Abstract TP132: Selection and Activation of Sites in a Large Multi-Center Randomized Clinical Trial

Stroke ◽  
2017 ◽  
Vol 48 (suppl_1) ◽  
Author(s):  
Bart M Demaerschalk ◽  
Robert D Brown ◽  
Virginia J Howard ◽  
MeeLee Tom ◽  
Mary E Longbottom ◽  
...  
Keyword(s):  
Site Selection ◽  
Performance Metrics ◽  
Interventional Neuroradiology ◽  
Interquartile Range ◽  
Carotid Revascularization ◽  
Training Requirements ◽  
Medical Centers ◽  
Wide Range ◽  
The Times ◽  
And Training

Introduction: Careful selection and timely activation of clinical sites in multicenter clinical trials is critical for successful enrollment, subject safety, and generalizability of results. Methods: In the Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2), a multidisciplinary Site Selection Committee evaluated applicants referred via participation in CREST, CREST principal investigators (PIs) and other investigators, StrokeNet and industry partners. Data for consideration included performance metrics in CREST and other carotid trials and a site selection questionnaire containing information on the investigators as well as quantitative data on carotid procedures performed. Any FDA warning letters were reviewed. Results: The Committee met bi-weekly for 36 months (n=64 meetings). Applications from 176 sites between March 2014 and July 2016 were evaluated: 153 were approved, 7 are under Committee review, 5 were approved but withdrew, 5 were placed on a waiting list, and 6 were rejected. One-hundred-four sites have completed the regulatory and training requirements to randomize: 51 (49%) academic medical centers, 31 (30%) private hospital-based centers, 16 (15%) private office-based practices, and 6 (6%) Veterans Administration medical centers. The mean times from application-to- approval was 5.2 weeks (interquartile range, 1.9, 6.2), and from approval-to-randomization status was 46.7 weeks (interquartile range, 35.4, 51.7). Specialties of the 104 site PIs are vascular surgery for 35 (33.7%), cardiology for 30 (28.8%), neurology for 25 (24%), neurosurgery for 8 (7.7%), interventional radiology for 4 (3.8%), and interventional neuroradiology for 2 (1.9%). Conclusions: Careful site selection is time-consuming for prospective sites and for trial leadership. Times from application-to-site-approval were modest (mean = 5.2 weeks), in contrast to the times for completing regulatory and training requirements (mean = 46.7 weeks). However, subject enrollment by teams from a wide range of medical centers led by a multi-disciplinary cohort of PIs will promote the generalizability of trial results.

Cardiology Fellowship Education in the Era of High-density Training, Data Tracking, and Quality Measures

2011 ◽  
Vol 9 (2) ◽  
pp. 99
Author(s):  
Alex J Auseon ◽  
Albert J Kolibash ◽  
◽  
Keyword(s):  
Ohio State University ◽  
Training Data ◽  
State University ◽  
Training Requirements ◽  
Healthcare Environment ◽  
Medical Centers ◽  
Work Hour ◽  
The Ohio State University ◽  
Data Tracking

Background:Educating trainees during cardiology fellowship is a process in constant evolution, with program directors regularly adapting to increasing demands and regulations as they strive to prepare graduates for practice in today’s healthcare environment.Methods and Results:In a 10-year follow-up to a previous manuscript regarding fellowship education, we reviewed the literature regarding the most topical issues facing training programs in 2010, describing our approach at The Ohio State University.Conclusion:In the midst of challenges posed by the increasing complexity of training requirements and documentation, work hour restrictions, and the new definitions of quality and safety, we propose methods of curricula revision and collaboration that may serve as an example to other medical centers.

scholarly journals Gene Expression Space Shapes the Bioprocess Trade-Offs among Titer, Yield and Productivity

2021 ◽  
Vol 11 (13) ◽  
pp. 5859
Author(s):  
Fernando N. Santos-Navarro ◽  
Yadira Boada ◽  
Alejandro Vignoni ◽  
Jesús Picó
Keyword(s):  
Gene Expression ◽  
Gene Transcription ◽  
Performance Metrics ◽  
Cell Mass ◽  
Gene Copy ◽  
Substrate Uptake ◽  
Promoter Strength ◽  
Expression Levels ◽  
Trade Offs ◽  
Wide Range

Optimal gene expression is central for the development of both bacterial expression systems for heterologous protein production, and microbial cell factories for industrial metabolite production. Our goal is to fulfill industry-level overproduction demands optimally, as measured by the following key performance metrics: titer, productivity rate, and yield (TRY). Here we use a multiscale model incorporating the dynamics of (i) the cell population in the bioreactor, (ii) the substrate uptake and (iii) the interaction between the cell host and expression of the protein of interest. Our model predicts cell growth rate and cell mass distribution between enzymes of interest and host enzymes as a function of substrate uptake and the following main lab-accessible gene expression-related characteristics: promoter strength, gene copy number and ribosome binding site strength. We evaluated the differential roles of gene transcription and translation in shaping TRY trade-offs for a wide range of expression levels and the sensitivity of the TRY space to variations in substrate availability. Our results show that, at low expression levels, gene transcription mainly defined TRY, and gene translation had a limited effect; whereas, at high expression levels, TRY depended on the product of both, in agreement with experiments in the literature.

scholarly journals Validation and standardization of DNA extraction and library construction methods for metagenomics-based human fecal microbiome measurements

Microbiome ◽  
2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Dieter M. Tourlousse ◽  
Koji Narita ◽  
Takamasa Miura ◽  
Mitsuo Sakamoto ◽  
Akiko Ohashi ◽  
...  
Keyword(s):  
Dna Extraction ◽  
High Throughput Sequencing ◽  
Performance Metrics ◽  
Collaborative Study ◽  
Human Microbiome ◽  
Second Phase ◽  
Intermediate Precision ◽  
Fecal Microbiome ◽  
Library Construction ◽  
Wide Range

Abstract Background Validation and standardization of methodologies for microbial community measurements by high-throughput sequencing are needed to support human microbiome research and its industrialization. This study set out to establish standards-based solutions to improve the accuracy and reproducibility of metagenomics-based microbiome profiling of human fecal samples. Results In the first phase, we performed a head-to-head comparison of a wide range of protocols for DNA extraction and sequencing library construction using defined mock communities, to identify performant protocols and pinpoint sources of inaccuracy in quantification. In the second phase, we validated performant protocols with respect to their variability of measurement results within a single laboratory (that is, intermediate precision) as well as interlaboratory transferability and reproducibility through an industry-based collaborative study. We further ascertained the performance of our recommended protocols in the context of a community-wide interlaboratory study (that is, the MOSAIC Standards Challenge). Finally, we defined performance metrics to provide best practice guidance for improving measurement consistency across methods and laboratories. Conclusions The validated protocols and methodological guidance for DNA extraction and library construction provided in this study expand current best practices for metagenomic analyses of human fecal microbiota. Uptake of our protocols and guidelines will improve the accuracy and comparability of metagenomics-based studies of the human microbiome, thereby facilitating development and commercialization of human microbiome-based products.

scholarly journals Design and Evaluation of Large-Scale IoT-Enabled Healthcare Architecture

2021 ◽  
Vol 11 (8) ◽  
pp. 3623
Author(s):  
Omar Said ◽  
Amr Tolba
Keyword(s):  
Packet Loss ◽  
Large Scale ◽  
Performance Metrics ◽  
Medical System ◽  
Healthcare Data ◽  
High Altitude Platforms ◽  
Wide Range ◽  
Simulation Results ◽  
Healthcare Architecture ◽  
The Internet Of Things

Employment of the Internet of Things (IoT) technology in the healthcare field can contribute to recruiting heterogeneous medical devices and creating smart cooperation between them. This cooperation leads to an increase in the efficiency of the entire medical system, thus accelerating the diagnosis and curing of patients, in general, and rescuing critical cases in particular. In this paper, a large-scale IoT-enabled healthcare architecture is proposed. To achieve a wide range of communication between healthcare devices, not only are Internet coverage tools utilized but also satellites and high-altitude platforms (HAPs). In addition, the clustering idea is applied in the proposed architecture to facilitate its management. Moreover, healthcare data are prioritized into several levels of importance. Finally, NS3 is used to measure the performance of the proposed IoT-enabled healthcare architecture. The performance metrics are delay, energy consumption, packet loss, coverage tool usage, throughput, percentage of served users, and percentage of each exchanged data type. The simulation results demonstrate that the proposed IoT-enabled healthcare architecture outperforms the traditional healthcare architecture.

scholarly journals Performance of the Precipitation Occurrence Sensor System as a Precipitation Gauge

2008 ◽  
Vol 25 (2) ◽  
pp. 196-212 ◽  
Author(s):  
B. E. Sheppard ◽  
P. I. Joe
Keyword(s):  
Interquartile Range ◽  
Sensor System ◽  
Precipitation Rate ◽  
Doppler Velocity ◽  
High Temporal Resolution ◽  
Velocity Spectrum ◽  
Ratio Distribution ◽  
Precipitation Occurrence ◽  
Solid Precipitation ◽  
Wide Range

Abstract The Precipitation Occurrence Sensor System (POSS) is a small X-band Doppler radar originally developed by the Meteorological Service of Canada for reporting the occurrence, type, and intensity of precipitation from Automated Weather Observing Stations. This study evaluates POSS as a gauge for measuring amounts of both liquid and solid precipitation. Different precipitation rate estimation algorithms are described. The effect of different solid precipitation types on the Doppler velocity spectrum is discussed. Lacking any accepted reference for high temporal resolution rates, the POSS precipitation rate measurements are integrated over time periods ranging from 6 h to one day and validated against international and Canadian reference gauges. Data from a wide range of sites across Canada and for periods of several years are used. The statistical performance of POSS is described in terms of the distribution of ratios of POSS to reference gauge amounts (catch ratios). In liquid precipitation the median of the catch ratio distribution is 82% and the interquartile range was between −12% and 19% about the median. In solid precipitation the median is 90% and the interquartile range is between −17% and 24% about the median. The underestimation in both liquid and solid precipitation is shown to be a function of precipitation rate and phase. The effects of radome wetting, raindrop splashing, wind, and the radar “brightband” effect on the estimation of precipitation rates are discussed.

The futures of the University of Tehran using causal layered analysis

foresight ◽  
2018 ◽  
Vol 20 (4) ◽  
pp. 393-415 ◽  
Author(s):  
Mohammadali Baradaran Ghahfarokhi ◽  
Ali Mohaghar ◽  
Fatemeh Saghafi
Keyword(s):  
Higher Education ◽  
Current System ◽  
Content Type ◽  
Balance Sheets ◽  
Master Plans ◽  
Wide Range ◽  
The Future ◽  
Causal Layered Analysis ◽  
The Times ◽  
The University

PurposeHigher education and universities have faced unprecedented and ubiquitous changes. The University of Tehran or “UT,” as the leading university in Iran, is not immune to these changes. The purposes of this study is to investigate the current situation and future of the UT and gain insights and possible responses to changes that suit its strengths and potential to progress in an increasingly competitive, complex environment with uncertainties. It identifies deep fundamental underpinnings of the issue and highlights them for policymakers to formulate strategies and future vision of the UT.Design/methodology/approachCausal layered analysis (CLA) was applied as a framework and the data collected from different sources such as literature reviews, content analysis of rules, regulations and master plans of the university and coded interviews of four different groups of university stakeholders were analyzed. The current system of UT, as well as hidden beliefs, that maintains traditional perceptions about university was mapped. Next, by applying a new recursive process and reverse CLA order, new CLA layers extracted through an expert panel, the layers of CLA based on new metaphors to envision future of UT were backcasted.FindingsThe results from CLA layers including litany, system, worldview and metaphor about the current statue of UT show disinterest and inertia against changes, conservative, behind the times and traditional perceptions, and indicate that the UT system is mismatched to the needs of society and stakeholders in the future. The authors articulated alternative perspectives deconstructed from other worldviews so there are new narratives that reframe the issues at hand. The results show that to survive in this fast-paced revolution and competition in higher education, UT should develop scenarios and formulate new strategies.Research limitations/implicationsThe authors had limited access to a wide range of stakeholders. As the UT is a very big university with so many faculties and departments, to access a pool of experts and top policymakers who were so busy and did not have time to interview inside and outside of university was very hard for the research team. The authors also had limitation to access the internal enactments and decisions of the trustee board of the UT and the financial balance sheets of the university.Originality/valueIn this paper, by mixing different methods of futures studies, the authors have shown how to move forward while understanding the perspectives of stakeholders about the future of UT by a new recursive process and reverse CLA order. A supplementary phase was added to improve CLA and to validate the method and results, which were ignored in previous studies.

The Effect of Concealed Handgun Carry Deregulation in Arizona on Crime in Tucson

2018 ◽  
Vol 30 (8) ◽  
pp. 1186-1203 ◽  
Author(s):  
Michael R. Smith ◽  
Matthew Petrocelli
Keyword(s):  
El Paso ◽  
Future Research ◽  
Multiple Time ◽  
Multiple Time Series ◽  
Training Requirements ◽  
State Adoption ◽  
Concealed Carry ◽  
And Control ◽  
The Impact ◽  
And Training

In 2010, the Arizona legislature effectively deregulated concealed handgun carry in the state by passing Senate Bill (SB) 1108, which eliminated licensing and training requirements for concealed carry. Although researchers have extensively examined the impact of state adoption of concealed carry laws, almost nothing is known about the effects of deregulating concealed carry altogether. This study contributes to the more guns, less crime debate by examining the impact of Arizona’s decision to deregulate concealed carry. Using a multiple time-series research design with an experimental (Tucson) and control city (El Paso), the present study examines the impact of deregulation on handgun-related violent crime and gun larcenies in Arizona’s second largest city—Tucson. We find that the passage of SB 1108 had no impact on handgun-related offenses that could be expected to change following deregulation. The implications of these findings for policy making and future research are discussed.

Pharmacy Technician Educators' Attitudes toward Education and Training Requirements for Pharmacy Technicians

2000 ◽  
Vol 16 (4) ◽  
pp. 133-137 ◽  
Author(s):  
Kathy D Moscou
Keyword(s):  
Response Rate ◽  
Training Programs ◽  
Education And Training ◽  
Level Of Education ◽  
Training Requirements ◽  
Pharmacy Technician ◽  
National Examination ◽  
Pharmacy Technicians ◽  
And Training

Objective: To poll members of the Pharmacy Technician Educators Council (PTEC) to determine their attitudes toward the level of education and training necessary for pharmacy technicians to perform current and expanded duties. Methods: A convenience survey was developed and sent to 130 PTEC member training programs. PTEC members include directors of college, vocational, and on-the-job training programs. Results: Thirty-seven PTEC members responded, yielding a response rate of 28.5%. Responses reflected the opinions of directors of pharmacy technician programs from 19 states. All respondents agreed that the length of training for pharmacy technicians should be standardized. They also agreed that minimum competencies should be established for pharmacy technicians and that examination should be required to obtain certification or licensure that would then enable the technician to be employed in the field. Conclusions: The use of pharmacy technicians will likely increase, as will the duties pharmacy technicians perform. Expansion of the role of pharmacy technicians, however, must be in tandem with standardizing training and establishment of competencies for pharmacy technicians. Increased responsibilities should be commensurate with increased education and national examination should be required to determine competency.

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