Search results for: clinical quality and safety

Authors: Sadia Afroza, Rakiba Rouf

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Road safety and associated behaviors have received significant attention in recent years, reflecting general public concern. This paper portrays a statistical scenario of the young drivers in UAE with emphasis on various concern points of young driver’s behavior and license issuance. Although there are many factors contributing to road accidents, statistically it is evident that age plays a major role in road accidents. Despite ensuring strict road safety laws enforced by the UAE government, there is a staggering correlation among road accidents and young driver’s at UAE. However, private organizations like BMW and RoadSafetyUAE have extended its support on conducting surveys on driver’s behavior with an aim to ensure road safety. Various strategies such as road safety law enforcement, license issuance, adapting new technologies like safety cameras and raising awareness can be implemented to improve the road safety concerns among young drivers.

Keywords: driving behavior, Graduated Driver Licensing System (GLDS), road safety, UAE drivers, young drivers

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Authors: Kamal Tolani, Sandeep Kumar, Rohit Luthra, Ankit Dadhania, Krishnaprasad K., Ram Gupta, Deepa Joshi

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Background: Post-operative analgesia remains a clinical challenge, with central and peripheral sensitization playing a pivotal role in treatment-related complications and impaired quality of life. Centrally acting opioids offer poor risk benefit profile with increased intensity of gastrointestinal or central side effects and slow onset of clinical analgesia. The objective of this study was to assess the clinical feasibility of induction and maintenance therapy with Tapentadol Nasal Spray (NS) in moderate to severe acute post-operative pain. Methods: Phase III, randomized, active-controlled, non-inferiority clinical trial involving 294 cases who had undergone surgical procedures under general anesthesia or regional anesthesia. Post-surgery patients were randomized to receive either Tapentadol NS 45 mg or Tramadol 100mg IV as a bolus and subsequent 50 mg or 100 mg dose over 2-3 minutes. The frequency of administration of NS was at every 4-6 hours. At the end of 24 hrs, patients in the tramadol group who had a pain intensity score of ≥4 were switched to oral tramadol immediate release 100mg capsule until the pain intensity score reduced to <4. All patients who had achieved pain intensity ≤ 4 were shifted to a lower dose of either Tapentadol NS 22.5 mg or oral Tramadol immediate release 50mg capsule. The statistical analysis plan was envisaged as a non-inferiority trial involving comparison with Tramadol for Pain intensity difference at 60 minutes (PID60min), Sum of Pain intensity difference at 60 minutes (SPID60min), and Physician Global Assessment at 24 hrs (PGA24 hrs). Results: The per-protocol analyses involved 255 hospitalized cases undergoing surgical procedures. The median age of patients was 38.0 years. For the primary efficacy variables, Tapentadol NS was non-inferior to Inj/Oral Tramadol in relief of moderate to severe post-operative pain. On the basis of SPID60min, no clinically significant difference was observed between Tapentadol NS and Tramadol IV (1.73±2.24 vs. 1.64± 1.92, -0.09 [95% CI, -0.43, 0.60]). In the co-primary endpoint PGA24hrs, Tapentadol NS was non–inferior to Tramadol IV (2.12 ± 0.707 vs. 2.02 ±0.704, - 0.11[95% CI, -0.07, 0.28). However, on further assessment at 48hr, 72 hrs, and 120hrs, clinically superior pain relief was observed with the Tapentadol NS formulation that was statistically significant (p <0.05) at each of the time intervals. Secondary efficacy measures, including the onset of clinical analgesia and TOTPAR, showed non-inferiority to Tramadol. The safety profile and need for rescue medication were also similar in both the groups during the treatment period. The most common concomitant medications were anti-bacterial (98.3%). Conclusion: Tapentadol NS is a clinically feasible option for improved compliance as induction and maintenance therapy while offering a sustained and persistent patient response that is clinically meaningful in post-surgical settings.

Keywords: tapentadol nasal spray, acute pain, tramadol, post-operative pain

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Authors: Farzana Rahman, Mohammed Hossain Ezaz, Dipak Halder, Proshanta Mondal

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Site safety is an important function regardless of project size. A key goal, which must be met for a successful project, is to finish the project with a good safety record. Construction safety is an important issue in all over the world. Today, developed countries strictly follow the safety procedure to avoid any hazard, accident or fatality. However, for a least developed country like Bangladesh, still accidents and fatalities are quite high due to lack of safety management. With the increased volume of construction work in Bangladesh, the need for proper attention in safety issues has become essential for human, economic and other consideration. Recently lots of accidents are taking place in construction sites of Bangladesh causing severe injury to death to the workers and pedestrians. There are a number of reasons/factors that these high numbers are widespread to the construction industry that are not found in most other businesses. The objective of this research work is to identify and explore the various factor that affect the construction site safety in Bangladesh. A questionnaire surveys was conducted to the reputed construction companies of Bangladesh to examine the present safety situation in construction sites. Nine factors were selected for the survey. The finding shows that 78% of organizations’ from the respondents are conscious about the safety procedure and they usually provide safety measures for the workers. Promotion of safety measures at the working site results in a better working environment, higher productivity and greater contentment among the workers.

Keywords: construction sites, fatalities, safety issues, safety situation

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Authors: Hassan Alsada

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Tank overfill accidents are major concerns for industries handling large volumes of hydrocarbons. Buncefield, Jaipur, Puerto Rico, and West Virginia are just a few accidents with catastrophic consequences. Thus, it is very important for any industry to take the right safety measures for overfill prevention. Moreover, one of the main causative factors in the overfill accidents was inadequate risk analysis and, subsequently, inadequate design. This study aims to provide a full assessment in accordance with the Functional safety standard: “IEC 615 11 – Safety instrumented systems for the process industry” to the tank overfill scenario according to the standard’s Safety Life Cycle (SLC), which includes: the analysis phase, the implementation phase, and the operation phase. The paper discusses in depth the tank overfills Independent Protection Layers (IPLs) with systematic analysis to avoid the safety risks of under-design and the financial risk of facility overdesign. The result shows a clear and systematic assessment in compliance with the standards that can help to assist existing tank overfilling setup or a guide to support designing new storage facilities overfill protection.

Keywords: IEC 61511, PHA, LOPA, process safety, safety, health, environment, safety instrumented systems, safety instrumented function, functional safety, safety life cycle

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Authors: Rodoula Stavroula Gkarnara, Nikolaos Andreadakis

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The purpose of this paper is to examine the relationship between quality and quality assurance in education. It constitutes a critical review of the bibliography regarding quality and its delimitation in the field of education, as well as the quality assurance in education and the approaches identified for its extensive study. The two prevailing and opposite views on the correlation of the two concepts are that on the one hand there is an inherent distance between these concepts as they are two separate terms and on the other hand they are interrelated and interdependent concepts that contribute to the improvement of quality in education. Finally, the last part of the paper, adopting the second view, refers to the contribution of quality assurance to quality, where it is pointed out that the first concept leads to the improvement of the latter by quality assurance being the means of feedback for the quality achieved.

Keywords: education, quality, quality assurance, quality improvement

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Authors: Umamaheswari Shanmugam, Silvia Ronchi

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Software, artificial intelligence, and machine learning can improve healthcare through innovative and advanced technologies that can use the large amount and variety of data generated during healthcare services every day; one of the significant advantages of these new technologies is the ability to get experience and knowledge from real-world use and to improve their performance continuously. Healthcare systems and institutions can significantly benefit because the use of advanced technologies improves the efficiency and efficacy of healthcare. Software-defined as a medical device, is stand-alone software that is intended to be used for patients for one or more of these specific medical intended uses: - diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease, any other health conditions, replacing or modifying any part of a physiological or pathological process–manage the received information from in vitro specimens derived from the human samples (body) and without principal main action of its principal intended use by pharmacological, immunological or metabolic definition. Software qualified as medical devices must comply with the general safety and performance requirements applicable to medical devices. These requirements are necessary to ensure high performance and quality and protect patients' safety. The evolution and the continuous improvement of software used in healthcare must consider the increase in regulatory requirements, which are becoming more complex in each market. The gap between these advanced technologies and the new regulations is the biggest challenge for medical device manufacturers. Regulatory requirements can be considered a market barrier, as they can delay or obstacle the device's approval. Still, they are necessary to ensure performance, quality, and safety. At the same time, they can be a business opportunity if the manufacturer can define the appropriate regulatory strategy in advance. The abstract will provide an overview of the current regulatory framework, the evolution of the international requirements, and the standards applicable to medical device software in the potential market all over the world.

Keywords: artificial intelligence, machine learning, SaMD, regulatory, clinical evaluation, classification, international requirements, MDR, 510k, PMA, IMDRF, cyber security, health care systems

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Authors: Natalia Ortega

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Safety Culture (SCU) involves various perceptual, psychological, behavioral, and managerial factors. It has been shown that creating and maintaining an SCU is one way to reduce and prevent accidents and fatalities. In the construction sector, safety attitude, knowledge, and a supportive environment are predictors of safety behavior. The highest possible proportion of safety behavior among employees can be achieved by improving their safety attitude and knowledge. Accordingly, top management's commitment to safety is vital in shaping employees' safety attitude; therefore, the first step to improving employees' safety attitude is the genuine commitment of top management to safety. One of the factors affecting the successful implementation of health and safety promotion programs is the construction industry's subcontracting model. The contractual model's complexity, combined with the need for coordination among diverse stakeholders, makes it challenging to implement, manage, and follow up on health and well-being initiatives. The Systems theoretic accident model and process (STAMP) concept has expanded global consideration in recent years, increasing research attention. STAMP focuses attention on the role of constraints in safety management. The findings discover a growth of the research field from the definition in 2004 by Leveson and is being used across multiple domains. A systematic literature review of this novel model aims to meet the safety goals for human space exploration with a powerful and different approach to safety management, safety-driven design, and decision-making. Around two hundred studies have been published about applying the model. However, every single model for safety requires time to transform into research and practice, be tested and debated, and grow further and mature.

Keywords: stamp, risk management, accident prevention, safety culture, systems thinking, construction industry, safety

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Authors: James D. Beauchemin

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This study tested whether youth mental health care quality, operationalized as the extent to which youth and families experienced system-of-care principles in service interactions with providers, varied by level of youth need after adjusting for sociodemographic and treatment factors. The relationship of quality to clinical outcomes was also examined. Using administrative data and cross-sectional surveys from a stratified random sample of 1,124 caregivers of youths ages 5 to 20 within a statewide system-of-care, adjusted analyses indicated youths with the most intensive needs were significantly less likely to experience high-quality care (51% vs. 63%, p=0.016), with marked deficits on 6 of 9 items. Receipt of lower-quality care predicted less improvement in youth functioning. Despite considerable effort to develop systems-of-care for youths with the most severe mental health needs, these data suggest quality disparities remain for the most impaired youths. Policy and intervention development may be needed to improve the quality of care for this population.

Keywords: system-of-care, adherence, mental health, youth

Procedia PDF Downloads 154

Authors: Lauren Dhugga, Meena Parameswaran, David Blundell, Abbas Khushnood

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Context: A multidisciplinary weekly safety briefing was implemented at the Paediatric Cardiothoracic Unit at the Freeman Hospital in Newcastle-upon-Tyne. It is a tertiary referral centre with a quarternary cardiac paediatric intensive care unit and provides complexed care including heart and lung transplants, mechanical support and advanced heart failure assessment. Aim: The aim of this briefing is to provide a structured platform of communication, in an effort to improve efficiency, safety, and patient care. Problem: The paediatric cardiothoracic unit is made up of a vast multidisciplinary team including doctors, intensivists, anaesthetists, surgeons, specialist nurses, echocardiogram technicians, physiotherapists, psychologists, dentists, and dietitians. It provides care for children with congenital and acquired cardiac disease and is one of only two units in the UK to offer paediatric heart transplant. The complexity of cases means that there can be many teams involved in providing care to each patient, and frequent movement of children between ward, high dependency, and intensive care areas. Currently, there is no structured forum for communicating important information across the department, for example, staffing shortages, prescribing errors and significant events. Strategy: An initial survey questioning the need for better communication found 90% of respondents agreed that they could think of an incident that had occurred due to ineffective communication, and 85% felt that incident could have been avoided had there been a better form of communication. Lastly, 80% of respondents felt that a weekly 60 second safety briefing would be beneficial to improve communication within our multidisciplinary team. Based on those promising results, a weekly 60 second safety briefing was implemented to be conducted on a Monday morning. The safety briefing covered four key areas (SAFE): staffing, awareness, fix and events. This was to highlight any staffing gaps, any incident reports to be learned from, any issues that required fixing and any events including teachings for the week ahead. The teams were encouraged to email suggestions or issues to be raised for the week or to approach in person with information to add. The safety briefing was implemented using change theory. Effect: The safety briefing has been trialled over 6 weeks and has received a good buy in from staff across specialties. The aim is to embed this safety briefing into a weekly meeting using the PDSA cycle. There will be a second survey in one month to assess the efficacy of the safety briefing and to continue to improve the delivery of information. The project will be presented at the next clinical governance briefing to attract wider feedback and input from across the trust. Lessons: The briefing displays promise as a tool to improve vigilance and communication in a busy multi-disciplinary unit. We have learned about how to implement quality improvement and about the culture of our hospital - how hierarchy influences change. We demonstrate how to implement change through a grassroots process, using a junior led briefing to improve the efficiency, safety, and communication in the workplace.

Keywords: briefing, communication, safety, team

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Authors: Douglas J. Kube

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At the beginning of the COVID-19 pandemic, the Canadian Red Cross deployed workers into long-term care homes across Canada to support our most vulnerable citizens. It began by recruiting and training small teams of workers to provide non-clinical services for facilities in outbreak. Deployed workers were trained on an approach based on successful Red Cross deployments used with Ebola in which zones were established, levels of protection used, and strict protocols followed to prevent exposure. This paper addresses aspects of human performance through a safety culture lens. The Red Cross deployments highlight valuable insights and are an excellent case study in the principles of human performance and organizational culture. This paper looks at human performance principles, including human fallibility, predictability of error-likely situations, avoiding events by understanding reasons mistakes occur, and the influence on behaviour by organizational factors. This study demonstrates how the Red Cross’s organizational culture and work design positively influenced performance to protect workers and residents/clients. Lastly, this paper shares lessons that can be applied in many workplaces to improve worker health and safety and safety culture. This critical examination is based on the author’s experience as a Senior Occupational Health and Safety Advisor with the Red Cross during the pandemic as part of the team responsible for developing and implementing biological safety practices in long-term care deployments.

Keywords: COVID, human performance, organizational culture, work design

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Authors: Monika Trzaskowska, Dorota Zielinska, Anna Lepecka, Katarzyna Neffe-Skocinska, Beata Bilska, Marzena Tomaszewska, Danuta Kolozyn-Krajewska

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Microbiological quality and food safety are important food characteristics. Regulation (EU) No 1169/2011 of the European Parliament and of the Council on the provision of food information to consumers introduces the obligation to provide information on the 'use-by' date or the date of minimum durability (DMD). The second term is the date until which the properly stored or transported foodstuff retains its physical, chemical, microbiological and organoleptic properties. The date should be preceded by 'best before'. It is used for durable products, e.g., pasta. In relation to reducing food losses, the question may be asked whether products with the date of minimum durability currently declared retain quality and safety beyond this. The aim of the study was to assess the sensory quality and microbiological safety of selected cereal products, i.e., pasta and millet after DMD. The scope of the study was to determine the markers of microbiological quality, i.e., the total viable count (TVC), the number of bacteria from the Enterobacteriaceae family and the number of yeast and mold (TYMC) on the last day of DMD and after 1 and 3 months of storage. In addition, the presence of Salmonella and Listeria monocytogenes was examined on the last day of DMD. The sensory quality of products was assessed by quantitative descriptive analysis (QDA), the intensity of 14 differentiators and overall quality were defined and determined. In the tested samples of millet and pasta, no pathogenic bacteria Salmonella and Listeria monocytogenes were found. The value of the distinguishing features of selected quality and microbiological safety indicators on the last DMD day was in the range of about 3-1 log cfu/g. This demonstrates the good microbiological quality of the tested food. Comparing the products, a higher number of microorganisms was found in the samples of millet. After 3 months of storage, TVC decreased in millet, while in pasta, it was found to increase in value. In both products, the number of bacteria from the Enterobacretiaceae family decreased. In contrast, the number of TYMCs increased in samples of millet, and in pasta decreased. The intensity of sensory characteristic in the studied period varied. It remained at a similar level or increased. Millet was found to increase the intensity and flavor of 'cooked porridge' 3 months after DMD. Similarly, in the pasta, the smell and taste of 'cooked pasta' was more intense. To sum up, the researched products on the last day of the minimum durability date were characterized by very good microbiological and sensory quality, which was maintained for 3 months after this date. Based on these results, the date of minimum durability of tested products could be extended. The publication was financed on the basis of an agreement with the National Center for Research and Development No. Gospostrateg 1/385753/1/NCBR/2018 for the implementation and financing of the project under the strategic research and development program 'social and economic development of Poland in the conditions of globalizing markets – GOSPOSTRATEG - acronym PROM'.

Keywords: date of minimum durability, food losses, food quality and safety, millet, pasta

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Authors: C. Ah Gang Getrude, Iqbal Hashmi Shazia, Mohd Nawi Nurul Hudani

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This study examined the effectiveness of a Traffic Psychology Workshop in enhancing positive attitudes towards road safety awareness among youths. We predicted that youths’ attitudes towards road safety would be more positive after they participated in the one-day workshop. We examined their attitudes towards road safety awareness before and after they attended a one-day workshop. There were 21 participants who completed the pre and post-studies (9 males & 12 females, mean age 22.86, SD=2.03). A Wilcoxon signed-ranks test showed that the mean for post-test ranks for students’ attitudes towards road safety awareness was higher than the mean pre-test ranks, z =-3.16, p = .00. The study showed that the Traffic Psychology Module which focuses on the three elements: i) personality & emotion; Sensation, perception and visual; and mental workload could have positive effects on youths’ attitudes towards road safety awareness. We believe that the Traffic Psychology Module could be used as a guide by relevant authorities, such as the Sabah Road Safety Department, in implementing road safety awareness workshops and programs for the public, particularly road-users.

Keywords: attitude, road safety, traffic psychology, youth

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Authors: Lea B. Milan

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This descriptive study evaluated the existing Food Safety Management in Central Elementary School Canteens of Region 3. It made used of survey questionnaires, interview guide questions and validated knowledge test on food for data gathering. Results of the study revealed that school principals and canteen managers shared responsibilities in food safety management of school canteen. It also showed that the schools applied different methods of communication, monitoring and evaluation of food safety management. The study further revealed that implementation of monitoring and evaluation of food safety compliance are not being practiced in all elementary schools in the region. The study also showed that school canteens in the Region 3 do not have the thermometers and timers to use to conduct proper monitoring of foods during storage, preparation and serving. It was also found out from the study that canteen personnel lacks the basic knowledge and trainings on food safety. Potential source of physical, chemical and biological hazards that could contaminate foods were also found present in the canteen facilities of the elementary schools in the region. Moreover, evaluation showed that the existing implementation of food safety management in the Central Elementary School Canteens of Region 3 were below the expected level and the need to strengthen the appreciation and advocacy on food safety management in school canteens of Region 3 is still wanting.

Keywords: food safety management, food safety school catering, food safety, school food safety management

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Authors: Erkan Rehber, Hasan Vural, Sule Turhan

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It is a fact that food is a vital need of human beings. As a consumer, everyone has the right to access adequate and safe food. There are considerable development to establish quality standards and schemes to have safe foods and sustainable agriculture alternatives to protect natural resources and environment to reach this target. Recently, there is also a remarkable development in integration and combination of these efforts. Food Safety and Sustainable Agriculture Forum organized in 2014, Beijing shows that it is a global awareness more than being an individual view. Eventually, quality standards, assurance systems applied to conventional agriculture has to be applied to sustainable agriculture alternatives to have a holistic sustainable food chain from seed to fork. All actors of the whole food system from farmer to ultimate consumers, along with the state, have to work together meeting this big challenge.

Keywords: integrated safe, food safety, sustainable food system, consumer

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Authors: Olayinka Risiquat Raimi

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FOS was produced from FTase of Aspergillus niger. HPLC analysis showed 32.24%. Consisting of 28.57% ketose and 4.67% nystose. Effects of FOS were studied on 12 weeks old albino rats. All animals survived until scheduled euthanasia. A low incidence of clinical sign and no toxicological effect were observed. Male rats fed with 2500mg/kg fructooligosaccharides had the highest weight. Male and female rat showed a significant increase in weight from first week to the fifth week. All haematological parameters examined were normal in male and female rats. Mean haematological and haemoglobin values for 2500mg/kg bw FOS fed male rats were the highest. Clinical chemistry test, glucose, albumin, and cholesterol were within normal laboratory values for a rat. The mean glucose value was lower for FOS fed male and female rats compared to those fed with honey and 60% sucrose. Gross necropsy observation showed no remarkable internal gross abnormalities for any of the animals.

Keywords: fructooligosaccharide, white albino rat, haematology values, clinical chemistry values

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Authors: Syeda Sahra, Abdullah Jahangir, Rachelle Hamadi, Ahmad Jahangir, Allison Glaser

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Background: Antimicrobial resistance is on the rise. The use of redundant and inappropriate antibiotics is contributing to recurrent infections and resistance. Newer antibiotics with more robust coverage for gram-negative bacteria are in great demand for complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs), hospital-acquired bacterial pneumonia (H.A.B.P.), and ventilator-associated bacterial pneumonia (V.A.B.P.). Objective: We performed this meta-analysis to evaluate the efficacy and safety profile of a new antibiotic, Imipenem/cilastatin/relebactam, compared to other broad-spectrum antibiotics for complicated infections. Search Strategy: We conducted a systemic review search on PubMed, Embase, and Central Cochrane Registry. Selection Criteria: We included randomized clinical trials (R.C.T.s) with the standard of care as comparator arm with Imipenem/cilastatin/relebactam as intervention arm. Analysis: For continuous variables, the mean difference was used. For discrete variables, we used the odds ratio. For effect sizes, we used a confidence interval of 95%. A p-value of less than 0.05 was used for statistical significance. Analysis was done using a random-effects model irrespective of heterogeneity. Heterogeneity was evaluated using the I2 statistic. Results: The authors observed similar efficacy at clinical and microbiologic response levels on early follow-up and late follow-up compared to the established standard of care. The incidence of drug-related adverse events, serious adverse events, and drug discontinuation due to adverse events were comparable across both groups. Conclusion: Imipenem/cilastatin/relebactam has a non-inferior safety and efficacy profile compared to peer antibiotics to treat severe bacterial infections (cUTIs, cIAIs, H.A.B.P., V.A.B.P.).

Keywords: bacterial pneumonia, complicated intra-abdominal infections, complicated urinary tract infection, Imipenem, cilastatin, relebactam

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Authors: Nelson Igaba, C. Onaga, S. Hlongwane

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Background: Medical Male Circumcision (MMC) is part of a comprehensive HIV prevention strategy. The quality of MMC done at Right To Care (RtC) sites is maintained by Continuous Quality Improvement (CQI) based on findings of assessments by internal and independent external assessors who evaluate such parameters as the quality of the surgical procedure, infection control, etc. There are 12 RtC MMC teams in Mpumalanga, two of which are headed by Medical Officers and 10 by Clinical Associates (Clin A). Objectives: To compare the quality (i) of care rendered at doctor headed sites (DHS) versus Clin A headed sites (CHS); (ii) of CQI assessments (external versus internal). Methodology: A retrospective review of data from RightMax™ (a novel RtC data management system) and CQI reports (external and internal) was done. CQI assessment scores of October 2015 and October 2016 were taken as the baseline and latest respectively. Four sites with 745-810 circumcisions per annum were purposively selected; the two DHS (group A) and two CHS (group B). Statistical analyses were conducted using R (2017 version). Results: There were no significant difference in latest CQI scores between the two groups (DHS and CHS) (Anova, F = 1.97, df = 1, P = 0.165); between internal and external CQI assessment scores (Anova, F = 2.251, df = 1, P = 0.139) or among the individual sites (Anova, F = 1.095, df = 2, P = 0.341). Of the total of 16 adverse events reported by the four sites in the 12 months reviewed (all were infections), there was no statistical evidence that the documented severity of the infection was different for DHS and CHS (Fisher’s exact test, p-value = 0.269). Conclusion: At RtC VMMC sites in Mpumalanga, internal and external/independent CQI assessments are comparable, and quality of care of VMMC is standardized with the performance of well-supervised clinical associates comparing well with those of medical officers.

Keywords: adverse events, Right to Care, male medical circumcision, continuous quality improvement

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Authors: Alaa Mostafa, Samuel Dagogo-Jack, Vivian Thieu, Maria Yu, Nan Zhang, Dara Schuster, Luis-Emilio Garcia-Perez

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Dulaglutide (DU), a once-weekly glucagon-like peptide-1 receptor agonist, was studied in the AWARD clinical trial program in adult patients with type 2 diabetes (T2D) and demonstrated significant hemoglobin A1c (A1c) reduction and potential for weight loss. To evaluate the efficacy and safety of DU 1.5 mg and DU 0.75 mg in patients with T2D by baseline A1c <8.5% or ≥8.5%, a post-hoc analysis was conducted on AWARD-1 to -6 and -8 at 6 months. Across 7 studies, 55% to 82% of the DU-treated patients had a baseline A1c <8.5%, and 18% to 45% had a baseline A1c ≥8.5%. The ranges of A1c reductions with baseline A1c <8.5% and ≥8.5%, respectively, were: DU 1.5 mg: -0.67% to -1.25% and -1.22% to -2.37%; DU 0.75 mg: -0.53% to -1.07% and -1.37% to -2.19%. The A1c reduction from the pooled analysis was greater in patients with baseline A1c ≥8.5% than patients with baseline A1c <8.5%, respectively: DU 1.5 mg: -1.86% and -1.02%; DU 0.75 mg: -1.75% and -0.83%. DU treatments were well tolerated among baseline A1c subgroups. Across the AWARD program, DU 1.5 mg and DU 0.75 mg demonstrated significant A1c reduction in both subgroups with an acceptable safety profile. Compared to patients with baseline A1c <8.5%, patients with baseline A1c ≥8.5% had greater A1c reduction. Disclosures: This study was supported and conducted by Eli Lilly and Company, Indianapolis, IN, USA.

Keywords: A1c reduction, dulaglutide, type 2 diabetes, weight loss

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Authors: C. Bay, A. Mahr, H. Groneberg, F. Döpper

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Additive Manufacturing processes are becoming increasingly established in the industry for the economic production of complex prototypes and functional components. Laser beam melting (LBM), the most frequently used Additive Manufacturing technology for metal parts, has been gaining in industrial importance for several years. The LBM process chain – from material storage to machine set-up and component post-processing – requires many manual operations. These steps often depend on the manufactured component and are therefore not standardized. These operations are often not performed in a standardized manner, but depend on the experience of the machine operator, e.g., levelling of the build plate and adjusting the first powder layer in the LBM machine. This lack of standardization limits the reproducibility of the component quality. When processing metal powders with inhalable and alveolar particle fractions, the machine operator is at high risk due to the high reactivity and the toxic (e.g., carcinogenic) effect of the various metal powders. Faulty execution of the operation or unintentional omission of safety-relevant steps can impair the health of the machine operator. In this paper, all the steps of the LBM process chain are first analysed in terms of their influence on the two aforementioned challenges: reproducibility and work safety. Standardization to avoid errors increases the reproducibility of component quality as well as the adherence to and correct execution of safety-relevant operations. The corresponding lean method 5S will therefore be applied, in order to develop approaches in the form of recommended actions that standardize the work processes. These approaches will then be evaluated in terms of ease of implementation and their potential for improving reproducibility and work safety. The analysis and evaluation showed that sorting tools and spare parts as well as standardizing the workflow are likely to increase reproducibility. Organizing the operational steps and production environment decreases the hazards of material handling and consequently improves work safety.

Keywords: additive manufacturing, lean production, reproducibility, work safety

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Authors: Mihaela Munteanu (Pila), Silvius Stanciu

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This paper presents the aspects of the official control of fishery in the Republic of Moldova. Currently, the regulations and the activity of national institutions with responsibilities in the field of food quality are in a process of harmonization with the European rules, aiming at European integration, quality improvement and providing a higher level of food safety. The National Agency for Food Safety is the main national body with responsibilities in the field of food safety. In the field of fishery products, the Agency carries out an intensive activity of informing the citizen and controlling the products marketed. The paper presents the dangers related to the consumption of fish and fishery products traded on the national market, the sanitary-veterinary inspections conducted by the profile institution and the improper situations identified. The national market of fishery products depends largely on imports, mainly focused on ocean fish. The research carried out has shown that during the period 2011-2018, following the inspections carried out on fishery products traded on the national market, a number of inconsistencies have been identified. Thus, indigenous products were frequently detected with sensory characteristics unfit for consumption, and being commercialized in inappropriate locations or contaminated with chemical pollutants. On import products controlled, the most frequent inconsistent situations have been represented by inconsistent sensory aspects and by parasite contamination. Taking into account the specific aspects of aquatic products, including the high level of alterability, special conditions of growth, marketing, culinary preparation and consumption are necessary in order to decrease the risk of disease over the population. Certificates, attestations and other documents certifying the quality of batches, completed by additional laboratory examinations, are necessary in order to increase the level of confidence on the quality of products marketed in the Republic. The implementation of various control procedures and mechanisms at national level, correlated with the focused activity of the specialized institutions, can decrease the risk of contamination and avoid cases of disease on the population due to the consumption of fishery products.

Keywords: fishery products, food safety, quality control, Republic of Moldova

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Authors: Omar Shakra

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This paper contains a huge number of benefits that we can use it in several places and times in fire safety protection in the Middle East especially in Egypt . People here in Egypt did not consider the safety and fire protection as important as it is. But on the other hand, its very important for them to contain the fire systems and safety in every facility, the companies , hospitals , police stations , and even the super markets must use the fire system. It makes the facility safe to the visitors while they are using it.From my point of view as the owner Fire Safety Company called Deluge Egypt , i can say that not all of the companies use the fire system protection according to the high cost they prefer to build their company without the protection, and this is make the building totally unsafe to be used from the visitors or client.So, i am looking for new methods and technology to invest in Egypt, and this is through attending this Conference and let the audiences know more about the services i provide and [to let them know about the importance of the Fire Safety in Egypt. The Objectives of my research 1- The system that i used in my Company. 2- The benefits of the Fire System Protection. 3-The importance of the Fire System and safety. 4-The use of the new Technologies. 5-The hardships that i found while having new deals with new clients.

Keywords: fire, system, protection, fire hydrants, security, alarms

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Authors: Alexandru Achim, Tamás Szűcsborus, Viktor Sasi, Ferenc Nagy, Zoltán Jambrik, Attila Nemes, Albert Varga, Călin Homorodean, Olivier F. Bertrand, Zoltán Ruzsa

Abstract:

Aim: Our study aimed to establish the safety and the technical success of distal radial access for balloon aortic valvuloplasty (DR-BAV). The secondary objective was to determine the effectiveness and appropriate role of DR-BAV within half year follow-up. Methods: Clinical and angiographic data from 32 consecutive patients with symptomatic aortic stenosis were evaluated in a prospective pilot single-center study. Between 2020 and 2021, the patients were treated utilizing dual distal radial access with 6-10F compatible balloons. The efficacy endpoint was divided into technical success (successful valvuloplasty balloon inflation at the aortic valve and absence of intra- or periprocedural major complications), hemodynamic success (a reduction of the mean invasive gradient >30%), and clinical success (an improvement of at least one clinical category in the NYHA classification). The safety endpoints were vascular complications (major and minor Valve Academic Research Consortium (VARC)-2 bleeding, diminished or lost arterial pulse or the presence of any pseudo-aneurysm or arteriovenous fistula during the clinical follow-up) and major adverse events, MAEs (the composite of death, stroke, myocardial infarction, and urgent major aortic valve replacement or implantation during the hospital stay and or at one-month follow-up). Results: 32 patients (40 % male, mean age 80 ± 8,5) with severe aortic valve stenosis were included in the study and 4 patients were excluded. Technical success was achieved in all patients (100%). Hemodynamic success was achieved in 30 patients (93,75%). Invasive max and mean gradients were reduced from 73±22 mm Hg and 49±22 mm Hg to 49±19 mm Hg and 20±13 mm Hg, respectively (p = <.001). Clinical success was achieved in 29 patients (90,6%). In total, no major adverse cardiac or cerebrovascular event nor vascular complications (according to VARC 2 criteria) occurred during the intervention. All-cause death at 6 months was 12%. Conclusion: According to our study, dual distal radial artery access is a safe and effective option for balloon aortic valvuloplasty in patients with severe aortic valve stenosis and can be performed in all patients with sufficient lumen diameter. Future randomized studies are warranted to investigate whether this technique is superior to other approaches.

Keywords: mean invasive gradient, distal radial access for balloon aortic valvuloplasty (DR-BAV), aortic valve stenosis, pseudo-aneurysm, arteriovenous fistula, valve academic research consortium (VARC)-2

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Authors: Armin Khaghani Boroujeni, Leila Dehghani, Parham Talebi Boroujeni, Sahar Rostamian, Ali Asilian

Abstract:

Background: Hair loss is a common complaint observed in both genders. Androgenetic alopecia is known pattern for hair loss. To assess new regenerative strategies (PRP, A-SC-BT, conditioned media, exosome-based treatments) compared to conventional therapies for hair loss or hair regeneration, an updated review was undertaken. To address this issue, we carried out this systematic review to comprehensively evaluate the efficacy of cell-based therapies on hair loss. Methods: The available online databases, including ISI Web of Science, Scopus, and PubMed, were searched systematically up to February 2022. The quality assessment of included studies was done using the Cochrane Collaboration's tool. Results: As a result, a total of 90 studies involving 2345 participants were included in the present study. The enrolled studies were conducted between 2010 and 2022. The subjects’ mean age ranged from 19 to 55.11 years old. Approaches using platelet rich plasma (PRP) provide a beneficial impact on hair regrowth. However, other cell-based therapies, including stem cell transplant, stem cell-derived conditioned medium, and stem cell-derived exosomes, revealed conflicting evidence. Conclusion: However, cell-based therapies for hair loss are still in their infancy, and more robust clinical studies are needed to better evaluate their mechanisms of action, efficacy, safety, benefits, and limitations. In this review, we provide the resources to the latest clinical studies and a more detailed description of the latest clinical studies concerning cell-based therapies in hair loss.

Keywords: cell-based therapy, exosome, hair restoration, systematic review

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Authors: Somaye Ghafarpour, Kamran Yazdanbakhsh, Mohamad Reza Zarbakhsh, Simin Hosseinian, Samira Ghafarpour

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Unsatisfactory sleep quality is one of the most common complications of pregnancy, which can predispose mothers to postpartum depression, requiring implementing effective psychological interventions to prevent and modify behaviors accentuating sleep problems. This study was a randomized clinical controlled trial with a pre-test/post-test design aiming to investigate the effectiveness of sleep behavioral interventions during the third trimester of pregnancy on sleep quality and postpartum depression. A total of 50 pregnant mothers in the 26-30 weeks of pregnancy suffering from sleep problems (based on the score obtained from the Pittsburgh Sleep Questionnaire) were randomized into two groups (control and intervention, n= 25 per group). The data were collected using interviews, the Pittsburgh Sleep Quality Index (PSQI), and the Edinburgh Postnatal Depression Scale (EPDS) were used. The participants in the intervention group received eight 60-minute sessions of combinational training for behavioral therapy techniques. At the end of the intervention and four weeks after delivery, sleep quality and postpartum depression were evaluated. Considering that the Kolmogorov Smirnov test confirmed the normal distribution of the data, the independent t-test and analysis of covariance were used to analyze the data, showing that the behavioral interventions were effective on the overall sleep quality after delivery (p=0.001); however, no statistically significant effects were observed on postpartum depression, the sub-scales of sleep disorders, and daily functioning (p>0.05). Considering the potential effectiveness of behavioral interventions in improving sleep quality and alleviating insomnia symptoms, it is recommended to implement such measures as an effective intervention to prevent or treat these problems during prenatal and postnatal periods.

Keywords: behavioral interventions, sleep quality, postpartum depression, pregnancy, delivery

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Authors: Tuula Heinonen, Wilhelm Gaus

Abstract:

At present safety, assessment starts with animal tests although their predictivity is often poor. Even after extended human use experimental data are often judged as the core information for risk assessment. However, the best opportunity to generate true evidence is to match all available information. Cross matching methodology combines the different fields of knowledge and types of data (e.g. in-vitro and in-vivo experiments, clinical observations, clinical and epidemiological studies, and daily life observations) and gives adequate weight to individual findings. To achieve a consolidated outcome, the information from all available sources is analysed and compared with each other. If single pieces of information fit together a clear picture becomes visible. If pieces of information are inconsistent or contradictory careful consideration is necessary. 'Cross' can be understood as 'orthographic' in geometry or as 'independent' in mathematics. Results coming from different sources bring independent and; therefore, they result in new information. Independent information gives a larger contribution to evidence than results coming repeatedly from the same source. A successful example of cross matching is the assessment of Ginkgo biloba where we were able to come to the conclusive result: Ginkgo biloba leave extract is well tolerated and safe for humans.

Keywords: cross-matching, human use, safety assessment, Ginkgo biloba leave extract

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Authors: Mette Kjerholt, Thora Grothe Thomsen, Connie Bøttcher Berthelsen, Bibi Hølge Hazelton

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Academic nursing is a relatively new phenomenon in Denmark. Leadership and management training in nursing does not prepare Danish nurse leaders to become leaders for nurses with academic background, and some leaders may feel estranged with including this kind of nursing staff in clinical settings. Currently there is a debate regarding what academic nurses can contribute with in clinical practice, and some managers express concern regarding whether this will lead to less focus on clinical practice and more focus on theoretical issues that may not seem so relevant in a busy everyday clinical setting. The paper will present the experiences of integrating three advanced nurse practitioners with Ph.D. degrees (ANP) in three different clinical departments at a regional hospital in Denmark with no prior experiences with such profiles among its staff.

Keywords: leadership, advanced nurse practitioners, clinical practice, academic nursing

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Authors: Enoch F. Sam, Kris Brijs, Stijn Daniels, Tom Brijs, Geert Wets

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Notwithstanding the growing body of literature that recognises the importance of personal safety to public transport (PT) users, it remains unclear what PT users consider regarding their safety. In this study, we explore the criteria PT users in Ghana use to assess bus safety. This knowledge will afford a better understanding of PT users’ risk perceptions and assessments which may contribute to theoretical models of PT risk perceptions. We utilised phenomenological research methodology, with data drawn from 61 purposively sampled participants. Data collection (through focus group discussions and in-depth interviews) and analyses were done concurrently to the point of saturation. Our inductive data coding and analyses through the constant comparison and content analytic techniques resulted in 4 code categories (conceptual dimensions), 27 codes (safety items/criteria), and 100 quotations (data segments). Of the number of safety criteria participants use to assess bus safety, vehicle condition, driver’s marital status, and transport operator’s safety records were the most considered. With each criterion, participants rightly demonstrated its respective relevance to bus safety. These findings imply that investment in and maintenance of safer vehicles, and responsible and safety-conscious drivers, and prioritization of passengers’ safety are key-targets for public bus/minibus operators in Ghana.

Keywords: safety evaluations, public bus/minibus, passengers, phenomenology, Ghana

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Authors: Siyathorn Khunon, Thanawit Buafai

Abstract:

This paper aims to investigate management of beach safety with a focus on tourist drownings in Samui. The data collected in this investigation will then lead to the proposal of a practical management model suitable for use in Samui. Qualitative research was conducted in the following manner: nine stakeholders from local government organizations and tourism businesses were interviewed in-depth. Additionally, a best practice case study from Phuket was applied to analyze beach safety. Twelve foreign tourists were also interviewed. Then, a focus group comprised of 32 people was used to determine practical solutions for enhancing tourists’ safety on the beach in Samui. A steering committee to coordinate between public and private organizations was proposed to manage and enhance tourists’ safety. A practical model is proposed to increase the safety level of tourists in Samui

Keywords: beach safety, drowning, tourist, Samui

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Authors: Hideyuki Shintani, Ichiro Koshijima

Abstract:

In Cyber Physical System (CPS), if there are a large number of persons in the process, a role of person in CPS might be different comparing with the one-man system. It is also necessary to consider how Human-in-The-Loop Cyber Physical Systems (HiTLCPS) ensure safety of each person in the loop process. In this paper, the authors discuss a system safety framework with an illustrative example with STAMP model to clarify what point for safety should be considered and what role of person in the should have.

Keywords: cyber-physical-system, human-in-the-loop, safety, STAMP model

Procedia PDF Downloads 325

Authors: Salma Ainine, Colin Ritchie, Tracey McFee

Abstract:

Background: The societal impact of antibiotic resistance is a major public health concern. The increase in the incidence of resistant bacteria can ultimately be fatal. Objective: To analyse the appropriateness of antibiotic prescribing in Dundee Dental Hospital, ultimately improving the safety and quality of patient care. Methods: Two examiners independently cross-checked approximately fifty consecutive prescriptions, and corresponding patient case notes, for three data collection cycles between August 2014–September 2015. The Scottish Dental Clinical Effectiveness Program (SDCEP) Drug Prescribing for Dentistry guidelines was the standard utilised. The criteria: clinical justification, regime justification, and review arrangements was measured, and compared to the standard. Results: Cycle one revealed 42% of antibiotic prescriptions were appropriate. Interventions included: multiple staff meetings, an introduction of a checklist attached to the prescription pack, and production of patient leaflets explaining indications for antibiotics. Cycle two and three revealed 44%, and 30% compliance, respectively. Conclusion: The results of the audit have yet to meet target standards set out in prescribing guidelines. However, steps are being taken and change has occurred on a cultural level.

Keywords: antibiotic resistance, antibiotic stewardship, dental infection, hygiene standards

Procedia PDF Downloads 225