Search results for: clinical quality and safety

Authors: Jehad Al Dallal

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Software engineers apply different measures to quantify the quality of software design. These measures consider artifacts developed at low or high level software design phases. The results are used to point to design weaknesses and to indicate design points that have to be restructured. Understanding the relationship among the quality measures and among the design quality aspects considered by these measures is important to interpreting the impact of a measure for a quality aspect on other potentially related aspects. In addition, exploring the relationship between quality measures helps to explain the impact of different quality measures on external quality aspects, such as reliability and maintainability. In this paper, we report a replication study that empirically explores the correlation between six well known and commonly applied design quality measures. These measures consider several quality aspects, including complexity, cohesion, coupling, and inheritance. The results indicate that inheritance measures are weakly correlated to other measures, whereas complexity, coupling, and cohesion measures are mostly strongly correlated.  

Keywords: quality attribute, quality measure, software design quality, Spearman correlation

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Authors: Sheraz Gul

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The requirements for progressing a compound to clinical trials is well established and relies on the results from in-vitro and in-vivo animal tests to indicate that it is likely to be safe and efficacious when testing in humans. The typical data package required will include demonstrating compound safety, toxicity, bioavailability, pharmacodynamics (potential effects of the compound on body systems) and pharmacokinetics (how the compound is potentially absorbed, distributed, metabolised and eliminated after dosing in humans). If the desired criteria are met and the compound meets the clinical Candidate criteria and is deemed worthy of further development, a submission to regulatory bodies such as the US Food & Drug Administration for an exploratory Investigational New Drug Study can be made. The purpose of this study is to collect data to establish that the compound will not expose humans to unreasonable risks when used in limited, early-stage clinical studies in patients or normal volunteer subjects (Phase I). These studies are also designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on their effectiveness. In order to reach the above goals, we have developed a pre-clinical high throughput Absorption, Distribution, Metabolism and Excretion–Toxicity (ADME–Toxicity) panel of assays to identify compounds that are likely to meet the Lead and Candidate compound acceptance criteria. This panel includes solubility studies in a range of biological fluids, cell viability studies in cancer and primary cell-lines, mitochondrial toxicity, off-target effects (across the kinase, protease, histone deacetylase, phosphodiesterase and GPCR protein families), CYP450 inhibition (5 different CYP450 enzymes), CYP450 induction, cardio-toxicity (hERG) and gene-toxicity. This panel of assays has been applied to multiple compound series developed in a number of projects delivering Lead and clinical Candidates and examples from these will be presented.

Keywords: absorption, distribution, metabolism and excretion–toxicity , drug discovery, food and drug administration , pharmacodynamics

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Authors: Henok Girma Abebe

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The Vision Zero is a long-term goal of preventing all road traffic fatalities and serious injuries which was first adopted in Sweden in 1997. It is based on the assumption that death and serious injury in the road system is morally unacceptable. In order to approach this end, vision zero has put in place strategies that are radically different from the traditional safety work. The vision zero, for instance, promoted the adoption of the best available technology to promote safety, and placed the ultimate responsibility for traffic safety on system designers. Despite Vision Zero’s moral appeal and its expansion to different safety areas and also parts of the world, important philosophical concerns related to the adoption and implementation of the vision zero remain to be addressed. Moreover, the vision zero goal has been criticized on different grounds. The aim of this paper is to identify and systematically categorize criticisms that have been put forward against vision zero. The findings of the paper are solely based on a critical analysis of secondary sources and snowball method is employed to identify the relevant philosophical and empirical literatures. Two general categories of criticisms on the vision zero goal are identified. The first category consists of criticisms that target the setting of vision zero as a ‘goal’ and some of the basic assumptions upon which the goal is based. Among others, the goal of achieving zero fatalities and serious injuries, together with vision zero’s lexicographical prioritization of safety has been criticized as unrealistic. The second category consists of criticisms that target the strategies put in place to achieve the goal of zero fatalities and serious injuries. For instance, Vision zero’s responsibility ascription for road safety and its rejection of cost-benefit analysis in the formulation and adoption of safety measures has both been criticized as counterproductive. In this category also falls the criticism that Vision Zero safety measures tend to be too paternalistic. Significant improvements have been recorded in road safety work since the adoption of vision zero, however, for the vision zero to even succeed more, it is important that issues and criticisms of philosophical nature associated with it are identified and critically dealt with.

Keywords: criticisms, systems approach, traffic safety, vision zero

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Authors: Weic-Ting Chen, Jo-Ming Tseng

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Ammonium nitrate (AN) has caused many accidents in the world, which have caused a large number of people’s life and serious economic losses. In this study, the safety of the AN production process was discussed deeply, and the influence of incompatible substances was estimated according to the change of their heat value by mixing them with incompatible substances by thermal analysis techniques, and their safety parameters were calculated according to their kinetic parameters. In this study, differential scanning calorimeters (DSC) were applied for the temperature rise test and adiabatic thermal analysis in combination with the Advanced Reactive System Screening Tool (ARSST). The research results could contribute to the safety of the ammonium nitrate production process. Manufacturers can better understand the possibility of chemical heat release and the operating conditions that will cause a chemical reaction to be out of control when storing or adding new substances, so safety parameters were researched for these complex reactions. The results of this study will benefit the process of AN and the relevant staff, which also have safety protection in the working environment.

Keywords: ammonium nitrate, incompatible substances, differential scanning calorimeters, advanced reactive system screening tool, safety parameters

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Authors: Assile Abou Diab, Shadi Najjar

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Fiber-reinforcement is an effective soil improvement technique for applications involving the prevention of shallow failures on the slope face and the repair of existing slope failures. A typical application is the stabilization of cohesionless infinite slopes. The objective of this paper is to present a probabilistic, reliability-based methodology (based on Monte Carlo simulations) for the design of a practical fiber-reinforced cohesionless infinite slope, taking into consideration the impact of various sources of uncertainty. Recommendations are made regarding the required factors of safety that need to be used to achieve a given target reliability level. These factors of safety could differ from the traditional deterministic factor of safety.

Keywords: factor of safety, fiber reinforcement, infinite slope, reliability-based design, uncertainty

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Authors: Choon Seong Ng, P. Petrick, C. L. Lau

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Background: Carbapenem-resistant isolates have been increasingly reported recently. Carbapenem stewardship is designed to optimize its usage particularly among medical wards with high prevalence of carbapenem prescriptions to combat such emerging resistance. Carbapenem stewardship programmes (CSP) can reduce antibiotic use but clinical outcome of such measures needs further evaluation. We examined this in a prospective manner using feedback mechanism. Methods: Our single-center prospective cohort study involved all carbapenem prescriptions across the medical wards (including medical patients admitted to intensive care unit) in a tertiary university hospital setting. The impact of such stewardship was analysed according to the accepted and the rejected groups. The primary endpoint was safety. Safety measure applied in this study was the death at 1 month. Secondary endpoints included length of hospitalisation and readmission. Results: Over the 19 months’ period, input from 144 carbapenem prescriptions was analysed on the basis of acceptance of our CSP recommendations on the use of carbapenems. Recommendations made were as follows : de-escalation of carbapenem; stopping the carbapenem; use for a short duration of 5-7 days; required prolonged duration in the case of carbapenem-sensitive Extended Spectrum Beta-Lactamases bacteremia; dose adjustment; and surgical intervention for removal of septic foci. De-escalation, shorten duration of carbapenem and carbapenem cessation comprised 79% of the recommendations. Acceptance rate was 57%. Those who accepted CSP recommendations had no increase in mortality (p = 0.92), had a shorter length of hospital stay (LOS) and had cost-saving. Infection-related deaths were found to be higher among those in the rejected group. Moreover, three rejected cases (6%) among all non-indicated cases (n = 50) were found to have developed carbapenem-resistant isolates. Lastly, Pitt’s bacteremia score appeared to be a key element affecting the carbapenem prescription’s behaviour in this trial. Conclusions: Carbapenem stewardship program in the medical wards not only saves money, but most importantly it is safe and does not harm the patients with added benefits of reducing the length of hospital stay. However, more time is needed to engage the primary clinical teams by formal clinical presentation and immediate personal feedback by senior Infectious Disease (ID) personnel to increase its acceptance.

Keywords: audit and feedback, carbapenem stewardship, medical wards, university hospital

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Authors: Danying Gu, Xiaoyan Li, Yuanlei He

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As a knowledge-intensive industry, nuclear industry highly values the importance of safety and quality. The life cycle of a NPP (Nuclear Power Plant) can last 100 years from the initial research and design to its decommissioning. How to implement the high-quality knowledge management and how to contribute to a more safe, advanced and economic NPP (Nuclear Power Plant) is the most important issue and responsibility for knowledge management. As the lead of nuclear industry, nuclear research and design institute has competitive advantages of its advanced technology, knowledge and information, DKM (Design Knowledge Management) of nuclear research and design institute is the core of the knowledge management in the whole nuclear industry. In this paper, the study and practice on DKM and knowledge transfer across the life cycle of a new-built NPP in China is introduced. For this digital intelligent NPP, the whole design process is based on a digital design platform which includes NPP engineering and design dynamic analyzer, visualization engineering verification platform, digital operation maintenance support platform and digital equipment design, manufacture integrated collaborative platform. In order to make all the design data and information transfer across design, construction, commissioning and operation, the overall architecture of new-built digital NPP should become a modern knowledge management system. So a digital information transfer model across the NPP life cycle is proposed in this paper. The challenges related to design knowledge transfer is also discussed, such as digital information handover, data center and data sorting, unified data coding system. On the other hand, effective delivery of design information during the construction and operation phase will contribute to the comprehensive understanding of design ideas and components and systems for the construction contractor and operation unit, largely increasing the safety, quality and economic benefits during the life cycle. The operation and maintenance records generated from the NPP operation process have great significance for maintaining the operating state of NPP, especially the comprehensiveness, validity and traceability of the records. So the requirements of an online monitoring and smart diagnosis system of NPP is also proposed, to help utility-owners to improve the safety and efficiency.

Keywords: design knowledge management, digital nuclear power plant, knowledge transfer, life cycle

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Authors: Rihab Gamaoun, Cynthia El Hage, Laura Ruiz, Erin Prosk, Antonio Vigano

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Introduction: Santé Cannabis (SC), a Canadian medical cannabis-specialized group of clinics based in Montreal and in the province of Québec, has served more than 5000 patients seeking cannabis-based treatment prescription for medical indications over the past five years. Within a research frame, data on the use of medical cannabis products from all the above patients were prospectively collected, leading to a large real-world database on the use of medical cannabis. The aim of this study was to gather information on the profiles of both patients and prescribed medical cannabis products at SC clinics and to assess the safety of medical cannabis among Canadian patients. Methods: Using a retrospective analysis of the database, records of 2585 patients who were prescribed medical cannabis products for therapeutic purposes between 01-November 2017 and 04-September 2019 were included. Patients’ demographics, primary diagnosis, route of administration, and chemovars recorded at the initial visits were investigated. Results: At baseline: 9% of SC patients were female, with a mean age of 57 (SD= 15.8, range= [18-96]); Cannabis products were prescribed mainly for patients with a diagnosis of chronic pain (65.9% of patients), cancer (9.4%), neurological disorders (6.5%), mood disorders (5.8 %) and inflammatory diseases (4.1%). Route of administration and chemovars of prescribed cannabis products were the following: 96% of patients received cannabis oil (51% CBD rich, 42.5% CBD:THC); 32.1% dried cannabis (21.3% CBD:THC, 7.4% THC rich, 3.4 CBD rich), and 2.1% oral spray cannabis (1.1% CBD:THC, 0.8% CBD rich, 0.2% THC rich). Most patients were prescribed simultaneously, a combination of products with different administration routes and chemovars. Safety analysis is undergoing. Conclusion: Our results provided initial information on the profile of medical cannabis products prescribed in a Canadian population and the experienced adverse events over the past three years. The Santé Cannabis database represents a unique opportunity for comparing clinical practices in prescribing and titrating cannabis-based medications across different centers. Ultimately real-world data, including information about safety and effectiveness, will help to create standardized and validated guidelines for choosing dose, route of administration, and chemovars types for the cannabis-based medication in different diseases and indications.

Keywords: medical cannabis, real-world data, safety, pharmacovigilance

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Authors: Eric Lee G. Escobedo-Wu, Nidhi Rohatgi, Fouzel Dhebar

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It is challenging for patients to navigate through healthcare systems after-hours. This leads to delays in care, patient/provider dissatisfaction, inappropriate resource utilization, readmissions, and higher costs. It is important to provide patients and providers with effective clinical decision-making tools to allow seamless connectivity and coordinated care. In August 2015, patient-centric Stanford Health Care established Clinical Advice Services (CAS) to provide clinical decision support after-hours. CAS is founded on key Lean principles: Value stream mapping, empathy mapping, waste walk, takt time calculations, standard work, plan-do-check-act cycles, and active daily management. At CAS, Clinical Assistants take the initial call and manage all non-clinical calls (e.g., appointments, directions, general information). If the patient has a clinical symptom, the CAS nurses take the call and utilize standardized clinical algorithms to triage the patient to home, clinic, urgent care, emergency department, or 911. Nurses may also contact the on-call physician based on the clinical algorithm for further direction and consultation. Since August 2015, CAS has managed 228,990 calls from 26 clinical specialties. Reporting is built into the electronic health record for analysis and data collection. 65.3% of the after-hours calls are clinically related. Average clinical algorithm adherence rate has been 92%. An average of 9% of calls was escalated by CAS nurses to the physician on call. An average of 5% of patients was triaged to the Emergency Department by CAS. Key learnings indicate that a seamless connectivity vision, cascading, multidisciplinary ownership of the problem, and synergistic enterprise improvements have contributed to this success while striving for continuous improvement.

Keywords: after hours phone calls, clinical advice services, nurse triage, Stanford Health Care

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Authors: Boo-Sung Koh, Seung-Eock Kim

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In this paper, a direct design using a nonlinear inelastic analysis is suggested. Also, this paper compares the load carrying capacity obtained by a nonlinear inelastic analysis with experiment results to verify the accuracy of the results. The allowable stress design results of a railroad through a plate girder bridge and the safety factor of the nonlinear inelastic analysis were compared to examine the safety performance. As a result, the load safety factor for the nonlinear inelastic analysis was twice as high as the required safety factor under the allowable stress design standard specified in the civil engineering structure design standards for urban magnetic levitation railways, which further verified the advantages of the proposed direct design method.

Keywords: direct design, nonlinear inelastic analysis, residual stress, initial geometric imperfection

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Authors: Michael Scott Evans, Andrew Smith

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The feeling of fatigue at work could potentially have devastating consequences. The aim of this study was to investigate whether the well-established objective indicator of fatigue – the Fatigue Risk Index (FRI) calculator used by the rail industry is an effective indicator to the number of safety incidents, in which fatigue could have been a contributing factor. The study received ethics approval from Cardiff University’s Ethics Committee (EC.16.06.14.4547). A total of 901 safety incidents were recorded from a single British rail franchise between 1st June 2010 – 31st December 2016, into the Safety Management Information System (SMIS). The safety incident types identified that fatigue could have been a contributing factor were: Signal Passed at Danger (SPAD), Train Protection & Warning System (TPWS) activation, Automatic Warning System (AWS) slow to cancel, failed to call, and station overrun. From the 901 recorded safety incidents, the scheduling system CrewPlan was used to extract the Fatigue Index (FI) score and Risk Index (RI) score of all train drivers on the day of the safety incident. Only the working rosters of 64.2% (N = 578) (550 men and 28 female) ranging in age from 24 – 65 years old (M = 47.13, SD = 7.30) were accessible for analyses. Analysis from all 578 train drivers who were involved in safety incidents revealed that 99.8% (N = 577) of Fatigue Index (FI) scores fell within or below the identified guideline threshold of 45 as well as 97.9% (N = 566) of Risk Index (RI) scores falling below the 1.6 threshold range. Their scores represent good practice within the rail industry. These findings seem to indicate that the current objective indicator, i.e. the FRI calculator used in this study by the British rail franchise was not an effective predictor of train driver’s FI scores and RI scores, as safety incidents in which fatigue could have been a contributing factor represented only 0.2% of FI scores and 2.1% of RI scores. Further research is needed to determine whether there are other contributing factors that could provide a better indication as to why there is such a significantly large proportion of train drivers who are involved in safety incidents, in which fatigue could have been a contributing factor have such low FI and RI scores.

Keywords: fatigue risk index calculator, objective indicator of fatigue, rail industry, safety incident

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Authors: Eun Hak Lee, Young-Hyun Seo, Hosuk Shin, Seung-Young Kho

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Among traffic crashes, driving under the influence (DUI) of alcohol is the most dangerous behavior in Seoul, South Korea. In 2016 alone 40 deaths occurred on of 2,857 cases of DUI. Since DUI is one of the major factors in increasing the severity of crashes, the intensive management of DUI required to reduce traffic crash deaths and the crash damages. This study aims to investigate the relationship between DUI and traffic safety in order to establish countermeasures for traffic safety improvement. The analysis was conducted on the habitual drivers who drove under the influence. Information of habitual drivers is matched to crash data and fine data. The descriptive statistics on data used in this study, which consists of driver license acquisition, traffic fine, and crash data provided by the Korean National Police Agency, are described. The drivers under the influence are classified by statistically significant criteria, such as driver’s age, license type, driving experience, and crash reasons. With the results of the analysis, we propose some countermeasures to enhance traffic safety.

Keywords: driving under influence, traffic safety, traffic crash, traffic fine

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Authors: Karla Lebedoff, Susan Walsh, Michelle Bain

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Eczema is a chronic atopy condition requiring long-term daily management in children. Written action plans for other chronic atopic conditions, such as asthma and food allergies, are widely recommended and distributed to pediatric patients' parents and caregivers, seeking to improve clinical outcomes and become empowered to manage the patient's ever-changing symptoms. Written action plans for eczema, referred to as "asthma of the skin," are not routinely used in practice. Parents of children suffering from eczema rarely receive a written action plan to follow, and commendations supporting eczema action plans are inconsistent. Pediatric patients between birth and 18 years old who were followed for eczema at an urban Midwest community hospital were eligible to participate in this quality improvement project. At the initial visit, parents received instructions on individualized eczema action plans for their child and completed two validated surveys: Health Confidence Score (HCS) and Patient-Oriented Eczema Measure (POEM). Pre- and post-survey responses were collected, and clinical symptom presentation at follow-up were outcome determinants. Project implementation was guided by Institute for Healthcare Improvement's Step-up Framework and the Plan-Do-Study-Act cycle. This project measured clinical outcomes and parent confidence in self-management of their child's eczema symptoms with the responses from 26 participant surveys. Pre-survey responses were collected from 36 participants, though ten were lost to follow-up. Average POEM scores improved by 53%, while average HCS scores remained unchanged. Of seven completed in-person follow-up visits, six clinical progress notes documented improvement. Individualized eczema action plans can be seamlessly incorporated into primary and specialty care visits for pediatric patients suffering from eczema. Following a patient-specific eczema action plan may lessen the daily physical and mental burdens of uncontrolled eczema for children and parents, managing symptoms that chronically flare and recede. Furthermore, incorporating eczema action plans into practice potentially reduces the likely underestimated $5.3 billion economic disease burden of eczema on the U.S. healthcare system.

Keywords: atopic dermatitis, eczema action plan, eczema symptom management, pediatric eczema

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Authors: Afolabi O.J, Simon-Oke I.A., Oniya M.O., Okaka C.E.

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River blindness is a skin, and an eye disease caused by Onchocerca volvulus and vectored by a female hematophagous blackfly. The study aims to evaluate the distribution of the clinical signs of river blindness and the efficacy of ivermectin in the treatment of river blindness in Idogun. Observational studies in epidemiology that involve the use of a structured questionnaire to obtain useful epidemiological information from the respondents, physical assessment via palpation from head to ankle was used to assess clinical signs from the respondents and skin snip test was used to evaluate the prevalence of the disease. The efficacy of the drug was evaluated and expressed in percentages. One hundred and ninety-two (192) out of the 384 respondents examined, showed various signs of river blindness. However, it was only 108 (28.1%) respondents with the clinical signs that demonstrated Onchocerca volvulus microfilariae in their skin snips. The clinical signs observed among the respondents include skin depigmentation such as dermatitis, leopard skin, papules, pruritus and self-inflicted injury, while ocular symptoms include cataract, ocular lesion and partial blindness. Among these clinical signs, papules, and pruritus were the most dominant in the community. The prevalence of the clinical signs was observed to vary significantly among the age groups and gender (P<0.05). The efficacy of the drug after 6 and 12 months of treatments shows that the drug is more effective at age groups 10-50 years than the age groups 51-90 years. Ivermectin is observed to be efficacious in the treatment of the disease. However, to achieve eradication of the disease, the drug may be administered at 0.15mg/kg twice a year.

Keywords: riverblindness, clinical signs, ivermectin, Idogun

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Authors: Mahmoud Ahmed Farrag, Ali Zain Elabdeen Heikal, Mohamed Shawky Ahmed, Ahmed Osama Amer

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Crowd-sourced data refers to data that is collected and shared by a large number of individuals or organizations, often through the use of digital technologies such as mobile devices and social media. The shortage in crash data collection in developing countries makes it difficult to fully understand and address road safety issues in these regions. In developing countries, crowd-sourced data can be a valuable tool for improving road safety, particularly in urban areas where the majority of road crashes occur. This study is -to our best knowledge- the first to develop safety performance functions using crowd-sourced data by adopting a negative binomial structure model and the Full Bayes model to investigate traffic safety for urban road networks and provide insights into the impact of roadway characteristics. Furthermore, as a part of the safety management process, network screening has been undergone through applying two different methods to rank the most hazardous road segments: PCR method (adopted in the Highway Capacity Manual HCM) as well as a graphical method using GIS tools to compare and validate. Lastly, recommendations were suggested for policymakers to ensure safer roads.

Keywords: crowdsourced data, road crashes, safety performance functions, Full Bayes models, network screening

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Authors: Osman Turkoglu, Alvin Estilo, Ritu Gupta, Liliam Pineda-Salgado, Rajesh Pandey

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Background: Hepatotoxicity can be linked to a variety of clinical symptoms and histopathological signs, posing a great challenge in the surveillance of suspected drug-induced liver injury (DILI) cases in the safety database. Additionally, the majority of such cases are rare, idiosyncratic, highly unpredictable, and tend to demonstrate unique individual susceptibility; these qualities, in turn, lend to a pharmacovigilance monitoring process that is often tedious and time-consuming. Objective: Develop a multifactorial algorithm to assist pharmacovigilance physicians in identifying high-risk hepatotoxicity cases associated with DILI from the sponsor’s safety database (Argus). Methods: Multifactorial selection criteria were established using Structured Query Language (SQL) and the TIBCO Spotfire® visualization tool, via a combination of word fragments, wildcard strings, and mathematical constructs, based on Hy’s law criteria and pattern of injury (R-value). These criteria excluded non-eligible cases from monthly line listings mined from the Argus safety database. The capabilities and limitations of these criteria were verified by comparing a manual review of all monthly cases with system-generated monthly listings over six months. Results: On an average, over a period of six months, the algorithm accurately identified 92% of DILI cases meeting established criteria. The automated process easily compared liver enzyme elevations with baseline values, reducing the screening time to under 15 minutes as opposed to multiple hours exhausted using a cognitively laborious, manual process. Limitations of the algorithm include its inability to identify cases associated with non-standard laboratory tests, naming conventions, and/or incomplete/incorrectly entered laboratory values. Conclusions: The newly developed multifactorial algorithm proved to be extremely useful in detecting potential DILI cases, while heightening the vigilance of the drug safety department. Additionally, the application of this algorithm may be useful in identifying a potential signal for DILI in drugs not yet known to cause liver injury (e.g., drugs in the initial phases of development). This algorithm also carries the potential for universal application, due to its product-agnostic data and keyword mining features. Plans for the tool include improving it into a fully automated application, thereby completely eliminating a manual screening process.

Keywords: automation, drug-induced liver injury, pharmacovigilance, post-marketing

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Authors: Mohsen Shirani, Micaela Demichela

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Food supply chain is one of the most complex supply chain networks due to its perishable nature and customer oriented products, and food safety is the major concern for this industry. IT system could help to minimize the production and consumption of unsafe food by controlling and monitoring the entire system. However, there have been many issues in adoption of IT system in this industry specifically within SMEs sector. With this regard, this study presents a novel approach to use IT and tractability systems in the food supply chain, using application of RFID and central database.

Keywords: food supply chain, IT system, safety, SME

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Authors: Jonix Owino

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Aging Out of Place refers to the physical and emotional experience of growing older in a foreign or unfamiliar environment. Refugees flee their home countries and migrate to foreign countries such as the United States for safety. The emotional and psychological distress experienced by refugees who are compelled to leave their home countries can compromise their ability to adapt to new countries, thereby affecting their well-being. In particular, implications of immigration may be felt more acutely in later life stages, especially when life-long attachments have been made in the country of origin. However, aging studies in the United States have failed to conceptualize refugee aging experiences, more so for refugees who entered the country as adults. Specifically, little is known about the quality of life among aging refugees. Research studies on whether the quality of life varies among refugees by sociodemographic factors are limited. Research studies examining the role of social connectedness in aging refugees’ quality of life are also sparse. As such, the present study seeks to investigate the sociodemographic (i.e., age, sex, country of origin, and length of residence) and social connection factors associated with quality of life among aging refugees. The study consisted of a total of 108 participants from ages 50 years and above. The refugees represented in the study were from Bhutan, Burundi, and Somalia and were recruited from an upper Midwestern region of the United States. The participants completed an in-depth survey assessing social factors and well-being. Hierarchical regression was used for analysis. The results showed that females, older individuals, and refugees who were from Africa reported lower quality of life. Length of residence was not associated with quality of life. Furthermore, when controlling for sociodemographic factors, greater social integration was significantly associated with a higher quality of life, whereas lower loneliness was significantly associated with a higher quality of life. The results also indicated a significant interaction between loneliness and sex in predicting quality of life. This suggests that greater loneliness was associated with reduced quality of life for female refugees but not males. The present study highlights cultural variations within refugee groups which is important in determining how host communities can best support aging refugees’ well-being and develop social programs that can effectively cater to issues of aging among refugees.

Keywords: aging refugees, quality of life, social integration, migration and integration

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Authors: Eva Nedeliakova, Juraj Camaj, Jaroslav Masek

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This contribution is focused on the methodology for identifying levels of quality and improving quality through new logistics model in railway transport. It is oriented on the application of dynamic quality models, which represent an innovative method of evaluation quality services. Through this conception, time factor, expected, and perceived quality in each moment of the transportation process within logistics chain can be taken into account. Various models describe the improvement of the quality which emphases the time factor throughout the whole transportation logistics chain. Quality of services in railway transport can be determined by the existing level of service quality, by detecting the causes of dissatisfaction employees but also customers, to uncover strengths and weaknesses. This new logistics model is able to recognize critical processes in logistic chain. It includes service quality rating that must respect its specific properties, which are unrepeatability, impalpability, their use right at the time they are provided and particularly changeability, which is significant factor in the conditions of rail transport as well. These peculiarities influence the quality of service regarding the constantly increasing requirements and that result in new ways of finding progressive attitudes towards the service quality rating.

Keywords: logistics model, quality, railway transport

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Authors: Mehrnaz Mostafavi

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Nanoliposomes, minute lipid-based vesicles at the nano-scale, show promise in the realm of photothermal therapy (PTT). This study presents an extensive overview of nanoliposomes in PTT, exploring their distinct attributes and the significant progress in this therapeutic methodology. The research delves into the fundamental traits of nanoliposomes, emphasizing their adaptability, compatibility with biological systems, and their capacity to encapsulate diverse therapeutic substances. Specifically, it examines the integration of light-absorbing materials, like gold nanoparticles or organic dyes, into nanoliposomal formulations, enabling their efficacy as proficient agents for photothermal treatment Additionally, this paper elucidates the mechanisms involved in nanoliposome-mediated PTT, highlighting their capability to convert light energy into localized heat, facilitating the precise targeting of diseased cells or tissues. This precise regulation of light absorption and heat generation by nanoliposomes presents a non-invasive and precisely focused therapeutic approach, particularly in conditions like cancer. The study explores advancements in nanoliposomal formulations aimed at optimizing PTT outcomes. These advancements include strategies for improved stability, enhanced drug loading, and the targeted delivery of therapeutic agents to specific cells or tissues. Furthermore, the paper discusses multifunctional nanoliposomal systems, integrating imaging components or targeting elements for real-time monitoring and improved accuracy in PTT. Moreover, the review highlights recent preclinical and clinical trials showcasing the effectiveness and safety of nanoliposome-based PTT across various disease models. It also addresses challenges in clinical implementation, such as scalability, regulatory considerations, and long-term safety assessments. In conclusion, this paper underscores the substantial potential of nanoliposomes in advancing PTT as a promising therapeutic approach. Their distinctive characteristics, combined with their precise ability to convert light into heat, offer a tailored and efficient method for treating targeted diseases. The encouraging outcomes from preclinical studies pave the way for further exploration and potential clinical applications of nanoliposome-based PTT.

Keywords: nanoliposomes, photothermal therapy, light absorption, heat conversion, therapeutic agents, targeted delivery, cancer therapy

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Authors: Abeer Alhazmi

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Introduction: Clinical education is considered a significant part of the learning process for nurses and nursing students. However, recruiting high- caliber individuals to train them to be tomorrow’s educators/teachers has been a recurrent challenge. One of the troubling challenges in this field is the absent of proper training programmes to train educators to be future education professionals and leaders. Aim: To explore the impact of a stage 1 and stage 2 clinical instructor courses on developing leadership skills for nurses as educators.Theoretical Framework: Informed by a symbolic interactionist framework, this research explored the Impact of stage 1 and stage 2 clinical instructor courses on nurses' knowledge, attitudes, and leadership skills. Method: Using Glaserian grounded theory method the data were derived from 3 focus groups and 15 in-depth interviews with nurse educators/clinical instructors and nurses who attended stage 1 and stage 2 clinical instructor courses at King Abdu-Aziz University Hospital (KAUH). Findings: The findings of the research are represented in the core category exploring new identity as educator and its two constituent categories Accepting change, and constructing educator identity. The core and sub- categories were generated through a theoretical exploration of the development of educator’s identity throughout stage 1 and stage 2 clinical instructor courses. Conclusion: The social identity of the nurse educators was developed and changed during and after attending stage 1 and stage 2 clinical instructor courses. In light of an increased understanding of the development process of educators identity and role, the research presents implications and recommendations that may contribute to the development of nursing educators in general and in Saudi Arabia in specific.

Keywords: clinical instructor course, educators, identity work, clinical nursing

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Authors: Dries Dulsster

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This research we want to discuss the implications of the concept of ‘lalangue’ and illustrate its importance for lacanian psychoanalysis and its clinical practice. We will look at this concept through an in depth reading of Lacan’s later seminars, his lectures at the North-American universities and his study on James Joyce. We will illustrate the importance of this concept with a case study from a clinical practice. We will argue that the introduction of ‘lalangue’ has several theoretical and clinical implications that will radically change Lacans teachings. We will illustrate the distinction between language and lalangue. Language serves communication, but this is not the case with lalangue. We will claim that there is jouissance in language and will approach this by introducing the concept of ‘lalangue’. We will ask ourselves what the effect will be of this distinction and how we can use this in clinical practice. The concept of ‘lalangue’ will introduce a new way of thinking about the unconscious. It will force us to no longer view the unconscious as Symbolic, but as Imaginary or Real. Another implication will be the approach on the symptom, no longer approaching it as a formation of the unconscious. It will be renamed as ‘sinthome’, as function of the real. Last of all it will force us to rethink the lacanian interpretation and how we direct the treatment. The implications on a clinical level will be how we think about the lacanian interpretation and the direction of the treatment. We will no longer focus on language and meaning, but focus on jouissance and the ways in which the subject deals with this. We will illustrate this importance with a clinical case study. To summarize, the concept of lalangue forces us to radically rethink lacanian psychoanalysis, with major implications on a theoretical and clinical level. It introduces new concepts such as the real unconscious and the sinthome. It will also make us rethink the way we work as lacanian psychoanalysts.

Keywords: Lacan's later teaching, language, Lalangue, the unconscious

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Authors: L. R. Ferreira, R. Biscaro, C. C. Danziger, C. M. Galhardi, L. C. Biscaro, R. C. Biscaro, I. S. Vasconcelos, L. C. R. Ferreira, R. Reis, L. H. Oliveira

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Introduction: There is a worldwide trend for the employer to be aware of investing in health promotion that goes beyond occupational hygiene approaches with the implementation of a comprehensive program with integration between occupational health and safety, and social/psychosocial responsibility in the workplace. Work accommodation is a necessity in most companies as it allows the worker to return to its function respecting its physical limitations. This study had the objective to verify if the integration of health and safety in the companies, with the inclusion of the concept of TWH promoted by an occupational health service has impacted in the management of absenteeism of workers in work accommodation. Method: A retrospective and paired cohort study was used, in which the impact of the implementation of the Program for the Health/Safety Integration and Total Worker Health Concept (PHSITWHC) was evaluated using the indices of absenteeism, health attestations, days and hours of sick leave of workers that underwent job accommodation/rehabilitation. This was a cohort study and the data were collected from January to September of 2017, prior to the initiation of the integration program, and compared with the data obtained from January to September of 2018, after the implementation of the program. For the statistical analysis, the student's t-test was used, with statistically significant differences being made at p < 0.05. Results: The results showed a 35% reduction in the number of absenteeism rate in 2018 compared to the same period in 2017. There was also a significant reduction in the total numbers of days of attestations/absences (mean of 2,8) as well as days of attestations, absence and sick leaves (mean of 5,2) in 2018 data after the implementation of PHSITWHC compared to 2017 data, means of 4,3 and 25,1, respectively, prior to the program. Conclusion: It can be concluded that the inclusion of the PHSITWHC was associated with a reduction in the rate of absenteeism of workers that underwent job accommodation. It was observed that, once health and safety were approached and integrated with the inclusion of the TWH concept, it was possible to reduce absenteeism, and improve worker’s quality of life and wellness, and work accommodation management.

Keywords: absenteeism, health/safety integration, work accommodation management, total worker health

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Authors: Omar Said Almushyt

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Quality management, in all countries all over the world, has become recently necessary to face challenges among companies. Software companies in KSA suffer from two problems, namely, low customer satisfaction, and low product quality. Implementation of quality management for a software company can solve these problems, by improving the quality of products and enhancing customer satisfaction. This will lead the company to be competitive. Introducing quality management system onto system analysis followed by system design and finally implementing that system can achieve these goals. Results of the present work showed that the proposed method can increase both the product quality by 10 % and the customer satisfaction by 20 %.

Keywords: quality, management, software, information engineering

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Authors: Nick Woodier, Paul Sampson, Iain Moppett

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Background: For years, healthcare across the world has recognised that patients are coming to harm from the very processes meant to help them. In response, healthcare tells itself that it needs to ‘be more like aviation.’ Aviation safety is highly regarded by those in healthcare and is seen as an exemplar. Specifically, healthcare is keen to learn from how aviation uses near misses to make their industry safer. Healthcare is rife with near misses; however, there has been little progress addressing them, with most research having focused on reporting. Addressing the factors that contribute to near misses will potentially help reduce the number of significant, harm patientsafety incidents. While the healthcare literature states the need to learn from aviation’s use of near misses, there is nothing that describes how best to do this. The authors, as part of a larger study of near-miss management in healthcare, sought to learn from aviation to develop principles for how healthcare can identify, report, and learn from near misses to improve patient safety. Methods: A Grounded Theory (GT) methodology, augmented by a scoping review, was used. Data collection included interviews, field notes, and the literature. The review protocol is accessible online. The GT aimed to develop theories about how aviation, amongst other safety-critical industries, manages near misses. Results: Twelve aviation interviews contributed to the GT across passenger airlines, air traffic control, and bodies involved in policy, regulation, and investigation. The scoping review identified 83 articles across a range of safety-critical industries, but only seven focused on aviation. The GT identified that aviation interprets the term ‘near miss’ in different ways, commonly using it to specifically refer to near-miss air collisions, also known as Airproxes. Other types of near misses exist, such as health and safety, but the reporting of these and the safety climate associated with them is not as mature. Safety culture in aviation was regularly discussed, with evidence that culture varies depending on which part of the industry is being considered (e.g., civil vs. business aviation). Near misses are seen as just one part of an extensive safety management system, but processes to support their reporting and their analysis are not consistent. Their value alone is also questionable, with the challenge to long-held beliefs originating from the ‘common cause hypothesis.’ Conclusions: There is learning that healthcare can take from how parts of aviation manage and learn from near misses. For example, healthcare would benefit from a formal safety management system that currently does not exist. However, it may not be as simple as ‘healthcare should learn from aviation’ due to variation in safety maturity across the industry. Healthcare needs to clarify how to incorporate near misses into learning and whether allocating resources to them is of value; it was heard that catastrophes have led to greater improvements in safety in aviation.

Keywords: aviation safety, patient safety, near miss, safety management systems

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Authors: Susan Ka Yee Chow

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Effective clinical preceptorship is affecting students’ competence and fostering their growth in applying theoretical knowledge and skills in clinical settings. Any difference between the expected and actual learning experience will reduce nursing students’ interest in clinical practices and having a negative consequence with their clinical performance. This cross-sectional study is an attempt to compare the differences between preferred and actual preceptorship experience of final year nursing students, and to examine the relationship between the actual preceptorship experience and perceived clinical competence of the students in a tertiary institution. Participants of the study were final year bachelor nursing students of a self-financing tertiary institution in Hong Kong. The instruments used to measure the effectiveness of clinical preceptorship was developed by the participating institution. The scale consisted of five items in a 5-point likert scale. The questions including goals development, critical thinking, learning objectives, asking questions and providing feedback to students. The “Clinical Competence Questionnaire” by Liou & Cheng (2014) was used to examine students’ perceived clinical competences. The scale consisted of 47 items categorized into four domains, namely nursing professional behaviours; skill competence: general performance; skill competence: core nursing skills and skill competence: advanced nursing skills. There were 193 questionnaires returned with a response rate of 89%. The paired t-test was used to compare the differences between preferred and actual preceptorship experiences of students. The results showed significant differences (p<0.001) for the five questions. The mean for the preferred scores is higher than the actual scores resulting statistically significance. The maximum mean difference was accepted goal and the highest mean different was giving feedback. The Pearson Correlation Coefficient was used to examine the relationship. The results showed moderate correlations between nursing professional behaviours with asking questions and providing feedback. Providing useful feedback to students is having moderate correlations with all domains of the Clinical Competence Questionnaire (r=0.269 – 0.345). It is concluded that nursing students do not have a positive perception of the clinical preceptorship. Their perceptions are significantly different from their expected preceptorship. If students were given more opportunities to ask questions in a pedagogical atmosphere, their perceived clinical competence and learning outcomes could be improved as a result.

Keywords: clinical preceptor, clinical competence, clinical practicum, nursing students

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Authors: Diane Ghanem, Whitney Kagabo, Rebecca Engels, Uma Srikumaran, Babar Shafiq

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Hospitalist co-management of orthopaedic surgery patients is a growing trend across the country. It was created as a collaborative effort to provide overarching care to patients with the goal of improving their postoperative care and decreasing in-hospital medical complications. The aim of this project is to provide a guide for implementing and optimizing a hospitalist co-management service in orthopaedic surgery. Key leaders from the hospitalist team, orthopaedic team and quality, safety and service team were identified. Multiple meetings were convened to discuss the comanagement service and determine the necessary building blocks behind an efficient and well-designed co-management framework. After meticulous deliberation, a consensus was reached on the final service agreement and a written guide was drafted. Fundamental features of the service include the identification of service stakeholders and leaders, frequent consensus meetings, a well-defined framework, with goals, program metrics and unified commands, and a regular satisfaction assessment to update and improve the program. Identified pearls for co-managing orthopaedic surgery patients are standardization, timing, adequate patient selection, and two-way feedback between hospitalists and orthopaedic surgeons to optimize the protocols. Developing a service agreement is a constant work in progress, with meetings, discussions, revisions, and multiple piloting attempts before implementation. It is a partnership created to provide hospitals with a streamlined admission process where at-risk patients are identified early, and patient care is optimized regardless of the number or nature of medical comorbidities. A wellestablished hospitalist co-management service can increase patient care quality and safety, as well as health care value.

Keywords: co-management, hospitalist co-management, implementation, orthopaedic surgery, quality improvement

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Authors: Carmen J. Savelli, Romy Conzade

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Background: Access to sufficient amounts of safe and nutritious food is a basic human necessity, required to sustain life and promote good health. Food safety and food security are therefore inextricably linked, yet the importance of food safety in this relationship is often overlooked. Methodologies: A literature review and desk study were conducted to examine existing frameworks for discussing food security, especially from an international perspective, to determine the entry points for enhancing considerations for food safety in national and international policies. Major Findings: Food security is commonly understood as the state when all people at all times have physical, social and economic access to sufficient, safe and nutritious food to meet their dietary needs and food preferences for an active and healthy life. Conceptually, food security is built upon four pillars including food availability, access, utilization and stability. Within this framework, the safety of food is often wrongly assumed as a given. However, in places where food supplies are insufficient, coping mechanisms for food insecurity are primarily focused on access to food without considerations for ensuring safety. Under such conditions, hygiene and nutrition are often ignored as people shift to less nutritious diets and consume more potentially unsafe foods, in which chemical, microbiological, zoonotic and other hazards can pose serious, acute and chronic health risks. While food supplies might be safe and nutritious, if consumed in quantities insufficient to support normal growth, health and activity, the result is hunger and famine. Recent estimates indicate that at least 842 million people, or roughly one in eight, still suffer from chronic hunger. Even if people eat enough food that is safe, they will become malnourished if the food does not provide the proper amounts of micronutrients and/or macronutrients to meet daily nutritional requirements, resulting in under- or over-nutrition. Two billion people suffer from one or more micronutrient deficiencies and over half a billion adults are obese. Access to sufficient amounts of nutritious food is not enough. If food is unsafe, whether arising from poor quality supplies or inadequate treatment and preparation, it increases the risk of foodborne infections such as diarrhoea. 70% of diarrhoea episodes occurring annually in children under five are due to biologically contaminated food. Conclusions: An integrated approach is needed where food safety and nutrition are systematically introduced into mainstream food system policies and interventions worldwide in order to achieve health and development goals. A new framework, “Food for Health” is proposed to guide policy development and requires all three aspects of food security to be addressed in balance: sufficiency, nutrition and safety.

Keywords: food safety, food security, nutrition, policy

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Authors: Camilo Andrés Agudelo Vélez, Lina María Martínez Sánchez, Isabel Cristina Ortiz Trujillo, Evert Armando Jiménez Cotes, Natalia Perilla Hernández, María de los Ángeles Rodríguez Gázquez, Daniel Duque Restrepo, Felipe Hernández Restrepo, Dayana Andrea Quintero Moreno, Juan José Builes Gómez, Camilo Ruiz Mejía, Ana Lucia Arango Gómez

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Preeclampsia is a clinical complication during pregnancy with high incidence in Colombia; therefore, it is important to evaluate the influence of external conditions and medical interventions, in order to promote measures that encourage improvements in the quality of life. Objective: Determine clinical and sociodemographic variables in women with preeclampsia. Methods: This cross-sectional study enrolled 50 patients with the diagnosis of preeclampsia, from a private institution in Medellin, during 2015. We used the software SPSS ver.20 for statistical analysis. For the qualitative variables, we calculated the mean and standard deviation, while, for ordinal and nominal levels of quantitative variables, ratios were estimated. Results: The average age was 26.8±5.9 years. The predominant characteristics were socioeconomic stratum 2 (48%), students (55%), mixed race (46%) and middle school as level of education (38%). As for clinical features, 72% of the cases were mild preeclampsia, and 22% were severe forms. The most common clinical manifestations were edema (46%), headache (62%), and proteinuria (55%). As for the Gyneco-obstetric history, 8% reported previous episodes of this disease and it was the first pregnancy for 60% of the patients. Conclusions: Preeclampsia is a frequent condition in young women; on the other hand, headache and edema were the most common reasons for consultation, therefore, doctors need to be aware of these symptoms in pregnant women.

Keywords: pre-eclampsia, hypertension, pregnancy complications, pregnancy, abdominal, edema

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Authors: Mirad Böhm, Diede De Kok

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It goes without saying that for many NGOs a high level of safety and security are crucial issues, which often necessitates the support of military personnel to varying degrees. The relationship between military and NGO personnel is usually a difficult one and while there has been progress, clashes naturally still occur owing to different interpretations of mission objectives amongst many other challenges. NGOs tend to view safety and security as necessary steps towards their goal instead of fundamental pillars of their core ‘business’. The military perspective, however, considers them primary objectives; thus, frequently creating a different vision of how joint operations should be conducted. This paper will argue that internalizing safety and security into the NGO organizational culture is compelling in order to ensure a more effective cooperation with military partners and, ultimately, to achieve their goals. This can be accomplished through a change in perception of safety and security concepts as a fixed and major point on the everyday agenda. Nowadays, there are several training programmes on offer addressing such issues but they primarily focus on the individual level. True internalization of these concepts should reach further by encompassing a wide range of NGO activities, beginning with daily proceedings in office facilities far from conflict zones including logistical and administrative tasks such as budgeting, and leading all the way to actual and potentially hazardous missions in the field. In order to effectuate this change, a tool is required to help NGOs realize, firstly, how they perceive and define safety and security, and secondly, how they can adjust this perception to their benefit. The ‘safety culture ladder’ is a concept that suggests what organizations can and should do to advance their safety. While usually applied to private industrial scenarios, this work will present the concept as a useful instrument to visualize and facilitate the internalization process NGOs ought to go through. The ‘ladder’ allows them to become more aware of the level of their safety and security measures, and moreover, cautions them to take these measures proactively rather than reactively. This in turn will contribute to a rapprochement between military and NGO priority setting in regard to what constitutes a safe working environment.

Keywords: NGO-military cooperation, organisational culture, safety and security awareness, safety culture ladder

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