scholarly journals 1433. Impact of 2019 US Food and Drug Administration (FDA) Guidance on Developing Drugs for Urinary Tract Infection (UTI) on the Perceived Efficacy of Antibiotics for the Treatment of Uncomplicated UTI (uUTI)

2021 ◽  
Vol 8 (Supplement_1) ◽  
pp. S798-S798
Author(s):  
Anne Santerre Henriksen ◽  
Lindsay Nicolle ◽  
Anita F Das

Abstract Background In 2019, the FDA issued guidance on drug development for treatment of UTIs. To explore the impact of this guidance, we compared clinical and microbiological outcomes of the fluoroquinolones norfloxacin and ciprofloxacin and the β-lactams pivmecillinam and sulopenem for treatment of uUTIs from original publications versus recent analyses conducted in accordance with the FDA guidance. Methods The efficacy of pivmecillinam 400 mg twice daily (BID), 3 days (3d) versus norfloxacin 400 mg BID, 3d was reported in a 2002 publication. Patient-level data were used to re-analyze clinical and microbiological outcomes in the microbiological intent-to-treat population in accordance with the 2019 FDA guidance. For descriptive comparison, we present the efficacy of ciprofloxacin 250 mg BID, 3d vs sulopenem 500 mg BID, 5d in the 2020 SURE-1 trial (also conducted in accordance with FDA guidance) alongside historical efficacy data for ciprofloxacin. Results Re-analysis of data from the trial of pivmecillinam and norfloxacin showed microbiological responses for pivmecillinam and norfloxacin of 64% and 79%, respectively. Microbiological responses were higher, 75% for pivmecillinam and 91% for norfloxacin, in the original analysis. For clinical response, re-analysis showed 75% for pivmecillinam and 88% for norfloxacin, while historical data were 82% and 88%, respectively. In the SURE-1 trial, the microbiological response of patients assessed at Day 12 was 76.6% for sulopenem and 79.1% for ciprofloxacin. In a 2002 publication, bacterial eradication at 4 to 11 days after treatment was 93.7% for ciprofloxacin 250 mg, a higher response rate than that reported in SURE-1. For clinical response, rates were 78.7% for ciprofloxacin in SURE-1 and 92.7% for the historical ciprofloxacin data. Conclusion When assessed in accordance with the 2019 FDA guidance, clinical and microbiological efficacy of both fluoroquinolones and β-lactam antibiotics appears lower than has been published in the past. Healthcare providers should be aware that newer antibiotics may appear to have a lower efficacy than older antibiotics due to the application of more stringent definitions in the FDA guidance. Disclosures Anne Santerre Henriksen, MS, Advanz (Consultant)Shionogi BV (Consultant)UTILITY Therapeutics (Consultant) Lindsay Nicolle, MD, Entos (Consultant)GSK (Consultant)Iterum (Consultant)Utility Therapeutics (Consultant) Anita F. Das, PhD, Adagio Therapeutics, Inc. (Consultant)

2021 ◽  
Vol 14 (8) ◽  
pp. 67
Author(s):  
Ashraf Elsafty ◽  
Mohammad Ragheb

HRM has a significant role in motivating the employees and ensuring that every employee is satisfied with the HR practices. Healthcare providers have been facing stress and depression especially in Egypt, due to COVID-19. In this country, the healthcare providers are looking for alternatives to achieve satisfaction as COVID-19 has affected their jobs, salaries, incentives, and bonuses. The past studies have focused on assessing the HRM’s role in employee retention and satisfaction during the COVID-19 pandemic in Egypt. The past research discussed the impact of motivation, incentives, and rewards on the employees’ motivation. This study focused on evaluating the role of HRM towards the healthcare providers' retention during COVID-19 in Egypt. This study relied on the quantitative approach for achieving the findings and conclusion. The sample size of the study involved 120 healthcare providers working in different hospitals. The results revealed that intrinsic motivation, rewards, incentives, monetary benefits, and non-monetary benefits have an essential role in maintaining the healthcare providers during COVID-19. It is concluded that HR can play a significant role in retaining key healthcare providers in COVID-19. The elements including intrinsic motivation, incentives, non-monetary, and monetary benefits can play a significant part in retaining healthcare providers. HR departments should focus on releasing salaries on time, providing specific bonuses, and providing incentives to healthcare providers whenever they perform at their best level.


2014 ◽  
Vol 6 (4) ◽  
pp. 137-146
Author(s):  
Anastasia Victorovna Ekimova

The article investigates numerous methods of representation of the past in contemporary TV-mocumentary exemplified by the series about British farming (British Farm). Despite the apparent authenticity of the television image, the attraction of the authors to usage of the on-screen real historical objects and documents reinforcing the narrative by opinions of noted experts, one cannot admit authenticity of the realm represented. The information in such historical series is often presented as a phenomenon, the task of which is rather to hide the true reality, than to represent it. Instead of reconstructing history through artistic means of docudrama, the TV-series mostly create it. For this purpose, effective techniques of artificial dramatization as a synthesis of live sound, vivid images, voiceover and an unusual angle are employed. The author considers the level of relations in contemporary screen document of historical data and pseudo household facts, interesting for the average viewer; knowledge of professional historians, based on authentic sources and documents, and the attraction of mass audience to myth and speculation, taking up science as entertainment. The relevance of this work is sustained by the growing influence of mass culture on contemporary TV, including documentary projects, which leads to the standardization of the screen document. The novelty of the article consists in the analysis of juxtaposition of the techniques of journalism and feature cinema in TV-series, and the impact of these combinations on the balance between the educational and entertaining components in the TV historic series.


Author(s):  
Edward J. Lusk

Univariate Time Series Models [TSM] use only a Panel of historical data to produce forecasts. The tacit belief in using TSM is that the past information portends the future of the longitudinal data-stream. This is likely in certain cases such as strictly Ergodic Panel segments of sufficient size in the overall Panel. A question of interest is: Is the success of TSM in these contexts generalizable? The test of this question used a Litmus-Test design to examine the performance profile of TSM for a longitudinal time series the last point of which is a Turning Point [TP]. Specifically, the inference measure will use the Relative Absolute Error [RAE] of the TSM tested over three forecasting horizons. In this testing, five TSM configurations were employed; the TPs are identified using a fixed screening filter applied to randomly selected firm Panels actively traded on the S&P500 from 2005 through 2013.  There is no evidence that any of the five TSM outperformed the RW model which is incidentally the TP. The impact of these results is that one cannot assume that the effectiveness of TSM generalizes to all domains—in particular—forecasting after TPs that seems to be a Domain Lacuna where the effectiveness of TSM will be compromised.


2020 ◽  
Vol 2 ◽  
pp. 92-95
Author(s):  
Hajar Bouali ◽  
Melody Okereke ◽  
Yusuff Adebayo Adebisi ◽  
Don Eliseo Lucero-Prisno III

Morocco, home to nearly 36 million inhabitants has undergone demographic and epidemiological transitions over the past 50 years. Alongside this transition is the prevalence of Non-Communicable Diseases (NCDs) which has also risen substantially and has contributed remarkably to the rise in the population's need for healthcare services. In order to respond to the increasing healthcare needs of the Moroccan population, it is necessary to ensure that healthcare providers are readily accessible and sufficient. As one of the most accessible healthcare providers, pharmacists are well positioned to address these demands. It is therefore essential to build a competent pharmaceutical workforce in Morocco with a specialized focus on pharmacy education and training. However, the education and training of pharmacy students in the country has been grossly disrupted by the present COVID-19 pandemic. In this paper, we examine the impact of the COVID-19 pandemic on pharmacy education in Morocco. The net impact of this unprecedented pandemic on pharmacy education in Morocco has become well pronounced with a lot of accompanying challenges. If not addressed, the results in the long-run may be devastating. Doi: 10.28991/SciMedJ-2020-02-SI-8 Full Text: PDF


2000 ◽  
Vol 9 (1) ◽  
pp. 71-81 ◽  
Author(s):  
ROBYN S. SHAPIRO ◽  
KRISTEN A. TYM ◽  
JEFFREY L. GUDMUNDSON ◽  
ARTHUR R. DERSE ◽  
JOHN P. KLEIN

Over the past several years, healthcare has been profoundly altered by the growth of managed care. Because managed care integrates the financing and delivery of healthcare services, it dramatically alters the roles and relationships among providers, payers, and patients. While analysis of this change has focused on whether and how managed care can control costs, an increasingly important concern among healthcare providers and recipients is the impact of managed care on the physician–patient relationship. The literature includes a number of theoretical articles and anecdotal accounts of managed care's impact on the doctor–patient relationship, but little data have been collected and analyzed. We designed a survey for distribution to Wisconsin physicians to analyze the prevalence and types of managed care arrangements in the state, and the impact of these arrangements on physicians and their relationships with patients.


2010 ◽  
Vol 29-32 ◽  
pp. 2794-2798
Author(s):  
Wei Guo Zhao ◽  
Li Ying Wang

In this paper, prediction system is developed based on a fuzzy neural network(FNN) by using the past groundwater level data to discover fuzzy rules and make future predictions. The learning algorithm is implemented to the past historical data. Compared to other predictors, our results show that the FNN predictor can reduce significantly both relative mean errors and root mean squared errors of predicted groundwater level. It is demonstrated that FNN performs well for groundwater data analysis and its feasibility of applying FNN to groundwater level prediction.


2004 ◽  
Vol 80 (4) ◽  
pp. 469-472
Author(s):  
Rémi Hébert

Permanent sampling plots in experimental forests have generated large quantities of data over the past decades. Methods used to collect certain of these data have often varied over the course of the sampling. The objective of this study was to develop a process to evaluate sampling differences in historical forest data. The proposed approach is to: (1) examine available data and seek out the missing ones in archives of the concerned organizations; (2) regroup data by inventory periods; (3) search for the sampling methodology in each of the different inventory periods; and (4) evaluate the impact of differences in methodology on data continuity. When using this approach on the historical data of the Lake Edward experimental forest, we were able to better define the strengths and the weaknesses of the database. Key words: forest inventories, La Mauricie National Park, permanent sample plots, regeneration inventories


Author(s):  
Leslie M. Loew

A major application of potentiometric dyes has been the multisite optical recording of electrical activity in excitable systems. After being championed by L.B. Cohen and his colleagues for the past 20 years, the impact of this technology is rapidly being felt and is spreading to an increasing number of neuroscience laboratories. A second class of experiments involves using dyes to image membrane potential distributions in single cells by digital imaging microscopy - a major focus of this lab. These studies usually do not require the temporal resolution of multisite optical recording, being primarily focussed on slow cell biological processes, and therefore can achieve much higher spatial resolution. We have developed 2 methods for quantitative imaging of membrane potential. One method uses dual wavelength imaging of membrane-staining dyes and the other uses quantitative 3D imaging of a fluorescent lipophilic cation; the dyes used in each case were synthesized for this purpose in this laboratory.


GeroPsych ◽  
2011 ◽  
Vol 24 (3) ◽  
pp. 143-154 ◽  
Author(s):  
Elmar Gräßel ◽  
Raffaela Adabbo

The burden of caregivers has been intensively researched for the past 30 years and has resulted in a multitude of individual findings. This review illustrates the significance of the hypothetical construct of perceived burden for the further development and design of the homecare situation. Following explanations regarding the term informal caregiver, we derive the construct burden from its conceptual association with the transactional stress model of Lazarus and Folkman. Once the extent and characteristics of burden have been set forth, we then present the impact of perceived burden as the care situation. The question of predictors of burden will lead into the last section from which implications can be derived for homecare and relief of caregivers.


2004 ◽  
Vol 34 (136) ◽  
pp. 339-356
Author(s):  
Tobias Wölfle ◽  
Oliver Schöller

Under the term “Hilfe zur Arbeit” (aid for work) the federal law of social welfare subsumes all kinds of labour disciplining instruments. First, the paper shows the historical connection of welfare and labour disciplining mechanisms in the context of different periods within capitalist development. In a second step, against the background of historical experiences, we will analyse the trends of “Hilfe zur Arbeit” during the past two decades. It will be shown that by the rise of unemployment, the impact of labour disciplining aspects of “Hilfe zur Arbeit” has increased both on the federal and on the municipal level. For this reason the leverage of the liberal paradigm would take place even in the core of social rights.


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