Pediatric blinatumomab preparation: Risk assessment on SmPC for software compliance

2020 ◽  
pp. 107815522096639
Author(s):  
Mario Cirino ◽  
Riccardo Provasi ◽  
Irina Cebulec ◽  
Clara Palmieri ◽  
Paolo Schincariol ◽  
...  

Introduction Blinatumomab is an anticancer drug used in the treatment of Acute Lymphoblastic Leukaemia (ALL) in both adults and children. ALL is the most common form of cancer in children and patients who are refractory to standard treatments have poor prognosis. The preparation of blinatumomab is unique and extremely complex. It’s important to carry out any information to identify all the critical issues related to the preparation of blinatumomab: sharing procedure between prescribers, staff of the Centralized Chemotherapy Preparation Unit [Unità Farmaci Antiblastici (UFA)] and administering nurses aimed at reducing the clinical risk related to the management of the drug blinatumomab and to obtain correct prescriptions on the real dose to be prepared, safe worksheets with computer processing of all variables (volumes to be added and corresponding dose of drug) and complete labels containing all the information necessary for the control of the preparation and its correct infusion. Methods A computerized process involves the use of specific software to which precise instructions must be given. This study is divided into two phases, the first one focused on the analysis of Summary of Product Characteristics (SmPC) and the extrapolation of any unclear part of SmPC. The second phase involved the manufacturer to answer a questionnaire. Results This comparison with the company allowed to perfect the blinatumomab preparation process leading to: 1. allow the patient to be discharged and return a few times for infusions and consequently reduce the number of medical prescriptions; 2. set up the drug for each patient every 4 days; 3. reduce costs related to devices, staff employed. Conclusion Computerizing the preparation of anti-blastic drugs is a necessary path for the safety of the patient and all the operators involved, however it may be necessary to make changes in the preparation process to allow the software to work correctly. The comparison between pharmacist, clinician and, where necessary, the manufacturer of the drug, was effective in the preparation of this drug.

2020 ◽  
Vol 45 (1/2) ◽  
pp. 103-120 ◽  
Author(s):  
Milad Ghelichkhani

Purpose This paper aims to trace the tectonic effects of openings as Heideggerian “built-things”. Design/methodology/approach This study has been organized in two phases. The first phase attempts to set up the theoretical framework through exploring the links between Heidegger’s notion of “built-thing” and contemporary tectonic discourses on dialectics between the values of matheme (construction, technology) and poetics (representation, meaning) to identify the key indicators in tectonic effects of openings. Accordingly, as the term “tectonic effects” is concerned with feelings and emotions that tectonics may evoke in people, the author searches for the indicators based on the poetic aspects of tectonic values and applies them within the phenomenological method implemented in the second phase of the research to explore the indicators in the designated case of the “Çavuşoğlu house”. Findings The results of this study indicate the significance of ontological nexus between tectonics as “poetic revealing” and the ability of the “built-thing” to generate tectonic effects within the embodied experience of dwellers. In fact, an opening can generate ontological tectonic effects in space only if it is brought about through a truthful build-dwell process which responds in a poetic way to the daily-life needs of the dwellers. The tangible examples of this fact are evident in the openings of the Çavuşoğlu house. Originality/value The theory of tectonics of openings as a separate “built-thing”, which is put forward in the present study, is a subject that has not been sufficiently studied so far and has the potential to be developed through further research. In light of this, the theoretical results of this study can contribute to tectonic thinking during the design process.


2008 ◽  
Vol 21 (3) ◽  
Author(s):  
Elfi Baillien ◽  
Hans De Witte ◽  
Guy Notelaers ◽  
Inge Neyens

Construction of a risk assessment tool to prevent workplace bullying Construction of a risk assessment tool to prevent workplace bullying E. Baillien, H. De Witte, G. Notelaers & I. Neyens, Gedrag & Organisatie, volume 21, August 2008, nr. 3, pp. 254-278. The aim of the current study was to develop a tool which helps organizations to prevent workplace bullying ('RATOG'). By measuring the most important antecedents of workplace bullying the tool indicates whether these antecedents have a safe, problematic or very problematic score. The tool was developed in two phases. In phase one, the most important antecedents of bullying were selected on the basis of a survey among employees of twenty Flemish organizations. These antecedents were role conflict, job insecurity, low social support from the colleagues, high frequency of conflict within the team, low employee-oriented organizational culture and low procedural justice. In the second phase, Relative Operating Characteristic analyses determined from which score these antecedents increased workplace bullying. The tool can be used to analyze an entire organization, large departments or smaller teams and contains 23 questions.


2021 ◽  
Vol 17 ◽  
pp. 41-45
Author(s):  
Sorin Zoican

This article presents a general frame-work for scheduling videoclips denoising processes ensuring the quality of service (QoS). In general, a denoising algorithm has two phases which are run sequentially: the first one determines the noisy pixels in the videoclip frames and the second applies a median filtering over the each frame considering the only good pixels. In all such denoising algorithms, the first phase is run for multiple times depend on the noise power. The second phase also may be executed more than one time but this depends on the specific algorithm. The issue in such applications is the denoising process may not terminate within its deadline. The proposed solution adapts the execution time in such way so the deadline to be respected by determining the remaining time to the deadline before running each phase and reducing the number of runs in each phase in order to not exceed the deadline. The goals of the article are the following: presents the QoS scheduling algorithm and proposes an implementation solution of based on Blackfin microcomputer with support of Visual DSP kernel (VDK). The article is organized in 5 sections: a briefly introduction to set up the general context of quality of services in videoclips denoising applications and to present the original video processing algorithm, two sections that present the proposed solution and its VDK implementation, the performance evaluation and the conclusions.


Author(s):  
Jordi Permanyer ◽  
Ester Omella

In 2005 the Diputació de Barcelona (Barcelona Provincial Council) set up a Laboratory to strengthen the collaboration between public libraries and school libraries at an suitable time for school libraries in our country, such is the interest in promoting them. The Laboratory’s first phase has now concluded and the institutions involved in the public library and school library services have set up a second phase for the Laboratory, which is currently under way. The presentation focuses on the results of the two phases of the “The School Library-Public Library Laboratory”, held in 2005 and 2006. The first Laboratory set out the framework for collaboration between public libraries and school libraries. The working sessions enabled consideration, discussion and analysis of the following questions: the model and functions of the school library within the framework of the school’s educational project; the elements and resources necessary to carry out its functions; the framework for collaboration between the public library and the school library; the services and activities to be carried out jointly; and the steps to take to advance together towards a reading society that is empowered in the use of information. The aim of the Laboratory’s second phase is to consolidate the framework for collaboration between the public and the school library around three core areas: the consolidation of the areas and methods for collaboration between public and school libraries and the necessary resources; the drawing up of a working protocol for each method so as to facilitate its implementation; and to define the structure for collaboration between the various institutions and services involved by setting out the steps showing what the framework for long-term collaboration between the public and the school library should be like.


Author(s):  
Meriem Adraoui ◽  
Asmaâ Retbi ◽  
Mohammed Khalidi Idrissi ◽  
Samir Bennani

This article aims to present a new method of evaluating learners by communities on Facebook groups which based on their interactions. The objective of our study is to set up a community learning structure according to the learners' levels. In this context, we have proposed a new algorithm to detect and evaluate learning communities. Our algorithm consists of two phases. The first phase aims to evaluate learners by measuring their degrees of ‘Safely’. The second phase is used to detect communities. These two phases will be repeated until the best community structure is found. Finally, we test the performance of our proposed approach on five Facebook groups. Our algorithm gives good results compared to other community detection algorithms.


2020 ◽  
Author(s):  
Marjan Beigi ◽  
Shahideh Jahanian Sadatmahalleh ◽  
Nasrin Changizi ◽  
Eesa Mohammadi ◽  
Ashraf Kazemi

Abstract Background The implementation of the maternal mortality surveillance system in Iran has significantly reduced the incidence of maternal mortality. However, the pattern of the causes of the mortalities, which has remained constant over the years, are still concerning. This study aimed to explain the experiences of the actors of the Iranian maternal mortality surveillance and provide strategies for improving this system. Methods This research is a qualitative study to develop strategies, that will be conducted in two phases. In the first phase, purposive sampling will be performed, and the data will be collected based on the experiences of the Iranian maternal mortality surveillance system actors in Iran's Ministry of Health and the selected universities (Shiraz, Isfahan, Tehran, Zahedan, Alborz, Shahrekord) through semi-structured interviews. Moreover, during this phase, some part of the data will be collected through random participation of the researcher in some maternal mortality committees of the selected universities. In order to carry out the second phase, a panel of experts will be set up to discuss the best strategies for improving the Iranian maternal mortality surveillance by considering the above results. Discussion The analysis of maternal mortality surveillance system needs to evaluate the experiences of the actors who are the policymakers of this system and can be effective in identifying its challenges. This analysis and formulation of the subsequent strategies can lead to maternal health indicators remaining within the range of international standards or even beyond those standards in Iranian universities and countries with similar surveillance system.


2018 ◽  
Vol 1 (1) ◽  
pp. 236-247
Author(s):  
Divya Srivastava ◽  
Rajitha B. ◽  
Suneeta Agarwal

Diseases in leaves can cause the significant reduction in both quality and quantity of agricultural production. If early and accurate detection of disease/diseases in leaves can be automated, then the proper remedy can be taken timely. A simple and computationally efficient approach is presented in this paper for disease/diseases detection on leaves. Only detecting the disease is not beneficial without knowing the stage of disease thus the paper also determine the stage of disease/diseases by quantizing the affected of the leaves by using digital image processing and machine learning. Though there exists a variety of diseases on leaves, but the bacterial and fungal spots (Early Scorch, Late Scorch, and Leaf Spot) are the most prominent diseases found on leaves. Keeping this in mind the paper deals with the detection of Bacterial Blight and Fungal Spot both at an early stage (Early Scorch) and late stage (Late Scorch) on the variety of leaves. The proposed approach is divided into two phases, in the first phase, it identifies one or more disease/diseases existing on leaves. In the second phase, amount of area affected by the disease/diseases is calculated. The experimental results obtained showed 97% accuracy using the proposed approach.


Author(s):  
Paulo César Antonini de Souza ◽  
Derick Trindade Bezerra

ResumoTendo por campo de investigação o Festival da América do Sul Pantanal (FASP) em 2018, na cidade de Corumbá (Brasil), objetiva-se identificar a materialidade e conceitos que permeiam as manifestações artísticas bidimensionais nesta região de fronteira, a partir da percepção de artistas da Bolívia. A pesquisa se organizou em duas fases: na primeira foi realizado um levantamento em plataformas online de produções acadêmicas em artes visuais, com foco no trabalho bidimensional, utilizando os descritores “arte popular” e “estética latina” resultando em três artigos. Na segunda fase foram selecionados dois trabalhos de uma artista da Bolívia, participante da mostra “Conexão Santa Cruz”, realizada durante o FASP 2018, que foram analisados em seus níveis representacional e simbólico. Pela interpretação das imagens foi possível construir uma leitura sobre a perspectiva da artista a respeito de suas condições culturais dentro da ordenação social em que se encontra situada.Palavras-chave: Artes Visuais. Arte Popular. Arte Regional. América Latina. Representation and symbolism: visual arts on the Brazil/Bolivia frontierAbstractHaving as research field the Festival da América do Sul Pantanal (FASP) in 2018, in the city of Corumbá (Brazil), the objective is to identify the materiality and concepts that permeate the two-dimensional artistic manifestations in this border region, from the perception of artists from Bolivia. The research was organized in two phases: in the first, a survey was carried out on online platforms of academic productions in visual arts, focusing on two-dimensional work, using the descriptors “arte popular” and “estética latina” resulting in three articles. In the second phase, two works were selected by an artist from Bolivia, participating in the exhibition “Conexão Santa Cruz”, held during FASP 2018, which were analyzed at their representational and symbolic levels. Through the interpretation of the images, it was possible to construct a reading on the artist’s perspective regarding her cultural conditions within the social order in which she is located.Keywords: Visual Arts. Folk Art. Regional Art. Latin America.Representación y simbolismo: artes visuales en la frontera de Brasil/BoliviaResumenTeniendo como campo de investigación el Festival de Sudamérica Pantanal (FASP) en 2018, en la ciudad de Corumbá (Brasil), el objetivo es identificar la materialidad y conceptos que permean las manifestaciones artísticas bidimensionales en esta región fronteriza, desde la percepción de artistas de Bolivia. La investigación se organizó en dos fases: en la primera, se realizó una encuesta en plataformas online de producciones académicas en artes visuales, con foco en el trabajo bidimensional, utilizando los descriptores “arte popular” y “estética latina” dando como resultado tres artículos. En la segunda fase, dos obras fueron seleccionadas por un artista de Bolivia, participante de la exposición “Conexão Santa Cruz”, realizada durante FASP 2018, que fueron analizadas en sus niveles representativos y simbólicos. A través de la interpretación de las imágenes, fue posible construir una lectura sobre la perspectiva de la artista sobre sus condiciones culturales dentro del orden social en el que se ubica.Palabras clave: Artes Visuales. Arte Popular. Arte Regional. América Latina.


Author(s):  
A. Geerinck ◽  
C. Beaudart ◽  
J.-Y. Reginster ◽  
M. Locquet ◽  
C. Monseur ◽  
...  

Abstract Purpose To facilitate the measurement of quality of life in sarcopenia, we set out to reduce the number of items in the previously validated Sarcopenia Quality of Life (SarQoL®) questionnaire, and to evaluate the clinimetric properties of this new short form. Methods The item reduction process was carried out in two phases. First, information was gathered through item-impact scores from older people (n = 1950), a Delphi method with sarcopenia experts, and previously published clinimetric data. In the second phase, this information was presented to an expert panel that decided which of the items to include in the short form. The newly created SFSarQoL was then administered to older, community-dwelling participants who previously participated in the SarcoPhAge study. We examined discriminative power, internal consistency, construct validity, test–retest reliability, structural validity and examined item parameters with a graded response model (IRT). Results The questionnaire was reduced from 55 to 14 items, a 75% reduction. A total of 214 older, community-dwelling people were recruited for the validation study. The clinimetric evaluation showed that the SF-SarQoL® can discriminate on sarcopenia status [EWGSOP2 criteria; 34.52 (18.59–43.45) vs. 42.86 (26.56–63.69); p = 0.043], is internally consistent (α = 0.915, ω = 0.917) and reliable [ICC = 0.912 (0.847–0.942)]. A unidimensional model was fitted (CFI = 0.978; TLI = 0.975; RMSEA = 0.108, 90% CI 0.094–0.123; SRMR = 0.055) with no misfitting items and good response category separation. Conclusions A new, 14-item, short form version of the Sarcopenia Quality of Life questionnaire has been developed and shows good clinimetric properties.


Author(s):  
Kui Xu ◽  
Ming Zhang ◽  
Jie Liu ◽  
Nan Sha ◽  
Wei Xie ◽  
...  

Abstract In this paper, we design the simultaneous wireless information and power transfer (SWIPT) protocol for massive multi-input multi-output (mMIMO) system with non-linear energy-harvesting (EH) terminals. In this system, the base station (BS) serves a set of uplink fixed half-duplex (HD) terminals with non-linear energy harvester. Considering the non-linearity of practical energy-harvesting circuits, we adopt the realistic non-linear EH model rather than the idealistic linear EH model. The proposed SWIPT protocol can be divided into two phases. The first phase is designed for terminals EH and downlink training. A beam domain energy beamforming method is employed for the wireless power transmission. In the second phase, the BS forms the two-layer receive beamformers for the reception of signals transmitted by terminals. In order to improve the spectral efficiency (SE) of the system, the BS transmit power- and time-switching ratios are optimized. Simulation results show the superiority of the proposed beam-domain SWIPT protocol on SE performance compared with the conventional mMIMO SWIPT protocols.


Sign in / Sign up

Export Citation Format

Share Document