma Task Force of the European Organization for Research and Treatment of Cancer, the International Society for Cutaneous Lymphomas, and the United States Cutaneous Lymphoma Consortium. The recommendations represent the state-of-the-art management of CD30+ LPDs and include definitions for clinical endpoints as well as response criteria for future clinical trials in CD30+ LPDs. PMID:21841159

Multicenter Clinical Evaluation of the Alere i Respiratory Syncytial Virus Isothermal Nucleic Acid Amplification Assay.

PubMed

Hassan, Ferdaus; Hays, Lindsay M; Bonner, Aleta; Bradford, Bradley J; Franklin, Ruffin; Hendry, Phyllis; Kaminetsky, Jed; Vaughn, Michael; Cieslak, Kristin; Moffatt, Mary E; Selvarangan, Rangaraj

2018-03-01

The Alere i respiratory syncytial virus (RSV) assay is an isothermal nucleic acid amplification test capable of detecting RSV directly from respiratory specimens, with results being available in ≤13 min after test initiation. The objective of this study was to evaluate the performance characteristics of the Alere i RSV assay in a point-of-care setting by using direct nasopharyngeal (NP) swab specimens (direct NP) and nasopharyngeal swab specimens eluted and transported in viral transport medium (VTM NP). The study was a prospective, multicenter, clinical trial conducted at 9 sites across the United States to evaluate the clinical performance of the Alere i RSV assay with respiratory specimens obtained from both children (age, <18 years) and older adults (age, >60 years). The performance of the Alere i RSV assay was compared with that of the reference method, the Prodesse ProFlu+ real-time reverse transcriptase PCR (RT-PCR) assay. All specimens with discrepant test results were tested further by a second FDA-cleared PCR assay (the Verigene respiratory virus plus nucleic acid test; Luminex Inc., TX). A total of 554 subjects with signs and symptoms of respiratory infections were enrolled, and respiratory samples were collected in this study. In comparison with the ProFlu+ real-time RT-PCR, the overall sensitivity and specificity of Alere i RSV assay for the detection of RSV were 98.6% (95% confidence interval [CI], 94.4 to 99.7%) and 98.0% (95% CI, 95.8 to 99.1%), respectively, for direct NP and 98.6% (95% CI, 94.4 to 99.7%) and 97.8% (95% CI, 95.5 to 98.9%), respectively, for VTM NP. The Alere i RSV is a highly sensitive and specific molecular assay ideal for rapid RSV detection in patients in the point-of-care setting due to its minimal hands-on time and rapid result availability. Copyright © 2018 American Society for Microbiology.

Hydrocortisone prevents immunosuppression by interleukin-10+ natural killer cells after trauma-hemorrhage.

PubMed

Roquilly, Antoine; Broquet, Alexis; Jacqueline, Cédric; Masson, Damien; Segain, Jean Pierre; Braudeau, Cecile; Vourc'h, Mickael; Caillon, Jocelyne; Altare, Frédéric; Josien, Regis; Retière, Christelle; Villadangos, Jose; Asehnoune, Karim

2014-12-01

Trauma induces a state of immunosuppression, which is responsible for the development of nosocomial infections. Hydrocortisone reduces the rate of pneumonia in patients with trauma. Because alterations of dendritic cells and natural killer cells play a central role in trauma-induced immunosuppression, we investigated whether hydrocortisone modulates the dendritic cell/natural killer cell cross talk in the context of posttraumatic pneumonia. Experimental study. Research laboratory from an university hospital. Bagg Albino/cJ mice (weight, 20-24 g). First, in an a priori substudy of a multicenter, randomized, double-blind, placebo-controlled trial of hydrocortisone (200 mg/d for 7 d) in patients with severe trauma, we have measured the blood levels of five cytokines (tumor necrosis factor-α, interleukin-6, interleukin-10, interleukin-12, interleukin-17) at day 1 and day 8. In a second step, the effects of hydrocortisone on dendritic cell/natural killer cell cross talk were studied in a mouse model of posttraumatic pneumonia. Hydrocortisone (0.6 mg/mice i.p.) was administered immediately after hemorrhage. Twenty-four hours later, the mice were challenged with Staphylococcus aureus (7 × 10 colony-forming units). Using sera collected during a multicenter study in patients with trauma, we found that hydrocortisone decreased the blood level of interleukin-10, a cytokine centrally involved in the regulation of dendritic cell/natural killer cell cluster. In a mouse model of trauma-hemorrhage-induced immunosuppression, splenic natural killer cells induced an interleukin-10-dependent elimination of splenic dendritic cell. Hydrocortisone treatment reduced this suppressive function of natural killer cells and increased survival of mice with posthemorrhage pneumonia. The reduction of the interleukin-10 level in natural killer cells by hydrocortisone was partially dependent on the up-regulation of glucocorticoid-induced tumor necrosis factor receptor-ligand (TNFsf18) on dendritic cell. These data demonstrate that trauma-induced immunosuppression is characterized by an interleukin-10-dependent elimination of dendritic cell by natural killer cells and that hydrocortisone improves outcome by limiting this immunosuppressive feedback loop.

The incidence of complications associated with loop duodeno-ileostomy after single-anastomosis duodenal switch procedures among 1328 patients: a multicenter experience.

PubMed

Surve, Amit; Cottam, Daniel; Sanchez-Pernaute, Andres; Torres, Antonio; Roller, Joshua; Kwon, Yong; Mourot, Joshua; Schniederjan, Bleu; Neichoy, Bo; Enochs, Paul; Tyner, Michael; Bruce, Jon; Bovard, Scott; Roslin, Mitchell; Jawad, Muhammad; Teixeira, Andre; Srikanth, Myur; Free, Jason; Zaveri, Hinali; Pilati, David; Bull, Jamie; Belnap, LeGrand; Richards, Christina; Medlin, Walter; Moon, Rena; Cottam, Austin; Sabrudin, Sarah; Cottam, Samuel; Dhorepatil, Aneesh

2018-02-02

The single-anastomosis duodenal switch procedure is a type of duodenal switch that involves a loop anastomosis rather than traditional Roux-en-Y reconstruction. To date, there have been no multicenter studies looking at the complications associated with post-pyloric loop reconstruction. The aim of the study was to report the incidence of complications associated with loop duodeno-ileostomy (DI) following single-anastomosis duodenal switch (SADS) procedures. Mixed of private and teaching facilities. The medical records of 1328 patients who underwent primary SADS procedure (single-anastomosis duodeno-ileal bypass with sleeve gastrectomy or stomach intestinal pylorus-sparing surgery) by 17 surgeons from 3 countries (United States, Spain, and Australia) at 9 centers over a 6-year period were retrospectively reviewed, and their results were compared with articles in the literature. Mean preoperative body mass index was 51.6 kg/m 2 . Of 1328 patients, 123 patients received a linear stapled duodeno-ileostomy (DI) and 1205 patients a hand-sewn DI. In the overall series, the anastomotic leak, ulcer, and bile reflux occurred in .6% (9/1328), .1% (2/1328), and .1% (2/1328), respectively. None of our patients experienced volvulus at the DI or an internal hernia. Overall, 5 patients (.3%) (3/123 [2.4%] with linear stapled DI versus 2/1205 [.1%] with hand-sewn DI [P<.05]) experienced stricture at the DI in this series. The overall incidence of complications associated with loop DI was lower than the reported incidence of anastomotic complications after Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch. SADS procedures may cause much fewer anastomotic complications compared with Roux-en-Y gastric bypass and biliopancreatic diversion with duodenal switch. Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

An international multicenter study comparing EUS-guided pancreatic duct drainage with enteroscopy-assisted endoscopic retrograde pancreatography after Whipple surgery.

PubMed

Chen, Yen-I; Levy, Michael J; Moreels, Tom G; Hajijeva, Gulara; Will, Uwe; Artifon, Everson L; Hara, Kazuo; Kitano, Masayuki; Topazian, Mark; Abu Dayyeh, Barham; Reichel, Andreas; Vilela, Tiago; Ngamruengphong, Saowanee; Haito-Chavez, Yamile; Bukhari, Majidah; Okolo, Patrick; Kumbhari, Vivek; Ismail, Amr; Khashab, Mouen A

2017-01-01

Endoscopic management of post-Whipple pancreatic adverse events (AEs) with enteroscopy-assisted endoscopic retrograde pancreatography (e-ERP) is associated with high failure rates. EUS-guided pancreatic duct drainage (EUS-PDD) has shown promising results; however, no comparative data have been done for these 2 modalities. The goal of this study is to compare EUS-PDD with e-ERP in terms of technical success (PDD through dilation/stent), clinical success (improvement/resolution of pancreatic-type symptoms), and AE rates in patients with post-Whipple anatomy. This is an international multicenter comparative retrospective study at 7 tertiary centers (2 United States, 2 European, 2 Asian, and 1 South American). All consecutive patients who underwent EUS-PDD or e-ERP between January 2010 and August 2015 were included. In total, 66 patients (mean age, 57 years; 48% women) and 75 procedures were identified with 40 in EUS-PDD and 35 in e-ERP. Technical success was achieved in 92.5% of procedures in the EUS-PDD group compared with 20% of procedures in the e-ERP group (OR, 49.3; P < .001). Clinical success (per patient) was attained in 87.5% of procedures in the EUS-PDD group compared with 23.1% in the e-ERP group (OR, 23.3; P < .001). AEs occurred more commonly in the EUS-PDD group (35% vs 2.9%, P < .001). However, all AEs were rated as mild or moderate. Procedure time and length of stay were not significantly different between the 2 groups. EUS-PDD is superior to e-ERP in post-Whipple anatomy in terms of efficacy with acceptable safety. As such, EUS-PDD should be considered as a potential first-line treatment in post-pancreaticoduodenectomy anatomy when necessary expertise is available. Copyright © 2017 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

Short- and Medium-Term Outcomes After Transcatheter Pulmonary Valve Placement in the Expanded Multicenter US Melody Valve Trial

PubMed Central

McElhinney, Doff B.; Hellenbrand, William E.; Zahn, Evan M.; Jones, Thomas K.; Cheatham, John P.; Lock, James E.; Vincent, Julie A.

2014-01-01

Background Transcatheter pulmonary valve placement is an emerging therapy for pulmonary regurgitation and right ventricular outflow tract obstruction in selected patients. The Melody valve was recently approved in the United States for placement in dysfunctional right ventricular outflow tract conduits. Methods and Results From January 2007 to August 2009, 136 patients (median age, 19 years) underwent catheterization for intended Melody valve implantation at 5 centers. Implantation was attempted in 124 patients; in the other 12, transcatheter pulmonary valve placement was not attempted because of the risk of coronary artery compression (n=6) or other clinical or protocol contraindications. There was 1 death from intracranial hemorrhage after coronary artery dissection, and 1 valve was explanted after conduit rupture. The median peak right ventricular outflow tract gradient was 37 mm Hg before implantation and 12 mm Hg immediately after implantation. Before implantation, pulmonary regurgitation was moderate or severe in 92 patients (81% with data); no patient had more than mild pulmonary regurgitation early after implantation or during follow-up (≥1 year in 65 patients). Freedom from diagnosis of stent fracture was 77.8±4.3% at 14 months. Freedom from Melody valve dysfunction or reintervention was 93.5±2.4% at 1 year. A higher right ventricular outflow tract gradient at discharge (P=0.003) and younger age (P=0.01) were associated with shorter freedom from dysfunction. Conclusions In this updated report from the multicenter US Melody valve trial, we demonstrated an ongoing high rate of procedural success and encouraging short-term valve function. All reinterventions in this series were for right ventricular outflow tract obstruction, highlighting the importance of patient selection, adequate relief of obstruction, and measures to prevent and manage stent fracture. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT00740870. PMID:20644013

The impact of cocaine and marijuana use on low birth weight and preterm birth: a multicenter study.

PubMed

Shiono, P H; Klebanoff, M A; Nugent, R P; Cotch, M F; Wilkins, D G; Rollins, D E; Carey, J C; Behrman, R E

1995-01-01

Our aim was to evaluate prospectively the effects of cocaine and marijuana use on pregnancy outcomes. A prospective multicenter cohort study was conducted at seven university-based prenatal clinics in the United States from 1984 to 1989. The cohort described herein consisted of a multiethnic population of 7470 pregnant women. Information on the use of drugs was obtained from personal interviews at entry to the study and assays of serum obtained during pregnancy. Pregnancy outcome data (low birth weight [< 2500 gm], preterm birth [< 37 weeks' gestation], and abruptio placentae) were obtained with a standardized study protocol. A total of 2.3% of the women used cocaine and 11.0% used marijuana during pregnancy. Cocaine use was not associated with having a low-birth-weight infant (adjusted odds ratio 0.7, 95% confidence interval 0.4 to 1.3) or a preterm birth (1.3, 0.9 to 2.0). There was no association between short-term exposure to cocaine and preterm delivery (1.1, 0.3 to 4.0). However, cocaine use was strongly associated with abruptio placentae (adjusted odds ratio 4.2, 1.9 to 9.5). Marijuana use was not associated with low birth weight (1.1, 0.9 to 1.5), preterm delivery (1.1, 0.8 to 1.3) or abruptio placentae (1.3, 0.6 to 2.8). By comparison, 35% of the women smoked cigarettes during pregnancy, and cigarette smoking was positively associated with low birth weight (1.5, 1.2 to 1.8). In this population of women receiving prenatal care, cocaine use was uncommon and was not related to most adverse birth outcomes. Marijuana use was relatively common and was not related to adverse pregnancy outcomes. Tobacco is still the most commonly abused drug during pregnancy, 15% of all cases of low birth weight in this study could have been prevented if women did not smoke cigarettes during pregnancy.

Exercise, Manual Therapy, and Booster Sessions in Knee Osteoarthritis: Cost-Effectiveness Analysis From a Multicenter Randomized Controlled Trial.

PubMed

Bove, Allyn M; Smith, Kenneth J; Bise, Christopher G; Fritz, Julie M; Childs, John; Brennan, Gerard P; Abbott, J Haxby; Fitzgerald, G Kelley

2018-01-01

Limited information exists regarding the cost-effectiveness of rehabilitation strategies for individuals with knee osteoarthritis (OA). The study objective was to compare the cost-effectiveness of 4 different combinations of exercise, manual therapy, and booster sessions for individuals with knee OA. This economic evaluation involved a cost-effectiveness analysis performed alongside a multicenter randomized controlled trial. The study took place in Pittsburgh, Pennsylvania; Salt Lake City, Utah; and San Antonio, Texas. The study participants were 300 individuals taking part in a randomized controlled trial investigating various physical therapy strategies for knee OA. Participants were randomized into 4 treatment groups: exercise only (EX), exercise plus booster sessions (EX+B), exercise plus manual therapy (EX+MT), and exercise plus manual therapy and booster sessions (EX+MT+B). For the 2-year base case scenario, a Markov model was constructed using the United States societal perspective and a 3% discount rate for costs and quality-adjusted life years (QALYs). Incremental cost-effectiveness ratios were calculated to compare differences in cost per QALY gained among the 4 treatment strategies. In the 2-year analysis, booster strategies (EX+MT+B and EX+B) dominated no-booster strategies, with both lower health care costs and greater effectiveness. EX+MT+B had the lowest total health care costs. EX+B cost ${\\$}$1061 more and gained 0.082 more QALYs than EX+MT+B, for an incremental cost-effectiveness ratio of ${\\$}$12,900/QALY gained. The small number of total knee arthroplasty surgeries received by individuals in this study made the assessment of whether any particular strategy was more successful at delaying or preventing surgery in individuals with knee OA difficult. Spacing exercise-based physical therapy sessions over 12 months using periodic booster sessions was less costly and more effective over 2 years than strategies not containing booster sessions for individuals with knee OA. © 2017 American Physical Therapy Association

Disparities in Adherence to Pediatric Sepsis Guidelines across a Spectrum of Emergency Departments: A Multicenter, Cross-Sectional Observational In Situ Simulation Study.

PubMed

Kessler, David O; Walsh, Barbara; Whitfill, Travis; Dudas, Robert A; Gangadharan, Sandeep; Gawel, Marcie; Brown, Linda; Auerbach, Marc

2016-03-01

Each year in the United States, 72,000 pediatric patients develop septic shock, at a cost of $4.8 billion. Adherence to practice guidelines can significantly reduce mortality; however, few methods to compare performance across a spectrum of emergency departments (EDs) have been described. We employed standardized, in situ simulations to measure and compare adherence to pediatric sepsis guidelines across a spectrum of EDs. We hypothesized that pediatric EDs (PEDs) would have greater adherence to the guidelines than general EDs (GEDs). We also explored factors associated with improved performance. This multi-center observational study examined in situ teams caring for a simulated infant in septic shock. The primary outcome was overall adherence to the pediatric sepsis guideline as measured by six subcomponent metrics. Characteristics of teams were compared using multivariable logistic regression to describe factors associated with improved performance. We enrolled 47 interprofessional teams from 24 EDs. Overall, 21/47 teams adhered to all six sepsis metrics (45%). PEDs adhered to all six metrics more than GEDs (93% vs. 22%; difference 71%, 95% confidence interval [CI] 43-84). Adherent teams had significantly higher Emergency Medical Services for Children readiness scores, MD composition of physicians to total team members, teamwork scores, provider perceptions of pediatric preparedness, and provider perceptions of sepsis preparedness. In a multivariable regression model, only greater composite team experience had greater adjusted odds of achieving an adherent sepsis score (adjusted odds ratio 1.38, 95% CI 1.01-1.88). Using standardized in situ scenarios, we revealed high variability in adherence to the pediatric sepsis guideline across a spectrum of EDs. PEDs demonstrated greater adherence to the guideline than GEDs; however, in adjusted analysis, only composite team experience level of the providers was associated with improved guideline adherence. Copyright © 2016 Elsevier Inc. All rights reserved.

Multicenter validation of the diagnostic accuracy of a blood-based gene expression test for assessing obstructive coronary artery disease in nondiabetic patients.

PubMed

Rosenberg, Steven; Elashoff, Michael R; Beineke, Philip; Daniels, Susan E; Wingrove, James A; Tingley, Whittemore G; Sager, Philip T; Sehnert, Amy J; Yau, May; Kraus, William E; Newby, L Kristin; Schwartz, Robert S; Voros, Szilard; Ellis, Stephen G; Tahirkheli, Naeem; Waksman, Ron; McPherson, John; Lansky, Alexandra; Winn, Mary E; Schork, Nicholas J; Topol, Eric J

2010-10-05

Diagnosing obstructive coronary artery disease (CAD) in at-risk patients can be challenging and typically requires both noninvasive imaging methods and coronary angiography, the gold standard. Previous studies have suggested that peripheral blood gene expression can indicate the presence of CAD. To validate a previously developed 23-gene, expression-based classification test for diagnosis of obstructive CAD in nondiabetic patients. Multicenter prospective trial with blood samples obtained before coronary angiography. (ClinicalTrials.gov registration number: NCT00500617) SETTING: 39 centers in the United States. An independent validation cohort of 526 nondiabetic patients with a clinical indication for coronary angiography. Receiver-operating characteristic (ROC) analysis of classifier score measured by real-time polymerase chain reaction, additivity to clinical factors, and reclassification of patient disease likelihood versus disease status defined by quantitative coronary angiography. Obstructive CAD was defined as 50% or greater stenosis in 1 or more major coronary arteries by quantitative coronary angiography. The area under the ROC curve (AUC) was 0.70 ± 0.02 (P < 0.001); the test added to clinical variables (Diamond-Forrester method) (AUC, 0.72 with the test vs. 0.66 without; P = 0.003) and added somewhat to an expanded clinical model (AUC, 0.745 with the test vs. 0.732 without; P = 0.089). The test improved net reclassification over both the Diamond-Forrester method and the expanded clinical model (P < 0.001). At a score threshold that corresponded to a 20% likelihood of obstructive CAD (14.75), the sensitivity and specificity were 85% and 43% (yielding a negative predictive value of 83% and a positive predictive value of 46%), with 33% of patient scores below this threshold. Patients with chronic inflammatory disorders, elevated levels of leukocytes or cardiac protein markers, or diabetes were excluded. A noninvasive whole-blood test based on gene expression and demographic characteristics may be useful for assessing obstructive CAD in nondiabetic patients without known CAD. CardioDx.

Heparin-Binding Protein Measurement Improves the Prediction of Severe Infection With Organ Dysfunction in the Emergency Department

PubMed Central

Arnold, Ryan; Boyd, John H.; Zindovic, Marko; Zindovic, Igor; Lange, Anna; Paulsson, Magnus; Nyberg, Patrik; Russell, James A.; Pritchard, David; Christensson, Bertil; Åkesson, Per

2015-01-01

Objectives: Early identification of patients with infection and at risk of developing severe disease with organ dysfunction remains a difficult challenge. We aimed to evaluate and validate the heparin-binding protein, a neutrophil-derived mediator of vascular leakage, as a prognostic biomarker for risk of progression to severe sepsis with circulatory failure in a multicenter setting. Design: A prospective international multicenter cohort study. Setting: Seven different emergency departments in Sweden, Canada, and the United States. Patients: Adult patients with a suspected infection and at least one of three clinical systemic inflammatory response syndrome criteria (excluding leukocyte count). Intervention: None. Measurements and Main Results: Plasma levels of heparin-binding protein, procalcitonin, C-reactive protein, lactate, and leukocyte count were determined at admission and 12–24 hours after admission in 759 emergency department patients with suspected infection. Patients were defined depending on the presence of infection and organ dysfunction. Plasma samples from 104 emergency department patients with suspected sepsis collected at an independent center were used to validate the results. Of the 674 patients diagnosed with an infection, 487 did not have organ dysfunction at enrollment. Of these 487 patients, 141 (29%) developed organ dysfunction within the 72-hour study period; 78.0% of the latter patients had an elevated plasma heparin-binding protein level (> 30 ng/mL) prior to development of organ dysfunction (median, 10.5 hr). Compared with other biomarkers, heparin-binding protein was the best predictor of progression to organ dysfunction (area under the receiver operating characteristic curve = 0.80). The performance of heparin-binding protein was confirmed in the validation cohort. Conclusion: In patients presenting at the emergency department, heparin-binding protein is an early indicator of infection-related organ dysfunction and a strong predictor of disease progression to severe sepsis within 72 hours. PMID:26468696

Job Satisfaction and Associated Factors among Anesthetists Working in Amhara National Regional State, Northwest Ethiopia, May 2017: A Multicenter Cross-Sectional Study

PubMed Central

Getinet Kasahun, Habtamu

2018-01-01

Background Job satisfaction is an important determinant of health staff's motivation, retention, and performance. Difficulties in critical decision-making and problems with lack of respect and recognition lead to lower job satisfaction level among anesthetists. It leads to high turnover intention, dropout from the profession, burnout, impaired health status of anesthetists, and lower work performance. Objective The aim of this multicenter cross-sectional study was to assess the level of job satisfaction and associated factors among anesthetists working in Amhara National Regional State. Methods A multicenter cross-sectional study was conducted from April 1 to June 30, 2017. Ninety-eight anesthetists that were working in Amhara National Regional State Hospitals were involved in this study. The structured questionnaire was scored on five-point Likert scales. Data were analyzed using Statistical Package for Social Sciences version 20. Binary logistic regression was used to measure statistical significance between dependent and each independent variable. Variables with P value of ≤0.2 on crude analysis were taken into multivariate analysis, and P value 0.05 and 95% CI was used as cut off point. Result 98 out of 104 participants were involved in this study with a response rate of 94.3%. The overall level of job satisfaction was 46.9%. Anesthetists in academic working position were satisfied with the odds of about 2.3 (AOR = 2.269; CI = 1.137–6.740) compared to those in clinical working position. Anesthetists were least satisfied with coworker relationships (37.8%), work schedule (43.9%), professional opportunity (46.9%), and recognition (49%) while they were most satisfied from their control of responsibility (59.2%), social interaction (55%), and salary and benefits (51%). Conclusion and Recommendation Job satisfaction of anesthetists was low, and we suggest that facilitation of professional development, creation of smooth relationship in working environment, increasing the number of anesthetists, and recognition of the anesthesia professional are of paramount importance to increase job satisfaction of anesthetists. PMID:29853872

Three-unit posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with layered and milled (CAD-on) veneering ceramics: 1-year follow-up of a randomized controlled clinical trial.

PubMed

Grohmann, Philipp; Bindl, Andreas; Hämmerle, Christoph; Mehl, Albert; Sailer, Irena

2015-01-01

The aim of this multicenter randomized controlled clinical trial was to test posterior zirconia-ceramic fixed dental prostheses (FDPs) veneered with a computer-aided design/computer- assisted manufacture (CAD/CAM) lithium disilicate veneering ceramic (CAD-on) and manually layered zirconia veneering ceramic with respect to survival of the FDPs, and technical and biologic outcomes. Sixty patients in need of one posterior three-unit FDP were included. The zirconia frameworks were produced with a CAD/CAM system (Cerec inLab 3D/Cerec inEOS inLab). Thirty FDPs were veneered with a CAD/CAM lithium disilicate veneering ceramic (Cad-on) (test) and 30 were veneered with a layered zirconia veneering ceramic (control). For the clinical evaluation at baseline, 6, and 12 months, the United States Public Health Service (USPHS) criteria were used. The biologic outcome was judged by comparing the plaque control record (PCR), bleeding on probing (BOP), and probing pocket depth (PPD). Data were statistically analyzed. Fifty-six patients were examined at a mean follow-up of 13.9 months. At the 1-year follow-up the survival rate was 100% in the test and in the control group. No significant differences of the technical outcomes occurred. Major chipping occurred in the control group (n = 3) and predominantly minor chipping in the test group (minor n = 2, major n = 1). No biologic problems or differences were found. Both types of zirconia-ceramic FDPs exhibited very good clinical outcomes without differences between groups. Chipping occurred in both types of FDPs at small amounts, yet the extension of the chippings differed. The test FDPs predominantly exhibited minor chipping, the control FDPs major chipping.

Apixaban versus Warfarin for the Prevention of Periprocedural Cerebral Thromboembolism in Atrial Fibrillation Ablation: Multicenter Prospective Randomized Study.

PubMed

Kuwahara, Taishi; Abe, Mitsunori; Yamaki, Masaru; Fujieda, Hiroyuki; Abe, Yumiko; Hashimoto, Katsushi; Ishiba, Misako; Sakai, Hirotsuka; Hishikari, Keiichi; Takigawa, Masateru; Okubo, Kenji; Takagi, Katsumasa; Tanaka, Yasuaki; Nakajima, Jun; Takahashi, Atsushi

2016-05-01

Stroke can be a life-threatening complication of atrial fibrillation (AF) catheter ablation. Uninterrupted warfarin treatment contributes to minimizing the risk of stroke complications. This was a prospective, open-label, randomized, multicenter study assessing the safety and efficacy of apixaban for the prevention of cerebral thromboembolism complicating AF catheter ablation. Two hundred patients with drug-resistant AF were equally assigned to take either apixaban (5 mg or 2.5 mg twice daily) or warfarin (target international normalized ratio, 2-3) for at least 1 month before AF ablation. Neither drug regimen was interrupted throughout the operative period. Diffusion-weighted magnetic resonance imaging was performed for all patients to detect silent cerebral infarction (SCI) after the ablation. Primary outcomes were defined as the occurrence of stroke, transient ischemic attack, SCI, or major bleeding that required intervention. The secondary outcome was minor bleeding. The groups did not statistically differ in patients' backgrounds or procedural parameters. During AF ablation, the apixaban group required administration of more heparin to maintain an activated clotting time > 300 seconds than the warfarin group (apixaban, 14,000 ± 4,000 units; warfarin, 9,000 ± 3,000 units). Three primary outcome events occurred in each group (apixaban, 2 SCI and 1 major bleed; warfarin, 3 SCI, P = 1.00), and 3 and 4 secondary outcome events occurred in the apixaban and warfarin groups (P = 0.70), respectively. Apixaban has similar safety and effectiveness to warfarin for the prevention of cerebral thromboembolism during the periprocedural period of AF ablation. © 2016 Wiley Periodicals, Inc.

Multicenter Observational Study to Evaluate Epidemiology and Resistance Patterns of Common Intensive Care Unit-infections.

PubMed

Venkataraman, Ramesh; Divatia, Jigeeshu V; Ramakrishnan, Nagarajan; Chawla, Rajesh; Amin, Pravin; Gopal, Palepu; Chaudhry, Dhruva; Zirpe, Kapil; Abraham, Babu

2018-01-01

There is limited data regarding the microbiology of Intensive Care Unit (ICU)-acquired infections, such as ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and catheter-related bloodstream infections (CRBSI) from India. To explore the microbiology and resistance patterns of ICU-acquired infections and evaluate their outcomes. This was a multicenter observational study, conducted by Indian Society of Critical Care Medicine (MOSER study) between August 2011 and October 2012. Patients in the ICU ≥48 h with any ICU-acquired infection within 14 days of index ICU stay were included. Patient demographics, relevant clinical, and microbiological details were collected. Follow-up until hospital discharge or death was done, and 6-month survival data were collected. Of the 381 patients included in the study, 346 patients had 1 ICU infection and 35 had more than one ICU infection. Among patients with single infections, 223 had VAP with Acinetobacter being the most common isolate. CAUTI was seen in 42 patients with Klebsiella as the most common organism. CRBSI was seen in 81 patients and Klebsiella was the most common causative organism. Multidrug resistance was noted in 87.5% of Acinetobacter, 75.5% of Klebsiella , 61.9% of Escherichia coli , and 58.9% of Pseudomonas isolates, respectively. Staphylococcus constituted only 2.4% of isolates. Mortality rates were 26%, 11.9%, and 34.6% in VAP, CAUTI, and CRBSI, respectively. VAP is the most common infection followed by CRBSI and CAUTI. Multidrug-resistant Gram-negative bacteria are the most common organisms. Staphylococcus aureus is uncommon in the Indian setting.

Professionals' perceptions about healthcare resources for co-occuring disorders in Spain.

PubMed

Roncero, Carlos; Vega, Pablo; Martínez-Raga, Jose; Barral, Carmen; Basurte-Villamor, Ignacio; Rodríguez-Cintas, Laia; Mesías, Beatriz; Grau-López, Lara; Casas, Miguel; Szerman, Nestor

2014-01-01

Since provision of integrated services for patients with dual pathology or dual disorders (coexistence of an addictive disorder and other psychiatric disorders) constitutes an important challenge, this study compared the perceptions of health-care professionals with the existing, current state of specific resources for patients with dual pathology in Spain. Epidemiological, observational, cross-sectional, multicenter study with a large, representative sample of health care professionals attending patients with dual pathology in treatment resources throughout Spain. Participants completed a specifically designed ad-hoc on-line questionnaire about their perceptions on the existence of available resources and treatment needs for patients with dual pathology. To compare professionals' perceptions with existing available resources, the same on-line questionnaire was also completed by commissioners and managers responsible for national and regional healthcare plans on drug abuse. A total of 659 professionals, mostly psychologists (43.40%) or psychiatrists (32.93%) agreed to participate in the study. The highest degree of concordance between the perceptions of professional and the actual situation was found regarding the existence of mental health and addiction networks (either separately or unified) (74.48%), followed by specific workshops (73.08%) and sub-acute inpatient units (67.38%), specific hospitalization units (66.26%), detoxification units (63.15%) and outpatient programs (60.73%). We detected a lower degree of agreement regarding specific occupational rehabilitation centers (59.34%) day hospitals (58.93%), day centers (57.88%), outpatient intermediate resources (48.87%), psychiatric acute admission units (46.54%) and therapeutic communities (43.77%). In addition, on average, health care professionals underestimated the number of resources present in their respective communities. Relevant differences exist between the perceptions of professional and existing available resources for dual pathology patients in Spain, thus supporting the need of additional efforts and strategies to establish a registry and clearly inform about available resources for patients with dual diagnosis.

77 FR 12598 - Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-03-01

... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Notice Correction; A Multi-Center International Hospital-Based Case-Control Study of Lymphoma in Asia (AsiaLymph) (NCI) The Federal... project titled, ``A multi-center international hospital-based case-control study of lymphoma in Asia (Asia...

Impact of a Developmental Care Training Course on the Knowledge and Satisfaction of Health Care Professionals in Neonatal Units: A Multicenter Study.

PubMed

Mosqueda-Peña, Rocío; Lora-Pablos, David; Pavón-Muñoz, Abraham; Ureta-Velasco, Noelia; Moral-Pumarega, María Teresa; Pallás-Alonso, Carmen Rosa

2016-04-01

The impact of health-related continuing education courses on knowledge acquisition and clinical practice is infrequently evaluated, despite higher numbers of people enrolling in them. The majority of health care professionals working in neonatal intensive care units (NICUs) have received no training in developmental care (DC). The purpose of this study was to determine whether participation in a theoretical-practical course on DC had an effect on the degree of knowledge possessed by professionals in general terms and with respect to neonatal intensive care. The relationship between course satisfaction and knowledge acquisition was also studied. This was an observational multicenter study conducted in 20 neonatal units in Madrid. A pre- and post-course questionnaire evaluated both knowledge and satisfaction levels regarding the course on DC and the Newborn Individualized Developmental Care and Assessment Program (NIDCAP). We carried out a multivariate linear regression analysis to determine whether there was a correlation between knowledge gained and satisfaction level. A total of 566 professionals participated, with a 99% pre-course and a 90% post-course response rate. The mean rate of correct pre-course answers was 65%, while the mean rate of post-course correct answers was 81% (p < 0.001). Results were similar at all levels of neonatal care (Level I: 64% vs 80%; Level II: 64% vs. 83%; and 65% vs. 81%). Scores on a scale of satisfaction from 1 to 5 were high (averages of above 4 for all lectures and workshops). Pre-course knowledge scores, but not satisfaction, significantly influenced post-course knowledge (β 0.499; p < 0.01). Previous DC knowledge among Madrid health care professionals was similar, regardless of the level of neonatal care. Course attendance significantly improved the rate of correct answers. Although course satisfaction was high, there did not seem to be a correlation between knowledge gained and satisfaction. Copyright © 2016. Published by Elsevier B.V.

Prevalence of malnutrition among older people in medical and surgical wards in hospital and quality of nutritional care: A multicenter, cross-sectional study.

PubMed

Bonetti, Loris; Terzoni, Stefano; Lusignani, Maura; Negri, Marina; Froldi, Marco; Destrebecq, Anne

2017-12-01

To determine and compare the prevalence of malnutrition in medical and surgical hospital units; to assess quality of nutritional care and patients' perception about quality of food and nutritional care. Hospital malnutrition in older people leads to increased mortality, length of stay, risk of infections and pressure ulcers. Several studies show that malnutrition is often caused by hospitalisation and related to poor nutritional care. Few studies report data on surgical older patients. A cross-sectional, multicenter study was conducted in 12 hospitals in northern Italy. Malnutrition prevalence was determined according to the Mini Nutritional Assessment full-version. Head nurses were interviewed in 80 units, through a validated questionnaire regarding quality of nutritional care. Semi-structured interviews were administered to a sample of patients, to investigate their perception about quality of food and nutritional care. Two hundred twenty-eight patients of 1,066 were malnourished (21.4%). Medical patients were at higher risk, so were women, patients aged 85 or more, with impaired autonomy, pressure ulcers or taking more than three drugs. The lack of personnel impacts on quality of care: in 55% of the units, no nutritional screening is performed; nutritional history is investigated in 48% only. No protocols for nutritional problems exist in 70% of the wards; hardly ever the intake is measured. Patients are mostly satisfied, even though they report that food has no taste and is not well presented. They remark the need for more personnel. Prevalence was high, as found in other studies. Medical patients were at higher risk. Nutritional care was inadequate, and often no measures were adopted to prevent malnutrition. Staffing should be increased during meals. These findings will provide indications on the strategies needed to overcome such barriers. © 2017 John Wiley & Sons Ltd.

Computerized Dental Injection Fear Treatment

PubMed Central

Heaton, L.J.; Leroux, B.G.; Ruff, P.A.; Coldwell, S.E.

2013-01-01

One in four adults reports a clinically significant fear of dental injections, leading many to avoid dental care. While systematic desensitization is the most common therapeutic method for treating specific phobias such as fear of dental injections, lack of access to trained therapists, as well as dentists’ lack of training and time in providing such a therapy, means that most fearful individuals are not able to receive the therapy needed to be able to receive necessary dental treatment. Computer Assisted Relaxation Learning (CARL) is a self-paced computerized treatment based on systematic desensitization for dental injection fear. This multicenter, block-randomized, dentist-blind, parallel-group study conducted in 8 sites in the United States compared CARL with an informational pamphlet in reducing fear of dental injections. Participants completing CARL reported significantly greater reduction in self-reported general and injection-specific dental anxiety measures compared with control individuals (p < .001). Twice as many CARL participants (35.3%) as controls (17.6%) opted to receive a dental injection after the intervention, although this was not statistically significant. CARL, therefore, led to significant changes in self-reported fear in study participants, but no significant differences in the proportion of participants having a dental injection (ClinicalTrials.gov, NCT00609648). PMID:23690352

Prevalence of Periodontal Diseases in a Multicenter Cohort of Perinatally HIV-Infected and HIV-exposed and Uninfected Youth

PubMed Central

Ryder, Mark I.; Yao, Tzy-Jyun; Russell, Jonathan S.; Moscicki, Anna-Barbara; Shiboski, Caroline H.

2016-01-01

Aims To compare the prevalence and severity of periodontal diseases between 180 perinatally HIV-infected (PHIV) and 118 perinatally HIV-exposed and uninfected (PHEU) youth in a cross-sectional study conducted at 11 clinical sites in the United States and Puerto Rico from the Adolescent Master Protocol (AMP) study of the Pediatric HIV/AIDS cohort study (PHACS) network. Methods Several analyses were conducted, employing the current CDC/AAP classification for periodontitis and incorporating a definition of gingivitis based on a bleeding on probing threshold, and analyses based on more detailed whole mouth, intraoral regionally, site-based, and tooth-based criteria of bleeding on probing, plaque levels, pockets depths and clinical attachment levels. Results After adjusting for plaque control habits, and behavioral and sociodemographic factors, there were no significant differences in periodontal diseases between the PHIV and PHEU youth using any of these criteria. For PHIV youth, there was no significant association between parameters of periodontal disease and current HIV status. Conclusions While no significant differences in periodontal parameters were noted between the PHIV and PHEU youth, the influence of antiretroviral therapy on merits further exploration in this cohort in a longitudinal study. PMID:27801947

Flipped script for gefitinib: A reapproved tyrosine kinase inhibitor for first-line treatment of epidermal growth factor receptor mutation positive metastatic nonsmall cell lung cancer.

PubMed

Bogdanowicz, Brian S; Hoch, Matthew A; Hartranft, Megan E

2017-04-01

Purpose The approval history, pharmacology, pharmacokinetics, clinical trials, efficacy, dosing recommendations, drug interactions, safety, place in therapy, and economic considerations of gefitinib are reviewed. Summary Lung cancer is one of the most commonly diagnosed cancers and is the leading cause of cancer death. Platinum-based chemotherapy and tyrosine kinase inhibitors, such as erlotinib and afatinib, are recommended therapies for nonsmall cell lung cancer. The European Medicines Association based their approval of gefitinib on the randomized, multicenter Iressa Pan-Asia Study (IPASS, NCT00322452) and a single-arm study showing effectiveness in Caucasians (IFUM, NCT01203917). Both studies were recently referenced by the United States Food & Drug Administration to reapprove gefitinib for the first-line treatment of advanced nonsmall cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 substitution. Diarrhea, acneiform rash, and interstitial lung disease are known side effects of gefitinib. Conclusion Use of gefitinib for the first-line therapy of metastatic nonsmall cell lung cancer with epidermal growth factor receptor exon 19 deletions (residues 747-750) or exon 21 substitution mutation (L858R) is well-documented and supported.

Potential testing of reprocessing procedures by real-time polymerase chain reaction: A multicenter study of colonoscopy devices.

PubMed

Valeriani, Federica; Agodi, Antonella; Casini, Beatrice; Cristina, Maria Luisa; D'Errico, Marcello Mario; Gianfranceschi, Gianluca; Liguori, Giorgio; Liguori, Renato; Mucci, Nicolina; Mura, Ida; Pasquarella, Cesira; Piana, Andrea; Sotgiu, Giovanni; Privitera, Gaetano; Protano, Carmela; Quattrocchi, Annalisa; Ripabelli, Giancarlo; Rossini, Angelo; Spagnolo, Anna Maria; Tamburro, Manuela; Tardivo, Stefano; Veronesi, Licia; Vitali, Matteo; Romano Spica, Vincenzo

2018-02-01

Reprocessing of endoscopes is key to preventing cross-infection after colonoscopy. Culture-based methods are recommended for monitoring, but alternative and rapid approaches are needed to improve surveillance and reduce turnover times. A molecular strategy based on detection of residual traces from gut microbiota was developed and tested using a multicenter survey. A simplified sampling and DNA extraction protocol using nylon-tipped flocked swabs was optimized. A multiplex real-time polymerase chain reaction (PCR) test was developed that targeted 6 bacteria genes that were amplified in 3 mixes. The method was validated by interlaboratory tests involving 5 reference laboratories. Colonoscopy devices (n = 111) were sampled in 10 Italian hospitals. Culture-based microbiology and metagenomic tests were performed to verify PCR data. The sampling method was easily applied in all 10 endoscopy units and the optimized DNA extraction and amplification protocol was successfully performed by all of the involved laboratories. This PCR-based method allowed identification of both contaminated (n = 59) and fully reprocessed endoscopes (n = 52) with high sensibility (98%) and specificity (98%), within 3-4 hours, in contrast to the 24-72 hours needed for a classic microbiology test. Results were confirmed by next-generation sequencing and classic microbiology. A novel approach for monitoring reprocessing of colonoscopy devices was developed and successfully applied in a multicenter survey. The general principle of tracing biological fluids through microflora DNA amplification was successfully applied and may represent a promising approach for hospital hygiene. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

Anti-ribosomal P antibody: a multicenter study in childhood-onset systemic lupus erythematosus patients.

PubMed

Valões, C C M; Molinari, B C; Pitta, A C G; Gormezano, N W S; Farhat, S C L; Kozu, K; Sallum, A M E; Appenzeller, S; Sakamoto, A P; Terreri, M T; Pereira, R M R; Magalhães, C S; Ferreira, J C O A; Barbosa, C M; Gomes, F H; Bonfá, E; Silva, C A

2017-04-01

Objectives Anti-ribosomal P protein (anti-P) autoantibodies are highly specific for systemic lupus erythematosus (SLE). However, the evaluation of this autoantibody in childhood-onset SLE (cSLE) populations has been limited to a few small series, hampering the interpretation of the clinical and laboratorial associations. Therefore, the objective of this multicenter cohort study was to evaluate demographic, clinical/laboratorial features, and disease damage score in cSLE patients with and without the presence of anti-P antibody. Methods This was a retrospective multicenter study performed in 10 pediatric rheumatology services of São Paulo state, Brazil. Anti-P antibodies were measured by ELISA in 228 cSLE patients. Results Anti-P antibodies were observed in 61/228 (27%) cSLE patients. Frequencies of cumulative lymphadenopathy (29% vs. 15%, p = 0.014), acute confusional state (13% vs. 5%, p = 0.041), mood disorder (18% vs. 8%, p = 0.041), autoimmune hemolytic anemia (34% vs. 15%, p = 0.001), as well as presence of anti-Sm (67% vs. 40%, p = 0.001), anti-RNP (39% vs. 21%, p = 0.012) and anti-Ro/SSA antibodies (43% vs. 25%, p = 0.016) were significantly higher in cSLE patients with anti-P antibodies compared to those without these autoantibodies. A multiple regression model revealed that anti-P antibodies were associated with autoimmune hemolytic anemia (odds ratio (OR) = 2.758, 95% confidence interval (CI): 1.304-5.833, p = 0.008) and anti-Sm antibody (OR = 2.719, 95% CI: 1.365-5.418, p = 0.004). The SLICC/ACR damage index was comparable in patients with and without anti-P antibodies ( p = 0.780). Conclusions The novel association of anti-P antibodies and autoimmune hemolytic anemia was evidenced in cSLE patients and further studies are necessary to determine if anti-P titers may vary with this hematological manifestation.

A review of the epidemiological methods used to investigate the health impacts of air pollution around major industrial areas.

PubMed

Pascal, Mathilde; Pascal, Laurence; Bidondo, Marie-Laure; Cochet, Amandine; Sarter, Hélène; Stempfelet, Morgane; Wagner, Vérène

2013-01-01

We performed a literature review to investigate how epidemiological studies have been used to assess the health consequences of living in the vicinity of industries. 77 papers on the chronic effects of air pollution around major industrial areas were reviewed. Major health themes were cancers (27 studies), morbidity (25 studies), mortality (7 studies), and birth outcome (7 studies). Only 3 studies investigated mental health. While studies were available from many different countries, a majority of papers came from the United Kingdom, Italy, and Spain. Several studies were motivated by concerns from the population or by previous observations of an overincidence of cases. Geographical ecological designs were largely used for studying cancer and mortality, including statistical designs to quantify a relationship between health indicators and exposure. Morbidity was frequently investigated through cross-sectional surveys on the respiratory health of children. Few multicenter studies were performed. In a majority of papers, exposed areas were defined based on the distance to the industry and were located from <2 km to >20 km from the plants. Improving the exposure assessment would be an asset to future studies. Criteria to include industries in multicenter studies should be defined.

Conducting multicenter research in healthcare simulation: Lessons learned from the INSPIRE network.

PubMed

Cheng, Adam; Kessler, David; Mackinnon, Ralph; Chang, Todd P; Nadkarni, Vinay M; Hunt, Elizabeth A; Duval-Arnould, Jordan; Lin, Yiqun; Pusic, Martin; Auerbach, Marc

2017-01-01

Simulation-based research has grown substantially over the past two decades; however, relatively few published simulation studies are multicenter in nature. Multicenter research confers many distinct advantages over single-center studies, including larger sample sizes for more generalizable findings, sharing resources amongst collaborative sites, and promoting networking. Well-executed multicenter studies are more likely to improve provider performance and/or have a positive impact on patient outcomes. In this manuscript, we offer a step-by-step guide to conducting multicenter, simulation-based research based upon our collective experience with the International Network for Simulation-based Pediatric Innovation, Research and Education (INSPIRE). Like multicenter clinical research, simulation-based multicenter research can be divided into four distinct phases. Each phase has specific differences when applied to simulation research: (1) Planning phase , to define the research question, systematically review the literature, identify outcome measures, and conduct pilot studies to ensure feasibility and estimate power; (2) Project Development phase , when the primary investigator identifies collaborators, develops the protocol and research operations manual, prepares grant applications, obtains ethical approval and executes subsite contracts, registers the study in a clinical trial registry, forms a manuscript oversight committee, and conducts feasibility testing and data validation at each site; (3) Study Execution phase , involving recruitment and enrollment of subjects, clear communication and decision-making, quality assurance measures and data abstraction, validation, and analysis; and (4) Dissemination phase , where the research team shares results via conference presentations, publications, traditional media, social media, and implements strategies for translating results to practice. With this manuscript, we provide a guide to conducting quantitative multicenter research with a focus on simulation-specific issues.

NASA Workshop on Hybrid (Mixed-Actuator) Spacecraft Attitude Control

NASA Technical Reports Server (NTRS)

Dennehy, Cornelius J.; Kunz, Nans

2014-01-01

At the request of the Science Mission Directorate Chief Engineer, the NASA Technical Fellow for Guidance, Navigation & Control assembled and facilitated a workshop on Spacecraft Hybrid Attitude Control. This multi-Center, academic, and industry workshop, sponsored by the NASA Engineering and Safety Center (NESC), was held in April 2013 to unite nationwide experts to present and discuss the various innovative solutions, techniques, and lessons learned regarding the development and implementation of the various hybrid attitude control system solutions investigated or implemented. This report attempts to document these key lessons learned with the 16 findings and 9 NESC recommendations.

Results of a Multicenter, Randomized, Double-Masked, Placebo-Controlled Clinical Study of the Efficacy and Safety of Visomitin Eye Drops in Patients with Dry Eye Syndrome.

PubMed

Brzheskiy, Vladimir V; Efimova, Elena L; Vorontsova, Tatiana N; Alekseev, Vladimir N; Gusarevich, Olga G; Shaidurova, Ksenia N; Ryabtseva, Alla A; Andryukhina, Olga M; Kamenskikh, Tatiana G; Sumarokova, Elena S; Miljudin, Eugeny S; Egorov, Eugeny A; Lebedev, Oleg I; Surov, Alexander V; Korol, Andrii R; Nasinnyk, Illia O; Bezditko, Pavel A; Muzhychuk, Olena P; Vygodin, Vladimir A; Yani, Elena V; Savchenko, Alla Y; Karger, Elena M; Fedorkin, Oleg N; Mironov, Alexander N; Ostapenko, Victoria; Popeko, Natalia A; Skulachev, Vladimir P; Skulachev, Maxim V

2015-12-01

This article presents the results of an international, multicenter, randomized, double-masked, placebo-controlled clinical study of Visomitin (Mitotech LLC, Moscow, Russian Federation) eye drops in patients with dry eye syndrome (DES). Visomitin is the first registered (in Russia) drug with a mitochondria-targeted antioxidant (SkQ1) as the active ingredient. In this multicenter (10 sites) study of 240 subjects with DES, study drug (Visomitin or placebo) was self-administered three times daily (TID) for 6 weeks, followed by a 6-week follow-up period. Seven in-office study visits occurred every 2 weeks during both the treatment and follow-up periods. Efficacy measures included Schirmer's test, tear break-up time, fluorescein staining, meniscus height, and visual acuity. Safety measures included adverse events, slit lamp biomicroscopy, tonometry, blood pressure, and heart rate. Tolerability was also evaluated. This clinical study showed the effectiveness of Visomitin eye drops in the treatment of signs and symptoms of DES compared with placebo. The study showed that a 6-week course of TID topical instillation of Visomitin significantly improved the functional state of the cornea; Visomitin increased tear film stability and reduced corneal damage. Significant reduction of dry eye symptoms (such as dryness, burning, grittiness, and blurred vision) was also observed. Based on the results of this study, Visomitin is effective and safe for use in eye patients with DES for protection from corneal damage. Mitotech LLC.

Astrophysical materials science: Theory

NASA Technical Reports Server (NTRS)

Ashcroft, N. W.

1984-01-01

A method of structural expansions for use in determining the equation of state of metallic hydrogen (and indeed other metals) up to the 4th order in the perturbation theory was developed. The electrical and thermal transport properties of the planetary interior of Jupiter were calculated. The nature of the interaction between molecules at short range and the importance of multicenter terms in arriving at an adequate description of the thermodynamic functions of condensed molecular hydrogen were also investigated.

The Knowledge-about-Older-Patients - Quiz (KOP-Q) for nurses: Cross-cultural validation between the Netherlands and United States of America.

PubMed

Dikken, Jeroen; Hoogerduijn, Jita G; Klaassen, Sharon; Lagerwey, Mary D; Shortridge-Baggett, Lillie; Schuurmans, Marieke J

2017-08-01

The Knowledge about Older Patients-Quiz (KOP-Q) is designed as a unidimensional scale measuring knowledge of hospital nurses about older patients. Furthermore, the KOP-Q measures a second unidimensional construct, certainty of hospital nurses about their knowledge. The KOP-Q is developed and validated in the Netherlands. Whether the KOP-Q can be used in other countries is unknown given the cultural and language differences. Investigate the level of measurement invariance of the KOP-Q between the Netherlands and United States of America (USA). A multicenter international cross-sectional design. Four general hospitals in the Netherlands and four general hospitals in the USA. Nurses from the Netherlands (n=201) and the USA (n=130) were invited to participate by email from the ward manager, distributing flyers and present messages on the online hospital communication boards. Questions of the KOP-Q were completed online. The level of measurement invariance (configural, metric or scalar invariance) across countries was tested by running increasingly constrained structural equation models, and testing whether these models fitted the data. Both the knowledge and certainty construct of the KOP-Q proved unidimensional in the Netherlands and USA sample. Test results of the measurement invariance across the Netherlands and USA indicated a stable, partial scalar invariance (15 items full scalar invariance) for the knowledge items and full scalar invariance for the certainty items. The KOP-Q shows to function uniformly across both language groups and can therefore be used to assess nurses' knowledge and their certainty about this knowledge which can be important for educational and/or quality improvement programs in the USA. Furthermore, the KOP-Q is suitable to make comparisons between the Netherlands and the USA using latent variable models. Before the KOP-Q can be used in other countries, cross-cultural tests should again be performed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Clinical safety of the ProMRI pacemaker system in patients subjected to head and lower lumbar 1.5-T magnetic resonance imaging scanning conditions.

PubMed

Bailey, William M; Rosenthal, Lawrence; Fananapazir, Lameh; Gleva, Marye; Mazur, Alexander; Rinaldi, C A; Kypta, Alexander; Merkely, Béla; Woodard, Pamela K

2015-06-01

Permanent cardiac pacemakers have historically been considered a contraindication to magnetic resonance imaging (MRI). The purpose of the ProMRI/ProMRI AFFIRM Study, which was a multicenter, prospective, single-arm, nonrandomized study, was to evaluate the clinical safety of the Biotronik ProMRI Pacemaker System under specific MRI conditions. The ProMRI Study (in the United States) and the ProMRI AFFIRM study (outside the United States) with identical design enrolled 272 patients with stable baseline pacing indices implanted with an Entovis or Evia pacemaker (DR-T or SR-T) and Setrox or Safio 53-cm or 60-cm lead. Device interrogation was performed at enrollment, pre-MRI and post-MRI scan, and 1 and 3 months post-MRI. End-points were (1) freedom from MRI- and pacing system-related serious adverse device effects (SADEs) through 1 month post-MRI, (2) freedom from atrial and ventricular MRI-induced pacing threshold increase (>0.5 V), and (3) freedom from P- and R-wave amplitude attenuation (<50%), or P wave <1.5 mV, or R wave <5.0 mV at 1 month post-MRI. Two hundred twenty-six patients completed the MRI and 1-month post-MRI follow-up. No adverse events related to the implanted system and the MRI procedure occurred, resulting in an SADE-free rate of 100.0% (229/229, P <.001). Freedom from atrial and ventricular pacing threshold increase was 99.0% (189/191, P = .003) and 100% (217/217, P <.001), respectively. Freedom from P- and R- wave amplitude attenuation was 99.4% (167/168, P <.001) and 99.5% (193/194, P <.001), respectively. The results of the ProMRI/ProMRI AFFIRM studies demonstrate the clinical safety and efficacy of the ProMRI pacemaker system in patients subjected to head and lower lumbar MRI conditions. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Five-Year Safety and Performance Results from the Argus II Retinal Prosthesis System Clinical Trial.

PubMed

da Cruz, Lyndon; Dorn, Jessy D; Humayun, Mark S; Dagnelie, Gislin; Handa, James; Barale, Pierre-Olivier; Sahel, José-Alain; Stanga, Paulo E; Hafezi, Farhad; Safran, Avinoam B; Salzmann, Joel; Santos, Arturo; Birch, David; Spencer, Rand; Cideciyan, Artur V; de Juan, Eugene; Duncan, Jacque L; Eliott, Dean; Fawzi, Amani; Olmos de Koo, Lisa C; Ho, Allen C; Brown, Gary; Haller, Julia; Regillo, Carl; Del Priore, Lucian V; Arditi, Aries; Greenberg, Robert J

2016-10-01

The Argus II Retinal Prosthesis System (Second Sight Medical Products, Inc, Sylmar, CA) was developed to restore some vision to patients blind as a result of retinitis pigmentosa (RP) or outer retinal degeneration. A clinical trial was initiated in 2006 to study the long-term safety and efficacy of the Argus II System in patients with bare or no light perception resulting from end-stage RP. Prospective, multicenter, single-arm clinical trial. Within-patient controls included the nonimplanted fellow eye and patients' native residual vision compared with their vision with the Argus II. Thirty participants in 10 centers in the United States and Europe. The worse-seeing eye of blind patients was implanted with the Argus II. Patients wore glasses mounted with a small camera and a video processor that converted images into stimulation patterns sent to the electrode array on the retina. The primary outcome measures were safety (the number, seriousness, and relatedness of adverse events) and visual function, as measured by 3 computer-based, objective tests. Secondary measures included functional vision performance on objectively scored real-world tasks. Twenty-four of 30 patients remained implanted with functioning Argus II Systems at 5 years after implantation. Only 1 additional serious adverse event was experienced after the 3-year time point. Patients performed significantly better with the Argus II on than off on all visual function tests and functional vision tasks. The 5-year results of the Argus II trial support the long-term safety profile and benefit of the Argus II System for patients blind as a result of RP. The Argus II is the first and only retinal implant to have market approval in the European Economic Area, the United States, and Canada. Copyright © 2016 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

HDU Deep Space Habitat (DSH) Overview

NASA Technical Reports Server (NTRS)

Kennedy, Kriss J.

2011-01-01

This paper gives an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) project Deep Space Habitat (DSH) analog that will be field-tested during the 2011 Desert Research and Technologies Studies (D-RATS) field tests. The HDU project is a technology pull project that integrates technologies and innovations from multiple NASA centers. This project will repurpose the HDU Pressurized Excursion Module (PEM) that was field tested in the 2010 D-RATS, adding habitation functionality to the prototype unit. The 2010 configuration of the HDU-PEM consisted of a lunar surface laboratory module that was used to bring over 20 habitation-related technologies together in a single platform that could be tested as an advanced habitation analog in the context of mission architectures and surface operations. The 2011 HDU-DSH configuration will build upon the PEM work, and emphasize validity of crew operations (habitation and living, etc), EVA operations, mission operations, logistics operations, and science operations that might be required in a deep space context for Near Earth Object (NEO) exploration mission architectures. The HDU project consists of a multi-center team brought together in a skunkworks approach to quickly build and validate hardware in analog environments. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Exploration Mission Systems Office (EMSO) to test destination elements in analog environments. The 2011 analog field test will include Multi Mission Space Exploration Vehicles (MMSEV) and the DSH among other demonstration elements to be brought together in a mission architecture context. This paper will describe overall objectives, various habitat configurations, strategic plan, and technology integration as it pertains to the 2011 field tests.

Multicenter Observational Study to Evaluate Epidemiology and Resistance Patterns of Common Intensive Care Unit-infections

PubMed Central

Venkataraman, Ramesh; Divatia, Jigeeshu V.; Ramakrishnan, Nagarajan; Chawla, Rajesh; Amin, Pravin; Gopal, Palepu; Chaudhry, Dhruva; Zirpe, Kapil; Abraham, Babu

2018-01-01

Background: There is limited data regarding the microbiology of Intensive Care Unit (ICU)-acquired infections, such as ventilator-associated pneumonia (VAP), catheter-associated urinary tract infections (CAUTI), and catheter-related bloodstream infections (CRBSI) from India. Objectives: To explore the microbiology and resistance patterns of ICU-acquired infections and evaluate their outcomes. Materials and Methods: This was a multicenter observational study, conducted by Indian Society of Critical Care Medicine (MOSER study) between August 2011 and October 2012. Patients in the ICU ≥48 h with any ICU-acquired infection within 14 days of index ICU stay were included. Patient demographics, relevant clinical, and microbiological details were collected. Follow-up until hospital discharge or death was done, and 6-month survival data were collected. Results: Of the 381 patients included in the study, 346 patients had 1 ICU infection and 35 had more than one ICU infection. Among patients with single infections, 223 had VAP with Acinetobacter being the most common isolate. CAUTI was seen in 42 patients with Klebsiella as the most common organism. CRBSI was seen in 81 patients and Klebsiella was the most common causative organism. Multidrug resistance was noted in 87.5% of Acinetobacter, 75.5% of Klebsiella, 61.9% of Escherichia coli, and 58.9% of Pseudomonas isolates, respectively. Staphylococcus constituted only 2.4% of isolates. Mortality rates were 26%, 11.9%, and 34.6% in VAP, CAUTI, and CRBSI, respectively. Conclusion: VAP is the most common infection followed by CRBSI and CAUTI. Multidrug-resistant Gram-negative bacteria are the most common organisms. Staphylococcus aureus is uncommon in the Indian setting. PMID:29422728

A Multicenter Pragmatic Interrupted Time Series Analysis of Chlorhexidine Gluconate Bathing in Community Hospital Intensive Care Units.

PubMed

Dicks, Kristen V; Lofgren, Eric; Lewis, Sarah S; Moehring, Rebekah W; Sexton, Daniel J; Anderson, Deverick J

2016-07-01

OBJECTIVE To determine whether daily chlorhexidine gluconate (CHG) bathing of intensive care unit (ICU) patients leads to a decrease in hospital-acquired infections (HAIs), particularly infections caused by methicillin-resistant Staphylococcus aureus (MRSA) and vancomycin-resistant Enterococcus (VRE). DESIGN Interrupted time series analysis. SETTING The study included 33 community hospitals participating in the Duke Infection Control Outreach Network from January 2008 through December 2013. PARTICIPANTS All ICU patients at study hospitals during the study period. METHODS Of the 33 hospitals, 17 hospitals implemented CHG bathing during the study period, and 16 hospitals that did not perform CHG bathing served as controls. Primary pre-specified outcomes included ICU central-line-associated bloodstream infections (CLABSIs), primary bloodstream infections (BSI), ventilator-associated pneumonia (VAP), and catheter-associated urinary tract infections (CAUTIs). MRSA and VRE HAIs were also evaluated. RESULTS Chlorhexidine gluconate (CHG) bathing was associated with a significant downward trend in incidence rates of ICU CLABSI (incidence rate ratio [IRR], 0.96; 95% confidence interval [CI], 0.93-0.99), ICU primary BSI (IRR, 0.96; 95% CI, 0.94-0.99), VRE CLABSIs (IRR, 0.97; 95% CI, 0.97-0.98), and all combined VRE infections (IRR, 0.96; 95% CI, 0.93-1.00). No significant trend in MRSA infection incidence rates was identified prior to or following the implementation of CHG bathing. CONCLUSIONS In this multicenter, real-world analysis of the impact of CHG bathing, hospitals that implemented CHG bathing attained a decrease in ICU CLABSIs, ICU primary BSIs, and VRE CLABSIs. CHG bathing did not affect rates of specific or overall infections due to MRSA. Our findings support daily CHG bathing of ICU patients. Infect Control Hosp Epidemiol 2016;37:791-797.

Pediatric Cardiopulmonary Arrest in the Postanesthesia Care Unit, Rare but Preventable: Analysis of Data From Wake Up Safe, The Pediatric Anesthesia Quality Improvement Initiative.

PubMed

Christensen, Robert E; Haydar, Bishr; Voepel-Lewis, Terri D

2017-04-01

Nearly 20% of anesthesia-related pediatric cardiac arrests (CAs) occur during emergence or recovery. The aims of this case series were to use the Wake Up Safe database to describe the following: (1) the nature of pediatric postanesthesia care unit (PACU) CA and subsequent outcomes and (2) factors associated with harm after pediatric PACU CA. Pediatric CAs in the PACU were identified from the Wake Up Safe Pediatric Anesthesia Quality Improvement Initiative, a multicenter registry of adverse events in pediatric anesthesia. Demographics, underlying conditions, cause of CA, and outcomes were extracted. Descriptive statistics were used to characterize data and to assess risk of harm in those suffering CA. A total of 26 CA events were included: 67% in children <5 years, and 30% in infants (<1 year); 18 (69%) were deemed likely or almost certainly preventable. All preventable CAs were respiratory in nature and most (67%) had purported root causes that included provider judgment or inexperience, inadequate supervision, and competing priorities. CAs of cardiac origin were associated with increased level of harm (temporary or greater), whereas those of respiratory origin were associated more often with no harm. PACU CA events are rare and generally survivable, with better outcomes for respiratory-based events, but most were deemed preventable, suggesting a need for further vigilance in the early postoperative period. Maintenance of monitoring during patient transport to PACU and continuing care by anesthesia care providers until emergence from anesthesia may further reduce the preventable arrest rate. The root cause analyses conducted by individual institutions reporting these data to the Wake Up Safe provided only limited insight, so multicenter collaborative approaches may allow for greater insight into effective CA-prevention strategies.

Costs and benefits of rapid screening of methicillin-resistant Staphylococcus aureus carriage in intensive care units: a prospective multicenter study

PubMed Central

2012-01-01

Introduction Pre-emptive isolation of suspected methicillin-resistant Staphylococcus aureus (MRSA) carriers is a cornerstone of successful MRSA control policies. Implementation of such strategies is hampered when using conventional cultures with diagnostic delays of three to five days, as many non-carriers remain unnecessarily isolated. Rapid diagnostic testing (RDT) reduces the amount of unnecessary isolation days, but costs and benefits have not been accurately determined in intensive care units (ICUs). Methods Embedded in a multi-center hospital-wide study in 12 Dutch hospitals we quantified cost per isolation day avoided using RDT for MRSA, added to conventional cultures, in ICUs. BD GeneOhm™ MRSA PCR (IDI) and Xpert MRSA (GeneXpert) were subsequently used during 17 and 14 months, and their test characteristics were calculated with conventional culture results as reference. We calculated the number of pre-emptive isolation days avoided and incremental costs of adding RDT. Results A total of 163 patients at risk for MRSA carriage were screened and MRSA prevalence was 3.1% (n = 5). Duration of isolation was 27.6 and 21.4 hours with IDI and GeneXpert, respectively, and would have been 96.0 hours when based on conventional cultures. The negative predictive value was 100% for both tests. Numbers of isolation days were reduced by 44.3% with PCR-based screening at the additional costs of €327.84 (IDI) and €252.14 (GeneXpert) per patient screened. Costs per isolation day avoided were €136.04 (IDI) and €121.76 (GeneXpert). Conclusions In a low endemic setting for MRSA, RDT safely reduced the number of unnecessary isolation days on ICUs by 44%, at the costs of €121.76 to €136.04 per isolation day avoided. PMID:22314204

The clinical practice of high-flow nasal cannula oxygen therapy in adults: A Japanese cross-sectional multicenter survey.

PubMed

Ito, Jiro; Nagata, Kazuma; Sato, Susumu; Shiraki, Akira; Nishimura, Naoki; Izumi, Shinyu; Tachikawa, Ryo; Morimoto, Takeshi; Tomii, Keisuke

2018-05-01

High-flow nasal cannula oxygen therapy (HFNC) is widely used mainly in the acute care setting, but limited data are available on real-world practice in adults. The objective of this study was to describe HFNC practices in Japanese adults. A retrospective cross-sectional multicenter survey of adult patients receiving HFNC from January through March 2015 was conducted in 33 participating hospitals in Japan. We obtained information on 321 patients (median age, 76; 218 men, 103 women; median estimated PaO 2 /F I O 2, 178 mm Hg) from 22 hospitals. Do-not-intubate status was determined in 37.4% of patients. Prior to HFNC, 57.9% of patients received conventional oxygen therapy; 25.9%, noninvasive ventilation; and 15.0%, invasive mechanical ventilation. The common indications for HFNC were acute hypoxemic respiratory failure (ARF) (65.4%), postoperative respiratory support (15.9%), and post-extubation respiratory support (11.2%). The underlying etiology of ARF included interstitial lung disease, pneumonia, and cardiogenic pulmonary edema. HFNC was administered mostly in intensive care units or intermittent care units (60.7%) and general wards (36.1%). Median duration of HFNC was 4 days; median total flow rate, 40 L/min; and median F I O 2 , 50%. HFNC significantly improved PaO 2 , PaCO 2 , SpO 2 and respiratory rate from baseline. Two-thirds of patients finally survived to be discharged or transferred. We documented patient demographics, clinical indications, and settings of HFNC use in the real world. We also demonstrated positive effects of HFNC on respiratory parameters. Further studies are urgently needed regarding the efficacy and safety of HFNC in populations outside of previous clinical trials. Copyright © 2018 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

Multicenter AIDS Cohort Study Quantitative Coronary Plaque Progression Study: rationale and design.

PubMed

Nakanishi, Rine; Post, Wendy S; Osawa, Kazuhiro; Jayawardena, Eranthi; Kim, Michael; Sheidaee, Nasim; Nezarat, Negin; Rahmani, Sina; Kim, Nicholas; Hathiramani, Nicolai; Susarla, Shriraj; Palella, Frank; Witt, Mallory; Blaha, Michael J; Brown, Todd T; Kingsley, Lawrence; Haberlen, Sabina A; Dailing, Christopher; Budoff, Matthew J

2018-01-01

The association of HIV with coronary atherosclerosis has been established; however, the progression of coronary atherosclerosis over time among participants with HIV is not well known. The Multicenter AIDS Cohort Study Quantitative Coronary Plaque Progression Study is a large prospective multicenter study quantifying progression of coronary plaque assessed by serial coronary computed tomography angiography (CTA). HIV-infected and uninfected men who were enrolled in the Multicenter AIDS Cohort Study Cardiovascular Substudy were eligible to complete a follow-up contrast coronary CTA 3-6 years after baseline. We measured coronary plaque volume and characteristics (calcified and noncalcified plaque including fibrous, fibrous-fatty, and low attenuation) and vulnerable plaque among HIV-infected and uninfected men using semiautomated plaque software to investigate the progression of coronary atherosclerosis over time. We describe a novel, large prospective multicenter study investigating incidence, transition of characteristics, and progression in coronary atherosclerosis quantitatively assessed by serial coronary CTAs among HIV-infected and uninfected men.

Utilizations and Perceptions of Emergency Medical Services by Patients with ST-Segments Elevation Acute Myocardial Infarction in Abu Dhabi: A Multicenter Study

PubMed Central

Callachan, Edward Lance; Alsheikh-Ali, Alawi A.; Nair, Satish Chandrasekhar; Bruijns, Stevan; Wallis, Lee A.

2016-01-01

Background: Data on the use of emergency medical services (EMS) by patients with cardiac conditions in the Gulf region are scarce, and prior studies have suggested underutilization. Patient perception and knowledge of EMS care is critical to proper utilization of such services. Objectives: To estimate utilization, knowledge, and perceptions of EMS among patients with ST-elevation myocardial infarction (STEMI) in the Emirate of Abu Dhabi. Methods: We conducted a multicenter prospective study of consecutive patients admitted with STEMI in four government-operated hospitals in Abu Dhabi. Semi-structured interviews were conducted with patients to assess the rationale for choosing their prehospital mode of transport and their knowledge of EMS services. Results: Of 587 patients with STEMI (age 51 ± 11 years, male 95%), only 15% presented through EMS, and the remainder came via private transport. Over half of the participants (55%) stated that they did not know the telephone number for EMS. The most common reasons stated for not using EMS were that private transport was quicker (40%) or easier (11%). A small percentage of participants (7%) did not use EMS because they did not think their symptoms were cardiac-related or warranted an EMS call. Stated reasons for not using EMS did not significantly differ by age, gender, or primary language of the patients. Conclusions: EMS care for STEMI is grossly underutilized in Abu Dhabi. Patient knowledge and perceptions may contribute to underutilization, and public education efforts are needed to raise their perception and knowledge of EMS. PMID:27512532

Australian nursing students' knowledge and attitudes towards pressure injury prevention: A cross-sectional study.

PubMed

Usher, Kim; Woods, Cindy; Brown, Janie; Power, Tamara; Lea, Jackie; Hutchinson, Marie; Mather, Carey; Miller, Andrea; Saunders, Annette; Mills, Jane; Zhao, Lin; Yates, Karen; Bodak, Marie; Southern, Joanne; Jackson, Debra

2018-05-01

The aim of this study was to assess student nurses' knowledge of and attitudes towards pressure injury prevention evidence-based guidelines. Pressure injuries are a substantial problem in many healthcare settings causing major harm to patients, and generating major economic costs for health service providers. Nurses have a crucial role in the prevention of pressure injuries across all health care settings. A multi-centered, cross-sectional study was conducted using a paper-based questionnaire with undergraduate nursing students enrolled in seven universities with campuses across five Australian states (Queensland, New South Wales, Western Australia, Victoria and Tasmania). Data were collected from nursing students using two validated instruments (Pressure Ulcer Knowledge Assessment Instrument and Attitude Toward Pressure Ulcer Prevention Instrument), to measure students' pressure injury prevention knowledge and attitudes. Students reported relatively low pressure injury prevention knowledge scores (51%), and high attitude scores (78%). Critical issues in this study were nursing students' lack of knowledge about preventative strategies to reduce the amount and duration of pressure/shear, and lower confidence in their capability to prevent pressure injury. Level of education and exposure to working in a greater number of different clinical units were significantly related to pressure injury prevention knowledge and attitude scores. The study findings highlight the need to implement a comprehensive approach to increasing Australian nursing students' pressure injury prevention and management knowledge, as well as ensuring that these students have adequate experiences in clinical units, with a high focus on pressure injury prevention to raise their personal capability. Copyright © 2018 Elsevier Ltd. All rights reserved.

Apixaban and dalteparin in active malignancy associated venous thromboembolism. The ADAM VTE Trial.

PubMed

McBane Ii, Robert; Loprinzi, Charles L; Ashrani, Aneel; Perez-Botero, Juliana; Leon Ferre, Roberto A; Henkin, Stanislav; Lenz, Charles J; Le-Rademacher, Jennifer G; Wysokinski, Waldemar E

2017-10-05

Currently, low molecular weight heparin (LMWH) is the guideline endorsed treatment of patients with cancer associated venous thromboembolism (VTE). While apixaban is approved for the treatment of acute VTE, there are limited data supporting its use in cancer patients. The rationale and design of this investigator initiated Phase IV, multicenter, randomized, open label, superiority trial assessing the safety of apixaban versus dalteparin for cancer associated VTE is provided (ADAM-VTE; NCT02585713). The main aim of the ADAM-VTE trial is to test the hypothesis that apixaban is associated with a significantly lower rate of major bleeding compared to dalteparin in the treatment of cancer patients with acute VTE. The primary safety outcome is rate of major bleeding. Secondary efficacy objective is to assess the rates of recurrent VTE or arterial thromboembolism. Cancer patients with acute VTE (n=300) are randomized to receive apixaban (10 mg twice daily for 7 days followed by 5 mg twice daily thereafter) or dalteparin (200 IU/Kg daily for 30 days followed by 150 IU/kg daily thereafter) for 6 months. Stratification factors used for randomization include cancer stage and cancer specific risk of venous thromboembolism using the Khorana score. Participating centers are chosen from the Academic and Community Cancer Research United (ACCRU) consortium comprised of 90 oncology practices in the United States and Canada. Based on the hypothesis to be tested, we anticipate that these trial results will provide evidence supporting apixaban as an effective treatment of cancer associated VTE at lower rates of major bleeding compared to LMWH.

[French law related to patient's rights and end of life: pediatric intensive care unit's health professionals' opinions].

PubMed

de Saint Blanquat, L; Cremer, R; Elie, C; Lesage, F; Dupic, L; Hubert, P

2014-01-01

To identify the knowledge of caregivers of pediatric intensive care units (PICUs) on the French law related to patients' rights and end of life, their views on withholding/withdrawing life-sustaining treatment (WWLST) decisions, and their feelings about how these decisions were made and implemented. A multicenter survey in 24 French PICUs during the fourth trimester 2010. One thousand three hundred and thirty-nine professional healthcare workers (1005 paramedics and 334 physicians) responded. Over 85% of caregivers had good knowledge of the WWLST decision-making processes required by law. More than 80% of caregivers accepted mechanical ventilation, hemodiafiltration, or hemodynamic support withdrawal or withholding. Nevertheless, the withdrawal of artificial nutrition and hydration generated reluctance or opposition for the majority of respondents. While paramedics' participation in the decision-making process was deemed necessary by all caregivers, paramedics found more often than physicians that they were insufficiently involved. The quality of end-of-life care was judged very positively by caregivers. The answers on how WWLST was applied suggest very different interpretations of the law. Some caregivers respect the principles of palliative care as stated in the public health code and 40% of doctors and 64% of caregivers consider it "acceptable" to hasten death if resulting from a collaborative decision-making process. This study is the first to show that caregivers of French PICUs have good knowledge of the French law concerning the end of life. Yet, there is still confusion about the limits of practice during the end-of-life period. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Both the intratumoral immune and microbial microenvironment are linked to recurrence in human colon cancer: results from a prospective, multicenter nodal ultrastaging trial

PubMed Central

Noguti, Juliana; Chan, Alfred A.; Bandera, Bradley; Brislawn, Colin J.; Protic, Mladjan; Sim, Myung S.; Jansson, Janet K.; Bilchik, Anton J.; Lee, Delphine J.

2018-01-01

Colon cancer (CC) is the third most common cancer diagnosed in the United States and the incidence has been rising among young adults. We and others have shown a relationship between the immune infiltrate and prognosis, with improved disease-free survival (DFS) being associated with a higher expression of CD8+ T cells. We hypothesized that a microbial signature might be associated with intratumoral immune cells as well as DFS. We found that the relative abundance of one Operational Taxonomic Unit (OTU), OTU_104, was significantly associated with recurrence even after applying false discovery correction (HR 1.21, CI 1.08 to 1.36). The final multivariable model showed that DFS was influenced by three parameters: N-stage, CD8+ labeling, as well as this OTU_104 belonging to the order Clostridiales. Not only were CD8+ labeling and OTU_104 significant contributors in the final DFS model, but they were also inversely correlated to each other (p=0.022). Interestingly, CD8+ was also significantly associated with the microbiota composition in the tumor: CD8+ T cells was inversely correlated with alpha diversity (p=0.027) and significantly associated with the beta diversity. This study is the first to demonstrate an association among the intratumoral microbiome, CD8+ T cells, and recurrence in CC. An increased relative abundance of a specific OTU_104 was inversely associated with CD8+ T cells and directly associated with CC recurrence. The link between this microbe, CD8+ T cells, and DFS has not been previously shown.

Effect of rasagiline as adjunct therapy to levodopa on severity of OFF in Parkinson's disease.

PubMed

Stocchi, F; Rabey, J M

2011-12-01

The LARGO study demonstrated that rasagiline 1 mg/day as adjunct to levodopa significantly reduces OFF time to the same magnitude as adjunct entacapone. This substudy of LARGO aimed to assess the effect of rasagiline and entacapone on the motor symptoms of PD during the practically defined OFF state. LARGO was a randomized, double-blind, multicenter trial that assessed the efficacy and safety of rasagiline (1 mg/day), entacapone (200 mg with each levodopa dose), and placebo in 687 levodopa-treated PD patients with motor fluctuations. A substudy of LARGO measured UPDRS motor scores in the practically defined OFF state in 32 rasagiline, 36 entacapone, and 37 placebo patients. Treatment with rasagiline produced a significant improvement over placebo of 5.64 units in UPDRS motor OFF score (P = 0.013 vs. placebo). By contrast, the effect of adjunct entacapone was not significant (P = 0.14 vs. placebo). Whereas rasagiline also showed a trend in reducing the UPDRS-ADL OFF score (P = 0.058 vs. placebo), no such trend was noted for entacapone (P = 0.26 vs. placebo). Retrospective analysis, using the Bonferroni correction, of UPDRS motor subdomains further revealed that rasagiline, but not entacapone, significantly improved bradykinesia (P < 0.001) and showed trends for improvements in facial expression, speech, and axial impairment during OFF time. This study provides the first objectively measured evidence that adjunct rasagiline 1 mg/day is effective in reducing the severity of motor symptoms in the OFF state. This suggests a continuous effect of rasagiline 1 mg/day throughout the day and night and is consistent with its extended duration of therapeutic action. © 2011 The Author(s). European Journal of Neurology © 2011 EFNS.

Daily chlorhexidine bathing does not increase skin toxicity after remission induction or stem cell transplantation.

PubMed

Deeren, Dries; Dewulf, Evelyne; Verfaillie, Lydie

2016-12-01

A recent multicenter study demonstrated that bathing with chlorhexidine reduces the transmission of resistant organisms and the risk of hospital-acquired bloodstream infections in ICUs. We wanted to confirm the feasibility of this strategy in a cohort of patients in a typical intensive haematology unit. Patients treated with remission induction chemotherapy, autologous or allogeneic stem cell transplantation received daily chlorhexidine bathing. To avoid deshydratation of skin, we used prophylactic application of hydrating lotion, replaced by corticosteroid cream in case of skin toxicity of chemotherapy or conditioning. We studied 15 consecutive admissions of 12 patients. Daily chlorhexidine bathing never needed to be interrupted, even though 53% of patients were treated with intravenous cytarabine. Patients were satisfied with the skin treatment and reported few unwanted effects. Daily chlorhexidine bathing was feasible in our intensive haematology unit in all patients and did not increase skin toxicity, even when treated with IV cytarabine.

Miguel Sánchez Peña (1925-2009) organizer of the space activities in Argentina

NASA Astrophysics Data System (ADS)

de León, Pablo; Sánchez Peña, Miguel Alejandro

2011-11-01

One of the most important and active pioneers of the space activities in Argentina was Miguel Sánchez Peña, an aeronautical engineer and an officer of the Argentine Air Force. Sánchez Peña was the organizer of Argentina's governmental space program in the 1970s and part of the 80s, and contributed immeasurably to the Nation's sounding rocket program. Born in Mendoza, Argentina in 1925, Sánchez Peña attended the Military Aviation School (Escuela de Aviación Militar) in Córdoba, and later the Air Force Engineering School. Graduated as an engineer in 1959 he was sent to the University of Michigan in the United States to complete his graduate studies earning a Masters of Science degree in Aerospace Engineering. There he had the opportunity to study with several future NASA astronauts such as Theodore Freeman, Edward White and James McDivitt. After his return to Argentina in 1961 he was put in charge of the Space Development Group (Grupo de Desarrollos Espaciales) of the Air Force in Córdoba. While with the Air Force he managed the development of a family of various sounding rockets for high altitude research. Sánchez Peña was also in charge of the first Argentine rockets launched from Antarctica in 1965, as well as the first tests on an Argentine-fabricated rocket (Orión) from Wallops Island in the United States, in 1966. The Orion was the first operational sounding rocket constructed in South America. In the middle of the 1970s Miguel Sánchez Peña was named president of the CNIE (National Space Research Commission). Starting with just a modest one-desk office at the Argentine Air Force headquarters, in only a few years he turned CNIE into a multi-center organization with several hundred employees, three operational launch centers across the country and a family of research rockets open to the international scientific community. He was also actively representing Argentina in many IAF congresses, and was a member of the International Academy of Astronautics. After leaving CNIE he became president of the Asociación Argentina de Ciencias Espaciales (AACE), an IAF Member organization which was the continuation of the space organization created by Teófilo Tabanera in 1951. Miguel Sánchez Peña was, without doubt, the most active president of CNIE and thanks to his vision, hard work and the international trust he created, his efforts made it possible for Argentina to participate in many cooperative space experiments with partners like France, Germany, Perú, the United Kingdom and the United States.

7 CFR 1160.104 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 9 2012-01-01 2012-01-01 false United States. 1160.104 Section 1160.104 Agriculture... Definitions § 1160.104 United States. United States means the 48 contiguous states in the continental United States and the District of Columbia, except that United States means the 50 states of the United States...

7 CFR 1160.104 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 9 2011-01-01 2011-01-01 false United States. 1160.104 Section 1160.104 Agriculture... Definitions § 1160.104 United States. United States means the 48 contiguous states in the continental United States and the District of Columbia, except that United States means the 50 states of the United States...

7 CFR 1160.104 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 9 2014-01-01 2013-01-01 true United States. 1160.104 Section 1160.104 Agriculture... Definitions § 1160.104 United States. United States means the 48 contiguous states in the continental United States and the District of Columbia, except that United States means the 50 states of the United States...

7 CFR 1160.104 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 9 2013-01-01 2013-01-01 false United States. 1160.104 Section 1160.104 Agriculture... Definitions § 1160.104 United States. United States means the 48 contiguous states in the continental United States and the District of Columbia, except that United States means the 50 states of the United States...

7 CFR 1160.104 - United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 9 2010-01-01 2009-01-01 true United States. 1160.104 Section 1160.104 Agriculture... Definitions § 1160.104 United States. United States means the 48 contiguous states in the continental United States and the District of Columbia, except that United States means the 50 states of the United States...

The Korean Neonatal Network: An Overview

PubMed Central

Chang, Yun Sil; Park, Hyun-Young

2015-01-01

Currently, in the Republic of Korea, despite the very-low-birth rate, the birth rate and number of preterm infants are markedly increasing. Neonatal deaths and major complications mostly occur in premature infants, especially very-low-birth-weight infants (VLBWIs). VLBWIs weigh less than 1,500 g at birth and require intensive treatment in a neonatal intensive care unit (NICU). The operation of the Korean Neonatal Network (KNN) officially started on April 15, 2013, by the Korean Society of Neonatology with support from the Korea Centers for Disease Control and Prevention. The KNN is a national multicenter neonatal network based on a prospective web-based registry for VLBWIs. About 2,000 VLBWIs from 60 participating hospital NICUs are registered annually in the KNN. The KNN has built unique systems such as a web-based real-time data display on the web site and a site-visit monitoring system for data quality surveillance. The KNN should be maintained and developed further in order to generate appropriate, population-based, data-driven, health-care policies; facilitate active multicenter neonatal research, including quality improvement of neonatal care; and ultimately lead to improvement in the prognosis of high-risk newborns and subsequent reduction in health-care costs through the development of evidence-based neonatal medicine in Korea. PMID:26566355

Outcome of the Respiratory Syncytial Virus related acute lower respiratory tract infection among hospitalized newborns: a prospective multicenter study.

PubMed

Alan, Serdar; Erdeve, Omer; Cakir, Ufuk; Akduman, Hasan; Zenciroglu, Aysegul; Akcakus, Mustafa; Tunc, Turan; Gokmen, Zeynel; Ates, Can; Atasay, Begum; Arsan, Saadet

2016-01-01

To determine the incidence and outcomes of respiratory syncytial virus (RSV)-related acute lower respiratory tract infection (ALRI) including morbidity, nosocomial infection and mortality among newborn infants who were admitted to the neonatal intensive care units (NICUs). A multicenter, prospective study was conducted in newborns who were hospitalized with community acquired or nosocomial RSV infection in 44 NICUs throughout Turkey. Newborns with ALRI were screened for RSV infection by Respi-Strip®-test. Main outcome measures were the incidence of RSV-associated admissions in the NICUs and morbidity, mortality and epidemics results related to these admissions. The incidence of RSV infection was 1.24% (n: 250) and RSV infection constituted 19.6% of all ALRI hospitalizations, 226 newborns (90.4%) had community-acquired whereas 24 (9.6%) patients had nosocomial RSV infection in the NICUs. Of the 250 newborns, 171 (68.4%) were full-term infants, 183 (73.2%) had a BW >2500 g. RSV-related mortality rate was 1.2%. Four NICUs reported seven outbreaks on different months, which could be eliminated by palivizumab prophylaxis in one NICU. RSV-associated ALRI both in preterm and term infants accounts an important percent of hospitalizations in the season, and may threat other high-risk patients in the NICU.

A Review of the Epidemiological Methods Used to Investigate the Health Impacts of Air Pollution around Major Industrial Areas

PubMed Central

Pascal, Laurence; Bidondo, Marie-Laure; Cochet, Amandine; Sarter, Hélène; Stempfelet, Morgane; Wagner, Vérène

2013-01-01

We performed a literature review to investigate how epidemiological studies have been used to assess the health consequences of living in the vicinity of industries. 77 papers on the chronic effects of air pollution around major industrial areas were reviewed. Major health themes were cancers (27 studies), morbidity (25 studies), mortality (7 studies), and birth outcome (7 studies). Only 3 studies investigated mental health. While studies were available from many different countries, a majority of papers came from the United Kingdom, Italy, and Spain. Several studies were motivated by concerns from the population or by previous observations of an overincidence of cases. Geographical ecological designs were largely used for studying cancer and mortality, including statistical designs to quantify a relationship between health indicators and exposure. Morbidity was frequently investigated through cross-sectional surveys on the respiratory health of children. Few multicenter studies were performed. In a majority of papers, exposed areas were defined based on the distance to the industry and were located from <2 km to >20 km from the plants. Improving the exposure assessment would be an asset to future studies. Criteria to include industries in multicenter studies should be defined. PMID:23818910

A Probabilistic Model for Cushing's Syndrome Screening in At-Risk Populations: A Prospective Multicenter Study.

PubMed

León-Justel, Antonio; Madrazo-Atutxa, Ainara; Alvarez-Rios, Ana I; Infantes-Fontán, Rocio; Garcia-Arnés, Juan A; Lillo-Muñoz, Juan A; Aulinas, Anna; Urgell-Rull, Eulàlia; Boronat, Mauro; Sánchez-de-Abajo, Ana; Fajardo-Montañana, Carmen; Ortuño-Alonso, Mario; Salinas-Vert, Isabel; Granada, Maria L; Cano, David A; Leal-Cerro, Alfonso

2016-10-01

Cushing's syndrome (CS) is challenging to diagnose. Increased prevalence of CS in specific patient populations has been reported, but routine screening for CS remains questionable. To decrease the diagnostic delay and improve disease outcomes, simple new screening methods for CS in at-risk populations are needed. To develop and validate a simple scoring system to predict CS based on clinical signs and an easy-to-use biochemical test. Observational, prospective, multicenter. Referral hospital. A cohort of 353 patients attending endocrinology units for outpatient visits. All patients were evaluated with late-night salivary cortisol (LNSC) and a low-dose dexamethasone suppression test for CS. Diagnosis or exclusion of CS. Twenty-six cases of CS were diagnosed in the cohort. A risk scoring system was developed by logistic regression analysis, and cutoff values were derived from a receiver operating characteristic curve. This risk score included clinical signs and symptoms (muscular atrophy, osteoporosis, and dorsocervical fat pad) and LNSC levels. The estimated area under the receiver operating characteristic curve was 0.93, with a sensitivity of 96.2% and specificity of 82.9%. We developed a risk score to predict CS in an at-risk population. This score may help to identify at-risk patients in non-endocrinological settings such as primary care, but external validation is warranted.

The Korean Neonatal Network: An Overview.

PubMed

Chang, Yun Sil; Park, Hyun-Young; Park, Won Soon

2015-10-01

Currently, in the Republic of Korea, despite the very-low-birth rate, the birth rate and number of preterm infants are markedly increasing. Neonatal deaths and major complications mostly occur in premature infants, especially very-low-birth-weight infants (VLBWIs). VLBWIs weigh less than 1,500 g at birth and require intensive treatment in a neonatal intensive care unit (NICU). The operation of the Korean Neonatal Network (KNN) officially started on April 15, 2013, by the Korean Society of Neonatology with support from the Korea Centers for Disease Control and Prevention. The KNN is a national multicenter neonatal network based on a prospective web-based registry for VLBWIs. About 2,000 VLBWIs from 60 participating hospital NICUs are registered annually in the KNN. The KNN has built unique systems such as a web-based real-time data display on the web site and a site-visit monitoring system for data quality surveillance. The KNN should be maintained and developed further in order to generate appropriate, population-based, data-driven, health-care policies; facilitate active multicenter neonatal research, including quality improvement of neonatal care; and ultimately lead to improvement in the prognosis of high-risk newborns and subsequent reduction in health-care costs through the development of evidence-based neonatal medicine in Korea.

31 CFR 515.321 - United States; continental United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States; continental United... General Definitions § 515.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof, including the Trust Territory of...

31 CFR 535.321 - United States; continental United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States; continental United... General Definitions § 535.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof including the Trust Territory of...

31 CFR 535.321 - United States; continental United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

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31 CFR 535.321 - United States; continental United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

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31 CFR 515.321 - United States; continental United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

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31 CFR 515.321 - United States; continental United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States; continental United... General Definitions § 515.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof, including the Trust Territory of...

31 CFR 500.321 - United States; continental United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

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31 CFR 515.321 - United States; continental United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

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31 CFR 535.321 - United States; continental United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

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31 CFR 535.321 - United States; continental United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States; continental United... General Definitions § 535.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof including the Trust Territory of...

31 CFR 515.321 - United States; continental United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States; continental United... General Definitions § 515.321 United States; continental United States. The term United States means the United States and all areas under the jurisdiction or authority thereof, including the Trust Territory of...

A multicenter, open-label trial to evaluate the quality of life in adults with ADHD treated with long-acting methylphenidate (OROS MPH): Concerta Quality of Life (CONQoL) study.

PubMed

Mattos, Paulo; Louzã, Mário Rodrigues; Palmini, André Luís Fernandes; de Oliveira, Irismar Reis; Rocha, Fábio Lopes

2013-07-01

The available literature provides few studies on the effectiveness of methylphenidate in improving quality of life in individuals with ADHD. To assess the effectiveness of methylphenidate OROS formulation (OROS MPH) through QoL in adults with ADHD. A 12-week, multicenter, open-label trial involving 60 patients was used. The measures used were Adult Self-Rating Scale, Adult ADHD Quality of Life Scale (AAQoL), State and Trait Anxiety Inventory (STAI), Hamilton Depression Rating Scale (HAM-D), Clinical Global Impression (CGI), and safety measures. A significance statistic level of 5% was adopted. Analyses included 60 patients (66.7% male; M age = 31.1 years) for safety and 58 patients for effectiveness. All AAQoL subscales improved from baseline to Week 12 (p < .0001), as well as the Total AAQoL (p < .0001). A significant reduction on Clinical Global Impression-Improvement (CGI-I), HAM-D, STAI, and ASRS scores was observed (p < .0001). No serious adverse event was reported. Treatment of adult ADHD patients with OROS MPH improves QoL.

An automated diagnostic process (PDA) in clinical psychopharmacology. An exemplification of its use in a sulpiride versus haloperidol comparative trial.

PubMed

Castrogiovanni, P; Cassano, G B; Conti, L; Maggini, C; Bonollo, L; Sarteschi, P

1976-01-01

One of the main unsolved problems, and one which produces divergent results in clinical psychopharmacology, is that concerning the selection of patients and their diagnostic definition. An automated diagnostic procedure (PDA) was set up in order to classify each patient into one nosographic category on the basis of a cross-sectional examination of his mental state. Such diagnostic procedure appears particularly suitable for multicenter drug trials, since it gives a profile and a diagnostic definition of patients, assessed by investigators from different areas and with different cultural, and clinical backgrounds. In a multicenter trial (sulpiride versus haloperidol) PDA offered a chance to re-examine and analyze the characteristics of each patient and therefore to control the criteria followed for the sample selection in the various experimental settings. The agreement between clinician and computer diagnosis was 78.9%; this agreement rises to 85.5% if the computerlabelled schizo-affective syndromes are considered within the schizophrenic group. Moreover, and attempt has been made to relate psychopathological patterns to drug responses.

Important questions asked by family members of intensive care unit patients.

PubMed

Peigne, Vincent; Chaize, Marine; Falissard, Bruno; Kentish-Barnes, Nancy; Rusinova, Katerina; Megarbane, Bruno; Bele, Nicolas; Cariou, Alain; Fieux, Fabienne; Garrouste-Orgeas, Maite; Georges, Hugues; Jourdain, Merce; Kouatchet, Achille; Lautrette, Alexandre; Legriel, Stephane; Regnier, Bernard; Renault, Anne; Thirion, Marina; Timsit, Jean-Francois; Toledano, Dany; Chevret, Sylvie; Pochard, Frédéric; Schlemmer, Benoît; Azoulay, Elie

2011-06-01

Relatives often lack important information about intensive care unit patients. High-quality information is crucial to help relatives overcome the often considerable situational stress and to acquire the ability to participate in the decision-making process, most notably regarding the appropriate level of care. We aimed to develop a list of questions important for relatives of patients in the intensive care unit. This was a multicenter study. Questions asked by relatives of intensive care unit patients were collected from five different sources (literature, panel of 28 intensive care unit nurses and physicians, 1-wk survey of nurses and 1-wk survey of physicians in 14 intensive care units, and in-depth interviews with 14 families). After a qualitative analysis (framework approach and thematic analysis), questions were rated by 22 relatives and 14 intensive care unit physicians, and the ratings were analyzed using principal component analysis and hierarchical clustering. The five sources produced 2,135 questions. Removal of duplicates and redundancies left 443 questions, which were distributed among nine predefined domains using a framework approach ("diagnosis," "treatment," "prognosis," "comfort," "interaction," "communication," "family," "end of life," and "postintensive care unit management"). Thematic analysis in each domain led to the identification of 46 themes, which were reworded as 46 different questions. Ratings by relatives and physicians showed that 21 of these questions were particularly important for relatives of intensive care unit patients. This study increases knowledge about the informational needs of relatives of intensive care unit patients. This list of questions may prove valuable for both relatives and intensive care unit physicians as a tool for improving communication in the intensive care unit.

Parental involvement and kangaroo care in European neonatal intensive care units: a policy survey in eight countries.

PubMed

Pallás-Alonso, Carmen R; Losacco, Valentina; Maraschini, Alice; Greisen, Gorm; Pierrat, Veronique; Warren, Inga; Haumont, Dominique; Westrup, Björn; Smit, Bert J; Sizun, Jacques; Cuttini, Marina

2012-09-01

To compare, in a large representative sample of European neonatal intensive care units, the policies and practices regarding parental involvement and holding babies in the kangaroo care position as well as differences in the tasks mothers and fathers are allowed to carry out. Prospective multicenter survey. Neonatal intensive care units in eight European countries (Belgium, Denmark, France, Italy, The Netherlands, Spain, Sweden, and the United Kingdom). Patients were not involved in this study. None. A structured questionnaire was mailed to 362 units (response rate 78%); only units with ≥50 very-low-birth-weight annual admissions were considered for this study. Facilities for parents such as reclining chairs near the babies' cots, beds, and a dedicated room were common, but less so in Italy and Spain. All units in Sweden, Denmark, the United Kingdom, and Belgium reported encouraging parental participation in the care of the babies, whereas policies were more restrictive in Italy (80% of units), France (73%), and Spain (41%). Holding babies in the kangaroo care position was widespread. However, in the United Kingdom, France, Italy, and Spain, many units applied restrictions regarding its frequency (sometimes or on parents request only, rather than routinely), method (conventional rather than skin-to-skin), and clinical conditions (especially mechanical ventilation and presence of umbilical lines) that would prevent its practice. In these countries, fathers were routinely offered kangaroo care less frequently than mothers (p < .001) and less often it was skin-to-skin (p < .0001). This study showed that, although the majority of units in all countries reported a policy of encouraging both parents to take part in the care of their babies, the intensity and ways of involvement as well as the role played by mothers and fathers varied within and between countries.

Recruitment and retention of participants for an international type 1 diabetes prevention trial: a coordinators' perspective.

PubMed

Franciscus, Margaret; Nucci, Anita; Bradley, Brenda; Suomalainen, Heli; Greenberg, Ellen; Laforte, Diane; Kleemola, Paivi; Hyytinen, Mila; Salonen, Marja; Martin, Mary Jean; Catte, Daniel; Catteau, Jacki

2014-04-01

The Trial to Reduce Insulin Dependent Diabetes Mellitus in the Genetically at Risk (TRIGR) is the first multicenter international type 1 diabetes (T1D) prevention trial to be undertaken. A unique feature of TRIGR has been recruitment of eligible pregnant women and enrollment of newborns for long-term follow-up assessments. Our purpose is to summarize the recruitment and retention strategies used to conduct TRIGR from the perspective of the study coordinators. TRIGR was designed to test whether weaning to formula containing hydrolyzed versus intact cow's milk protein would be efficacious in decreasing risk for development of T1D-associated autoantibodies and T1D among infants identified to be at increased risk for T1D based on their human leukocyte antigen (HLA) profile and family history. Multiple strategies tailored to local issues were required to enroll and follow the target number of infants. This study was conducted in the United States, Canada, Australia, and 12 countries in Europe. Of the 5606 mothers registered worldwide, 5000 of their infants were randomized. Of these, 2159 were HLA eligible and enrolled in the 8-month intervention and 10-year follow-up phases of this study. The TRIGR study met the accrual goal after 4.7 years of recruitment, 2.7 years longer than projected initially. Challenges included difficulty in finding fathers with T1D, a higher than expected rate of premature delivery among T1D mothers, and implementation of new privacy regulations mid-trial. The majority of participants were recruited from primary care antenatal clinics located near the study centers and from a general hospital or pediatric center that was affiliated with a TRIGR Study center. Internet and magazine advertisements were found to be useful for recruitment of families. Alternative follow-up strategies are offered to families who wish to reduce or discontinue participation. Our experience is limited to a single international multicenter trial. TRIGR coordinators played key roles in the recruitment and intervention periods and continue to be instrumental in retaining families and children during the 10-year follow-up period for each child.

Optimal sequencing of ibrutinib, idelalisib, and venetoclax in chronic lymphocytic leukemia: results from a multicenter study of 683 patients.

PubMed

Mato, A R; Hill, B T; Lamanna, N; Barr, P M; Ujjani, C S; Brander, D M; Howlett, C; Skarbnik, A P; Cheson, B D; Zent, C S; Pu, J J; Kiselev, P; Foon, K; Lenhart, J; Henick Bachow, S; Winter, A M; Cruz, A-L; Claxton, D F; Goy, A; Daniel, C; Isaac, K; Kennard, K H; Timlin, C; Fanning, M; Gashonia, L; Yacur, M; Svoboda, J; Schuster, S J; Nabhan, C

2017-05-01

Ibrutinib, idelalisib, and venetoclax are approved for treating CLL patients in the United States. However, there is no guidance as to their optimal sequence. We conducted a multicenter, retrospective analysis of CLL patients treated with kinase inhibitors (KIs) or venetoclax. We examined demographics, discontinuation reasons, overall response rates (ORR), survival, and post-KI salvage strategies. Primary endpoint was progression-free survival (PFS). A total of 683 patients were identified. Baseline characteristics were similar in the ibrutinib and idelalisib groups. ORR to ibrutinib and idelalisib as first KI was 69% and 81%, respectively. With a median follow-up of 17 months (range 1-60), median PFS and OS for the entire cohort were 35 months and not reached. Patients treated with ibrutinib (versus idelalisib) as first KI had a significantly better PFS in all settings; front-line [hazard ratios (HR) 2.8, CI 1.3-6.3, P = 0.01], relapsed-refractory (HR 2.8, CI 1.9-4.1, P < 0.001), del17p (HR 2.0, CI 1.2-3.4, P = 0.008), and complex karyotype (HR 2.5, CI 1.2-5.2, P = 0.02). At the time of initial KI failure, use of an alternate KI or venetoclax had a superior PFS when compared with chemoimmunotherapy. Furthermore, patients who discontinued ibrutinib due to progression or toxicity had marginally improved outcomes if they received venetoclax (ORR 79%) versus idelalisib (ORR 46%) (PFS HR .6, CI.3-1.0, P = 0.06). In the largest real-world experience of novel agents in CLL, ibrutinib appears superior to idelalisib as first KI. Furthermore, in the setting of KI failure, alternate KI or venetoclax therapy appear superior to chemoimmunotherapy combinations. The use of venetoclax upon ibrutinib failure might be superior to idelalisib. These data support the need for trials testing sequencing strategies to optimize treatment algorithms. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Rationale of a novel study design for the BIOFLOW V study, a prospective, randomized multicenter study to assess the safety and efficacy of the Orsiro sirolimus-eluting coronary stent system using a Bayesian approach.

PubMed

Doros, Gheorghe; Massaro, Joseph M; Kandzari, David E; Waksman, Ron; Koolen, Jacques J; Cutlip, Donald E; Mauri, Laura

2017-11-01

Traditional study design submitted to the Food and Drug Administration to test newer drug-eluting stents (DES) for marketing approval is the prospective randomized controlled trial. However, several DES have extensive clinical data from trials conducted outside the United States that have led to utilization of a novel design using the Bayesian approach. This design was proposed for testing DES with bioresorbable polymer compared with DES most commonly in use today that use durable polymers for drug elution. This prospective, multicenter, randomized, controlled trial is designed to assess the safety and efficacy of the Orsiro bioresorbable polymer sirolimus-eluting stent (BP SES). Up to 1,334 subjects with up to 3 de novo or restenotic coronary artery lesions who qualify for percutaneous coronary intervention with stenting will be randomized 2:1 to the BP SES versus the Xience durable polymer everolimus-eluting stent (DP EES). Data from this trial will be combined with data from 2 similarly designed trials that also randomize subjects to BP SES and DP EES (BIOFLOW II, N=452 and BIOFLOW IV, N=579) by using a Bayesian approach. The primary end point is target lesion failure at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a test of noninferiority of the BP SES versus DP EES on the primary end point according to a noninferiority delta of 3.85%. Secondary end points include stent thrombosis and the individual components of target lesion failure. Subjects will be followed for 5 years after randomization. The BIOFLOW V trial offers an opportunity to assess clinical outcomes in patients treated with coronary revascularization using the Orsiro BP SES relative to a commonly used DP EES. The use of a Bayesian analysis combines a large randomized cohort of patients 2 two smaller contributing randomized trials to augment the efficiency of the comparison. Copyright © 2017 Elsevier Inc. All rights reserved.

Multicenter, randomized, double-blind phase 2 trial of FOLFIRI with regorafenib or placebo as second-line therapy for metastatic colorectal cancer.

PubMed

Sanoff, Hanna K; Goldberg, Richard M; Ivanova, Anastasia; O'Reilly, Seamus; Kasbari, Samer S; Kim, Richard D; McDermott, Ray; Moore, Dominic T; Zamboni, William; Grogan, William; Cohn, Allen Lee; Bekaii-Saab, Tanios S; Leonard, Gregory; Ryan, Theresa; Olowokure, Olugbenga O; Fernando, Nishan H; McCaffrey, John; El-Rayes, Bassel F; Horgan, Anne M; Sherrill, Gary Bradley; Yacoub, George Hosni; O'Neil, Bert H

2018-06-15

Regorafenib, a multikinase inhibitor that inhibits angiogenesis, growth, and proliferation, prolongs survival as monotherapy in patients with refractory colorectal cancer. This international, double-blind, placebo-controlled, multicenter trial assessed the efficacy of regorafenib with folinic acid, fluorouracil, and irinotecan (FOLFIRI) as a second-line treatment for metastatic colorectal cancer. Patients with metastatic colorectal cancer who progressed on first-line oxaliplatin and fluoropyrimidine enrolled at 45 sites in the United States and Ireland. Patients, stratified by prior bevacizumab use, were randomized 2:1 to regorafenib or placebo. The treatment consisted of FOLFIRI on days 1 and 2 and days 15 and 16 with 160 mg of regorafenib or placebo on days 4 to 10 and days 18 to 24 of every 28-day cycle. Crossover was not allowed. The primary endpoint was progression-free survival (PFS). Under the assumption of a 75% event rate, 180 patients were required for 135 events to achieve 90% power to detect a hazard ratio (HR) of 0.65 with a 1-sided α value of .1. One hundred eighty-one patients were randomized (120 to regorafenib-FOLFIRI and 61 to placebo-FOLFIRI) with a median age of 62 years. Among these, 117 (65%) received prior bevacizumab or aflibercept. PFS was longer with regorafenib-FOLFIRI than placebo-FOLFIRI (median, 6.1 vs 5.3 months; HR, 0.73; 95% confidence interval [CI], 0.53-1.01; log-rank P = .056). The median overall survival was not longer (HR, 1.01; 95% CI, 0.71-1.44). The response rate was higher with regorafenib-FOLFIRI (34%; 95% CI, 25%-44%) than placebo-FOLFIRI (21%; 95% CI, 11%-33%; P = .07). Grade 3/4 adverse events with a >5% absolute increase from regorafenib included diarrhea, neutropenia, febrile neutropenia, hypophosphatemia, and hypertension. The addition of regorafenib to FOLFIRI as second-line therapy for metastatic colorectal cancer only modestly prolonged PFS over FOLFIRI alone. Cancer 2018. © 2018 American Cancer Society. © 2018 American Cancer Society.

A multicenter mortality prediction model for patients receiving prolonged mechanical ventilation

PubMed Central

Carson, Shannon S.; Kahn, Jeremy M.; Hough, Catherine L.; Seeley, Eric J.; White, Douglas B.; Douglas, Ivor S.; Cox, Christopher E.; Caldwell, Ellen; Bangdiwala, Shrikant I.; Garrett, Joanne M.; Rubenfeld, Gordon D.

2012-01-01

Objective Significant deficiencies exist in the communication of prognosis for patients requiring prolonged mechanical ventilation after acute illness, in part because of clinician uncertainty about long-term outcomes. We sought to refine a mortality prediction model for patients requiring prolonged ventilation using a multicentered study design. Design Cohort study. Setting Five geographically diverse tertiary care medical centers in the United States (California, Colorado, North Carolina, Pennsylvania, Washington). Patients Two hundred sixty adult patients who received at least 21 days of mechanical ventilation after acute illness. Interventions None. Measurements and Main Results For the probability model, we included age, platelet count, and requirement for vasopressors and/or hemodialysis, each measured on day 21 of mechanical ventilation, in a logistic regression model with 1-yr mortality as the outcome variable. We subsequently modified a simplified prognostic scoring rule (ProVent score) by categorizing the risk variables (age 18–49, 50–64, and >65 yrs; platelet count 0–150 and >150; vasopressors; hemodialysis) in another logistic regression model and assigning points to variables according to β coefficient values. Overall mortality at 1 yr was 48%. The area under the curve of the receiver operator characteristic curve for the primary ProVent probability model was 0.79 (95% confidence interval, 0.75–0.81), and the p value for the Hosmer-Lemeshow goodness-of-fit statistic was .89. The area under the curve for the categorical model was 0.77, and the p value for the goodness-of-fit statistic was .34. The area under the curve for the ProVent score was 0.76, and the p value for the Hosmer-Lemeshow goodness-of-fit statistic was .60. For the 50 patients with a ProVent score >2, only one patient was able to be discharged directly home, and 1-yr mortality was 86%. Conclusion The ProVent probability model is a simple and reproducible model that can accurately identify patients requiring prolonged mechanical ventilation who are at high risk of 1-yr mortality. PMID:22080643

Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study.

PubMed

Khandhar, Sandeep J; Bowling, Mark R; Flandes, Javier; Gildea, Thomas R; Hood, Kristin L; Krimsky, William S; Minnich, Douglas J; Murgu, Septimiu D; Pritchett, Michael; Toloza, Eric M; Wahidi, Momen M; Wolvers, Jennifer J; Folch, Erik E

2017-04-11

Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions. NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing. ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively. One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield. ClinicalTrials.gov NCT02410837 . Registered 31 March 2015.

Targeting RET in Patients With RET-Rearranged Lung Cancers: Results From the Global, Multicenter RET Registry

PubMed Central

Milia, Julie; Filleron, Thomas; Wolf, Juergen; Carbone, David P.; Owen, Dwight; Camidge, Ross; Narayanan, Vignhesh; Doebele, Robert C.; Besse, Benjamin; Remon-Masip, Jordi; Janne, Pasi A.; Awad, Mark M.; Peled, Nir; Byoung, Chul-Cho; Karp, Daniel D.; Van Den Heuvel, Michael; Wakelee, Heather A.; Neal, Joel W.; Mok, Tony S.K.; Yang, James C.H.; Ou, Sai-Hong Ignatius; Pall, Georg; Froesch, Patrizia; Zalcman, Gérard; Gandara, David R.; Riess, Jonathan W.; Velcheti, Vamsidhar; Zeidler, Kristin; Diebold, Joachim; Früh, Martin; Michels, Sebastian; Monnet, Isabelle; Popat, Sanjay; Rosell, Rafael; Karachaliou, Niki; Rothschild, Sacha I.; Shih, Jin-Yuan; Warth, Arne; Muley, Thomas; Cabillic, Florian; Mazières, Julien; Drilon, Alexander

2017-01-01

Purpose In addition to prospective trials for non–small-cell lung cancers (NSCLCs) that are driven by less common genomic alterations, registries provide complementary information on patient response to targeted therapies. Here, we present the results of an international registry of patients with RET-rearranged NSCLCs, providing the largest data set, to our knowledge, on outcomes of RET-directed therapy thus far. Methods A global, multicenter network of thoracic oncologists identified patients with pathologically confirmed NSCLC that harbored a RET rearrangement. Molecular profiling was performed locally by reverse transcriptase polymerase chain reaction, fluorescence in situ hybridization, or next-generation sequencing. Anonymized data—clinical, pathologic, and molecular features—were collected centrally and analyzed by an independent statistician. Best response to RET tyrosine kinase inhibition administered outside of a clinical trial was determined by RECIST v1.1. Results By April 2016, 165 patients with RET-rearranged NSCLC from 29 centers across Europe, Asia, and the United States were accrued. Median age was 61 years (range, 29 to 89 years). The majority of patients were never smokers (63%) with lung adenocarcinomas (98%) and advanced disease (91%). The most frequent rearrangement was KIF5B-RET (72%). Of those patients, 53 received one or more RET tyrosine kinase inhibitors in sequence: cabozantinib (21 patients), vandetanib (11 patients), sunitinib (10 patients), sorafenib (two patients), alectinib (two patients), lenvatinib (two patients), nintedanib (two patients), ponatinib (two patients), and regorafenib (one patient). The rate of any complete or partial response to cabozantinib, vandetanib, and sunitinib was 37%, 18%, and 22%, respectively. Further responses were observed with lenvantinib and nintedanib. Median progression-free survival was 2.3 months (95% CI, 1.6 to 5.0 months), and median overall survival was 6.8 months (95% CI, 3.9 to 14.3 months). Conclusion Available multikinase inhibitors had limited activity in patients with RET-rearranged NSCLC in this retrospective study. Further investigation of the biology of RET-rearranged lung cancers and identification of new targeted therapeutics will be required to improve outcomes for these patients. PMID:28447912

Stakeholders' views on data sharing in multicenter studies.

PubMed

Mazor, Kathleen M; Richards, Allison; Gallagher, Mia; Arterburn, David E; Raebel, Marsha A; Nowell, W Benjamin; Curtis, Jeffrey R; Paolino, Andrea R; Toh, Sengwee

2017-09-01

To understand stakeholders' views on data sharing in multicenter comparative effectiveness research studies and the value of privacy-protecting methods. Semistructured interviews with five US stakeholder groups. We completed 11 interviews, involving patients (n = 15), researchers (n = 10), Institutional Review Board and regulatory staff (n = 3), multicenter research governance experts (n = 2) and healthcare system leaders (n = 4). Perceptions of the benefits and value of research were the strongest influences toward data sharing; cost and security risks were primary influences against sharing. Privacy-protecting methods that share summary-level data were acknowledged as being appealing, but there were concerns about increased cost and potential loss of research validity. Stakeholders were open to data sharing in multicenter studies that offer value and minimize security risks.

Interlaboratory quality control of total HIV-1 DNA load measurement for multicenter reservoir studies.

PubMed

Gantner, Pierre; Mélard, Adeline; Damond, Florence; Delaugerre, Constance; Dina, Julia; Gueudin, Marie; Maillard, Anne; Sauné, Karine; Rodallec, Audrey; Tuaillon, Edouard; Plantier, Jean-Christophe; Rouzioux, Christine; Avettand-Fenoel, Véronique

2017-11-01

Viral reservoirs represent an important barrier to HIV cure. Accurate markers of HIV reservoirs are needed to develop multicenter studies. The aim of this multicenter quality control (QC) was to evaluate the inter-laboratory reproducibility of total HIV-1-DNA quantification. Ten laboratories of the ANRS-AC11 working group participated by quantifying HIV-DNA with a real-time qPCR assay (Biocentric) in four samples (QCMD). Good reproducibility was found between laboratories (standard deviation ≤ 0.2 log 10 copies/10 6 PBMC) for the three positive QC that were correctly classified by each laboratory (QC1

Brain Tumor Epidemiology – A Hub within Multidisciplinary Neuro-oncology. Report on the 15th Brain Tumor Epidemiology Consortium (BTEC) Annual Meeting, Vienna, 2014

PubMed Central

Woehrer, Adelheid; Lau, Ching C.; Prayer, Daniela; Bauchet, Luc; Rosenfeld, Myrna; Capper, David; Fisher, Paul G.; Kool, Marcel; Müller, Martin; Kros, Johan M.; Kruchko, Carol; Wiemels, Joseph; Wrensch, Margaret; Danysh, Heather E.; Zouaoui, Sonia; Heck, Julia E.; Johnson, Kimberly J.; Qi, Xiaoyang; O’Neill, Brian P.; Afzal, Samina; Scheurer, Michael E.; Bainbridge, Matthew N.; Nousome, Darryl; El Bahassi, Mustapha; Hainfellner, Johannes A.; Barnholtz-Sloan, Jill S.

2015-01-01

The Brain Tumor Epidemiology Consortium (BTEC) is an open scientific forum, which fosters the development of multi-center, international and inter-disciplinary collaborations. BTEC aims to develop a better understanding of the etiology, outcomes, and prevention of brain tumors (http://epi.grants.cancer.gov/btec/). The 15th annual Brain Tumor Epidemiology Consortium Meeting, hosted by the Austrian Societies of Neuropathology and Neuro-oncology, was held on September 9 – 11, 2014 in Vienna, Austria. The meeting focused on the central role of brain tumor epidemiology within multidisciplinary neuro-oncology. Knowledge of disease incidence, outcomes, as well as risk factors is fundamental to all fields involved in research and treatment of patients with brain tumors; thus, epidemiology constitutes an important link between disciplines, indeed the very hub. This was reflected by the scientific program, which included various sessions linking brain tumor epidemiology with clinical neuro-oncology, tissue-based research, and cancer registration. Renowned experts from Europe and the United States contributed their personal perspectives stimulating further group discussions. Several concrete action plans evolved for the group to move forward until next year’s meeting, which will be held at the Mayo Clinic at Rochester, MN, USA. PMID:25518914

Tentative Evidence for Striatal Hyperactivity in Adolescent Cannabis Using Boys: A Cross-Sectional Multicenter fMRI Study

PubMed Central

Jager, Gerry; Block, Robert I.; Luijten, Maartje; Ramsey, Nick F.

2013-01-01

Adolescents' risk-taking behavior has been linked to a maturational imbalance between reward (“go”) and inhibitory-control (“stop”) related brain circuitry. This may drive adolescent drug-taking, such as cannabis use. In this study we assessed the non-acute effects of adolescent cannabis use on reward-related brain function. We performed a two-site (United States and Netherlands; pooled data) functional magnetic resonance imaging (fMRI) study with a cross-sectional design. Twenty-one abstinent but frequent cannabis-using boys were compared with 24 non-using peers on reward-related brain function, using a monetary incentive delay task with fMRI. Focus was on anticipatory and response stages of reward and brain areas critically involved in reward processing like the striatum. Performance in users was normal. Region-of-interest analysis indicated striatal hyperactivity during anticipatory stages of reward in users. Intriguingly, this effect was most pronounced during non-rewarding events. Striatal hyperactivity in adolescent cannabis users may signify an overly sensitive motivational brain circuitry. Frequent cannabis use during adolescence may induce diminished ability to disengage the motivational circuit when no reward can be obtained. This could strengthen the search for reinforcements like drugs of abuse, even when facing the negative (non-rewarding) consequences. PMID:23909003

Stress and mental health among midlife and older gay-identified men.

PubMed

Wight, Richard G; LeBlanc, Allen J; de Vries, Brian; Detels, Roger

2012-03-01

We investigated associations between stress and mental health (positive affect, depressive symptoms) among HIV-negative and HIV-positive midlife and older gay-identified men, along with the mediating and moderating effects of mastery and emotional support. We also studied the mental health effects of same-sex marriage. We obtained data from self-administered questionnaires completed in 2009 or 2010 by a subsample (n = 202; average age = 56.91 years; age range = 44-75 years) of participants in the University of California, Los Angeles component of the Multicenter AIDS Cohort Study, one of the largest and longest-running natural-history studies of HIV/AIDS in the United States. Both sexual minority stress (perceived gay-related stigma, excessive HIV bereavements) and aging-related stress (independence and fiscal concerns) appeared to have been detrimental to mental health. Sense of mastery partially mediated these associations. Being legally married was significantly protective net of all covariates, including having a domestic partner but not being married. Education, HIV status, and race/ethnicity had no significant effects. Sexual minority and aging-related stress significantly affected the emotional lives of these men. Personal sense of mastery may help to sustain them as they age. We observed specific mental health benefits of same-sex legal marriage.

Measurement of nurses' attitudes and knowledge regarding acute care older patients: Psychometrics of the OPACS-US combined with the KOP-Q.

PubMed

Dikken, Jeroen; Hoogerduijn, Jita G; Lagerwey, Mary D; Shortridge-Baggett, Lillie; Klaassen, Sharon; Schuurmans, Marieke J

In clinical practice, identifying positive and negative attitudes toward older patients is very important to improve quality of care provided to them. The Older People in Acute Care Survey - United States (OPACS-US) is an instrument measuring hospital nurses attitudes regarding older patients. However, psychometrics have never been assessed. Furthermore, knowledge being related to attitude and behavior should also be measured complementing the OPACS-US. The purpose of this study was to assess structural validity and reliability of the OPACS-US and assess whether the OPACS-US can be complemented with the Knowledge about Older Patients-Quiz (KOP-Q). A multicenter cross sectional design was conducted. Registered nurses (n = 130, mean age 39,9 years; working experience 14,6 years) working in four general hospitals were included in the study. Nurses completed the OPACS-US section A: practice experiences, B: general opinion and the KOP-Q online. Findings demonstrated that the OPACS-US is a valid and reliable survey instrument that measures practice experiences and general opinion. Furthermore, the OPACS-US can be combined with the KOP-Q adding a knowledge construct, and is ready for use within education and/or quality improvement programs in the USA. Copyright © 2017 Elsevier Inc. All rights reserved.

Management of bipolar disorder in the intercontinental region: an international, multicenter, non-interventional, cross-sectional study in real-life conditions.

PubMed

Samalin, Ludovic; Vieta, Eduard; Okasha, Tarek Ahmed; Uddin, Mm Jalal; Ahmadi Abhari, Seyed Ali; Nacef, Fethi; Mishyiev, Vyacheslav; Aizenberg, Dovi; Ratner, Yaël; Melas-Melt, Lydie; Sedeki, Idir; Llorca, Pierre Michel

2016-05-16

Most of the existing data on real-life management of bipolar disorder are from studies conducted in western countries (mostly United States and Europe). This multinational, observational cohort study aimed to describe the management and clinical outcomes of bipolar patients in real-life conditions across various intercontinental countries (Bangladesh, Egypt, Iran, Israel, Tunisia, and Ukraine). Data on socio-demographic and disease characteristics, current symptomatology, and pharmacological treatment were collected. Comparisons between groups were performed using standard statistical tests. Overall, 1180 patients were included. The median time from initial diagnosis was 80 months. Major depressive disorder was the most common initial diagnosis. Mood stabilizers and antipsychotics were the most common drugs being prescribed at the time of the study. Antidepressants (mainly selective serotonin uptake inhibitors [SSRIs]) were administered to 36.1% of patients. Patients with bipolar I disorder received higher number of antipsychotics and anxiolytics than those with bipolar II disorder (p < 0.001). Presence of depressive symptoms was associated with an increase in antidepressant use (p < 0.001). Bipolar disorder real-life management practice, irrespective of region, shows a delay in diagnosis and an overuse of antidepressants. Clinical decision-making appears to be based on a multidimensional approach related to current symptomatology and type of bipolar disorder.

A randomized, double-blind, placebo-controlled trial of coenzyme Q10 in Huntington disease.

PubMed

McGarry, Andrew; McDermott, Michael; Kieburtz, Karl; de Blieck, Elisabeth A; Beal, Flint; Marder, Karen; Ross, Christopher; Shoulson, Ira; Gilbert, Peter; Mallonee, William M; Guttman, Mark; Wojcieszek, Joanne; Kumar, Rajeev; LeDoux, Mark S; Jenkins, Mary; Rosas, H Diana; Nance, Martha; Biglan, Kevin; Como, Peter; Dubinsky, Richard M; Shannon, Kathleen M; O'Suilleabhain, Padraig; Chou, Kelvin; Walker, Francis; Martin, Wayne; Wheelock, Vicki L; McCusker, Elizabeth; Jankovic, Joseph; Singer, Carlos; Sanchez-Ramos, Juan; Scott, Burton; Suchowersky, Oksana; Factor, Stewart A; Higgins, Donald S; Molho, Eric; Revilla, Fredy; Caviness, John N; Friedman, Joseph H; Perlmutter, Joel S; Feigin, Andrew; Anderson, Karen; Rodriguez, Ramon; McFarland, Nikolaus R; Margolis, Russell L; Farbman, Eric S; Raymond, Lynn A; Suski, Valerie; Kostyk, Sandra; Colcher, Amy; Seeberger, Lauren; Epping, Eric; Esmail, Sherali; Diaz, Nancy; Fung, Wai Lun Alan; Diamond, Alan; Frank, Samuel; Hanna, Philip; Hermanowicz, Neal; Dure, Leon S; Cudkowicz, Merit

2017-01-10

To test the hypothesis that chronic treatment of early-stage Huntington disease (HD) with high-dose coenzyme Q10 (CoQ) will slow the progressive functional decline of HD. We performed a multicenter randomized, double-blind, placebo-controlled trial. Patients with early-stage HD (n = 609) were enrolled at 48 sites in the United States, Canada, and Australia from 2008 to 2012. Patients were randomized to receive either CoQ 2,400 mg/d or matching placebo, then followed for 60 months. The primary outcome variable was the change from baseline to month 60 in Total Functional Capacity score (for patients who survived) combined with time to death (for patients who died) analyzed using a joint-rank analysis approach. An interim analysis for futility revealed a conditional power of <5% for the primary analysis, prompting premature conclusion in July 2014. No statistically significant differences were seen between treatment groups for the primary or secondary outcome measures. CoQ was generally safe and well-tolerated throughout the study. These data do not justify use of CoQ as a treatment to slow functional decline in HD. NCT00608881. This article provides Class I evidence that CoQ does not slow the progressive functional decline of patients with HD. © 2016 American Academy of Neurology.

Design of the Prevention of Adult Caries Study (PACS): A randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries

PubMed Central

2010-01-01

Background Dental caries is one of the primary causes of tooth loss among adults. It is estimated to affect a majority of Americans aged 55 and older, with a disproportionately higher burden in disadvantaged populations. Although a number of treatments are currently in use for caries prevention in adults, evidence for their efficacy and effectiveness is limited. Methods/Design The Prevention of Adult Caries Study (PACS) is a multicenter, placebo-controlled, double-blind, randomized clinical trial of the efficacy of a chlorhexidine (10% w/v) dental coating in preventing adult caries. Participants (n = 983) were recruited from four different dental delivery systems serving four diverse communities, including one American Indian population, and were randomized to receive either chlorhexidine or a placebo treatment. The primary outcome is the net caries increment (including non-cavitated lesions) from baseline to 13 months of follow-up. A cost-effectiveness analysis also will be considered. Discussion This new dental treatment, if efficacious and approved for use by the Food and Drug Administration (FDA), would become a new in-office, anti-microbial agent for the prevention of adult caries in the United States. Trial Registration Number NCT00357877 PMID:20923557

Patient-days: a better measure of incidence of occupational bloodborne exposures.

PubMed

Chen, Luke F; Sexton, Daniel J; Kaye, Keith S; Anderson, Deverick J

2009-09-01

There is currently no accepted standard denominator to calculate and to report the incidence of occupational exposures to bloodborne pathogens (OEBBPs) in health care. We performed a multicenter study of OEBBP injuries reported from 31 community hospitals in the southeastern United States from January 2003 to December 2006. A qualitative design was used to assess 4 commonly used denominators to calculate the incidence of OEBBP: patient-days; staffed beds; occupied beds and full-time employee equivalents (FTEs). Six criteria were used to assess the quality and suitability of each denominator as a standard method to calculate incidence of OEBBP. We also analyzed the correlation of hospital rankings produced by these 4 denominators. During 4 years of study, a total of 3375 occupational exposures were reported. Patient-days outperformed others as a denominator to calculate rates of OEBBP when judged by 6 predefined criteria. Data for staffed beds, occupied beds, and FTE were manually collected, infrequently reported, and often subject to missing data. Furthermore, FTE and staffed beds data also captured unoccupied beds and non-clinical employee data that were not associated with risk of OEBBP. Patient-days may be the most suitable and readily available denominator for standard reporting and benchmarking of incidence of OEBBP. Patient-days may be used as a standard method for comparing rates of OEBBP.

The Lifestyle Interventions and Independence for Elders Study: design and methods.

PubMed

Fielding, Roger A; Rejeski, W Jack; Blair, Steven; Church, Tim; Espeland, Mark A; Gill, Thomas M; Guralnik, Jack M; Hsu, Fang-Chi; Katula, Jeffrey; King, Abby C; Kritchevsky, Stephen B; McDermott, Mary M; Miller, Michael E; Nayfield, Susan; Newman, Anne B; Williamson, Jeff D; Bonds, Denise; Romashkan, Sergei; Hadley, Evan; Pahor, Marco

2011-11-01

As the number of older adults in the United States rises, maintaining functional independence among older Americans has emerged as a major clinical and public health priority. Older people who lose mobility are less likely to remain in the community; demonstrate higher rates of morbidity, mortality, and hospitalizations; and experience a poorer quality of life. Several studies have shown that regular physical activity improves functional limitations and intermediate functional outcomes, but definitive evidence showing that major mobility disability can be prevented is lacking. A Phase 3 randomized controlled trial is needed to fill this evidence gap. The Lifestyle Interventions and Independence for Elders (LIFE) Study is a Phase 3 multicenter randomized controlled trial designed to compare a supervised moderate-intensity physical activity program with a successful aging health education program in 1,600 sedentary older persons followed for an average of 2.7 years. LIFE's primary outcome is major mobility disability, defined as the inability to walk 400 m. Secondary outcomes include cognitive function, serious fall injuries, persistent mobility disability, the combined outcome of major mobility disability or death, disability in activities of daily living, and cost-effectiveness. Results of this study are expected to have important public health implications for the large and growing population of older sedentary men and women.

The Canadian American Ticlopidine Study (CATS) in thromboembolic stroke. Design, organization, and baseline results.

PubMed

Gent, M; Blakely, J A; Easton, J D; Ellis, D J; Hachinski, V C; Harbison, J W; Panak, E; Roberts, R S; Sicurella, J; Turpie, A G

1988-10-01

The Canadian American Ticlopidine Study is a randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy and safety of ticlopidine hydrochloride in patients who have suffered a thromboembolic stroke no less than 1 week and no more than 4 months before entry into the study. The primary assessment of efficacy will be based on the cluster of outcome events recurrent stroke, myocardial infarction, or vascular death. Twenty-five clinical centers, 12 in Canada and 13 in the United States, entered a total of 1,072 patients during a 3-year recruitment period; these patients were randomly allocated to receive either 250 mg ticlopidine or identical-appearing placebo tablets twice daily for up to 3 years. Patient recruitment was completed in December 1986. Patients were followed for a maximum of 3 years or until the close of the study in December 1987; at that time an average follow-up of 25 months had been achieved. We summarize the protocol and organization of the study and document the methods of execution and analysis, with corresponding criteria, before disclosure of the treatment code to any of the study investigators. We also provide a clinical description of the patients at entry into the study.

Rasch Analysis of a New Hierarchical Scoring System for Evaluating Hand Function on the Motor Assessment Scale for Stroke

PubMed Central

Sabari, Joyce S.; Woodbury, Michelle; Velozo, Craig A.

2014-01-01

Objectives. (1) To develop two independent measurement scales for use as items assessing hand movements and hand activities within the Motor Assessment Scale (MAS), an existing instrument used for clinical assessment of motor performance in stroke survivors; (2) To examine the psychometric properties of these new measurement scales. Design. Scale development, followed by a multicenter observational study. Setting. Inpatient and outpatient occupational therapy programs in eight hospital and rehabilitation facilities in the United States and Canada. Participants. Patients (N = 332) receiving stroke rehabilitation following left (52%) or right (48%) cerebrovascular accident; mean age 64.2 years (sd 15); median 1 month since stroke onset. Intervention. Not applicable. Main Outcome Measures. Data were tested for unidimensionality and reliability, and behavioral criteria were ordered according to difficulty level with Rasch analysis. Results. The new scales assessing hand movements and hand activities met Rasch expectations of unidimensionality and reliability. Conclusion. Following a multistep process of test development, analysis, and refinement, we have redesigned the two scales that comprise the hand function items on the MAS. The hand movement scale contains an empirically validated 10-behavior hierarchy and the hand activities item contains an empirically validated 8-behavior hierarchy. PMID:25177513

Optimizing Outcome Assessment in Multicenter TBI Trials: Perspectives From TRACK-TBI and the TBI Endpoints Development Initiative.

PubMed

Bodien, Yelena G; McCrea, Michael; Dikmen, Sureyya; Temkin, Nancy; Boase, Kim; Machamer, Joan; Taylor, Sabrina R; Sherer, Mark; Levin, Harvey; Kramer, Joel H; Corrigan, John D; McAllister, Thomas W; Whyte, John; Manley, Geoffrey T; Giacino, Joseph T

Traumatic brain injury (TBI) is a global public health problem that affects the long-term cognitive, physical, and psychological health of patients, while also having a major impact on family and caregivers. In stark contrast to the effective trials that have been conducted in other neurological diseases, nearly 30 studies of interventions employed during acute hospital care for TBI have failed to identify treatments that improve outcome. Many factors may confound the ability to detect true and meaningful treatment effects. One promising area for improving the precision of intervention studies is to optimize the validity of the outcome assessment battery by using well-designed tools and data collection strategies to reduce variability in the outcome data. The Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) study, conducted at 18 sites across the United States, implemented a multidimensional outcome assessment battery with 22 measures aimed at characterizing TBI outcome up to 1 year postinjury. In parallel, through the TBI Endpoints Development (TED) Initiative, federal agencies and investigators have partnered to identify the most valid, reliable, and sensitive outcome assessments for TBI. Here, we present lessons learned from the TRACK-TBI and TED initiatives aimed at optimizing the validity of outcome assessment in TBI.

Multicenter study of QuantiFERON®-TB Gold Plus in patients with active tuberculosis.

PubMed

Horne, D J; Jones, B E; Kamada, A; Fukushima, K; Winthrop, K L; Siegel, S A R; Kovacs, A; Anthony, P; Meekin, K A; Bhat, S; Kerndt, P; Chang, A; Koelle, D M; Narita, M

2018-06-01

QuantiFERON®-TB Gold Plus (QFT-Plus), recently approved for use in the United States, is a new-generation QuantiFERON assay that differs from its predecessors in that it uses an additional antigen tube containing peptides to elicit both CD8+ and CD4+ T-lymphocyte responses. To assess the sensitivity of QFT-Plus compared with QuantiFERON®-TB Gold In-Tube (QFT-GIT) in participants with active TB. Adult patients with active TB at three US and two Japanese sites were eligible for this study if they had culture-confirmed TB and were either untreated or had received 14 days of anti-tuberculosis treatment. We enrolled 164 participants, nine of whom had indeterminate results. Excluding indeterminate values, there were 150 QFT-GIT-positive results among 159 tests and 146 QFT-Plus-positive results among 157 tests, with sensitivities of respectively 94.3% (95%CI 89.5-97.4) and 93.02% (95%CI 87.8-96.5%). The estimated sensitivities for the two tests were not significantly different (P = 0.16). Overall test agreement was 98.7%, with a κ statistic of 0.89 (95%CI 0.75-1.00). In this multisite study, we found that QFT-Plus had similar sensitivity to QFT-GIT in adult patients with active TB.

Depression, anxiety and somatization in primary care: syndrome overlap and functional impairment.

PubMed

Löwe, Bernd; Spitzer, Robert L; Williams, Janet B W; Mussell, Monika; Schellberg, Dieter; Kroenke, Kurt

2008-01-01

To determine diagnostic overlap of depression, anxiety and somatization as well as their unique and overlapping contribution to functional impairment. Two thousand ninety-one consecutive primary care clinic patients participated in a multicenter cross-sectional survey in 15 primary care clinics in the United States (participation rate, 92%). Depression, anxiety, somatization and functional impairment were assessed using validated scales from the Patient Health Questionnaire (PHQ) (PHQ-8, eight-item depression module; GAD-7, seven-item Generalized Anxiety Disorder Scale; and PHQ-15, 15-item somatic symptom scale) and the Short-Form General Health Survey (SF-20). Multiple linear regression analyses were used to investigate unique and overlapping associations of depression, anxiety and somatization with functional impairment. In over 50% of cases, comorbidities existed between depression, anxiety and somatization. The contribution of the commonalities of depression, anxiety and somatization to functional impairment substantially exceeded the contribution of their independent parts. Nevertheless, depression, anxiety and somatization did have important and individual effects (i.e., separate from their overlap effect) on certain areas of functional impairment. Given the large syndrome overlap, a potential consideration for future diagnostic classification would be to describe basic diagnostic criteria for a single overarching disorder and to optionally code additional diagnostic features that allow a more detailed classification into specific depressive, anxiety and somatoform subtypes.

A report of the automated radiosynthesis of the tau positron emission tomography radiopharmaceutical, [18 F]-THK-5351.

PubMed

Neelamegam, Ramesh; Yokell, Daniel L; Rice, Peter A; Furumoto, Shozo; Kudo, Yukitsuka; Okamura, Nobuyuki; El Fakhri, Georges

2017-02-01

The radiotracer, [ 18 F]-THK-5351, is a highly selective and high-binding affinity PET imaging agent for aggregates of hyper-phosphorylated tau protein. Our report is a simplified 1-pot, 2-step radiosynthesis of [ 18 F]-THK-5351. This report is broadly applicable for routine clinical production and multi-center trials on account of favorable half-life of flourine-18 and the use of a commercially available radiosynthesis module, the GE TRACERlab™ FX FN . First, the O-THP protected tosyl precursor underwent nucleophilic fluorinating reaction with potassium cryptand fluoride ([ 18 F] fluoride (K[ 18 F]/K 222 )) in Dimethyl sulfoxide at 110°C for 10 minutes followed by O-THP removal by using diluted hydrochloric acid (HCl) at same temperature. [ 18 F]-THK-5351 was purified via semi-preparative high-performance liquid chromatography and formulated by using 10% EtOH, United States Pharmacopeia (USP) in 0.9% sodium chloride for injection, USP and an uncorrected radiochemical yield of 21 ± 3.5%, with a specific activity of 153.11 ± 25.9 GBq/μmol (4138 ± 700 mCi/μmol) at the end of synthesis (63 minutes; n = 3). Copyright © 2016 John Wiley & Sons, Ltd.

Toscana meningoencephalitis: a comparison to other viral central nervous system infections

PubMed Central

Jaijakul, Siraya; Arias, Cesar A.; Hossein, Monir; Arduino, Roberto C.; Wootton, Susan H.; Hasbun, Rodrigo

2012-01-01

Background Toscana virus (TOSV) is an emerging pathogen causing central nervous system (CNS) infection in Mediterranean countries, mostly during summer season. Objectives To compare the clinical and laboratory characteristics of Toscana CNS infections to the most common viral pathogens seen in the United States. Study Design We performed a case series of patients with 41 TOSV infection and compared the clinical characteristics, laboratory findings, imaging results and clinical outcomes to the most commonly recognized viral causes of meningoencephalitis in the US (enterovirus (n=60), herpes simplex virus (n=48), and west nile virus (n=30) from our multi-center study of patients with aseptic meningoencephalitis syndromes in the Greater Houston area. Results TOSV infection occurs in different age groups compared to enterovirus, HSV, and WNV. All infections most frequently occur during summer-fall except HSV which distributes throughout the year. All patients with TOSV had history of travel to endemic areas. There are differences in clinical presentation and CSF findings comparing TOSV and enterovirus, HSV, and WNV infection. There are no significant differences in outcomes of each infection except WNV meningoencephalitis which had a poorer outcome compared to TOSV infection. Conclusions TOSV is an emerging pathogen that should be considered in the differential diagnosis of patients with CNS infections and a recent travel history to endemic areas. PMID:22867730

Design and Implementation of the Hispanic Community Health Study / Study of Latinos

PubMed Central

Sorlie, Paul D.; Avilés-Santa, Larissa M.; Wassertheil-Smoller, Sylvia; Kaplan, Robert C.; Daviglus, Martha L.; Giachello, Aida L.; Schneiderman, Neil; Raij, Leopoldo; Talavera, Gregory; Allison, Matthew; LaVange, Lisa; Chambless, Lloyd E.; Heiss, Gerardo

2010-01-01

PURPOSE The Hispanic Community Health Study (HCHS)/Study of Latinos (SOL) is a comprehensive multi-center community based cohort study of Hispanics/Latinos in the United States. Its rationale, objectives, design and implementation are described in this paper. METHODS The HCHS/SOL will recruit 16,000 men and women who self-identify as Hispanic or Latino, age 18-74 years, from a random sample of households in defined communities in the Bronx, Chicago, Miami and San Diego. The sites were selected so that the overall sample would consist of at least 2000 persons in each of the following origin designations: Mexican, Puerto Rican and Dominican, Cuban, and Central and South American. The study includes research in the prevalence of and risk factors for heart, lung, blood and sleep disorders, kidney and liver function, diabetes, cognitive function, dental conditions, and hearing disorders. CONCLUSIONS The HCHS/SOL will 1) characterize the health status and disease burden in the largest minority population in the U.S; 2) describe the positive and negative consequences of immigration and acculturation of Hispanics/Latinos to the mainstream U.S. life-styles, environment and health care opportunities; and 3) identify likely causal factors of many diseases in a population with diverse environmental exposures, genetic backgrounds and early life experiences. PMID:20609343

Management of bipolar disorder in the intercontinental region: an international, multicenter, non-interventional, cross-sectional study in real-life conditions

PubMed Central

Samalin, Ludovic; Vieta, Eduard; Okasha, Tarek Ahmed; Uddin, MM. Jalal; Ahmadi Abhari, Seyed Ali; Nacef, Fethi; Mishyiev, Vyacheslav; Aizenberg, Dovi; Ratner, Yaël; Melas-Melt, Lydie; Sedeki, Idir; Llorca, Pierre Michel

2016-01-01

Most of the existing data on real-life management of bipolar disorder are from studies conducted in western countries (mostly United States and Europe). This multinational, observational cohort study aimed to describe the management and clinical outcomes of bipolar patients in real-life conditions across various intercontinental countries (Bangladesh, Egypt, Iran, Israel, Tunisia, and Ukraine). Data on socio-demographic and disease characteristics, current symptomatology, and pharmacological treatment were collected. Comparisons between groups were performed using standard statistical tests. Overall, 1180 patients were included. The median time from initial diagnosis was 80 months. Major depressive disorder was the most common initial diagnosis. Mood stabilizers and antipsychotics were the most common drugs being prescribed at the time of the study. Antidepressants (mainly selective serotonin uptake inhibitors [SSRIs]) were administered to 36.1% of patients. Patients with bipolar I disorder received higher number of antipsychotics and anxiolytics than those with bipolar II disorder (p < 0.001). Presence of depressive symptoms was associated with an increase in antidepressant use (p < 0.001). Bipolar disorder real-life management practice, irrespective of region, shows a delay in diagnosis and an overuse of antidepressants. Clinical decision-making appears to be based on a multidimensional approach related to current symptomatology and type of bipolar disorder. PMID:27181262

Tentative evidence for striatal hyperactivity in adolescent cannabis-using boys: a cross-sectional multicenter fMRI study.

PubMed

Jager, Gerry; Block, Robert I; Luijten, Maartje; Ramsey, Nick F

2013-01-01

Adolescents' risk-taking behavior has been linked to a maturational imbalance between reward ("go") and inhibitory-control ("stop")-related brain circuitry. This may drive adolescent drug-taking, such as cannabis use. In this study, we assessed the non-acute effects of adolescent cannabis use on reward-related brain function. We performed a two-site (United States and Netherlands; pooled data) functional magnetic resonance imaging (fMRI) study with a cross-sectional design. Twenty-one abstinent but frequent cannabis-using boys were compared with 24 non-using peers on reward-related brain function, using a monetary incentive delay task with fMRI. Focus was on anticipatory and response stages of reward and brain areas critically involved in reward processing like the striatum. Performance in users was normal. Region-of-interest analysis indicated striatal hyperactivity during anticipatory stages of reward in users. Intriguingly, this effect was most pronounced during non-rewarding events. Striatal hyperactivity in adolescent cannabis users may signify an overly sensitive motivational brain circuitry. Frequent cannabis use during adolescence may induce diminished ability to disengage the motivational circuit when no reward can be obtained. This could strengthen the search for reinforcements like drugs of abuse, even when facing the negative (non-rewarding) consequences.

Selenium, fluorine, and arsenic in surficial materials of the conterminous United States

USGS Publications Warehouse

Shacklette, Hansford T.; Boerngen, Josephine G.; Keith, John R.

1974-01-01

Concentrations of selenium, fluorine, and arsenic in 912, 911, and 910 samples, respectively, of soils and other regoliths from sites approximately 50 miles (80 km) apart throughout the United States are represented on maps by symbols showing five ranges of values. Histograms of the concentrations of these elements are also given. The geometric-mean concentrations (ppm) in the samples, grouped by area, are as follows: Selenium-- Entire United States, 0.31; Western United States, 0.25; and Eastern United States, 0.39. Fluorine-- Entire United States, 180; Western United States, 250; and Eastern United States, 115. Arsenic-- Entire United States, 5.8; Western United States, 6.1; and Eastern United States, 5.4.

Spinal Cord Injury

MedlinePlus

... A recent prospective multicenter trial called STASCIS is exploring whether performing decompression surgery early (less than 24 ... A recent prospective multicenter trial called STASCIS is exploring whether performing decompression surgery early (less than 24 ...

[Pathogenetic associations of periodontal diseases with somatic therapeutic pathology, comorbid conditions in patients of advanced and senile age: state-of-the-art review. Part 1. Associations of periodontal diseases with somatic therapeutic pathology in patients of advanced and senile age].

PubMed

Ar'eva, G T; Solov'ev, M M; Ar'ev, A L; Ryzhak, G A

2014-01-01

The state-of-the-art review of literature on existing views on the association of periodontal diseases with somatic therapeutic pathology (first part of the review) and comorbid conditions (second part of the review) is submitted. The conclusion about need of carrying out the further multicenter researches which purpose is development of new integrated indicators, in a complex and comprehensively characterizing not only the periodontal status, but also set of available somatic therapeutic pathology, especially at pa- tients of advanced and senile age is drawn.

Report of a Brazilian multicenter study on nephropathic cystinosis.

PubMed

Vaisbich, Maria Helena; Koch, Vera H

2010-01-01

The Brazilian Multicenter Nephropathic Study Group, founded in 1999, is currently composed of 16 pediatric nephrology units, which are coordinated by the Pediatric Nephrology Unit of Instituto da Criança--HCFMUSP. This Study Group intends to better know our patients, their special characteristics and facilitates the treatment. To present an update on the demographics of the ongoing study participants with interest on renal function status, response to therapy, and extra-renal complications. Patient recruitment to the study is based on informed consent and has been supported by the Brazilian Society of Nephrology, by the creation of an electronic homepage and by the participation in medical meetings and publications in medical periodicals. Our study protocol involves the initial and follow-up questionnaire, the measurement of intraleukocyte cystine content, initiation and follow-up therapy with cysteamine, and clinical patient follow-up based on a protocol of subsidiary exams. We identified 102 patients (42 females) with nephropathic cystinosis in Brazil since 1999. Forty-six children are followed at the Instituto da Criança/SP, 15 at the Hospital Pequeno Príncipe/PR, 12 at the UNICAMP/SP, 10 at the Unidade de Transplante Renal - HCFMUSP/SP and 3 at the Santa Casa/SP; the remaining patients are followed at the Instituto da Criança and at their respective doctors' offices in different nephrology services in Brazil. Of these patients, 23/102 (22.5%) have normal renal function, 19/102 (18.6%) are in chronic renal failure with conservative treatment, 26/102 are on dialysis (18 on peritoneal dialysis and 8 on hemodialysis), and 34/102 received a renal transplant. The extra-renal involvement diagnosed was: hypothyroidism in 63 patients, diabetes mellitus in 8 patients, muscular involvement in 7 patients, a compromised central nervous system in 5 patients, hepatic complications in 5 patients, and deglutition dysfunction in 2 patients. During this period, 10/102 patients died. Cysteamine has been used by 81/102 patients (20 children started the therapy under 2 years of age). Growth parameters were improved by cysteamine, mainly in the youngest patients. We used recombinant growth hormone in 15 patients with persistent low growth velocity and stature z score under 2.5%. We could also observe a delay in appearance of extra-renal complications in patients receiving cysteamine. Our study demonstrates the importance of a multi-center study for recruitment, diagnosis and management of rare diseases. This study promotes access to the adequate treatment with profound impact on the quality of life. Copyright 2009 S. Karger AG, Basel.

31 CFR 596.313 - United States person.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States person. 596.313 Section... General Definitions § 596.313 United States person. The term United States person means any United States... States, or any person in the United States. ...

31 CFR 596.313 - United States person.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States person. 596.313 Section... General Definitions § 596.313 United States person. The term United States person means any United States... States, or any person in the United States. ...

31 CFR 596.313 - United States person.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States person. 596.313 Section... General Definitions § 596.313 United States person. The term United States person means any United States... States, or any person in the United States. ...

Bordetella Pertussis is an Uncommon Pathogen in Children Hospitalized with Bronchiolitis During the Winter Season

PubMed Central

Piedra, Pedro A.; Mansbach, Jonathan M.; Jewell, Alan M.; Thakar, Sneha D.; Grant, Cameron C.; Sullivan, Ashley F.; Espinola, Janice A.; Camargo, Carlos A.

2015-01-01

Background In the United States (U.S.), Bordetella pertussis incidence has increased. Cough and apnea are common findings in pertussis and also in bronchiolitis, the most common cause of hospitalization in U.S. infants. The objective was to determine the prevalence of B. pertussis infection in children hospitalized with bronchiolitis and to describe its clinical course. Methods Children hospitalized with bronchiolitis and age <2 years were eligible for a prospective, multicenter cohort study during three consecutive winter seasons (November to March) from 2007 to 2010. 16 sites in 12 states participated using a standardized enrollment protocol. Families were asked the 2010 Centers for Disease Control and Prevention (CDC) pertussis classification questions. Nasopharyngeal aspirates were obtained and tested by real time polymerase chain reaction for 16 viruses, Mycoplama pneumoniae and B. pertussis. Results 2068 (94%) of 2,207 children had one or more respiratory pathogens. B. pertussis was identified in 4 children (0.2%; 95% CI, 0.1–0.5%) with 3 having a viral co-infection. All 4 were younger than four months; 2 met the CDC definition of probable pertussis, and 3 had received at least one dose of an acellular pertussis vaccine. During the hospitalization, 2 had paroxysmal cough, 1 required ICU care, and the median length of stay was 13 days. Conclusion Our data support that B. pertussis is an uncommon pathogen in U.S. children hospitalized with bronchiolitis in the winter. Making a diagnosis of pertussis can be challenging because the disease can be atypical, and may not meet the CDC definition of probable infection. PMID:25970109

Longitudinal study of effects of patient characteristics on direct costs in Alzheimer disease.

PubMed

Zhu, C W; Scarmeas, N; Torgan, R; Albert, M; Brandt, J; Blacker, D; Sano, M; Stern, Y

2006-09-26

To estimate long-term trajectories of direct cost of caring for patients with Alzheimer disease (AD) and examine the effects of patients' characteristics on cost longitudinally. The sample is drawn from the Predictors Study, a large, multicenter cohort of patients with probable AD, prospectively followed up annually for up to 7 years in three university-based AD centers in the United States. Random effects models estimated the effects of patients' clinical and sociodemographic characteristics on direct cost of care. Direct cost included cost associated with medical and nonmedical care. Clinical characteristics included cognitive status (measured by Mini-Mental State Examination), functional capacity (measured by Blessed Dementia Rating Scale [BDRS]), psychotic symptoms, behavioral problems, depressive symptoms, extrapyramidal signs, and comorbidities. The model also controlled for patients' sex, age, and living arrangements. Total direct cost increased from approximately 9,239 dollars per patient per year at baseline, when all patients were at the early stages of the disease, to 19,925 dollars by year 4. After controlling for other variables, a one-point increase in the BDRS score increased total direct cost by 7.7%. One more comorbid condition increased total direct cost by 14.3%. Total direct cost was 20.8% lower for patients living at home compared with those living in an institutional setting. Total direct cost of caring for patients with Alzheimer disease increased substantially over time. Much of the cost increases were explained by patients' clinical and demographic variables. Comorbidities and functional capacity were associated with higher direct cost over time.

The results of therapeutic plasma exchange in patients with severe hyperthyroidism: a retrospective multicenter study.

PubMed

Keklik, Muzaffer; Kaynar, Leylagul; Yilmaz, Mehmet; Sivgin, Serdar; Solmaz, Musa; Pala, Cigdem; Aribas, Sulbiye; Akyol, Gulsah; Unluhizarci, Kursat; Cetin, Mustafa; Eser, Bulent; Unal, Ali

2013-06-01

Hyperthyroidism characterized by elevated serum levels of circulating thyroid hormones. The aim of hyperthyroidism treatment is to achieve a euthyroid state as soon as possible and to maintain euthyroid status. However, drug withdrawal and utilization of alternative therapies are needed in cases in which leucopenia or impairment in liver functions is observed during medical therapy. In the present study, we aimed to present our cases which underwent therapeutic plasma exchange (TPE) due to severe hyperthyroidism. The results of 22 patients who underwent therapeutic plasma exchange due to hyperthyroidism in Apheresis Units of Erciyes University and Gaziantep University, between 2006 and 2012, were retrospectively reviewed. These cases had severe thyrotoxic values despite anti-thyroid drug use. After TPE, we observed a significant decrease in free thyroxin (FT4) (p<0.001) and free triiodotyhronin (FT3) (p<0.004) levels. There was statistically significant increase in the mean values of TSH levels after TPE (p<0.001). Clinical improvement was achieved in hyperthyroidism by TPE in 20 cases (91%). Both FT3 and FT4 levels remained above the normal limits in two of 22 patients. TPE should be considered as an effective and safe therapeutic option to achieve euthyroid state before surgery or radioactive iodine treatment. TPE is a useful option in cases with severe hyperthyroidism unresponsive to anti-thyroid agents and in those with clinical manifestations of cardiac failure and in patients with severe adverse events during anti-thyroid therapy. Copyright © 2013 Elsevier Ltd. All rights reserved.

31 CFR 560.510 - Transactions related to the resolution of disputes between the United States or United States...

Code of Federal Regulations, 2012 CFR

2012-07-01

... of disputes between the United States or United States nationals and the Government of Iran. 560.510... between the United States or United States nationals and the Government of Iran. (a) Except as otherwise... with awards, decisions or orders of the Iran-United States Claims Tribunal in The Hague, the...

31 CFR 560.510 - Transactions related to the resolution of disputes between the United States or United States...

Code of Federal Regulations, 2010 CFR

2010-07-01

... resolution of disputes between the United States or United States nationals and the Government of Iran. 560... between the United States or United States nationals and the Government of Iran. (a) Except as otherwise... with awards, decisions or orders of the Iran-United States Claims Tribunal in The Hague, the...

Neonatal Intensive Care Unit Census Influences Discharge of Moderately Preterm Infants

PubMed Central

Profit, Jochen; McCormick, Marie C.; Escobar, Gabriel J.; Richardson, Douglas K.; Zheng, Zheng; Coleman-Phox, Kim; Roberts, Rebecca; Zupancic, John A. F.

2011-01-01

Objective The timely discharge of moderately premature infants has important economic implications. The decision to discharge should occur independent of unit census. We evaluated the impact of unit census on the decision to discharge moderately preterm infants. Design/Methods In a prospective multicenter cohort study, we enrolled 850 infants born between 30 and 34 weeks' gestation at 10 NICUs in Massachusetts and California. We divided the daily census from each hospital into quintiles and tested whether discharges were evenly distributed among them. Using logistic regression, we analyzed predictors of discharge within census quintiles associated with a greater- or less-than-expected likelihood of discharge. We then explored parental satisfaction and postdischarge resource consumption in relation to discharge during census periods that were associated with high proportions of discharge. Results There was a significant correlation between unit census and likelihood of discharge. When unit census was in the lowest quintile, patients were 20% less likely to be discharged when compared with all of the other quintiles of unit census. In the lowest quintile of unit census, patient/nurse ratio was the only variable associated with discharge. When census was in the highest quintile, patients were 32% more likely to be discharged when compared with all of the other quintiles of unit census. For patients in this quintile, a higher patient/nurse ratio increased the likelihood of discharge. Conversely, infants with prolonged lengths of stay, an increasing Score for Neonatal Acute Physiology II, and minor congenital anomalies were less likely to be discharged. Infants discharged at high unit census did not differ from their peers in terms of parental satisfaction, emergency department visits, home nurse visits, or rehospitalization rates. Conclusions Discharges are closely correlated with unit census. Providers incorporate demand and case mix into their discharge decisions. PMID:17272621

7 CFR 1220.615 - State and United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false State and United States. 1220.615 Section 1220.615... CONSUMER INFORMATION Procedures To Request a Referendum Definitions § 1220.615 State and United States. State and United States include the 50 States of the United States of America, the District of Columbia...

7 CFR 1220.615 - State and United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false State and United States. 1220.615 Section 1220.615... CONSUMER INFORMATION Procedures To Request a Referendum Definitions § 1220.615 State and United States. State and United States include the 50 States of the United States of America, the District of Columbia...

7 CFR 1220.129 - State and United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false State and United States. 1220.129 Section 1220.129... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.129 State and United States. The terms State and United States include the 50 States of the United States of America, the District...

7 CFR 1220.129 - State and United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false State and United States. 1220.129 Section 1220.129... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.129 State and United States. The terms State and United States include the 50 States of the United States of America, the District...

7 CFR 1220.129 - State and United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false State and United States. 1220.129 Section 1220.129... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.129 State and United States. The terms State and United States include the 50 States of the United States of America, the District...

7 CFR 1220.129 - State and United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false State and United States. 1220.129 Section 1220.129... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.129 State and United States. The terms State and United States include the 50 States of the United States of America, the District...

7 CFR 1220.129 - State and United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false State and United States. 1220.129 Section 1220.129... CONSUMER INFORMATION Soybean Promotion and Research Order Definitions § 1220.129 State and United States. The terms State and United States include the 50 States of the United States of America, the District...

7 CFR 1220.615 - State and United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false State and United States. 1220.615 Section 1220.615... CONSUMER INFORMATION Procedures To Request a Referendum Definitions § 1220.615 State and United States. State and United States include the 50 States of the United States of America, the District of Columbia...

7 CFR 1220.615 - State and United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false State and United States. 1220.615 Section 1220.615... CONSUMER INFORMATION Procedures To Request a Referendum Definitions § 1220.615 State and United States. State and United States include the 50 States of the United States of America, the District of Columbia...

7 CFR 1220.615 - State and United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false State and United States. 1220.615 Section 1220.615... CONSUMER INFORMATION Procedures To Request a Referendum Definitions § 1220.615 State and United States. State and United States include the 50 States of the United States of America, the District of Columbia...

Functional Recovery and Life Satisfaction in the First Year After Severe Traumatic Brain Injury: A Prospective Multicenter Study of a Norwegian National Cohort.

PubMed

Anke, Audny; Andelic, Nada; Skandsen, Toril; Knoph, Rein; Ader, Tiina; Manskow, Unn; Sigurdardottir, Solrun; Røe, Cecilie

2015-01-01

(1) To examine the impact of demographic and acute injury-related variables on functional recovery and life satisfaction after severe traumatic brain injury (sTBI) and (2) to test whether postinjury functioning, postconcussive symptoms, emotional state, and functional improvement are related to life satisfaction. Prospective national multicenter study. Level 1 trauma centers in Norway. 163 adults with sTBI. Functional recovery between 3 and 12 months postinjury measured with Glasgow Outcome Scale Extended, Rivermead Postconcussion Symptoms Questionnaire, Hospital Anxiety and Depression Scale, and satisfaction with life situation. 60% of cases experienced functional improvement from 3 to 12 months postinjury. Multivariate logistic regression analysis revealed that discharge to a rehabilitation department from acute care (odds ratio [OR] = 2.14; P < .05) and fewer days with artificial ventilation (OR = 1.04; P < .05) were significantly related to improvement. At 12 months postinjury, 85% were independent in daily activities. Most participants (63%) were satisfied with their life situation. Regression analysis revealed that older age (>65 years), low education, better functional outcome, and the absence of depressive and postconcussion symptoms were significant (P < .05) predictors of life satisfaction. Functional improvement was significantly associated with emotional state but not to life satisfaction. Following sTBI, approximately two-thirds of survivors improve between 3 and 12 months postinjury and are satisfied with their life. Direct discharge from acute care to specialized rehabilitation appears to increase functional recovery.

Pandemic preparedness in Hawaii: a multicenter verification of real-time RT-PCR for the direct detection of influenza virus types A and B.

PubMed

Whelen, A Christian; Bankowski, Matthew J; Furuya, Glenn; Honda, Stacey; Ueki, Robert; Chan, Amelia; Higa, Karen; Kumashiro, Diane; Moore, Nathaniel; Lee, Roland; Koyamatsu, Terrie; Effler, Paul V

2010-01-01

We integrated multicenter, real-time (RTi) reverse transcription polymerase chain reaction (RT-PCR) screening into a statewide laboratory algorithm for influenza surveillance and response. Each of three sites developed its own testing strategy and was challenged with one randomized and blinded panel of 50 specimens previously tested for respiratory viruses. Following testing, each participating laboratory reported its results to the Hawaii State Department of Health, State Laboratories Division for evaluation and possible discrepant analysis. Two of three laboratories reported a 100% sensitivity and specificity, resulting in a 100% positive predictive value and a 100% negative predictive value (NPV) for influenza type A. The third laboratory showed a 71% sensitivity for influenza type A (83% NPV) with 100% specificity. All three laboratories were 100% sensitive and specific for the detection of influenza type B. Discrepant analysis indicated that the lack of sensitivity experienced by the third laboratory may have been due to the analyte-specific reagent probe used by that laboratory. Use of a newer version of the product with a secondary panel of 20 specimens resulted in a sensitivity and specificity of 100%. All three laboratories successfully verified their ability to conduct clinical testing for influenza using diverse nucleic acid extraction and RTi RT-PCR platforms. Successful completion of the verification by all collaborating laboratories paved the way for the integration of those facilities into a statewide laboratory algorithm for influenza surveillance and response.

75 FR 5373 - United States Mint

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-02

... DEPARTMENT OF THE TREASURY United States Mint ACTION: Notification of Pricing for 2010 United States Mint Presidential $1 Coin Proof Set. \\TM\\ SUMMARY: The United States Mint is announcing the price of the 2010 United States Mint Presidential $1 Coin Proof Set. The 2010 United States Mint...

31 CFR 800.225 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 800.225 Section 800.225... FOREIGN PERSONS Definitions § 800.225 United States. The term United States or U.S. means the United States of America, the States of the United States, the District of Columbia, and any commonwealth...

31 CFR 800.225 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 800.225 Section 800.225... FOREIGN PERSONS Definitions § 800.225 United States. The term United States or U.S. means the United States of America, the States of the United States, the District of Columbia, and any commonwealth...

31 CFR 800.225 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 800.225 Section 800.225... FOREIGN PERSONS Definitions § 800.225 United States. The term United States or U.S. means the United States of America, the States of the United States, the District of Columbia, and any commonwealth...

31 CFR 800.225 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 800.225 Section 800.225... FOREIGN PERSONS Definitions § 800.225 United States. The term United States or U.S. means the United States of America, the States of the United States, the District of Columbia, and any commonwealth...

Distribution of respiratory syncytial virus subtypes A and B among infants presenting to the emergency department with lower respiratory tract infection or apnea.

PubMed

Jafri, Hasan S; Wu, Xionghua; Makari, Doris; Henrickson, Kelly J

2013-04-01

Respiratory syncytial virus (RSV), a leading viral respiratory pathogen worldwide, has 2 major subtypes, A and B. To describe the temporal and geographic distribution and parameters of disease severity associated with RSV A and B in the United States. A US multicenter active surveillance study was conducted in emergency departments (EDs) during 2 RSV seasons. Infants <1 year of age presenting to the ED with symptoms of lower respiratory tract infection or apnea were enrolled. RSV subtypes were detected in nasal swabs by reverse transcriptase polymerase chain reaction. Of 4248 patients enrolled, 4172 patients were evaluable; 32.4% of patients were positive for any RSV subtype in season 1 and 29.9% in season 2. RSV A and B were detected in each region studied. More patients presented to the ED with RSV A than with RSV B (853 [20.4%] versus 453 [10.9%], respectively); RSV A-positive patients were more likely to be admitted to the hospital or intensive care unit (47.7%, versus RSV B, 35.8%; P < 0.0001); hospitalized RSV A-positive patients were less likely to be prescribed antibiotics (32.4%, versus RSV B, 47.8%; P < 0.001). This is the largest epidemiologic study in EDs reporting trends in RSV subtypes. RSV subtypes A and B were documented in both seasons across all US regions studied and detected in September to May. The results of this study support suggestions from smaller studies that RSV A may be more virulent than RSV B; however, more quantitative assessments of disease severity are needed.

7 CFR 1150.106 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 9 2011-01-01 2011-01-01 false United States. 1150.106 Section 1150.106 Agriculture... Order Definitions § 1150.106 United States. United States means the 48 contiguous States in the continental United States. ...

7 CFR 1150.106 - United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 9 2010-01-01 2009-01-01 true United States. 1150.106 Section 1150.106 Agriculture... Order Definitions § 1150.106 United States. United States means the 48 contiguous States in the continental United States. ...

Microsurgical reconstruction of the head and neck region: Current concepts of maxillofacial surgery units worldwide.

PubMed

Kansy, Katinka; Mueller, Andreas Albert; Mücke, Thomas; Koersgen, Friederike; Wolff, Klaus Dietrich; Zeilhofer, Hans-Florian; Hölzle, Frank; Pradel, Winnie; Schneider, Matthias; Kolk, Andreas; Smeets, Ralf; Acero, Julio; Haers, Piet; Ghali, G E; Hoffmann, Jürgen

2015-10-01

Microvascular surgery following tumor resection has become an important field of oral maxillofacial surgery (OMFS). Following the surveys on current reconstructive practice in German-speaking countries and Europe, this paper presents the third phase of the project when the survey was conducted globally. The DOESAK questionnaire has been developed via a multicenter approach with maxillofacial surgeons from 19 different hospitals in Germany, Austria and Switzerland. It was distributed in three different phases to a growing number of maxillofacial units in German-speaking clinics, over Europe and then worldwide. Thirty-eight units from Germany, Austria and Switzerland, 65 remaining European OMFS-departments and 226 units worldwide responded to the survey. There is wide agreement on the most commonly used flaps, intraoperative rapid sections and a trend towards primary bony reconstruction. No uniform concepts can be identified concerning osteosynthesis of bone transplants, microsurgical techniques, administration of supportive medication and postoperative monitoring protocols. Microsurgical reconstruction is the gold standard for the majority of oncologic cases in Europe, but worldwide, only every second unit has access to this technique. The DOESAK questionnaire has proven to be a valid and well accepted tool for gathering information about current practice in reconstructive OMFS surgery. The questionnaire has been able to demonstrate similarities, differences and global inequalities. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Initial digital vasculitis in a large multicenter cohort of childhood-onset systemic lupus erythematosus.

PubMed

Sakamoto, Ana Paula; Silva, Clovis Artur; Silva, Marco Felipe Castro da; Lopes, Anandreia Simões; Russo, Gleice Clemente Souza; Sallum, Adriana Maluf Elias; Kozu, Katia; Bonfá, Eloisa; Saad-Magalhães, Claudia; Pereira, Rosa Maria Rodrigues; Len, Claudio Arnaldo; Terreri, Maria Teresa

To assess clinical digital vasculitis (DV) as an initial manifestation of childhood-onset systemic lupus erythematosus (cSLE) within a large population. Multicenter cross-sectional study including 852 cSLE patients (ACR criteria) followed in ten Pediatric Rheumatology centers in São Paulo State, Brazil. DV was observed in 25/852 (3%) cSLE patients. Periungual hemorrhage was diagnosed in 12 (48%), periungual infarction in 7 (28%), tip finger ulceration in 4 (16%), painful nodules in 1 (4%) and gangrene in 1 (4%). A poor outcome, with digital resorption, occurred in 5 (20%). Comparison of patients with and without DV revealed higher frequency of malar rash (80% vs. 53%, p=0.008), discoid rash (16% vs. 4%, p=0.017), photosensitivity (76% vs. 45%, p=0.002) and other cutaneous vasculitides (80% vs. 19%, p<0.0001), whereas the frequency of overall constitutional features (32% vs. 61%, p=0.003), fever (32% vs. 56%, p=0.020) and hepatomegaly (4% vs. 23%, p=0.026) were lower in these patients. Frequency of female gender, severe multi-organ involvement, autoantibodies profile and low complement were alike in both groups (p>0.05). SLEDAI-2K median, DV descriptor excluded, was significantly lower in patients with DV compared to those without this manifestation [10 (0-28) vs. 14 (0-58), p=0.004]. Visceral vasculitis or death were not observed in this cSLE cohort. The frequency of cyclophosphamide use (0% vs. 18%, p=0.014) was significantly lower in the DV group. Our large multicenter study identified clinical DV as one of the rare initial manifestation of active cSLE associated with a mild multisystemic disease, in spite of digital resorption in some of these patients. Copyright © 2017. Published by Elsevier Editora Ltda.

Military Guilty Plea Inquiry: Some Constitutional Considerations.

DTIC Science & Technology

1987-01-01

Sanchez v. United States, 417 F. 2d 494 (5th Cir. 1969). Trujillo v. United States, 377 F. 2d 266 (5th Cir. 1967). 188 United States v. Baylin, 696 F. 2d...States, 412 F. 2d 189 (3rd Cir. 1969). 190 Sanchez v. United States, 572 F. 2d 210 (9th Cir. 1977). 191 United States v. Rivera-Ramirez, 715 F. 2d 453...1981). 360 United States v. Dawson, 10 M.J. 142 (CMA 1981). United States v. Connell, 13 M.J. 156 (CMA 1982). 361 United States v. Cifuentes , 11 M.J

41 CFR 301-10.131 - What does United States mean?

Code of Federal Regulations, 2013 CFR

2013-07-01

... 41 Public Contracts and Property Management 4 2013-07-01 2012-07-01 true What does United States... Carrier Transportation Use of United States Flag Air Carriers § 301-10.131 What does United States mean? For purposes of the use of United States flag air carriers, United States means the 50 states, the...

41 CFR 301-10.131 - What does United States mean?

Code of Federal Regulations, 2010 CFR

2010-07-01

... 41 Public Contracts and Property Management 4 2010-07-01 2010-07-01 false What does United States... Carrier Transportation Use of United States Flag Air Carriers § 301-10.131 What does United States mean? For purposes of the use of United States flag air carriers, United States means the 50 states, the...

41 CFR 301-10.131 - What does United States mean?

Code of Federal Regulations, 2011 CFR

2011-07-01

... 41 Public Contracts and Property Management 4 2011-07-01 2011-07-01 false What does United States... Carrier Transportation Use of United States Flag Air Carriers § 301-10.131 What does United States mean? For purposes of the use of United States flag air carriers, United States means the 50 states, the...

41 CFR 301-10.131 - What does United States mean?

Code of Federal Regulations, 2014 CFR

2014-07-01

... 41 Public Contracts and Property Management 4 2014-07-01 2014-07-01 false What does United States... Carrier Transportation Use of United States Flag Air Carriers § 301-10.131 What does United States mean? For purposes of the use of United States flag air carriers, United States means the 50 states, the...

31 CFR 560.319 - United States depository institution.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States depository institution... General Definitions § 560.319 United States depository institution. The term United States depository... within the United States, or any agency, office or branch located in the United States of a foreign...

7 CFR 60.127 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false United States. 60.127 Section 60.127 Agriculture... FOR FISH AND SHELLFISH General Provisions Definitions § 60.127 United States. United States means the... the United States, and the waters of the United States as defined in § 60.132. ...

5 CFR 8.2 - Appointment of United States citizens.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 5 Administrative Personnel 1 2013-01-01 2013-01-01 false Appointment of United States citizens. 8... APPOINTMENTS TO OVERSEAS POSITIONS (RULE VIII) § 8.2 Appointment of United States citizens. United States... appointments for United States citizens recruited within the continental limits of the United States whenever...

7 CFR 60.127 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false United States. 60.127 Section 60.127 Agriculture... FOR FISH AND SHELLFISH General Provisions Definitions § 60.127 United States. United States means the... the United States, and the waters of the United States as defined in § 60.132. ...

31 CFR 560.319 - United States depository institution.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States depository institution... REGULATIONS General Definitions § 560.319 United States depository institution. The term United States... United States or any jurisdiction within the United States, or any agency, office, or branch located in...

7 CFR 60.127 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false United States. 60.127 Section 60.127 Agriculture... FOR FISH AND SHELLFISH General Provisions Definitions § 60.127 United States. United States means the... the United States, and the waters of the United States as defined in § 60.132. ...

5 CFR 8.2 - Appointment of United States citizens.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Appointment of United States citizens. 8... APPOINTMENTS TO OVERSEAS POSITIONS (RULE VIII) § 8.2 Appointment of United States citizens. United States... appointments for United States citizens recruited within the continental limits of the United States whenever...

7 CFR 60.127 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false United States. 60.127 Section 60.127 Agriculture... FOR FISH AND SHELLFISH General Provisions Definitions § 60.127 United States. United States means the... the United States, and the waters of the United States as defined in § 60.132. ...

31 CFR 560.319 - United States depository institution.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States depository institution... REGULATIONS General Definitions § 560.319 United States depository institution. The term United States... United States or any jurisdiction within the United States, or any agency, office, or branch located in...

5 CFR 8.2 - Appointment of United States citizens.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 5 Administrative Personnel 1 2014-01-01 2014-01-01 false Appointment of United States citizens. 8... APPOINTMENTS TO OVERSEAS POSITIONS (RULE VIII) § 8.2 Appointment of United States citizens. United States... appointments for United States citizens recruited within the continental limits of the United States whenever...

5 CFR 8.2 - Appointment of United States citizens.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 5 Administrative Personnel 1 2012-01-01 2012-01-01 false Appointment of United States citizens. 8... APPOINTMENTS TO OVERSEAS POSITIONS (RULE VIII) § 8.2 Appointment of United States citizens. United States... appointments for United States citizens recruited within the continental limits of the United States whenever...

75 FR 13345 - Pricing for Certain 2010 United States Mint Products

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-19

... DEPARTMENT OF THE TREASURY United States Mint Pricing for Certain 2010 United States Mint Products AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing the price of the 2010 United States Mint Presidential $1 Coin and First Spouse Medal...

Clinical Features, Short-Term Mortality, and Prognostic Risk Factors of Septic Patients Admitted to Internal Medicine Units: Results of an Italian Multicenter Prospective Study.

PubMed

Mazzone, Antonino; Dentali, Francesco; La Regina, Micaela; Foglia, Emanuela; Gambacorta, Maurizia; Garagiola, Elisabetta; Bonardi, Giorgio; Clerici, Pierangelo; Concia, Ercole; Colombo, Fabrizio; Campanini, Mauro

2016-01-01

Only a few studies provided data on the clinical history of sepsis within internal Medicine units. The aim of the study was to assess the short-term mortality and to evaluate the prognostic risk factors in a large cohort of septic patients treated in internal medicine units. Thirty-one internal medicine units participated to the study. Within each participating unit, all admitted patients were screened for the presence of sepsis. A total of 533 patients were included; 78 patients (14.6%, 95%CI 11.9, 18.0%) died during hospitalization; mortality rate was 5.5% (95% CI 3.1, 9.6%) in patients with nonsevere sepsis and 20.1% (95%CI 16.2, 28.8%) in patients with severe sepsis or septic shock. Severe sepsis or septic shock (OR 4.41, 95%CI 1.93, 10.05), immune system weakening (OR 2.10, 95%CI 1.12, 3.94), active solid cancer (OR 2.14, 95% CI 1.16, 3.94), and age (OR 1.03 per year, 95% CI 1.01, 1.06) were significantly associated with an increased mortality risk, whereas blood culture positive for Escherichia coli was significantly associated with a reduced mortality risk (OR 0.46, 95%CI 0.24, 0.88). In-hospital mortality of septic patients treated in internal medicine units appeared similar to the mortality rate obtained in recent studies conducted in the ICU setting.

3 CFR - Designation of Officers of the United States Section, International Boundary and Water Commission...

Code of Federal Regulations, 2010 CFR

2010-01-01

..., International Boundary and Water Commission, United States and Mexico To Act as the Commissioner of the United... States and Mexico To Act as the Commissioner of the United States Section Memorandum for the Commissioner of the United States Section, International Boundary and Water Commission, United States and Mexico...

75 FR 10561 - Pricing for 2010 United States Mint America the Beautiful QuartersTM

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-08

... DEPARTMENT OF THE TREASURY United States Mint Pricing for 2010 United States Mint America the...: Notice. SUMMARY: The United States Mint is announcing the price of the 2010 United States Mint America the Beautiful Quarters Two-Roll Set and the 2010 United States Mint America the Beautiful Quarters 100...

Rapanos v. United States & Carabell v. United States

EPA Pesticide Factsheets

Documents associated with guidance for implementing the definition of waters of the United States under the Clean Water Act following the Rapanos v. United States, and Carabell v. United States Supreme Court decision.

Multicenter Guidelines | Division of Cancer Prevention

Cancer.gov

A Lead Organization conducting multi-institutional studies in the consortium has specific responsibilities in order to comply with the DCP Multicenter Guidelines. The Lead Organization is responsible for the following at all Participating Organizations as well as the Lead Organization: |

7 CFR 65.255 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false United States. 65.255 Section 65.255 Agriculture..., PEANUTS, AND GINSENG General Provisions Definitions § 65.255 United States. United States means the 50... United States. ...

7 CFR 65.255 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false United States. 65.255 Section 65.255 Agriculture..., PEANUTS, AND GINSENG General Provisions Definitions § 65.255 United States. United States means the 50... United States. ...

7 CFR 65.255 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false United States. 65.255 Section 65.255 Agriculture..., PEANUTS, AND GINSENG General Provisions Definitions § 65.255 United States. United States means the 50... United States. ...

7 CFR 65.255 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false United States. 65.255 Section 65.255 Agriculture..., PEANUTS, AND GINSENG General Provisions Definitions § 65.255 United States. United States means the 50... United States. ...

A multicenter, randomized, controlled trial of osteopathic manipulative treatment on preterms.

PubMed

Cerritelli, Francesco; Pizzolorusso, Gianfranco; Renzetti, Cinzia; Cozzolino, Vincenzo; D'Orazio, Marianna; Lupacchini, Mariacristina; Marinelli, Benedetta; Accorsi, Alessandro; Lucci, Chiara; Lancellotti, Jenny; Ballabio, Silvia; Castelli, Carola; Molteni, Daniela; Besana, Roberto; Tubaldi, Lucia; Perri, Francesco Paolo; Fusilli, Paola; D'Incecco, Carmine; Barlafante, Gina

2015-01-01

Despite some preliminary evidence, it is still largely unknown whether osteopathic manipulative treatment improves preterm clinical outcomes. The present multi-center randomized single blind parallel group clinical trial enrolled newborns who met the criteria for gestational age between 29 and 37 weeks, without any congenital complication from 3 different public neonatal intensive care units. Preterm infants were randomly assigned to usual prenatal care (control group) or osteopathic manipulative treatment (study group). The primary outcome was the mean difference in length of hospital stay between groups. A total of 695 newborns were randomly assigned to either the study group (n= 352) or the control group (n=343). A statistical significant difference was observed between the two groups for the primary outcome (13.8 and 17.5 days for the study and control group respectively, p<0.001, effect size: 0.31). Multivariate analysis showed a reduction of the length of stay of 3.9 days (95% CI -5.5 to -2.3, p<0.001). Furthermore, there were significant reductions with treatment as compared to usual care in cost (difference between study and control group: 1,586.01€; 95% CI 1,087.18 to 6,277.28; p<0.001) but not in daily weight gain. There were no complications associated to the intervention. Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants.

Applicability Evaluation of Simplified Cognitive Behavioral Therapy.

PubMed

Zhang, Li; Zhu, Zhipei; Fang, Fang; Shen, Yuan; Liu, Na; Li, Chunbo

2018-04-25

We have developed a structured cognitive behavioral therapy manual for anxiety disorder in China, and the present study evaluated the applicability of simplified cognitive behavioral therapy based on our previous research. To evaluate the applicability of simplified cognitive behavioral therapy (SCBT) on generalized anxiety disorder (GAD) by conducting a multi-center controlled clinical trial. A multi-center controlled clinical trial of SCBT was conducted on patients with GAD, including institutions specializing in mental health and psychiatry units in general hospitals. The participants were divided into 3 groups: SCBT group, SCBT with medication group and medication group. The drop-out rates of these three groups, the therapy satisfaction of patients who received SCBT and the evaluation of SCBT from therapists were compared. (1) There was no significant difference among the drop-out rates in the three groups. (2) Only the duration and times of therapy were significantly different between the two groups of patients who received the SCBT, and the therapy satisfaction of the SCBT group was higher than that of the SCBT with medication group. (3) Eighteen therapists who conducted the SCBT indicated that the manual was easy to comprehend and operate, and this therapy could achieve the therapy goals. The applicability of SCBT for patients with GAD is relatively high, and it is hopeful that SCBT can become a psychological treatment which can be applied in medical institutions of various levels.

Consensus statement for use and technical requirements of thyroid ultrasound in endocrinology units.

PubMed

Martín-Hernández, Tomás; Díez Gómez, Juan José; Díaz-Soto, Gonzalo; Torres Cuadro, Alberto; Navarro González, Elena; Oleaga Alday, Amelia; Sambo Salas, Marcel; Reverter Calatayud, Jordi L; Argüelles Jiménez, Iñaki; Mancha Doblas, Isabel; Fernández García, Diego; Galofré, Juan Carlos

2017-03-01

Thyroid nodule detection has increased with widespread use of ultrasound, which is currently the main tool for detection, monitoring, diagnosis and, in some instances, treatment of thyroid nodules. Knowledge of ultrasound and adequate instruction on its use require a position statement by the scientific societies concerned. The working groups on thyroid cancer and ultrasound techniques of the Spanish Society of Endocrinology and Nutrition have promoted this document, based on a thorough analysis of the current literature, the results of multicenter studies and expert consensus, in order to set the requirements for the best use of ultrasound in clinical practice. The objectives include the adequate framework for use of thyroid ultrasound, the technical and legal requirements, the clinical situations in which it is recommended, the levels of knowledge and learning processes, the associated responsibility, and the establishment of a standardized reporting of results and integration into hospital information systems and endocrinology units. Copyright © 2017 SEEN. Publicado por Elsevier España, S.L.U. All rights reserved.

78 FR 70414 - Pricing for the 2013 United States Mint Limited Edition Silver Proof SetTM

Federal Register 2010, 2011, 2012, 2013, 2014

2013-11-25

... DEPARTMENT OF THE TREASURY United States Mint Pricing for the 2013 United States Mint Limited Edition Silver Proof Set TM AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: The United States Mint is announcing a price of $139.95 for the 2013 United States Mint Limited...

77 FR 62601 - United States Department of Energy and United States Department of Defense v. Baltimore & Ohio...

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-15

...] United States Department of Energy and United States Department of Defense v. Baltimore & Ohio Railroad..., 2012, United States Department of Energy and the United States Department of Defense (the Government...) Terrance A. Spann, U.S. Department of Defense, 9275 Gunston Road, Suite 1300, Fort Belvoir, VA 22060; and...

75 FR 10345 - Pricing for 2010 United States Mint America the Beautiful Quarters Proof Set, etc.

Federal Register 2010, 2011, 2012, 2013, 2014

2010-03-05

... DEPARTMENT OF THE TREASURY United States Mint Pricing for 2010 United States Mint America the.... SUMMARY: The United States Mint is announcing the prices of the 2010 United States Mint America the Beautiful Quarters Proof Set; 2010 United States Mint America the Beautiful Quarters Silver Proof Set; 2010...

7 CFR 1205.23 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false United States. 1205.23 Section 1205.23 Agriculture... Procedures for Conduct of Sign-up Period Definitions § 1205.23 United States. The term United States means the 50 states of the United States of America. Procedures ...

7 CFR 1250.308 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1250.308 Section 1250.308 Agriculture... Research and Promotion Order Definitions § 1250.308 United States. United States means the 48 contiguous States of the United States of America and the District of Columbia. ...

7 CFR 1250.308 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false United States. 1250.308 Section 1250.308 Agriculture... Research and Promotion Order Definitions § 1250.308 United States. United States means the 48 contiguous States of the United States of America and the District of Columbia. ...

7 CFR 1205.23 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1205.23 Section 1205.23 Agriculture... Procedures for Conduct of Sign-up Period Definitions § 1205.23 United States. The term United States means the 50 states of the United States of America. Procedures ...

7 CFR 1250.308 - United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1250.308 Section 1250.308 Agriculture... Research and Promotion Order Definitions § 1250.308 United States. United States means the 48 contiguous States of the United States of America and the District of Columbia. ...

7 CFR 1250.308 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1250.308 Section 1250.308 Agriculture... Research and Promotion Order Definitions § 1250.308 United States. United States means the 48 contiguous States of the United States of America and the District of Columbia. ...

7 CFR 1250.308 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false United States. 1250.308 Section 1250.308 Agriculture... Research and Promotion Order Definitions § 1250.308 United States. United States means the 48 contiguous States of the United States of America and the District of Columbia. ...

7 CFR 1205.23 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false United States. 1205.23 Section 1205.23 Agriculture... Procedures for Conduct of Sign-up Period Definitions § 1205.23 United States. The term United States means the 50 states of the United States of America. Procedures ...

7 CFR 1205.23 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1205.23 Section 1205.23 Agriculture... Procedures for Conduct of Sign-up Period Definitions § 1205.23 United States. The term United States means the 50 states of the United States of America. Procedures ...

76 FR 19124 - United States Section, Notice of Availability of a Draft Supplemental Environmental Assessment...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-04-06

... INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO United States Section... States Section, International Boundary and Water Commission, United States and Mexico (USIBWC). ACTION..., Environmental Management Division, United States Section, International Boundary and Water Commission; 4171 N...

7 CFR 1205.23 - United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Procedures for Conduct of Sign-up Period Definitions § 1205.23 United States. The term United States means the 50 states of the United States of America. Procedures ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1205.23 Section 1205.23 Agriculture...

Flight Avionics Hardware Roadmap

NASA Technical Reports Server (NTRS)

Hodson, Robert; McCabe, Mary; Paulick, Paul; Ruffner, Tim; Some, Rafi; Chen, Yuan; Vitalpur, Sharada; Hughes, Mark; Ling, Kuok; Redifer, Matt;

Tug-of-war between classical and multicenter bonds in H-(Be)n-H species

NASA Astrophysics Data System (ADS)

Lundell, Katie A.; Boldyrev, Alexander I.

2018-05-01

Quantum chemical calculations were performed for beryllium homocatenated compounds [H-(Be)n-H]. Global minimum structures were found using machine searches (Coalescence Kick method) with density functional theory. Chemical bonding analysis was performed with the Adaptive Natural Density Partitioning method. It was found that H-(Be)2-H and H-(Be)3-H clusters are linear with classical two-center two-electron bonds, while for n > 3, three-dimensional structures are more stable with multicenter bonding. Thus, at n = 4, multicenter bonding wins the tug-of-war vs. the classical bonding.

33 CFR 125.23 - United States citizens.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 33 Navigation and Navigable Waters 2 2014-07-01 2014-07-01 false United States citizens. 125.23... VESSELS § 125.23 United States citizens. Acceptable evidence of United States citizenship is described in... of birth. (e) United States passport. (f) A commission in one of the armed forces of the United...

33 CFR 125.23 - United States citizens.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 33 Navigation and Navigable Waters 2 2013-07-01 2013-07-01 false United States citizens. 125.23... VESSELS § 125.23 United States citizens. Acceptable evidence of United States citizenship is described in... of birth. (e) United States passport. (f) A commission in one of the armed forces of the United...

33 CFR 125.23 - United States citizens.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 33 Navigation and Navigable Waters 2 2010-07-01 2010-07-01 false United States citizens. 125.23... VESSELS § 125.23 United States citizens. Acceptable evidence of United States citizenship is described in... of birth. (e) United States passport. (f) A commission in one of the armed forces of the United...

33 CFR 125.23 - United States citizens.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 33 Navigation and Navigable Waters 2 2011-07-01 2011-07-01 false United States citizens. 125.23... VESSELS § 125.23 United States citizens. Acceptable evidence of United States citizenship is described in... of birth. (e) United States passport. (f) A commission in one of the armed forces of the United...

33 CFR 125.23 - United States citizens.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 33 Navigation and Navigable Waters 2 2012-07-01 2012-07-01 false United States citizens. 125.23... VESSELS § 125.23 United States citizens. Acceptable evidence of United States citizenship is described in... of birth. (e) United States passport. (f) A commission in one of the armed forces of the United...

7 CFR 1219.26 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1219.26 Section 1219.26 Agriculture..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.26 United States. United States means collectively the several 50 States of the United States, the District of...

7 CFR 1219.26 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1219.26 Section 1219.26 Agriculture..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.26 United States. United States means collectively the several 50 States of the United States, the District of...

7 CFR 1219.26 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false United States. 1219.26 Section 1219.26 Agriculture..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.26 United States. United States means collectively the several 50 States of the United States, the District of...

7 CFR 1219.26 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false United States. 1219.26 Section 1219.26 Agriculture..., AND INFORMATION Hass Avocado Promotion, Research, and Information Order Definitions § 1219.26 United States. United States means collectively the several 50 States of the United States, the District of...

31 CFR 597.318 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 597.318 Section 597... General Definitions § 597.318 United States. The term United States means the United States, its territories, states, commonwealths, districts, and possessions, and all areas under the jurisdiction or...

7 CFR 1212.31 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1212.31 Section 1212.31 Agriculture..., Consumer Education, and Industry Information Order Definitions § 1212.31 United States. “United States... territories and possessions of the United States. ...

7 CFR 1212.31 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false United States. 1212.31 Section 1212.31 Agriculture..., Consumer Education, and Industry Information Order Definitions § 1212.31 United States. “United States... territories and possessions of the United States. ...

7 CFR 1212.31 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1212.31 Section 1212.31 Agriculture..., Consumer Education, and Industry Information Order Definitions § 1212.31 United States. “United States... territories and possessions of the United States. ...

7 CFR 1217.30 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false United States. 1217.30 Section 1217.30 Agriculture..., and Industry Information Order Definitions § 1217.30 United States. United States means collectively... possessions of the United States. Softwood Lumber Board ...

7 CFR 1217.30 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1217.30 Section 1217.30 Agriculture..., and Industry Information Order Definitions § 1217.30 United States. United States means collectively... possessions of the United States. Softwood Lumber Board ...

7 CFR 63.13 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 3 2011-01-01 2011-01-01 false United States. 63.13 Section 63.13 Agriculture... IMPROVEMENT CENTER General Provisions Definitions § 63.13 United States. United States means collectively the... possessions of the United States. Board of Directors ...

7 CFR 63.13 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 3 2012-01-01 2012-01-01 false United States. 63.13 Section 63.13 Agriculture... IMPROVEMENT CENTER General Provisions Definitions § 63.13 United States. United States means collectively the... possessions of the United States. Board of Directors ...

7 CFR 63.13 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 3 2014-01-01 2014-01-01 false United States. 63.13 Section 63.13 Agriculture... IMPROVEMENT CENTER General Provisions Definitions § 63.13 United States. United States means collectively the... possessions of the United States. Board of Directors ...

7 CFR 1217.30 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1217.30 Section 1217.30 Agriculture..., and Industry Information Order Definitions § 1217.30 United States. United States means collectively... possessions of the United States. Softwood Lumber Board ...

7 CFR 63.13 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 3 2013-01-01 2013-01-01 false United States. 63.13 Section 63.13 Agriculture... IMPROVEMENT CENTER General Provisions Definitions § 63.13 United States. United States means collectively the... possessions of the United States. Board of Directors ...

7 CFR 1212.31 - United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1212.31 Section 1212.31 Agriculture..., Consumer Education, and Industry Information Order Definitions § 1212.31 United States. “United States... territories and possessions of the United States. ...

78 FR 30398 - Re-pricing of the 2012 and 2013 United States America the Beautiful Quarters Silver Proof Set...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-05-22

...], and 2013 United States Mint Congratulations Set AGENCY: United States Mint, Department of the Treasury..., and the 2013 United States Mint Congratulations Set. 2012 and 2013 United States Mint America the... Silver Proof Set will be offered for sale at a price of $60.95. 2013 United States Mint Congratulations...

8 CFR 252.3 - Great Lakes vessels and tugboats arriving in the United States from Canada; special procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... in the United States from Canada; special procedures. 252.3 Section 252.3 Aliens and Nationality... and tugboats arriving in the United States from Canada; special procedures. (a) United States vessels... vessel of United States registry or a tugboat of United States registry arriving from Canada at a port of...

31 CFR 592.311 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 592.311 Section 592.311....311 United States. The term United States, when used in the geographic sense, means the several States, the District of Columbia, and any commonwealth, territory, or possession of the United States. ...

31 CFR 597.318 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 597.318 Section 597.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 597.318 United States. The term United States means the United States, its territories, states...

31 CFR 597.318 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 597.318 Section 597.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 597.318 United States. The term United States means the United States, its territories, states...

31 CFR 592.311 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 592.311 Section 592.311....311 United States. The term United States, when used in the geographic sense, means the several States, the District of Columbia, and any commonwealth, territory, or possession of the United States. ...

7 CFR 1208.29 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1208.29 Section 1208.29 Agriculture... § 1208.29 United States. United States means collectively the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, and the territories and possessions of the United States. National Processed...

31 CFR 592.311 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 592.311 Section 592.311....311 United States. The term United States, when used in the geographic sense, means the several States, the District of Columbia, and any commonwealth, territory, or possession of the United States. ...

7 CFR 1208.29 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1208.29 Section 1208.29 Agriculture... § 1208.29 United States. United States means collectively the 50 states, the District of Columbia, the Commonwealth of Puerto Rico, and the territories and possessions of the United States. National Processed...

31 CFR 592.311 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 592.311 Section 592.311....311 United States. The term United States, when used in the geographic sense, means the several States, the District of Columbia, and any commonwealth, territory, or possession of the United States. ...

31 CFR 597.318 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 597.318 Section 597.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 597.318 United States. The term United States means the United States, its territories, states...

31 CFR 597.318 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 597.318 Section 597.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 597.318 United States. The term United States means the United States, its territories, states...

31 CFR 592.311 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 592.311 Section 592... § 592.311 United States. The term United States, when used in the geographic sense, means the several States, the District of Columbia, and any commonwealth, territory, or possession of the United States. ...

22 CFR 120.13 - United States.

Code of Federal Regulations, 2010 CFR

2010-04-01

... 22 Foreign Relations 1 2010-04-01 2010-04-01 false United States. 120.13 Section 120.13 Foreign... United States. United States, when used in the geographical sense, includes the several states, the Commonwealth of Puerto Rico, the insular possessions of the United States, the District of Columbia, the...

Effect of Levosimendan on Renal Outcome in Cardiac Surgery Patients With Chronic Kidney Disease and Perioperative Cardiovascular Dysfunction: A Substudy of a Multicenter Randomized Trial.

PubMed

Zangrillo, Alberto; Alvaro, Gabriele; Belletti, Alessandro; Pisano, Antonio; Brazzi, Luca; Calabrò, Maria G; Guarracino, Fabio; Bove, Tiziana; Grigoryev, Evgeny V; Monaco, Fabrizio; Boboshko, Vladimir A; Likhvantsev, Valery V; Scandroglio, Anna M; Paternoster, Gianluca; Lembo, Rosalba; Frassoni, Samuele; Comis, Marco; Pasyuga, Vadim V; Navalesi, Paolo; Lomivorotov, Vladimir V

2018-02-26

Acute kidney injury (AKI) occurs frequently after cardiac surgery. Levosimendan might reduce the incidence of AKI in patients undergoing cardiac surgery. The authors investigated whether levosimendan administration could reduce AKI incidence in a high-risk cardiac surgical population. Post hoc analysis of a multicenter randomized trial. Cardiac surgery operating rooms and intensive care units of 14 centers in 3 countries. The study comprised 90 patients who underwent mitral valve surgery with an estimated glomerular filtration rate <60 mL/min/1.73 m 2 and perioperative myocardial dysfunction. Patients were assigned randomly to receive levosimendan (0.025-0.2 μg/kg/min) or placebo in addition to standard inotropic treatment. Forty-six patients were assigned to receive levosimendan and 44 to receive placebo. Postoperative AKI occurred in 14 (30%) patients in the levosimendan group versus 23 (52%) in the placebo group (absolute difference -21.8; 95% confidence interval -41.7 to -1.97; p = 0.035). The incidence of major complications also was lower (18 [39%]) in the levosimendan group versus that in the placebo group (29 [66%]) (absolute difference -26.8 [-46.7 to -6.90]; p = 0.011). A trend toward lower serum creatinine at intensive care unit discharge was observed in the levosimendan group (1.18 [0.99-1.49] mg/dL) versus that in the placebo group (1.39 [1.05-1.76] mg/dL) (95% confidence interval -0.23 [-0.49 to 0.01]; p = 0.07). Levosimendan may improve renal outcome in cardiac surgery patients with chronic kidney disease undergoing mitral valve surgery who develop perioperative myocardial dysfunction. Results of this exploratory analysis should be investigated in future properly designed randomized controlled trials. Copyright © 2018 Elsevier Inc. All rights reserved.

Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: Study Protocol for the FRAGILE Multicenter Randomized Controlled Trial.

PubMed

Mejía, Omar Asdrúbal Vilca; Sá, Michel Pompeu Barros Oliveira; Deininger, Maurilio Onofre; Dallan, Luís Roberto Palma; Segalote, Rodrigo Coelho; Oliveira, Marco Antonio Praça de; Atik, Fernando Antibas; Santos, Magaly Arrais Dos; Silva, Pedro Gabriel Melo de Barros E; Milani, Rodrigo Mussi; Hueb, Alexandre Ciappina; Monteiro, Rosangela; Lima, Ricardo Carvalho; Lisboa, Luiz Augusto Ferreira; Dallan, Luís Alberto Oliveira; Puskas, John; Jatene, Fabio Biscegli

2017-01-01

Advances in modern medicine have led to people living longer and healthier lives. Frailty is an emerging concept in medicine yet to be explored as a risk factor in cardiac surgery. When it comes to CABG surgery, randomized controlled clinical trials have primarily focused on low-risk (ROOBY, CORONARY), elevated-risk (GOPCABE) or high-risk patients (BBS), but not on frail patients. Therefore, we believe that off-pump CABG could be an important technique in patients with limited functional capacity to respond to surgical stress. In this study, the authors introduce the new national, multicenter, randomized, controlled trial "FRAGILE", to be developed in the main cardiac surgery centers of Brazil, to clarify the potential benefit of off-pump CABG in frail patients. FRAGILE is a two-arm, parallel-group, multicentre, individually randomized (1:1) controlled trial which will enroll 630 patients with blinded outcome assessment (at 30 days, 6 months, 1 year, 2 years and 3 years), which aims to compare adverse cardiac and cerebrovascular events after off-pump versus on-pump CABG in pre-frail and frail patients. Primary outcomes will be all-cause mortality, acute myocardial infarction, cardiac arrest with successful resuscitation, low cardiac output syndrome/cardiogenic shock, stroke, and coronary reintervention. Secondary outcomes will be major adverse cardiac and cerebrovascular events, operative time, mechanical ventilation time, hyperdynamic shock, new onset of atrial fibrillation, renal replacement therapy, reoperation for bleeding, pneumonia, length of stay in intensive care unit, length of stay in hospital, number of units of blood transfused, graft patency, rate of complete revascularization, neurobehavioral outcomes after cardiac surgery, quality of life after cardiac surgery and costs. FRAGILE trial will determine whether off-pump CABG is superior to conventional on-pump CABG in the surgical treatment of pre-frail and frail patients. ClinicalTrials.gov, ID: NCT02338947. Registered on August 29th 2014; last updated on March 21st 2016.

HBOC-201 as an alternative to blood transfusion: efficacy and safety evaluation in a multicenter phase III trial in elective orthopedic surgery.

PubMed

Jahr, Jonathan S; Mackenzie, Colin; Pearce, L Bruce; Pitman, Arkadiy; Greenburg, A Gerson

2008-06-01

The ability of hemoglobin based oxygen carrier-201 (HBOC-201) to safely reduce and/or eliminate perioperative transfusion was studied in orthopedic surgery patients. A randomized, single-blind, packed red blood cell (PRBC)-controlled, parallel-group multicenter study was conducted. Six hundred eighty-eight patients were randomized to treatment with HBOC-201 (H, n = 350) or PRBC (R, n = 338) at the first transfusion decision. Primary endpoints were transfusion avoidance and blinded assessment [Mann-Whitney estimator (MW)] of safety noninferiority. Groups were compared directly and by paired/matching group analyses predicated on a prospectively defined dichotomy [treatment success (HH) vs. failure (HR)] in the H arm and an equivalently defined dichotomy [3 (R3+) units PRBC] in the R arm, based on need (moderate vs. high) for additional oxygen carrying capacity. A total of 59.4% of patients in the H arm avoided PRBC transfusion. Adverse events (8.47 vs. 5.88), and serious adverse events (SAEs) (0.35 vs. 0.25) per patient were higher in the H versus R arms (p < 0.001 and p < 0.01) with MW = 0.561 (95 CI 0.528-0.594). HH versus R3- had identical (0.14) serious adverse events/patient and a MW = 0.519 (95% confidence limit 0.481-0.558), whereas the incidence was higher (0.63 vs. 0.47) for HR versus R3+ with a MW = 0.605 (95% confidence limit 0.550-0.662). Age (>80 years), volume overload and undertreatment contributed to this imbalance. HBOC-201 eliminated transfusion in the majority of subjects. The between arms (H vs. R) safety analysis was unfavorable and likely related to patient age, volume overload, and undertreatment and was isolated to patients that could not be managed by HBOC-201 alone. However, patients <80 years old with moderate clinical need may safely avoid transfusion when treated with up to 10 units of HBOC-201.

Clinical impact of the disposable ventouse iCup® versus a metallic vacuum cup: a multicenter randomized controlled trial.

PubMed

Equy, Véronique; David-Tchouda, Sandra; Dreyfus, Michel; Riethmuller, Didier; Vendittelli, Françoise; Cabaud, Victoire; Langer, Bruno; Margier, Jennifer; Bosson, Jean-Luc; Schaal, Jean-Patrick

2015-12-15

Assisted vaginal delivery by vacuum extraction is frequent. Metallic resterilizible metallic vacuum cups have been routinely used in France. In the last few years a new disposable semi-soft vacuum extraction cup, the iCup, has been introduced. Our objective was to compare maternal and new-born outcomes between this disposable cup and the commonly used Drapier-Faure metallic cup. This was a multicenter prospective randomized controlled open clinical trial performed in the maternity units of five university hospitals and one community hospital in France from October 2009 to February 2013. We included consecutive eligible women with a singleton gestation of at least 37 weeks who required vacuum assisted delivery. Women were randomized to vacuum extraction using the iCup or usual Drapier-Faure metallic cup. The primary outcome was a composite criterion including both the risk of cup dysfunction and the most frequent maternal and neonatal harms: the use of other instruments after attempted vacuum extraction, caesarean section after attempted vacuum extraction, three detachments of the cup, caput succedaneum, cephalohaematoma, episiotomy and perineal tears. 335 women were randomized to the disposable cup and 333 to extraction using the metallic cup. There was no significant difference between the two groups for the primary outcome. However, failed instrumental delivery was more frequent in the disposable cup group, mainly due to detachment: 35.6 % vs 7.1 %, p < 0.0001. Conversely, perineal tears were more frequent in the metallic cup group, especially third or fourth grade perineal tears: 1.7 % versus 5.0 %, p = 0.003. There were no significant differences between the two groups concerning post-partum haemorrhage, transfer to a neonatal intensive care unit (NICU) or serious adverse events. While the disposable cup had more detachments and extraction failures than the standard metallic cup, this innovative disposable device had the advantage of fewer perineal injuries. www.clinicaltrials.gov : NCT01058200 on Jan. 27 2010.

The Habitat Demonstration Unit Project Overview

NASA Technical Reports Server (NTRS)

Kennedy, Kriss J.; Grill, Tracy R.; Tri, Terry O.; Howe, Alan S.

2010-01-01

This paper will describe an overview of the National Aeronautics and Space Administration (NASA) led multi-center Habitat Demonstration Unit (HDU) Project. The HDU project is a "technology-pull" project that integrates technologies and innovations from numerous NASA centers. This project will be used to investigate and validate surface architectures, operations concepts, and requirements definition of various habitation concepts. The first habitation configuration this project will build and test is the Pressurized Excursion Module (PEM). This habitat configuration - the PEM - is based on the Constellation Architecture Scenario 12.1 concept of a vertically oriented habitat module. The HDU project will be tested as part of the 2010 Desert Research and Technologies Simulations (D-RATS) test objectives. The purpose of this project is to develop, integrate, test, and evaluate a habitat configuration in the context of the mission architectures and surface operation concepts. A multi-center approach will be leveraged to build, integrate, and test the PEM through a shared collaborative effort of multiple NASA centers. The HDU project is part of the strategic plan from the Exploration Systems Mission Directorate (ESMD) Directorate Integration Office (DIO) and the Lunar Surface Systems Project Office (LSSPO) to test surface elements in a surface analog environment. The 2010 analog field test will include two Lunar Electric Rovers (LER) and the PEM among other surface demonstration elements. This paper will describe the overall objectives, its various habitat configurations, strategic plan, and technology integration as it pertains to the 2010 and 2011 field analog tests. To accomplish the development of the PEM from conception in June 2009 to rollout for operations in July 2010, the HDU project team is using a set of design standards to define the interfaces between the various systems of PEM and to the payloads, such as the Geology Lab, that those systems will support. Scheduled activities such as early fit-checks and the utilization of a habitat avionics test bed prior to equipment installation into PEM are planned to facilitate the integration process.

Safety Aspects of Postanesthesia Care Unit Discharge without Motor Function Assessment after Spinal Anesthesia: A Randomized, Multicenter, Semiblinded, Noninferiority, Controlled Trial.

PubMed

Aasvang, Eske Kvanner; Jørgensen, Christoffer Calov; Laursen, Mogens Berg; Madsen, Jacob; Solgaard, Søren; Krøigaard, Mogens; Kjærsgaard-Andersen, Per; Mandøe, Hans; Hansen, Torben Bæk; Nielsen, Jørgen Ulrich; Krarup, Niels; Skøtt, Annette Elisabeth; Kehlet, Henrik

2017-06-01

Postanesthesia care unit (PACU) discharge without observation of lower limb motor function after spinal anesthesia has been suggested to significantly reduce PACU stay and enhance resource optimization and early rehabilitation but without enough data to allow clinical recommendations. A multicenter, semiblinded, noninferiority randomized controlled trial of discharge from the PACU with or without assessment of lower limb motor function after elective total hip or knee arthroplasty under spinal anesthesia was undertaken. The primary outcome was frequency of a successful fast-track course (length of stay 4 days or less and no 30-day readmission). Noninferiority would be declared if the odds ratio (OR) for a successful fast-track course was no worse for those patients receiving no motor function assessment versus those patients receiving motor function assessment by OR = 0.68. A total of 1,359 patients (98.8% follow-up) were available for analysis (93% American Society of Anesthesiologists class 1 to 2). The primary outcome occurred in 92.2% and 92.0%, corresponding to no motor function assessment being noninferior to motor function assessment with OR 0.97 (95% CI, 0.70 to 1.35). Adverse events in the ward during the first 24 h occurred in 5.8% versus 7.4% with or without motor function assessment, respectively (OR, 0.77; 95% CI, 0.5 to 1.19, P = 0.24). PACU discharge without assessment of lower limb motor function after spinal anesthesia for total hip or knee arthroplasty was noninferior to motor function assessment in achieving length of stay 4 days or less or 30-day readmissions. Because a nonsignificant tendency toward increased adverse events during the first 24 h in the ward was discovered, further safety data are needed in patients without assessment of lower limb motor function before PACU discharge.

Development of a website and biobank database for the Nanosized Cancer Polymarker Biochip Project: a Multicenter Italian Experience.

PubMed

Leon, Antonette E; Fabricio, Aline S C; Benvegnù, Fabio; Michilin, Silvia; Secco, Annamaria; Spangaro, Omar; Meo, Sabrina; Gion, Massimo

2011-01-01

The Nanosized Cancer Polymarker Biochip Project (RBLA03S4SP) funded by an Italian MIUR-FIRB grant (Italian Ministry of University and Research - Investment Funds for Basic Research) has led to the creation of a free-access dynamic website, available at the web address https://serviziweb.ulss12.ve.it/firbabo, and of a centralized database with password-restricted access. The project network is composed of 9 research units (RUs) and has been active since 2005. The aim of the FIRB project was the design, production and validation of optoelectronic and chemoelectronic biosensors for the simultaneous detection of a novel class of cancer biomarkers associated with immunoglobulins of the M class (IgM) for early diagnosis of cancer. Biomarker immune complexes (BM-ICs) were assessed on samples of clinical cases and matched controls for breast, colorectal, liver, ovarian and prostate malignancies. This article describes in detail the architecture of the project website, the central database application, and the biobank developed for the FIRB Nanosized Cancer Polymarker Biochip Project. The article also illustrates many unique aspects that should be considered when developing a database within a multidisciplinary scenario. The main deliverables of the project were numerous, including the development of an online database which archived 1400 case report forms (700 cases and 700 matched controls) and more than 2700 experimental results relative to the BM-ICs assayed. The database also allowed for the traceability and retrieval of 21,000 aliquots archived in the centralized bank and stored as backup in the RUs, and for the development of a centralized biological bank in the coordinating unit with 6300 aliquots of serum. The constitution of the website and biobank database enabled optimal coordination of the RUs involved, highlighting the importance of sharing samples and scientific data in a multicenter setting for the achievement of the project goals.

The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty.

PubMed

Lass, Jonathan H; Riddlesworth, Tonya D; Gal, Robin L; Kollman, Craig; Benetz, Beth A; Price, Francis W; Sugar, Alan; Terry, Mark A; Soper, Mark; Beck, Roy W

2015-03-01

To examine the long-term effect of donor diabetes history on graft failure and endothelial cell density (ECD) after penetrating keratoplasty (PK) in the Cornea Donor Study. Multicenter, prospective, double-masked, controlled clinical trial. One thousand ninety subjects undergoing PK for a moderate risk condition, principally Fuchs' dystrophy or pseudophakic or aphakic corneal edema, were enrolled by 105 surgeons from 80 clinical sites in the United States. Corneas from donors 12 to 75 years of age were assigned by 43 eye banks to participants without respect to recipient factors. Donor and recipient diabetes status was determined from existing medical records. Images of the central endothelium were obtained before surgery (baseline) and at intervals for 10 years after surgery and were analyzed by a central image analysis reading center to determine ECD. Time to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD. There was no statistically significant association of donor diabetes history with 10-year graft failure, baseline ECD, 10-year ECD, or ECD values longitudinally over time in unadjusted analyses, nor after adjusting for donor age and other significant covariates. The 10-year graft failure rate was 23% in the 199 patients receiving a cornea from a donor with diabetes versus 26% in the 891 patients receiving a cornea from a donor without diabetes (95% confidence interval for the difference, -10% to 6%; unadjusted P=0.60). Baseline ECD (P=0.71), 10-year ECD (P>0.99), and changes in ECD over 10 years (P=0.86) were similar comparing donor groups with and without diabetes. The study results do not suggest an association between donor diabetes and PK outcome. However, the assessment of donor diabetes was imprecise and based on historical data only. The increasing frequency of diabetes in the aging population in the United States affects the donor pool. Thus, the impact of donor diabetes on long-term endothelial health after PK or endothelial keratoplasty, or both, warrants further study with more precise measures of diabetes and its complications. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Safety and immunogenicity of a booster dose of meningococcal (groups A, C, W, and Y) polysaccharide diphtheria toxoid conjugate vaccine.

PubMed

Robertson, Corwin A; Greenberg, David P; Hedrick, James; Pichichero, Michael; Decker, Michael D; Saunders, Martha

2016-10-17

Quadrivalent meningococcal conjugate vaccines (MenACWY) were developed to offer long-term protection against invasive disease caused by serogroups A, C, W, and Y. Reduced MenACWY effectiveness within 5 years after primary vaccination (likely due to declining bactericidal antibody titers) has been described, particularly with respect to C and Y disease in the United States. We evaluated the safety and immunogenicity of a single booster dose of quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine (MenACWY-D) in adolescents and adults who received a previous dose 4-6 years earlier. This phase 2, open-label, multicenter study of 834 persons was conducted in the United States. Participants received a single 0.5-mL booster dose of MenACWY-D. Serogroup-specific bactericidal antibody geometric mean titers (GMTs) were measured with a serum bactericidal antibody assay using human complement (hSBA). Proportions of participants achieving antibody titers of ⩾1:8 for each vaccine serogroup on Days 6 and 28 were determined. Rates of adverse events (AEs), including serious adverse events (SAEs), were also assessed. Before booster vaccination, 38.7-68.5% of participants had an hSBA titer ⩾1:8, depending on vaccine serogroup. By Day 6 post-vaccination, 98.2-99.1% of participants had hSBA titers ⩾1:8. By Day 28, >99% of participants achieved this threshold and the primary hypothesis (lower limit of the one-sided 95% confidence limit ⩾85% for each serogroup) was met. The GMT ratios (post-vaccination divided by pre-vaccination) at Day 28 ranged from 47.2 (serogroup A) to 209.1 (serogroup Y). Rates of AEs, including SAEs, were similar to those observed among adolescents and adults who received a primary dose of MenACWY-D in previous studies. There were no study discontinuations due to an AE and no deaths. Booster vaccination with MenACWY-D was safe and induced robust bactericidal antibody responses, consistent with immune memory, among adolescents and adults 4-6 years after primary vaccination. ClinicalTrials.gov registration: NCT01442675. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Effectiveness and safety of procalcitonin-guided antibiotic therapy in lower respiratory tract infections in "real life": an international, multicenter poststudy survey (ProREAL).

PubMed

Albrich, Werner C; Dusemund, Frank; Bucher, Birgit; Meyer, Stefan; Thomann, Robert; Kühn, Felix; Bassetti, Stefano; Sprenger, Martin; Bachli, Esther; Sigrist, Thomas; Schwietert, Martin; Amin, Devendra; Hausfater, Pierre; Carre, Eric; Gaillat, Jacques; Schuetz, Philipp; Regez, Katharina; Bossart, Rita; Schild, Ursula; Mueller, Beat

2012-05-14

In controlled studies, procalcitonin (PCT) has safely and effectively reduced antibiotic drug use for lower respiratory tract infections (LRTIs). However, controlled trial data may not reflect real life. We performed an observational quality surveillance in 14 centers in Switzerland, France, and the United States. Consecutive adults with LRTI presenting to emergency departments or outpatient offices were enrolled and registered on a website, which provided a previously published PCT algorithm for antibiotic guidance. The primary end point was duration of antibiotic therapy within 30 days. Of 1759 patients, 86.4% had a final diagnosis of LRTI (community-acquired pneumonia, 53.7%; acute exacerbation of chronic obstructive pulmonary disease, 17.1%; and bronchitis, 14.4%). Algorithm compliance overall was 68.2%, with differences between diagnoses (bronchitis, 81.0%; AECOPD, 70.1%; and community-acquired pneumonia, 63.7%; P < .001), outpatients (86.1%) and inpatients (65.9%) (P < .001), algorithm-experienced (82.5%) and algorithm-naive (60.1%) centers (P < .001), and countries (Switzerland, 75.8%; France, 73.5%; and the United States, 33.5%; P < .001). After multivariate adjustment, antibiotic therapy duration was significantly shorter if the PCT algorithm was followed compared with when it was overruled (5.9 vs 7.4 days; difference, -1.51 days; 95% CI, -2.04 to -0.98; P < .001). No increase was noted in the risk of the combined adverse outcome end point within 30 days of follow-up when the PCT algorithm was followed regarding withholding antibiotics on hospital admission (adjusted odds ratio, 0.83; 95% CI, 0.44 to 1.55; P = .56) and regarding early cessation of antibiotics (adjusted odds ratio, 0.61; 95% CI, 0.36 to 1.04; P = .07). This study validates previous results from controlled trials in real-life conditions and demonstrates that following a PCT algorithm effectively reduces antibiotic use without increasing the risk of complications. Preexisting differences in antibiotic prescribing affect compliance with antibiotic stewardship efforts. isrctn.org Identifier: ISRCTN40854211.

The Effect of Donor Diabetes History on Graft Failure and Endothelial Cell Density Ten Years after Penetrating Keratoplasty

PubMed Central

Lass, Jonathan H.; Riddlesworth, Tonya D.; Gal, Robin L.; Kollman, Craig; Benetz, Beth A.; Price, Francis W.; Sugar, Alan; Terry, Mark A.; Soper, Mark; Beck, Roy W.

2014-01-01

Objective To examine the long term effect of donor diabetes history on graft failure and endothelial cell density (ECD) after penetrating keratoplasty (PKP) in the Cornea Donor Study Design Multi-center prospective, double-masked, controlled clinical trial Participants 1090 subjects undergoing PKP for a moderate risk condition, principally Fuchs’ dystrophy or pseudophakic/aphakic corneal edema (PACE), were enrolled by 105 surgeons from 80 clinical sites in the United States. Methods Corneas from donors 12 to 75 years old were assigned by 43 eye banks to participants without respect to recipient factors. Donor and recipient diabetes status was determined from existing medical records. Images of the central endothelium were obtained preoperatively (baseline) and at intervals for ten years postoperatively and analyzed by a central image analysis reading center to determine ECD. Main Outcome Measure(s) Time to graft failure (regraft or cloudy cornea for 3 consecutive months) and ECD. Results There was no statistically significant association of donor diabetes history with 10-year graft failure, baseline ECD, 10-year ECD or ECD values longitudinally over time in unadjusted analyses nor after adjusting for donor age and other significant covariates. The 10-year graft failure rate was 23% in the 199 cases receiving a cornea from a donor with diabetes versus 26% in the 891 cases receiving a cornea from a donor without diabetes (95% confidence interval for the difference: −10% to +6%; unadjusted p = 0.60). Baseline ECD (p=0.71), 10-year ECD (p>0.99), and changes in ECD over 10 years (p=0.86) were similar comparing donor diabetes and no-diabetes groups. Conclusions and Relevance The study results do not suggest an association between donor diabetes and PKP outcome. However, the assessment of donor diabetes was imprecise and based on historical data only. The increasing frequency of diabetes in the aging population in the United States affects the donor pool, thus the impact of donor diabetes on long term endothelial health after penetrating and/or endothelial keratoplasty warrants further study with more precise measures of diabetes and its complications. Trial Registration clinicaltrials.gov NCT00006411 PMID:25439611

22 CFR 1101.2 - Definitions.

Code of Federal Regulations, 2010 CFR

2010-04-01

... Relations INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION... and Mexico. (d) Commissioner means head of the United States Section, International Boundary and Water Commission, United States and Mexico. (e) Individual means a citizen of the United States or an alien...

22 CFR 1103.170 - Compliance procedures.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Foreign Relations INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES... INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION § 1103.170... Mexico, United States Section, The Commons, Building C, Suite 310, 4171 North Mesa, El Paso, Texas 79902...

22 CFR 1101.2 - Definitions.

Code of Federal Regulations, 2014 CFR

2014-04-01

... Relations INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION... and Mexico. (d) Commissioner means head of the United States Section, International Boundary and Water Commission, United States and Mexico. (e) Individual means a citizen of the United States or an alien...

22 CFR 1101.2 - Definitions.

Code of Federal Regulations, 2011 CFR

2011-04-01

... Relations INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION... and Mexico. (d) Commissioner means head of the United States Section, International Boundary and Water Commission, United States and Mexico. (e) Individual means a citizen of the United States or an alien...

22 CFR 1101.2 - Definitions.

Code of Federal Regulations, 2012 CFR

2012-04-01

... Relations INTERNATIONAL BOUNDARY AND WATER COMMISSION, UNITED STATES AND MEXICO, UNITED STATES SECTION... and Mexico. (d) Commissioner means head of the United States Section, International Boundary and Water Commission, United States and Mexico. (e) Individual means a citizen of the United States or an alien...

12 CFR 390.314 - United States Treasury General Account.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 12 Banks and Banking 5 2012-01-01 2012-01-01 false United States Treasury General Account. 390.314... Affecting All State Savings Associations § 390.314 United States Treasury General Account. The term United States Treasury General Account means an account maintained in the name of the United States Treasury the...

7 CFR 1205.313 - United States.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 7 Agriculture 10 2011-01-01 2011-01-01 false United States. 1205.313 Section 1205.313 Agriculture... Research and Promotion Order Definitions § 1205.313 United States. United States means the 50 States of the United States of America. [31 FR 16758, Dec. 31, 1966. Redesignated at 56 FR 64472, Dec. 10, 1991] ...

7 CFR 1205.313 - United States.

Code of Federal Regulations, 2012 CFR

2012-01-01

... 7 Agriculture 10 2012-01-01 2012-01-01 false United States. 1205.313 Section 1205.313 Agriculture... Research and Promotion Order Definitions § 1205.313 United States. United States means the 50 States of the United States of America. [31 FR 16758, Dec. 31, 1966. Redesignated at 56 FR 64472, Dec. 10, 1991] ...

7 CFR 1205.313 - United States.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 7 Agriculture 10 2014-01-01 2014-01-01 false United States. 1205.313 Section 1205.313 Agriculture... Research and Promotion Order Definitions § 1205.313 United States. United States means the 50 States of the United States of America. [31 FR 16758, Dec. 31, 1966. Redesignated at 56 FR 64472, Dec. 10, 1991] ...

12 CFR 390.314 - United States Treasury General Account.

Code of Federal Regulations, 2014 CFR

2014-01-01

... 12 Banks and Banking 5 2014-01-01 2014-01-01 false United States Treasury General Account. 390.314... Affecting All State Savings Associations § 390.314 United States Treasury General Account. The term United States Treasury General Account means an account maintained in the name of the United States Treasury the...

12 CFR 390.314 - United States Treasury General Account.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 12 Banks and Banking 5 2013-01-01 2013-01-01 false United States Treasury General Account. 390.314... Affecting All State Savings Associations § 390.314 United States Treasury General Account. The term United States Treasury General Account means an account maintained in the name of the United States Treasury the...

7 CFR 1205.313 - United States.

Code of Federal Regulations, 2013 CFR

2013-01-01

... 7 Agriculture 10 2013-01-01 2013-01-01 false United States. 1205.313 Section 1205.313 Agriculture... Research and Promotion Order Definitions § 1205.313 United States. United States means the 50 States of the United States of America. [31 FR 16758, Dec. 31, 1966. Redesignated at 56 FR 64472, Dec. 10, 1991] ...

7 CFR 1205.313 - United States.

Code of Federal Regulations, 2010 CFR

2010-01-01

... Research and Promotion Order Definitions § 1205.313 United States. United States means the 50 States of the United States of America. [31 FR 16758, Dec. 31, 1966. Redesignated at 56 FR 64472, Dec. 10, 1991] ... 7 Agriculture 10 2010-01-01 2010-01-01 false United States. 1205.313 Section 1205.313 Agriculture...

31 CFR 592.305 - Importation into the United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false Importation into the United States... General Definitions § 592.305 Importation into the United States. The term importation into the United States means the bringing of goods into the United States. ...

31 CFR 592.305 - Importation into the United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false Importation into the United States... General Definitions § 592.305 Importation into the United States. The term importation into the United States means the bringing of goods into the United States. ...

Rapid induction of single donor chimerism after double umbilical cord blood transplantation preceded by reduced intensity conditioning: results of the HOVON 106 phase II study

PubMed Central

Somers, Judith A.E.; Braakman, Eric; van der Holt, Bronno; Petersen, Eefke J.; Marijt, Erik W.A.; Huisman, Cynthia; Sintnicolaas, Kees; Oudshoorn, Machteld; Groenendijk-Sijnke, Marlies E.; Brand, Anneke; Cornelissen, Jan J.

2014-01-01

Double umbilical cord blood transplantation is increasingly applied in the treatment of adult patients with high-risk hematological malignancies and has been associated with improved engraftment as compared to that provided by single unit cord blood transplantation. The mechanism of improved engraftment is, however, still incompletely understood as only one unit survives. In this multicenter phase II study we evaluated engraftment, early chimerism, recovery of different cell lineages and transplant outcome in 53 patients who underwent double cord blood transplantation preceded by a reduced intensity conditioning regimen. Primary graft failure occurred in one patient. Engraftment was observed in 92% of patients with a median time to neutrophil recovery of 36 days (range, 15–102). Ultimate single donor chimerism was established in 94% of patients. Unit predominance occurred by day 11 after transplantation and early CD4+ T-cell chimerism predicted for unit survival. Total nucleated cell viability was also associated with unit survival. With a median follow up of 35 months (range, 10–51), the cumulative incidence of relapse and non-relapse mortality rate at 2 years were 39% and 19%, respectively. Progressionfree survival and overall survival rates at 2 years were 42% (95% confidence interval, 28–56) and 57% (95% confidence interval, 43–70), respectively. Double umbilical cord blood transplantation preceded by a reduced intensity conditioning regimen using cyclophosphamide/fludarabine/4 Gy total body irradiation results in a high engraftment rate with low non-relapse mortality. Moreover, prediction of unit survival by early CD4+ lymphocyte chimerism might suggest a role for CD4+ lymphocyte mediated unit-versus-unit alloreactivity. www.trialregister.nl NTR1573. PMID:25107890

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the design and operation of multi-center clinical trials: a qualitative research study.

PubMed

Eisenstein, Eric L; Diener, Lawrence W; Nahm, Meredith; Weinfurt, Kevin P

2011-12-01

New technologies may be required to integrate the National Institutes of Health's Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies.

Impact of the Patient-Reported Outcomes Management Information System (PROMIS) upon the Design and Operation of Multi-center Clinical Trials: a Qualitative Research Study

PubMed Central

Diener, Lawrence W.; Nahm, Meredith; Weinfurt, Kevin P.

2013-01-01

New technologies may be required to integrate the National Institutes of Health’s Patient Reported Outcome Management Information System (PROMIS) into multi-center clinical trials. To better understand this need, we identified likely PROMIS reporting formats, developed a multi-center clinical trial process model, and identified gaps between current capabilities and those necessary for PROMIS. These results were evaluated by key trial constituencies. Issues reported by principal investigators fell into two categories: acceptance by key regulators and the scientific community, and usability for researchers and clinicians. Issues reported by the coordinating center, participating sites, and study subjects were those faced when integrating new technologies into existing clinical trial systems. We then defined elements of a PROMIS Tool Kit required for integrating PROMIS into a multi-center clinical trial environment. The requirements identified in this study serve as a framework for future investigators in the design, development, implementation, and operation of PROMIS Tool Kit technologies. PMID:20703765

The reproductive endocrinology of the menopausal transition.

PubMed

Butler, Laura; Santoro, Nanette

2011-06-01

The menopause transition is a dynamic process that begins with the first appearance of menstrual irregularity and ends with a woman's final menstrual period. As ovarian follicle numbers dwindle, the hypothalamic-pituitary-ovarian axis enters a state of compensated failure. In this state, elevated FSH is capable of maintaining relatively regular folliculogenesis and ovulation, but fertility is reduced. Eventually, this state of compensated failure cannot be sustained, and the ovary becomes unable to produce functioning follicles. Recent multicenter studies from several countries have addressed the pattern of change in hormones and a model form reproductive aging has been developed that helps explain the changes in hormone patterns and fertility that accompany menopause. Perhaps more important, the hormonal changes of the menopausal transition may be predictive of future disease risk. This review will undertake an explanation of the current literature on this topic. Copyright © 2011 Elsevier Inc. All rights reserved.

31 CFR 543.310 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 543.310 Section 543.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN....310 United States. The term United States means the United States, its territories and possessions...

31 CFR 543.310 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 543.310 Section 543.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN....310 United States. The term United States means the United States, its territories and possessions...

31 CFR 558.310 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 558.310 Section 558.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN....310 United States. The term United States means the United States, its territories and possessions...

32 CFR 575.6 - Catalogue, United States Military Academy.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 32 National Defense 3 2013-07-01 2013-07-01 false Catalogue, United States Military Academy. 575.6... ADMISSION TO THE UNITED STATES MILITARY ACADEMY § 575.6 Catalogue, United States Military Academy. The latest edition of the catalogue, United States Military Academy, contains additional information...

32 CFR 575.6 - Catalogue, United States Military Academy.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 32 National Defense 3 2011-07-01 2009-07-01 true Catalogue, United States Military Academy. 575.6... ADMISSION TO THE UNITED STATES MILITARY ACADEMY § 575.6 Catalogue, United States Military Academy. The latest edition of the catalogue, United States Military Academy, contains additional information...

31 CFR 543.310 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 543.310 Section 543.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN....310 United States. The term United States means the United States, its territories and possessions...

31 CFR 560.307 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 560.307 Section 560.307 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, including its territories and possessions. ...

31 CFR 543.310 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 543.310 Section 543.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN....310 United States. The term United States means the United States, its territories and possessions...

31 CFR 560.307 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 560.307 Section 560.307 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, including its territories and possessions. ...

32 CFR 575.6 - Catalogue, United States Military Academy.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 32 National Defense 3 2010-07-01 2010-07-01 true Catalogue, United States Military Academy. 575.6... ADMISSION TO THE UNITED STATES MILITARY ACADEMY § 575.6 Catalogue, United States Military Academy. The latest edition of the catalogue, United States Military Academy, contains additional information...

31 CFR 547.310 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 547.310 Section 547.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 547.310 United States. The term United States means the United States, its...

31 CFR 575.319 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 575.319 Section 575.319 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....319 United States. The term United States means the United States, its territories and possessions...

31 CFR 548.310 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 548.310 Section 548.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....310 United States. The term United States means the United States, its territories and possessions...

31 CFR 539.312 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 539.312 Section 539.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 539.312 United States. The term United States means the United States, its...

31 CFR 551.309 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 551.309 Section 551.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....309 United States. The term United States means the United States, its territories and possessions...

31 CFR 587.310 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 587.310 Section 587...) MILOSEVIC SANCTIONS REGULATIONS General Definitions § 587.310 United States. The term United States means the United States, its territories and possessions, and all areas under the jurisdiction or authority...

31 CFR 585.316 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 585.316 Section 585.316 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF... General Definitions § 585.316 United States. The term United States means the United States, its...

31 CFR 586.318 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 586.318 Section 586...) KOSOVO SANCTIONS REGULATIONS General Definitions § 586.318 United States. The term United States means the United States, its territories and possessions, and all areas under the jurisdiction or authority...

31 CFR 542.310 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 542.310 Section 542.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....310 United States. The term United States means the United States, its territories and possessions...

31 CFR 537.318 - United States.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States. 537.318 Section 537.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF....318 United States. The term United States means the United States, its territories and possessions...

31 CFR 596.313 - United States person.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false United States person. 596.313 Section... FOREIGN ASSETS CONTROL, DEPARTMENT OF THE TREASURY TERRORISM LIST GOVERNMENTS SANCTIONS REGULATIONS General Definitions § 596.313 United States person. The term United States person means any United States...

The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

PubMed

Wilt, Timothy J

2012-12-01

Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason histologic grade, and tumor stage, it was found that approximately 40% had low-risk, 34% had medium-risk, and 21% had high-risk prostate cancer based on local histopathology. Comparison to our national sample of eligible men declining PIVOT participation as well as to men enrolled in the Scandinavian trial indicated that PIVOT enrollees are representative of men being diagnosed and treated in the United States and quite different from men in the Scandinavian trial. PIVOT enrolled an ethnically diverse population representative of men diagnosed with prostate cancer in the United States. Results will yield important information regarding the relative effectiveness and harms of surgery compared with WW for men with predominately PSA-detected clinically localized prostate cancer.

22 CFR 46.3 - Aliens whose departure is deemed prejudicial to the interests of the United States.

Code of Federal Regulations, 2010 CFR

2010-04-01

... United States or the United Nations for the defense of any other country. (c) Any alien who seeks to... Forces of the United States and who fails to present a Registration Certificate (SSS Form No. 2) showing... defensive operations of the United States or of any nation cooperating with the United States in the...

31 CFR 562.309 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 562.309 Section 562.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 562.309 United States. The term United States means the United States, its territories and...

31 CFR 538.314 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 538.314 Section 538.314 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 540.313 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 540.313 Section 540.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... REGULATIONS General Definitions § 540.313 United States. The term United States means the United States, its...

31 CFR 544.310 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 544.310 Section 544.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... REGULATIONS General Definitions § 544.310 United States. The term United States means the United States, its...

31 CFR 539.312 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 539.312 Section 539.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 539.312 United States. The term United States means the United States, its territories and...

31 CFR 548.310 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 548.310 Section 548.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 590.312 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 590.312 Section 590.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... General Definitions § 590.312 United States. The term United States means the United States, its...

31 CFR 598.317 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 598.317 Section 598.317 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 598.317 United States. The term United States means the United States, its territories and...

31 CFR 542.310 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 542.310 Section 542.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 560.307 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 560.307 Section 560.307 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 560.307 United States. The term United States means the United States, its territories and...

31 CFR 594.313 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 594.313 Section 594.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... § 594.313 United States. The term United States means the United States, its territories and possessions...

31 CFR 536.315 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 536.315 Section 536.315 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 536.315 United States. The term United States means the United States, its territories and...

31 CFR 588.309 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 588.309 Section 588.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... § 588.309 United States. The term United States means the United States, its territories and possessions...

31 CFR 551.309 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 551.309 Section 551.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 536.315 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 536.315 Section 536.315 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 536.315 United States. The term United States means the United States, its territories and...

31 CFR 546.310 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 546.310 Section 546.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 536.315 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 536.315 Section 536.315 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 536.315 United States. The term United States means the United States, its territories and...

31 CFR 590.312 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 590.312 Section 590.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... General Definitions § 590.312 United States. The term United States means the United States, its...

31 CFR 548.310 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 548.310 Section 548.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 551.309 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 551.309 Section 551.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 539.312 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 539.312 Section 539.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 539.312 United States. The term United States means the United States, its territories and...

31 CFR 596.312 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 596.312 Section 596.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 596.312 United States. The term United States means the United States, including its territories...

31 CFR 570.311 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 570.311 Section 570.311 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 546.310 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 546.310 Section 546.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 576.315 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 576.315 Section 576.315 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... General Definitions § 576.315 United States. The term United States means the United States, its...

31 CFR 540.313 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 540.313 Section 540.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... REGULATIONS General Definitions § 540.313 United States. The term United States means the United States, its...

31 CFR 562.309 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 562.309 Section 562.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 562.309 United States. The term United States means the United States, its territories and...

31 CFR 570.311 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 570.311 Section 570.311 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 552.309 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 552.309 Section 552.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 542.310 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 542.310 Section 542.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 537.318 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 537.318 Section 537.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

39 CFR 221.1 - The United States Postal Service.

Code of Federal Regulations, 2010 CFR

2010-07-01

... 39 Postal Service 1 2010-07-01 2010-07-01 false The United States Postal Service. 221.1 Section 221.1 Postal Service UNITED STATES POSTAL SERVICE ORGANIZATION AND ADMINISTRATION GENERAL ORGANIZATION § 221.1 The United States Postal Service. The United States Postal Service was established as an...

31 CFR 596.312 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 596.312 Section 596.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 596.312 United States. The term United States means the United States, including its territories...

31 CFR 539.312 - United States.

Code of Federal Regulations, 2012 CFR

2012-07-01

... 31 Money and Finance:Treasury 3 2012-07-01 2012-07-01 false United States. 539.312 Section 539.312 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 539.312 United States. The term United States means the United States, its territories and...

31 CFR 576.315 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 576.315 Section 576.315 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... General Definitions § 576.315 United States. The term United States means the United States, its...

31 CFR 562.309 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 562.309 Section 562.309 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 562.309 United States. The term United States means the United States, its territories and...

31 CFR 595.314 - United States.

Code of Federal Regulations, 2011 CFR

2011-07-01

... 31 Money and Finance:Treasury 3 2011-07-01 2011-07-01 false United States. 595.314 Section 595.314 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 540.313 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 540.313 Section 540.313 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... REGULATIONS General Definitions § 540.313 United States. The term United States means the United States, its...

31 CFR 598.317 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 598.317 Section 598.317 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 598.317 United States. The term United States means the United States, its territories and...

31 CFR 541.310 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 541.310 Section 541.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 537.318 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 537.318 Section 537.318 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 598.317 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 598.317 Section 598.317 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... Definitions § 598.317 United States. The term United States means the United States, its territories and...

31 CFR 570.311 - United States.

Code of Federal Regulations, 2013 CFR

2013-07-01

... 31 Money and Finance:Treasury 3 2013-07-01 2013-07-01 false United States. 570.311 Section 570.311 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...

31 CFR 548.310 - United States.

Code of Federal Regulations, 2014 CFR

2014-07-01

... 31 Money and Finance:Treasury 3 2014-07-01 2014-07-01 false United States. 548.310 Section 548.310 Money and Finance: Treasury Regulations Relating to Money and Finance (Continued) OFFICE OF FOREIGN... United States. The term United States means the United States, its territories and possessions, and all...