Best Practices for Improving the Quality of Individual Case Safety Reports in Pharmacovigilance

2016 ◽  
Vol 50 (4) ◽  
pp. 464-471 ◽  
Author(s):  
Rishi Kumar ◽  
Pranay Kumar ◽  
Vivekanandan Kalaiselvan ◽  
Ismeet Kaur ◽  
G. N. Singh
Author(s):  
Olha Pavlenko

The article discusses the current state of professional training of engineers, in particular, electronics engineers in Ukrainian higher education institutions (HEIs) and explores best practices from US HEIs. The research outlines the features of professional training of electronics engineers and recent changes in Ukrainian HEIs. Such challenges for Ukrainian HEIs as lack of collaboration between higher education and science with industry, R&D cost reduction for HEIs, and downsizing the research and academic staff, the disparity between the available quality of human capital training and the demanded are addressed. The study attempts to identify successful practices of US HEIs professional training of engineers in order to suggest potential improvements in education, research, and innovation for training electronics engineers in Ukraine.


2018 ◽  
Vol 47 (3) ◽  
pp. 303-317
Author(s):  
H.M. Bowers ◽  
A.L. Wroe

Background: Previous research suggests benefits of targeting beliefs about the unacceptability of emotions in treatment for irritable bowel syndrome (IBS). Aims: The current study developed and tested an intervention focusing on beliefs and behaviours around emotional expression. Method: Four participants with IBS attended five group sessions using cognitive behavioural techniques focusing on beliefs about the unacceptability of expressing emotions. Bi-weekly questionnaires were completed and a group interview was conducted. This study used an AB design with four participants. Results: Averages indicate that participants showed decreases in beliefs about unacceptability of emotions and emotional suppression during the intervention, although this was not reflected in any of the individual trends in Beliefs about Emotions Scale scores and was significant in only one individual case for Courtauld Emotional Control Scale scores. Affective distress and quality of life improved during follow-up, with only one participant not improving with regard to distress. Qualitative data suggest that participants felt that the intervention was beneficial, referencing the value in sharing their emotions. Conclusions: This study suggests the potential for beliefs about emotions and emotional suppression to be addressed in cognitive behavioural interventions in IBS. That beliefs and behaviours improved before outcomes suggests they may be important processes to investigate in treatment for IBS.


2014 ◽  
Vol 16 (4) ◽  
pp. 475-491 ◽  
Author(s):  
Elke Krahmann

In 2012, the United Nations approved new Guidelines on the Use of Armed Private Security Companies by its agencies, funds and programmes. The Guidelines hold the potential to not only enhance the quality of armed security services contracted by the un, but also raise professional standards within the military and security industry more generally by serving as a model for other consumers and companies. Nevertheless, a close reading of the Guidelines indicates that there is still room for improvements. Drawing on best practices identified by industry associations, major clients and academic research, this article makes six recommendations for revision. Specifically, the article contends that expanding the scope, content and enforcement of the Guidelines would contribute to strengthening the control over private security contractors.


Author(s):  
Lauren Auer Lopes ◽  
Elizabeth Bernardino ◽  
Karla Crozeta ◽  
Paulo Ricardo Bittencourt Guimarães

Abstract Objective: to identify the factors related to the quality of umbilical cord and placental blood specimens, and define best practices for their collection in a government bank of umbilical cord and placental blood. Method: this was a descriptive study, quantitative approach, performed at a government umbilical cord and placental blood bank, in two steps: 1) verification of the obstetric, neonatal and operational factors, using a specific tool for gathering data as non-participant observers; 2) definition of best practices by grouping non-conformities observed before, during and after blood collection. The data was analyzed using descriptive statistics and the following statistical software: Statistica(r) and R(r). Results: while there was a correlation with obstetrical and neonatal factors, there was a larger correlation with operational factors, resulting in the need to adjust the professional practices of the nursing staff and obstetrical team involved in collecting this type of blood. Based on these non-conformities we defined best practices for nurses before, during and after blood collection. Conclusion: the best practices defined in this study are an important management tool for the work of nurses in obtaining blood specimens of high cell quality.


2011 ◽  
Vol 20 (01) ◽  
pp. 146-155
Author(s):  
A. V. Alekseyenko ◽  
Y. Aphinyanaphongs ◽  
S. Brown ◽  
D. Fenyo ◽  
L. Fu ◽  
...  

SummaryTo survey major developments and trends in the field of Bioinformatics in 2010 and their relationships to those of previous years, with emphasis on long-term trends, on best practices, on quality of the science of informatics, and on quality of science as a function of informatics.A critical review of articles in the literature of Bioinformatics over the past year.Our main results suggest that Bioinformatics continues to be a major catalyst for progress in Biology and Translational Medicine, as a consequence of new assaying technologies, most predominantly Next Generation Sequencing, which are changing the landscape of modern biological and medical research. These assays critically depend on bioinformatics and have led to quick growth of corresponding informatics methods development. Clinical-grade molecular signatures are proliferating at a rapid rate. However, a highly publicized incident at a prominent university showed that deficiencies in informatics methods can lead to catastrophic consequences for important scientific projects. Developing evidence-driven protocols and best practices is greatly needed given how serious are the implications for the quality of translational and basic science.Several exciting new methods have appeared over the past 18 months, that open new roads for progress in bioinformatics methods and their impact in biomedicine. At the same time, the range of open problems of great significance is extensive, ensuring the vitality of the field for many years to come.


2020 ◽  
Author(s):  
E. Parimbelli ◽  
S. Wilk ◽  
R. Cornet ◽  
P. Sniatala ◽  
K. Sniatala ◽  
...  

AbstractIntroductionThanks to improvement of care, cancer has become a chronic condition. But due to the toxicity of treatment, the importance of supporting the quality of life (QoL) of cancer patients increases. Monitoring and managing QoL relies on data collected by the patient in his/her home environment, its integration, and its analysis, which supports personalization of cancer management recommendations. We review the state-of-the-art of computerized systems that employ AI and Data Science methods to monitor the health status and provide support to cancer patients managed at home.ObjectiveOur main objective is to analyze the literature to identify open research challenges that a novel decision support system for cancer patients and clinicians will need to address, point to potential solutions, and provide a list of established best-practices to adopt.MethodsWe designed a review study, in compliance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, analyzing studies retrieved from PubMed related to monitoring cancer patients in their home environments via sensors and self-reporting: what data is collected, what are the techniques used to collect data, semantically integrate it, infer the patient’s state from it and deliver coaching/behavior change interventions.ResultsStarting from an initial corpus of 819 unique articles, a total of 180 papers were considered in the full-text analysis and 109 were finally included in the review. Our findings are organized and presented in four main sub-topics consisting of data collection, data integration, predictive modeling and patient coaching.ConclusionDevelopment of modern decision support systems for cancer needs to utilize best practices like the use of validated electronic questionnaires for quality-of-life assessment, adoption of appropriate information modeling standards supplemented by terminologies/ontologies, adherence to FAIR data principles, external validation, stratification of patients in subgroups for better predictive modeling, and adoption of formal behavior change theories. Open research challenges include supporting emotional and social dimensions of well-being, including PROs in predictive modeling, and providing better customization of behavioral interventions for the specific population of cancer patients.


F1000Research ◽  
2017 ◽  
Vol 6 ◽  
pp. 1627 ◽  
Author(s):  
Noam D. Fine ◽  
Jeffrey P. Weiss ◽  
Alan J. Wein

Nocturia is a widespread condition that can negatively impact quality of sleep and overall health. This condition is multifactorial in nature and is best approached through the analysis of frequency volume charts. Through these charts, clinicians may classify each individual case of nocturia into one of four distinct categories: global polyuria, nocturnal polyuria, reduced bladder capacity, and mixed. Treatments should then be tailored to each individual based upon the category of their nocturia. In some cases, appropriate therapy will consist of behavioral modification techniques or addressing underlying systemic diseases. In other cases, medical therapy may be necessary, but, to date, medications have shown limited efficacy at treating nocturia.


2021 ◽  
Vol 3 (1) ◽  
pp. 01-05
Author(s):  
Dan Jiang

Incidence and prevalence of infected Covid-19 are still rampant in the West and the most countries throughout world from 2020 to 2021. Although the incidence of infected Covid-19 in the developed countries has decreased down by the popular vaccination, it is still anxiety and worry to make more serious widespread from the variated coronavirus. It is a rigorous fact that there still are higher on the mortality to the seniors, special seniors who are resided at nursing homes. For seniors, the infected Coronavirus may product them a disastrous attack according to their pre-existing diseases, complication accompanied with Covid-19, and post-syndromes caused by Covid-19. Their Covid-19 may be more complex, more serious, harder to find a fast and effective therapies and easier to become to the post-syndromes which will make a bad influence to the quality of life in the rest of their life. TCM focuses to individual case, and pay attention more for their pre-existing diseases, complication with Covid-19, and possibility of post-syndrome’s production while some anti-coronavirus herbs are prescribed, so a more fixed prescription is made. In this clinical trial, the author classified 60 cases into two groups: over 45 years old as the observing group and under of 44 years old as the contrasted group, incidences on pre-existing diseases, complication and post-syndromes are observed separately; their results after treated by Chinese medical herbs are also observed. We recognize from these observation and analysis TCM treatment can significantly stabilized pre-existing diseases, treat complication together and prevent the post-syndromes’ occurrence while is treating to Coronavirus. TCM is a suitable treating choice to Senior with Covid-19.


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