Barriers and Enablers for Continuous Improvement Methodologies within the Irish Pharmaceutical Industry

This study aims to investigate the barriers that exist when implementing continuous improvement methodologies, such as Lean Six Sigma (LSS), within the Irish Pharma industry. The main finding of this study is that 45% of participants perceived that a highly regulated environment could be a barrier to continuous improvement implementation, while 97% of respondents utilised Continuous improvement (CI) methods, such as Lean, Six Sigma, and LSS, within their organisations. While the International Conference of Harmonisation integrates CI into its Pharmaceutical Quality Systems (PQS) regulations, the highest motivation for CI implementation amongst the Irish Pharma industry is to improve Productivity and Quality. The main obstacles highlighted for CI implementation in Pharma attributed to stringent regulatory regimes were fear of extra validation activity, a compliance versus quality culture, and a regulatory culture of being “safe”. Another relevant finding presented in this paper is that participants CI LSS tools are very strongly integrated into the pharma industries corrective and preventative action system, deviations, and internal audit systems. Limitations of the research are that all the data collected in the survey came from professionals working for multinational Pharmaceutical companies based in Ireland. The authors understand that this is the first research focused on the barriers and status of CI initiatives in the pharmaceutical industry. The results of this study represent an important step towards understanding the enablers and obstacles for the use of continuous improvement methodologies in pharmaceutical manufacturing industries on a global scale.

Physics in the structure and form of the architectural project. Museum of Contemporary Art Niterói, Brazil

This article analyzed the formal, functional, and structural aspects of the Museum of Contemporary Art Niterói in Brazil, by identifying the criteria associated with architecture and physics; this is to establish the importance of the analysis of the architectural project to obtain the basic skills of the architect. A mixed methodological framework was used, the quantitative phase was developed from a questionnaire under a non-probabilistic sample allowed to recognize the formal, structural, and functional aspects of the work under study, the qualitative phase used an interview that established the value represented by the recognition of the application of physics in architecture. As a relevant finding, it is highlighted a basic understanding of the physical elements applied to architecture, specifically in the case of Museum of Contemporary Art Niterói, Brazil, and that they recognize the importance of the analysis of architectural works as a pedagogical tool that favors obtaining the basic skills of the architect.

Interrelationship between the Microbial Communities of the Root Canals and Periodontal Pockets in Combined Endodontic-Periodontal Diseases

Periodontal and Endodontic diseases are biofilm-related diseases. The presence of microorganisms in root canals (RCs) and the complex microbiota of periodontal pockets (PPs) contribute to the development of endodontic-periodontal diseases. This study performed a systemic analysis using state-of-the-art sequence data to assess the microbial composition of infected RCs and PPs to further assess the microbiota and verify the possibility of cross-infection between these sites. The microbiomes of these combined diseases were examined with a focus on the V3-V4 hypervariable region of the 16S rRNA gene. The number of species in PP was higher than in RC, and there was a predominance of obligate anaerobes and gram-negative bacteria. In the RCs, the genera Enterococcus, Parvimonas, Stomatobaculum predominated, in contrast, the PPs revealed a predominance of Enterococcus, Parvimonas, Stomatobaculum, Peptostreptococcus and Mogibacterium. The RC and PP microbiome was not similar with regards to the sharing of OTUs for phyla and genera (8 and 67, respectively). The evaluation of molecular markers revealed a large number of markers for resistance to antibiotics of the carbapenem and beta-lactam type (broad spectrum). Another relevant finding of this study was the markers related to systemic diseases related to cardiac muscle and rheumatology, among others. In conclusion, the RC microbiota was less complex and diverse than PP. Interactions between microbial communities were present. The shared genus can signal communication between the endodontic and periodontal microbiomes.

Circulating miR-146a as a possible candidate biomarker in the indeterminate phase of Chagas disease

Background Chagas disease is considered important and presents intense inflammatory and fibrotic processes induced by the perpetuation of the parasite in the affected tissues and organs. Therefore, it is necessary to inquire about the host defense and attack mechanisms to have a more detailed knowledge about Chagas disease. MicroRNAs are found in blood, tissues and extracellular vesicles. These small regulators of gene expression are involved in physiological and pathological processes in both mammals and parasites. Several microRNAs have deregulated expression in chagasic heart disease, although little is known about their extracellular expression. Our main objective was to evaluate the involvement of miR-21, miR-146a and miR-155 in several samples from mice infected with the TcI Ninoa strain from the acute and indeterminate phases. We also explored a potential functional association of the selected microRNAs using STRING software. This software identified 23 pathways associated with Trypanosoma cruzi infection. In addition, eleven genes were identified through bioinformatics analysis, and we found that SMAD family member 5 was downregulated in both phases. This gene serves as a mediator in the TGF-β signaling pathway. Thus, forty female mice of the CD1 strain were distributed into 4 groups and the expression levels of miR-21, miR-146a and miR-155 were measured in samples of heart tissue, total plasma and plasma extracellular vesicles by quantitative real-time polymerase chain reaction. Results Overexpression of miR-21, miR-146a and miR-155 was observed in heart and plasma in both phases. Moreover, in extracellular vesicles miR-21 and miR-146a were also overexpressed in the acute phase, whereas in the indeterminate chronic phase we found only miR-146a up-regulated. Conclusions The expression of inflammatory microRNAs miR-21, miR-146a and miR-155 were up-regulated in each of the samples from acutely and chronically infected mice. The relevant finding was that miR-146a was up-regulated in each sample in both phases; therefore, this miRNA could be a possible candidate biomarker in Chagas disease.

Wearable Devices for Environmental Monitoring in the Built Environment: A Systematic Review

The so-called Internet of Things (IoT), which is rapidly increasing the number of network-connected and interconnected objects, could have a far-reaching impact in identifying the link between human health, well-being, and environmental concerns. In line with the IoT concept, many commercial wearables have been introduced in recent years, which differ from the usual devices in that they use the term “smart” alongside the terms “watches”, “glasses”, and “jewellery”. Commercially available wearables aim to enhance smartphone functionality by enabling payment for commercial items or monitoring physical activity. However, what is the trend of scientific production about the concept of wearables regarding environmental monitoring issues? What are the main areas of interest covered by scientific production? What are the main findings and limitations of the developed solution in this field? The methodology used to answer the above questions is based on a systematic review. The data were acquired following a reproducible methodology. The main result is that, among the thermal, visual, acoustic, and air quality environmental factors, the last one is the most considered when using wearables even though in combination with some others. Another relevant finding is that of the acquired studies; in only one, the authors shared their wearables as an open-source device, and it will probably be necessary to encourage researchers to consider open-source as a means to promote scalability and proliferation of new wearables customized to cover different domains.

Fit Testing Disposable P2/N95 Respirators during COVID-19 in Victoria, Australia: Fit Check Evaluation, Failure Rates, and a Survey of Healthcare Workers

Quantitative fit testing was utilised to evaluate the Department of Health and Human Services in Victoria (DHHS) recommended fit check and determine pass/fail rates for self-selected P2/N95 respirators. Survey experience and training related to P2/N95 respirators were also obtained. This was an observational study at a specialist tertiary referral centre, Melbourne, Australia, between 29 May 2020 and 5 June 2020. The primary outcome was quantitative fit test pass/fail results, with fit check reported against fit test as a 2 × 2 contingency table. The secondary outcomes were the number of adjustments needed to pass, as well as the pass rates for available sizes and types of self-selected respirators, survey data for attitudes, experience and training for P2/N95 respirators. The fit check predicts respirator seal poorly (PPV 34.1%, 95% CI 25.0–40.5). In total, 69% (40/58) of respirators failed quantitative fit testing after initial respirator application and is a clinically relevant finding (first-up failure rate for P2/N95 respirators). Only one person failed the fit test for all three respirator fit tests. There was significant variability between each of the seven types of self-selected P2/N95 respirators, although sample sizes were small. Few participants were trained in the use of P2/N95 respirators or the fit check prior to COVID-19, with a high number of participants confident in achieving a P2/95 respirator seal following a fit test. The fit check alone was not a validated method in confirming an adequate seal for P2/N95 respirators. Quantitative fit testing can facilitate education, improve the seal of P2/N95 respirators, and needs to be integrated into a comprehensive Respiratory Protection Program (RPP).

Fadiga em idosos submetidos ao tratamento hemodialítico

Identificar a ocorrência de fadiga em idosos com doença renal crônica em hemodiálise. Estudo descritivo, transversal e abordagem quantitativa, realizado de setembro a novembro de 2018 por meio da Escala de Fadiga de Piper-revisada. Participaram do estudo 45 idosos com idades entre 60 a 86 anos, 62,2% eram do sexo masculino. Identificou-se fadiga em 97,7% dos idosos e as causas atribuídas com maior frequência foram às sessões de hemodiálise (37,8%) e estresse (13,3%). Quanto aos fatores que promoveram alívio de fadiga, foram descritos descansar (53,3%), dormir (6,7%) e se alimentar (6,7%). A fadiga mostrou-se um achado relevante entre os idosos pesquisados, por isso merece a atenção da equipe de enfermagem para identificação e adequado manejo.Descritores: Diálise Renal, Idoso, Fadiga. Fatigue in elderly submitted to hemodialysis treatmentAbstract: To identify the occurrence of fatigue in the elderly with chronic kidney disease undergoing hemodialysis. A descriptive, cross-sectional study with a quantitative approach, carried out from September to November 2018 using the revised Piper Fatigue Scale. 45 elderly people aged 60 to 86 years participated on the study, 62.2% were male. Fatigue was identified in 97.7% of the elderly and the most frequently attributed causes were hemodialysis (37.8%) and stress (13.3%). As for the factors that promoted fatigue relief, rest (53.3%), sleep (6.7%) and eating (6.7%) were described. Fatigue proved to be a relevant finding among the elderly surveyed, which is why it deserves the attention of the nursing team for identification and adequate management.Descritores: Renal Dialysis, Age, Fatigue. Fatiga en personas mayores presentadas al tratamiento de hemodiálisisResumen: Identificar la aparición de fatiga en ancianos con enfermedad renal crónica en hemodiálisis. Un estudio descriptivo, transversal con un enfoque cuantitativo, llevado a cabo de septiembre a noviembre de 2018 utilizando la Escala de Fatiga Piper revisada. 45 personas mayores de 60 a 86 años participaron en el estudio, 62.2% eran hombres. La fatiga se identificó en el 97.7% de los ancianos y las causas más frecuentemente atribuidas fueron la hemodiálisis (37.8%) y el estrés (13.3%). En cuanto a los factores que promovieron el alivio de la fatiga, se describió el descanso (53.3%), el sueño (6.7%) y la alimentación (6.7%). La fatiga resultó ser un hallazgo relevante entre los ancianos encuestados, por lo que merece la atención del equipo de enfermería para su identificación y manejo adecuado.Descriptores: Diálisis Renal, Anciano, Fatiga.

A Scoping Review Protocol of Malaria Vectors in Malaysia

Introduction: Malaria is still a public health threat. From 2010 to 2017, a total of 33, 181 malaria cases were recorded in Malaysia. Thus, effective intervention and key entomological information are vital to interrupt or in preventing malaria transmission. Therefore, availability of malaria vectors information is desperately needed. The objective of this study is to established protocols of new and potential malaria vector as a part of existing malaria vectors in Malaysia for human and zoonotic infection. Methods and analysis: Scoping review will be conducted based on Arksey and O’Malley’s methodology on four electronic databases; Scopus, PubMed, Google Scholar and Science Direct. Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Scoping Review (PRISMA-ScR) will be used as a systematic approach. All relevant finding will be managed by Mendeley software and Microsoft Excel program. Ethics and dissemination: Ethical approval is not required on secondary of data. Study findings will be submitted for peer-reviewed publication.

Anandamide Exerts a Differential Effect on Human Placenta Before and After the Onset of Labor

The onset of labor involves the action of multiple factors and recent reports have postulated the endocannabinoid system as a new regulator of this process. Our objective was to study the role of anandamide, one of the main endocannabinoids, on the regulation of placental molecules that contribute to the onset of labor at term. Placental samples were obtained from patients with laboring vaginal deliveries and from non-laboring elective cesarean sections. Vaginal delivery placentas produced higher prostaglandins levels than cesarean section samples. Besides, no differences were observed in NOS basal activity between groups. Incubation of vaginal delivery placentas with anandamide increased prostaglandins concentration and decreased NOS activity. Antagonism of type-1cannabinoid receptor (CB1) did not alter the effect observed on NOS activity. Conversely, incubation of cesarean section placentas with anandamide reduced prostaglandins levels and enhanced NOS activity, the latter involving the participation of CB1. Furthermore, we observed a differential expression of the main components of the endocannabinoid system between placental samples, being the change in CB1 localization the most relevant finding. Our results suggest that anandamide acts as a modulator of the signals that regulate labor, exerting differential actions depending on CB1 localization in laboring or non-laboring term placentas.

Transport Poverty with Special Reference to Sustainability: A Systematic Review of the Literature

The aim of this work is to analyse the state of the art of scientific research related to transport poverty with special reference to sustainability and to identify new research needs. To this end, a methodology has been used in line with the objective set out, choosing the systematic review of the literature as the most suitable method. The results show that transport poverty is an under-exploited issue and is not well articulated by researchers, and there are great differences between the different areas of knowledge studied. The subjects related to health and medicine have more publications, almost 58%, with the rest distributed among 11 different subjects. Of the works analysed, only 26.69% refer to the topic of sustainability, and therefore this is a branch which is little studied in the literature in this field. Another relevant finding is that all the articles analysed highlight the vulnerability and inequality of the groups affected by transport poverty, with the elderly being the least studied in the research work.